Princeton Journal of Bioethics - 2016 by Princeton Journal of Bioethics

XIII | 2016 Fall 2016 Volume XIII Volume | Fall

Princeton Journal of Bioethics

Foreword On behalf of the staff of the Princeton Journal of Bioethics, we are pleased to present the thirteenth issue of the Journal. The eight papers included in this edition of the Journal explore a diverse set of ethical issues, including the responsibility of physicians to address conditions leading to poor health, the regulation of dietary supplement usage, the involuntary hospitalization of patients with anorexia nervosa, the regulation of malfunctioning medical devices, the North/South divide in mental health understanding and treatment, the advance directives of dementia patients, the legal permissibility of placebo-controlled trials, and the use of nursing homes to house elderly patients. We hope you find these pieces stimulating and that they inspire you to further explore the wide field of bioethics. Established in 1997 as the first undergraduate bioethics publication in the nation, the Princeton Journal of Bioethics provides a forum for undergraduate discussion of the compelling bioethical issues ofthe modern era and serves to highlight exceptional undergraduate research from universities nationwide. This past year has been one of profound growth of the Journal, which has increased its distribution worldwide and has

Staff received record levels of submissions from which those of highest quality have been carefully selected, reviewed, and revised. We would like to thank both the student writers and Journal staff editors, whose dedication and hard work have been instrumental in establishing the Journal as both a leading resource and outlet for undergraduate scholars in this emerging field of study. We would also like to thank Joseph Redmond for lending his incredible design and layout skills to make the Journal’s publication possible. Furthermore, we greatly appreciate the commitment and support of the Technical Review Board of professionals in bioethics who have contributed their time and experience to ensure the accuracy and quality of the Journal. We hope that the Journal provides you with new perspectives and material to ponder, debate, and discuss. It is only through sustained dialogue and awareness that progress in bioethics can be made, and we invite you to become an active participant in this exciting and rapidly growing field. We encourage any readers interested in biology, medicine, philosophy, law, or research to submit their work for possible future publication.

Thank you and enjoy this issue of the Princeton Journal of Bioethics.

Sincerely, David Weiner

Maria Wissler

Editors-in-Chief

Editors-in-Chief: David Weiner ‘18 Maria Wissler ‘18

Editorial Staff: Metodi Balev ‘18 Varun Bhave ‘19 Morgan Brewton-Johnson ‘18 Bo-Ryene Chung ‘18 Carol Gu ‘17 Julianna Hsing ‘16 Julia Langer ‘16 Gabriella Molina ‘18 Michael Moorin ‘16 Summer Ramsay-Burrough ‘17 Nandita Rao ‘17 Maddy Russell ‘16 Emerson Salovaara ‘19 Min Ji Suh ‘18 Janelle Tam ‘17 Xiao Yang Yu ‘18

Executive Layout Editor / Graphic Designer: Joe Redmond ‘18

Layout Editors: Megan Abbott ‘16 Ashley Stone ‘19

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Princeton Journal of Bioethics

Technical Review Board We would like to extend our appreciation to the professionals on our Technical Review Board who donated their time and expertise to ensure the accuracy and quality of the Journal.

Joseph Amon, Ph.D. Lecturer of Public and International Affairs Princeton University Robert George, J.D., Ph.D. McCormick Professor of Jurisprudence Princeton University Eric Gregory, Ph.D. Professor of Religion Princeton University Irene Jillson, Ph.D. Assistant Professor in the School of Nursing and Health Studies Georgetown University Harold Shapiro, Ph.D. President Emeritus/Professor of Economics and Public Affairs Princeton University Peter Singer, B.Phil. Ira W. DeCamp Professor of Bioethics Princeton University Shirley Tilghman, Ph.D. President Emerita/Professor of Molecular Biology Princeton University

Princeton Journal of Bioethics

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Contents

6 9 20 28 31 38 43 49 4

A Closer Look at â&#x20AC;&#x153;Greater Physician Accountabilityâ&#x20AC;?: Negotiating Idealism with Pragmatism

Melina Manolas | Cornell University

Regulation of Dietary Supplement Usage by Hospitals: An Ethical Mandate?

Christina Seluzicki | University of Pennsylvania The Most Compassionate Aid: An Analysis of the Ethical Imperative to Treat Involuntary Patients with Severe Anorexia Nervosa

Lauren Abruzzo | Northwestern University

Defects and Decisions: A Case Study in the Ethics of Medical Device Failure

Karen Hsu | Northwestern University

The North/South Paradigm in Global Mental Health: Definitions and Interventions

Rebecca Rinehart | Georgetown University A Loss of Character: Dementia and Advance Directives

Safwan Jalal | Cornell University

The Moral and Legal Permissibility of Placebo-Controlled Trials

Mina Henaen | Princeton University Elderhood: a Case for Abolishing Nursing Homes in the United States

Richard Chen | Cornell University

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The articles herein do not reflect the views of the Princeton Journal of Bioethics.

Princeton Journal of Bioethics

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A Closer Look at “Greater Physician Accountability” Negotiating Idealism with Pragmatism Melina Manolas Cornell University This paper examines whether physicians have a special responsibility to not only treat their patients, but also to seek to alter the conditions that are creating ill-health among the populations they serve. Despite positive support for a widened and idealistic view of physician accountability, it is tractable to critique, poorly defined, and comes with unique bioethical implications. Upon closer look, “greater physician accountability” might not be feasible in practice if we negotiate idealism with pragmatism. It is ineffectual if it perpetuates a mere cognitive understanding rather than substantive action, and leads to unintended, sometimes dangerous, consequences that violate the ethical principle of non-maleficence. This paper argues why it is not yet justifiable to expect physicians to act upon this call for increased accountability, particularly by examining the current medical education system that trains physicians and the complex structural and social levels onto which this accountability plays out. Re-conceptualization toward a more collaborative approach among disciplines, health professionals, and institutions might prove to be more effective and sustainable in improving health care equity and outcomes.

With a push for “greater physician accountability” comes the expectation for physicians to not only treat their patients, but also to seek to alter the conditions that are creating ill-health among the population they are treating. In this view, physicians hold a special and unique responsibility within the social justice system to address local and global health issues, especially as they pertain to the underserved and destitute sick. Although seemingly beneficent in its intent and outcomes, this broadened view of physician accountability is susceptible to critique. I argue that the current medical education system does not adequately train physicians to take on this accountability, and the many complex and interlacing levels at which this accountability comes into play makes its attribution more complicated than it may first appear. The idealism of what a doctor should do ought to be contrasted against the pragmatism of what a doctor can feasibly do. As it stands, it is not justifiable to expect physicians to act upon this call for greater physician responsibility, which has both limitations and bioethical implications seriously challenging its validity. In fact, an entirely re-strategized, collaborative approach might be the more compelling and feasible course of action toward promoting health care

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equity. As an anthropologist and physician widely known for his humanitarian work providing health care to under-resourced areas in developing countries, Paul Farmer firmly believes that physicians, given their privilege, should be judged by a “special calculus of responsibility” (Farmer, 2005, p. 210). He is an advocate for targeting health care wherever the pathology lies heaviest– where “the patients are sicker and poorer, but what you do makes more of a difference” (Hopkins, Living in Emergency). This standpoint does indeed have merit - much can be accomplished by treating systemic roots of health problems rather than simply treating effects and leaving the causes untouched. As social justice becomes inserted into medical ethics discussions, I agree that improving health outcomes should account not only for cutting-edge biomedical technology, but also the social, political, and environmental determinants of health disparities (Turner, 2005, p. 377). In the context of Egypt, where water pollution contributes to the country’s growing burden of renal disease, this would mean advocating for cleaner water systems rather just pushing for more dialysis machines when the kidney failure manifests (Hamdy, 2008, p. 563). Nev-

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ertheless, it remains unclear whether “greater physician accountability” means targeting care for the suffering poor, attempting to address the underlying structural causes that contribute to their ill health, or both. As a term it remains abstract in that it has not been institutionally defined nor does it have set limits. This makes it less of a clear framework to act upon and more of a mere rhetorical understanding or discussion point. Secondly, it is difficult to reconcile the various levels at which this responsibility comes into play. There is the structural level, where health inequities manifest as a result of built and social environments, and the individual level, where those forces become embodied as individual experiences of illness. It is not necessarily valid to require physicians, who typically treat patients at the individual level, to address illness-contributing forces that exist on an expansive, social level. Not to mention that to do so can be a paralyzing challenge for a single physician. Social workers, lawyers, policy makers in government and legislation, and public health leaders would add key interprofessional perspective. We need to recognize the value in a collaborative approach that holds multiple professions and health care institutions accountable, not just physicians. Furthermore, physicians cannot be called out for lack of accountability without addressing the role, or lack thereof, their medical education plays in preparing them to tackle such issues of structural inequity. Frederic Hafferty and Ronald Franks, pioneering voices of professionalism in medicine who have extensively studied the structure of medical education, have found that traditional physician training models do not place emphasis on cultural competence or basic public health principles. In fact, they are historically structured to de-emphasize macro communities by using case studies and framing learning within the context of the doctor-patient relationship (Hafferty and Franks, 2004, p. 867). This can lead to a “blindness to the social”, where physicians and health institutions look purely at biological, clinical factors when presented with sick patients. Patients, however, are not merely bodies to be fixed when they are ailing, but unique human stories heavy with sociocultural meaning. Thus, a potential for cultural myopia or blindness in medical school graduates does not project well onto greater physician accountability to treat diverse and underserved populations. This begs the question – if physicians are schooled and disciplined to prioritize clinical case facts and high-tech interventions over broader public health measures and lower-tech medicine that might be more effective in treating underserved patients, is it justifiable

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to expect them to do otherwise? Unless the structure of medical education is changed to de-emphasize individualism and examine more interdependent sociological issues that contribute to health, physicians cannot be expected to act upon this call for greater accountability. We must also be wary of unintended consequences. By broadening the responsibility we attri-

The idealism of what a doctor should do ought to be contrasted against the pragmatism of what a doctor can feasibly do. As it stands, it is not justifiable to expect physicians to act upon this call for greater physician responsibility, which has both limitations and bioethical implications seriously challenging its validity. bute to physicians, it can become easier for medicine to serve the dangerous purposes of political expediency, as in the apartheid state. In South Africa, physician accountability for marginalized black women at one point became distorted and used as an excuse to manipulate reproduction for state eugenic policy (De Gruchy & Baldwin-Ragaven, 2000, p. 312). This suggests the difficulty of drawing a line between “helping” an underserved patient and compromising that patient care for the purpose of a larger sociopolitical cause. We also cannot assume that physicians who account for sociopolitical factors in their provision of medical care will not exploit that responsibility. “The presumption that doctors and scientists would behave ethically reflects the hegemony of scientific positivism, and of rationalism more generally” (p. 324). In places like South Africa, where black female bodies have been historically disrespected, it has been difficult for health professionals to take on women-centered practice styles and redress power imbalances. Similarly, the case of the Israeli Open Clinic is an example of how a humanitarian aid organization involving physicians can become a placeholder for a state lacking in a comprehensive or functioning

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health care system (Gottlieb, 2012, p. 840). The physicians working in an “Open Clinic” run by an Israeli human rights organization, in the process of trying to give voice to marginalized population needs, obstructed medical treatment by becoming politically involved. By operating the clinic, physicians entered a relationship with patient communities that could not be easily withdrawn. Relieving the state of its responsibilities to address the healthcare needs of its underserved populations led physicians to become involved in roles that go beyond healing, such as humanitarian and legitimizing political advocate. Discrepancies in the health care delivered by the physicians to asylum seekers versus immigrants also raises critical issues of “deservingness” in discourse about accountability (p. 844). Yes, physicians should ideally target their care to those most in need, but what counts as need? Despite the good intentions of their humanitarian work, physicians found that they took on too much to handle with the frustrations of low-grade medicine and lack of governmental support, and in turn the quality of the medical care suffered. Acting on this principle of “greater physician accountability” becomes unethical if it compromises the medical treatment of individual patients. Ironically, it is highly educated experts and health professionals who are having these discussions, rather than the actual populations that would be impacted most by broadened physician accountability. Without placing rhetoric of “greater physician responsibility” in the context of power imbalance, the phrase alienates the target populations by not giving them a voice in this matter. This somewhat narrow frame of an ideal physician with both privilege and increased responsibility hides other important questions. Is it currently feasible for physicians to be advocates both inside of health institutions (offices, clinics, hospitals, etc.) and outside of them (local and global community networks)? What does the physician sacrifice personally and professionally if their practice shifts to target the “neediest” patients? Should physicians who practice in high-need areas be receiving higher monetary reimbursement, and should other physicians be incentivized to do the same? These are the kinds of questions that need to be asked when considering the validity and feasibility of “greater physician accountability”. This is not to say that there is not a rightful calling for a socializing of medical ethics and a time for physicians to prioritize care for destitute sick and underserved populations. Even though there is no “prescription”, so to speak, for poverty, violence, unemployment, environmental racism, etc., there is still potential for physician action to permeate the streets

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where the connection between structural disparity and ill health develops. The important question, however, is whether practice can and will keep up with rhetoric. Speaking of accountability in idealistic terms is both hopeful and necessary to provoke discussion and jumpstart change, but it is limiting if it perpetuates a mere cognitive understanding rather than substantive action. As it stands, physicians cannot be expected to act upon the principle of “greater physician accountability”, a term which remains obscure and comes with serious ethical implications. Moving forward, it should be re-conceptualized and re-strategized as a more collaborative approach toward establishing sustainable links between marginalized populations, health care institutions, and socioeconomic support systems. References De Gruchy, Jeanelle, Baldwin-Ragaven, Laurel. “Serving Nationalist Ideologies: Health Professionals and the Violation of Women’s Rights: The Case of Apartheid South Africa,” in Globalizing Feminist Bioethics, Rosemarie Tong, ed. Boulder, CO: Westview Press (2000): 312-333. Farmer, Paul. “New Malaise: Medical Ethics and Social Rights in the Global Era,” in Pathologies of Power: Health, Human Rights, and the New war on the Poor. Berkeley: University of California Press (2005): 196-212. Print. Gottlieb, Nora, Dani Filc, and Nadav Davidovitch. “Medical Humanitarianism, Human Rights and Political Advocacy: The Case of the Israeli Open Clinic.” Social Science & Medicine 74.6 (2012): 839-45. Web. Hafferty, Frederic. W., and Ronald Franks. “The Hidden Curriculum, Ethics Teaching, and the Structure of Medical Education.” Academic Medicine 69.11 (1994): 861-71. Web. Hamdy, Sherine F. “When the State and Your Kidneys Fail: Political Etiologies in an Egyptian Dialysis Ward.” American Ethnologist 35.4 (2008): 553-69. Web. Living in Emergency. Dir. Mark N. Hopkins. Prod. Mark N. Hopkins, Naisola Grimwood, Daniel Holton-Roth. Perfs. Chris Brasher, Davinder Gill, Tom Krueger, Chiara Lepora. Bev Pictures, 2008. Turner, Leigh. “Bioethics, Social Class, and the Sociological Imagination.” Cambridge Q. Healthcare Ethics Cambridge Quarterly of Healthcare Ethics 14.04 (2005). Web. *Note: At several points throughout this paper, I am indebted to lectures given by Professor Rachel Prentice at Cornell University (January-May 2015) in a course entitled “Ethical Issues in Health and Medicine”.

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Regulation of Dietary Supplement Usage by Hospitals: An Ethical Mandate? Christina Seluzicki Perelman School of Medicine, University of Pennsylvania

In 2013, the Children’s Hospital of Philadelphia revised its policy on dietary supplements to become the first hospital in the nation to officially discourage their use. The Children’s Hospital of Philadelphia (CHOP) is questioning and regulating dietary supplement use because the FDA does not routinely review the manufacturing of dietary supplements, and therefore cannot guarantee their safety and effectiveness. There are a number of arguments for and against CHOP’s decision, including lack of regulation, insufficient research, patient-provider communication, lack of provider education, unknown interactions with prescription medications, and recognition of other cultural healing systems. As the popularity of CAM in the U.S. continues to increase, dollars invested in the dietary supplement industry reach into the billions, and few health care institutions have formal stated policies regarding dietary supplement use, CHOP’s new regulation is an important and far-reaching medical ethics issue. By using an abundance of caution, CHOP is creating an environment in which patients and health care providers are more aware of the state of dietary supplement regulation and safety and will make more educated decisions about their use.

In October 2013, the Children’s Hospital of Philadelphia (CHOP) became the first hospital in the nation to essentially disallow the use of dietary supplements in what was widely reported as a “ban” on their use (Kabat, 2013; Abrams, 2013). CHOP is known as the first hospital in the country dedicated to the care of children and is consistently ranked as one of the best children’s hospitals in the United States (“Rankings & Ratings”). But the institution had generally not included many forms of complementary and integrative medicine (CIM) or complementary and alternative medicine (CAM), of which dietary supplements are included, in the care of its young patients. As the popularity of CAM in the U.S. continues to increase and dollars invested in the dietary supplement industry reaches into the billions (Sax, 2015, 375), CHOP’s new regulation is an important medical ethics issue. The role hospitals and health care providers should play in the regulation of patients’ dietary supplement usage is complex because it brings together questions of patient autonomy and patient safety with

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a largely unregulated multi-billion dollar industry frequently marketed as an essential part of a healthy lifestyle. Dietary supplements are defined as “vitamins, minerals, herbs, botanicals, amino acids, enzymes, and animal extracts meant to ‘supplement’ the diet and…not intended to replace a healthy diet or to treat, diagnose, prevent, or cure diseases” (“Research Communications”). While it may seem that CHOP was being overly restrictive in its decision to discourage the use of dietary supplements, there are many arguments that support this decision. Although the solution may not be an ideal one, considering the huge patient safety questions that remain unanswered for both children and adults, not enough is known about the content and interactions of the vast majority of products considered to be dietary supplements to safely allow their use. This concern is amplified in an inpatient setting at an institution like CHOP in which many of the patients are children who are often quite ill with complex and rare health conditions.

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Dietary Supplements and CAM Complementary and alternative medicine (CAM) is a group of medical, health care and healing systems other than those included in mainstream (allopathic) health care in the United States (“Chapter 2: Overview”). CAM includes mind and body practices such as acupuncture, meditation, yoga, massage therapy, tai chi, and hypnotherapy (“CAM Basics”) and ancient

The role hospitals and health care providers should play in the regulation of patients’ dietary supplement usage is complex because it brings together questions of patient autonomy and patient safety with a largely unregulated multi-billion dollar industry frequently marketed as an essential part of a healthy lifestyle. healing systems including Ayurveda, from India, and Traditional Chinese Medicine (“Chapter 2: Overview,” “Complementary and Alternative Medicine”). Dietary supplements, including natural products, like herbs, probiotics and vitamins and minerals, are a part of CAM. The use of many forms of CAM in conjunction with allopathic medicine is on the rise (Tovey, 2004, 51) and herbal medicine and use of dietary supplements may be one of the fastest growing areas (Cohen, 2000, 107). The NIH’s National Center for Complementary and Alternative Medicine (NCCAM) reports that results from its 2007 Complementary and Alternative Medicine National Health Interview Survey (NHIS) indicate that 38% of adults (approximately 83 million people) and 12% of children use some form of CAM (Nahin, 2009, 1). The survey also found that adults spent nearly $34 billion on out-ofpocket visits to CAM practitioners and on purchases of CAM products, classes, and materials (Nahin 2009, 3). Non-vitamin, non-mineral natural products made up nearly 44% of spending (“The Use of Complementary”). CHOP’s definition of a dietary supplement is in line with the definition put forth by the Food and Drug

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Administration (FDA), which Congress defined in 1994 in the passage of the Dietary Supplement Health and Education Act (DSHEA) as, “a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet. The ‘dietary ingredients’ in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet” (“Research Communications”). Dietary supplements are considered to be foods, not drugs (“Strength Knowledge”). Because individual dietary supplements can be classified in different ways, causing confusion as to the category in which they belong, many are sold as combination products containing numerous ingredients (Glisson, 2010, 577). CHOP provides the following as examples of some of the most commonly used supplements: melatonin, Echinacea, chondroitin sulfate, glucosamine, CoEnzyme Q10, milk thistle and probiotics (“Research Communications”). Dietary Supplement Use Since the passage of the DSHEA in 1994, use of dietary supplements in the U.S. has soared. The DSHEA defines dietary supplements, but leaves them largely unregulated, with consumers spending some $23 billion annually on “natural products marketed to maintain or enhance health” (Ashar, 2008, 91). In fact, the DSHEA is estimated to have resulted in average annual growth rates of 15-20% for the dietary supplement industry in the 1990s (Gershwin, 2010, 107). A 2006 national survey of dietary supplement use found that 48% of the U.S. adult population reported using some type of dietary supplement, with one survey of 2,000 adults indicating that 85% had used one or more type of supplement in the past year (Timbo, 2006, 1966). More recently, a 2010 study states that 40-60% of Americans report using some type of dietary supplement (Gershwin, 2010, 107). However, Americans are not replacing allopathic medicines with dietary supplements. Reports indicate that between 16% and 45% of adult Americans are taking herbal products along with their prescription medications (Sparber, 2004, 133; Ashar, 2008, 91). When it comes to dietary supplements use by children, a study by Wu et al. showed that fewer children in the U.S. use herbs or dietary supplements than adults and reported a pattern of, “moderate and

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appropriate herb and supplement use in the pediatric population” (Wu, 2013, 358). However, a significant number of children still use these products. According to the 2007 National Health Interview Survey, 37% of U.S. children use some type of dietary supplement (Dwyer, 2013, 1333). Dietary supplements and CAM in general are particularly popular with children and adolescents, especially those with chronic illnesses or disabilities requiring frequent medical care and those with a poor prognosis and limited medical treatments available (Ball, 2005, 81; Gardiner, 2008, e775; Harris, 2005, 34). Parents of hospitalized children, especially those in neonatal and pediatric intensive care units, have a strong interest in providing CAM to their children during hospitalization (Kemper, 2001, 449). The 2007 National Health Interview Child Complementary and Alternative Medicine Supplement showed that children with activity limitations due to chronic health conditions, long-term prescription use, or relatively heavy use of physician services were more likely to use herbal and dietary supplements (Wu, 2013, 361). Ball et al. reported that in a sample of 505 parents of chronically ill children and adolescents, 62% of the population used dietary supplements and 30% used non-prescribed supplements (Ball, 2005, 78). However, parents rarely discuss this use with their children’s health care provider; one study reported that only 20% of those using non-prescribed supplements had discussed their use with a health care provider (Kemper, 2001, 449; Ball, 2005, 81). These products are also used preventatively, with up to 70% of parents giving their children herbs and dietary supplements to preserve good health and treat minor illnesses (Woolf, 2010, 155). Regulation of Dietary Supplements When it comes to regulation, dietary supplements can be divided into two categories: those marketed before 1994 and those marketed after the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. The DSHEA has several aims, including defining dietary supplements and holding manufacturers responsible for safety. It also identifies how literature may be used in connection with sales, specifies types of statements of nutritional support that may be made on labels as well as certain labeling requirements, and provides for the establishment of good manufacturing practices to help ensure product quality and consistency (“Executive Summary”; Frankos, 2010, 239). In addition, its passage also led to the creation of the Office of Dietary Supplements (ODS) in the National Institutes of Health (NIH), which was charged with coordinating scientific research relat-

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ing to dietary supplements within NIH and with advising federal agencies on issues relating to dietary supplements (“Executive Summary”). In the United States, the FDA is responsible for regulating dietary supplements, but it does so under a different set of regulations than those covering “conventional” foods and drug products (prescription and over-the-counter). Under the DSHEA, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Manufacturers must make sure that product label information is truthful and not misleading. The FDA’s post-marketing responsibilities include monitoring safety, such as creating the Safety Reporting Portal, a secure online method for consumers and those in the supplement industry to voluntarily submit a report if they experience an adverse event or suspect defects in quality or safety, and product information, such as labeling, claims, package inserts and accompanying literature (“Strength Knowledge”). Furthermore, the DSHEA specifies that supplement ingredients marketed before the DSHEA do not need approval from the FDA as long as the manufacturer ensures that they are safe (Glisson 2010, 577; Frankos, 2010, 239-40; Cohen, 2012, 458). The failure to require FDA approval and instead simply trust the judgment of these manufacturers leaves the consumer open to potential harm. Advertising of dietary supplements in newspapers, magazines, direct mail, radio, television, or the Internet is regulated by the Federal Trade Commission (FTC), which requires that all information about supplements be truthful and not misleading. The FDA is responsible for acting against marketed dietary supplements that are unsafe (Glisson, 2010, 578). It must offer evidence that a product is unsafe, contains a controlled substance or does not have ingredients it claims to have before the product may be removed from the market (Denham, 2011, 428). The FDA monitors dietary supplement safety by following adverse event reports and reviewing labeling and labeling requirements (Glisson, 2010, 578). Because the DSHEA classifies dietary supplements as foods rather than drugs, they are not regulated by the FDA’s Center for Drug Evaluation and Research, but instead by the Center for Food Safety and Applied Nutrition. Therefore, dietary supplement manufacturers are forbidden from making any drug-like claims, which means they may not market their products to treat, cure, diagnose or prevent disease (Glisson, 2010, 578). They are allowed to make “structure” or “function” claims; for example, they

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may market a product to “improve joint health” but they cannot claim to treat arthritis or joint pain (Glisson, 2010, 578). The FDA therefore requires that any dietary supplements making structure or function claims state on the label: “This claim has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease(s)” (Glisson, 2010, 578; Frankos, 2010, 239). To further ensure the quality and safety of dietary supplements the FDA implemented the Current Good Manufacturing Practices guidelines in 2007 (Glisson, 2010, 578). These practices include quarantining herbs, proper identification of herbs based on chemical composition and pharmaceutical grade production practices (Ashar, 2008, 93). The Dietary Supplements Final Rule requires manufacturers to evaluate the identity, purity, strength and composition of dietary supplements (Gershwin, 2010, 111). Despite these safety attempts, not advertising dietary supplements as drugs that serve to cure or treat an illness may lead consumers to view these supplements as harmless. This could lead to a dangerous lack of concern for the potential of these supplements to cause adverse events, alone or in combination with prescription medications consumers may be taking. Consumer Spending on Dietary Supplements The implementation of the DSHEA led to a dramatic rise in the sale of dietary supplements (Ashar, 2008, 91). In 2007, dietary supplement sales reached $27 billion, with almost 50% of Americans reporting that they use these products (Woolf, 2010, 155). However, along with these dramatic sales, many consumers of dietary supplements have assumed that because these products are “natural,” they are automatically both safe and effective (Woolf, 2010, 155). As Julie Stone writes in An Ethical Framework for Complementary and Alternative Therapists, “Much reliance in the marketing of herbal remedies is placed on the idea that these remedies are natural and, by implication, free from side effects” (Stone, 2002, 234). In fact, a 2009 U.S. Government Accountability Office report found that consumers are often not well informed about the safety and efficacy of dietary supplements (Denham, 2011, 428). Patients often assume that the FDA regulates dietary supplements in the same way as prescription medications (Woolf, 2010, 155). Nearly 60% of respondents in a national survey reported believing that dietary supplements, “must be approved by a government agency like the FDA…before they can be sold to the public” (Gershwin, 2010, 112). Furthermore, Dodge et al. reported that consumers do not understand how the FDA

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regulates dietary supplements, and that information about FDA approval did not have a statistically significant effect on their beliefs about the safety or efficacy of dietary supplements (Dodge, 2011, 230). This is a troubling finding because it suggests that consumers of dietary supplements do not seek to educate themselves about the substances they are ingesting, often in large quantities. Research on Dietary Supplements In fact, there is little data on the efficacy and safety of many of the dietary supplements currently available, though some systematic reviews and small, nonrandomized or unblinded clinical trials have recently been published (Ashar, 2008, 93). As of May 31, 2014, there were 29,483 active studies on dietary supplements according to clinicaltrials.gov. By far, the majority of these studies are categorized as “Vitamins” (22,696 or 77%), followed by “Other dietary

Despite these safety attempts, not advertising dietary supplements as drugs that serve to cure or treat an illness may lead consumers to view these supplements as harmless. This could lead to a dangerous lack of concern for the potential of these supplements to cause adverse events, alone or in combination with prescription medications consumers may be taking. supplements” (3,565 or 12.1%), “Amino Acids” (2,080 or 7%), “Herbal and Botanical” (677 or 2.3%), “Flavonoid” (254 or 0.9%) and “Mineral” (211 or 0.7%)(“See Studies by Topic”). This suggests that many scientists are conducting rigorous research in the field of dietary supplements. Considering the amount of money consumers spend on dietary supplements each year, it seems likely that research will continue to be conducted and that the rigor of the studies funded will continue to rise. However, when it comes to pediatric populations, few clinical studies support the use of herbs and dietary supplements for treating common

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childhood conditions and there are a number of research and ethical barriers to building this type of evidence base (Woolf, 2010, 155). The National Center for Complementary and Integrative Health (NCCIH) has spent more than $1 billion in research on CAM, but “laments the continuing lack of rigorous scientific studies investigating the use and safety of dietary supplements in children” (Woolf, 2010, 156). Questioning Dietary Supplement Use by Healthcare Institutions Dietary supplement use is being questioned and regulated by CHOP because the FDA does not routinely review the manufacturing of dietary supplements, and therefore cannot guarantee their safety and effectiveness (“Research Communications”). Because of this lack of regulation, there are a number of concerns about supplement use, including adverse events and drug interactions, patient non-disclosure of use, unclear contents and a lack of clinical trials. Additional concerns about children’s use of dietary supplements are related to differences between children and adult dosages. Adverse Events, Drug Interactions, and Patient Non-Disclosure of Use In general the use of herbal and dietary supplements is an issue because of adverse reactions and drug interactions (Wu, 2013, 358-59). The 1994 DSHEA did not stipulate that dietary supplement manufacturers report adverse events related to their products, meaning that the FDA was reliant on voluntary reporting. Concern about this system led to Congress passing the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act, which established a definition of serious adverse events and set requirements for labeling and mandatory reporting for the dietary supplement industry (Frankos, 2010, 240). While this was an important step toward improving the safety of dietary supplements, much is left to learn about the safety and efficacy of dietary supplements — including the adverse effects of these supplements and their interactions with medications — in the inpatient pediatric setting. Despite this lack of knowledge, many patients, or parents of pediatric patients, wish to continue using them (Gardiner, 2008, e775). Further complicating the issue is the fact that not only do patients or their parents often fail to disclose their use of dietary supplements to their health care providers (Ashar, 2008, 91; Gilmour 2011, Harris, 2005, 36), but that inpatient supplement use often goes unnoticed because physicians do not ask about its use (Boyer, 2005, 32). This makes identifying possible adverse events difficult.

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Few Clinical Trials Specific concerns about pediatric use of dietary supplements have been raised due to physiological differences between children and adults and their subsequent dosage issues as well as the presence of potentially dangerous additives or adulterants (Wu, 2013, 359). Although this type of CAM is one of the most commonly used, few studies have focused on dietary supplement use in pediatric populations and few have been found to support the use of herbs and supplements for treatment of common childhood conditions (Woolf, 2010, 156; Ball, 2005, 78). Furthermore, because the FDA does not require clinical trials for supplements before they enter the market, there is little scientific data or consensus about the benefits of these supplements for any population (Sax, 2015, 379). Unclear Contents Dietary supplements may also contain undeclared or simply unclear contents (Woolf 2010, 156). The uncertainty of a product’s contents means that it may not contain the substances as claimed on the label and that it may contain other substances that are unaccounted for, with potentially catastrophic results. A pediatric patient was inadvertently poisoned and nearly died, because his mother had been giving him an Asian patent remedy that, when analyzed, was found to contain a number of adulterants (Boyer, 2002, e49). Further complicating matters, some supplements have been intentionally “spiked” (for example, including prescription stimulant drugs in weight loss supplements or prednisone to “natural” supplements for arthritis) by unethical manufacturers looking to turn a quick profit (Glisson, 2010, 580). CHOP’s New Policy CHOP’s formulary (list of medications approved for use) will no longer include most dietary supplements. This regulation is being called a landmark case because it makes CHOP the first hospital in the United States to “discourage patients from using [dietary supplements] without a doctor’s provision as a matter of policy” (“Research Communications”). In its press release, the hospital states that it is taking this action because the FDA cannot guarantee safety or effectiveness of dietary supplements since it does not regularly review their manufacturing (“Research Communications”). As a result of these findings, CHOP created a new policy that states that when a child is admitted, his or her parent or guardian will be asked if the child is taking any medications or supplements. If the child is taking a supplement, the attending nurse or physician

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will “review the hospital’s policy discouraging the use of supplements and inform parents or guardians of the potential risks associated with the supplement.” They list these potential risks to include contamination, mislabeling, interactions with medications, or unforeseen adverse effects (“Research Communications”). Some dietary supplements will be allowed, as long as they are on CHOP’s formulary. They include some key vitamins, minerals and amino acids (Imus, 2013). In order to be on this list, supplements must follow guidelines similar to those for FDA-approved medications. CHOP has stated that if a supplement is able to meet these criteria, its pharmacy will stock and dispense it as a formulary medication, avoiding the need for a waiver. The parent or guardian must sign a hospital waiver stating that they agree to be responsible for providing products that are not part of CHOP’s formulary if they insist that their child continue to take them while at CHOP. The hospital’s previous formulary included most dietary supplements as approved for use (“Research Communications”). Arguments On Both Sides of CHOP’s Policy There are a number of arguments for and against CHOP’s decision to discourage dietary supplement use. Lack of Regulation of Dietary Supplements Perhaps the most obvious argument in favor of the regulation is that dietary supplements are not regulated. Since the FDA does not review manufacturing of dietary supplements, it cannot guarantee that they are safe or effective. Paul Offit has stated that lack of good manufacturing practices is a major concern, with what he estimates to be fewer than 0.001 percent meeting the U.S. Pharmacopeial Convention standards of strength, quality, and product purity (Wanjek, 2013). However, some might respond that simply “because the FDA or another regulating body puts their stamp of approval on something does not necessarily guarantee its quality” (Imus, 2013). As a case in point, Merck removed its painkiller, Vioxx, from the market in 2004 after it was not only shown to increase the risk of heart attacks and strokes, but was linked to thousands of deaths (Imus, 2013). Insufficient Research on Dietary Supplements The lack of clinical trials measuring the benefits or risks associated with taking dietary supplements is a major concern for those in favor of the regulation. “FDA-approved medications also certainly have side effects,” Offit said, but at least doctors understand what the dangers are because they have been documented in studies (Wanjek, 2013). Although it is true

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that more research is needed on dietary supplements in order to determine their safety, one counterargument is that hospitals in the U.S. administer medications or therapies with known side effects to patients on a daily basis because the benefits outweigh the potential risks (Imus, 2013). Those against the regulation might contend that it limits potentially beneficial treatments. However, those in favor of the regulation would respond that without proper research to back up the potential benefits, the risks weigh more heavily. Communication Between Patient and Provider As previously stated, communication between patients and providers is already tenuous when it comes to discussing complementary and alternative medicine, with many providers wary of patients coming to them with their homeopathic remedies or professing the wonders of Reiki. Patients may not feel that they can trust their provider to support use of or to provide feedback about certain CAM modalities. This type of regulation could lead to families withholding or hiding supplement usage from doctors and other healthcare providers because they fear having the dietary supplements taken away from them or being shamed for their decision to use them. In a study examining patient-provider communication about CAM, a subject stated, “When my little boy was born, I used to give him herbs for his stomach aches. And…I wouldn’t tell [the doctor] because… ‘she’ll get madder.’ So I don’t tell them that I use herbs on the kids” (Shelley, 2009, 143). However, the policy could also improve health care providers’ dialogues with families, leading to an improvement in tracking everything that patients are taking and how these things are affecting them. Patients may feel that because they are being asked about their use of dietary supplements, their providers are open and possess some level of knowledge about the products they are taking. Lack of Provider Education About Dietary Supplements Another argument in favor of the regulation is based on the fact that western healthcare providers are simply not educated about dietary supplements like herbs and often do not know what they are for or how they will interact with allopathic medicine and/or treatments. This lack of knowledge could be especially dangerous in cases where experimental drugs are being administered to children. Sarah Erush, a member of CHOP’s Therapeutic Standards Committee, states, “Administering these medications — particularly to children with serious health compli-

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cations — is unethical when the risks are unknown, and when there are alternative treatments that have been proven in clinical trials to be safe and effective,” (“Research Communications”). However, in a letter to CHOP, Michael McGuffin of the American Herbal Products Association counters that, “simply removing these popular vitamins and supplements from the CHOP Formulary is unlikely to eliminate unintended drug interactions with dietary supplements.” He adds: “A more effective approach would be to educate staff and patients about the benefits and risks of drugs and supplements so patients have informed and safe access to the broadest selection of health care options” (McGuffin, 2013). Unknown Interactions with Standard Medications The issue of medicinal and unknown interactions is an important argument in favor of the regulation. Because we do not know how allopathic medications might interact with dietary supplements, health care providers and patients cannot be certain what risks they are taking in mixing these different products. For example, St. John’s wort is an herb that is metabolized through the liver and can cause life-threatening side effects when taken with certain medications (Wanjek, 2013). Other herbal medicines are blood thinners, may be contraindicated for pregnant women, or may impact health negatively in some other way. A health care provider with little or no knowledge of herbal interactions with allopathic medications could unintentionally endanger patients. However, this is the case with allopathic medications as well. While many common side effects of allopathic medications are known, as well as a number of common interactions, patients are commonly taking a number of medications that have not been combined in that particular manner before, which poses a number of potential risks. However, health care providers frequently prescribe medications in unknown groupings regardless of this because there are far too many possible combinations to be reasonably tested. Culturally Limiting and Insensitive The regulation is culturally limiting and insensitive to large populations of patients whose primary approach to medicine may not be allopathic. Cultural influence may play a strong role in patients’ and parents’ decisions to use dietary supplements such as herbs (Gardiner, 2007, 862). These patients may have different views on health and choose to utilize various other healing practices. While allopathic health care professionals approach therapy from a knowledge base, patients may have strong beliefs about a product’s efficacy that could stem from effective-

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ness in a friend/family member, or a religious, ethnic or historical view (Harris, 2000, 1299). Restricting a patient’s culturally significant medical philosophy and treatment is a significant argument against the regulation, which makes it all the more essential for hospitals to recognize the ways in which their treatment methodology may differ from that of their patients. While allopathic medicine relies on scientific evaluations of data from clinical trials, patients may not understand the importance of this type of data or simply choose to prioritize anecdotal reports, testimonials, and non-controlled studies (Harris, 2000, 1299). Futhermore, clinicians must be attuned to and educated about the potential for cultural misunderstandings regarding the use of certain herbal medi-

It is essential for both parties to find effective ways to communicate about their beliefs and relay their knowledge about health care and healing practices so that patients receive the best possible care. cines or other supplements. For example, Traditional Chinese Medicine has included the use of the herb known as ephedra (Ma huang) for more than 5,000 years as a bronchodilating and stimulatory agent (Sadovsky 2008). However, a patient who admitted to taking ephedra would cause alarm in the US, where it is considered to be a dangerous workout and weight loss enhancing supplement and was banned in 2004 due to hundreds of reports of toxicity and 22 deaths (“Drugs and Supplements”). Such disparities in approaches to and understandings of treatment could create difficulties in communication and bring about issues of trust between patients and health care providers. It is essential for both parties to find effective ways to communicate about their beliefs and relay their knowledge about health care and healing practices so that patients receive the best possible care. Other Health Care Institution Policies Health care institutions often have ambiguous policies about herbs and dietary supplements (Woolf, 2010, 155) or lack them entirely. In a recent survey of 109 U.S. children’s hospitals, Woolf et al. found that

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while only 2% of hospital formularies include herbs and 38% include other dietary supplements, 84% of these hospitals would allow a hospitalized child to use a home supply of dietary supplements (Woolf, 2010, 155). Little is known about how many children’s hospitals have created their own policies regarding dietary supplements on hospital formularies or the patient’s home supply, and in cases where they do exist, little is known about both the content of these policies and their implementation in the inpatient setting (Gardiner, 2008, e776). Gardiner et al. reported that there was currently no universal guideline for managing a patient’s dietary supplements in the pediatric hospital setting (Gardiner, 2008, e776). Boyer et al. found that hospitals are managing inpatient use of herbal and dietary supplements from patients’ home supplies in a number of ways, including banning them entirely; developing a policy that allows their use, but does not require that they are identified; and permitting restricted use of dietary supplements because of a lack of policy regulating this field (Boyer, 2005, 31). In a study researching policies governing use of CAM therapies in 19 U.S. hospitals, Cohen et al. found that less than one third of the hospitals had a formal stated policy regarding dietary supplement use (Cohen, 2005, 289). This lack of policy was echoed in the results from a national survey of more than 300 pharmacy directors to determine policies and practices related to dietary supplement use, which concluded that many acute care facilities had neither a formal policy for dietary supplements nor had they implemented planning for such a policy (Bazzie, 2006, 65). The study results showed that institutions with such policies commonly required a written order by an authorized prescriber, documentation of use in the medication record, and a mechanism for the provider to identify the supplement prior to patient use (Bazzie 2006, 67). Consistent with CHOP’s stated reasons for its policy, pharmacists in this study expressed concerns about the consistency of dietary supplement formulations, the lack of FDA regulation, and the difficulty of identifying supplements and distinguishing reputable manufacturers (Bazzie, 2006, 68). Calls to Action While several calls to action have been made by regulatory and oversight organizations, there is still a lack of consensus about the use of dietary supplements. In 2001, the National Institutes of Health Clinical Center implemented a policy titled “Use of patient’s own dietary supplements and alternative consumable products brought into the Clinical Center,” which stated that patients may only use these types of products upon authorizing orders by their

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Clinical Center physician (Sparber, 2004, 135). The Institute of Medicine also recommended that the FDA set up a panel of experts to review the safety of certain supplements and to require more vigorous reporting of adverse events (Sparber, 2004, 133). As a result of the lack of institutionalized regulation of CAM therapies, the Joint Commission Accreditation of Healthcare Organizations (JCAHO) and the American Health System Pharmacists created standards and guidelines for the use of dietary supplements in hospitals (Gardiner, 2008, e776). JCAHO asks hospitals seeking accreditation specific questions about how patients who bring herbal supplements from home are being managed, whether herbs are on the hospital formulary, and whether physicians are required to assess the use of herbals during the hospital stay (Sparber, 2004, 133; Gardiner, 2008, e776). On the other side of the process, there has been an increase in voluntary verification programs, in which manufacturers of dietary supplements can receive recognition from the United States Pharmacopeia for complying with audits, product and ingredient testing and manufacturing document review (Williams, 2011, 1657). As steps are taken to determine the best ways to manage dietary supplements and to improve the DSHEA, scientists have begun proposing possible pathways. In 2008, Ashar et al. presented a 6-step approach to advising patients who are considering dietary supplement use that includes a discussion of regulatory issues, efficacy and safety, potential interactions between dietary supplements and prescription drugs and monitoring for both adverse and therapeutic effects (Ashar, 2008, 91). In 2010, Woolf et al. used the American Society for Clinical Pharmacology and Therapeutics’ 2005 position statement to improve the oversight and safety of herbs and dietary supplements as a framework to propose six recommendations for specifically safeguarding children’s interests (Woolf, 2010, 156; Morrow, 2005, 114). These recommendations included giving the FDA expanded regulatory oversight and funding for supplements, heath care provider education about theses products prior to discussing them with patients, higher priority of researching the safety and efficacy of these supplements by government agencies as well as more clinical trials, the adoption of best-practice guidelines by hospitals and the support of new research and public policy initiatives to address poisoning prevention and abuse of certain supplements (Woolf, 2010, 157).

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CHOP’s Policy: The Next Natural Step These calls to action all speak to the major issues in dietary supplement use, including the general lack of regulation, research data, and health provider education, as well as unknown contents and interactions with prescriptions medications. CHOP’s policy speaks to these issues and provides a framework for its healthcare providers to provide consistent care for their pediatric patients. While the policy received a great deal of press as a “ban” on dietary supplements, in announcing the change, CHOP’s own media used the word “disallows” in the title of its press release, and went on to state that the institution was the first in the nation to “discourage patients from using these products without a doctor’s provision as a matter of policy” (“Research Communications”). To discourage use is quite different from implementing a ban. In fact, in discouraging use, CHOP is leaving a sense of autonomy in the hands of its patients and their families; the patient’s ability to choose is left intact. By giving its patients a waiver to sign in the event that they choose to continue to take their dietary supplement while an inpatient at the hospital, CHOP is creating a moment in time for contemplation, a cautious pause. Such a gate-keeping mechanism provides the opportunity for CHOP to remind its patients and health care providers that hospitals must be vigilant when it comes to dispensing — and therefore taking responsibility for the consequences of — dietary supplements for those under their care. Rather than focusing on the policy change as a moratorium, perhaps the greater insight to be had is in understanding the motivations and implications of safety and caution, rather than in the act of blocking dietary supplements. CHOP is not, in fact, “banning,” dietary supplement use by inpatients, but rather, by using an abundance of caution, the institution is creating an environment in which not only patients but pharmacists, nurses, doctors and other health care providers are more aware of the state of dietary supplement regulation and safety. When prompted to develop this awareness, patients will, hopefully ask more questions and make more educated decisions about their use of dietary supplements. As we become more aware of dietary supplement regulation in the U.S., it is likely that more research will be conducted that will provide safety data about specific dietary and herbal products so that consumers will be able to make wise choices if they decide to complement their diets with these types of supplements.

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References Abrams, L. “Philly children’s hospital bans herbs and supplements.” Salon.com, November 14, 2013. Web. Ashar B.H., Miller R.G., Pichard C.P., Levine R., Wright S.M.. “Patients’ understanding of the regulation of dietary supplements.” J Community Health. 33.1(2008): 22-30. Ball S.D., Kertesz D., Moyer-Mileur L.J.. “Dietary supplement use is prevalent among children with a chronic illness.” J Am Diet Assoc. 105.1(2005):7884. Bazzie K.L., Witmer D.R., Pinto B., Bush C., Clark J., Deffenbaugh J. Jr. “National survey of dietary supplement policies in acute care facilities.” Am J Health Syst Pharm. 63.1(2006): 65-70. Boyer E. “Issues in the management of dietary supplement use among hospitalized patients.” J Med Toxicol. 1.1(2005): 30-4. Boyer, E. “Poisoning From a Dietary Supplement Administered During Hospitalization.” Pediatrics. 109.3(2002): E49. “CAM Basics: Complementary, Alternative, or Integrative Health: What’s In a Name?” U.S. Department of Health and Human Services. National Institutues of Health, National Center for Complementary and Alternative Medicine (NCCAM). Web. Created 2008, updated July 2014. “Chapter 2: Overview of CAM in the United States: Recent History, Current Status, And Prospects for the Future.” White House Commission on Complementary and Alternative Medicine Policy. Web. March 2002. ClinicalTrials.gov. “See Studies by Topic: Dietary Supplements,” n.d. Web. Cohen, Michael H. Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution. Ann Arbor: The University of Michigan Press, 2000. Print. Cohen M.H., Hrbek A., Davis R.B., Schachter S.C., Kemper K.J., Boyer E.W., Eisenberg D.M.. “Emerging credentialing practices, malpractice liability policies, and guidelines governing complementary and alternative medical practices and dietary supplement recommendations: a descriptive study of 19 integrative health care centers in the United States.” Arch Intern Med. 165.3 (2005): 289-95. Cohen P.A. “A false sense of security? The U.S. Food and Drug Administration’s framework for evaluating new supplement ingredients.” Antioxid Redox Signal.16.5(2012): 458-60. Denham B.E. “Dietary supplements--regulatory issues and implications for public health.” JAMA.

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306.4(2011): 428-9. Dodge T., Litt D., Kaufman A.. “Influence of the dietary supplement health and education act on consumer beliefs about the safety and effectiveness of dietary supplements.” J Health Commun. 16.3(2011): 230-44. Dwyer J., Nahin R.L., Rogers G.T., Barnes P.M., Jacques P.M., Sempos C.T., Bailey R.. “Prevalence and predictors of children’s dietary supplement use: the 2007 National Health Interview Survey.” Am J Clin Nutr. 97.6(2013): 1331-7. “Executive Summary.” Health.gov. Commission on Dietary Supplement Labels, n.d. Web. Frankos V.H., Street D.A., O’Neill R.K.. “FDA regulation of dietary supplements and requirements regarding adverse event reporting.” Clin Pharmacol Ther. 87.2(2010): 239-44. Gardiner P., Phillips R.S., Kemper K.J., Legedza A., Henlon S., Woolf A.D.. “Dietary supplements: inpatient policies in US children’s hospitals.” Pediatrics. 121.4(2008):e775-81. Gardiner P., Riley D.S.. “Herbs to homeopathy-medicinal products for children.” Pediatr Clin North Am. 54.6(2007): 859-74, ix. Gershwin M.E., Borchers A.T., Keen C.L., Hendler S., Hagie F., Greenwood M.R.. “Public safety and dietary supplementation.” Ann N Y Acad Sci. 1190(2010):104-17. Gilmour J., Harrison C., Cohen M.H., Vohra S.. “Pediatric use of complementary and alternative medicine: legal, ethical, and clinical issues in decision-making.” Pediatrics. 128.Suppl 4(2011): S149-54. Glisson J.K., Walker L.A.. “How physicians should evaluate dietary supplements.” Am J Med. 123.7(2010): 577-82. Harris A.B. “Evidence of increasing dietary supplement use in children with special health care needs: Strategies for improving parent and professional communication.” J Am Diet Assoc. 105.1(2005): 34-7. Harris I.M. “Regulatory and ethical issues with dietary supplements.” Pharmacotherapy. 20.11(2000): 1295-302. Imus, D. “Is Philadelphia hospital’s ban on supplements a slippery slope?” FoxNews.com. Web. October 23, 2013. Kabat, G. “Children’s Hospital of Philadelphia Bans Dietary Supplements From Its Pharmacy.” Forbes. com, October 18, 2013. Web. Kemper K.J., Wornham W.L.. “Consultations for holistic pediatric services for inpatients and outpatient oncology patients at a children’s hospital.” Arch Pediatr Adolesc Med. 155.4(2001): 449-54.

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Mayo Clinic Staff. “Complementary and alternative medicine.” Mayo Clinic. Healthy Lifestyle: Consumer Health, n.d. Web. Mayo Clinic Staff. “Drugs and Supplements: Ephedra (Ephedra spp.), ma huang.” Mayo Clinic. n.d. Web. http://www.mayoclinic.org/drugs-supplements/ephedra--ma-huang/background/hrb20059270 McGuffin, M. “American Herbal Products Association letter to CHOP from Michael McGuffin.” American Herbal Products Association. Web. October 29, 2013. Morrow J.D., Edeki T.I., El Mouelhi M., Galinsky R.E., Kovelesky R., Noveck R.J., Preuss C. “American Society for Clinical Pharmacology and Therapeutics position statement on dietary supplement safety and regulation.” Clin Pharmacol Ther. 77.3(2005): 113-22. Nahin, R.L., Barnes P.M., Stussman B.J., and Bloom B. “Costs of Complementary and Alternative Medicine (CAM) and Frequency of Visits to CAM Practitioners.” National Health Statistics Reports; no 18. Hyattsville, MD: National Center for Health Statistics, 2009. Research Communications. “Children’s Hospital First in Nation to Disallow Use of Dietary Supplements.” The Children’s Hospital of Philadelphia Research Institute. Web. October 9, 2013. Sadovsky R. “Patient use of dietary supplements: a clinician’s perspective.” Current Medical Research and Opinion. Vol 24, no 4 (2008):1209-1216. Sax J. “Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.” Am J Law Med. 41(2015):374-394. Shelley, B., Sussman A., Williams R. “‘They don’t ask me so I don’t tell them’: patient-clinician communication about traditional, complementary, and alternative medicine.” Ann Fam Med. 7.2(2009):139-47. Sparber A, Ford D., Kvochak P.A.. “National Institutes of Health’s Clinical Center sets new policy on use of herbal and other alternative supplements by patients enrolled in clinical trials.” Cancer Invest. 22.1(2004):132-7. Stone, J. An Ethical Framework for Complementary and Alternative Therapies. London and New York: Routledge, 2002. Print. “Strength Knowledge and Understanding of Dietary Supplements: Frequently Asked Questions (FAQ).” National Institutes of Health, Office of Dietary Supplements. Web. July 2013. “The Use of Complementary and Alternative Medicine in the United States: Cost Data.” U.S. Department of Health and Human Services. National

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Institutes of Health, National Center for Complementary and Alternative Medicine (NCCAM). Web. July 2009. Timbo B.B., Ross M.P., McCarthy P.V., Lin C.T.. “Dietary supplements in a national survey: Prevalence of use and reports of adverse events.” J Am Diet Assoc. 106.12(2006): 1966-74. Tovey, P., Easthope, G., Adams J., eds. The Mainstreaming of Complementary and Alternative Medicine: Studies in Social Context. London and New York: Routledge, 2004. Print. U.S. News and World Report Health, www.health.usnews.com. “Rankings & Ratings: Children’s Hospital of Philadelphia,” n.d. Web. Wanjek, C. “Philadelphia Children’s Hospital Bans Dietary Supplements.” Livescience. Web. October 10, 2013. Williams R.L. “Dietary supplements and regulation.” JAMA. 306.15(2011): 1657-8. Woolf AD1, Gardiner P. “Use of complementary and alternative therapies in children.” Clin Pharmacol Ther. 87.2(2010): 155-7. Wu C.H., Wang C.C., Kennedy J. “The prevalence of herb and dietary supplement use among children and adolescents in the United States: Results from the 2007 National Health Interview Survey.” Complement Ther Med. 21.4(2013): 358-63.

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The Most Compassionate Aid: An Analysis Of The Ethical Imperative To Treat Involuntary Patients With Severe Anorexia Nervosa Lauren Abruzzo Northwestern University

Oftentimes in medicine, patients refuse care that a care staff has deemed necessary to save their lives. When a patient’s health is clearly salvageable, involuntary hospitalization becomes a crucial treatment option. In the context of mental illnesses like anorexia nervosa, this care method is questioned since disregarding a patient’s explicit will seems to conflict with her autonomy. However, for anorexia, there is another factor to consider: the extent to which the disease acts as a coercive factor in shaping her decisions regarding health and body. Despite understanding the nature of the illness, a patient with severe anorexia often fails to comprehend the depth to which the disorder infiltrates her life. Considering this impediment on her specific medical judgment, it does not seem right to grant such a patient the ability to reject medically-necessitated, life-saving care. Thus compulsory care seems to not only be the kindest option but also ethically mandated.

Introduction In the field of medicine, patients do not always accept professional advice about the best course of treatment. A clinician’s obligation to protect the patient’s health creates tension with the patient’s fundamental right to refuse care. For severe mental illnesses such as anorexia nervosa, doubts about decision-making capacity stemming from the patient’s unstable psychological state complicate the issue of compulsory detainment as a life-saving measure. According to Mental Health America (MHA), hospitalization of mentally ill patients is only acceptable when the person poses an imminent threat to herself or someone else. In the case of anorexia, we articulate this threat by asking: To what degree is the disease itself coercive, controlling one’s thoughts, attitudes and emotions? The ethical dilemma in this context must consider the specific tolls that the disorder takes on patient decision-making capacity as well as the varying effectiveness of relevant healthcare techniques. The question becomes: does the nature of the illness provide legitimate reason to disregard the patient’s apparent wishes?

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The issue of coerced treatment is relevant to a range of parties who must assess important practical and ethical issues. Notably, medical decisions in the US are not only the product of patient and physician inclinations but also insurance coverage and state legislation. Because hospitals must be conscientious of financial costs, a patient’s economic resources may be crucial to their path of medical treatment. For example, a study by Fisher et al. found that a committed person’s length of stay often depended heavily upon insurance status, and without insurance, patients would be released sooner (Fisher et al., 2001, pg. 344). Additionally, many state laws provide guidelines for civil commitment. The legal standard for detaining a person with a mental disorder depends on the threat she poses to herself; she must be “suicidal, physically violent, or grossly unable to perform activities of daily living” (Testa and West, 2010, pg. 34). Since detainment of patients with mental illnesses is frequently accepted in cases where the disorder skews interpretation of reality, the question is more ambiguous when this perception is not compromised, as in eating disorders, drug addiction and personality disor-

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ders, for instance (Testa and West, 2010, pg. 31). However, clinicians do not always agree on whether these standards have been met in eating disorder patients, and the American Psychiatric Association lacks a specific protocol to direct involuntary hospitalizations of these persons (Testa and West, 2010, pg. 37). We will address a general case of severe anorexia with certain guidelines to ensure that we are assessing the core of the issue: whether involuntary care truly puts into conflict a patient’s right to refuse care and a clinician’s duty to act in the patient’s best interests. Our example involves a woman between ages 18 and 25 since “95% of those who have eating disorders are between the ages of 12 and 25.8” (“Eating Disorders Statistics”). Otherwise physically healthy, the patient has life-threatening anorexia and refuses treatment that her therapist and/or physician strongly believes will restore her physical condition. We focus on an adult patient rather than a minor to ensure that doubts about her decision-making faculties do not stem from her youth, inexperience or incomplete brain development. Rather, the question about her capacity to give consent arises from mental health considerations – namely, distorted values engrained in her by the eating disorder. Finally, and most essential to this debate, her clinician contends that the severity of her condition demands urgent care. Otherwise, compulsory treatment may not seem like a rational option if the proposed treatment is not of immediate value to the patient’s health. She seems to understand this, yet she rejects aid. One solution to this case balances protecting the autonomy of the patient and caring for her physical health by the beneficence principle. “Beneficence” here means acting with the goal of creating what the caregiver believes is the best outcome for the patient. This investigation is part of the broader issue of whether compulsory treatment is ever justifiable – a discussion that requires consideration of the nature of the illness and potential effectiveness of care. If thorough clinical evaluation determines that the patient’s condition can improve, I argue that involuntary treatment of anorexia under the given conditions is not only justifiable but morally imperative because (1) the patient’s disorder interferes with specific decision-making capacity regarding health and body, undermining her autonomy, and (2) denying her treatment is not in her best interests if allowing her to live with an untreated life-threatening disease will likely lead to her death. “Treatment” refers not only to hospital detention but also replenishing the patient’s physical state. These two elements of care have significantly different moral implications; namely, the former may be

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restricted by time (e.g. 72 hours), whereas the latter is determined by rate of recovery (e.g. a specific body mass index (BMI)). The US handles involuntary detainment of mentally ill patients by individual state laws (“Emergency Hospitalization”). Many states demand immediate medical evaluation of a patient who is in danger as a result of his or her disorder (Testa and West, 2010, pg. 34). In such cases, hospitalization is considered justifiable and obligatory so long as an authority (say, a physician, clinician or police officer) deems the patient’s condition life-threatening (“Emergency Hospitalization”). With respect to medical care, Position 22 of MHA contends that “involuntary treatment should only occur as a last resort and should be limited to instances where persons pose a serious risk of physical harm to themselves or others in the near future and to circumstances when no less restrictive alternative will respond adequately to the risk.” Although mental illness treatment insurance boosted enormously after the 2013 Affordable Care Act (“After Parity”), the US does not have a federal policy to protect the health of noncompliant patients with severe mental illnesses. However, other countries have explicit laws to address involuntary hospitalization, specific to the disorder. For example, the Mental Health Act Commission in England requires “that in certain situations, patients with severe anorexia nervosa whose health is seriously threatened by food refusal may be subject to detention in hospital and further that there are occasions when it is necessary to treat the self-imposed starvation to ensure the proper care of the patient” (qtd. in Ramsay, 1999, pg. 147). In the US, state commitment laws for mentally ill patients recognize the attenuating impact of psychological disorders on a person’s health, yet these policies only provide a route for compulsory treatment rather than a duty, and the extent to which eating disorders apply is not obvious. Beyond hospitalization we must also consider whether it is just to invoke involuntary treatment methods for patients with life-threatening anorexia. Such techniques often involve coerced regular meals, nutritional supplements, ingestion of calories via nasogastric tube, parenteral nutrition, and even isolation or physical restraint to ensure consumption of food (Matusek and Wright, 2010, pg. 435). These forms of care are morally ambiguous because attempts to secure the patient’s health in the long-term may involve a more significant restriction on her autonomy than simply requiring a 72-hour stay for the purpose of examination preceding release. In order to respect the often persistent nature of the illness, consideration of the patient’s best medical interests includes

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action that promotes more permanent treatment outcomes. Rather than focusing on the ethical implications of each individual care method, we examine the idea of compulsory hospitalization with the understanding that a medical care staff will invoke necessary and compassionate measures to safely return the patient to a physically and mentally stable state. Protecting Patient Autonomy The strongest objection to involuntary hospitalization appeals to the idea that contradicting a patient’s volition is morally unacceptable. Often considered a human right, autonomy defends a person’s life-shaping freedom, command over body, and self-determination. The legal concept of informed consent defends this right with exceptions for minors and, sometimes, mentally ill persons whose disorders undermine their judgment with respect to their health. In the case of compulsory treatment of anorexia, issues to consider regarding the patient’s autonomy include (A) how consequences of the illness limit her decision-making capacity and (B) whether it is justifiable to disrespect present autonomy for the sake of restoring her autonomy in the future. If compulsory treatment does not actually violate the principle of autonomy, involuntary care may be morally

Since detainment of patients with mental illnesses is frequently accepted in cases where the disorder skews interpretation of reality, the question is more ambiguous when this perception is not compromised, as in eating disorders, drug addiction and personality disorders. necessary given the severity of her illness. Regarding (A), if physical and psychological effects of anorexia diminish the patient’s decision-making capacity in the domain of her health, compulsory treatment may be justifiable. Restricting her autonomy in the short-term does not limit her freedom on the whole when disorder-related consequences and beliefs act as coercive forces at the time of ad-

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mission. The Supreme Court case SW Hertfordshire Health Authority vs. KB (1994) upheld this position, permitting force-feeding as a means of care since the anorexia of patient KB undermined her decision-making capacity (Dolan, 1998, pg. 171). However, a powerful argument against such logic contends that consent is always necessary for adult patients unless they are unconscious (Rathner, 1998, pg. 193). Being “conscious” here assumes awareness and capacity to process information. But what about the ability to weigh relevant options rationally in order to make an informed decision? Decreased physical functioning resulting from starvation may damage this capacity. A patient’s refusal of treatment may be influenced by biochemical changes in her brain stemming from nutritional deprivation – a notable limit on her cognitive functioning (Vitousek et al., qtd. in Matusek and Wright, 2010, pg. 442). A study published in The Biology of Human Starvation by the University of Minnesota Press reported that participants who were “semi-starved” in the experiment had decreased focus, understanding and decision-making ability as well as overwhelming emotions and even depression (Kaplan and Rucklidge, 2013). Likewise, in a study by O.A. Tan, numerous women with anorexia were found to relate experiences of “difficulties with concentration and muddled thinking processes” (Tan et al., 2006). Considering the extreme cognitive consequences of insufficient calorie consumption, we should be hesitant to deem a patient with severe anorexia capable of rationally refusing treatment of her eating disorder. An alternate view contends that even if anorexia undermines decision-making capacity by virtue of the physical symptoms of the disorder, how is this different from a patient with life-threatening yet treatable cancer who must give informed consent for chemotherapy? After all, such a patients may also have decreased mental functioning at the time of consent as a result of physical weakness and fatigue, for instance. Why should we deny a person with anorexia the right to refuse care when we consider a non-anorexic patient with notably similar physical symptoms capable in this respect? This objection is problematic because it fails to acknowledge psychological factors directly associated with many mental illnesses like anorexia. Namely, a patient may lack the ability to acknowledge her disease or view her condition objectively. Her situation differs from that of a cancer patient because this psychological phenomenon is a component of her condition. In the case of anorexia, the patient’s opinion on the urgency of her condition is not always clear (Tan et al., 2006). Even if she comprehends her clinician’s

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explanation of her risk of fatality by anorexia, she may not agree that her own situation is life-threatening; there is a mismatch in applying her cognitive understanding to her own struggle (Tan et al., 2006). If a given patient with anorexia often does not recognize that a problem exists, lacking awareness of her disorder as it presents itself in her life, how can she make an informed decision about treatment based on her comprehension of relevant risks? One might respond to this argument by noting that patients with many different health problems frequently deny when they are ill as a coping mechanism, so why should we consider patients with anorexia as lacking decision-making capacity? On the other hand, refusal to admit the reality of one’s disorder should be distinguished from cognitive reappraisal of one’s circumstances. Although many sick persons use denial to deal with challenging diseases, rejection of illness characteristic of anorexia is part of the condition anosognosia, which involves impaired physiological functioning of the right hemisphere of the brain (Torrey). In an article for an eating disorder treatment organization called the Kartini Clinic, author Julie O’Toole explains how anosognosia entails that “the brain does not perceive the extent of the illness, sometimes not even its presence” (2011). The term has been defined as “failure to systematically gather, integrate, and retain the relevant information, or failure to make use of the information to draw an obvious conclusion” (Rinn et al., 2002, pg. 55). A patient’s refusal of treatment in this case clearly reflects more than patient obstinacy. How can we justifiably give such a patient the right to deny herself treatment when anosognosia constitutes “a feature of anorexia” (O’Toole, 2011)? By its very nature, her condition may prevent her from truly understanding the presence of an eating disorder in her life, obstructing her ability to fully weigh her treatment options. It is also important to consider that not all patients with severe anorexia have anosognosia. Other reasons for treatment refusal may include beliefs about the ineffectiveness of treatment due to previously unsuccessful hospitalizations, lack of motivation to be treated, time commitment of the program, or religious reasons. Interestingly, patients with anorexia often make rational judgments in other areas of life and even pass standardized competence exams, displaying “global competence” (Matusek and Wright, 2010, pg. 444). Researchers Stephen W. Touyz and Terry Carney noted that a patient’s decision-making ability depends on how well she can “grasp, retain, weigh and rationally process information,” regardless of how reasonable or compliant her choice may be; thus the clinician has a responsibility to adhere to her

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wishes (Touyz and Carney, 2010, pg. 6). Though most patients with anorexia display adequate judgment skills in areas of their lives such as occupation and education, this is not the case for issues concerning their own body, food and health (Matusek and Wright, 2010, pgs. 443-4). If relevant decision-making faculties are important prerequisites to exercising the right of autonomy, then we should hesitate in emphasizing the principle of self-determination in our consideration of involuntary treatment of persons with mental disorders like severe anorexia. It does not seem morally justifiable for a clinician to endorse patient refusal of care for the sake of respecting the patient’s autonomy when the disease undermines her present and “specific competence” (Matusek and Wright, 2010, pg. 443). We now turn to (B) to evaluate the validity of protecting the future autonomy of someone with severe anorexia. Should we recognize her life-shaping decisions as representative of her actual wishes, or should these choices be treated as induced by the eating disorder? In other words, would accepting the patient’s goals of the moment truly be accepting those of the disorder? If the patient’s ability to reject care is questionable due to the nature of anorexia, the objective of treatment is in part to fully give her back decision-making capacity with regards to her health. This claim raises the moral question of violating autonomy as it appears in the form of explicitly-stated volition with the intention of replenishing it later on. (B) considers first how anorexia acts as a coercive factor in the patient’s choice to refuse necessary care, followed by an investigation of how hospitalization seeks to reestablish her self-determination and independence from the eating disorder. Since the nature of anorexia involves an unattainable ideal of thinness and an altered perspective of health and body, we might consider the patient’s denial of her present condition as imposed by her eating disorder. This notion conceptualizes her refusal of treatment as a reflection of the eating disorder’s will, per se, rather than her own. According to an American Journal of Psychology article, the heart of anorexia involves the controlling influence of specific “overvalued beliefs” rather than an obsessive-compulsive or psychotic issue (Andersen, 2007, pg. 10). The fear of gaining weight is associated with this consumptive view of “fatness” that may even reign over religious commitments such as accepting Host during Catholic Mass (Andersen, 2007, pg. 10). The strength of her disordered beliefs may be sufficient to damage her perception of what is deeply important to her. In summary, the patient’s explicit wishes may be contrary to the values she prioritized before her disorder

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progressed. Therefore, adhering to her expressions of treatment rejection seems to give in to the eating disorder’s potency. If the patient’s illness acts as a coercive force in her decision to refuse, the choice is not truly self-driven, so contradicting her outright wishes may actually defend her autonomous faculties as we understand them in a healthy mental state. One response is as follows: If informal manipulation (e.g. assertion of preferences by a close friend) does not fall under the legal category of coercion, why should an eating disorder to do so? After all, voluntary patients might be subject to this phenomenon (Matusek and Wright, 2010, pg. 435). Additionally, it seems that interpreting an urge to starve oneself as bullying or persuasion may open the door for any distressing, troubling thought to be considered sufficiently forceful to compromise autonomy. However, in the case of anorexia, coercion is unique in that it constitutes an internal element of the illness. The patient is aware that the consequences of her behaviors will likely lead to death, and although the desire to end her life is not a given characteristic of anorexia, her behaviors contradict her volition to continue living (Matusek and Wright, 2010, pg. 444). Namely, she rejects essential nutrition for survival and may also engage in dangerous purging behaviors with the use of laxatives or diuretics to eliminate consumed food (Andersen, 2007, pg. 10). Given our understanding of the illness, anorexia seems to act as a coercive force insofar as it coaxes the patient to understand her situation in a specific, distorted way. To some extent, compulsory care actually seeks to defend the patient’s rightful autonomy, liberated from the disorder’s imposition of values. Autonomy is not simply a matter of explicitly stated wishes. Rather, it deals with a patient’s right to make decisions regarding her health. Although we cannot guarantee that a patient with severe anorexia will provide consent after the initiation of care, it is important to recognize that treatment strives to restore autonomy, returning the patient to a physically and psychologically stable state free of the disorder’s grip. Touyz and Carney argue that the probability of “retrospective consent” legitimizes use of coercion by a medical professional (Touyz and Carney, 2010, pg. 6). Although this view is quite extreme, it is important to recognize that involuntary patients sometimes acknowledge the importance of treatment and express gratitude for compulsory aid. In a Guarda et al. study (2007), around half of the hospitalized eating disorder participants who initially refused treatment admitted its necessity given their condition after only two weeks of being in the hospital (Guarda et al., 2007, pg. 108). In another study, post-hospitalized involuntary

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patients explained how they had adjusted their appraisal of compulsory care compared to before; they eventually identified the urgency and effectiveness of treatment (Watson et al., 2001). Although this research certainly does not guarantee a patient’s consent after-the-fact, this example illustrates that involuntary hospitalization does not necessarily ignore the goals and values she holds in a physically and mentally stable state. An objection asks: is anorexia unique in this respect? Treating this disease as such seems to justify involuntary hospitalizations for a slew of illnesses, including many mental disorders, simply on the basis of clinician judgment. In the case of severe alcohol abuse, for example, cognitive issues involved in the disease have been linked to addiction denial (Rinn et al., 2002, pg. 52). However, although anorexia and alcohol addiction both may undermine judgment with respect to health, a comprehensive argument for the moral imperative to treat involuntary patients with severe mental illnesses such as substance abuse disorders is beyond the scope of this investigation. A convincing argument for compulsory care requires an additional analysis of the effectiveness of treatment methods in restoring cognitive functioning and physical well-being. It should be noted that clinician judgment is indeed crucial in determining the nature of a patient’s condition. The “doctor’s orders” are legitimate insofar as they reflect extensive knowledge of the patient’s history, thorough investigation into treatment options, and urgent corroboration by other experts. Beneficent Objectives In addition to the issue of upholding the patient’s volition, justifying compulsory treatment calls for an assessment of the potential outcomes of care. Traditionally, violating a patient’s declared wishes requires a cost-benefit assessment of the harm in restricting her autonomy versus the benefits of hospitalization. However, this conceptualization of the moral issue fails to consider the psychological complications of anorexia and thus the manifestation of beneficence in this context due to its blind defense of present autonomy. If her illness undermines her decision-making faculties with regards to her health care, and respecting her explicit desires does not truly respect her autonomy, we must place less emphasis on respect for the patient’s expressed inclinations regarding hospitalization. The moral issue of compulsory treatment thus focuses on an assessment of the physical and mental benefits and consequences of forcing a patient into treatment. The first priority after detaining a patient with

Princeton Journal of Bioethics

severe anorexia is returning her to a state of physical stability. According to the National Eating Disorders Association, when her body fights to provide her with energy she does not consume from food, she struggles with health consequences such as decreased heart rate, dehydration, possible liver failure, reduction of muscle mass and strength, weak bone density, and hair loss. This evidence of significantly diminished quality of life resulting from her illness indicates that effective treatment may be admirable when it successfully safeguards her well-being. If acting beneficently toward a patient with anorexia involves minimizing her suffering, and if her condition is salvageable and she does not seek to die, involuntary hospitalization may provide a route to sparing her from further harm induced by the illness. In our case, adequate care involves life-saving measures, and these measures have had success in the past. In fact, several notable studies concluded that compulsory treatment was beneficial to patients’ recovery at least in the short-term. In one by Ramsay et al. (1999), both voluntary and involuntary anorexia patients who participated in the experiment gained weight after treatment. The former group increased by an average of 11.0 kg (~24 lbs.) in 88 days and the latter by 12.1 kg (~27 lbs.) in 133 days (Ramsay et al., 1999, pg. 151). Although the compulsory care group took almost two months longer to reach a healthier weight, these patients still successfully reversed their deprived physical state. Another study observed that involuntary patients regained weight at the approximately the same rate as voluntary (2.6 and 2.2 lbs. per week respectively) (Watson et al., 2001). When she receives care that will improve her severe yet reparable condition, a patient with anorexia has a strong chance of success regardless of her attitude prior to admission. Despite the optimistic results of these treatment tactics, not all research supports their efficacy, especially in cases of involuntary admission. In terms of physical health, the accomplishment of shortterm weight gain does not seem worthwhile unless the healthy body mass is maintained over time. In Ramsay’s study, mortality was significantly higher in involuntary than voluntary patients after an average of 5.7 years in treatment (12.7% versus 2.56%, respectively) (Ramsay et al., 1999, pg. 150). Forced treatment may result in decreased risk for survival in association with the greater number of prior admissions of involuntary patients. However, Ramsay inferred that the necessity of forced treatment did not simply arise out of low BMI but rather the severity of the condition combined with refusal to acknowledge this (Ramsay et al., 1999, pg. 151). Although some

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other long-term studies have been conducted, more are necessary to determine how these patients recover in the years following hospitalizations (Watson et al., 2001). The nebulousness of actual results raises doubts as to whether compulsory treatment is justifiable given the patient’s outright refusal and uncertain long-term outcome. On the other hand, if the principle of autonomy involves more than simply respecting the right to explicitly refuse, we are left with the fact that, without an attempt at treatment, she will likely die. Assuming that thorough clinical evaluation has established that the patient’s condition be salvageable, and that her eating disorder clearly not be terminal, it does not seem right to allow her to refuse treatment that has strong potential to return her to a physically and mentally stable state. Health improvements during hospitalization

The patient’s explicit wishes may be contrary to the values she prioritized before her disorder progressed. Therefore, adhering to her expressions of treatment rejection seems to give in to the eating disorder’s potency. If the patient’s illness acts as a coercive force in her decision to refuse, the choice is not truly self-driven, so contradicting her outright wishes may actually defend her autonomous faculties as we understand them in a healthy mental state. bring into question how long a detainment period is morally acceptable before treatment infringes on patient rights to self-determination. At what point should she have the autonomous right to leave the hospital as she regains physical health? To justify goals of treatment, mental health care must also be required as an extension of involuntary hospitalization. After all, restoring the patient’s weight does not

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imply release from the grip of her eating disorder whether or not she voluntarily sought out intensive care initially. From an ethical perspective, it does not seem reasonable to treat the patient’s physical condition if self-starvation will persist upon release from the hospital; saving her life in the short-term holds more value if treatment methods are likely to make lasting improvements. In addition to considering physical health outcomes of compulsory care, we also must assess the impact on the patient’s mental state. Even if the patient’s body weight is within a healthy range, and her brain has more nutrients to function, she may still struggle with psychological issues related to her eating disorder, such as intense urges to restrict food consumption. In some cases, compulsory care ex-

In addition to providing the medical assistance necessary to save her life, compulsory treatment of a patient with severe anorexia nervosa may defend her values and goals as would be expressed in a physically and psychologically stable state. One should not fall under the guise of defending a patient’s explicitly-stated refusal when, in reality, anorexia often constrains her capacity to see beyond illnessimposed views of health and body. acerbates the patient’s disorderly behaviors and attitudes post-treatment rather than reducing them. Examples might include attempts to lose weight gained in the hospital, increased suicidal inclinations, or reduced probability of reaching out for necessary aid in the future (Matusek and Wright, 2010, pg. 439). In one study, Theils (2008) investigated 25 women ages 16 to 39 with potentially fatal anorexia who were admitted to the hospital and received treatment in the form of normal meals, supplements and feeding

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tubes in some cases (Touyz and Carney, 2001, pg. 8). Researchers observed that some patients rebelled against the care team, adjusting their feeding tubes and making comments such as, “So far I have beaten everybody and have not put on weight.” (qtd. in Touyz and Carney, 2001, pg. 15). A strong objection to compulsory treatment asserts that the risk of increasing the patient’s suffering (i.e. by submitting her to apparently coercive measures and fighting the eating disorder too aggressively) exceeds the likelihood of salvaging her condition (i.e. achieving physical stability and psychological well-being). After all, the medical community could instead be exerting time and effort on patients with a greater chance of long-term survival. This argument contends that it is not morally acceptable to force treatment simply because the condition is life-threatening. Further, any attempt to help her condition is not automatically more moral than none. Although these claims raise valid questions, they neglect the importance of variability in treatment programs’ methodologies and conduct. In Theils’ study for instance, we cannot discount the importance of care center atmosphere in influencing health outcomes (Touyz and Carney, 2001, pg. 15). Quality of treatment becomes a dramatic factor in assessing clinician beneficence since we consider compulsory treatment obligatory insofar as the patient’s condition can improve. To require detainment of a patient with life-threatening anorexia, there must be a standard of supportive, effective patient-staff interaction. Compassionate yet assertive treatment methods seem to be the strongest combat to the eating disorder. For instance, shame associated with consuming food may be relieved when staff members oversee patient meals and require compliance (Matusek and Wright, 2010, pg. 439). In addition, motivational interviewing and other cognitive-behavioral therapy methods may decrease patient stubbornness arising from the sense of being stripped of autonomy (Matusek and Wright, 2010, pg. 438). With a caring, conscientious staff focused on preserving the patient-clinician relationship, therapy as a necessary requirement of compulsory treatment helps legitimize long-term hospitalization. After initial admission, preventing her disorder from regaining control and interrupting her life must be a priority if treatment truly promotes her best interests. When she receives immediate, intensive and benevolent aid with lasting results, detaining and caring for an involuntary patient with anorexia is both morally defensible and mandatory.

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Conclusion In addition to providing the medical assistance necessary to save her life, compulsory treatment of a patient with severe anorexia nervosa may defend her values and goals as would be expressed in a physically and psychologically stable state. One should not fall under the guise of defending a patient’s explicitly-stated refusal when, in reality, anorexia often constrains her capacity to see beyond illness-imposed views of health and body. Such considerations may be relevant to diseases such as substance abuse disorders, when certain relevant cognitive abilities are often undermined. If thorough clinical evaluation establishes that a patient’s condition has the potential to improve, involuntary hospitalization and subsequent treatment of anorexia is not only the most compassionate option but also morally obligatory. References “After Parity, No Upswing in Use of Mental Health Services.” Treatment Advocacy Center. Treatment Advocacy Center, 16 June 2014. Web. 6 June 2015. Andersen, Arnold E., MD. “Eating Disorders and Coercion.” American Journal of Psychology 164.1 (2007): 9-11. Web. 6 May 2015. Dolan, Bridget. “Food Refusal, Force Feeding and the Law of England and Wales.” Treating Eating Disorders: Ethical, Legal and Personal Issues. Ed. Walter Vandereycken and Pierre J. V. Beumont. London: The Athlone Press, 1998. 171. Web. 12 Feb. 2016. “Eating Disorders Statistics.” National Association of Anorexia Nervosa and Associated Disorders. ANAD, n.d. Web. 12 Feb. 2016. “Emergency Hospitalization for Evaluation.” Treatment Advocacy Center. Treatment Advocacy Center, n.d. Web. 13 Feb. 2016. Fisher, William H., PhD, Paul J. Barreira, MD, Alisa K. Lincoln, MPH, PhD, Lorna J. Simon, MS, Andrew W. White, MA, Kristen Roy-Bujnowski, BS, and Marylou Sudders, MSW, ACSW. “Insurance Status and Length of Stay for Involuntarily Hospitalized Patients.” The Journal of Behavioral Health Services and Research 28.3 (2001): 334-346. Web. 14 Apr. 2016. Guarda, Angela S., MD, Angela Marinilli Pinto, PhD, Janelle W. Coughlin, PhD, Shahana Hussain, Nancy A. Haug, PhD, and Leslie J. Heinberg, PhD. “Perceived Coercion and Change in Perceived Need for Admission in Patients Hospitalized for Eating Disorders.” The American Journal of Psychiatry 164.1 (2007): 108-114. Web. 12 Feb. 2016. Kaplan, Bonnie, PhD, and Julia Rucklidge, PhD. “Starvation: What Does it Do to the Brain?” Mad in

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America. Mad in America Foundation, 28 May 2013. Web. 6 June 2015. Matusek, Jill Anne and Margaret O’Dougherty Wright. “Ethical Dilemmas in Treating Clients with Eating Disorders: A Review and Application of an Integrative Ethical Decision-making Model.” European Eating Disorders Review 18.6 (2010): 434-452. Web. 6 June 2015. Mental Health America. Mental Health America, n.d. Web. 12 Feb. 2016. O’Toole, Julie. “When Other Family Members are Affected by an Eating Disorder Too.” Kartini Clinic. Kartini Clinic, 12 Aug. 2011. Web. 6 June 2015. Ramsay, Rosalind, Anne Ward, Janet Treasure and Gerald F.M. Russell. “Compulsory Treatment in Anorexia Nervosa: Short-Term Benefits and LongTerm Mortality.” British Journal of Psychiatry 175.2 (1999): 147-153. Web. 6 May 2015. Rathner, Günther. “A Plea Against Compulsory Treatment of Anorexia Nervosa Patients.” Treating Eating Disorders: Ethical, Legal and Personal Issues. Ed. Walter Vandereycken and Pierre J. V. Beumont. London: The Athlone Press, 1998. 193. Web. 12 Feb. 2016. Rinn, William, PhD, Nitigna Desai, MD, Harold Rosenblatt, MD, and David R. Gastfriend, MD. “Addiction Denial and Cognitive Dysfunction: A Preliminary Investigation.” The Journal of Neuropsychiatry and Clinical Neurosciences 14.1 (2002): 52-57. Web. 10 Apr. 2016. Tan, Dr. Jacinta O. A, Tony Hope, Dr. Anne Stewart, and Raymond Fitzpatrick. “Capacity to Make Treatment Decisions in Anorexia Nervosa: Thinking Processes and Values.” Philosophy, Psychiatry, & Psychology: PPP 13.4 (2006): 267–282. Web. 6 May 2015. Testa, Megan, MD, and Sara G. West, MD. “Civil Commitment in the United States.” Psychiatry (Edgemont” 7.10 (2010): 30-40. Web. 13 Apr. 2016. Torrey, E. Fuller. “Impaired Awareness of Illness: Anosognosia.” Mental Illness Policy Organization. Mental Illness Policy Org, n.d. Web. 6 June 2015. Touyz, Stephen W. and Terry Carney. “Compulsory (Involuntary) Treatment for Anorexia Nervosa.” Research Gate Jan. 2010: 1-22. ResearchGate.net. Web. 6 May 2015. Watson, Tureka, MS, Wayne Bowers, PhD, and Arnold Anderson, MD. “Involuntary Treatment of Patients with Eating Disorders.” Gürze Books, 2001. Reprinted from Eating Disorders Review 12.2 (2001): n. pag. Web. 6 May 2015.

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Defects and Decisions: A Case Study in the Ethics of Medical Device Failure Karen Hsu Northwestern University

Medical technology and devices have developed exponentially in the recent decades, but they come with inevitable consequences including risks and defects. Guidant, a medical device company, released an implantable cardioverter defibrillator (ICD) in 2000. Meant to save patients suffering from heart problems, the device contained a defect that sometimes caused it to fail. When cases surfaced revealing repercussions of this defect, Guidant faced a difficult situation and battled with the standards of ethical conduct. At first glance, it seems the company made poor decisions to deal with this. However, upon further investigation, it becomes evident that Guidant’s actions were sensible and ethical, and that they handled the situation as best they could.

Medical technology has proliferated in recent decades, providing important, and often life-saving, advances but also risks and complications. These include recent developments in prosthetic vessels, cortical electrodes to record brain activity, and cardiovascular stents to treat narrow arteries, just to name a few. A particular medical device of interest is the implantable cardioverter defibrillator (ICD), which is introduced and explored in this paper. With all medical devices, there come risk and malfunction, and complications arise regarding the right course of actions to handle the situation. The first case of malfunction surfaced in 2005 when Joshua Oukrop, a college student with an ICD, entered cardiac arrest. The ICD, which is supposed to shock the heart and return the heartbeat to normal, did not fire. As a result, he passed away. After close examination, doctors and engineers found that the connection between the device and the leads to the heart, which is what delivers the shock, had short-circuited. At this point, Guidant, the company that manufactured this ICD, admitted that earlier testing of their product had already revealed this defect back in 2002, but failed to notify patients and doctors that the devices sold between 2000 and 2002 contained these defects (Baura, 2011). Surely, the question was raised regarding whether Guidant took an unethical course of action in dealing with the defects of their

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product. However, after thorough research and consideration of all factors in play, it becomes evident that Guidant’s actions could be considered necessary and sensible. Their devices were only meant to be a preventative solution; Guidant did improve and notify authorities of this defect, and the failure rate of the ICDs is a mere 0.002% – near infinitesimal. Guidant launched the defective product in 2000, called the Guidant Prizm 2DR ICD. As with an automated external defibrillator (AED), it shocks the victim’s heart in the event of a heart attack, arrhythmia, or cardiac arrest. It is implanted near the collarbone and has electrical wires that run to the walls of the heart, which will shock the heart if needed to return its heartbeat to normal. Patients who are at risk for these heart conditions would buy this product so that their daily lives are not interrupted by the need to have access to an AED at all times. However, medical devices and products like these are engineered and created by humans, and thus have the capacity for error and malfunctions. Because Joshua’s death could have been prevented by the ICD, some may make the erroneous assumption that his death was directly caused by the short-circuiting defect when the ICD was supposed to fire. Despite this, it should be noted that the company never guaranteed 100% efficacy of the product, and they made this fact known to customers. The ICD

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is meant to be a backup, and when it is needed, it can either save a life or have no effect or impact on the victim. In no way should the device worsen the victim’s condition. Based on these facts, there are two scenarios worth considering. The first is that the patient at risk for a heart problem goes about his daily life being cautious of his condition but does not get an implant. One day, his heart might malfunction, and if help is not available, he may die. The second scenario is that the same patient, with the same risk, goes about his life being cautious as well, but this patient gets an ICD implanted in case of an emergency. Now, if his heart malfunctions, the worst-case scenario is that the device also malfunctions and he dies as well, because the device does not fire and so has no effect. These two scenarios are identical except the second person paid the money to buy an ICD as a backup, and the first did not. The only difference is the money that went into getting the ICD. For this reason, Guidant pays a big sum of money to the victim’s family; it is not to “pay” for the loss of the patient, but rather it is a “refund” of the device. Of course, much more often than not, the ICD saves the lives of the patients. Even in the worst case, the ICD does not harm or kill the patient any more than a patient would be harmed without the ICD. Patients know that the ICD is meant to be only a preventative measure, not a guarantee that lives will be saved. Thus, it is neither fair nor correct to say that the ICD is the cause of death. Some also argue that Guidant did not take necessary steps to alleviate this problem, but there is proof otherwise. Further investigation into Joshua’s case revealed that Guidant’s engineers did change the design immediately after testing had revealed this defect in 2002. For the two years that the defected device was marketed and sold, 37,000 patients received the faulty devices (Stahl, 2007). Guidant reported each failure case – 26 out of the affected 37,000 (0.07%) – to the Food and Drug Administration (FDA), which was published on FDA’s Manufacturer and User Facility Device Experience Database. The company also met and explained to select cardiologists involved in the implantation of the ICD the risks and defects that the ICD had (Baura, 2011). By 2005, Guidant had released warning screens to all physicians associated with the defective ICDs to notify them of this possible risk. Finally, also in 2005, Guidant published a story to New York Times notifying the public about the defect. All affected ICDs, which dropped to 24,000 by 2005, were recalled due to this defect (Baura, 2011). All in all, Guidant had complied with all required laws such as notifying the FDA, making design changes, and recalling the device. Although it took a critical few years to take this course of action, one must con-

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sider that testing and repairing a device for a defect, when it has happened only in 26 of 37,000 devices, is extremely difficult and indeed time consuming. Evidently, Guidant had done everything required of them and complied with all the engineering guidelines within a reasonable time frame. Perhaps the most important aspect to be explored in a case like Guidant’s is the failure rate and the actual risks. As stated earlier, there were only 26 reports of device failure out of 37,000 affected devices. This is a solid 0.002% failure rate per month. Compared to the average industry rate of ICD failure, which is 0.01% per month, Guidant’s ICD failure rate is five times lower (Baura, 2011). Furthermore, research shows that the death rate of open-heart surgery has been 0.3% in the past years, which would have been even higher ten years ago when the Guidant case was relevant (Ezekowitz, Armstrong, and McAlister, 2003, 445). Taking into account the extremely low failure rate of the Guidant ICDs, it is actually statistically safer to leave the defective device in because of the higher mortality rate for open-heart operations.

Taking into account the fact that the device can only help and cannot harm, that the company did repair, warn, and notify the public, and that the failure rate is so low deem Guidant’s and its engineers’ actions, all in all, imperative, sensible, and ethical. More specifically, Guidant stated, “The odds of the defect causing harm to the patient were lower than the risk of the replacement surgery plus the odds of a random failure in the new unit.” Clearly, it is extremely rare for this short-circuiting defect to occur, and in many ways, it is not worth it for most people to go in for a replacement surgery. In all ethical cases, including this one, it is possible to find room for improvements, especially from an engineering point of view. According to the Code of Ethics published by the National Society of Professional Engineers, engineers have the duty to fully disclose all risks and warnings “in an objective and truthful manner.” It would follow that the most rel-

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evant point of opposition is that Guidant’s engineers should have notified affected patients and physicians about the defect right away rather than waiting until they had repaired the defect 3 years later. Although the engineers did comply completely with the courses of actions required of them, the fact that stakeholders, including the patients, their families, and physicians, were not informed for 3 years is the concern noted here. Still, it is worth discussing the flipside. If the engineers had notified the public right away, it would have effectively discouraged a number of patients from getting an ICD implanted due to fear of failure or reevaluation of the ICD’s value. However, studies have shown that an ICD can prolong life for 8-10 years and reduce risk of death by 43% with a 95% confidence interval (Ezekowitz, Armstrong, and McAlister, 2003, 445). Based on this statistic, it is indisputable that it is much safer to have an ICD implanted, and that dismissing an ICD’s value and effectiveness might cost more lives than not. Although it is practically better to not have revealed the defect right away, the argument of whether or not it was ethical to withhold this information is still in question. According to the New Oxford American Dictionary, being ethical means avoiding something that does harm to people or the environment. In this case, whether Guidant’s actions were ethical depends only on the consequences. Based on the above facts and previous arguments that the ICD is more helpful than harmful, the company’s actions are indeed moral and acceptable. Taking into account the fact that the device can only help and cannot harm, that the company did repair, warn, and notify the public, and that the failure rate is so low deem Guidant’s and its engineers’ actions, all in all, imperative, sensible, and ethical. Despite the fact that Guidant held off publicly announcing the ICD’s defect, it was likely for the better because of the high efficacy and success rates of having the ICD implanted nevertheless. Considering that the product’s successes have dramatically exceeded its failures, the actions of the company were not only justified, but morally imperative. As philosopher Jeremy Bentham once said, “it is the greatest good to the greatest number of people which is the measure of right and wrong” (Burns, 2005, 46). By this standard, Guidant and its engineers have indeed taken ethical actions.

Equation.” Utilitas 17.01 (2005): 46–61. Cambridge Journals Online. Web. Ezekowitz, Justin A., Paul W. Armstrong, and Finlay A. McAlister. “Implantable Cardioverter Defibrillators in Primary and Secondary PreventionA Systematic Review of Randomized, Controlled Trials.” Annals of Internal Medicine 138.6 (2003): 445–452. Silverchair. Web. Stahl, Eric. “Guidant Prizm II DR ICD Recall.” Major Recalls of Organ Replacement Devices. Brown University, 1 Apr. 2007. Web. 18 Apr. 2015.

References Baura, Gail. Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Academic Press, 2011. Print. Burns, J. H. “Happiness and Utility: Jeremy Bentham’s

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Princeton Journal of Bioethics

The North/South Paradigm in Global Mental Health: Definitions and Interventions Rebecca Rinehart Georgetown University

As the global health community become increasingly aware of a significant gap in mental health care access in high-income countries (HICs) and low- and middle-income countries (LMICs), mental health leaders must decide if and how to address the inequity. However, because of varied cultural understandings of mental illness and a historic power imbalance between the Global North and the Global South, this task is fraught with controversy. Proponents of the “Global Mental Health Movement” believe that lack of mental healthcare is a human rights issue and call for increased mental health access in LMICs. Opponents, on the other hand, argue that cultural variation in understandings of mental health are too significant, and a Global Mental Health Movement would inevitably lead to the imposition of the Western biomedical approach in communities that do not ascribe to it. Various mental health interventions, including PRIME and Dr. Lambo’s Aro Village program, respond to the mental health treatment gap and these concerns in different ways. Ultimately, the mental health treatment gap is a global health issue that must be addressed, but steps should be taken to ensure this is done in a way that is respectful and effective in a variety of contexts.

Executive Summary Undeniably, there is a gap in access to mental health treatment between Low- and Middle-income countries (LMICs) and High-income countries (HICs). Neurological diseases account for 14% of the global burden of disease, yet mental health is still neglected worldwide; generally, countries prioritize healthcare efforts that target physical diseases without addressing their interactions with mental health (WHO, 2001). Low-Income and Middle-Income countries are particularly lacking in access to mental healthcare, with four out of every five people with a mental illness going without any care (PRIME, n.d.). Since mental health is understood differently across different cultures, addressing or even acknowledging this lack of mental healthcare means answering challenging questions about global mental health and differences in across the North-South political and socioeconomic divide: How do understandings and definitions of mental health from the Global North impact the efforts to close the treatment gap in the Global South? How can we move past cultural differ-

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ences to provide respectful and effective interventions globally? Leading specialists, governments, and NGOs have proposed varied intervention strategies, each with their own strengths and weaknesses, but the issue of how best to address mental illness is still filled of controversy. Two opposing viewpoints characterize the controversy surrounding cross-cultural issues in the movement for global mental health. On the one hand, opposition to the global mental health movement argues that mental health is locally defined and that scaling up mental health in LMICs inevitably means imposing a Western understanding of mental illness on other cultures. Indeed, views of mental illness, including labels like “depression”, differ across cultures. On the other hand, proponents of the global mental health movement argue that inequality in access to mental health care is a violation of human rights, and they advocate for scalable but localized interventions. Ultimately, considering the controversy as well as the research on global mental health, it is clear that further steps need to be taken to address the men-

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tal health treatment gap, but that policies and programming need to speak to ethical concerns. Four key goals need to be emphasized as the global health community addresses this issue: (1) Expand interventions focusing on mental health, (2) Increase reliance on partnerships (3) Increase focus on research, and (4) Bolster mental health education. Mental healthcare is often deprioritized because of its relative “invisibility” compared to physical illnesses and particularly infectious diseases. However, it is now clear that mental illness is a serious public health concern that contributes significantly to quality of life globally. Through these four strategies, public and private organizations can begin the hard work of tackling the issue ethically and effectively.

Since mental health is understood differently across different cultures, addressing or even acknowledging this lack of mental healthcare means answering challenging questions about global mental health and differences in across the North-South political and socioeconomic divide. Key Findings I. Mental Health and the Treatment Gap: Although it is now clear that issues of mental wellbeing have significant impacts on the emergence of disease, social relationships, and even global and local economies, the WHO only started seriously looking into the topic as a global health concern in the 1990s (WHO, 2001). Their work opened a conversation that inspired an increased interest in mental health. This conversation eventually led to a decisive series of articles in The Lancet in 2007, which inspired the “Movement for Global Mental Health” (Movement for Global Mental Health, n.d.). Although this issue is now at the forefront of conversations in global health, mental illness as a concept – even as a term – is contentious, complex, and confusing. The personal nature of psychological health problems makes mental health challenging to define, measure, and address across cultural

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contexts. According to the WHO, “There is a widely shared but mistaken idea that all mental health interventions are sophisticated and can only be delivered by highly specialized staff” (WHO, 2010), and this attitude has led to a large gap in mental health resources in HICs with access to these specialized services versus LMICs with fewer resources. Whereas 80% of the world’s population lives in LMICs, 80% of mental health care resources are concentrated in HICs. Now that we know mental health care is feasible even in LMICs, the question becomes how and if we will address the gap. Generally, those who control resources also control its allocation, so, in line with colonial histories, the decisions of the high-income Global North impact the future of the low-income Global South in this topic. With this historical power imbalance, the WHO and The Lancet’s call to action, which challenges actors to narrow the gap, inevitably entails answering complex questions like: Does mental illness exist, and if so, what is it? How do we address the issue when the definition of mental illness is variable? How HICs talk about mental health directly impacts the interventions supported in LMICs, ethically challenging questions regarding implementation necessarily come to the forefront. Although there are discrepancies in cross-cultural understandings of mental illness, there is no doubt that mental health impacts overall health, and that we must do something to ameliorate mental health care in LMICs considering the gap in resources. According to the WHO’s 2003 report, “While the prevalence of major depression in the general population can go from an average 3% up to 10%, it is consistently higher in people affected by chronic disease” (WHO, 2003, p.10). So, even when data adjusts for inconsistencies in research, and even taking into account issues of labeling (not every culture uses the term “depression,” for example), we can generally conclude that there is a correlation between physical and mental illness. According to this report, major depression is associated with increased prevalence of some chronic disease up to 44% (WHO, 2003, p.11). While this research follows a Western, medicalized model for understanding mental illness (it depends on questionnaires and similar criteria to determine who has a disease), the results make sense across cultures. When a person undergoes psychological distress, they are less likely to take their medications or follow through with treatment plans for other, unrelated health issues (WHO, 2003, p.10). In fact, because of this correlation, lack of access to mental health care can be considered a form of structural violence Johan Galtung, the founder of the discipline of peace and conflict studies, defines violence as “the cause of the difference

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between the potential and the actual, between what could have been and what is” (Galtung 1969, p. 168). In this case, people in countries without mental health care services are not able to achieve full potential because of physical and mental the physical and mental results of that lack of access. Therefore, this is not a simple issue of quality of life, but rather of systemic injustice towards people in LMICs. Similar results exist across many mental illnesses, and this data likely underestimates the impact of the mental health treatment gap because it does not take into account the way mental illness affects communities, not just the afflicted individuals. When a person has a mental illness, or a comorbid physical illness, it affects the family and larger community that must support them, especially in LMICs. With respect to mental illness, “the burden of care falls heavily on women, as they are usually the primary caregivers, and on the poor, who do not possess adequate resources” (Desjarlais, 1995, p.220). These secondary effects of mental illness are hard, if not impossible to measure, but can be assumed to be extensive. Most importantly, it is well established that LMICs are severely lacking in mental health care resources. From the number of beds in clinical settings, to the number of mental health professionals, to the availability of medicines, to the prevalence of advocacy organizations, to the level of government funding, LMICs do not have support for the mentally ill (Saxena, Thornicroft, Knapp, Whiteford, 2007). The data on this lack in resources is drastic: overall, despite the fact that mental illness disproportionately afflicts LMICs, “The poorest countries spend the lowest percentages of their overall health budgets on mental health” (Saxena, Thornicroft, Knapp, Whiteford, 2007, p. 878). For example, in Africa and Asia, most countries spend less than 1% of their total health budget on mental health (Saxena, Thornicroft, Knapp, Whiteford, 2007, p. 881). The Declaration of Alma Ata in 1978 established health as a human right, and considering the obvious impact of mental health on physical wellbeing and quality of life, the mental health resource gap between HICs and LMICs is a human rights issue that must be addressed. II. The “Global Mental Health” Controversy It is clear from widespread research that mental health care in LMICs is a problem, and yet how this data is interpreted and how to address the problem are sources of major controversy. At the most basic level, there is controversy over whether the labels we use to define “mental illness” are culturally based. Understanding mental illness, just like understanding any other disease with social risk factors, is com-

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plex. In a speech at the 2012 Advanced Study Institute Conference, David Summerfield, an honorary senior lecturer at the Institute of Psychaitry, King’s College in the UK and the a leading opponent of the global mental health movement, discusses a particular refugee from Zimbabwe diagnosed with depression. The woman wondered why she had been referred to a medical team; she did not think she had a mental illness. She was HIV-positive, risking deportation back to Zimbabwe “where she would die,” and living in an unpleasant home. Instead of depression, she diagnosed herself with “Kufungisisa,” which means “thinking too much;” in other words, she was leading a hard life and was understandably upset (Summerfield, 2012). Not only did she use a different word to describe her psychological status, she attributed it to external factors rather than internal ones. The external contributors to her “Kufungisisa” are overwhelming, so Summerfield denies that the woman’s symptoms warrant a diagnosis of depression, a medical disorder. However, the narrow, medicalized mental health model that Summerfield criticizes here limits his assessment of mental health in general. This woman was likely experiencing “depression” as one part of a co-existing and related factors including poverty and refugee status, among others. That is, experiencing other life problems exacerbates the experience of psychological distress, but does not minimize that experience. Rather, it underscores the importance of taking a holistic approach to mental

The idea of a “global” health movement suggests that we are implementing something around the world, yet we still do not have mental health treatments figured out, even in HICs like the U.S. health care and recognizing the intersections between mental health as a medical illness and mental health in a social context. However, even if we recognize that it is possible to define mental health cross-culturally by resisting labels and acknowledging different social factors, Summerfield points out the challenges involved with implementation. The idea of a “global” health movement suggests that we are implementing something around the world, yet we still do not have mental

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health treatments figured out, even in HICs like the U.S. For example, Summerfield highlights the overuse of pharmaceuticals and suggests that pharmaceutical companies have too much incentive to over-expand their drugs into LMICs that often have non-medical understandings of mental illness, thus imposing a medical model where it may not exist otherwise. Furthermore, Summerfield points out that scaling up evidence-based treatments from the Global North is not a good idea because we do not yet have evidence that such treatments work in high-income contexts, let alone LMICs. Overall, David Summerfield is concerned that scaling up mental health care will result in the imposition of western understandings of mental health on LMICs, too reminiscent of imperialist attitudes. In opposition to Summerfield, Vikram Patel, a leader in the global mental health movement, claims that injustice due to lack of access to mental health care in LMICs is undeniable and reprehensible, and we must find effective ways to scale up global mental health care (Patel, 2012). He argues that the pitfalls Summerfield outlines are avoidable by rooting interventions in local understandings of mental health care. He emphasizes that although there is a specific understanding of mental health in the Global North, mental health as a concept did not originate in any one part of the world, mental health has existed for centuries in LMICs and HICs alike. He addresses controversy over the Mental Health Gap Action Programme (mhGAP), an extensive explanation of interventions proposed by the WHO in 2010 to address the mental health treatment gap. It includes flow charts and descriptions to help health care providers choose mental health treatments. Patel describes this sort of resource as a toolkit rather than a prescription, intended to be adapted to different contexts. He advocates for the use of randomized control trials to assess the efficacy of interventions (which use randomly selected groups and probability to determine whether an intervention is effective), task-shifting to address lack of human resources, among other strategies. Overall, Patel sees this issue as too important to pass up due to concerns about implementation. III. Innovative Interventions: A wealth of innovative interventions have been implemented, each with their own strengths and weaknesses with regard to addressing cross-cultural concerns. Two strategies in particular depict differing but successful approaches to this issue: Dr. Lambo’s Aro village system in Nigeria and PRIME (Programme for Improving Mental health carE). Dr. Lambo, a Western-trained Nigerian psychiatrist and

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scholar, founded the village-based mental health program in Western Nigeria in 1954. Patients, accompanied by a family member who took care of them, were temporarily integrated into particular villages with a hospital and smaller clinics. Family members were paid to compensate for time off work. As the patients underwent traditional and locally appropriate mental health treatment, they participated in community activities. In exchange, the hospital awarded the village with grants to improve water and sanitation issues (Desjarlais, 1995). By partnering with the village and patient family members and providing traditional care, the project benefited from the pre-existing village structure socially, medically, and economically while simultaneously treating patients and fostering their personal support system. This is an example of a project that depends entirely on the “local.” Without intimate knowledge of the village structure, hierarchies, and medical practices, it would not have been possible. The project was extremely successful and managed to treat three times the number of patients compared with the traditional hospital that existed before (Sheid, Brown, 2010). The project therefore increased access to mental health care without imposing external understandings of medicine. However, due to globalization and development, the Aro Village Project was not scalable. The structure only worked in a small, agrarian village and Western models expanded in other parts of the country as development increased. Also, in this case, the leader of the project was Nigerian (albeit educated in the UK). His intimate knowledge of Nigerian culture likely helped him better meet the needs of the patients, families, and village partners. But considering current global distribution of resources, in most cases, funding and medical professionals will often come from the West, which makes partnership even more important. Although the project was a good example of strong partnership and localized efforts without much influence from the North, its impact was limited. On the other hand, PRIME’s main objective is to implement the WHO’s mhGAP, a much more standardized implementation strategy than the village health project. PRIME works in five LMICs: Ethiopia, India, Nepal, South Africa, and Uganda. The very fact that one organization works in multiple countries and communities reveals that PRIME is part of the global health movement. The mhGAP provides detailed diagnostic tools and suggests treatment plans for twelve neuropsychological disorders, including depression, alcohol abuse, and dementia. However, this structure is intended to empower health care providers in the context of pre-established primary health systems,

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not establish hard-and-fast rules. This allows local healh systems to adjust implementation based on local understandings of mental health to some extent. PRIME works with the WHO, partners in the UK, and local leaders and organizations in the LMICs it serves to generate research and implement interventions based on expanding primary health care (PRIME, n.d.). This is a scalable project that focuses on local interventions by integrating standardized strategies on a case-by-case basis in primary care settings. It creates partnerships that give LMIC leaders a voice while harnessing the resources of HICs, the WHO, and other powerful entities. It creatively addresses the issue of a human resource gap through task-sharing and task-shifting, educating primary health care providers enough so they can provide counseling and psychiatric services usually only provided by specialists. However, PRIME’s strategy as well as the mhGAP’s depends at least to some degree on research methods, language, and definitions of mental illness from the Global North. For example, the mhGAP uses language like “depression,” and as Summerfield pointed out in his talk, this term may not be locally relevant in some LMICs. Gotlib and Hammen’s Handbook of Depression (2010) extensively expounds why even this one word has Western underpinnings. Among other reasons, decreases in self-esteem are only viewed as abnormal in cultures that assume that having positive emotions and feeling good about oneself is a normal and healthy way of being.” And this means that “conceptions of depression are influenced by the Western view of the individual” which doesn’t translate in cultures that “view individuals as interdependent, connected with others, and defined by the social context” (p. 468). Further, PRIME and other global mental health organizations often depend on randomized controlled trials. Among other ethical concerns, some question whether complex interventions across different cultural groups can be assessed using objective measurements as a predictor of future success (Allen, Barn, Lanphear, 2015).

titudes. In order to approach this project holistically, global entities and smaller organizations should focus on four key areas: (1) Mental health interventions, (2) Partnerships (3) Research, and (4) Education. First and foremost, global health agencies and organizations should fund more localized mental health interventions that create sustainable, equitable, and economically responsible projects. They should give priority to interventions that promote task shifting and task sharing in order to maximize the number of health care providers in low-resource settings. These projects should provide financial support to all health care providers and have a plan for substantial, longterm training and support to non-professional providers in order to ensure they are effective and that the project is sustainable. They should also give priority to interventions that provide long-term strategies for integrating the broader community where

Recommendations Although there are limitations that impede accurate assessment and implementation of global mental health interventions, the inequity in mental health support between HICs and LMICs is undeniable, and we must make efforts to close that gap. However, keeping in mind the unequal power relationship due to imbalanced resource distribution in the Global North and Global South, these efforts must thoughtfully address concerns about cross-cultural understandings of mental health and imperialistic at-

the interventions are implemented. At minimum, this means the project must build off any pre-existing primary care structure in the community. However, especially if there is no strong healthcare system in place, this could also mean partnering with community members to build off the community’s social, economic, or other structure (as in the Aro village scheme). By building off pre-existing health infrastructure, projects can use a diagonal approach (strengthening health systems and addressing the particular issue of mental health) that allows room for

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As established at the Alma Ata Conference, health is a human right, and across the board, research, case studies, and fieldwork substantiate the idea that mental health contributes to overall health of populations. Therefore, despite complex ethical challenges that must be considered and addressed thoughtfully, it is a moral imperative to narrow the gap in mental health care between HICs and LMICs.

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expansion into new areas of mental health or public health in general and reduces costs. In addition to these benefits, by including the community in some capacity, effective interventions can increase awareness in the community and reduce stigma surrounding mental health. Further, this kind of partnership minimizes the tensions and mistrust associated with West-imposed interventions. Next, governments (and NGOs when applicable) should help fund increased anthropological research in mental health as opposed to research using quantitative measurements and randomized controlled trials. Anthropological research is certainly more long-term and less intervention-focused, however, it is a better way to achieve the knowledge necessary to implement truly localized interventions and avoid an imposition of Western understandings reminiscent of imperialism. Anthropological research should specifically address issues of stigma and local medicine in order to understand the local history and current beliefs surrounding mental health. When appropriate, if traditional healing or treatment exist, research should investigate the efficacy of those practices in comparison to Western models. The WHO should deemphasize the dependence on mhGAP interventions, since these are based on the Western model, except in cases where these models are locally appropriate and accepted, as determined by anthropological studies and research into existing health infrastructure. Finally, governments should provide incentives to medical and nursing schools in LMICs to strengthen their education on mental illness and encourage careers in mental health care in order to minimize the gap in mental health care professionals between HICs and LMICs. More generally, as a long-term strategy to address issues of stigma, awareness, and to increase participation in finding effective interventions, international agencies like the WHO should encourage discussions surrounding mental health care in a variety of educational settings, both in HICs and LMICs. Widespread understanding of mental health as part of broader health issues (and acknowledgement of The Lancet’s claim that there is “no health without mental health” (Prince et al, 2007)) will inevitably lead to increased interest and activism with respect to closing the mental health care gap between HICs and LMICs. Considering the vast number of organizations committed to this cause – from relatively large-scale programs like PRIME to global and governmental entities to small projects by NGOs – the WHO should serve as a supportive liaison connecting organizations and sharing knowledge. By incentivizing part-

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nerships between countries and organizations, specifically between entities from the North and South, the WHO can provide a low-cost service to improve communication so that LMICs have a real say in intervention implementation. Essentially, organizations and larger entities focused on mental health should (1) scale up local and global support for mental health care and (2) emphasize local contexts in the implementation of mental health care. As established at the Alma Ata Conference, health is a human right, and across the board, research, case studies, and fieldwork substantiate the idea that mental health contributes to overall health of populations. Therefore, despite complex ethical challenges that must be considered and addressed thoughtfully, it is a moral imperative to narrow the gap in mental health care between HICs and LMICs. References Altevogt, B. (2010). Mental, neurological, and substance use disorders in Sub-Saharan Africa reducing the treatment gap, improving quality of care : Summary of a joint workshop by the Institute of Medicine and the Uganda National Academy of Sciences. Washington, D.C.: National Academies Press. Beem, D., & D’souza, N. (2012, July 23). Global Mental Health and its Discontents. Retrieved April 21, 2015. Bruckner, T., Scheffler, R., Shen, G., Yoon, J., Chisholm, D., Morris, J., . . . Saxena, S. (2011). The mental health workforce gap in low- and middle-income countries: A needs-based approach. Bulletin of the World Health Organization, 184-194. Collins, P., Holman, A., Freeman, M., & Patel, V. (2006). What is the relevance of mental health to HIV/ AIDS care and treatment programs in developing countries? A systematic review. AIDS, 1571-1582. Retrieved March 31, 2015. Crossette, B. (1995, May 15). Mental Illness Found Rising in Poor Nations. Retrieved April 21, 2015. Desjarlais, R. (1995). World mental health: Problems, and priorities in low-income countries. New York: Oxford University Press. Galtung, J. (1969). Violence, Peace, And Peace Research. Journal of Peace Research, 6(3), 167-191. Global Mental Health 2007. (2007, September 3). Retrieved April 30, 2015, from http://www.globalmentalhealth.org/about/history Gotlib, I. (2002). Handbook of Depression. New York: Guilford Press. Grand Challenges in Global Mental Health. (2012). Retrieved April 21, 2015. Integrating mental health into primary care: A global

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perspective. (2008). Retrieved March 31, 2015. History: Movement for Global Mental Health. (n.d.). Retrieved April 30, 2015, from http://www.globalmentalhealth.org/about/history Investing in Mental Health. World Health Organization (2003). Retrieved April 21, 2015. Mendenhall, E., De Silva, M., Hanlon, C., Petersen, I., Shidhaye, R., Jordans, M., . . . Lund, C. (2014). Acceptability and feasibility of using non-specialist health workers to deliver mental health care: Stakeholder perceptions from the PRIME district sites in Ethiopia, India, Nepal, South Africa, and Uganda. Social Science and Medicine, 33-42. mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP). Geneva: World Health Organization; 2010. I, Introduction.Available from: http:// www.ncbi.nlm.nih.gov/books/NBK138693/ Patel, Vikram. (2012, June). Mental Health for all by Involving All. Retrieved from https://www.ted. com/talks/vikram_patel_mental_health_for_ all_by_involving_all?language=en Prince, Martin et al. No Health without Mental Health. The Lancet , Volume 370 , Issue 9590 , 859 - 877 Programme for Improving Mental Health Care. (n.d.). Retrieved April 30, 2015, from http://www.prime. uct.ac.za/ Rosenberg, T. (2012, July 22). OPINIONATOR; Healing One Village at a Time. Retrieved April 21, 2015. Saxena, S., Thornicroft, G., Knapp, M., & Whiteford, H. (2007). Resources For Mental Health: Scarcity, Inequity, And Inefficiency. The Lancet, 370(9590), 878-889. Retrieved March 31, 2015. Scale up services for mental disorders: A call for action. (2007). The Lancet, 370(9594), 1241-1252. Retrieved March 31, 2015. Semrau, M. (2015). Strengthening mental health systems in low- and middle-income countries: The Emerald programme. BMC Medicine, 13(79). Shawgi, M. (2015, April 10). Mental Illness Dangerously Ignored By Health Services. Retrieved April 21, 2015. The World Health Report 2001: Mental Health: New Understanding, New Hope. (2001). Retrieved March 31, 2015. The global burden of mental disorders and the need for a comprehensive, coordinated response from health and social sectors at the country level. (2012). Retrieved March 31, 2015. WHO Mental Health Gap Action Programme (mhGAP). (2014). Retrieved April 21, 2015. MhGAP Intervention Guide. (n.d.). Retrieved April 21, 2015.

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Volume XIII | Fall 2016

A Loss of Character: Dementia and Advance Directives Safwan Jalal Cornell University

Should individuals with dementia be able to overturn binding directives signed before the onset of their illness that deny them the ability to seek treatment for curable diseases? This question defines the final moments of many afflicted with dementia and is an important ethical question that must be answered in order to afford the best care to individuals in such situations. Margo was an average person who was diagnosed with dementia and signed an advance directive stating her desire to receive palliative care and to not receive treatment should she contract a treatable illness. After experiencing dementia, Margo contracts pneumonia and wishes to seek medical treatment. This paper argues why Margo should not receive this treatment as she no longer recognizes any long term values she once held and as such, is no longer able to act out of a continuous sense of self.

Advance directives are documents that allow individuals to specify which medical treatments they would like to receive at the end of their lives. Suppose Margo, an elderly woman experiencing the later stages of dementia, has contracted pneumonia. Before the onset of dementia, Margo signed an advance directive stating that should she contract a life threatening illness such as pneumonia, doctors will not implement life-sustaining treatments. Although Margo may have changed her mind about treatment in her current state, lawyer and philosopher Ronald Dworkin argues that in the case of impaired individuals, the advance directive should be honored over current preferences because the wishes of impaired individuals no longer incorporate the individual’s critical interests and are not derived from a continuous sense of the self. This paper will first discuss different interpretations of autonomy and why autonomy is morally important, then cover why individuals with dementia should no longer have autonomous rights. Finally, this analysis will demonstrate how Dworkin’s autonomy argument holds true for Margo’s case. Dworkin defines autonomy as an individual’s right to make important decisions regarding his or her life (Dworkin, 1993). Autonomy is a basic principle that allows individuals to make decisions for themselves without external interference in order to exercise control over the course of one’s own life. Autonomous actions can be as simple as deciding to put on a

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certain pair of shoes or as complex as deciding what field of study to enter and what career path to follow. Thus, Dworkin asserts that it is morally important to respect an individual’s decisions because individuals should be allowed to determine the course of their own lives. Dworkin substantiates this position by considering two different views of autonomy: the evidentiary and the integrity views. Dworkin describes the evidentiary view as the notion that we should respect the decisions that individuals make about their own lives even if we disagree because individuals tend to know their best interests better than anyone else (Dworkin, 1993). What others may see as detrimental to my interests, I may see as beneficial. For example, coal miners see it fit to work in dangerous coal mines in order to make enough money to put food on the table for their families. Even though others may deem it unwise to risk their health to make money, they do not have a firsthand understanding of the dilemma. Therefore, we must treat individuals as experts on their own lives and respect that they are therefore in the best possible position to understand their interests. According to this evidentiary view, individuals must have a right to autonomy. However, Dworkin complicates this evidentiary view by proposing two scenarios in which individuals my not act in their own best interest. He first states that individuals often take actions that they

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know are not in their best interest and yet continue to indulge in these actions (Dworkin, 1993). For example, an individual that is diabetic and obese may continue to eat sugary and fattening foods even if he knows that eating such foods is not in his best interests and could lead to fatal health consequences. This shows that individuals often do not act in their ultimate self-interests, which the evidentiary view does not account for. Second, individuals often go against their best interests in order to promote the interests of others (Dworkin, 1993). A father may run into a burning building in order to save his son or a brother may donate a kidney to his sister in order to save her life. In both of these cases, both the brother and the father act against their own self-interest in order to promote the interests of another. Thus, the evidentiary view is not a compelling argument for the right to autonomy. The integrity view offers a better explanation. Dworkin describes the integrity view as the notion that autonomy acknowledges an individualâ&#x20AC;&#x2122;s capacity to express oneâ&#x20AC;&#x2122;s character through their actions. This character is expressed through critical interests, according to which an individual reflects on his desires and pursues long-term goals, and experiential interests that allow an individual to enjoy a pleasurable quality of life (Dworkin, 1993). The integrity view states that we as human beings have certain values that we uphold or aspire to and that every action we take is a reflection of these values. This is a stronger argument for why individuals act autonomously, as it holds true even when individuals act against their immediate self-interests. They do so because of their dedication to a set of values and beliefs, and every action they take in this regard further expresses those values. Therefore, the father who runs into a burning building in order to save his son does so because he values his family as well as his altruistic duty as a father. Similarly, in the case of the diabetic man choosing to continue to eat sugary and fattening foods, he does so because the utility he gains from eating the food outweighs the negative health consequences that he will likely face. In order to thoroughly understand why this view of autonomy is more comprehensive, it is important to understand critical and experiential interests. Critical interests allow us to feel that our lives are worth living. They allow us to reflect on the type of person we want to be and prioritize long-term aims that must be satisfied to feel fulfilled. These interests are not concerned with day-to-day experiences, but rather add an overarching value to life. Critical interests are crucial to the notion of autonomy because they allow an individual to live his life according to

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his own values, even if those decisions seem unwise to others or appear to go against his best interests. For example, while an artist that is living in utter poverty may make more money and experience a greater quality of life if she chose a different profession, she

Autonomy is a basic principle that allows individuals to make decisions for themselves without external interference in order to exercise control over the course of oneâ&#x20AC;&#x2122;s own life. Autonomous actions can be as simple as deciding to put on a certain pair of shoes or as complex as deciding what field of study to enter and what career path to follow. may feel that the value she derives from painting fulfills her critical interests and outweighs the costs associated with being impoverished. When considering her critical interests, she may feel that her life would have been worse off had she not become a painter. Similarly, while a medical student faces years of grueling study before becoming a doctor, he does so because he derives a certain value from being a doctor that makes his life meaningful. Our critical interests allow us to determine whether our lives and the sum of our actions were meaningful on the whole. Experiential interests, on the other hand, allow us to appreciate the immediate quality of our lives. These are interests that allow us to enjoy pleasurable experiences and to avoid painful ones. By fulfilling our experiential interests we derive value from enjoying a high quality of life. For example, one may derive value from simple acts such as watching a movie with friends or sleeping after a long day of work. These are experiences that allow me to fulfill my immediate desires. If we consider the integrity view as a whole, taking both critical and experiential interests into account, we are able to see what it means to act autonomously. Further, this also allows us to see why autonomous actions are morally important. If every individual is endowed with a unique and distinct set of values through which they derive their sense

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of self from and if both our critical and experiential interests guide our lives and the actions we take, it then follows that every autonomous action that we take is derived from an intrinsic sense of self which is unique to each individual. Therefore, every individual who possesses both these critical and experiential interests is the best possible actor to decide which action is more in line with his values. Thus, because each individual possesses a unique and intrinsic set of values that they ascribe to, it is morally important that autonomous actions ought be a right endowed to each individual. With this understanding, it is also then possible to foresee scenarios in which autonomy comes into conflict with personal welfare. Dworkin gives primacy to liberty in the face of life and death situations for this reason, using the example of the Jehovah’s Witness who should be allowed to refuse a life saving blood transfusion on the basis of his religious convictions (Dworkin, 1993). While the Jehovah’s witness is clearly going against his own personal welfare when refusing the blood transfusion, he should be able to act autonomously to satisfy his critical interests in accordance with his religious beliefs. The Jehovah’s Witness places great value on his religious convictions and satisfies his critical interests by adhering to them, therefore deriving greater value from religious fidelity than he would from receiving the blood transfusion. Critical to the discussion regarding advance directives and dementia, Dworkin argues that this philosophy only applies when individuals are of sound mind. He argues that patients with dementia are no longer capable of autonomous decision making, as they do not have a clear understanding of past and future and are unable to reflect on their past actions or maintain long-term aims. An individual with dementia can no longer look back on her life and evaluate whether or not her life had meaning. When she is unable to do so, she is consequentially unable to fulfill any of her prior critical interests, so her actions no longer reflect the integrity of her life and no longer express her true character (Dworkin, 1993). In short, they cannot recognize their critical interests and as such are no longer able to act out of a continuous sense of self, making them incapable of acting autonomously. Competence in this sense means being able to reflect on past actions and beliefs and translate those experiences into future decisions that advance personal values. Incompetence refers to an individual’s inability to uphold a certain set of values and have long terms aims and aspirations. This also means that while critical interests are generally more important than experiential interests, an individual

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with dementia who understands immediate sensations but does not remember long-term values will prioritize experiential interests over critical interests. However, we have established that critical interests give life broader meaning and are therefore more important, and should not be sacrificed with a decline in mental health. An individual has a right to designate their critical interests—to be prioritized in any circumstance—and have those upheld even when they cannot remember them. An advance directive serves as an individual’s official statement of critical values and preferences that they would like upheld even when they are unable to articulate their wishes. While this usually comes into play should a patient enter a coma, Dworkin goes so far as to state that dementia constitutes such a state of incapacitation and that the advance directive should override articulated desires in such a state. This position is founded in the established understanding that an individual rendered incompetent by dementia is no longer able to have a continuous sense of self. They are no longer able to adopt a value based upon which they can live out their life, let alone foresee whether or not their actions are in line with this value. Therefore they do not have the right to what Dworkin calls a “fresh exercise of autonomy,” or the right to override the autonomy designated by their past self in a sound state of mind (Dworkin, 1993). To reintroduce Margo in the context of Dworkin’s argument, it is clear that should she contract pneumonia at the end of her life and request life-saving antibiotic treatment that contradicts her advance directive, her advance directive must be honored. She should receive palliative care that will ease her pain and will allow her to die peacefully in accordance with her prior preferences. We ought give Margo this palliative care for while she does not have the ability to make reasonable decisions in line with her character, the fact that she still experiences pain and pleasure on a daily basis means that she die a peaceful death, devoid of any pain and suffering. Margo is no longer able to discern the set of values and beliefs that she molded her life around when she was competent and as such, she is no longer capable of making choices that reflect the integrity of her character. If Margo, while competent, states that she does not want life saving treatment in the event that she contracts a life threatening illness, this should be honored because it reflects the set of beliefs by which she wanted to live her life as designated in her competent state. For example, she may have preferred not to become burden on her family or prolong the loss of memory and identity, which she may have felt would leave her to die a former shell of herself. This fact about Margo

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also delineates a key distinction between patients with dementia and patients with other lifelong mental impairments. Margo’s case is different from other individuals with mental impairments because Margo, at one point, decided to live her life according to certain values and these values dictated the choices that she made. A person with lifelong mental impairments usually does not have this change in values and as such is given autonomy for he is always making decisions in accordance with these values. Thus, Margo is no longer able to make value judgments in accordance with her critical values and long-term sense of self, and as such should not be allowed to overturn the decisions articulated in her advance directive. This argument will incite two potential objections: one could argue that before the onset of her dementia, Margo was incapable of making an informed decision for her future state, or that her needs and identity have changed with the change in her mental state, and she should therefore be treated as an autonomous individual with a mental impairment whose experiential interests now outweigh her former critical interests. A critic could claim that Margo was incapable of making decisions concerning her future needs and wellbeing before having ever experienced dementia. Therefore, even while considering her critical interests, she could not have anticipated her immediate desires in her impaired state. For example, many women who experience unplanned pregnancies say that they do not want to keep their babies and wish to put them up for adoption. Once the child is born, however, many of these women change their minds and decide to keep their babies. Humans are not always able to adequately foresee the outcomes of events that significantly affect their lifestyles and day-to-day decision-making processes. Therefore, some argue that we should allow the present Margo to opt into treatments that contradict her advance directive. The difference between these two cases is that the pregnant woman retains her competence before and after pregnancy. That is, she preserves the ability to compare her every action to a set of beliefs that she wishes to live by, so she maintains the right to autonomous decision-making. Margo’s dementia, on the other hand, renders her incapable of fulfilling her critical interests and acting in accordance with her personal value set. Therefore, though she had not yet experienced dementia when she wrote her advanced directive, she was still capable of anticipating future declines in health and choosing treatment plans in accordance with her critical interests. One could also object that Margo is a different person now, and as such should be treated as an in-

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dividual who lacks critical interests as a result of her mental disorder. If Margo is perfectly happy experiencing the simple pleasures of life and fulfilling her experiential interests, one could argue that she has a right to request treatments that would allow her to continue living this way. One may respond to this by stating that because Margo lived the majority of her life as a sound-minded individual with aspirational values, decline in her mental faculties later in life does not constitute a new identity that is entitled to negate her expressed wishes. According to the integrity view, which states that individuals have the right to determine the course of their lives as a whole, we

According to the integrity view, which states that individuals have the right to determine the course of their lives as a whole, we must respect her autonomy as a competent individual by allowing her to choose the way she would like to die. must respect her autonomy as a competent individual by allowing her to choose the way she would like to die. One could further defend the decision to uphold Margo’s advanced directive on the grounds of medical beneficence. The medical community ought strive to protect the interests of any person who is not able to do so themselves. In this sense, the medical community has a duty to ensure that Margo’s decision-making calculus in accordance with the belief system that she wished to live by is not overturned while she does not have any critical interests. A critic to this claim could argue that a doctor has a duty to promote Margo’s best interests in her current state. If this means reversing her advanced directive, the doctor should do so under the principle of beneficence. One may respond to this argument by weighing Margo’s current state against that of her former, pre-dementia state. We should not simply respect one decision over the other simply because one decision is more recent. Given that Margo with dementia only acts according to what maximizes her current pleasures and minimizes her current pains, a doctor ought protect

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the integrity of the decisions that she made when she retained her critical interests. Ultimately in Margoâ&#x20AC;&#x2122;s case, her advance directive, created in accordance with her sound-minded values, must be respected as the true determinant of how Margo at her most competent state, wanted her life and body to be treated should she become incapable of expressing those wishes. Dementia constitutes a significant change in mental state that renders Margo unable to make autonomous decisions in line with her critical interests; therefore her advance directive should be honored without question. References Dworkin, Ronald. Lifeâ&#x20AC;&#x2122;s Dominion: An Argument about Abortion and Euthanasia. London: HarperCollins, 1993. Pages 218-241.

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The Moral and Legal Permissibility of Placebo-Controlled Trials Mina Henaen Princeton University

Leaders of research ethics organizations have made placebo-controlled trials illegal whenever placebo groups would not receive currently existing treatment for their ailment, slowing down research for cheaper and more effective treatments. In this essay, I argue that placebo-controlled trials (PCTs) are both morally and legally permissible whenever they provide care that is better than the local standard of care. Contrary to what the anti-PCT often put forth, I argue that researchers conducting PCTs are not exploiting other developing nations, or subjects from these nations, when they conduct their research there. I then show how these researchers are also not especially legally required to provide treatment to their placebo-group subjects. I present some of the benefits of such research to the placebo groups as well and consider the moral impermissibility of making such research illegal.

In this essay, I will address the issue of placebo-controlled trials (PCTs) in research experiments. Research Ethics leaders around the globe have denounced PCTs in developing countries as being exploitative, leading to their illegalization around the globe. This illegalization has not only slowed down research for cheaper and more effective treatment, but has also withheld the partial health benefits that would be bestowed on the experimental subjects who do participate. I argue that PCTs are morally permissible when they provide care that is better than the local standard of care. I do this by first showing that PCTs are not exploitative, and that even if PCTs were morally impermissible, this would not necessarily establish them as being legally impermissible. In a 2010 study (Temel et al., 2010), 151 patients with newly diagnosed metastatic non-small-cell lung cancer were randomly placed into one of two treatment groups. In one group, patients received early palliative care integrated with standard oncological care. In the other, patients received only standard oncological care. The results of the study showed that the patients who underwent the early palliative care had a higher quality of life and survived about 2.5 months longer than those who did not undergo this care. It seems that the researchers’ refusal to give early palliative care to about 75 patients led to a lower quality of life and an earlier death for them.

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Could what the researchers have done be considered unethical? It might seem so at first, but once we understand that, up to that point, there was not much evidence supporting the idea that early palliative care was indeed effective, we can refrain from claiming that the researchers conducted an unethical experiment. The afore-mentioned example shows that, if there is not sufficient evidence supporting one treatment group over another, it would not be unethical for researchers to place subjects into said groups. In fact, this is the commonly held ethical principle called equipoise, which states, “Prior to conducting the trial, researchers must have no good evidence for thinking that one treatment (in the experimental arm) is better or worse than the other treatment (in the control arm)”. However, would the inverse be true as well? Some argue that, if there is sufficient evidence that one treatment group is more effective than another, it would be unethical for researchers to place patients in the less effective group. For example, the Food and Drug Administration (FDA) has refused to let researchers conduct placebo-controlled trials of surfactants for the idiopathic respiratory distress syndrome in the United States because there are “available approved surfactants that are the standard of care” (Charatan). The surfactant drug would save lives of infants while the placebo would not. To refuse

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to give the surfactant drug and to give the placebo instead would constitute knowingly letting infants die from idiopathic respiratory distress syndrome, where they would have otherwise received the standard of care: the life-saving surfactant drug. It seems that in this case, it is not difficult to agree with the FDA’s decision to refuse such placebo-controlled trials in the U.S. However, the researchers wanted to conduct this trial in Bolivia, in which the standard of care consisted of no life-saving surfactant drug at all. Would it still be unethical to conduct this PCT? This is the question that this paper will explore. It is important to note that pharmaceutical companies and research organizations favor placebo-controlled trials because they are cheaper and are argued to be scientifically more informative than active-controlled trials or historical comparisons. That is why the researchers would rather have a placebo group instead of a different treatment group.

If we accept that the Bolivians have no claim towards the benefits of the research, then it follows that it is still unclear how the researchers are exploiting their subjects by taking an unfair advantage of the Bolivians. If the researchers do not conduct the PCT, no Bolivian patients would receive treatment. However, if the researchers do conduct the PCT, at least some patients – those in the treatment group – would receive what might potentially be treatment. Moreover, there might also be some benefits for the placebo group, like the possibility of partially effective placebo effect and the potential benefits that could come from the presence of professional medical personnel. Despite the fact that the outcome of the PCT would be better than the outcome of no PCT at all, many still object to conducting the PCT because it would seem exploitative of Bolivians. This objection is based on two premises: first, that this PCT is exploitative, and second, that exploitative actions are immoral. I will accept the second premise as true and only focus on the first. If it can be shown that this PCT is not exploitative, then there would be no need to object to the second premise.

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It might be thought that the PCT is exploitative because it is taking unfair advantage of Bolivians, whose standard of care is below that of developed countries, to conduct research, which would be illegal in developed countries. Let us consider another case: George is a businessman living in the US. He owns a small business that sells quality home telephones with cords. Lately however, he has not been able to sell much due to the flourishing of cordless home phones and cell phones. He decides to move his business to Bolivia (or some other underdeveloped country) in order to sell his phones there at the same price. In Bolivia, cell phones and cordless home phones have not yet made their way into the mainstream market. It does not seem that what George is doing is exploitative. It can be said that George is taking advantage of the slower market in Bolivia in order to sell his phones, but he is not treating them any worse than anyone else. Going back to the PCT case, we might also say that the researchers are simply taking advantage of the lower standard of care in Bolivia. They are not treating them any worse than they would be treating subjects in the United States (because they would have done the same experiment there if the standard of care in the US was the same as that in Bolivia). In this way we can distinguish between taking unfair advantage of people and taking advantage of people’s unfair, or unfortunate, circumstances. What George and the PCT researchers are doing could be considered taking advantage of the unfair circumstances of people, but it could not be considered taking an unfair advantage. Neither George nor the researchers caused the unfortunate circumstances of the Bolivians (slow market and low standard of care). If we define exploitation as to refer to those actions that take unfair advantage of others, then PCT would not be considered exploitative for the reasons just mentioned. Now, one might respond to this by stating that taking advantage of one’s unfair circumstances is unfair in itself. One might present an example in which a doctor overcharges for a necessary life-sustaining procedure, or in which a company underpays its employees simply because the employees live in an area with minimal job opportunities. These cases might be considered examples of taking an unfair advantage of one’s unfair circumstances because the doctor ought to gain less money than he is asking for and the company ought to pay more money than they are paying their employees. However, these cases are not completely analogous to the PCT case. When comparing what one ought to gain from the transaction, it is not so clear that the Bolivians ought

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to receive the best treatment. Maybe in a more general theory of the distribution of wealth or health resources, the Bolivians ought to receive the best treatment. However, this responsibility would not solely be that of these specific researchers, but also that of the governments and leaders who have any sort of control over the economy and/or health resources. If we say that, in the transaction between the Bolivians and the PCT researchers, the Bolivians do not have any right to receive the best treatment from them, then we cannot conclude that the PCT researchers are taking an unfair advantage of the Bolivians. In the case of the overcharging doctor and underpaying company, fairness is lost when what one ought to gain/lose is not gained/lost. In the PCT case, there would need to be evidence for something that the Bolivians ought to gain that the researchers are not giving for one to claim that they are exploiting the Bolivians. At this point, one might say that the Bolivians ought to gain the benefits of the research. In other words, this research must be intended to discover some way to treat some disease that inflicts Bolivians, or to treat them at a cheaper rate. If the research is conducted by foreign researchers to benefit foreign patients, then it could be said that the researchers are taking an unfair advantage of the Bolivians. One might even add that the individual participating in the experiment is not necessarily gaining the benefits of the research. After possibly 300 deaths resulting from the placebo group (or resulting from sickness that was not cured for the placebo group, but that could have been cured by a different treatment), even if some cure for a disease in Bolivia is discovered as a result of the research, the participants in the placebo group will obviously not be receiving that treatment as they would already have passed away. This would suggest that the researchers are taking unfair advantage of the Bolivians because the research subjects themselves ought to benefit from the experiments being conducted on them, yet are not. However, it is not necessarily true that the PCT subjects are not benefiting from the research. Although they might die before some cure is discovered, participating in the research and taking a placebo is better than the standard of care in that area of the world. Even if the research is intended for foreign patients, the Bolivian research subjects will still possibly benefit from participation. This, however, does not respond to the claim that the Bolivians, in general, ought to receive the benefits of the research. Let us return to the case of George and his corded telephone business. George intends to benefit himself, and possibly his family, by earning a living through

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selling corded phones in Bolivia. Surely, the specific persons that buy a phone from George will have some benefit of having a corded home telephone. However, it does not seem to be the case that the Bolivians, in general, ought to receive the benefits of George’s business. George is simply making a living for him and his family. Those who buy phones from him are individually opting to choose to buy a corded home phone for themselves. Any other Bolivian who wants a cordless phone or a cell phone cannot put demands on George that he give, sell, or make available those products to them simply on the basis that the market in Bolivia is slower than the one in the U.S. Likewise, in the PCT case, the researchers could simply be trying to discover some cure for themselves or for patients within their own nation. It does not seem to be the case that the Bolivians, in general, ought to benefit as a result of the ventures of these researchers. The specific Bolivians who decide to be participants in the research are individually consenting to receive at least placebo care, which is better than the Bolivian standard of care, namely no treatment at all for idiopathic respiratory distress syndrome. If we accept that the Bolivians have no claim towards the benefits of the research, then it follows that it is still unclear how the researchers are exploiting their subjects by taking an unfair advantage of the Bolivians. The conclusion that the researchers are not unethical in conducting a PCT on Bolivians is however not held by some of the leaders of research ethics. The 1962 Declaration of Helsinki of the World Medical Association states that, “[I]n any medical study, every patient—including those of a control group, if any—should be assured of the best proven diagnostic and therapeutic method”. Furthermore, the International Ethical Guidelines for Biomedical Research Involving Human Subjects stated that the ethical standards applied in a study “should be no less exacting than they would be” for research in the sponsoring country itself. To many, the use of PCTs in developing countries seems to be ethically indefensible because it elicits imagery of hypocrisy: the researchers are conducting research abroad that would be illegal at home. We can lessen this unethical imagery by looking at a more specific, individual case: Arnold’s sister has just been diagnosed with a newly discovered fatal cancer. There is currently no cure for this malady. Arnold, a researcher, figures out that if fruit A can fill an empty stomach over a onemonth period, then fruit A can cure this disease. To test this, Arnold needs to conduct an experiment in which one group of subjects eat fruit A with water for a month, while the other subjects eat fruit B with water for the same period of time. Fruit B is exactly

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like fruit A except that it lacks the healing properties in Fruit A. However, he cannot test this fruit in the United States because it would be unethical to have research subjects live on only fruit A or fruit B in the United States â&#x20AC;&#x201C; Fruits A and B lack most essential nutrients, rendering those, who purely consume those fruits for 30 days, in a drastically malnourished state. However, in severely underdeveloped country B, hunger is rampant and the death rate is high due to lack of food. Arnold decides to go to country B and conduct the research. He would give fruit A and water to 100 starving participants, and would give fruit B and water to another 100 participants. It does not seem that the imagery of hypocritical researchers arises in this example. Arnoldâ&#x20AC;&#x2122;s research would be illegal at home but not in country B. However, not only is he conducting this research in order to save his dying sister, but he is also providing water and food to all participants. Given the standard of hunger in the area, these participants would not have had something to eat that is as healthy and as abundant as fruits A and B. In fact, we can even justifiably add to the example that the placebo participants who received fruit B lived longer than their relatives who did not participate in the experiment. In this case, it would seem morally impermissible to prohibit Arnold from conducting his research abroad. A PCT is not much different from this case. Those in the placebo group benefit, given the low standard of care in their country. Even though the research is not intended for those who are research subjects, the research still seems to be morally permissible. It does not seem to be the case that Arnold elicits imagery of hypocrisy either. Surely one might say that this is not always the case with PCTs. Sometimes the researchers are not attempting to discover a cure, but are looking for cheaper ways to find a cure. Arnold would, in this situation, not be trying to save his sister, but would be trying to save money. This response seems to ignore the moral benefit of cheaper medicine. Cheaper medicine is more accessible, especially for those in underdeveloped countries. If we view Arnold as a researcher who is trying to find a cure that is affordable for the diseased poor, he would no longer elicit images of hypocrisy. One case is often given to suggest that it is still morally impermissible to conduct a PCT: a man is walking down the street when he spots a house on fire that is not his own. In a heroic act of courage, the man runs inside to save whomever he could find. He spots a crying baby and a parrot. The man picks up the parrot and leaves the baby in the burning house. This example suggests that, although the man

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might have been a very moral person for risking his life to save whomever was inside the house, leaving the stranger baby inside the fire is immoral. The analogy shows that, although the researchers might be giving some subjects treatment, allowing the placebo subjects to not receive the best available treatment would be immoral. However, in the baby/parrot case, there is only one baby in one house on fire, while in the PCT case, there could be millions of individuals in need of a specific treatment. We should expect the heroic man to save the baby once he is in the house already, but we would not expect him to save every baby in the house if there were, for instance, eight babies. One might respond and say that the researchers are responsible for those patients who are research subjects. This response is predicated on the premise that the moral obligation to help another person gets stronger as the difficulty imposed by helping gets lesser. A popular example that highlights this premise is the example of the baby drowning in a pond: a man wearing a suit is walking next to a pond when he spots a random baby drowning in the pond. It seems that the man is morally obligated to save that baby, even though it probably will get his suit wet. However, it seems that another man who is also wearing a suit, but living in another country, is less morally obligated to save the drowning baby if he somehow knew that the baby was drowning. The proximity to the baby, or the ease by which one can save the baby, seems to affect the strength of the moral obligation to help. In the case with the baby/parrot, the man, once inside the house, seems to be morally obligated to save the baby if it is within his capability to carry the baby. However, if there were eight babies, we might say that the man is morally obligated to save as many babies as he can carry, but not necessarily all of them due to the difficulty of carrying so many babies at the same time. Let us look back at the PCT case: The previous example would suggest that the researchers have a stronger moral duty to provide the best treatment for their subjects because it is not too difficult for the researchers to do so. However, a disanalogy remains in this case as well. Surely we can assume that it would not be too relatively cumbersome for the researchers to give the best treatment to their subjects. However, the ease by which they could aid their subjects is not that much more than the ease by which they could aid random patients who are not subjects in their experiment. To shed some light on this response, let us return to the pond case: Suppose, in an obviously hypothetical scenario, that there were thousands or tens of thousands of babies drowning all at the same time. We might say that a man is obligated to save a drowning baby

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in a pond right next to him. However, if there was a pond just a tiny bit further from the man, that also had a drowning baby, it would seem difficult to say that the man is more morally obligated to save the baby closest to him than the one slightly further. If the two ponds were a mile apart, and the man was a few yards from one pond, then we might say that the man is much more morally obligated to save the closer baby. Likewise, the same can be said in the baby/parrot case. If there was another baby in the room just further down within the burning house, we would not say that the man is more morally obligated to save the closer baby. Returning to the PCT case, we might say the same for the relative difficulty in assisting research subjects and non-research subjects. Surely one might say that the researchers would not have much difficulty in giving the best treatment to their subjects, but also that it wouldnâ&#x20AC;&#x2122;t be that much more difficult for them to give the best treatment to other patients in, say, the hospital from which they acquired subjects. This argument suggests that the researchers would not be more morally obligated to aid their research subjects than their non-research subjects. An expected response would be that the researchers are still obligated to give the best treatment to some subjects. This is true. However, simply because the researchers are in close physical proximity to the sick patients does not mean that they are any more obligated to provide the best treatment to them than an individual who can easily contribute to their treatment through donation via Internet. There would be no reason to especially obligate the researchers to treat nearby subjects or non-subject patients. In the same way that it would not be illegal for a vacationer from a developed country in an underdeveloped country to pay the expenses for treatment of random patients in the local area, it should not be illegal for researchers in the underdeveloped country to refuse to pay for the best treatment of subjects or non-subjects. Surely it would be moral and supererogatory for the researchers to donate some of their private wealth to fund the cost of the best available treatment, but it would not be legally required of them to do so. Some might say that the researchers are morally obligated to provide the best treatment and that anyone sitting at home with the ability to easily donate online is also morally obligated to provide the best treatment. This, however, is a different topic of discussion that does not address the issue of whether PCTs are especially morally impermissible. Furthermore, even if PCTs were morally impermissible, this would not establish that they should be illegal. It would be difficult to claim that individuals

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who desire to be subjects of experiments should be prevented from being so out of some sort of paternalistic care for those individuals by the government (given that being a subject will personally benefit the individual). There seems to be a fear that if this argument were to go through, citizens of underdeveloped countries would somehow be abused or extensively exploited. This would give the green light for many experiments

In the same way that it would not be illegal for a vacationer from a developed country in an underdeveloped country to pay the expenses for treatment of random patients in the local area, it should not be illegal for researchers in the underdeveloped country to refuse to pay for the best treatment of subjects or nonsubjects. that would otherwise be illegal in developed countries to be done in underdeveloped countries. However, this argument seems to ignore the previous arguments. What have been argued thus far is that PCTs are not exploitative and that researchers are no more obligated to provide treatment to their experimental subjects than they would be obligated to provide treatment to other locals. No harm would be done if these experiments were to occur like wildfire. In fact, there would be the potential of much more benefit. If PCTs are given the green light, then we should expect many (who become subjects) to receive some sort of minimal quality of care, and we would expect discoveries of treatments that could benefit the sick in both developed and underdeveloped countries. References Charatan, Fred. â&#x20AC;&#x153;Surfactant Trial in Latin American Infants Criticised.â&#x20AC;? BMJ : British Medical Journal. BMJ, n.d. Web. Frick, Johann D. CHV 333/PHI 333: Bioethics: Clinical and Population-Level: Seminar 12, March 4: Standards of Care and Exploitation in Clinical Trials in

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the Developing World. Notes. “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” Council for International Organizations of Medical Sciences. Web. Temel et al. Early Palliative Care for Patients with Metastatic Non-Small-Cell Lung Cancer. The New England Journal of Medicine, August 19, 2010. “WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI: Ethical Principles for Medical Research Involving Human Subjects.” Journal of Obstetrics and Gynaecology Research 27.2 (2001): Xiii-Xv. Web.

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Princeton Journal of Bioethics

Elderhood: A Case for Abolishing Nursing Homes in the United States Richard Chen Cornell University

The American nursing home is a total institution, with rigorous top-down control over the environment and personal property of residents. Medicare and Medicaid initiated the modern nursing home industry and the medicalization of geriatric care management. These structural and historical factors produced dehumanizing systems of bureaucratic long-term care that obstruct the autonomy and dignity of elderly residents. Therefore, nursing homes are oppressive institutions, constructed to facilitate ageism, discrimination against older adults based on a sociocultural perception that values physical beauty, sexuality, and economic productivity. The effect of ageism on elder rights grows progressively more difficult to address, as death and dying become increasingly taboo subjects of discourse. The case for abolition contends that nursing homes actualize these ageist norms, committing physical and psychosocial injustices against 1.4 million aged Americans, a class of marginalized people often disregarded in civil rights advocacy. Abolition will initiate a cultural revaluation of old age towards elderhood, a stage of life where individuals can have independent, meaningful lives with space for growth and development.

Most Americans dread the thought of nursing homes. We imagine sick and dying elderly people in hospital beds or wheelchairs, emotionally disengaged and bored with life (Hogan and Mickus, 2002). The sociologist Erving Goffman likens nursing homes to prisons, as â&#x20AC;&#x153;total institutionsâ&#x20AC;? where individuals lead isolated, supervised and carefully administered lives, in which there is no control over environment or personal property (Goffman, 1961). The nursing home contributes to the stereotype that old age is equal to frailty and requires the standardized medicalization of personal needs. However, alternatives to this highly regimented life exist that optimize dignity for the elderly by adjusting resources to provide only enough for basic activities in daily living and establishing community-based residential homes necessary for strong long-term care. This essay will argue that the 15,700 nursing homes in the United States harm over 1.4 million marginalized residents based on their age and health (Harris-Kojetin et al., 2013). First, the case will be framed within the history of nursing homes and the current debate over the ethics of care of the elderly.

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Then it will be argued that principally, nursing home abolition would preserve the dignity of the elderly and help overcome societal ageism through culture shifts, which is preferable to increasing enforcement of standards and system reform. These contentions collectively support the value of elderhood, a proposed stage of life past adulthood. Finally, the practicality of alternatives, such as assisted living and the experimental Green House Project, will be assessed. What are nursing homes and what is their purpose? Many types of residential community facilities for the old exist. They are either managed commercially, through voluntary nonprofits, or by the government. Nursing homes specifically focus on providing constant nursing care, assistance with daily living and mobility, psychosocial and personal care and paramedical care (Morley et al., 2013). Within the total institution, every sequence of daily activities is tightly scheduled and enforced by officials. There is no segregation between settings for work, play and sleep and almost every phase of life is carried out in the immediate company of others (Johnson and Grant,

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1985). This contrasts with other types of facilities, such as assisted living housing (also called residential homes), which require no more nursing care than can be provided by a visiting nurse. However, nursing aides and personnel with little or no training provide the most care. Generally, residents have private, apartment-style rooms that are independently managed. Assistance is given for everyday activities, including help with dressing.

Nursing home reform has and continues to be the subject of focused debate in bioethics because increased standards (e.g. fire and safety standards) often hurts smaller nursing homes, allowing larger forprofit homes to homogenize the industry. However, the U.S. Nursing Home Reform Act of 1987 finally set national minimum standards for care and rights of people living in long-term care facilities. Through modern eyes, nursing homes seemingly act to house the elderly when they become too old to be cared for at home. However, the evolution of long-term care in America reveals an unexpected purpose of the nursing home. Its history begins with the emergence of almshouses and poorhouses as solutions to indigence after the American Revolution. Poor relief administrators designed these institutions to reform and punish the poor through close supervision, but also through minimal standards of comfort and cleanliness. Grungy living conditions encouraged residents to find work and families to care for their members. Older Americans who were infirm, poor and without family support had few options other than the almshouse (Haber, 1993). Since the old were less likely to find work, attitudes towards them harshened and they were excluded from a standard of being “worthy” that was reserved for younger, able-bodied inmates. Hospitals and private

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charities refused to assist the old, who were viewed as chronically impaired, permanently dependent and therefore a waste of resources (Rosenberg, 1987). Over time, reformers moved different groups into separate institutions (the young to orphanages, the insane to mental institutions and the able-bodied to workhouses), relegating the almshouse to a residence for older, often foreign-born poor people (Katz, 1984). The stigma against almshouse incarceration motivated the struggle for old-age pensions to provide older people with a dependable source of income. The modern nursing home industry began in the 1930s to compensate for the failures of the Social Security Act in providing sufficient health insurance benefits, as well vacating hospital beds for “better” use. Old Age Assistance funds authorized federal grants for needy older people, ensuring that they avoid indigence in almshouses and either remain at home or seek care in commercial nursing homes. Proprietary nursing homes continued to receive expanded loan programs, proliferating their construction. The Hill Burton Act of 1965 required long-term care facilities to affiliate with a hospital, which initiated a trend towards the greater medicalization of nursing homes (Binstock et al., 1997). The adoption of Medicare and Medicaid in 1965 accelerated the spread of nursing homes by limiting the time between hospitalization and nursing home placement. This unintentionally supported for-profit facilities, which had shorter waiting lists than voluntary homes (Dunlop, 1979). Furthermore, because Medicaid provided medical coverage to all people who met the criteria for medical indigence, more patients were reclassified as needing skilled nursing care (Vladeck, 1980). States began to transfer patients from state-supported institutions, such as hospitals, to nursing homes to capitalize on this federal funding stream. The number of nursing homes had increased by 58% in the 1950s, but increased by 107% in the following decade (Binstock et al., 1997). Nursing home reform has and continues to be the subject of focused debate in bioethics because increased standards (e.g. fire and safety standards) often hurts smaller nursing homes, allowing larger for-profit homes to homogenize the industry. However, the U.S. Nursing Home Reform Act of 1987 finally set national minimum standards for care and rights of people living in long-term care facilities. As can be seen from this history, the modern nursing home developed by accident. America did not turn to them immediately to help the elderly manage daily living, but relied on hospitals, where the frailties and sicknesses of old age could be “cured.” While pensions could give the elderly funds to manage in-

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dependently, it could not restore them from suffering physical decay and senility. Almshouses emptied and hospitals overflowed. The modern nursing home was constructed as a custodial extension to the hospital to clear out hospital beds, not to altruistically care for beloved elderly Americans. Nursing homes are dehumanizing The goal of long-term care is a good quality of life for the elderly. However, quality of life is dependent on the viewpoint of nursing home residents, not on how satisfied society is with standards. Entrenched stereotypes and total institutional constructs make nursing homes dehumanizing by nature even if regulatory compliance, resident rights and high-quality care are achieved (Berdes, 1987). Dehumanization, characterized by a loss of human attributes (e.g. self-awareness, intellect, will, the capacity to love), is the cumulative impact of top-down norms, rules and systems, and is not necessarily the fault of the often well-intentioned staff of these nursing homes (Vail, 1966). It is instructive to recognize that all health care is dehumanizing to the extent that it objectifies patients (Howard and Strauss, 1975); however, nursing homes are unacceptably dehumanizing because of the level of resident control and access to privacy. A sense of control over one’s self and one’s environment is related to high morale, high life satisfaction and a higher likelihood of survival (Noelker and Harel, 1978). Unfortunately, the defining structure of nursing homes restricts numerous important openings for autonomy throughout the process of institutionalization. Firstly, residents often do not choose whether to be admitted to a nursing home or which nursing home they would like to live in. This arrangement happens either through family members or through health care institutions when no family support exists. Often, the decision to institutionalize can be traumatic, causing new residents to feel unwanted or abandoned by their family members, causing despondency and dependency. In situations where individuals do choose to institutionalize themselves, it is usually caused either by societal pressures to avoid becoming a “burden” or because community and familial support systems break down (e.g. death of a spouse) (Cox, 2001). Within the nursing home, standardized treatment of residents depersonalizes and dissociates. For example, residents are often fed and bathed with insufficient regard for individual differences. Complaints and other activities that assert dignity but interfere with staff priorities are met with resistance and abuse (Gawande, 2014). A study conducted in Michigan found that the estimated incidence of abuse in

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nursing homes was 24.3%. These incidences ranged from physical mistreatment, like hitting, to caretaking mistreatment, such as forced feeding, to sexual abuse (Schiamberg et al., 2012). Furthermore, activities of daily living (e.g. showers, routine wheelchair rides, meals) are restrictive and regimented. As residents become accustomed to their nursing home’s itinerary, they can become defeatist and do not express their own desires. Moreover, residents have little control over doctor-patient relationships. Physicians generally visit at the discretion of nursing staff and are barriers rather than facilitators of conversations about the resident’s fears and concerns. For example, a study in Chicago found pervasive attitudinal conflicts between hospice care physicians and nursing home staff, where providers withhold prescribed pain medication, assuming that they have a claim to the best interest of patients (Denys, 2010). One of the largest issues with the medical model of nursing homes is the hospital-like environment. Unfortunately, the homelike setting, which is more conducive to visitors and privacy, is physically impossible to arrange considering that nursing homes must be built to maximize efficiency and to blur the boundaries between private and public spaces (Trierweiler, 1978). Since residents often share spaces with roommates, family visits cannot be truly private and intimate. Furthermore, the elderly often lose control over personal possessions either during admission to a nursing home or through theft. These personal items symbolize continued context and identity to the elderly (Hofzapfel, 1982). Without sufficient privacy, individuals cannot live life as they choose and stop existing as individuals with agency. For this reason, the physical structure of nursing homes can obstruct social relationships, personal identity and human dignity by depriving the elderly of privacy, a privilege enjoyed by the “young.” Nursing homes obstruct the struggle against ageism America has a cultural problem: we hold stereotypic and usually negative biases against older adults, using age as a primary social category. This form of discrimination, called ageism, is distinct (e.g. from sexism, racism) because age classifications change over the life cycle and thus everyone experiences ageism (Butler, 1969). Ageism is damaging not only because this prejudice affects the way we treat older adults, but also because the elderly often internalize these societal perceptions and come to believe them. The nursing home, analogous to slavery as an institution that purveys racism, is a symbol of and a mechanism for ageism, which in the long term has major psychosocial impacts on the elderly.

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The issue is related to America’s hyperbolic youth-oriented society and its modern values of physical beauty, sexuality and productivity (Butler, 1975). In the past, surviving into old age was uncommon and the elderly were treasured as guardians of tradition and knowledge, commanders of respect and political power and as heads of the household (Fischer, 1978). People used to lie and pretend to be older, a demographic phenomenon called “age heaping.” However, over the eighteenth century this trend reversed and old age was devalued. The elderly no longer held a monopoly over knowledge and wisdom; new technologies led to new occupations and new expertise, undermining the value of experience (Gawande, 2014). Furthermore, global economic development had transformed opportunities for the young, encouraging individual fulfillment, irrespective of family expectations. As mainstream culture became increasingly divided from the elderly, the reverence of old age became alien and replaced by generalized assumptions. The most common emotion felt towards the elderly is pity (Fiske et al., 2002). Dying and death are socially taboo subjects and discourse about death is considered morbid or boring. When these conversations do occur, they are filled with euphemisms (e.g. “out to greener pastures”) that reveal our perception that old age is defined by the inevitability of death. However, old age is neither inherently depressing nor incredible. It is contingent on physical health, personality, earlier life experiences and social support systems (e.g. finances, medical care, religious support). However, because of this emphasis on youth and productive capacity, we allow cultural myths to pervert our conception of old age, causing us to blame the old for being burdens and neglecting their physical and emotional needs (Butler, 1975) when they fail to satisfy society’s mold of the “perfect grandparent” or “golden ager” (Fuscher, 1978). It has been argued that the most crucial determinant of well-being is how individuals are defined and categorized by others in their social environment. People often behave and identify with the stereotypical images carved out by their social world (Cox, 2001). One common stereotype is that all elderly people are alike, regardless of actual differences in health, lifestyle, race and socioeconomic circumstances. This outlook spawns the mechanisms for the loss of individualization discussed previously (e.g. residents all served the same food), which dehumanizes the elderly. A further misconception is that elderly people are all in poor health; that is, old age is equivalent to disease and frailty. In fact, among Americans over the age of 85, over 55% are able to live independently without assistance (Harris-Kojetin et al., 2013). How-

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ever, this stereotype often encourages family members to preemptively admit the elderly into nursing homes, worried that a single fall could be fatal. This concern is not unreasonable; although, it is often the action of transferring to the nursing home lifestyle, which instigates identity loss and fosters depression and senility. The fear of age-related incidents creates a self-fulfilling prophecy where older adults are sent to nursing homes, which result in greater psychosocial and physical damage. The elderly are stereotyped as incapable of sexual intimacy despite the statistic that 53% of older Americans, aged 65 to 74, report being sexually active (Lindau, 2008). Nursing homes actualize our discomfort with this sexuality, implementing explicit policies that restrict sexual expression and enforce propriety, shaming sexually active residents as abnormal (Jonathan, 2013). Retirement is heralded as the start of the dying process despite longitudinal studies that find that most retirees show slight improvements in health following retirement (Heidi et al., 2013). These misconceptions are ingrained into the structure of nursing homes and not only allow the continuous, tangible infliction of prejudice on the elderly, but also pressure them into becoming complicit, leading to a loss of identity. Dr. Bill Thomas argues that “prejudice and bigotry of all kinds take root where people fail to understand the experience of others as individuals” (Thomas, 2015). Therefore, the struggle against ageism benefits from a conception of old age as not the process of dying, but as a new stage in the life cycle beyond adulthood with wide possibilities for growth and development. Dr. Thomas calls this stage “elderhood.” This cultural shift requires, in the abstract, that society accept that aging is inevitable and ultimately good for us. It involves a revaluation of the elderly, who are capable of binding families, providing affection and acculturation and leading independent, meaningful lives. Nursing homes are an obstacle to this culture change. They allow Americans to neglect valuable individuals while pursuing their fast-paced work lives. Ageism cannot simply be reformed away. Like issues of racism and sexism, ageism is a cultural and structural battle, requiring abolition, rather than a reformation of the standards and conditions of indelibly unethical institutions. Nursing homes did not cause ageism, but they are the most harmful way to forget the issue exists. Practical assessment of alternatives The cost of nursing homes is unsustainable. They are the most expensive long-term care option, with

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private rooms costing an average of up to $83,000 per year. Presently, 10,000 baby boomers turn 65 everyday and by 2050 the total population is projected to reach 89 million. However, only 2.8% of the present population actually lives in nursing homes (Centers for Medicare & Medicaid Services, 2013). 20.4% of the 1.4 million American residents in nursing homes have no Activities of Daily Living (ADL) impairment and 36.6% have no more than mild cognitive impairment (Ellis, 2013). This population is

The bureaucratic structure of nursing homes opposes the values of human dignity, personal identity and autonomy. These issues cannot be solved through reform, as the concept and nature of nursing homes are unethical. As cultural symbols of ageism, nursing homes misguide our perception of the elderly and alienate them. likely to profit the most from nursing home abolition as they do not require 24-hour skilled nursing, and would benefit from reduced dependency and increased autonomy in alternatives such as assisted living facilities and Green House Project homes. The Green House Project is a non-profit organization founded by Dr. Bill Thomas in 2003 that helps companies and individuals build residential homes that provide “person-centered” assisted living and foster “person-directed” lifestyles. This mission aligns with the fight for elderhood by creating non-institutional, affordable options for the elderly that also use core values of intimacy, autonomy and warmth to drive structural decisions. The Green House Project homes provide the necessary amenities and emergency medical security for daily living, while empowering older adults to control their identity and environment (Larsen, 2015). However, on the extreme side of the elderly are the people that fit the stereotypes of the demographic: the terminally ill or clearly dying. Generally, these residents are held in nursing homes under a hospice

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care program, which focuses on improving quality of life through compassionate end-of-life care rather than medication (Hanks et al., 2011). Ostensibly, this could be an obstacle for nursing home alternatives: how can proper hospice care be delivered outside a hospital-like setting? A major assertion in hospice care is that the presence of the home environment is essential to maintaining the natural dying process, an ideal associated with dignity. Nursing home alternatives provide space for homeliness and well being, invaluable to the dying process, and unobtainable in total institutions. Conclusion The bureaucratic structure of nursing homes opposes the values of human dignity, personal identity and autonomy. These issues cannot be solved through reform, as the concept and nature of nursing homes are unethical. As cultural symbols of ageism, nursing homes misguide our perception of the elderly and alienate them. Abolition is the first, at the very least principled, step in recognizing that individuals have an intrinsic and societal value beyond their youth and productivity in elderhood. This new stage of life can be achieved by the birth of a cultural, anti-ageist movement and by the downfall of the nursing home. References Berdes, C. (1987). The Modest Proposal Nursing Home: Dehumanizing Characteristics of Nursing Homes in of Nursing Home Residents. Journal of Applied Gerontology, 6, 372–388. Binstock, R.H., Cluff, L.E., and Mering, O.v. (1997). The Future of Long-Term Care: Social and Policy Issues. Baltimore: Johns Hopkins University Press. Butler, R.N. (1969). Age-ism: Another Form of Bigotry. The Gerontologist, 9, 243-246. Butler, R.N. (1975). Why Survive? Being Old in America. New York: Harper & Row, Publishers, Inc. Centers for Medicare & Medicaid Services. (2013). Nursing Home Data Compendium 2013 Edition. Retrieved from https://www.cms.gov/Medicare/ Provider-Enrollment-and-Certification/CertificationandComplianc/downloads/nursinghomedatacompendium_508.pdf. Cole, T.R. (1992). The Journey of Life. New York: Cambridge University Press. Cox, H.G. (2001). Later Life: The Realities of Aging. Upper Saddle River: Prentice-Hill. Denys, T.L., Masin-Peters, J., Berdes, C. Ong, M. (2010). Perceived Barriers that Impede Provider Relations and Medication Delivery: Hospice Providers’ Experiences in Nursing Homes and Private Homes. Journal of Palliative Medicine, 13, 305-310.

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Dunlop, B.D. (1979). “The Growth of Nursing Home Care.” Lexington: Lexington Books. Ellis, B. (2013). Nursing home costs top $80,000 a year. Retrieved from: http://money.cnn. com/2013/04/09/retirement/nursing-homecosts/. Fischer, D.H. (1978). Growing Old in America. Oxford: Oxford University Press. Fiske, S.T., Cuddy, A.J.C., Glick, P., and Xu, J. 2002. A Model of (Often Mixed) Stereotype Content: Competence and Warmth Respectively Follow From Perceived Status and Competition. Journal of Personality and Social Psychology, 82, 878-902. Gawande, A. (2014). Being Mortal: Medicine and What Matters in the End. New York: Metropolitan Books. Goffman, E. (1961). Asylums: Essays on the Social Situation of Mental Patients and Other Inmates. New York: Anchor Books. Haber, C. (1983). Beyond Sixty-five. New York: Cambridge University Press. Haber, C. (1993). Over the hill to the poorhouse: Rhetoric and reality in the institutional history of the aged. Societal Impact on Aging: Historical Perspectives. New York: Springer. Hanks, G., Cherny, N.I., Christakis, N.A., Fallon, M., Kaasa, S., and Portenoy, R.K. (2011). Oxford Textbook of Palliative Medicine. Oxford: Oxford University Press. Harris-Kojetin, L., Sengupta, M., Park-Lee, E., and Valverde, R. (2013). Long-term care services in the United States: 2013 overview. National Center for Health Statistics. Vital Health Stat 3(37). Heide, I.v.d., Rijin, R.M.v., Robroek, S.J.W., Burdorf, A., and Proper, K.I. (2013). Is retirement good for your health? A systematic review of longitudinal studies. BMC Public Health, 13, 1180. Hofzapfel, S.K. (1982). The importance of personal possessions in the lives of institutionalized elderly. Journal of Gerontological Nursing, 8, 156-158. Hogan, A.J. and Mickus, M.A. (2002). Through Rose Colored Glasses: Public Perceptions of Nursing Home Quality. State of the State Survey, Briefing Paper 02-52. East Lansing: Institute for Public Policy & Social Research. Howard, J.M. and Strauss, A.L. (1975) Humanizing Health Care (Health, medicine & society). New York: John Wiley & Sons, Inc. Hummert, M.L., Garstka, T.A., Shaner, J.L., and Strahm, S. (1994). Stereotypes of the elderly held by young, middle-aged, and elderly adults. Journal of Gerontology: Psychological Sciences, 49, 240-249. Johnson, C.L. and Grant, L.A. (1985). The Nursing Home in American Society. Baltimore: The John

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Hopkins University Press. Jonathan, E. (2013). Delicate Issues of Sexuality in the Nursing Home. Caring for the Ages, 14, 16-17. Katz, M.B. (1984). Poorhouses and the origins of public old age homes. Milkbank Memorial Fund Quarterly/Health and Society, 62, 110-140. Larsen, D. (2015). The Green House Project: The Next Big Thing in Long-Term Care? Retrieved from: http://www.aplaceformom.com/blog/greenhouse-project-next-big-thing-in-long-termcare/. Schiamberg, L.B., Oehmke, J., Zhang, Z., Barboza, G., Griffore, R.J., Von Heydrich, L., Post, L.A., Weatherill, R.P., and Mastin, T. (2012). Physical Abuse of Older Adults in Nursing Homes: A Random Sample Survey of Adults With an Elderly Family Member in a Nursing Home. Journal of Elder Abuse & Neglect, 24, 65-83. Lindau, S.T. (2008). A Study of Sexuality and Health among Older Adults in the United States. New England Journal of Medicine, 357, 762-774. McFarland, M.S.J. (2012). Why We Care about Privacy. Retrieved from: http://www.scu.edu/ethics/ practicing/focusareas/technology/internet/ privacy/why-care-about-privacy.html. Morley, J., Tolson, D. Ouslander, J. and Vellas, B. (2013). Nursing Home Care: a Core Curriculum from the International Association for Gerontology and Geriatrics. New York City: McGraw-Hill Education. Noelker, L. and Harel, Z. (1978). Predictors of well-being and survival among instutitonalized aged. Gerontologist, 18, 562-567. Rosenberg, C.E. (1987). The Care of Strangers: The Rise of America’s Hospital System. New York: Basic Books. Thomas, B. (2015). Second Wind: Navigating the Passage to a Slower, Deeper, and More Connected Life. New York: Simon & Schuster Paperbacks. Trierweiler, R. (1978). Personal space and its effects on an elderly individual in a long-term care institution. Journal of Gerontological Nursing, 4, 21-23. Vail, D.J. (1966). Dehumanization and the institutional career. Springfield: C.C. Thomas. Vladeck, B.C. (1980). Unloving Care: The Nursing Home Tragedy. New York: Basic Books.

Princeton Journal of Bioethics

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Princeton Journal of Bioethics