Volume IV Issue i

Penn Bioethics Journal The nation’s only peer-reviewed undergraduate bioethics journal

Volume IV, issue i

Penn Bioethics Journal Fall 2007 Executive Editor and Publisher Bo Peng Associate Editors Shirley Ahn Palak Kundu Daniel Albornoz Ingrid Lindquist Anand Bhagwat Jared Mendelsohn Claire Chang Nadia Mikhail Emily Knudsen-Strong Rajini Murthy Menghan Fu Ali Nill Bianca Gonzalez Sasha Riser-Kositsky Armin Gollogly Liz Rubin Rohan Grover Daniel Santos Benjamin Himes Lakshmi Sivarajan Stephanie Joco Lauren Talman Lulu Liu Lee Vandivier Associate Pulishers Claire Chang Shirley Ahn Jules Shen Markley Foreman Lauren Talman Business Manager Jules Shen Cover Design Chava Cogan Webmaster Anand Bhagwat Managing Editors Markley Foreman Rachel Han Jules Shen Justin Masterman Katryn Bowe Kavita Vinekar Faculty Advisors Connie Ulrich, RN, PhD Paul R. Wolpe, PhD

External Advisory Board Connie Ulrich, RN, PhD Paul R. Wolpe, PhD Arthur Caplan, MD, PhD Jonathan Moreno, PhD Andrew Rosenthal

Outstanding Contribution to Undergraduate Bioethics Award The Penn Bioethics Journal is pleased to announce the writing award for outstanding submissions. The Outstanding Contribution to Undergraduate Bioethics award, administered in conjunction with the Center For Undergraduate Research and Fellowships (CURF) at Penn, has been established to recognize outstanding undergraduate writing in bioethics. All undergraduates with articles published in Penn Bioethics Journal are considered for the prize. An outstanding articles in the journal will be recognized with a first place prize. The recognition will be awarded in conjunction with the publication of each issue. See Table of Contents for the winners.

All submissions--those that meet either the early or regular deadlines--will be considered in the selection. Executive members of the PBJ editorial board and the PBJ faculty advisors, in partnership with CURF, will select the winners.

A deep understanding of the issues, insightful exploration and writing style are just some of the qualities by which prospective articles will be judged. Submissions are considered without regard to home institution.

Letter From the Editor January 2008 To all new and old readers: I proudly present to you the fifth publication (Volume IV, issue i) of the Penn Bioethics Journal. With the close of another year, the development of new and innovative technologies in the frontiers of science continues to remind us of the dominant presence of growing ethical issues in contemporary society. From Michael Moore’s revisit to the American health care dilemma in Sicko to more recent breakthroughs in stem cell research, we find ourselves inundated with growing questions on the implications of a not-too-distant futuristic society. The current issue brings to light several pressing global dilemmas, highlighting the complexity and forward-thinking nature of undergraduates today. In accordance with the dynamic frontline of scientific inquiry, we received the article on clinical trials and the HIV vaccine amidst the developments of the Merck HIV vaccine trials. Thanks to our hardworking board, you can find a supplement after the article giving a brief update on a new and still developing breakthrough event.

I am very pleased to present our exclusive interview with Renée Fox, PhD, recipient of the 2007 Lifetime Achievement Award from the American Society for Bioethics and Humanities, and Annenberg Professor Emerita of the Social Sciences at the University of Pennsylvania. Various scholars point to her as one of the forefront medical sociologists of the field, making her interview a rare look into one of the top members of the Bioethics field. She has graciously given us a glimpse of her professional life and personal perspectives on the current state of the growing Bioethics field. I hope you find her words both inspiring and enlightening.

Many thanks again to the Center for Undergraduate Research and Fellowships (CURF) at the University of Pennsylvania for their continual support of our Award for Excellence in Undergraduate Bioethics and our dedicated

external advisory board for their aid in giving professional perspective on our undergraduate submissions. The award winner for this issue is Melinda Yang of Swarthmore College on the Effects of Society on the Development and Categorization of Mental Health. We sincerely congratulate her for her work and encourage those reading our journal to submit for this award.

Finally, I’d like to thank all of the members of the PBJ board for making this issue possible. We have greatly expanded our editorial board and our possibilities are endless. We have clocked countless hours debating, reviewing, editing and evaluating the submissions for this issue. This journal reflects the dedication and diligence of each editor in the spirit of undergraduate research. Also, I’d like to congratulate and thank all the submitters for their support of our journal, we could not do it without the ever-increasing number of submissions we receive for each issue. I would also like to point out our new additions to the external advisory board, Dr. Jonathan Moreno and Andrew Rosenthal. Last, but certainly not least, I would like thank our graduating seniors especially Justin, Jules, Rachel, Katryn, and Chava, the last of our founders. Your hard work laid the foundation for our journal and I have gained so much from your help. With your exit we rush in a new era of young scholars bustling with energy and excitement.

I hope you have enjoyed the ride.

Please enjoy your bite of PBJ. Sincerely, Bo Peng Executive Editor and Publisher University of Pennsylvania C’09

inside this issue...

Exclusive PBJ Interview

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with RenĂŠe Fox, PhD, 2007 Annenberg Professor Emerita of the Social Sciences, University of Pennsylvania

Winning Article

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First Award: The Effects of Society on the Development and Categorization of Mental Illness

MELINDA YANG, Swarthmore College

Feature Articles

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The Moral Permissibility of Abortion

13

Gradualism and the Fetus

15 19 23

GINA BABINEC, Dalhousie University

PHIL GALLIGAN, Stanford University

The Need for Patient Preference Research: A Case Study in the Rationing of Limited Resources for Treating HIV/AIDS Patients

MICHELLE PARILO, Harvard University with Ames Dhai and Mark Brady

The Search for an HIV Vaccine: Ethical Issues of Phase III Clinical Trials

JESSICA HO, University of Pennsylvania

Recent Development Focus: Failure of the Merck HIV Vaccine

KAVITA VINEKAR, University of Pennsylvania

Penn Bioethics Journal Vol. IV, Issue i

Interview with Renée C. Fox, PhD:

2007 Lifetime Achievement Award, American Society for Bioethics and Humanities; Annenberg Professor Emerita of the Social Sciences, University of Pennsylvania Interviewers: Rachel-Xiaolu Han, Markley Foreman, Armin Gollogly, Lakshmi Sivarajan, Lauren Talman Biography

Renée C. Fox, PhD is a summa cum laude graduate of Smith College and earned her Ph.D. in Sociology from Harvard University. Before joining the faculty of the University of Pennsylvania in 1969, she was a member of the Columbia University Bureau of Applied Social Research, taught at Barnard College, and was a Visiting Lecturer in the Department of Social Relations at Harvard. At Penn, she was a professor in the Department of Sociology with secondary appointments in the Departments of Psychiatry and Medicine, the School of Nursing and an interdisciplinary chair as the Annenberg Professor of the Social Sciences. From 1972 to 1978 Fox was the Chair of the Penn Sociology Department, as one of the first women in university history to chair any academic department. In 1998, she became the Annenberg Professor Emerita of the Social Sciences.

She is also an Emerita Senior Fellow of Penn’s Center for Bioethics.

She has lectured in schools throughout the United States and has taught in a number of universities abroad.

Fox is the author of seven books and numerous articles.

Her best-known books are Experiment Perilous: Physicians and Patients Facing the Unknown; The Courage to Fail: A Social View of Organ Transplants and Dialysis, and Spare Parts: Organ Replacement in American Society (both of which were written with medical historian Judith Swazey); and In the Belgian Château: The Spirit and Culture of a European Society in an Age of Change. She has recently finished writing another book coauthored with Judith Swazey, Observing Bioethics, which is to be published by the University of Oxford Press in spring 2008. Fox is also in the process of completing a first-hand study of practical and ethical dilemmas associated with medical humanitarian action that she has been conducting inside of Médecins Sans Frontières (Doctors without Borders) for almost a decade.

Fox is a member of the American Academy of Arts and Sciences, and of the Institute of Medicine of the National Academy of Sciences, a Fellow of the American Association for the Advancement of Science, and an Honorary Member of Alpha Omega Alpha Honor Medical Society. She is the holder of a Radcliffe Graduate School Medal, a Centennial Medal from the Graduate School of Arts and Sciences of Harvard University, and a recipient of the American Sociological Association’s Leo G. Reeder Award for Distinguished Contributions to Medical Sociology. She has received several teaching awards and holds nine honorary degrees. In 1995, she was named Chevalier of the Order of Leopold II by the Belgian Government. Most recently, Fox received the 2007 Lifetime Achievement Award from the American Society for Bioethics and Humanities.

Penn Bioethics Journal Vol. IV, Issue i Fall 2007

Dr. Fox, you are a sociologist and a pioneer in medical sociology. What are some of the factors that led to your decision to become a sociologist, and to center a significant part of your work on health, illness, and medicine?

When I began my undergraduate education (at Smith College) as a freshman, I was interested in literature, writing, teaching, and in the possibility of becoming a social worker.

There is a sense in which I have been able to combine elements of all these interests in the sort of career that I have had as a sociologist.

Late in the summer of 1945, just before my sophomore year, I fell ill with a life-threatening, severe form of poliomyelitis that paralyzed most of my body. Through great good fortune, excellent care, and prolonged, rehabilitative physical therapy, I recovered sufficiently to resume my studies. But by this time, my original interest in social phenomena and issues had become more intellectualized and cerebral. I think this was partly attributable to the fact that my conception of social work had been rather physical and muscular – influenced by the summer that I had spent as a volunteer at Henry Street Settlement House in New York City, where I had been the recreational director of a group of energetic young girls, and by the home visits that Henry Street’s famed visiting nurses made to patients and families in need of care. I became a sociology major in the college’s honors program, while continuing throughout all my undergraduate years to take courses in the English department. Somewhere en route, I made a quietly serene decision to go to graduate school and study for a PhD in sociology, with the intent of having an academic career as a member of a college or university faculty, from which base I would teach, do research, write, and publish.

I was admitted to the Department of Social Relations at Harvard University in 1949, where I received my doctorate in sociology in 1954. As its name implies, Social Relations was an experimental, interdisciplinary department in which sociology was conjoined with anthropology and psychology. All of the graduate students were required to take the same, basic courses in each of these fields, after which we branched out to do advanced work in the particular social science that we had elected to study for our graduate degree. Talcott Parsons, a premier sociologist

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and the founding chairman of the department, became my most important teacher and mentor. He was an intellectual of great stature and scope, and one of the foremost social theorists of the 20th century. Although the sub-field of the sociology of medicine did not yet exist at that time, he was very interested in conceptually exploring what insights thinking sociologically about health, illness, and medicine, and the doctor-patient relationship might yield. During my years as a graduate student, in a book that he authored, titled The Social System, he wrote a seminal chapter on “the case of modern medical practice,” which was foundational in making medicine amenable to sociological analysis. In this chapter, he formulated the notion of the “sick role” – the idea that being ill was not just a biological or a psychological condition, but that it was also a social state in which the sick person was cast in a role that had its distinctive obligations and exemptions. He examined the professional attributes of the physician’s role. And he wrote perceptively about the human condition aspects of medicine – its relationship to birth, pain, suffering, accident, aging, and death – and about the uncertainty that is intrinsic to the physician’s work of preventing, diagnosing, treating, and ameliorating illness, no matter how advanced medical science and technology may be. Parsons played a cardinal role in launching me down the path that led to my first ventures in the nascent area of medical sociology. It is possible that my personal experience as a polio patient heightened this sociological interest that he had awakened in me.

Parsons was the conduit and the catalyst for the dissertation research that I undertook. He introduced me into the milieu of the Harvard Medical School affiliated Peter Bent Brigham Hospital (now the Brigham and Women’s Hospital) where, over the course of 1951 to 1954, in the context of a long-term, hospital-wide investigation of the biochemical, psychological, and social concomitants and effects of stress, I made a study of Ward F-Second.

On this male metabolic ward, through firsthand research conducted in the role of a participant observer, I studied the tragi-comic community created by the patients on this ward who were gravely ill with conditions that lay outside the mastery of modern medicine, and who had consented to be research subjects for clinical investigations, and by the physicians who cared for, and about them, conducted research on them, but could not make them better. The dissertation became my first book, Experiment Perilous. Its title was inspired by the famous Hippocratic aphorism: Life is short And the art long The occasion instant Experiment perilous Decision difficult My experience on Ward F-Second and the dissertation and book that grew out of it could be said to have

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constituted the rite of passage experiences that definitively launched me on my career as a sociologist of medicine.

The book dealt with themes and topics with which I have been consistently concerned over the years – among them, the ethical and existential significance of health, illness, and medicine; the process of advancing medical scientific knowledge, and the moral dilemmas it involves; medical research (particularly patient-oriented clinical research); and therapeutic innovation. Interestingly, it came to be regarded by some as a precursor to bioethics – a work that depicted the lived reality of crucial bioethical decisions. It also led to my first, post-doctoral job: my engagement in a major study of the education, training, and socialization of medical students, conducted under the aegis of the Columbia University Bureau of Social Research, and directed by the renowned sociologist, Robert K. Merton.

On the subject of medical education, many graduate programs in bioethics have developed in the United States. How do you feel about this, and how and where do you think bioethics should be taught?

Since 1910 when Abraham Flexner issued his famous report with its recommendations for radical changes in U.S. medical education, recurrent waves of curriculum reform have taken place in American medical schools and their curriculums. One of the objectives of virtually all of these periodic reforms has been to improve the training that physicians-in-becoming receive in the social, cultural, and psychological aspects of health, illness, and medical care. In my view, one of the factors that has contributed to the introduction of courses in bioethics into medical education has grown out of the misguided notion that it is a way of furthering training and competence in these so-called “non-biological” aspects of medical care. I say it is misguided because of the conceptual framework within which American bioethics is cast. Paramount among the principles around which U.S. bioethics is structured is the precept of “autonomy.” This is a concept that fits the importance attached to individualism and individual rights in the American value system, and that is consistent with the place of privilege that they are accorded in AngloAmerican analytic philosophy from which the conceptual framework of bioethics is largely derived. In my view, this makes bioethics a weak medium for teaching the social and cultural aspects of medicine. I consider this to be all the more problematic when it comes to taking cross-cultural differences and public health issues into account. This is because in the majority of societies and cultures in the world (and also in certain sub-cultures of our own society), what is emphasized are the interconnections between persons – their contextual and relational nature – rather than an autonomously individualistic perspective. And by definition, matters of public health involve the welfare of

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Penn Bioethics Journal Vol IV, Issue i Fall 2007

Exclusive Interview with Renée C. Fox, PhD

whole communities, sometimes in ways that may necessitate putting these collective considerations before the well-being of particular individuals.

Whether bioethics is taught as part of medical training or in separate Master’s degree programs, another reason why I feel uneasy about it concerns the ambiguous intellectual nature of the field of bioethics. What exactly is bioethics?

It consists of the convergence of a number of different disciplines – philosophy, theology and religious studies, medicine, law, and to a lesser extent, the social sciences – around a number of presumably ethical issues associated with health, illness, medicine, and especially with medical scientific and technological advances. What exactly should the academic content of this pluridisciplinary field – which has achieved no more than tenuous interdisciplinarity – be?

What constitutes competence within it? And competence to do what? The answers to these questions are not clear to me.

As to the question of where and how bioethics should be taught, in the context of the medical school curriculum, at any rate, I think that the most appropriate place would be during medical students’ clinical years when they are in direct contact with ethical issues that arise in situ with regard to patients, their families, and members of the medical and nursing staff. And it should include attention to experiences that medical students are having that they feel are ethically troubling. Incidentally, I think that the clinical years are also the best time for trying to teach medical students about the social and cultural aspects of illness and care.

You mentioned briefly how public health does not have a central role in bioethical discourse. Why is it not a pressing issue compared to technological advances such as stem cell research or organ transplantation?

Bioethics has grown up around certain biomedical advances – among them organ transplantation and stem cell research. . The name “bioethics” suggests that an underlying assumption of the field is that particular biomedical developments have created ethical problem in a direct, cause-effect way. I think this is an oversimplification of a much more complex sociological phenomenon. My hypothesis is that such biomedical and medical technological advances have augmented and accentuated the degree to which questions like, “What is life, and when does it begin?”, “What is death, and when does life end?”, “What is a human person?”, “How vigorously should we intervene in the human condition?”, and the like, were already being asked in American society where bioethics had its inception towards the end of the 1960s. Bioethics has given us a lingua franca, a medical language, in which to talk about, and ponder these questions in the public domain.

From its inception, U.S. bioethics has been more than just a new, academic field. The issues around which it turns Penn Bioethics Journal Vol IV, issue i Fall 2007

have been continually in the media, in the public square, and in the courts and legislatures and the executive branch of our government, from regional levels, all the way up to the Supreme Court, the Congress, and the Office of the President. For me, this suggests that a quintessence of bioethics is the shared, public concern we are experiencing in our society over “collective conscience” issues that are integral to our values and our beliefs. Bioethics has given us a “medicalized” form, centered on certain biomedical advances, to publicly contemplate and debate such value and belief laden issues.

One of the side-effects of bioethics’ preoccupation with “high-tech” biomedical advances is that it has reinforced a pre-existing tendency in American medicine to attach greater importance and prestige to the delivery of medical care to individuals than to public health. This means that we have not grappled as vigorously as a society, as I think we ideally should, with issues that involve the dilemmas of the “good of the collectivity” vs. the “good of the individual,” the allocation of scarce medically-relevant resources, and with questions of social justice and of social solidarity.

If public health were to hold a more commanding position in bioethical discussions, how much local knowledge of the setting in which one works do you think would be necessary to design and implement effective health programs?

A great deal. It would be of paramount importance.

However, I consider what you term “local knowledge” not only to be crucial to public health programs, but to all health- and medical-relevant activities.

What would be a setting where you would need cultural knowledge? Is it sometimes necessary?

In my opinion, social and cultural knowledge and understanding, and competence in applying them are always necessary in planning, designing, organizing, and implementing the best, most humane, most appropriate, and most effective medical care and public health measures.

I don’t think this is a bias on my part that is attributable purely, or even mainly to the fact that I am a social scientist.

Bioethical issues often seem to be sensationalized in the media. Do you think that the sensationalized portrayal of these issues has an adverse effect on how the public views them, or is the media integral in maintaining public awareness of these issues?

A better question to ask might be why are these issues featured so prominently and so continually in the media?

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The media pays as much attention to them as it does partly because it is responding to the public interest in them that already exists. Newspaper, magazine, radio, and TV coverage may enhance and even “hype” the interest in bioethical questions, but their “mediatization” is not the root cause of this interest. Nor does it account for the fact that the acrimoniously passionate “culture wars” taking place on the larger American scene between “liberals” and “conservatives” have penetrated the debates being waged around bioethical questions and made them more susceptible to being treated in a flamboyant fashion, and being sensationalize by the media. Why this is happening returns us to a question that we have already discussed: the reasons for which concern about matters deemed bioethical is not only present in academia and in medicine in American society, but also in the public square.

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Penn Bioethics Journal Vol IV, Issue i Fall 2007

Outstanding Contribution to Undergraduate Bioethics: First Prize

Penn Bioethics Journal Vol. IV, Issue i

The Effects of Society on the Development and Categorization of Mental Illness Author: Melinda Yang, Swarthmore College Faculty Sponsor: Virginia O’Connell, PhD Abstract Mental illnesses affect a significant portion of the population, from children with attention deficit hyperactivity disorder to adults suffering from depression. There are mental illnesses with definite biochemical origins, but they will not be discussed in the following paper. The process of labeling a mental state an illness is unclear, however, which leads to problems in diagnosis and treatment. The standard used for comparison is a vague concept of normality, which often depends on the values of society. The Diagnostic and Statistical Manual of Mental Disorders is the accepted standard, but even this is revised every few years. Even in use, doctors often cannot concretely diagnose a patient. Society greatly influences the categorization of mental illnesses in this manual, and while this may provide some function for the wider society, it can often be detrimental to the individual’s autonomy. The degree of influence society has on the diagnosis and treatment of various mental illnesses will not be discussed here. We must understand how mental illnesses are categorized and diagnosed in order to address the potential harm to the individual’s health and autonomy and to find a compromise in cross cultural conflicts. The influence of society on perceptions of mental illness is a significant aspect that we, as a society, as the medical community, and as individuals, must be more aware of to better treat mentally ill patients.

Introduction Physicians from as early as the fourth century have diagnosed several mental illnesses, including melancholia (now called clinical depression) and hysteria (Foucault, 1965). The medical community continues to add new disorders to the list of mental illnesses, among them Attention Deficit Hyperactive Disorder (Conrad, 2004).

The rise in mental illnesses continues today; medical researchers continuously publish studies on new mental illnesses, as exemplified by an article that described a study that claims road rage is actually a result of a mental disorder called “intermittent explosive disorder” (Associated Press, 2005). According to statistics from the National Institute Melinda Yang is a Sophomore at Swarthmore College and is majoring in Biological Anthropology with a minor in History.

Email: myang2@swarthmore.edu Dr. Virginia O’Connell is the faculty sponsor for this submission. She is a Visiting Assistant Professor of Sociology at Swarthmore College Address: 500 College Ave, Swarthmore, PA 19081 Email: voconne1@swarthmore.edu Penn Bioethics Journal Vol. IV, Issue i Fall 2007

of Mental Health (NIMH), 26.2% of Americans eighteen or older are diagnosed each year with mental illnesses, which translates to approximately 57.7 million Americans. Mental illness is the leading cause of disability in the United States for people between the ages of 15 and 44 (NIMH, 2006).

These statistics make this author wonder how the medical community decides what should be labeled a mental disorder and whether past claims of mental illness are valid.

In particular, this author is concerned about the effect of society on the conceptualization of a mental illness.

Individuals are constantly influenced by society’s demands and values. Advertisements, the media, and interactions with other members of our communities pressure and teach us to behave a certain way; parents and other mentors instill in us a set of common morals. Yet, while we are immersed in American society, the medical community and the general populace value the concept of autonomy greatly. How can this conflict between influences of society and value for a person’s individuality be reconciled, especially when the concept of mental illness lies in question?

The effect of society on the definition of mental illness affects all four of the bioethical principles: autonomy, beneficence, nonmaleficence, and justice. Societal influences can affect decisions made by individuals, undermining the principal of autonomy, which says that individuals make the decisions about what treatments to use.

When societal and individual values conflict, the principles of beneficence (doing good) and nonmaleficence (not doing harm) also conflict. Different societal values and cross-cultural differences and tensions make it uncertain whether doctors will observe the principle of justice, or equality in treatment.

There are three main points to address concerning the influence of society on categorizing mental illness: 1.

2.

3.

What is the extent of the influence of society on the labeling of mental illnesses?

What do the effects of society’s role imply, both for the individual and society?

Should the medical community and American public address the influence of society in diagnosing mental illnesses?

In answering these questions, we can hopefully achieve a greater understanding of the relationship between society and the individual.

Extent of Society’s Influence To examine how extensively society influences the

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categorizing of mental illnesses, it is necessary to first understand what mental illness is. The problem with defining mental illness lies in the lack of definite criteria for examining and labeling mental illnesses.

Definitions for Mental Illness All definitions of mental illness share a common element: a reference to an unclear standard. One definition begins with the concept of disease. Disease is “synonymous with ‘unhealthy condition’” (Boorse, 1981, p. 78), so to define a disease, we must define what a healthy condition entails. However, there is no clear definition of health.

Physical health is easier to describe than mental health because every body part has a specific function—as long as the body part performs its function, it is considered healthy.

Mental health is harder to describe because there is no standard function to use in comparison. Instead, we use the relative concept of normality as a standard (Boorse, 1981). Normality can be defined as what most people are like, or as what most people ought to be like. Sometimes, the two definitions coincide, but usually they do not. For instance, 9.5% of the American population in any given year suffers from a form of depression, which is approximately 20.9 million people (“Depression,” 2006). This rate seems to indicate that depression is a normal mood for at least a portion of people to have at any given time, but it is considered a mental illness because society does not accept that as a normal mood. Societal values reflect the social pressure for people to be productive and rational human beings; depression inhibits productivity and affects emotion.

Jahoda considers the second definition of normality to be synonymous with mental healthiness (1985), but that leads to the question of who decides what people ought to be like.

Another method of distinguishing between mental health and illness looks at the effects of that condition on the individual’s well being. One pediatrician wrote: “The boundary between mental health and illness is about function. If a person is able to go to school, work productively at a job, and have healthy relationships, then they are generally mentally healthy. If, however, their symptoms cause them suffering, disability, or interfere with day to day functioning, then I would classify them as ‘mentally ill’—at least temporarily.”

(Pediatrician1 , personal interview, Nov. 25, 2006) Here, mental illness is a mental condition that interferes with living a normal life. None of these definitions define a standard conclusively, though, so we have to look elsewhere for this standard.

1

A female pediatrician whom I interviewed by email.

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Developing a Standard The American Psychiatric Association (APA) categorizes mental illness by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV).

The manual covers all mental health disorders for adults and children and describes five approaches to diagnosing a person as mentally ill. Doctors use this manual as the standard for comparison to decide whether a person is mentally ill (“Psychiatric Disorders,” 2004). However, several criticisms of the manual exist. For most, the problems lie in the fact that there are no conclusive tests available; instead, the manual functions by providing lists of symptoms. When a patient exhibits a certain fraction of the list of symptoms for each mental illness, the doctor can claim that that form of mental illness afflicts the patient (Carey, 2006). Also, many mental health professionals use the manual loosely, knowing that many patients do not fit well into a category (Spiegel, 2005).

The criterion in the manual concerns many in the medical field too. Robert Spitzer led the creation of the third edition of DSM, and there is very little information on the process he and his staff used to write the manual.

In fact, it seemed that many of his final decisions about what to include were made with minimal consultation with his staff (Spiegel, 2005). When Spiegel asked Spitzer what he based his decisions on, Spitzer replied, “How logical it was…whether it fit in. The main thing was that it had to make sense. It had to be logical” (qtd. in Spiegel, 2005).

He made many of his decisions based on logical thinking and rationality—two hallmarks of modern western society, which is based upon an appreciation of reason (Foucault, 1965). Spitzer seems to follow societal values when he categorizes mental illnesses based on how logical they seem.

Boorse describes how society’s view of what is good and bad influences the public’s view on what is healthy and diseased. He uses the example of homosexuality, which was considered a disease because society disapproved of homosexuality and considered it sinful (1981). Carey mentions how, in 1973, the APA removed homosexuality from the list of mental disorders, and as a result, approximately four to five million people became “well” (2005). If depression, ADHD, or other controversial diseases were to be removed from this list, the number of people with mental disorders would decrease dramatically, as it did after homosexuality was removed.

Does Autonomy Hold?

As Spitzer was revising the DSM, the American public was embracing the concept of autonomy. Medical issues were once a private matter between doctors and patients. Usually, the doctor was accepted as the expert (Wolpe, 1998), but in America in the 1960s, the concept of autonomy arose; autonomy means that the patient makes

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The Effects of Society on the Development and Categorization of Mental Illness

the decisions concerning his or her medical health. Doctors can inform a patient of their opinion, but the final decision lies with the individual.

As Taylor writes, however, the, “crucial feature of human life is its fundamentally dialogical character” (1994).

We cannot define ourselves without using products of society such as concepts, language, and values. In addition, when we ask ourselves, “who am I?” we draw our answers from, “categories of role system, such as name, age, sex, occupation, memberships, religious affiliation, marital status, and political party affiliation.” (Sarbin, 1969) These categories imply relationships and are constructs of society.

We express individuality only through functioning with other members of the community and developing concepts of our society to define ourselves. When we base our individuality on society, the influences of society on our decisions are great. Thus, our decisions cannot truly be autonomous.

Societal Pressures If an individual does make decisions that conflict with mental conditions legitimized as diseases, society—our community as a whole—pressures the individual to get treatment or face becoming ostracized. Individuals labeled as mentally ill by society behave in ways deviant from regular social behavior, and they become objects of public concern. Mental illness prevents members of society from functioning well in the community. It fights the organized structure and conformity in society, so its presence threatens society’s power structure (London, 1969). Conrad describes the problem society brings to this issue. He says we, “…seek to change the ‘victim’ rather than the society...rather than seeing certain deviant behaviors as symptomatic of problems in the social system, the medical perspective focuses on the individual diagnosing and treating of the illness, generally ignoring the social situation.” (Conrad, 1975, p. 159) Either the doctor tries to pressure the individual into accepting treatment she feels the patient needs, or the individual is mentally unstable enough that the individual cannot make the autonomous decision to accept or refuse treatment. When autonomous decisions are based on an individual’s mental outlook and the individual’s mentality is the problem, how can they make autonomous decisions?

The individual’s autonomy is discarded since society sees the individual’s behavior as diseased.

On the other hand, if the doctor does not agree with the individual on the diagnosis or cannot find a disease to fit the symptoms, the doctor cannot supply a clear cause or method to fix the problem. The patient wants a cure, so the doctor’s lack of an answer or treatment is dissatisfying.

Redlich states, “patients expect treatment and clinicians have the obligation and desire to treat” (1976). Doctors Penn Bioethics Journal Vol IV, issue i Fall 2007

research new treatments and once a drug is found that can fix the problem, the outcome is a new disease. However, instead of fixing the problem, the drug may just change a person’s nature to fit society’s standards.

ADHD developed in this manner. Hyperactive behavior in children used to be seen as a behavioral problem, but it was not considered a medical disorder.

Teachers noticed disruptive or distracted behavior by children in school and notified the parents. Parents brought children to doctors, but no medical reason or solution could be found. Research was conducted until a cure was created. In the 1950s, a new drug called Ritalin was created that helped children calm down, and in 1957, the term “hyperkinetic impulse disorder” was coined (Conrad, 1975).

The disorder appeared in children explosively in the 1960s (Conrad, 1975), since there suddenly seemed to be a cause and cure. Taking drugs to relieve symptoms of ADHD helps the children focus more in class and leads to a more tranquil classroom environment (Conrad, 1975). However, today there is debate over whether the pill is really a cure or actually a drug that fundamentally changes the user’s personality to fit the parents’ concept of what is normal (Scully, 2004).

The influence of society on categorizing and labeling mental illness permeates the discipline. Just as we cannot define ourselves without bringing society in, the medical community cannot define a mental illness regardless of the influence of society. These influences affect both the society and individuals, stabilizing the society and conforming the individual to the society.

The Effects of Society’s Influence Since the ambiguity of the definition of mental illness lies in the lack of a standard for mental health, using social values as a standard potentially resolves that problem.

Despite criticisms, DSM-IV seems ideal because it exists as a standard that all mental health professionals can fall back on. However, society’s values are slowly adjusting to satisfy new trends, so the medical community must constantly revise the manual, while the standards change over time. Currently, the manual is in its fourth edition, and the APA has projected that a fifth edition will be published by 2011. Despite the shifting, having the standard helps doctors diagnose mental illness much more easily. In some ways, the DSM-IV still does not standardize mental health enough.

A recent article addresses the problems of not having a decent standard to use. The article describes how one boy visited several psychiatrists over the course of his life, and each psychiatrist diagnosed him differently. Each diagnosis involved a new treatment, many proving ineffective (Carey, 2006). This lack of uniformity in diagnoses is disturbing and harmful to the patient. The patient might experience not only physical harm without the influence of society,

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but may also lose freedom of expression.

While society’s influence on categorizing mental illness addresses problems that are potential threats, and thus this mechanism helps to keep society functioning, this influence is detrimental sometimes because it does not allow for deviation. The individual’s freedom of expression is ignored in favor of a functioning, healthy society, as seen in the following example: “Samuel Tuke tells how he received at the Retreat [mental asylum] a maniac, and prodigiously strong, whose seizures caused panic in those around him and even among the guards. When he entered the Retreat, he was loaded with chains, he wore handcuffs; his clothes were attached by ropes. He had no sooner arrived than all his shackles were removed...the keeper explained that the entire house was organized in terms of the greatest liberty and the greatest comfort for all, and that he would not be subject to any constraint so long as he did nothing against the rules of the house or the general principles of human morality.” (Foucault, 1965, p. 245-246) The house and its rules were the constraints of society that kept society functioning optimally and the maniac was a member of the society. The maniac later leaves the Retreat, completely “cured” (Foucault, 1965, p. 246). While this example is extreme, the patient’s personal expression was exchanged for an ability to function normally in society.

The question lies in how much or in which cases individual expression should be suppressed to keep society performing without problems.

Society’s influence in defining a mental illness helps society, but it does so at the expense of the individual.

While we live and function in a society and our individual decisions and values are based upon societal values and pressures, we treasure the concept of autonomy and praise the individual above all else. This paradoxical situation illustrates why we cannot arrive at a consensus on mental illness. The effect of society in defining mental illness is both good and bad: it makes it easier to diagnose illness and keep society functioning, but at the same time, the individual loses freedom.

Addressing the Influence of Society Since societal values seem to influence our decisions in mental health, we must further address this idea.

Society’s presence in medical decisions causes conflicting conclusions; understanding society’s influence helps the medical community, the afflicted patients, and the community to reach a compromise. Knowing that society has such a profound effect on medical decisions will also help doctors and patients understand that a problem exists, while helping them work around conflicts as more cases of mental illness appear.

Cross-cultural differences within our society also

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make it important to understand society’s effect on defining mental illness. The American population consists of several different cultures with different values. For example, Madsen wrote of how cultural differences affected perspectives on mental illness between MexicanAmericans and Anglo-Americans in Texas. He summarizes by saying: “Mental illness, as defined by Mexican-American culture, belongs to the group of folk diseases that are most resistant to modern medical treatment. Even if mental illness among Mexican-American is defined by broader Anglo standards, it seldom receives psychiatric treatment except among those individuals who have adopted Anglo values in the process of cultural transfer.” (Madsen, 1969, p. 238) He adds: “An Anglo who claimed to have had long conversations with angels would certainly be deemed mentally ill, but the Mexican-American curandero [folk healer] who converses with angels and a host of other supernatural beings is regarded as being mentally superior to others.”

(Madsen 1969: 238) An individual raised as Mexican-American would have a different set of values and thus, a different definition of mental illness as compared to an individual raised as an Anglo-American.

Another example comes from the following doctor: “Different societies have different ideas. There was this son who came one day to the hospital, and he seemed pretty clearly to be manic, but his mother thought he was having a shamanic conversion. It was frustrating to not be able to treat the boy because of his parents.”

(Doctor in Family Medicine2 , personal interview, Nov. 12, 2006)

Cultural differences between her and the mother show the disparity in diagnosis. The doctor sees manic depression in the child, while the mother believes that the child is experiencing an otherworldly experience. The cultural difference between these two parties created a rift that the doctor struggled to cross.

Without understanding society’s influence, the doctor cannot possibly reach a conclusion or even understand the problems when cross-cultural issues are involved. Even when doctors realize that cultural differences cause the disagreements, can they create a treatment that satisfies the values of both cultures? Not only do cross-cultural differences in society exist; in our global community, there are several different societies that must coexist peacefully.

The cultural differences in America reflect values in societies around the world. Therefore, in this increasingly A female doctor in the Dept. of Family Medicine. I interviewed her by phone.

2

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The Effects of Society on the Development and Categorization of Mental Illness

global community, such differences in values must also be addressed.

V. Conclusion Societal values influence the development of mental illnesses by setting standards, pressuring for conformity, and expressing themselves subtly in our decisions and expressions. While this influence helps keep our society stable and healthy and makes diagnosing mental illness much easier, it also takes away some of our individual freedom and autonomy. Understanding societal influences will help us compromise what is necessary to keep society healthy and what is important for expressing individual freedom.

It will also help the medical community and the patient understand each other in cross-cultural situations where different sides hold different values. In today’s increasingly global community, understanding societal influences will help ease the tensions brought about by conflicting values in different societies. Our society does not discuss this issue enough at the national level; the next step is to determine why we do not discuss this issue more and then rectify the problem.

References 1.

The Associated Press, “Road Rage Gets a Medical Diagnosis”, msnbc.com, 5 Jun 2006, (http://www.msnbc.msn.com/id/13152708/ #storyContinued) 2.

Boorse, Christopher, 1981, “On the Distinction between Disease and Illness,” in Caplan A L., J. J. McCartney, and D. A. Sisti, Health, Disease, and Illness: Concepts in Medicine. (Georgetown University Press, Washington D.C., 2004) 3.

Caplan Arthur L., James J. McCartney, and Dominic A. Sisti, Health, Disease, and Illness: Concepts in Medicine. (Georgetown University Press, Washington D.C., 2004) 4.

Carey, Benedict, “What’s Wrong With a Child? Psychiatrists Often Disagree,” The New York Times, 11 November 2006, (http://www.

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5.

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nytimes.com/2006/11/11/health/psychology/11kids.html?_r=1&th &emc=th&oref=login) Conrad, Peter, “The Discovery of Hyperkinesis,” in Caplan A L., J. J. McCartney, and D. A. Sisti, Health, Disease, and Illness: Concepts in Medicine. (Georgetown University Press, Washington D.C., 2004) “Depression,” National Institute of Mental Health, 13 Sep. 2006, (http://www.nimh.nih.gov/publicat/depression.cfm) Foucault, Michel, trans. R. Howard, Madness and Civilization: A History of Insanity in the Age of Reason, (Random House, Inc., New York, 1965) Jahoda, Marie, Current Concepts of Positive Mental Health. (Basic Books, Inc., New York, 1958) London, Perry, 1969, “Morals and Mental Health,” in Plog, Stanley C. and Robert B.Edgerton, Changing Perspectives in Mental Illness. (Holt, Rinehart, and Winston, Inc., United States of America, 1969) Madsen, William, 1969, “Mexican-Americans and Anglo-Americans: A ComparativevStudy of Mental Health in Texas,” in Plog, Stanley C. and Robert B. Edgerton, Changing Perspectives in Mental Illness. (Holt, Rinehart, and Winston, Inc., United States of America, 1969) “The Numbers Count,” National Institute of Mental Health, 17 Feb. 2006, (http://www.nimh.nih.gov/publicat/numbers.cfm#Eating) Plog, Stanley C. and Robert B. Edgerton, Changing Perspectives in Mental Illness. (Holt, Rinehart, and Winston, Inc., United States of America, 1969) Redlich, F.C., “Editorial Reflections on the Concepts of Health and Disease”, The Journal of Medicine and Philosophy, Volume 1, No. 3, 1976, pp: 269-280 Sarbin, Theodore R., 1969, “The Scientific Status of the Mental Health Metaphor,” in Plog, Stanley C. and Robert B. Edgerton, Changing Perspectives in Mental Illness. (Holt, Rinehart, and Winston, Inc., United States of America, 1969) Scully, Jackie L., “What is a disease?: Disease, disability, and their definitions,” Nature: EMBO Reports, 2004, (http://www.nature. com/embor/journal/v5/n7/full/7400195.html) Spiegel, Alix, “The Dictionary of Disorder,” The New Yorker, 3 Jan., 2005, (http://www.newyorker.com/fact/content/articles/050103fa_ fact?050103fa_fact) Taylor, Charles, “The Politics of Recognition,” Multiculturalism: Examining the Politics of Recognition. (Princeton University Press, Princeton, New Jersey, 1994) Wolpe, Paul Root: “The Triumph of Autonomy in American Medical Ethics,” in DeVries, Raymond and Hanardan Subedi, Bioethics and Society: Sociological Investigations of the Enterprise of Bioethics.

(Prentice Hall, New York, 1998)

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Penn Bioethics Journal Vol. IV Issue i

The Moral Permissibility of Abortion Author: Gina Babinec, Dalhousie University Faculty Sponsor: Ms. Meredith Schwartz Abstract While the legal permissibility of abortion is firmly established in most countries, the moral permissibility of the act is an issue that still remains a topic of consistent debate. This paper addresses the moral permissibility of abortion by outlining conditions under which it is the most morally just. Focusing first on the elements of the ethical perspectives most commonly considered in the debate, conservative and liberal, I explore the overall similarities and differences between the two, highlighting their flaws in providing sufficient moral guidance as ethical theories. Then, I compare the principles of these two perspectives to those of the feminist position. I propose that the principles of the liberal and conservative perspectives, respectively, are less morally just than those offered by the feminist perspective. Thus, abortion is always morally permissible if carried out under the principles of the feminist perspective.

Full Text Abortion and its permissibility has been the root of considerable debate among ethical theorists and public alike since this practice was widely acknowledged in western society. While abortion is legally permissible in North America, whether it is morally permissible still remains a topic of heated dispute. Of the many perspectives on abortion, two have emerged to become the primary conflicting positions in this debate: conservative and liberal, also known, respectively, as pro-life and pro-choice.

Though these positions oppose in most respects, they share a lack of regard for the pregnant woman’s involvement in abortion. On the contrary, the feminist perspective places great significance on women, and, when compared to the conservative and liberal perspectives, supports the conditions under which I believe abortion to be morally permissible. I believe this position is the most morally justified of the three because of its focus on the significance of the relationships involved in abortion and because of its placement of the pregnant woman at the center of the issue.

The primary issue dividing liberal and conservative positions on abortion is that of the moral status of the fetus Gina Bainec is a Sophomore at Dalhousie University and is majoring in English and Philosophy.

Email: gina@dal.ca Ms. Meredith Schwartz is the faculty sponsor for this submission. She is a PhD student and Instructor at Dalhousie University in the Department of Philosophy Address: Dept. of Philosophy, 6135 University Ave, Halifax, NS, B3H 4P9 Email: meredith.schwartz@dal.ca Penn Bioethics Journal Vol. IV, Issue i Fall 2007

or, more specifically, the degree to which a fetus has rights, if any (Sumner, 2004). Though both the conservative and liberal camps believe it is morally wrong to proceed with an abortion if the fetus were considered a person (thus, granted full rights), both camps strongly disagree on whether the fetus is, in fact, a person (Little, 1999).

The conservative perspective on abortion is founded in the belief that the fetus is a human with its own unique set of genetic material and, as such, is granted full rights (Sumner, 2004; Noonan, 2005). This idea is problematic due to the fact that in the early stages of embryonic development, a zygote (with its own unique set of DNA) has the potential to divide and develop into two fetuses with identical DNA. If unique DNA is what confers moral status, what, is to be said of identical twins? Because a twin does not possess his or her own unique DNA, will conservatives refrain from granting them moral status?

When taken to this extreme, it is clear to see at least one of the problems of the conservative’s method of allocating rights.

A second fundamental component of the conservative position is that because fetuses are granted the highest moral standing, it is believed that abortion is akin to homicide and is never morally permissible (Sumner, 2004). This argument is also problematic because we are then faced with the issue of deciding if prohibiting abortion is an infringement on the rights of the pregnant woman whom conservatives believe, as stated above, is of equal moral standing to the fetus (as both are granted the same rights). As noted by Margaret Olivia Little (1999, p. 297), conservatives do not consider this relevant since “the procreational decision at issue with abortion is a decision about whether a fetus will live inside [a woman’s] womb.” Rather, what is more relevant to conservatives is the idea that, in deciding to proceed with an abortion, a woman is simply terminating the life of another.

Conservatives give no consideration to the possibility that in so doing, a woman may be neglecting to act on any rights she has over her own life; conservatives believe that a woman’s interests cannot counter the fetus’ claims (Ibid).

What emerges from the conservative position, then, is a situation in which the degree to which one individual may act on his or her rights is dependent on how far the other is permitted to act upon on his or hers At which point is it moral to inhibit one person’s rights in order to allow another to act upon his or hers? Missing from this picture is the necessary acknowledgement of a deeper relationship between these two individuals (the woman and the fetus).

With this relationship in mind, it is debatable as to whether or not the fetus should even be referred to as an individual,

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The Moral Permissibility of Abortion

as its existence depends on that of the woman whose womb it is occupying.

As Little (1999, p. 299) claims, there is an “extraordinary physical enmeshment” between mother and fetus. Little continues to argue that the depth of the relationship, decided by the mother, between herself and the fetus is directly proportional to her moral responsibility to follow through with gestation. A conservative approach to abortion certainly does not allow for such (if any) flexibility in women’s choice. Feminist ethicist Susan Sherwin (2005, p.

95) furthers Little’s argument by stressing that the feminist position accounts for “the actual concerns that particular women attend to in their decision-making on abortion, such as the nature of a woman’s feelings about her fetus, her relationships with her partner, other children she may have, and her various obligations to herself and others.” I believe the importance of these factors cannot be overlooked when constructing a moral theory to guide women in making a morally just decision. The disregard for these issues is an oversight the pro-life movement has been too quick to make.

With respect to abortion, the liberal perspective is one based on the idea that, while it may be human, a fetus is not considered a person and, as a result, is granted no rights (Sumner, 2004). Because liberals do not consider fetuses worthy of being protected by rights – including those against killing – abortion is always morally permissible.

Let us consider Mary Anne Warren’s argument. While she places some emphasis on the rights of women, in “On the Moral and Legal Status of Abortion” (1996), Warren holds a liberal view, claiming that “a woman’s right to protect her health, happiness, freedom, and even her life, by terminating a pregnancy will always override whatever right to life it may be appropriate to ascribe to a fetus, even a fully developed one”. While this may seem like a feminist claim, Warren comes to this conclusion because of her belief that “neither a fetus’s resemblance to a person, nor its potential for becoming a person provides any basis whatever for the claim that it has any significant right to life”.

As emphasized by Warren’s argument, liberals and feminists both hold that a woman has the right to choose;.

However, each party employs a different set of moral reasoning to support this conclusion. The liberals focus on the fetus whereas the feminists focus on the woman.. This is the major distinction between the liberal and feminist arguments (Sherwin, 2005). While the liberal position does allow the female to exercise her autonomy by having the right to choose, this position still does not allow for consideration of the relationships involved in pregnancy, nor does it place the woman at the center of the issue, or anywhere in the issue for that matter. This is troublesome because the moral justification of abortion is, then, solely based on the claim that the fetus is unworthy of rights. Of this association between fetal rights and the choice to abort, Penn Bioethics Journal Vol IV, issue i Fall 2007

Sherwin claims, “feminists have often felt pushed to reject claims of fetal value, in order to protect women’s needs.”

Sherwin continues to state, however, that the feminist position is one in which “fetuses are morally significant, but their status is relational rather than absolute” (p. 101).

Therefore, When women are faced with the decision of whether or not to procure an abortion, , the liberal view does not provide women with sufficient moral guidance as it neglects to acknowledge the fact that women may experience serious moral conflict throughout their decisionmaking process. As women may indeed experience moral conflict, the liberal position is unlikely to guide women toward making what they truly believe to be a morally just decision. The liberal view shares a complete lack of regard for the many social factors involved in pregnancy and decision-making with conservatives.

In summary, both the conservative and liberal positions are problematic due to their lack of regard for the pregnant woman and the issues associated with her involvement in pregnancy. Both positions lack significant recognition of the relationships involved in pregnancy, thereby creating a scenario where the woman has no moral obligation to consider the wishes of the individual(s) with whom she is in what may (or may not) be considered a very intimate relationship. According to Sherwin (2005, p.95), the significance of these relationships--along with that of other social practices relevant to pregnancy and abortion--has been what nonfeminist arguments continue to “ignore (and thereby obscure).” While the liberal position is an improvement on the conservative position in that it respects a woman’s autonomy by allowing her the freedom to choose, its foundation still lacks any further regard for the woman and the obligation she may feel to respect all relationships and social factors involved. What is needed, then, is a position that places the highest value on a woman’s interests, while considering the importance of all relationships involved.

In the abortion debate, the central issue dividing liberal and conservative positions lies in their different perceptions of the status of the fetus. However, I believe that the woman’s rights and interests are what should be the constant thread linking all theoretical perspectives considered in this debate. Because of her total involvement in gestation emphasized by the fact that a fetus is occupying her body, the woman has a direct, if not pivotal, role in abortion. It is for this reason that a woman should have the right to have her interests taken into account in any resulting debate or moral theory. The feminist perspective is one that allows for the conditions under which I believe abortion to be morally permissible.

As emphasized by both Margaret Olivia Little (1999) and Judith Thompson (1971), gestation is, fundamentally, an occupation of a woman’s body, whether welcome or not.

While Little likens the distress of unplanned and unwanted

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pregnancy to sex without consent, Thompson compares the act of gestating to being kidnapped against one’s will and forced to support another’s life. Both of these examples serve to validate the idea that gestation can be considered a violation of one’s self, or as Little (p. 303) words it, a ”liberty harm”. As such, shouldn’t a woman have the right to terminate that which has taken up uninvited residence in her body? From a feminist perspective, though she may not have chosen to enter into the relationship between fetus and herself, a woman has the right to determine its depth once the relationship is established at the point of conception (Ibid). However, this relationship is subject to change over the course of the pregnancy. A feminist approach accounts for this by recognizing the aforementioned correlation between depth of relationship and moral obligation.

According to feminists, if a woman decides that the depth of a relationship has increased, her moral responsibility to consider that individual when making a decision about abortion should also increase.

According to studies based on numerous in-depth interviews and observations, psychologist Carol Gilligan was able to hypothesize a difference between male and female approaches to moral decision-making. Gilligan concludes (as cited in Davis, 1993, p. 144) that females “often define themselves through connection with others…and tend to perceive a moral conflict as a problem of care and responsibility in relationships…” As has been discussed in the works of Little (1999) and Sherwin (2005), the feminist perspective is one that emphasizes the importance of each relationship involved in a pregnancy, and both recognizes and legitimizes a woman’s likelihood to consider the value and depth of these relationships when gauging the permissibility of a particular abortion. Because a feminist approach to abortion acknowledges the emphasis women place on relationships, a woman’s decision to abort based on the status of a relationship in which she is involved (i.e. a weak relationship with fetus or potential father) is accepted as a valid reason to proceed with abortion. This perspective encourages women to consider the depth of the relationship with their sexual partner as well as the fetus in order to

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come to a decision. It must be emphasized, however, that whether or not a woman chooses to consider the potential father’s opinion, her decision is based on her established depth of relationship. To relationship-valuing women, this is a more reasonable approach than a liberal perspective, which offers no guidance to women wishing to consider other factors in coming to a decision.

By outlining the similarities and differences of the two major perspectives in the abortion debate and by exploring relevant ethical and psychological theories, I have revealed what I believe to be the fallacies of both the conservative and liberal perspectives. This was done to help establish why I believe the feminist perspective is the most morally justified of the three examined here. After having compared the principles of a feminist position on abortion to those of a conservative and liberal position, I have found and wish to emphasize that both opposing camps place an insufficient amount of moral weight on the need to centralize women and their relationships in the ongoing debate on abortion.

References 1. Davis, S. (1993). Do Women Judges speak “In a Different Voice?”

Carol Gilligan, Feminist Legal Theory and The Ninth Circuit.

Wisconsin Women’s Law Journal. 8, 143-173 2. Little, M. (1999). Abortion, intimacy and the duty to gestate.

Ethical Theory and Moral Practice. 2(3), 295-312.

3. Lopes, A., King, PA., Duthie, SJ., To, WK., & Ma, HK. (1991). The

impact of multiple induced abortions on the outcome of

subsequent pregnancy. Aust N Z J Obstet Gynaecol. 31(1), 41-43.

4. Noonan, John T. (2005) An Almost Absolute Value in History. In

White, James E (Ed), Contemporary Moral Problems (pp 98-103).

Toronto: Wadsworth Publishing.

5. Sherwin, Susan. (2005). Abortion Through A Feminist Ethics

Lens. In Cragg, Wesley & Koggle, Christine M (Eds),

Contemporary Moral Issues (pp 95-108). Canada: McGraw-Hill

Ryerson.

6. Sumner, L. W. (2004). A Third Way. In Baylis, F., Downie, J.,

Hoffmaster, B., & Sherwin, S. (Eds.), Health Care Ethics in

Canada. (pp.347-356). Canada: Thomson.

7. Thomson, J. J. (1971). A defense of Abortion. Retrieved March

13, 2007, from http://spot.colorado.edu/~heathwoo/Phil160,Fall02/

thomson.htm 8. Warren, Mary Ann. (1996). On The Moral and Legal Status

of Abortion. Retrieved November 17, 2007, from http://instruct.

westvalley.edu/lafave/warren_article.html

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Penn Bioethics Journal Vol. IV, Issue i

Gradualism and the Fetus Author: Phil Galligan, Stanford University Faculty Sponsor: Agnieszka Jaworska, PhD Abstract Warren Quinn’s “gradualism” purports to defend the moral status of the fetus on the basis that it is a “partly existent” human being, and therefore deserving of moral consideration in proportion to its degree of existence. My counterargument is in the form of a dilemma: On one horn, if a fetus is properly thought of as a partly existent human being because of its potential to develop into a human being, Quinn has to solve the problem faced by all views that ascribe actual rights on the basis of potential properties; it seems absurd to treat an entity as though it already is an X just because it will become an X sometime in the future. On the other horn, if Quinn’s argument relies only on attributes currently possessed by the fetus, he must specify what these morally relevant attributes are.

Full Text Warren Quinn has described a metaphysical view of identity called “gradualism.” Gradualism holds that sometimes the best description of an object is that it is “a partly real X” or “a partly existent X,” where “X” designates whatever substance sortal the thing in question belongs to.

In such cases, the partly existent object’s right to be treated as an X is proportional to its degree of existence (Quinn, 1984, p. 33). Quinn considers gradualism to have important consequences for the moral status of the fetus, which is held to be a partly existent human being. The relationship between fetuses and fully developed humans is similar to the relationship between a house that is under construction and a finished house; its right to be described as a member of the appropriate substance sortal increases as it develops.

Since fetuses are human beings that gradually become more real, they ought to be viewed as morally considerable in proportion.

It seems to me that the metaphysical component of Quinn’s argument ultimately rests on an appeal to the fetus’s potential. When we are considering what substance sortal a fetus belongs to, whether we are tempted to think of it as a human being depends on its potential to become a human being. If the development of a fetus were permanently Phil Galligan is a Senior at Stanford University and is majoring in Philosophy.

Email: philigan@stanford.edu Prof. Agnieszka Jaworska is the faculty sponsor for this submission. She is an Assistant Professor of Philosophy at Stanford University Address: Dept. of Philosophy, Bldg. 90, Stanford, CA, 94305-2155 Email: jaworska@stanford.edu Penn Bioethics Journal Vol. IV, Issue i Fall 2007

arrested, we would cease to consider it a partly existent human being; this would not be the best way of describing it anymore, since it really is not and never will be much like one of us. Instead, it seems it would best be described as just a fetus, the same way that a foundation on which nothing is ever going to be built is just a foundation and not any kind of house. When it seems reasonable to think of something as a partly existent individual, this is not entirely on the basis of features it already possesses, but to some extent because of features that we think it will possess in the future.

If this is the right way to understand the concept of partial existence, Quinn’s argument for the moral status of the fetus is open to the very serious objections faced by any view that ascribes moral considerability on the basis of potential properties. In particular, the “Jimmy Carter” objection seems to be fatal. This is just the commonsense observation that it would have been absurd to allow Jimmy Carter to exercise presidential powers, such as command of the armed forces, at any time before he actually became president, simply because he had the potential to hold the office (Feinberg, 1986, p. 269). Rights are conferred by the actual possession of relevant properties, not by the mere potential to possess them. If, for example, autonomy is among the morally relevant properties possessed by mature human beings but not by fetuses, the fetuses’ potential to develop autonomy is no reason to treat them as though they already have it.

This dismissal of potential as a basis for moral status may seem unjustified. There are certainly situations in which something’s potential influences our conduct toward it. To return to the prior example, even when a house is in the initial stages of construction we are likely to want to protect it so that we can eventually enjoy the benefits of having a complete house. I agree that the fetus’s potential may matter to us in a similar way. But in such cases it is not that we acknowledge some claim that the house or the fetus has on us to be taken care of; rather, we are concerned about it only to the extent that it happens to be important to people who are themselves morally considerable. We must distinguish between intrinsic and extrinsic morally relevant properties. Clearly, we are sometimes obliged to consider the welfare of the fetus on the basis of its extrinsic properties (for example, it may have parents who want to raise a child). What Quinn argues, and I disagree with, is that we ought to accord the fetus a privileged moral status for its own sake, on the basis its intrinsic properties.

Perhaps the comparison of the fetus to a house seems to miss something important. Even a completed house is

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not usually considered intrinsically valuable; we take care of it because we need a place to live, not because it is otherwise deserving of such treatment. In that case, suppose that what is under construction is not a house, but an enormous sculpture, so that when it is completed we will value it for its beauty, an intrinsic property. (But be careful to keep in mind that it is not currently beautiful; to assume otherwise would beg the question, since what is up for discussion here is the relevance of entirely potential, as opposed to actual, properties.) In the initial stages of construction – say, when a few blocks of marble have been arranged – we would not treat the sculpture-in-the-making with any degree of the reverence or admiration that we would treat the completed sculpture. Privileged treatment is accorded only to objects that already possess the relevant qualities (in this case, beauty), not to any degree on the basis of the unrealized potential to possess them.

I have been arguing that the aptness of Quinn’s description of the fetus as a partly existent human being depends on its potential to develop into a human being, and consequently that it is vulnerable to the “Jimmy Carter” objection. But even if we accept that a fetus is a partly existent human being, and that this means something other than that it is merely a potential human being, it is still not clear what conclusions we should draw about its moral status, because as long as we know that the fetus is not a complete human being we may doubt that it has the properties which give us our privileged moral status. If what is important about a house is that it provides shelter, it makes little difference whether a foundation is a partly existent house or not. Similarly, if what is morally important about a human being is that human beings have the capacity for autonomy, and fetuses lack this property, it does not matter whether a fetus is a partly existent human being.

Even if a fetus is best described as a partly existent human being, this does not settle the question of what its moral status is, because we may be thought to owe our moral status to our possession of more specific properties. In fact, this position even seems uncontroversial; when we are asked why it is wrong to harm normal adult human beings, it does not seem as though the answer is already present in the question. Instead, we feel the need to cite particular properties of human beings that make it wrong to harm them.

My argument takes the form of a destructive dilemma: When it is asserted that a fetus is a partly existent human

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being, either 1) The aptness of this description depends on the mere potential of the fetus to become a mature human being, in which case we may deny that the fetus is deserving of moral consideration on the basis of the “Jimmy Carter” objection; or 2) The aptness of the description depends only on properties actually possessed by the fetus, in which case we may hold that the fetus lacks the features of mature human beings that are morally relevant (for example, autonomy). Either way, Quinn has failed to show that fetuses have any kind of privileged moral status.

There may still be some value to the gradualist view.

It might be argued that the morally relevant properties of human beings are not acquired suddenly, with the “pop” that Quinn thinks is so implausible; instead, there is some kind of gradual process, and at intermediate stages it might be appropriate to describe an entity as, for example, “a partly existent autonomous agent” or simply “partly autonomous.” Properly formulated, this kind of gradualism is not vulnerable to either of the objections I raised against Quinn’s view. So long as it is made clear that the gradualist’s claim about the moral status of the entity in question rests on its current possession, to some degree, of whatever property is held to be morally relevant (rather than on its simply being the kind of thing that will eventually be deserving of moral consideration), the gradualist need not rely on the entity’s potential. Of course, even this kind of gradualist position will not be plausible unless an appropriate property is specified. No one is likely to be persuaded that we are obliged to consider the interests of entities to the extent that they possess a bone structure similar to that of an adult human being.

In order to support the claim that the fetus possesses some degree of the moral status of a mature human being, this revised gradualism would have to find some morally relevant property that the fetus actually possesses. It would then imply that the fetus is increasingly deserving of moral consideration as this property develops. The question of what the morally relevant similarity is between a mature human being and a fetus is, of course, possibly the most difficult faced by those who argue for the rights of the fetus, but it cannot be avoided by an appeal to gradualism.

References 1.

Feinberg, J. (1986). Abortion. In T. Regan (Ed.), Matters of Life and Death: New Introductory Essays in Moral Philosophy (pp. 256-275, 291-292). New York, NY: Random House.

2.

Quinn, W. (1984). Abortion: Identity, and Loss. Philosophy and Public Affairs, 13, no. 1, 24-54.

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Penn Bioethics Journal Vol IV, Issue i Fall 2007

Penn Bioethics Journal Vol. IV, Issue i

The Need for Patient Preference Research: A Case Study in the Rationing of Limited Resources for Treating HIV/AIDS Patients Author: Michelle Parilo, Harvard University, Ames Dhai, Mark Brady Faculty Sponsor: Daniel Wikler, PhD Abstract Despite the ever-increasing international focus on the HIV/AIDS epidemic, most HIV infected patients needing antiretroviral drugs are still not receiving them. One important reason is severely restrained resources. Decisions need to be made about how to distribute these resources as countries like South Africa work towards the goal of universal HIV treatment access (Bachmann, 2006, p. 109-120). The pressing questions are 1) how to distribute these life-saving, but limited, resources and 2) who should decide. This paper explores the different ways of approaching the question of distribution, but its main focus is patient participation in the decision making process. It is concluded that those who are most affected by the decision should have a say in deciding how the limited resources are allocated to ensure patient autonomy and allow policies to be driven by the consumer. In doing a HIV patient preference pilot study over the summer in Johannesburg, South Africa, the writers of this paper discovered that it is possible (and necessary) to ask HIV-positive patients their preferences.

Introduction Despite the ever-increasing international focus on the HIV/AIDS epidemic, most HIV infected patients needing drugs are still not receiving them. However, as available resources increase the questions arise of how they will be distributed and who should decide.

HIV/AIDS is devastating South Africa. One in ten South Africans is infected with HIV, which includes one out of every three pregnant women, for a total of 5.4 million infections (Noble, 2007; Meldrum, 2007, p. 28-29).

Moving about Johannesburg, one will see advertisements for funeral companies on every corner and hear people joke that undertakers have a promising future (Meldrum, 2007, p. 28-29). The loss of life in South Africa attributable to HIV (900 people per day) is equivalent to the Titanic sinking Michelle Parilo is the primary author for this paper. She is a Sophomore at Harvard University and is majoring in Government and Social Anthropology with a Spanish Language Citation.

Email: mparilo@fas.harvard.edu Dr. Daniel Wikler is the faculty sponsor for this submission. He is the Mary B. Saltonstall Professor of Ethics and Population Health in the Department of International Health Address: Harvard School of Public Health, 665 Huntington Ave., FXB636, Boston, MA, 02115 Email: wikler@hsph.harvard.edu Penn Bioethics Journal Vol. IV, Issue i Fall 2007

every other day [~1500 died, ~700 were rescued], and the dilemma of who gets into one of the limited number of life boats is also similar. Though South Africa’s former minister of health has been notorious for promoting such nonscientific approaches to treating AIDS as encouraging eating garlic and beetroot, it does appear that the government is now getting serious about providing real treatment (BBC News, 2006). South Africa hopes to provide antiretroviral drugs to 80% of AIDS patients and to prevent half of new infections by 2011 (Sidley, 2006, p. 606-607). On paper, this is a wonderful goal. However, the number of AIDS patients on highly active antiretroviral therapy (HAART) in South Africa has increased 100 fold in just two years (Nattrass, 2006, p. 618-623).

A majority of the increasing access to treatment (“scale up�) is occurring in urban areas. Rural areas are largely being left behind in the increasing access to treatment, partly because there are more HIV clinics in urban centers.

This means that decisions are already being made based on certain values (efficiency/ maximizing number of patients being treated with limited resources) and not on others (equity of access across rural and urban areas).

The bottom line is that there are severely restrained resources for treating HIV, and decisions need to be made about how to distribute the resources until the goal of universal HIV treatment access is met (Bachmann, 2006, p. 109-120). The questions are how to distribute these lifesaving, but limited, resources and who should decide.

Who should decide who gets treatment?

If there were enough resources to treat all patients that would benefit from treatment, then the resource would not be considered limited. However, there are not enough resources to treat everyone, and those who do not have access to needed treatments will die from AIDS. Who is making the decision about who receives treatment?

Until now, it has been implied and largely unquestioned that the decision about who gets treatment may be made by international funding agencies, national governments, ministries of health, and/or managers of treatment facilities (Rosen et al., 2005, p. 354-356). In some cases, nurses are even playing a role in deciding how to distribute the limited drugs (Rosen et al., 2005, e303). But who should be making the decision? Should the preference of potential recipients come into the decision making process?

Over the summer of 2007, the authors of this

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paper conducted a study to demonstrate the feasibility of engaging HIV infected persons to determine their treatment preferences. The study took place at the Themba Lethu HIV/AIDS Comprehensive Care Management and Treatment and TB site, which serves the Guateng Province, centrally located in South Africa. In this province, approximately 1 in 5 members of the population is HIV infected. The government of South Africa guarantees antiretroviral therapy (ART) treatment for all patients. At this clinic, patients are put on ART when there is evidence that it would benefit them. The Themba Lethu Clinic funds all medicines and 20% of salaries; the President’s Emergency Plan for AIDS Relief (PEPFAR) provides the other 80% of staff salaries.

Once the CD4 count of people with HIV falls below a certain threshold, the patient is put on first-line ART. First-line drugs are relatively cheaper and can help a person to live a long and healthy life. Unfortunately, they do not last forever. Once a person grows resistance, he or she must be given second-line HIV drugs. The type of drugs are different in each country, but essentially first-line drugs come first and second-line drugs come second. Second-line drugs are generally ten times or more the price of the most common first-line treatment in Africa (Clinton Foundation, 2006). Therefore, the cost of treating one person with second-line therapy is not allowing ten people to initiate first-line therapy. One comes to a dilemma in distributing the drugs because one can provide many people with firstline drugs, thereby maximizing the benefit, or one can

remain with his or her patient and provide the patient with second-line drugs, thereby “not abandoning” the patient.

Typically in the medical field, doctors do not abandon their patients, despite the fact that doctors could provide a greater number of people with drugs if they provided more people with first line rather than continuing a patient with second line drugs. This is a dilemma introduced to HIV patients in the study, to see which route of treatment they prefer.

The authors’ study included HIV positive people who did not yet need, or know if they needed, ART. The participants were asked their preferences between guaranteeing first-line to a greater number of people, but no second-line treatment; or providing a fewer number of patients with first-line drugs, but for those who were lucky enough to get into the program, also providing second-line drugs when necessary. Personal and group autonomy happen not to conflict in this case based on empirical data, but nonetheless, the conflict should be mentioned. Although this was a pilot study with only 20 participants, it is still worthy to note that a majority of the patients preferred providing first-line AIDS drugs to more people and forfeiting the non-abandonment pledge from their doctor. This showed that the participants preferred a higher chance of receiving treatment, despite the fact that they would definitely not receive second-line drugs if they needed them to control their HIV/AIDS. Please see Diagram One for an illustrated example of the type of questions asked.

One ancillary benefit of the survey was that most

st

A. 1 -line ART available to all

bbbbb bbbbb bbbbb

Outcome st

1 -line keeps working

b st

A

1 -line stops workingÆ no 2nd-line

Policy Decision (Choose A or B)

:

1st-line keeps working

b 1st-line stops workingÆ 2nd-line

B B. 1st-line ART available to 1 in 15 needing them

b

b:::: ::::: ::::: Diagram One: Decision Tree Analysis of one of the questions asked in our 2007 research study.= HIV infected Diagram One: Treedrugs; Analysis one progresses of the questions asked inthe ourperson 2007dies. research study. person benefits fromDecision antiretroviral  =of AIDS and eventually b= HIV infected person benefits from antiretroviral drugs; : = AIDS progresses and eventually the person dies.

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www.bioethicsjournal.com One ancillary benefit of the survey was that most patients identified learning

The Need for Patient Preference Research

patients identified learning something new as a benefit of the study. Participants used this opportunity to probe the research investigation and counselor translator teams with questions regarding their disease. These questions were referred to the counselor to be answered privately after the study was finished.

This study concluded that patient preference surveys of HIV infected individuals are feasible, and that the survey resulted in few observed untoward effects. Participants were willing to answer all questions, and all reported that they would be willing to participate in similar surveys in the future.

Should we even ask these questions?

Does asking questions about distributing limited resources assume we are denying access to someone? The question is then posed whether asking patients’ preference is condoning or justifying the lack of resources. Médecins Sans Frontières (MSF) considers rationing to be a tacit acceptance of injustice (Zachariah et al., 2006, p. 78-80).

This topic is debated in Stuart Rennie’s Article: “Is It Ethical To Study What We Ought Not To Happen?” Rennie states the MSF did not sponsor his research project because his study accepted rationing, and the MSF believes it is every human’s right to have access to health care. Ironically, MSF must ration because it does not have enough medicine to supply universally, but it refuses to study how to ration because doing so would acknowledge a contradiction with their ideal goal.

The question is how to research the best possible rationing strategy while at the same time continuing to push for adequate resources. Unfortunately, we do not live in a perfect world, and we cannot provide enough education, counseling, and guaranteed access to multi-line regimens for the 5.4 million South Africans infected with AIDS. The need to ration is a reality for health care, not just HIV/AIDS. One United Nations resolution claims access to medical drugs in areas of pandemics, such as HIV/AIDS, a basic human right (UN Resolution 2001/33). However, this claim does not explicitly state who is responsible. A right without a reciprocal responsibility or a responsibility without the means to fulfill it is meaningless for dictating action.

Further, there is an acutely limited amount of resources in the developing world, and more resources put into HIV care means less for other sectors. Therefore, goods must be rationed somewhere, somehow.

Unlike the West, Sub-Saharan Africa needs to ration The term rationing “does not imply intent to deprive people of a good resource, but rather describes the allocation of a scarce resource” (Rosen et al., 2005, p. 354356).

In the West, many patients can afford the best treatment and the best monitoring systems. Meanwhile, despite the Penn Bioethics Journal Vol IV, issue i Fall 2007

billions of invested dollars in Sub-Saharan Africa, “there is almost no chance that African countries will have the human, infrastructural, or financial resources to treat everyone who is in need” (Rosen et al., 2005, e303). An author of the aforementioned quote runs a clinic in Johannesburg, South Africa that guarantees access to ART to anyone who steps foot through their doors. Therefore, although he may work at the ideal clinic, he realizes his clinic’s policies are not the reality for all of South Africa.

Currently, about 25% of HIV infected patients needing treatment in South Africa are receiving ART, although the government hopes to increase that percentage to 80% within the next five years (“Fast Facts”, 2006).

How to scale up access to ART is not an easy question, but there are successful designs across the globe: Brazil, Thailand, and Botswana, among others. The question is not when to ration, but HOW to (Rosen et al., 2005, e303). We understand that due to limited resources, the necessity of rationing is reality. Below are the different approaches one can take in rationing HIV/AIDS resources. The choices can be difficult, and thus, one must ask patient preference.

Kant’s Ethical Theory: The No Abandonment Pledge HIV/AIDS is the focus of this paper because it is on the front burner of the world health agenda. However, this does not mean patient preference research is only applicable to HIV/AIDS. Ensuring that the priorities of all stakeholders are known when creating health policy is important to every health care sector, not just when discussing HIV/AIDS. Until now, it has been common thought that a doctor has the duty to continue treating his or her patient whenever the patient grows resistance to a drug; we will call this a no abandonment pledge. This is based on a Kantian notion of practical rationality, in which all doctors must consistently follow the pledge in order for it to be effective.

In the case of HIV/AIDS, a no abandonment pledge to one’s patient may have undesired consequences. For example, second line AIDS drugs are 10-20 times as expensive as first line drugs. A patient moves onto second line drugs if he or she has detrimental side effects from the first line drugs, or does not properly adhere to the drug schedule. Thus, when a medical doctor continues his or her patient onto second line drugs, the cost is the prevention of 10 other patients sitting in the waiting room to receive first line AIDS drugs due to budget constraints.

Utilitarian Approach: Maximize Life and Health Giving first line treatments to more patients would be the utilitarian approach because it would maximize life years of the overall population rather than provide a minority of HIV infected persons first- and second-line AIDS drugs. As previously stated, first line drugs are much less expensive than second line drugs. Following the no abandonment

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pledge guarantees less patients will be provided for. In doing so, biases come out because not every HIV positive patient will be cared for, and a decision needs to be made about for whom will treatment be provided. In order to maximize the life and health of the population, it would be necessary to provide more people with first line AIDS drugs, which are cheaper, rather than providing only a few patients with first line drugs and second line AIDS drugs if necessary.

Conclusion: Just Ask! HIV infected individuals should be included as stakeholders in forming national plans to treat and prevent the virus, in order to provide patients with self determination and autonomy in regards to their medication. Rather than being told by the government at the time of treatment to choose between drug regimens ambiguously named “1a and 1b” (as in South Africa), bringing the patients to the decision-making table at the beginning of the process will give the patients the autonomy allowed with other chronic diseases.

A key component in deciding how the resources should be allocated is to ask those who are most affected by the decision. Asking patient preference will ensure patient autonomy and allow policy to be made with the consumer in mind. Thus, policy makers will be able to ensure their scale up plans considered everyone’s opinions. As for now, the medical sector is following the no abandonment pledge, which provides HIV positive patients with new treatment upon their resistance to the old. Though only a small pilot study, HIV positive participants called for a different option in our summer 2007 study. The majority of the participants chose greater access to drugs for more patients, forfeiting their doctors’ no abandonment pledge.

The authors’ study concluded that participants are willing and able to answer policy questions about rationing, thereby providing their preferences or priorities. All participants stated that they would be willing to do a similar study again in the future. Researchers need to broaden their perspective, from just asking which drug company should be used or what dosage should be given; they need to begin assessing patient priorities when it comes to health care.

It is necessary for patients’ preferences or priorities to be considered among policy decisions to allocate resources in health care.

South Africa has a growing economy and is deemed to be one of the most powerful and economically successful African countries. Considering concern for the people on the ground, Amartya Sen intelligently stated,

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Growth of GNP or of industrial incomes can, of course, be very important as means to expanding freedoms enjoyed by the members of the society. But freedoms depend also on other determinants, such as social and economic arrangements (for example, facilities for education and health care) as well as political and civil rights (for example, the liberty to participate in public discussion and scrutiny) (Sen, 2000).

It is necessary for HIV positive South Africans, or any HIV positive person, to participate in public discussion and scrutiny not only so that practitioners and policy makers understand consumer choice, but also so that people have the liberty to participate in and be empowered by public discussion (which is their political and civil right). Assessing patient preference is a double positive, and one that should not be left in the dust any longer. As for now, policy makers and researchers are doing patients a disservice by not including them at the decision making table when discussing allocation policies that affect them.

References 1.

Bachmann, M. O. (2006). Effectiveness and cost effectiveness of early and late prevention of HIV/AIDS progression with antiretrovirals or antibiotics in Southern African adults. AIDS Care; Vol 18 Issue 2. p109-120.

2.

Clinton Foundation Press Release: New Agreements to Lower Prices of HIV/AIDS Rapid Tests and Second-line Drugs, January 12, 2006.

3.

“Fast Facts” on AIDS. South African Institute of Race Relations.

July 2006 4.

Meldrum, Andrew. (2007) AIDS Activist Turns South Africa Around.

Progressive;Vol. 71. Issue 5, p28-29.

5.

Nattrass, Nicoli. (2006). South Africa’s “Rollout” of Highly Active Antiretroviral Therapy. Journal of Acquired Immune Deficiency Syndromes; Vol. 43 Issue 5, 618-623.

6.

Noble, Rob. (2007, April 20). South Africa HIV & AIDS Statistics. <http://www.avert.org/safricastats.htm> (cited June 2007).

7.

Rosen, Sydney. Sanne, Ian; Collier, Alizanne; Simon, Jonathon.

(2005). Hard choices: rationing antiretroviral therapy for HIV/AIDS in Africa. The Lancet; Issue 365, 354-356.

8.

Rosen, Sydney. Sanne, Ian; Collier, Alizanne; Simon, Jonathon.

(2005). Rationing Antiretroviral Therapy for HIV/AIDS in Africa: Choices and Consequences. PLoS Medicine; Vol 2 Issue 11, e303.

9.

Sen, A. (2000). Development as Freedom. New York: First Anchor Books.

10. Sidley, Pat. (2006). South Africans to get AIDS plan. British Medical Journal; Vol. 334 Issue 7594, 606-607.

11. United Nations HR Resolution 2001/33 on `Access to medication in the context of pandemics such as, HIV/AIDS’ 12. BBC News. (2006, Sept. 6). Aids experts condemn SA minister. http://news.bbc.co.uk/2/hi/africa/5319680.stm (cited June 2007).

13. Zachariah, Rony; Janssens, Vincent; Ford, Nathan. (2006). Do Aid Agencies Have an Ethical Duty to Comply with Researchers?

A Response to Rennie. Developing World Bioethics; Vol. 6 No. 2, 78-80.

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Penn Bioethics Journal Vol IV, Issue i Fall 2007

Penn Bioethics Journal Vol. IV, Issue i

The Search for an HIV Vaccine: Ethical Issues of Phase III Clinical Trials Author: Jessica Ho, University of Pennsylvania Faculty Sponsor: Arthur Caplan, MD, PhD Abstract The devastating impact of the HIV/AIDS impact is well known: the epidemic has killed and orphaned millions, reversed gains in life expectancy, negatively impacted national economies, and shows few signs of abating in particularly stricken countries. Given the recent developments in the biomedical sciences, the fact that we have not yet developed an HIV vaccine seems unfathomable. A survey of the vast body of literature available on the topic provides an overview of the constellation of factors which are delaying the development of the vaccine. A comprehensive summary of the logistical and ethical issues involved in testing candidate vaccines and in particular, holding Phase III clinical trials, follows. It highlights the intense and controversial debate over the clinical tests of HIV vaccines which is occurring both at the local level and in the international arena.

Introduction In 2007, the U.S. entered its twenty-sixth year since the beginning of the HIV/AIDS epidemic with approximately 1.2 million people living with HIV/AIDS (The Kaiser Family Foundation, 2007, p. 1). The impact of HIV/AIDS has been profound. Two thirds of all adults and children with HIV/AIDS live in sub-Saharan Africa, where the epidemic has drastically reduced gains in life expectancy (UNAIDS, 2006, p. 3). The International AIDS Vaccine Initiative (IAVI) estimates that without a vaccine, the number of new infections per year could increase from 6 million today to 10 million by 2030 (Tonks, 2007, p. 1348).

Given these statistics, many have wondered at the current lack of an HIV vaccine.

Complications involving clinical trials have been cited as a major cause of delay in the search for a vaccine.

Typically, trials are divided into phases, which differ from each other in their purpose and the required number of trial participants. Phase I trials are usually small and meant to test the safety of the vaccine. In the larger Phase II Jessica Ho is a Junior at the University of Pennsylvania and is majoring in Economics and Health and Societies, with a concentration in Disease and Society.

Email: yjho@sas.upenn.edu Dr. Arthur Caplan is the faculty sponsor for this submission. He is the Emanuel and Robert Hart Professor of Bioethics at the University of Pennsylvania Address: 3401 Market St., Philadelphia, PA, 19118 Email: caplan@mail.med.upenn.edu Penn Bioethics Journal Vol. IV, Issue i Fall 2007

trials, researchers look for the vaccine’s ability to stimulate an immune response. In the largest trials, Phase III trials, scientists strive to demonstrate efficacy – that the vaccine actually works in preventing the disease (Specter, 2003, p.

57). Without completion of these three phases, there will be no regulatory approval, no HIV vaccines licensed, and no products developed (Esparza and Bhamarapravati, 2000, p. 2062). Lengthy and complex, clinical trials are the most costly and time-consuming steps in the development of any new pharmaceutical product. This has been particularly true for HIV vaccine research. It has been estimated that in the most optimistic scenario, six to nine years would elapse between the start of Phase I trials and seeing the results from Phase III trials for an HIV candidate vaccine (Esparza, 2001, p. 1135). The recent phase III failure of a long-anticipated HIV vaccine in development by Merck exemplifies this challenge (See accompanying article).

Causes of Delay While HIV candidate vaccines do exist, economic, ethical, logistical, political, and scientific factors are hindering progression through Phase III trials (Guenter, Esparza, & Macklin, 2000, p. 37). In order to test vaccine efficacy, large populations with high incidences of the disease are required. Because these populations are primarily located in developing countries, not only are there shortages of appropriate trial sites, but the areas where trials must take place are generally very poor and politically unstable (WHO-UNAIDS HIV Vaccine Initiative and the Quality Assurance and Safety of Biologicals Team of the World Health Organization, 2002, p. W22). Often, developing countries lack adequate research facilities and staff, which is “a major bottleneck to the conduct of clinical trials” (Coordinating Committee of the Global HIV/AIDS Vaccine Enterprise, 2005, p. 0116.) The scarcity of local investigators may be due to lack of sufficient training and/ or expertise to undertake the trials or to commitments to other research projects (WHO-UNAIDS, 2002, p. W22).

It is widely acknowledged that strong political and community support is necessary to conduct clinical trials.

In countries with highly unstable governments, such as Sudan, Côte d’Ivoire, and many other African countries, civil strife can greatly retard researchers’ progress and ability to begin and sustain clinical trials. Scientists are often unable to run clinical trials without community support, which is often challenging to procure. Public awareness of AIDS and infectious disease transmission may be limited, with

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greater attention being devoted to basic survival needs such as clean drinking water. Furthermore, international research often proves extremely burdensome for the trial communities and participants. Clinical trials by nature impose inconvenience and uncertainty on research subjects.

They face possible threats to their health, stigma, time loss, and the risk of exploitation (Shapiro & Benatar, 2005, p.

42). Other commonly cited reasons for refraining from enrollment include a fear of side effects from the vaccine, worse being the possibility of contracting HIV itself from the vaccine, difficulties with obtaining insurance, and a distrust of drug companies, the government, researchers, and clinical research in general (Mills et al, 2004, p. 2239). A complex ethical problem arises when individuals who want to participate in trials may be prevented from doing so by tribal leaders or village elders who withhold their approval (Bayer, 2000, p. 1053).

Ethical Issues Time and resources are not the only constraints in this stage of HIV vaccine development. Clinical trials of HIV vaccines have proven particularly controversial in both the scientific and the wider community. A deceptively simple, one-line description- “Phase III generally involves several thousand healthy volunteers at a relatively high risk of HIV infection”- instantly suggests a number of ethical issues (Bayer, 2000, p. 1051-1052). A tension exists between the need to clearly and efficiently demonstrate vaccine efficacy and to protect trial subjects (Bayer, 2000, p. 1051-1052). In order to establish efficacy, new infections must occur since the results must show a difference in incidence between the control and the treatment group. A conflict of interest arises between researchers, who need to prove efficacy, and trial participants, who naturally desire to protect themselves (Guenter et al, 2000, p. 40).

It has been proven that HIV can be prevented by reductions in risky behavior through interventions such as counseling and STD barrier methods. However, if the ethical imperative is followed, study results could be jeopardized. A decrease in the risk and incidence of HIV infection in the entire community could reduce the power of the study to determine whether the trial results were due to public health interventions or the efficacy of the vaccine candidate (Bayer, 2000, p. 1051-1052).

International Conflicts A disconnect between foreign and local priorities can lead to accusations of paternalism and exploitation. Ethical issues arise early with the selection of HIV subtypes for vaccine candidates. Developed and developing countries have different priorities for a vaccine, depending on which strains are most prevalent in their regions. A developed country may invoke tensions if it initiates a clinical trial for a vaccine targeting a subtype which is not one of the host

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country’s priorities (Abdool Karim, 2000, p. 2129). Since vaccines against certain subtypes may not prevent infection by other subtypes, it makes sense for the strains included in candidate vaccines to be those which are most prevalent in the trial population. However, even this proves problematic in African countries where circulating recombinant forms (CRFs) exist (Esparza & Bhamarapravati, 2000, p. 2063).

CRFs are created when different subtypes of the HIV virus recombine to create new, infectious hybrid viruses (Esparza, 2001, p. 1134).

Any time a developed country enters a developing country to conduct a clinical trial, its actions are closely scrutinized because of the huge disparities which exist between the industrialized and developing worlds. If regulatory authorities and institutional review boards (IRBs) are not well-developed in host countries, political and economic interests can influence which vaccines proceed in clinical trials. For example, after failing to secure the support of local AIDS researchers, a U.S.-based company offered the president of South Africa a free license to test its vaccine (Abdool Karim, 2000, p. 2129). It is evident that developing countries may be averse to trusting pharmaceutical companies and researchers from sponsoring countries, as well as their governments. Lawrence Corey, the principal investigator of the HIV Vaccine Trials Network, has identified another dimension of the situation: “We are asking the Third World to take risks that we have actually never taken ourselves. Every other time that we have gone in with a vaccine – whether polio, measles, mumps – we have been able to say, ‘It works on our people.’ With AIDS, we can’t say that” (Specter, 2003, p. 64).

Other sources of friction include differing ethical standards for holding clinical trials. The CIOMS Guidelines (formally the International Ethical Guidelines for Biomedical Research Involving Human Subjects), which lay out a set of ethical principles for human experimentation, dictate that when research is externally sponsored, it must be reviewed by both the sponsoring and the host countries (Bayer, 2000, p. 1055). This leads to a dilemma: if the ethical norms and standards of care differ between countries, whose rules prevail – those of the country which has developed the vaccine and is holding the clinical trial, or those of the host country? (Bloom, 1998, p. 188). Researchers are currently unsure of how to resolve a situation where the review board of the host country permits the research but the sponsoring nation fails to approve (Bayer, 2000, p. 1055). Overall, trial sponsors run the risk of appearing paternalistic or imperialistic despite intentions to prevent the exploitation of host countries.

The Standard of Care Debate Worldwide, scientists, ethicists, funders, and governments have been unable to agree on an accepted standard of care for trial participants who contract HIV

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The Search for an HIV Vaccine: Ethical Issues of Phase III Clinical Trials

during the course of a clinical trial. In the general case, factors such as time, duration, and severity of the disease are considered for provision of care during a clinical trial.

The situation is complicated when the disease is a chronic rather than acute condition and when the trials are held in resource-constrained environments, as is the case with HIV (Tarantola et al, 2007, p. 4867). In particular, researchers and the international scientific community are working to reach a consensus on what standard of care should be provided, to whom and for how long it should be provided, and who has the obligation to ensure that protocols concerning standard of care are implemented (Tarantola et al, 2007, p. 4866).

Recommendations range from providing the same services that are currently available to patients in the country, to the best treatment currently in existence – namely antiretroviral drugs (ARVs), or some level of care between the two. What is clear, however, is that “no country in Africa, and few countries elsewhere in the developing world, can afford Western levels of treatment” (Specter, 2003, p. 56). As of 2006, the current pricing of highly active antiretroviral treatment (HAART), the standard drug regimen for those infected with HIV, was estimated to be $730 per patient-year, although many sources cite higher numbers (Braithwaite & Tsevat, 2006, p. 0014). Use of certain generic combinations lowers this figure to approximately $300 per person per year (UNAIDS, 2003). Although drug prices are falling, spending $300 per person per year on a single disease is beyond the reach of most developing countries. Additionally, treatment of HIV/AIDS encompasses more than purchasing and supplying medications. Frequent follow-up and monitoring of patients are required due to the high prevalence of side effects from HAART and the development of drug resistance. Developing countries and even clinical trial sites may lack the infrastructure to carry out this type of surveillance on a sustainable basis.

The question of “appropriate treatment” gives rise to heated debates over extremely sensitive issues. Because the majority of clinical trials for HIV candidate vaccines must be performed in developing countries, one of the main fears is the creation of a “double standard” for developed and developing countries owing to funding and infrastructure capacities. Those observing the progress and protocols of clinical trials may ask if appropriate treatment in a rural African community can be equated to appropriate treatment in a major U.S. city. Clinical trials conducted in America or Europe require that infected participants receive the best available care, a lifetime regimen of ARVs, but for similar trials held in developing countries, the prospect seems unfeasible (Specter, 2003, p. 56).

A number of people feel that it is morally unacceptable to allow patients to go untreated, particularly if treatment exists and is known to be effective. Additionally, medical Penn Bioethics Journal Vol IV, issue i Fall 2007

care provided through clinical trials can be viewed as a way to reduce harm to and compensate trial participants, a health intervention, and a means of distributing resources more equitably across industrialized and developing nations. If vaccine trials also serve as health initiatives, there exists an obligation to treat host populations when life-threatening or severe health conditions are detected over the course of a trial, even if they are unrelated to the trial’s purpose (Tarantola et al, 2007, p. 4868). Some argue that global responsibilities may go even further than the provision of treatment for HIV/AIDS. Kathy Shapiro and Solomon Benatar maintain that rich countries sponsoring research in poorer countries have greater access to resources and are therefore ethically obligated to contribute to sustainable improvements in the health of developing nations (Shapiro & Benatar, 2005, p. 39).

Another viewpoint focuses on the many economic and logistical difficulties that would be incurred in providing the best available medical care. A particularly provocative analysis of the situation concludes that “if the rules of clinical trials required participants to receive the best care on earth, there would be no clinical trials” (Specter, 2003, 65). As a result, proponents of this view argue, the world as a whole would benefit more from continued scientific advances and furthering of medical knowledge than from implementing guidelines that would make HIV vaccine trials and other scientific research impossible to conduct.

Challenges The logistical, economic, and ethical barriers involved in providing medical care during clinical trials are both formidable and numerous. One of the easily identifiable consequences of providing lifetime ARV therapy to infected trial participants is a sharp decrease in the scientific community’s ability to carry out clinical trials. Funding and infrastructure would be insufficient for full provision of such care. Furthermore, manufacturers’ and other trial sponsors’ incentives to conduct essential research in developing countries would be eroded (Berkley, 2003, p.

992). High costs would likely deter sponsors, researchers, and local health authorities from initiating innovative and more ambitious projects (Tarantola et al, 2007, p. 4869).

Patients who become infected with HIV need ARVs for the rest of their lives, since ARVs are non-curative and merely delay progression to AIDS. The drug regimens are not only extremely expensive but also complex to administer. Local health workers may not have the training to provide such treatment. In addition, patients often experience numerous adverse effects from the drugs.

Without the proper infrastructure in place for monitoring individuals who are taking the ARVs, patients are put at significant risk of harmful side effects resulting from treatment (Guenter et al, 2000, p. 41). Drug resistance to HIV is common and has resulted in the development

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of costlier, second-line drugs to replace first-line therapy.

Access to and administration of second-line drugs poses yet another challenge to the health systems of developing countries.

Additionally, an array of equity issues arises from provision of treatment. For example, it seems unpalatable that trial participants would be exposed to high risk situations but reap no benefits from their participation.

At the same time, community and familial relations can become tense if volunteers receive free and better medical care than other people in the same villages and their own family members, who may receive treatment from an abysmal public system. Analysts caution that “despite good intentions, well resourced, research sponsored care in an otherwise impoverished healthcare facility is a microcosm of global health inequities” (Shapiro & Benatar, 2005, p.

40).

Scientists holding clinical trials are seen to walk a thin line between exploitation and bribery. In resourcepoor areas, access to the medical care provided to trial participants can be seen as undue inducement to participate in a clinical trial (Specter, 2003, p. 57). A counterpoint to this view states that “access to health care when this is otherwise unavailable is arguably valuable enough to outweigh what are understood to be risks of participation” (Shapiro & Benatar, 2005, p. 40). However, care is often expensive and proves unsustainable at the trial’s conclusion (Shapiro & Benatar, 2005, p. 40).

Conclusion In recent years, stakeholders in HIV research have developed novel programs to actively confront and resolve the standard of care dilemma. For U.S. researchers, the situation has proven particularly difficult due to the congressional statute that National Institutes of Health (NIH) research funds cannot be used to pay for treatment that is not the specific focus of the research being undertaken (Fitzgerald et al, 2003, p. 993). However, in 2003, the HIV Vaccine Trials Network (HTVN), a collaboration of scientists from 28 research sites, announced that participants who become infected during HTVN trials will receive long-term antiretroviral treatment.

Some factors involved in this decision include the belief that provision of ARVs is now feasible, improved ethics guidance from the international community, and the view that providing treatment may aid research by assuring parity between participants at all stages of the trials (Fitzgerald et al, 2003, p. 993).

Initiatives such as those created by IAVI and the South African AIDS Vaccine Initiative (SAAVI) are

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promising steps toward greater international consensus on HIV vaccine research. These programs are indicative of researchers’ noteworthy efforts to actively consider the application of ethical principles to their work and interpret them to the best of their ability (Berkley, 2003, p. 992).

It is hoped that they will also facilitate open discussion, resolution of these ethical issues, and fulfillment of the overarching goal: developing an HIV vaccine.

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Abdool Karim, S.S. (2000). Globalization, ethics, and AIDS vaccines. Science, 288(5474), 2129.

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Bayer, R. (2000). Ethical challenges of HIV vaccine trials in less developed nations: conflict and consensus in the international arena. AIDS, 14(8), 1051-1057.

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Berkley, S. (2003). Thorny issues in the ethics of AIDS vaccine trials. Lancet, 362(9388), 992.

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Bloom, B.R. (1998). The highest attainable standard: ethical issues in AIDS vaccines. Science, 279(5348), 186-8.

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Braithwaite, R.S., & Tsevat, J. (2006). Is antiretroviral therapy costeffective in South Africa? PLoS Medicine, 3(1), 0014-5.

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Coordinating Committee of the Global HIV/AIDS Vaccine Enterprise.

(2005). The global HIV/AIDS vaccine enterprise: scientific strategic plan. PLoS Medicine, 2(2), 0111-0121.

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Esparza, J., & Bhamarapravati, N. (2000). Accelerating the development and future availability of HIV-1 vaccines: why, when, where, and how? Lancet, 355(9220), 2061-2066.

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Esparza, J. (2001). An HIV vaccine: how and when? Bulletin of the World Health Organization, 79(12), 1133-1137.

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Fitzgerald, D., Pape, J., Wasserheit, J., Counts, G., & Corey, L. (2003). Provision of treatment in HIV-1 vaccine trials in developing countries. Lancet, 362(9388), 993-994.

10. Guenter, D., Esparza, J., & Macklin, R. (2000). Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS). Journal of Medical Ethics, 26(37), 37-43.

11. The Kaiser Family Foundation. (2007, July 11). HIV/AIDS Policy Factsheet: the HIV/AIDS Epidemic in the United States. Retrieved July 26, 2007, from http://www.kff.org/hivaids/upload/3029-071. pdf.

12. Mills, E., Cooper, C., Guyatt, G., Gilchrist, A., Rachlis, B., Sulway, C., et al. (2004). Barriers to participating in an HIV vaccine trial: a systematic review. AIDS, 18(17), 2235-2242.

13. Shapiro, K., & Benatar, S.R. (2005). HIV prevention research and global inequality: steps towards improved standards of care. Journal of Medical Ethics, 31(1), 39-47.

14. Specter, M. (2003, February 3). The vaccine. The New Yorker, 78(45), 54-65.

15. Tarantola, D., Macklin, R., Reed, Z.H., Kieny, M.P., Osmanov, S., Stobie, M., et al. (2007). Ethical considerations related to the provision of care and treatment in vaccine trials. Vaccine, 25(26),4863-74.

16. Tonks, A. (2007). The quest for the AIDS vaccine. British Medical Journal, 334(7608),1346-1348.

17. UNAIDS: The Joint United Nations Programme on HIV/AIDS. (2003). Fact Sheet: Access to HIV Treatment and Care. Retrieved August 3, 2007, from http://siteresources.worldbank.org/ INTEAPREGTOPHIVAIDS/Resources/fs_treatment_en_pdf.pdf.

18. UNAIDS: The Joint United Nations Programme on HIV/AIDS. (2006, December). AIDS Epidemic Update – Dec 2006. Retrieved July 26, 2007, from http://data.unaids.org/pub/EpiReport/2006/2006_ EpiUpdate_en.pdf.

19. WHO-UNAIDS HIV Vaccine Initiative and the Quality Assurance and Safety of Biologicals Team of the World Health Organization.

(2002). Scientific considerations for the regulation and clinical

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Penn Bioethics Journal Vol IV, Issue i Fall 2007

Penn Bioethics Journal Vol. IV, Issue i

Recent Development Focus: Failure of the Merck HIV Vaccine Author: Kavita Vinekar, University of Pennsylvania

The submission of the above paper coincided with Merck’s announcement of the failure of its HIV vaccine, V520, in phase II clinical trials in September 2007.

The vaccine was administered in randomized doubleblinded trials to 3,000 uninfected “high-risk” volunteers, primarily in the US and Latin America. After initiation of the trial in 2004, more cases of HIV contraction were reported in the treatment group than in the placebo group. The trial was immediately halted after this finding.

V520 was the first in a new class of HIV vaccines that uses a weakened flu adenovirus to deliver synthetic HIV genes to blood cells.

Upon the discovery of the ineffectiveness of Agence France-Presse / Mehdi Fedouach V520, Merck also halted clinical trials of another vaccine in South Africa. Currently, human clinical trials are being performed on nearly 30 HIV vaccines developed by other companies.

The Merck vaccine failure brings forth pertinent bioethical issues. The glaring concern is that of trial subject protection. Currently, the reason for a higher incidence of HIV in the treatment arm of the Merck trial remains unknown. Still, the ethicality of administering such poorly understood drugs to high-risk patients is questionable.

Furthermore, the implications of this vaccine failure for future HIV vaccine trials have been brought

into question. The AIDS Vaccine Advocacy Coalition asserted in a statement that the failure “is in no way the end of the search for an AIDS vaccine”. Even so, the recruitment of volunteer participants in future vaccine trials after such a highly publicized failure may dramatically affect future clinical trials.

Finally, this is a unique case in HIV drug trials in that many of the trial subjects were US residents (rather

Agence France-Presse / Narinder Nanu

than residents of developing countries). The extent to which this fact affected the responses of scientific, intellectual and corporate communities is not easily determinable, but provides for provocative speculative discussion.

Source: 1. Altman, L.K., Pollack, A. (2007). Failure of Vaccine Test Is Setback in AIDS Fight. New York Times.

Kavita Vinekar is a Junior at the University of Pennsylvania and is majoring in Biology and minoring in English.

She is also a managing editor of the Penn Bioethics Journal.

Email: kavitasv@sas.upenn.edu

Penn Bioethics Journal Vol. IV, Issue i Fall 2007

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Inside: Exclusive Interview with RenĂŠe Fox The Effects of Society on the Development and Categorization of Mental Illness Moral Permissibility of Abortion Gradualism and the Fetus The Need for Patient Preference Research: A Case Study in the Rationing of Limited Resources for Treating HIV/AIDS Patients The Search for an HIV Vaccine: Ethical Issues of Phase III Clinical Trials