InsIde• Special Feature: Genomics and personalized Medicine

• Neoliberalism & Agriculture

• Performance-Enhancing drugs

Ivy Journal of EthIcs

Spring 2009Volume iX iSSue iiCornell uniVerSity

T he field of Bioethics is rapidly adapting to face new challenges posed by technology and society. One could argue the single greatest advance of the past decade has been the completion of the Human Genome Project in 2003. The goal of the project, to sequence and define over 24,000

genes of the human genome both physically and functionally, was an ambitious undertaking. As a result of this project, the field of genomics has been brought to the forefront of scientific research, medicine, and the media. Greater public interest into learning more about their ancestry and the susceptibility to disease has led to a number of private companies offering sequencing services to the public.

Although the initial Human Genome Project had cost billions of dollars in federal and private funding, bio-technology companies today are racing to offer the first $1000 genome to the public. As the availability of sequencing technology becomes more available to the general population, a number of ethical quandaries have emerged as to how to interpret and handle the information gathered from the sequencing. This tech-nology has the potential to identify adverse reactions to drugs or predisposition to certain pathologies. Unfortunately, this technology can be conceived as a double-edged sword. Along with the benefits of this knowledge, this information has the potential to be used to deny individuals health insurance, employ-ment, and equal standing in society.

This issue of the Ivy Journal of Ethics contains a special feature covering the topic of genomics and per-sonalized medicine from a multitude of perspectives and levels of analysis from students throughout the globe. In addition to the special feature, this issue contains a number of submissions covering a wide-range of topics in contemporary Bioethics. These subjects include: physician responsibilities when treat-ing AIDS patients, conscientious objection in the field of pharmacy, the potential of an open market for organs to satisfy the rising demand for donors, and the use of performance-enhancing drugs.

This past year has been a period of profound growth for the journal, receiving record levels of submis-sions from universities and colleges throughout the United States and the United Kingdom. My goal has been to make the journal a forum for undergraduate students to analyze, discuss, and debate, in an effort to raise awareness about important issues within the diverse field of Bioethics. I encourage any student with an interest in Biology, Medicine, Law, Philosophy, or Research to submit their work to our journal.

Finally, I would like to express my sincere gratitude to our editorial staff that has worked diligently and with great care to produce our current issue. Their determination to contact faculty, organizations, and departments among many institutions has been instrumental in generating the high quality submissions, which have been selected for this issue.

Jyoti DuggalBiological Sciences

College of Arts & SciencesCornell University ‘09

From the Editor

Jyoti Duggal

EDitor-in-ChiEf

ivy Journal of EthiCsEDitorial staff

Senior editor

Kevin K. Kumar

Subscriptions:This journal is published se-mesterly and is distributed free of charge. If you are in-terested in either a personal or institutional copy, please send your request to the ad-dress below. Also see the on-line edition of the Journal at:www.rso.cornell.edu/bsc

Submissions:The Ivy Journal of Ethics publishes original articles, reviews, and opinions per-taining to any and all ethical issues and concerns in con-temporary society. If you are interested in submitting your work, please contact the Jour-nal at: ethics@cornell.edu

Disclaimer:The Ivy Journal of Ethics con-tains viewpoints on ethical topics that are not necessarily representative of those held by the Bioethics Society of Cornell (BSC), the publisher. Authors are allowed to freely express their views as entities that are independent of the BSC.

Cover Design by Nikolay V. PLoS Computational Biology July 2006.Obtained under Creative Comments Attribution License.

Managing editorS

Janice Ye

ShaillY PraSad

Kiwoong Yoo

olivia Fecteau

charleS Jiao

JeSSica heimler

naina vohra

Copy editorS

madhu JaYaKumar

liuqing Yang

Sanchit guPta

Kavita BaBa

naomi drucKer

neha BodaPati

chriStine lee

FaCulty adviSor

dr. Kathleen vogel

Office of Undergraduate BiologyCornell University

Ethics & Public LifeCornell University

Student Assembly Finance CommissionCornell University

Michele Moody-AdamsVice Provost,Undergraduate EducationCornell University

Professor David J. SkortonPresident,Cornell University

Acknowledgements

We would like to thank the following faculty and organizations for their con-tinued support. Through your efforts and contributions, the Ivy Journal of Ethics has become one of the most well-received undergraduate publications in the nation. We hope to increase the impact of our publication at academic institutions, fostering discussion regarding contemporary issues in Bioethics.

The Prisoner Dis-Analogy as a Defense of Stem Cell 6Research on Spare EmbryosIlana Yurkiewicz, Yale University

Duty to Treat? AIDS and the Physician’s Responsibilities 12Benjamin Derman, Northwestern University

Conscientious Objections in the Field of Pharmacy 17Michael A. Goldsticker, Amherst College

An Examination of the Organ Market Debate: 21Should People Have the Right to Buy and Sell Organs?Alicia Chen, Brown University

IJE Special Feature 27Genomics & Personalized Medicine

A Scientific Expedition in Procreative Beneficence 56Justin D. Stahl, Johns Hopkins University

Social Context for Women’s Health: 60AIDS Prevention in South AfricaSarah Palmer, Cornell University

The Ethics of Performance-Enhancing Drugs and 67Gene Doping in SportsToni-Marie Hudson, Georgetown University

Agricultural Bioethics in a Neoliberal Society 72Yasaswi Paruchuri, University of Michigan

Table of Contents

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The Prisoner Dis-Analogy as a Defense of Stem Cell Research on Spare Embryos

Ilana YurkiewiczYale University

AbstrAct

Under the premise that an embryo is a full person, the argument against using spare IVF embryos for stem cell research is the prisoner analogy. Namely, the analogy contends that just as we may not ravage a prisoner on death row for his body parts, likewise we may not harvest the embryo for its stem cells simply because it is destined for destruction. This article illustrates that this comparison does not hold true, for an immoral ac-tion is committed against the prisoner as a result of certain characteristics present in the prisoner but absent from the embryo. In particular, three wrongs – infliction of suffering, imposition of double punishment, and violation of human dignity – are perpetrated against the prisoner, but do not apply in the case of the embryo. Therefore, the repudiation of the analogy implies that it is morally permissible to use spare IVF embryos for the purposes of stem cell research. Key Words: in vitro Fertilization, Stem Cell, Prisoner Analogy

Introduction

According to the notion of “ethics of compromise,” it is ac-ceptable to act in sinful ways in order to achieve a greater good, as long as certain absolutist standards are main-tained (Mendiola 2001). With regard to embryonic stem cell research, the destruction of the embryo is the sinful act, while the potential benefits (including understand-ing cell differentiation, testing drug efficacies, and pro-viding replacement tissues or organs without immune rejection) is the greater good. However, the clause “main-taining absolutist standards” implies that it is not suffi-cient to simply weigh the magnitude of the sin against that of the good and decide an outcome based on which we perceive as overriding. If the practice comprises an act regarded as an absolute wrong, then it is unjustifi-able under any circumstance, regardless of how great the good that may result. The deontological framework of moral decision-making, based on Kantian principles that every person must be treated as an end in itself, asserts that it is an absolute wrong to sacrifice one person in order to save another (Alexander et al. 2007). In most cases, the har-vesting of stem cells from an embryo requires the emb-

ryo’s destruction.1 The deontological framework thus reduces the embryonic stem cell debate to determining whether embryos are persons. That is, if an embryo is a complete person, on a moral par with all other persons, then its sacrificial destruction for research purposes con-stitutes an intrinsic, absolute wrong, making the practice immoral regardless of its benefits. However, the Kantian reasoning does not directly speak to how to treat those already sacrificed. As a re-sult, auxiliary moral proposals have arisen to address the guidelines for determining ethical action under these circumstances. One such proposal is the “nothing is lost” principle, defined by Paul Ramsey, which states it is ac-ceptable to take an innocent human life if two conditions are met (1961): 1) the subject’s death is inevitable, and 2) other innocent human lives will be saved as a result. Gene Outka applies this principle to justify stem cell research on spare embryos from in vitro fertilization (IVF) procedures (2002). As a result of low success rates, multiple embryos are created per round of IVF, resulting in several spares that are never implanted. Unless the parents express other wishes, these embryos are discard-

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ed. Thus, the application of the “nothing is lost” defense goes as follows: even if the embryo is a life, its certain de-struction means that no harm is done in expediting this certainty in order to reap the potential benefits that stem cell research may provide. However, the opposing viewpoint maintains that one wrong does not justify another. Just because an inno-cent embryo was (wrongly) sentenced to death does not mean that we may inflict further wrongs upon it. Implicit in this argument, however, is the notion that harvesting an embryo for its stem cells is indeed a wrong. What is the basis for this claim? The position is backed by analogy; specifically, the prisoner comparison points out that a criminal on death row cannot be ravaged for his body parts simply because his death is impending. As the United States Conference of Catholic Bishops asserts, “the idea of experimenting on human beings because they may die anyway poses a grave threat to convicted prisoners, terminally ill pa-tients, and others” (2008). This stance is not strictly a religious one; Howell alleges that “this mentality is con-sistent with Nazi medicine. Taken to its logical conclu-sion, prisoners on death row… and others destined to die or be cast away from society could and should be used for experimentation in the name of furthering research to save others” (2002). Thus, under the premise that an embryo is a human life, the argument against stem cell research on spare IVF embryos is analogous. However, in order for the analogy to stand, we must examine the rationale of why it is considered a wrong to take the body parts of a prisoner before his unavoidable death. This article pro-poses three reasons for this belief: namely, infliction of suffering, double punishment, and violation of human dignity. Each reason is examined independently to prove that it can be refuted when the embryo is the subject. That is to say, taking biological materials is not an uncon-ditional immorality, but only constitutes an immorality when the subject possesses certain prerequisite traits. Thus, we must reject the legitimacy of the analogy as an argumentative tool. As harvesting stem cells from em-bryos fated for destruction does not entail an absolute wrong, the implication is that we may use ethics of com-promise to justify the utilization of these embryos in the worthy pursuit of research.

Basis of the Full Personhood Premise

The moral status of the embryo has long been and re-mains the subject of contentious debate. Some try to

identify a distinct point at which life beings, such as conception, the formation of the primitive streak, or capacity for viability. Others assert that personhood is a gradient and life develops in degrees (Perring 1997). Still others acknowledge the debate but be-lieve it is irrelevant in the context of making ethical decisions. As Krauthammer posits, “Either you be-lieve it [the personhood of the embryo] or you don’t. The discussion ends there.” (2002). This debate proceeds under the premise that embryos are complete human beings. There are two reasons for this proposal. First, the personhood of the embryo – and for that matter, the personhood of any phase of human development – is indeterminate and can be likened to the Sorites Paradox. In this paradox, we consider a heap as having a distinct identity, and we know it is composed of grains of wheat. However, one grain is not considered a heap, nor is two, nor is three, and thus following this logic it would seem no amount of grain would make a heap – which we know to be false (Hyde 1997). Similarly, we have a clear image of a person, but there is no distinct point at which the cells comprising it stop becoming “just cells” and become the person. As a human life is such a significant, worthy entity, we must err on the side of not violating it; as such, we should treat the em-bryo, at the moment of conception (analogous to the first grain in the heap) as a person for the purposes of moral decision-making. However, a comprehensive analysis of the in-determinacy principle with regard to the embryo is beyond the scope of this paper, which leads to the second, more practical reason of why it is useful to debate under the full personhood premise. That is: even irrespective of one’s stance on the moral status of the embryo, if we can show that stem cell research on spare embryos is justifiable under the most con-servative viewpoint, then clearly the practice is justi-fiable under all viewpoints.

The Prisoner Analogy

The existence of IVF as an established and legally permissible practice results in the creation of thou-sands of extra embryos whose fate is destruction. Re-gardless of one’s belief on the morality of this fact, these conditions are the reality, and we must there-fore make subsequent decisions operating within this reality.2 Under the full personhood assumption, the argument against using spare embryos for stem cell

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research is analogous to a prisoner on death row. Both instinctive revulsion and legal precedent assert that it is wrong to use the prisoner for his body parts, even for the noblest research purposes. How-ever, in order for the analogy to hold, we must ex-amine the basis for the assertion in order to resolve whether a comparable wrong is committed against the embryo. This article sets forth three primary rea-sons for the above assertion, each of which will be examined to determine if the logic applies in the case of the embryo as well.

Suffering

The suffering a person may experience can fall un-der two categories: physical pain and mental anguish. The former is a direct result of the biology of a com-plete nervous system, encompassing pain receptors, nerve pathways to transmit the signals from the sen-sors, and a brain that converts the signals into feel-ings of pain. While some state laws require physi-cians to inform women considering abortions that fetuses can feel pain at twenty weeks (Grady 2005), the exact time remains a matter of debate. The most conservative figures state that pain perception is pos-sible at seven and a half weeks when reflex responses begin (Humphrey 1964). Other research, however, draws a distinction between reflex response and con-scious awareness of pain, with the latter developing at around twenty-six weeks when structures known as thalamocortical fibers penetrate the cortical plate (Mrzljak et al. 1988, Derbyshire 2006). Still, the de-bate is over the point at which a fetus can process pain; it is a scientifically established, uncontroversial fact that the early embryo in the first few weeks of development is devoid of the necessary sensory com-ponents required to experience pain. It requires no sophisticated argument to show that the infliction of physical pain on prisoners is mor-ally problematic; however, this alone is not sufficient reason to defend the immorality of taking limbs, as we could easily imagine a situation in which the prisoner were given an anesthetic numbing his sensation. In this scenario, however, the prisoner remains capable of suffering via mental anguish. Humans possess not only consciousness, but self-consciousness, referring to an awareness of one’s own mental states – “know-ing that one knows” (Eccles 1982). Unlike other an-imals, people do not simply feel pain, but interpret and experience it as “my pain” (Lewis 1940, Pence

2008). It is not difficult to imagine that an awareness of being harvested for limbs – having one’s body used by another as if it were an object unattached to a liv-ing, emotionally invested owner – would bring about psychological distress in a prisoner. And yet, as con-sciousness develops at around twenty-six weeks af-ter conception, self-consciousness certainly cannot develop before that. Thus, the notion of suffering – encompassing both physical pain and mental anguish – as a ratio-nale for the immorality of ravaging a prisoner for his limbs does not hold for the embryo, as the latter is biologically incapable of either experience.

Double Punishment

The idea of double punishment says this: the prison-er’s punishment was the death sentence, so it is there-fore unjust to condemn him to an additional penalty with no additional reasons to warrant it. However, this argument is based on the premise that having limbs removed is, in fact, punishment. Yet why is this so? The definition of punishment insists that an individual is subjected to treatment that causes phys-ical pain or emotional distress. Thus, punishment is inextricably linked to reason one, the notion of suffer-ing. Cutting off a prisoner’s limbs is only punishment in the sense that it causes the subject to undergo an unpleasant experience. If the embryo is incapable of such an experience, we can deduce that harvesting its stem cells is not actually a second “punishment” at all.

Human Dignity

Within the “nothing is lost” framework, and based solely on the reasons elucidated, we can imagine the prisoner instead as a coma patient on her deathbed. Supposing it could be proven, beyond any doubt, that the patient could experience neither physical pain nor psychologi-cal torment, then the previous two reasons against her sacrifice would be invalidated, meaning we could justifi-ably take her limbs if the research prospects were sub-stantially auspicious in their potential to save others. However, the idea of ravaging the coma patient for her body parts seems like a proposal that would abhor us, one that we would immediately reject just as we would in the prisoner example. What is the basis for this instinc-tive revulsion? Is there something beyond the notions of

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suffering and punishment that protects a person’s right to remain intact before an inevitable death? And if there is, does it apply to the embryo as well? An explanation for these questions requires us to invoke the concept of “human dignity.” The notion of human dignity is one much cited, yet often weakly defined, in a range of bioethical debates, including abortion, cloning, human-animal hybridism, assisted suicide, and offspring selection. In the context of the stem cell debate, Pope Benedict XVI declared that embryonic stem cell research has “shattered” human dignity (Pullella 2008). Leon Kass, former chair of the President’s Council on Bioethics, advocates for the pro-tection of the “dignity of nascent human life, threatened by treating embryonic human beings as mere raw ma-terial for exploitation and use in research” (2008). The phrase has even made its way into legislation. For exam-ple, the United Nations Universal Declaration of Human Rights states that all individuals have it (1948), and the United Nations Declaration on Cloning prohibits genetic engineering procedures that act contrary to it (2005). So what is dignity? Kant proposed that the world could be divided into two categories: entities with a price, and entities with a dignity, meaning that the latter im-plies inherent worth not subject to measurement by ap-praisal (1785). The Judeo-Christian viewpoint similarly contends that dignity is synonymous with innate value (Cole-Turner 1999, Novak 1998). Kass defends dignity as belonging to something “elevated” that is “deserving of respect,” pointing to the existence of the soul as central to the dignity of humans (2008). If embryos are considered humans, then, is it self-evident that they are automatically worthy of “hu-man dignity”? In order to answer this question, it would be useful to first address two fundamental questions. First: what is the basis for human dignity? That is, why do humans have it and, say, chairs do not? Second: how is dignity obtained? As Peters asks, is it “intrinsic or con-ferred?” (2001). In terms of the first question, one notion is that human dignity is based on the sum of factors that dis-tinguish people from animals, namely reasoning, moral-ity, language, appreciation, religious beliefs, and love of beauty (Fukuyama 2003). The Kantian conception of human dignity points to rationality as its foundation, in that this quality equips individuals to behave as moral agents (Hill 1992). Similarly, others point to character-istics such as “emotions, language, sociality” as the basis for dignity (Hill 2004). Religious arguments, particularly Judeo-Christian ones, contend that human dignity stems

from “Imago Dei,” or being created by God, in His Image, so that people may relate to other people and ultimately to Him (Soulen et al. 2006, Peters 2001, Resnik 2007). Nuances aside, every definition of human dignity shares one focal idea: all, in one way or another, encapsulate the idea that humans have an effect on others. As essence of humanity is our ability to relate to one another, to share ideas, thought, and emotions, and to use reasoned thought to treat one another and the world in a moral way. This answer segues directly into the second ques-tion of how dignity is obtained. As dignity is character-ized by how humans treat, influence, and interact with others, it is, as Peters suggests, “not simply inborn, [but] rather, it is the fruit of a relationship, a continuing, loving relationship…. Phenomenologically dignity is relational” (2001). Human dignity is fostered in individuals as they are both influenced by others and in turn exert influence on others. It is a product of our social world. It makes no sense to speak of an innate dignity that humans would have if, in some hypothetical realm, they passed their ex-istences as standalone entities, completely independent of one another. Dignity only exists because of our inter-personal reality. Thus, perhaps answering the intrinsic versus conferred question is a matter of semantics. The two are not necessarily mutually exclusive. Indeed, dignity is intrinsic – meaning it is present in all individuals – but only because it is conferred, either from one person to another or from a divine Creator to a person. That is, people have an innate dignity, but not arbitrarily so. By intrinsic, we mean that it is universally granted – not that there is no rhyme or reason behind its being granted. We can now attempt to address the question at hand, which is: do embryos – if considered complete per-sons – have human dignity? It has already been argued that dignity is not arbitrarily conferred; rather, it is exis-tent only because of certain characteristics that humans possess as a direct result of living in a social climate. As a result, even if the embryo is human, it does not follow that it is naturally endowed with this perhaps incorrectly named “human dignity,” for the concept is defined only within our relational world – a world that the embryo is not part of. This claim – that something human does not au-tomatically possess dignity – is perhaps an unsavory one to recognize. We invoke the idea of universal human dig-nity precisely to prevent potential abuses in which indi-viduals with unfortunate traits, such as the poor or weak or disabled, are viewed as less worthy than any other in-

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dividuals. And yet, we need not worry, as the definition of “human dignity” outlined thus far does not change this protection. The existence of universal human dignity in living people in our living environment is not denied; rather, this proposal of human dignity simply asserts that this environment is a prerequisite for its realization. If the appropriate social context is not defined, then neither can the foundationally social conception exist within it. Let us bring back the idea of the coma patient; however, let us now perform a thought experiment, imagining that the individual was never able to think or feel, never achieved self-awareness, and was somehow technologically created without relatives, never coming in contact with another human, such that she had abso-lutely zero inter-relational effect on the world. Does this being have that “innate dignity” that all others humans have? She is, in essence, missing every quality that we have identified as comprising human dignity. Still, we may be loath to answer this question in the negative, but perhaps only because it is so difficult to separate the thought-experiment patient from the real patient – the one with a home and family, the one lying in a hospital bed under physician care, the one who – by mere virtue of being alive – has made some impact, good or bad, on her fellow human beings. Yet, if the thought-experiment coma patient could exist, it follows that such a being would not have human dignity because then this qual-ity would be arbitrarily conferred, disconnected from the domain in which we have delineated it. Likewise, the spare embryo from IVF has not forged an identity, has not affected other individuals, and has made no mark on the world. Here is where the embryo is fundamentally different from a prisoner, from a terminally ill patient, and from the coma patient. By virtue of having lived already, the latter individuals have made some impact – large or small, positive or negative – in the social world, and thereby have obtained human dignity. The embryo has not.

Conclusion

Under the most conservative viewpoint that an em-bryo is a complete human being, the rationale against using destruction-bound embryos from IVF for stem cell research is the prisoner analogy. This discussion rejects the analogy: spare embryos harvested for stem cells do not undergo additional punishment because they lack the ability to suffer, and they do not possess a dignity capable of being violated because they have not influenced other beings in a social world. Thus,

the reasons we deem it immoral to ravage a prisoner for his limbs only hold as a result of specific traits that the prisoner has but the embryo lacks. As this analogy – the reason behind opposition to stem cell research on spare embryos – does not stand, we must therefore conclude that it is morally acceptable to use spare IVF embryos for the purposes of stem cell re-search.

Endnotes

1 In January 2008, a peer-reviewed paper announced that it had created five embryonic stem cell lines without the destruction of embryos. The research-ers removed single cells from embryos and then cul-tured the cells in environments optimally engineered to maximize growth and development (Chung et al. 2008). While this development provides promise that perhaps embryonic stem cell research may even-tually proceed without the controversial embryo de-struction, significant additional testing is needed to confirm the procedure’s safety and efficacy. More-over, even if the new procedure is shown successful, the issue of embryonic destruction to harvest stem cells remains unlikely to escape public consciousness anytime soon simply because of the abundance of spare embryos created each year as a result of IVF.

2 The creation of spare embryos for IVF could be claimed to constitute a wrong because: 1) the proce-dure entails a higher than normal risk of producing deformities, meaning that the embryos may be con-sidered subjects of an experimentation of sorts; 2) it is known that the majority of embryos will never come to fruition, meaning embryos are created with their foreseen destruction. On the other hand, even those who believe embryos are human life may still contend the procedure is justifiable in that each em-bryo is created with the intent of becoming a child, an end in itself, so that any embryo loss is comparable to embryo loss occurring in natural procreation (Presi-dent’s Council, 2002). Still, as IVF is an accepted practice and will likely remain so, our position on the morality of the practice is irrelevant in the context of the embryonic stem cell debate. We are not deciding whether the embryos should have been created in the first place; we are deciding how to proceed with the spare ones already in existence.

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References

Alexander A, Moore M. Deontological Ethics. In: Zalta EN, editor. The Stanford Encyclopedia of Philosophy (Fall 2008 Edition) [Internet]; 2007. [cited 2008 Dec 5]. Available from: <http://plato.stanford.edu/entries/ethics- deontological/>.Chung Y, Klimanskaya I, Becker S, Li T, Maserati M, Lu SJ, et al. (2008). Human Embryonic Stem Cell Lines Generated without Embryo Destruction. Cell Stem Cell. 2(2): 113-117.Cole-Turner R. (1999). Cloning humans from the perspective of the Christian churches. Science and Engineering Ethics. 5(1): 33–46.Derbyshire SWG. (2006). Can fetuses feel pain? British Medical Journal. 332: 909-912.Eccles JC. (1982). Animal consciousness and human self-consciousness. Expe- rientia. 38(12): 1384-91. Fukuyama F. (2003). Our posthuman future. New York (NY): Picador. 148-181.Grady D. (2005). Report Finds Fetuses Feel Pain Later Than Thought. The New York Times [Internet]. [cited 2008 Dec 5]. Available from: <http:// www.nytimes.com/2005/08/23/health/23cnd-fetus.html>.Hill T. (1992) Dignity and practical reason in Kant’s moral theory. Ithaca (NY): Cornell University Press.Hill T. (2004). The philosophy of the good life. Lewiston (NY): The Edwin Mellen Press. Howell KJ. (2002). Nobel Laureates’ Letter to President Bush Contains Misinformation and Omissions. Do No Harm: The Coalition of Americans for Research Ethics Press Release [Internet]. [cited 2008 Dec 5]. Available from: <http://www.stemcellresearch.org/facts/laureates.htm>.Humphrey T. (1964). Some correlations between the appearance of fetal reflexes and the development of the nervous system. Progress in Brain Research. 4: 93-135.Hyde D. Sorites Paradox. In: Zalta EN, editor. The Stanford Encyclopedia of Philosophy (Fall 2008 Edition) [Internet]; 1997. [cited 2008 Dec 5]. Avail- able from: <http://plato.stanford.edu/archives/fall2008/entries/sorites- paradox>.Kant I. (1981) [1785]. Groundwork of the Metaphysic of Morals. In: Ellington J, translator. Indianapolis (IN): Hackett Publishing Company, Indianapolis. 1-73.Kass LR. (2008). Defending Human Dignity. In: Human Dignity and Bioethics: Essays Commissioned by the President’s Council on Bioethics. Washington, D.C.: The President’s Council on Bioethics. 297-331.Krauthammer C. (2002). Crossing Lines; A secular argument against research cloning. The New Republic. 226(16): 20-23.Lewis CS. (1940). The Problem of Pain: How Human Suffering Raises Almost Intolerable Intellectual Problems. New York (NY): Macmillan. 131-133.Mendiola MM. (2001). Human Embryonic Stem Cells: Possible Approaches from a Catholic Perspective. In: Holland S, Lebacqz K, Zoloth L, editors. Hu- man Embryonic Stem Cell Debate. Cambridge (MA): MIT Press. 119-125.Mrzljak L, Uylings HBM, Kostovic I, van Eden CG. (1988). Prenatal develop- ment of neurons in prefrontal cortex: a qualitative Golgi study. Journal of Comparative Neurology. 271(3): 355-386.Novak M. (1998). The Judeo-Christian foundation of human dignity, personal liberty, and the concept of the person. The Journal of Markets and Morality [Internet]. [cited 2008 Dec 5]; 1(2): 107-121. Available from: <http:// www.acton.org/publications/mandm/publicat_m_and_m_1998_oct_novak. php>.Outka G. (2002). The ethics of human stem cell research. Kennedy Institute of Ethics Journal. 12(2): 175-213. Pence GE. (2008). Classic Cases in Medical Ethics. 5th ed. New York (NY): McGraw-Hill. 1-447.Perring C. (1997). Degrees of personhood. Journal of Medicine and Philoso- phy. 22(2): 173-197.Peters T. (2001). Embryonic Stem Cells and the Theology of Dignity. In: Hol- land S, Lebacqz K, Zoloth L, editors. Human Embryonic Stem Cell Debate. Cambridge (MA): MIT Press. 127-139.President’s Council on Bioethics. (2002). Human Cloning and Human Dignity: The Report of the President’s Council on Bioethics. Washington, D.C.: The President’s Council on Bioethics. Repr. New York: Public Affairs. 1-245.

Pullella P. (2008). Pope says some science shatters human dignity. Reuters [Internet]. [cited 2008 Dec 5]. Available from: <http://www.reuters.com/ article/scienceNews/idUSL3189220620080131>.Ramsey P. (1961). War and the Christian Conscience: How Shall Modern War Be Conducted Justly? Durham (NC): Duke University Press.Resnik DB. (2007). Embryonic Stem Cell Patents and Human Dignity. Health Care Analysis. 15(3): 211–222.Soulen RK, & Woodhead L. (2006). God and Human Dignity. Grand Rapids (MI), Cambridge (UK): William B. Eerdmans. 1-27.United Nations General Assembly. (1948). Universal Declaration of Human Rights, G.A. res. 217A (III), U.N. Doc A/810 at 71.United Nations General Assembly. (2005). General Assembly Adopts United Nations Declaration on Human Cloning by Vote of 84-34-37. Fifty-Ninth General Assembly Press Release. [cited 2008 Dec 5]. Available from: <http://www.un.org/News/Press/docs/2005/ga10333.doc.htm>.USCCB Secretariat of Pro-Life Activities. (2008). Stem Cell Research and Hu- man Cloning: Questions and Answers. Washington, DC: United States Con- ference of Catholic Bishops. [cited 2008 Dec 5]. Available from: <http:// www.usccb.org/prolife/stemcellQ&A.pdf>.

Ilana Yurkiewicz is a junior at Yale University majoring in Molecular, Cellular and Developmental Biology. She re-searches in a neurogenetics laboratory and is Editor-in-Chief of the Yale Scientific Magazine. In addition to stem cell ethics, her academic interests include gene therapy and neuroethics. She hopes to attend medical school.

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Duty to Treat? AIDS and the Physician’s Responsibilities

Benjamin Derman Northwestern University

AbstrAct

Ethical discussions concerning physician-patient relationships have been largely focused on the paternalistic attitudes of physicians. Many of these conflicts arise from physicians who deem it necessary to procedures which contradict the wishes of their patients. The recent AIDS epidemic has brought an entirely new ethical dilemma to the attention of physicians and medical ethicists that shifts the focus towards the other end of the spectrum: the right of the physician to refuse treatment to HIV patients. The unique nature of HIV is the source of many negative connotations, a great deal of misunderstanding, and apprehension on the part of both physi-cians and the rest of the society. But how does this translate within a medical context?

Key Words: HIV/AIDS, Physician Risk, Code of Ethics

Introduction

The American Medical Association (AMA), along with the several other ethicists, take the position that physicians do have an obligation to treat HIV patients, but one can contend that the virtue-based approach used by the AMA and company does not rest on solid foundation. As pro-fessor John Arras of Northwestern University asks, “Must [physicians] subject themselves to the very small, but nonetheless terrifying, risk of becoming infected them-selves [with HIV] in order to live up to the ethical de-mands of their calling?” (Arras 1988). A physician does not have a duty to treat a patient with HIV, but there must be a plausible reason for denying treatment, such as a le-gitimate possibility that the physician will contract the deadly virus.

History of Responsibilities During Epidemics

The first recorded account of health policy in modern history occurred in Italian cities during the Black Death epidemics that recurred frequently for the three centu-ries following the year 1348 (Fox 1988). Physicians at the time (called “plague doctors”) were offered large sums of money to treat those that fell ill, but even then many were still unwilling to provide treatment for fear of

contracting the deadly illness. Daniel Fox comically told of how the physicians of the day would have surgeons shout out from an open window what the conditions of the patients were, and the physicians would shout back directions to the surgeons as to how to proceed. Largely, there was no general sense of professional conscious-ness or ethics that guided these physicians––they were primarily driven by “economic interest or, more broad-ly, fear of a loss of stature” (Fox 1988). Throughout the 18th and 19th centuries in the United States, repeated epidemics of cholera and yellow fever were often met with fear by most physicians and those who did treat pa-tients did so for economic advantages. During the Yellow Fever epidemic of 1853 in New Orleans, Fox described how several doctors came into town seeking fame and fortune as news got out about the spread of the disease. Nevertheless, there is evidence that suggests that some physicians did feel a sense of obligation to treat patients during an epidemic. When Yellow Fever struck Philadelphia in 1793, Dr. Benjamin Rush wrote to his wife “if he were to become ill, it would be as much [her] duty not to desert him in that situation, as it is [his] not to desert [his] patients” (Huber & Wynia 2004).

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Dangers in Treating HIV Positive Patients

Human Immunodeficiency Virus (HIV) is a condition that causes the immune system to fail, leading to life-threat-ening infections. Infection with HIV occurs through the transfer of bodily fluids such as blood, semen, vaginal fluids, and breast milk. The majority of HIV transmis-sions occur via sexual contact, when sexual secretions from one partner come into contact with the other’s gen-itals. Assuming that physicians are not typically engag-ing in sexual relations with their patients, transmissions through the blood is what serves as the primary concern for physicians. Physicians are at a risk (the level of which is de-bated) of becoming infected with HIV when operating on individuals who are HIV positive, as surgeries often involve contact between the patient and the physician’s bodies. John Arras writes that the risk of transmission usually involves needle-stick accidents and blood splash-ing during operations (Arras 1988). Though the level of risk is considered to be moderate if the proper precau-tions are taken, it is still significant. Indeed, there have been several incidences of health care workers who have acquired HIV due to occupational exposure. In addition, surgeons and obstetricians are at an even greater risk than most physicians or other health care workers due to their heightened exposure to high quantities of blood.

History of the AMA Guidelines

The 1847 AMA Code of Ethics was the first widely accept-ed ethics code for physicians, covering the vast realms of physician-patient, physician-physician, and physi-cian-public relations. Written originally by Isaac Hays and John Bell, the code presented and recognized oc-cupational risk, served as an organized body that repre-sented the entire profession, and was made aware to the public––three features that were essential for physicians to be able to accept a duty to treat, according to Huber and Wynia (p. W7). The 1912 version of the AMA Code of Ethics explicitly addressed the issue of the obligation to treat: “When an epidemic prevails, a physician must continue his labors for the alleviation of suffering people, without regard to the risk to his own health or to finan-cial return” (p. W7). However, the 1912 version was later revised in 1958 and again in 2001 to protect the professional au-tonomy of physicians: “A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with who to associate, and

the environment in which to provide medical care” (Clark 2005). This principle appeared to protect the physician’s autonomy in all cases except in ill-defined, nebulous cas-es of emergencies. While the matter seemed to be at rest, the arrival of the Human Immunodeficiency Virus (HIV) epidemic in the 1980s led to a whole new discussion re-garding the obligation to treat. The AMA shyly stated in 1986 that “treating HIV-positive patients was required only if the physician was ‘emotionally able’ to do so” (Hu-ber & Wynia 2004). Widely disparaged for its shaky con-clusion, the AMA revised its ambiguous stance again one year later, which is still its current position:

Our AMA believes that a physician may not ethi-cally refuse to treat a patient whose condition is within the physician’s current realm of compe-tence solely because the patient is HIV seroposi-tive. Persons who are seropositive should not be subjected to discrimination based on fear or prejudice. Physicians who are unable to provide the services required by HIV-infected patients should make referrals to those physicians or fa-cilities equipped to provide such services. It is in the best interest of the patient for the physician to focus on treatment of the disease, rather than on making value judgments about how the dis-ease was contracted (AMA 2007).

Problems with AMA Guidelines

The AMA has taken a position that might be described as a “virtue-based approach” towards the physician’s duty to treat. The professional virtue concept states that there are “certain characters and role-specific duties of a good physician” (Arras 1988). The AMA essentially claims that physicians must treat patients with AIDS, regardless of the health risks involved, because ‘good physicians’ have voluntarily committed themselves to the end of healing. In other words, those who refuse to treat “lack the virtue necessary for accomplishing the most fundamental goal of medicine” and should consequently not be physicians (Arras 1988). But how is the physician’s duty to be defined? While the physician has taken on the responsibility to treat his patients, he also has a personal duty to protect his life and livelihood. The physician might easily claim that there is no binding obligation because the duties to himself and to his family outweigh the duties to his patient. The prioritization of these duties is, in essence, subjective. Arras (1988) pointed out that most doctors

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no longer “share the traditional vision of the good” and that “in its place, they wish to substitute something dif-ferent…like the idea of medicine as a career” There has also been considerable criticism of the AMA’s ambiguous teetering between autonomy rights and societal obligations in the AMA Code (Clark 2005). The physician’s autonomy principle and his duty to treat HIV patients seem to directly contradict each other. Clark (2005) writes, “the question thus is whether physicians should be ethically bound to subordinate their autonomy rights when faced with the threat of an acute public med-ical need” (p. 68). While it may be logical to conclude that a physician’s societal obligations can override au-tonomy rights in cases of emergency, that does not mean that the physician has an obligation to assist at his or her own peril under normal circumstances. Professor Norman Daniels of Harvard University, who argues for a duty to treat, even acknowledges prob-lems with the AMA position. Daniels writes that the re-fusal to treat HIV patients is more about self-protection than it is about “invidious discrimination,” yet he believes that the AMA statement “implies, without argument, that categorically refusing to treat HIV-positive patients is in-vidious discrimination” (Daniels 1991). As Daniel claims, the avoidance of unwarranted risk significantly differs from discrimination.

Legal Responsibilities of Physicians

The refusal of physicians to treat AIDS patients has been met with differing opinions from an ethical perspective, but what does the law have to say about the physician’s duty to treat? American common law is based on the no-tion that no citizen owes anything to any other citizen. Professor Annas of Boston University (1988) notes that, in the absence of a prior agreement, common law states that the physician can discriminate among patients on the basis of any criteria provided that there is no prior consensual patient-physician relationship. However, courts over the years have limited the scope of physi-cians’ autonomy by levying upon physicians the obli-gation to treat patients in the case of emergencies, and prohibiting physicians from discriminating against race, religion, or ethnicity. Nevertheless, the emergency treat-ment rule has limited application to the treatment of pa-tients who are HIV positive; most HIV positive patients do not require urgent medical attention. If a prior doctor-patient relationship has been initiated, and the physician determines or discovers that the patient is HIV positive after this initiation, the doc-

tor cannot abandon or refuse to treat that patient with-out reasonable notice (Annas 1988). If the relationship has not been initiated, however, there is not sufficient evidence that a physician’s refusal to treat an HIV posi-tive patient constitutes discrimination from a legal as-pect, because of the aforementioned potential dangers and risks. Annas correctly identified the fact that, “HIV-infected individuals would have a more compelling legal claim of access to care if antidiscrimination statutes in each state clearly included them in the category of handi-capped individuals,” which would include accommoda-tions such as in hospitals and dental offices (p. 8).

‘Fear and Loathing’ and the Refusal to Treat

Though the risks involved in treating a patient may be ample enough to justify a physician’s refusal to treat, there are other valid (and invalid) reasons that physicians do so as well. HIV carries with itself many connotations, conjuring up certain behaviors to mind such as homo-sexuality or IV drug usage. Some physicians may refuse to treat due to a deep sense of homophobia, causing a profound stigmatization surrounding AIDS patients. Other physicians may also feel that their services would be of better use on patients that were not using/abusing recreational drugs, and where there was no risk of infection of an ultimately fatal disease. Green and Platt (1997) performed a study to investigate the “fear and loathing” in health care settings reported by people with HIV. It was concluded that the stigma accompanying HIV/AIDS was indeed due to the virus’s infectivity and its association with societal deviance. It was also found that as health professionals have become more familiar with treating HIV patients, the related stigma has notice-ably declined. The results suggest that if physicians were obligated to treat AIDS patients, perhaps the “fear and loathing” experienced would drastically decrease.

Arguments for Refusal to Treat

Norman Daniels’s main argument was that since physi-cians have consented to a standard of risk (albeit vaguely defined) when they entered the medical profession, if the situation (i.e. HIV) falls under that standard of risk, then the physician has a duty to treat even at his own personal risk. However, Daniels conceded that “We must believe that there are some limits, however vaguely specified, to the risks physicians have agreed to face” (Daniels 1991). Daniels insisted, though, that in most instances, the risk

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of contracting HIV does not exceed the standard level of risk of infection (p. 4). The metaphor of the physician’s obligations as a lifeguard’s duty to protect swimmers is one well crafted by Chalmers (2005) in his discussion of the duty to treat and serves as an apt counterargument to Daniels. The lifeguard carries a greater responsibility for the safety of a swimmer than the rest of the beachgoers, just as a phy-sician shoulders a greater obligation to care for the ill or injured than does the average citizen. If the lifeguard is to be excused from his or her life-saving expectations if a drowning victim is, for example, “caught in a strong cur-rent that plunges precipitously over a lofty cliff”, surely the physician is also to be excused from his or her normal duty to treat if the risk is overwhelming. Certainly, this level of risk of infection is subjec-tive. For some physicians, the risk of infection may seem to be simply too overwhelming. Daniels claimed that health care workers are at no greater hazard than society as a whole, and attempted to establish a sort of univer-sal level of risk by providing various statistics that imply a low aggregate risk of HIV transmission to health care workers. Daniels wrote, “physicians learn to distinguish standard risks from exceptional risks through medical education, clinical training, and observation of the role models who surround them in various institutions” (p. 9). But these learning environments are not identical for all physicians, nor might they even be so within the same learning environment. However, in this logic Daniels cre-ated a uniform level of potential peril for all physicians, which certainly deprives physicians of their basic right of autonomy. Freedman (1988) makes the same point regard-ing the AMA’s position as well: “medicine has relied upon oaths and statements of principle attributed to exemplars of practice….these statements were chosen for their ex-cellence rather than a supposed representative quality.” He contends that only recently have ethical statements (such as those made by the AMA and Daniels) been draft-ed for the sake of uniformity; doing so is an “aberration in the history of professional ethics” (Freedman 1988).

Conclusions and Proposals

In regards to the physician’s duty to treat AIDS patients, Loewy (1986) writes, “We (physicians) have a choice—we can contribute further to society’s decay by evading our contract in pursuit of comfort, or we may contribute to a renaissance of society by salvaging that which seems

valuable.” While I have supplied the basis for why phy-sicians do not in fact have a duty to treat patients who are HIV positive, I find Loewy’s black-and-white distinc-tion to be an aptly-stated modification (not counterar-gument) to the position that a physician may refuse to treat. Sheldon (1990) explains that Loewy is expressing the “notion that physicians by participating humanely in a patient’s care, can contribute towards making soci-ety itself more humane and responsive to human need.” Sheldon appears to make the argument that the physi-cian has no obligation to treat HIV patients, but that the physician should still take an active interest and should have an emotional and professional stake in the well be-ing of those patients. Though I partially concur with Sheldon’s point, I would extend it to argue that although there is no duty to treat, there should be a sense of admiration and re-spect reserved for those physicians that voluntarily treat patients with AIDS. In addition, the absence of a duty to treat should not serve as justification for physicians to become neglectful or overly hesitant in their duties as healers. Chalmers (2005) writes that all physicians should meet a standard of “minimal decency” that is de-fined by the consensus of the medical community. Though this ”minimal decency” is vaguely de-fined, it appears that any medical education coupled with a sense of socially-accepted morality would allow any physician to possess a concept of what defines it. More-over, physicians that refuse to treat HIV patients should be held accountable for their actions––that is, the opera-tion being performed by the physician must pose a suf-ficient risk of infection to themselves. A bloodless opera-tion, as a more basic example, surely does not constitute a sufficient risk of infection. While the institution of incentives (which has been suggested by various authorities in the fields of medicine and ethics) might serve as an impetus for phy-sicians to treat patients with AIDS, this idea is likely to face a great deal of opposition from multiple sources. Rather, I propose the creation of a comprehensive data-base of physicians who have explicitly expressed a will-ingness to treat patients with HIV/AIDS. In this manner, the “fear and loathing” experienced by patients can easily be avoided, as they will not have to confront health care workers that do not wish to treat them. In a way, the physicians who treat these patients will be rewarded financially by increasing their business with more patients. By providing a means for appropri-ate treatment, and by preserving the emotional security and dignity of HIV positive patients, physicians along

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with the rest of the medical community ultimately ful-fill their prime goal as healers of the human body and spirit.

References

AMA. (2007). H-20.908 Medical Care of HIV-Infected Patients. Code of Ethics. Annas GJ. (1988). Legal risks and responsibilities of physicians in the AIDS epidemic. The Hastings Center Report. 18.n2 (April-May 1988).Arras JD. (1988). The fragile web of responsibility: aids and the duty to treat. The Hastings Center Report. 18.n2 (April-May 1988).Clark C. (2005). In harm’s way: AMA physicians and the duty to treat. Journal of Medicine & Philosophy. 30(1): 65-87.Daniels N. (1991). Duty to treat or right to refuse? The Hastings Center Report. 21(2): 36.Fox DM. (1988). The politics of physicians’ responsibility in epidemics: a note on history. The Hastings Center Report. 18.n2 (April-May 1988).Freedman B. (1988). Health professions, codes, and the right to refuse to treat HIV-infectious patients. The Hastings Center Report. 18.n2 (April- May 1988).Green G & Platt S. (1997). Fear and loathing in health care settings reported by people with HIV. Sociology of Health & Illness. 19(1): 70-92.Huber SJ & Wynia MK. (2004). When pestilence prevails: physician responsi- bilities in epidemics. American Journal of Bioethics. 4(1): 5-11.Loewy EH. (1986). AIDS and the physician’s fear of contagion. Chest. 89(3): 325-326.NIH. (1995). The relationship between the Human Immunodeficiency Virus and the Acquired Immunodeficiency Syndrome. 1-64.Pear R. (1987, November 13). AMA rules that doctors are obligated to treat AIDS. The New York Times. A14. Sheldon M. (1990). HIV and the obligation to treat. Theoretical Medicine. 2(3): 201-212.

Benjamin Derman is currently in his third year at North-western University, as part of a seven-year dual BA/MD program. He will be graduating at the end of the year, and plans to begin studying at Northwestern’s Feinberg School of Medicine next fall.

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Background

In the wake of Roe v. Wade, 45 states passed “conscience clauses” in an attempt to balance a physician’s consci-entious objection to abortion with a patient’s right to non-discriminatory access to services. This balance is accomplished through a referral (Charo 2005). In recent years, there has been an attempt to extend these con-science clauses to a wider range of morally questionable services. Many health care professionals have claimed a right to refrain from other services such as teenage birth control without parental consent, terminal sedation, and the use of vaccines developed from aborted fetuses (Charo 2005). This conflict is especially prevalent in the pharmaceutical field as seen in the constant debate over pharmacists’ responsibility for filling drugs needed in emergency contraception. In states like Texas, Wisconsin, and Illinois, pharmacists were disciplined for not filling a rape victim’s emergency contraception prescription (Ev-ans 2007). Should pharmacists have a right to refuse to fill the “morning after pill” as a conscientious objector?

A Pharmacist’s Right

How can we as a society force pro-life pharmacists to do

something that they believe to be an act of murder? In-disputably, the “morning after pill” is a form of abortion when it destroys a conceived egg. In the minds of all pro-life advocates, abortion is murder, or the unjustified kill-ing of another person. Thus, pro-life pharmacists believe that in taking an emergency contraception prescription, one could potentially be ending an innocent life. There-fore, on conscientious grounds a pharmacist will not fill a prescription that would in essence commit what he be-lieves to be murder. It is important to recognize that the pharmacist’s decision is not a form of paternalism. Julian Savulescu describes, in his paper “Conscientious Objection in Medi-cine,” his view of paternalism:

Doctors have always given a special place to their own values in the delivery of health care. They have always had greater knowledge of the effects of medical treatment, and this fostered a belief that they should decide which treatments are appropriate for patients—that is, paternal-ism. (Savulescu 2006).

Conscientious Objectionsin the field of Pharmacy

Michael A. GoldstickerAmherst College

AbstrAct

Doctors and other medical professionals are the medium between a patient and his or her needed care. How-ever, what do we do in situations where either the doctor or another health care professional morally objects to the patient’s desired treatment? On one hand, we often believe that a person should not be forced to engage in behavior that he or she deems morally unacceptable. Yet, at the same time it seems unjust to deny one a legally entitled treatment because her medical professional has moral qualms towards it. This dilemma can be seen as a conflict between two primary ideals at the heart of the Hippocratic Oath: doing no harm and keeping the patients’ interest first. We then must ask ourselves: What is the role for conscientious objections of profes-sionals in the field of medical care?

Key Words: Pharmacist Objections, Emergency Contraceptives, Patient Freedom

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Paternalism is a decision by the doctor on behalf of what he or she believes to be best for the patient; the pharma-cist is unable to commit to what he believes to be an im-moral action. In other words, paternalism focuses upon the good of the patient but the pharmacist is focusing upon himself. One might try to argue against conscientious ob-jections in issuing drugs for emergency contraception by showing the distinction between performing an actual abortion and giving one the means to do so. This same view is applied in order to distinguish euthanasia and physician assisted suicide. It is often argued that “it is permissible, at least in some cases, to withhold treatment and allow a patient to die, but it is never permissible to take any direct action designed to kill the patient.” By analogy, a pharmacist would not have to compromise her morals by giving the prescription since she is not direct-ly causing the cessation of a pregnancy. The pregnancy would only end upon the ingestion of the pills—an action from which the pharmacist is entirely removed. However, this distinction has little, if any, moral significance. One common bumper sticker supporting the National Rifle Association is “Gun’s don’t kill people, people kill people.” Yet, even though people kill people, one needs a gun to do so. Let us imagine the guns sales-man who sells a gun, knowing it will immediately be used to kill an innocent victim. The buyer walks in the store, tells the salesman he needs a gun to shoot the first per-son he sees. The salesman sells the gun to the buyer, the buyer walks out, and shoots the first person he sees as he previously pledged. Although the salesman might not be as morally reprehensible as the gunman, he is still liable to some extent. Thus, the pharmacist who believes to be directly providing the means to kill an innocent child must still hold himself morally liable, even if he is not di-rectly involved in the ingestion of the pills. One might also argue that a pharmacist is never required to do anything; he or she has the option of leav-ing the field. Imagine a vegan who desperately needs work. He applies and is hired at a meat packing plant. Should the vegan be allowed to stay, get paid, and not work on the grounds of conscientious refusal? Obviously not. We would say that he should have refrained from ap-plying for this job in the first place knowing that it would require activities he deems morally objectionable. Con-scientious refusal is similar to any other inability to fulfill a job. Imagine a construction worker who becomes old and has arthritis, which prevents him from fulfilling the required manual labor of the job. Although unfortunate, it is not unjust to fire him because he cannot reasonably

satisfy the duties that his job requires. In an ideal world, practicing pharmacists would not conscientiously object to the job’s requirements; however, having them leave the field of medicine (will-fully or through firing) does not seem to be a desirable option. The field of pharmaceuticals includes multiple medications that are objected to by more than just pro-life pharmacists who conscientiously object to emergen-cy contraception:

Many pharmacists also have strong feelings about dispensing drugs used for assisted suicide, euthanasia, and capital punishment, and ethical questions regarding the dispensing of erectile dysfunction drugs for convicted sex offenders and HIV-positive patients. (Evans 2007).

If we enacted a policy such that those “who compromise the delivery of medical services on conscience grounds must be punished through removal of license to practice and other legal mechanisms”, then the pharmaceutical profession would most likely become seriously depleted of qualified pharmacists (Savulescu 2006). It would also have to be understood by pharma-ceutical students, trainees, and individuals potentially interested in practicing within the field of pharmacy that if they are not prepared and committed to offer every le-gal drug on the market, they should not practice within this field (Savulescu 2006). This would further reduce the already depleted number of qualified practicing pharmacists. Finally, as technology continues to develop, it seems that the quantity of morally questionable drugs is only going to increase. This will in turn increase the need for a better strategy than firing to deal with con-scientious objections. From a consequentialist perspec-tive, this proposed policy would be bad for pro-life and pro-choice advocates. Therefore, forcing pharmacists to leave is not an optimal method of addressing conscien-tious objectors. Another argument against the right of conscien-tious refusal states that citizens do not have the right to override a law, even if they disagree with it. A pharma-cist does not possess the right to refuse to fill a prescrip-tion on the grounds of his own personal code of morality. Rather it is the government who decides what policies are legal and illegal. For instance, when a K-Mart pharmacist in Wisconsin refused to fill an emergency contraception prescription, a judge ruled that he “violated Wisconsin law by deviating from the standard of care ordinarily exercised by his profession” (Evans 2007). It is not the

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role of the medical professional to place his private views above those of the public sphere. Savulescu takes this argument one step further. He argues that without uniform law regarding health care, the effects could be disastrous. As Savulescu writes:

…values and conscience have different roles in public and private life. They should influence discussion on what kind of health system to de-liver. But they should not influence the care an individual doctor offers to his or her patient. The door to “value driven-medicine” is a door to a Pandora’s Box of idiosyncratic, bigoted, dis-criminatory medicine. Public servants must act in the public interest, not their own.

In the form of a slippery slope, Savulescu predicts that if a doctor’s care is influenced by a personal code of moral-ity, then the patient’s care would be negatively affected. For instance, a racist pharmacist should not be allowed to choose to fill or not fill prescriptions based on his per-sonal views towards skin color. Thus, in order to prevent this discrimination, doctors should be bound by govern-ment policy rather than their own private views. However, why should the public policy of a cur-rent regime override a higher ordered code of morality? There are numerous historical examples of government policy, where we commended those individuals who refused to act on moral grounds. For instance, during World War II the Vichy regime mandated that many of its doctors perform morally reprehensible actions includ-ing, but not limited to, eugenic “research” and psychiat-ric “treatment” of dissidents (Smith 2006). Looking back on that horrific time, one can hope that many doctors rejected Savulescu and had the courage to stand up for their moral convictions by breaking with the policy of the Nazi government. This would only be the case if doctors “felt part of an independent medical profession with alle-giance to something higher and more enduring than the regime of that day” (Smith 2006).

A Pharmacist’s Duty

Despite these arguments in favor of conscientious objec-tions, it can be argued that a practicing pharmacist must be able to ensure that his or her patients have fair access to all legal drugs in order to fulfill the standard of care re-quired in the field of pharmacy. Furthermore, providing this appropriate standard of care is the core requirement of a pharmaceutical job. If one is not able to meet the

job’s core requirement (that is, offering fair access to all legal drugs), then as in all other professions, that person should quit or be fired. Medical and government organizations create the policies that dictate to pharmacist which drugs they are legally obligated to provide citizens. As previously stated, one might argue that in offering fair access to all legal drugs, a pharmacist simply follows the policy of constantly changing organizations rather a higher moral code. Yet, in allowing patients to have fair access to all legal drugs pharmacists are, in fact, swearing “allegiance to something higher and more enduring than the regime of that day”—a respect for patient autonomy. One tenet of all medical fields is respect for the patient’s intrinsic right to self-determination. As autonomous beings, we possess the positive right to choose which treatment op-tion we believe to be best for our health. By preventing a patient from receiving her desired treatment, the phar-macist is violating the patient’s right to choose which treatment option she and the physician believe to be best. From a consequentialist perspective, without a federal law mandating the fill of all prescriptions, the ad-verse affects to patients’ autonomy outweigh the gains of the conscientiously objecting pharmacists. A woman and her doctor, when deciding which drug is most ap-propriate for a given circumstance, are operating under the assumption that she has access to all legal drugs. However, if we allowed a pharmacist to pick and choose which drugs were acceptable according to his own moral codes, this assumption would be incorrect. A loss of self determination would result because patients could not reasonably determine which option of treatment they desired if they did not know what the pharmacist would be willing to fill. Specifically in the case of emergency contracep-tion, since time is of the essence, the pharmacist must be obligated to give you the drug. A woman does not al-ways have the luxury of going to another location if the first pharmacist conscientiously objects. Such a scenario could occur in rural areas where there is only one phar-macy for the entire county or in cities where travel may be difficult due to weather and geography. For example, when the K-Mart pharmacist in Wisconsin refused to fill an emergency contraception prescription, the rape vic-tim was forced to get a surgical abortion since she didn’t receive the contraception in time (Charo 2005). In many circumstances, the patient would be at the whim of the pharmacist if conscientious objections were allowed. But what if the previously described fear that

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mandating pharmacists to provide access to all legal drugs would deplete the number of practicing profes-sionals in the field of pharmacy? Many pharmacists ob-ject to a variety of drugs and prescribing particular drugs in certain situations, e.g. Viagra for registered sex offend-ers. How do we prevent all pharmacists who have an ob-jection to some drug or circumstance from leaving the field? And how do we recruit future pharmacists when extremely controversial drugs continue to emerge? A second objection to mandating fair and equal access to all treatments within the pharmaceutical field is the implication for other areas of medical practice. Let us discuss this view as applied to obstetrics and gynecol-ogy, specifically in the case of female genital mutilation. If asked to do so, should an obstetrician/gynecologist (OB-GYN) be required to reinfibulate (the process of reseal-ing the vagina after childbirth) a woman assuming it is a legal procedure? Arguably, if a pharmacist is required to provide all legal prescriptions, an OBGYN should be re-quired to offer all legal procedures as well. However, we certainly cannot mandate this procedure by doctors. Through “identifying alternative mutual agree-able strategies” we can arrive at a solution to the previous two objections (Jecker et al. 1995). For instance, through cooperation the pharmaceutical network can collectively satisfy patients’ needs and desires without violating in-dividuals’ personal principles. This is what R. Alta Chars describes as a “collective obligation.” She writes

Accepting a collective obligation does not mean that all members of the profession are forced to violate their own consciences. It does, however, necessitate ensuring that a genuine system for counseling and referring patients is in place, so that every patient can act according to his or her own conscience just as readily as the profes-sional can (Charo 2005).

Therefore, a pharmacist could reconcile the pro-vider and patient goals by working shifts with another pharmacist who does not share his objections. As another option, a pharmacist could avoid the problem altogether by specializing in a specific field of pharmacy that doesn’t require filling emergency contraception prescriptions. Although there will always be cases under such a stan-dard of care where a pharmacist has no other alternative other than to fill the prescription himself, such a network can drastically minimize the occurrence of such a situa-tion. What we can learn from the field of pharmacy

is that patients are always at an inherent disadvantage. Medical professionals have the means to help a patient obtain what the patient believes to be the best possible treatment. The patients’ right to this legal treatment trumps medical professionals’ conscientious objections towards it because of the patient’s substantial right to self determination. Therefore, if medical professionals cannot themselves provide the desired legal treatment due to conscientious objections, they must find an alter-nate means of doing so or leave the field.

References

Charo A. (2005). The Celestial Fire of Conscience—Refusing to Deliver Medical Care. The New England Journal of Medicine. 352: 2471.Curlin F. (2007). Interview. Day to Day. National Public Radio. 12 Feb. Evans E. (2007). Conscientious Objections: A pharmacist’s right or professional negligence? American Journal of Health-System Phar- macy. 64: 139.Jecker N, Carrese J, Pearlman R. (1995). Caring for Patients in Cross Cultural Settings. The Hastings Center Report. 25: 7.Savulescu J. (2006). Conscientious Objections in Medicine. British Medi- cal Journal. 332: 295. Smith VP. (2006). Conscientious objection in medicine. Letter to the editor. British Medical Journal. 332: 425.

Michael Goldsticker is currently a senior at Amherst Col-lege, majoring in Philosophy. He is writing his thesis on Dissociative Identity Disorder, personal identity, and moral responsibility. After graduation, he plans to attend law school.

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An Examination of the Organ Market Debate: Should People Have the Right to Buy and Sell Organs?

Alicia ChenBrown University

AbstrAct

There are significant problems with the current organ transplantation system, specifically the gap in supply and demand and the difficulty in regulating this donation-driven system. Possible solutions include creating a regulated market in the United States where people have the right to buy and sell organs, which is a topic of debate regarding the ethics of such a system. Through analysis of the validity of the commodification argu-ment, the potential exploitative impact of an organ market on the poor, the concept of indirect altruism with philanthropy, and the strength of the “repugnance” factor can be explored. One can conclude that it is ethically sound for people to buy and sell organs and that implementing an organ market in the United States should be seriously considered. Organs are already commodified in a donation-driven system, preventing the poor from receiving payment for their efforts does them no favors, and in many cases organs sold through indirect altruism, or any other personal motivation, is not instrumentally or morally inferior to one given with philan-thropic intent. Though most of the information and analysis of this paper directly concerns kidneys because it is the organ in the greatest demand, the ethical principles discussed pertain to all life-sustaining organs for transplant.

Key Words: Organ Donors, Organ Commodification, Altruism

American Organ Transplantation System

According to the Organ Procurement and Transplan-tation Network (OPTN) there are 82,797 people in the United States on the waitlist for a kidney transplant as of November 21, 2008 (OPTN 2008). People suffering from chronic kidney disease (CKD), which is caused by a variety of factors like diabetes and high blood pres-sures, need a kidney transplant or dialysis. A kidney per-forms the essential function of filtering waste and regu-lating other critical bodily functions such as regulating blood pressure and volume (National Kidney Foundation 2008). A transplant is usually preferred over dialysis be-cause a patient has a better chance of regaining a normal life with a transplant. Transplants from live donors are also preferable to those from cadavers. More than 3,500 Americans die each year waiting for a new kidney and the World Health Organization estimates that only one

in ten people who need a kidney in the world ever receive one (Dubner et al. 2006, The Economist 2008). Clearly, there is a problem: the demand for organs is far outstrip-ping supply. There are several factors that account for the supply-and-demand gap. First, transplant operations have generally become safer and more effective, increas-ing demand. Surgeons are achieving better surgical out-comes and more effective immunosuppressants been developed since the first kidney transplant decades ago (Capron 2001). A wider variety of organs can also be transplanted now, increasing the total number of people who qualify for transplants. Second, general lifestyle changes, like indulging a richer diet and a more seden-tary lifestyle, have increased the number of Americans suffering from hypertension and obesity. These health

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problems in turn lead to a greater chance of diabetes-related kidney failure, which requires a transplant or dialysis. Third, on the supply side, the number of traffic fatalities has decreased in most Western countries, re-ducing the flow of organs from one usual avenue of do-nation. Fourth, media reports about malpractice in the healthcare and the funeral industry may have discour-aged more people from donating (The Economist 2008). Finally, most economists agree that the incentives for a person, particularly a potential live donor, to decide to give a kidney in today’s donation-driven system are sim-ply not powerful enough. This incentive problem is due to a specific federal policy decision that can be more easily reversed than the other factors contributing to the sup-ply and demand gap, which derive from more momen-tous and far-reaching technological and lifestyle trends. Some suggest abolishing the National Organ Transplant Act’s ban on selling and buying organs and then creating an organ market in which donors can receive monetary payment for their services.

United Network for Organ Sharing (UNOS)

Passed in 1984, the National Organ Transplant Act (NOTA) established the basic infrastructure of the Amer-ican organ transplant system. NOTA created a Task Force on Organ Transplantation to make recommendations about establishing equitable access to and allocation of organs and an Organ Procurement and Transplantation Network (OPTN) to keep up a national organ matching registry. In contract with the US Department of Health and Human Services since 1986, the United Network of Organ Sharing (UNOS) is the non-profit organization that administers the OPTN and enforces the NOTA guidelines for Organ Procurement Organizations (OPOS) (Childress 2001). NOTA explicitly prohibited any monetary com-pensation to donors beyond that for “expenses of travel, housing, and lost wages” and forwarded the principle that people can only give organs out of the spirit of phi-lanthropy, either by bequeathing their organs for do-nation upon death or agreeing to become a live donor (National Organ Transplant Act 1984). In 2006, the In-stitute of Medicine published a report “Organ Donation: Opportunities for Action” that, despite its title, does not discuss any drastic changes to the current system. A pa-tient’s ranking on UNOS’s organ waitlist is determined by a variety of factors, like need, probable success, and wait-ing time (Childress 2001). If a donor wishes to give his organs to a specific recipient, then that person can jump

ahead of the line. There has been significant criticism of UNOS in the past few years. In 2006, the Los Angeles Times pub-lished a blistering investigation detailing the transplant monitor’s weaknesses in oversight and enforcement. The paper reported that:

[UNOS has] a daunting job. The competition for scarce organs is growing. And because the stakes are so high—life or death for patients, prestige and millions of dollars for hospitals—the temp-tations for transplant centers to bend or break the rules are ever-present (Ornstein 2006).

It is difficult for UNOS to fulfill its responsibilities as a regulator. In fact, UNOS has never recommended that an active transplant program be closed despite high death rates or any other serious problems and rarely enforces penalties for transplant centers that do not follow guide-lines. For example, though UNOS had known since 1999 that Temple University Medical Center in Philadelphia was routinely exaggerating its patients’ level of sickness so that they would unfairly jump ahead in the waitlist, UNOS merely put the center on confidential probation in 2002 rather than revoking the hospital’s transplant standing. In 2001 when UNOS found that the Children’s Hospital of Wisconsin’s pediatric lung transplant pro-gram was performing too few surgeries and had a high death rate, the regulator finally acted in 2005, putting the program on confidential probation. For UNOS critics, the main problem lies in its very nature: it is a member or-ganization comprised mostly of doctors. Dr. John J. Fung, the director of the Cleveland Clinic’s transplant center, is quoted by the Times reflecting, “UNOS really can’t police itself. Everybody is beholden” (Ornstein 2006). Coupled with the scarcity in organ supply, these UNOS controversies have many clamoring for a change in the way organs are procured and allocated. Various solu-tions have been proposed, like adopting Europe’s opt-out system or expanding the New England Program for Kid-ney Exchange, but this paper will focus on the proposal that has garnered the most debate and criticism: creating an organ market.

Benefits of an Organ Market

A regulated organ market, a system in which people have the power to legally buy and sell organs, has the potential to eliminate the organ supply-and-demand gap. In Iran,

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where a government agency pays living donors for a one of their kidneys, the waiting list has been basically elimi-nated (The Economist 2008). Economics Nobel Laureate Gary Becker and Julio Jorges Elias estimated that:

Monetary incentives would increase the supply of organs for transplant [in the United States] sufficiently to eliminate the very large queues in organ markets, and the suffering and deaths of many of those waiting, without increasing the total cost of transplant surgery by more than 12% (Becker et al. 2007).

More people will become organ transplant recipients and live a longer and better life; they will no longer have to spend years on dialysis painfully waiting for a trans-plant. In 2005, the United States spent $21 billion—more than 6% of Medicare’s total budget— on kidney dialysis; by reducing the wait time the government can poten-tially save a significant amount of money (The Economist 2008). A regulated market system could also increase the transparency of a now painfully baffling process. Every-one could potentially benefit: more people in need will receive organs, donors will earn a much-needed influx of money, and society could save money overall. From a strictly utilitarian perspective, there will be a greater amount of total happiness.

Organ Commodification

Yet, despite all of these benefits, people seem to instinc-tively recoil at the thought of selling organs. However, as bioethicist Janet Radcliffe-Richards points out, “If we are to deny treatment to the suffering and dying we need better reasons than our own feelings of disgust” (Rac-liffe-Richards 1998). Thus, to arrive at a reasonable con-clusion about the subject both sides of the debate sur-rounding the ethics of buying and selling organs must be analyzed. It is important to note the difference between the narrow and broad definitions of commodification in terms of the debate about organ sales. Under the narrow definition, it is merely the social practice of buying or selling something. Under the broad definition, commodi-fication, or the commodifying attitude, is not just the practice of buying or selling, but the mindset of interpret-ing interactions as simply sales transactions (Wilkinson 2001). For example, under the broad definition, the hu-man body would be regarded solely as a resource. Most objectors of organ sales find fault with the implementa-

tion of an organ market based on this broader definition of commodification. They fear that if an organ is purchasable, organs will become viewed as market commodities (Wilkinson 2001). This worry is echoed by many prominent health organizations, including the National Kidney Foundation (Israel Medical Association Journal 2004). Many religions, like Christianity and Islam, have also expressed their dis-taste of selling organs (Delmonico et al. 2002). By thus commodifying organs through a market, the logic goes, the inherent dignity of the individual is undermined. Bio-ethicist Stephen Wilkinson puts such commodification arguments into the following logical form:

1. Permitting the buying and selling of X (a class of entities: e.g. body parts) causes people to commodify (in the ‘attitude’ sense) X.2. Such commodification of X is bad and/or wrong3. This badness and/or wrongness is sufficient to justify prohibiting the buying and selling of X4. Therefore: prohibiting the buying and sell-ing of X is justified (Racliffe-Richards 1998)

Organ market proponents raise some notable counterpoints to this argument. To address the first claim, they contend that under the current system of or-gan transplantation, organs are already viewed as com-modities. A donated or purchased organ has all three of the qualities that compose the commodifying attitude which organ market objectors find so detestable: denial of subjectivity, instrumentality and fungibility (Racliffe-Richards 1998). Since organ transplantation uses organs only for their instrumental value in performing a necessary bodi-ly function, it is far removed from the personal attributes of the individual who gave it regardless of whether it was donated or sold. Tellingly, Dr. James Childress, the vice-chair of the federal Task Force on Organ Transplantation, testified before the Senate that “donated organs should be viewed as scarce public resources” (Childress 2001). In Childress’s choice to refer to organs as “resources” his diction suggests that he sees organs as commodities. Thus, it is unlikely that selling organs will dramatically change our perception of them. The second part of the objectors’ contention must also be addressed: whether or not commodifying the body will undermine the dignity of and respect for the individual. In other words, by commodifying the body of

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the donor, will society also commodify the unique indi-vidual owner of that body? Wilkinson contends that it is incorrect to assume that body commodification will inev-itably lead to person commodification. As long as people understand that the person is conscious, has both non-instrumental and instrumental value, and is unique and therefore non-fungible, the slippery slope to the com-modification of the individual will not necessarily result. People are capable of making this distinction. For exam-ple, if a man holds some sort of manual construction job, then society is reaping the rewards of his instrumental value. In this aspect, he is a human resource. However, people are still able to see him as an individual. If they did not, then the problems of commodification would in-volve not just organ transplants, gifted or sold, but the whole of human labor (Racliffe-Richards 1998). Becker also brings up several interesting points. He notes that it is already acceptable to commodify body parts for money for certain other uses. For example, a woman may serve as a surrogate for another and women and men can donate eggs or sperm to provide the pos-sibility for a family of having child if the family cannot biologically (Becker et al. 2007). Selling one’s organs to someone who cannot naturally sustain their own life fol-lows the compelling moral logic. Upon review of both sides of the argument, it ap-pears clear that one of the major arguments against sell-ing organs does not have a firm foundation. Organs are already viewed as commodities under today’s system so suggesting that a market will cause commodification is baseless. The logical form of the commodification argu-ment breaks down due to the assumption of the first con-tention; buying and selling organs does not necessarily cause people to hold a commodifying attitude towards people. The distinction between body and person com-modification can be made. Thus, all of the steps following do not form a valid justification for banning organ sales.

Effect on the Poor Critics assert that implementing an organ market would be tantamount to becoming a society that approves of the self-sacrifice of impoverished individuals desperate for money. A group of prominent objectors, including Dr. Francis Delmonico, the vice-president of the Board of Directors of UNOS, wrote in the New England Journal of Medicine:

The fundamental truths of our society, of life and liberty, are values that should not have a mon-

etary price. These values are degraded when a poor person feels compelled to risk death for the sole purpose of obtaining monetary payment for a body part (Delmonico et al. 2002).

In the World Health Organization’s latest draft of its “Guiding Principles” for transplants, it includes the idea of a worldwide ban on organ trading because it fears that making it legal will exploit the poor and encourage more human trafficking (Dubner et al. 2008). These concerns do not hold up to an examination of the evidence. A recent study by Harvard researchers published in the International Journal of Health Services throws doubt on the assumption that the poor will be ex-ploited more in a legal organ market than they are now. It was found that under the current donation-based sys-tem “lack of insurance was a stronger predictor of organ donation than was any demographic factor (other than age) or hospital characteristic.” Compared with other hospitalized patients, organ donors were much more likely to be uninsured. In fact, while 16.9% organ donors were uninsured, only 0.8% of transplant recipients were uninsured (Herring et al. 2008). Given that most of the uninsured are relatively poor, this study illustrates that that the poor suffer under the current system of organ transplantation as well. Since it is evident that the un-insured donate a significant number of organs, a system where organ sale is legal may actually benefit them be-cause then they would receive just compensation. It seems distinctly unfair that everyone involved in an organ transplant benefits in some way except for the organ donor in the current system. As Freakonomics’ authors Stephen Levitt and Stephen Dubner wrote in a recent New York Time Magazine column:

Consider the parties who stand to profit from this transaction: Recipient, certainly, as well as the transplant surgeons, the nurses, the hospi-tal, the drug companies. Everyone will be paid in some form—except for the donor. […] Surely there are some people, and not just economists, who would find this situation—well, repugnant (Dubner et al. 2008).

Radcliffe-Richards believes that banning the legal sale of organs does nothing to help the poor out of poverty. These potential sellers want to sell their organs and pre-venting them from exercising their personal decision can be harmful (Becker et al. 2007). Preventing the poor from earning money in such a way only keeps them in the

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impoverished condition which may inspire them to com-mit other desperate illegal acts. Radcliffe-Richards also argues that certain standards of procedure can be imple-mented to insure that potential “organ vendors” are not ignorant of the dangers involved in giving an organ and are making a rational decision (Becker et al. 2007). In response to the WHO statement, it is very probable that continuing to ban legal organ sales may just continue to drive transactions deeper into the black market, which will be even more dangerous for the poor. All around the world, there have been horrifying reports of illegal organ-harvesting operations that take advan-tage of the poor and serve people who cannot lawfully purchase new organs and do not wait to take their chanc-es on the waitlist. For example, Dr. Amit Kumar, currently on trial in India, confessed to luring day laborers into his clinics and offering them $2,000 for a kidney, which he often took whether they agreed or not. With these organs he gave hundreds of organ transplants to desperate rich clients in Western countries. Also, potential donors from Brazil, Israel, and Romania could go to South Africa and sell a kidney for up to $20,000 for rich Israelis on ‘trans-plant holidays’. They would lie and say that they were related to circumvent South African law (The Economist 2008). By establishing a legal market for organs, it would be safer for donors and recipients alike. There would be more organs available for all and the donors would earn a well-deserved and needed payment for their work.

Philanthropy vs. Indirect Altruism

Most major religions like Christianity and Islam agree “only philanthropy is a proper motive for giving and receiving organs” (Israel Medical Association Journal 2004). This is the moral principle our system operates on today. Under the Christian tradition, selling one’s body is wrong because it is believed that God intended us to use our bodies to glorify Him. Furthermore, the Gospel states that people should love their neighbors unconditionally. Thus, a donated organ is a gift of God and should be giv-en based on need, not greed. In theory, these are noble goals. However, in reality, it is sometimes difficult to dis-tinguish the moral difference between philanthropy and indirect altruism. The money that a donor would earn under a market system could be used to forward altruis-tic goals. Why should philanthropy be acceptable and not indirect altruism? The following scenario is often brought up in the debate:

An impoverished father… wants to help his se-riously ill daughter. If she had renal failure, he would gladly donate his kidney with no thought of financial compensation. However, she does not have renal failure but a white-cell malig-nancy that requires expensive treatment. The father sells his kidney to obtain the money to pay for her medical treatment (Israel Medical Association Journal 2004).

Under the traditional definition of philanthropy that our present donation-based system operates on this would not be permitted. However, it is difficult to see why this is not altruistic enough for it would save the daughter’s life by giving her a kidney—though not directly. Another scenario of indirect altruism that is proposed is of the poor widow in India who can only provide her daughters a dowry for marriage—which is important in lifting them out of a life of poverty—by selling one of her kidneys. It is interesting to note that under Judaism mon-etary compensation is not necessarily forbidden and that a law was recently passed in Israel that allowed for mon-etary compensation of donors. Dr. Grazi and Dr. Wolowel-sky reflected in the Israel Medical Association Journal that while Halakhah, Jewish law, takes into account the moti-vation behind one’s religious observances, it believes that the value of a good deed, a mitzvah, is not necessarily re-duced by the lack of proper motivation. They state “inad-equate motivation does not undermine the inherent ethi-cal value of the act itself, or provide an exemption to the obligation to perform a particular mitzvah (Israel Medi-cal Association Journal 2004). Getting paid to do some-thing does not necessarily negate its positive outcome. It is a reality today that most ostensibly philanthropic organizations have paid staff in addition to volunteers. Radcliffe-Richards also points out “nobody believes in general that unless some useful action is altruistic it is better to forbid it altogether” (Racliffe-Richards 1998). Clearly, giving another a kidney— whether through as a gift or sale—is useful because it saves the recipient’s life.

Changing Attitudes: An Evolution in Morality

One of the biggest challenges to actually establishing a legal market for organs is the repugnance that many people instinctively feel about it (Duber et al. 2006). It just seems wrong and fundamentally at conflict with our value system to establish some sort of price for an organ of life. As sociologist Vivian Zelizer notes, “Market ex-change, although perfectly compatible with the modern

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values of efficiency and equality, conflicts with human values which defy its impersonal, rational, and economiz-ing influence” (Zelizer 1978). However, it is important to note that this attitude can change. For example, Dr. Michael Friedlaender wrote in the Lancet a few years ago about how his own feelings about the right to sell or buy a kidney gradually changed through his experiences at the renal transplant clinic of Hadassah University Hospital in Israel. In the beginning, he was a vociferous opponent of such trade, and would quote from Shakespeare’s Merchant of Venice, “the pound of flesh … is dearly bought, is mine, and I will have it.” However, as he observed many of his patients go to other countries and pay for an organ transplant and while oth-ers languished on the official waitlist he realized that the present system was not working. Since then, he has tac-itly given many of his patients permission to seek organs from other countries, promising healthcare upon their return (Zelizer 1978). A fascinating example of evolving human atti-tudes towards establishing a monetary equivalent for life is society’s acceptance of life insurance. In the begin-ning of the 19th century, Americans were offended by the prospect of life insurance because it put a value to something that was supposed to be invaluable, it made a connection “between the sacred and the profane” (Zel-izer 1978). However, as life insurance came to take on a more symbolic value as a “form of ritual with which to face death and a processing of the dead by those kin left behind” it became not only accepted but expected. Men who did not purchase some sort of life insurance policy were seen as irresponsible. Societal norms can change; for example, ideas like gender equality, interracial mar-riage, and cadaver organ transplants that were once de-plored are now accepted. This suggests that one day sell-ing body parts may become an acceptable practice too (Zelizer 1978).

Conclusion

The right to buy and sale organs—particularly kid-neys—is a concept that should be seriously consid-ered given the scarcity of organs available for trans-plant. An organ market that is well designed and regulated could eliminate the long waitlist for organs. This will save thousands of lives and potentially mil-lions of dollars. Although many have raised concerns over the ethics of such a policy—suggesting that sell-ing organs will commodify the body and promote the violation of our inherent humanity—it has been seen

that these worries, though genuine, do not have a lot of support. Also, by selling an organ rather than do-nating it, the value of the organ and the act of provid-ing the organ are not diminished. By overcoming the initial feelings of repugnance about such a system, perhaps the United States can make this necessary advance—establishing an organ market—to save lives.

References

Becker GS & Elias JJ. (2007). “Introducing Incentives in the Market for Live and Cadaveric Organ Donations.” Journal of Economic Perspectives. 21.Capron AM. (2001). “Reexamining Organ Transplantation.” JAMA. 285: 334- 36.Childress JF. (2001). “Putting Patients First in Organ Allocation: An Ethical Analysis of the US Debate.” Cambridge Quarterly of Healthcare Ethics. 365- 76.“Data.” OPTN: Organ Procurement and Transplantation Network. 21 Nov 2008. OPTN: Organ Procurement and Transplantation Network. 21 Nov 2008 <http://www.optn.org/data/>.Delmonico FL, et al. (2002). “Ethical Incentives- Not Payment - For Organ Donation.” NEJM. 346: 2002-004.Dubner SJ & Levitt SD. “Flesh Trade.” The New York Times Magazine 9 July 2006. New York Times. New York Times. 15 Nov. 2008 <http://www. nytimes.com/2006/07/09/magazine/09wwln_freak.html?_r=1&ex=11895 69600&en=5baab363cbbfbb67&ei=5070>.The Economist. “The gap between supply and demand.” The Economist. 9 Oct 2008. The Economist. 20 Nov. 2008. <http://www.economist.com/world/ international/printerfriendly.cfm?story_id=12380981>.Friedlaender M (2002). “The right to sell or buy a kidney; are we failing our patients?” The Lancet. 369: 971-73.Herring AA, Woolhandler S, Himmelstein DU. (2008). “Insurance Status of U.S. Organ Donors and Transplant Recipients: The Uninsured Give, But Rarely Receive.” International Journal of Health Services. 38: 641-52.“Jewish Medical Ethics: Monetary Compensation for Donating Kidneys.” (2004). Israel Medical Association Journal. 6: 185-87.National Organ Transplant Act, Vol. Title 42 United States Code, 1984.Ornstein C & Weber T. “Transplant monitor lax in oversight.” Los Angeles Times. 22 Oct. 2006.Racliffe-Richards J. (1998). “The case for allowing kidney sales.” The Lancet. 351: 1950-52.“Transplantation.” National Kidney Foundation. 2008. National Kidney Foun- dation. 23 Nov. 2008 <http://www.kidney.org/transplantation/>.Wilkinson S. (2001). “Commodification Arguments for the Legal Prohibition of Organ Sale.” Health Care Analysis. 8: 189-200.Zelizer VA. (1978). “Human Values and the Market: The Case of Life Insurance and Death in 19th Century America.” The American Journal of Sociology. 84: 591-610.

Alicia Chen is currently a freshman at Brown University. She is a potential Economics concentrator and is in the Program for a Liberal Medical Education.

Genomics

Personalized medicine

&

Genomics

Personalized medicine

IJE SpEcIal FEaturE

&

Special Feature Design from November 21, 2006 Issue of Biomedical Beathttp://publications.nigms.nih.gov/biobeat/gallery/index.

Knowing Yourself Too Well: A Forward-Looking Analysis 29of the Ethical Questions Surrounding GenomicsJeffrey Brooks, Tufts University

Computational Genomics, Genetic Databases and the 33Protection of Privacy: Mission Impossible?John D. Picano, Boston College

Abusing the Genomic Pandora’s Box: 36Direct-to-Consumer Advertising of Genetic TestingJohn Kleimeyer, Cornell University

Better the Devil you know? 41Screening in the Post-Genomic EraGregory Lewis, Cambridge University

Human Genetic Engineering of the Embryo 44and the Pluralistic SocietyMichelle Fleshner, University of Michigan

An Alternative to the Treatment-Enhancement Distinction 48Michael Garcia, University of California, San Diego

One Size Does Not Fit All: 52Race Should Not be a Substitution for Genetic VariationHeather Pace, Cornell University

Table of Contents

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Knowing Yourself Too Well:A Forward-Looking Analysis of the Ethical QuestionsSurrounding Genomics

Jeffrey BrooksTufts University

AbstrAct

Beginning in the 1970s and growing exponentially into the twenty-first century, the science of genomics has come into its own as one of the most important scientific movements in the history of empirical study. After initial studies came under close public scrutiny, numerous ethical questions arose, many of which did not have clear-cut answers and which implied an infinite regress for the bioethical and medical communities. These seemingly unsolvable ethical issues involved the risks associated with initial clinical trials to treat multifacto-rial polygenic diseases in isolated genomes, the nature of “informed consent” in these trials, and the question of whether or not to share familial genetic information with a patient’s relatives. The most important ethical task for the medical and scientific communities is to ensure genetic privacy for those who participate in stud-ies in order to prevent genetic discrimination, and to educate the public and the media about the biological and philosophical nature of genetic information. Until these provisions are met, the valuable and important possible contributions of genomics will not be fully realized.

Key Words: Genetic Risks, Privacy, Public Awareness

Introduction

In 1977, the first DNA-based genome to be sequenced in its entirety was presented by English biochemist Fred-erick Sanger. This finding and many like it were the im-petus for what would become a boom in both funding for and public interest in the burgeoning science of ge-nomics. The 1990s saw this interest grow at an unprec-edented rate, with the $3 billion Human Genome Proj-ect and the 1997 establishment of the National Human Genome Research Institute (NHGRI) in America. This decade also saw the new science become applied, with the first instance of gene therapy occurring in Septem-ber 1990. Initial returns from these studies isolated sus-ceptibility genes for numerous multifactorial polygenic diseases and some initial evidence of genes that are asso-ciated with human behavioral traits. The natural human inclination to essentialism and democratization of infor-mation caused society to be excited by the prospect of learning more about their biological blueprints, desiring the affirmations and surprises that would no doubt come

from viewing one’s own biochemical makeup. The scien-tific community was similarly excited, with some making the exaggerated claim that every characteristic of human life was now known to be heritable (Turkheimer 2000). This excitement began to wane as ethical prob-lems became salient in the midst of these exhilarating new discoveries. Many of the first clinical trials for gene ther-apy had catastrophic effects such as death and leukemia in patients (Kimmelman 2005), and prospective patients wishing to test their susceptibility genes soon realized the psychological and emotional implications of learning one’s possible medical future (Thomas 1999). Currently, as projects such as biologist George Church’s “Personal Genome Project” and companies such as 23AndMe and Navigenics promise to make sequencing and viewing your genome affordable, new ethical issues are entering the collective conscience of the medical community and society at large. This new situation brings an entire new meaning to protection (or lack thereof) of one’s privacy.

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Trinidad and Tobago has already instituted laws that require prospective police officers to submit their DNA in order to isolate their propensity for violence, risk taking and fear, and to calculate insurance liability issues (Lei 2007). In America, the Genetic Information Nondis-crimination Act (GINA) currently prevents employers and insurance companies from discriminating potential employees and customers on the basis of their genetic information (Annas et al.). However, the medical com-munity argues that it is just as morally irresponsible to withhold this information from free use, claiming that it will cause a barrier to the future of clearly communicated and valuable inclusion of genetic data in medical practice (Goodman 1995). The scientific community is in danger of an ethical infinite regress in which the current findings are rendered useless unless it finds away to balance ethi-cal concerns with these exciting scientific advances in a way that will please both the intellectual community and humankind in general.

The Issues

At this very moment, thousands of variants of genetic material are being tested in labs across the world to iso-late them as potential markers associated with increased or decreased susceptibility for major multifactorial poly-genic diseases (Christensen & Murray 2007). In and of itself, this research is one of the great scientific achieve-ments of our time, yet the longer that this research has continued, the more ethical problems have surfaced that place the future of the research and applications of ge-nomics in jeopardy. Many clinical-based genome projects are attempt-ing to create extensive databases in order to observe trends in patients with the same genes or susceptibilities (Thomas 1999, Goodman 1995). However, after submit-ting their DNA to this database, how informed should donors remain about categorical advances in knowledge pertaining to their personal genome? How could a situa-tion like this truly be accounted for when requesting the patient’s “informed” consent? The issue of communication is at the forefront of the issues that will plague the genetic community in the coming decade. After decades of argument over wheth-er it was ethical at all to sequence the human genome (Thomas 1999), the scientific community needs to in-stead focus on the ethical questions of privacy, education and effective communication in order to allow the clini-cal promise of genetic screening, creating databases and research to be fully actualized (Annas et al.).

Proper communication of risk in clinical research is an issue with which the medical community has long had to grapple, but after the publicity that early findings in genomics received brought the entire endeavor under intense public scrutiny, the importance of analyzing and communicating every possible risk became a tangible necessity. Public reminders of the risks of clinical genom-ics and gene therapy, such as the well-publicized death of 18-year old Jesse Gelsinger still serve as reinforcements that applied genomics is far from being quotidian in med-icine and life (Dettweiler & Simon 2001). All common codes of medical ethics hold that clinical research is not worthwhile unless the risks are outweighed by potential for valuable advances in medical knowledge (Emanuel et al. 2000), and assessments of risk in gene therapy have shown that the mysterious variable nature of the human genome provides for an unsafe environment in clinical trials, both for patients and third parties. Particularly, a clinical risk that is unique to gene therapy is the marked-ly long latency of gene modification, allowing for the pos-sibility of multiple generations of negative externalities stemming from only one patient (Kimmelman 2005). In response to early these issues with gene ther-apy, the primary medical application of genomics, scien-tists and bioethicists unanimously claimed that the key to unhindered research and full realization of potential benefits could only take place when an effective meth-od of informed consent was established for clinical tri-als (Friedmann 2000; Kimmelman 2005). Genomics is unique; however, in that it poses completely new hurdles to clinical ideals of information and communication: the attached difficulty to clinical research in genomics is that the informed consent of one patient to disclose their genetic information effectively constitutes a release of the genetic information of their relatives and offspring (Goodman 1996). Disclosing genetic risk information is a process that, as in all other medical arenas, involves careful weigh-ing of possible benefits and risks, and it is becoming ap-parent that the families of consenting patients should be necessarily involved in the process (Hamilton et al. 2005, Ashida et al.). The ethical dilemma here is twofold: non-disclosure to affected parties can be seen as outdated paternalism that denies them their innate human desire for autonomy and democratization of information, while disclosure to relatives of a patient could be seen as un-ethical medical practice and violation of privacy (Thom-as 1999). An additional ethical issue is the right of patients not to know their particular genetic susceptibility to a

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major disease (Thomas 1999). Indeed, James Watson, co-discoverer of DNA and one of the first humans to have his genome sequenced, requested not to learn whether he carried the apolipoprotein E (APOE) ε4 gene, a trustwor-thy predictor of Alzheimer’s susceptibility (Pinker 2009, Farrer et al. 1997). Although this may seem like an ethical non-issue, it serves as a counter-argument to questions of the ethicality of disclosing information to patients and relatives. Currently, the genetics community is facing a new proliferation of ethical issues, relating to the impor-tant issue of personal privacy, which is in many ways re-lated to the ongoing issue of communication and consent in genetic testing and distribution. As recently as 2005, the sequencing of a human genome to any useful degree would cost somewhere in the area of $20 million. Geneti-cists displayed eager ambition to lower this price in order to allow people of typical financial status to have the op-portunity to have their genomes sequenced, with the ul-timate goal of finding out more about themselves and/or donating their information to a clinical database (Church 2006). The foremost example of this emerging “era of consumer genetics” (Pinker 2009) is Harvard biologist George Church’s “Personal Genome Project”. This project has created a very public collection of the genetic infor-mation of 100,000 individuals, in a massive-scale sourc-ing endeavor that has been likened to the Wikipedia or Google of genetics (Church 2006, Pinker 2009). In addi-tion to this formal project, companies such as 23AndMe, Knome, and Navigenics now offer partial sequences for under $500. Idealists have imagined the future in this new era of freedom of information as one necessarily including national health insurance, personalized medi-cal regimens that will remove trial and error completely from medicine, and overall increased scientific conscien-tiousness in the general public (Pinker 2009). However, even the most positive possibilities are not without their attached ethical issues: how will personalized medicine be fair to all patients? Will healthcare really be equal? Will people be judged based on their biological makeup? The last question has already sparked a fury of ethical debate by those who acknowledge the possibility of genetic discrimination if this information were to fall into the hands of employers and health insurers (Clayton 2003). The nature of human life is based on plurality, yet it comes with little surprise that the most fundamental and base level of human difference is becoming a source of discrimination. The bioethicist George Annas has al-ready coined the term “genism” (Annas et al.), a form of discrimination that has been previously evidenced as

concurrent with racism (McDermott 1998). Lawmakers in the small country of Trinidad and Tobago have passed laws requiring prospective police officers to offer DNA samples, so that genes that have been implicated in vio-lence, risk-taking, and fear can be isolated and evaluated (Lei 2007). Although most people would immediately qualify this as unethical, the past five decades in America have demonstrated clear public interest in knowing the medical histories and predispositions of elected officials (Green & Annas 2008). Luckily in America, the recent-ly passed Genetic Information Nondiscrimination Act (GINA) ensures the public that their genetic information as it relates to pathologic and behavioral susceptibili-ties and predispositions will not be used to discriminate against them in any way. For the scientific community, this act was a sign that more citizens would decide to be-come research subjects now that their fears of discrimi-nation were allayed. The need for this act, in addition to the volume of concerns expressed by the public during the last decades of genetic research, makes it clear that the main issue for the future study of genetics will not be the ethics of research, but the ethics of privacy (Annas et al.) in an age where technology has eroded personal privacy, the expectation for such a central initiative in sci-ence should be that privacy is promised and retained.

“Geno’s Paradox”

If genetic privacy is promised and secured, there is no doubt that the future will hold unprecedented medical and scientific advances based in large part on human ge-nomics and its wealth of possible applications. In light of this possibility, the public and the media must be educat-ed so that they can know exactly what sequencing their genome means, and so that they will be able to give truly informed consent. The primary reason for this necessity is so that participants will be able to view their results in light of a very real fact: genetic data sequencing is not remark-ably conclusive. This unfortunate actuality, termed by psychologist Steven Pinker as “Geno’s Paradox,” is the reason why so much risk was associated with early clini-cal trials: it is an extremely hit-or-miss venture to base an entire plan of medical action on one gene reading. Addi-tionally, the currently expanding concept of “behavioral genetics,” based on isolated genotypes that have statisti-cal linkage to certain traits, has the potential to have di-sastrous political and social consequences if the public is not informed that their genes, whether it be the gene to have red hair or the gene to be impulsive, represent ca-

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pacities, not destinies. Although it may be easy to imagine a dystopian, genetically modified future, these fears are mislaid. The probabilistic nature of genes makes them very complex: they are dynamic and corruptible, able to be affected by environment within the loose boundary that nature makes for them (Pinker 2009). An additional threat of poor education of the public and the media regarding genetics is a future in which every single isolated behavioral gene or suscep-tibility gene incites a sensationalist reaction, termed by the epidemiologist Robert C. Green as “genetic McCarthy-ism” (Green & Annas 2008). The scientific community got a taste of what the media could potentially do to a genetic finding less then ten years ago when the press made the dramatic claim that there was a specific gene for homosexuality, unfortunately termed “the gay gene” (Satinover 2001). Of course, all of this could be avoided with the public knowledge that genes are not in and of themselves conclusive evidence of a certain tempera-ment or medical issue. Unlike the corresponding “Meno’s Paradox,” this is a dilemma that can be solved.

Conclusion

Genomics is a powerful and important scientific venture that will come to define this generation’s intellectual history. Initial ethical issues surrounding this area of re-search included the ethicality of clinical risks and patient selection, the nature of informed consent, and the ques-tion of who deserved to know genetic information about a family member. Although these are all valid concerns, the beginning of the twenty-first century has seen a dramatic decrease in personal privacy on a practical level. In order for genomics to have a successful and profitable future in medicine and science, the primary ethical issue that needs to be handled is the question of genetic privacy. Once this issue is handled, scientists and medical prac-titioners will have the distinct responsibility to educate the public, the media, and future policymakers about the scientific and philosophical truths regarding the human genome. Increased knowledge about these facts will help ease the transition into an era of medicine that will have significant contribution to the growth and implementa-tion of responsible and valuable new methods of genetic analysis and treatments.

References

Annas GJ, Roches P, Green RC. GINA, Genism and Civil Rights. Bioethics. (In Press).

Ashida S, Koehly LM, Roberts JS, Chen CA, Hiraki S, Green RC. Disclosing the disclosure: Factors associated with communicating the results of genetic susceptibility testing for Alzheimer’s disease. Journal of Health Communi- cation. (In Press).Christensen K & Murray JC. (2007). What Genome-Wide Association Studies Can Do For Medicine. N Engl J Med. 356(11): 1094-1097.Church GM. (2006). Genomes for All. Scientific American. January 2006.Clayton EW. (2003). Ethical, legal, and social implications of genomic medi- cine. N Engl J Med. 349(6): 562-569. Dettweiler U & Simon P. (2001). Points to Consider for Ethics Committees in Human Gene Therapy Trials. Bioethics. 15(5/6).Emanuel EJ, Wendler D, Grady C. (2000). What Makes Clinical Research Ethi- cal? JAMA. 283: 2701-2711.Farrer LA, Cupples LA, Haines JL, Hyman B, Kukull WA, Mayeux R et al. (1997). Effects of age, sex, and ethnicity on the association between apolipoprotein E genotype and Alzheimer disease. A meta-analysis. APOE and Alzheimer Disease Meta Analysis Consortium. JAMA. 278(16): 1349- 1356. Friedmann T. (2000). Medical Ethics: Principles for Human Gene Therapy Studies. Science. 287(5461): 2163-2165.Goodman KW. (1996). Ethics, Genomics, and Information Retrieval. Comput. Biol. Med. 26(3): 223-229.Green RC, Annas G. (2008). Genetic privacy of presidential candidates. New England Journal of Medicine. 359: 2192-93.Hamilton RJ, Bowers BJ & Williams JK. (2005). Disclosing genetic test results to family members. J Nurs Scholarsh. 37(1): 18-24. Kimmelman J. (2005). Recent Developmnts in Gene Transfer: Risk and Ethics. BMJ. 330: 79-82.Lei H. (2007). Want a Job? Submit Your DNA. Accessed on January 14th, 2009. <http://www.eyeondna.com/2007/05/19/want-a-job-submit-your-dna/>McDermott R. (1998). Ethics, Epidemiology and the Thrifty Gene: Biological Determinism as a Health Hazard. Soc. Sci. Med. 47(9): 1189-1195.Pinker S. (2009). My genome, myself. New York Times Sunday Magazine. January 11.Satinover J. The Gay Gene? Accessed on January 13, 2009. <http://www. leaderu.com/jhs/satinover.html>Thomas SM. (1999). Genomics: The Implications for Ethics and Education. British Medical Bulletin. 55(2): 429-445.Turkheimer E. (2000). Three laws of behavior genetics and what they mean. Current Directions in Psychological Science. 9: 160-164.

Jeffrey Brooks is currently a freshmen at Tufts Univeristy. His plans after graduation are to pursue a PhD in Cogni-tive Science and engage in a career of research and teach-ing at the University level, in addition to remaining active in issues related to politics and social ethics.

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Computational Genomics,Genetic Databases and the Protection of Privacy:Mission Impossible?

John D. PicanoBoston College

AbstrAct

Genetic databases containing information specific to the genomes of individuals will prove to be vital for the future of biomedical research and medicine. A wealth of information can be discovered upon mapping and analyzing a person’s genome, and it is imperative to set forth adequate guidelines in accordance with patients’ and subjects’ rights when collecting and using this data. With the integration of computational genomics and genetic databases paving the way for improved personalized healthcare, novel ethical concerns associated with the compilation of large-scale DNA databases have emerged.

Key Words: Genetic Privacy, Policy Formation, Bioinformatics

In recent years, the creation of genetic databases and the applications of computational genomics have revo-lutionized the field of biomedicine. With advances in technology, our knowledge of biological mechanisms and the genomes of different organisms has increased at an impressive rate. Although the integration of this new material with modern medicine has not been complete-ly brought to fruition, it certainly paves the way for the promising future of biomedicine. It is the common goal of researchers, scientists, and donors alike that information amassed in scientific studies will result in a greater good, benefiting human health universally. Nonetheless, many ethical obligations arise as this new frontier of medicine develops. The incorporation of computers as analytic tools and the formation of large databases require new considerations in the realms of privacy and protection. It is essential that we first identify the moral and ethical concerns involved in large-scale DNA work in order for us to appropriately further our understanding of the hu-man genome and improve health care for the long term. As a whole, Bioinformatics represents the scien-tific field that deals with “the use of information technol-ogy to acquire, store, manage, share, analyze, represent

and transmit genetic data” (Goodman et al. 2008). Bio-informatics uses high-throughput machinery, namely computers, to analyze large quantities of biological in-formation in a relatively short period of time. Genomes, or the entirety of information included in an organism’s DNA, can be broken down into a sequence of letters, rep-resentative of chemical bases. At this microscopic level, genomes become rather complicated as a result of the breadth of information encompassed in the entire se-quence. Even seemingly simple organisms such as the bacterium Escherichia coli possess about five million base pairs (Moody 2004). Furthermore, specially designed algorithms can sort through the vast quantity of “junk DNA,” or non-coding DNA, in the genome, locate genes and even detect errors in DNA sequences. Gene finding is a prime example of a process rendered much more ef-ficient with the use of computers. The invention of ultra high-throughput machines not only increased the speed at which analysis could be performed, but also reduced the cost of detailing genomes. In the 1990s, the abun-dance of relatively affordable personal computers, com-bined with newly accessible sequence programs such as Basic Local Alignment Search Tool (BLAST) via the

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internet made data mining more achievable for a glob-al community of scientists. It comes as no surprise that computer machinery has been labeled the “single most important tool” for studying genomes (Moody 2004). The emergence of bioinformatics in recent years has been coupled with an increasing amount of tissue collection and genetic database construction. Genetic databases are formed from the “collection, storage and use of physical tissue (usually blood, but by no means ex-clusively so), genotype and other biological information derived from that tissue, and a variety of personal data from populations of various sizes” (Tutton et al. 2004). In the last eleven years, a substantial number of large-scale, database construction projects have begun in countries such as Iceland, the United Kingdom, Estonia, Canada, Latvia, Singapore, and the United States (Tutton et al. 2004). As with all biomedical research, the topic of con-sent is often analyzed by bioethicists and policy-makers. For genetic studies, it is similarly imperative that possible database subjects be made clear of both the implications and consequences before deciding whether they wish to participate. According to Oonagh Corrigan, a sociologist concerned with developments in genetic research and the implications for human participants, certain issues associated with genetic databases pose new questions regarding the limits of existing consent models, and may require the rewriting of today’s guidelines. The main problem with current models lies in the fact that they do not give adequate attention to what the future uses of donor materials will be. Often, tissue donated to genetic studies is used again in secondary studies with different aspirations. In order to protect an individual from ex-ploitation, Corrigan properly argues that more concrete consent laws must be established which specify the long-term uses of donated samples, in addition to calling for protection beyond informed consent readings (2004). It is evident that computational genomics shares many of the same ethical issues as genetics and other fields involving clinical research. However, it is more important to examine the ways in which gathering col-lections of DNA differ from “Genethics”, to determine ap-propriate ethical guidelines and distinctions. Utilizing computers to decode information present in one’s DNA can have unforeseeable consequences. As a result, it is difficult to set stringent regulations in advance without knowing the outcome of such studies (Tavani 2006). Bio-informatics also raises several new issues of privacy and confidentiality with building genetic databases, three of which are outlined in a recent journal publication by

Kenneth Goodman et al. (2008):

1. Using digital devices to store and transmit large volumes of genetic material augments the risk of “inappropriate disclosure,” more so than other media.2. Collecting data for genetic databases may enable researchers to draw conclusions about certain communities within a population. Any correlations made between genomic analysis and the behavioral traits of a certain subgroup must take ethical considerations into account, so as not to attach a stigma to research par-ticipants and their respective communities. The authors underscore the importance of re-alizing that incorporating individuals’ data for genetic analysis has consequences for broader populations, in addition to the study partici-pants.3. Data mining machinery can discover infor-mation about individuals they may not feel comfortable divulging, without it being im-mediately clear that this is the case. The ques-tions these issues bring forth concerning pri-vacy and protection need to be “identified and elucidated” to help determine “which kinds of normative policies should be adopted” (Tavani 2006).

With the cooperation of computational genom-ics, genetic databases, and modern medicine, there is a shared goal of bettering the future of healthcare for ev-eryone. In order to accomplish this, genetic databases are continually being constructed with large pools of in-formation. This translates into “a repository of informa-tion that can be used as a research tool” such that genetic mapping and computational analysis can be performed to learn more about “the interactions between genes, environment and lifestyle that are thought to be respon-sible for common diseases” (Kaye 2004). Being informed that one’s DNA contains, or makes a person more suscep-tible to, a malady is beneficial in that it allows for careful planning and discussion between a physician and a pa-tient (Moor 1999). Furthermore, understanding that one is considered to be highly at-risk for a certain condition, or genetically predisposed to a disease, allows for the im-plementation of preventative care. In turn, this informa-tion could be integrated with a personal plan of attack, in which physicians develop a scheme of treatment that best suits an individual. Physicians and geneticists, with

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pharmaceutical research and genetic databases at their disposal, should be better prepared to predict how a pa-tient will respond to specific drugs, based on knowledge of how others with similar genetic makeup responded to a particular course of medication. The future of these inter-related fields is gener-ating much excitement in the scientific community, but there are several reasons to proceed with caution. Many ethicists have discussed hypothetical situations that could arise in the future as consequences of advance-ments in our knowledge of genetic information. Such speculation proves useful when outlining rules and regu-lations for the creation of genetic databases and the use of gathered information. It is imperative that data amassed from genetic testing and analysis not be used in any way “to discriminate against individuals to deny them health benefits, educational programs, [or] employment oppor-tunities” (Moor 1999). Since DNA sequencing and ge-nomic analysis may discover, sometimes accidentally and undesirably, information encoded by one’s genetic mate-rial, it is necessary to keep these records private and in-accessible to those not granted permission by a patient. It has also been suggested that discrimination of individuals included in such sizeable databases may be facilitated as a result of researchers not having person-al relations with participants. This is evidenced by one estimate that as many as “80% of the invasions of pri-vacy within a hospital come from one employee improp-erly reading another employee’s medical records” (Moor 1999). To combat this, anyone employed by a hospital, healthcare facility, or data collecting agency should be thoroughly informed of all HIPAA laws and privacy rights reserved for patients. After all, this “culture” of respect for others, their privacy and equality, is a central compo-nent of healthcare. While some view the notion of non-disclosure as “an ideal,” there is no denying that “it has been, and should still be, central to the patient-physician relationship” as well as the various relationships among others in health-related positions (Lowrance 1997). With the increasing use of electronic medical records, it is now more important than ever that:

1. strong access control and authorization gov-ern record-keeping systems,2. identifiable patient information, such as one’s name or address, be hidden when pos-sible,3. oversight and audit practices continually re-view the actions of individuals and organiza-tions (Cooper et al. 2005).

Clarifying and formalizing laws regarding our right to privacy will enhance our means and understand-ing of protection significantly. Increasing the penalties for violating such laws may emphasize their significance, but is not sufficient in and of itself. It would be wise to revisit laws concerning both inappropriate use and disclosure after having discussed some ethical considerations as-sociated with genetics and computing. In a world where caste systems continue to exist, and instances of geno-cide have been recently documented, an ethically-sound system of respect and privacy is crucially importance for the future of both healthcare and human relations (Moor 1999).

References

Cancer Genome Project [Internet]. [updated 2008 Sep 16]. Cambridge (UK): Wellcome Trust Sanger Institute; [cited 2008 Nov 9]. Available from: <http://www.sanger.ac.uk/genetics/CGP/>.Cooper T & Collman J. (2005). Managing Information Security and Privacy in Healthcare Data Mining: State of the Art. In: Chen H, Fuller SS, Friedman C, Hersh W, editors. Medical Informatics: Knowledge Management and Data Mining in Biomedicine. New York: Springer Science + Business Media, Inc. 97-137,Corrigan O. (2004). Informed consent: the contradictory ethical safeguards in pharmacogenetics. In: Tutton R, Corrigan O, editors. Genetic Databases: Socio-ethical issues in the collection and use of DNA. New York (NY): Rout- ledge. 78-96.Goodman KW & Cava A. (2008). Bioethics, Business Ethics, and Science: Bio- informatics and the Future of Healthcare. Cambridge Quarterly of Health- care Ethics. 17(4): 361-372. Kaye J. (2004). Abandoning informed consent: the case of genetic research in population collections. In: Tutton R, Corrigan O, editors. Genetic Databases: Socio-ethical issues in the collection and use of DNA. New York (NY): Rout- ledge. 117-138.Lowrance WH. (1997). Privacy and Health Research: A Report to the U.S. Sec- retary of Health and Human Services. U.S. Department of Health and Hu- man Services [Internet]. [cited 2008 Nov 3]. Available from: <http://aspe. hhs.gov/DATACNCL/ PHR1.htm>.Moody G. (2004). Digital Code of Life: How Bioinformatics is Revolutionizing Science, Medicine and Business. Hoboken (NJ): Wiley and Sons, Inc. 333- 334.Moor JH. (2006). Using Genetic Information While Protecting the Privacy of the Soul. In: Tavani HT, editor. Ethics, Computing and Genomics. Boston (MA): Jones and Bartlett Publishers. 109-119.Tavani HT. (2006). Ethics at the Intersection of Computing and Genomics. In: Tavani, HT, editor. Ethics, Computing and Genomics. Boston (MA): Jones and Bartlett Publishers. 5-26.Tutton R & Corrigan O. (2004). Introduction: public participation in genetic databases. In: Tutton R, Corrigan O, editors. Genetic Databases: Socio- ethical issues in the collection and use of DNA. New York (NY): Routledge. 1-18.

John Picano is currently a senior at Boston College ma-joring in Biology with a minor in French. After college, he plans to pursue a Masters in the Biomedical Sciences and attend Medical School.

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Abusing the GenomicPandora’s Box: Direct-to-Consumer Advertising

John KleimeyerCornell University

AbstrAct

Traditionally, drugs and health products from penicillin to hip replacements were marketed first to hospitals and doctors, and then they were prescribed to patients. In 1997, this practice began to shift as the Food and Drug Administration (FDA) relaxed its restrictions on direct-to-consumer advertising (DTCA) (Frost 2003). Drug advertisements, like those showing worry-free allergy sufferers dancing across our televisions, are to blame for this regulatory change. DTCA has since exploded, changing the roles of consumers to managers of their own health care as they learn about treatments from corporations, not from their physicians (Frost 2003). The growing business of genetic testing has also turned to DTCA. Today, thousands of genetic varia-tions, some benign and some deadly, can be tested both easily and economically. Indeed, with no more than a computer and a credit card, consumers can order a test for hundreds of mutations without ever involving their health care provider (Wolfberg 2006). Yet, understanding of this information’s utility is still limited (Hunter et al. 2008).

Key Words: Advertising, Genetic Testing, Freedom of Action

Distinguishing the genetic causes of a disease from its environmental causes is often difficult. Other conditions, like the trait “learning to avoid errors,” offered by the testing company 23andMe, have little support and often exaggerate scientific evidence (23andMe.com). Myriad Genetics’ BRACAnalysis test for BRCA mutations that af-fect 1 in 400 women can only show a 35-84% probability of developing breast cancer (Pollack 2007). Even with a physician involved, such probabilistic results may be mis-interpreted. For dubious or frequently unnecessary tests like these, companies are profiting from their customers’ fears and the hype surrounding their services. DTCA of-ten sugarcoats tests’ benefits while downplaying their limitations. This can lead to avoidable anxiety and point-less overtreatment. The need for additional oversight of genetic tests and their advertising is clear. A stronger regulation of DTCA will better protect people from im-proper advertising for genetic testing while preserving the benefits of awareness of those tests’ availability. The FDA has long governed DTCA in the United

States. Its authority is based on the 1938 Federal Food, Drug, and Cosmetic Act, with final regulations for DTCA entering the law in 1969 (Donohue et al. 2007). From its first appearance in the 80’s, DTCA of prescription drugs and treatments certainly occurred, but at that time, it was limited by heavily enforced regulation that adver-tisements “must not be false” and must present a “fair balance” of information about the advertised product’s risks and benefits (Boden & Diamond 2008). Since the 1997 FDA Modernization Act relaxed these regulations in an attempt to promote consistency in policy, only “major risk information” must be disclosed (Boden & Diamond 2008). Evidence shows that the direct market-ing of health products has boomed as regulation erod-ed. Total spending grew from $11.4 to $29.9 billion (or 14.2% to 18.2% of sales) from 1996 to 2005 (Donohue et al. 2007). Industry analyst David Stassen claims that “there’s no question that direct-to-consumer is a definite thing of the future for the health care industry. No ques-tion at all” (Frost 2003).

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Many groups, including the Government Ac-countability Office (GAO), have criticized the FDA’s en-forcement of regulations governing DTCA (Donohue et al. 2007). The FDA is required to take regulatory action against any advertisements that fail to provide full dis-closure of risks and inadequacies (Donohue et al. 2007). The number of regulatory actions taken by the FDA has fallen dramatically in recent years (Donohue et al. 2007). There are two possible causes of this. Either the indus-try has responded to reduced misrepresentative DTCA, or FDA oversight has worsened considerably. Interest-ingly, a GAO report found that the number of investiga-tive letters issued had decreased and that delays often prevented sending them until after the advertising cam-paigns has run their course (Donohue et al. 2007). It was shown that FDA review of broadcast advertisements be-fore airing declined from 64% in 1999 to only 32% in 2004 (Donohue et al. 2007). These data show a sharp decline in the regulatory authority of the FDA, not a re-duction in misleading advertising. Greater regulation and enforcement of that regulation will be necessary to adequately protect consumers against potential false and misleading advertisements. Genetic testing companies have joined the ranks of other health product businesses in marketing their tests directly to the consumer. While their overall adver-tising spending is far less than pharmaceutical compa-nies, these costs make up a much larger portion of their income (Donohue et al. 2007). In addition to print and television, many companies use the internet to market and even sell their services directly to the consumer (DTC) (Frost 2003). Genetic tests have recently pro-gressed with remarkable speed, today relying on mi-croarrays able to “probe” for specific sequences of DNA across the genome to assess up to over 300,000 single nucleotide polymorphisms (SNPs), or single base varia-tions, in each sample tested (Hunter et al. 2008). As ge-netic tests become more integrated into clinical practice, DTCA is likewise expected to increase (Hull and Prasad 2001). As of the end of 2007, three companies offered DTC “personal genome services.” These companies 23 and Me, Decode Me, and Navigenics, take clients’ DNA samples in whole blood, analyze the sample by SNP array, and store the results online (Hunter et al. 2008). These SNPs can be compared with allele databases based on scientific literature for various diseases, giving the client a specific risk level for conditions from cancer suscepti-bility to HIV/AIDS resistance (23andMe.com). DTCA for genetic testing can provide consum-ers and physicians with information on a wide range

of genetic tests in an expanding market. While this in-formation can be beneficial to the right individual, its presentation in most DTCA it is very problematic. Such advertisements are often “manipulative, misleading, and misguiding” (Hull and Prasad 2001). More than the clin-ical value of the genetic tests motivates genetic testing companies. Advertising serves to manipulate behavior, and in the case of DTCA for genetic testing, it targets wor-ried consumers, capitalizing on fear and anxiety (Gollust et al. 2002). In Fit Pregnancy magazine, a full-page ad features a newborn baby’s eyes. Above it reads: “A simple new test could save your baby’s life” (Gollust et al. 2002). This disturbing ad plays on the worries of a mother for her newborn, turning a genetic test into the key to the baby’s life. The advertisements can also overstate the test’s value. A Playbill ad for Myriad Genetics’ BRACAnalysis, a whole blood based test for cancer susceptibility genes BRCA1/2, shows a distressed woman covering her breast with her hands. Alongside was printed: “There is no stronger antidote for fear than information… [The test] could provide hope and dispel fear” (Gollust et al. 2002). As the ad claims, used properly, a genetic test is meant to dispel fear, not to contribute to it. Yet, because the ad targets far more women than those who need the testing, it mostly creates more anxiety. Advertisements can also promote products with “incomplete and at times incorrect information,” exag-gerating consumers’ risks while stressing a direct re-lationship between genes and disease (Hull & Prasad 2001). Another example of a BRACAnalysis ad, is a TV commercial that shows a group of women of many ages in succession saying: “Breast cancer runs in my family.” “My mother.” “My grandmother.” “My dad’s sisters” (Pol-lack 2007). In a second example, an ad depicted a weary, dark-haired woman in a Jewish magazine. Below it read, “If you often feel tired, it could be anemia. If you’re Jewish, it could be Gaucher disease” (Gollust et al. 2002). These ads maximize fears and exaggerate risks for the financial benefit of the testing companies. Inaccurate or even probabilistic genetic informa-tion can be a dangerous thing “in the hands of the less than completely informed” (Frost 2003). Most consum-ers have little certainty in the results of a test or what to do about them. Genetic information is complex informa-tion. Genetics is a subject known to many people, but in general knowledge it is characterized by misconceptions and exaggerated expectations (Gollust et al. 2002). The advertisers can use this context to their advantage. “[The BRACAnalysis test] really preys on the fears of our soci-

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ety, and one of those fears is getting breast cancer,” said Dr. Matloff, director of cancer genetic counseling at the Yale Cancer Center (Pollack 2007). This use of advertis-ing can create a cycle of unwarranted fear and expensive, unnecessary testing. It is a good thing when patients take charge of their own health and wellbeing. When they are improp-erly manipulated with themes of “choice,” “hope,” and “fear” however, the advertisements both validate the consumers’ worries and appeal to their desire to control their potential outcome. DTCA informs consumers about certain tests, but lacks the depth of accurate descriptions of what the results are or how patients should act in reac-tion to them. Indeed, the BRACAnalysis Playbill ad guided consumers to contact the company, not their healthcare provider, in order to have more complete control over the course of their testing and treatment (Gollust et al. 2002). When results speak of probabilities and an inde-terminate need for treatment however, it is always best to involve a health professional. At least there is then some experience and clinical knowledge behind the de-cisions that are made. Genetic testing results can even be confusing to physicians. These physicians can by caught between the hype of the ads and the needs of their patients. Perhaps DTCA can provide patients with more information about their condition and care for their short meetings with their physicians. Yet, patients making demands about their health care and the services they receive may unneces-sarily and perhaps dangerously complicate that care. Dr. Thornhill of Brigham and Women’s Hospital in Boston claims: “Many of my clinic days are spent dispelling ru-mors. These are not dumb people; these are smart pa-tients” (Frost 2003). Yet, for doctors less knowledgeable than Dr. Thornhill, it is hard to argue against a patient asking for genetic testing. A survey by the Centers for Disease Control and Prevention found that many doctors in regions with DTCA for genetic testing had an incorrect or incomplete understanding of the necessary genetics (Pollack 2007). There is little concern for physical harm from the tests. Unless the tests are provided only to more at-risk individuals however, advertising such complex genetic tests can create more anxiety and lead to expen-sive overuse of the tests (the BRACAnalysis test alone runs $3,120) or dangerous overtreatment with drugs and medical procedures (Pollack 2007). Furthermore, there is a lack of consensus about the clinical utility of some tests (Gollust et al. 2002). Even the BRACAnalysis test, supported by a large body of research on the BRCA1/2 gene mutations and their

effects on breast cancer, has such a wide range of prob-ability of carcinogenesis (35-84% for afflicted individu-als) that physicians will treat patients with the same test result very differently based on their family history and other factors (Pollack 2007). One woman may receive preventative surgery while another would be cautioned and simply screened. Viewed from a different perspec-tive, women might be wrongly assured by a false negative result or might have unnecessary surgery if their physi-cian misinterprets a result. Additionally, both mutations only account for less than 10% of breast cancer cases, and they are present in only 0.25% of the female population (Pollack 2007). These data show that a random woman can have less than a 0.1% chance of having breast cancer because of a BRCA mutation. These data also show that a physician cannot solely use the test result for either diagnosis or treatment of breast cancer. Well-documented tests like this may still require careful thought and assessment be-fore and after use (Genome.gov 2004). Tests lacking the scientific research to fully support them still share simi-lar uncertainties, but are even less reliable. With these concerns and caveats, attempts at popularizing genetic testing seem premature and misrepresentative of cur-rent technologies (Hull & Prasad 2001). Even under the liberal guidelines by the American Medical Association (AMA), only about 2% of women might be candidates for BRCA testing (Pollack 2007). This begs the question: why then does Myriad Genetics advertise the BRACAnal-ysis test to so many if it can help so few? To answer this question, we must consider per-haps the most damaging effect of DTCA. Such advertise-ments, emphasizing benefits and glossing limitations, can encourage healthy people to believe they need medi-cal attention because of non-clinical genetic testing re-sults. When does a worry become an unwarranted fear, or a “market opportunity” from the perspective of test-ing companies, rather than a genuine indication for treat-ment (Mintzes 2002)? DTCA breaks across this line again and again, often leading to medicalization, the “process by which non-medical problems become defined and treated as medical problems” (Mintzes 2002). This has been seen in the pharmaceutical industry in everything from pain medication to antidepressants. For example, in 1996 the FDA approved Paxil for treatment of depres-sion in an already saturated market (Conrad 2007). The manufacturer, GlaxoSmithKline (GSK), requested FDA ap-proval of the drug for additional applications like social anxiety disorder (SAD) and generalized anxiety disorder (GAD). Approval was granted, and Paxil was prescribed

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for conditions such as “worry” and “shyness” (Conrad 2007). GSK then spent millions on an awareness cam-paign for SAD, making it appear common and bloating SAD diagnoses (and GSK’s market share) from 3% to 13% of the US population (Conrad 2007). Here, adver-tising the disease rather than the drug led to medicaliza-tion. Testing companies are all too happy to support this process as well. They often target the healthy to make returns on their research and large marketing expenses (Donohue et al. 2007). Companies concentrate on either diseases that afflict many people or diseases with con-siderable national attention. For example, breast cancer due to a BRCA mutation only afflicts 0.1-0.3% of women (Pollack 2007). Yet, Myriad Genetics advertises its test to the whole female population. Genetic testing compa-nies, like Myriad Genetics, are in the business of making money first and saving lives second. This leads to what the World Health Organization has called “an inherent conflict of interest between the legitimate business goals of manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way” (Mintzes 2002). Thus, Myriad Genetics advertises to so many for the regrettable goal of making money. Not only does it sensationalize its service, but, by using DTCA to pres-ent its test is such a highly favorable light, it also mis-represents its efficacy, ignores its limited applicability, and uses manipulative themes of fear and hope. Myriad Genetics is consequently participating in medicalization. Indeed, its ad in Playbill includes only a small mention of the company behind the test in the fine print. Instead, it concentrates on the disease and on consumers’ worries (Gollust et al. 2002). Medicalization of genetic testing is a different problem from that of pharmaceuticals. It does not medicalize a demonstrated problem, but only the possibility of one for the hope of prevention. Adver-tising to such a large population leads to overtesting and overtreating, and there is little evidence that preventa-tive medicine extends life expectancy for all but the most special of circumstances (Hunter et al. 2008). Even the drugs and preventative treatments used successfully to limit the possibility carcinogenesis in at risk patients, such as a mastectomy for breast cancer, are dangerous and life threatening. DTCA is not completely lacking in benefits. It does provide some information about the availability of tests to the consumer (Frosch et al. 2007). There is con-sumer support behind such advertising and it still rep-resents a fair way to inform the public about new and

potentially useful testing (Berndt 2005). However, many of the arguments for less regulated DTCA are flawed. For example, proponents argue that knowledge of increased susceptibility to a disease will motivate patients to ben-eficially change their lifestyle. This argument seems in-tuitive, but evidence to support it is scarce (Hunter et al. 2008). In one such case, exercise and healthy eating habits are known to help patients with a genetic predis-position to Type 2 Diabetes (Hunter et al. 2008). Regard-less of the fact that diabetes is a complex disease with multiple genes and environmental interactions, changing lifestyle is still a choice, not a result of a positive genetic test. On the other side of the argument, false negative results may reassure patients, therefore being less moti-vated to change (Hunter et al. 2008). Increasing awareness of genetic testing, especial-ly when the test has clinically utility, is often described as the best argument in support of DTCA (Frosch et al. 2007). However, this mistakenly treats advertising as education. The average American TV viewer will see 16 hours of DTCA a year – far more than the time they will spend with their physician (Frosch et al. 2007). In a study of DTCA pharmaceutical ads however, it was found that around 90% were ambiguous about the le-gitimacy of the product, the risk factors, the prevalence of the condition, and the subpopulations at risk (Frosch et al. 2007). These ads were not educational; they were sensational and manipulative. They persuade emotion-ally, rather than from a rational consideration of benefits, limitations, and costs (Frosch et al. 2007). Myriad Genetics itself launched one of the first DTCA campaigns for genetic testing in 2002 to “raise awareness of cancer prevention options among women with a family history of breast cancer or ovarian cancer” (Myriad Genetics, Inc. 2002). The Playbill ad was a part of this campaign (Gollust et al. 2002). Surveys showed that this campaign did increase consumer awareness of the BRACAnalysis test (MMWR Weekly 2004). Yet, while more of the public knew about the availability of these genetic tests, providers still lacked the knowledge to advise pa-tients about testing results (MMWR Weekly 2004). Addi-tionally, there was no increased interest in testing among women who are candidates for BRCA1/2 testing due to their family history and other factors (MMWR Weekly 2004). Most strikingly however, no additional women were referred to oncology although the number of tests ordered increased (MMWR Weekly 2004). From these surveys, physicians appeared to order tests simply from increased requests for tests, not from an exhibited need. DTCA did not educate these patients; it scared them into

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requesting a test. Further research showed that Myriad Genetics’ DTCA failed to accurately portray the ability to predict cancer or encourage consumers to contact their health care provider” (MMWR Weekly 2004). A balance between regulation and freedom of ac-tion is necessary to protect people from improper DTCA for genetic testing while preserving the benefits of in-creased awareness of those tests. Yet, since 1997, this balance has tilted too far from regulation, allowing for the current, pervasive collection of DTCA that are to various extents manipulative, misleading, and misguiding (Hull & Prasad 2001). DTCA itself is not the problem; the lack of regulatory control is to blame. Indeed, as DTCA for ge-netic testing is technically not covered under the slightly more restrictive regulations for pharmaceuticals, based on the simple reason that genetic tests are not drugs, the need for sound public policy to be developed in oversight of the provision and marketing of such tests is that much more important (Genome.gov 2004). A first step could include a return to pre-1997 regulation. While a replacement of the FDA would be as counterproductive as a complete ban of DTCA, evidence suggesting a waning of FDA regulative authority illus-trates the need for additional funding or a reorganization of this government institution. New legislation further restricting DTCA for genetic testing, especially outlawing the manipulative themes and misleading claims of these advertisements, would also help right this regulatory im-balance. More information is necessary about the thou-sands of different genetic tests now available and their real clinical utility. One scenario may be to put the tests and their advertisements through a review process to ensure that their efficacy is scientifically supported and that they will benefit, not harm, consumers (Gollust et al. 2002). To reduce the dangers of currently marketed DTCA, all tests from BRACAnalysis to 23andMe should require physician or genetic counselor consent and in-volvement in the results. Gaining accurate knowledge about these tests is necessary for physicians as well as consumers who have a real need for them. In cases where there are valid opportunities for prevention of debilitating disease, the potential value of genetic tests is high. Given the risk of commercial ex-ploitation however, misleading advertisements directed at consumers are a dangerous and potentially damaging practice (Hunter et al. 2008). Few of these advertise-ments are sufficiently reviewed by the FDA, and thus, many are completely unregulated. Stronger oversight of DTCA can provide for a balanced market and for the necessary protections against improper advertisements

while still preserving the benefits of the tests they mar-ket. Without this increased regulation and enforcement, the danger warned of by Lewis Thomas, “becoming a na-tion of healthy hypochondriacs, living gingerly, worrying ourselves half to death,” is all too real.

References

23andMe.com. (2008). Accessed 10/30/08. <http://www.23andme.com>.Berndt E. (2005). To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs. The New England Journal of Medicine. 352(4): 325- 329.Boden W & Diamond G. (2008). DTCA for PTCA -- Crossing the Line in Consumer Health Education? The New England Journal of Medicine. 358(21): 2197.CDC. (2004). Genetic Testing for Breast and Ovarian Cancer Susceptibility: Evaluating Direct-to-Consumer Marketing. MMWR Weekly. 53(27): 603- 606.Conrad P. (2007). The Medicalization of Society: On the Transformation of Hu- man Conditions into Treatable Disorders. The Johns Hopkins University Press. 3-21.Donohue J, Cevasco M, Rosenthal M. (2007). A Decade of Direct-to-Consumer Advertising of Prescription Drugs. The New England Journal of Medicine. 357(7): 673.Frosch D, Krueger P, Hornik R, Cronholm P, Barg F. (2007). Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consum- er Advertising. Annals of Family Medicine. 5: 6-13.Frost R. (2003). Hip Marketing: Targeting a New Audience. Accessed Sep- tember 19, 2008. <http://www.brandchannel.com/features_effect.asp?pf_ id=185>. Gollust S, Hull S & Wilfond B. (2002). Limitations of Direct-to-Consumer Advertising for Clinical Genetic Testing. The Journal of the American Medi- cal Association. 288: 1762-1767.Hull S & Prasad K. (2001). Reading between the Lines: Direct-to-Consumer Advertising of Genetic Testing. The Hastings Center Report. 31(3): 33-35.Hunter D, Khoury M & Drazen J. (2008). Letting the Genome out of the Bottle -- Will We Get Our Wish? The New England Journal of Medicine. 358(2): 105.Mintzes B. (2002). Direct to consumer advertising is medicalising normal hu- man experience. British Medical Journal. 324: 908-911.Myriad Genetics, Inc. (2002). Myriad Genetics Launches Direct to Consumer Advertising Campaign For Breast Cancer Test. Accessed 9/20/08. <http:// www.corporate-ir.net/ireye/ir_site.zhtml?ticker=mygn&script=413&layou t=9&item_id=333030>.NHGRI. Direct to Consumer Marketing of Genetic Tests. (2004). Accessed 9/20/08. <http://www.genome.gov/12010659>. Pollack A. (2007). A Genetic Test that Very Few Need, Marketed to the Masses. The New York Times. Accessed 10/30/08. <http://www.nytimes. com/2007/09/11/business/media/11genetics.html>.Wolfberg AJ. (2006). Genes on the Web - Direct-to-Consumer Marketing of Genetic Testing. The New England Journal of Medicine. 355(6): 543-546.

John Kleimeyer is currently a senior at Cornell University in the College of Arts and Sciences. He plans to pursue a career in the Biomedical Sciences.

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Better the Devil you know? Screening in the Post-Genomic Era

Gregory LewisCambridge University

AbstrAct

The advance of genetic technology in recent years has been remarkable. The medical applications of such techniques are still emerging, but promise much more information about ourselves – perhaps most impor-tantly, our genetic risk of disease. An active topic of discussion is how such information should be handled, and the principle of Individual Sovereignty of own Information (ISI). How well ISI copes with expected challenges across research, medical and social theatres is evaluated. Perhaps the greatest effect of genomics on the field of Bioethics will be bringing the existing tensions and difficulties surrounding medical genetics into sharp relief.

Key Words: Individual Sovereignty, Rules of Consent, Control of Information

Since the sequencing of the human genome, the advances in high-throughput sequencing have been astounding. The first sequence was a effort across many labs over several years, and cost billions of dollars: now the race is on to reach the ‘thousand dollar genome’, as a pre-requi-site for use in personalized medicine (Hutchinson 2007). Having ones genome sequenced privately remains too expensive for most, but it is reasonable to suggest that genome sequencing will be cheap and readily available in the near future, given current trends. One technique, scanning a genome for a large number of single-nucle-otide polymorphisms and associating the results with disease risk, is offered by companies directly to individu-als. Advances in genetic techniques have also allowed us to study genetic variation between individuals, and to associate this to disease. Some diseases are known to be genetically determined. Many others have a heritable component, but no single gene seems to be the cause. With the ability to analyse a genome for hundreds of thousands of variants at a time, we can associate variants to risk of developing the disease. In these cases, genetic risk is often composed of a large ensemble of slightly-

risk-enhancing variants (Barnett et al. 2008). Research can grant insights into the mechanisms underlying these diseases, and such understanding can be employed to en-hance treatment. Looking further ahead, this can be one of the heralds of personalized medicine - the information in our genomes could be used to predict which diseases we are likely to suffer, which drugs we will have adverse effects to, and such knowledge can inform clinical and public health practice. The boon of information carries with it the risks of misuse: few of us want to be discriminated against based on our genetic code, and if knowledge of suscepti-bility outstrips ability to treat, we may find information an individual may be better off not knowing. There are two issues of importance. The first is what restrictions should be placed upon the dissemination and use of this new information. Genomic information has special characteristics. It is the more readily quantifiable com-ponent of disease risk, when compared to environmental factors. It is also be persistent and fertile – when later associations between given genetic variants and disease becomes available, past genomes can be screened ret-rospectively. Finally, the information is not restricted to

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a single person – it can implicate family members too. Advancing technology both extends and focuses these is-sues – all of us have different profiles of genetic risk to common diseases, as opposed to the few who have or carry the rarer, exclusively genetic conditions. This leads to more precise knowledge of the extent of genetic risk, as opposed to generalized heritability. Importantly, this information signals propensity to disease, rather than the disease itself – the confluence of genetic factors are only partly penetrant, and one can have a high-risk geno-type without ever exhibiting the disease phenotype. For those who opt to be screened, they can be offered a wide variety of information about their risk to large numbers of commonplace diseases (as well as potentially associations with other clinical matters, like outcomes for surgery, drug reactions, etc.) This knowl-edge can have positive or negative results for the indi-vidual – both in terms of personal well-being and the po-tential for this information to be used against them in the case of voluntary disclosure to employers and insurers. The widespread use of this technology could exert both changes in the genetics of the population and in their at-titudes. A whole genome scan of a patient can be treated as simply another sort of sensitive medical information. Thus when a genome is taken a patient (or research sub-ject) can specify whether the genome is to be kept or discarded, or the circumstances when this information is to be disclosed, to them or to others. In other words, the patient remains sovereign over their medical infor-mation, and medical staffs are obliged to obey their com-mands as a matter of duty. Let this be called the principle of Individual Sovereignty of own Information (ISI). Does this principle – rooted in the ideas of respect for patient autonomy and control over their personal information – cope with modern challenges?

Should We Relax the Rules of Consent?

In many cases, the issues of genetic research in the case of genomic scanning do not represent much of a step for-ward compared to the ground already covered by genetic testing. The type of information gained through genomic testing is much more diffuse, and thus does not implicate family to the same extent. Also, the risk of inadvertently discovering clinical information is low – one cannot see genetic risks ‘at a glance’ (as opposed to imaging tech-nologies) and thus information will only be of the sort explicitly sought after. One exception to this is the risk of discovering mistaken paternity, but such an issue applies

widely in genetic studies. There is a drive to widen consent – instead of an individual consenting to each trial in turn; they con-sent in general to their genetic information being used for research. This leads to large libraries of genetic data to be used for research (Knopper & Saginur 2008). Such a move is broadly supported by legislative bodies, and chimes with the wish of the large majority for their sam-ples to be used in research (Wendler 2006). Considering that the logistics of requiring repeated narrow consent can hamper or cripple research, and the lack of objection towards broad use of genetic samples, there seems to be a strong ethical case for such a relaxation. But the rights of the minority who do not want their genetic samples so used (or wish to be used in a limited way) should be respected, and individuals are informed to what catego-ries of research they are consenting to, and are at liberty to know or be ignorant of the results of such studies into their own genome. ISI encompasses these concerns.

What Do We Really Want to Know?

Information about genetic risk towards common chronic diseases has clinical utility. We can encourage those at risk to make lifestyle choices to minimize their environ-mental risk in compensation, as well as to target pro-phylactic therapies on at risk groups. They also have the potential to be intensely distressing, particularly condi-tions which are highly stigmatizing and feared, and those of which there is no control. Genomic scans offer less definite information than a test for Huntington’s, and in some sense do not represent much of an advance over prior knowledge – in many cases, we already possess a measure of heritabil-ity for a given disease. What it does offer is precision: in much the same way a Huntington’s test can transform a 50% risk for a suspected carrier to nearly 1 or 0 proba-bility, a person with a family history of a disease can get a better idea of risk through genomic scanning. Is it worth it for one to have a better idea of one’s own susceptibil-ity? It is well known a large number of factors affect our decisions about risk, and many of these are irratio-nal (Klein & Cerully 2007). There seems little reason to value these irrational motivators – to do so would imply the entire praxis of Bioethics, with its focus on rational decisions making, misses the point. If so, these other fac-tors cloud ethical decision making – they crowd out the signal from ones own values with psychological noise. Is this ground for medical paternalism? If in any situation it

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can be justified, the case is strongest for information of whole genome-scans, given both the limited information it offers and the difficulties in its interpretation. There remain benefits to respecting autonomy but now this has only conditional value, as opposed to the central place granted to it in the formation of ISI. As well as restricting information from an indi-vidual, one can also manipulate or withhold this infor-mation. Openness and honesty are traditionally valued communication styles for Doctors to their Patients, but in some circumstances there may be reason to adopt eu-phemistic or evasive responses sample the range of an extensive literature. Discretion in disclosure remains particularly important, especially for those who might over-react to knowledge of a risk.

Shared or Forsaken Sovereignty

Genetic information about an individual is also about their relatives. Navigating the issues when one per-son’s information can imply information about an-other is an ethical minefield. Instead, we should rec-ognise that information can have shared sovereignty amongst family members. We can hope that the fami-ly forms a mutual covenant surrounding disclosure of genetic information or family members respect each others right not to know – but neither of these are guaranteed, and situations arise where it is not pos-sible to satisfy ISI (Doukas & Berg 2001). Other prin-ciples can be employed instead, but they give differ-ing results (Fulda & Lykens 2006). Again, the nature of genomic information means that the implications towards family members are not so significant – how-ever, these families will be additions to those already grappling with such difficulties. Other issues arise when the individual lacks the ability to rule on how their genetic information is used, commonly through immaturity or mental ill-ness. These circumstances are less problematic for genomic scanning – its information tends to con-cern chronic diseases later in life and the harms and benefits can be assessed for an incapable individual. Neither of these represents novel concerns. Genomic screening has uses in reprogenetics and enhancing future children.

Does ISI Work?

Each advance in technology serves as a crucible for ethical theory. Individual sovereignty over own Infor-

mation represents orthodoxy in medical practise. Ge-nomic screening extends rather than revolutionizes the difficulties of medical genetics – not least because all stand to be affected. Although in some cases this is innocuous to ideas like ISI, in other cases it sug-gests ISI to be methodologically feckless or conceptu-ally misguided. It is hard to imagine these difficulties avoided by developing a different wording of ISI to abide by the same principles – the faults run deeper than linguistic legerdemain. Either these difficulties need to be solved, or we should cease to rely on the ethical orthodoxy on which ISI is based. Neither op-tion is easy, yet it is important to choose the right one.

References

Barnett JC, Hansoul S, et al. (2008). Genome-wide association defines more than thirty distinct susceptibility loci for Crohn’s disease. Nature Genetics. 40: 955-962.Beauchamp TL & Childress JF. (1994). Principles of Biomedical Ethics, 4th ed. New York: Oxford University Press.Doukas DJ & Berg JW. (2001). The Family Covenant and Genetic Testing. The American Journal of Bioethics. 1(3): 2.Fulda KG & Lykens K. (2006). Ethical issues in predictive genetic testing: a public health perspective. J. Med. Ethics. 32: 143-147.Higgs R. (1985). On telling patients the truth. In Lockwood, M. Moral Dilem- mas in Modern Medicine. Oxford University Press, Oxford.Hollowell N, Foster C, et al. (2003). Balancing autonomy and responsibility: the ethics of generating and disclosing genetic information. J Med Ethics. 29(2): 74-79.Hutchinson CA. (2007). DNA sequencing: bench to bedside and beyond. Nucleic Acids Res. 35(18): 6227–6237.Juengst ET. (1996). Respecting Human Subjects in Genome Research: A Pre- liminary Policy Agenda. In Vandepool, H. Y. The Ethics of Research Involv- ing Human Subjects: Facing the 21st Century. University Publishing Group, Maryland.Klein WMP & Cerully JL. (2007). Health Related Risk Perception and Decision Making: Lessons from the Study of Motives in Social Psychology. Social and Personality Psychology Compass. 1/1: 334-358.Knopper BM & Saginur M. (2008). Bio-banking. In Singer, P. A. and Viens, A. M. (eds) The Cambridge Textbook of Bioethics. Cambridge University Press, New York.Maguire P & Faulkner A. (1988). Communicate with cancer patients: handling bad news and difficult questions. BMJ. 297: 907-9.Terrenoire G. (1992). Huntington’s disease and the ethics of genetic predic- tion. J Med Ethics. 18(2): 79-85. The Wellcome Trust Case Control Consortium. (2007). Genome-wide as sociation study of 14,000 cases of seven common diseases and 3000 shared controls. Nature. 447: 661-678.Wendler D. (2006). One time general consent for research on biological samples. BMJ. 332: 544-7.

Gregory Lewis is currently a second year Medical stu-dent at Gonville and Caius College, Cambridge. He as-pires to a career in medical research.

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Human Genetic Engineering and Pluralistic Society

Michelle FleshnerUniversity of Michigan

AbstrAct

Through the completion of the Human Genome Project, we can now use genetic engineering not only for therapeutic purposes but also to enhance or reverse certain traits (e.g. small stature or baldness) before birth. Supporters of genetic enhancement argue that using advances in genetic engineering to improve an individual is acceptable because: 1) genes do not define an individual, and 2) improvement is not necessarily negative. Opponents believe that genes do define individuals and that using technology for enhancement will change both human nature and society. Future bioethical regulations, including the inclusion of lay people in bioeth-ics committees to account for the diversity found in society, and the emphasis that humanity will be protected best if individuals rely upon their personal moral codes rather than those of society when making decisions about genetic engineering.

Key Words: Genetic Enhancement, Theological Perspectives, Bioethical Regulation

The Science of Human Genetic Engineering

Technological advances in today’s society are nearing a breakthrough. The Human Genome Project was com-pleted in 2003. Approximately 20,000-25,000 genes in human DNA have been identified, sequenced, and stored (“Human Genome Project Information”). Based on this advent, it is foreseeable that genetic engineering is on the horizon. There are two types of cells in embryos that can be modified. The first are somatic cells. Somatic cell therapy does not get passed on to the next generation, as it is performed in tissues that are not located in the reproductive organs (Klug et al. 2006). Currently, genetic recombination in somatic cells has the most promise. The main technique used is called Pre-Implantation Di-agnoses, which is performed by removing embryos and selecting one or more unaffected embryos for transfer, thereby ensuring that the fetus will be healthy. This tech-nique has been used for successful births in families with a pre-disposition for diseases such as Cystic Fibrosis,

Tay Sachs disease, sex-linked genetic disorders, fragile X syndrome, and chromosomal abnormalities (Fletcher et al. 1996). The second type of potentially modifiable cells in embryos is germ-line cells. Germ-line cell therapy is performed in the reproductive cells, so the changes are passed on from generation to generation (Klug et al. 2006). This type of genetic engineering has not been re-searched as thoroughly as that of somatic cells, primarily because it is still not approved by the National Institute of Health, and will most likely not be available clinically for a number of years (Shannon 1993). Germ-line appli-cation to human beings is impractical at this point, but is not unforeseeable (Friedmann 2003).

Gene Therapy vs. Gene Enhancement

The main bioethical question regarding human genetic

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engineering involves distinguishing between gene ther-apy and gene enhancement. The first to arrive was gene therapy, also known as genetic engineering, which is cur-rently solely in somatic cells, limited to disease preven-tion. Genetic enhancement is the more heavily debated and potentially dangerous side of genetic engineering because it will be used to improve a trait that doesn’t necessarily need to be fixed. While genetic enhancement is far from being clinically available, it is on the horizon of human genetic engineering. The definition between therapy and enhance-ment is vague. At what point will something that was initially considered enhancement become therapy? In today’s society, therapy is limited to disease prevention. For example, screening a child for and preventing Cystic Fibrosis would be considered gene therapy. Screening a child’s entire genome and ensuring that he or she will be tall, beautiful, and intelligent is not. Will there be a time in the future where it is considered ‘therapeutic’ to give a child the traits for features such as height and strength? When does therapy become enhancement and at what point does enhancement become unethical? In human genetic engineering, where should the line be drawn?

Nurture, Common Good, and Memory-Life

Supporters of genetic engineering believe that genes play little role in what it means to be human. Instead, they believe that the human race is chiefly defined by ex-ternal factors; supporters take the “nurture” side of the renowned nature verse nurture debate. In other words, because of the constant increase in knowledge about genetic influences on physical and psychological expres-sion, there is temptation to define a person and his or her identity and relationships by their genetic profile. None-theless, when it comes to family values and personhood, it is important to consider emotions and environment, as genetics are not all that defines us (Charo 2000). Proponents of genetic engineering further ex-plain their views by emphasizing that even if genetic en-hancement were to change the meaning of being human, this wouldn’t necessarily be a bad thing. “Is what humans are defined as of now what humans ‘ought’ to be defined as? (Norgaard 2004).” Utilitarianism would argue that humans have a moral obligation to perform genetic en-hancement. This perspective can even go so far as to say that it would be unethical not to ‘design babies,’ because this is what would be best for society as a whole (Har-ris 2007). It is within human nature to resist change, but there is no real reason to do so. After all, genetic en-

hancement is called enhancement for a reason, and is not necessarily a negative consequence (Green 2008).

Opposing Perspectives to Genetic Enhancement

In the immediate future, gene therapy and gene enhance-ment may seem like admirable ideas. But what happens later? Sally Deneen, free-lance writer and bioethicist, believes that those who can’t afford gene enhancement will be relegated to second-class citizenship, which will eventually lead to two segregated species of human be-ings (Deneen 2001). Another fear is that genetic enhancement will change the moral order of humans and diminish the val-ue of human life. Enhancement to the point of perfection will cause humans to forget classic human traits that are not created by genes, such as kindness and virtue. Leon Kass considers that these are traits that make humans human and “Perfect bodies are achieved at the price of flattening souls” (Kass 2004). Excessive genetic enhance-ment may lead to an increase in inequality and discrimi-nation (Shannon 1993). The Islamic religion has primarily one school of thought, which disagrees with most forms of genetic en-hancement. The Qur’an says, “He creates what He wills and plans” (Athar 2008). In other words, enhancement therapies would be changing God’s plan and under Is-lam, this is not acceptable. Certain Christians agree with this sentiment and state that nature is God’s creation. Any manipulation of a person will objectify the body as a “thing” in nature that can be influenced, and this should be avoided (Lustig 2008). The last main fear of genetic engineering involves the critical bioethical question of how to distinguish be-tween therapy and enhancement. The key danger of gene therapy is that it would open doors for enhancement therapy. First, a family might try to ensure that its future child does not have any heart defects. Then, while they are doing so, they will ask if they can choose the sex of their baby. Just one more thing, will their child be good-looking and strong? This exemplifies the “slippery slope” that opponents fear will inevitably result from using gene therapy, which could eventually spiral out of control and change who and what human beings are (Shannon 1993).

Societal Abuse of Biotechnology

Ultimately, to be human is not purely genetically deter-mined, but play a significant role in determining who we

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are. Using genetic engineering as a way to enhance a hu-man being will cause change, if only because society will consist of a different gene pool. In some cases, enhance-ment could be looked at as beneficial if the enhanced individual uses his or her enhancement to contribute positively to the world. However, who is to say that this individual would not have contributed positively to the world otherwise? Bioethicist Greg Easterbrook argues the following point:

“Just think for a minute: If you had a choice be-tween a short, clumsy child who was going to become prematurely bald, and a tall, athletic, handsome kid with a full head of hair, every par-ent would choose kid number 2. You’d almost have some sort of weird responsibility to choose kid number 2. And yet, think of the great con-tributions that have been made to the world by short, clumsy, bald people (Kass 2004).”

Genetic enhancement most likely will not cause much visible harm to society. However, is this really the better option? One of the great things about society is diversity, and some of the most intelligent and talented people are those who do not appear asthetically superior to society at large. It is human nature in today’s competitive and in-dividualistic society for individuals to try to be the best they can, as society naturally seeks to be improved. This adds to the temptation to use genetic engineering to cre-ate “designer babies” (Deneen 2001). As dangerous or dehumanizing as this new genetic technology may be, none of these feared effects will occur if society does not misuse this technology. In other words, the problem is society’s use of science, not the science itself. Genetic en-gineering may scientifically arrive at the point where it can give parents the opportunity to have children with the most superior genetic profile possible. When looked at from a different perspective, if society does not treat enhanced individuals differently, then a change in the hu-man condition may not even be apparent. In turn, par-ents would feel fewer obligations to use technology to control features such as the outward appearance of their future children. Genetic engineering in the embryo may have the potential to do harm to society, but this is purely society’s choice.

Genetic Engineering - Pluralistic Society

When making bioethical decisions, all diverse viewpoints

of scholars must be considered and included. Looking beyond this, all diverse viewpoints of today’s pluralistic society must be considered and included as well. Bioethicist John Evans discusses the shift from “thick” to “thin” bioethics, specifically with regard to the debate on genetic engineering. As critics Karanen and Parker discuss in a review of Evans’ theory, thick bioeth-ics is the more substantial debate on what it means to be human, while thin Bioethics is a narrower, “formally rational” debate on the guidelines that must be formed concerning genetic engineering (Karanen et al. 2003). According to Evans, because society is so plural-istic, guidelines were needed to incorporate all the val-ues of society, and this is what caused the shift to thin Bioethics. Evans says that this shift has restricted the bioethical debate on genetic engineering to guidelines, rather than exploring deeper theoretical issues. More specifically, bioethicists are not considering the poten-tial long-term effects of genetic engineering on humans in society (thick Bioethics). Rather, they are focusing on the guidelines that are needed to form a pathway toward prevention of these hypothetical effects (thin Bioethics). In doing so, Evans fears they are not entirely considering the moral issues at stake. Consequently, the public should not over-rely on bioethical regulations because they may not accurately consider all views of society (Karanen et al. 2003). The idea of a ‘pluralistic society’ is one of the most important things to consider when analyzing this bioethical debate. When creating bioethical guidelines for genetic engineering, it is definitely important to con-sider the “thick” aspects of this argument because this is where the real ethical ramifications lie. Still, it is im-portant to keep in mind that thin Bioethics in the form of regulations is what accounts for the pluralistic nature of society. On the other hand, it is impossible to account for the pluralistic nature of society without examining the pluralistic views of society, which are found in thick Bioethics – or the more deeply rooted values of society. Ultimately, it is impossible to have one without the other, as thick and thin Bioethics together will comprise a more accurate way to study bioethical issues.

The Future of Bioethical Regulations

In determining whether human genetic engineering is ethical or not, there are several important factors to con-sider. First, the pluralistic nature of today’s society re-quires the incorporation of as many perspectives as pos-sible. In taking this approach, it is crucial to look at what

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might be the end result of gene enhancement (thick Bio-ethics), as John Evans discussed. A way of incorporating this idea would be to involve lay people in Bioethics com-mittees, as they may more accurately represent society than professionals. A major fear of including the public in Bioethics committees is that lay people may be less trust-worthy than professionals, mainly because their opinions are based on intuitions and prejudice rather than knowl-edge. Consequently, the inclusion of lay people must be carefully planned to ensure that as many perspectives as possible are incorporated into decision making (Scully et al. 2006). This system will avoid using a limited kind of analysis and will incorporate the theory of a ‘deliberative democracy’ into bioethical decision making. It is also important to note that after regulations on biotechnology are created, there will inevitably be sci-entific advances that could cause them to be outmoded. It is critical that any regulatory effort be flexible so as to change with science, if at all possible. At the very least, the public must be made aware that these laws have a strong potential for change at some point in the near future. This understanding can prevent the fears of the major opponents of genetic engineering from coming to fruition, and ensure that gene enhancement is kept un-der control and not abused.

References

Athar S. (2008). Enhancement technologies and the person: An Islamic view. Journal of Law, Medicine and Ethics. 36(1): 59-64, 62.Berger P. (1963). Invitation to sociology: A humanistic perspective. New York: Anchor Books, Doubley and Company. Charo A. (2000). And baby makes three – Or four, or five, or six: Redefining the family after the reprotech revolution. Wisconsin Women’s Law Journal. 15(231): 231-253, 232.Deneen S. (2001). Designer people. E-Magazine. 26-33. Fletcher J & Richter G. (1996). Human fetal gene therapy: Moral and ethical questions. Human Gene Therapy. 7(13): 1605-1614.Friedmann T. (2003). Approaches to gene transfer to the mammalian germ line. Designing our descendants: Promises and perils of genetic modifica- tion. ed. A.R. Chapman, and M. S. Frankel. Baltimore, MD: The John Hopkins University Press. 39-54. Green R. (2008). Babies by design: The ethics of genetic choice. Yale University. Harris J. (2007). Enhancing evolution: The ethical case for making better people. Princeton University Press.Human Genome Project Information. (2008). Human Genome Program. 2008. U.S. Department of Energy Office of Science. 11 Nov. 2008. <http://www. ornl.gov/sci/techresources/Human_Genome/home.shtml>.Karanen L & Parker L. (2003). Playing God? Human genetic engineering and the rationalization of public bioethical debate. JAMA. 289(10): 1313-1314.Kass L. (2004). Biotech ethics: Modern man and the pursuit of happiness. The American Enterprise. 15(2): 34-39. Klug W, Cummings M & Spencer C. (2006). Concepts of genetics. New Jersey: Pearson Education.Lustig A. (2008). Enhancement technologies and the person: Christian per- spectives. Journal of Law, Medicine and Ethics. 36(1): 41-50, 48.Mahoney J. (2003). Christian doctrines, ethical issues, and human genetics. Theological Studies. 64(4): 719-749, 746.

Norgaard R. (2004). Posthuman enough? Bioscience. 54(3): 255-259, 257.Scully J, Shakespeare T & Banks S. (2006). Gift not commodity? Lay people deliberating social sex selection. Sociology of Health and Illness. 28(6): 749-767.Shannon T. (1993). Bioethics: Basic writings on the key ethical questions that surround the major, modern biological possibilities and problems. Paulist Press.Zoloth L. (2008). Go and tend the earth: A Jewish view on an enhanced world. Journal of Law, Medicine and Ethics. 36(1): 10-25.

Michelle Fleshner is currently a junior at the University of Michigan majoring in Mathematical Biology and prepar-ing for a career in medicine. After graduation, she plans to pursue a dual degree in medicine and public health, focusing primarily on infectious diseases in developing countries.

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An Alternative to the treatment-Enhancement Distinction

Michael GarciaUniversity of California, San Diego

AbstrAct

With progress in the field of genetic screening and genetic engineering, important ethical questions have emerged. We now have the technology to screen fetuses for genetic abnormalities and provide information to potential parents who would rather abort disabled fetuses or consider medical treatment. Methods for screen-ing for Down syndrome, Spina bifida, Tay-Sachs and many other serious diseases are currently available. In addition, we also have technologies that allow us to enhance children through genetic and medical means. In such an environment exists an important question: should medical technology be used for treatment purposes only, or also for enhancement purposes? If we use it for both purposes, where should we draw the line? One reasonable answer is, “We should use genetic screening for serious disabilities and use enhancements only for moderate purposes so that it does not place people who lack access to such technology at a disadvantage.” This is the essence of the treatment-enhancement distinction - it attempts to draw a line between interventions meant to prevent or cure diseases or disabilities, and interventions that improve a condition that we view as a normal function or feature of humans (Cambridge Quaterly of Healthcare Ethics 2000).

Key Words: Freedom of Pain, Genetic Screening, Social Prejudice

This moral principle should first be justified in light of popular opinion. Most would agree that pleasure is a fundamental feeling that contributes to positive life ex-periences and improves quality of life, and that we all should have the right to pursue a high-quality life. Even though pleasure is difficult to define operationally or to quantify, it encompasses feelings of joy and is a source of happiness. Possessing the ability to avoid suffering al-lots an individual the means for increasing pleasure by minimizing pain, thereby improving quality of life. The importance of this moral principle is noticeable in societ-ies where citizens condemn forms of cruel and unusual punishment for prisoners, even in cases where criminals have committed violent crimes. These societies believe suffering is undesirable and should be minimized wher-ever possible. The right to feel pleasure and avoid pain can also be considered a value because it is a desirable

quality and is generally held in high regard. The freedom of pain principle can be used to ra-tionalize why screening should be permissible. Glover presents a compelling case where a married couple gave birth to a baby girl with Epidermolysis Bullosa (EB) and subsequently discovered that future pregnancies would run a 25% risk of a similar outcome (Sandel 2004). EB is a rare and painful genetic disorder that has no definitive cure other than prevention through screening. People born with EB lack the anchoring junctions that hold the layers of skin together; as a result, any rubbing or pres-sure creates painful sores. A child with EB has a limited capacity to avoid pain because the disease progressively becomes worse until death. For this reason, Glover labels EB as a disastrous disability and distinguishes it from other moderately severe disabilities (Glover 1992). The parents had to “watch [their] child die slowly and pain-

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fully” (Glover 1992). The freedom of pain principle pro-vides a persuasive argument for choosing to bring into the world a healthier child rather than one with EB – the reason being that dying a slow and painful life con-flicts with the freedom of pain principle. Herein, genetic screening is permissible. Likewise, the principle can be used to rational-ize why screening is not appropriate in other particu-lar cases. For instance, take a case where parents might want to screen for forms of severe depression. The future holds the potential for biomedical breakthroughs where the markers for depression might be well understood, and provide ‘solutions’ for undesired traits or predispo-sitions (Gonzalo et al. 2007). Parents could argue that depression has been linked to somatic and psychological pain – people with severe depression often wish they had never been born. Why would potential parents want to conceive a child who would experience such distress? Nevertheless, many forms of depression are readily treatable with cognitive-behavioral and medical interventions. With such measures, psychosomatic pain can be avoided without genetic screening. With help, the pain can be minimized substantially with a potential cure. More importantly, the capacity to derive pleasure from life can be restored. This can be seen in patients who have lived long, happy, and productive lives despite having been diagnosed with depression at some point in their lives. If we endeavor to protect people from being subjected to a terrible quality of life, we need to ensure that the link between predictable genetic conditions and negative life experience is unambiguous (Kaplan 1993). The depression case is simply not predictable enough and shows that the freedom of pain principle can be up-held without intervention. Cases of EB violate the freedom of pain prin-ciple and thus should be subject to genetic screening. This principle accounts for why people intuitively feel that those with severe or painful disabilities experience a lower quality of life than someone who is healthy. Ar-guably, an individual who experiences constant pain is likely to suffer more than someone who possesses the ability to avoid similar pain. For instance, someone suf-fering from arthritis is likely to avoid pain by avoiding ac-tivities that are likely to cause excessive joint movement. But someone with EB has very limited means of avoiding the pain. The skin is torn in places where placing protec-tive barriers like dressings to avoid scraping or scarring is impossible. Structures, such as the inner lining of the digestive tract and other deep tissue layers, are likely to blister, and protecting these structures is virtually im-

possible. Sufferers of EB have even compared the sores to third-degree burns (O’Brien 2004). In view of the fact that someone with arthritis can seek effective medical interventions to avoid the pain (e.g. taking mild pain medication) without serious side effect and the EB patient cannot, the EB patient’s mor-al principle is violated, and the only effective interven-tion available is to avoid the pain is through prevention -- genetic screening. One must emphasize, only extreme cases (like EB) should be screened. In these cases, avoid-ing pain is virtually impossible. There is no cure, no ef-fective treatment, no hope, and the pleasure potential is extremely limited. An argument against using the treatment-en-hancement distinction is that drawing a boundary be-tween the two is entirely arbitrary; defining exactly what entails a treatment or an enhancement can be problem-atic. The freedom of pain principle avoids the problem of arbitrariness. For example, Buchanan et al. presents a case where Johnny and Billy are potential candidates for growth hormone (GH) treatment due to their limit-ed projected height of 5 feet 3 inches (Buchanan et al. 2000). Without treatment, both candidates would suffer disadvantage equally despite their different etiologies (Johnny’s being a brain tumor affecting normal growth hormone secretions and Billy’s being pure genotype). It is important to note that neither Billy nor John-ny can be blamed for their heights because their heights are the result of the “natural lottery” (Buchanan et al. 2000). Moreover, their desire to be taller is based on an existing social prejudice, which discriminately favors taller males. This is precisely why it is considered a dis-advantage. So why should one consider Billy’s therapy enhancement and Johnny’s treatment? After all, the out-come is the same for both cases. Clearly, the distinction creates controversy and suggests that choosing a line is arbitrary or socially de-fined. Using the freedom of pain principle can resolve the problem by focusing on whether a violation of their right to live pleasurable lives and their capacity to avoid pain is occurring. This principle provides a non-arbitrary method of looking at the question, subsequently open-ing a forum to discuss whether the social stigma of being short constitutes a form of pain or hindrance in attaining pleasure. The freedom of pain principle is useful in that it acknowledges that there are forms of disabilities that should not be screened; as a result, it can draw a clear line even when two disabilities negatively affect the qual-ity of life. The determining factor should be whether the

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right to live a pleasurable life or avoid pain is violated. Glover’s narrative of The Woman shows how a disorder that can potentially dampen the quality of life should not be genetically screened in lieu of the odds (Glover 1992). The Woman is about a woman with Spina bifida who managed to live a pleasurable life despite her disabil-ity; she obtained a university degree, got married, and conceived two healthy children (Glover 1992). Simply screening against Spina bifida or similar disorders could lead to aborting a fetus whose freedom of pain principle could still be upheld. Is it reasonable to assume, defini-tively, that someone with Spina bifida has no chance at living a pleasurable life or no capacity to avoid pain? The Woman defended her right to be alive and stated before a court, “Thank God this ‘abnormal’ fetus was conceived in 1947,” referring to herself (Glover 1992). It is easy to assume that a disability like Spina bifida would severely dampen the quality of life by causing excessive pain and limiting pleasure. The Woman proves otherwise, howev-er: the freedom of pain principle is not violated. Who are we to decide the value of another per-son’s life by choosing who gets to be born? Another direct objection is that screening programs send a subtle and disturbing message--that it would be better if severely disabled persons were never born (Glover 1992). This message engenders a form of discrimination against dis-abled people in general. This seems rather blatant when in vitro fertilization is attempted--only the most viable embryos and those least likely to develop developmental abnormalities or disabilities are chosen for implantation In such a process, active efforts are undertaken to weed out unacceptable embryos. Glover states that such screening could endanger the equality of respect for disabled people and reinforce negative attitudes towards them (Glover 1992). Simi-larly, Kaplan would argue that such screening would be sending a negative message to the disabled community already present in our society. This is evident in the deaf community, which has actively challenged the medical community in its efforts to use cochlear implants for deaf children. All of these are reasonable objections. Cases of depression do not generally violate the freedom of pain principle and thus should not be sub-ject to genetic screening. However, there are objections to this premise as well. The potential parent, for example, could argue that depression causes severe pain (somatic and psychological) and such suffering would significantly decrease a child’s quality of life. For example, one notable symptom of severe depression is anhedonia, the inability to derive pleasure from life. The general loss of ability to

feel pleasure is a clear violation of the freedom of pain principle and would therefore follow guidelines similar to an EB case. Furthermore, depression can become so severe that sufferers may commit suicide; most people who commit suicide have a diagnosable mental disorder like depression (Andrew 2008). Although one could ar-gue whether or not depression itself is the direct cause of suicide, the notion that depression would cause this level of distress is alarming and suggests a significant amount of pain or critical lack of pleasure. This is an apparent violation of the freedom of pain principle and would lend support to allowing genetic screening in cases of depres-sion. In the case of Billy and Johnny, does living in a society that is biased against males who are shorter than 5 feet 3 inches create a significant amount of pain or in-ability to feel pleasure? Their parents may argue that happiness is intricately tied to society’s attitude towards us. This idea is congruent with Kaplan’s argument that, in many cultures, there is a traditional belief that the ex-istence of a disability is an overall negative trait (Kaplan 1993). A society that places more value on a taller male would look unfavorably on Billy and Johnny in pursuit of particular goals, a life partner, or general acceptance into a community, and, as a result, give them significant psychological distress. The capacity to avoid the stigma is hampered by the constant negative public perception of being short. This distress could hypothetically lead to depression or psychological pain. As a result, the objec-tion raised is that such psychological pain would violate the freedom of pain principle, and can be avoided with genetic screening. The freedom of pain principle can be upheld in the case of depression and, as a result, genetic screen-ing for depression should not be allowed. The objections previously mentioned in favor of allowing genetic screen-ing for depression centered on the idea that depression can lead to psychosomatic forms of pain and potentially limit an individual’s capacity to feel pleasure. However, depression is mitigated not only by genetic makeup but also by environmental factors. For this reason, relying solely on genetic screening as a form of preventing pain is not sufficient. Furthermore, one can utilize Glover’s compromise policy to help differentiate between disas-trous disability (e.g. EB) and moderate or mild disabili-ties (e.g. depression). The disastrous disability would create much greater pain and hindrance for pleasure than a moder-ate to mild disability. Another important aspect to con-

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sider is that people in general are prone to feeling variant forms of depression. When people face personal difficul-ties, there is a natural tendency to feel depressed. It is a natural propensity that can often be overcome through willpower and determination. According to Sandel, the moral status of nature is important (Sandel 2004). Thus, performing genetic screening to remove the natural ten-dency to feel depressed would undermine the “gifted-ness” of life (Sandel 2004). The giftedness of life puts forward the notion that, despite our efforts, we are not completely respon-sible for our endowments because our powers and ac-complishments are a gift. As such, our ability to naturally overcome forms of depression is also a natural (e.g. ge-netic) gift. Even while there are natural cases of depres-sion that can be overcome by sheer spirit, there are se-vere forms of depression that may require professional help. But even in such severe cases, medical intervention and not genetic screening can help uphold the freedom of pain principle by providing therapy that will minimize pain and aid in enhancing quality of life. Simply screen-ing against depression would be a quick solution to the problem, but this would come at the expense of losing the giftedness of life. Despite the objections posed against the free-dom of pain principle, the principle helps clarify, to some degree, when genetic screening is permissible without relying on the conflict-ridden treatment-enhancement distinction. It helps provide a non-arbitrary line between enhancement and distinction. Although the objections are valid, the freedom of pain principle can address each by placing the emphasis on pleasure potential and the ca-pacity to avoid pain.

References

Andrew LB. (2008). Depression and Suicide. Retrieved 2008 from <http:// www.emedicine.com/EMERG/topic129.htm>.Buchanan, Allen, Brock D, Daniels N & Wikler D. (2000). From Chance to Choice: Genetics and Justice. Cambridge: Cambridge University Press. 115.Cambridge Quarterly of Healthcare Ethics. (2000). Breaking Bioethics Special Section: In Pursuit of Perfect People: The Ethics of Enhancement. Normal Functioning and the Treatment-Enhancement Distinction. 9:309-322.Glover J. (1992). Future people, disability, and screening. In: Laslett P and Fishkin JS (eds.) Justice between Age Groups and Generations. 127–143. Connecticut, NH: Yale University Press. 431-35.Gonzalo L, et al. (2007). Markers for depression. Am J Psychiatry. 164: 1530- 1538. Genetic Markers of Suicidal Ideation Emerging During Citalopram Treatment of Major Depression.Kaplan D. (1993). Prenatal Screening and its Impact on Persons with Disabili- ties. Clin Obstet Gynecol. 36(3): 605-12, 135.Mann D. (2005). Out of the Blue: Brooke Shields’ Struggle With Postpartum Depression. Retrieved from WebMD. <http://www.webmd.com/depres- sion/postpartum-depression/features/brooke-shieldsdepression-strug- gle>.

O’Brien M. (2004). The Columbia Observer. Retrieved from <http://www. columbia.edu/cu/observer/issues/2004Fall/nonfic/Caroline.html>.Sandel M. (2004). The Case Against Perfection: What’s wrong with designer children, bionic Athletes and genetic engineering. The Atlantic. 51; 57.

Michael Garcia is a senior at the University of California, San Diego. He is an aspiring researcher in the field of bio-medicine and hopes to pursue his graduate sutdies at the Univeristy of California, Los Angeles.

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One Size Does Not Fit All: Race should not be asubstitution forgenetic variation

Heather Pace Cornell University

AbstrAct

It is believed that the variation in drug reactions stems from “metabolic and genetic differences between pa-tients” (Weigmann 2006). The budding field of pharmacogenomics aims to eradicate the problem of adverse drug reactions by determining how an individual’s genes affect the body’s response to certain drugs (AMA [updated 2008], Weigmann 2006). In the past, as well as the present, physicians have made assessments for medical treatments based on race or ethnicity (Weigmann 2006). This practice fosters the erroneous belief that race and ethnicity are biological factors rather than a social construct. While prescribing medication based on race seems to be an effective method, the practice of taking race and ethnicity into account, rather than genetic variances, may promote the production of race-based drugs. With the emergence of pharmacog-enomics, the health care industry should cease the practice of race-based medicine and stop designing drugs for specific races.

Key Words: Race-Based Drugs, Adverse Drug Reactions, FDA Regulation

Despite the rigorous clinical trials that prescription drugs undergo before entering the market, the persistence of adverse drug reactions (ADRs) among groups of individ-uals illustrates the need for more specialized drugs. ADR is a serious and potentially fatal problem in U.S. medicine, causing an estimated 100,000 deaths in hospitalized pa-tients and 2.2 million injuries annually (Lazarou et al. 1998). The incidence of “fatal cases among hospitalized patients has been reported at 6% to 7%, making [ADR] the fourth leading cause of death in the United States” after cancer, coronary heart disease, and stroke (Weig-mann 2006, Lee 2005). It is common protocol for physicians to assess their patient’s race, and this has evolved into the use of race as a factor for “individualized” treatment with pre-scription drugs. Sally Satel, a psychiatrist and resident scholar at the American Enterprise Institute for Public Policy Research, asserted in a New York Times Magazine editorial that a patient’s race is always noted “because

certain diseases and treatment responses cluster by ethnicity. Recognizing these patterns can help prescribe medications more effectively” (Weigmann 2006). In a specific occurrence, Dr. Satel wrote that Prozac is always prescribed at a lower dosage for African Americans “be-cause clinical experience shows that blacks metabo-lize antidepressants more slowly than Caucasians and Asians” (Weigmann 2006). Indeed, from 1995 to 1998, information for fif-teen new drug products contained a statement about their differing effectiveness by race. A 2004 Nature Ge-netics article observed that additional claims had been made in peer-reviewed journals that at least 29 medi-cations “have racial or ethnic differences in efficacy or safety” (Tate & Goldstein 2004). The distribution of the article was immediately taken up by the media with the Los Angeles Times reporting “29 drugs that are known to have different efficacies in the two races” and the Times of London asserting “research from the University College

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London showing that 29 medicines have efficacy profiles that vary between ethnic or racial groups” (Kahn 2005). However, the original Nature Genetics article also stated that the claims were “universally controversial” and there was “no consensus on how important race or ethnicity is in determining drug response” (Tate & Goldstein 2004). None of the drugs were thought to result in differing reac-tions by race. In fact, the authors only considered 4 of the 29 drugs to have a possible genetic causation related to the differential drug response, while an additional 9 pro-vided evidence of “association” with “reasonable under-lying physiological basis” and the remaining 16 had “no demonstration of a physiological basis” (Kahn 2005). Nevertheless, proponents of race-based medi-cine continue to argue that, until individualized genetic medicine is a fully viable option, race can stand in for hu-man genetic variance. While race does exist in society, it is not concrete like an individual’s genome. For instance, depending on the facial characteristics and skin color of a person, he or she may be labeled Hispanic or Caucasian in different societies. If two different societies label an in-dividual differently based on race, how can race be a reli-able method by which to determine medical treatments? Broad racial categorizations such as Hispanic or Cauca-sian are often meaningless, acting as a “blurry proxy” that includes almost as much genetic diversity as exists within the population as a whole (Christensen 2004). Even if the broad racial categories were made more specific, significant variation exists. This is demon-strated by a study noting that 62% of Ethiopians have al-lele frequencies of drug-metabolizing enzymes closer to Eurasian populations than to other recognized Ethiopi-ans (Phimister 2003). A specific example of genetic vari-ability within a defined category is the enzyme CYP2D6, which metabolizes codeine, antipsychotics, and antide-pressants (Ng et al. 2008). The CYP2D6*17 form has a lower enzymatic activity than the wild type and is pres-ent in African populations; however, various populations within Africa have different frequencies of the variant (Ng et al. 2008). For instance, the *17 allele of CYP2D6 is present in 9% of the Ethiopian population, 17% in the Tanzanian population, and 34% in the Zimbabwean pop-ulation (Ng et al. 2008). Therefore, grouping all of Africa into one racial category is not an effective way to repre-sent specific populations and their genetic variability. Even with studies that demonstrate the existence of genetic variation within specific racial categories, the routine practice of administering medical treatments based on race has led to the inevitable pursuit of race-based drugs. In a 2004 article published in the Journal of Pediatrics, Dr. Richard Garcia commented on the well-established method of assessing patients first in terms

of age, race, and gender – “always in that order” (Garcia 2004). A “46 year old white female” or “three month old Asian male” are typical initial assessments that play a sig-nificant role in determining medical treatment (Garcia 2004). In his criticism of using race in medical diagnoses, Dr. Garcia mentions the current textbooks used in medi-cal schools, which emphasize that knowing the patient’s race “helps the doctor make an accurate diagnosis” and “should influence the doctor’s thinking about possible di-agnoses” (Garcia 2004). As a result, various racial groups have been linked to certain diseases. An Ashkenazic Jewish patient might have Tay-Sachs disease, an African boy might have sickle-cell anemia, or an Asian girl might have thalas-semia. However, the only Tay-Sachs patient Dr. Garcia ever diagnosed was actually Mexican (Garcia 2004). In a scenario where the established medical assessment has become detrimental to the patient, Dr. Garcia reports the incidence of a black girl being misdiagnosed for a fever at 2 years of age and pneumonia at 4 years of age (Garcia 2004). Only when a radiologist, who had never physically seen the girl, saw her chest radiograph was the patient correctly diagnosed at age 8 with cystic fibrosis. This in-grained practice of associating a racial group with a spe-cific disease or response to a drug suggests that there is a seemingly legitimate link, erroneously implying the exis-tence of a separate genetic factor for race. The approval of BiDil, a drug “specific for” Afri-can Americans, is further evidence of the continued asso-ciation of racial categories with specific disease or drug responses. In 2005, NitroMed introduced BiDil, a drug comprised of two generic drugs previously used to treat heart failure, as the first race-specific drug approved by the U.S. Food and Drug Administration (FDA) (Kahn 2005). Initially touted as the first personalized, pharma-cogenomic drug, BiDil targeted African American popu-lations and was approved by the FDA based on A-HeFT (African-American Heart Failure Trial), a clinical trial that enrolled self-identified African Americans (Kahn 2005). In actuality, BiDil’s efficiency was not determined by any genetic markers in the African American popu-lation, thereby replacing it as a race-based medication rather than a pharmacogenomic drug. Although the re-search stated that BiDil improved hospitalization rates by 43 percent, NitroMed failed to mention that the only subjects tested were self-identified black patients (Kahm 2005). Thus, “the results sa[id] nothing about whether BiDil works differently or better in African Americans than in anyone else” (Kahn 2005). Ultimately, the ac-ceptance of BiDil creates a major racial difference where none might otherwise exist. In approving BiDil on the ba-sis of trials consisting only of African Americans, the FDA

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further condoned the use of race trials and allowed “the use of race as a biological category” (Harry 2008). In allowing researchers to consider race instead of genetics, the FDA is facilitating a trend towards race-based clinical trials, resulting in the creation of ethnic drugs rather than individually tailored therapy. Unfortu-nately, if drug approval can be obtained after race-based clinical trials, there will be no economic incentive for pharmaceutical companies to take on the costly clinical testing necessary to discover the genetic basis of differ-ential response. For instance, Dr. Satel used the authorization of BiDil to support her claim of factoring race into the as-sessment of patient prescriptions; this allowed her to use “skin color as a marker for genetic heritage” (Satel 2002). Contrary to Dr. Satel’s belief, most scientists agree that race makes “a bad scientific concept” (Weigmann 2006). Not only do humans share 99.9% of their genetic make-up, regardless of race, most of the variance that occurs in the remaining 0.01% is shared between whole popu-lations as well as individuals (Weigmann 2006). In the 2008 Nature article analyzing the genome of Dr. Watson, it was discovered that he is homozygous for the *10 al-lele of CYP2D6, a variant prevalent in East Asian popu-lations. However, Dr. Watson self-identifies as Caucasian (Ng et al. 2008). As a result, his genotype indicates that he will metabolize certain drugs differently than most of the Caucasian population. If physicians used race as a deciding factor in drug prescription, individuals like Dr. Watson, who aren’t genetically representative of their ra-cial group, may be inaccurately prescribed an ineffective drug or one that might be detrimental to their health. The fact remains that there is currently no evi-dence that suggests a unique link between genetic vari-ants and racial groups. Charles Rotimi, a biochemist and genetic epidemiologist at the National Human Genome Center, emphasizes the importance of recognizing that “genetic variants cut across social demographic groups in ways that make it difficult for us to consistently say who is black or Hispanic, for example” (Weigmann 2006). Moreover, the increased percentage of mixed-race indi-viduals also adds to the difficult process of labeling an individual’s ethnic makeup. Dr. Garcia, a Mexican born in Northern Califor-nia, and his wife, an African American, have a biological child who is blonde with green eyes and pale skin (Gar-cia 2004). To any physician, she would be assessed as a white female even if “her race can never be known” (Gar-cia 2004). Because mixed-race individuals cannot be cat-egorized into specific racial groups, they must be treated

as individuals and will not benefit from the continued substitution of race for genetic variants. Pharmacogenomics are the only reliable way an individual can be assessed for a genetic variant that ultimately affects drug response. Currently, most phar-macogenomic therapies have been applied to cancer patients. For instance, TPMT (thiopruine methyltrans-ferase) is an enzyme that metabolizes thiopurines, thera-peutic compounds used in treating childhood leukemia. Approximately 5% of Caucasians have genetic variants that prevent them from producing the active form of TPMT (Pistoi 2002, Tai et al. 1996). As a result, patients with these genetic variants used to have adverse drug reactions due to the high toxic levels of thiopurine buildup (Pistoi 2002). Today, doctors can use a genetic test to screen patients for this deficien-cy before prescribing the drug, subsequently monitoring the patient to determine the appropriate dosage levels of thiopurine (Pistoi 2002). Unlike race-based medicine where the prescription given would have been based on the drug response of the Caucasian population as a whole, pharmacogenomics is a more efficient and trustworthy method for making sure the individual is prescribed the right drug at the correct dosage. It is erroneous to think of race-based drugs as per-sonalized or individualized medicine. There is no sound evidence that exclusively links racial groups to specific diseases or drug responses. How can something as sub-jective as race be a reliable indicator of how much of a drug a patient should be prescribed? Unfortunately, race is a significant factor in physician assessments and does influence a patient’s drug prescription. With the approv-al of BiDil, it is a concern that pharmaceutical companies will start to tailor the creation of drugs to specific racial groups. This would promote and further the current use of race as a “biological factor.” Therefore, pharmaceutical companies should not actively pursue the development of race-based drugs. Such drugs lead to the over-gener-alization of racial groups and thwart genetically variant individuals from getting effective treatment. A proposed solution to prevent pharmaceutical companies from creating “ethnic drugs” is to prohibit drug approval on this basis during the NDA (new drug application) process required by the FDA. Dr. Craig Ven-ter, founder of the Institute for Genomic Research, sug-gests an approach by the FDA to refuse “to accept race as a proxy by passing guidelines requiring genomic analysis of large admixed populations to determine if distinct ge-netic variations between groups exist” (Harry 2008). If race or ethnicity is used as a “pseudo-biological variable,”

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the FDA could require an explanation of how the racial group was selected, justifying their decision by provid-ing convincing scientific evidence “supporting their as-sertion that race-specific genetic differences result in the relevant medical condition” (Harry 2008, Kahn 2005). In the clinical setting, physicians should not allow race to significantly influence their diagnoses. Medical students and physicians alike must be taught that an observed re-lationship between certain racial groups and a disease or drug response should not preclude the possibility that other racial subpopulations can have a similar result. If the current practice continues, misdiagnoses will occur and “real, physical harm can come from calling a child with cystic fibrosis an African American” (Garcia 2004).

References

Braun L, Fausto-Sterling A, Fullwiley D, Hammonds EM, Nelson A, Quivers W, Reverby SM, Shields AE. (2007). Racial categories in medical practice: how useful are they? PloS Medicine [Internet]. [cited November 23, 2008]; 4(9):1423-1428. Available from: <http://www.pubmedcentral.nih.gov/ picrender.fcgi?artid=1989738&blobtype=pdf>.Christensen D. (2004). Scientists divided on relevance of race in medical research. Nature Medicine. 10(12): 1266.Garcia R. (2004). The Misuse of Race in Medical Diagnosis. Pediatrics. 113(5): 1394-5.Harry S. (2008). FDA Approval of BiDil: First Sem to Pharmacogenomics or Detour into Race-based Medicine? Health Law Review. 16(4): 34-35.Lazarou J, Pomeranz BH, Corey PN. (1998). Incidence of adverse drug reac- tions on hospitalized patients: a meta-analysis of prospective studies. JAMA. 279: 1200-1205.Lee SS. (2005). “Racializing Drug Design: Implications of Pharmacogenomics for Health Disparities.” American Journal of Public Health. 95(12): 2133- 2138.National Cancer Institute [Internet]. U.S. National Institutes of Health; [cited September 21, 2008] Available from: <http://www.cancer.gov/Templates/ db_alpha.aspx?CdrID=454742>.Ng PC, Zhao Q, Levy S, Strausberg RL, Venter JC. (2008). Individual genomes instead of race for personalized medicine. Clinical Pharmacology & Thera- peutics. 84(3): 206-309.Pharmacogenomics [Internet]. [updated October 6, 2008]. American Medical Association; [cited September 11, 2008] Available from: <http://www.ama- assn.org/ama/pub/category/2306.html>.Phimister E. (2003). Medicine and the racial divide. NEJM. 348(12): 1081- 1082.Pistoi S. (2002). Facing your genetic destiny, part II. Scientific American [Internet]. [cited September 21, 2008]. 6: 20. Available from: <http:// www.sciam.com/article.cfm?id=facing-your-genetic-desti>.Satel S. [Internet]. [published May 5, 2002] I am a racially profiling doc- tor. New York Times Magazine. [cited September 21, 2008] Available from: <http://query.nytimes.com/gst/fullpage.html?res=9B02E2DA1F3EF936A 35756C0A9649C8B63>.Tai HL, Krynetski EY, Yates CR, Loennechen T, Fessing MY, Krynetskaia NF, Evans WE. (1996). Am J Hum Genet. 58(4): 694-702.Tate SK & Goldstein DB. (2004). Nature Genetics. 36: S34-S42.U.S. Food and Drug Administration [Internet]; [cited September 25, 2008] Available from: <http://www.fda.gov/oc/gcp/default.htm>.Weigmann K. (2006). Racial medicine: here to stay? EMBO reports. 7(3): 246- 249.

Heather Pace is currently a senior at Cornell University, planning to work at an international pharmaceutical company and traveling before returning to the U.S. for graduate school.

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A Scientific Expedition in ProcreativeBeneficence

Justin D. StahlJohns Hopkins University

AbstrAct

Congenital disorders have been viewed as unwelcome since the dawn of humanity. As Allen G. Roper writes in Ancient Eugenics, “the first Eugenist was not the Spartan legislator, but the primitive savage who killed his sickly child…the weakly, the deformed, and the superfluous were a burden to the tribe. [Thus] Human law, superseding natural law, strove to eliminate them at birth” (Roper 1913). In contemporary society, such ac-tions would be met with a fury of protest, yet we embrace prenatal testing and subsequent termination if an abnormality is found. With this in mind, some have argued that our mens rea has not changed over time but rather that our procedures have simply become less barbaric. In fact, prenatal testing often screens for over 250 birth defects—many of which carry comparably high abortion rates (Leroi 2006). Despite public policy championing equality and social justice for the disabled, the popularity of genetic testing, followed by abor-tion upon discovery of an abnormality, there remains a palpable dichotomy between theory and practice. With this in view, perhaps it is time for a change in policy. The ethics of these decisions will be examined given the way the brain, physiologically speaking, responds to ‘moral’ dilemmas as advanced by Joshua Greene and consider these findings in the context of traditional, moral thought.

Key Words: Eugenics, Doctrine of Double Effect, Economic Cost of Disability

In A Treatise on Human Nature, David Hume raised the proverbial is-ought problem (Hume 2000). The idea be-hind this problem is that many philosophers, attempt-ing to make statements about what ought to be, end up relying on statements about what is. Hume’s argument is essentially the driving force behind what has since been dubbed the naturalistic fallacy by G.E Moore, and what Bernard Davis has called the moralistic fallacy. The naturalistic fallacy is the idea that what is ethical can be reduced to a natural property such as the tendency to produce happiness (Moore 1903). Conversely, the mor-alistic fallacy is invoked whenever a claim is made that if something is immoral, then it cannot be ingrained in human nature (Davis 1978). While it is essential to keep these ideas in mind when discussing ethical behavior in general, it is doubly important in the case of procreative beneficence. The reason behind the added significance is what Nicholas Rescher calls “value restandardiza-

tion.” In a medical context, this means that conditions that were once considered untreatable are now seen as conditions that require prevention, treatment, or both (Rescher 1969). Prenatal diagnosis has clearly led to a value restandardization in the same sense that—prior to amniocentesis or chorionic villus sampling—we did not see Down syndrome, cystic fibrosis, or Tay-Sachs disease as requiring prevention, and those who did were sharply put in line by a wave of anti-eugenist sentiment. Thus, when dealing with procreative beneficence, the ‘norma-tive’ state of affairs is changing so rapidly that we can easily lose sight of what “ought” to be and what “is.” With this weakness in mind, the next step is to reason through the question of moral agency. In criminal law, the legal system differentiates between the physical (objective) and the mental (subjec-tive) components of a criminal offense. In order to ob-tain a conviction, the law typically requires that the actus

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reus (guilty act) along with the mens rea (guilty mind) are coordinated such that they constitute a violation of the law. This legal presumption illustrates the difference between intention and causation, both of which are cru-cial to moral agency. However, one encounters a problem in parsing the significance of these two elements. An agent, intending to produce a good consequence, may also end up producing a foreseen–but unintended–bad consequence. This problem has been addressed by what is known as the Doctrine of Double Effect. The traditional formulation of the Doctrine of Double Effect is the follow-ing:

1. That the action itself from its very object be good or at least indifferent; 2. That the good effect and not the evil effect be intended;3. That the good effect not be produced by the evil effect;4. That there be a proportionately grave reason for permitting the evil effect (Mangan 1949).

In assessing the significance of moral agency, the Doctrine of Double Effect comes in handy by highlighting the im-portance of defining fundamental axioms such as “good” and “evil.” When defining these terms from a deontologi-cal perspective, selective abortion violates the protection of human life and is found unethical in both the first and third rules. However, if we are to define these terms in accordance with the particular brand of consequental-ism that contemporary US law embraces, then there is no need to apply the doctrine as abortion is a morally neu-tral action. Thus, if we truly stand by our acceptance of abortion—and the statistical ‘we’ do—then isn’t this util-itarian approach what logically follows? Isn’t this what we ‘ought’ to be promoting? This idea becomes increasingly poignant when viewed side-by-side with the information presented by cutting-edge neuroscience. For instance, Joshua Greene, an assistant professor of psychology at Harvard Univer-sity, has begun using functional MRI to study the physi-ological basis of moral decision-making. In doing so, Greene presents his subjects with the following moral dilemma:

A trolley is running out of control down a track. In its path are 5 people who have been tied to the track by a mad philosopher. Fortunately, you can flip a switch which will lead the trolley down a different track to safety. Unfortunately,

there is a single person tied to that track. Should you flip the switch? (Greene 2007).

As Greene points out, “the consensus among philoso-phers, as well as people who have been tested experi-mentally, is that it is morally acceptable to save five lives at the expense of one in this case” (Mangan 1949). How-ever, Greene’s fMRI data demonstrates that those who say “yes, it is ethical”—the consequentalist argument—show greater activity in areas of the brain associated with higher ‘cognitive’ functions, while those who say “no, it is immoral”—the deontological argument—have greater activity in the ‘emotive’ areas of the brain. Greene then presents his subjects with a revision of Judith Jarvis Thomson’s “footbridge problem”(Thompson 1976):

As before, a runaway trolley threatens to kill five people, but this time you are standing next to a large stranger on a footbridge spanning the tracks, in between the oncoming trolley and the five people. The only way to save the five people is to push this stranger off the bridge and onto the tracks below. He will die as a result, but his body will stop the trolley from reaching the oth-ers. Is it okay to save the five people by pushing this stranger to his death (Greene 2007)?

Here, however, the general consensus is that it is immor-al. Thus, in the trolley problem people take a consequen-talist stance, while in the footbridge problem they take a deontological stance. In light of this, Greene identifies the trolley problem as an ‘impersonal’ moral decision, while identifying the footbridge problem as an ‘up close and personal’ moral decision. An ‘impersonal’ moral decision is one that evokes little-to-no emotional response, and thus favors the cost-benefit analysis of consequental-ism, while the ‘up close and personal’ dilemma triggers an alarm-like emotional response that favors a deonto-logical approach. Thus, as Greene notes, Joseph Stalin’s infamous truism “the death of one man is a tragedy; the death of a million is a statistic” actually has a physiologi-cal underpinning. What this information lends to pre-implantation genetic diagnosis (PGD) and subsequent abortion is that the scenario is ‘impersonal’; we are not ‘wired’ to perceive it as interpersonal violence and con-sequently find it permissible. It is also worth noting that many evolutionary bi-ologists consider moral decision making to be an evolved trait. “Up close and personal” violence was dominant long before our brains developed the capacity for reason,

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and so it should come as no surprise that we developed a primitive, emotional response to interpersonal violence as a means of conditioning our behavior to link surviv-al with cooperation and individual restraint. As Greene comments:

Nature doesn’t leave it to our powers of reason-ing to figure out that ingesting fat and protein is conducive to our survival. Rather, it makes us hungry and gives us an intuitive sense that things like meat and fruit will satisfy our hun-ger. Nature doesn’t leave it to us to figure out that fellow humans are more suitable mates than baboons. Instead, it endows us with a psy-chology that makes certain humans strike us as appealing sexual partners, and makes baboons seem frightfully unappealing in this regard. And, finally, Nature doesn’t leave it to us to fig-ure out that saving a drowning child is a good thing to do. Instead, it endows us with a pow-erful “moral sense” that compels us to engage in this sort of behavior (under the right circum-stances). In short, when Nature needs to get a behavioral job done, it does it with intuition and emotion wherever it can. Thus, from an evolu-tionary point of view, it is no surprise that moral dispositions evolved, and it is no surprise that these dispositions are implemented emotionally (Greene 2007).

The notion that we evolved to have these intuitive re-sponses count as evidence of moral meaning is not radi-cal. In fact, Leon Kass, the former chair of the President’s Council on Bioethics, unknowingly expressed this exact mechanism in his book, the Wisdom of Repugnance (Asch 1999). Philosophically, this concept has also been ex-plored. David Hume recognized this cardinal fact when he wrote that if we have no sensory experience of a con-cept—such as a fetus in the womb—then that concept cannot be meaningful (Hume 2000). To illustrate this, compare infanticide and abortion in terminating a genet-ically abnormal child. Infanticide involves the slaying of a newborn. Since the child has exited the womb, we have sensory experience of it and it is therefore ‘meaningful’ in the sense that essentially all nations today endow it with the rights of a fully-functioning child. Thus, to kill this child is to commit homicide. We deem this immoral, amongst other reasons, because we perceive it as inter-personal violence. When it comes to abortion however,

we do not perceive it as interpersonal violence—thus finding it morally neutral or permissible—because we have no sensory experience of the “individual” being harmed. Ultimately, what this scientific digression lends to the PGD/’new’ eugenics debate is that we are hard-wired to favor a utilitarian approach. But this is just de-scriptive ethics--clearly there is more needed to justify the ethics of PGD and selective abortion in the same way as you cannot derive an ‘ought’ from an ‘is.’ What is remarkable, however, is that there is also an entire school of consequentalist thought devoted to espousing the very same cost-benefit analysis that we in-nately uphold. According to this prescriptive perspective, prenatal diagnosis followed by abortion of a genetically abnormal fetus will spare the family and society the costs of childhood disability. In regards to the family, Adrienne Asch, an ethicist at Yeshiva University, has made the man-ifest statement that disability “subverts parental dreams” (Asch 1999). However, she also makes the case that PGD and selective abortion may lead down to a slippery slope. For instance, some have argued to take the stance that disabled persons suffering, or that their conditions some-how subvert parental dreams, leaving the door open for abortions based on gender, race, sexual preferences, and a slew of other ‘undesirable’ characteristics. However, to allay such fears, childhood disability is unlike any other characteristic in that it comes at a considerable economic cost. A study published in the American Journal of Medi-cal Genetics concluded that the average lifetime cost of a Down syndrome child to only their family is $451,000—and that is in 1992 dollars (Miller 2000). Today it would cost well over $700,000—and parents today complain about the cost of a college education. The cost to soci-ety—medically, nonmedically, and indirectly—is a sober-ing $1.8 billion dollars (once again 1992 dollars) (Miller 2000). Thus, selective abortion on the basis of genetic abnormality unmistakably spares the family and society at large the financial costs associated with childhood dis-ability. In summary:

1. We are not only hardwired to favor PGD and abortion 2. Through value restandardization we have begun to view genetic abnormalities as requir-ing prevention or treatment3. We accept this innate utilitarian philosophy in practice 4. An ethical school of thought espouses this as a moral imperative granted the economic cost 5. We can draw the line in selective abortion

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on the basis of this unique (economic) cost

Furthermore, while it is worth recognizing that there is little agreement amongst thinkers on the a priori truths, religious values, doctrines or universal axioms re-garding the sanctity of life, we live in an atmosphere that tolerates abortion. Thus, it is a question of public policy and as such, our response needs to be both theoretically defensible and practically useful. In order to achieve this ideal solution, evolutionary biology, paleopsychology, and neuroscience give us the extraordinary ability to rec-oncile the dissonance between our physiology and our beliefs. The beauty of this scientific approach towards PGD and selective abortion is that it is both theoretically defensible and also practically useful; our physiology is in sync with both our thought and common practice (i.e. is = ought). Therefore, the use of these technologies should be considered the favored alternative as it is mor-ally justified from the perspective of the agent.

References

Asch A. (1999). Prenatal Diagnosis and Selective Abortion: A Challenge to Practice and Policy. American Journal of Public Health. 89(11): 1649-1657.Davis B. (1978). The Moralistic Fallacy. Nature. 272(5652): 390.Greene JD. (2007). The Secret Joke of Kant’s Soul. In W. Sinnott-Armstrong (Ed.) Moral Psychology Vol 3: The Neuroscience of Morality: Emotion, Brain Disorders, and Development. Cambridge: MIT Press.Hume D. (2000). A Treatise on Human Nature. (DF Norton & MJ Norton, Eds.). Oxford: Clarendon Press.Leroi AM. (2006). The future of neo-eugenics. Now that many people approve the elimination of certain genetically defective fetuses, is society closer to screening all fetuses for all known mutations? EMBO Reports. 7(12): 1184- 1187.Mangan J. (1949). An Historical Analysis of the Principle of Double Effect. Theological Studies. 10: 41-61.Mansfield C, Hopfer S, Marteau TM. (1999). Termination rates after prenatal diagnosis of Down syndrome, spina bifida, anencephaly, and Turner and Klinefelter syndromes: a systematic literature review. Prenatal Diagnosis. 19(9): 808-812.Miller VL, Ransom SB, Ayoub MA, Krivchenia EL, Evans MI. (2000). Fiscal Im- pact of a Potential Legislative Ban on Second Trimester Elective Termina- tions for Prenatally Diagnosed Abnormalities. American Journal of Medical Genetics. 91(5): 359 - 362.Moore GE. (1903). Principia Ethica. Cambridge: Cambridge University Press.Rescher N. (1969). What is Value Change? A Framework for Research. In K. Baier & N. Rescher (Eds.). Values and the Future. New York: Free Press.Roper AG. (1913). Ancient Eugenics. Minneapolis, Minnesota, U.S.A: Cliveden Press and Burgess Publishing Co.Thomson JJ. (1976). Killing, Letting Die, and the Trolley Problem. The Monist. 59(2): 204-17.

Justin Stahl is a Cognitive Science major and Aitchsion Fellow in Public Service & Government at Johns Hopkins University. In the future, he plans on synthesizing cogni-tive research and the law to serve the public interest.

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Social Context for Women’s Health: AIDS Prevention in South Africa

Sarah J. PalmerCornell University

AbstrAct

Many observations regarding women’s health in South Africa can help us understand specific issues about the spread of Acquired Immune Deficiency Syndrome (AIDS), which has deeply affected the African continent as well as the global population. John Iliffe describes the AIDS epidemic of South Africa as, “an extreme version of a continental pattern” (Iliffe 2006). Through examining sexually transmitted diseases (STD) and the human immunodeficiency virus (HIV) prevention efforts in South Africa, gender power dynamics can contribute to the spread of HIV. In addition, knowledge, technological advances, and community support can help women gain advocacy despite the disadvantageous gender power dynamics. Difficulties lie within the intricacies of provid-ing women with support, as access to these support programs is very limited, and some women find themselves unable to seek out help in a society where they hold a social position unequal to that of men.

Key Words: sub-Saharan Africa, Female Autonomy, Gender Power Dynamics

A Wheel Set in Motion

Iliffe argues that the spread of AIDS through the Afri-can continent is merely a matter of time, seeing as the nature of the disease leant it the name “a catastro-phe in slow motion,” which spread, “silently for many years before anyone recognized its existence” (Iliffe 2006). Although a great deal of worthwhile research could be devoted to investigating the true origins and proprietors of AIDS, it is far more constructive to ex-amine immediate issues in order to begin thinking about possibilities for change and improvement. The wheel has been set in motion and it can be histori-cized to imagine how it started turning, or one can search for different ways to stop it. Today, approximately forty million people are infected with HIV/AIDS worldwide (Cooper 2007). Of these individuals, 60% live in sub-Saharan Af-rica, which is also home to 75% of the global popu-lation of HIV positive women (Ibid, 274). Hit hard-est from the AIDs epidemic is the country of South Africa, where HIV/AIDS prevalence among pregnant women increased from 1% in 1990 to 30% in 2005,

coinciding with South Africa’s standing as the country with the largest HIV positive population in the world: 5.5 million, which is one-eight of South Africa’s to-tal population (Ibid, 275). Of the South Africans who are HIV positive, however, the 20-24 year old demo-graphic shows a particularly steep difference in in-fection rates between men and women. The preva-lence rate among women in this age group is 23.9%, while the corresponding rate among men is only 6% (Hunter 2007). Multiple sources show that there is a “dramatic disproportion of male to female HIV infec-tions in southern African and South African contexts,” as a national survey of 11,904 people between 15 and 24 years old showed women with a 15.5% likelihood of being infected with HIV compared to men’s likeli-hood of 4.8% (Stadler 2008). These statistics clearly show that gender and HIV prevalence are linked; social inequalities and mo-bility can only partly explain the magnitude of South Africa’s AIDS epidemic. Didier Fassin argues that the three social factors that place South Africa at a higher

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risk of HIV are:

1. social inequalities in income and employ-ment status2. mobility that is especially complex in South Africa due to, “mass resettlements of populations under apartheid, seasonal labor migrations, movement along major trade routes, refugees fleeing war in other parts of Africa, and, since 1990, return of political exiles and liberation armies”3. sexual violence (Fassin et al. 2003).

As Fassin explains, all three of these social factors come together in the practice of “survival sex,” where women, “use their bodies as an ordinary economic resource outside the context of prostitu-tion but within the culture of male violence” (Ibid). Not only does this factor provide a model to begin to understand the gender inequalities around AIDS infection in South Africa, it also shows how factors within a society directly impact the spread of disease. The rapid spread of AIDS among young South African women is not simply just a matter of time, it is a mat-ter of a combination of preexisting gender power dy-namics and a society that is in a period of tumultuous change. Knowledge about “survival sex” as a prime suspect in the AIDS epidemic provides us with the opportunity to devise an effective method for pre-venting the spread of the disease. If contraceptive prevention efforts – whether in the form of a condom, or a microbicide - are focused on women who depend on their significant other for financial stability, and if those efforts are successful, change in the spread of AIDS through South Africa is entirely feasible. Unfortunately, a lack of resources and men’s general distaste for condoms places women who want to protect themselves between a rock and a hard place. If they insist on using condoms, they could lose financial stability. If they don’t insist, they might be-come infected with AIDS. While alternative methods like microbicides are going through clinical trials, as shown later in this paper, access to such methods is limited to the select few who can participate in a study, and only lasts during the period of the trial. The unfortunate predicament of these women forces us to take on one of the essential issues be-hind the spread of the AIDS epidemic: gender power dynamics. Gender power dynamics affect sexual be-

havior that ultimately creates a vulnerability to infec-tion, thereby placing responsibility for the disease’s spread on behavior, rather than simply the nature of the disease. One must be cautious to not place blame on behavior, but use this behavior as an opportunity for positive change.

Economic Impact on Female Autonomy

Among Iliffe’s contributing causes of the HIV epidem-ic, he includes “the association with migration,” and explains the epidemic’s severe impact “in the inde-pendent states of Lesotho and Swaziland, both tied to South Africa by labor migration” (Iliffe 2006). Iliffe continues to explain how the virus carriers were re-turning mineworkers of whom 48% were estimated to be infected in 2000, and who “transmitted the vi-rus to the women who in 2002 were 55% of those infected” (Iliffe 2006). Clearly some correlation be-tween male migration and infection must exist. Still, Iliffe fails to examine female migration, which is also related to HIV infection. In his study, “The changing political economy of sex in South Africa,” Mark Hunt-er shows how women who are placed at an economic disadvantage through post-apartheid changes and unforgiving gender power dynamics find themselves in “informal settlements,” where HIV rates are two times the national average (Hunter 2007). Hunter characterizes these “informal settle-ments” as urban areas where the poor who have been unable to find formal housing will set up imijondo-los (roughly translated to “shacks”) (Hunter 2007). Since the twentieth century informal settlements have been understood as, “places of poverty and sex exchanges, but also as places that allowed women a certain independence” (Ibid). This ‘independence,’ however, comes at a high price and as a last resort. Researchers estimate annual HIV incidence rates in urban informal settlements at 7%, while incidence rates in urban formal settlements stand at only 1.8% (Ibid, 692). Despite the heightened risk of becoming part of a demographic with such high HIV incidence rates, women do migrate to urban informal settle-ments. Unlike the migration of men to and from the mines, however, women’s journeys to live in these informal settlements are not governed by their own volitions, but are a result of harmful gender power dynamics that force them to search for economic se-curity in these high-risk environments. In order to visualize these gender power dy-

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namics, Hunter narrates the experience of a woman named Fikile (a pseudonym) to contrast the arche-typal male migration pattern that was used to explain the infection of syphilis by Sydney Kark in 1949 (Ibid, 692). While Fikile’s male counterpart was a rural miner who, during his time on the job, gets infected by an urban prostitute and then passes syphilis on to his wife. Fikile exercises much less advocacy in her own journey, which is explained in the article as fol-lows:

Fikile was 26 years old when she was inter-viewed in 2003. She grew up in Northern KwaZulu-Natal and mothered two children from two different men. At the time of the in-terview, one of these children had died while the other stayed with her grandmother in Fikile’s rural home. Throughout the 20th century a growing number of women gave birth out of wedlock. But Fikile, like most young women today, had a very low prospect of marrying the biological father of a child. Fikile had not therefore moved into a hus-band’s umazi (homestead) as most women of her parents’ generation would have done. Instead, like many rural women, Fikile mi-grated to an informal settlement (Ibid).

Hunter’s article implies that Fikile’s motiva-tion for moving to the informal settlement was to seek out boyfriends who could support her. The ar-ticle describes her two boyfriends, one “main” boy-friend who provides her with food and money, and an umakhwapeni (secret lover, literally “under the arm-pit”) who gave her 50 to 100 Rand irregularly, about $8-$16 in US dollars (Ibid, 693). Although Hunter interprets the fact that Fikile sends some food and money back home to provide for her mother and her child as a reversal of the “longstanding pattern of men acting as ‘providers’ for rural households.” Fikile’s source of income depends on female subjuga-tion to male control (Ibid). Except for the 50 Rand she earns once a week for doing laundry, Fikile’s entire livelihood depends on her sexual relationships as a result of, “the absence of marriage as a rural alter-native, and the very poor opportunities for income generation in the informal sector” (Ibid). These fac-tors advance the male role of “provider,” to a position that is much more active in controlling Fikile and her family’s livelihood, as in order to survive Fikile must

maintain her sexual relationship with him. This de-pendence allows men override female advocacy in the context of “survival sex.” As Fikile’s situation demonstrates, monetary control is an important aspect of gender power dy-namics. Fikile’s story might have been different if she belonged to the prior generation, seeing as post-apartheid South Africa depicts a treacherous terrain of socio-economical troubles that are still causing so-cial upheaval. While the new government’s neo-lib-eral approach to economic growth pushed the mar-ket to become more competitive, jobs became harder to find and unemployment pushed past 40% (Ibid, 694). Economic instability and the inability for men to pay ibolo, or bridewealth, contribute to the decline in marriage that could push more women like Fikile to seek informal settlements (Ibid, 695). This sce-nario is just one of many where women depend on their sexual relationships for economic stability. If a woman’s sexual partner threatens to withhold mate-rial goods unless she agrees not to use condom, often times she will have to oblige at the risk of going hun-gry or not being able to provide for her family, as Fikile did. A subject in Jonathan Stadler’s study, “Women’s perceptions and experiences of HIV prevention trials in Soweto, South Africa,” states the situation plainly:

I think if you have a boyfriend and he buys you expensive stuff he feels like he owns you. That’s why if you want to do something he tries to stop you and he will start making de-cisions for you, tell you what to do, where to go. And if he finds you with anyone else you are in trouble (Stadler 2008).

While the gender power dynamic as explained by this woman can apply to countless situations, it is certainly relevant to the spread of AIDS, as women in Stadler’s focus groups “often complained that their significant others stubbornly refused to wear con-doms,” and that men, “cited the popular analogy that compared sex with a condom to eating sweets with the wrappers on, or unpeeled bananas” (Ibid, 194). Although Hunter never clarified whether Fikile was subject to such control – he does say that she did not use condoms with her “main” boyfriend, but did with her “secret” boyfriend – we can read her case as the result of socio-economic circumstances that grow out of necessity rather than nature.

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Even if women do get married, they can also lose advocacy over their bodies in conjugal bonds. African families, as studied in general, place a lot of importance on fertility to ensure the family lineage, providing extra labor strength to help gain economic stability. As a result of the availability of mechanisms for sharing child costs and benefits, other family members often assist parents in raising their chil-dren (Bertrand 1993). Bearing children also benefits the wife, as it secures her status in the lineage, grant-ing her a chance at economic stability. Rather than empowering the wife in the conju-gal bond, however, the importance of childbearing is placed under the husband’s control, as he is respon-sible for most of the reproductive decision-making (Ibid, 104). This gender power dynamic places the wife at a disadvantage, seeing as, “a woman who con-templates family limitation must face the possibility that any interruption in childbearing may signal both to the husband and to his lineage, that she has effec-tively abandoned the marriage” (Ibid, 114). In both the conjugal model, and the “survival sex” model, we can see how society prevents women from having ad-vocacy over their bodies. Both models cannot help women separate unprotected sex from economic sur-vival, thus contributing to the spread of HIV/AIDS. Concluding from his case studies, Stadler pro-motes the idea that the men in his study view sexual desire as “a powerful hydraulic force, owing to the accumulation of blood that demanded immediate re-lease. At moments of heightened desire, men simply lost control over their bodies” (Stadler 2008). While these characteristics of desire are often incompatible with reasoning about the unintended consequenc-es of unprotected sex, women’s narratives are con-structed more around socio-economic circumstances, much like Fikile’s efforts to provide for herself and her family (Ibid). Here, we can see how women may be concerned about HIV infection, and might desire to have control over how they use their own bodies in childbirth, or in intercourse, and yet they often forfeit their advocacy to the desire or assumed con-trol of a sexual partner. In order to combat this loss of advocacy, efforts in contraceptive technology and women’s advocacy have become central to staving off HIV infection rates.

Women taking control: female advocacy

In 2000, President of the Republic of South Africa,

Thabo Mbeki, wrote a letter to world leaders, “ex-pressing his doubt that HIV was the exclusive cause of AIDS and arguing for a consideration of socioeco-nomic causes” (Fassin et al. 2003). While President Mbeki’s disregard for the biomedical explanation of AIDS caused controversy among public health work-ers and researchers, the years prior to this argument show a history of South Africa’s politicized attitude toward the treatment of AIDS. In 1996, the government was criticized for us-ing public money as a musical show that was meant to promote prevention, and in 1997 it was criticized again for officially supporting the treatment Vi-rodene, which was later found to be an industrial sol-vent with no benefit (Ibid, 3). The government was criticized yet again in 1998, when it blocked the use of antiretroviral drugs, citing the drugs’ side effects as a valid reason (Ibid). A common thread through all of these actions is a mistrust of the country’s white conservatives and the pharmaceutical’s history. It has recently been revealed that in its last years, the apartheid government had laboratories developing chemical and biological weapons to eliminate black leaders, researching contraceptive methods to ster-ilize the African population, and allegedly trying to spread HIV through a network of infected prostitutes (Ibid). It is no wonder that many South Africans hold a deep mistrust of Western science, medicine, and public health. The very toll that HIV/AIDS has taken on South Africa demands a practical approach that will help its people stave off a deadly virus. While many South Africans do hold a mistrust of Western medi-cine, clinical trials have become more conducive to social sensitivity. As Stadler says in his introduction, “there is growing recognition that an understand-ing of the social nature of clinical trials may enhance the way in which [they] are implemented,” that may help understand the factors that would influence par-ticipation in microbicide clinical trials, as “a general distrust and negative disposition towards medical re-search exists.” Stadler and Fassin both express sensi-tivities to the gross human rights violations made by the apartheid regime. By treating the issues of mistrust and skep-ticism about medical research with sensitivity and communication, however, Stadler’s research was able to transcend Western medicine’s tainted past and es-tablish a trusting relationship with his subjects. This mutual respect allowed his research to delve into

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some revealing social aspects of the study’s location: Soweto, South Africa. While already examining an extremely promising method of contraception – in-travaginal microbicides that protect against HIV in-fection without the need for a condom – Stadler also found that by testing the subjects of his study for HIV, he thereby empowered them to behave responsibly whether or not they tested positive (Ibid, 196). One HIV negative woman talks about how getting tested gave her the confidence and motivation to protect her health, as she says:

I joined [the study] because I wanted to know about my status. Then after finding out that I am [HIV] negative I just told myself I must continue with the study. The thing that made me continue with the study is that I knew that I can keep my status by coming here and doing counseling. So this can keep me strong and encourage me to behave in a good man-ner. It changed the way I was using condoms because sometimes I would use a condom, sometimes I would not. So now I use it every day (Ibid).

Beyond the actual practice of HIV prevention, AIDS testing itself is believed to hold a considerable pow-er to “transform the body, to bring it under control,” as “the outcome of the test is usually less important than the test itself. It makes people feel better, safe, confident, and reassured” (Ibid, 198). Stadler’s conclusion only applies to those few with access to the support system found in studies like his own. The subjects in Stadler’s study not only received a supply of microbicide that, although un-der trial, would prevent the transmission of AIDS, but also got free HIV testing and quarterly check-ups for a period of 12 months, where they would have pel-vic exams, be interviewed about socio-demographic, behavioral and symptom information, and would re-ceive risk reduction counseling, free condoms, and 50 Rand for transportation at each visit (Ibid, 191). While the results of this study showed a marked im-provement in the general sense of empowerment among subjects, the study itself selected only a tiny proportion of the population. Access to medical resources for many Africans is generally restricted to:

1. structured research and treatment pro-

grams funded by donors, like Stadler’s study2. gazetted treatment centers that provide drugs on a fee-for-service basis3. private practitioners who provide dis-crete treatment for those who can afford it4. informal networks that supply friends and relatives on a less regular basis, some-times at no cost, and sometimes for cash (Whyte 2005).

While these models of “drug flow” are outlined in the context of unequal access to antiretrovirals in Ugan-da, they are useful for understanding the unequal ac-cess to many beneficial medical treatments in South Africa. One can only imagine a situation where a proper support system complete with medical and educational counseling would empower all South Af-rican women to take charge of their sexual lives, see-ing as research projects must have, “explicit inclusion and exclusion criteria; [and] donor projects and pro-grams have defined target groups and procedures for becoming a beneficiary,” (Ibid, 4). In order for such a support system to be instituted, the South African government would need to make a massive effort in public health that, but from the evidence above, it is not likely to take action soon. Unfortunately, providing women with this support has thus far proven to be expensive, selective, and temporal, such as Stadler’s study. The truth is that Stadler’s subjects only had access to the study’s ser-vices for twelve months, after which the study ended. As long as Stadler’s study showed positive results, another method can be noted for changing the pros-pects for young women at risk of contracting AIDS in South Africa. Through providing testing and counsel-ing for support, it is possible to empower women to be more adamant about protection through knowl-edge of their own bodies.

Gender power dynamics

Apart from the importance placed on conjugal fer-tility, condoms are unpopular among many South African men because they reduce the pleasure of in-tercourse, and imply infidelity. Efforts to market con-doms to Africans, or condom social marketing (CSM), also fail to take into account the complex structure of gender power dynamics and the economy of sex.

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James Pfeiffer describes how CSM in South Africa’s neighboring country, Mozambique, “has developed a central message that not only encourages condom use but is interpreted by many as endorsing ‘promis-cuous’ sexuality through its controversial images and suggestive slogans” (Pfeiffer 2004). This method of CSM validates the pre-existing association of con-doms with infidelity so that a woman who wants to use condoms can be even more easily connected to promiscuity, which could jeopardize her relationship with her significant other. Meanwhile, in response to a growing “moral” panic around risky sexual behavior, “Pentecostal and African Independent Churches also expanded across the region, spreading an entirely different message about perceived promiscuous be-havior … [these churches] frown on condoms because they believe their use promotes prostitution and im-morality” (Ibid). This view is significantly different from Stadler’s results that showed men’s distaste for condoms was due to the discomfort they cause com-pared to unprotected sex. Although it is difficult to allow either of these cases to speak alone as to why condoms have not be-come a more widely accepted part of South African sexual practice, Stadler does make a valid point that the, “overwhelming sense of inevitability of HIV infec-tion [does] little to encourage or support individual behavior change” (Stadler 2008). In the midst of this despair, condom use conflicts with trust as well as re-ligion and social standing. When people are unable to understand the health reasons for using condoms, their negative connotations obscure any possible ben-efit. At this point, society begins to play in the gender power dynamics observed on individual bases. When a South African woman in any of the aforementioned contexts asks her partner to use a condom, whether he is her husband or partner in “survival sex,” she is not just suggesting an item that will reduce the plea-sure of intercourse. However, she is either making a statement about her intent to control her own fertil-ity, which is an affront to the conjugal bond; or she is expressing infidelity as suggested by CSM, which could jeopardize her relationship with a significant other.

Conclusion

While President Mbeki’s view that, “The world’s big-gest killer and the greatest cause of ill health and suffering across the globe, including South Africa,

is extreme poverty,” seems to discredit the biomedi-cal aspects of the epidemic, it also contributes to the idea that societal factors such as economic despair and sexual subjugation impact the spread of disease. Ultimately, epidemics and behavior are inextricably linked. Although Fassin argues, “biological and be-havioral explanations cannot provide an exhaustive interpretation of the epidemic; observable inequali-ties must have a place in the aetiological model of AIDS” (Fassin 2003). Despite efforts in Western medicine striving to develop effective methods of prevention of HIV/AIDS, progress is slow, trials selective, and the South African government reluctant to trust Western medi-cine. Alternatively, the government in Senegal has developed effective programs for reducing infection rates among prostitutes by providing STD testing, free condoms, counseling, and regular medical exams in high-risk communities, which serve as an example to South Africa and other countries around the world, since they have shown visible effect by dramatically reducing AIDS infection rates (Renaud 1997). Rather than forcing the South African gov-ernment to realize the effectiveness of a biomedical approach to AIDS prevention, as many activists are trying to do, social change can be incorporated by helping to stimulate the economy and encourage sup-port groups in different communities. These develop-ments could provide women with the ability to con-trol their livelihoods in order to prevent themselves from catering to the demands of their significant oth-ers. If communities formed support groups that could provide counseling similar to that in Stadler’s study, perhaps women in those communities could become more empowered through these connections. Not only does this idea lend some credibility to Mbeki’s statement, as economic changes can help slow down an epidemic, it also places importance on the peoples’ struggle. The issues around AIDS reach beyond the biomedical and into the private lives of human be-ings. Epidemics have a tendency to highlight certain aspects of the society they infect, and those aspects are usually connected with how the disease spreads. When studying the AIDS epidemic in South Africa, sexual behavior in a foreign country is discussed, eas-ily leading to the assumption of promiscuity among those infected, thus encouraging an attitude of ste-reotypism. In order to counteract this effect, the mod-els discussed do not speak for any entire population.

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Instead, they offer scenarios assumed to affect many South African women, each of which involving a de-bilitating gender power dynamic. Rather than allow-ing these dynamics to continue, the examples includ-ed offer possibilities of feminine empowerment that, if implemented in society, can provide much hope in South Africa’s fight against the AIDS epidemic.

References

Bertrand JT, Bauni EK, Lesthaeghe RJ, Montgomery MT, Tambashe O, Wawer MJ. (1993). Factors Affecting Contraception Use in Sub-Saharan Africa. Washington DC: National Academy Press. Cooper D, Harries J, Myer L, Orner P, Bracken H, Zweigenthal V. (2007). Life is still going on’: Reproductive intentions among HIV-positive women and men in South Africa. Social Sciences & Medicine. 65(2): 274-283. Duncan ME, Tibaux G, Kloos H, Pelzer A, Mehari L, Perine PL, Peutherer J, Young H, Jamil Y, Darougar S, Lind I, Reimann K, Piot P, Roggen E. (1997). STDS in Women Attending Family Planning Clinics: A Case Study in Addis Ababa. Social Sciences & Medicine. 44(4): 441-454. Fassin D. (2003). The embodiment of inequality. EMBO Reports. 4: S4-S9.Fassin D, Schneider H. (2003). The politics of AIDS in South Africa: beyond the controversies. BMJ. 326(7387): 495-497.Gyimah SO, Takyi BK, Addai I. (2006). Challenges to the reproductive-health needs of African women: On religion and maternal health utilization in Ghana. Social Sciences & Medicine. 62(12): 2930-2944. Hunter M. (2007). The changing political economy of sex in South Africa: The significance of unemployment and inequalities to the scale of the AIDS pandemic. Social Sciences Medicine. 64(3): 689-700. Iliffe J. (2006). The African AIDS Epidemic: A History. Athens, Ohio: Ohio University Press.Pfeiffer J. (2004). Condom Social Marketing, Pentecostalism, and Structural Adjustment in Mozambique: A Clash of AIDS Prevention Messages. Medical Anthropology Quarterly. 18(1): 77-103.Renaud ML. (1997). Women at the Crossroads: A Prostitute Community’s Response to AIDS in Urban Senegal. New York, NY: Gordon and Breach Science Publishers. Stadler JJ, Delany S, Mntambo M. (2008). Women’s perceptions and experi- ences of HIV prevention trials in Soweto, South Africa. Social Sciences & Medicine. 66(1): 189-200. Whyte SR, Whyte MA, Meinert L, Kyaddondo B. (2005). Accessing antiretrovi- ral drugs: dilemmas for families and health workers. Essential Drugs Moni- tor. 34: 14-15.

Sarah Palmer is currently a junior at Cornell University. She will pursue a career in international law, and hopes to apply whatever skills she can acquire toward promot-ing patient advocacy and human rights to health care across the globe.

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The Ethics of Performance- Enhancing Drugs and Gene Doping in Sports

Toni-Marie HudsonGeorgetown University

AbstrAct

Following her admission of having used performance-enhancing drugs, Olympian Marion Jones was con-victed and sentenced to six months in prison and stripped of her five Olympic medals while having her name removed from record books (CNN). For many other athletes similar to Jones, winning medals and setting re-cords are huge achievements that these athletes have dreamed and strived for so long. Unfortunately, some athletes decided to accomplish this achievement by resorting to covert means such as using drugs and gene doping to enhance their performance. This very problem that athletes face will be examined: the ethics of performance-enhancing drugs and gene doping in sports. Performance-enhancing drugs and gene doping are morally reprehensible and should therefore be banned. Additionally, two possible objections against this position will be raised. These objections include the arguments that performance enhancement drugs are rather beneficial and having non-drug conditions in sports is essentially unfair.

Key Words: Exogenous Drugs, Athletic Integrity, “Soft” Coercion

In many ways, sports have been openly and honestly manipulated to ensure stellar athletic performances and success. The best training facilities, experts, equipment, medical support, foods, opportunities, and the most ad-vanced technologies have all shown advantageous in improving an athlete’s performance (Friedmann et al. 2006). For society, this unbounded attention has driven the strengthening belief of striving and achieving one’s highest aspirations while building confidence and in-spiration into the hearts of young athletes. Yet on the contrary, sports have also been subtly manipulated to similarly ensure such outstanding performance and success. Exogenous drugs such as anabolic androgenic steroids to increase muscle growth, amphetamine to improve alertness and reaction time, and human re-combinant erythropoietin (EPO) to increase blood cell production (helps with endurance) have been relied upon to enhance athletic performance and surpass one’s competitors. This dependence, however, is not necessarily a new phenomenon; the history of sports

doping can be traced to ancient Greece where lotions, ointments, mushrooms, and herbs were used to overtly and covertly boost athletic performance and gain an edge on their competition (Friedmann et al. 2006). In the early 19th century, French cyclists drank Vin Mari-ani, “the wine of athletes,” to increase stamina and cycle for longer. In 1964, the use of steroids first emerged in the Olympics; in 1976, female East German swimmers questionably swam faster than their competitors while simultaneously developing extensive body hair and deeper voices. With the advent of new technology, perfor-mance-enhancing drugs have drastically changed. Now, one must worry about the rising prospect of genetically enhanced athletes. Do these drugs require regulation, control, or banning? Athletic organizations around the world have responded with strong opposition against such drug usage. Their opposition remains evident in the creation of an international foundation dedicated to the fight against doping in sports through monitoring, promotion, and coordination: the World Anti-Doping

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Agency (WADA). WADA has coordinated, implemented, and regulated the World Anti-Doping Code, which houses anti-doping policies applicable to all sports and all coun-tries (Friedmann et al. 2006). Should the autonomy of an athlete be respected in their choice to enhance their ath-letic performance by any means, or should anti-doping policies be commissioned? Performance-enhancing drugs and gene doping are ethically reprehensible justified paternalistically on the grounds of non-maleficence and thus, their use should be banned. Non-maleficence is a principle requiring first and foremost that no harm be done upon others. One example of such justification based on non-maleficence is evident in an August 11, 2001 edition of New Scientist article entitled “Race to Death.” The article addressed the issue of insulin and its increasing use among athletes, es-pecially bodybuilders and distance runners, to illegally boost performance (Coghlan 2001). Insulin is cheap, readily available, and almost impossible to detect in drug tests. Insulin is a great way to increase stamina and endurance for middle-distance runners and other track athletes. It is complementary to anabolic steroids because it prevents the muscles that have been built from breaking down. The trouble with insulin, however, is that it can be lethal if administered incorrectly or in excessive dosages. Insulin can elicit a fa-tal coma by clearing vast amounts of sugar from blood so quickly that the brain is starved of oxygen and energy. In accordance to the principle of non-maleficence, when an athlete takes a form of performance-enhancing drugs (such as insulin in this case), it results in significant harm to him/herself. Such harm, however, may not solely affect the individual athlete but ultimately extend further to the athletes’ associates or partners. Other research has shown that steroid use, in extreme cases, may be associated with increased ag-gression and violence, which may affect the very part-ners of these steroid-users. In June 2007, Chris Benoit, a professional wrestler, had killed his wife, his 7-year-old son, and then himself. The wrestler was found to have had nandrolone, anastrozole, Xanax, hydrocodone, and elevated levels of testosterone in his body, (evidence of steroid abuse), which had apparently contributed to his violent behavior leading to the double-murder suicide. Although one cannot say that steroid abuse necessarily caused Chris Benoit to murder his loved ones, one can-not ignore the correlation between his increased aggres-sion with his use of such drugs. Although the murders committed by Chris Benoit may be an extreme case of the possible harm that can result from abusing performance-

enhancing drugs, still as seen in such cases, it seems jus-tifiable on the grounds of non-maleficence to ban perfor-mance-enhancing drugs because of its subsequent harm to others. In addition to the direct harm that athletes using PEDs (performance enhancing drugs) may receive from the drugs’ effects, the potential presence and availability of such drugs ultimately affect other non-drug athletes as well. These drugs contribute to an environment where others are subtly and possibly placed at risk by direct and indirect coercion. It is quite obvious that many times athletes are pushed by coaches to take drugs in order to succeed. “Soft” coercion by coaches negates that athlete’s decision-making capacity because taking the drugs is not done voluntarily; the athlete is not fully informed and therefore should be considered incompetent regarding the drugs’ risks, benefits, and overall effects (Foddy et al. 2007). Unfortunately, such “soft” coercion may even ex-tend to younger athletes through the mentality that suc-cess is only attainable through performance-enhancing drugs and gene doping when they view the actions of older athletes. In studies by Schwellnus et al., they report-ed the “significant use of anabolic androgenic steroids among schoolchildren involved in sports.” In these cases, paternalism (governing people in a fatherly manner) is defended on the grounds of non-maleficence because un-der pressures of the situation it is unreasonable to expect an athlete to resist performance-enhancing drugs. More subtly, however, apart from the pressure by the athlete’s coach, the pressure of the surrounding competition as well as the athletes’ own desire to succeed may override their better thinking to not resort to drug usage. It is the very availability of these drugs that can be considered to affect the athletes’ decisions in times of such tremendous stress. Many professional athletes devote their lives to their sport. Spending countless hours for training, travel-ing tirelessly to compete, structuring how they eat and sleep, these athletes essentially “live” for their sport. For some of these athletes, their sport may become a means of employment and thus this aspect ultimately creates greater incentive to become the best athlete of their sport. With such critical situations and decisions, some athletes may result in using any means to achieve the ends, which includes confrontation with the choice to take a banned drug to keep up with competitors. Thus, to avoid such confrontation in any sense, the banning of performance-enhancing drugs should be considered as a most appropriate solution.

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Although the banning of drugs can be strongly justified paternalistically on the grounds of non-malefi-cence, one must also evaluate the ethical implications of such drugs usage in sports. In 1988, Florence Joyner, an American track athlete, improved her 100-meter time by 0.47 seconds to a mere 10.49 seconds and her 200-meter time by 0.62 seconds to 21.34 seconds in the matter of only months. In comparison to previous records, Joyner’s im-provement in time within such a short period was un-doubtedly extraordinary. Currently, holding the world re-cord in both events, “Flo Jo” ran the times that only men had accomplished in the Olympics. Her story sparked controversy, especially after she retired shortly after these races when the Olympic committee announced they would require testing the following year in 1989. She died in her sleep with the cause of death identified as suffocation after a severe epileptic seizure. The coroner’s office could not test for steroid use because no accurate test was available nor was such a test possible. Although Joyner’s possible use of steroids can still be questioned and debated, in the scenario that she did (one case among many others), one must address the ethical principles of taking such performance-enhancing drugs. In general, when athletes take steroids or any other PED, it irrefutably affects athletic integrity. In the situation that performance-enhancing drugs are banned, such banning would test the athlete’s character in his or her decision to take or not take drugs. Integrity means honesty and adherence to moral and ethical principles; thus, an athlete of integrity would not dishonestly seek to surpass his or her competitors through illegitimate means. Furthermore, when an athlete resorts to using drugs, the playing field becomes tilted and technology determines performance instead of the combination of natural capabilities and effort. Banning drugs will, to a minimal extent, strengthen the meaning and value of sports. Such exclusion of drugs encourages human excel-lence in its stress for authenticity and adherence to one’s natural talents. Drugs mask the true ability of an athlete as well as the dedication and courage that we admire. Performance enhancing drugs and gene doping devalue sports, depriving the diligent and virtuous athlete of his or her victory. However, two objections can be made against this view. It was earlier contended that because performance-enhancing drugs had the potential to cause significant harm to the athlete, such drug usage should be banned justified paternalistically on the grounds of non-malefi-cence. One opposing view uses this very idea of paternal-

ism to argue that the banning of PEDs remains unjustified in its deprivation of the athlete’s autonomy. Because the athlete’s body is within his or her control, accordingly, he or she should have the freedom to do whatever he or she pleases with his or her body as long as he or she does not harm others. Rather, opponents argue further that by not banning the drugs and allowing the option for athletes to take these drugs, the principle of beneficence would be adhered ultimately. Beneficence is the principle of preventing harm, providing benefits and balancing these benefits against risks and costs. It is argued that because most of the ef-forts to ban these drugs have been unsuccessful, legal-izing performance-enhancing drugs would be overall easier in preventing harm. In the case that performance-enhancing drugs were to be banned, some fear that tech-nology would be used to make drugs that were undetect-able instead of safe. Thus, if drugs were allowed, athletes would be under less pressure to take unsafe drugs, forc-ing drug companies to manufacture safer products and generally minimizing risks (Foddy et al. 2007). Expanding upon this argument that by not ban-ning PEDs the athletes would be placed at less risk, sup-porting critics also point to the compelling evidence of non-drug risks that equally place athletes in grave dan-ger (Foddy et al. 2007). Sports that emphasize leanness in order to compete, such as gymnastics, long-distance running, and figure skating, have higher prevalence rates of eating disorders than any other sports (Cintado 1997). An estimated 10-15% of gymnasts are anorexic. In 1989, after being told that she would have to lose weight in order to compete in future international competitions, Christy Henrich became obsessed with her weight and spiraled down a dangerous road of anorexia nervosa weighing as low as 47 pounds. Originally 4’11” and 93 pounds, Henrich died in 1994 of multiple organ failure at 59 pounds. On the contrary, in sports such as American foot-ball, a large body size is required to play certain posi-tions. Overeating to achieve such a size could lead to fu-ture complications including heart disease, diabetes, and hypertension. Also, in any sport, the undeniable risk of accidental injuries such as brain injuries suffered in rug-by and American football exists. It is thus possible that athletes may already put themselves at risk from non-drug practices. Since in such cases athletes continue to play their sports despite such risks and health concerns, on the same line critics highlight that PED use should not be banned because of its associated health risks. Instead, they argue that if one were to be concerned about an ath-

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lete’s health, one should test for health indicators rather than for PED drugs (Foddy et al. 2007). For example, a physician should check for heart murmurs or other ar-rhythmias that could pose a serious risk to the athlete and ban them on those grounds; this would seem far more beneficial to the athlete in ensuring his or her well being rather than solely checking the athlete for drug usage. Therefore, advocates defending the use of PEDs assert that a safe limit of performance enhancing drugs should be established and anyone whose health poses a great risk should not be allowed to compete. Conse-quently, anyone that exceeds this threshold in perfor-mance enhancing drugs should likewise not be allowed to compete. Thus, considering the athlete’s well being as being WADA’s primary concern, proponents against PED banning find WADA inconsistent in its banning of the ath-lete because of his or her use of such drugs while remain-ing simultaneously aloof to the serious risks he or she is exposed to constantly while playing the sport. The second opposing view concerns the idea that taking a performance-enhancing drug would tilt the playing field. Opponents highlight that rather than focus-ing on the “unfairness” created by PEDs to the playing field, the natural and legal factors such as genetic endow-ments providing an athlete seemingly “unfair” advantag-es should be considered instead. Why does one not con-sider an athlete’s biological potential as a determinant of winning or losing? With or without drugs, an athlete’s natural hematocrit level could make the difference in his or her performance in a sport for increased red blood cell production would mean increased endurance (Foddy et al. 2007). Likewise, a person’s metabolism rate could help them to burn calories faster which would be con-ducive if he or she wrestled because it would help them classify for their weight class more quickly and easily. In essence, sports seem considerably, or to a large extent, a test of genetic inequality, which should be considered as “unfair” because the playing field is not leveled to begin with. For the first objection, the problem with creating a threshold (“safe level”) that considers the welfare of the athlete is that there remains a problem with the actu-al definition of a threshold. If a threshold were to be de-fined, then anyone who goes beyond this level would be banned. This is unacceptable because genetically, people have varying tolerance levels. Bob Veatch would similarly argue the unacceptable nature of such a model because a threshold would imply that WADA (or any agency that implements such a threshold) would decide what works the best and should be considered the best for the ath-

lete based on mere statistics. Every athlete is unique and would thus most likely respond differently to this thresh-old such as individual responses to alcohol. In the U.S., a blood-alcohol content (BAC) of 0.08% or more is considered illegal when driving. It seems somewhat unrealistic to arrest a large male, who is 6’8” and 300 pounds for the same BAC (0.08%) as a woman who is 5’0” and 100 pounds. Both people would react differently to such levels of alcohol in their blood. More likely, a man of this stature would not experience the level of impairment as the woman. Athletes that take the same amount of performance enhancing drugs up to the so defined threshold could perform very differently. A man might require more PED than a woman. Should different thresholds be created for each sport? A catego-ry for a man and another for a woman? Would we have to customize this level according to an athlete’s natural talent or ability? Creating a threshold would not be ac-ceptable. In addition, this threshold disregards the harm-ful effects of specific drugs. In some cases, the risks will outweigh the benefits depending on the drug. Drug A in a certain dose may be more potent than a drug B in the same dose; this would not adhere to the principle of non-maleficence. What about drugs with unknown side effects? What “threshold” could be established for such drugs to ensure safety? In regards to the second objection, if drugs were not banned on paternalistic grounds, then it would be up to the athlete to decide what drugs they can take and in whatever amount they please in order to win. Could one even imagine what sports would look like if one allowed this to occur? If performance-enhancing drugs were al-lowed because genetic endowments were considered “unfair advantages,” it would open doors to possible abuse in the creation and use of such drugs. By supplying the athlete with excess drugs, this would be a manipulation of human capacity. We are al-ready on our way to cloning humans; gene doping would create opportunities for a customized superhuman. Should there be a specific category created for these su-perhumans? For athletes who are genetically manipulat-ed, how should they be respected and compete in sports without diminishing the meaning of the sport? Sports provide an environment where people out of free will and love for the sport test their skills against other com-petitors. By supporting the use of performance enhanc-ing drugs, ultimately, one would lose this very spirit and meaning of playing sports. Thus, it has been shown that performance en-

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hancing drugs and gene doping are ethically reprehen-sible and justified paternalistically on the grounds of non-maleficence. Performance enhancing drugs degrade athletic integrity, create unfair competition, and finally demean the meaning and value of sports.

References

Beauchamp TL. (2007). The Four Principles Approach to Medical Ethics. Principles of Health Care Ethics. Ed. Raanan Gillon. London: John Wiley and Sons, 1994.Cintado A. (1997). Eating Disorders and Gymnastics. Vanderbilt University. <http://www.vanderbilt.edu/ans/psychology/health_psychology/gym- nasts.html>.CNN. Track Star Marion Jones Sentenced to 6 months. CNN.com. January 11, 2008. <http://www.cnn.com/2008/CRIME/01/11/jones.doping/index. html >.Coghlan A. (2001). Race to Death. New Scientist. 11: 4-5.Foddy B & Savulescu J. (2007). Ethics of Performance Enhancement in Sport: Drugs and Gene Doping. Principles of Health Care Ethics. Ed. R.E. Ashcroft, A. Dawson, H. Draper and J.R. McMillan. 511-519.Friedmann T & Schneider AJ. (2006). Gene Doping in Sports: The Science and Ethics of Genetically Modified Athletes. Theobald’s Road, London: Elsevier Academic Press.Levine C. (2006). Taking Sides: Clashing Views on Controversial Bioethical Is- sues. Dubuque, Iowa: McGraw-Hill/Dushkin.Oliver S. (1996). Drugs in Sport. The America Journal of Sports Medicine. 24: S43-S45.Schwellnus MP, Lambert MI, Todd MP, et al. (1992). Androgenic Anabolic Steroid Use in Matric Pupils. South African Medical Journal. 82: 154-158.Skowno J. (1992). Drug Survey Among First Team Schoolboy Rugby Players. South African Medical Journal. 82: 204.Tamburrini C & Tännsjö T. (2005). Genetic Technology and Sport. New York, NY: Routledge Taylor & Francis Group.

Toni-Marie Hudson is currently a junior at Georgetown University, majoring in Human Science. She plans on go-ing to graduate school to pursue a dual degree in Pedi-atric Nurse Practioning and Public Health. She is very interested in doing advocacy work in public health for children affected with HIV/AIDS around the world, espe-cially in sub-Saharan Africa.

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Agricultural Bioethics in a Neoliberal Society

Yasaswi ParuchuriUniversity of Michigan

AbstrAct

Widely publicized outbreaks of E. coli and salmonella caused by tainted spinach and tomatoes led to height-ened public concern about the safety of our food and the questioning of our system’s agriculture. Contemporary agriculture is a highly mechanized system built around heavy use of biochemicals and more recently, genetic modification of food products. The regulations that govern agricultural production and food consumption can be analyzed in terms of the various players that are regulated: producers, consumers, and researchers. The current regulatory system, which stresses corporate profit, autonomy, and deregulation, is built on the values of neoliberalism. Any consideration of the bioethics of food must analyze the connections between food safety agriculture and neoliberalism.

Key Words: Salmonella, Food Poisoning, Genetically Modified Crops

In 2006, it was with dismay that restaurateurs and citi-zens alike denied their desire for spinach in light of re-ports from federal officials that this innocuous leafy green might give them food poisoning. “More than 200 people in 26 states were sickened and three people were killed by spinach contaminated with E. coli,” reported Eric Schlosser, author of Reefer Madness and Fast Food Nation, in an op-ed in the New York Times. So what’s new? An-other item recalled? Just recently in the summer of 2008, any tomato not sold on the vine, grown organically, or grown by the consumer him or herself was a threat for salmonella (Harley & Allison 2008). However, what seem like singular incidents – tomato and salmonella, spinach and E. coli – are part of a larger problem. Dr. Maki, in the New England Journal of Medicine points out that “…although this outbreak captured media attention for weeks, it must be put in perspective: during each day of the outbreak, there were at least 5 to 10 times as many cases of endemic…E. coli infection throughout the country as there were outbreak cases.” Food poi-soning by E. coli is far more common than realized, and it is difficult to trace it back to a specific food item like spinach or tomato. Thus, contamination of foods seems

widespread and random. Some suggest that contami-nation could be halted by irradiation of all foods before sale on the market (Maki 2006). However, that is merely a technical solution, which does not address the larger societal changes that affect the entire food supply chain. The causes of food contamination are built into today’s system of food production. Therefore, it is not as produc-tive to address the bioethics of irradiation or treatment of contaminated foods; rather it is better to address the production system that brings contaminated food to the market. Dr. Maki wondered what factors allow the fre-quent contraction of bacteria common to developing nations in a highly developed society such as the United States (2006). To this question, Schlosser provides the beginning of an answer:

Over the past 40 years, the industrialization and centralization of our food system has greatly magnified the potential for big outbreaks. Today only 13 slaughterhouses process the majority of the beef consumed by 300 million Americans. And the fast-food industry’s demand for uni-

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form products as encouraged centralization in every agricultural sector. Fruits and vegetables are now being grown, packaged and shipped like industrial commodities (Schlosser 2006).

Those innocuous leafy greens are simply the spearhead for the “industrialization and centralization” of agri-culture; a much larger social and political change. The changing face of agriculture has had two major recent public health concerns:

1. The recall of major crops such as spinach and tomato;2. The introduction and continued use of ge-netically-modified crops such as canola, soy bean, sprouts, wheat, rice, corn, and more (Prakash 2001).

Public concern on these two issues leads to greater ques-tioning of our agricultural system and its use of biotech-nology. By analyzing regulations on agriculture and food consumption in terms of the bioethical principles the regulations support, it becomes clear that the systems of food production are held up in a larger societal frame-work of neoliberalist policies. This larger framework does not benefit the greater good of society; it must be recognized and made obvious while future regulations should aim to change that framework rather than miti-gate its negative effects. First, the food supply chain will be analyzed, and next the ethically informed regulations in three major sectors of that chain will be explored. After considering these two aspects, it becomes evident that the underlying values of the food supply chain fit with the larger societal framework of neoliberalism.

Mechanized Agriculture and GM Crops

The word “farm” inspires images of a traditional rus-tic American homestead. Perhaps the sun rises over a red barn, animals rustle, and a lone rooster crows. The farmer himself appears and he is clearly an honest, hard-working, and capable man. He alone, perhaps with the help of his sons, tends to the fields and harvests the crops that feed his family and the local town. This idyllic ideal is far from the agribusiness reality of today. “Production of food is often a long, anonymous process in which large-scale industry farms, multinational processing industries, and supermarkets are involved” (Meijboom et al. 2006). Instead of the lone farmer and his family on a small local farm, most of the food available today is manufactured as

though it were a commodity, like the production of a car or computer, the various parts are separately produced, and then assembled and processed to give us common foods. This includes everything from Raisin Bran® to Chiquita® bananas. The farming itself has gone from small-scale, low-input, and diverse to large-scale, high-input, and exclusive. Today’s agribusiness uses heavily mecha-nized techniques on monoculture crops, requiring large amounts of fertilizer and pesticides. The mechanization of food production is directly linked to the spinach E. coli breakouts of 2006 because E. coli are a natural bacteria found in digestive systems of animals and humans. It seems that a spinach processing plant was near several cattle factories. The local water was contaminated with the enormous feces runoff from the cattle farms and thus the spinach processed in the nearby plant came to har-bor E. coli (Maki 2006). Another health concern and controversy in the current system of agribusiness is the use of biotechnol-ogy for higher yields (Falk et al. 2002). Biotechnology in agriculture is most commonly seen in the case of geneti-cally modified foods or GM crops. “Over the past 20 years, the development of genetic engineering techniques now allows the development of crops containing specific sin-gle gene transfers” (Falk et al. 2002). An example of these crops is RoundUpReady® canola, produced by agricultur-al biotechnology firm Monsanto in the United States and Canada. RoundUp is a pesticide commonly for the aver-age gardener. When it is applied in higher concentrations it indiscriminatingly kills all plants, not just weeds. The canola manufactured by Monsanto is engineered so that this canola can grow only after the application of Round-Up. This supposedly leads to higher yields since nothing else can grow on the farmland when RoundUp is present (The Future 2008). GM crops like this are dependant on the application of agrichemicals and feed into the overall agricultural system of monoculture and mechanization. The two main controversies that surround GM crops are the ethical responsibility of the GM crop producing cor-porations to farmers and consumers, and the health ef-fects of the crops themselves.

Neoliberal Bioethics of Agriculture Regulation

It is clear that the food supply chain has changed from that of an idyllic farmer to a larger, more complex sys-tem – a food supply chain – with unprecedented health effects. The new system of agriculture is not without its regulations and ethical committees. These national and

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supranational regulatory (Pechlaner & Otero 2008) bar-riers and ethical concerns can be divided by different sectors in the food supply chain: producers, consumers, and research. In doing so, it will become clear that the underlying bioethical values in each sector fit with the neoliberalist model that the overall society has adopted.

Producers: Corporate Interests & Deregulation

The producers sector includes corporations like Mon-santo, which apply and market agricultural biotechnol-ogy, large industrial farms, processing plants, distribu-tors, and even the local grocery store. The producing actors include every entity in the growing, processing, and distributing of food. It seems that, “two regulatory factors feature prominently with respect to the technol-ogy’s adoption: the intellectual property regime in place to protect the technology developer’s interests, and the regulatory regime that oversees any [Genetically Engi-neered] crops, once adopted…found both in national and supranational laws” (Pechlaner & Otero 2008). In terms of the producers, the prominent regulations are intellec-tual property regulations and the greater regulations on GM crops – or trading regulations. In addition, there are some environmental regulations regarding the use of ag-richemicals like fertilizers and pesticides. The regulations on intellectual property rights are “corporate friendly” (Pechlaner & Otero 2008). In the United States and Canada, a company like Monsanto can patent the genetic material contained in specific crops. This takes away the farmers’ traditional ability to save the seeds from the previous year’s crop and use them for the next year’s crops. It requires that the farmer pur-chase each year’s seed from the seed company. With the ability to patent and own specific genomes of plants and animal technology, corporations have begun to patent ge-nomes of plants traditionally farmed in the Third World (Levidow 2001), and because of the natural spread and reproduction of plants, patented GM varieties of plants cannot be absolutely confined. This allows the unregu-lated spread of patented biotechnology. Thus, if patented varieties spread onto other fields, companies have the ability to sue unwitting farmers for growing patented GM varieties without purchasing seeds (The Future 2008) even though farmers never intended to grow GM crops. This patent regulation places great control of the world’s agricultural crop squarely in the hands of agricultural biotechnology companies. Further, the trade regulations on GM crops are prescribed by the WTO and the GATT (Santaniello &

Evenson 2004). These two supranational bodies foster trade liberalization where trade between nations is free and unobstructed. The only legitimate barriers to trade are those that protect the safety and health concerns of a nation. Thus, the only barrier to the worldwide spread of GM crops is that enacted by the EU: “European Union has set out a plan for genetically modified food labels. It states that labels are required if any ingredient in a product contains more than 1% of GM material. Afraid that consumers view GM labels as a warning, European manufacturers are avoiding GM ingredients, thus elimi-nating the choice at the market (Falk et al. 2002).” Thus, the only requirements of producers are that they have a patent for the technology, and if they are marketing to the EU, they provide a label. Separate from GM food, the use of pesticides and fertilizers are a health concern for the farm workers themselves. Once the pesticide or fertilizer has been adopted, companies can export production to Third World countries where little or no environmental regulation exists. Often, companies will spray pesticides over their farms while workers are still in the fields at concentrations that harm both humans and the ecosys-tem (The Future 2008). These regulations on the producers in the food supply chain put forth three bioethical issues, resolved by regulations that support neoliberalism over other ethical perspectives. The three bioethical issues are:

1. the ability to “own life” by patenting genetic material; 2. the public health concerns of tak-ing the control of agricultural away from the farmer;3. the health concerns to the working farmer himself.

First, according to religious views and virtue ethics, it is unethical for anyone to own life. However, the ability to patent genetic material has led to advances in genetic re-search that benefit the common good. The regulations on patenting of genetic material have ruled over and over again in favor of the corporations and research for the benefit of common good (The Future 2008). The next issue concerns the public health of agriculture. While farmers have a right to be able to control what they are farming, corporations have a right to able to protect their products. Despite both those facts, the public has a right to nutritional foods that are safe to eat. However, the reg-ulations in place do not require food to be nutritious and safety regulations are fading (Schlosser 2006). The reg-ulations do not require corporate social responsibility

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(Maloni & Brown 2006). Again, regulation rules in favor of the corporation, and the ability of a company to pro-tect its product is ensured. Lastly, the unregulated use of pesticides is against the common good – it hurts both the environment and the farmers. It also goes against farmer rights to a safe and healthy working environment. At the same time, the corporations operate un-der a duty to their employees. Corporations must make a profit to maintain salaries and to remain competitive in the market. In order to remain competitive, they will make a profit by any means possible. The law should be able to regulate corporations so the rights of the farm-ers and the environment are protected, but it is clear that the ethics informing the law choose the rights of the corporations over that of the farmer. While the actions of corporations in the producing sector of the food supply chain follow the regulations provided, those regulations are designed to further trade liberalization and corpo-rate interests rather than address the ethicality of “own-ing life,” the public’s right to nutritious food, or the health rights of the farmers.

Consumers: Labels & Autonomy

The consumers constitute the next sector of the food supply chain, including every individual who is able to buy food. It is important to recognize that although the consumers can be addressed as a group, it is an underly-ing principle that each acts as an individual. The capital-ist system identifies the basic unit of the economy as an individual who makes rational choices. In the free market system, it is assumed that market competition regulated by government standards will provide the consumer with the best possible products. Thus, those given to produc-ers determine regulations that concern consumers. The controversies of food production as described by Upton Sinclair during the Industrial Revolution (Zwart 2000) inspired some FDA and USDA food safety regulations. While the regulations by the FDA and USDA on food safety protect all consumers, regulations take the form of labels only aiming to help the consumer make the best individual choice. There are the previously men-tioned labeling requirements on GM foods given by the EU, organic and fair trade labels, and nutrition fact labels. Those labeling requirements are an example of how con-sumer power influences regulations on producers. “As some biotechnology products reached the commercial stage in the late 1990s, however, they were hit by mass protest and scientific controversy in Europe. Threatened consumer boycotts there led major supermarket chains

to exclude GM ingredients from their own-brand lines” (Levidow 2001). The combined efforts of consumers showed governing bodies the addition of GM crops to processed food would not pass apathetically. This led to regulation requiring producers to label foods containing GM crops, which in turn dissuaded manufacturers from using GM food. In reference to mechanized agriculture, consumers have further voiced their opinion, inspiring the labels for organic and fair trade. In the consumer sector, the two areas that are central to bioethical concern are safety and common good (Kline 1990) and personal health. Food safety con-cerns the right of the individual to eat foods that are not contaminated with disease-causing agents. In this case, the regulations (in the form of FDA controls on food safe-ty) favor corporate social responsibility and the rights of the individual over profit. Since all foods are held to these FDA standards, the overall goal is for the common good as all individuals are protected. Beyond food safety, bioethical decisions regard-ing food are left up to the individual consumer who can make an informed decision based on the required food labels (if we exclude cost concerns). For personal health, “in order to help consumers make informed choices about what to eat, most countries have regulations about nutrition labeling – be it optional or mandatory. Consum-ers are thus able to read on the labels of food products which nutrients they contain and perhaps how this quan-titatively relates to recommended daily intake of those same nutrients” (Holm 2003). The nutritional informa-tion provided on the label is not intended to inform the consumer whether or not that food is “healthy.” Instead it is intended to provide unbiased scientific facts about the product’s content. Health information is provided by the medical system in the form of recommendations from doctors, public health campaigns such as the food pyr-amid, and personal values. “By accepting certain labels and rejecting others, the contemporary food consumer is allowed to develop a moral Self, to live a morally exam-ined life and to take sides in the political conflicts of the present” (Zwart 2000). In requiring food labels, regulation acts on behalf of the rights of the individual to make an informed deci-sion, and the bioethics of personal health in food choices is defined by autonomy. Those who believe in common good may choose (again, excluding cost concerns) to eat only organic or fair trade foods, those who have religious beliefs may choose Halaal or kosher food, and those who believe in animal rights may choose not to eat certain foods at all. There is no overarching regulation on how

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people consume food in the free market system adopted by a majority of the world. Thus, beyond national laws that support food safety (like the FDA), the bioethical de-bates of food consumption are decided by the individual consumer and trade liberalization in the form of the food supply chain.

Research: Common Good or Corporate?

The research portion of the food supply chain features the most regulation and this is where the FDA and NIH bear their weight. The research and application of agri-cultural biotechnology in the United States is regulated first by the same principles that govern all genetic re-search through the NIH and then by tests from the FDA in regards to the stability of the technology and potential harm to human health. The principles of the NIH con-cerning biotechnology require that

…institutions that conduct this type of research must set up an Institution Biosafety Commit-tee (IBC) that is composed of experts in various fields relating to the subject matter and are en-couraged to open their meetings to the public. The IBC is responsible for all the guidelines set forth by the NIH and must approve a project either before or during initiation, depending of the nature of the project and is keenly aware of pathogenicity and containment issues (57). (Falk et al. 2002).

In order for the food to enter the producing sector of the food supply chain, it must be approved by the FDA, which requires that food products go through the BET.

The Biotechnology Evaluation Team (BET) was created by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), Office of Surveil-lance and Compliance (OSC), and Center for Vet-erinary Medicine (CVM). The BET is composed of a consumer safety officer, molecular biolo-gist, chemist, environmental scientist, toxicolo-gist, nutritionist, and may include supplemental expertise depending on the product in question. The BET requests information, such as intended uses of the food, source of genetic material, in-tended technical affect of the modification, the expected effect of the composition of the food, the identity, function, and concentration of all newly expressed products, any known or sus-

pected allergens or toxins, a comparison of the composition of the new food to that of the pa-rental variety, and any other relevant informa-tion concerning the safety and nutritional as-sessment of the bioengineered food (Falk et al. 2002).

The bioethical issues are the concerns of scientists to en-sure ethical research and the duty of the FDA to protect human health. In order to have ethical research, scien-tists must take into account the rigor of the methodol-ogy – assessed by the NIH in the form of IBC committees – and the rights of research participants. “The four prin-ciples of protection of a research participant are autono-my (self-determination), beneficence (maximal benefit), nonmalfeasance (minimal harm), and justice (distribu-tion of benefits and harms across groups in society)” (Bergmann et al. 2008). The regulations in the research sector of the food supply chain seem to advocate for common good and protect personal health in that they protect both the rights of the research participant and the contribution of worthy scientific knowledge. This also seems to hold true for the FDA and the BET, which assesses the safety of food. However, there are more stakeholders here than initially obvious. “The current chief of staff at the Agri-culture Department used to be the beef industry’s chief lobbyist. The person who headed the Food and Drug Ad-ministration until recently used to be an executive at the National Food Processors Association. Cutbacks in staff and budgets have reduced the number of food-safety in-spections conducted by the FDA to about 3,400 a year — from 35,000 in the 1970s. The number of inspectors at the Agriculture Department has declined to 7,500 from 9,000” (Schlosser 2006). While there are regulations in place to protect individual and societal health, they are not upheld very well. Corporate corruption of governmental regulatory bodies and lack of funding for proper regulation has led to the situation we have today: increased mechanization of agriculture and use of questionable biotechnology. Many argue that the testing done on agricultural biotechnology is not adequate to warrant its use and that we need to heavily consider the effects that agricultural biotechnol-ogy and mechanization may have on future generations (McLean 2008). However, concerns for future effects, harm to human health, and damage to the environment (Strauss & Bradshaw 2001) are left to the wayside with the FDA’s corrupted regulation of agricultural biotech-nology. Thus, the application of biotechnology in agri-

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culture actually does not further the public good or the rights of the consumer and again only serves business’s ability to make profits. Since those businesses fund re-search of biotechnology, many times the regulations pro-vided by the NIH for ethical research can be blurred and again trade liberalization for mechanized agriculture and agricultural biotechnology is supported over all else. In all sectors of the food supply chain, the ethical considerations of ‘owning life,’ farmers’ rights, working conditions, food safety, common good, scientific knowl-edge, rights of research participants, and governmental duties are overcome by the corporate desire to make a profit. The political and economic structure of neoliber-alism does not allow for the protection or practical dis-cussion of any other ethical framework. “The reduction of ethics to concerns about consumer choice (which are currently crystallizing around the debate over labeling) is an example of how ethical discourse supposedly resist-ing the power of the biotechnology industry is actually recolonized by it” (Fraser 2001). All regulation in the form of labels: --EU labeling, fair trade, organic, nutrition labels—and public health efforts to inform consumer choices on what is “healthy” operates under neoliberal-ism and the need to make profits. The same applies for the producers and research sectors of the food supply chain. While this system has been developing over the last 30 years, it was only thrust into the light of bioethics with the inception of biotechnology. As others have ar-gued, the “application of this technology throws existing problems into much sharper focus and will force realis-tic resolution of difficulties which have been ignored for years. As such, many of the criticisms leveled at particu-lar applications of biotechnology are really aimed at the basic system which underlies our agricultural economy, a system in need of form” (Gendel 1990). Outbreaks of E. coli or salmonella from spinach and tomato merely pro-vide ethical “fires” that bioethical consideration attempts to put out by asking the FDA for more regulation, advis-ing to the public on how to eat healthy or safe foods, or recommending more research through the NIH for dis-ease resistant crops. This approach of bioethics does not address the deeper social system defined by neoliberal-ism that continues agricultural mechanization and bio-technology.

Increased Production and the Third World

Some argue that the mechanized system of agriculture and neoliberalism work for the greater good of Third

World countries by helping to fight world hunger by in-creasing food production and giving poor farmers dis-ease-resistant varieties of crops (Levidow 2001). How-ever, upon adopting food supply chain crops those same Third World farmers found them less than ideal. In India, “many farmers had been abandoning mixed farming systems in favour of cotton monoculture, thus intensifying their dependence upon purchased seeds, which sometimes led to crop failures” (Levidow 2001). Adopting monoculture cash crops also reduces the ability to produce subsistence crops and forces reli-ance on imported, processed foods. The increased yield of specific crops is not fed back into the Third World so-ciety; rather, it is used in the processed foods marketed to developed countries like the United States and sold at high prices in developing nations. People in these devel-oping countries are then forced to pay those high prices for processed food because of their decreased ability to farm subsistence crops because of monoculture agricul-ture. Thus, the system of neoliberalism and agricultural mechanization and biotechnology does not feed more people or give them a greater income and does not work for the greater good.

The Future of Food

The future of food lies in peril as more GM crops are ad-opted and mechanized agriculture continues to expand. Just recently, Iran adopted an 11-year plan for the devel-opment of biotechnology in agriculture (Mousavi et al. 2008). The role of bioethicists in the future should not be to put out more ethical fires; rather, it should be to address the structural realities that enable such agricul-tural practices to go on as they are (Buttel 1990) and to recommend practical changes that can be made. As it stands, the blame is shifted from group to group:

Producers justify disputable methods of produc-tion, for instance regarding animal welfare, by pointing towards economic pressure and to-wards the consumers that still buy the products. Consumers point to the difference in prices and the responsibility of the government. Politicians emphasize the responsibility of producers and so on, until a deadlock is reached (Meijboom et al. 2006).

Supranational bodies like the World Health Organization need to support new infrastructure to end the deadlock described above. It is imperative that this new infrastruc-

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ture is shaped by region-specific needs for food. It would provide transparent regulations and discussion between all portions of the food supply chain to hopefully mitigate the separation between producer and consumer, work-ing instead for a democratic, ethical good rather than the corporate good. Aside from the connections mentioned, there are links between disease outbreaks and the agri-cultural system and its contradictory ‘free trade regula-tions.’ These connections cannot be ignored, particularly if we are striving for a developing agricultural system.

References

Bergmann, Manuela M, Gorman U, Mather JC. (2008). “Bioethical Consider- ations for Human Nutrigenomics.” Annual Review of Nutrition. 28: 447-67. Annual Reviews. 18 Nov. 2008. <http://arjournals.annualreviews.org. proxy.lib.umich.edu/doi/pdf/10.1146/annurev.nutr.28.061807.155344>.Buttel, FH. (1990). “Biotechnology, Agriculture, and Rural America: Socioeco- nomic and Ethical Issues.” Agricultural Bioethics : Implications of Agricul- tural Biotechnology. Ed. Steven M. Gendel, A. David Kline and Dennis M. Warren. Malden: Wiley-Blackwell.Falk MC, Chassy BM, Harlander SK, Hoban TJ, McGloughlin MN, Akhlaghi AR. (2002). “Food Biotechnology: Benefits and Concerns.” The Journal of Nutri- tion. 132: 1384-390. The American Society for Nutritional Sciences. 1 Dec. 2008 <http://jn.nutrition.org/cgi/reprint/132/6/1384>.Fraser V. (2001). “What’s the Moral of the GM Food Story?” Journal of Agricu- lutural and Environmental Ethics. 14: 147-59. 15 Dec. 2004. UMUL. Pro- Quest. 28 Nov. 2008. <http://proquest.umi.com.proxy.lib.umich.edu/pqdw eb?index=11&did=352545411&srchmode=3&sid=1&fmt=10&vinst=prod &vtype=pqd&rqt=309&vname=pqd&ts=1227912244&clientid=17822&a id=1>.The Future of Food. (2008). Dir. Deborah Koons. DVD.Gendel SM. (1990). “Biotechnology and Bioethics.” Agricultural Bioethics : Im- plications of Agricultural Biotechnology. Ed. Steven M. Gendel, A. David Kline and Dennis M. Warren. Malden: Wiley-Blackwell.Holm L. (2003). Food Health Policies and Ethics: Lay Perspectives on Functional Foods. Journal of Agricultural and Environmental Ethics. 16(6): 531-544.Horsley S & Aubrey A. (2008). “Reacting to the Tomato Scare: Overdone or Not Enough?” Health and Science: Talk of the Nation. NPR. 1 Dec. 2008. <http://www.npr.org/templates/story/story.php?storyid=91483945>.Kline AD. (1990). “Introduction: Agricultural Bioethics and the Control of Science.” Agricultural Bioethics : Implications of Agricultural Biotechnology. Ed. Steven M. Gendel, A. David Kline and Dennis M. Warren. Malden: Wiley- Blackwell.Levidow L. (2001). “Utilitarian bioethics? Market fetishism in the GM crops debate.” New Genetics and Society. 20: 75-84. IngentaConnect. 28 Nov. 2008. <http://docserver.ingentaconnect.com.proxy.lib.umich.edu/deliver/ connect/routledg/14636778/v20n1/s6.pdf?expires=1227914994&id=47 435544&titleid=625&accname=university+of+michigan+at+ann+arbor&c hecksum=6b56e79883c48495b9174686e05fb472>.Maki DG. “Don’t Eat the Spinach — Controlling Foodborne Infectious Disease.” 9 Nov. 2006. The New England Journal of Medicine. 1 Dec. 2008. <http:// content.nejm.org/cgi/content/full/355/19/1952>.Maloni MJ & Brown ME. (2006). “Corporate Social Responsibility in the Sup- ply Chain: An Application in the Food Industry.” Journal of Business Ethics. 68: 35-52. SpringerLink. 28 Nov. 2008. <http://www.springerlink.com. proxy.lib.umich.edu/content/420785n1k263r12p/fulltext.pdf>.McLean MR. (2008). “A Framework for Thinking Ethically About Human Biotechnology.” Markula Center for Applied Ethics. Santa Clara University. 30 Nov. 2008. <http://www.scu.edu/ethics/publications/submitted/ mclean/biotechframework.html>.Meijboom F, Visak T, Brom F. (2006). “From Trust to Trustworthiness: Why Information is not Enough in the Food Sector.” Journal of Agricul-

tural and Environmental Ethics. 19: 427-42. 14 Nov. 2006. SpringerLink. 29 Nov. 2008. <http://www.springerlink.com.proxy.lib.umich.edu/con- tent/q47g1n6205315384/fulltext.pdf>.Mousavi A, Malboobi MA, Esmailzadeh NS. (2007). “Development of agricul- tural biotechnology and biosafety regulations used to assess the safety of genetically modified crops in Iran. (Special Guest Editor Section).” National Institute of Genetic Engineering and Biotechnology. 30 Nov. 2008. <http:// find.galegroup.com.proxy.lib.umich.edu/itx/retrieve.do?contentset=iac- documents&resultlisttype=result_list&qryserid=locale(en%2cus%2c)%3a fqe%3d(jn%2cnone%2c31)%22journal+of+aoac+international%22%3aa nd%3alqe%3d(da%2cnone%2c8)20070901%24&sghitcountty>.Pechlaner G & Otero G. (2008). “The Third Food Regime: Neoliberal Global- ism and Agricultural Biotechnology in North America.” Sociologia Ruralis. 48: 351-71. 8 Aug. 2008. InterScience. Wiley. 29 Nov. 2008. <http://www3. interscience.wiley.com.proxy.lib.umich.edu/cgi-bin/fulltext/121373459/ pdfstart>.Prakash CS. (2001). “The Genetically Modified Crop Debate in the Context of Agricultural Evolution.” Plant Physiology. 126: 8-15. American Society of Plant Biologists. 2 Dec. 2008. <http://www.plantphysiol.org/cgi/con- tent/full/126/1/8?view=full%20&pmid-11351063>.Santaniello V & Evenson RE. (2004). The Regulation of Agricultural Biotech- nology. New York: CAB International, 2004. Scholar.google.com. Interna- tional Consortium on Agricultural Biotechnology Research. 28 Nov. 2008. <http://books.google.com/books?id=qrwd-uuxbzic&printsec=frontcover>.Schlosser E. (2006). “Has Politica Contaminated our Food Supply.” Nytimes. com. 11 Dec. 2006. The New York Times. 1 Dec. 2008.Strauss SH & Bradshaw HD. (2001). “International Symposium on Ecologi- cal and Societal Aspects of Transgenic Plantations.” Oregon State Univer- sity and University of Washington, Tree Biotechnology; in the new milleni- um, 22-24 July 2001, Columbia River Gorge, United States of America. Scholar.google.com. 28 Nov. 2008. <http://www.fsl.orst.edu/tgerc/iu fro2001/eprocd.pdf#page=92>.Zwart H. (2000). “A Short History of Food Ethics.” Journal of Agriculu- tural and Environmental Ethics. 2000th ser. 12: 113-26. SpringerLink. 28 Nov. 2008. <http://www.springerlink.com.proxy.lib.umich.edu/content/ h766663752221224/fulltext.pdf>.

Yasaswi Paruchuri is currently a junior at the University of Michigan in the College of Literature, Arts and Scienc-es. She is concentrating in Illness, Health and Inequality through the Individualized Concentration Program and is minoring in Program in the Environment. She will ap-ply to medical school after pursuing a Masters in Urban Planning.

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ivy Journal oF ethiCS

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