Grounds | Vol. I, Iss. 1

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VOL. I, ISSUE 1

GROUNDS THE VIRGINIA JOURNAL OF BIOETHICS

REDEFINING PERSONHOOD AND THE IMPACT ON STEM CELL RESEARCH

BRIDGING THE GAP BETWEEN CARE AND COMMUNICATION

CRISPR/CAS-9 DEVELOPMENTS WHAT YOU NEED TO KNOW

PLUS WHY DISABILITY IS ABILITY

REFLECTIONS OF A MEDICAL STUDENT AND MORE

LEARNING TO LIVE WITH ALS

EDITORIAL STAFF Editor-in-Chief Dallas Ducar Senior Editors Logan Brich Alana Castro-Gilliard Catherine Firth Associate Editors Katharine Biegert Melissa Freidhoff Jennifer Goertz Sasheenie Moodley Melanie Norris Design Editor Logan Brich

SPONSORS Faculty Sponsor James F. Childress

FUNDING The Grounds Editorial Staff is thankful to the Institute for Practical Ethics and Public Life at the University of Virginia for its gracious funding of both the print and online versions of the Virginia Journal of Bioethics.

CONTACT US For more information about the Journal or to learn about submitting your own piece, visit us at: VABIOETHICS@GMAIL.COM WWW.VABIOETHICS.COM

ON THE COVER Situated at the head of the Lawn at the University of Virginia, the Rotunda is an instantly recognizable icon of knowledge and educational exploration. Completed in 1826, the Rotunda used to serve as the main library for the University and continues to function as the center of academic life at UVa. The building is unique in its location -- at the time of construction, most universities had churches at the center of campus. The UVa Grounds, as campus is called, are instead built around an enduring representation of the "authority of nature and power of reason" that school architect and founder Thomas Jefferson envisioned as being the guiding tenets of the University.

Nearly two centuries after the establishment of the University and the construction of the Rotunda, this inaugural edition of the Virginia Journal of Bioethics seeks to continue exploring those tenets. Addressing the bioethical principles guiding modern society, this Journal aims to provide a place for open discussion and reflection, much as the UVa Grounds have served to do for the entirety of their existence. And, much like the Rotunda seen above, the progress of this Journal and bioethics as a whole remains incomplete, unfinished. We thank you for your accompaniment on this journey, and we hope that we may together contribute towards constructing something inspiring.

CONTENTS 01

LETTER FROM THE EDITOR-IN-CHIEF

GROUNDS FOR DISCUSSION

03

ON THE NOTION OF PERSONHOOD

11

THE VIRTUOUS PHARMACIST

19

CRISPR/CAS-9: THE ETHICS OF IMPLEMENTATION

Finn Dobkin

Dallas Ducar

Sarah Alberstein

27

MISINFORMED MORALS

33

CONSIDERATION OF A MANDATORY GENETIC REGISTRY

Logan Brich

Catherine Firth

40

GOSSIP IN THE NEONATAL ICU

51

PROTECTING RESEARCH SUBJECTS OVERSEAS

Kathryne Appleby

Carla Andrea Pierini, JD, MPH

33

IT'S IN THE GENES The Ethics of Genetic Registries

GROUNDS FOR REFLECTION

59

THE UNKNOWN

60

DISABILITY IS ABILITY

61

EFFIGY, IDOL, AND ICON

64

NOT ALL DEATHS ARE "GOOD" DEATHS

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A DEAR SCHIZOPHRENIC PATIENT

68

QUITE SOME TIME

69

HOPE: IF ANYONE IS SELLING, I'M BUYING

67

Moira Smith Christina Sisti, DPS, MPH Darian Stahl Kelly O'Connell

11

Melina Rapazzini Abram Brummett Tom Palmer

WANT MORE?

FOR CONTENT UPDATED WEEKLY, VISIT US ONLINE AT: VABIOETHICS.COM

REFLECTING ON SCHIZOPHRENIA

A NEW ROLE FOR PHARMACISTS

The story of a patient as told through the eyes of an observant and loving care provider.

To ensure better outcomes, pharmacists must play a greater role in medical decision-making.

Welcome to

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Letter from the Editor-in-Chief

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Welcome to the inaugural edition of the Virginia Journal of Bioethics. The Journal, akin to the path of ethical dialogue and discourse, was born of many trials and tribulations. However, it is with the support and strength of copious thinkers and agents of change at the University of Virginia that the Journal has come to fruition. I am especially gracious for the generous support the Institute for Practical Ethics and Public Life has provided to make the Journal a reality. I would also like to thank Professor Jim Childress for his ardent support of student initiatives and reflection at the University. Moreover, the Journal would be nothing without the time and commitment of our writers and the entire Editorial Board. In the past year the Journal has become a powerful venue for impassioned debate and careful analysis; all of which would not have been possible without the aforementioned support and dedication.

It is often said that in bioethics we never reach moral certitude. The bioethicist is not an exemplar of ethics, but rather, simply a student of ethics. This must remain the foundation of all bioethical “knowledge,” to move forward with awareness as Socrates was purported to have said, “[ἓν οἶδα ὅτι] οὐδὲν οἶδα", [èn oîda óti] oudèn oîda” or, “I know that I know nothing.” With this in mind, the Journal is not only intended to be a space for advancing positions, but also admitting ignorance. This Journal is intended to serve as a space for collaboration and connectedness. I hope that this edition will usher in a space which can pave the way for engaging and enlightening dialogue.

Bioethics is an amalgamation of various perspectives joined on a path together. The Journal, like Bioethics, is intended to be an open dialogue, in constant flux. Viewpoints in the Journal are just one part of a larger conversation which will contribute to future positions and inspire meaningful action. Moving forward, it is my genuine hope that this Journal can stand as a bastion for justice, open-mindedness, and beneficence.

The entire Editorial Board would like to dedicate this first edition to the late, great, John Arras. As the Porterfield Professor of Biomedical Ethics and Professor of Philosophy and Public Health Sciences at the University of Virginia, John inspired many and his impact continues to reverberate strongly across the world of bioethics.

In the spirit of John, we would like to establish this Journal as a forum for “secular blessedness,” what he described as “a Socratic connection … which is as good as it gets.” So we inaugurate this Journal in the name of Professor John Arras and the pursuit of ethical reflection to which he devoted his life.

Ethics was born from Logos, birthed from Mythos. This mythical worldview transformed into rational and heated debate about the nature of reality and where we find meaning in the world. This spark has ignited a passion which continues to transform the world. It is my sincere hope that this Journal, most of all, will encourage active contemplation and reflection, to truly harness the power of this Logos. With this in mind, I hope that this is only the beginning of a dialogue that will foster compassionate intention and mindful awareness.

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"Fear paralyzes; curiosity empowers. Be more interested than afraid."

Patricia Alexander

DALLAS DUCAR Editor-in-Chief

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GROUNDS FOR DISCUSSION

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ON THE NOTION OF PERSONHOOD Personhood from an Ethical Perspective and its Implications on Stem Cell Research Finn Dobkin The University of Puget Sound

ABSTRACT This paper will argue that a human embryo should be considered non-human despite possessing human biological characteristics. I will argue this based on the fact that human embryos lack the fundamental characteristics that give individuals intrinsic value, therefore denying them the right to equal moral status of humans. Additionally, I will argue that from a deontological standpoint, the lack of equal moral status of the blastocyst allows them to be used for purposes of research in regenerative medicine and stem cell research; however, they should not be exploited for frivolous purposes that will not benefit humanity as a whole. I will then argue that while the blastocyst may be used for stem cell research, considerations must be made of the donor and the ethical implications of the use of a woman’s body for obtaining the blastocyst. Overall, the aim of this paper is to draw a framework of how the blastocyst lacks personhood in order to justify its use in experimentation from a deontological perspective.

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INTRODUCTION Biology, a word derived from the Greek words “bios” meaning life and “logos” meaning study is defined as the study of the science of life. The study of biology, the fundamental science of all organisms, living and nonliving, is the principle basis of defining what it means to be human and what it means to be non-human. To the biologist, the human is an individual “belonging to the species Homo sapiens distinguished from other animals by superior mental development, power of articulate speech, and upright stance” [1]. From the scientific standpoint, this definition is commonly accepted.

However true this may be, it is important to question whether the use of the scientific lens is the best way to examine this issue. If the answer is no, then should we consider the given definition of “human” to be correct?

Personhood is a concept that cannot be formally defined in any specific manner; there are fundamental characteristics that are shared by all people that create individuality amongst the human race placing value on not just humanity but on the life of a single entity. These characteristics are the determining factor in differentiating the human from the non-human, the blastocyst from the adult, and the individual from the species.

Without acknowledging the genetic structure, cellular functions, or neural directives of the human, the discourse surrounding what it means to be human circles largely around the realms of the theological, legal, and philosophical. Indeed, the debate over personhood has not only taken on many forms but has proven to be of great importance as it is ground zero of nearly all bioethical discourse, having led to the the ground-breaking decision in Roe v. Wade or been used to falsely justify the notorious atrocities of the Nazi extermination of minority groups during World War ll.

In any case, the fluid definition of humanity and personhood is all as relevant today as it was decades ago.

In an attempt to create a boundary along what is and what is not personhood, I will argue that humans possess certain intrinsic values that define them not only as human, but more importantly, as individuals. These characteristics are uniquely proximal to humanity and go beyond biological function to define who we are as people on an individual level. Furthermore, I will argue that not only is personhood beyond biological function, but that the ethical perspective on personhood trumps that of the biological perspective of personhood. I contend this based on the notion that an ethical perspective accounts for a greater degree of one’s individual contributions to societal values and positions which a scientific perspective does not take into effect. I will preface this paper by stating that this is simply a profile of what it means to be human. No formal definition will be given nor can it be given at our level of knowledge and enlightenment.

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Furthermore, I will argue that the boundaries of personhood established in this paper are grounds for experimentation in regenerative medicine, specifically embryonic stem cell research. This will be argued from a Kantian ethical perspective wherein the blastocyst, the source of embryonic stem cells, does not achieve the fundamental characteristics set forth by the proposed framework on personhood. Thus, using them for purposes of medical research is morally permissible on the grounds that using them as a means to an end is morally sound as they are not people but instead tissue of the woman’s body. Furthermore, I will argue that the ultimate decision on the moral permissibility of this issue lies in the hands of women as it is the responsibility of society to trust the moral judgement of women on issues that are uniquely proximal to their wellbeing. The overarching format of this argument will be a discussion of the concepts that define personhood: consciousness, relational status, rationality, reflection, emotion, agency, and will to live. These will be discussed in relation to the blastocyst followed by the permissibility of stem cell research when considering the stated principles.

WHY USE THE KANTIAN FRAMEWORK? While the importance of the Kantian framework will not come up until later in this paper, the implications of its importance should be considered throughout. Kantian deontology states that no individual should be used as a means to an end or that we should never use a person solely for the utility they can provide us [2]. Thus, even if the outcome of the actions are morally permissible, but the steps taken to get to the outcome of such actions are not permissible, then the actions and results as a whole are not morally permissible.

When comparing this to an opposing framework such as utilitarianism, which stresses that the greatest good is that which produces the greatest net benefit for the most people, Kantian deontology is superior because it places value on the life and free will of the individual. I argue that this is of greater importance because when we try to produce the most good for the most people, we are treating them as a single unit. This mentality devalues the individuality of each person, turning them simply into any other faceless person thus commodifying them by rejecting their unequivocal circumstances and contributions. Additionally, utilitarianism contributes to a negative societal construct by ignoring the ethical implications of the actions taken to achieve a result. This is problematic because it requires that we ignore standards of justice in order to produce good [3]. This means that in order to produce the most good, we must

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ignore the importance of human rights, moral virtues, and ethical principles that place value on our character and lives as people. Additionally, the use of Kantian ethics is important in analyzing this issue because it places value on the freewill of individuals. This is vital to the ethical framing of stem cell research and the harvesting of blastocysts because of the unique ways in which stem cell research affects different people in different ways.

WHY DEFEND ETHICAL PERSONHOOD? It must be established that the biological criterion for describing humanity is certainly valid in circles of both science and ethics. It allows humanity to be viewed through an objective lens that specifically denotes what is and is not human in the least fluid of manners through a solidified framework. In fact, one can connect the ethical and biological views of personhood on the basis that “we as humans, have moral value simply because we have a human genotype” [4]. However, human biology does not account for the aggregate qualities that not only distinguish one as a human but as an individual with a unique upbringing, contributions, and qualities to society. The social and cultural forces that affect these aggregate qualities are of far greater importance than any biological factors that define one’s existence as a human species because our biology is for the most part shared as a species, however our individual identities are not common.

I. Consciousness To describe the essence of consciousness is as vague and ambiguous as describing the essence of the mind itself.

However, the importance of consciousness as it relates to personhood cannot be overstated. To begin, personhood is not a state of being. Instead, personhood is a vector for the experiences by which one sees the world which underlies the importance of morality [5]. In any case, consciousness becomes necessary as a mental state in which one can relate to the world around them as it is the only manner by which one can experience life. As John Locke stated: “I do not say there is not soul in man because he is not sensible of it in his sleep. But I do say he can not think at anytime, waking or sleeping, without being sensible of it.

Our being sensible of it is not necessary to anything but our thoughts, and to them it is and to them it always will be necessary” [6].

This idea sums up the importance of consciousness not as a trait one must find in order to become human, but also to experience all the other fundamental characteristics listed below. Without it, one simply cannot possess the means by which personhood is ascribed.

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II. Relational Status In itself, personhood is based largely off relational status. This status is what derives roles and obligations from a societal perspective. Thus, the relationship one has with the environment around him or her does not create personhood, but rather it defines the social bonds that we form to bring value to our lives and gives us moral obligations that arise from our interactions with others [7]. Additionally, the connections that one forms with others place value not just on one’s own life but on that of others. Value to life is an inherent necessity for one’s existence; even from the most nihilistic viewpoint, one must acknowledge that to be human and to exist is of its own importance as an end in itself. It should be noted that relational status is not limited to person-toperson interactions. Dr. Elaine L. Graham of the University of Chester notes the importance of cultural interaction as a “prerequisite for the development of beings into persons” [8]. Thus, the use of relational status as a condition of personhood defines not who we are in ourselves but instead how it is that we see others.

This is important as our view of others links to how they are treated by us and consequently how they treat us in return.

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III. Rationality

...our biology is for the most part shared as a species, however our individual identities are not common.

In the human condition, rationality occurs in two forms. First, rationality occurs as the ability to reason in a practical sense.

This occurs in the form of means-end reasoning wherein an individual has a problem, and after identifying the problem, the same individual forms a solution in which to solve the problem. Though such intentions or the means by which to solve such intentions may seem impractical, it is the notion that such an intention must be solved that gives rationality [9].

Rationality occurs on another level however, and that is not just based on our ability to have beliefs but based on our ability to evaluate them as well [10]. This is necessary to weigh our beliefs not just against others but against what our end goals are. Conceptually, this is necessary for personhood on the grounds that a functioning being must be able to identify the good and the bad, not necessarily from an objective standpoint, but at least from a subjective standpoint based on his or her own beliefs.

IV. Reflection Reflection in this instance will be defined as the careful and collected thought about one’s personal beliefs and the behavior that such beliefs result in. This definition extends to how one’s beliefs affect those in the surrounding environment. The importance of self-reflection lies in its influence on our motives. What happens in the past is our gateway to the story of our future. As an example, “a baby learns that it is looking at a table by being told by an adult; the baby can see that the adult is looking at the table. They are both looking at the same thing, which the adult calls the table.

So in learning to identify its experience – seeing a table – the baby also learns to identify the adult’s experience” [11]. As humans are social animals, the use of reflection as a form of connection is vital to our existence as co-ordination between individuals is the basis for societal cultivation and maintenance V. Emotion For purposes of clarity, emotion in this case will be defined as the mental state made with no conscious effort that affects one’s cognitive state with either positive or negative feelings.

This virtual phenomenon creates reasoning behind why we rationalize certain decisions despite whether or not they are practical in an analytical sense. Though emotion has a tendency to cloud our decision making ability, sometimes to our detriment, its existence highlights the fact that all of our actions have meaning beyond the physical result of what we do. Instead, they have meaning on a level that touches people in a poignant and more meaningful sense. Thus, as we can see, emotion gives an individual an awareness of deeper feeling by placing meaning on our individual actions.

VI. Agency An agent is defined as an individual with the ability to act in his or her own capacity in a physical environment. Agency is a way in which the individual becomes involved in the social structure around them. It allows the individual to work within one’s own wishes and desires instead of following the same path of other individuals.

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VII. Will to Live The will to live as both a psychological force and survival instinct is not unique to any certain individual yet instead is present as an unconscious force that is directly affected by what Sigmund Freud refers to as the “pleasure principle.” This principle which states that “humans make decisions to seek pleasure and minimize pain” is the driving force behind one’s desire to live [12]. The will to live is not just attached to oneself but also to promoting the will of others existence. According to Dr. Joseph Fletcher: “The extent to which this capacity is actually in play is debatable. But whether concern for others is disinterested or inspired by enlightened self interest, it seems plan that a conscious extra-ego orientation is the trait of the species” [13].

The will to live is uniquely proximal to those with personhood as it requires consciousness, rationality, and reflection. These three characteristics that give one the will to live are not present in for example a blastocyst or embryo. Thus, one can ascribe personhood to a fullgrown human but not the precursor to a full-grown human, the embryo or the blastocyst which simply constitute a potential human.

NOTE ON EXCEPTIONS It is possible to possess the listed characteristics and not possess personhood itself. As an example, many animals such as the Great Apes possess a higher level of cognition giving them the ability to maintain the standards set forth that would define them as a person by the standards set forth in this paper. Recent debate has tried to give certain animals personhood on the basis that such animals including the Great Apes possess similar cognitive states as humans. However, the boundaries set forth in this paper do not account for whether or not an individual has been diagnosed with a condition that disallows them from possessing such traits. Those that may be comatose, schizophrenic, sociopathic, have an underdeveloped prefrontal cortex, or another disease or condition that limits or altogether neutralizes the characteristics set forth should still be considered human on the grounds that they have possessed such traits at a time in their lives in addition to their biological identification and thus should still be given personhood [14]. I will argue that they have personhood on the basis that they possess fragments of the necessary conditions, even if they are not considered fully rational human beings [15].

DOES THE BLASTOCYST FALL UNDER THIS CRITERION? To begin, the blastocyst is identified as a fertilized egg composed of 25-30 undifferentiated cells. These five to

nine day old undifferentiated cells are what is known as pluripotent, meaning they can multiply into various specialized cells distinct to specific organ systems [16]. As this is a fertilized egg, it shares the biological aspects of a full grown human i.e. DNA, genetic codes, cells. However, questions arise when examining what characteristics it shares within the boundaries established in this paper.

At five to nine days old, the cells that make up the blastocyst have yet to begin operating as a singular unit [17]. Without coordinated function between cells, the blastocyst is reduced to the status of tissue of the woman’s body. This means that while the blastocyst may be biologically human in its shared DNA, it lacks the listed characteristics necessary to give such an entity intrinsic value and thus does not possess equal moral status of a full-grown human that possesses the stated characteristics.

IMPLICATIONS ON STEM CELL RESEARCH AND THERAPY As has been established above, the blastocyst holds the biological characteristics that can relate it to a full-grown human; however, it lacks the fundamental characteristics that give it ethical personhood. As I have argued, the importance of ethical personhood is more important to the validity of human existence than is biological personhood. Kant himself argued that a person must possess rational capacity for decision making in order to be human. Thus, without personhood, the blastocyst does not achieve the same moral status of the full-grown human. With this all being the case, the blastocyst (when viewed from a deontological standpoint) can be used as a means to an end because it is not a person by both Kantian and normative ethical standards.

To add to the argument, we have established that the blastocyst is 25-30 undifferentiated cells with no coordinated function. If one is to contend that to destroy the blastocyst is to kill a human, then one could also contend that every time one brushes their teeth, they are committing mass genocide as millions of cells are being killed in the process. This is an illogical belief based on the idea that killing cells is equivalent to killing a human no matter how sophisticated their bodily function. Thus, through normative standards alone, this proves that Stem Cell Research is morally permissible.

Throughout the writings of Kant, one can see the common theme of the importance of autonomy. As we have proven that blastocysts are not humans, we must consider who makes the ultimate decision on the ethical permissibility of the use of blastocysts for Stem Cell Research. I will argue that due to the deontological importance of autonomy, the woman, specifically the

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donor, is the ultimate deciding factor in this issue as she is the one being used as the vector for obtaining stem cells.

This is important because egg donation is uniquely proximal to a woman’s body and thus should be decided from a female point of view.

PERSONHOOD OF THE BLASTOCYST CONSIDERED The conclusion that the blastocyst lacks personhood does raise the idea that since the blastocyst is not human, it is naturally going to be classified as a potential human since it is capable of the traits described above but has yet to achieve them. As it has the status of a potential human, what (if any) rights does the blastocyst possess? From a Kantian perspective, a potential human should incur rights that allow it to be utilized for lifesaving purposes i.e. stem cell therapy. However, it should not be abused for frivolous ends. To repurpose Kant’s categorical imperative argument, blastocysts should not be used as a means to a purposeless end, thus maintaining certain rights that are inalienable to living substance yet not sharing full moral status of full-grown humans.

COUNTERARGUMENT: WOMEN’S PERSPECTIVES We have established that the blastocyst may be used for Stem Cell Research on the basis that it does not possess personhood. One must keep in mind however, that this blastocyst is not a singular being created out of itself.

Whether the blastocyst is harvested from spare embryos created as a result of in vitro fertilization or the egg and sperm were united for the sole purpose of harvesting the blastocyst, the woman’s body is a factor to consider in this argument. We will consider three possible scenarios in which the blastocyst can be harvested and the ethical

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implications of each scenario on the woman.

In the case of spare embryos from in vitro fertilization, I will argue that this is morally permissible on the grounds that consent is obtained from the egg donor. On the grounds that the fertility needs of the egg donor are met, and that the embryos are not purchased, the use of the blastocyst for stem cell therapy is permissible as the woman is not being used as a means to an end but instead is donating her tissue for the purposes of either research or therapy.

In the case of embryos being purchased from a woman, I will argue that this is not morally permissible on the grounds that the woman’s body is being used as an object instead of placing value on the woman herself. This violates the categorical imperative in that the woman is no longer valued as a living being but instead as a source of commodity production. This reduces the woman to a product of our own usage instead of a being capable of free, rational thought that is able to guide her own life.

In the case of embryos coming from eggs donated by a woman, I will argue that this is morally permissible on the grounds that the woman is giving the embryos out of the intrinsic value of goodwill instead of a need for monetary compensation. In this manner, the categorical imperative is not violated as the woman is not being used as a means to an end but merely as a voluntary agent in the process whose goals are to better the world.

While it is theoretically possible for the harvesting of embryos to be morally permissible from a Kantian perspective, due to the difficulty and stress involved in donating embryos, we can conclude that women are being used as a means to an end in the process of stem cell research except in the case of the use of spare embryos. It should be noted however that one can be

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used as a means to an end and still have the result be ethically permissible by Kantian standards. The case of stem cell research is a worthy example of this as the harvested blastocysts could go towards treating the donor or a family member of the donor in which case the action would be morally permissible on the grounds that the woman benefits from the action.

IMPLICATIONS OF THIS PAPER ON PERSONHOOD No matter what one’s belief is on the issue of personhood, no conclusion will be reached on the matter. The diversity of beliefs and the origin from which they arise make a conclusion on the issue impossible. With that said however, the implications of personhood remain important in the field of ethics. Every issue we face as people is sourced at the same point. What is human and what rights do we as humans deserve? Why is going to war bad? It is bad because human lives are put at stake.

Why should we increase funding to healthcare? Because health care can help save human lives. While the axioms presented in this paper are at this point self-evident, on a macro level, they raise greater questions such as the fact that many non-human animals share these same traits.

Does this mean that non-human animals possess personhood? This paper raises the question of individuals with cognitive disorders who may not possess all these traits. Do they possess personhood as well? Thus, are all the traits listed necessary for personhood? These questions in themselves raise ethical dilemmas that at times can be solved through simple reasoning and at other times may simply not be solved at all. The notion of personhood is no elementary or negligible issue. As this is the case, the ideas set forth in this paper have provided some amount of clarity in the way of the answers to these questions and many more like them.

IMPLICATIONS OF THIS PAPER ON STEM CELL RESEARCH The method by which applied ethical issues are analyzed is the deciding factor in the outcome of the decision over whether an issue is morally permissible or not. From this standpoint, the use of the Kantian perspective is important here because unlike traditional approaches to the issue of stem cell research which often utilize the utilitarian approach, the Kantian approach is more holistic by looking at the effects of stem cell research on the individual, specifically the women. Due to the rise in both technology and controversy on this issue, ensuring that all ethical frameworks are utilized to look at this issue is important as we must consider all ways in which this controversial issue affects people.

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FINAL THOUGHTS This paper has considered the beliefs of personhood that have been established over the years and how such beliefs affect the status of stem cell research. Through the information gathered and thoughts shared, the following can be concluded: 1. Personhood is not an objective concept but is instead fluid in its definition and based on one’s personal opinions of what it means to be human.

2. The Biological aspects of personhood are outweighed in importance by the ethical implications of personhood.

3. Stem cell research is affected by the boundaries of personhood.

4. When Stem Cell Research is observed from a Kantian perspective, one must consider the implications on both the blastocyst and the donor.

These conclusions highlight the importance of maintaining fluidity in one’s beliefs when analyzing the issue of personhood. Additionally, one cannot conclude the discussion of personhood without addressing the importance of individuality. Throughout this paper, the importance of individuality is addressed from time to time. To frame the importance of this, personhood is what identifies the individual on a macro level; individuality is what identifies the individual on a micro level thus placing value on the life of a singular being instead of a species or group as a whole. The fundamental characteristics mentioned throughout this paper are what gives discernment that describes each person on a singular level.

When it comes to Stem Cell Research we must remember the importance of looking at the societal effects of using stem cells and blastocysts. This is why we should reject the utilitarian perspective.

While stem cell research is a promising field that may cure many diseases, we must remember that its usage bears a great detriment to women in that it is using them as an object for someone else good. It is in this instance that we must consider the potential for opening the doors to the devaluation of the lives of donors by using them as an item of production. This is where we see the moral impermissibility take hold.

To conclude, the split between the individual and the common aggregate of people that creates humanity is that which is described in this paper. This paper not only describes the noteworthy characteristics that create the individual, but also highlights the importance of being able to discern the individual from the whole. The effects of this are readily observable in the field of stem cell research as such effects are the determining factors in the moral permissibility of the issue. These characteristics of personhood cannot be described through simple biology. No objective framework can describe what it means to be human. It is in

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this basis that lies the importance of ethical personhood and how it affects our outlook on stem cell research.

When we add in the use the Kantian framework to analyze the issue, we see that multiple approaches should be taken to analyze this issue, but that the ultimate decision in the moral permissibility of Stem Cell Research lies in the hands of the donor. To end, this dialogue of personhood and stem cell research will maintain its relevancy for years to come. As long as there are conflicting opinions on this issue, there will be a need to analyze stem cell research from multiple ethical frameworks. I believe analysis that focuses on the individual is most important in justifying the use of the Kantian framework. Thus, we cannot conclude whether stem cell research is morally permissible or not as not one ethical framework can be proven correct as it applies to all viewpoints on this issue. All that can be said is that stem cell research and personhood are tightly bound in their relationship to each other and will remain as such for however long this debate continues.

REFERENCES [1] Anderson, David L. “What Is a Person?” The Mind Project. November 4, 2000. Accessed April 8, 2016. http://www.mind.ilstu.edu/curriculum/what_is_a_person.

[2] Singer, Peter. A Companion to Ethics. Oxford, UK: Blackwell Reference, 1991.

[3] Lyou, Jihan. “The Right-Based Criticisms of Utilitarianism and The Response Strategies of Utilitarianism. “ Journal of Ethics vol. 4 no. 23 (2008): 129. Accessed April 5, 2016

[10] Macklin, Ruth. “Personhood in the Bioethics Literature.” The Milbank Memorial Fund Quarterly.

Health and Society 61, no. 1 (1983): 35-57. Accessed April 21, 2016.

[11] David, Nurit Bird. “Animism” Revisited: Personhood, Environment, and Relational Epistemology.” Current Anthropology 40 (February 1999): 67-91. Accessed April 14, 2016. JSTOR. [12] Freud, Sigmund. Beyond the Pleasure Principle. New York: Norton, 1975.

[4] Brannigan, Michael C., and Judith A. Boss. Healthcare Ethics in a Diverse Society. Mountain View, CA: Mayfield Publications., 2001.

[13] Fletcher, Joseph. “Indicators of Humanhood: A Tentative Profile of Man.” The Hastings Center Report 2, no. 5 (1972): 1-15. Accessed April 18, 2016.

[5] Gulick, Robert Van. “Consciousness.” Stanford Encyclopedia of Philosophy. 2004. Accessed April 14, 2016. http://plato.stanford.edu/entries/consciousness

[14] Parens, Erik. “Alzheimer’s Disease and Personhood.”

Hastings Center Report 43, no. 3 (January 11, 2013).

Accessed April 18, 2016. Wiley Online Library.

[6] Locke, John. An Essay concerning Human Understanding. New York: Dover Publications, 1959.

[15] Manninen, Bertha Alvarez. “Are Human Embryos Kantian Persons?: Kantian Considerations in Favor of Embryonic Stem Cell Research.” Philosophy, Ethics, and Humanities, in Medicine 3, no. 4 (January 31, 2008).

Accessed April 19, 2016. US National Library of Medicine.

[7] Zlatev, Jordan. The Shared Mind: Perspectives on Intersubjectivity. Amsterdam: John Benjamins Publications., 2008.

[8] Harris, Harriet A. “Should We Say That Personhood Is Relational?” SJT Scottish Journal of Theology 51, no. 02 (1998): 214-29. Accessed April 14, 2016 [9] Bratman, Michael. “Intention and Means-End Reasoning.” The Philosophical Review 90, no. 2 (1981): 252-68. Accessed April 15, 2016. JSTOR

[16] Johnson, Martin H. “Human ES Cells and a Blastocyst from One Embryo: Exciting Science but Conflicting Ethics?” Cell Stem Cell 2, no. 2 (February 7, 2008): 103-04.

Accessed April 21, 2016. Science Direct.

[17] Beeson, Diane, and Abby Lippman. “Egg Harvesting for Stem Cell Research: Medical Risks and Ethical Problems.” Reproductive BioMedicine Online 13, no. 4 (2006): 573-79. Accessed April 22, 2016. Science Direct.

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THE VIRTUOUS PHARMACIST Preventing Disease and Medication Overuse Dallas M. Ducar The University of Virginia

ABSTRACT Laws have been used as methods to incentivize or punish behavior, which is deemed morally wrong. One example of an incentive in healthcare today is the federal 340B program. While the 340B program was initiated to aid in providing low-cost medications to indigent populations, current data suggest that 340B institutions are disproportionately expanding care to higher-income areas. This is one example of how the practice of the law differs from the intent. Rather than argue for additional laws to regulate this expansion, or determine how 340B funds should be utilized, I argue for a focus on preventive care. Effective prevention of disease is multidisciplinary and requires virtuous persons, specifically within the modern pharmacy. I argue that practical wisdom is necessary for hospital pharmacists to provide quality and effective care. Virtuous care addresses not only the patient mentally, physically, and socially, but also ensures quality and meaningful care for vulnerable populations while using resources prudently, in line with the intent of 340B.

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CARROTS, STICKS, AND MEDICATIONS

340B eligible patients are not just indigent patients. To be eligible to receive 340B-purchased drugs, patients must receive health care services other than drugs from the 340B-covered entity. The individual must meet three requirements, as defined by federal regulations:

Laws are born out of need and desire for justice. Oliver Wendell Holmes once observed, "The law is the witness and external deposit of our moral life. Its history is the history of the moral development of the race” (Holmes, 1897). Law is born out of moral consensus; therefore, the law is intended not only to be a reflection of present society but also a guide for future generations.

Moreover, the law is typically seen as a reaction to unacceptable behavior and legal changes are ideally seen as a mark of progress. Legislations which protect patient confidentiality, promote just distribution of donated organs, or incentivize care of vulnerable populations remain examples of how American society has reacted to immoral and unprincipled behavior.

Unfortunately, while laws generally construct the floor for behavior within society, they do not prescribe an ethical ceiling. In these cases, legislation acts as a means to an end, using carrots (incentives) or sticks (punishments) to alter behavior.

● “The covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual's health care; and

In this essay, I will describe current debates regarding these carrots and sticks using the example of the federal 340B program. Instead of taking a definitive stance on how best to turn a profit, I will advocate for a virtue ethics approach. Specifically, I will argue that pharmacists have obligations to participate virtuously amongst the medical team. Increasing pharmacist involvement in patient care will greatly transform care and even reorient the goals of healthcare organizations (HCOs) towards individualized care. Therefore, I argue that pharmacies and pharmacy schools have good reason to foster virtues in young pharmacists, to shape future aims towards preventive over reactive care.

As mentioned, one stark example of the inadequacy of these carrots and sticks can be found amongst interpretations of the federal 340B program. This program was named for a section of the Veterans Health Care Act of 1992, and was intended to give assistance to low-income and uninsured patients (Government Accountability Office, 2011). Specifically, the text states that the intent of the program is to allow registered entities to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services” (Veterans Health Care Act of 1992, 1992). The 340B program allows qualified 340B entities, which include qualified health centers and state AIDS Drug Assistance Programs, to enjoy large discounts on pharmaceuticals. Moreover, all drug manufacturers who wish to have their drugs covered by Medicaid must participate in the 340B program. 340B represents a reaction to recent public awareness regarding the lack of access to affordable medication, and provides measure to ameliorate this.

● the individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity; and ● the individual receives a health care service or range of services from the covered entity which is consistent with the service or range of services for which grant funding or federally-qualified health center look-alike status has been provided to the entity. Disproportionate share hospitals are exempt from this requirement” (Veterans Health Care Act of 1992, 1992).

It is clear that the statute itself defines who is eligible for 340B and how HCOs and manufacturers are required to comply with the statute. However, the law does not specify how savings from 340B should be utilized.

Interpretations of the law have varied. Some federally qualified health centers have stated that 340B was never meant to simply provide cheap medication, but that it was rather meant to aid hospitals in treating indigent patients and stretching federal resources. Proponents of this view believe that profiting from 340B helps to keep hospitals operating, consequently allowing them to continue helping said patients. Opponents, such as Senator Charles E. Grassley, disagree. Grassley has argued, “If ‘nonprofit’ hospitals are essentially profiting from the 340B program without passing those savings to its patients, then the 340B program is not functioning as intended” (Pollack, 2013). 340B has allowed for increased profits. Specifically, an oncologist may use two and a half million dollars to four million dollars in drugs a year, and if these drugs can receive a 25 percent discount, the potential profit is upwards of one million dollars.

Moreover, if the patient is insured, the hospital is permitted to keep the difference between the low price it paid for the drug and the high price it charged the insurer. In the end, the law aids hospitals, which serve low-income populations and in turn, generally provide access to cheaper medications for patients. Despite this, investigations are underway to ascertain if HCOs are utilizing savings appropriately. Perhaps tellingly, only Republicans have joined in the recent re-examination of the 340B program, and investigations are only directed at HCOs and not pharmaceutical companies.

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340B is an example of just one healthcare law wherein two groups severely disagree. Any area of healthcare policy wherein multiple groups stand to profit will undoubtedly result in argument over differing interpretations. What makes 340B unique is the growing reliance of the United States on high-cost pharmaceuticals. This is observed with drugs, which treat chronic conditions: hepatitis C drugs can cost $1,000 a pill or more, and cystic fibrosis drugs can cost upwards of $300,000 a year. Oncologic pharmaceutical treatment generally extends life for a couple of months and can routinely exceed $100,000 a year. While costs continue to increase, so do the number of prescriptions.

In 2005, 133 million Americans were living with at least one chronic condition and 63 million were diagnosed with multiple chronic conditions (Wu & Green, 2000). In 2020, these numbers are projected to grow to 157 and 81 million, respectively (Wu & Green, 2000). Moreover, beneficiaries of multiple chronic conditions accounted for 76 percent of Medicare expenditures in 2002; this number is expected to grow from five million to 21 million in 2050, ensuring a major increase in high-cost patients (Thorpe & Howard, 2006). The aforementioned demographic changes will lead to greater dependence on the Centers for Medicare and Medicaid Services (CMS) and, as a result, greater dependence on 340B. It is clear that current demographic changes are leading to an increase in costs, and related profit opportunities for organizations. The current law provides an opportunity to provide medications at lower costs. It does not, however, provide incentives for any supererogatory behavior. Specifically, hospitals are able to profit from 340B expansion without being required toaccount for said profits. Recent reports have scrutinized HCOs for possibly expanding in ways that could maximize profits. Enrollment in 340B programs has increased sharply since 2011, doubling since 2001 (Government Accountability Office, 2011). Conti and Bach (2014) found that hospital-affiliated clinics that registered for the 340B program in 2004 or later served wealthier communities when compared to older clinics.

These wealthy communities also had higher rates of health insurance. Because HCOs can elect to sell all of their 340B drugs to only fully-insured patients, they can also choose to expand their services strictly to more affluent areas. These findings are consistent with past reports, which suggest that the 340B program is currently being converted from a system which serves vulnerable populations to a system which maximizes profits for HCOs (Alexander, Garloch, & Neff, 2012; Pollack, 2013).

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REFRAMING THE CONVERSATION Many health systems across the country participate in the 340B program. Current dialogue revolves around how profits should be spent. This discussion, however, should be reframed. With rising costs and prescriptions, hospital systems should focus on decreasing the number of medications, which are prescribed for preventable disease. From the perspective of an HCO, increased profits may be necessary to pay for the increase in uninsured patients. However, preventing disease can reduce costs for uninsured patients. Socioeconomic status is a major risk factor for chronic disease, and indigent patients, on average, are more likely to be diagnosed with one or more chronic diseases (Abeyta, 2012). Good preventive care would target all patients, but would more beneficially impact indigent patients as they are at higher risk for chronic disease. Effective chronic disease prevention could decrease recurring visits from high-risk populations and lead to a more balanced ratio of uninsured to insured patients being seen by the HCO. Because a greater proportion would be able to pay, there would be less justification to recoup costs from treating indigent populations. This alone is good reason to reorient the focus away from profiting from medication and toward reducing reliance on medication. In this way, preventive care can be feasible and sustainable.

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Unfortunately, possible tension exists between reducing reliance on medication and capturing more opportunities to profit from 340B. The ability of an HCO to successfully promote and effectively prevent chronic disease could still result in less profit for the organization. Herein it is important to reflect on the intentionality of the law. While the direct text of the legislation may only specify eligibility and compliance, the context of the law tells a different story. If the law is the witness and external deposit of our moral life, we must then, in good conscience, reflect on the purpose of the law. The law was included within a section of the Public Health Service Act (PHSA) dedicated to maintaining services and lowering medication costs.

Therefore, lowering overall medication reliance is in line with the intention of the law. In keeping with 340B, hospital pharmacies have good reason to reduce reliance on prescription medications, to “provide more comprehensive services” (Veterans Health Care Act of 1992, 1992). It may be that focusing on 340B expansion is more profitable, but if preventive care is effective then it is difficult to see how this is not comprehensive.

Even if pharmacies reorient their perspective away from profiteering, an organizational change must also occur.

Structural organization within a pharmacy must be effective in preventing more costly outcomes, which greatly affect a patient’s quality of life. HCOs in general are increasingly relying on protocols and documentation. Many HCOs argue that the increasing amount of bureaucratic paperwork lessens the quality of care that can be provided (Sanders, 2005). When more attention is directed towards paperwork and less attention is focused on the actual patient, there is less opportunity to tend to the patient’s specific needs.

Pharmacists have the best knowledge of medication properties and are the best candidates to directly address patients’ medication concerns. Pharmacist-provided medication reconciliation has been shown to decrease readmission rates, improve quality of care, and save millions of dollars annually (Kilcup, Schultz, Carlson, & Wilson, 2003). To prevent medication overuse, pharmacists must attend to the patient directly to know what intervention is appropriate and when it is appropriate to intervene.

PREVENTING PHARMACEUTICAL OVERUSE A HCO pharmacy could reduce the upward trajectory of the chronic disease prevalence curve. What role, if any, does a hospital pharmacy have in preventing chronic disease? Moreover, would a pharmacy be effective in preventing an increase in chronic disease? In the coming paragraphs, I will argue for the need of pharmaceutical organizations to foster ethical behavior by utilizing a virtue theory framework. Moreover, I will rely on recent research in cognitive science and positive psychology to provide evidence of why virtue ethics is the best approach to encouraging preventive care and how it can be effective in doing so.

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Many studies have focused on the integration of pharmacists into primary care teams. A recent Cochrane review concluded that research regarding pharmacist integration reveals positive effects (e.g. a reduction in utilization of health services and improved patient outcomes) (Bero, Mays, Barjesteh, & Bond 2000).

Specifically, pharmacist team members may contribute to the care of chronic disease by reviewing drug regimens to reduce adverse effects (Hanlon et al., 1996; Leape 1999) and increase efficacy (Bogden et al., 1998).

Traditionally, pharmacists have not been at the bedside.

However, increasing their presence could ameliorate patient concerns. Patients’ primary worries remain being given the wrong medicine (61 percent) and being given medicines that interact in a negative way (58 percent) (Hayward & Hofer, 2001). Pharmacists at the bedside could assuage concerns and educate patients.

This alone could decrease dependence on health services. CMS estimates 11 percent of hospital readmissions occur due to medication non-adherence, resulting in a $100 billion impact annually (Osterberg & Blaschke, 2005). An increase in the pharmacists’ clinical presence can lead to improved patient outcomes and reduced adverse effects.

Promoting pharmaceutical preventive care does not simply mean placing a pharmacist on a unit; the pharmacist must know how and when to act. For example, if a pharmacist is given the option between recommending two similar medications, the pharmacist must be able to deliberate on a choice of action wisely.

The pharmacist must also know when to educate in order to reach out when a patient is in Stage A heart failure. In this case, the pharmacist could encourage the patient to take their hypertension medication, aiding in the prevention of progression to latter stages which would require polypharmacy and costlier medications (Long, Swain, & Mangi, 2014). These are just two examples; the pharmacist may find oneself in countless dilemmas when involved with clinical care. The virtuous pharmacist must therefore know how to act with phronesis, or practical wisdom.

Practical wisdom has recently been under investigation by researchers of positive psychology. While some investigators such as Peterson and Seligman (2004) argue that the virtues can be broken into 24 character strengths, others such as Schwartz and Sharpe (2006) propose that virtues are independent and that practical wisdom is the “master virtue.” Practical wisdom is knowing what to aim at – knowing the purpose of fulfilling one’s perceived role. Moreover, these virtues must be balanced, though the correct equilibrium will depend on the particular context; Schwartz and Sharpe (2006) argue that practical wisdom is necessary to achieve this balance. This skill must be balanced by the will. To be practically wise, one must not only know the right thing to do, but one must also desire to do it (Schwartz & Sharpe 2006).

Recommending virtue ethics as a guiding approach also relies on recent discoveries in the field of cognitive

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science. Moral rules generally depend on categorical boundaries, which become unclear when attempting to apply human-constructed rules. Schwartz and Sharpe (2006) argue: “concepts structured to have clear defining features (e.g. a square, triangle, or circle) are rare in human experience.” Wittgenstein demonstrates this with his famous example of the ambiguous definition of a game (Wittgenstein, 1953). Humans are much more effective at applying obscure boundaries to graded membership, allowing for picture-perfect examples and less-than-perfect examples. This research presents good reason for the pharmacist to be engaged in experiential learning, not guided by sticks and carrots. Healthcare legislation and HCO rules cannot change behavior alone; the individual must learn over time.

The virtuous person must learn from experience, not from rules. Because behavior is context-sensitive, this account of wisdom can be explained by the connectionist parallel distributed processing models of cognition (McClelland and Rummelhart, 1986). These models describe learning as a process wherein learning occurs when one constructs associations from within one’s cognitive landscape. Pharmacists therefore must be confronted with difficult and ambiguous situations, and learn from experience. In keeping with this evidence, it appears that the best way for a pharmacist to truly learn to be virtuous is for the pharmacist to be in the thick of the situation, to be clinically involved with the team. The aforementioned Cochrane evidence supports this hypothesis that pharmacist engagement on teams reduces errors and improves outcomes (Bero, Mays, Barjesteh, & Bond, 2000). Instead of managing large spreadsheets and budgeting items, a pharmacist involved in clinical care is confronted with these real, morally ambiguous life experiences.

Virtuous action depends not only on the right behavior, but also the right timing. Haidt (2001) and Gladwell (2005) both reveal strong evidence for two separate neuronal systems (i.e. a fast and slow system). The fast, automatic system remains reactive and can be fostered via inculcation of habits. The second slow, decisionmaking system is optional, and requires deliberation of some kind. Importantly, both of these neuronal systems can be developed over time with both experiential and informational learning. These systems are strongly supported by modern positive psychology and do not depend on any magical or superfluous thinking (Schwartz and Sharpe, 2006). Along these lines, the pharmacist must have the time to exercise appropriate judgment. The virtuous pharmacist cannot be expected to effectively review medications, alter as one sees fit, and educate, all within minutes. Therefore, education and experience are not sufficient to foster virtuous pharmacists; the pharmacist must also have time to make virtuous decisions and act on them. If the organization truly wishes to prevent disease and foster well-being, the pharmacist must be allotted time with the patient.

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OBSTACLES TO VIRTUE IN CONTEMPORARY PHARMACY Two impediments were previously identified as difficulties to reducing reliance on medication: profiteering from 340B and the increasing amount of paperwork. In congruence with these observations, Schwartz and Sharpe, (2006) identify two threats to practical wisdom, increasing market pressure and increasing bureaucratization. Unsurprisingly, these barriers are one in the same and can be improved upon.

Financial competition is a constant concern for large HCOs. Increasing market pressure increases the drive for hospitals to compete with similar academic medical centers. Administrators may argue that if they actively orient goals towards prevention rather than profiting from 340B, additional “missed opportunities” will be lost.

Specifically, if HCOs focus on preventing disease amongst indigent patients, it is very possible that others can capture this “opportunity.” This very real pressure can decrease profits for the HCO, reducing their ability to provide appropriate care for the indigent populations they serve. However, a focus in quality of care for indigent populations remains in line with the intention of 340B, and may still result in large profits to keep the HCO afloat.

Fostering virtuous pharmacists will promote the quality of care patients receive. If a reduction in medication errors, increase in medication adherence, and prevention of illness can be accomplished by dedicating more personal time to the patient, this may “capture those opportunities.” In other words, patients may see quality care emanating from an institution and flock for the sake of care itself. More patients mean more opportunities for financial growth. While quality care should be delivered to all socioeconomic groups, expansion of services should be oriented towards the mission of the organization. The virtuous pharmacist can guide the organization. The virtuous pharmacist should thereby exemplify practical wisdom and know what to aim at – to act with purpose and willingly do so. Because hospital pharmacists are responsible for filling all medications, they must do so justly and prudently.

Reflecting on the historical intention of 340B, hospital pharmacists should therefore deliberate on whether current expansion towards more affluent areas is the moral thing to do. Even if finances are a factor, an increase in care can still amount to an increase in profits. Moreover, the end goal should be reflected upon.

In many cases, it is not prudent to seek financial gain simply for the sake of profit alone. These decisions cannot simply be accomplished with more carrots and sticks; they require sincere ethical deliberation by virtuous caregivers.

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Increasing bureaucratization remains an obstacle for all healthcare workers, including pharmacists. Specifically, bureaucratization remains a threat to the development of practical wisdom as it limits the ability of the pharmacist to learn from experience and apply abstract notions to real-life events. The virtuous pharmacist must be able to meet with the patient, attend to worries, fears, hopes, and dreams, and integrate this information into medication reconciliation and recommendation. The pharmacist’s role must therefore be expanded to incorporate more clinical time with patients and less time behind the computer. As illustrated previously, two of the three most common worries among patients reside under the purview of the pharmacist, and can thus be assuaged by the pharmacist (Hayward & Hofer, 2001).

Increasing the pharmacist’s time to attend to the patient builds a trusting relationship, integrates the pharmacist with the team, and encourages the possibility of future intervention. If the end goal is preventive medicine, the starting point relies on building this foundation.

Reorienting opportunities in pharmacy towards prevention requires a fundamental change in the role of the pharmacist. The pharmacist has traditionally been required to compound and dispense drugs safely and effectively. Ever since the advent of “Big Data” and recent shifts towards capturing lost profits, the pharmacist has become an administrator as well.

However, the World Health Organization (WHO) recommends a different approach. The pharmacist, according to WHO, should be treated as a healthcare provider. They should participate in patient care as a “caregiver, communicator, decision maker, teacher, lifelong learner, leader, manager, and researcher” (Wiedenmayer et al., 2006). The American Society of Hospital Pharmacists (ASHP) has proposed that the pharmacist is responsible for medication-related care, which can improve a patient’s quality of life (American Society of Hospital Pharmacists, 1993). The focus, therefore, has shifted from simply aiding in treatment to being responsible for outcomes. Along with this, the ASHP has also stated that the pharmacist is responsible for “drug selection, untreated indication, adverse reactions, and toxic dosing” (American Society of Hospital Pharmacists, 1993). The ASHP is recommending the prerequisites for the virtuous pharmacist, a role which is deeply involved in clinical care and responsible for improving patient outcomes, not simply profiteering from bureaucratic loopholes.

Importantly, both increasing market pressure and increasing bureaucratization are self-perpetuating in their function. As Schwartz and Sharpe (2006) illustrate, “The less practice people get, the worse their judgment will be, and the worse their judgment is, the more people in charge will perceive a need for rules.” In the same vein, the greater the threat of market-forces, the less desire people will have to willingly act virtuously. In such an instance, laws will instead be necessary to police or incentivize behavior. Virtue does not eliminate the

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need for sticks and carrots altogether, but it decreases reliance on them. As seen with 340B, these sticks and carrots may appear effective in the short-term, but they can deviate far from the historical intention if external forces are strong enough. An organization filled with virtuous pharmacists is resilient to external forces. It promotes active reflection, a strong moral compass, a vivid desire to do good, and fosters wellbeing in others.

It is highly unlikely after reading these words that a pharmacist will simply decide to be virtuous. In fact, it is antithetical to current research in cognitive science and positive psychology that any one person can become virtuous overnight. A virtuous person must not only inculcate habits and reflect on intention, but also know their end and desire to achieve it, all while remaining immune to external threats. Pharmacists typically represent strong authority figures in HCOs. Therefore, pharmacists must begin by reshaping their institutions to promote the development of practical wisdom.

Pharmacy schools must offer more experiential patient care muddled with ethical dilemmas, HCOs must restructure the pharmacist’s schedule with most hours dedicated to direct patient interaction, and all institutions must embed necessary time for ethical reflection and deliberation. Perhaps most importantly, all pharmaceutical organizations must perpetuate an ethos of prevention, actively encouraging opportunities to intervene early. Pharmacists can prudently act to prevent disease. For example, just one virtuous pharmacist can work to prevent type 1 diabetes from progressing to neuropathy by educating a patient about adherence, courageously working with the team to recommend using medications with fewer side effects, and even taking time to change the system from the bottom-up, all while using practical wisdom.

Healthcare, like many other organizations is at a crossroads. Leaders within all HCOs must take a step back and reflect, taking time to decide on virtues. It may be attractive to chase after profits and to rely on carrots and sticks; this path is easy and hardly relies on cognitive and emotional processes. A divergent path is one of virtue, one which not only promotes moral choices, but may also be more effective in promoting the goals of the HCO. The practically wise pharmacist chooses opportunities for prevention over opportunities for profit, truly focusing on quality care for the patient. It is in taking time to reflect, talk, and educate that a true difference can be made for a lifetime.

REFERENCES Abeyta, Ian Matthew. 2012. "Effect of community affluence on the association between individual socioeconomic status and cardiovascular disease risk factors, Colorado, 2007–2008." Preventing chronic disease 9.

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Ames, Alexander, Karen Garloch, and Joseph Neff. 2012.

“Nonprofit hospitals thrive on profits.” Charlotte Observer. April 21.

McClelland, James L., and David E. Rumelhart. 1986. "A distributed model of human learning and memory." In Parallel distributed processing, pp. 170-215. MIT Press.

Almeter, Philip, Gary L. Johnson, and Rafael Saenz. 2012.

“Optimizing 340B purchasing practices.” Am J Health Syst Pharm., 69(16), 1366-8.

Peterson, Christopher, and Martin EP Seligman. 2004.

Character strengths and virtues: A handbook and classification. Oxford University Press.

American Society of Hospital Pharmacists. 1993. “ASHP Statement on Pharmaceutical Care.” American Journal of Hospital Pharmacy 50 1720–3.

Pollack, A. 2013. "Dispute develops over discount drug program." New York Times, February 12.

Beny, Johnny, Lisa Bero, and Christine Bond. 2000.

“Abstract of review: expanding outpatient pharmacists' roles and health services utilization, costs, and patient outcomes.” Cochrane Library. 1.

Gladwell, Malcolm. 2005. Blink (Little Brown, New York).

Government Accountability Office. 2011. Drug pricing: manufacturer discounts in the 340B program offer benefits, but federal oversight needs improvement.

Washington (DC): GAO. Haidt, J. (2001). The emotional dog and its rational tail: a social intuitionist approach to moral judgment.

Psychological Review, 108(4), 814.

Hanlon, Joseph T., Morris Weinberger, Gregory P. Samsa, Kenneth E. Schmader, Kay M. Uttech, Ingrid K. Lewis, Patricia A. Cowper, Pamela B. Landsman, Harvey Jay Cohen, and John R. Feussner. 1996. "A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy." The American Journal of Medicine 100, no. 4: 428-437.

Hayward, Rodney A., and Timothy P. Hofer. 2001.

"Estimating hospital deaths due to medical errors: preventability is in the eye of the reviewer." JAMA 286, no. 4: 415-420.

Holmes, Oliver Wendell. 1897. "Address, The Path of the Law." Harv. L. Rev. 10: 457-469.

Kilcup, Meg, Diane Schultz, Jim Carlson, and Bruce Wilson. 2013. "Postdischarge pharmacist medication reconciliation: impact on readmission rates and financial savings." Journal of the American Pharmacists Association 53, no. 1: 78-84.

Leape, Lucian L., David J. Cullen, Margaret Dempsey Clapp, Elisabeth Burdick, Harold J. Demonaco, Jeanette Ives Erickson, and David W. Bates. 1999. "Pharmacist participation on physician rounds and adverse drug events in the intensive care unit." Jama 282, no. 3: 267270.

Sanders Jr, James H. 2005. "How much paperwork is too much?." Family Practice Management 12, no. 1: 12-12.

Osterberg, Lars, and Terrence Blaschke. 2005.

"Adherence to medication." New England Journal of Medicine 353, no. 5: 487-497.

Thorpe, Kenneth E., and David H. Howard. 2006. "The rise in spending among Medicare beneficiaries: the role of chronic disease prevalence and changes in treatment intensity." Health Affairs 25, no. 5: w378-w388.

Wiedenmayer, Karin, Rob S. Summers, Clare A. Mackie, Andries GS Gous, Marthe Everard, and D. Tromp.2006.

"Developing pharmacy practice: a focus on patient care."

The Hague: WHO-FIP. Wittgenstein, L. 1953. "Philosophische Untersuchungen [Philosophical Investigations, translated by GEM Anscombe, New York, Macmillan.]."

Wu, Shin-Yi, and Anthony Green. 2000. "Projection of chronic illness prevalence and cost inflation." Santa Monica, CA: RAND Health 18.

Veterans Health Care Act of 1992. 1992. Pub. L. No. 102585 § 602, 106 Stat. 4943, 4967-497.

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CRISPR / CAS-9 The Ethics of Implementation Sarah Alberstein The University of Virginia

ABSTRACT In 1987, the first clustered regularly interspaced palindromic repeat sequences were discovered in Escherichia coli (E. coli bacteria). These sequences have come to be known as CRISPR, and in 2007 were discovered to be a potential protection against bacteriophages [1]. This discovery was the beginning of the development of a revolutionary technology with the potential for expediting contemporary medical progress. I will argue, however, that the use of this powerful technology comes with immensely questionable ethics and potentially dystopian consequences.

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THE MECHANISM In order to understand the power of CRISPR technology, one must first understand how it works. CRISPR sequences are a naturally occurring component of bacterial and microorganismal immune systems that act to protect the bacteria or microorganism by destroying the genome of predatory viruses. The destruction of the viral genome prevents a virus from replicating and thus prevents potential ongoing viral infection of the bacteria or microorganism.

This destruction of the viral genome is made possible through the bacteria’s ability to store pieces of the viral attacker’s DNA as ‘spacer sequences’ which are interspersed throughout each already existing CRISPR sequence. When a recognized virus attacks the bacteria, these spacer sequences are transcribed resulting in CRISPR RNAs composed of previously stored viral DNA. The RNAs are then bound to Cas9 proteins and are dispatched throughout the bacteria. The RNA acts as a guide for the Cas9 protein, which is designed to destroy the viral genome of the attacking virus whose DNA matches the sequences of the transcribed RNA. When an unrecognized virus attacks the microorganism, a new spacer sequence is created from the viral DNA and is stored. Importantly, because the spacer sequences are comprised of exact copies of viral genomes, this destruction is incredibly precise. Essentially, the bacteria are kept entirely intact and only the viral DNA is destroyed [2]. In short, the CRISPR/Cas9 system protects the bacteria by keeping tabs on intruding viruses and precisely destroying those viruses it has previously encountered. The ability of the CRISPR/Cas9 system to store viral genetic material and destroy viruses comprised of matching genetic material with such incredible precision holds great promise for the future of biological technological innovation and progress.

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viral attack while maximizing efficiency for the researcher [3]. Additionally, the CRISPR/Cas9 system can be utilized in organisms larger than bacteria – from fruit flies to humans. Altering an organism’s genes traditionally yields the potential for broad, unintended, and possibly fatal consequences for the organism as a whole. However, in utilizing the CRISPR/Cas9 system, it is now theoretically possible to alter a specific gene without influencing any other genes in the organism’s genome.

This makes it possible to observe specific effects of a particular gene and thus allows for more precise data collection and observation. This degree of specificity of gene editing also simplifies the creation of gene-edited animal models used in medical research [4].

The implications of this technology extend far beyond the laboratory, however. CRISPR/Cas9 systems are currently being explored as a means of gene-editing in humans.

Numerous studies are being conducted with the intent of using CRISPR/Cas9 in curing previously incurable diseases via gene-editing or silencing. In March 2014, Nature Biotechnology published a research study reporting the use of CRISPR/Cas9 technology to cure mice of a rare liver disorder - type I tyrosinemia - caused by a single genetic mutation. This study is the first to indicate that CRISPR/Cas9 technologies can be used to “correct a defective gene in a living adult animal” [5]. That same year, researchers at the University of California, San Francisco were able to increase resistance to HIV by using CRISPR/Cas9 technology to essentially transform human stem cells into white blood cells containing a naturally occurring HIV-resistant mutation [6]. These and other studies are conceived of with a noble intent – to cure devastating diseases. Why then is the use of CRISPR/Cas9 technology still shrouded in controversy and met with apprehension?

CONTROVERSY

In the same way that CRISPR RNAs are comprised of genetic material of the virus they are trying to destroy, it is possible to transcribe CRISPR RNA out of sequences derived from other undesired or harmful genetic material. By exploiting this naturally occurring bacterial CRISPR/Cas9 process, the scientific community has begun utilizing CRISPR/Cas9 as a way to silence mutated organismal DNA, replace it with correct sequences, or both in conjunction.

The answer lies in the technology’s potential.

CRISPR/Cas9 technology can conceivably be used to edit genetic material in egg and sperm cells, resulting in germline modification. Germlines are “series of germ cells each descended or developed from earlier cells in the series, regarded as continuing through successive generations of an organism” [7]. More simply, germlines are comprised of cells containing hereditary genetic material. An alteration made to an organism’s germline is permanently recorded and passed down to future generations. It is this facet of CRISPR/Cas9 gene editing which is most daunting.

These techniques can be potentially utilized by companies that use bacterial cultures in their research.

They can use CRISPR/Cas9 immunity systems to sustain and lengthen the lifespan of their bacterial cultures by protecting them from viral attack. This can minimize hassle and time spent re-growing cultures following a

In May 2015, several scientists at Sun Yat-sen University in Guangzhou, China experimented with this daunting aspect of CRISPR/Cas9 germline modification in a research study that sparked controversy within the scientific community and beyond [8]. In an attempt to modify a gene responsible for a fatal blood disorder, the

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HOW CRISPR WORKS How the bacteria-derived system can be used to correct genetic defects in human cells.

GUIDE MOLECULES An RNA guide molecule is programmed to match a unique DNA sequence in the human genome.

Guide RNA

Target Sequence

Genomic DNA CAS-9 Protein

CAS-9 The RNA guide molecule is attached to the CAS-9 enzyme, which finds the specific sequence of DNA.

CLEAVAGE The RNA aligns with the target DNA and CAS-9 cuts both strands of the DNA.

CORRECTION Cuts in the DNA can be fixed with an extra genetic insertion or deletion of defective DNA.

Repair

Donor DNA

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team of scientists, led by Junjiu Huang, injected the CRISPR/Cas9 system into fertilized single-cell human embryos (which cannot yield a viable fetus, but do undergo the preliminary developmental stages) [9]. This study marked the beginnings of CRISPR/Cas9’s use in experiments influencing future human generations’ genome. While this could be perceived as the beginnings of a biomedical revolution, both the execution and results of this study provide insight into the ethical and logistical shortcomings of CRISPR/Cas9 technology.

LOGISTICAL SHORTCOMINGS In their Nature article about Huang’s study, David Cyranoski and Sara Reardon state that “of the 71 embryos that survived, 54 were genetically tested [10]. This revealed that just 28 were successfully spliced, and that only a fraction of those contained the replacement genetic material.” While these results indicate that CRISPR/Cas9 technology is capable of fixing mutated genes responsible for fatal diseases, it also illuminates the unreliability of the technology. Furthermore, Huang and his team discovered an alarming number of gene mutations potentially introduced by the CRISPR/Cas9 technology itself [11]. Low success rates paired with the potential for new mutations paint a pessimistic picture of the future of CRISPR/Cas9 technology. These two logistical shortcomings serve as a disclaimer reminding scientists that this is a relatively new and unexplored technology which ultimately, could be quite harmful.

In my opinion, however, these logistical shortcomings do not expose a series of unfixable flaws of CRISPR/Cas9 but instead serve as evidence of a need for further research.

CRISPR/Cas9 technology has just begun to be used and explored within the last 10 years. In the realm of scientific research, 10 years is a short period of time to produce a polished, problem-free piece of technology. For example, the first U.S Polio epidemic took place in 1894. It was not until the 1950s that an effective vaccine was developed and, even this vaccine was modified several times following its original implementation [12]. It is therefore unsurprising that there are still kinks in the implementation of CRISPR/Cas9 in biomedical research and practice. The aforementioned potentially harmful consequences of low success rates and possible CRISPR/Cas9-induced mutations can be mitigated given time and more in-depth study. It is still too soon to dismiss CRISPR/Cas9 technology on the basis of technological or logistical shortcomings as these shortcomings have not been given due time to be corrected. However, the ethical implications of CRISPR/Cas9 technology seem to be much less justifiable and certainly require attention and discussion within and throughout the scientific and bioethics communities.

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ETHICAL SHORTCOMINGS CONSENT Fortunately, such attention and discussion has already begun. One facet of this discussion considers the duty of physicians and researchers to acquire informed consent from a participant in a research study or medical procedure. The Federal Policy for the Protection of Human Subjects states that informed consent must be sought “under circumstances that provide the prospective subject…sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. [Furthermore] the information that is given to the subject… shall be in language understandable to the subject.” It then states that “no informed consent… [can be] made to waive or appear to waive any of the subject’s legal rights” [13].

The acquisition of informed consent is necessary to preserve and respect an individual’s autonomy by allowing one to make an educated decision about their own body and well-being. As such, it is legally mandated and rarely waived.

Issues regarding informed consent are seemingly absent when an individual expresses interest in, illustrates understanding of, reaps benefit from, and knowledgeably consents to the use of CRISPR/Cas9 technology in editing their genomic sequences. However, due to the germline modification inherent to the use of CRISPR/Cas9 technology, any future offspring of that individual are consequently subjected to this modification without their knowledge or their consent.

This inevitability violates the vast majority of ethical codes and legal texts which abhor the neglect of the acquisition of informed consent, given that such neglect would potentially invalidate the presumed autonomy of the individual. It also raises many questions about the existence of the autonomy of an unborn, theoretical individual. Could such an individual be considered autonomous at all? Even if considered an autonomous being, would they be given the rights of one? If considered an autonomous being with rights, should that autonomy or those rights influence the abilities of their ancestors to make decisions about their own bodies?

Much of the current debate regarding the autonomous status of an unborn child is centered on fetuses - whose physical existence is undeniable but, whose moral status is dependent on subjective values and is therefore undeniably variable. In these cases, the variable degrees of autonomy awarded to the fetus are determined based on the point in development reached by the existing fetus – not on the existence itself. That is to say, there does not seem to be disagreement over the existence of

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the fetus but, rather if the fetus’ degree of existence warrants moral status and therefore, the rights of an autonomous individual. In the case of CRISPR/Cas9induced germline modification, however, the theoretical unborn child does not yet exist. Therefore, existencebased assignments of autonomy cannot appropriately apply. Notably, however, a knowledgeable, competent, and consenting individual requesting CRISPR/Cas9 germline modification undeniably exists and, possesses the moral status and the rights of an autonomous individual. Should the ethically saturated question of consent and the autonomy of the individual be a deciding factor in the implementation of CRISPR/Cas9 technology, it should be the consent and autonomy of the existing individual that is considered, not the consent and autonomy of an individual whose existence is not yet realized.

ETHICAL SHORTCOMINGS DESIGNER BABIES Beyond the question of consent, another broad ethical concern is being raised: the fear of using CRISPR/Cas9 technology for non-therapeutic modifications, thus “raising the specter of so-called designer babies,” or babies genetically crafted to be disease-free and, possess only traits deemed desirable by the parents [14]. Some fear that designer babies will be stripped of the ability to craft and discover their own eventual identities and, will be subject only to the preemptive desires of the parent.

For example, if a parent wants their child to be artistic rather than athletic, they would then select traits which yield such a child. The likelihood of that child becoming an athlete is thus genetically diminished, even if becoming an athlete was the eventual fate of the child and the fate he would have chosen for himself in the absence of genetic intervention. However, others, like philosopher Bonnie Steinbock, claim that selecting such traits is no different from hiring tutors, getting music lessons or any other external influence a parent subjects their child to in an attempt to foster specific characteristics [15].

I disagree with Bonnie Steinbock and sentiments shared by like-minded philosophers and ethicists. While it seems apparent that parental influence greatly shapes identities of their children and that exposing one’s child to specific fields or interests will likely garner preemptively desired traits upon such exposure, I do not think this can be equated to the genetic selection of traits. A non-designer baby may be exposed to a specific field of interest but, will be able to craft their own opinion and desires toward that field. A designer baby, however, would be genetically predisposed to enjoy that field of interest as it would be programed into their DNA. This genetic modification strips the child of a self-determined identity and the opportunity to decide their own likes and interests. Their identity and interests will

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have been selected by their parent and this therefore relinquishes the child’s control over their own eventual future and awards it to their parents. In this way, the prospect of designer babies violates an individual’s autonomous rights and cannot be equated to normal experiential exposure garnered throughout the course of one’s lifetime.

Another concern raised by the possibility of designer babies is the potential for a halt in medical progress. The threat of designer babies resulting from CRISPR/Cas9 germline modification carries great potential for societal rejection of CRISPR/Cas9 technology. Edward Lanphier, chairman of the Alliance for Regenerative Medicine, stated that “[CRISPR/Cas9] research could be exploited for non-therapeutic modifications. [There is concern] that a public outcry about such an ethical breach could hinder a promising area of therapeutic development” [16]. Scientists, like Lanphier, who research CRISPR/Cas9 technology with therapeutic intent may be forced to halt their research should such public outcry result in stigmatization or possibly, banishment of the technology as a whole.

SECULAR RESPONSE Such questions and concerns are constantly being raised within the scientific community, and have resulted in varying degrees of support for CRISPR/Cas9 and other technologies resulting in germline modification. This contention can lend itself to legislation banning the technology entirely. Today, as many as 40 countries prohibit technologies or research which result in germline modification [17]. In Europe, specifically, 15 of 22 countries have banned the use of such technologies and, in other places like the United States, while not explicitly banned, germline modifying technology and research are discouraged [18]. Even still, the powerful potential of CRISPR/Cas9 technology is alluring enough to warrant further exploration despite the legislative pushback. This is marvelously illustrated by an ongoing patent lawsuit between three major universities each battling to protect their ownership rights regarding CRISPR/Cas9. Harvard, MIT, and UC Berkeley are each fighting for patent rights “worth billions of dollars…in large part because of how useful the experts believe the technology will soon be to determining the causes of genetic diseases – not to mention how instrumental the technology will be in DNA sequencing and modification” [19]. Remarkably, the combination of internationally legislated prohibition, logistical issues of low success rates and induced mutations, and ethical issues of consent and designer babies is not enough to ignore the incredible potential of CRISPR/Cas9 technology or to halt its development. However, I believe the potential harrowing socioeconomic consequences of CRISPR/Cas9 will be the ultimate downfall of the technology.

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THE SOCIOECONOMIC DISCUSSION In the final sentence of her article for The Science Times, Karla Lant supplements MIT neurobiologist Guoping Feng’s sentiment that “humans with edited genes are only ’10 to 20 years away,’” by adding “but only for those of a certain socioeconomic class” [20]. This sentiment provides initial insight into the broader societal implications of CRISPR/Cas9 technologies in both therapeutic and non-therapeutic intervention. It alludes to the hypothetical financial costs of undergoing a CRISPR/Cas9 germline modification procedure, which will likely be extravagant enough to exclude socioeconomically disadvantaged populations unable to afford it.

While it is difficult to guess the future costs of a CRISPR/Cas9 human germline modification procedure, current costs for already existing fertility treatments that allow for some degree of genetic editing are known [21].

In her article, Jean Twenge describes the processes and financial costs involved in conceiving through a more progressive, newfangled in vitro fertilization (IVF) egg retrieval technology that allows for “little worry of miscarriage, twins...chromosomal or genetic disease, and [there is the opportunity to choose] the gender” of the future child. These perks come at about a $50,000 cost, however. Firstly, $20,000 or more are required to harvest and freeze a woman’s eggs with the intent of later artificially inseminating them. The eggs are then screened for genetic abnormalities and undesired maladies after which, ‘healthy normal’ eggs are transferred to the woman’s uterus in the hopes of implantation and pregnancy. This process requires another $10,000 to $15,000 [22]. Twenge goes on to say she “expect[s] the next decade will find many more people drawn to this greater control, giving them the ability to… screen for abnormalities, and choose their gender” [23].

Standard IVF treatments without the opportunity to so specifically genetically customize a child, cost around “$15,000 a try and is rarely covered by insurance” [24].

The greater control made possible by more progressive, and costlier, IVF egg retrieval treatments account for the huge difference in cost between it and its standard IVF counterpart. However, the additional control given in egg retrieval IVF is comparatively negligible when considering the broad, precise, and powerful capabilities of CRISPR/Cas9. It is therefore reasonable to stipulate that the much broader uses of CRISPR/Cas9 technologies in germline modification, in both non-therapeutic modifications and therapeutic disease mitigation, would be quite costly.

The high costs associated with egg retrieval IVF are

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already isolating and exclusionary for those of a lower socioeconomic class, for whom such treatments, and the subsequent possibility of a genetically advantaged child, are out of reach. This fact can be easily applied to a hypothetical world in which CRISPR/Cas9 technology is available and likely, costlier. In such a world, only those financially capable would have access to disease-free children with CRISPR/Cas9-crafted characteristics and dispositions. Conversely, financially disadvantaged peoples and thus their offspring would not. Furthermore, it is doubtful that elective germline modification procedures would be covered by insurance. It is also important to remember that CRISPR/Cas9 gene editing can also be used in living adults, not just in the realm of fertility treatments. While such procedures may be covered by insurance, they will likely still be quite costly.

Such a discrepancy in access would likely translate to a genetically-based social division where only the wealthy will be genetically advantaged and the poor will not.

Today the prevalence and influence of discrimination based on race, gender, sexual orientation, disabilities and the like is felt in the workplace, media, and society as a whole. With the existence of CRISPR/Cas9 technology, characteristics deemed acceptable by the greater society would be overwhelmingly selected for while those who cannot afford CRISPR/Cas9 modification will continue to be discriminated against, and potentially on the basis of genetics alone. This discrimination would be founded on an incredibly integral and fundamental part of an individual – their DNA - resulting in a genetically-based societal stratification which would conceivably be incredibly difficult to combat or provide justification against.

THE EVOLUTIONARY DISCUSSION In addition to the introduction of commonplace noncombatable genetically-based discrimination, such social stratification may yield irreversible evolutionary consequences. The ability of CRISPR/Cas9’s to modify germline cells unquestionably changes the genetic makeup of each subsequent generation’s descendants.

Hypothetically speaking, if a large number of parents opt for CRISPR/Cas9-modified babies, the entire gene pool of that population will begin to shift over time. The new gene pool will reflect the population’s tendency to select for specific traits and to prevent other traits from being passed down to future generations. This could manifest itself in a few catastrophic ways. First, though not universally applicable, in countries like China and India the male sex is the preferred sex for one’s child [25].

With the introduction of CRISPR/Cas9 technology, and even with the previously mentioned IVF treatments, parents would be able to select the gender gender of their child, which

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would often be male. If the majority of parents with access to such technology select for only male children, the sex ratio would be greatly skewed resulting in a population of mostly males. Reproductively and evolutionarily speaking, such a population would be on the verge of extinction as the number of women with whom to reproduce would exponentially decrease.

Second, if the same traits are consistently deemed desirable and are then broadly selected for, this can result in a generally homogenous gene pool. This, ironically, may decrease the population’s survival rates as genetic homogeneity makes populations more likely to succumb to external environmental factors like disease while genetic diversity “is critical to a species’ ability to survive and evolve through [these] environmental changes” [26]. Furthermore, the polarizing social effects generated by the cost of these hypothetical CRISPR/Cas9 germline modification procedures have the potential to create two different species of human between the rich and the poor as explained by ‘sympatric speciation.’

Sympatric speciation “occurs when two individual populations diverge from an ancestral species without being separated geographically” [27] and can result from trends in sexual selection [28]. Should the previously described discrimination against those unable to afford CRISPR/Cas9 modification influence the population’s mating habits, the interbreeding between those wealthy enough to afford CRISPR/Cas9 and those who are not would decrease. Thus, as the wealthy and the financially disadvantaged become further and further reproductively isolated, as a result of changing, discriminatory sexual selection habits, the two classes would get closer and closer to irreconcilable speciation.

CONCLUSION Throughout the course of this paper, I have illustrated the ways in which new CRISPR/Cas9 technologies possess the incredible power to cure disease and more broadly, revolutionize medicine, research, and biotechnology.

However, the ethical and socioeconomic implications of this technology give pause to the perhaps unwarranted celebration of its discovery and potential for implementation. Such implications merit, at the very least, a cautious and critical discussion. I do not believe that CRISPR/Cas9 technologies should be used in germline modification, but do concede that it would be wasteful to disregard it as a means of therapeutic treatment. Even still, it seems unrealistic to allow CRISPR/Cas9 to be used as a therapeutic treatment and expect that it will not eventually find its way into the realm of reproduction and germline modification. As such, I believe any use or further research of the technology should be halted until an international agreement on the allowed uses of CRISPR/Cas9 is developed and excludes the possibility of germline modification entirely.

REFERENCES [1] Monroe, Margo R. "History of CRISPR Cas - A tale of survival and evolution." AddGene Blog. November 25, 2013. Accessed April 12, 2016. http://blog.addgene.org/ history-of-crispr-cas-a-tale-of-survival-and-evolution.

[2] Pak, Ekaterina "CRISPR: A game-changing genetic engineering technique." SITN: Science in the News.

Harvard University. July 31, 2014. Accessed November 30, 2015. http://sitn.hms.harvard.edu/flash/2014/crispr-agame-changing-genetic-engineering-technique/.

[3] Ibid.

[4] Ibid.

[5] "CRISPR Reverses Disease Symptoms in Living Animals for First Time." GEN. Genetic Engineering & Biotechnology News. March 31, 2014. Accessed November 30, 2015. http://www.genengnews.com/gennews-highlights/crispr-reverses-disease-symptoms-inliving-animals-for-first-time/81249682/.

[6] Aldhous, Peter "Gene editing tool can write HIV out of the picture." New Scientist. June 9, 2014. Accessed November, 30 2015. https://www.newscientist.com/article/dn25698-geneediting-tool-can-write-hiv-out-of-thepicture? cmpid=RSS%25257CNSNS%25257C2012GLOBAL%25257Conline-news#.U5r3PURdVz3.

[7] "germ line." Oxford Dictionaries. Oxford University Press, 2015. Web. 30 Nov. 2015. http://www.oxforddictionaries.com/us/definition/america n_english/germ-line.

[8] Cyranoski, David, and Sara Reardon. "Chinese scientists genetically modify human embryos."

Nature.com. April 22, 2015. Accessed November 30, 2015. http://www.nature.com/news/chinese-scientistsgenetically-modify-human-embryos-1.17378#/b1.

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[9] Cyranoski, David. "Scientists sound alarm over DNA editing of human embryos." Nature.com. March 12, 2015.

Accessed November 30, 2015. http://www.nature.com/news/scientists-sound-alarmover-dna-editing-of-human-embryos-1.17110.

[25] Hsu, Jeremy. "There Are More Boys Than Girls in China and India." Scientific American. August 4, 2008.

Accessed December 2, 2015. http://www.scientificamerican.com/article/ there-aremore-boys-than-girls/.

[10] Cyranoski and Reardon 2015.

[26] Friedl, Sarah. "How Gene Pool Diversity Affects a Group's Survival Potential."Study.com Accessed December 2, 2015. http://study.com/academy/lesson/ how-gene-pool-diversity-affects-a-groups-survivalpotential.html.

[11] Ibid.

[12] "The History of Vaccines: Polio Timeline." The History of Vaccines. The College of Physicians of Philadelphia, Accessed November 30, 2015. http://www.historyofvaccines.org/content/timelines/ polio.

[13] United States. Office for Human Research Protections. Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects.

Washington: GPO, 2009. Print.

[14] Pollack, Andrew. "A Powerful New Way to Edit DNA." The New York Times. March 3, 2014. Accessed November 30, 2015. http://www.nytimes.com/2014/03/04/health/ apowerful-new-way-to-edit-dna.html?_r=1.

[15] Ibid.

[16] Cyranoski, 2015.

[17] Lanphier, Edward, et al., "Don't edit the human germ line." Nature.com. March 12, 2015. Accessed November 30, 2015. http://www.nature.com/news/don-t-edit-thehuman-germ-line-1.17111.

[18] Ibid.

[19] Lant, Karla. "Universities Are Arguing Over Genome Editing Technology, But What Does The Law Have to Say About It?" The Science Times. May 15, 2015. Accessed November 30, 2015. http://www.sciencetimes.com/articles/6360/20150515/univ ersities-are-arguing-over-genome-editing-technology-butwhat-does-the-law-have-to-say-about-it.htm.

[20] Ibid.

[21] Twenge, Jean. "'Designer' Babies Are Only for the Rich." The Daily Beast. July 7, 2014. Accessed December 2, 2015. http://www.thedailybeast.com/articles/2014/07/07/designe r-babies-are-only-for-the-rich.html.

[22] Ibid.

[23] Ibid [24] Ibid.

[27] “Sympatric Speciation.� Boundless Biology. July 21, 2015. Accessed December 3, 2015. https://www.boundless.com/biology/textbooks/boundles s-biology-textbook/evolution-and-the-origin-of-species18/formation-of-new-species-125/sympatric-speciation503-11729/ [28] Higashi, M., G. Takimoto, and N. Yamamura.

"Sympatric speciation by sexual selection." PubMed.Gov. Nature. December 2, 1999. Accessed December 2, 2015. http://www.ncbi.nlm.nih.gov/pubmed/10591210.

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Misinformed Morals Why Social Darwinism and Eugenics are in fact NonDarwinian in Origin Logan Brich The University of Virginia

ABSTRACT Social Darwinism is a belief that applies the principle of natural selection to political and sociological contexts.

Inherent in this ideology is the belief that there are distinct classes of “superior” and “inferior” individuals, and that it would cause a degeneration of society for the inferior individuals to be continually supported and encouraged to survive and reproduce. Eugenics is an extension of Social Darwinism in that the former actively seeks to intervene to guarantee the eradication of “inferior” populations, whereas the latter believes in only removing social support from those inferior populations.

After giving a short recapitulation of Darwin’s theory of evolution by natural selection and the varied reactions to it, including the eugenicist interpretation, I will argue that said eugenicist approach to evolution is in fact misguided and lacks the Darwinian origins it claims to possess.

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Shortly after the halfway point of the nineteenth century, English naturalist Charles Darwin published his revolutionary opus on the theory of evolution by natural selection. The idea itself of evolution was not an entirely novel one by Darwin’s time; there had long been propositions of organic evolutionary processes by which organisms could develop into more advanced forms of life. The novelty of Darwin’s theory lay in the mechanism he claimed to be responsible for evolution. In seeking to explain the vast and unique variations seen amongst organisms across the globe, Darwin developed a scientific model that understood the creative processes of these spectacularly diverse adaptations to be entirely naturalistic and wholly unguided in their conception and development. The natural clockwork of evolution as seen by Darwin needed no watchmaker.

Reception of Darwin’s theory was as diverse as it was impassioned. Critics, predominantly and predictably of the creationist camp, argued that Darwin’s proposed mechanism left no room for God to exercise His creative dominion over life on Earth.

The theory did not require or even allow a higher being to enact the changes that led to the remarkable adaptations among life. Furthermore, by appealing to the Malthusian struggle for existence, Darwin was lambasted for rejecting the inherent and infinite beneficence of a loving creator. The Draconian image of a harshly unforgiving world painted by Darwin in his Origin shocked and enraged a Victorian audience well-versed in the belief of Natural Theology, a Romantic understanding of the world that saw order and beauty in nature as proof of God’s existence. Not only did the process of natural selection not require a deity to proceed, but the mechanism was also inherently amoral and directionless, adding insult to injury for the Romantic creationists.

Unsurprisingly, many facets of Darwin’s theory that appalled religious objectors garnered support from the scientific and secular communities. The removal of an omniscient deity from the list of prerequisite necessitations for evolution allowed the study of biology to proceed under the auspices of a natural and thus respectable science. The theory also recognized the prodigious variability upon which constantly shifting selective pressures could act, and thus also recognized the shifting survival outcomes and reproductive opportunities of such varied individuals. This was seen as a close analogy to the nascent molecular theory of chemistry, which heavily incorporated the principle of Brownian, constant motion. Contemporary philosophies of science in Darwin’s time argued that fecundities such these, which could be analogized across various disciplines, were valuable in furthering the plausibility and accuracy of a scientific theory.

A third faction of readers, which will be the focus of this paper, responded to Darwin’s theory by extending it into the realms of sociology and politics.

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This group proposed its own interpretation of Darwin’s theory, utilizing aspects of the mechanism of natural selection to further its own ideology of human social evolution. Initiated in 1883 by Francis Galton, a half-cousin of Darwin’s, the eugenics movement believed in improving the quality of individuals born into the world [1]. To the eugenicists, there was a clear distinction between individuals of the superior and inferior types upon which natural selection acted. Among the “inferior” types were those of the lower classes, the mentally ill, homosexuals, individuals with physical disabilities, promiscuous women, drunkards, and those of the “degenerate” races such as the Jews and the Gypsies [2]. The “superior” individuals were concerned that the rapidly expanding “inferior” populations would place a burden on the “better fit” populations and restrict their reproduction, limiting the propagation of those “superior” traits they possessed. This would, the eugenicists believed, lead to the degeneration of the progress that natural selection had hitherto accomplished in the human race. As the idea of eugenics reached overwhelming popularity in the early twentieth century, forced sterilization and institutionalization for those deemed unfit to reproduce became a societal norm, and mass executions of “unfit” individuals began to take place in Nazi Germany and other nations [3].

Those leading the movement selected only the aspects of evolutionary theory and its critiques that supported their own claims. Numerous shortcomings, which will be explained in greater detail in the following pages, weakened the argument for eugenics. The movement failed to address natural selection in the breadth of its contextual implications, choosing to instead make sweeping generalizations from a few conveniently chosen excerpts of Darwin’s writing. The eugenicists drew wholly invalid conclusions from the theory of natural selection, instead propagating scientifically unsound beliefs that were easily deniable, even in Darwin’s age.

Additionally, much of what the eugenics movement put forth was explicitly and implicitly addressed and denied by Darwin himself within the Origin and other writings. An examination and refutation of the claims made by the eugenicists easily demonstrates the invalidity of their arguments and proves that there is no substantial Darwinian ground for the beliefs the movement espoused.

Clearly and disturbingly discriminatory, eugenics claimed to have its basis in the ideas put forth by Darwin in his Origin. Those of supposed inferior disposition, the invalids, were seen as mishaps in the progressive march of evolution. It was believed that the ultimate result of natural selection was to eradicate such populations, as they were unfit compared to the more dominant members of the human race. As evolution progressed, the eugenicists argued, only the most superior individuals would, and should, survive. Darwin’s writings contain

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example upon example of the demonstrated survival and reproductive success of better-adapted individuals, which beat out the less fit individuals.

After all, Darwin states in the Origin that “natural selection will always tend to preserve all the individuals varying in the right direction…so as better to fill up [an] unoccupied space” [4]. The eugenicists saw this and similar passages throughout Darwin’s writings as indication that natural selection was a constructive force, the result of which was a population of increasingly “better” individuals who were born of the disposition to vary in the “right direction”; while Darwin believed in the progressive nature of evolution, it will be shown that he did not share the belief as to an absolute “right direction” so much as an environmentally-informed one. In addition to using Darwin’s own words to support the

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idea of genetic superiority, eugenicists borrowed argumentative ground from both of the two aforementioned dichotomous reactions to the Origin.

Taken from the creationist camp, a belief in the necessary intervention in the selection process was prominent in the eugenics movement.However, the eugenicists believed it was the duty of the upper classes to act as this guiding hand, and not a deity.

This is best captured by writings from the Reverend W. R. Inge, an English eugenicist, who stated: Since the object of all social morality is the good of the human race, and since eugenics also has no other end in view except the improvement of the human race, it is plain that social morality and eugenics are indissolubly connected. The moralist and the biologist may have a somewhat different standard of values, but they want the same thing—to make men better [5].

It is the final clause that demonstrates eugenicist belief in the moral duty of the upper classes to act as the “guiding hand” that was conspicuously absent from Darwin’s theory. The hope was that playing such a role would result in a genetically perfect society, the pinnacle of the progress developed by natural selection. From the secular stance, eugenicists respected evolutionary theory as a natural science and argued a place for their own theory alongside Darwin’s. The movement understood Mendelian inheritance to be the method of transmission of these heritable variations from one generation to the next, a phenomenon implicate unexplained in Darwin’s work. Eugenics sought to supplement the course of natural selection through the promotion of reproduction among populations deemed superior and the reduction of reproduction among those groups deemed inferior. To that end, pedigrees were drafted to scientifically assert a genetic component to such traits as promiscuity and alcoholism, and institutions were established which led research regarding the genetic basis for these and other inferior characteristics [6]. In determining a scientific basis for eugenics, “superior” members of the human race could be justified in guaranteeing invalid traits were not passed from parent to child, thus ending the perpetuation of such maladaptations.

In sum, eugenicists felt they had the full backing of Darwin’s revolutionary theory and understood their own claims to be direct consequences of those laid out by Darwin himself. In addition, the eugenics movement combined arguments from both of the two most divergent arguments for and against it, as seen above. It stands to show, however, that the ideas espoused by the eugenicists are not logical consequences, individually or in confluence, of any of the three aforementioned Darwinian, moral, or scientific claims of origin. Close examination reveals that the theory of natural selection is decidedly anti-

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eugenic in its very essence. Furthermore, the supposition of a necessary guiding hand in the process of eugenics, borrowed from the religious objections to Darwin’s theory, cannot be reconciled with the statements describing the scientific naturalism of evolution as put forth in the Origin.

To begin with the claim of Darwinian inspiration, eugenicists understood evolution to act in a way that promoted the survival and reproduction of inherently “better” individuals. This claim is entirely inaccurate, and is in fact incompatible with the consequences put forth by the theory of natural selection. While natural selection asserts that “better” adapted individuals are more likely to have survival and reproductive success, it makes no assertion as to the value of the individuals or the adaptations themselves. Instead, Darwin’s theory only claims that successful organisms are better adapted to their specific environment. It is clearly absurd to say that humans are superior to the prehistoric beasts such as the dinosaurs simply because humanity persists while the dinosaurs died out long ago. Such is the case only because the niche filled by dinosaurs was interrupted, and the populations were unable to adapt to the environment post-asteroid [7]. Only then were mammals able to evolve to more conspicuous forms without the selective pressure of the dominant reptilian predators [8].

Extending this idea to the sub-classes of humanity as presented by the eugenicists, it is invalid to claim that the “superior” members of society are in any way better evolved than those deemed inferior. It is simply a product of the environment, in this case the social context, that a specific type of person should enjoy greater success. With the example of income inequality, it largely due to the cultural transmission of poverty, and not the result of any supposed genetic fitness or lack thereof, that individuals become trapped in destitute circumstances. While eugenicists are wont to attribute a biologically inherited component to such “inferior” traits as poverty, a more reasoned explanation would appeal to the societal constraints at play that restrict upward mobility for those who are poor. One such example is the lack of education available to those in poverty. This resource would serve as one method of enabling an individual to pursue an upward social mobility. However, because poor individuals cannot access the resource of education, they are trapped, at no fault of their own. Being trapped, these individuals pass on their condition to their offspring, who are further trapped in destitute poverty.

However, this transmission is not the result of genetics. Instead, the condition of poverty is perpetuated by offspring being born into the same conditions as their parents and therefore similarly lacking the resources for social mobility. This case demonstrates that while eugenics relied so heavily

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on determining genetic components to traits, it ignored the multifactorialism of many supposed “inferior traits” such as poverty, instead writing their causes off as singularly biological and thus eradicable through reproductive intervention. This is yet another example of the distorted eugenicist view of genetic determinism and the lack of regard for the role of environmental context in selection and evolution.

Beyond the scope of class categorizations, a eugenicist might have argued that physical and mental disabilities such as deafness and certain learning disabilities are inherently evolutionarily disadvantageous and should therefore be eliminated.

Certainly those who possess such traits are not as well-formed as those without any restrictions and cannot participate in society at the same level as the “superior” individuals. Yet again, however, this is an example of environmental factors informing an opinion and not an absolute value judgment. The construction of society is such that those with disabilities are disadvantaged, but only because of a lack of accommodation and not because of an inherent inferiority.

Some prominent eugenicists addressed this lack of environmental context within their theory, and in fact encouraged it. The Reverend W. R. Inge, quoted earlier, goes on to say that, “Progress, for the moralist and for the biologist alike, means improvement in the people themselves, and not in their conditions” [9]. He asserts that it is not the duty of man to ameliorate the conditions of life that would act to select against disadvantaged populations, but rather to ensure that the “progress” of evolution continue to produce superior individuals. It is instead the job of mankind, according to Inge, to regulate the reproduction of all individuals and guarantee the perpetuation of traits deemed superior, thus safeguarding the genetic integrity of future generations.

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Darwin, contrary to the above assertion by Inge, did believe that it was the responsibility of society to promote welfare of the “inferior” populations.

Continuing with the above discussion of environmental contributions to certain traits, Darwin also recognized the importance of education in ameliorating such conditions, even if he did believe the traits were inherent. He writes in the Descent of Man that: The more efficient causes of progress seem to consist of a good education during youth whilst the brain is impressionable, and of a high standard of excellence, inculcated by the ablest and best men, embodied in the laws, customs and traditions of the nation, and enforced by public opinion [10].

This excerpt shows that Darwin, in contrast from the eugenicists, recognized the multiple factors contributing to “inferior” conditions. He sought to encourage methods of alleviating the social contributions to these conditions, rather than seeking to eliminate some inherent genetic component from a population.

As further evidence against this claim of mankind’s duty to select the “best” individuals, Darwin asserted in the Origin that artificial selection, driven by the caprice of man, holds no water to the awesome selective power of nature. He writes, “How fleeting are the wishes and efforts of man […] and consequently how poor will his products be, compared with those accumulated by nature…” [11].

Though most likely not Darwin’s direct intent, this statement refutes the claim that man can supplement natural selection as was proposed by the eugenicists. The “truer” productions of nature ensure that organisms are “infinitely better adapted to the complex conditions of life” than what man can produce in his short time on earth [12]. In relating this to the analogy of artificial selection with which Darwin opens his Origin, man can select for traits he deems superior, but this does not make said trait objectively “better”; the trait is only favorable to survival or reproduction within a specific context. As environments shift and thus selective pressures change, what was once deemed a superior trait could very easily become a disadvantage to an individual or entire population. This again hearkens to the environmental component of natural selection; there is no absolute “better,” and Darwin believed that humankind certainly could not be the arbitrator of such if it were to exist.

On a similar note, the eugenicist proposal that superior individuals should act as a guiding hand for selection of the pure races and populations is incompatible with the premise of natural selection.

Nature is better equipped to act on adaptations within a given environment, and any other selective pressures beyond nature and random acts thereof are not necessarily selecting for what is beneficial to

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a population in said environment. By introducing a sentient willfulness into the selection process, the evolution of a species no longer takes place by natural means, but rather by artificial ones. This is of importance because it demonstrates the impossibility of reconciling the ideas of oversight and natural selection, as the eugenicists were wont to do. This not only shows that the eugenic theory was not as unified as proponents thought, but also that eugenics cannot claim to have its basis in natural selection when it encourages artificial selective behaviors and demonstrates a clear misunderstanding of Darwin’s theory.

Given the mounting evidence against the idea that eugenics is Darwinian in origin, it follows to explore what Darwin’s theory of natural selection truly entails. In contrast with the ruthless pragmatism proposed by the eugenicists, sympathy and reason are the two main results of human evolution through natural selection. In this way, the ideals of compassion and understanding can be argued to have their basis in Darwinian evolution while the proposals of the eugenics movement do not.

Darwin outlines his thesis on the evolution of the moral sense of mankind in his work The Descent of Man, published in 1871 and available before the rise of the eugenics movement [13]. Though the theory is heavily detailed and complex, natural selection only plays a minor role in the formation of human morality. Still, Darwin believed that a social intuition evolved that encouraged individuals to act in a sympathetic manner toward fellow creatures. This instinct was evolutionarily advantageous, and thus groups with a greater proportion of sympathetic individuals had greater reproductive and survival success. Over time, and with the codification of the moral instinct through language, codes of ethics were easily spread amongst populations. Though at this point natural selection no longer played as important a role as it did in initially propagating the moral intuition, it was still necessary that individuals retain an instinct to do good to others. Therefore, the instilled moral sense to act benevolently towards other members of the human race is a result of the Darwinian mechanism of natural selection.

Darwin believed that this instinctual benevolence that was instilled in humankind was the crowning epitome of natural selection. He further believed that violation of this instinct, even in cases of the supposed “bettering” of the human population through eugenic practices, was an immoral act. In the Descent, he writes that: The surgeon may harden himself while performing an operation, for he knows that he is acting for the good of his patient; but if we were intentionally to neglect the weak and helpless, it could only be for a contingent benefit, with an overwhelming present evil. We must therefore bear the undoubtedly bad

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effects of the weak surviving and propagating their kind… [14].

While Darwin here sees the possibility of degeneration should the “weak and helpless” continue to reproduce, he believes a greater degeneracy would result from backtracking against the march of evolution that had instilled in mankind the moral sense. Because said sympathy is opposite those eugenicist ideas, and because it is a result of evolution by natural selection, it does not follow that the proposals of the eugenics movement are Darwinian in origin. Therefore, despite their best efforts, the eugenicists cannot claim support from Darwin’s ideas, and the basis for their entire movement crumbles.

And why should it not? The mass killing, institutionalization, and sterilization of individuals deemed inferior is a morally repugnant fact of history grounded in ignorant beliefs and misguided interpretations of scientific theory. To act on these incorrect ideals of superiority in order to enhance progress of natural selection is not a moral duty, as was argued for by Inge and other eugenicists, but rather an immoral act. To Darwin, instinctual morality was one of the best aspects of humanity.

The ruthless preservation of the best genetic specimens, as the eugenicists were wont to accomplish, ignored and violated this morality, and thus denied humanity of its best nature.

References [1] Elof Carlson. “Scientific Origins of Eugenics.”

Image Archive on the American Eugenics Movement, Dolan DNA Learning Center.

[2] Barry Mehler. “Eliminating the Inferior: American and Nazi Sterilization Programs.” Science for the People (Nov-Dec 1987); pp. 14-18.

[3] Ibid.

[4] Charles Darwin, annotated by James T. Costa.

“The Annotated Origin.” Harvard University Press, Cambridge, MA, 2009; p. 102.

[5] Rev. W. R. Inge. “Some Moral Aspects of Eugenics.” Eugenics Review (April 1909); p. 26.

[6] “Pedigree Charts, American Eugenics Society, and Fitter Families.” Historical Collections at the Claude Moore Health Sciences Library, University of Virginia (2004).

[7] Steve Stewart-Williams. “Darwin, God, and the Meaning of Life.” Cambridge University Press, Cambridge, England, 2010; p. 173.

[8] Ibid.

[9] Rev. W. R. Inge. “Some Moral Aspects of Eugenics.” Eugenics Review (April 1909); p. 26.

[10] R. B. Freeman. “The Works of Charles Darwin: An Annotated Bibliographical Handlist.” Dawson Books, Folkstone, England (1977); p. 169.

[11] Charles Darwin, annotated by James T. Costa.

“The Annotated Origin.” Harvard University Press, Cambridge, MA, 2009; p. 84.

[12] Ibid.

[13] R. B. Freeman. “The Works of Charles Darwin: An Annotated Bibliographical Handlist.” Dawson Books, Folkstone, England (1977); pp. 128-141.

[14] Ibid. 159-160.

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CONSIDERATION OF A MANDATORY GENETIC REGISTRY For the Purpose of Improving Prenatal Genetic Counseling

ABSTRACT In recent years, prenatal genetic screening and testing have become a recommended standard for couples that have conceived or are preparing to conceive. The process requires patients to be knowledgeable about their family genetic history and, in many cases, be able to provide additional information about the genetic history of relatives, both immediate and distant. For a multitude of reasons, patients are often unable to provide this information, which greatly affects the quality of care that genetic counselors are able to provide. This paper will (1) discuss the problems that arise within the current system of relying on family members to provide genetic information by using a hypothetical case study about an expecting couple, Jack and Kate, (2) propose a mandatory genetic registry as a solution to these problems, and (3) discuss the ethical tensions associated with such a registry.

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THE PROBLEM In a prenatal genetic counseling session, a counselor takes a family history and recommends certain genetic screenings or tests based on the information collected. Important details for the clinician to consider include, but are not limited to, the occurrence of birth defects, chromosomal disorders, late term miscarriages, reoccurrence of cancer in several generations, and early deaths in immediate family members. The results of any genetic evaluations (e.g. carrier tests or chromosome studies) performed on family members are also crucial to the counseling process. In order for the counselor to recommend the appropriate tests, the mother and father of the fetus must be accurate and thorough in providing the family history. This requires the parents’ family members to be forthcoming about genetic conditions that exist in their family, which is not always the case. Therefore the ability for the prenatal genetic counselor to accurately treat the couple greatly relies upon the willingness of multiple parties to participate.

Consider the example of Jack and Kate, a young couple who are expecting their first child. Now twelve weeks into the pregnancy, Jack and Kate meet with a prenatal genetic counselor to discuss any potential risks to the pregnancy and receive the appropriate testing. The counselor takes a detailed family history and the result is shared below in the form of a pedigree. Of note, the purple diamond represents Jack and Kate’s current pregnancy.

A number of items in the family history warrant further discussion. First, the counselor notes that both Kate’s sister and mother died of breast cancer at young ages. Since early onset breast cancer can be hereditary, and given the multiple occurrences in Kate’s family, the counselor is concerned and follows up with a number of questions: Did Kate’s mother and/or sister undergo genetic testing to determine if they had any of the gene mutations associated with an increased risk for developing breast cancer, such as mutations on the BRCA1/2, TP53, PTEN, STK11, or CDH1 genes? If so, what were the results? Have other family members been encouraged by their physicians to take extra precautions in order to manage their cancer risk? Has Kate ever been tested for one of these mutations? These questions are important for assessing Kate’s risk of developing breast cancer, as well as the risk posed to her future child. If members of Kate’s family do have an increased risk of developing breast cancer, Kate and Jack will want to have this information available when making decisions about family planning.

Having this information may mean different things to different people. For Jack and Kate, it could be empowering to have that information so they can stress the importance of regular testing and

preventive treatment to their future children.

Conversely, if they are uncomfortable with the possibility of passing on the gene mutation to their child, then this information could be enough for them to warrant termination of the pregnancy. If Kate is unable to provide answers to the counselor’s questions, she and Jack will not be able to make these decisions based on accurate information. The counselor might try requesting access to the relatives’ medical records in order to determine if genetic testing was ever completed, however, the process of requesting access to medical records can be time consuming and difficult, especially since the deceased individuals are not able to give consent.

Even if Kate’s father or brother-in-law give the counselor permission to access the records, legal barriers can still arise, preventing the counselor from acquiring the necessary data.

Another item of concern involves Kate’s other sister, who terminated a pregnancy at twenty weeks because of abnormal results on an amniocentesis test. Amniocentesis is a procedure in which a woman’s amniotic fluid, which contains fetal cells, is tested in order to identify the existence of genetic conditions in a fetus [1]. Upon learning of the abnormal results, Kate and Jack’s genetic counselor has several questions. What chromosomal abnormalities were noted in the amniocentesis? Did the mother follow up with carrier testing and if so, what were the results? Should Kate have carrier testing? Should Kate rely on screening tests to assess her risk of having a child with a chromosomal abnormality, or should she opt for a risky but definitive test such as a Chorionic Villus Sampling (CVS) or an amniocentesis? Knowing the specific chromosomal abnormalities that were present in the terminated pregnancy would enable the counselor to determine whether or not there is a significant

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chance of the condition appearing in Kate’s pregnancy. If anyone in the family were determined to be a carrier of the abnormality, this too would help determine Kate and Jack’s specific risk of having a child with a chromosome abnormality. Again, if Kate is unable to answer these questions for any reason, she and Jack will not be able to make fully informed decisions regarding family planning.

Finally, Jack notes that he has a child from a previous marriage who he recalls exhibited several developmental delays and physical differences. For a number of complex social reasons, Jack is not in contact with his ex-wife or his son. He has no access to his son’s medical information, nor is he aware if any diagnosis was made. As before, the counselor has a number of questions: Can Jack get in touch with his ex-wife to get medical records for his son? Can he find out if a chromosome study was ever performed?

Should Jack receive carrier testing for specific chromosomal abnormalities? If Jack tests positive for being a carrier, should Kate be tested as well? Again, should Kate rely on screening tests or opt for a CVS or an amniocentesis test to rule out chromosomal abnormalities? Having detailed answers to these questions would allow the genetic counselor to determine Kate and Jack’s risk of having a child with developmental problems and make the appropriate recommendations for additional testing. This information would then enable Kate and Jack to make informed decisions about family planning.

Studying the case of Jack and Kate highlights the importance of possessing information about one’s familial genetic history. The inability to provide this information to a genetic counselor can be extremely detrimental to the process and can limit a couple’s information about the condition of their fetus and make appropriate decisions. Unfortunately, a number of factors hinder the sharing of health information within families, therefore making it difficult for effective and accurate genetic counseling to take place. One such factor is culture. In some cultures, health is considered a private matter that should only be discussed with family members. For example, the Latino population considers the topic of illness to be reserved for only the closest of relatives [2]. In some circles, certain health conditions are considered “shameful,” and therefore are not discussed with anyone outside of the home, including physicians. According to a University of Michigan clinical manual on cultural communication, patients of Russian descent often do not disclose information about psychiatric or sexual disease, as these conditions are considered “disgraceful” [3]. In other cultures, inquiring about the cause of a relative’s death or illness is considered rude. The same is true of developmental delays and physical abnormalities.

Social factors also play a role in hindering the sharing of health information among family members. Patients who have complex family situations may not be informed about the health statuses of all of their relatives. Members of families that are estranged will likely not know relevant health information for each of their relatives, nor is it likely that they will be able to acquire that information. Finally, the ability of genetic counselors to acquire this information about their patients is hindered by the structure of the healthcare system.

All individuals are guaranteed privacy and confidentiality in the health system, so acquiring access to another person’s medical records without their consent is not a feasible solution. Even with full participation from all involved parties, the process of acquiring consent to seek medical records for relatives is complicated and time consuming. Test results may be held by the original lab and, if not properly documented in the medical record, can be impossible to locate.

THE PROPOSAL A mandatory genetic registry would eliminate the problems caused by individuals not sharing relevant genetic information with their family members.

Collecting health data, both with and without an individual’s consent, is not a revolutionary concept.

Voluntary registries exist for many health conditions, including cancer, addiction and substance abuse, ALS, and Down syndrome. The information collected for these registries is only available to health officials and researchers and is used to increase knowledge about possible causes and improve diagnosis and treatment techniques. More recently, online registries like Flu Near You have made it possible for individuals to provide data about their health through online programs like Facebook and Google+ [4]. The data is used to propose theories about the spread of disease and, in some cases, determine the allocation of resources.

Mandatory registries also exist. Public health officials use registries to track individuals with infectious diseases and often require affected patients to provide contact information for other individuals who might have contracted the disease. Additionally, every state has a “reportable diseases” list, which includes approximately sixty conditions that must be reported to the CDC upon diagnosis. Often these registries are used to allow for contact tracing.

Contact tracing is an important part of public health and involves the process of contacting individuals who may have been exposed to an infectious disease and following up to ensure that affected parties take

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adequate precautions. This process was famously used during the AIDS epidemic, and more recently played a role in tracking down potential carriers of the Ebola virus. Finally, many states require hospitals to report birth defects that occur in children under the age of two. This information is added to a registry, which is then used to expand knowledge and provide resources.

The common factor among current health registries is that all provide information to health officials and researchers; no information is accessible to members of the general public. The mandatory genetic registry would be different in this regard, as the registry would give individuals and their clinicians access to the genetic information of patients’ relatives. This information would be retrievable through the Electronic Medical Record (EMR). Any and all documented genetic testing would be uploaded to the EMR and linked to relevant family members. The data would then be provided in the form of a pedigree. To use the example of Jack and Kate, the counselor would be able to click on the circle denoting Kate’s mother and see the diagnosis of breast cancer. The counselor would also be able to see any relevant testing and the results of those tests.

The data itself would be de-identified, meaning the clinician would not be able to see the individual’s name, birthdate, medical record number, or any other patient identifiers. It is likely that the patient, Kate, would know her mother’s identity, but the deidentification would protect her mother’s privacy by ensuring that the clinicians are not able to acquire more information than necessary.

Due to the sensitive nature of genetic information, in the case of the creation of the registry, the prenatal genetic counselor would need to establish some guidelines with the patient before the sharing of information begins. First, the clinician would begin the appointment by asking if the patient is interested in reviewing any available family genetic history.

Three responses are likely: (1) Yes, I would like to discuss that information and use it to make decisions about my care, (2) No, I would not like to discuss that information but I would like my physician to use it to make decisions about my care, or (3) No, I would not like to discuss that information and I do not want my physician to use it to make decisions about my care.

Taking the time to ask this question beforehand gives the patient the ability to exercise the “right to not know.” Patients would also be able to make specific requests. For example, Kate may ask if anyone in her family has tested positive for condition X, but request not to know her relationships to those individuals, therefore keeping their identities private.

Clinicians would also warn their patients that although their family members’ genetic information is accessible in the EMR and available if they would like it, some of their relatives might have requested

not to know about their own conditions. Therefore, individuals should approach future conversations with family members with caution. It would be crucial to stress to all patients the importance of respecting a relative’s wish to opt-out of learning about the genetic conditions prevalent in the family.

It might be prudent to consider drafting legislation making it illegal for an individual to disclose unwanted information to a relative, but such a law would require an entirely separate debate. It is important to recognize that this registry would not require individuals to seek genetic testing that they would not otherwise have received in order to provide information for their family. Rather, the results of any tests that a clinician recommends as part of the care plan would simply be saved and made accessible to family members.

It is important to note that without a background in computer science and knowledge of the interworking of EMRs, this author is unable to advocate for the practicality of a mandatory genetic registry. While this author has some knowledge about the difficulty associated with improving the interoperability of EMRs and making information-sharing among both collaborators and competitors a more efficient process, this paper will not attempt to address these logistical challenges. Instead, this paper will focus on the ethicality of the proposal.

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ETHICAL TENSIONS The proposal of a mandatory sharing of health data requires discussion of several key ethical issues, including themes associated with both clinical and public health ethics. Many of the tensions will address the concern of the wrongful disclosure of health information. The Health Insurance Portability and Accountability Act (HIPAA), which was developed to safeguard privacy and confidentiality, has guided health care policy and ensured the security of patient information since its creation in 1996. The privacy rule of HIPAA reads as follows: … [HIPAA] establishes national standards to protect individuals’ medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically. The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The Rule also gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections [5].

In order to argue that a mandatory genetic registry is ethical, it will be necessary to demonstrate that such a registry would meet other ethical requirements in a way that trumps concerns about privacy and confidentiality. This section will discuss the following ethical themes: beneficence and nonmaleficence, health equity, justice, the least infringement principle, and duty to warn.

The implementation of a mandatory genetic registry will address a common problem in prenatal genetic counseling in a way that benefits patients and prevents harms, therefore appropriately adhering to the principles of beneficence and nonmaleficence.

Providing a way for individuals to gather information about their health and the genetic health of their future children from existing test results is beneficial because it enables them to address any risks and take the necessary precautions; withholding information could cause harm. One possible counter argument is that requiring individuals to report their genetic information would be a violation of autonomy.

Additionally, a mandatory registry might deter individuals from receiving genetic testing, even when testing is recommended by a physician. If these points are accepted as true, the registry would seem to cause a larger harm, and therefore violate the principle of nonmaleficence. However, Mill’s harmto-others principle suggests restricting an individual’s autonomy and liberty if the following conditions are met: (1) there is a concern that the individual will

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harm others and (2) the harm can be prevented by limiting the individual’s liberty. As has been discussed, a concern does exist for the harms caused by the failure of individuals to share relevant genetic information with their families. Additionally, limiting liberty by requiring individuals to submit known genetic diagnoses and test results to the registry would prevent this harm. Therefore, the mandatory registry would not violate the principle of nonmaleficence.

Rather, the registry would uphold this principle by ensuring that others are unable to do harm by withholding relevant genetic information from their family members.

Another theme worthy of discussion is health equity.

Health equity is achieved when all members of a population have the same level of health and access to healthcare [6]. The burden of establishing health equity falls on the field of public health. The effect of social determinants such as race, ethnicity, social status, gender, economic status, and level of education on access to family genetic information indicates a health inequity, especially because these factors result in a health disparity. The disparity at play here is the differing health outcomes experienced by individuals based on their access to family genetic information.

The implementation of a mandatory genetic registry would provide individuals with the resources needed to make better decisions about family planning.

However, it is important to consider that the registry would not completely eliminate the existing health inequity. Some individuals with poor access to care or little resources will likely still have an incomplete family genetic history, thus widening the gap between health disparities among certain races and ethnic groups. Since the registry would only collect information acquired “organically” and would not require individuals to seek unnecessary genetic testing, some individuals would have access to more family genetic history than others. However, the registry would certainly help lessen the health inequity for some, by making it possible for individuals to utilize any existing genetic information and make more educated family planning decisions.

Next, it is necessary to consider the role of justice. The registry seems to benefit all people by ensuring fair distribution of knowledge and information.

Specifically, the registry follows the terms of distributive justice by ensuring that no one is placed at a disadvantage because their social, cultural or religious status hinders the sharing of health information with their family. If the information is available, meaning that someone in the family has received testing, that data would be equally available to the relevant family members. Additionally, the terms of the mandatory registry state that all individuals would be required to participate and contribute, therefore satisfying the theory of procedural justice. For these reasons, the mandatory registry seems justified.

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It is important to consider whether or not a mandatory registry is the only way of preventing the harm being discussed. If there are ways of preventing harm without requiring individuals to submit their genetic information to a database, then those solutions should be considered. Ruth Macklin proposed a Genetic Miranda Warning that requires physicians to warn patients, before genetic testing is conducted, of possible outcomes that would require them to break doctor-patient confidentiality in order to warn the patient’s relatives of a hereditary health risk [7]. One concern with this system, and with the mandatory registry as well, is that requiring individuals to share genetic information with their family members would deter those individuals from seeking testing. However, it is difficult to state for sure that these policies would serve as a deterrent.

Surveys might help gauge public response, but the only way to fully answer this question would be to fully implement testing of one of these policies in society and to gather data during the first few months or years of their active status.

While the Genetic Miranda Warning seems to solve the initial problem of genetic data sharing within families, it does not address the logistical issues associated with sharing medical records among clinicians and patients. As many individuals in the field of health care are aware, acquiring records for patients not under one’s practice can be nearly impossible, even with proper consent. The registry would alleviate this issue by making all information easily accessible in the patient’s EMR. Finally, the remaining ethical tension to consider is that of “duty to warn.” While the HIPAA Privacy Rule forbids disclosure of protected health information, an exception to the rule states that disclosure is allowed if the following conditions are met: (1) there exists a “serious and imminent threat to the health or safety of a person or the public,” (2) the threat is posed on an identifiable third party, and (3) by disclosing health information, the clinician has the capacity to “prevent or lessen the threat” (Legal Information Institute, 2014). A number of court cases have established that physicians have a “duty to warn” if a patient poses a threat to another person. The argument will now be made that a “duty to warn” exists in the field of prenatal genetic testing, therefore a mandatory genetic registry falls under the HIPAA Privacy Rule’s exception (45 CFR 164.512) as

appropriate disclosure of protected health information [8].

Duty to warn was established in the landmark case Tarasoff v. Regents of University of California. In August of 1969 Prosenjit Poddar, a graduate student at UC Berkeley, revealed to psychologist Lawrence Moore plans to kill fellow student Tatiana Tarasoff.

Moore decided that Poddar should be committed to the hospital for evaluation. Officers took Poddar into custody but he was quickly released. The head of psychiatry at the hospital ordered that Moore’s notes be destroyed and that Poddar not be subject to detention. In October of that year, Poddar stopped seeing his psychologist and moved into an apartment with Tarasoff’s brother. On October 27, 1969, Poddar went to Tarasoff’s residence and killed her. Tarasoff’s parents sued the physicians involved in the case and the University for failing to inform the victim of the threat made against her life. The California Supreme Court ruled that a physician has a duty to warn a third party if their patient “poses a serious danger of violence to another” [9]. This ruling set the precedent for requiring physicians to disclose confidential medical information in cases of infectious disease or violent crimes.

Recently, cases heard by the lower courts have raised the question of whether or not having, or not having, a genetic trait constitutes “an imminent threat to health or safety.” In Pate v. Threlkel (1995), Heidi Pate, who was diagnosed with advanced stage thyroid cancer three years after her mother was diagnosed with the same condition, sued her mother’s physician for failing to inform her about the genetic risk. Pate argued that since the physician did not warn her about her risk, she was unable to take preventive action and possibly avoid the condition. The Florida Supreme Court ruled that the physician did have a duty to warn her about the hereditary nature of the disease, but that the duty was “satisfied by warning the patient,” meaning Heidi’s mother, about the risk to family members [10]. One year later, in Safer v.

Estate of Pack, the Superior Court of New Jersey, Bergen County ruled that a physician had a duty to warn the daughter of a patient with colorectal cancer of her risk to inherit the condition and stated that the physician should have taken “reasonable steps” to assure that the relevant family members are made aware of their risk [11]. This case extended the duty to warn to family members in the case of hereditary conditions.

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Finally, in Molloy v. Meier (2004), the Supreme Court of Minnesota faulted a physician for medical malpractice after the physician failed to perform the appropriate carrier testing on the parents of a child suspected to have Fragile X Syndrome. The mother of the child went on to give birth to a second child who was also diagnosed with Fragile X Syndrome. The court’s justification was based on their finding that the second child “sustained injury from [the] appellants’ alleged negligence” [12]. This case is significant because it demonstrates that the failure to warn parents about genetic risks in their unborn children constitutes malpractice.

While legislation has been developed establishing a duty to warn in cases involving infectious disease and violent crimes, legislation applying duty to warn in genetic cases is still needed. Despite the ruling in Safer v. Estate of Pack, the American Society of Human Genetics holds the same position as the one found in Pate v. Threlkel, which is that physicians have a duty to warn their patients about hereditary conditions that might affect their relatives [13]. Yet it seems reasonable to suggest that since there exists a duty to warn family members about the risks of hereditary conditions (Safer v. Estate of Pack) and failure to warn parents about the potential to pass down genetic donations to their unborn children is a punishable offense, that clinicians have a responsibility to use relevant family medical history to treat their patients who seek prenatal genetic counseling. Therefore, a mandatory genetic registry would fall under HIPAA’s privacy rule exception as an appropriate disclosure of protected health information.

CONCLUSION The failure to share genetic health information with family members is problematic for couples receiving prenatal genetic counseling. Collecting individuals’ existing genetic information and making it available to their family members and clinicians through a mandatory genetic registry would drastically improve the standard of care in genetic counseling. Clinicians would be able to better advise their patients about hereditary conditions that may arise in current and future pregnancies, empowering couples with the resources necessary to make important decisions regarding family planning. An extensive analysis of relevant ethical themes demonstrates that a mandatory genetic registry adheres to the standards of beneficence, nonmaleficence, health equity, justice, least infringement, and duty to warn. The benefits that this registry would offer to individuals and communities certainly warrant the minimal restriction of autonomy and liberty such a registry would entail. A mandatory genetic registry would serve as an ethical way of improving the state of prenatal genetic counseling.

REFERENCES [1] "Amniocentesis." American Pregnancy Association.

2012. Accessed May 24, 2016. http://americanpregnancy.org/prenataltesting/amniocentesis/.

[2] Carteret, Marcia. "Modesty in Health Care: A Crosscultural Perspective." Dimensions of Culture. 2011.

Accessed April 20, 2015.

[3] "Cultural Competence for Clinicians." University of Michigan Health System. Accessed April 20, 2015.

[4] "About Flu Near You." Flu Near You. 2015. Accessed May 24, 2016. https://flunearyou.org/about.

[5] "HIPAA Privacy Rule and Sharing Information Related to Mental Health." U.S. Department of Health & Human Services. February 20, 2014. Accessed April 13, 2015.

[6] Bernheim, Ruth Gaare. "Equity in Public Health."

Class Lecture, PHS 5250 Public Health Ethics from University of Virginia, Charlottesville, February 11, 2015.

[7] Ruth Macklin. "Privacy Control of Genetic Information." In: G Annas, S Elias, eds.Gene Mapping: Using Law and Ethics as Guides, 157-172. New York, New York: Oxford University Press, 1992.

[8] “45 CFR 164.512 - Uses and Disclosures for Which an Authorization or Opportunity to Agree or Object Is Not Required." Legal Information Institute. October 1, 2014. Accessed April 13, 2015.

[9] Tarasoff v. Regents of University of California, 17 Cal.3d 425. 1976. Print [10] Southern Reporter, 2d, Florida Cases, Volumes 37999. 2nd ed. St. Paul, Minn., Minnesota: West Pub., 1950. 278-282.

[11] Safer v. Estate of Pack, 291 N.J. Super. 619. 1996.

Print [12] Molloy v. Meier, 660 N.W.2d 444. 2003. Print [13] Knoppers, B. M. "The American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure." The American Journal of Human Genetics 62, no. 2 (1998): 474-83.

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GOSSIP IN THE NEONATAL INTENSIVE CARE UNIT Kathryne Appleby The University of Virginia

ABSTRACT This paper explores the ethical implications of gossip in the Neonatal Intensive Care Unit (NICU) in the University of Virginia Health System. Because of the prevalence of gossip, its constitutive nature, and the ethically-charged focus of this informal communication, it is important to consider what type of organization is created through gossip in the NICU. This paper first discusses the definition and purpose of gossip to clarify the central terms of this topic. After describing two examples of gossip in the NICU, it considers the frameworks of principlism, virtue ethics, and the ethics of care to better understand the ethical implications of these examples. Finally this paper concludes with a discussion of recommendations for understanding and addressing gossip in the NICU in the future.

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BACKGROUND Anyone who ventures into the Neonatal Intensive Care Unit (NICU) of the University of Virginia Health System during peak hours might be overwhelmed by the sheer number of people present in such a specialized unit. The fifty-one beds of NICU require a staff composed of nearly one hundred and thirty nurses, more than ten attending physicians as well as many fellows, nurse practitioners, respiratory therapists, social workers, interns, residents, medical students, and nursing students. On an average day, well over forty of the fifty-one available beds are filled by exceptionally sick infants, born far earlier than a full-term pregnancy of forty weeks.

Caring for these ailing infants is a complex task requiring years of specific neonatology training to create highly skilled and specified medical teams ready to respond to the extreme health needs of premature infants. Coordinating this care requires strict, written communication guidelines which mandate that every action taken in the care of a baby be recorded meticulously in the infant’s chart.

Other forms of verbal communication are also necessary to orchestrate care. Each morning, the attending physician and other key medical team members visit each patient to discuss the baby’s current plan of care. Less formal practices of communication occur at the bedside during shift change, when nurses preparing to end their shifts transition their patients into the charge of oncoming nurses. Informal communication transpires among the numerous staff of the NICU at the work stations within the pods of the unit, by the bedside with a crying parent, in the break room over lunch, and behind closed office doors. Each method of communication plays an important role in coordinating the care of these infants and shapes the NICU as an organization, particularly in its structure and culture.

GOSSIP AS ORGANIZATIONAL COMMUNICATION In her work Gossip and Organizations, Kathryn Waddington describes the importance of these communicative processes in the formation of organizations like the Neonatal Intensive Care Unit.

“Organizations are quite literally talked into existence on a day-to-day basis as well as over time, and they are always ‘in process’” [1]. Communication defines and creates an organization by influencing its structure and culture through both formal and

informal processes; it is constitutive in nature, having the power to form and shape. As her book title reflects, Waddington is most interested in the informal communicative process of gossip that occurs within any organization. Waddington claims that gossip is absolutely crucial to study in any organization because “its ubiquitous nature and pervasiveness suggest that gossip, as a form of communication, is constitutive of organizations” [2].

The NICU of the University of Virginia Health System is no exception. Gossip plays an active role in the communicative processes of the NICU, especially in the informal, background conversations among staff members. As with any organization, gossip occurs frequently in the NICU and has significant implications and consequences for this organization.

As a moral space, the NICU is fraught with challenging ethical dilemmas regarding how best to care for the youngest, and arguably, most vulnerable members of the population. Deep ethical questions surround the care of these infants requiring members of the medical team to often face difficult ethical decisions. Such ethical dilemmas are highly complex, and many remain unresolved. Discussions of the ethical issues surrounding a baby’s care often surface through both formal and informal communication mechanisms. Particularly, considerations regarding ethical dilemmas seem to make their way into the gossip of the NICU [3].

Gossip provides an opportunity to consider the choices made in an infant’s plan of care and the ethics involved in those decisions.

THE GUIDING QUESTION Because of the prevalence of gossip, its constitutive nature, and the ethically-charged focus of this informal communication, it is important to consider what type of organization is created through gossip in the NICU. More particularly, this paper will consider the question: “What are the ethical implications of gossip in the NICU?” Consideration of this question will constitute the remainder of this paper. To better understand the question both theoretically and practically, it is important to first analyze two examples of gossip in the NICU. A discussion of the definition and purpose of gossip will clarify the central terms of this question. The frameworks of principlism, virtue ethics, and the ethics of care will then be applied to the guiding question and the examples. Finally this paper will conclude with a discussion of recommendations for understanding and addressing gossip in the NICU in the future.

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UVA NICU BY THE NUMBERS *

51

130

8

Beds in the NICU

Nurses on Call

Attending Physicians

5

13

9

Fellows

Nurse Practitioners

Respiratory Therapists

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COUNTLESS Interns, Residents, Medical Students, Nursing Students

* numbers from c. 2015, subject to update

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TWO EXAMPLES Two different instances of gossip that occurred in the NICU may serve as clarifying examples of the forms gossip can take. The first example arose after the NICU received a new baby born at 27 weeks to Mother Smith, a young woman who was, at the time of the baby’s birth, a patient in a state psychiatric hospital [4]. Mother Smith’s mental health remained relatively unstable often resulting in dangerous episodes. However she seemed to care about her baby, wanting to receive updates about the child and speak directly with the baby’s care team. In these interactions, many different details about Mother Smith’s past were revealed by Smith to multiple nurses, doctors, and social workers. A few days later, after further information was provided by Mother Smith’s care team, it came to light that many of these details provided initially by Smith were false. Even though these details were found to be false, they were particularly dramatic, providing ideal material for gossip within the NICU. The second example highlights the experience of the Conroy family. The medical team had worked with Mother and Father Conroy before their baby’s birth, as Mother Conroy had had many complications throughout her pregnancy. Together with the parents, the medical team created a plan for how to proceed once Baby Conroy was born. Knowing this birth would be very dangerous and the baby was unlikely to survive the delivery, the Conroys and the medical team together created a care plan that stated the medical team would not use extreme measures to save the baby during delivery. When Mother Conroy went into labor, the attending physician on call that evening took extreme measures to save the baby’s life, overriding the plan of care that had been previously established. The next six months of Baby Conroy’s life were a continuous battle. Consistently, the medical team would inform the Conroys that they were preparing to end their futile efforts to keep Baby Conroy alive. In each case, this plan of care was overridden, and the medical team pursued increasingly extreme measures to sustain the baby’s life. Often the medical team itself was divided over these decisions, and gossip provided an opportunity for the management and expression of the emotional tension surrounding this case as well as for sensemaking and the negotiation of power.

DEFINING GOSSIP In Gossip and Organizations, Waddington defines gossip as “informal evaluative talk about individuals/issues/groups in and about organizations between at least two people which may be spoken, written, or visual” [5]. The first two words within this definition are the most fundamental to understanding the nature of gossip.

Waddington differentiates gossip from any form of formal communication by emphasizing the characteristic informality of this type of talk. By this definition, there are no formal methods of communication that require gossip or could allow for gossip; gossip is completely separated from formal talk. The second word in the definition, “evaluative,” emphasizes the personal judgments and evaluations layered into this conception of gossip. In gossip, the gossiper offers some aspect of their evaluation of and opinions about the information they are sharing with the hearer. Gossip is not the spread of unbiased facts or information, but of evaluative talk, shaped and altered by opinions, emotions, or intuitions.

Waddington’s definition reflects an equitable silence regarding the morality of gossip as “informal evaluative talk.” Intuitively, gossip is often considered to be, at its best, harmless, idle talk that is inherently frivolous and inauthentic; at its worst, it is toxic and malicious. Philosophers such as Heidegger, Kierkegaard, and Aristotle “expressed an abhorrence of gossip” as inauthentic discourse about insignificant things [6]. Although gossip may take the form of the frivolous, groundless, idle chatter described by these thinkers, seeing gossip solely in this light neglects a crucial aspect of its purpose, namely its role as an essential communicative process of every organization, society, and community.

In the NICU, the dismissing and censoring of gossip could lead to harmful outcomes. As previously stated, Waddington argues that gossip serves an important purpose in creating and shaping an organization’s structure and culture. Limiting any form of communication with a critical organizational function may result in many complex and unforeseen consequences for that organization.

Waddington’s definition does not force gossip into a frivolous or malicious category, allowing us to understand that the automatic response to the central question of “What are the ethical implications of gossip in the NICU?” need not be negative. Using Waddington’s definition, we are permitted to consider the broadest ranges of response to this central question.

HIDDEN VIRTUES In addition to avoiding the negative connotations of gossip, Waddington’s definition expands the definition of gossip to potentially incorporate what she describes as “the hidden virtues of gossip” [7].

Patricia Spacks, in her work In Praise of Gossip, notes that the communicated information found in

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gossip is often valuable, stating “all gossip is not necessarily frivolous, nor need it be malicious” [8].

Spacks, like Waddington, separates gossip into two categories: “bad” and “good.” The “bad” gossip is represented by the type of gossip described by Heidegger—frivolous, inauthentic talk that often becomes toxic or malicious with time. However, this cannot be the only form of gossip; there is an additional type of gossip that accounts for Waddington’s “hidden virtues of gossip.” Spacks similarly describes this category as “good gossip” or “healing talk” because of the cathartic and sensemaking purposes it serves. Both authors argue that this “good” gossip fits within an intuitive understanding and definition of gossip and is beneficial for the management and expression of emotion, for sense-making and knowledge gathering, and for community building within an organization.

Waddington and Fletcher, in a study on the role of gossip in emotional expression and management, concluded that “gossip is used as a means of communicating a range of emotions including care and concern about others, anger, annoyance, and anxiety” [9]. The healthcare setting, especially an intensive care unit like the NICU, is an emotionallycharged space that requires staff members to do “emotional work” to ensure that private feelings are suppressed or presented in a way that is appropriate to the organizational context [10]. Gossip often allows “true feelings” to be expressed and “may play a role as a valuable safety valve” in settings like the NICU [11]. As a tool for emotional expression and management, gossip can provide a more appropriate opportunity for members of the medical team in the NICU to release some of the emotions that build up in their daily work context.

Additionally, using gossip as a mechanism for emotional expression and management can support sense-making processes within an organization.

Waddington states “emotions are a means by which we make sense of, and relate to, our physical, social, and organizational worlds” [12]. Expressing emotions through gossip can help staff members in the NICU make sense of the complicated realities of their organizational world. As with gossip, Waddington concludes, “sense-making is about developing ideas, putting things into frameworks, constructing meaning and mutual understanding, redressing surprise, and patterning” [13]. Gossip helps individuals and communities make sense of the world around them.

The final “hidden virtue of gossip” considered here is gossip’s role in community-building within an organization. As a mechanism for managing the emotional climate of an organization, gossip can

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create “us” and “them” classifications based on who is privy to the gossip. Brown and Brooks explain that the emotional climate of an organization can include “emotional tones and patterns that differentiate social groups or categories by virtue of the fact that they are shared by their members and are unlikely to be shared with non-members” [14]. When gossip creates an in-group, it also simultaneously establishes an out-group. Waddington states that “gossip also has the potential to change the relations of meaning between organization members” [15].

Because of this, gossip plays an integral role in “membership negotiation” in any organization [16].

By allowing for the creation of in-groups and this membership negotiation process, gossip can help build deep community within an organization.

ETHICAL ANALYSIS The aforementioned examples depict scenarios where gossip occurred in the NICU and begin to identify the ethical implications of gossip. By using three ethical frameworks to understand the challenges and consequences of gossip’s “hidden virtues,” we can begin to answer the central question of this paper. Principlism, virtue ethics, and the ethics of care framework will help clarify what is at stake when considering the value of gossip in this question.

PRINCIPLISM Understanding the ethical principles of respect for autonomy and nonmaleficence is essential to grasp the ethical implications of gossip in the healthcare setting of the NICU. Privacy and confidentiality, both important considerations for gossip, fall within the principle of respect for autonomy in a principlism framework according to Beauchamp and Childress [17]. Waddington states that gossip ultimately “represents a transgression of the private/public boundary” [18]. In principlism, “personal autonomy encompasses self-rule that is free from both controlling interference by others and from certain limitations” [19]. Respecting autonomy – and privacy and confidentiality by extension – means protecting a patient’s or a family’s right to limit access to their person and their personal information.

Gossip can violate this respect for autonomy.

Sharing confidential information about a patient or a patient’s family with other members of the NICU staff, without the consent of the patient’s family, fundamentally disregards the respect for autonomy.

In the NICU, many staff members are given confidential information about a patient and their

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family in order to provide adequate care for the infant. However, when gossip goes unchecked in the NICU, it is easy to imagine a scenario in which confidential information being conveyed through gossip could be inadvertently heard by parents, visitors, or staff members who do not have access to this confidential information. Thus, violating respect for autonomy is a potential ethical implication of gossip in the NICU. Still, in the two examples given previously, the privacy and confidentiality of the patient and patient’s family were not the primary ethical concerns of the gossip. The individuals involved in gossip were all privy to the information being shared.

The ethical framework of principlism can also highlight the role of the principle of nonmaleficence in considering the ethical implications of gossip in the NICU. The principle of nonmaleficence “imposes an obligation not to inflict harm on others” [20].

According to Beauchamp and Childress, inflicting harm can include “significant bodily harms and other setbacks to the significant interests” of others [21]. While gossip may compromise the care of an infant and thus cause significant bodily harm, it is more likely that gossip would violate the principle of nonmaleficence by inflicting a setback to someone’s significant interests. In the case of Mother Smith and her baby, the false information spread via gossip in the NICU could result in a skewed perception of Smith’s ability to care for her baby. This could result in Mother Smith being kept from visiting her infant in the NICU which might pose a significant setback to her interests in caring for her newborn.

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VIRTUE ETHICS Virtue ethics can also provide a useful framework for understanding some of the ethical challenges of gossip in the clinical setting. Waddington explains that the virtue ethics framework is “an Aristotelian approach which favors virtues and character over principles [and] emphasizes the cultivation of virtuous individual character traits” [22]. The American Nurses Association also states, “in virtue ethics, moral character is learned and habituated” [23]. This ethical framework considers the intention and motivation of an act as well as the nature and implications of these acts. Beauchamp and Childress state that in virtue ethics, “if the motive is improper, a critical moral ingredient is missing; and if a person characteristically lacks this motivational structure, a necessary condition of virtuous character is absent” [24]. Ethical acts within a virtue ethics framework are constituted by an alignment with or participation in virtuous acts. Virtue ethics uses these characteristics to describe the right way to live.

Those in line with these virtues act ethically.

In the instance of gossip, most situations potentially undermine the moral virtues of respectfulness and truthfulness. As described in Waddington’s definition, gossip often incorporates opinions or personal judgments about individuals, issues, or groups that “have been judged as morally reprehensible” [25]. These opinions and personal judgments, wrapped up in the informal talk of gossip, spread information the gossiper knows

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the gossiper knows may be incorrect or unduly invasive. In the example given of Mother Smith, gossip perpetuated false information about Smith’s background which initially violated the virtue of respectfulness toward Mother Smith and later, once this information was known to be false, disregarded the moral virtue of truthfulness. Similarly, in the example of the Conroy family, a virtue ethics framework reveals that gossip prevented the medical team of the NICU from pursuing respectful and truthful interactions with the Conroy family as the medical team consistently shifted what was being conveyed to the family in the midst of a challenging medical and ethical situation.

ETHICS OF CARE Care is a crucial obligation to consider for any ethical analysis of a clinical setting like the NICU. In fact, care plays such a critical role in the NICU that it is used as a pivotal descriptor of the title of the unit itself as an Intensive Care Unit. When considering the medical team’s ethical obligation to care for their patients and patients’ families, it is most beneficial to leverage the feminist ethics of care framework to best understand the ethical implications of gossip and care. In contrast to a Kantian ethical framework that views morality in terms of rights and rules, the feminist ethics of care framework understands the world through the lens of relationship and connection [26]. Lindemann states, “Care ethics is based on a morally crucial relationship between people that has too often been ignored or dismissed by non feminist ethicists [27].” In care ethics, relationships have moral significance and must be protected and respected like principles or virtues in the previous ethical frameworks.

In the Guide to the Code of Ethics for Nurses, editor Marsha Fowler outlines nine provisions that describe the nurse’s ethical obligations as a practitioner.

Many of these provisions find their basis in an ethics of care framework because of the weight that is placed on the relationship the nurse has with the patient, the patient’s family, and other members of the medical team. For example, Provision Six states “the nurse participates in establishing, maintaining, and improving healthcare environments and conditions of employment conducive to the provision of quality healthcare and consistent with the values of the profession through individual and collective action [28].” In this provision, the nurse is responsible for the establishment, maintenance, and improvement of the relationships necessary for an ethical, caring environment. Fowler highlights this fact in the interpretation of the provision by declaring that “each individual nurse has a role in creating an ethical environment [29].” To neglect this role is to violate the ethics of care.

This feminist ethics of care framework may be helpful to further understand the ethical implications of gossip in the NICU. Gossip has the potential to work directly counter to a robust ethic of care, neglecting and sabotaging the relationships and connections necessary to pursue an ethical, caring environment. In the given example of the Conroy family, the relationship among the members of the medical team was greatly impacted by the presence of gossip within the clinical setting. The medical team unconsciously used gossip to wrestle through the complexities of Baby Conroy’s care, which resulted in oft confused information and difficult in-/out-group dynamics within the team. Gossip also prevented members of the medical team from supporting the relationships and connections necessary to provide the best care to Baby Conroy and the Conroy family.

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DISCUSSION After analyzing the ethical implications that could occur from gossip in the NICU, it is clear that there is a tension between the “hidden virtues of gossip” as described by Waddington and the consequences of gossip revealed through the frameworks of principlism, virtue ethics, and the ethics of care. As described earlier, gossip can play a crucial role in creating organizational structure and culture and creates the opportunity for emotional expression and management, sense-making, and community building within an organization. These positive characteristics and the useful work of gossip seem to present strong reasons for protecting gossip in the clinical setting. However, it is clear that gossip can compromise and violate the principles of respect for autonomy and nonmaleficence, the moral virtues of respect and truthfulness, and the feminist responsibility of caring.

The tension between the hidden virtues of gossip and the ethical implications of gossip can paralyze organization managers and healthcare practitioners alike, not allowing them to support the value of gossip or prevent the ethical violations that gossip can cause. Ignoring this tension is equally as unproductive in a clinical setting like the NICU. But what are the best steps forward to resolve this tension?

Let us again consider the second example of the case of the Conroy family. Gossip in the second instance seemed to primarily take the form of rehashing the troubling ethical calls that were made by the medical team in the case of Baby Conroy. There was clearly discontentment and distress over the ethical calls that were made throughout Baby Conroy’s life. Many different members of the medical team experienced “moral distress” which describes an experience where: the clinician knows, or believes he/she knows, the ethically appropriate action, but feels constrained from acting because of some obstacle inherent in the situation, such as lack of time or supervisory support, institutional or legal constraints, or physician power over nursing and nursing practice [30].

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community, but not among the whole medical team.

Instead, gossip worked counteractively and subversively to augment the distrust and disunity in the medical team. Waddington’s “hidden virtues” can become dangerous coping mechanisms that, like a feedback loop, continuously exacerbate the problem instead of resolving the emotions connected with moral distress. Hamric warns that in situations like that surrounding the Conroy family, “moral distress can compromise health professionals’ moral integrity, a profoundly negative consequence that can, in turn, compromise the care they provide” [31].

By allowing for a superficial release of emotions, sense-making separated from productive action, and communication that furthered disunity, gossip perpetuated itself and eventually prevented the root issues of moral distress from being actively addressed by all members involved. Based on the example of the Conroy family, it is clear that moral distress increases the negative ethical consequences of gossip in the NICU, leveraging the “hidden virtues” of gossip to actually worsen moral distress instead of providing a beneficial opportunity for resolution.

Power dynamics can also help further clarify the relationship between gossip and moral distress.

Hamric states, “the vertical hierarchies and steep power gradients of clinical care contribute to clinicians’ experience of moral distress” [32]. More specifically, “the power differential between nurses and doctors can be both a barrier to good care and a source of moral distress” [33]. Spacks explains that gossip as a form of communication relates directly to power dynamics: Knowledge is power, knowledge about other people is power over them, knowledge of the past provides an illusion of predictive possibility and an air of interpretive authority. The interpretations gossip offers inhere in the stories it tells. The organizer of a narrative controls its meaning, thus takes partial possession of other people's lives [34].

Instead of identifying this scenario as a case of moral distress, gossip provided a way for various members of the medical team to “let off steam” as pressure from moral distress increased.

Spacks claims that gossip plays a role in establishing the power dynamic of an organization. Applying Spacks’ argument to the second example of Baby Conroy reveals that members of the medical team may have been trying to assert power because of perceived lack of power. Similarly in the example of Mother Smith, the assertion of power may help explain why gossipers continued to spread intriguing information about Smith even after they knew it to be false. Power play actions like these are hallmarks of moral distress.

In this case, gossip was helping the medical team to manage and express their emotions as well as make sense of the challenging, ethically-fraught situation they were experiencing. However, using gossip to alleviate the emotional work of the scenario resulted in the team neglecting the root cause of moral distress. In this case, gossip acted to build

Waddington describes a similar mechanism of gossip to create or destroy communities. Because of the constitutive power of gossip for organizations, “gossip is both a community-building device and something that gnaws away at the grounds of propriety, legitimacy, and respect, dividing organizations” [35]. Gossip as a communicative

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... gossip, by acting as a “safety valve” for moral distress, allows the problem to go largely unnoticed until the distress build up is irreversibly high.

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mechanism can create or destroy power structures within an organization. In the healthcare context, the medical team hierarchy is a critical structure, required for the provision of effective, ethical care for all patients. Because gossip has the power to support or destroy this hierarchy, it has direct implications for the care of patients. In the NICU, this might manifest itself through tension within the medical team or resistance to the plan of care established by the person in power, namely the attending physician.

Ultimately, because of the feedback loop of gossip that augments moral distress and feeds contentious power dynamics, gossip does not serve as an effective way to manage and express emotion surrounding ethical calls in the NICU. Gossip, as emotional management and power control, attempts to relieve the tension and frustration created by the long-term build-up of moral distress. In essence, gossip, by acting as a “safety valve” for moral distress, allows the problem to go largely unnoticed until the distress build up is irreversibly high. This acknowledges the benefits of gossip as a catharsis, but also shows that gossip’s “hidden virtues” still have consequences and do not actually resolve the problems of moral distress build up over time.

CONCLUSIONS We need another communicative mechanism that can provide the emotional management and expression, sense-making, and community building that gossip provides without coming at the high cost of violating moral principles, virtues, and responsibilities of care and increasing moral distress in the NICU. I believe the first step to addressing the troubling ethical implications of gossip is to acknowledge that gossip occurs in all organizational contexts. Spacks describes gossip as “forbidden talk” [36]. She explains, “Secrecy, an essential aspect of gossip's every mode--the secrecy of shared confidences, the secrecy of gossip's pleasure, power, and alliances--secrecy, obviously, implies something to hide” [37]. This makes gossip alluring, even appealing to participate in behind closed doors. The first step to addressing gossip is to remove the “forbidden,” secret nature of this informal, evaluative talk.

Acknowledging the occurrence of gossip in organizations, as Waddington champions, begins to remove the forbidden stigma of gossip. By allowing this fact to be acknowledged, gossip and, more importantly, the ethical implications of gossip can begin to be addressed by all stakeholders.

Additionally, recognizing gossip creates an opportunity for conversation about the implications, both good and bad, of gossip in the context of the NICU. Revealing and removing the stigma

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surrounding gossip and the secrecy of these often unethical conversations can provide opportunity for further dialog about why these conversations are occurring in the first place. This can then lead to a greater emphasis on the root cause of moral distress rather than simply “letting off steam” through gossip when strong emotions are involved.

Leaders and managers within the healthcare context may overlook both the importance of gossip for organizational culture and experience, as well as the challenges and potential ethical consequences of gossip. A manager’s recognition of gossip could help facilitate honest conversations about other communicative opportunities which address the core needs that gossip currently serves, namely emotional management, sense-making, and community building. All conversations about gossip within the clinical setting should be pursued with the end goal of conserving the beneficial aspect of gossip as an organizational process while eliminating the unethical compromises of respect for autonomy, nonmaleficence, respectfulness and truthfulness, and the responsibility to care.

REFERENCES [1] Waddington, Kathryn, Gossip and Organizations (New York: Routledge, 2012), 18.

[2] Ibid., 1.

[11] Waddington and Fletcher. "Gossip and Emotion in nursing and health-care organizations." Journal of Health Organization and Management, 389.

[12] Waddington, Gossip and Organizations, 72.

[3] NICU nurse, personal communication, September 24, 2013.

[13] Ibid., 71.

[4] Names and clinical details of this case and those that follow have been altered to preserve confidentiality.

[14] Brown and Brooks. "Emotion at Work: Identifying the emotional climate of night nursing." Journal of Management in Medicine, 332.

[5] Ibid., 25.

[15] Waddington, Gossip and Organizations, 107.

[6] Spacks, Patricia M. "In Praise of Gossip." The Hudson Review 35, no. 1 (1982): 22.

[16] Ibid., 92.

[7] Waddington, Gossip and Organizations, 1.

[17] Beauchamp, Tom L., and James F. Childress, Principles of Biomedical Ethics (New York: Oxford University Press, 2009).

[8] Spacks, "In Praise of Gossip." The Hudson Review, 2.

[18] Waddington, Gossip and Organizations, 44

[9] Waddington, Kathryn, and Clive Fletcher. "Gossip and Emotion in nursing and health-care organizations." Journal of Health Organization and Management 19, no. 4 (2005): 388.

[19] Beauchamp and Childress, Principles of Biomedical Ethics, 99.

[10] Brown, Reva B., and Ian Brooks. "Emotion at Work: Identifying the emotional climate of night nursing." Journal of Management in Medicine 16, no.

6 (2002): 327-44.

[21] Ibid., 153.

[20] Ibid., 149.

[22] Waddington, Gossip and Organizations, 111.

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[23] Fowler, Marsha D., ed. Guide to the Code of Ethics for Nurses: Interpretation and Application.

(Silver Spring, MD: American Nurses Association, 2008), 74.

[24] Beauchamp and Childress, Principles of Biomedical Ethics, 31.

[25] Waddington, Gossip and Organizations, 45.

[26] Lindemann, Hilde. An Invitation to Feminist Ethics. (Boston: McGraw Hill, 2005), 86.

[27] Ibid., 98.

[28] Fowler, Guide to the Code of Ethics for Nurses: Interpretation and Application, 71.

[29] Ibid., 78.

[30] Hamric, Ann B., Walter S. Davis, and Marcia D. Childress. "Moral distress in healthcare professionals: What is it and what can we do about it?" The Pharos (2006): 18.

[31] Hamric, Davis, and Childress. "Moral distress in health care professionals: What is it and what can we do about it?" The Pharos (2006): 18.

[32] Ibid., 18.

[33] Ibid., 20.

[34] Spacks, "In Praise of Gossip." The Hudson Review, 30.

[35] Waddington, Gossip and Organizations, 106.

[36] Spacks, "In Praise of Gossip." The Hudson Review, 19.

[37] Ibid., 35.

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THE IMPORTANCE OF ETHNOGRAPHIC RESEARCH In Protecting Research Subjects Overseas Carla Andrea Pierini, JD, MPH Northwestern University Graduate School, Medical Humanities & Bioethics

ABSTRACT This paper discusses how a social science perspective, and specifically anthropology, can help to evolve and heighten ethical standards employed in global clinical trials. The analysis includes a general summary of eminent bioethical scholarship on the subject, and how ethnographic research is critical to stimulating thoughtful debate and encouraging sound public policy to protect the autonomy and well-being of research subjects overseas.

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INTRODUCTION In 2014, global pharmaceutical sales reached a milestone of USD $1 trillion, and market forecast reports show continued growth in the future (Thomson Reuters). The pharmaceutical industry is highly marketing-driven as drug companies spend nearly twice as much on the promotion of products than on research and development (“R&D”) innovation. This allocation of money underscores the primary objective of these corporate behemoths: substantial monetary gain. Because a drug company is poised to make hundreds of millions, if not billions, of dollars from a single blockbuster drug, R&D portfolio diversification has not traditionally been of paramount importance (Ding). Although new patent legislation and the advent of biopharmaceuticals prompted a shift in investments, obtaining lucrative gains from a few drugs has long been the industry’s modus operandi.

As a result, expediency and cost-effectiveness are at the core of a pharmaceutical company’s operations.

The faster it can invent, tweak, and patent drugs at low costs, the sooner it can sell and make exorbitant profits from a few highly profitable drugs. Before a drug can be offered on the market, however, it must go through a series of testing procedures to assess quality, safety, and effectiveness, and subsequently obtain regulatory approval. In recent years, there has been a substantial increase in the amount of clinical testing conducted abroad. This attractive cost reduction strategy has become an industry practice allowing companies to redirect R&D funds (Petryna 2-3). This offshoring practice is not without its risks as research suggests that it often jeopardizes the health and dignity of its research subjects.

The field of anthropology plays an imperative role in better understanding the variability in research ethics stemming from the globalization of clinical trials. Sociocultural anthropology is an exceptionally relevant subfield as it emphasizes social patterns and practices as well as the interrelationships of cultural, economic, political and social life within a particular setting. Ethnography, which is commonly referred to as "field work," is the recording and study of a culture or society. Ethnographic research is one of the anthropologist's main tools, and it can be employed in a multitude of methods, including participant observation, unobtrusive direct observation, interviewing, and audio-visual accounts. This method of data collection can provide valuable insight into the inner workings of geographic, political, religious, or socioeconomic environments (American Anthropological Association).

Ethnographic studies on offshored clinical trial practices reveal flagrant violations of human rights

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as ethical guidelines are being recast in these international settings, leading to the coinage of the term “ethical variability” by prominent anthropologist Adriana Petryna. In an effort to further cut costs, drug companies have bypassed quintessential “ethical” steps. For example, they largely fail to: implement studies that take local culture and traditions into account; devise clear and coherent informed-consent forms; and generally respect the scientific integrity of the research. The trials rely heavily on the participation of economically vulnerable individuals in need of money and healthcare services. Among the myriad problems plaguing the issue, economic incentives and weak regulatory frameworks permit drug companies to expeditiously obtain approval from local ethical review boards, many of which are privately funded and stand to make a profit (Petryna 16).

The adoption of an anthropological lens to the issue of overseas clinical trials is not intended to serve as an exposé, but rather as an accurate portrayal of the social and political realities of this outsourcing practice. In a world with infinite moving parts and actors, it can often be a challenge to ascertain the origin of seemingly inextricable problems. By framing the underlying motivations for subject participation and by identifying the variables at play, anthropological knowledge illuminates the gross inequalities of the global experimental enterprise.

Ethnographic fieldwork can call much needed attention to the plight of vulnerable and marginalized research subjects and can incite social change in the form of public policy.

This paper will discuss how a social science perspective, and specifically anthropology, can help to evolve and heighten ethical standards employed in global clinical trials. The analysis includes a general summary of eminent bioethical scholarship on the subject, and how ethnographic research is critical to stimulating thoughtful debate and encouraging sound public policy to protect the autonomy and well-being of research subjects overseas.

ROLE OF THE ANTHROPOLOGIST: “THE ISSUE SPOTTER” Anthropologists are bona fide “issue spotters.”

Ethnographic research often sheds light on issues that may have otherwise gone unnoticed, ignored, or kept hidden from the public. In the context of global clinical trials, the goal of the anthropological research is to illustrate how particular institutional or cultural settings handle ethical issues, or in other words, how ethical decisions are made in practice.

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This profound understanding requires micro and macro levels of analysis. To hone in on the intricacies and nuances of a particular environment, anthropologists must first understand the “universe of phenomena” in which their field site is an example (Boellstorff 178). By piecing together the smaller and larger pieces of the “puzzle,” anthropologists convey accurate and complete accounts of a people’s reality.

Through inductive reasoning and discussion on how a cultural belief or norm is broadly shared, anthropologists can then hypothesize on whether or not their findings apply to a larger group (179).

The pharmaceutical industry is known for guarding its practices under a shroud of secrecy. Because of the selfprotective nature of corporations, few scholars have been able to observe the inner workings of their business operations, let alone their clinical trials.

Adriana Petryna has been a leader in the investigation of the realities of global clinical trials. In her book When Experiments Travel, Petryna documents her findings from time spent in corporate and scientific offices in the U.S. as well as in research and public health sites in Brazil and Poland. Aiming to understand how populations enroll in clinical trials and what subsequently becomes of “citizenship” and individual autonomy in the process, Petryna employs traditional conceptual and methodological tools of anthropology.

Through participant-observation, interviews, and comparative analysis, Petryna tracked the lives of individuals and institutions over time, collecting valuable insight on global clinical trials.

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Effective interviewing is a powerful tool employed by ethnographers. A successful interview depends largely on the ethnographer’s ability to listen and gradually gain the trust of informants (Boellstorff 95). In the context of clinical trials, informants may be reluctant to share health information or motivations for participating in the trials. For that reason, referrals from well-respected community members may provide a foundation for trust on which the ethnographer can build. Interviews may be particularly valuable in the corporate setting where an ethnographer may not have full access to company files or clearance to attend board meetings. Face time with pharmaceutical executives is generally difficult to obtain, which is why such opportunities need to be well executed; the framing and selection of interview questions, for example, is crucial.

The non-elicited data gathered through participant observation allows anthropologists to observe how practices and beliefs meld organically in quotidian life (Boellstorff 105). Though interviews are key opportunities to ask specific questions pertaining to a people’s representation of their social worlds, they do not depict complete pictures. To account for the difference between people’s speech and action, ethnographers document “unconscious” culture through participant observation.

Participant observation is a qualitative method of data collection in which the investigator actively participates in the daily life of those he or she is studying rather than being a mere bystander (Merriam-Webster). In the context of clinical trials, a combination of interviews and participant observation will most accurately portray the landscape. For example, an interview format allows the ethnographer to pose follow-up questions about an occurrence that transpired in public in order to glean a more thorough understanding of social dynamics and cultural conventions which may not have been readily evident while observing in the field (Boellstorff 106).

An in-depth analysis of the economic, political, and social underpinnings of the pharmaceutical industry practice also helps to contextualize the actions and motivations of research subjects. In his book The Professional Guinea Pig, Robert Abadie seeks to identify the omnipresent variables which come into play in U.S. clinical trials. He comments that his “research calls attention to hidden problems brought about by the increasing commodification of the body in clinical trials, in the context of an emerging professional subjectivity created by new regimes of technoscience and capital accumulation” (17). A better understanding of the cultural context in which individuals make decisions about risks and benefits will allow the ethnographer to present the most accurate account (18).

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CONTEXTUALIZING BIOETHICAL SCHOLARSHIP ON HUMAN RESEARCH SUBJECTS Ethnographic research in the field of global human research subjects focuses on the organizational cultures of industry-sponsored clinical research. The global landscape of commercial clinical research is multifaceted and pervasive, yet certain recurring themes surface in the literature: commodification of the body, inadequate ethical guidelines, and nebulous standards of informed consent.

The experimental enterprise has undeniably commodified and integrated the body into a market economy (Abadie 8). Bioethical scholarship suggests that there are two major underlying motivations for participating in a trial: those people who primarily seek financial compensation—often referred to as the professional guinea pigs—and those who hope to gain better access to healthcare or an alternative treatment for their condition (5-6). The literature reveals the exploitative and dehumanizing nature of clinical trials, especially those conducted abroad.

Under what ethical principle would it be deemed acceptable for a pharmaceutical company to target its testing operations in countries with decrepit healthcare systems where subjects volunteer out of necessity and desperation? Pharmaceutical companies have become de facto suppliers of healthcare to impoverished regions, especially through the recruitment of disenfranchised participants. To refer to these trial subjects as “volunteers” sounds rather erroneous. Although subjects may consent to participation on their own volition, the decision may be largely in part out of necessity to obtain health care that is otherwise nonexistent or unaffordable. Subjects are essentially “selling” their bodies to survive and companies capitalize on this human necessity.

Labeling these “healthcare” contributions by the pharmaceutical company as generous and benevolent would wholly disregard the immense profits companies subsequently reap from these studies. By offshoring clinical trials, pharmaceuticals can tremendously lower their drug development costs. Foreign governments in these targeted sites are generally receptive to allowing pharmaceutical testing, often seeking to position themselves as clinical trial hubs. These host countries recognize the economic advantages of pharmaceutical investments, which grant access to new markets and may help to supplant debilitated state-run healthcare infrastructure (Petryna 18-19). Thus, government

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stakeholders frequently cater to business demands and significantly lower barriers of entry for these companies. Unfortunately, clinical trials do not, and should not, replace traditional models of healthcare delivery due to the inherent special interests of the pharmaceutical industry.

It should come as no surprise then that pharmaceuticals, through contract research organizations (“CROs”), evaluate prospective testing sites by first assessing a country’s regulatory environment. CROs look primarily at “country approval time”—time it takes to obtain authorization to begin a trial—and “country activation time”—time it takes to establish and commence a study (Petryna 16). The prioritization of speed and cost-efficiency over everything else underscores the gradual devaluation of scientific integrity that is taking place.

Ethnographic data has revealed the problems stemming from the local, privately funded review boards which stand to make a profit by rapidly approving clinical trials (17). Because the business of clinical trials is comprised of a complex web of powerful stakeholders, both local and foreign, who are motivated by financial gain, reconciling the conflict between economic efficiency and equity and human rights will be a challenge of epic proportions.

Existing scholarship also emphasizes the importance of informed consent forms and how this convoluted paperwork, laden with legal and scientific jargon, weakens the autonomy of subjects. These “thick” forms are found abroad as well as domestically, signaling a grave and widespread problem of transparency and information asymmetry. If the professional guinea pigs—the trial veterans—do not comprehend the forms, how will subjects in different countries, who have never “volunteered” before, be cognizant of the risks? Ethnographic research among professional guinea pigs in the U.S. indicates that many volunteers do not fully comprehend the informed-consent forms they ultimately sign (Abadie 140). This is particularly worrisome because these forms should provide clear information on the design and risks associated with the trial to enable subjects to make educated decisions to participate.

Why do these individuals sign incomprehensible consent forms without understanding the experimental design or being fully aware of potential side effects? The answer ties back to the commodification of the body and how these contractual agreements are an exploitation of people’s need for money or healthcare (141).

Bioethical scholarship on global clinical trials documents the “discourses and practices in the particular historical and sociocultural context in which research subjects live and make decisions” (Abadie 18). Hence, in the process of conducting a study, an ethnographer must observe the larger picture to make sense of the people and institutions

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whose lives are entangled. Based on her extensive studies and conversations with leading scientists in Brazil and Poland, Petryna comments on how the impact of these global trials extends to academic medicine and the public health of host countries.

Pharmaceutical assistance, which is provided in return for permitting clinical trials, often helps to sustain crippled healthcare systems by funneling earmarked money and drugs into the country (Petryna 146). Consequently, research hospitals and physicians are more inclined to prescribe a pharmaceutical company’s drug over another.

In an ethnographic study conducted in Brazil, Petryna observed how the independent medical judgment of physicians involved in industrysponsored research is often compromised (Petryna 159). To protect the quality of the data, investigators are to strictly adhere to the research protocols of the study. As a result, physicians can only collect the information required by the sponsor, and they usually do not have access to a subject’s record of clinical and treatment history. This practice differs greatly from traditional delivery of care and from the standard patient-physician relationship. Once the trial concludes, physicians usually have neither access to data gathered on a subject nor additional financial resources to provide post-trial treatment or long-term medical care to research participants (160). Hence, in agreeing to carry out research trials, physician-investigators may actually be inflicting more harm than good, as many subjects will ultimately be deprived of post-trial treatment (173).

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CONTRIBUTION OF ANTHROPOLOGICAL KNOWLEDGE TO GLOBAL CLINICAL RESEARCH In the context of global experimentation and the future, the contribution of anthropological knowledge has tremendous potential. Bioethical scholarship has already brought much needed attention to the area of experimental design and its application in vulnerable populations. For example, the use of a placebo in 1994 during short-course AZT treatment to prevent perinatal HIV transmission in Africa stirred up major public health controversy (Petryna 33). The discussion revolved around the lower standard-of-care therapy given to those on the placebo arm of the study, and whether or not this practice was discriminatory and ethical. The global community shunned this practice of denying treatment to the control group in order to obtain more “accurate” and “natural” results, comparing it to the flagrant ethical violations of the U.S. government-sponsored Tuskegee Syphilis Study. This particular fieldwork revelation also highlighted the inadequacies of experimental design in offshore trials, emphasizing the need for locally-designed studies that integrate local realities, beliefs, and concerns. Ultimately, the tremendous public outcry led to the sixth revision to the Declaration of

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Helsinki, which is often considered to be cornerstone document on human research ethics (34-35).

CONCLUSION

Bioethical scholarship should focus on the issues that emerge at the local level and which may not be readily evident at first glance. For example, Petryna’s studies document how the business of clinical trials overseas has wide-scale implications that go beyond the well being of the subjects (Petryna 3). The practice of offshoring trials has the capacity to affect the entire local delivery of medicine, including the motivations of physicians. Because the salaries of local physicians in host countries are often dismal, it is not uncommon for these professionals to become study monitors in clinical trials in return for generous compensation. For example, a Russian physician can earn more for overseeing research protocols than for treating patients (Petryna 4). This finding is another way in which ethnographic research can untangle and examine environmental factors which are closely intertwined.

Anthropological studies in the field of human subjects research show that the practice of offshore trials reflects the poverty status of subjects who are victims of their state’s failure to uphold ethical standards of care for its citizens (Petryna 31).

Existing bioethical scholarship illuminates a myriad of ethical violations that occur overseas, confirming the need for social and political reform. While innovation and market growth are important, they cannot be pursued at the cost of sacrificing ethical principles. Because ethnographic studies generate powerful data that is actionable, more efforts should be directed at conducting additional ethnographic research on global clinical trials to bolster arguments for social change.

Through their astute observations, anthropologists can identify those contextual variables which exacerbate the rampant inequities generated by these clinical trials. If the research garners sufficient attention, it has the power to spark debate and public policy to protect the integrity of clinical trial subjects abroad. In a world in which corporate responsibility and public image are of paramount importance, pharmaceutical companies and governments may be more inclined to take measures to rectify those concerns. This research could even galvanize the global community to propel the creation, for example, of a publicly funded international review board to help undercut the pharmaceutical industry’s political clout.

Because the pharmaceutical industry is constantly evolving with the advent of new technologies and drugs such as pharmacogenetics and biopharmaceuticals, the use of clinical trials to approve drugs could eventually become obsolete.

Genetics play an increasingly important role in drug discovery and development, as scientists hope it will one day allow for individualized treatment. Because diseases are not necessarily homogeneous, and they may manifest in various ways, customizable drugs are an attractive alternative (Lindpaintner 472).

Unlike their mainstream chemically synthesized predecessors, biopharmaceuticals are derived from life forms. The side effects of these protein-binding drugs can be thoroughly studied in vitro, as any response is the result of the substance’s pharmacological action. Given the scientific community’s increased reliance on genetics and in vitro testing to develop new drugs, the future may be devoid of clinical trials requiring human participants (Science Daily). However, these technologies are still in a nascent stage, and they are not applicable to the full gamut of drugs.

The implementation of more stringent regulation, increased transparency, and clearer informedconsent forms would certainly provide subjects with additional safeguards against physical harm. To say, however, that these changes would make the offshore testing practice “ethical,” would simply water down the field of bioethics to a regulatory framework. A coherent informed-consent form will certainly correct information asymmetry, but it alone cannot rectify the gross inequalities generated by these contractual relationships. For long-lasting change, there also needs to be a shift in how individual autonomy and human life is valued. The question is whether ethnographic research can spark sufficient debate as to incite monumental ideological change.

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REFERENCES Abadie, Roberto. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects.

Durham: Duke University Press, 2010. Print.

“Biopharmaceutical.” Science Daily News. Last modified December 5, 2014. http://www.sciencedaily.com/articles/b/biopharmace utical.htm.

Boellstorff, T., et al. Ethnography and Virtual Worlds.

Princeton: Princeton University Press, 2012. Print.

Ding, Min, et al. Innovation and Marketing in the Pharmaceutical Industry: Emerging Practices, Research, and Policies. New York: Springer, 2014.

“Global Pharma Sales to Reach $1.3 Trillion.”

Thomson Reuters. Last modified August 4, 2015. http://thomsonreuters.com/en/articles/2015/globalpharma-sales-reach-above-1-trillion.html.

Lindpaintner, Klaus. “Genetics in drug discovery and development: challenge and promise of individualizing treatment in common complex diseases.” British Medical Bulletin 55. 2 (1999): 47173. Electronic.

“Participant Observation.” Merriam-Webster.com.

2014. Electronic.

Petryna, Adriana. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects.

New Jersey: Princeton University Press, 2009. Print.

“What is Anthropology?” American Anthropological Association. 2016. http://www.americananthro.org

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GROUNDS FOR REFLECTION

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The Unknown Moira Smith Where did you come from that you would give to people you never met?

Were you a mother? Were you a brother? Were you a grandparent?

Were you a teacher? Were you an artist? Were you a caretaker?

When you were born, did your mother hold you and smile, shedding tears of joy over you?

Did you climb trees growing up? Or play in the mud? Did you love learning?

Were you an avid reader?

What did you consider your greatest achievement? Starting the business that was your dream? Becoming the first person in your family to go to college?

Raising your children?

How did you respond when you were told you needed a pacemaker? What did it feel like to recover from surgery?

Did you know about that aneurysm?

Did you fight a long battle with cancer?

Did you die peacefully in your sleep?

Were you a physician yourself, who had the same experience of learning from others who gave their bodies?

Did that make you want to give as well?

Whatever the differences among you, the commonality is that you were all willing to share your last gift, to give not only to a group of students that you would never meet, but to the generations that follow: the patients we will treat and the future students we will teach. Your generosity has created a ripple effect of learning and caring.

What were your simple pleasures in life? That morning cup of coffee? Hearing your granddaughter’s giggle? Completing the daily crossword puzzle? Walking in your garden?

Thank you for your gift to the next generation of physicians and to the patients we take care of. You will not be forgotten.

Did you have a booming laugh? Did your smile light up the room?

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Disability is Ability Overcoming Expectations Christina Sisti, DPS, MPH

First impressions determine how we are categorized and treated by society. As a woman with disabilities, my role in society was determined at birth because of my gender and birth defects. I believe, however, that human character and behavior are shaped by the person’s environment, and individual choice, not how society views the person or their DNA. I propose it is imperative for those who are able bodied and disabled to rethink how we view those with disabilities.

Growing up, I learned quickly that there would be those who shunned me, made fun of me, and those who were friendly towards me. It was during adolescence, the time when most girls were forming strong social relationships with each other and with boys, that I began to fully perceive my value to society and my prescribed roles within society. I didn’t date because boys did not want to try to explain to their peers why they were dating the disabled girl. It was isolating and made me doubt my own selfworth in society and amongst my peers. I was able to find an alternative route of acceptance through academic achievement. Instead of following the prescribed roles for girls and finding acceptance through social relationships I found acceptance by following the male role in society: education. Being shunned made me delve deeper into my studies where I excelled. By adapting to society’s expectations, I found financial freedom through higher education. I found the ability to access societal organizations, which may have been denied to me if not for positive reinforcement of my self-worth throughout my childhood by my family. I learned how to ask for and achieve more because no one expected it of me. I adapted and created my own expectations based upon my abilities, not my perceived limits. Barriers were merely obstacles to go around; I learned how to go against the norm because I had to if I wanted to succeed.

As a disabled woman I face unquestionable barriers in society because I do not fit the standard. Women with disabilities are less likely than non-disabled women or disabled men to fulfill roles customarily reserved for their respective genders because we don’t fit the norm. For me, this was liberating as I could define who I am and what I do because no one knew what to expect. Education and confidence were key elements to my being able to shatter the role I was assigned by society. However, it is society which ultimately helped me and many other disabled women find their own path. For disabled women to further their role in society we must break all expectations and create our own.

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| EFFIGY | | IDOL | ICON |

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Artist Statement Darian Goldinstahl

The central theme of these works concerns the anxious memory of being medically scanned in a hospital. I am most interested in the tension between reductive medical artifacts and the living, whole body they are meant to serve. I aim to mend this disconnect by portraying hospital gowns that have been embodied and personified by the uneasy recollections of their wearer. This arts-based research is a collaborative effort to rehumanize the patient experience with my sister, Dr. Devan Stahl, who is a Clinical Bioethicist at Michigan State University.

My printmaking process begins by photographing standard hospital gowns that are twisted, falling, or crumpled—a gesture that points to the worry one feels while wearing the garment. I then combine the gown imagery with photographs of domestic spaces, such as Venetian blinds, to reflect how the memories intrude on the patient’s daily life.

To print these collages, I developed a toner transfer technique that binds the photographic layers between coatings of wax. The resulting prints join the past and present by combining modern printmaking with the historical use of wax and anatomical illustration.

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Pictured: Title Page: Idol Below: Icon Opposite: Effigy Images2016. Š Darian Goldinstahl.

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The elements of this work read as a psychological snapshot of the patient’s anxious mind while she is being scanned, and how these memories weigh on everyday life.

The mechanical lines and hypersaturated colors emphasize the artifice of medical object, while the organic curves of the hospital gown recall the realities of the ill body in its noticeable absence. The aim of this work is to remind the viewer that our bodies are not made of pixels and glossy facades, but of real and complex matter that is not always beautiful, but is always wondrous.

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NOT ALL DEATHS ARE "GOOD" DEATHS

I once thought I was comfortable with death. My father died when I was three. He had brain cancer. He died at home thanks in large part to my mother, uncle, and hospice. My mother remarried; his name was Kevin, but I called him “Dad.” He died when I was 11. He had brain cancer.

He died at home thanks in large part to my mother, his mother (my grandmother), and hospice. Before the age of 12, I witnessed death not once but twice. I learned later that what I witnessed were “good” deaths.

Both of them died at home, a wish they made clear early on. My father and my dad died surrounded by their family, knowing they were not alone, knowing they were loved. Within my first week off orientation as a new graduate nurse, I learned not all deaths are “good” deaths. Not everyone dies as they wish, not everyone dies surrounded by loved ones, knowing they are not alone, knowing they are loved.

His name was James. He was 13.

James had a complex medical history due to his premature birth at 24weeks gestation. He had a tracheostomy and was ventilatordependent. James was developmentally delayed, nonverbal, and orientated neither to time, nor place, nor person. James lived in a long-term care facility his entire life.

He presented to the Children’s Hospital of Philadelphia (CHOP) in respiratory distress. He was admitted to the Pediatric Intensive Care Unit (PICU) on a Friday evening. I took care of him on Saturday and Sunday.

During that time, I observed James’ grimace and acknowledged his suffering as his organs failed and he approached the end of his life.

When I arrived on Saturday morning, I was told the plan was to “tweak his vent and send him back to his facility.” But, I soon realized the latter would never occur. At 0730, when I took his vital signs, I discovered James was hypotensive. The team decided to give him a bolus. His blood pressure did not normalize as we had wished; in fact, he became increasingly hypotensive. The team placed a central line and an arterial line; throughout each intervention, James suffered. Then, I placed a Foley catheter. When I inserted the Foley catheter I saw a flash of urine. I measured it, five millimeters. I informed the team of my findings, they were not concerned and explained he was “dry.” The team ordered more fluids and told me to

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monitor his blood pressure and urine output closely. I did. James’s blood pressure was not responding to the fluids and he continued to produce no urine, so the team added Dopamine and later Epinephrine. Before I knew it, James was on multiple vasoactive drugs and my shift was over.

I felt exhausted and accomplished.

Throughout the shift I participated in more procedures and started more medications than I did throughout my ten-week orientation. I had not only completed the tasks of the day but I also thought critically and advocated for my patient, who could not advocate for himself and did not have family at the bedside to speak on his behalf. Despite this sense of accomplishment, I also remember feeling frustrated because it seemed easier for the team to ignore patients without family at the bedside and, therefore, required me to advocate more forcefully than usual.

The following day, Sunday, my assignment had changed. I quickly found the charge nurse and asked, “Why?” She explained that James had deteriorated further overnight and would likely die within the next few hours, so she wanted to put a more seasoned nurse in that assignment.

“Plus,” she said, “it would be sad, so I am giving you a break.” “Thanks,” I retorted, “But no thanks.” I wanted my assignment back. I wanted to take care of James, even if that meant caring for him while, and when, he died.

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When the team rounded, the resident explained the overnight events; James was hypotensive, hypoxic, acidotic, and oliguric. The fellow declared it was time to call James’s family, present them with their options, and allow them to decide how to proceed. Of note, on Saturday, the team, myself included, had attempted to contact James’s family on numerous occasions, each time leaving a voicemail, and requesting a call back. I also called and spoke to a nurse at his longterm care facility, at which point I learned that James’s family neither visited nor called. Eventually, the fellow was able to reach James’s parents and encouraged them to come to the hospital to see their son.

When James’s parents arrived, I explained the purpose of each tube, line, and wire. I identified each monitor beep. I offered to answer any questions they had, but his parents had none. I informed the team that James’s parents had arrived. The team gathered and established a plan for the difficult discussion ahead. We entered the room, sat down, introduced ourselves, and had the shortest, quietest, and most subdued end of life discussion I would ever be a part of during my time in the PICU. James’s parents decided to withdraw care; and then, they left explaining they wanted to go home to watch the Eagles game and asked us to call them when “he was gone.”

It was as if James knew he had permission to die. Within minutes, his skin was mottled and weeping, he was not synching with the ventilator, his oxygen requirement was 100%, he no longer had a cough and gag reflex, and his extremities were cold and blue. The attending told me to “Get all of the Morphine we have in the Pyxis.”

The fellow, resident, respiratory therapist, and I stood at James’s bedside as the attending pushed Morphine. I held James’s hand, said a silent prayer, and seven minutes after disconnecting the ventilator from his tracheostomy, James died. The attending called James’s parents to inform them that their son had died. James’s parents said they did not want a funeral and asked that we “dispose of the body.”

Throughout the shift, the charge nurse came to check on James and me, mostly me, because she knew what I had learned, the truth, that not all deaths are “good.” When James died, the charge nurse helped me perform post-mortem care. We worked silently; cleaning his body, preserving his dignity, tying a patient identification notecard to his toe, zipping his body into a white bag, bringing him downstairs to the morgue, and lifting his lifeless body onto the cold, metal shelf. On our way back to the unit, we remained silent. Our silence was neither uncomfortable nor awkward.

Our silence was peaceful. Our silence was a sign of respect.

When we returned to the unit, the charge nurse gathered the team so we could debrief. We talked about what went well and what we would have done differently. Later the attending pulled me aside to say, “Thank you for your hard work.” I will never forget what she said next, “Today was upsetting, not only did a child die but he also died alone, without family at his bedside. But know that James died with dignity surrounded by providers who cared.” It was as if she read my mind.

It was as if she knew I was struggling with how alone James was when he died and how “bad” his death was compared to how I envisioned death.

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I learned many things while caring for James. I learned not all deaths are “good,” not everyone dies as they wish, not everyone dies surrounded by loved ones, knowing they are not alone, knowing they are loved. I also solidified my personal nursing philosophy: nurses are fortunate to be invited into people’s lives when they are most vulnerable and it is a privilege to serve and care from them, especially those who are dying.

By integrating my experiencing while caring for James into my worldview, I discovered that although not all deaths are “good;” nurses have the opportunity and the ability to make death as “good” as possible by easing the suffering of a human being, treating patients with respect throughout the dying process, and being present with patients as they die. If you, the nurse, are with your patient, then they have not died alone; instead they died in the attentive presence of someone who cared.

During my two years as a nurse in the PICU at CHOP, I cared for many children while and when they died. I remember each child. I remember each death. Each death was significant. However, my experience caring for James while and when he died transformed not only my nursing practice, but also impacted my personal comfort with death and dying.

The events described above occurred when I was 22. Now, at 25, when I reflect on my time in the PICU, I cannot stop thinking about the suffering endured by my patients and their families. I cannot stop asking myself what “we” could have done (or not done) to prevent (or ease and even end) their suffering.

FALL 2016

This is my version of a common healthcare analogy: Disease is the enemy. Illness is the battle. If you win, you live. If you lose, you die. Either way you suffer, because it is, after all, a war. Why do we glorify suffering?

Why is suffering synonymous with bravery and courage?

I think this analogy is best illustrated in obituaries. I like to read obituaries because they are a celebration of an individual’s life written by their loved ones. Most obituaries highlight an individual’s successes at home, work, and beyond. Yet, many obituaries also include an individual’s final defeat: death. For instance, “Mr. Jones fought bravely but lost his battle to cancer at 70 years of age.” Why do we highlight an individual’s final loss, death, in a celebration of their life? Furthermore, why do we view death as a failure, a lost battle? Death is inevitable.

In my opinion, the notion that a patient’s death is synonymous with failure is routed in medicine’s fixated focus on cure. As a result of this belief, patients, whether they live or die, suffer not only due to disease but also due to the interventions employed to “cure” their illness. Nursing offers an alternative to the disease focused medical model.

At 17, when I proclaimed, “I want to be a nurse,” most people retorted, “Why? You are so smart. You could be a doctor.” At the time, my response was naïve and simple, “I want to help people.” Now, at 25, when confronted with the same question, my response is more informed, but still simple, “I want to help people. Medicine is cure focused.

Nursing is care focused. I want to care for people. Not just cure their disease.”

Palliative care is the essence of nursing. It is caring for a person with an illness. Its focus is the person,

not their illness. Palliative care is managing a person’s symptoms and easing their suffering as they experience an illness, undergo treatment, and in some cases, die as a result of disease.

In children, disease and death is particularly upsetting because children are not supposed to die.

Parents are not supposed to bury their children. Unfortunately, in an attempt to prevent the unthinkable, death, children often experience endless amounts of pain and suffering. Yet despite suffering, many still die. I believe children should not have to suffer as they die. I believe while they are sick, and in the months, weeks, days, hours, and minutes leading up to their deaths, children deserve the highest quality of life possible. The symptoms of their illness and side effects of their treatments should not keep them from playing. I believe every child deserves a “good” death.

FALL 2016

GROUNDS | 67

A DEAR SCHIZOPHRENIC PATIENT Melina Rapazzini

Behold a mind, beauteous once, now lost cruel World you claimed, a love, a laugh, a life Giver of life, wanton One why, steal naught brothers, sisters, fathers, lovers of mine

No longer daisies danced, sweet singing stopped Monsters, demons, voices consumed her mind “What then is known? What then is real? This thought has overtaken me and made me blind.”

She was the Sun, darkness was none, a light Aura of gold, sweet kind and bold, a child with daisies danced, fairy fields of romance her heart belong’d, days drifted in song

The Serpent said to her, “swiftly strike”, slay the son of Satan who stole your life” Sweet Sun succumbed, thief’s soul sent to Sheol two sacred lives were lost. Fie God. Fie World.

Upon her darkness fell, a man of hell harrowed, haunted, held hostage by his hand escape was sought, friend family helped her naught Disaster struck. Her mind could not withstand

Behold a girl, the rays no longer shine Prison alone, body wilts with her mind Giver of life, wanton One, why? Steal naught your daughter whom your Son so bravely fought

68 | GROUNDS

FALL 2016

QUITE S ME TIME Abram Brummett

We puzzled and pined and thought we knew That to fix our problems we need divide the world in two But if then two, then why not three?

This could go on for quite some time, you see If a world needs another to solve all the problems Of ethics and purpose and origin and knowledge Then the source world must be a troubled, cold, and lonely place An inevitable sadness, despite not existing in space Btu waht fi ew fnoud our qusetonis colud be resolevd By raelzinig we wree not bulit, but evolved Thruogh blindenss and trial and toil and might We began to say “ought,” “injustice,” and “right” And we called things "good" not because they were true But because they were loved, and love got us through Yet it wasn't all kindness, there's plenty to dread There's a heaven and hell in us all, it's been said

AUTHOR'S SUMMARY In bioethics we spend time wondering about the basis of our moral claims, where morality comes from, and how we are to justify our decisions. This poem is about attempts to justify morality by appealing to an otherworldly source, by dividing our world in two. It examines the shortcomings of such an approach, and instead appeals to evolutionary biology for answers — if our bodies evolved, then why not our brains and, by extension, our morality as well?

The first two stanzas point out that if we need to appeal to another world to solve our philosophical problems, then one of two things happens. Either we end in an infinite regression, “This could go on for quite some time, you see” or the ultimate source world is left with all the philosophical problems unresolved. This is because—being the ultimate source world—it has no further world to appeal to for resolution of these problems. It would be “An inevitable sadness, despite not existing in space.”

In the third and fourth stanzas I suggest that perhaps morality evolved and that the ultimate “basis” of our moral claims is their utility, not their truth. For example, our capacity to love one another is not the result of humans using reason to discover a “moral truth” about love. Rather, we love one another for the same kind of reasons that we have two legs — because such features have allowed our species to survive and reproduce in varied environments.

However, I do not wish to paint an overly-rosy picture of human behavior. As we know, humans are plenty capable of evil as they are good, and I must say that many of our “evil” traits have also evolved.

Hence, “there’s a heaven and hell in us all”, but maybe that’s just the way it is.

FALL 2016

GROUNDS | 69

H O P E

If Anyone is Selling, I'm Buying

TOM PALMER

I have ALS and have been on death row, so to speak, since my diagnosis almost a year ago. Popular perception holds that the skyhigh mortality rate of this disease does not offer me an even faintly realistic hope of survival. Well, if that's true, then I'll take an unrealistic hope for survival. Hope, no matter how frail or fleeting, is essential to the quality of life of someone who has been sentenced to near certain death by a terminal illness. My best and most hopeful days are those when I feel even just a little better than the day before, when it seems possible, against all reason, that my

inexorable march to the grave might yet halt a few paces shy. My worst days are the hopeless ones when something I could do, with effort, the week before, I can no longer do at all and the creeping fatality of my disease feels inescapable. My hope and therefore, to a certain extent, the quality of my day-to-day life rests on a knife's edge of slim chance that I can beat the odds of this disease and live. Those cold, hard odds may be very long against remission and recovery or even surviving for more than a matter of months but without any hope for living, what choice does anyone have but to die?

70 | GROUNDS

I have fought in earnest to hang onto any semblance of hope since my initial self-diagnosis on the Internet, the summer before last. When I noticed twitching in my muscles, like little worms wriggling under my skin, and it didn't stop the next day or the next week, the first word an Internet search taught me was 'fasciculations'.

But fasciculations as my only symptom left Dr. Google plenty of latitude to suggest benign and relatively benign diagnoses; no wishful thinking was required to ignore the pretty terrifying, though very uncommon possibilities it also suggested. Comforted by the odds against it being anything rare, I went back to my normal life, for a few more weeks anyway until some consonant combinations started to be difficult to articulate.

Then, dysarthria was the next word I learned from the Internet. When I entered fasciculations plus dysarthria as my search, then nearly all the online road signs pointed in the same direction.

But the long shot odds of an ALS diagnosis, only two or three people out of 100,000, made my denial strong enough to carry the weight of a lot of my fear and doubt. No question about it, though, it was time for a second opinion. So, with some hope still intact, I nervously ventured forth out of the morass of information, misinformation, rumor, superstition and conjecture that is the World Wide Web where anything, even surviving ALS, is possible and stepped into the frigid, rigid arms of main stream medicine, where all hope for ALS patients dies eventually.

From PCP to specialist after specialist and test after test I ran the medical gauntlet for almost a year with no diagnosis and my hope for healing still afloat though taking on water as my symptoms progressed. Finally, in late spring, my second EMG test confirmed ALS. My death sentence, with no chance of parole, was pronounced. All hope sank and I joined the somber fraternity of the terminally ill waiting to die. Next stop, palliative care.

FALL 2016

Like the flip of a switch, I went from the hopeful 'none of our tests tell us what you have' to the hopeless 'how can we make your slow motion death more comfortable' with no stops in between to reconcile with my fate. Of course I have no bone to pick with the medical professionals who did their job and, through the process of elimination, ruled out every other curable or treatable explanation for my symptoms. My beef is that ALS seems to have somehow become, at least to many people, including many in the medical community, a disease that is dealt with as if it is 100% fatal and quickly fatal at that.

This is my first terminal illness so forgive me if I sound unreasonable when I request that someone, anyone with some credibility in the mainstream medical management of ALS mention at least now and again that, for some people, even if for just a few, there is life on the other side of this diagnosis. As it is, all I can see now of my future, without forcing myself to be hopelessly optimistic is what has been painted for my mind's eye by those both inside and outside the medical profession - the image of me relentlessly wasting and inevitably dying from this disease, likely sooner rather than later. I'm not advocating that anyone who knows better try to sell me false hope but, as far as I know, every disease has at least a few survivors. Can someone please, just occasionally, tell me a bedtime story about one of those ALS patients who cheated death so every once in a while I can drift off to sleep and dream a dream of living even while I'm busy dying.

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