Volume IX Issue i

Volume IX Issue i

Healthcare Jurisprudence

Also in this issue: Presidential Commission for the Study of Bioethical Issues Reports A Conversation with David Magnus, Editor in Chief of AJOB Stigma in Public Health Decision-Making

Penn Bioethics Journal The Penn Bioethics Journal (PBJ) is the nation’s premier peer-reviewed, undergraduate bioethics journal. Established in 2004, the Journal features and provides a venue for the contributions of undergraduates to bioethics. PBJ, embracing the interdisciplinary focus of bioethics, reviews and publishes reports of empirical research and analysis of previous work— addressing debates in medicine, technology, philosophy, public policy, law, theology, and ethics, among other disciplines.

The biannual issues also feature news briefs and editorials reviewing current bioethical issues, as summarized by our undergraduate editorial staff. Undergraduate editors and authors have a unique opportunity to get involved with the peerreview process through the collaborative and rigorous review and preparation of the Journal. With an audience ranging from scholars in the field to a broader public seeking unbiased information, PBJ scholastically involves all undergraduates interested in the extensive field of bioethics.

Email bioethicsjournal@gmail.com for more information about bioethics at Penn.

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The Penn Bioethics Journal is published twice a year by the University of Pennsylvania, Philadelphia, PA. All business correspondence, including subscriptions, renewals, and address changes, should be addressed to the Penn Bioethics Journal, 3401 Market Street, Suite 320, Philadelphia, PA 19104.

Archived editions of the Journal and information about the submission process can be found on our website: http://bioethicsjournal.com Permission must be requested for any kind of copying, such as copying for general distribution, advertising, or promotional purposes, creating new collective works, or for resale. Requests for these permissions or further information should be addressed to bioethicsjournal@gmail.com Copyright © 2014 Penn Bioethics Journal, all rights reserved.

Philadelphia, PA. ISSN: 2150-5462

Contents Letter from the Editor in Chief EDITOR IN CHIEF Anand Muthusamy PUBLISHER Kathleen Sun MANAGING EDITORS Klyde Breitton Lucy Chen Lilian McKinley Ruchita Pendse Aditi Verma ASSOCIATE EDITORS Mohammad Almagweshi Nikhil Ananth Alanna CruzBendezu Diana Blidarescu Evan Cernea Shayan Cheraghlou Aneesh Chona Samantha Freedman Elana Furman Elizabeth Gonzalez Andy Guo Audrey Harnagel Jacqui Kemmer Kurt Koehler Georgio Legerme Rosalie Machado Darby Marx Eileen Mayro Loren Miller David Montgomery Zaina Naeem Hari Nath Sagar Patel Dave Saraswat Rachel Shaw Alex Shazad Tim Shinn Jane Shmushkis Chloe Swanson Iulia Tapescu Girish Valluru Hannah Victor Abby Worthen Garrett Young Ahmed Yousef Samir Zaman Nikolai Zapertov Kenneth Zhou Timothy Zhou FACULTY ADVISOR Jonathan Moreno, Ph.D.

Anand Muthusamy

Bioethics in Brief

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Implementation of the Individual Mandate and Heterogeneous Access Considerations

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Brain Death Cases and Termination of Care

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Guidelines on Incidental Findings: Presidential Bioethics Commission Emphasizes Anticipation and Communication

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BRAIN Initiative and the Presidential Commission’s Focus on Neuroethics

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Interview A Conversation with David Magnus

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Articles How Alleviating the Tensions Between Individual Liberty and Community Matter for the Affordable Care Act

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Chelsea A. Jack

Personhood at the Beginning of Life: Construction of Ethics for Abortion and Stem Cell Research in Japan

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Phoebe Oldach

Levelling the Playing Field: A Case for Widening Access to Ritalin

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Emily Salt

Examining Stigmatization of Smoking and Obesity: An Ethical Framework to Guide Public Health Decision-Making Margaret E. Weiss

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Letter from the Editor

Anand Muthusamy Editor in Chief

Penn Bioethics Journal

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Dear Readers,

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Thank you for picking up this issue of the Penn Bioethics Journal. We are continuing our tradition of peerreviewed publication of undergraduate work into our ninth volume. As our submission volume and readership grows, our editors remain committed to a couple core principles. First, we keep our journal open to all approaches to the field of bioethics and unconventional thinking from authors around the world. Second, we strive to provide critiques and work with authors to hone their voices.

I would like to thank the entire editing staff of the Penn Bioethics Journal for their work throughout the peer-review and publishing process, especially the managing editors who have worked with the authors of the submissions published in this issue. Special thanks goes to Aditi Verma, Editor in Chief 2014-15, for facilitating the printing and publising process for this issue.

Our submissions in this issue reflect the re-emergence of political philosophy and ethics in healthcare jurisprudence.

From 2008 to 2010, the United States engaged in yet another iteration of debate on healthcare. On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA) into law; however, the passage of the law only shifted debate from the public sphere to the courts. Legal challenges to the law rose to the Supreme Court in National Federation of Independent Business v. Sebelius, where the Court upheld the individual mandate portion of ACA in a 5-4 ruling. Author Chelsea Jack details the ethical thinking behind the law and the Supreme Court’s jurisprudence and offers a framework that accounts for both communitarianism and libertarianism. Political philosophy certainly shapes the development of law, but, in cases like healthcare, a specific set of professionals are responsible for interpreting and carrying out the intentions of that law. Margaret Weiss’ article on stigma in public health connects to a larger project of understanding social interventions and disruptive practices or technologies.

Two other articles look beyond the United States in considering the intersection of bioethics and law. Phoebe Oldach offers a historical and cultural analysis explaining how Japan has lagged in stem cell research. Emily Salt considers UK law and argues for the legalization and medical regulation of cognitive enhancement drugs, such as Ritalin, on the basis of removing the willingness to violate rules as a barrier to gaining an advantage.

Back in the US, the Presidential Commission for the Study of Bioethical Issues has released two reports, calling for substantial innovation in bioethics. The December 2013 report on “incidental findings” calls for the “anticipation” of possible medical information that could be learned from diagnostic tools, namely genetic screening, and its communication to the patient. The May 2014 report on neuroscience calls for the integration of ethics research into the early stages of neuroscience. For the next report, the Commission plans on addressing neuroscience’s interaction with culture and society’s institutions. These two reports bolster the role of the academic bioethicist in cohering different fields and beginning to anticipate new futures unbeknownst to any one vantage point. Our interview with David Magnus, PhD, the Thomas A. Raffin Professor in Medicine and Biomedical Ethics at Stanford University and current Editor in Chief of the American Journal of Bioethics, highlights the development of the field of bioethics, the role of the academic bioethicist, and his own research. The reader will find this issue generally as a guide to the current thinking in the field and a continuation of the Penn Bioethics Journal’s forum in undergraduate bioethics.

Anand Muthusamy Editor in Chief University of Pennsylvania C’14

Bioethics in Brief

Bioethics in Brief Implications of the Individual Mandate and Heterogeneous Access Considerations On March 23, 2010, Congress passed the Patient Protection and Affordable Care Act (ACA) into law. At its core, the ACA establishes an individual mandate to purchase insurance, expands Medicaid coverage, establishes insurance exchange markets, prohibits insurers from denying coverage due to prior medical conditions, and allows children to stay on parents’ insurance until age 26 (Connors 2010). Together, these provisions significantly expand access to health insurance coverage in the United States, but most recently, states and the federal government have begun to grapple with the widely controversial individual mandate. This mandate requires the establishment of health insurance marketplaces, also known as health exchanges, to provide U.S. citizens and legal residents access to a marketplace with affordable health insurance options.

Due to the political dynamics in the United States, a single payer health care system, where the government finances and manages healthcare plans, would be quite controversial. Most recently, the United States National Health Care Act, a bill supporting a single payer health system, was reintroduced in 2013, but received only 39 of co-sponsorships from the Senate and therefore was referred to the Committee on Veterans’ Affairs (Expanded and Improved Medicare For All Act H.R. 671 2013).

With this in mind, the design of the ACA had shifted the bulk of implementing the bill to the states—providing a compromise between the single payer system and strong decentralization. However, not all states are equal; in fact, the wide variations in political affiliation, resource availability, and general administrative capabilities raise problems for delivering homogenous quality of services and care. In the past year, states have made decisions on two elements of implementing the bill that have brought this particular point of heterogeneous access to the forefront: establishing state-run insurance exchanges and expanding Medicaid coverage.

Currently, there are only 17 states that have established their own state-run insurance exchange. Of the remainder, 7 states have established joint-partnerships with the federal government, and 26 have deferred their exchange to the federal government completely (Keith 2014). The 17 states that have chosen to run their own insurance exchange have received substantial funding and support, improving their offerings and providing better service to their residents; however, the federal budget may have become spread too thin to provide the same focused attention to the 33 other states (Dunning 2014). States that defer to the federal government leave much administrative, service, and infrastructure costs to the federal government (March 2014).

Penn Bioethics Journal Volume IX Issue i 5 Source: public domain

Penn Bioethics Journal

Volume IX Issue i

Bioethics in Brief

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In 2010, the National Association of Insurance Commissioners conducted surveys to assess states’ abilities to enforce the ACA and found that “half of the states have the ability to enforce the federal law either through explicit state laws or general powers granted to the commissioner. [And] almost all states can use their approval process, investigative powers, and/or market conduct exam authority to hold licensed insurers accountable for their compliance with the federal laws” (Cline 2010). Do states then have an obligation to, if having the resources, build these state exchanges and implement the ACA? With a $4.7 billion dollar pot of federal funding grants for running an insurance exchange, it was unexpected that so many states would defer, yielding the widely varying outcomes; however, it does still raise questions on whether the federal government should be taking steps to equalize outcomes of the exchanges across states. (March 2014).

Moreover, due to lack of resources or political commitment, some states are not increasing the coverage of Medicaid to ACA limits (Buck 2011). This has become problematic in states like Florida as the federal government begins to dismantle health programs, expecting states to increase the Medicaid levels to make up for the federal cuts. On the other hand, when states do increase the Medicaid levels to the maximum allowed limits, excellent high-quality publically funded services go unused as people transition to Medicaid and private insurance (2011). These are the cases, specifically in New York, where the new policy, in this case the ACA, sets a lower bar for minimal services than what was required by the state originally. These inequalities in between the differing states further emphasize the heterogeneous access to health care that some say is prevalent within the United States.

Overall, as state and federal governments share responsibilities for funding programs, they must act cohesively to prevent disparities and inequalities in access to healthcare. Despite the additional funding and support given, many states still remain reluctant to engage in new policy, and therefore much potential capacity goes unutilized. However, since health care systems are now seen as a priority of the federal government, a public entity

by definition, the benefits of public initiatives should accessible universally to all residents; however, these heterogeneous health systems do not remain cogent with the principles associated with public initiatives, resulting in a sense of injustice. Since the 10th Amendment protects the states from being forced by the federal government to engage in any of these actions, the future of universal access will need to be analyzed through dialogue and discussion to develop a culture that universally prioritizes the health care and insurance coverage for all residents and citizens and is able to incentivize stakeholders to make that vision a reality.

References Buck, Jeffrey A. “The looming expansion and transformation of public substance abuse treatment under the Affordable Care Act.” Health Affairs 30(2011): 1402-10.

Cline, Jane. Jane Cline to Kathleen Sebelius, August 5, 2010. Letter. http:// www.naic.org/documents/index_health_reform_section_letter_kathleen_sebelius.pdf (accessed June 2014).

Connors, Elenora E., and Lawrence O. Gostin. “Health care reform—a historic moment in US social policy.” JAMA 303(2010): 2521-22.

Dunning, Matt. “State-run exchanges grab lion’s share of health plan enrollees.”

Business Insurance 48(2014): 18.

Keith, Katie and Kevin W. Lucia. “Implementing the Affordable Care Act: The State of the States.” The Commonwealth Fund, 2014. http://www. commonwealthfund.org/~/media/Files/Publications/Fund%20Report/2014/ Jan/1727_Keith_implementing_ACA_state_of_states.pdf (accessed June 2014).

Scotti, Christina. “Why State-Run Health Exchanges Are Faring Better.”

Fox Business, October 16, 2013. http://www.foxbusiness.com/personalfinance/2013/10/16/why-state-run-health-exchanges-are-faring-better/ (accessed June 2014).

“Expanded and Improved Medicare For All Act H.R. 671.” Annals of Congress.

Senate, 113th Congress. February 2013. From Library of Congress. http:// beta.congress.gov/bill/113th-congress/house-bill/671 (accessed June 2014).

Mach, Annie and Redhead C. Stephen. “Federal Funding for Health Insurance Exchanges.” Congressional Research Services. Washington DC: U.S. Government Printing Office, March 2014. http://www.fas.org/sgp/crs/misc/ R43066.pdf (accessed June 2014).

Bioethics in Brief

Brain Death Cases and Termination of Care

References “Texas Health & Safety Code Ann. § 166” Texas Statues. September 1999. From Find Law. http://codes.lp.findlaw.com/txstatutes/HS/2/ H/166/B/166.033.

Collins, Terry. “Jahi McMath, Girl Left Brain Dead From Routine Tonsillectomy, to be Kept on Life Support.” The Huffington Post, December 21, 2013. http://www.huffingtonpost.com/2013/12/21/jahi-mcmathlife-support_n_4485119.html.

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At first glance, these cases seem to simply demonstrate renewed interest in issues of end-of-life care that have a long history of capturing public interest, from Karen Quinlan’s case in the 1970s, to Nancy Cruzan’s in the late 1980s, to Terri Schiavo’s case that dragged on from the 1990s through 2005 (Fine 2005). However, these particular stories are unique because they both involve brain-dead patients. In the past decades, brain death has become the legal and medical standard for determination of clinical death, as it presents reliable criteria for diagnosis and is irreversible. Brain death emerged as the standard for death when cessation of cardiopulmonary circulation became a problematic standard in light of the development of technologies that could restart the heart or mechanically inflate the lungs and pump blood for the patient (Magnus 2014). Until now, the termination of care cases that have received this level of media attention concerned patients in a coma or persistent vegetative state, with some low levels of brain stem activity. These individuals therefore could not be declared brain-dead, the legal definition of death, which is why their cases entailed more compelling moral, legal, and medical uncertainty (Fine 2005).

However, in both the Muñoz and McMath cases, the medical verdicts were indisputable, which should have preempted the moral and legal debates. In the Muñoz case, the family members acknowledged this distinction and fought to have care terminated while the hospital refused to remove the machines from Muñoz until the baby was delivered or had died. The McMath case was the opposite, as the hospital recognized her status as brain dead and sought to remove her from the machines while her family insisted she was alive and sued to ensure the continuation of care.

Even though medically both cases were quite clear, the fact that they engaged the nation for weeks speaks to broader cultural and social phenomena. With resurgence in the debate on abortion and the proposal of numerous state laws that are more conservative than existing statutes, the nation is again questioning how we define life, and as a result, how we define death. The events of the past year indicate that we are still a nation struggling to reach agreement on ideas of life, personhood, and death. Legally, it is difficult to accommodate the range in people’s beliefs as they are often so polarized. In the coming year, it will be interesting to see how this in topic of defining life and personhood pans out, especially with the midterm elections and new abortion laws up for approval later in the year.

Penn Bioethics Journal

In past months, two brain death cases have reignited national debate on the termination of care at the end of life.

Marlise Muñoz, a 33-year-old pregnant woman in Texas, and Jahi McMath, a 13-year-old girl in California, were both kept alive using life-sustaining machines despite clinical determinations of brain death. These stories and the surrounding legal battles captivated the nation for weeks, as experts in medicine, law, religion, and ethics all weighed in on whether the patients should be removed from their mechanical ventilators.

Marlise Muñoz was 33 years old when she was found unconscious in her kitchen on November 26, 2013 (Gillette 2014). She was subsequently taken to the John Peter Smith Hospital in Fort Worth, Texas, where she was declared brain dead after apparently having suffered from an embolism in her lung (Fernandez 2014). Her family accepted this diagnosis, and wanted to respect Marlise’s strong desire to never be kept alive on machines, which she had voiced to her family many times (Goodwyn 2014). However, as she was then 14 weeks pregnant, the hospital refused to remove the machines, citing a part of the Texas Advance Directives Act that states, “a person may not withdraw or withhold life-sustaining treatment from a pregnant patient” (Tex. Health & Safety Code Ann. § 166). They made this decision despite the fact that the fetus had been deprived of oxygen for over an hour, and had little chance of survival. The family was forced to pursue legal action to fulfill Muñoz’s wishes, questioning whether she would still qualify as a “patient” and whether the treatment could be called “life-sustaining” in light of the determination of brain death (Fernandez and Eckholm 2014). Finally, on January 24 2014, a Texas judge ruled in favor of the family, saying the hospital was misapplying the law since the Muñoz was no longer alive. Muñoz’s body was removed from life support on the morning of January 26 (Fernandez 2014; Goodwyn 2014).

In the latter case, Jahi McMath was a 13 year old teenager struggling with sleep apnea when she and her family decided to pursue surgical options to allow her to sleep better. The surgery to remove her tonsils, uvula, and some surrounding tissues took place at Oakland Children’s Hospital in California on December 9 (Levs 2014). McMath woke up from the surgery and seemed fine, only complaining of some discomfort in her throat. Shortly afterward, she began bleeding profusely from her nose and mouth, and then abruptly entered cardiac arrest. On December 12, she was declared brain dead by two physicians independently. Her mother, however, refused to allow for the termination of care, suing the hospital to ensure her daughter wasn’t removed from the machines (Collins 2014). After weeks of legal battles, the hospital reached an agreement with the family to release Jahi’s body, still on the ventilator, into the custody of her mother. Her mother and a team of physicians took Jahi to an undisclosed care facility where her body continues to be sustained by machines at the time of publication (Wells 2014; Levs 2014).

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Bioethics in Brief Fernandez, Manny and Eckholm Erik. “Pregnant, and Forced to Stay on Life Support.” The New York Times, January 7, 2014. http://www.nytimes.com/2014/01/08/us/pregnant-and-forced-to-stay-on-life-support. html?_r=0.

Fernandez, Manny. “Judge Orders Hospital to Remove Pregnant Woman From Life Support.” The New York Times, January 24, 2014. http:// www.nytimes.com/2014/01/25/us/judge-orders-hospital-to-remove-lifesupport-from-pregnant-woman.html.

Fine, Robert L. “From Quinlan to Schiavo: medical, ethical, and legal issues in severe brain injury.” Proceedings (Baylor University Medical Center) 18(2005): 303-10..

Gillette, Hope. “Pregnant, ‘Brain Dead’ Marlise Munoz On Life Support Sparks Controversy And Lawsuit.” The Huffington Post, January 16, 2014. http://www.huffingtonpost.com/2014/01/16/marlise-munozcontroversy_n_4609452.html.

Goodwyn, Wade. “The Strange Case Of Marlise Munoz And John Peter Smith Hospital.” National Public Radio, January 28, 2014. http://

www.npr.org/blogs/health/2014/01/28/267759687/the-strange-case-ofmarlise-munoz-and-john-peter-smith-hospital.

Levs, Josh, Catharine E. Shoichet and Caleb Hellerman. “Terri Schiavo family joins fight over Jahi McMath.” CNN Health, January 2, 2014. http://www.cnn.com/2014/01/01/health/jahi-mcmath-girl-brain-dead/.

Magnus, David C., Benjamin S. Wilfond, and Arthur L. Caplan. “Accepting Brain Death.”New England Journal of Medicine 370 (2014): 891-4..

Peters, Jeremy W. “Parties Seize on Abortion Issues in Midterm Race.”

The New York Times, January 20, 2014. http://www.nytimes. com/2014/01/21/us/politics/parties-seize-on-abortion-issues-in-midterm-race.html.

Wells, Jason. “Jahi McMath Family Attorney Fires Back at Medical Ethics Critics.” Los Angeles Times, January 10, 2014. http://articles.latimes. com/2014/jan/10/local/la-me-ln-jahi-mcmath-attorney-defendsactions-20140110.

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Guidelines on Incidental Findings: Presidential Bioethics Commission Emphasizes Anticipation and Communication

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Angelina Jolie surprised the public with a May 2013 New York Times op-ed that revealed her decision to undergo a double mastectomy after discovering she has the BRCA1 gene, a mutation that increases the risk of early-onset breast and ovarian cancers. Because her mother died of ovarian cancer at age 56, Jolie actively sought genetic testing for BRCA1/2. But what if a BRCA1/2 mutation was found in a genetic screen for an unrelated disease? Or if a BRCA1/2 mutation is found retroactively in data collected from research subjects before 1990, when evidence first suggested such a gene exists? Is there an ethical obligation to release that information to patients? How should we determine guidelines for these ethical challenges?

These are some of the questions President Obama delegated to the Presidential Commission for the Study of Bioethical Issues, comprised of leading experts in medicine, science, philosophy, and law and chaired by University of Pennsylvania President Amy Gutmann. The commission’s goal is to promote socially and ethically responsible policies and practices in scientific research and health care delivery.

The commission released a report on December 12, 2013 titled “Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts”, offering 17 recommendations for how to best handle incidental findings: “results that arise that are outside the original purpose for which a diagnostic test or procedure was conducted” (Wolf 2008). The recommendations drew from 16 U.S. and 16 international professional societies, as well as four public meetings (Presidential Commission for the Study of Bioethical Issues 2013).

The commission concluded that while there are many situations where incidental findings may arise, the best way to handle them is to anticipate all possible incidental findings for a given procedure and clearly communicate the risks to patients, who can then decide whether they want to continue

with the test and if so, choose what results they would want to learn. This recommendation separates anticipatable findings from unanticipatable findings, which are not part of scientific knowledge at the time of the test and are only discovered retroactively. The report also emphasizes the importance of whether these findings are clinically relevant and actionable.

Another consideration is whether the incidental findings happen in the setting of a clinician, researcher, or direct-toconsumer provider (DTC), a company who markets at-home genetic testing straight to consumers through mediums like television and radio ads, such as 23andMe. “Clinicians have a primary fiduciary duty to their patients to act in their interests. Research investigators have more limited duties to research participants. Obligations of DTC providers toward consumers, beyond honest dealings, are most uncertain and in flux,” Gutmann wrote in a Science editorial explaining the rationale behind the report (2013, 1321). In each of the three contexts, the ethical obligations differ based on the provider’s relationship to the patient, with the most moral responsibility placed on the clinician.

The report outlines general recommendations for clinicians and emphasizes patient autonomy. One of the guidelines is that if a patient decides not to learn incidental findings, the clinician does have the option of declining to perform the test and referring the patient elsewhere if he feels uncomfortable with the patient’s decision. If the clinician does proceed with the test, he must omit information mutually agreed upon by the patient and doctor before the test is performed. Both decisions are ethically defensible, within certain limitations. The recommendations also emphasized the need for more education of practitioners and institutional review boards, who govern human subjects research. Under the proposed recommendations, IRBs should allow researchers to exclude research subjects who do not want to receive incidental findings from their studies, within certain circumstances.

Bioethics in Brief However, while the recommendations outlined by the commission do align with previous guidelines and literature, they are still contentious. A major discrepancy did arise between the commission and the American College of Medical Genetics and Genomics, which recommended in a March 2013 report that doctors could override patient consent in some cases and act upon incidental findings in a patient’s medical interest: “We felt that clinicians and laboratory personnel have a fiduciary duty to prevent harm by warning patients and their families about certain incidental findings and that this principle supersedes concerns about autonomy” (Green 2013). The commission disagreed and emphasized that clinicians do not have the right to override patient consent, and the report prioritized patient autonomy (Hayden 2013).

A criticism of the commission’s report is that it missed an opportunity to set clearer guidelines by being “highly general,” and some question how exactly the findings will shape future debate and policy (Hayden 2013). Rather than serving to set exact rules, the report instead encourages providers to anticipate the possibility of incidental findings and communicate that information to patients, leaving the details, such as which specific incidental findings to return and whether biobanks have similar responsibilities, to organizations and individuals.

Ultimately, incidental findings are a risk that providers and patients cannot avoid with increased diagnostics. What they

can do, though, is be more informed about anticipatable incidental findings and participate in a shared decision-making process. As Gutmann wrote, “The commission emphasizes the need—based on justice and fairness—not just for a privileged few but for all individuals to have access to up-to-date information and the guidance needed to make informed choices about what tests to undergo, what kind of information to seek, and what to do with information once received” (2013).

References Green, Robert C. “ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing.” Genetics in Medicine 15(2013): 565-574.

Gutmann, Amy. The Bioethics Commission on Incidental Findings. Science 342(2013): 1321-23.

Hayden, Erika C. “Medics should plan ahead for incidental findings.” Nature, December 12, 2013. http://news.sciencemag.org/health/2013/12/presidents-bioethics-panel-weighs-how-u.s.-should-handle-incidental-findings.

Jolie, Angelina. “My Medical Choice.” New York Times, May 14, 2013. http:// www.nytimes.com/2013/05/14/opinion/my-medical-choice.html?_r=0.

Presidential Commission for the Study of Bioethical Issues. Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. Washington, DC: U.S. Government Printing Office, December 2013. http://bioethics.gov/ sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf Wolf, Susan M. “Managing incidental findings in human subjects research: Analysis and recommendations.” Journal of Law, Medicine & Ethics: 36(2008), 219-48.

Recent Reports Released by the Presidential Commission for the Study of Bioethical Issues Penn Bioethics Journal Volume IX Issue i 9

Bioethics in Brief

Penn Bioethics Journal

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The BRAIN Initiative and the Presidential Commission’s Focus on Neuroethics

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With about 100 billon neurons acting in symphony to give rise to consciousness, the brain has uniquely captivated fields ranging from philosophy to the basic sciences. With an aging population, understanding neurodegenerative diseases, such as Alzheimer’s and Parkinson’s Diseases, becomes increasingly important to maintaining quality of life and a healthy, productive society. Moreover, understanding the human brain could lead to advances in cognitive enhancements and brain-computer interface technologies. On the horizon is also the potential of neuroscience to reveal principles of human nature.

The Obama administration has catalyzed neuroscience research with the new Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, which seeks to create a neural map of the human brain, link brain activity to behavior, create tools to modulate brain activity, and develop methods for conducting human research (NIH 2013).

President Obama’s plan called for a $100 million allocation in the 2014 fiscal year budget and approximately $300 million over the next 10 years after to fund relevant research (Markoff 2013). The administration made an initial pledge of $40 million to the National Institutes of Health for basic science and $50 million to the Defense Advanced Research Projects Agency (DARPA) for developing more immediate applications. In July 2013, President Obama charged the Presidential Commission for the Study of Bioethical Issues, led by University of Pennsylvania President Dr. Amy Gutmann, to consider the proper process of conducting neuroscience research and the possible impacts of the research findings (Obama 2013).

While bioethics has grappled with general problems with advances in biomedicine, neuroscience poses unique problems that deal with altering or enhancing consciousness and regulation of the use of brain activity information in society.

In May 2014, the Commission published “Gray Matters: Integrative Approaches for NeuroScience, Ethics, and Society,” the first volume in a planned two-part response to President Obama’s charge. The report’s first and most fundamental recommendation calls for the integration of ethics “early and explicitly” across all stages of research (Presidential Commission for the Study of Bioethical Issues 2014). The report emphasizes the need to create new educational models and infrastructures within institutions, such as universities, hospitals, and other private companies like DARPA to accommodate an “integrated ethics” approach. The second and third recommendations support the first by calling for government agencies to begin research on methods to integrate ethics in research and develop new education models that tie science and ethics together. The fourth recommendation seeks to increase accountability by calling for “ethical perspectives on advisory and review bodies” (Presidential Commission for the Study of Bioethical Issues 2014). This point can be read as most directly applicable to the BRAIN initiative’s advisory committee, which has not published any ethical considerations to date.

With the report just released, key players such as DARPA, NIH, and universities have not yet responded to the recommendations. The subfield of neuroethics within bioethics, however, has been rapidly growing with the rise of new technologies and has anticipated many of the concerns addressed in the Commission’s report. This year, two issues of the American Journal of Bioethics Neuroscience have covered how culture, the individual, and neurotechnologies all shape each other and the appropriate use of neurotechnologies in legal proceedings. The bioethics literature spans several fields and will most likely serve as a foundation for framing the potential problems with advances in neuroscience. Once bioethics research has been integrated into neuroscientific process, new connections between science, technology, and social activities may be exposed. The Commission will meet in June and August 2014 to consider potential ethical and social impacts of neuroscience for the second part of their response to President Obama’s charge (Underwood 2014).

References Emily Underwood. “U.S. BRAIN Initiative Gets Ethical Advice.” Science, May 14, 2014. Accessed June 2014. http://news.sciencemag.org/brainbehavior/2014/05/u.s.-brain-initiative-gets-ethical-advice Markoff, John. “Obama Seeking to Boost Study of Human Brain.” New York Times, February 17, 2013. Accessed June 2014. http://www.nytimes.com/2013/02/18/science/project-seeks-to-build-map-of-humanbrain.html?pagewanted=all&_r=0 National Institutes of Health. Advisory Committee to the Director, Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Working Group, Interim Report — Executive Summary. Washington, DC: U.S. Government Printing Office, 2013. http://www.nih.gov/science/brain/11252013-Interim-Report-ExecSumm.pdf.

Obama, Barack H. Barack Obama to Amy Gutmann, July 1, 2013. Letter. http://bioethics.gov/sites/default/files/news/Charge%20from%20President%20Obama.pdf (accessed June 2014).

Presidential Commission for the Study of Bioethical Issues. Gray Matters: Integrative Approaches for NeuroScience, Ethics, and Society. Washington, DC: U.S. Government Printing Office, May 2014. http://www. bioethics.gov/sites/default/files/Gray%20Matters%20Vol%201.pdf

Interview

A Conversation with Dr. David Magnus Dr. David Magnus is the Director of the Stanford Center for Bioethics and Editor-in-Chief of the American Journal of Bioethics (AJOB). The Penn Bioethics Journal spoke with him about his entry into the field of bioethics and ways undergraduates can do the same, the founding of AJOB, changes he has seen in the field over the past two decades, and the controversial SUPPORT study involving point-of-care randomziation, a research method that allows systematic variation in treatment protocol when there is no known optimal protocol. Dr. Magnus discusses his role in developing an ethical framework for point-of-care randomization with careful consideration of consent, risks, and, the value of this kind of research.

Penn Bioethics Journal: Can you tell us a bit about your academic background, and how you got into bioethics?

DM: I think you first need to distinguish between what needs to be done for training physicians in ethics and what is involved in bringing people into the field, which are very different. For training physicians, I think it’s an open question about exactly how much value and how much impact the kinds of courses we teach really have on practices. There

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PBJ: How important is it for students now to pursue a formal bioethics education to get involved in the field?

is some data, for example, that typical research ethics training has very little impact on how likely misbehaviors are to arise for researchers. In contrast, training through mentorship does have an actual impact. In terms of training medical students, it has become something that they have to know for boards, so it has become routinized in some ways. But virtually every study of shared decision-making and informed consent shows how incredibly rare it is for an encounter between and physician and patient to meet even basic standards. The data is overwhelmingly depressing that the quality of communication is abysmal, and having a couple of lectures on giving bad news in a hematology/oncology fellowship is not going to make people good at it or care about it. And, the measures we use for determining quality have nothing to do with those kinds of issues. You spend a lot of time making sure your hematology/oncology fellows know a lot about receptors on the surfaces of cells to be able to correlate that with the newest medical findings. But you don’t teach them to talk to patients, so you can’t be really surprised when they’re not very good at it, which they aren’t.

So the big question is, can we find ways of doing a better job with teaching these students? There are some folks who are doing work on finding smaller interventions that could work, but so far, the results are not promising.

I actually have an idea for a study that uses a strategy commonly used to train teachers. We would come in and do recordings of conversations and then do some kind of content analysis. Then, scale up a scoring system to demonstrate

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Dr. David Magnus: Nobody who is my generation or older set out when they were graduate students to do bioethics because bioethics as a field didn’t really exist. In a way, bioethics was a perfect fit for me, though. When I was a PhD student, I was really torn between two different areas: ethics, and the history and philosophy of biology, so I did work on both of those. My final dissertation topic was in the history and philosophy of biology, and in fact, there is a whole group of us in bioethics who had that philosophy of science background: Art [Arthur] Caplan did his dissertation on altruism and evolutionary biology, David Resnick, too.

But I was at the same time very interested in ethics. My first academic job had mostly to do with teaching philosophy and philosophy of biology. It was when I was first a professor when I really started taking interest in bioethics topics. I was at a liberal arts college when I first got a couple of grants on reproductive ethics. Genetics and ethics were some things I had always been interested in, and they were a logical fit. As that interest grew and I began to do work on the intersection between philosophy of biology and ethics; it was natural that I would start to slide over into other kinds of medical topics.

I later collaborated on teaching some health courses with clinicians, so I had some exposure to medical topics there. For me, it was big jump from there to the University of Pennsylvania School of Medicine, where I was an Assistant Professor of Medical Ethics. That’s where I really learned about medicine and did rounds with the Medical Intensive Care Unit folks and had my interests shift from just genetics and ethics to a broader range of topics. I’ve now been doing clinical ethics for a long time. I do rounds in the ICU every week; I’ve learned a lot of medicine. I have published a lot on things like doctor patient communication and organ transplantation and have worked on a lot of clinical ethics issues as well as research ethics issues.

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David Magnus where there are missed opportunities in conversations, where they have used language that is too technical, things like that, and have scores for these things, and then have those transcripts with the scores and feedback returned to physicians as part of an ongoing quality improvement measure, and see whether that ends up feeding the physician’s drive to improve. There are a lot of type A personalities in medicine, so their drive to be successful and get better scores could be a more successful intervention.

On the other hand, in terms of getting people into the field of bioethics, there are a lot more people who want to do bioethics to supplement their careers in law or medicine. A lot of people come to me and say they want to be a bioethicist and ask, “Should I be a doctor, a lawyer, or a philosopher?”

There still aren’t clear pathways into the field, but I would say medicine is the obvious path for people to take. There are just a lot more opportunities for physicians to get some kind of bioethics training, whether it’s a Master’s program or concentrations like ours [at Stanford], the opportunities to conduct research, or fellowship programs for post-docs. There are a lot of opportunities for interested parties in the field to develop expertise that way.

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PBJ: I know you were very involved in the founding of the American Journal of Bioethics (AJOB). Could you tell us a little about that, and any challenges you faced as you launched it in 1999?

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DM: Well, it’s funny. Everybody said we were crazy when we told them about AJOB and were putting together the editorial board. We had an editorial board from the very beginning of superstar people who all said, “I’ll do it, but you’re crazy.” But we were very lucky right from the beginning.

Nowadays, everyone accesses journals online, but in those days everyone accessed them physically, so a journal had to have subscriptions to get placed in libraries. There was always a risk whenever you published in a new journal that nobody would see it. In spite of that, we had home runs right in the very first issue, and we owe lots to those folks who gave us those pieces.

John Robertson, who was a huge figure in law and bioethics, was then chair of the ethics committee for the American Society for Reproductive Medicine, which had been working a controversial issue around sex and gender selection that got a lot of media attention. He gave us his article on that topic.

We decided to give that issue away for free and kept it free for many years. Tons of big names were writing OPCs [open peer commentary] for us right from the beginning. Our first two target articles were John Robertson and Todd Chambers, then Norm Daniels wrote a piece for us for our second issue.

Having all these prominent people writing articles or serving on the editorial board just helped AJOB make a huge splash right away, and people started paying attention to it.

Of course, Glenn McGee [the founding Editor-in-Chief ] was a master of hype and so that made a difference, too.

Glenn was always cutting edge. With the Internet, we weren’t just the first bioethics journal to have a blog—we were the

first journal of any journal of any type to have a blog. And we were, if not the first, one of the very first journals to have a Facebook and a Twitter.

Right from the beginning, AJOB made a big splash. That being said, one of our biggest struggles was with MIT Press and our lack of resources. This was being done on a shoestring budget, and we were fighting with them constantly, and the technology piece of it was a huge struggle with them.

But then we moved to Taylor and Francis, and they saw the value of we brought and that we could be one of their biggest and most influential journals, and that in fact has been the case. We have 30,000 articles downloaded a month, so it’s been a very rapid period of growth.

PBJ: Do you see an expansion of fields represented in submissions to AJOB over the last decade?

DM: For sure. There was no such thing as neuroethics when we started. Some of the folks that I knew on the faculty [at Stanford] helped launch a society for neuroethics.

We dedicated a special three issues a year to that subtopic and then spun it out as a separate journal. In general, the growth of the field is reflected in what we had to do. When we started, we were quarterly, then six times a year, and now it’s monthly. That happened partly because we were just swamped with excellent articles. As we became more successful and our impact factor was good, we started getting swamped with articles that weren’t really good choices for target articles but still good quality, which is what led to the spinoff of AJOB Empirical Bioethics [formerly AJOB Primary Research].

I would say genetics had always been there since the beginning, as was reproduction. We always had stem cells and cloning. In a way, you can see the Journal as an outgrowth of the discussions in the field, so in the earlier days, those were big topics. It’s always been a mix of looking inward and writing about the field of bioethics and writing about new cutting edge technologies, dealing with issues of justice in global health, and dealing with issues of clinical practice. Obviously, the new cutting edge technologies have changed over time, so synthetic biology became an issue, and new topics are constantly emerging. The biggest area that emerged de novo since launch has been neuroethics, though. I don’t think that term had even been coined yet when we launched.

PBJ: There was a controversy in the field in last year regarding the SUPPORT study, and more generally, the idea of point-of-care randomization. You were a very vocal supporter of that type of research, particularly when the Office for Human Research Protections (OHRP) released their letter condemning this practice. Could you tell us a little bit about that controversy, and why you decided to raise your voice on this issue? [Point-of-care randomization: a study design that randomizes the clinical treatment a patient will receive when no good evidence is available to determine the optimal clinical practice.]

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of research and practice that arises in the learning health care system. Menikoff had been very clear about saying that randomization and being on a research protocol are always more risky than a clinician just exercising best clinical judgment because of the differences in the obligations of the actors.

There is not a shred of evidence to support this view, and there is in fact evidence to the contrary. I believe his views to be fundamentally based on a false assumption that comes from the fact that he and many others have spent so much time worrying about therapeutic misconceptions, particularly in cutting edge frontier research, that it’s blinded them to the realities about how much we really don’t know and what really governs clinical decision-making in practice.

I was working on a project with some other folks around point of care randomization when the OHRP letter came out, and I realized all of the work I’ve been doing for the last months I can pretty much flush down the toilet because OHRP is now coming out with a crazy insane stance that’s going to make it almost impossible to carry out lots of valuable research, which just seemed completely wrong to me. I immediately wrote an op-ed saying why I thought this was crazy, and this was one of the advantages of the mouthpiece I have with AJOB, so I wrote a blog post about this on bioethics.net that wound up getting circulated to the entire network of people involved in the SUPPORT study. They all saw it and thought it was really good, and people said you should do a version of this for the New England Journal of Medicine (NEJM). So I asked Art Caplan to co-write it with me, and we produced it very quickly so it could come out in a timely way in NEJM. Later, I was actually at an ABPD (Association of Bioethics Program Directors) meeting of 60 to 70 heads of most of the bioethics programs in the country, and at this meeting, a bunch of people knew about SUPPORT and the NEJM article written, so people started to say ABPD should come out and say something about it. Initially, we were going to do this formally as ABPD, but we decided to go outside the entity and include others as well. So Ben [Wilfond, current president] and I [past president] got this organized and reached out to NEJM and got this letter published. We actually heard back that this letter was critical to getting the NIH to publish their letter against the OHRP because the Undersecretary of Health and Human Services saw our letter, which showed that the bioethics community, IRB community, and research community were all arrayed against the stance of the OHRP. There were some bioethicists on the other side, and they worked very hard to get as many people as possible to sign onto their side and it’s pretty clear they were scraping the barrel to get a number of signatories into the 40s. There are some good people with the opposite view, but I think there’s also now a lot more nuance in how to think about risks and consent in different and complex ways for research in the range of common practice.

Overall, our efforts were very successful. OHRP was forced to take back their initial finding in a second letter, and now they have to issue guidance for conducting point of care randomization research, which is clearly needed. I hope the

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DM: The OHRP issued a letter stating that the University of Alabama at Birmingham and other institutions part of the NIH-funded SUPPORT study—23 institutions with 23 IRBs approvals—all failed to get adequate informed consent. Particularly worrisome to the OHRP was the claim being made by researchers both in print and in the informed consent form that because patients were being randomized within the range of standard practice, it was a minimal risk study, as there was no risk introduced by being in the study.

It’s complicated because if you look at it from a regulatory perspective, the section from the Common Rule that says IRBs are charged with evaluating risks and benefits of research and making sure that risks are justified. It says very clearly and explicitly that the risks and benefits are to be the risks and benefits of the novel research, not things that would otherwise happen even if they weren’t participants in research.

This makes a lot of sense because if you were doing, for example, a research trial on a brain tumor and your first step is to do a surgical procedure that you would do anyway, you don’t want to say the benefits or a harms of the surgery are benefits or harms of participating in the study because they aren’t unique to the study. But later, the Common Rule talks about risks and the obligation to state any foreseeable risk in the informed consent. When you say any foreseeable risk, what goes in the parentheses after that? Is it the same language that occurs in the benefits section—the novel risks introduced by the research—or is it the risks of the procedures that are described as part of the protocol but would take place anyways?

In the SUPPORT trial, premature infants are randomized to oxygen levels somewhere between 85 and 95. Outside of the study, if they were in Texas, they were going to get 85 to 89, at Tufts 88 to 92, at some other places 91 to 95, and here at Lucile Packard Children’s Hospital, they would get the whole wide range. It was all over the map what they were going to get, but it would be somewhere in that range, and nobody knew what was better and where the sweet spot was. There was going to be a lot of death and blindness either way, and it was thought there might be more blindness at the higher level, but there was no agreement whether there would be more death at the higher or lower level. These risks are true whether they’re involved in the SUPPORT study or not. So the informed consent said they would get something in the standard range of practice, so there are no new risks added by the study.

It said that there could be a reduction in blindness at the lower end. It seems to me that that’s pretty accurate. Could the forms have been written better? Sure, but most consent forms could be written better. It just seems this letter from the OHRP was very misguided. Claiming there was a problem with the function of the IRBs because the OHRP had a certain interpretation of what those parentheses should be was an abuse of their power and an overreach.

Prior to the SUPPORT controversy, the head of OHRP, Jerry Menikoff, had been a participant in another project in which they raised concerns about using the same standards and views about research in clinical practice and a blurring

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guidance that comes out is good, though I’m nervous about some of the guidance that OHRP has been producing lately—I’ve some concerns about the alterations to the Common Rule that they’ve been acting on. Asking for HIPPA standards to be met in all areas and phases of research could be highly problematic, but it’s complicated because the language in the Common Rule isn’t consistent.

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PBJ: Thank you so much for taking the time to talk with us. Do you have any other closing thoughts or advice you would like to relay to undergraduates interested in this field?

DM: I would say if you are really interested in bioethics, figure out if you want it to be an avocational interest or a vocational interest. If you think of it as an avocational interest, where bioethics would supplement another profession, this is a great time for you. More and more places have courses for undergraduates, there are conferences, and just a ton of ways to explore this interest. Participate in those things and take advantage of them. And you can continue doing that in graduate school, law school, medical school—no matter where you go, you’re going to have some options.

For a vocational interest, it remains the case that there is no clear pathway into the field. If you want to be a bioethicist for your career, there is no obvious best path to get there. But if you’re passionate about this, you’ll be able to find a pathway

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Article

How Alleviating the Tensions Between Individual Liberty and Community Matter for the Affordable Care Act Chelsea Anne Jack‡ This article will provide an ethical assessment of the individual health insurance mandate in the Patient Protection and Affordable Care Act upheld by the U.S. Supreme Court in June 2012. This assessment examines legal justifications for the act with the purpose of addressing ethical questions lurking just beneath the technical mechanisms of the new health law. Two different theoretical perspectives of justice, namely, libertarianism and communitarianism, will be used to focus the direction of this examination. While libertarianism and communitarianism seem to oppose one another, in the context of biomedicine and health policy debates, theoretical perspectives such as these should be viewed not as oppositional, but instead as complementary, for the sake of facilitating compromise-building. This article not only seeks to analyze the ethical concerns behind the new health law that impacts the lives of ordinary citizens, but also offers a possible framework for using complementary theoretical perspectives in order to conduct more meaningful and productive conversations in the creation of health law.

In 2013, the Kaiser Family Foundation reported on the public pandemonium resulting from massive cancellations of insurance policies that would have otherwise been grandfathered. The ACA does not require insurers to cancel policies that were in effect at the time of the law’s passage in March 2010, but insurers remain free to significantly modify or cancel those policies – and many have. Such cancellations have been anticipated to impact millions of Americans. i

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(U.S. Department of Health and Human Services 2013).

The mandate requires those without coverage to pay a tax penalty to the Internal Revenue Service that will be phasedin between 2014 and 2016, imposing either a $695 exaction on individuals or a penalty equaling 2.5 percent of household income (Kaiser Family Foundation 2010). Twenty-six states brought suit in the Federal District Court to challenge the constitutionality of the individual mandate and expansion of Medicaid, and ultimately, the Roberts Court partially affirmed but reversed the judgment made by the Court of Appeals for the Eleventh Circuit in June 2012. This paper specifically discusses the Court’s decision to affirm the constitutionality of the individual mandate as a tax.

Applied medical ethicist James Taylor observes that although much emphasis has been placed on discussing the legal justifications for the individual mandate, not as much emphasis has been placed on the moral acceptability of this new provision (2012, 14). An examination of both is required in order to develop a framework for compromisebuilding in the health policy arena. The individual mandate met—and continues to meet—much resistance because the provision represents the tension between the value of individual freedom and the demands of community life. Although the dichotomy drawn between autonomy and community requires qualification for most ordinary Americans, the mandate represents exactly that tension.

This assessment of the individual mandate will not seek to answer the question of whether or not a right to health

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On June 28, 2012, in National Federation of Independent Business v. Sebelius, the U.S. Supreme Court upheld the individual health insurance mandate provision of the Patient Protection and Affordable Care Act (ACA) enacted two years prior to increase the number of Americans covered by health insurance and decrease the cost of health care. The individual mandate required U.S. citizens and legal residents to have qualifying health coverage that complied with ACA regulations and protections by March 31, 2014. For those covered by a plan that existed on or prior to March 23, 2010, that business or individual plan may be “grandfathered,” or carried over without a required end date, as long as an insurer or employer does not make significant changes to a plan’s benefits or payment amounts through copays, deductibles, or premiums (Barr 2013). So-called grandfathered plans are exempt from some of the requirements for the ACA, meaning while many consumers might enjoy the convenience of keeping their old plan, consumers with these plans may not receive some of the new protections required by the healthcare law.i However, what does the individual mandate mean for those without qualifying grandfathered plans? As noted

by Justice Roberts in National Federation of Independent Business v. Sebelius, “For individuals who are not exempt, and who do not receive health insurance through an employer or government program, the means of satisfying the requirement is to purchase insurance from a private company” (567 U.S. 113 [2012]), through the new Health Insurance Marketplace which opened in every state in October 2013

‡ University of Virginia, chelsea.jack14@gmail.com

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Political Philosophy of the Affordable Care Act care exists, but instead it will examine how differently people conceive of their own individual rights and notions of justice. ii In parsing the tension between autonomy and community, this assessment will first examine the jurisprudential dimension of the individual mandate to demonstrate how many Americans conceive of the actual impacts of health law on their lives. Then, it will expand on the legal justifications for the ACA in order to respond to the ethical questions lurking just beneath technical mechanisms. This analysis will be focused through two different perspectives of justice – libertarianism and communitarianism – which create a rift between these seemingly opposing interests of autonomy and community.

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The Taxation Justification In National Federation of Independent Business v. Sebelius, the Court partially affirmed and reversed the ACA. This analysis will not focus on the rejection of the Medicaid expansion as provided for by the ACA but will instead examine why the Roberts Court rejected the appeal by the federal government to Congress’s power to regulate commerce but upheld Congress’s broad power to tax.

One of the primary legal defenses of the individual mandate directly and indirectly invoked the Constitution’s Commerce Clause. Bioethicist and legal scholar Mark Hall explains that although the Court has traditionally upheld Congress’s power to regulate commercial activity, in the case of the individual mandate, the Court stressed the distinction between regulating commercial activity and forcing people into commerce in order to regulate them (Hall 2012, 3). The Court held that the government could not justify the individual mandate under the premise of regulating commerce due to this important distinction.

Having rejected a direct appeal to the Commerce Clause, the Court also rejected a defense of the individual mandate on the basis of the Necessary and Proper Clause. Hall explains how the government assumed the individual mandate to be necessary and proper to prevent insurers from medical underwriting, or the tendency of insurers to use medical information to offer a type of coverage for an applicant. This second argument has been interpreted as an indirect appeal to the Commerce Clause because, in practice, it justifies the mandate as a necessary mechanism for regulating interstate commerce. However, the Court rejected this indirect appeal to the Commerce Clause as too broad a construction of Congress’s regulatory powers (Hall 2012, 2-3).

Although Chief Justice Roberts held that commerce powers could not authorize the individual mandate, Roberts upheld the mandate based on Congress’s power to levy taxes, even for “activit[ies] that it cannot authorize, forbid, or otherwise control” (567 U.S. 11 [2012]); this gives the federal government influence even in areas where it cannot

Libertarian Theory James Childress and Tom Beauchamp, co-authors of the seminal Principles of Biomedical Ethics, explain that libertarian theories of justice emphasize rights to social and economic liberty, invoking fair procedures rather than substantive outcomes. They explain that “the United States has traditionally accepted the free market ideal that distributions of health care are best left to the marketplace, which operates on the material principle of ability to pay, either directly or indirectly through insurance” (2009, 244-45). For libertarians, the ideal health care system is privatized and allows people to protect their health on their own initiative. Childress and Beauchamp apply Robert Nozick’s “entitlement theory” in order to clarify the libertarian position on health care: Nozick emphasized the enforcement of just procedures, not the production of just outcomes that liberal egalitarians espouse. These procedures affirm individual rights, especially freedom of choice and voluntariness, rather than create patterns of economic distribution. “Governments,” according to the libertarian belief, “act coercively and unjustly when they tax the wealthy at a progressively higher rate than those who are less wealthy, and then use the proceeds to underwrite state support of the indigent.” For libertarians, “society is not morally obligated to provide health care” but “is morally obligated to refrain from providing funds by coercive taxation”

For arguments in defense of health care as a human right, please see the following sources under References: Buchanan 1984, Menzel 2013.

For arguments in favor of abandoning rights talk regarding access to health care, please see the following source under References: Brody 1991. ii

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directly regulate. As Hall notes, the collection of the penalty, “entirely through the tax system, is calculated as a percent of income”; ergo, this “tax defense” does not represent a gross stretch from prior precedents (3-4).

Legal scholar Timothy Jost also notes that the tax defense allows for the individual mandate to constitutionally ensure legalization for an array of other insurance reforms.

For example, the government could only require insurers to guarantee issue through the implementation of the individual mandate (Jost 2012, 15). The reason being, without the individual mandate, healthy people may wait until they get sick and then purchase insurance. If this were the case, then insurance companies would take huge hits all at once; the mandate prevents this kind of unfair imposition on insurance companies.

In summary, the Court struck down Congress’s power to enforce the individual mandate on the basis of powers delegated through the Commerce Clause, but since the penalty for neglecting to purchase a qualifying health insurance plan operates through the tax system, the Court justified the individual mandate of requiring the purchase of a qualifying plan by affirming Congress’s authority to levy taxes. From here, this analysis will examine the implications of this decision through philosophical perspectives that hold all public action up to the yardstick of individual liberty against obligations to society, namely, libertarianism and communitarianism.

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Political Philosophy of the Affordable Care Act plans” (2009, 99-100, 103). This understanding of autonomy is very instructive when looking at the implications of individual mandate on our private and collective understandings of autonomous individuals. Taylor argues, for one concerned with the moral value of autonomy, that the individual mandate and the ACA fail to respect autonomy in two ways: the mandate does not “merely fail to respect the autonomy of those who are forced to purchase health care insurance; it also fails to respect the autonomy of those whom [tax payers] are forced to subsidize” (2012, 16-17). He explains that one can fail to respect another person’s autonomy either by subjecting someone to direct coercion (e.g. forcing someone to buy health insurance) or by holding another person’s autonomy as unworthy of respect, even if one does not actually act so as to compromise it. Childress and Beauchamp echo a similar sentiment when they write that autonomy entails not only respectful actions as dictated by an obligation of noninterference, but also acknowledgments of decision-making rights of persons by cultivating a respectful attitude.

Healthcare as a Negative Right

For more on liberal egalitarian theories of justice as fairness or equality of opportunity, please see the following source under References: Rawls 1971. iv Jost questions whether or not people will experience this coercive government action differently because it’s being called a tax. He writes, “Although taxes are uniformly unpopular, most people accept the fact that paying taxes is a social obligation. Out-and-out tax resistance is relatively uncommon” (2012, 16). He makes a fair point. Most libertarians even submit to taxation as a necessary practice of modern government. However, the question still remains whether it matters whether calling this a tax justifies the action, since the effect and payment is still the same economically. iii

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Concerns for rights and obligations have been majorly at stake in discussions on the individual mandate. Although health care as a right remains a somewhat open question, the value placed by libertarians on so-called “negative rights” has a significant place in conversations about the individual mandate. This is a classic libertarian understanding of natural rights as negative rights, or as rights to be free from action by others, which correlatively translates into an obligation of noninterference on others (Sade 2008, 352-53, 468). In the context of health and medicine, this preference for noninterference fosters an understanding of health as an individual responsibility, not subject to government pressure or coercion. Such an understanding of health care as a negative right led to the widespread castigation of Mayor Michael Bloomberg for implementing public health policy changes in New York City over the past decade. Many Americans understood Bloomberg’s policy initiatives as coercive: the government ought not limit the portion size of sugary drinks, ban trans fats, or encourage initiatives to reduce salt intake to promote the health of its citizens. The idea is, “If I want to chug a 7-Eleven Double Gulp, I’m only hurting myself.

The Nanny State shouldn’t get to meddle with my soft-drink preferences, even if I might be better off choosing a healthier option.” In the case of the ACA, libertarians have a prima facie reason to object to the mandate by virtue of the fact that it requires government interference through a tax scheme at

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(246). Further, wrapped up in libertarianism are several fundamental concepts, including liberty, autonomy, rights and obligations, which ethically charge debates on the individual mandate.

At its core, libertarian political philosophy demands protection for the individual against external coercion. Libertarian bioethicist Robert Sade explains that liberty protects against the “use of individuals for purposes to which they have not consented,” and with this constraint, government cannot justly make exactions upon non-consenting individuals (2008, 468). Sade argues for a health care system operating solely within the free market based on his understanding of freedom as synonymous with unimpeded freedom of choice, as opposed to liberal egalitarian understandings of freedom wrapped up in notions of equality of opportunity and fairness.iii A libertarian, like Sade or Nozick, would most definitely object to the individual mandate based on a prima facie rejection of coercive government actions that fail to respect liberty as a meta-constraint. It might go without saying, but the individual mandate is just that – a mandate. Federal law now requires individuals to have qualifying health insurance or else face a coercive tax. Furthermore, in the past year, potentially millions of Americans, with plans that would have otherwise been grandfathered, have and will continue to receive notifications of policy cancellations from their providers who are adjusting offerings based on the impacts of the ACA (Appleby 2013). These cancellations will force those who were happy with their previous plans to purchase new, qualifying plans. Arguably, some choice is built into this decision when one decides between either purchasing insurance or paying a tax penalty, but by no means is purchasing a health insurance policy any longer an unimpeded, voluntary, personal decision. Public policy scholar Len Nichols explains that this “somewhat involuntary redistribution inherent in subsidizing the low-income uninsured” represents a move towards “wise stewardship of social assets,” but to be clear, the measure is not “somewhat involuntary” (2012, 17-18).

A legal mandate by default eliminates true volition from the equation. Voluntary choice has unquestionably been diminished by a coercive tax designed as a penalty for those unwilling, not unable, to obtain health insurance either through their employer, a government program, or a private company.iv Childress and Beauchamp believe that respect for liberty, or independence from controlling influences, represents a crucial condition of autonomy. They write that an autonomous individual “acts freely in accordance with a self-chosen plan” and that “a person of diminished autonomy, by contrast, acts as if controlled by others, or as if incapable of deliberating and acting on the basis of their own desires and

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Political Philosophy of the Affordable Care Act

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the expense of free exchange within the market and property rights. This objection holds only if one believes in the value of being able to make free and voluntary choices about one’s own health insurance in the free market. For example, one might argue that a family benefits immediately from having the option of foregoing the purchase of a health insurance policy if that decision allows them to use that money to meet other family needs and desires. Libertarians would not support policies that punitively tax such a family for exercising their liberty in making a decision on how to spend their own resources. However, public health scholars Norman Daniels and Marc Roberts argue that such a view is made less persuasive by the fact that to privilege these negative rights over all tax schemes, which aim to protect opportunity, equality of respect, and social welfare, would make almost all modern government impossible. They would argue that the concept of a negative right “misconstrues the more qualified nature of property rights” (Daniels and Roberts 2008, 83-88), since every American can only enjoy rights to noninterference as beneficiaries of government services aimed at protecting those rights through institutions made possible through the collection of tax revenue.v The ethical considerations detailed here provoke several follow-up questions, some of which communitarianism seeks to answer. Is libertarianism too limited because it excludes communal values? Should it consider alternative definitions of autonomy, perhaps definitions that incorporate considerations for social relationships as components within an individual’s plan for self-direction? Many political philosophies, some of which will be mentioned briefly in the following section, look at the tenets of libertarianism and question the demands of community life. The ethical concerns addressed by communitarianism provide a productive lens through which to evaluate the tension behind the individual mandate.

Communitarian Theory Communitarian theories emphasize principles of justice that evolve through traditions and practices in different communities, but communitarians react negatively to models of society that base human relationships on “natural rights,” like Robert Nozick’s. “Communitarians stress the obligations of the community to the individual and the obligations of the individual to the community” (Childress and Beauchamp 2009, 246-47, 356). This perspective tends to gravitate towards the language of solidarity in order to characterize a relationship of mutual obligation between the two, whereas the libertarian perspective tends to gravitate towards rights in order to characterize a relationship of weighted obligation on the part of the state to protect the natural rights of individuals. Furthermore, principles of justice vary among communitarians; there is not one single theory of justice for every society, but instead only relative standards derived by the members of a certain community. The primary considerv

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ations for communitarians are collective responsibilities, the common good, and traditional practices. Communitarianism is not the only philosophical theory interested in these considerations, but this assessment will focus on these considerations through the lens of communitarianism.

Social policy expert Deborah Stone explained that, above all else, communities help each other. “Mutual aid,” she wrote, “among a group of people who see themselves as sharing common interests is the essence of community; a willingness to help each other is the glue that holds people together as a society” (Stone 1993, 289). From a communitarian perspective, the individual mandate appeals to this conception of collective responsibility characterized by obligations of mutual aid. Jost refers to Stone when he writes that the Court accepted the authority of Congress to establish a mutual aid-based health care financing system through the legalization of the mandate and “largely rejected the idea that the principle of actuarial fairness is enshrined in the Constitution” (2012, 15). While mutual aid connotes an understanding of sickness as a widely accepted human condition that should trigger mutual aid and cost sharing, actuarial fairness connotes an understanding of each person as the sole bearer of the burdens imposed by his or her own health risks. Jost means, although the Court struck down the defense of the individual mandate as a provision of the Commerce Clause, that particular decision should not be misconstrued as the Court saying that Congress lacked the authority to create a national community of mutual aid. The Court simply implied that Congress must do so under its power to tax.

A crowd awaits the Supreme Court ruling on the individual mandate. Photo credit: Paul Blake.

Ultimately, the Court accepted Congress’s authority to coerce uninsured individuals to join the community of the insured—to engage in mutual aid—and, in doing so, strengthened the reality of a national community (Jost 2012, 16).

For more on all rights as “positive rights,” please see the following source under References: Holmes and Sunstein 1999.

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Political Philosophy of the Affordable Care Act Health as a Communal Endeavor

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Bioethicist Daniel Callahan writes that the difficulties faced in passing the individual mandate bespoke the profound resistance to this communitarian perspective in favor of the idea of collective responsibility for health care, even though the basic premise of solidarity finds route in universal human conditions: “that we are all finite creatures, all of us together subject to disease, illness, and the threat of death.”

Here, Callahan premises a communitarian argument in favor of the mandate not only for the sake of solidarity, but also for the sake of the common good. He believes that “we must all help each other, not for the abstract reasons of justice and rights, but because of a felt empathy for our fellow human beings, knowing full well that their afflictions will sooner or later be matched by similar afflictions of our own” (Callahan 2011, 351-362). Although Taylor and his peers might look at the individual mandate as shamelessly paternalistic, Callahan articulates a strong communitarian preference in favor of enacting public policy based on a shared consensus about the good of society, rather than on the basis of individual rights. Those who value a communitarian theory of justice would argue that the 41.3 million uninsured Americans—who in terms of financial insecurity, morbidity, and mortality—gravely jeopardize the health and well-being of our national community. For this reason, a communitarian would suggest that the individual mandate and subsequent health care reforms work in the interest of the common good by seeking to bring the uninsured into a national community of mutual aid (Jost 2012, 15). This reasoning logically holds when considering the unique aspects of health care, particularly health insurance, which tremendously implicate community by establishing health insurance pools. Individuals purchase insurance to share the immense risks of morbidity and mortality, which universally characterize the human condition, throughout the community; therefore, political action today can be interpreted through a communitarian perspective which views health insurance pools as manifestations of ethical principles, such as collective responsibility and support for the common good. On the other hand, a libertarian, like Sade, would argue that one can neither truly say to what extent people are collectively responsible nor define the common good, nor should government preference any one notion of the common good, but instead respect liberty as a “metanormative” condition of self-direction (Sade 2008, 468). Philosopher Michael Walzer voices the communitarian response to this charge by stressing the importance of cultural meanings and interpretations of the common good through traditional practices and rituals.

Unlike libertarians, communitarians believe that one can determine the common good by identifying what individuals owe one another within the communities they actually inhabit. Within the context of health care in the United States, Walzer argues that medicinal treatments, physicians, emergency rooms, hospitals and health insurance all represent the cultural construction of social and moral necessities within our national community. Although the principles of

justice are pluralistic for someone like Walzer, health care and health insurance as social goods must be distributed according to the traditional practices that have established both of these things as socially recognized needs. Public health expert Sherry Glied echoes this sentiment when she writes that the individual mandate for the purchase of health insurance represents the government signaling to its citizens that coverage is critical, that a public commitment to coverage has determined this as a public action in favor of the common good (2008).

Moreover, based on the social resources and investments made in order to establish the primacy of health care and the health insurance industry in this country, Walzer also argues that lack of access is not only dangerous for the uninsured, but also degrading. Communitarians might argue for the individual mandate on the grounds of its humaneness, on the grounds of its intention to purge the nasty habit of social fragmentation from health insurance industry. Recall how Jost importantly explained that the individual mandate made it possible for the Court to require insurers to guarantee issue, which is the crux of the ACA’s design to increase access to health insurance. Even if insurers were not required to guarantee issue, Stone argues, the health insurance industry still fragments communities into even smaller communities through the process of medical underwriting. She notes that underwriting has all the trappings of scientific objectivity, with its numerical rating systems and medical terminologies, even though health insurance is a social endeavor and insurability is a collective decision about membership. Insurance underwriting criteria used to justify denying health insurance to those with preexisting conditions “dovetail precisely with those identities that have formed our major social cleavages: race, ethnicity, class, and more recently sexual orientation and disability” (Stone 1993, 314). This logic affirms the institution of the mandate not only on the basis of the mandate as a signifier of health insurance as a communal priority, but also on the basis of the mandate as a measure meant to eradicate the degradation of the uninsured, of those subjected to segregation from the community of the insured.

These concerns for collective responsibility, the common good, and traditional practices illustrate the importance of community in an ethical assessment of the mandate, but, like libertarian concerns, these considerations provoke many constructive challenges. Does communitarianism misinterpret individualism? This analysis has been premised on an existing tension between autonomy and community, but this dichotomy requires a final qualification.

Childress and Beauchamp offer that a more accurate picture of the individual is available: we, as individuals, inherit social roles and goals, which we attempt to improve and adjust for based on community values, yet self-determination is still a requirement of an individual located within a community (2009, 361). However, without one single framework for justice, is society not exposing itself to the moral hazard of relativistic, inconsistent policies without any guiding ethical principles? These are the questions provoked by communitarian theory worth considering in an ethical assessment

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Political Philosophy of the Affordable Care Act of the individual mandate, but, more generally, these questions concerning collective responsibility, the common good, and traditional practices are useful for ethically assessing the merits of health policies surrounding a number of bioethical issues outside access to health care. For example, in Oregon v. Gonzales, a U.S. Supreme Court case concerning physician-assisted death in Oregon, Justice Kennedy continued to question whether the legalization of physician-assisted death would create a “slippery-slope” and normalize suicideby-prescription (546 U.S. 243 [2006]). In oral arguments, Justice Kennedy seemed to suggest that legalization of physician-assisted death might jeopardize the value of collective responsibility for one another and disrespect the preservation of life as a common good. In this way, legal questions have and will continue to center around communitarian concerns, and acknowledging the value of these concerns might help to bridge gaps in policy discussions.

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Conclusions: Recognizing Theories of Justice as Complementary

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This analysis has sought to demonstrate the way in which complementary and opposing ethical perspectives might inform our reading of technical mechanisms in the field of health policy and, ultimately, demonstrate a model for compromise-building in policy. In the case of the individual mandate, both libertarian and communitarian perspectives pose constructive ethical concerns through which a focused and rich discussion might be had. Although Childress and Beauchamp suggested that the dichotomy between autonomy and community might be a false one, ordinary citizens articulate this tangible distinction in their endorsements and rejections of the individual mandate, and for this reason, attempting to forge a compromise by weighting these opposing concerns might be the most prudent and satisfying strategy for productive debates on access to health care.

Some accuse libertarians of neglecting communal values, but rights language serves as a valuable source of personal protection against inhumane treatment and as a source of dignity. Libertarian concerns for autonomy, voluntariness, rights and obligations give political muscle to a universal desire to be treated with respect, and, for that reason, it bodes well to examine the individual mandate with these concerns in mind. Some accuse communitarians of misinterpreting the value of rights, but communitarians emphasize the creation of neighborly ties and national goals that stress the importance of community. Communitarian concerns for collective responsibility, the common good and traditional practices emphasize that, as human beings facing mortality and affliction, all people are in this together, even if liberal values are accepted (Callahan 2011, 355). This assessment has attempted to demonstrate that while people may not always be able to meet on common ground, understanding the strengths of these two different perspectives leaves hope for the potential of compromise.

With this model serving as a discussion, health policy conversations should be structured to reveal the ethical complexities lurking beneath the legal technicalities of health care reform. The first part of this framework requires approaching law as part of our lived reality: if the words of the Constitution are to be more than idle talk, then we need to understand how they are made real in the lives of citizens. The second part of the framework requires tackling, not side-stepping, ethical perspectives. Addressing the ethical concerns for both libertarian and communitarian theories here required exposing their tensions, while still working to constructively identify the potential each theory has for complicating the other.

Each presentation of these theoretical perspectives concluded with open-ended questions that members from opposing positions might offer counter-strategically. For example, in the conclusions that followed the discussion on libertarianism, several questions were offered, such as, “Is libertarianism too limited because it excludes communal values?” This argument for compromise requires that such counters follow the presentation of any ethical perspective for the sake of a more productive conversation. It has yet to be determined whether or not these ethical perspectives in particular are mutually exclusive in the context of the American health care debate.

However, the aim of this analysis has been to demonstrate that they need not be.

Many different theories of justice constitute the field of political philosophy, and an attitude of openness towards these different theoretical perspectives has and will continue to yield productive conversations on a number of bioethical cases, not just on the individual mandate. In the past, several legal decisions concerning reproductive health for women in the United States have been characterized by this kind of complementary debate. Roe v. Wade and later, Planned Parenthood of Southeastern Pa. v. Casey were cases that not only dealt with individual liberties and rights to privacy for women in the United States, but also questioned fetal subjectivity (i.e. understanding the fetus as a person) and the possible interests of the fetus as a potential person situated in human society (410 U. S. 113 [1973] and 510 U. S. 1309 [1994]). The emergence of such questions suggests that individual and communal values have underpinned the legal restrictions on abortion and contraception. In the context of the ACA, policy initiatives to promote shared decisionmaking in clinical practice might benefit from the introduction of political philosophy. Shared decision-making initiatives have emerged to address seemingly oppositional needs for rationing communal health care costs with obligations to respect individual patient preferences (Elwyn et al. 2012). In sum, a framework that seeks to understand the strengths and weaknesses of facially hostile perspectives on justice has the potential to render these ethical perspectives complementary for bioethicists.

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Political Philosophy of the Affordable Care Act References

About the Author Chelsea Anne Jack attended the University of Virginia and earned a B.A. in Political & Social Thought, a B.A. in Anthropology, and a minor in bioethics. She is currently a research assistant at the Hastings Center.

Professor John Arras, is the faculty sponsor for this work. He is the Porterfield Professor of Biomedical Ethics and Director of Bioethics Minor Program at the University of Virginia and a fellow at the Hastings Center.

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Appleby, Julie. “Why Insurers Cancel Policies, And What You Can Do When It Happens.” Kaiser Health News, October 30, 2013. Accessed: December 31, 2013. http://www.kaiserhealthnews.org/stories/2013/october/30/insurance-policy-cancellations-insurers-consumers.aspx.

Barr, Sarah. “FAQ: Grandfathered Health Plans.” Kaiser Health News, November 13, 2012. Accessed: December 31, 2013. http://www.kaiserhealthnews.org/stories/2012/december/17/grandfathered-plans-faq.aspx.

Brody, Baruch A. “Why the Right to Health Care is Not a Useful Concept for Policy Debates.” In Rights to Health Care, edited by T.J. Bole III and W.B. Bondeson, 113 – 131. Netherlands: Kluwer Academic Publishers, 1991.

Buchanan, Allen. “The Right to a Decent Minimum of Health Care.” Philosophy and Public Affairs, 13(1984): 55-59.

The Oyez Project at IIT Chicago-Kent College of Law. “BUCK v. BELL.” Last modified May 21, 2014. Accessed: February 1, 2014. http://www. oyez.org/cases/1901-1939/1926/1926_292.

Callahan, Daniel. “Health care reform: Can a communitarian perspective be salvaged?” Theoretical Medicine and Bioethics 32.5 (2011): 351-62.

Childress, James and Tom Beauchamp. Principles of Biomedical Ethics (Sixth Edition). New York: Oxford University Press, 2009.

Daniels, Norman and Marc Roberts. “Health Care Reform.” In From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, edited by Mary Crowley, 83-88. Garrison, NY: The Hastings Center, 2008.

Daniels, Norman. Just Health Care. New York: Cambridge University Press, 1985.

Dworkin, Ronald. “To Each His Own.” Review of An Exchange on Sphere of Justice, by Michael Walzer. New York Times Review of Books, April 14, 1983. http://www.nybooks.com/articles/archives/1983/apr/14/to-each-his-own/.

Elwyn, Glyn. “The ethical imperative for shared decision-making.” European Journal for Person Centered Healthcare 1(2012): 129-31.

Glied, Sherry. “Universal Coverage One Head at a Time – The Risks and Benefits of Individual Health Insurance Mandates.” The New England Journal of Medicine 358 (2008): 1540-42.

The Henry J. Kaiser Family Foundation, Summary of New Health Reform Law, 2010. PDF file.

Holmes, Stephen, and Cass R Sunstein. The Cost of Rights: Why Liberty Depends on Taxes. New York: W.W. Norton, 1999.

Jost, Timothy S. “A Mutual Aid Society?” Hastings Center Report 42(2012): 14-16.

Mastroianni, Anna and Jeffrey Kahn. “Risk and Responsibility: Ethics, Grimes v. Kennedy Krieger, and Public Health Research Involving Children.” Am J Public Health 92(2002): 1073-76.

Menzel, Paul. “The Realistic Moral Right to a Basic Minimum of Accessible Health Care.” In Ethical Issues in Modern Medicine, 8th ed., edited by B. Steinbock, A. London, and J. Arras, 210-21. McGrawHill, 2011.

Nichols, Len. “Justice Roberts’s Health Care Stewardship.” Hastings Center Report 42(2012): 17-18.

Nussbaum, Martha. From Disgust to Humanity: Sexual Orientation and Constitutional Law. New York: Oxford University Press, 2010.

Oregon v. Gonzales, Oral Argument. Supreme Court: Oral Arguments, 546 U. S. 243 (2006). Accessed: January 1, 2014. Available at: http://www.supremecourt.gov/oral_arguments/argument_transcripts/04-623.pdf Rawls, John. A Theory of Justice. Cambridge, MA: Harvard University Press, 1971.

The Oyez Project at IIT Chicago-Kent College of Law. “ROE v.

WADE,” Last modified June 8, 2014. Accessed: January 1, 2014. http://www.oyez.org/cases/1970-1979/1971/1971_70_18.

Sade, Robert. “Foundational Ethics of the Health Care System: The Moral and Practical Superiority of Free Market Reforms,” Journal of Medicine and Philosophy 33(2008): 468.

Stone, Deborah A. “The Struggle for the Soul of Health Insurance.” Journal of Health Politics, Policy and Law, 1993 18(1993): 289.

Taylor, James. “The Carelessness of Affordable Care,” Hastings Center Report 42(2012): 14.

U.S. Department of Health and Human Services. “How the Health Care Law Benefits You.” Last modified December 31, 2013. Accessed: December 31, 2013. http://www.hhs.gov/healthcare/facts/bystate/ Making-a-Difference-National.html

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Article

Personhood at the Beginning of Life: Construction of Ethics for Abortion and Stem Cell Research in Japan Phoebe Oldach‡ Consideration of the transitional stages at the beginning and end of life has challenged assumptions of simple delineations in conceptions of personhood, igniting much debate on topics such as abortion and stem cell research. In investigating the personhood of embryos, the early development of regulations on the field of human embryonic stem cell research (hESR) in Japan is particularly informative, as Japan paradoxically had one of the world’s most permissive, yet strict, research policies. The treatment of the embryo embodied in this discrepancy echoes the treatment of the fetus in abortion policies in Japan, and both highlight the distinction between personhood and spirithood status in Japanese culture. While the embryo was denied legal personhood status, a precedent set by the historical acceptance of abortion in Japan, it retained a cultural spirithood status, conferring social privilege and necessitating protective regulations. The distinction between personhood and spirithood has negatively impacted the pace of hESR in Japan until the explosive attention drawn to the field by the achievements of Nobel Laureate Shinya Yamanaka precipitated revaluation and streamlining of regulations. Investigations into the cultural and legal processes at work in the negotiation of status for beings of liminal personhood highlight the important distinction between spirithood and personhood statuses. The complex and culturally specific negotiations of personhood and spirithood statuses, as seen in the case of stem cell research in Japan, underscore the need for a global bioethics framework to facilitate international collaboration and exchange in fields with varying contested ethics.

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Delineation of Personhood and Spirithood

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Many governmental and societal functions depend on a clear construction of rights for individual persons; however, advancing technologies continue to raise new questions regarding the limits of personhood. This issue arose dramatically with the blossoming field of human embryonic stem cell research (hESR), which prompted global discussion on the moral status of the embryo and the ethicality of its use in research. In Japan, determination of the status of the embryo was predicated upon the legal and social construction of abortion, and in both cases, a distinction between two statuses—personhood and spirithood—emerged.

Personhood, a legally powerful status, formally recognizes the status bearer as a living, conscious being, who garners the legal rights and protections associated thereof. Related but distinct from personhood is spirithood, which extends past the boundaries of personhood to encompass objects with person-like qualities, the potential for personhood, or the remnants of a person. Under this definition, spirithood can be applied to ancestors, ghosts, and personified objects, among other examples (Oaks 1994). The status of spirithood is a necessary differentiator within the realm of non-persons, as a being attributed with spirit is considered a subject rather than an object and as such is often the recipient of differential treatment and respect, regardless of the lack of explicit legal protections. ‡ Dickinson College, phoebe.oldach@gmail.com

This paper investigates the formal denial of personhood and informal acceptance of spirithood of the fetus seen in the progression of abortion policy and culture in Japan. Furthermore, it analyzes how the respective denial and acceptance of the fetal personhood and spirithood status were reiterated for the embryo with the advent of hESR, with the justification for the denial of personhood to both embryos and fetuses based upon a utilitarian argument appealing to the valuation of community over the individual. Finally, it probes how denial of personhood status led to Japan’s permissive hESR policy, while simultaneous acceptance of spirithood status manifested in restrictive protocol regulations, and how this conflict impacted the field of stem cell research in Japan.

History of Japanese Abortion Policy Japan has sustained one of the highest abortion rates of the world’s developed nations, despite a history of fluctuating abortion policies (Norgren 2001). Abortion and infanticide were common methods for family planning until the Tokugawa government (1600-1868) limited the procedures through incentivizing large families and penalizing abortion recipients and providers, having condemned the procedures as immoral and accused citizens of weakening the state by “depriving [it] of future taxpayers” (23). These measures were formalized in 1880 under the Meiji rule, when abortion was criminalized in Japan’s first modern penal code modeled off

Personhood, Spirithood, and Stem Cell Research in Japan Abortion and hESR Law Timeline by Political Era Tokugawa (1600-1868) Abortion and infanticide, incentives for large families, and penalties for abortion common Meiji (1868-1912) 1880: Codification of first modern penal code, criminalizes abortion 1907: Revision of the penal code: Criminal Abortion Law of 1907 Taisho (1912-1926) 1923: Legalization of emergency abortions to protect maternal health Showa (1926-1989) 1940: National Eugenics Law Passed: allows for sterilization, lays out procedure for doctors performing abortions 1948: Eugenic Protection Law Passed: legalizes abortion for eugenics campaigns and maternal health 1949: Economic Hardship Clause: legalizes abortion to protect economic health Haisei (1989- present) 1997: Maternal Health Protection Law: removes eugenics framework from abortion policy, abortion legal to protect physical and economic health 1998: First derivation of human embryonic stem cells 2000: Human Cloning Regulation Act 2001: MEXT publishes Guidelines for the Derivation and Utilization of hESC 2007: Yamanaka publishes Induction of Pluripotent Stem Cells from Adult Human Fibroblasts by Defined Factors 2008: MEXT invests 10 billion yen for iPSC R&D

2012: Yamanaka wins Nobel Prize Moriguchi fraudulent claims to have successfully used therapeutic iPSC in humans 2013: RIKEN Center initiates first legitimate iPSC clinical study. Law passes stipulating that safety is the only requirement for clinical use of iPSC

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2009: MEXT loosens hESR regulations

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of Western documents. The penalties intensified in the 1907 revision, justified by policy makers who emphasized the state’s need for a large population of pure Japanese bloodline to support territorial expansion and solidification of power on the global stage. The first concession to this blanket criminalization came in 1923, when emergency abortions for pregnancies that threatened the mother’s life became legal (28).

The onset of World War II and the rise of the eugenics movements dramatically increased national interest in reproduction and minzoku eisei, or race hygiene, motivated by an even stronger push for national security to be upheld by a strong military force drawn from a large, robust, and purely Japanese population (24). However, under the National Eugenics Law of 1940, the stance shifted from strict pronatalism as sterilizations were permitted to “ensure the improvement of the national character by means of preventing an increase in the [number of ] persons with a predisposition toward malignant hereditary disease,” while still encouraging prolific reproduction of individuals with “sound constitutions” (30). While not explicitly legalizing abortion, this law laid out an approval procedure for doctors to follow in the case of abortions, thus adding to the 1923 mother’s health emergency exemption and obliquely legitimizing the procedure, though the government maintained a strongly pronatalist policy overall (32).

In response to post-war depression and mass starvation, the pronatalist stance softened even more with the 1948 Eugenic Protection Bill, which expanded access to abortion, birth control, and sterilizations in an effort to counter overpopulation and improve the national character by preventing undesired births (39-40). Though still criminalized under the 1907 penal code, abortions were permissible with the approval of a Eugenic Protection Committee for pregnancies that resulted from rape, endangered the mother’s life, or exhibited a greater probability for hereditary disease or behavioral disorder based upon family history (40). The following year, another amendment resulted in the creation of the economic hardship clause, legalizing abortion in cases where the birth of a child would cause serious harm “for physical or economic reasons” (45).

The economic component of this clause was first interpreted in a strict sense, only permitting the procedure for families facing financial devastation, but without an absolute definition of economic harm, the usage soon loosened to include any family for whom the birth of an additional child would lower the standard of living, regardless of whether the family qualified as impoverished (Hardacre 1997, 63). From 1949 to 2001, economic hardship was cited in procedural paperwork for 99 percent of the abortion cases, evidencing the power of the law’s ambiguity to expand access to the procedure (Norgren 2001, 46).

In 1997, the Maternal Health Protection Law was passed, disassociating abortion, sterilization, and birth control from the eugenics framework of the previous governance and requiring approval of the physician, mother, and spouse for any abortion (Maternal Health Protection Law 1997). The 1907

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Personhood, Spirithood, and Stem Cell Research in Japan criminalization was never explicitly reversed, but the laws since then have implicitly allowed for the widespread practice of abortion, maintaining the prominence of the procedure as one of the primary methods for family planning in Japan (Oaks 1994).

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Personhood and Spirithood of the Fetus

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Embedded in these policies and the contradiction of abortion’s widespread use despite its criminalization is the construction of abortion as an unethical act in need of regulation. But the progression of the policies also conceded to abortion as a necessary act, permissible as its harms were outweighed by the potential benefits to the greater good, namely, improvements to the character of the nation and the economic security of the family.

The utilitarian arguments supporting the potential of abortion to improve the character or economic standing of the nation or family are further evidenced by examining cases of unacceptable abortions. While generally sympathetic to abortions necessitated by any degree of economic hardship, those stemming from out-of-wedlock pregnancies were stigmatized by the community (Hardacre 1997, 72). Even at the onset of abortion’s criminality in the Tokugawa period, the penalizations primarily were enforced in cases that resulted from adultery (Norgren 2001, 23). The condemnation of these abortions reflected the hierarchy of interests, placing state and family interests over individual rights. While sacrificing the fetus for the good of the state or the family was seen as acceptable, sexual pleasure, as an individual interest, did not offer any benefits to larger society, and thus both pregnancies and abortions stemming from unmarried matches were seen as selfish.

Furthermore, women did not have autonomy in decision-making over their bodies, as the wartime promotion of kokkateki bosei, or “motherhood in the interest of the state,” echoed throughout later abortion policies (34). Specifically, the legality of postwar abortions was contingent upon approval of a Eugenic Protection Committee and later on the father and spouse’s consent (Williams 1997, 27). This further reflected the community’s control of reproduction and the devaluation not only of the fetus, but also of the mother and her body to be subjected to the interests of the family and state (Norgren 2001, 34).

While the practice of abortion was met with widespread public acceptance, as seen in Japan’s high abortion rates and the continued reluctance to adopt other forms of birth control, its legality depended upon an official denial of the fetus’ personhood, as the practice of abortion contradicts the right to life recognized for all people under Article 13 of the 1946 Japanese Constitution. Despite the persistence of the 1907 penal code criminalization in reputedly protecting the fetus, the formal denial of the fetus’s personhood was explicitly made by the Ministry of Justice to the National Diet, which upheld the constitutionality of abortion: “A fetus is part of a mother’s body until born, and not by itself a person. There-

fore, the fetus is not a legal subject of human rights under the Constitution” (Hardacre 1997, 5).

However, while personhood status was legally denied to the fetus, the cultural assignation of spirithood was uncontested, and its continued affirmation was seen both in terminology and in ritual practices. Rather than differentiating the fetus in discourse, both newborn infants and aborted fetuses were referred to as mizuko (Oaks 1994, 515). The use of the identical term minimizes distinction between newborn and stillborn, thus implicitly acknowledging the fetus’s previous potential for personhood, and by extension, its spirithood.

The spirithood of the fetus is more explicitly addressed in the Buddhist mizuko kuyō rituals, performed to honor and appease the spirit of an aborted fetus (516). In recognizing the fetus in attempts to prevent it from seeking revenge in the form of illness or misfortune to the family, these rituals acknowledged the spirithood of the fetus as a force with human emotions and the ability to influence others’ lives. Thus, through the succession of policies and perceptions surrounding abortion, the treatment of the fetus established a strong precedent for the legal denial of personhood and cultural acceptance of spirithood for humans before birth.

Inception and Reaction to hESR Following the precedent of the fetus, the embryo easily adopted the same status of denied personhood but acknowledged spirithood, being granted respect and conscientious treatment while not being protected in the fundamental right to life. After the first derivation of human embryonic stem cells (hESC) in 1998, hESR began to develop as a rapidly growing field of biomedical research. While the use of hESC was met with significant public resistance and debate in many countries, Japan saw very little public response, allowing the government to quickly enact the “Human Cloning Regulation Act” in 2000, followed by explicit approval for use of ES cell lines in 2001 (Sleeboom-Faulkner 2008).

These policies were recognized globally for their exceptional leniency and research-friendly stances (Kawakami 2010, 415). The unchallenged acceptance of hESR in Japan cannot be attributed to apathy of the population, as the debate over personhood in the case of brain death was a significant political issue that culminated in the 1997 Organ Transplantation Law (Sleeboom-Faulkner 2010, 61). Instead, the lack of public protest is likely attributable to a taboo on discussion of reproduction and the fact that legal denial of personhood status for pre-born humans was already securely established through the widespread acceptance of abortion, which facilitated an easy extension to policies denying personhood to embryos.

Like the justification of abortion for the good of the family and the state, the permissive policies for the use of human stem cells were encouraged due to the great potential seen in hESR for the advancement of Japan through improvements to both population health and the national economy.

The potential benefits of stem cell research to medical fields

Personhood, Spirithood, and Stem Cell Research in Japan multaneously defending its privileged spirithood status.

State of hESR Research With the combination of a research-friendly policy, the willingness of citizens to donate embryos for research purposes, and high performance in animal-model stem cell research, Japan seemed to be the perfect environment for breakthroughs in hESR. However, Japanese research fell short of achievement expectations, paradoxically lagging behind countries with stricter hESR regulations, such as the US and Britain (Cyranoski 2005, 263). Only a quarter of the laboratories expected to pursue hESR had switched from animal models to work with human cells by 2009 (Cyranoski 2009, 1068). Further, only 3 of the 259 scientific publications on hESR in 2004 and 2005 were from Japanese laboratories (Cyranoski 2005, 263), and only one Japanese laboratory contributed to the international rush to establish immortalized hESC lines from 1998 to 2005 (Kawakami 2010, 416).

Source: EuroStemCell, “Stem Cell Research: Trends and Perspectives on the Evolving International Landscape”, figure D3, pg. 55.

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The hindrance to research can be traced back to the MEXT guidelines stipulating special respect in hESR in deference to the embryo’s spirithood. In attempts to ensure that the research allowed under the permissive policy maintained due respect for the embryo’s spirithood, a complex web of regulations was created, requiring protocols to pass two levels of approval and subjecting investigators to “zealous review committees,” which probed researchers on their personal beliefs (Cyranoski 2005, 263). While approval to use hESR took two to three months in many countries, such as Singapore, South Korea, Australia, and Britain and only a few weeks in the US, approval in Japan took an average of 12.5 months (263). Scientists have been vocal with their frustrations over the crippling regulations, with one leading scientist lamenting that “these irrational guidelines have done and probably will continue to do great damage to all related research fields in Japan” (Cyranoski 2009, 1068). Thus, while strict hESR policies stemming from consideration for the embryo’s personhood limited research in many other countries, in Japan, ironically, the acknowledgement of spirithood, not person-

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were widely acknowledged in the scientific community and ranged in use from disease models to regenerative therapeutics (Saegusa, 2000 ; Campbell 2005, 50). As an aging nation facing significant health challenges, the potential medical breakthroughs promised by hESR were particularly resonant in Japan, so scientists went to efforts to stress the use of the cells. In addition to new knowledge and treatments that could be globally advantageous from a medical perspective, the Japanese government had an interest in encouraging stem cell research motivated by the possibility for economic growth and international prestige associated with leading the global biomedical research community in the field of hESR. Surveys have corroborated this by demonstrating public recognition of scientific leadership as a critical component to Japanese quality of life and economy (Campbell 2005, 82).

Beyond importance in fostering acceptance of hESR at the policy level, the perception of hESR as beneficial to the country was also critical for gaining support from citizens.

This is especially crucial in hESR as research is dependent upon donations of reproductive materials, which in Japan came most commonly in the form of supernumerary embryos from in vitro fertilization (IVF) (Kato and SleeboomFaulkner 2011). While women were reported to be initially reluctant to donate their supernumerary embryos, a study on IVF decision-making found that the experience of treatment and pregnancy changed perceptions and resulted in a final donation rate of 95% (2011). When queried about their decision to donate these embryos to research, couples often expressed remorse for denying the embryo’s potential for life but used the beneficial application to research as justification for the decision. One woman said regarding her donation of surplus embryos: “I hesitated, but dying for nothing is more cruel. To give a meaning to their life, I think I will finally choose to donate them” (2011, 442). Another woman stated similarly: “It is strange that my child is used for research, but I think that the child would be happier being able to contribute to society rather than being discarded for nothing” (442).

These statements illustrate the public’s conception of research as promoting societal good and implicitly demonstrate acknowledgement of the embryo’s spirithood through labeling the embryo as a “child,” echoing the identical terminology used for the fetus and newborn, personifying it with emotions and preferences, and acknowledging the need to respect those preferences.

Lending formality and international bioethical terminology to the public’s unspoken acknowledgement of embryo’s spirithood, the Ministry of Education, Culture, Sports, Science, and Technology (MEXT) in their 2001 Guidelines for the Derivation and Utilization of hESC recognized embryos as the “Germ of Life,” imbued with fundamental human dignity, and as such requiring conscientious handling. The guidelines explicitly state that hESR is allowed only for research that is “scientifically necessary and rational,” echoing the utilitarian justification seen in abortion (MEXT 2001, 2). Through these stipulations, these guidelines and legislation deny the embryo the constitutional protection of personhood status while si-

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Personhood, Spirithood, and Stem Cell Research in Japan hood, and the resulting informal regulations to respect the spirit of the embryo was the largest block to research.

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Yamanaka as an Exception

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A major exception to Japan’s underperformance in hESR exists in the notable work of Shinya Yamanaka. Awarded the 2012 Nobel Prize for Physiology and Medicine, Yamanaka pioneered the creation of induced pluripotent stem cells (iPSC), giving the power and research potential of ESC to fibroblasts. By inducing expression of four genes in the fibroblasts, Yamanaka was able to achieve dedifferentiation, with resultant cells identical to ESC in phenotypic and functional analyses, thus potentially bypassing the need for reproductive material and the ethical quandary of using embryos in research (Takahashi 2007). His work is lauded throughout Japan as a great source of national pride, as demonstrated by the commentary of Hitoshi Niwa of the RIKEN Center for Developmental Biology in Kobe: “This is the first time that medical-related research of world importance has been done entirely in Japan” (Fackler 2007).

Yamanaka’s great success serves as an example of the immense potential for hESR to contribute to Japan’s status as a global leader in biotechnology. Paradoxically, his success also emphasizes the problematic regulations. The ESC work contributing to Yamanaka’s Nobel Prize-winning discovery was carried out in his satellite laboratory at the University of California, San Francisco, as he had not undergone the regulatory procedure necessary for ESC work in Japan (2007).

This realization and the protests of scientists who felt limited by the intense regulations prompted MEXT to invest 10 billion yen for iPSC research and development over a five-year period starting in 2008 and to revise and loosen hESR regulations in 2009 (Shineha 2010 ; Cyranoski 2009).

However, many scientists felt that the beginning years of strict regulations set Japan irrevocably behind in hESR and that private American research labs were at a competitive advantage to commandeer the field of iPSC away from Japanese researchers (Cyranoski 2009, 1068 ; Kato and Kawakami 2012). This anxiety was manifested in the publications of Hisashi Moriguchi, who claimed in 2012 to be the first to use iPSC therapeutically to save six patients from heart failure.

His publications were promptly discovered to be fraudulent, and when questioned as to why he had fabricated such a massive study, ruining his scientific career, he stated, “Japan is in danger of being overtaken in the field of human iPSC-cell research,” thus echoing the valuation of state over individual by invoking the nation’s interests, rather than the desire to advance his own research career (Cyranoski 2012, 321). The shame of Moriguchi’s fraud quickly was redeemed by legitimate Japanese breakthroughs in iPSC however; as of August 2013, Japan’s RIKEN Center initiated the first clinical study utilizing the cells (Cyranoski 2013). Further, in November 2013, a law was passed stipulating that clinical use of iPSC required proof only of the safety and not the efficacy of the treatment, thus putting Japan foremost among the world’s

most attractive environments for the development and usage of novel stem cell therapies (Jiji 2013).

The policy changes and response of the scientific community to Yamanaka’s achievement highlight the importance placed on hESR to help Japan gain status as a global research leader. When the government recognized the threat that the regulations posed to all of the potential good from hESR, the regulations were changed to expedite research, fitting the mentality voiced by embryo donors that the embryo’s spirit is best respected when it is able to contribute to the overall good of the nation.

Yamanaka himself expressed similar sentiments in a 2007 interview following his groundbreaking success in creating iPSC, summing up his reasons for pursuing research as: “If embryonic stem cell research is the only way to help patients, then I think that it is what we should do. At the same time…as a natural feeling, I do want to avoid the usage of human embryos… Human embryos are not like skin cells. They can be babies if transplanted. That is why we are doing what we are doing.” (Fackler 2007) Yamanaka’s statement represents the conflict of using the cells, as it balances acknowledgement of the privileged status of stem cells over other cells and reluctance to deny their potential for human life with recognition of the great benefits to society that could be gained from the use of these cells. Ultimately, in Yamanaka’s statement, as in society, the underlying valuation of communal interests over the interests of the individual embryo won out, allowing research that was made legal through denial of the embryo’s personhood and made socially acceptable through continued regulations that maintained respect for the embryo’s spirit.

Personhood, Spirithood, and Stem Cell Research in Japan

Broader Implications of Spirithood and Personhood for International Bioethics

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If iPSC research continues in its current trajectory, it theoretically could eliminate the need for embryos in research entirely, making the personhood status of the embryo largely irrelevant.

Because of this, iPS cells are widely regarded to be the “ethical solution” to hESR, as their use is generally accepted as noncontroversial. This raises the question, however, that if hESC are valued and attributed with spirithood precisely because they have the potential to create humans, why are iPSC not similarly attributed with spirithood, given that they are functionally analogous to hESC and thus likewise have the potential to develop into an organism in utero? While it is possible to speculate about the vague understanding of iPSC in the public or the distinction between natural pluripotency versus human-made pluripotency as being reasons for excluding iPS cells from spirithood status, the point taken from this observation is a further division between spirithood and personhood. The boundaries of personhood can be quickly and clearly defined in legal discourse with statements such as “organisms that cannot exist outside of the mother’s body are not persons.” The cultural negotiation of spirithood, however, is slower to adapt to new situations and defies such simple definitions as “everything with the potential for human life has spirithood.”

While laws often change with rapidity unmatched by societal norms, there is necessarily an interchange between laws and norms, as laws have the power to shape societal norms but laws that diverge too dramatically from norms risk non-adherence.

This is seen clearly in the case of abortion criminalization, where illegal and potentially dangerous abortions occur when bans of the procedure conflict with continued need for family planning and dearth of contraceptive availability or knowledge. In the case of hESR, reproductive material donation and enrollment in clinical studies would suffer if the research were deemed unacceptable by cultural values. Thus, to be effective, laws must appeal to societal values on some level, and in the case of Japan’s abortion and hESR policies, this was done continuously through the utilitarian argument, invoking the Japanese cultural valuation of states and families over individual interests. By maintaining this argument, formulated through borrowed Western notions of eugenics, Japanese policy makers were able to implement biopolitical campaigns to control population size throughout the various abortion laws without interfering with the societal acceptance of the fetus’s spirithood.

The state-based utilitarian argument still held throughout the development of hESR laws and regulations, but stem cell research is an unavoidably international field, with new findings, cell lines, and scientists such as Yamanaka himself routinely crossing country borders for the advancement of the science. This necessitates the addition of international values into the balance of interests needed to create ethical and implementable laws. Japanese policy makers made a commendable nod towards this balance by formally addressing the embryo’s spirithood (which was never legally addressed in the case of the fetus) using the international bio-

ethical terminology of “human dignity” (MEXT 2001 ; Andorno 2002). However, while commendable in formulation, the strict regulations stifled the advance of research. Thus it is fortunate that the resounding success of Shinya Yamanaka provided a catalyst for national reflection and realization of the stark discrepancy between expected and actual achievements, precipitating change in the regulations. By reformulating and streamlining the regulations, it was possible to retain the basis for respectful treatment of the cells yet also increase their effectiveness in moving research forward, thus making the stem cell work more ethical and more true to the donors’ desires that the cells “have a purpose.”

Periodic reanalysis of research in the larger context of its societal implications and success is highly beneficial; however, catalysts for change as strong as that of the acclaim of Yamanaka’s work are unique, and many countries with research limited by strict or ambiguous regulations lack a similar pause for reflection.

Thus, in fields pioneering new bioethical standards, it would be valuable to set regular markers for reassessment to keep policy aligned with ethical considerations and research goals. Beyond that, there is a need for the continued development of global bioethical standards to prevent the competitive pressure of emerging fields from resulting in laws misaligned with ethical or cultural values in the interest of “getting ahead” in research, and to ensure that collaborative research and shared resources comply to the ethical requirements of each of the parties involved. The nod towards “human dignity” in the Japanese guidelines works towards this goal, but the confusion in regulating “respect” further illustrates the need for standardized and actionable regulatory recommendations. Creating an international bioethical framework on the globally acknowledged concept of “human dignity” and the Kantian directive to treat people as ends and not means is a good foundation, but the framework needs to allow for the status of “human,” as seen through assignations of the status of personhood and spirithood, to vary with legal and cultural differences around the world (Andorno 2002). Thus, constructing multiple frameworks could be beneficial, to create standards both for the treatment of non-contested persons as well as for beings with contested personhood status or acknowledged spirithood but not personhood. If each country developed their own specific and culturally appropriate laws in accordance with these international baselines, it would ensure that an ethical minimum, respectful to the varying conceptions of these beings, is met, thus facilitating future collaborations and global exchange.

Even beyond the scope of fetuses and embryos, the need to redefine boundaries of liminal personhood and spirithood will always remain relevant, as technological advances continue to raise situations in which legal and ethical standards must be developed to fit new contexts. The study of abortion and hESR in Japan is informative in demonstrating the distinction between spirithood and personhood, their assignations based on historical precedent, and their ethical implications. Investigating the role of cultural values in shaping bioethical debates will be particularly beneficial in the consideration of global bioethical guidelines, which necessitate the convergence of sometimes conflicting cultural values into an ethical framework that can be universally applied.

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Personhood, Spirithood, and Stem Cell Research in Japan References

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Andorno, Roberto. “Biomedicine and international human rights law: in search of a global consensus.” Bull World Health Org. 80(2002): 959963.

Campbell, Angela. “Ethos and economics: Examining the rationale underlying stem cell and cloning research policies in the U.S., Germany, and Japan.” American Journal of Law and Medicine 31(2005): 47-86.

Cyranoski, David. “Japan’s embryo experts beg for faster ethical reviews.”

Nature, November 17, 2005, 263. http://www.nature.com/nature/journal/v438/n7066/full/438263a.html.

Cyranoski, David. “Japan relaxes stem-cell rules.” Nature, August 21, 2009, 1068. http://www.nature.com/news/2009/090826/full/4601068a.html.

Cyranoski, David. “Stem cell fraud hits febrile field.” Nature, November 12, 2012, 321. http://www.nature.com/news/stem-cell-fraud-hits-febrilefield-1.11598.

Castelvecci, Davide. “Japan to start stem-cell study on humans.” Nature News, July 30, 2013. http://blogs.nature.com/news/2013/07/japan-tostart-stem-cell-study-on-humans.html.

Fackler, Martin. “Risk taking is in his genes.” New York Times, December 11, 2007. Accessed November 23, 2012. http://www.nytimes. com/2007/12/11/science/11prof.html.

Hardacre, Helen. Marketing the Menacing Fetus in Japan. Berkeley: University of California Press, 1997.

Jiji. “Bill passed on regenerative meds.” The Japan Times, November 20, 2013. Accessed January 9, 2014. http://www.japantimes.co.jp/news/2013/11/20/national/bills-passed-onregenerative-meds/#.Us5AwWQW3p4.

Kato, Masae. and Sleeboom-Faulkner, Margaret. “Meanings of the embryo in Japan: narratives of IVF experience and embryo ownership.” Sociology of Health and Illness 33(2011): 434-47.

Kawakami, Masahiro, Sipp, Douglas, and Kato, Kazuto. “Regulatory impacts on stem cell research in Japan.” Cell Stem Cell Forum 6(2010): 415-418.

Maternal Health Protection Law (1997). http://www.hsph.harvard.edu/ population/abortion/JAPAN.abo.htm Ministry of Education, Culture, Sports, Science, and Technology (MEXT).

Guidelines for derivation and utilization of human embryonic stem cells.

2001. Accessed December 11, 2012. http://www.lifescience.mext.go.jp/ files/pdf/32_90.pdf Norgren, Tiana. Abortion before Birth Control: The Politics of Reproduction in Postwar Japan. Princeton, NJ: Princeton University Press, 2001.

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Oaks, Laury. “Fetal spirithood and fetal personhood: The cultural construction of abortion in Japan.” Women’s Studies Int. Forum 17(1994): 511-23.

Saegusa, Asako. “Japan okays stem cells.” Nature Biotechnology 18(2000): 246.

Shineha, Ryuma. “Familiarity and prudence of the Japanese Public with research into induced pluripotent stem cells, and their desire for its proper regulation.” Stem Cell Rev and Rep 6(2010): 1-7.

Sleeboom-Faulkner, Margaret. “Contested embryonic culture in JapanPublic discussion, and human embryonic stem cells research in an aging welfare society.” Medical Anthropology: Cross-Cultural Studies in Health and Illness. 29(2010): 44-70.

Sleeboom-Faulkner, Margaret. “Debates on human embryonic stem cell research in Japan: Minority Voices and their political amplifiers.” Science as Culture. 17(2008):85-97.

Takahashi, Kazutoshi, Tanabe, Koji, Ohnuki, Mari, Narita, Megumi, Ichisaka, Tomoko, Tomoda, Kiichiro, and Yamanaka, Shinya. “Induction of pluripotent stem cells from adult human fibroblasts by defined factors.”

Cell 5(2007): 861-72.

Williams, Noel. The Right to Life in Japan. New York: Routledge, 1997.

About the Author Phoebe Oldach studied biochemistry and molecular biology at Dickinson College.

Dr. Sean Bender is the faculty sponsor for this work. He is an Associate Professor of East Asian Studies at Dickinson College.

Article

Levelling the Playing Field: A Case for Widening Access to Ritalin Emily Salt‡ Methylphenidate hydrochloride, better known as Ritalin, is a DEA Schedule II Substance in the United States and a class B registered drug in the United Kingdom, where the penalty for possessing Ritalin without a prescription is a 5-year prison sentence and/or an unlimited fine (Open Government License 2014). Ritalin is prescribed to treat inattentive and impulsive behaviours characteristic of attention deficit hyperactivity disorder (ADHD). The concentration-boosting effect of Ritalin has resulted in an estimated 25% (de Jongh 2008) of students illegally sourcing the drug to enhance their academic performance (hereinafter “academic doping”), a practice that gives an advantage to those willing to break the law. This paper argues in favour of widening access, under the regulation of the National Health Society and similiar bodies, to Ritalin to all individuals and remarketing the drug as a “Concentration Aid” in an attempt to redress this unfairness in order to level the playing field.

Introduction

Diagnosing Attention Deficit Hyperactivity Disorder (ADHD)

‡ University of St. Andrews, emilysalt55@gmail.com

The principle psychoactive compound in Ritalin, methylphenidate hydrochloride, is a stimulant with a pharmacological structure similar to amphetamines. It has been shown to increase the activity of dopamine and noradrenaline, two naturally occurring chemicals in the brain required for controlling attention and regulating inhibitions. Ritalin is available on prescription to ADHD patients to help restore the control and focus that they might otherwise be unable to achieve and can also help narcoleptics stay awake during the day.

Despite the possibility of side effects, which can include addiction, appetite loss and insomnia, physicians write approximately 11 million Ritalin prescriptions each year in the US, 80% of which go to youths between the ages of 5 and 19. It is believed that as of last year, 21% of all American kindergartners have been prescribed the drug at one stage or other (O’Meara n.d.). Prescribing Ritalin has become a standard response to managing difficult children.

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ADHD refers to a collection of symptoms grouped into three main categories of behaviour: inattentiveness: a short attention span, a tendency to make careless mistakes, forgetfulness, and an inability to concentrate; hyperactivity: the inability to sit still particularly in quiet surroundings, fidgeting, and both excessive talking and physical movement; and impulsiveness: impatience, acting without thinking, interrupting conversations, and an impaired recognition of danger (de Jongh 2008).

ADHD is usually diagnosed in children aged between three

Ritalin – Its Purpose and Effects

Penn Bioethics Journal

The purpose of this paper is to draw attention to the fact that academic doping is endemic and that the standards within higher education have irreparably changed. Compulsory urine testing—the only means available for catching “dopers”—is pragmatically unfeasible, and the current legislation has proven incapable of preventing widespread access to performanceenhancing drugs on the black market. As it stands, the enhanced concentration and alertness afforded by Ritalin is only available to those individuals willing to break the rules for self-serving ends, giving them an academic edge over their law-abiding peers. Continuing to deny universal access to Ritalin sustains an already uneven playing field within the academic community.

As such, the most effective way to redress the balance between those who are willing to break the law, and those who are not, is to widen and regulate access to the medication in question.

Provided its use is deemed medically safe in each case, Ritalin should be made available to anyone requiring, or desiring, its use as a concentration-aid.

and seven, most frequently amongst those whose behaviour is disruptive. The reason for this is believed to be that hyperactivity and unruliness are easier to spot, rather than because these symptoms are more common than inattentive or dreamy forms of the disorder. Importantly, “it is not understood whether these problems are an extreme form of normal behaviour, or part of a separate range of behaviour”(National Health Services Choices n.d.). While there is evidence to suggest that ADHD is due to an imbalance of dopamine and noradrenaline in the brain, diagnosis only requires observation of a person’s conduct.

Any individual who bares the hallmarks of the disorder will likely be diagnosed with the disorder, with its severity directly correlating to the severity of their behavioural issues.

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Legalizing Cognitive Enhancement Drugs Legality Under the 1971 UK Misuse of Drugs Act, methylphenidate hydrochloride is considered a class B illegal substance due to its pharmacological similarity to amphetamines. Likewise, in the United States, the drug is a DEA Schedule II Substance under the Controlled Substances Act, and has been given the same classification by the World Health Organization. In the United States, any medication containing the chemical must carry with it the FDA Black Box Warning to indicate the possible risk of “serious, or even life-threatening adverse effects” (Drug Enforcement Administration 2012). The justification for this is that “it can be abused, or lead to dependence” (“Ritalin Side Effects” 2013).

Illegal possession of Ritalin in the UK can result in up to five years imprisonment, and/or an unlimited fine. Dealing the drug risks sentencing of up to 14 years.

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Performance Enhancement and Cheating

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Unlike other forms of psychoactive medication (e.g. antidepressants, anaesthesia, antipsychotics, etc.), Ritalin has stimulating effects on mental focus that are equally as significant when used by “healthy individuals” as when taken by those with underactive levels of dopamine and noradrenaline (Glannon 2006). Any individual who takes Ritalin will find himelf or herself more awake and more alert, and less prone to distraction and procrastination than they otherwise would be without the drug.

It is widely accepted that impaired concentration increases the risk of preventable mistakes and directly interferes with the ability to absorb information. Within any high-pressure environment, an individual’s ability to concentrate on tasks without distraction can be the difference between success and failure.

As a result, Ritalin is fast gaining popularity amongst students of all ages, replacing caffeine as the go-to chemical “study aid.” Using a chemical stimulant lets individuals focus on working when their concentration and willpower may otherwise falter, such as at times of increased stress, anxiety, or tiredness. Moreover, in the age of the Internet and the distractions of social media, Ritalin allows students to combat procrastination in a way that coffee never could. As a result, whether motivated by the need to focus in the exam hall or the desire to revise late into the night, thousands of students across the UK and America are resorting to buying, or otherwise illegally obtaining, Ritalin as a means to enhance performance.

The huge increase in ADHD diagnoses and the subsequent rise in demand for medication over the past two decades have opened the door to a new form of black market enterprise.

Naturally, parallels have been drawn between academic “doping” and the use of performance enhancing drugs in sport.

Amongst athletes, anabolic steroids offer a means to quickly and effectively increase stamina and muscle mass. Without prescription, they are a Class C illegal substance in the UK. Importantly, the majority of sporting organisations have banned the use of performance enhancing drugs by their participants; any sportsman or woman caught using steroids for the purpose

of improving their athletic abilities risks disqualification and a temporary, if not a lifetime, ban from professional sport. This is because doping constitutes cheating. Any athlete who abuses steroids, or any such drug, gains an unfair advantage over clean competitors—it creates an uneven playing field. Dopers successful in their field will be mistakenly accredited, and the competition itself loses meaning.

For this reason, the potential ethical implications of using Ritalin as a study aid go beyond those attached to standard substance abuse. Where there is a clear argument to support the notion that the use of some illegal drugs, notably cannabis and ecstasy, are “victimless crimes,” there is no doubt that enhancing performance through drugs within a competitive environment has a direct, detrimental impact on everyone else involved.

Whether it is appropriate to condemn this behaviour as “cheating,” however, depends on the concept of cheating itself. As argued by Vince Cakic, a Professor in Psychology at the University of Sydney, “Widespread biological and environmental inequalities…already exist” (2009).

Inequality is an empirical fact that can, but need not, have a normative dimension and is therefore not synonymous with cheating. Cheating depends on more than just an individual having an advantage that competitors do not, or even could not have; if it were, then Usain Bolt’s legs, or Stephen Hawking’s brain would themselves constitute tools for cheating.

One may argue the contrary; that mere inequality can constitute cheating under certain circumstances. The controversy surrounding Caster Semenya, the masculine-framed women’s 800-meter World Champion, serves as a poignant example of this. As reported by the BBC, “the IAAF…questions whether she may have a rare medical condition which gives her an unfair advantage,” prompting the IAAF to withhold her medal until gender tests had been carried out (“SA fury over athlete gender test” 2009).

From this, it could be concluded that Caster’s naturally manly physique gives her an unattainable advantage over her female peers and thus ought to be treated as a form of cheating.

However, it is crucial to recognise that “cheating” depends upon context: i.e. the rules of the competition. It was not her frame or unbeatable speed that prompted the IAAF to test Caster’s gender—it was the race she was running in. The integrity of the competition relies upon the exclusivity of its participants, in this case, all-women, and Caster’s physical build led IAAF officials to question her eligibility against this criterion. The fairness of her participation would not have been called into question had the race been open to other sexes.

Moreover, neither does cheating entail that the advantages had by one competitor over another are artificial, or “unnatural.”

Using technologically enhanced equipment and developing game tactics exemplify means used for securing a lead over one’s rivals that are considered legitimate by the relevant authorities.

Naturally, this raises questions about access to resources.

Many will intuit that any test of human ability won by technology, particularly the sorts of technology that are unavailable to the other competitors, should count as cheating.

However, it is important to recognise the distinction between actual cheating and “unsporting behaviour,” the latter of which

Legalizing Cognitive Enhancement Drugs

Importantly, this principle cannot be universalised to all performance enhancing drugs. Consider again the comparisons drawn between anabolic steroid usage in sport and Ritalin doping in academia, and it becomes clear that the alleged parallels are misleading. First, steroid use has a direct impact on an athlete’s results in a way that academic doping does not. A maths student using Ritalin will not become better at maths in a way that a weightlifter on steroids will become better at lifting weights. Ritalin does not make its users smarter, or increase

“Widening access to Ritalin will disadvantage those who cannot, or will not take it.”

Though when used properly, “Ritalin is…safer than Aspirin” there are some to whom methylphenidate hydrochloride is dangerous and should be denied (Hallowell 2012). This includes people with a history of mental illness or substance abuse, high blood pressure and heart problems. There are also a significant number of individuals who will refuse the drug on principle. Arguably, legitimising Ritalin as a study aid will actively disadvantage these groups, which is reason enough not to widen access.

Albeit regrettable, there are three reasons why exclusion alone should not influence the decision to widen access to Ritalin. First, to repeat, methylphenidate hydrochloride does not have the capacity to alter an individual’s intellectual or academic abilities. Some critics speak of remarketing of Ritalin as a “cognitive cosmetic” as if it marks the beginning of a Huxleyan dystopia, when in reality the drug serves merely to help improve productivity and clarity in its users. Second, to reiterate the sentiment of Dr. Cakic, the potential for inequality should not in itself be sufficient to halt the rest of society from progression. There are many activities and opportunities that are denied to people with relevant debilitating medical conditions.

More importantly, it is not as if the benefits gained from Ritalin cannot otherwise be achieved by hard work and effort, at least amongst members of the non-ADHD community. While it is unfortunate that some people will be medically prohibited from using the drug, this alone does not constitute a sufficient enough reason to prevent the state from widening access to everyone else. Third, to reiterate, the disadvantage is already being felt.

Regardless of its legal status, there will be those that can and will take advantage, and those who can, or will not. However, this author concedes that the disadvantage will become more marked as the number of Academic dopers rises.

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“If we permit academic doping, sport doping will follow.”

mental agility beyond the scope of an individual’s natural ability.

Instead, Ritalin allows its users to work at peak efficiency, like using premium petrol over regular.

Second, the most obvious fear related to the promotion of performance enhancing drugs concerns the risks to health.

Unlike steroids, which are prescribed in short courses to help treat specific conditions, any doctor that prescribes Ritalin does so with the knowledge that their patient may be required to take their medication daily for an unspecified length of time.

The health risks associated with continued Ritalin usage have been deemed insignificant enough by the relevant medical authorities to warrant long-term prescriptions in their millions.

The potential damage to health is incomparable between the two; each drug must be dealt with on its own terms.

As a result of the combination of these reasons, the ban on anabolic steroid use can never be lifted from the world of sport.

Any move to legitimise drugs of this type would inevitably lead to their dangerous misuse for the sake of beating the competition.

The widening of access to, and regulation of, Ritalin to improve academic performance does not suffer the same risks.

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may apply both with and without cheating having occurred.

Unsporting behaviour reflects the intuitive, subjective sense of unfairness that often accompanies the attitudes of “local football” fans to international transfers. For the purposes of this paper, one prerequisite of cheating is that a rule must be broken.

Therefore, in order for something to be a method of cheating, 1) it must violate one or more rules of the competition for the purpose of gaining an advantage and 2) the agent must be aware of this fact. This is to prevent ignorance from counting as cheating.

As it currently stands, any individual who knowingly uses non-prescribed Ritalin to improve or enhance their academic performance is, by this definition, a cheat. Illegal academic doping is endemic and must be stopped, not only to level the playing field, but also to bring the black market, which has rapidly grown to accommodate demand, to an end. However, catching and punishing the guilty parties is pragmatically unfeasible. Unlike in professional sport where urine tests can identify the presence of steroids in an athlete’s system two weeks after ingestion, and up to one month if the drugs were injected, Ritalin becomes undetectable after 48 hours (“How Long Will A Drug Stay In My System?” 2014). The administrative task would be astronomical, extortionate, and, more likely than not, ineffective. Moreover, due to the huge numbers of students whose access to Ritalin is prescribed and perfectly legal, private dealing is equally as difficult to trace. Finally, outlawing nonprescribed possession of the drug has proven to be an inadequate deterrent and continually fails to solve what is rapidly becoming a significant problem facing the UK education system.

A better solution can be found in the above definition of cheating. An act counts as cheating if and only if it violates one or more rules and is known to do so. Remove that relevant rule/s, and it becomes legitimate. The use of Ritalin as a study aid is currently illegal. However, by providing universal access to Ritalin, everyone will have the opportunity to reap the performance-optimising benefits already being taken advantage of by cheats. It should also halt the growth of opportunistic drug dealing that occurs on campuses and over the Internet.

But “universal access” does not equate to “over-the-counter.”

The recommendation in this paper is that Ritalin be made more readily available for prescription to non-ADHD/narcolepsy sufferers through the NHS, or other similar medical bodies internationally. The decision to prescribe must be at the doctor’s discretion, with regular follow-up appointments and reiterated medical guidance on usage.

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Legalizing Cognitive Enhancement Drugs

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The NHS should not pay for Ritalin

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During times of economic hardship, it might seem extravagant to demand of an already squeezed public health service that it freely provides medication rightly considered “surplus to requirement.” As it stands, a year’s prescription of Ritalin to an ADHD child—30 grams per day—costs the NHS £200, or approximately $335 (“NHS Go Ahead For HyperActivity Drug” 2000). However, it is crucial to acknowledge that the type of prescription being recommended in this paper is of a different variety. A course prescribed for the purpose of performance optimisation would be limited in much the same way that painkillers are, i.e. to be taken as needed, not in daily doses. By restricting the quantity in this manner, the additional cost to the NHS would be a fraction of what it might initially appear.

An associated consideration is the cost saved by reducing the potential for drug-related injury and illness. Currently, the Ritalin market is entirely unregulated, orchestrated in the most part by both ethically and legally dubious traders. Individuals attempting to illegally source Ritalin have no guarantee that the tablets they are buying meet the required standards or that they contain methylphenidate hydrochloride at all. Even those fortunate enough to acquire legitimate tablets will inevitably do so without receiving the information necessary for safe usage.

Widening access will not only provide a guaranteed route to the medication for those who want it but will also allow the health services to regulate consumption and ensure that the appropriate measures are taken to assure safe usage.

Moreover, as previously suggested the numbers of Ritalin prescriptions themselves are increasingly high and based upon subjective interpretations of behaviour. Symptoms need only be faked, or merely misinterpreted, for the drug to be legally obtained. Let us concede that, potentially, there are hundreds of individuals using Ritalin without what is currently perceived to be “the medical necessity for it.” The resulting disparity between those receiving the benefits and those who are not is both unjust and unnecessary. However, if the conditions under which Ritalin can be prescribed are extended to include the aiding of concentration for any and all individuals, the disparity will fade away. Much as beta-blockers, initially designed to help lower blood pressure, were re-marketed as anti-anxiety medication upon the discovery of their calming effects, the rebranding of Ritalin as a concentration-booster could have an equally positive effect on individuals and society alike.

The problem can, and thus should, be dealt with by other means The symptoms of ADHD are such that effectively safeguarding against misplaced diagnoses is incredibly difficult.

Pseudo-ADHD is a term given to children whose disruptive/ inattentive behaviour is the result of environmental factors, such as familial instability, lack of discipline and/or the desire for attention. In spite of their “health,” Ritalin is regularly prescribed in these cases, either as the result of a genuine misdiagnosis or as a means to help parents control their child’s problem-behaviour. It should also be noted that Ritalin can,

and regularly is, misused by genuine ADHD sufferers. An individual’s choosing to double their daily allowance will generate the same benefits desired by their healthy peers.

It is naïve to assume that the problem of academic doping would disappear even if access to Ritalin could be limited to those whom it is legally prescribed. The only option available to the state for efficiently managing these problems is to universalise and regulate access.

One might balk at the prospect of kowtowing to these “cheats” and legitimising their behaviour for the sake of proactivity alone. Yet as already elucidated, the behaviour itself is only socially problematic while it continues to be a divisive force; the ethical implications supervene upon the pragmatic.

Moreover, even if the problem could be dealt with by other means, there are additional reasons to support the widening of access to Ritalin. Provided its use is determined to be medically safe, the benefits afforded by the drug to both the individual and to society are innumerable. Beyond the walls of competitive academia, where cheating remains a contentious issue, it is in everyone’s interest that employers and employees alike work at peak efficiency. Ritalin is not just a drug; it is an opportunity for nationwide advancement.

About the Author Emily Salt studies philosophy at the University of St. Andrews.

Cakic, Vince. “Ethics: Smart Drugs for Cognitive Enhancement:Ethical References and Practical Considerations in the Era of Cosmetic Neurology.”

Journal of Medical Ethics 35(2009): 738.

Drug Enforcement Administration. Title 21 United States Code: Schedules of Controlled Substances. 2012.

Glannon, W. “Psychopharmacology and Memory.” Journal of Medical Ethics 2006;32:74-78 Hallowell, Edward. “Ritalin Redux.” Attitude Magazine, February 1, 2012.

Accessed 2013. http://www.additudemag.com/adhdblogs/11/9378. html.

“How Long Will A Drug Stay In My System?” Talk to Frank, January 27, 2014. Accessed 2013. http://www.talktofrank.com/faq/how-long-willdrug-stay-my-system. de Jongh, Reinoud. “Botox For the Brain: Enhancement of Cognition, Mood and Social Behaviour, and Blunting Unwanted Memories.”

NeuroScience Behaviour Review 32(2008): 760-776.

National Health Services Choices. Side Effects of Methylphenidate Hydrochloride. Datapharm. http://www.nhs.uk/medicine-guides/pages/ MedicineSideEffects.aspx?condition=Behavioural%20Problems&medi cine=Methylphenidate%20hydrochloride.

“NHS Go Ahead For Hyper-Activity Drug.” British Broadcasting Corporation, October 31, 2000. Accessed 2013. http://news.bbc.co.uk/1/hi/ health/998711.stm.

O’Meara, Kelly Patricia. “Ritalin Proven More Potent Than Cocaine Nearly Ten Million Kids Drugged.” Insight Magazine, June 28, n.d.

Accessed 2013. http://www.rense.com/general13/kidsf.htm.

Open Government License. 2014.The Home Office Misuse of Drugs Act 1971. The National Archives. Last modified April 29, 2014. http:// www.homeoffice.gov.uk/drugs/drug-law/ .

“Ritalin Side Effects.” Drug Inquirer, November 6, 2013. Accessed 2013. http://www.ritalinsideeffects.net.

“SA fury over athlete gender test.” British Broadcasting Corporation, August 20, 2009. Accessed 2013. http://news.bbc.co.uk/2/hi/africa/8211319.stm.

Article

Examining Stigmatization of Smoking and Obesity: An Ethical Framework to Guide Public Health Decision-Making Margaret E. Weiss‡ Public health is fraught with the concept of stigma. The attempt by public health officials to mitigate diseases is often responsible for creating stigmatization as a byproduct such as in the cases of HIV/AIDS and tuberculosis, where stigmatization harms already vulnerable populations. Today, smoking and obesity represent two major public health goals that also happen to harbor stigmatization as a tool to change social norms and encourage people to engage in healthier behavior. Even though stigmatization can potentially be a useful tool to promote change, its justification must be examined through a defined framework to ensure that it is being used ethically. This work demonstrates that stigmatization against the practitioners of unhealthy behaviors is not ethically permissible insofar it marginalizes those people, often leading to poorer health outcomes.

Introduction

After analysis of a variety of philosophical literature and ethical terms, the following six dimensions were chosen for their ability to illustrate different aspects of control affected through stigmatization: beneficence, nonmaleficence, autonomy, distributive justice, collective action, and privacy.

Beneficence can be defined as “all forms of action intended to benefit or promote the good of others” (Beauchamp 2013).

Government and public health officials often use beneficence as a major argument to justify stigmatization. For instance, North Carolina was one of the first states to institute a program that made not wearing a seat belt a primary offense. While this action was unheard of and appeared to be drastic, it was justified by

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‡ University of Virginia, m.weiss91@gmail.com

Dimensions of a “Stigma Case”

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The term “stigma” originated from the Greeks to describe physical signs that exposed something negative and different about an individual. Today, however, “stigma” describes “the situation in which the individual is disqualified from full social acceptance” (Goffman 1963, 4). David Wasserman, Director of Research at the Center for Ethics at Yeshiva University, and Adrienne Asch, an internationally known bioethicist, describe stigma as “imputations of difference and inferiority,” which then leads to individuals being treated differently, such as by receiving sub par accommodations, being overlooked in employment opportunities, and even losing relationships (Wasserman , et al. 2013).

Stigma exists simply because people both are different from each other and impose on each other their own values. This concern for stigma, which can be seen in a wide variety of places, is especially prevalent in the realm of public health because of the outcomes associated with it. Many hail stigmatization as a useful strategy to encourage better health behaviors. However, this behavioral change can also be counterproductive or even dangerous. For these reasons, public health officials must pay particular attention to the role of stigma and mitigate its use.

To understand how stigmatization is seen in society and specifically public health, one must first understand more fully how stigmatization manifests itself. Stigmatization can be characterized by actions being done to the stigmatized individual rather than something an individual chooses of their own accord. It is precisely this inability to choose, and therefore the lack of control, that needs to be assessed in situations of stigmatization.

However, one cannot necessarily disregard the benefits of stigmatization within the public health realm as an extension of instilling a certain code for the healthy. Stigmatization attempts

to discourage these unhealthy behaviors by labeling them as negative within a larger value system and linking them to an individual’s personal character. Despite the goodness of the goal of stigma in these cases, this goal is not always adequately met.

This work provides a unique framework that can be used to analyze different cases of stigma. Each dimension will be examined in order to illustrate its relevancy to issues of public health issue and the logic by which it can be utilized. Once the framework is proposed, it will be applied to two specific cases in public health: smoking and obesity. While there exist is much literature about ethical problems with using stigma for public health measures, its fundamental decision-making process for the application of stigma has yet to be illustrated.

The dimensions of a stigma case also act as a tool to point out shortcomings of the current public health measures. If, as is the case with both smoking and obesity, stigmatization is deemed impermissible, the framework helps illustrate where future public health efforts should strive to improve in order to promote the healthy behavior that is desired.

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assessing the benefits for the individual. The implementation of this program led to increased seatbelt use from 64% to 81% over 10 months (Williams 1996, 36-8).

The second aspect of the framework is nonmaleficence, a concept that can be embodied in the phrase “first, do no harm.” Specifically, within public health, nonmaleficence is violated when harms to an individual are overlooked in favor of accomplishing the overarching goal (Beauchamp 2013).

In the 1980s, at a time when homosexuals appeared to be the first reported cases of AIDS, public health officials enacted anti-sodomy laws, thinking that by criminalizing same-sex relations, AIDS, this “gay plague,” would dissipate. Later, once “innocent” individuals were infected, such as children and blood-transfusion patients, it became obvious that the disease was not caused by homosexuality. At the same time, it became apparent that the stigma surrounding the disease was actively fuelling its spread because patients were reluctant to be tested and diagnosed (Bayer and Stuber 2006, 48). In the desire to do good and decrease the prevalence of AIDS, public health officials harmed entire groups of people.

The third dimension of a stigma case is autonomy, which “concerns the independence and authenticity of the desires (values, emotions, etc.) that move one to act in the first place” (Christman 2011). The principle of autonomy particularly recognizes an individual’s agency to self-determination. This dimension within a stigma case illustrates whether or not society is able to respect an individual’s ability to make informed decisions about personal matters. First, public health officials must ensure that stigma does not impede an individual’s choice—whether healthy or unhealthy, competent individuals should be allowed the agency to choose for themselves. The second aspect of autonomy, however, is generally more relevant in cases of stigma. Public health officials must ensure that one actually has the autonomy to choose to alter or not alter his or her unhealthy behavior. Stigmatizing the lack of seatbelt use is an example that preserves autonomy since each individual retained the ability to choose to change his behavior with complete information on the consequences – a primary driving offense.

The fourth component of a stigma case is distributive justicewhich refers to the economic principles of fairness within a given society as seen in its laws, policies, and institutions (Favor and Lamont 2013). This paper refers to a quasiegalitarian principle where resources and information, as agents of change, should be shared equally among all individuals of a society. For instance, in Richmond, Virginia, when tuberculosis (TB) began to spread, African Americans accounted for 57% of the deaths caused by TB, a number disproportionate to the percent composition of the city population (Pomeranz 2008, 94). However, rather than investing in the actual treatment of tuberculosis, the mayor of city issued “a warning against the indiscriminate employment of negroes in our household.” This denouncement drastically marginalized African Americans in the name of public health to decrease the chances of catching tuberculosis. As a stigmatized group, African Americans, did not have access to resources, such as money or health information

to address their condition, but were instead separated as a prevention method. Stigmatization of TB ultimately caused African Americans to receive worse medical attention, which led to further spread of the disease rather than appropriate treatment.

The fifth component of a stigma case is privacy. Privacy plays a crucial role in stigmatization cases because mechanisms in which an external entity peers into the private life of the marginalized individual to build judgment and criticism. One can think of privacy as four main interests within the concept: intrusion upon an individual’s private affairs, disclosure of private facts about an individual, placing someone in a false light publicly, and taking an individual’s likeness for the advantage of another (Prosser 1960, 389). Whether physically obvious to one’s eye or requiring of disclosure, the way public health measures have tried stigmatize individuals can often times jeopardize an individual’s privacy. During the AIDS crisis, anti-sodomy laws were enacted as a prevention scheme, where landlords and employers would demand disclosure of homosexuality, impeding homosexual individuals from being employed or finding housing. It was clear that their privacy had been violated, as affected individuals were no longer free to live according to their own desires.

The final dimension of a stigma case is collective action.

Collective action refers to the state of requiring coordinated action and near-universal participation” in order to achieve a public good, which in this case is health (Faden and Shebaya 2010). In Oklahoma, anti-littering campaigns strove to appeal to the individual conscience and community identity to create feelings of shame in those that littered (Grasmick 1991). Littering is a case in which one individual’s actions have repercussions outside one’s own sphere; in other words, everyone needs to cease littering for a campaign to be affective, demonstrating emphasis of collective action in this example.

Using the Framework Therefore, as one can see, there can be cases where one can analyze the issue within this framework and come to a decision that affirms the usage of stigma. On the other hand, one can definitely see when stigma violates this framework and should not be used, even for the benefit for public health. However, when rigorously applying the framework to the case of stigma, one needs to first assess every consideration in the framework to be aware of all the relevant ethical considerations. Next, one needs to evaluate the considerations that have the most weight and most extreme violations. These issues need to be weighed against the benefits and contextualized with the probability of achieving those benefits in order to determine whether stigma may actually be used as a public health measure.

This paper has evaluated stigma and its ethical considerations with regards to smoking and obesity. It has then focused on the critical components and determined how to most effectively address those ethical violations. It can be seen that in both cases, that the most severe violations are of the individual’s autonomy and of distributive justice. Solutions to these two considerations

Stigma in Public Health Decision-Making are then given to illustrate changes that must be made before stigma could potentially be used ethically.

Stigma as a Current Method of Public Health Smoking and obesity are two current prominent public health concerns in which stigma has been implemented as a tool to change behavior. However, when evaluated under the dimensions of a stigma case, the use of stigma no longer seems an appropriate method of public health.

Smoking

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According to the Center for Disease Control (CDC) cigarette smoking is currently the leading cause of preventable death in the United States (2014). When smoking was first linked to poor health and secondhand smoke to poor health in non-smokers, public health officials differentiated the two by deeming non-smokers “normal” and smokers “deviants.”

Laws defining smoking and non-smoking areas have furthered the separation between the two groups, restricting smoking in outdoor areas, and even prescribing a certain distance of entrances and windows of buildings where smoking is not permissible (Bayer and Stuber 2006, 48). The American Non-Smokers’ Foundation reports that 23 states have laws that completely ban smoking in non-hospitality workplaces, restaurants, and bars. These laws enforce a physical separation between these two groups of people, which signal smokers as not fit to be around non-smokers when engaging in their illicit behavior. Public health officials readily admit this as an act of stigmatization, yet do not find it problematic due to the direct medical consequences of second-hand smoke to bystanders (47). The stigmatization employed in the case of smoking needs to be examined under the dimensions of a stigma case to examine whether or not its use is permissible.

The idea of secondhand smoke calls into question the dimension of collective action. “Secondhand smoke” is the concept that cigarette smoke in a shared space corresponds with increases in rates of heart disease and cancer even in those who do not smoke themselves. As this theory emerged, smokers were blamed for deaths of innocents even before there was scientific evidence to back the charge (48). Therefore, when stigmatization of smoking was first employed, there was no basis for a collective action argument. As scientific evidence has continued to emerge, however, it has become clear that there is merit to the problems associated with secondhand smoking. The CDC reports that secondhand smoke can lead to respiratory issues, cardiovascular problems, and even lung cancer in non-smokers (U.S. Centers for Disease Control and Prevention 2014). This evidence illustrates how one individual’s unhealthy behavior can negatively impact people surrounding them, upholding the dimension of collective action.

Over time, the act of smoking became associated with a key aspect of an individual’s identity affecting the way smokers were perceived by their general environment, which ultimately led to strong privacy violations. The perspective that smoking was so

essential to an individual’s identity grew and many companies began to refuse to hire an individual, or even go as far as to fire an employee, if they were a smoker, claiming that the act did not fit with the image of their company and may pay pose additional health costs (Bayer and Stuber 2006, 47). At one point, an insurance company in Michigan implemented a ban on smoking that prohibited employees from smoking both during and outside of work hours. Workers were subjected to random testing and warned that if they failed, they would be fired (Peters 2005). Therefore, companies required individuals to divulge information about himself and his actions against their will and sometimes to an extreme level, violating their privacy.

When examined under the dimension of nonmaleficence, it is clear that this stigmatization resulted in harming the targeted individuals. One example of direct and immediate harm is the tendency of doctors to overemphasize smoking as the predominant cause of medical problems, belittling other problems a patient may have and attributing all symptoms to the one act. While often times, smoking did yield medical calamities; doctors indirectly harmed patients by giving inadequate medical attention for smokers. In a qualitative study from the United Kingdom, individuals, both smokers and nonsmokers, with lung cancer were interviewed regarding their experience. The smokers cited a lack of access to medical care as the most detrimental consequence of their disease, stating that smoking prevented doctors from taking symptoms seriously, leading to issues progressing unchecked (Chapple 2004).

While smoking has increasingly been viewed as an unhealthy behavior, there is little correlation between the stigma individuals felt and smokers breaking the habit, demonstrating the dearth in evidence of beneficence from using stigma in this public health issue. The stigma of being a smoker did cause some individuals to quit, but the majority of smokers continued on with their habit despite understanding the negative health consequences and experiencing the negative public opinion brought on by stigmatization. In a Canadian study, twentyfive smokers were interviewed regarding their experience handling and responding to stigma. Only three of the twentyfive individuals indicated that stigma had caused them to cease smoking. The other twenty-two felt that stigmatization led them to feel more shame at their behavior and the need to hide their habit (Bell 2010, 922-6). Stigma is not improving the lives of smokers, which, in most cases, would be demonstrated by helping them quit and leading a healthier life. Therefore, since most continue to smoke, the beneficence cannot be upheld.

The fact that stigma does not work to only decrease smoking habits, points to the need to consider distributive justice and autonomy. One answer to this is that smoking is addictive because of its nicotine content, raising the consideration of autonomy. Second, smokers may not have the structural resources to eliminate their habit. Information about and access to smoking cessation programs is limited. Without the means to deal with their addiction, it is clear that the dimension of distributive justice has also been violated. Stigmatization in the realm of smoking failed five of the six dimensions of a stigma case. Therefore public health officials must reevaluate their

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Stigma in Public Health Decision-Making methods.

Rather than trying to stigmatize smoking, public health officials can utilize the results of this ethical framework to develop a program that addresses the problems while maintaining the benefits that come with stigmatizing an unhealthy behavior. A better program can address the distributive justice and access concerns by ensuring that students within the program are knowledgeable but recognizing that help is available if students do start smoking. While this information within the program is important, public health officials should be spreading their reach such that all people are given similar access regardless of background. Therefore, using resources such as the United Nations and World Health Organization provides a useful first step to developing a system for all, not just privileged people – an important element to maintaining the collective action benefits of stigma.

Additionally, studies have found that smoking in adolescents is associated with depression and other mood disorders. Rather than using stigma to attempt to dissuade individuals from smoking, officials can address the autonomy consideration by encouraging physical activity in schools and improving understanding and treatment of mental health conditions. Therefore, rather than placing the blame on smokers, officials can reinforce the autonomy of individuals by helping them realize why they began smoking in the first place, giving them the informed ability to fight the addiction. And finally, by destigmatizing this behavior, public health officials can foster a society that is accepting and nurturing of these individuals, developing a culture that does not try to investigate and violate the privacy of individuals, but instead tries to help them. In doing so, public health officials can tackle ethical problems of stigma while helping reduce unhealthy behaviors.

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Obesity

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Obesity has been a growing problem in the United States, with adult obesity growing to 35.7% and childhood obesity to 17% over the past twenty years. Obesity is related to many other conditions such as heart disease, stroke, type 2 diabetes, and certain cancers (U.S. Centers for Disease Control and Prevention 2014). Because of the serious health repercussions, public health officials have tried to find ways to combat the problem, one of which is through stigmatizing obesity. If public health officials hope to use stigmatization, however, it must be thoroughly examined under an ethical framework.

The first dimension of a stigma case that must be examined is that of autonomy. As is the case with smoking, many people incorrectly view obesity as a condition brought on solely by individual choice (Puhl and Heuer 2010, 1019). Because of this choice component, these individuals are held responsible for their conditions, connecting their identity to their appearance, thus increasing stigma against those people. What is ignored is that these individuals have largely lost their autonomy to change this condition. Studies have shown similarities between over-eating and drug abuse. Various brain pathways involved in drug addiction have been mapped and connected to reward,

motivation, and memory pathways—the same ones stimulated in overeating (Volkow 2008).

Obesity is unique in that one an individual cannot readily hide their obesity to the public eye. In the modern culture that focuses on physique, the culture and society together infringes upon the rights an individual has to leading their life free from external judgment. This attitude has drastically jeopardized the privacy of these individuals, posing as serious problems when searching for jobs, buying a housing and other everyday matters. In 2008, Mississippi went as far as to propose a law that would prohibit restaurants from serving obese individuals (Puhl and Heuer 2010, 1024). Similarly, a Texas hospital required potential employees to divulge their body mass indexes and would not hire anyone with a BMI over 35, in order to uphold the image of a healthcare professional (Miller 2012).

Finally, studies have shown that collectively, obese workers pay a penalty in their wages due to predicted, but not established, health care costs the employer predicts they will need to bear (Baum and Ford 2004).

The third dimension to be addressed is that of collective action. As the prevalence of obesity has grown, the media, alongside public health efforts, has labeled obesity as an “epidemic.” One study examined individuals over the course of 32 years, and investigated clusters of obesity and correlations between social contacts and the strength of each of these social ties. Researchers found that obesity could be tracked according to social networks and that there were higher correlations in weight gain between friends than between family members, indicating that collective action may play a role (Christakis and Fowler 2007). If public health efforts can induce changes in a group of people, those results will spread more quickly due to social influence, meaning that one individual’s behavior has implications beyond his or her own health. If an individual is in an environment where healthy eating and exercise are emphasized and valued, they are more likely to begin to engage in healthier behavior and potentially lose weight. However, the results of stigmatization do not indicate similar benefits of helping groups adequately reduce weight.

This result can be seen more clearly when considering the considerations of beneficence and nonmaleficience. A study was done on women engaged in an obesity support group to assess their response to perceived stigmatization regarding their weight. When asked about the affect stigma has on their eating patterns, 79% of overweight and obese reported that their response to perceived stigma is to eat more, and 75% also indicated that they cope by refusing to diet. Additionally stress internalized from stigmatization may lead to some chemical changes that cause a change in mood, increased appetite, and blunt satiety system (Puhl and Heuer 2010, 1022-3). These studies and statistics illustrate violations of both nonmaleficence and beneficence. Feelings of low self-confidence and potentially destructive tendencies including unhealthy dieting and eating disorders emerge when stigma is overused. Not only does stigma cause harm to individuals, but also it fails to produce the desired result of making obese individuals healthier.

Finally, the problem of distributive justice is falls into two

Stigma in Public Health Decision-Making women to love their bodies, such as Dove’s “Real Beauty” campaign, but more work needs to be done by public health officials to foster a positive community.

Secondly, public health officials must determine a plan of action to prevent individuals from becoming obese in the first place. This prevention must at its core come from structural changes; these changes can come in many forms, but must address both food and exercise in order to fully initiate change.

In terms of food, public health measures could include to both subsidizing healthy foods and working with the Food and Drug Administration (FDA) to limit or eliminate unhealthy ingredients from FDA. For example, the New York City Board of Health eliminated the use of trans fats in New York restaurants (Brownell 2010, 385). Extrapolating this initiative, if sugar or fat content in pre-packaged food were to be regulated, healthier eating would be encouraged with no additional cost to the consumer. In addition to healthier eating, obesity must be battled by encouraging a more active lifestyle. In order to best promote exercise, public health officials must eliminate the most prominent barriers that individuals note as preventing them from exercising. In truly hurting neighborhoods, simple actions such as adding traffic lights to make neighborhoods safer or adding public spaces such as parks in which individuals can exercise public health officials would be indirectly promoting physical activity to help reduce obesity (Umstattd Meyer 2013, 7). On the simplest level, public health officials cannot look to stigma to correct the problem of obesity because it is ineffective, conversely resources must be used more responsibly to proactively address the root issues of access to various resources.

Conclusion

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After looking at each of these issues through the framework set forth, it is clear that stigmatization cannot be justified in the cases of smoking and obesity. In these cases the act of stigmatization does not help achieve the goal of public health, making people healthy in an acceptable manner. In each of these instances there was no indication of efficacy, yet in some cases evidence of harm.

On the one hand, stigmatization can simply be viewed as “robust paternalism,” no different from simply pushing a patient to a healthier lifestyle (Bayer 2008, 470). On the other hand, there are those, such as Herek, who argue that “stigma and discrimination are the enemies of public health” (Bayer 2008, 466). Neither of these arguments, however, truly gets to the heart of the role and ethicality of stigmatization in public health. Its function in public health must primarily be considered within the ultimate goal of public health, making people healthy. While this is the overarching goal, this goal is not absolute, but rather defined prima facie. Certain duties and principles can and should override this goal, it is precisely these duties and principles that the dimensions of a stigma case seek to examine and uphold through analysis and a cost benefit analysis.

The framework set out in the dimensions of a stigma case must be applied to every instance of stigma appearing in public

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categories of access to resources: environmental and healthcare.

Environmental factors include the availability of healthy foods and prevalence of education regarding healthy eating and exercise. One study of mothers and children in communities along the US-Mexico border, a disproportionately poor area, found that this group of individuals is 87% more likely to be diagnosed with diabetes, largely associated with obesity.

These individuals noted that the biggest barriers to engaging in physical activity were unleashed dogs in the street, high traffic volume, and lack of parks or areas to exercise (Umstattd Meyer 2013, 7). These structural problems, along with others such as the relatively high cost of healthy food, indicate serious environmental factors that contribute to high obesity levels.

Additionally, socioeconomic factors also seem to be tied to obesity. Those that are of lower socioeconomic status are less affected by education efforts to combat obesity and are most burdened by the cost of healthy living (Pomeranz 2008, 95).

Many resources to help eliminate obesity are costly, which prevents certain groups of people from using them to become healthier; these include access to regular doctor check ups to detect weight gain early on, access to fitness centers, and the engagement of a supportive community. In addition to environmental resources, there are serious discrepancies in healthcare resources available to obese individuals. Healthcare resources include doctors’ knowledge of treating obesity as well as the quality of doctors’ visits. Studies indicate that health practitioners feel as though they are not adequately trained to provide obesity counseling, nor do they have the time or resources to do so. This feeling of inadequacy results in less time spent with and fewer preventative screenings for obese patients (Forhan and Salas 2013, 206). Because they are not receiving satisfactory care, patients feel as though they do not have the support and means to battle their obesity. Due to these issues of access, many individuals do not have the ability to change their lifestyle.

If stigma is impermissible with regards to obesity, how are public health officials meant to tackle the issue? If the goal of public health is to make individuals healthy, then it is not enough for stigma to be eliminated and the issue of obesity ignored. By taking steps to eliminate the issues illustrated through this framework, public health officials would be on a good path to decreasing the prevalence of obesity in an ethical manner.

In order to resolve these issues, one must first examine how to treat individuals who are already obese. Public health officials must work at the physician level to determine appropriate and effective ways of helping these individuals, whether this is determining better eating plans, weight loss routines, or looking into more drastic measures such as medicine and surgery, improving the access to care. Second, the cultural stigma driven by the desire to be thin, beautiful, and fit needs to be curbed to help decrease the privacy violations of individuals. Employees, families, and other social institutions, by one single glance at a person, develop prejudices, indicating the cultural insensitivity to the private life and considerations of an individual’s life.

Companies have begun with large initiatives that encourage

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Stigma in Public Health Decision-Making health. Once each dimension is examined for a particular case, public health officials must weigh the different considerations to determine whether or not stigma is permissible or not.

This is perhaps the most difficult question regarding stigma in public health because there is no one clear answer. Generally speaking, each of the six dimensions is weighted equally. No one dimension can be considered on its own, but rather all must be examined together to determine, within the bigger picture, whether or not stigma is ethical and can therefore be used to further public health goals. By this understanding, if the majority of the dimensions are violated, then stigma must be deemed impermissible. It is possible to imagine,

however, certain specific instances in which one dimension is so egregiously violated that, despite passing other dimensions, causes stigma to be deemed permissible or impermissible. A pure cost benefit analysis argument does not allow for this gray area, however this same type of argument is seen in other public health issues. For example, in cases of emergency, public health officials have the ability to restrict personal liberties in a way that would be impermissible under normal circumstances.

One instance of this is with the outbreak of severe acute respiratory syndrome in 2003 in Toronto. Despite violations of personal liberty and privacy, the imminent danger of the spread

outweighed these infringements, thus justifying stigmatization in that case (Singer 2003, 1342). This same idea applies to stigma, if one violation is so grievous due to circumstances, the cost benefit application of the framework must be open enough to allow for that stigma to be deemed permissible or impermissible.

Ultimately it must be acknowledged that stigma exists in the public health sphere. Once it is acknowledged, public health officials have a duty to examine its use to determine whether or not it is being appropriately used. The framework here provides a mechanism through which public health officials can scrutinize instances of public health, ensuring that beneficence, nonmaleficence, distributive justice, collective action, autonomy, and privacy have not been disproportionately violated.

About the Author Margaret E. Weiss studied biology, religous studies, and bioethics at the University of Virginia.

John Childress is the faculty sponsor for this work. He is the John Allen Hollingsworth Professor of Ethics and Professor of Medical Education.

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