Volume X Issue i

Volume X Issue i

PENN BIOETHICS JOURNAL

Paternalism & Protection

Euthanasia, the ACA, and Lethal Injection

Also inside: A Conversation with Ezekiel Emanuel Social Value of Clinical Research Experimental Ebola Therapies Burwell v. Hobby Lobby

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 reviewing current issues in the field, as summarized by our editorial staff.

Editors and authors have a unique opportunity to get involved with the peer-review 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.

www.bioethicsjournal.com

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 EDITOR IN CHIEF Aditi Verma MANAGING EDITORS Evan Cernea Lucy Chen Kurt Koehler Darby Marx Ruchita Pendse Garrett Young

Letter from the Editor Bioethics in Brief

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Experimental Therapies for Ebola

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Burwell v. Hobby Lobby

6

Supervision of Lethal Injection by Doctors

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PUBLISHER Lucy Chen

Impact of the Affordable Care Act on the Labor Market and Insurance Premiums

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TREASURER Timothy Zhou

Admitting Privileges and Access to Abortion

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ASSOCIATE EDITORS Nikita Agarwal Nikhil Ananth Jacquelyn Andrews Josh Bryer Alanna Cruz-Bendezu Ria Desai Carlos Dos Santos Elizabeth Gonzalez Audrey Harnagel Tina Kartika Jacqui Kemmer Georgio Legerme Rachel Mardjuki Sagar Patel Rachel Shaw Alex Shazad Tim Shinn Jane Shmushkis Chloe Swanson Iulia Tapescu Girish Valluru Ahmed Yousef Samir Zaman Kenneth Zhou Timothy Zhou FACULTY ADVISOR Autumn Fiester, PhD

The Debate over Vaccinations in Schools

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Interview A Conversation with Dr. Ezekiel Emanuel

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Articles Who Owns the Right to Die? An Argument About the Legal Status of Euthanasia and Assisted Suicide in Canada

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Miranda Barbuzzi

Where is the Value in Social Value?

A Framework and Policy Recommendations for Assessing the Social Value of Clinical Research

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Kaitlin Sibbald

Should Healthcare Professionals Restrict the Diets of Obese Individuals?

Maximilian Peluso

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Letter from the Editor

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Aditi Verma Editor in Chief

Dear Readers, Thank you for picking up the 14th issue of the Penn Bioethics Journal. The publishing of this journal marks two major milestones in the publication process of the PBJ. First, we have implemented a new publication timetable with a one-semester turnaround for all submissions. The editors who conduct peer-review will subsequently oversee the revision and publication process. Authors of accepted papers will enjoy a dynamic peer-review system where they can quickly refine their work with our feedback. Second, we have restarted our subscription program which, in addition to broadening our global reach and improving readership, we hope will inspire the launch of new undergraduate bioethics journals and pioneer new pedagogical tools for undergraduates interested in bioethics.

I want to thank all the PBJ editors for their hard work and dedication for this issue, especially the managing editors and authors who have worked diligently together for the finalized published pieces, our publisher for her extraordinary work standardizing the journal design and overseeing the renovation of the website, and our treasurer for formalizing and streamlining our advertisement process and funding protocol.

This issue, called “Paternalism & Protection,” features several works concerning how the conception of the individual should inform public health policy. The Bioethics in Brief section highlights some developments in healthcare policy. The implementation of the Affordable Care Act sparked interesting procedural questions regarding the responsibilities of different agents. The landmark ruling in Burwell v. Hobby Lobby established a precedent that allows owners of privately owned companies to use religious belief to object to a legal mandate if there is a less imposing method for carrying out the intent of that law. With the outbreak of Ebola, reevaluating the process of experimentation and distribution of scarce resources raises many ethical concerns and confirms the need for progress.

The authors of the articles featured in this issue all consider promoting social good through managing different agents.

The recent ruling in Carter v. Canada, which allowed for end-of-life treatment on the basis that safeguards can be created to protect vulnerable individuals, will be appealed in the Canadian Supreme Court in October 2014. Miranda Barbuzzi’s piece discusses the former legal boundaries for suicide in Canada and its tension with active euthanasia. Also in this issue is an interview with Professor Ezekiel Emanuel, one of the most popularly vocal figures standing in opposition to assisted suicide.

Even if a desired outcome is eventually found in consensus, policy improvements may be needed to tweak procedures to better realize its intended effect. As stated by Health Affairs Editor in Chief Alan R. Weil, “The path to effective policy is rarely straight. Odds are low that we will get it right on our first attempt to address a need or solve a problem.”

For instance, most efforts to combat obesity involve outreach campaigns, nutritional modules, and weight management programs, all in an effort to influence individual choice without outright inhibiting it. There exists, rightfully so, a strong commitment to freedom of choice and autonomy, yet as Maximilian Peluso writes, there are hidden possibilities when other more direct, paternalistic influences are considered, as shown in his piece on the ethical practice of dietary restriction for inpatient obese individuals.

Beyond regulating specific health practices, bioethics is concerned with value judgments in promoting biomedical research to realize new healthcare options. Kaitlin Sibbald considers the process and structure of the Canadian Research Ethics Boards to show how Canada’s REB governance model can be changed to engage with our community as new technologies emerge.

The President’s Commission of Bioethics is similarly reviewing many topics and calling for ethics research to be a part of basic science research. However, methods in combining ethics research with other fields in their initial stages (e.g. neuroscience) have no substantial precedent. For this reason, bioethics education at the undergraduate level is also key. As we learn about the professional world, be it scientific research, medicine, law, or even entrepreneurship, our growing minds give undergraduates a unique advantage to develop new frameworks and reform fundamentally held beliefs in our society.

To begin this process, the Penn Bioethics Journal will be hosting the first Bioethics Symposium at Penn in October.

We hope to connect our university to students across the nation and start a professional movement where bioethics has a unique advantage for undergraduates pursuing all types of careers, allowing them to make larger influences within their networks and becoming leaders in our increasingly technologically-based societies.

Thank you, readers. I hope you all will follow this journal as it grows through the years.

Aditi Verma Engineering and Wharton ’15 University of Pennsylvania

Bioethics in Brief Experimental Therapies for Ebola

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The recent Ebola outbreak in Western Africa has University, stated, “I think there are very special commitraised ethical questions regarding treatment options for ments that we must make ethically to the health care prothose stricken with the disease. Since the outbreak be- viders that are willing to go in and serve,” justifying the gan in Guéckédou, Guinea, the virus has affected several prioritized treatment of the two American health workers countries, including Liberia, Nigeria, and Sierra Leone, who had served in Liberia (Pollack 2014). and there is growing concern that it may become more Meanwhile, some activists have voiced dissatisfacwidespread (Park 2014). The outbreak, the most severe in tion with the lack of treatment for Africans. Maina Kiai, recorded history, has claimed at least an estimated 4,000 a lawyer and Kenyan human rights activist, brought up lives. the apparent inequity at a While there are curWashington, DC, summit rently no drugs apof African leaders, statproved to treat Ebola ing, “There was a sense Virus Disease (EVD), of the same pattern … an experimental drug the life of an African is called ZMapp has alless valuable” (Pollack ready been tested on 2014). Others have simitwo American healthlarly stated that ZMapp care workers who should be given to Afcontracted the virus. rican patients, suggestZMapp has helped the ing that prioritization two Americans fight of healthcare workers is the virus, but supplies unjust. are currently reported However, due to histo be “exhausted,” actory and different value cording to Mapp Biosystems, African mistrust pharmaceutical, Inc., of Western medicine may in San Diego (Brown undermine any potential Dr. Kent Brantly treats an Ebola patient in Liberia. Brantly later re2014). The use of this ceived the first dose of the experimental drug ZMapp after contracting efforts to treat those with drug has prompted deEVD. Dr. Salim S. Abdool the disease himself. Photo courtesy of bate regarding the ethics Karim, a physician from The Associated Press. of fighting an unusual South Africa, pondered epidemic. Specifically, it the consequences of usraises questions about the allocation of scarce medical ing an experimental drug on sick Africans: “It would have resources and the ethics of testing a drug with unknown been the front-page screaming headline: ‘Africans used efficacy. How can a short supply of ZMapp be allocated as guinea pigs for American drug company’s medicine’” among the thousands of people with EVD? Who receives (Pollack 2014). Thus, while some consider it unethical to priority? prioritize health care workers, treating Africans may elicit On August 11, members of the World Health Orga- the same critical response, making this situation a complinization (WHO) convened to discuss the ethical implica- cated and delicate predicament. tions of testing a drug with unknown efficacy on human subjects. The panel of ethicists voted unanimously to support the use of unproven interventions such as ZMapp in References this unique emergency circumstance, but it did not offer recommendations for which persons should receive the Brown, M. H. 2014. “Experimental Ebola drugs raising ethics questions.” The Baltimore Sun, August 22. drug first (Macklin 2014). Some bioethicists have argued Macklin, R. 2014. “The Ethics of the Ebola Outbreak: Who Should Rethat healthcare workers should be given priority because ceive Experimental Treatment?” The Huffington Post, August 21. they can help others survive the epidemic. Furthermore, Park, M. 2014. “Report: Ebola outbreak probably started with 2-year-old in Guinea.” CNN, August 12. they best understand the risks of taking an untested drug and are more likely to give proper informed consent. Dr. Pollack, A. 2014. “Ebola Drug Could Save a Few Lives. But Whose?” The New York Times, August 8.

Nancy Kass, professor of bioethics at Johns Hopkins

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Bioethics in Brief

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Burwell v. Hobby Lobby

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On June 30, the U.S. Supreme Court handed down its verdict on Burwell v. Hobby Lobby, deciding 5-4 in favor of Hobby Lobby Stores, Inc. In doing so, the Supreme Court created an allowance for closely held for-profit corporations to opt out from a mandate in the Affordable Care Act requiring all employer-sponsored health insurance to include coverage for contraceptives.

Hobby Lobby Stores, Inc., a chain of retail arts and crafts stores owned by the Evangelical Christian Green family, brought forth this case against the Department of Health and Human Services (HHS) and its Secretary, Kathleen Sebelius, in 2012. Sylvia Burwell succeeded Sebelius as Secretary in 2014 (Mears 2014). The Affordable Care Act requires women’s preventive care to be covered, allowing HHS to define what such care includes. The HHS includes contraception coverage among those essential benefits (Sepper 2014).

The plaintiffs believed the contraceptive coverage mandate violated the Religious Freedom and Restoration Act, which protects a person’s ability to freely practice their religion.

They argued that providing such coverage to their 23,000 employees was a violation of the Green family’s religious beliefs (Mears 2014). Specifically, the plaintiffs contested the coverage of four out of the twenty mandated contraceptives, as they believed that the use of two emergency contraceptive pills and two intrauterine devices prevented implantation of a fertilized egg, and thus constituted an abortion (Liptak 2014).

Many doctors and scientists disagree with this characterization, clarifying that both these methods of contraception prevent ovulation itself, thereby intervening before conception rather than after fertilization of the egg (Belluck and Eckholm 2012). The HHS also argued that not providing the full mandated coverage to employees would impose the religious beliefs of the Green family upon their employees, who may not share the same convictions.

The Religious Freedom and Restoration Act (RFRA), passed in 1993, states that if the federal government passes a general law that imposes a substantial burden on an individual’s free exercise of religion, the government must be acting to serve a “compelling interest,” and it must use the “least restrictive means” of achieving that interest. Three key points were salient in the Supreme Court’s consideration of Burwell vs. Hobby Lobby: (1) whether a company can be considered an “individual” as used in the RFRA, (2) if the contraception coverage mandate places a “substantial burden” on the company’s exercise of its religion, and (3) if the contraceptive coverage mandate meets the “compelling interest” and “least restrictive means” standards of the RFRA (Sepper 2014, Stoeffel 2014).

The Supreme Court’s 5-4 ruling in favor of Hobby Lobby has created much controversy, both among the general public and within the court itself. The majority opinion, authored by Justice Samuel A. Alito, Jr., agreed with the plaintiffs that closely-held corporations had religious freedoms that, in this case, were being infringed upon by the HHS

mandate. While the majority emphasized that the ruling had limited scope, Justice Ruth Bader Ginsburg wrote a scathing dissenting opinion, arguing that this ruling established precedent for any “closely-held” corporation to claim a coverage exemption from any number of other mandated health services (Levs 2014). The Internal Revenue Service defines a “closely-held” corporation as one in which at least 50% is owned by five or fewer people. Roughly 90% of all US companies are closely held, including large companies like Mars Inc., which employs 72,000 people (Armour and Feintzeig 2014). There is concern, then, that any such company could claim an exemption on religious grounds, including Jehovah’s Witnesses claiming exemption from covering blood transfusions, Scientologists from antidepressants, and more fundamentalist Christians from any type of contraception.

It remains to be seen whether such exemptions will come to head in future cases (Ponnuru 2014). Some members of the general public also protest the ability of these companies to control their employees’ decisions regarding birth control by limiting their contraceptive options.

To alleviate these concerns, in late August, the Obama Administration put forth a new set of regulations elucidating the procedures for filing a religious exemption in accordance with the Supreme Court’s ruling in Burwell v. Hobby Lobby.

The guidelines ensure the federal government is made aware that a company is exercising its right to religious exemption so that the government can coordinate with insurers to fill in the gaps in coverage of the affected employees (Radnofsky 2014).

Though ideological concerns about the Hobby Lobby decision remain, as does uncertainty regarding the scope of its effect on future litigation, for now it seems the Obama Administration’s new workaround will at least ensure employees’ coverage will not be affected, while the government and these companies continue to battle over who must supply it.

References Armour, S. and R. Feintzeig. 2014. “Hobby Lobby Ruling Raises Question: What Does ‘Closely Held’ Mean?” The Wall Street Journal, June 30.

Belluck, P. and E. Eckholm. 2012. “Religious Groups Equate Some Contraceptives With Abortion.” The New York Times, February 16.

Levs, J. 2014. “What the Supreme Court’s Hobby Lobby decision means.”

CNN Politics, June 30.

Liptak, A. 2014. “Supreme Court Rejects Contraceptives Mandate for Some Corporations.” The New York Times, June 30.

Mears, B. 2014. “Justices to Hear ‘Hobby Lobby’ case on Obamacare birth control rule.” CNN Politics, March 23.

Millheiser, I. 2014. “Obama Administration Calls the Supreme Court’s Bluff in Hobby Lobby.” ThinkProgress, August 22.

Ponnuru, R. 2014. “A few things the Hobby Lobby ruling won’t do.” American Enterprise Institute, June 30.

Radnofsky, L. 2014. “Administration Offers Contraception Compromise for Religious Employers.” The New York Times, August 22.

Sepper, E. 2014. Contraception and the Birth of Corporate Conscience.

Journal of Gender, Social Policy & the Law, 22(2): 305-342.

Stoeffel, K. 2014. “Everything You Need to Know About the Hobby Lobby Ruling.” New York Magazine, June 30.

Bioethics in Brief

Supervision of Lethal Injection by Doctors dation that medical professionals should assist in the administration of lethal injections. The authors first note that the participation by doctors in lethal injection would explicitly go against the Code of Ethics of the American Medical Association. Additionally, in responding to claims that the participation of medical professionals in the lethal injection process would result in the development of a protocol that would be more humane and painless, the authors contend that an execution, definitionally the involuntary taking of an individual’s life, is an act that opposes the fundamental goals of medicine (2014).

Others have offered a similar response. Dr. Steve Baumrucker, Associate Editor in Chief of The American Journal of Hospice and Palliative Medicine, appealed to the principle of non-maleficence in his response to the suggestion that medical professionals should participate in lethal injections. He stated, “The number one idea is ‘nonmaleficence,’ which is ‘first do no harm.’ The key word in that statement is ‘first.’ Number one, don’t do any harm.

Now whether you agree with lethal injection or not, or the death penalty or not, it is considered to be unethical for a physician to participate” (quoted in Mosendz 2014).

With the complications that have occurred in these recent executions, concerns over lethal injection as a viable and ethical method of execution are mounting. Commenting on the possible future of the death penalty, Austin Sarat, a professor at Amherst who has studied the history of capital punishment in America, states, “I believe that the death penalty is in decline in the United States because many Americans have concluded that whatever its abstract appeal, the death penalty cannot be delivered in the way that is compatible with American values” (2014).

References

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Associated Press. 2014. “Three executions gone wrong: Details of lethal injections in Arizona, Ohio, Oklahoma.” San Jose Mercury News, July 24.

Berman, M. 2014. “The prolonged Arizona execution used 15 doses of lethal injection drugs.” The Washington Post, August 4.

Cohen, E. 2007. “Lethal injection creator: Maybe it’s time to change formula.” CNN, April 30.

Death Penalty Committee. 2014. “Irreversible Error: Recommended Reforms for Preventing and Correcting Errors in the Administration of Capital Punishment.” The Constitution Project.

Horne, J. 2014. “Lethal Injection Drug Shortage.” The Council of State Governments.

Lyman, R. 2014. “Ohio Execution Using Untested Drug Cocktail Renews the Debate Over Lethal Injections.” The New York Times, January 16.

Mosendz, P. 2014. “Recipe for Disaster: The Difficulties of Concocting a Lethal Injection.” The Wire, August 11.

Sarat, A. 2014. Interview with Steve Inskeep. NPR. Truog, R. D., I. G. Cohen, and M. A. Rockoff. 2014. Physicians, Medical Ethics, and Execution by Lethal Injection. The Journal of the American Medical Association, 311(23): 2375-2376.

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In all 32 states that allow the death penalty, lethal injection is the preferred method of execution. However, due to complications that arose from three separate executions in 2014, questions have risen about the efficacy and ethicality of lethal injection. Three cases that demonstrate the controversial nature of lethal injection have occurred in three different states: Ohio, Oklahoma, and, most recently, Arizona.

In January, the execution of Dennis McGuire in Ohio took 26 minutes — the longest of any in the state’s history (Associated Press 2014). In April, Clayton Lockett’s execution in Oklahoma was stopped after a problem arose with the IV delivering the life-ending compounds. He died of a heart attack 43 minutes after the execution began (Associated Press 2014). Finally, in July, Joseph Rudolph Wood, who was sentenced to death in Arizona, was given 15 doses of the state’s two-drug injection combination, which should only require one dose. His execution lasted over 90 minutes (Berman 2014). In all of these cases, the individuals being executed writhed in pain, often gasped for air, and in some cases, even spoke as the drugs were being administered.

Lethal injection became the method of choice for executions in the 1970s, when Dr. Jay Chapman proposed a combination of three drugs: sodium thiopental (a sedative), pancuronium bromide (a paralytic compound), and potassium chloride (a compound that can induce cardiac arrest) as an alternative to electrocution, the method most commonly used for execution at the time (Cohen 2007).

However, in 2011, production of sodium thiopental in the United States ended, as Hospira, the only company licensed to manufacture the compound in the U.S., announced they would cease production in response to a global campaign to eliminate the death penalty (Horne 2014). Because of this drug shortage, many states have been forced to come up with new lethal injection protocols, often using drugs and doses that, although predicted to be effective, are untested and unproven. One such combination, containing the drugs midazolam and hydromorphone, was used in the controversial executions in Ohio and Arizona (Lyman 2014).

In light of these complications, the Death Penalty Committee of The Constitution Project, a group of legal professionals, has published a set of 39 recommendations they believe can fix the problems that have plagued lethal injection as a method of execution. Among these recommendations is the suggestion that “jurisdictions should ensure that qualified medical personnel are present at executions and responsible for all medically-related elements of executions” (2014). This recommendation has presented medical professionals with an ethical dilemma.

In a piece published in The Journal of the American Medical Association, Robert D. Truog, MD, I. Glenn Cohen, JD, and Mark A. Rockoff, MD responded to the recommen-

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Bioethics in Brief

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Impact of the Affordable Care Act on the Labor Market and Insurance Premiums

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September marked half a year since the end of open enrollment on the health insurance exchanges established by the Patient Protection and Affordable Care Act (ACA). According to the Department of Health and Human Services, in the first enrollment period, more than 8 million Americans signed up for health insurance plans through the Health Insurance Marketplace (2014). Of those enrolled, 60% were previously uninsured (Palosky 2014). As a result, the percentage of uninsured individuals between the ages of 19 and 64 has declined from 20% in the July-to-September 2013 period to 15% in the April-to-June 2014 period, falling across nearly every key demographic group of race and socio-economic status (Levy 2014). This came as a surprise to critics of the ACA; during the enrollment period, the opposition believed that slow early enrollment rates and technical issues with the launch of HealthCare.gov would stop the Obama administration from reaching its goal of 7 million enrollments within its first year.

With more data regarding the effect of the ACA, potential issues predicted by its critics can now be addressed. One predicted issue was that the ACA would be a “job killer,” stifling economic growth for years to come by placing an increased burden on employers to provide health insurance coverage to all employees regardless of medical history. Used to support this view is a 2014 CBO report on jobs; in this report, the CBO estimates that the ACA will reduce the total number of hours worked by about 1.5% to 2.0% during the period from 2017 to 2024, representing a decline in the number of full-time workers. While some employers have chosen to reduce some full-time workers to part-time to cover costs, the CBO reports that this decline in full-time workers is “almost entirely because workers will choose to supply less labor.” This claim is supported by economic data from the White House Council of Economic Advisers, which states the economy has created 6.5 million full-time jobs since the ACA’s passing, while the number of part-time jobs has essentially remained constant (Furman 2014). This directly supports the CBO claim that reductions in total hours worked is not mainly due to the reduction of full-time employees to part-time. Rather, in the old system, many individuals stay in their jobs for fear of leaving and being uninsured. When offered an opportunity to obtain affordable health coverage untied to an employer, many choose to leave their job. Moreover, with fewer people tied to their job for insurance, more positions will become open for the 6.2% of Americans unemployed in the U.S. since July.

Another consideration was that the passing of the ACA would lead to “skyrocketing” premiums. This was due to concerns over the large influx of lower income consumers and those at high risk of illness or with preexisting conditions. Additionally, in order for an insurance plan to be approved, it now must cover the ten items of “Minimal Essential Coverage.”

This includes normal hospital inpatient and outpatient services, mental health, and rehab, as well as maternity and newborn

care and pediatric services for every individual. One of the ideas behind having even men and consumers beyond childbearing age be covered by maternity and newborn care is to prevent the discrimination against women on the individual insurance market. According to the 2009 National Womens’ Law Center, in the old market, more than 90% of insurers charged women more than men for the same coverage (Courtot 2009).

Similarly, those with known health risks were denied coverage or given prices outside of the market. This points to a greater problem within the old individual insurance marketplace; a report from Health Affairs in 2012 found that more than half of all individual plans sold in 2010 offered too little protection to qualify for even the “bronze” rating on the ACA’s quality scale (Gabel 2012). The requirement of all plans to provide a full range of coverage, even of services that are not directly necessary, acts to align the individual buyers market with the group market by providing individuals with the same security of highquality insurance as those that take employer-sponsored health insurance. This moves the U.S. towards a system of providing a “legal entitlement to some forms of health care”: a step towards providing an essential human right as argued by American ethicist Allen Buchanan (Daniels 2014).

While health insurance premiums increase every year, the rate of increase this year has actually decreased an average of 8% across states, according to analysis of preliminary data by PricewaterhouseCoopers (2014). This is a decrease from the average annual health insurance premium increase of 10% in the years before the passing of the ACA. Since 1999, health care costs have been growing faster than inflation (Nussbaum 2012). This acts as one of the primary reasons for constantly increasing health insurance premiums. However, the change in health care premium cost varies greatly on a state and individual level. Actual change in premiums range from 23% decrease in Arizona and Colorado, to 50% increase in Arkansas. Moreover, Americans making under 400% of the federal poverty line are eligible for premium tax credits, as are small employers for insuring their employees. Due to the collective nature of the ACA, higher earners may see their rates increasing. In addition, there are many anecdotal accounts of consumers losing their non-compliant plans and being forced to turn to coverage with higher premiums than they anticipated.

These accounts may reflect the adverse individual outcomes as a result of the ACA, but they may not represent overall changes. By contrast, economic evidence of broad data sets can reflect net change in jobs and premiums, at the cost of obscuring individual, real-world impacts. Overall, millions of previously uninsured American now have the access to affordable, high-quality health insurance, and women and those with health risks can no longer be charged differently by insurers.

As more information emerges about the overall impact of the ACA, it will be important to take into account both the individual and big-picture impacts.

Bioethics in Brief References “A preliminary look at 2015 individual market rate filings.” 2014. PricewaterhouseCoopers, August 27.

Courtot, B. and J. Kaye. 2009. “Still Nowhere to Turn: Insurance Companies Treat Women Like a Pre-Existing Condition.” National Women’s Law Center, October 9.

Daniels, N. 2013. “Justice and Access to Health Care,” The Stanford Encyclopedia of Philosophy, edited by Edward N. Zalta.

Department of Health and Human Services. 2014. “Enrollment in the Health Insurance Marketplace totals over 8 million people.” May 1.

Furman, J. and B. Stevenson. 2014. “New Data: Most of the Increase in Employment is in Full-Time Positions Since the Affordable Care Act Became Law.” The White House, February.

Gabel, J. R., R. D. McDevitt, J. D. Pickreign, H. Whitmore, M. Slover, and E. LevyForsythe. 2012. More Than Half Of Individual Health Plans Offer Coverage That Falls Short Of What Can Be Sold Through Exchanges As Of 2014. Health Affairs 31(6):1339-1348.

Levy, J. 2014. “U.S. Uninsured Rate Drops to 13.4%.” Gallup, May 5.

Palosky, C. 2014. “New Kaiser Survey of People with Non-Group Insurance Finds Nearly Six in 10 People Enrolled in Marketplace Plans Were Previously Uninsured.” Kaiser Family Foundation, June 19.

Nussbaum, A. 2012. “Health-Care Costs Rise Faster Than U.S. Inflation Rate.”

Bloomberg, May 21.

“Price Index - eHealth Affordable Care Act Resource Center.” 2014. eHealth Affordable Care Act Resource Center.

“The Budget and Economic Outlook: 2014 to 2024: Appendix C.” 2014. Congressional Budget Office, February 4.

Admitting Privileges and Access to Abortion stitutional, it was predicted that abortion clinics in Birmingham, Mobile, and Montgomery would have closed, leaving only two clinics in the state (Eckholm 2014). In his 172-page ruling, Thompson expressed that with the privileges law in place, “a significant number of the women would be prevented from obtaining an abortion; others would be delayed in obtaining abortions, exposing them to greater risks of complications.” With only two clinics to choose from, a woman seeking an abortion could encounter financial and geographical strains and medical complications. Faced with a range of obstacles, other women might be forced to keep their baby despite instabilities, resulting in a reduced quality of life for mother and child and potential financial dependency on the state. Thus, Thompson found that the law placed an undue burden on women and ruled it unconstitutional.

According to Texas District Court Judge Lee Yeakel, who is presiding over a case pertaining to intense clinic regulations, when it comes to closing clinics, a key concern is the equal protection of women in remote areas. In a statement in early August, Yeakel discussed gender and abortion, stating, “Would we stand [to travel large distances] if you had a sprained ankle or needed an appendectomy? I don’t believe we would stand for this for any other medical procedure” (quoted in Ura 2014).

Women living farther from clinics must have an equal chance at maximizing their quality of life, Yeakel and other opponents of admitting privileges for abortion clinic doctors argue.

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References Eckholm, E. 2014. “Alabama’s Requirement for Abortion Clinic Doctors Is Ruled Unconstitutional.” The New York Times, August 4.

Millman, J. 2014. “Why abortion ‘patient safety’ laws may actually hurt women.” The Washington Post, August 5.

Somashekhar, S. 2014. “Admitting-privileges laws have created high hurdle for abortion providers to clear.” The Washington Post, August 10.

Ura, A. 2014. “In Abortion Trial, Judge Questions Definition of ‘Undue Burden.’” The Texas Tribune, August 13.

Zaragovia, V. 2014. “What It Takes For Texas Abortion Doctors To Get Admitting Privileges.” KUT, February 19.

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In 2013, abortion clinics began to close at alarming rates in Texas and Tennessee after these states enacted laws that require abortion clinic doctors to secure admitting privileges at local hospitals. Currently, Louisiana, Oklahoma, and Wisconsin are in the process of adopting similar legislation (Somashekhar 2014). Admitting privilege is the doctor’s ability to admit and treat patients at a specific hospital and is designed to guarantee that the patient receives proper care in the case of complications after an abortion (Eckholm 2014). While clinics in these states are already heavily regulated, legislators maintain that admitting privileges requirements further protect women’s health.

In order to secure admitting privileges, hospitals may require that a doctor live within a radius of the facility, admit a certain number of patients, or annually carry out a minimum number of surgeries (Zaragovia 2014). Many abortion clinic doctors, however, only perform abortions, or they live out-ofstate, making it difficult for them to satisfy the requirements at certain hospitals. Furthermore, religiously affiliated hospitals might refuse to grant doctors privileges due to religious convictions or because they do not wish to practice controversial procedures (Millman 2014).

Conservative legislators and anti-abortion groups agree that despite the difficulty for certified clinic doctors to acquire privileges, admitting privileges laws are crucial for the safety of women. Background checks, which are commonly required to obtain privileges, verify the credentials of clinic doctors.

Opponents of admitting privileges argue that women receiving early-term abortions rarely face any sort of complications: one of the five Alabama abortion clinics estimates that its complication rate is as low as 1 in 3,500 (Millman 2014).

In addition, those opposed to admitting privileges legislation contend that if a medical issue were to arise post-abortion, a patient could receive emergency care at any hospital, regardless of the privilege status of the clinic doctor.

For many pro-choice activists, the number of abortion clinics closing their doors as a direct result of these laws is unsettling. In early August, had Alabama District Court Judge Myron Thompson not ruled the state’s admitting privileges law uncon-

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Bioethics in Brief

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The Debate over Vaccinations in Schools

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In June 2014, Judge Williams Kuntz of Federal District Court in Brooklyn upheld the lower-court decision that New York City schools have the right to ban unvaccinated children during the breakout of vaccine-preventable disease. However, many parents of these children feel that both their first amendment right for religious freedom and fourteenth amendment right to equal protection under the law are being violated (Mueller 2014). Vaccines have prevented disease and death since they were introduced into modern medicine. The National Institute of Health (NIH) reports that prior to the use of the Diphtheria vaccination, there was an average of 175,885 cases per year.

In 2009, no cases of Diphtheria were reported in the United States (NIH 2010). However, some parents choose not to immunize their children with vaccines.

The reasoning behind refusing vaccines can be philosophical, religious, or medical. New York City allows exemptions to be granted for children whose parents prefer not to vaccinate them based on religious or medical reasons. Philosophical reasons, however, are not considered adequate justifications for exemptions due to their questionable bias and lack of corroboration by scientific research. For example, the common beliefs that allergies and autism can developed as a side effect of vaccinations has not been supported by any studies to date (Institute of Medicine 2004, Offit 2003). Therefore, parents who request exemptions based on those beliefs are denied and are required to vaccinate their children.

The case of the Check family was heard at the same court date in June of 2014. The Check family sued the school system for denying a religious exemption for their daughter, after being denied a medical exemption as well. According to them, their young daughter, Mary, has a compromised immune system that cannot handle the toxic chemicals in vaccines. However, the Check family did not present evidence confirming Mary’s adverse reactions to vaccination from a licensed doctor during the court case. Having lost faith in the current medicine, they turned to “holistic” medicine. However, Mary’s school claimed there was a lack of medical evidence supporting the Check’s decision not to vaccinate their daughter, which led to the denial of their request for a medical exemption. Following this, they

filed the religious exemption that was also denied. Although the Check family claims that their Catholic faith objects to the use of vaccination, the court did not “substantiate a finding that [they] hold genuine and sincere religious beliefs which are contrary to immunization” (Bellamy 2014). Because the Check family did not originally claim to have religious beliefs against immunization, only medical benefits, the court felt a lack of legitimacy in their request for the second exemption.

While those against mandatory vaccination argue that individuals should be able to freely exercise their autonomy to choose whether or not to get immunized, proponents argue that the health of the general public is put at risk with outbreaks of easily preventable infectious disease. Some point to Ohio and surrounding areas where over 341 cases of measles have been reported that resulted from the lack of vaccinations in an Amish population. Since the outbreak, a majority of the Amish have reconsidered their decision to refuse vaccines (Tribble 2014). Situations like this are what the New York City school district wants to prevent by banning unvaccinated children during the breakout of such diseases.

References Bellamy, J. 2014. “NY federal court hands triple loss to anti-vaccination ideology.” Science-Based Medicine, June 26.

Institute of Medicine (US) Immunization Safety Review Committee. 2004.

Immunization Safety Review: Vaccines and Autism.” Washington, DC: National Academy of Sciences.

Offit, P. and C. Hackett. 2003. “Addressing Parents’ Concerns: Do Vaccines Cause Allergic or Autoimmune Diseases?” Pediatrics 111(3): 653-659.

Mueller, B. 2014. “Judge Upholds Policy Barring Unvaccinated Students During Illnesses.” The New York Times, June 23.

Szabo, Liz. 2013. “Whooping cough may be becoming resistant to vaccines.”

USA Today, February 8.

“Top 20 Questions about Vaccination.” 2014. The College Physicians of Philadelphia, July 31.

Tribble, Sarah. 2014. “Measles Outbreak In Ohio Leads Amish To Reconsider Vaccines.” NPR, June 24.

“Vaccine Benefits.” 2014. National Institute of Allergy and Infectious Disease, March 6.

Bioethics in Brief Contributing Writers Elizabeth Gonzalez Kurt Koehler Darby Marx

Ruchita Pendse Garrett Young Samir Zaman

Bioethics in Brief

The Scattergood Program for the Applied Ethics of Behavioral Healthcare is dedicated to applied research and scholarship in all areas of behavioral healthcare ethics. Housed at the University of Pennsylvania, in the Department of Medical Ethics & Health Policy, the ScattergoodEthics Program is a regional and national effort that welcomes all those active in the field of behavioral healthcare.

Interview

A Conversation with Dr. Ezekiel Emanuel Ezekiel J. Emanuel is the Vice Provost for Global Initiatives, the Diane S. Levy and Robert M. Levy University Professor, and Chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.

He was the founding chair of the Department of Bioethics at the National Institutes of Health and held that position until August 2011. Until January 2011, he served as a Special Advisor on Health Policy to the Director of the Office of Management and Budget and National Economic Council. He is also a breast oncologist and author.

Penn Bioethics Journal (PBJ): Could you briefly describe your career trajectory and how your interest in bioethics led to your involvement in health policy?

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Dr. Ezekiel Emanuel (EE): One way of looking at it is` I was a medical student and hated medical school. Simultaneously, a lot of what we were doing — for example, decision-making about end-of-life care and resuscitations — just seemed sort of crazy to me. I felt that there had to be a better way and there wasn’t much good thinking on these issues. I had also done a lot of undergraduate and some graduate ethics and political theory and thought that you could wed these two, and I have a better ability to answer some of these important questions. So I interrupted my medical school career after the third year and went across the river in Boston to do a PhD in Political Science at the Faculty of Arts and Sciences at Harvard, and then I got a fellowship to the Kennedy School [of Government at Harvard University]. So that was the initial career.

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I think, to some degree, the few things that distinguish my career are first, by having the MD degree and the PhD, I had an interdisciplinary approach. I had also had some experience taking some law school courses, so I at least had some understanding of how lawyers thought. Second, almost all of my career can be seen as taking some conventional wisdom or accepted practice and trying to do something to show that it’s not right. When I went into the end-of-life care field, the Dean of Students at Harvard Medical School said that it was a career ender, no one goes into end-of-life care, that’s not a really wise move; I did it nonetheless.

I think history has shown that I was right. I’ve also done “what do most people think and why is that probably wrong?” For example, when I started working on research ethics, I thought all the issues were settled; we have regulations, we have things like the Nuremburg Code and the Declaration of Helsinki.1 But then the moment you unpack them, you realize there’s not a lot there.

There’s still a lot of work and unsolved problems, or problems which have been answered incorrectly in the literature. Similarly, I got into the health policy area at a time when no one thought there was going to be health policy change. Everyone in the field was kind of negative and morose, while I was thinking, “If you did universal coverage, what would it look like?” So, I have sort of

Photo by Candace diCarlo.

a long career of trying to go against the grain. And I think that, at least for me, that’s put me in good stead.

PBJ: You published several years ago on your belief that employing universal healthcare vouchers would best serve the American public in terms of being the most economically efficient and insuring the most people.2 Could you tell us a little bit about that idea and then discuss how that it might solve problems that, even after the passing of the Affordable Care Act (ACA), might still plague our current health care system?

EE: Our idea about universal healthcare vouchers was to create an exchange where insurance companies are competing and to give every American a voucher to buy insurance. If they want a higher, fancier product, they have to pay more. That has some analogies to what we have in the ACA. We have an exchange, we have competing insurance companies, people don’t get vouchers but they get subsidies, which by the way are much more complicated to administer than a simple voucher. Not everyone is in the exchange, whereas in our view, everyone would be in the same place on the exchange. But in the ACA, the subsidies are geared toward the second lowest silver plan. People can buy up to a gold or a platinum plan if they so desire.3 So, there are some analogies and some disanalogies. By having everyone in the same marketplace, it creates a great pooling effect and it also generates a lot

The Nuremburg Code of 1949 and the Declaration of Helsinki of 1964 were two of the early attempts at codifying “ethical” research practices, and have a strong influence on modern practices. The Nuremburg Code is available at http://history.nih.gov/research/downloads/nuremberg.pdf. The Declaration of Helsinki is available at http://www.wma.net/en/30publications/10policies/b3/17c.pdf.

2 Emanuel, E. J. and V. R. Fuchs. 2005. “Solved! It covers everyone. It cuts costs. It can get through Congress. Why Universal Healthcare Vouchers is the next big idea.”

Washington Monthly, June.

3 On the health insurance exchanges, the different insurance plans are tiered according to the comprehensiveness of their coverage. The plans offering the most coverage are “platinum,” then there’s “gold,” “silver,” and finally “bronze.” The government offers subsidies for households at certain income levels that are based upon the premium for the second-lowest silver tier plan.

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A Conversation with Ezekiel Emanuel of competition. And, it’s got the element of equality in that everyone’s got the same base level, and a lot of people, whether middle class, upper middle class, or rich, are likely to go into the voucher.

So there are some overlaps with the ACA and some dissimilarities.

One of the virtues of the universal voucher program is its simplicity of administration. You’re not calculating someone’s income, making projections about the future, giving a subsidy based upon the income. And you’re also taking the money in a completely different mechanism in our view, through a value added tax, which is both an economically valuable way of taxing but also makes the administration of the system much more efficient.

PBJ: Looking ahead, there’s a feeling that this landmark legislation was passed, and now the healthcare system is in a sense “fixed,” so it might not be on the political agenda anymore. Where do you think the system is headed right now, and do you think there’s going to be another opportunity to have more of an overhaul? And is that even necessary?

EE: First of all, I would say you don’t fix a system with one piece of legislation and you don’t fix it overnight. These are multi-year programs and the full ramifications of the ACA — both on the positive and on the negative, like what adverse unintended consequences are going to arise — we don’t know yet. It’s still a work in progress.

EE: It certainly made it slower. The Supreme Court has said that states don’t have to adopt this expansion. If they don’t adopt it, they won’t lose all of their Medicaid funding. But what we’re seeing, and what you’ll continue to see, is that in states that have adopted, much fewer people are uninsured, the hospitals are healthier, and they’re getting federal dollars. I think, in the end, once the political rhetoric has quieted down a little bit, more states are going to adopt it.

Pennsylvania’s Medicaid approach in which people with Medicaid go into the private exchanges looks like it’s going to be accepted by the federal government. So I think we’re going to have more of the states that haven’t adopted it go that route, and we’ll have just a lot more acceptance of that version of expansion. Which will be good — I think if you put more people into the exchange, that’s generally a good thing. I think by the end of the decade, every state will have expanded their Medicaid in some form. It would have been instantaneous, it would have been 2014, but 2020 isn’t bad. I just don’t think states like Texas and Florida are going to hold out forever. The governors are going to change there, it’s not going to be the hot button issue, and it’s going to be accepted that Obamacare is here to stay.

PBJ: A lot of the rhetoric around health care reform placed a great emphasis on cost-cutting. A number that has been thrown around a lot has been that over a quarter of Medicare spending is on the last six months of life7, which has been characterized as inefficient spending. Is this really an area to focus cost-cutting measures?

EE: Whoa, just because we spend 25% of Medicare dollars on patients who die, doesn’t mean it’s inefficient. Of course people who are dying are using a lot of resources. In their body various organs are failing, they’re in the midst of getting cared for, and optimal compassionate care is not going to be free — even if it’s lower than intensive chemotherapy or intensive cardiac treatment, it’s not free. So the idea that, somehow, there’s huge amounts of savings here needs to be tempered by these savings not being really found. Second of all, even as we’ve had this shift out of the hospital for end-of-life care over the last thirty years, it’s not like there’s been this pot of gold where you realize suddenly that Medicare spending has dropped because 50% of cancer patients no longer die in the hospital. So I think people who look at end-of-life care and say we can save a ton of money there need to be a little more sober about the fact that it’s unlikely you’re going to get away really

Emanuel, E. J. 2014. Reinventing American Healthcare: How the Affordable Care Act Will Improve Our Terribly Complex, Blatantly Unjust, Outrageously Expensive, Grossly Inefficient, Error Prone System. New York: PublicAffairs.

5 Referring to the 1965 Medicare Amendment to the Social Security Act. 6 The ACA originally mandated all states to expand their Medicaid programs, with federal assistance. That mandate was struck down by the Supreme Court in 2012. For further reading, see Edquist, D. J. et al. 2012. “Analysis: U.S. Supreme Court Upholds the Affordable Care Act: Roberts Rules?”. The National Law Review, June.

7 Pasternak, S. 2013. “End-of-Life Care Constitutes Third Rail of U.S. Health Care Policy Debate.” The Medicare Newsgroup, June 3.

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We’re nowhere near done. There are many things, which I point out in my book Reinventing American Healthcare4 that still have to be done; it’s an unfinished agenda. And by the way, this is never done — I keep making this analogy — it’s not like running a 10K or the marathon and you cross the finish line and you’re done and you get the gold medal and it’s all over and you go home. This is a constant, ongoing effort. Nonetheless, I don’t think there’s going to be another piece of major, major legislation on healthcare; it took 50 years to get to the ACA from Medicare/Medicaid.5 It’ll probably take 30, 40, 50 years until the next really big piece of reform. But along the way there’ll be changes and modifications, as there should be. But this framework of the ACA and exchanges, competition among private insurers, this is here to stay certainly as far as we can see. It’s going to be one of those things that political

PBJ: There have been elements of the legislation that were passed but then overturned by the Supreme Court, most notably Medicaid Expansion.6 How has that impacted the future efficacy of the legislation?

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It’s certainly going in the right direction at the moment. We’re getting much more widespread uptake of the exchange than had been anticipated. There seems to be much more of a view on the part of the public that having insurance is standard practice.

There’s pretty impressive cost control; not all of that’s the ACA, but certainly some of it is. And I think most importantly, there is a complete change of mindset in the healthcare system to, “This thing is here to stay. We have got to change how we deliver care.

It has to be more value-based, more focused on high quality at a low cost.” I think all of those things are definitely moving in the right direction.

scientists called path-dependent. Once you create these structures, it’s hard to un-create these structures.

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A Conversation with Ezekiel Emanuel cheap. Does that mean there aren’t ways of making care at the end of life both better and cheaper? I think there are, but can I tell you what they are? No, we haven’t had that series of great studies that can tell us “do the following four things and you really can deliver high quality, low cost end-of-life care.” We’re still far from knowing what those elements are.

PBJ: End-of-life care is obviously a very complicated issue and involves many parties and different kinds of considerations, which can often conflict. So in a typical case of a patient at the end of life, what kinds of factors are salient while trying to reach a medical decision?

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EE: Well, number one, two, and three is what does the patient want? And how do they view the end of their life? Have they come to accept it and recognize that, if they’re older, this isn’t a tragedy — this is the way the world works, the way biological systems work? On the other hand, there are many people who want to live for as long as possible and sort of rebel against that idea.

There can be family conflicts; not all family members can accept that their relative is dying, especially if it’s premature, before old age, or in young people. I’m an oncologist and that happens many times, and we perfectly well understand that nobody wants to see a forty-year-old die. And there’s always family dynamics, what is the family dynamic around this? Typically end-of-life care is not separate from whatever else is going on in the family: are our relations good where people are talking to each other, or are our relations strained where people are pointing fingers and yelling and screaming at each other? End-of-life care is always a good way into seeing where the family is fractured.

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PBJ: Many bioethicists support euthanasia or physicianassisted suicide (PAS) on the grounds that the physician is morally obligated to respect the patient’s autonomy, assuming that the patient is capacitated to make their decision, and also has an obligation to relieve suffering. So what are your thoughts on how these commitments might compete against the obligation to save lives?

EE: I’ve never been for legalizing euthanasia and PAS. I have a long, almost 25-year history writing that I oppose legalization of euthanasia and PAS.8 And I think that there are two fundamental, most important points here. First, even in a place like Oregon that has legalized PAS, 0.1% of all deaths involve assisted suicide.

Well, why are we spending all this time worrying about something that doesn’t affect 99.9 percent? Okay, tell me 1% of people think about it. Fine, if 99% of people don’t think about it, then PAS was entirely irrelevant to their deaths, so this just doesn’t seem to me a solution to the problem of compassionate, end-of-life care. If 99% aren’t even thinking about it, it’s not a solution to any real relevant problem. Second, all the data we have suggests that in endof-life care, for the people who want euthanasia or PAS, the main driver is depression, hopelessness, and control issues. I published that in the early 1990s; we were the first people to show this in a big way.9 Before that time and even after that time, people who don’t keep up with the literature say it’s people in excruciating pain who 8 9

want this. No, those people are not interested in euthanasia; they’re interested in pain relief. People interested in euthanasia and PAS look much more like people who are interested in suicide: they’re depressed and life is hopeless for them. The answer to someone who’s like that is not “oh, here are the pills.” The answer is usually “let’s address your depression and hopelessness,” and it seems to me that’s just a much better way to go on those issues.

When we first published this, there was a lot of skepticism, so we reaffirmed it in some other research we did. The Dutch especially were like, “no, that may be true with American patients, but it’s not true in Dutch patients.” So then the Dutch studied what was motivating their patients, and turns out it’s the same thing! Depression and hopelessness. It’s not about a quick, painless way to go because of extreme pain. So I just think our best answer to people who are depressed and hopeless should not be “Alright, let’s end your life.”

That’s just the wrong approach.

PBJ: In your opinion, are there any circumstances where PAS is ethically justified? What are the ethical distinctions between termination of life-sustaining care versus PAS that render one more justifiable than the other?

EE: First of all, they’re very different and anyone who’s participated in them realizes they’re very different. In stopping a medical treatment or not starting a medical treatment, you’ve shoved something down someone’s throat — a respirator, for example.

You’re taking it out away from the body; you’re stopping it intervening in the body. That’s very different than “I’m coming up to you and I’m going to inject something into you.” Those are two very different actions, very different motivations, and very different experiences. And I think morally they are very different.

Can I imagine circumstances where PAS might be the right thing to do in some cases? Probably, but it would be way down my list of thinking about it. Again, it’s a minority of people; it’s not where I think we should focus our energy. Much, much before we get there, we need to think about optimizing compassionate care for the vast majority of people. And that’s been my position, that’s been what I’ve worked for, for nearly thirty years in the field of bioethics. I think it takes time for attitudes to catch up with practices. The fact of the matter is, on optimal end-of-life care, we’ve actually had a big shift over the thirty years I’ve been working in this area. We do a much better job today — even though it’s not perfect, far from it — than when I started in the field. When I started in the field, over 70% of cancer patients died in the hospital and today it’s closer to 20%. Most patients did not get hospice, now most cancer patients get hospice. Even if they don’t get the optimal amount, there are still very different approaches to endof-life care.

Interview conducted by Ruchita Pendse and Kurt Koehler on behalf of the Penn Bioethics Journal.

Emanuel, E. J. 1997. “Whose Right to Die?” The Atlantic, March 1.

Emanuel, E. J., E. R. Daniels, D. L. Fairclough, and B. R. Clarridge. “Euthanasia and physician-assisted suicide: attitudes and experiences of oncology patients, oncologists, and the public.” The Lancet, 347(9018): 1805-1810.

Bioethics

Life, Health, and Environment M.A. in Bioethics The NYU master’s program promotes a broad conception of Bioethics encompassing both medical and environmental ethics through conferences, workshops, public lectures, and graduate courses. Students may choose to follow a health track or an environment track, and in both cases they will receive training in broader bioethical theories and application.

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For further information, please see our website:

www.bioethics.as.nyu.edu/page/discover New York University is an affirmative action/equal opportunity institution.

Article

Who Owns the Right to Die? An Argument about the Legal Status of Euthanasia and Assisted Suicide in Canada Miranda Barbuzzi‡

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The groundbreaking 2012 Supreme Court of British Columbia case Carter v. Canada struck down Section 241 (b) of the Criminal Code of Canada that makes assisted suicide illegal. This decision is currently under appeal by the defence, which fears that “vulnerable populations” will be in danger of being coerced into using the right to request physician-assisted suicide. This paper examines one approach to the moral and legal justifications for the decision of the Supreme Court of British Columbia in its landmark ruling in Carter v. Canada in 2012, which legalized physician-assisted suicide. It provides a model for the implementation of legally assisted suicide that Canada could follow. The model examined is the model used in the Netherlands, which has stringent procedures in place to ensure that those requesting physician-assisted suicide are not coerced into or in the wrong mental state when making their decision.

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Assisted suicide and euthanasia have long been contentious issues worldwide. Views vary depending on a number of considerations including autonomy, the “vulnerability” of the population in question, and sanctity vs. quality of life. The groundbreaking 2012 Supreme Court of British Columbia case Carter v. Canada struck down Section 241 (b) of the Criminal Code of Canada that makes assisted suicide illegal. This decision is currently under appeal by the defence, which fears that “vulnerable populations” will be in danger of being coerced into using the right to request physician-assisted suicide.

Within Canada’s current legal landscape, suicide is a legal act. However, assisted suicide and active euthanasia in any form are considered crimes. This status has the potential to change in the coming months and years. The Supreme Court of Canada, the highest judicial power in the country, will hear the appeal of the B.C. decision in Carter v. Canada in late 2014, a case that argues that the illegal status of assisted suicide is a violation of Section 7 and Section15 of the Canadian Charter of Rights and Freedoms (see Appendix A).

The long-standing prohibition on any form of assisted suicide or active euthanasia stems from a number of issues.

The first major fear is that individuals in question may not request assisted suicide with true autonomy, which is defined as an individual’s ability to make a subjective decision based on relevant facts and a personal assessment of their own condition (Carter v. Canada, 2012). The second issue deals with the idea that assisted suicide and active euthanasia may pave the way for non-voluntary and involuntary euthanasia. These fears are reflected in the legislation of countless countries, and often cause appeals and amendments to fail to pass regardless of whether they were subject to appropriate debate. ‡ Ryerson University, miranda.barbuzzi@ryerson.ca

The Netherlands is one country that has addressed these fears, establishing suitable legal and medical policies in 2002.

The resulting legislation is the Termination of Life on Request and Assisted Suicide Act. Under this act, physicians who perform an act of euthanasia or assist in the suicide of a patient are not punishable under law if they have followed specific guidelines (Rietjens, Van Tol, and Van Der Heide 2009). Through this system, all patients seeking euthanasia or assisted suicide in the country are examined by at least two medical experts prior to the procedure, and medical, legal, and ethical experts analyze each case afterwards. This aids in upholding and ensuring the autonomy of the patient in question leading up to the procedure, and ensures that acts of euthanasia or assisted suicide are reviewed for ethical breaches. This Act addresses the concerns of true autonomy among patients while also analyzing cases in order to prevent a ‘slippery slope.’ As such, the Netherlands model could offer an example of a legal and medical structure to successfully deal with Canada’s concerns surrounding the issue of assisted suicide.

Passive vs. Active Euthanasia An act of passive euthanasia involves the withdrawal or cessation of treatment, allowing the patient’s medical condition to run its natural course. This form of euthanasia is often referred to as “letting die” and is currently legal in Canada. Active euthanasia, on the other hand, is defined as the use of lethal substances to end a patient’s life. There has been a long-standing prohibition against this form of euthanasia, and the Supreme Court of Canada most recently

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Euthanasia and Assisted Suicide in Canada upheld its illegal status in the 1992 Sue Rodriguez case. This ruling is currently being challenged by Carter v. Canada in British Columbia and will be heard by the Supreme Court of Canada later this year.

Both passive and active euthanasia, as well as assisted suicide, should be legal options in the Canadian context within the parameters of voluntary consent. The reasons for justifying the legitimacy of passive euthanasia — ­ autonomy and self-determination — can also be applied to these other forms of medically assisted death. This paper will attempt to show how legal status should be granted to active euthanasia and assisted suicide on the grounds that it protects autonomy, follows from the legality of passive euthanasia, and avoids the ‘slippery slope’ argument through following the precedent of the Netherlands’ euthanasia laws.

Carter v. Canada: Overview

The plaintiffs believed that S.241(b) of the Canadian Criminal Code (which prohibits physician-assisted suicide) violated their S.7 and S.15 Charter rights (see Appendix A).

Justice Lynn Smith stated that the Court believed the Criminal Code provisions regarding assisted suicide “unjustifiably infringe on the equality rights of Gloria Taylor and on the rights to life, liberty and security of the person of Gloria Taylor, Lee Carter and Hollis Johnson” (Carter v. Canada 2012). The majority of the Justices came to the conclusion

Previous cases of assisted suicide justified the maintenance of S.241(b) of the Criminal code based on the beliefs of the ruling Justices. They held that the legalization of assisted suicide would prove to be too damaging to both society and the justice system’s successful protection of Canadian citizens (Carter v. Canada 2012). These concepts are reflected in the main concerns of the defendant in the Carter v. Canada case, which were: 1) the endangerment of ‘vulnerable populations’ and 2) the incapability to make a system of safeguards that protected citizens against ‘inherent’ risks.

The most commonly stated reason for maintaining a legal distinction between currently recognized end-of-life practices and physician-assisted suicide is that any system of safeguards would not be able to adequately protect ‘vulnerable’ persons and their autonomy (see Appendix B for definition of ‘vulnerable’ persons) (Carter v. Canada 2012). Within the medical framework, autonomy is defined as the patient’s ability to make a subjective decision regarding their treatment based on their understanding of the relevant medical facts given by the doctor and on their assessment of their own personal circumstances (Carter v. Canada 2012). The Supreme Court of B.C. agreed with the plaintiff that S.241(b) of the Criminal Code took away the autonomy of certain individuals who desired a physician-assisted suicide. It must again be noted that suicide without the aid of another individual is legal in Canada. In this way, Canadian law gives a physically able person the ability to exercise their autonomy and end their life, yet denies a physically incapable individual

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Legal Issues

Concerns of Exploitation

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Carter v. Canada was filed in April 2011 and ruled on by the Supreme Court of British Columbia on June 15, 2012. The plaintiffs included Lee Carter, Hollis Johnson, Dr. William Shoichet, The British Columbia Civil Liberties Association (BCCLU), and Gloria Taylor. Lee Carter and Hollis Johnson aided Carter’s mother, Kay Carter, upon hearing of her desire to go to Switzerland in order to have a legal physicianassisted suicide due to her chronic pain (Carter v. Canada 2012). Dr. William Shoichet is a family physician from Victoria, B.C. who believed that physician-assisted suicide was an integral part of providing health care to grievously and irremediably ill patients. The British Columbia Civil Liberties Association, being heavily involved in the advocacy for and education around end-of-life choices, believed that there was reasonable cause to question whether Canadian citizens have a constitutional right to physician-assisted suicide (Carter v.

Canada 2012). The final individual involved in this case was Gloria Taylor, who had ALS (amyotrophic lateral sclerosis), a disease that causes progressive muscle weakness, leading to near complete paralysis while leaving cognition and sensation generally unaffected (Carter v. Canada 2012). Taylor wished to have a physician assist her in ending her life when she deemed her disease to have progressed to the point where her physical deterioration was too much to bear. She petitioned the court due to the fact that she wanted her family with her when she passed away and was financially unable to travel to Switzerland to obtain legally acceptable assistance in committing suicide (Carter v. Canada 2012).

that Taylor and Carter, as persons who were disabled to the extent of being incapable of ending their own lives, were denied something available to the able-bodied (Gurney 2012).

This is due to the fact that Canada does not have a standing prohibition against the act of suicide, so able-bodied persons are able to commit suicide under Canadian law. Canadian legislation only criminalizes acts of suicide in which another person aids the individual in question in committing suicide.

It is this distinction, in regards to the physically disabled, that the Court deemed to be a violation of S.15 equality rights.

Section 7 of the Charter guarantees the rights of life, liberty, and security of the person. The Court held that prohibiting assisted suicide endangered the lives of physically disabled citizens who wished to commit suicide since continued criminalization of this act may shorten their lives. As outlined in the official case, “Ms. Taylor’s reduced lifespan would occur if she concludes that she needs to take her own life while she is still physically able to do so, at an earlier date than she would find necessary if she could be assisted.”

(Carter v. Canada 2012) As this accelerated timeline would be caused by both the legal status and access to physicianassisted suicide, the Court ruled that the S.241(b) of the Criminal Code was unjustifiable, and was not in accordance with fundamental justice. In the eyes of the court, this possible scenario, along with the infringement of equality rights, overturned previous rulings in Canada, and in particular, the 1992 Sue Rodriguez case.

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Euthanasia and Assisted Suicide in Canada the tools necessary to make the same decision. A majority of those against assisted suicide, including the defence in Carter v. Canada, claim that they are trying to protect the autonomy of these individuals by maintaining the illegal status of assisted suicide. They believe that since these individuals are particularly susceptible to coercion when making the decision to request a physician-assisted suicide, they must protect against this possible scenario by revoking the choice altogether. In doing this, those against assisted suicide believe they are intervening against a patient’s autonomy in order to protect it from other people attempting to control the patients’ opinions and desires regarding assisted suicide.

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Euthanasia and Assisted Suicide Laws in the Netherlands

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The legal system of the Netherlands allows both passive and active euthanasia, and successfully manages the two through its Termination of Life on Request and Assisted Suicide Act. The Act, introduced in April of 2002, states that physicians who perform euthanasia or assist in the suicide of their patient are no longer punishable under law if they have followed the Due Care Criteria (see Appendix C) and reported the death of the patient to one of the regional euthanasia review committees (Rietjens, Van Tol, and Van Der Heide 2009). As the Netherlands’ laws regarding legal euthanasia only apply to physicians and their patients, restriction is placed not only on those permitted to commit the act, but also the recipients. If a patient’s quality of life is poor due to extreme pain, and she has no hope for improvement of health, then if she wishes to die, the law states that her wish should be respected (De Haan 2002).

In the Netherlands, euthanasia is no longer a hazy and indeterminate aspect of society. It now has concrete processes in line with the basic rights of citizens, as the Due Care Criteria act as the law and the review committee acts as the judge. In this way, active euthanasia is defended against the ‘slippery slope’ argument and the protection of citizens is ensured. Each case is reviewed by one of the euthanasia boards, which consist of a legal expert who acts as the head, a physician, an ethicist, as well as a lawyer who assists them as secretary. This system of law differs from the way in which the laws in the provinces of Canada allow passive euthanasia through the right to refuse or end medical treatment. This right is covered under provincial legislation but is upheld by S.7 of the Canadian Charter of Rights and Freedoms. In the provinces of Canada, a case is reviewed only if suspicion of illegality is present.

Autonomy Within Passive Euthanasia and Assisted Suicide Dr. Bonnie Steinbock is a distinguished philosophy professor with a specialization in bioethics. She argues against using autonomy to justify active euthanasia despite its use in justifying passive euthanasia. She believes there are two issues within the question of whether a patient should be

allowed to refuse or terminate medical treatment: first, wanting to end one’s life due to suffering and second, the patient’s right to autonomy. The legality of refusing medical treatment is based on the patient’s right to make her medical decisions unhindered (Steinbock 1979). This clarification supports the underlying purpose of the right of autonomy, which is to enable a competent person to make her choices freely. The reasoning behind the permission for passive euthanasia undermines prohibition of active euthanasia and assisted suicide since they share the same foundation. If allowing a patient to refuse or discontinue medical treatment is justified because it protects their autonomy, then it is contradictory to say that legalizing active killing and assisted suicide does not do the same thing.

The ‘Slippery Slope’ Argument The main ethical support of passive euthanasia is the right to autonomy, which dictates that individuals have the right to make their own choices and have those choices be respected.

However, limits on autonomy have been placed in order to “…protect individuals from others who may wish to control their lives” (Tiedemann and Valiquet 2008). This line of thinking is based on the idea that if active euthanasia and/ or assisted suicide were legalized, patients could be somehow coerced to request euthanasia against their true wishes. The belief that the decision to legalize these forms of medically assisted death, even if morally sound, could lead to an unscrupulous result is a ‘slippery slope’ argument and a main foundation in the anti-euthanasia/assisted suicide position.

In applying the slippery slope argument to euthanasia and assisted suicide, critics claim that if society legally accepts active killing for terminally ill patients who request it due to extreme pain or disability, less serious cases will eventually be accepted. Some proponents of this argument go so far as to state that legalizing active suicide will inevitably lead to the killing of those who simply request it without facing imminent death, and will finally end with the euthanizing of those who do not ask for death (Collier and Haliburton 2011). These fears stem from questioning the true autonomy of patients, as well as the grounds for approving a request for assistance in committing suicide. Groups against legalizing assisted suicide believe that an individual, especially elderly individuals, could feel pressured to ask for assisted suicide for several improper reasons (Not Dead Yet, Disability Rights Education and Defense Fund (DREDF), Care NOT Killing). These reasons include not wanting to be a burden to their family, a lack of good health care or in-home support, or fear of going to a nursing home (DREDF). The physician’s ability in this context to appropriately identify such a situation is uncertain.

These fears could be mitigated through mandatory psychological exams and counseling for both the patient in question and his or her family by a psychologist specializing in terminal illnesses. These sessions would allow a professional to properly analyze the psychological status of the patient and any real or imagined external pressures on them. The

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Euthanasia and Assisted Suicide in Canada Netherlands euthanasia and assisted suicide laws display a simplistic version of this model, as the primary physician of the patient must obtain a secondary assessment by another physician. This secondary physician is often part of a network of “general practitioners and other physicians that are trained to provide expert assessments,” called the Euthanasia in the Netherlands Support and Assessment Project (Publication of the Netherlands Ministry of Foreign Affairs).

The second primary concern of anti-euthanasia groups considers the grounds upon which a request for assisted suicide or voluntary euthanasia would be approved. This mainly results from concerns that a prognosis of “terminally ill” can be inaccurate, especially in cases that the patient is given six months or fewer to live. These groups state that such a prognosis is often wrong, and as such an individual who chooses assisted suicide due to that prognosis could have lived for several more years or even decades (DREDF, Not Dead Yet). Therefore, they believe that legalizing assisted suicide and/or voluntary euthanasia jeopardizes the lives of ill patients. These concerns are addressed in the Due Care Criteria, which state that the patient’s suffering must be judged to be unbearable and have no prospect of improvement (Termination of Life on Request and Assisted Suicide Act, see Appendix C). Such suffering is defined by the prevailing medical opinion, which must be confirmed by two physicians. Additionally, the primary doctor and the patient are required to discuss every possible alternative treatment. As long as a feasible alternative is available, there is, in a medical sense, a prospect of improvement and therefore the Due Care Criteria have not been met (Publication of the Netherlands Ministry of Foreign Affairs). It must also be noted that there are certain diseases from which there is no recovery and the progression of the illness is well documented and is unlikely to deviate (like Amyotrophic Lateral Sclerosis (ALS), and Huntington’s Disease). In such cases a terminal illness prognosis is an expected event in the progression of their disease and is unlikely to alter their perspective regarding their future.

patient, and not their right to die, with patients facing imminent death such a line of thinking is unavoidable. It is impossible to remove that variable from the decision making process of passive euthanasia and, as such, should not be used as justification for prohibiting active euthanasia or physicianassisted suicide. Within the Canadian context of legalizing physician-assisted suicide, considering quality of life could be used to mark a distinction between those whose request is reasonable (those facing imminent death) and those who would ask to be killed despite not facing terminal illness. In this way the consideration of quality of life when dealing with requests for physician-assisted suicide could be one of many safeguards against the possibility of a ‘slippery slope’.

The current laws of the Netherlands condone physicianassisted suicide, and use quality of life along with numerous other factors in order to successfully ensure that a ‘slippery slope’ does not occur.

Sanctity of Life vs. Quality of Life

APPENDIX A

As a country, Canada’s belief in the sanctity of life dictates the current status of euthanasia and assisted suicide. It is believed that all life is sacred and that it is immoral to be deprived of life, whether that decision is made by another person or the individual in question (Carter v. Canada 2012).

As such, the Canadian legal system does not view quality of life as valid reasoning to permit active euthanasia and assisted suicide. However, quality of life should be a deciding factor in the legal context, as it already is on a personal level. The determination of quality of life is often a factor in a patient deciding whether to invoke their right to refuse or discontinue medical treatment. A patient will decide that their current as well as future quality of life is not worth the physical and emotional pain, and will therefore opt out of life-preserving medical treatment. Although the right to refuse treatment is intended to protect the autonomy of the

Abridged Canadian Charter of Rights and Freedoms:

Closing Statement

Section 7: “Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice.”

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Section 15 “(1) Every individual is equal before and under the law and has the right to the equal protection and equal benefit of the law without discrimination and, in particular, without discrimination based on race, national or ethnic origin, colour, religion, sex, age or mental or physical disability.

(2) Subsection (1) does not preclude any law, program or activity that has as its object the amelioration of conditions of disadvantaged individuals or groups including those that are disadvantaged because of race, national or ethnic origin, colour, religion, sex, age or mental or physical disability.”

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Canadian law regarding assisted suicide and active euthanasia has reflected the country’s moral beliefs and fears for decades. The possible amendment to these laws would mark a milestone in Canadian legal history, as well as a reflection in the changing moral landscape of the country. The fears surrounding the issue of assisted suicide and active euthanasia are valid, as has been seen in the upholding of the law since its creation. However, new legislation and medical models could make it possible to pacify the major fears surrounding true autonomy and the ‘slippery slope’ scenario. An example of this success can be seen in the Netherlands, which has extensive safeguards in place both prior to and following an act of physician-assisted suicide. The prerequisites of this model aid in ensuring true autonomy, and the review committees watch for any violations in the current criteria and movements towards the feared ‘slippery slope.’ As such, the Netherlands model appears to strike a balance between protection and freedom.

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Euthanasia and Assisted Suicide in Canada APPENDIX B

References

B.C. Supreme Court Document- Carter v. Canada [2011]

Canadian Charter of Rights and Freedoms, S. 7 and S. 15, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (UK), 1982, c 11.

Care NOT Killing. “About Care Not Killing.”

Carter v. Canada, [2012] B.C.S.C. 886.

Collier, C., and R. F. Haliburton. 2011. Bioethics in Canada: A Philosophical Introduction. Toronto, ON, Canada: CSPI. Gurney, M. 2012. “Court Strikes the Right Balance on Assisted Suicide.”

National Post, June 18.

Criminal Code, RSC 1985, c C-46 S. 241(b).

Disability Rights Education and Defense Fund. “Why Assisted Suicide Must Not Be Legalized.”

Haan, J. D. 2002. The New Dutch Law on Euthanasia. Medical Law Review, 10(1): 57-75.

Netherlands Upper House of the States General. 2000. “Schreeuw Om Leven.” Ministry of Justice, Ministry of Health, Welfare and Sports, November 28.

Netherlands Ministry of Foreign Affairs International Information and Communication Department. “Q & A. Euthanasia: A guide to the Dutch Termination of Life on Request and Assisted Suicide (Review Procedures) Act.” Not Dead Yet. “Not Dead Yet Disability Activists Oppose Assisted Suicide As A Deadly Form of Discrimination.”

Rietjens, J. A., D. G. Van Tol, and A. Van Der Heide. 2009. Judgement of Suffering in the Case of a Euthanasia Request in The Netherlands. Journal of Medical Ethics, 35(8): 502-507.

Steinbock, B. 1979. The Intentional Termination of Life. Social Science & Medicine, 6(1): 59.

Tiedemann, M., and D. Valiquet. 2008. “Euthanasia and Assisted Suicide in Canada.” ON: Parliament of Canada.

Section 624: The groups upon which Battin et al. focussed are those which are usually identified as vulnerable in the public, political and professional debates over physician-assisted dying: the elderly; women; uninsured persons; persons with AIDS; persons with low educational status; the poor; racial and ethnic minorities; persons with physical or mental disabilities or chronic non-terminal illnesses; minors and mature minors; and persons with psychiatric illnesses, including depression.

APPENDIX C

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Section 2 of the Termination of Life on Request and Assisted Suicide Act:

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The Due Care Criteria Physicians must: 1. be satisfied that the patient’s request is voluntary and well-considered; 2. be satisfied that the patient’s suffering is unbearable and that there is no prospect of improvement; 3. inform the patient about his situation and further prognosis; 4. discuss the situation with the patient and come to the conclusion that there is no reasonable alternative; 5. consult at least one other physician with no connection to the case, who must then see the patient and state in writing that the attending physician has satisfied the due care criteria listed in (1) to (4) above; and exercise due medical care and attention in terminating the patient’s life or medical care and attention in terminating the patient’s life or assisting in his suicide.

About the Author Miranda Barbuzzi is a student at Ryerson University majoring in Inquiry and Invention and minoring in English.

Dr. Meredith Schwartz, Assistant Professor of Philosophy at Ryerson University, served as the faculty sponsor.

Schwartz is also a past member-at-large for the executive board of the Canadian Bioethics Society (2007-2009).

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Article

Where is the Value in Social Value?

A Framework and Policy Recommendations for Assessing the Social Value of Clinical Research Kaitlin Sibbald‡ Social value is a key component of ethical clinical research; however, there are barriers that prevent it from being accurately assessed as such. I argue that there is an inherent confusion of social value with social benefit in the clinical ethics literature, in the sense that social value must take into consideration possible social harms of research, whereas social benefit should not. Currently, social benefit is being assessed, not social value. The structural barrier I examine in this paper is the composition of Research Ethics Boards (REBs). Canada does not require that anyone knowledgeable in possible social implications of the research be present on an REB. Thus, making a value judgment, which must consider both potential benefits and harms, becomes nearly impossible. Using concepts from valuation processes across research domains, I suggest a model to better assess social value. Based on this model, I recommend three amendments to help improve REBs’ ability to judge the social value of clinical research.

Section 1: Introduction

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‡ University of King’s College/Dalhousie University, kaitlin.sibbald@dal.ca

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In their influential paper, “What Makes Clinical Research Ethical,” Ezekiel Emanuel, David Wendler, and Christine Grady (2000) outline the seven requirements of ethical clinical research.

The first of these requirements is social or scientific value. ‘Value’ is the generation of knowledge and/or the development or evaluation of interventions that could lead to human health or well-being (adapted from Emanuel, Wendler, and Grady 2000).

Its purpose, these authors suggest, is twofold. First, it protects research participants from being exploited by preventing them from being exposed to the potential harms of research without the possibility of social benefit. Second, it promotes the responsible use of finite resources (Emanuel, Wendler, and Grady 2000).

As such, this component is integral to ethical clinical research, as it ensures both respect for the research subjects and maximizes the benefits of the research results for society.

The importance of social value can also be seen in how it persistently appears in the criteria for ethical clinical research. The requirement of social value is present in both the Nuremberg Code (1949), which suggests research should be conducted for the good of the society, and the Declaration of Helsinki (1964), which suggests participants can only undertake risks if they are proportionate to the importance of the research objective.

As Benjamin Freedman (1987) explains, under the Nuremburg model, value is judged twice, once as a minimum threshold and again as a factor in assessing the risk:benefit ratio. In a Helsinki model, however, value is only judged once, as a part of the

risk:benefit calculation (Freedman 1987). Although the role of social value is seen differently in the two models, both suggest that research needs to be socially valuable in order to be ethical.

It may appear that this condition for ethical clinical research is practically self-evident in the community because there is no motivation to produce socially invaluable research. In a profitdriven consumer market, clinical researchers are motivated to produce safe and effective treatments so that their treatments, for example, pharmaceuticals, will be approved by the Therapeutic Products Directorate (TPD) and meet the requirements of the Food and Drugs Act (Health Canada 2001). These steps are necessary in order for the treatment to be bought and sold and therefore return a profit. Additionally, products that are safe and effective motivate consumers to purchase them, again increasing profit and making them economically valuable. It may therefore seem that hidden behind the guise of the economic value to the research company, particularly in privately funded research, is implied social value. I argue, however, that this is not necessarily the case. An economically valuable product is one that is likely to return a profit because it is likely to be consumed. This may be because it satisfies a social necessity, is comparably better than other products on the market, or simply because it is well advertised. In contrast, a product is socially valuable because it “leads to human well-being” (Emanuel, Wendler, and Grady 2000). Economic value and social value are distinguishable because it is possible that the product of research, be it a piece of information or a literal object, may turn a profit for the producers and do no good for human well-being.

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Social Value of Clinical Research

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Take, for example, the planned Surfaxin trial to treat Respiratory Distress Syndrome (RDS) in infants in 2000. As described

by Hawkins and Emanuel (2008), Discovery Labs, the company behind this drug, did not think that Surfaxin would fare well in a head-to-head trial against the leading drug to treat RDS. Instead, they wanted to do the trial running Surfaxin against a placebo to prove that it was effective. This is an economically valuable move because, had the trial revealed Surfaxin to be more effective than a placebo, it would have returned a large profit to Discovery Labs.

However, the result of this trial would not necessarily have been socially valuable. Yes, society would have gained the knowledge that Surfaxin was more effective than a placebo, but in order to enhance well-being, it would be necessary to prove that Surfaxin was more effective than the leading competitor, something that the company was not willing to do. Thus, the motivation to produce economically valuable research may lead to socially valuable research, but, as in the proposed Surfaxin trial, this is not necessarily the case.

We may question whether the social value component is a superfluous addition to the list because it is implied in the definition of research. One goal of research is to generate new knowledge.

As we can never preemptively guarantee the results and only gain evidence for, but never prove, causality, all research should be socially valuable as long as it produces evidence. Therefore, all research, if done properly, will produce knowledge that is at least somewhat valuable. Thus, stating that clinical research must have social value to be ethical when it by definition does so is superfluous.

Importantly, however, value is not a binary quality of research.

Value is not either present or not. Rather, it exists on a continuum of more or less value in comparison to other options. An example used by John Worrall (2008) illustrates this point. In 1980, the University of Michigan started to treat babies suffering from pulmonary hypertension using extracorporeal membrane oxygenation (ECMO). This technique was new and evidence was not available to suggest that it was as effective or more effective than the treatments currently available. The trials to test ECMO were designed in such a way that the medical community would not accept the results, whether positive or negative. Thus, multiple trials were necessary. On a social value continuum, this trial is not valueless because it does add to the knowledge body on the subject by producing what the scientific community considers to be weak evidence. However, because this evidence was not accepted by the medical community and therefore could not enhance treatment opportunities, it had less social value than a trial that did not have these shortcomings. The fact that there is value is not sufficient. We require a certain amount of value in research in order to consider it ethical. How we decide how much value is required depends on many different factors, one of which is the risk to benefit ratio.

The necessity for social value does not stand alone, but it is implicated in the risk to benefit calculation. D. Wendler and F. G. Miller suggest that “risks and burdens to participants‌are justified by the potential clinical benefits to participants, if any, and the social value of the knowledge to be gained from the researchâ€?

(2007). Although they disagree on the methodology for assessing risks and benefits, C. Weijer and P. B. Miller (2004) also agree on this point. They suggest the potential for social value justifies a

risk:benefit calculation that would otherwise be unfavorable (Weijer and Miller 2004). Thus, we not only need social benefit, but enough social value to balance the risks of the trial.

These examples suggest that social value is a necessary component of ethical clinical research. As demonstrated by the ECMO trial, not all experiments automatically meet this component, as value must not only be present, but also balance out other risks of the trial. As well, in the Nuremburg model, social value is also required as a component in itself, regardless of the trial risks to protect participants. In addition, while it may appear that companies who are motivated to produce economically valuable research simultaneously produce socially valuable research, the Surfaxin proposal shows that it is not necessarily the case that they do.

Currently, however, there are barriers that prevent social value from being accurately assessed. The main conceptual barrier I examine in this piece is the confusion of social value with social benefit in the clinical ethics literature. I argue that social value must take into consideration possible social harms of research, whereas social benefit does not, and that what is being assessed currently is only social benefit. This lends itself to the need to scrutinize structural institutions that help conduct these evaluations. The main structural barrier I examine is the composition of Research Ethics Boards in Canada, where the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), does not require that anyone knowledgeable in possible social implications of the research be present on a Research Ethics Board.

Section 2: Structural and Conceptual Barriers to Social Value Assessment As Emanuel, Wendler, and Grady (2000) point out, the overarching objective of research is to generate knowledge that can promote understanding and/or human well-being. Thus, inherent in the idea of research is that knowledge of the result does not exist prior to its generation through the act of researching. It thus follows that the impact this knowledge will have on society is also unknown. Therefore, before the research is conducted, it is impossible to know exactly what knowledge will be generated and exactly what impact it will have on society. It may therefore be argued that it is impossible to prospectively assess social value.

This idea appears in conflict with the notion that social value can be a requirement of ethical research that must exist prior to the research being conducted.

However, arguing that individuals cannot prospectively know the consequences of their actions does not consider that people can still be reasonably sure of the consequences of their actions before they act, allowing actions to still hold moral value. For instance, while it may be the case that the actual social value of research cannot be assessed until after the research is conducted, the probable social value of research can still be assessed just as one assesses the probable consequences of all other actions when deciding to perform them. Thus, despite epistemic concerns, social value can still be assessed prior to research being conducted.

However, in order for this to be the case, those who determine if the research is ethical should have some background understanding in the probabilities of social implications occurring

Social Value of Clinical Research

Section 3: Concepts for Assessing Social Value

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This role is comparable to step one of Daily et al.’s (2000) valuation process.

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Although I argue social value is a key component of ethical research, ‘value’ is an abstract concept and it is difficult to determine how to assess it. Literature on assessing social value in clinical research contexts is scarce. However, other disciplines have explored this issue. I argue that the principles used in other disciplines to assess value may generalize across academic genres and may be useful in assessing the social value of clinical research.

In their paper entitled “The Value of Nature and the Nature of Value,” Daily et al. (2000) explore the process of assessing value in the context of ecosystem preservation and industrial development. Daily et al. (2000) outline three steps in the process of valuation, or assessing the value of a project. The first step involves brainstorming different methods for achieving the same

goal (Daily et al. 2000). The second step assesses the impacts of each alternative (Daily et al. 2000), including risks, social benefits, costs, experimental design, and other factors relevant to the research process. Many of these factors, specifically the ones that assess possible harms, are currently being left out of the ethical assessment of research. The third step translates the respective impacts into comparable units so researchers can compare the resulting effect on human well-being for both the present and the future (Daily et al. 2000). In the context of clinical trials, these steps highlight the importance of ensuring that research tackles a specific issue while positively impacting the well-being of people in the society.

In addition to this quantitative approach, there is growing recognition that value is contingent, “not simply ‘added,’ but… mutually ‘created’ and ‘re-created’ among actors with different values” (Ramirez 1999). The idea that value is not an inherent quality, but something that is contingent with respect to the actors that create it, indicates that in order to maximize value for society, the priorities of those who determine the value of research should reflect the beliefs of those in society who will be engaging with the research and its results. As such, according to this theory, a collaborative, situated assessment of social value may maximize the value of research for society.

Stephen Gilbert highlights these ideas of contingency and collaboration in his article that recommends supplementing traditional review with community review (2006). Gilbert (2006) proposes the establishment of Environmental Health and Community Review Boards (EHCRBs) to assess ethical, legal, and social implications that extend beyond the protocols of the study. As well as performing the traditional duties of an REB, an EHCRB would also have an ethical commitment to the community in which the research is taking place to ensure the research will be valuable. One of the core principles of his model is that it “promotes active collaboration and participation at every stage of research” (Gilbert 2006), thus taking into account the variety of perspectives present in contemporary society and allowing for a collaborative discussion of all factors pertaining to the clinical trial (Ramirez 1999).

As well, Dilbert Miller and Neil Salkind (2002) describe the characteristics of applied social research as outlined by Donald Rubin (1983). Rubin addresses a third technique to evaluate social value of trials. He highlights four positions that allow for the assessment of the impact of research. The duties of these positions include studying social processes and describing alternatives that exist to solve the social problems that exist1, studying social processes to determine if a program or project is accomplishing what it is intended to accomplish, interpreting the outcomes of data, and examining outcomes data to discover patterns that require some organizational or governmental action (Miller and Salkind 2002). These concepts are important in applied research to assess its impact, both positive and negative, and its ability to achieve its research goals.

These experts highlight the following concepts as important in assessing value: 1) considering other methods of achieving the same goal, 2) examining the possible positive and negative consequences of alternatives, collaboration and joint production of value, 3) examining the impact of a project and its ability to ac-

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— something that is not presently required at any point during the research process and more specifically during REB review (MRC et al. 2010). Article 6.4 of the TCPS2 (MRC et al. 2010) outlines the required size and composition of REBs. Although, among other requirements, the policy requires one person to be a community member, it does not require that any member be knowledgeable in the probability of social implications occurring or the effects of research on society. While it may be argued that the community member is supposed to offer insight into these areas, the policy asserts that the community member’s primary role is to reflect the view of the research subjects (MRC et al.

2010), not the community that will be implicated in the results.

An advertisement seeking a community member for an REB states: “Community members represent the perspective of the research participants. Their role is to ensure that the information being provided to research participants is readable, correct and can be understood” (CDHA 2014). Thus, their role is to ensure informed consent occurs with the information provided, but it does not include assessing the research’s value for the community, a problematic distinction because it is unlikely that social value will be assessed when no one with the information to perform this assessment is present or is responsible to attain this information.

The community member, although the name suggests she may be able to judge the social value of the research, is only responsible for ensuring participants can understand the information, not assessing the value of the research.

The question then becomes: how can the ethical review process be modified to ensure social value is taken into account? As William Rosenzweig describes, “As a result of the lack of common practice around social impact assessment and reporting, ultimately many of the ventures we have studied are judged solely on financial terms, even if their goals are a primary driver for operational choices, or if social goals were a key motivation from the outset” (Rosenzweig 2004). As the Surfaxin trial described above highlights some of the key issues with using a solely financial framework to assess the social value of research, we are in need of a framework to assess the social value of clinical research. Specifically, a model that, first, includes considering the probable effects of research results on society and second, looks at both the possible social benefits and social harms that the research causes will raise key areas for evaluating social value.

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Social Value of Clinical Research complish what it was intended, and 4) ensuring the proper follow up occurs to assess the social implications of the research. Linking these concepts, I will attempt to develop a model that will allow REBs to better assess social value.

Section 4: Developing a Framework In this section, I will explain how each of these five criteria may help to promote socially valuable research, and I will provide an example that demonstrates the importance of each.

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Make a True Social Value Calculation

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This element involves making a value calculation that includes both the possible social benefits and possible harms of the research, as well as the risks and benefits to individuals participating in the research.

An example of an equation that allows for such a calculation is below.

1. Estimated Social Benefit - Risk of Social Harm = A 2. A must be > 0 3. Possible Benefit to Participants + (A) – Risk of harm to participants = J 4. J must be > 0 Statements 1 and 2 represent equations that take into account both potential social benefit and potential social harm, thus allowing for a social value calculation to be made, rather than just a calculation of social benefit. The variable A represents the net social benefit that remains once social harm has been accounted for. By ensuring that A is greater than 0, we ensure that the research being conducted is socially valuable.

The variable J represents the net benefit overall of the research. The calculation made in statement 3 ensures that participants will not be exploited because they cannot assume more risk than the net social benefit and the possible benefit to themselves.

Although it is debatable exactly how much risk participants may undertake in proportion to the value of the research2, these equations provide an example of how social value may be calculated and included in the risk benefit ratio instead of considering social benefit, which is current practice.

Collaboration and Joint Value Production One way to promote collaborative value production is for the researchers to make the participants aware of the purpose of the research and the possible social consequences of the results during the informed consent process. By informing the participant during the informed consent process of not only the risks she is expected to undertake in the trial, but also the potential risks the research poses to her community, it allows the participant’s values to inform the research. She has the choice, based not only on the risks and benefits to her, but also to her community, to choose whether or not to participate in the research. As bioethicist Mark A. Yarborough explains in a commentary regarding incorporating patient values into clinical research, “We owe the public honest disclosure about why any given trial is being conducted so that they understand the extent to which a trial, if completed, could 2

promote the common good” (2013). Yarborough advocates that including a value statement on informed consent forms will help build public trust and increase participants in clinical trials.

I suggest that including a value statement not only consisting of the possible social benefits, but also social harms, may motivate researchers to produce not only economically valuable, but also socially valuable research and allow participants values to help inform research.

Ensure the proper follow up occurs to assess the social implications of the research This element consists of ensuring that there is a way to track the consequences of the results to better inform the future valuation of research. This criterion may allow us to examine the impact of a project and its ability to accomplish what it was intended.

This statement builds off of Gilbert’s (2006) recommendation to implement EHCRBs to increase social accountability and assess the consequences after the research is complete, as well as Miller and Salkind’s (2002) recommendations for assessing the value of applied research.

Minimize the extent of possible social harm in the specific social context of the research This element ensures that government or organizational structures are in place to deal with social harm, should it arise.

This criterion ensures that there are adequate organizational resources in place to deal with the consequences of the research and that there is a way to assess the impact of the research to determine if it is necessary to mobilize these resources. This allows us to ensure that we are conducting research within a community that is prepared to deal with both the potential positive and negative effects of the research, allowing us to minimize potential social harm and increase overall social value.

Make a comparative value judgment with other types of research Once the goal of the research is determined, other methods of achieving the same goal that have fewer risks to the participants are identified and considered. This point builds off of the Daily et al.’s (2000) first step, which suggests that we should consider other alternatives of accomplishing the same goal. A comparative value judgment highlights the notion that value exists on a continuum and researchers should not strive simply to produce research that is of value, but research that is comparatively more valuable than the alternatives.

These elements of my framework, laid out in separate points, may make it easy to see the merits of each point. However, it may still be unclear as to how these criteria interact to promote valuable research. To demonstrate how this framework may be used, I will examine the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) as an example (Drazen, Solomon, and Greene 2013; Magnus and Caplan 2013). The goal of this trial was to “determine the appropriate oxygen-saturation levels in very premature infants” (Magnus and Caplan 2013).

For a debate on the subject, see Weijer and Miller (2004), and Wendler and Miller (2007).

Social Value of Clinical Research It is unclear whether the purpose of the trial was included in the informed consent form, so it is difficult to tell whether it satisfies the requirement of collaborative value production.

It is also unclear whether there was a way to track the implications of the results. However, much of the impact of this trial occurred not only in the clinical context, but also in the research context as it generated wide-spread controversy about the ethics of informed consent and disclosure of unknown risks (Magnus and Caplan 2013). We may be able to use these negative consequences to improve future social value calculations by promoting the validity of historically controlled trials by adapting the evidence hierarchy to promote trials that may not have the same issues but still produce the same result. This action may limit the social harm caused by trials such as this.

Thus, one can see how these criteria interact to attempt to produce research that is currently socially valuable and increase the value of clinical research in the future.

Section 5: Proposed Amendments to the TCPS2

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In order for REBs to use this framework, however, there need to be some changes in their policy to give them the resources to do so. Using the concepts outlined above, I have developed three proposed amendments for the TCPS2, pertaining to the composition REB’s and the social value assessment, to better assess social value.

Amendment 1: Add a person to the Research Ethics Board, who I will call the ‘Society Expert’, who has enough knowledge of the society implicated in the research, its organizational structures, and the likelihood of social implications occurring, to make a reasonable hypothesis about what the effect of the trial result may have on the society.

By adding this criterion to the policy, REB’s will have someone with the knowledge to hypothesize the implications of the research. Inspired by Daily et al.’s (2000) second step in the valuation process, this person can consider potential positive and negative social implications of research, and assess social value — not just social benefit. While assessing these equations may not actually be as straight forward as it mathematically appears in the example calculation, because this person has knowledge of the likely social implications, they can better estimate the magnitude and probability of different impacts to ensure that the research is valuable and that participants are not exploited. Additionally, this person will have knowledge of the government and organizational structures in the society and be able to assess whether they are prepared to deal with the impact of the research.

Amendment 2: Ensure that the person on the ethics board who is the ‘community member’, who is supposed to ensure the ethical treatment of the participants, is a member of the same community as the participants and as those the research will affect.

This amendment may allow us to perform a more complex risks and benefits calculation, one that includes risks and benefits to the participant and social risks and benefits. As the Community Member is assessing the informed consent information, making sure that it is readable, correct, and understandable, she may ensure a statement regarding the social value of the research is present. A community member that is

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Before the research was conducted, it was acceptable for physicians to use oxygen concentrations anywhere from 85% to 95%. Physicians knew that higher oxygen levels increased the risk of retinopathy of prematurity (ROP); however, the scientific community was in equipoise about whether higher or lower oxygen concentrations produced a higher likelihood of survival (Drazen, Solomon, and Greene 2013). After obtaining informed consent, researchers assigned more than 1300 babies to receive either oxygen concentrations between 85% and 90% or between 90% and 95%, with both ranges typically used in their contemporary clinical practice (Drazen, Solomon, and Greene 2013).

Now if we were to make a comparative value judgment between this research and other possible research that is targeted at achieving the same goal, we may find that a historically controlled trial, where we examine the records of what concentration of oxygen babies got and whether or not they lived or died and whether or not they suffered ROP, we may find that we could achieve the same goal in a less risky manner. However, because the data produced from this type of research is lower down on the evidence hierarchy, the scientific and medical community is less likely to accept it, decreasing the benefit that it could have, thus decreasing its social value. Thus the organizational structure of a society that values highly certain types of evidence and not others would be a barrier to a historically controlled trial that could accomplish the same goal.

As well, we may look to the understanding that the trial has three possible results: 1. Both oxygen concentrations have equal likelihoods of death or retinopathy.

2. One oxygen concentration has a higher likelihood of death and retinopathy.

3. One oxygen concentration has a higher likelihood of death and the other has a higher likelihood of retinopathy.

Keeping this in mind, we can run a value calculation. The first result may cause high benefit and low risk to society. It would provide the benefit of alleviating the doctors’ concerns about making what they perceive to be a life and death decision with no evidence. The social risk of result 1 is low because it would not change current practice. The second result has the highest social value because it can accomplish the same result as option one, while also improving clinical practice to promote health in premature babies. The third option has both risks and benefits. Benefit arises for the same reason as in result 2. However, there is the risk that the decision between a higher likelihood of death, or higher chances of disability may overwhelm parents who already have to make difficult decisions.

However, there are other procedures that produce the same social risks, so there are existing structural and organizational procedures to deal with these implications. As well, the researchers were in a clear position of equipoise. Therefore, there were no risks to the participants that would not have occurred had they been randomly assigned and oxygen concentration somewhere between 85%-95%, as was typical practice.

Thus, the social value calculation would likely be positive, as would the risk to benefit ratio.

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Social Value of Clinical Research of the same community as the participants may then advocate for participants’ rights while understanding the social context in which they are living. She may find that information regarding the potential harms and benefits is missing in regards to the particular social context in which the research is being conducted. This is important because as value is mutually ‘created’ and ‘re-created’ among actors with different values” (Ramirez 1999), those who are participating in the research and thus who the research will affect3 may have different values and may find that the research is not as socially valuable as expected.

This amendment may be problematic, however, because the question of how to define ‘community’ arises. At present, ‘community’, at least for some REBs, appears to be defined by educational background and institutional affiliation4 (CDHA 2014). If we are implicating the community member in the social value assessment, however, we may have to redefine ‘community’ to better reflect those who will be implicated in the results of the research. Yet, where we draw those lines may produce drastically different assessments of value.

A broad definition, such as ‘a community is all of those who live in the country where the research is being conducted’, may be too broad to generate an understanding of how the research may impact the particular lives of the participants and those the research may help or hurt. Whereas a definition of community that is too narrow may exclude research considerations that increase the value for more people. Additionally, we must also consider what social biases go into defining different groups of people to ensure we do not further oppress those who are already marginalized. Although I do not have a concrete solution to this problem, it may be worth considering looking to disease advocacy groups to find members who understand what research may be valuable to those whom the research will affect.5 Thus, by having the community member on the REB be of the same community as the participants, we may gain a better understanding of the social value of the trial for participants who have to give informed consent and the community the research will affect. However, it creates a dilemma in how we define ‘community’ to maximize the social value of the research.

Amendment 3: Ensure there is a follow-up from the research to determine what the actual social benefits and harms were so that we have a better idea of how research affects society in the future.

As Rosenzweig describes, “one can not [sic] get to a high quality assessment of impact without having good tools to track process outputs” (2004). Thus, in order to become better at assessing value, we must track how research impacts society so that hypotheses about social value may improve in accuracy.

Investigating whether a program or project is accomplishing what it intended to accomplish, interpreting the outcomes of data, and examining outcomes data to discover patterns that require some organizational or governmental action are ways of doing this (Miller and Salkind 2002). In his proposal for EHCRBs, Gilbert (2006) also recommends that the ethical,

Section 6: What Is Missing From these Amendments Although these proposed amendments help ensure that social value is assessed and assessed properly, they neglect a component I identify as important in maximizing the social value of clinical research. Both Daily et al. (2000) and Miller and Salkind (2002) argue that ideas should be generated from as many perspectives as possible and their costs and benefits assessed and compared for their ability to solve specific problems. Even with my recommendations, this component is not included.

While an REB can find ways to ensure a particular study is valuable, it does not compare different methods of achieving socially valuable results to decide which one is going to have the best social impact or is most ethical in comparison to others.

REBs deal with the ethics of specific research procedures, not the questions being asked or the areas in which researchers are asking them. Improvements in health come from many disciplines. These disciplines may include pharmacology, epidemiology, public health, environmental biology, therapeutic psychology, and others. We still need a way to compare the social value of research from all of these disciplines if we want the most social value in research.

Using the feedback that is generated from Amendment 3, which ensures that the impact of the research is tracked, we can develop a stronger conception of which types of research produce the most social benefit, the least social harm, and accomplish what they are intended to accomplish. We can then use this information to inform government funding so that research that is likely to have the highest value is more likely to be funded. At present, evidence suggests that this may not necessarily be the case6, but without an impact assessment, it is difficult to determine. However, if we can determine which type of research is likely to be the most valuable based on the impact of previous research, we may be able to choose to fund research that is likely to produce the most value.

Section 7: How Would These Amendments Work In Practice?

When considering how these amendments may work in practice, it is important to remember that the elements of the TCPS2 that I have highlighted are not used in isolation. As well, although I have focused here on social value, all of the seven7 components outlined by Emanuel, Wendler, and Grady (2000)

See Emanuel et al. (2004) for a more detailed description of how this works for international research in developing countries.

“A community member cannot be affiliated with the Capital District Health Authority and cannot have a science based educational background” (Capital).

5 For an example, see description of Epstein (1995) in Section 5.

6 Research by Armstrong and Armstrong (2010) suggests public health research is the most socially valuable, whereas the Canadian Institutes of Health Research (2011) Internal Assessment Report suggests that in 2010, more than five times as much funding was allocated to clinical and biomedical research.

3 4

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legal, and social implications of research that extend beyond the border of the study are considered. When considering research proposals, the REB should ensure that the researchers have a way of tracking the impact of their research so that the proper organizational or governmental action is taken to deal with the results and improve the accuracy of future value judgments.

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entific community, may not be the kind of knowledge that is of value to those who the trial is supposed to help.

Additionally, the Social Expert may identify that setting stringent exclusion criteria and seeking ‘pure’ test subjects creates a large social risk. She may describe how people lie on their research forms about taking other drugs so they can get into a trial that may save their life, which may skew the results (Epstein 1995). Or she may point out that many people refuse to enter trials so that they can remain ‘pure’ for future research when there is a higher likelihood of finding a cure, thus making finding participants difficult and putting themselves at significant risk by refusing any treatment (Epstein 1995).

As well, the community member, who as I mentioned is of the same community as the research participants, in this case would be someone who is part of the AIDS community, whether it be someone with AIDS, an AIDS activist, or a close friend or family member of someone with AIDS. As she is a member of the same community as the participants, she can put the trial in the context of the life-and-death circumstances of those who are participating and factor their desperation and their ability to give informed consent based on their values and their perception of the social value of the research.

Based on this information, the REB can make a social value calculation that includes both possible social harm and social benefit. As researchers have a duty to minimize risk and maximize the value of their research, this framework helps to identify ways that this may be done in areas that may be missed by the existing framework.

The AIDS trials of the late 1980s, while providing a clear example of the strengths of this framework, are not the most contemporary example of why a framework that emphasizes the social value of research is necessary today. However, we can see strong ties between the problematic elements of these trials and issues that are still occurring today. For example, many pregnant women are still being systematically excluded from drug trials because of the fear of risks to their fetuses, although research into this area is of high social value because many pregnant women require medical treatment that involves pharmaceuticals (Lyerly, Little, and Faden 2008). Furthermore, with the high comorbidity of psychiatric disorders in the population (Mash and Wolfe 2013), pharmaceutical research that sets exclusion criteria against comorbid disorders decreases the value of the research for the population as a whole. As well, Mark Tonelli points to a significant gap between the knowledge generated by randomized controlled trials (RCTs) and what it required for clinical decisionmaking (1998). Yet, RCTs still remain the gold standard for clinical trials. Many of the issues present in the social value calculation of the AIDS trials of the 1980’s are still issues that are faced in research today. While simply shifting the framework for assessing social value cannot solve not all of these issues, this new framework and these proposed amendments help us identify areas that we can address to increase the social value of research. As I began by examining why social value is an important component of ethical clinical research, finding ways to improve its assessment is important if we strive to produce research that is ethical and valuable to our society.

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play an important role in creating ethical clinical research. It is also important to consider that this framework was developed to assess the value of clinical research and not necessarily investigative research.

Below, I provide an example of how the amendments I have made based on the framework I have created may assess the social value of a particular type of case in comparison to how it may be assessed currently. I hope to show that my framework increases the likelihood of generating research with a high social value.

In 1989, research into finding a cure and/or treatment for Autoimmune Deficiency Syndrome (AIDS) was a priority among medical researchers. The scientists set strict criteria for entering their clinical trials and excluded those who were taking other medications, had taken them in the past, had other diseases, or had demographic values outside of the specified range (Epstein, 1995). They did this to ensure that the data produced by their trials was ‘pure’ so that they could develop a platform on which to understand this strange new disease (Epstein 1995).

Were we to examine a trial of this sort under the existing framework for assessing social value, it would surely be acceptable. The strict criteria of the trial would allow for results to be generated that are clean and interpretable, producing knowledge that indeed holds value to the scientific community. The community member, who is likely a member of the general public, would look at the informed consent form and determine that it is understandable. The general consensus of the REB would likely be that any risks the participant must undertake are justified by the fact that the knowledge being produced has a good chance of saving many lives, and the trial would be given permission to proceed.

However, when we examine this same trial under my framework, we may find there are significant social risks involved in this study and that by changing some of the research protocols, we can generate results that will be of higher social value.

Were this case to go to a REB acting with the amendments I have suggested, the same considerations examined above would still be brought to light. Other important considerations, however, would be made as well. The Society Expert may acknowledge that “trials…designed, with their emphasis on specific strategies of ensuring methodological purity and cleanliness, reflected a dangerous abstractness from pressing social realities” (Epstein 1995). Having ‘pure’ participants, while making the results ‘clean’, creates a gap between the information derived from the trial and what can be used in clinical practice. As clinical research involving treatments is meant to be applied, if it cannot be because most of the population requiring the treatment is different from the population of trial participants, the social value of the trial decreases. The reality was that many people with AIDS also had other diseases, were taking other medications, and had different demographic values. The knowledge the trial intended to produce, while arguably of value, is of less value if it cannot be used to promote the well-being of the individuals it is intended for.

As Epstein describes, trials “should be designed not to answer ivory tower theoretical questions, but to inform day-to-day clinical practice and help patients and doctors make meaningful decisions when confronted with treatment dilemmas” (1995). Thus, with its aim to produce good, clean knowledge, this trial ignores the idea that this type of knowledge, while of value to the sci-

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Section 8: Conclusion

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I began this paper by highlighting the importance of the social value component of ethical clinical research. By examining previous clinical trials, I attempted to demonstrate how social value may overlap with, but is different from, economic value. I also explored how the requirement of social value helps protect against the exploitation of research participants and promotes the responsible use of finite resources. Despite its importance, however, I argued that because risk to benefit calculations fail to account for the risk of social harm, and because of the current composition of REBs as outlined by the TCPS2, social value is currently not being properly assessed.

Following, I developed a model in which social value can be better assessed by bringing the risk of social harm into the risk to benefit calculation. I used the SUPPORT trial to help explain why considering other methods of achieving the same goal, examining the possible positive and negative consequences of alternatives, collaboration and joint production of value, examining the impact of a project and its ability to accomplish what it was intended, and ensuring the proper follow up occurs to assess the social implications of the research, are important for maximizing social value. I then made three recommendations of how this model can be used by REBs by suggesting three amendments to the TCPS2. These amendments include having a Social Expert present on the board to help assess the possibility of social harm, having the community member be from the same community as the research participants to take into account the unique valuation of research based on unique circumstances, and having a route of feedback from the research product back to the REB to enhance the accuracy of value judgments in the future and ensure the proper social measures are being taken to minimize harm and maximize the benefit of the results. I also examined how my framework neglects to include assessing different methods of achieving the same goal, and suggested how feedback from the impact assessment can help overcome this barrier by informing funding choices.

Finally, I used the example of the AIDS trials in the late 1980s as an example of how this model may look, were it to be implemented. I highlighted how contemporary social issues, such as the excluding pregnant women from clinical trials, and research into treating comorbid psychological disorders may benefit from this type of framework. Thus, I have argued that if social value is as important of a component as it appears to be in conducting ethical clinical research, amendments to the current consideration of social value by REBs should be made.

References Armstrong, H., & P. Armstrong. 2010. From chemicals to carrots and condoms: The development of Canadian health care. As cited in Heath Care Ethics in Canada (3rd ed.), F. Baylis, K. Borgerson, B. Hoffmaster, S. Sherwin ed. Toronto: ON: Nelson.

Canadian Institutes of Health Research. 2011. “CIHR Internal Assessment – Report for the 2011 International Review.”

Capital District Health Authority. 2014. Recruitment of community members for the Capital Health Research Ethics Board. Message posted July 8 to

http://www.careerbeacon.com/search/en/-1/1,2,3,4/31/-1/0/-1/-1,1I/-1/-1/0/3/MB1407085266 Daily, C. et al. 2000. The value of nature and the nature of value. Science, 289(5478): 365-396.

Drazen, J. M., C. G. Solomon, and M. F. Greene. 2013. Informed consent and SUPPORT. New England Journal of Medicine, 368(20): 1929-1931.

Emanuel, E. J., D. Wendler, and C. Grady. 2000. What makes clinical research ethical?. Journal of the American Medical Association, 283(20): 2701-2711.

Emanuel, E. J., D. Wendler, J. Killen, and C. Grady. 2004. What makes clinical research in developing countries ethical?: The benchmarks of ethical research.

The Journal of Infectious Diseases, 189(5): 930-937.

Epstein, S. 1995. The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials. Science, Technology, & Human Values, 20(4): 408-437.

Freedman, B. 1987. Scientific value and validity as ethical requirements for research: A proposed explication. IRB: Ethics and Human Research, 9(6): 7-10.

Gilbert, S. G. 2006. Supplementing the traditional institutional review board with an environmental health and community review board. Environmental Health Perspectives, 114(10): 1626-1629.

Hawkins, J. S, and E. J. Emanuel, E. J., eds. 2008. Case studies: The Havrix trial and the Surfaxin trial. In Exploitation and Developing Countries: The Ethics of Clinical Research, (55-61). Princeton, NJ: Princeton University Press.

Health Canada. 2001. “How Drugs are Reviewed in Canada.”

Lyerly, A., M. Little, and R. Faden. 2008. Toward responsible inclusion of pregnant women in research. The International Journal of Feminist Approaches to Bioethics, 1(2): 5-20.

Magnus, D., and A. L. Caplan. 2013. Risk, consent, and SUPPORT. New England Journal of Medicine, 368(20): 1864-1865.

Mash E. J., and D. A. Wolfe. 2013. Abnormal Child Psychology (5th ed.). Canada: Nelson.

Miller, D. C., and N. J. Salkind. 2002. Handbook of Research Design and Social Measurement (6th ed.). Thousand Oaks, CA: Sage Publications, Inc. (MRC) Medical Research Council (Canada), Natural Sciences and Engineering Research Council of Canada, & Social Sciences and Humanities Research Council of Canada. 2010. 2nd edition of Tri-council policy statement: Ethical conduct for research involving humans. Ottawa: Medical Research Council of Canada.

Ramirez, R. 1999. Value co-production: Intellectual origins and implications for practice and research. Strategic Management Journal, 20(1): 49-65.

Rosenzweig, W. 2004. Double bottom line project report: Assessing social impact in double bottom line ventures. Centre For Responsible Business, University of California, Berkeley.

The Nuremburg Code. 1949.

Tonelli, M. R. 1998. The philosophical limits of evidence-based medicine. Academic Medicine, 73(12): 1234-1240.

Weijer, C., and P. B. Miller. 2004. When are research risks reasonable in relation to anticipated benefits?. Nature Medicine, 10(6): 570-573.

Wendler, D., and F. G. Miller. 2007. Assessing research risks systematically: The net risks test. Journal of Medical Ethics, 33(8): 481-486.

World Medical Association. 1997. Declaration of Helsinki. Journal of the American Medical Association, 277(11): 925-926.

Worral, J. 2008. Evidence and ethics in medicine. Perspectives in biology and medicine, 51(3): 418-431.

Yarborough, M. A. 2013. Increasing enrollment in drug trials: The need for greater transparency about the social value of research in recruitment efforts. In Mayo Clinic Proceedings, 88(5): 442-445.

About the Author Kaitlin Sibbald graduated in 2014 from the University of King’s College/Dalhousie University with a Bachelor of Science in Psychology, Sociology and Social Anthropology and a Minor in Bioethics.

Dr. Kirstin Borgenson, Associate Professor of Philosophy at Dalhousie University, served as the faculty sponsor for this article.

Union Graduate College Icahn School of Medicine at Mount Sinai MS IN BIOETHICS DEGREES AND CERTIFICATES IN:

Clinical Ethics + Bioethics Policy + Research Ethics +

bioethics.uniongraduatecollege.edu

Article

Should Healthcare Professionals Restrict the Diets of Obese Inpatients?

Maximilian Peluso‡

Penn Bioethics Journal

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This piece considers a formal initiative to restrict the diet of inpatients who, on admission to hospital, are obese, without asking for their consent (as is done in the case of malnourishment). This would be done on the premise that a medical intervention should only be implemented if it will increase the patient’s wellbeing. Through modifying L. W. Sumner’s authentic happiness account to an authentic health account of wellbeing, I will attempt to demonstrate how dietary restriction may promote patient wellbeing.

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In 2008, half a billion adults in the world were obese, supplanting malnutrition as a leading cause of death globally (World Health Organisation). In contrast with obesity, the MUST tool (Malnutrition Universal Screening Tool) is used in U.K. hospitals to identify and treat all adult inpatients who are either at risk of or already malnourished, regardless of rationale for admittance (Nursing 2008). However, there is no such formal initiative to treat obese inpatients admitted for reasons other than obesity.

Given that obesity complicates medical procedures and increases the length of hospital stay, delaying the scarce availability of a bed for another patient, it seems pertinent to question why the justification for the MUST protocol does not apply to the treatment of obesity.

Furthermore, it is common practice in U.K. hospitals to provide diabetic patients with a “diabetic menu,” without asking their consent to do so. Again, such an initiative prompts the question of why the rationale behind MUST does not also apply to obesity.

The MUST tool was introduced at a time when malnutrition was left undiagnosed in 70% of hospital admissions. It was felt that since malnourishment prolongs recovery – patient outcomes would be improved if prevalence was reduced (Lean 2008). Therefore, every patient on admission to a U.K. hospital is assessed and if necessary, referred to a dietician to increase and improve nutrition during the hospital stay. The patient will be offered multiple supplements each day, and intake will be recorded. In this instance, and for a diabetic menu, a judgement is made by the doctor as to what is medically best for the patient. However, in both cases, the patient is not obligated to accept the measures (i.e. one does not have to select food from the diabetic menu or eat the dietary supplements). However, failure to accept ‡ University of Bristol, MP0235.2010@my.bristol.ac.uk

these measures would generally cause a medical professional to explain to the patient the potential downsides that may result. This ensures that a patient’s refusal to comply is informed, although nutritional supplements will still, in most cases, continue to be offered to these patients. Neither measure is thought to be controversial, and neither is perceived as a threat to patient autonomy or liberty. On performing a literature search, not one article could be found challenging the ethics of these measures. Though this should not be thought of as surprising per se, it does call into question whether or not a similar measure for the management of obesity should be considered at all objectionable.

This paper considers dietary restriction as reducing caloric intake, or reducing intake of food with a high energy density. Obesity will be defined as a body mass index greater than 30, and although much debated and contestable, I will work on the grounds that obesity is a disease, as there is “a clear majority view among the general public, as well as among authoritative bodies that it is reasonable to [do so]” (Allison 2008). Obesity is complex, with multiple aetiologies, and although I will focus on diet only, any successful remedy would likely require a multi-disciplinary approach.

One possible intervention for obesity is restricting caloric intake to less than what the individual requires.

This will cause weight loss, thereby reducing the severity of obesity. However, the results and nature of an intervention must be shown to impart some benefit to the patient’s wellbeing, else there would little reason for the individual to pursue it. Merely providing treatment, with the objective of achieving a good medical outcome, wrongly assumes that this is the only good people strive to attain (Takala 2007). A more plausible notion is that any medical treatment should be given to fulfill a medi-

Imposed Dietary Restrictions for Obese Inpatients cal good that will further the patient’s wellbeing. Therefore, I will first examine what is meant by wellbeing and how it relates to conceptions of health held in medicine and by the patient. This will lead to clarity in deciding whether dietary restriction should be adopted for obese inpatients and if so, how this can be done in a way that does not diminish the individual’s wellbeing.

Defining Wellbeing Relative to Health

Autonomy

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Aside from its role in wellbeing, respect for an agent’s autonomy is considered imperative so that an individual can determine who they are (Sartre 1993). An external decision to restrict an obese inpatient’s caloric intake, when they would choose otherwise, may undermine his autonomy. This is undesirable because, not only is the inpatient’s self challenged by an external agent, but also he is denied the opportunity to decide whether such a regimen would improve their subjective wellbeing. When the inpatient’s autonomy is examined from this point of view, it seems that to impose any dietary restriction on a patient would require their consent. Without this, we cannot know whether dietary restriction will increase the individual’s authentic health. However, before progressing onto the notion of informed consent, it is necessary to examine how obesity may affect one’s true self-governance, thus inhibiting “autonomous” judgement.

Obesity can be such that the individual may eat excessively due to an insatiable, pathological feeling of hunger. People who are obese are often predisposed to being

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A purely objective account of wellbeing is unhelpful, as it nominates, without justification or explanation, the criteria required to achieve a state of wellbeing. Such a model would mean that an individual could meet the demands set by the account and be unaware that they have done so; they could unknowingly be in a state of wellbeing (Sumner 1996). This state of affairs does not appear to resemble or signify a realistic model of what wellbeing truly is.

Nevertheless, a medical assessment of health is objective, as it examines for the presence of pathologies.

It attempts to restore and maintain health by reducing pathology with the motive that less health (presence of pathology) reduces our wellbeing.

However, although it is often the case that health increases wellbeing, it is not always so. Take a person, Gabriel, who smokes even though it exacerbates his asthma. The objective view in clinical practice dictates Gabriel would be healthier and have greater wellbeing by giving up smoking. Gabriel is aware of this, but he feels his wellbeing is improved far greater by smoking, compared to not smoking. Thus, this objective view of health and wellbeing is not necessarily representative of the patient’s perception of health and wellbeing. Since the clinical practice of medicine depends on an objective conception of health, which the patient perceives subjectively, both outlooks must be made compatible. It is therefore necessary to formulate a separate, patientrelative account of wellbeing with respect to health.

When an individual’s state of health compromises his subjective wellbeing, he seeks an objective clinical assessment. For these individuals, a specific lack of health, as they perceive it, has caused them to be dissatisfied with their state of wellbeing. Sumner’s account of wellbeing as authentic happiness appears suited to describing the patient’s assessment of health (and its absence) relative to their wellbeing. The next paragraph will focus this sentiment directly upon the scenario this paper is interested in.

I am looking at inpatients who are obese but whose reason for being admitted into hospital is unrelated to this. The self-perceived health of such patients has been a cause of reduced happiness, and therefore wellbeing, and so they have sought medical help. They have then been admitted to hospital. An objective medical assessment (i.e. comparing the actual functioning of

the patient’s biological systems to the ideal physiological norm) is made of the health problem and a solution offered. The patient must then decide whether such a remedy will make them authentically happy (i.e. in conformation with the beliefs/outlooks of the person as an individual) with their health and increase their wellbeing sufficiently to proceed. If this decision is made authentically, the healthcare professional must respect it, regardless of whether doing so will increase health as objectively assessed in the clinical practice of medicine.

This is because an inpatient’s wellbeing is only likely to be improved by interventions which fulfill their conception of authentic health, and not necessarily those which increase clinical health, as Gabriel demonstrated earlier on. Therefore, the objective clinical view of health in medical practice, need not exclude or override the individual’s subjective conception of health, as both can be accommodated for, leaving each account intact.

It is the subjective (i.e. authentic) account that necessitates the objective (i.e. clinical) account of health. This is because only when a lack of authentic health causes the patient to feel their wellbeing is compromised does he request counsel from the medical view of health by way of a clinical assessment. The objective clinical assessment of health exists to improve the individual’s subjective authentic perception of health and in turn their wellbeing. Thus, though distinct, both notions of wellbeing relate well together. Applying this model prima facie suggests dietary restriction of obese inpatients can only improve wellbeing if, on being informed, the individual autonomously determines it will improve his health. Consideration will now be given to both limbs of this formulation of authenticity.

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Imposed Dietary Restrictions for Obese Inpatients

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less able in assessing how much food they need or when to stop eating due to a dysfunctional satiety reflex (Cummings 2002). Normally, filling of the stomach inhibits the sensation of hunger (via the hypothalamus) causing eating to cease. This mechanism does not generally work in patients who are obese, hence there is a predisposition to consume more calories than is required, culminating in gain weight.

Secondly, it has been suggested in the literature that some severely obese patients have a higher than average propensity to become bored, potentially also complicating assessment of autonomous decision-making.

As boredom is something most inpatients normally feel, those who are severely obese may be more likely to overeat when presented with the choice or opportunity to do so (Bjorvell 1989). Consequently, the pathophysiology of obesity may sometimes prevent the inpatient from exercising autonomous judgement regarding what and how much to eat. If this is the case, prescribing a separate set of dietary choices with restricted caloric values would not be contrary to self being. As obesity inhibits self-governance with regards to choosing how much to eat, the decision to eat excessively is not reflective of the self. It is not autonomous. Obesity alters the self, such that the inpatient may not be able to assess, and perform, that which will increase his wellbeing with regards to eating.

Taking autonomy to be “self-governance,” we must acknowledge the self as being composed of many constituents. The values of each constituent are expressed through choices that we make: this is governance. Thus, governance allows self-held values to be expressed in the choices that we make (Mele 1995). Therefore, absence of a choice does not necessarily contravene autonomy because only when one has a choice can governance be exercised. I will examine autonomy further after we address the second category of authenticity: the need to be “informed.”

Being Informed and Informed Consent Failure to assess wellbeing by taking into account one’s own experiences, factual information and other such sources likely renders ones assessment inaccurate.

Hence, uninformed assessments of what will improve one’s health will probably not increase wellbeing. Therefore, an informed subjective assessment of wellbeing is vital if it is to be accurate. However, a compromised satiety reflex sometimes inhibits obese inpatients from acting on their informed assessment as to what quantity of food they should eat to promote their wellbeing. This is demonstrated by the fact that few people with obesity want to be obese (O’Neil 2000). Therefore, it is unlikely that they freely choose to remain in a positive energy balance. It is more likely that instead, the nature of obesity prevents the patient from acting on informed assessments concerning when they should stop eating. This is

because a subjective authentic assessment of health, for the vast majority of those who are obese, leads to the conclusion that their wellbeing would be greater if they could lose weight (Garner 1997). Dietary restriction, however, would facilitate this informed desire (for the sake of increasing wellbeing) to reach a healthier weight, thus countering the pathological, and often prevailing feeling, that one must eat more to satiate a false hunger.

Furthermore, the obese inpatient has two conflicting first order desires: they want to eat less, but they also, when food is available, want to eat in excess. Additionally, they want to lose weight and thus have a second order volition for their first order desire, not to eat, to prevail (Frankfurt 1971). Their disease, however, prevents this second order volition to be expressed, and thus they do not have free will to restrict their nutritional intake.

By helping them express their second order volition, the healthcare professional would remove the conflicting first order desire and promote the free will of the patient. This account provides a compelling reason to restrict the diet of inpatients who are obese and would, authentically, prefer not to be.

However, it is possible that not every obese patient considers that a loss of weight will increase wellbeing.

Their second order volition requires that their first order desire to eat is realised. To impose a dietary restriction on them would arguably reduce their sense of authentic health. As has been previously posited, an intervention should not be pursued by medicine if, in the individual’s view, it will be of no improvement to their authentic health. In such an instance, it may be argued that we should seek the individual’s consent to be given the menu designed for patients who are obese, as is done for the patient who has diabetes, the patient who suffers from gluten intolerance, etc.

However, merely giving an obese person a different set of choices to that of a malnourished person, “does not intervene in their private or bodily sphere,” nor is it “constitutive of a substantial intervention” (Eyal 2012).

It is contestably a trivial initiative. But when an obese patient’s length of stay in hospital is increased because of his weight, another patient in need of care may be denied a bed. Therefore, it seems reasonable not to seek consent from an obese inpatient (for this particular form of dietary restriction), whether or not being obese promotes his authentic health assessment. This is because it could jeopardise another individual’s health by causing a delay in receiving medical attention.

Another reason why not seeking consent from an obese inpatient to provide a modified menu is permissible is that he would not be forced to eat or even choose from the menu. Nor would healthcare professionals impose negatively on their liberty by preventing them from acquiring the food that they prefer, from an external source. So, in the same way we do not ask inpatients who have consented to surgery to then consent to being nil by mouth, we should not need to ask inpatients who are

Imposed Dietary Restrictions for Obese Inpatients obese for consent to provide them with a calorie restricted menu. This measure therefore allows inpatients whose authentic health will be improved by losing weight to do so, whilst not restricting the liberty of others.

For healthcare professionals to give an obese inpatient an obesogenic choice of food would be to contravene their duty not to deliberately worsen a pathology. However, if the patient provides themselves with an alternative to the diet restricted menu, the healthcare professionals have not contravened their duty or the liberty of the patient. Therefore, where dietary restriction constitutes the provision of a calorie controlled menu, to all obese inpatients, it seems on grounds of promoting wellbeing to be ethically unobjectionable.

In considering dietary restriction for patients, language must be used which sensitively deals with the issue in hand. For instance, it seems unacceptable, as one health secretary suggested, that we replace the term obesity with “fat” (Randeep 2010). This illustrates no understanding of the condition, no sympathy for what the patient may be going through and will almost certainly stigmatize them further. Stigma requires power for it to be exerted.

Therefore, we must ensure when imposing dietary restriction, any power entrusted to healthcare professionals is not used to stigmatize patients who are obese but instead works to remove it.

Public Health Ethics

Penn Bioethics Journal Volume X Issue i

Obesity has been recognised as a public health dilemma as early as 1952. Since this time much guidance has been dispersed into the public sphere about measures which individuals should employ in order to control their weight (Harvard 1952). This advice changes regularly and hence, can be confusing. In 1980, a report was produced that suggested measures to reduce prevalence of obesity, one of which was to recognize that obesity was a disease which, where present, should increase insurance premiums (Stunkard 1980). Following these 23 pages of recommendations, other documents followed; however, few were implemented because, among other factors, funding was not identified and the authors of such reports did not appreciate realistically the complex nature of obesity. They failed to appreciate the environmental barriers that exist to such measures.

Over the following decade, obesity levels increased and the U.S. Public Health Service focused their attention on preventative strategies and behavioural change.

Despite these well-intended interventions, obesity has become only more prevalent.

Currently, UK public health guidelines encourage people who are obese to reduce snacking on unhealthy food (BBC 2014). They point out that consuming food that is high in fat and sugar causes weight gain and should therefore be avoided. To this end, it has been suggested that all sugary drinks should be taxed at 20%, and such an intervention is predicted to result in a 1%

reduction of obesity cases in the UK (~180,000) (NHS 2014, Briggs 2014). This intervention does not seem prima facie objectionable since it does not restrict liberty of individuals to drink the beverage of their choice. At the same time, the measure would perhaps cause people to think twice before purchasing the high sugar drink.

This, in a sense, would be autonomy-promoting since the consumer’s decision will have been more informed.

However, what is perhaps more questionable is the food served to patients in hospital. For instance, inpatients must be offered a choice of desserts (of which one must be hot) for both lunch and dinner. Furthermore, there is a possibility chips may be offered as a meal choice (Savage 2005). In addition, it is instructed that an offer of sugary snacks and a hot drink is made at least twice a day (Department of Health, 2013, Allison, 2001). This illustrates that contrary to their own concern with obesity, the health service provides high energy density food as a major component of hospital meals and snacks. Furthermore, it does so to all patients, irrespective of whether they are obese or not. By its own standards, the provision of food that is high in fat and rich in sugar is deleterious to patients who are obese (Department of Health, “An Update...”, 2013). Therefore, it seems objectionable and illogical for the health system to do something that it holds will compromise health and thus, objective wellbeing.

Additionally, if the purpose of a healthcare professional such as a doctor or nurse is “defined by what is in the best interest [wellbeing] of patients and of the population served” these practices may undermine their role (NHS Employers). The diametric opposition between dietary advice given to patients who are obese and actual hospital practices could quite reasonably, in the patient’s mind, call into question the credibility of the hospital (Malhotra 2013). This is also detrimental because it fails to educate the patient in weight loss strategies and instead confuses them as to how they should eat once discharged.

The inconsistency of the healthcare system through advocating one practice and adopting another is irrational. Arguably, to issue advice formed on a rational basis and adopt practices that are not is irresponsible of a system that also endorses evidence-based medicine. To ban smoking in hospitals, whilst selling cigarettes is akin to advising one to reduce their intake of high energy density food and simultaneously offering it to patients.

Implementing restrictive dietary measures for obese inpatients would therefore be a responsible measure to take by ensuring rational advice is reflected in practice.

Thus, healthcare professionals should restrict the diet of inpatients who are obese, with the provision of a low calorie menu and provide advice that is consistent with their practice. Alongside interventions such as this, if we are to reduce the prevalence of obesity significantly in the future, the healthcare system must provide patients with clear diet plans and accessible help.

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Imposing Dietary Restrictions for Obese Inpatients Conclusion Consequently, healthcare professionals should restrict the diet of adult inpatients that are obese. This paper has attempted to demonstrate that by providing patients who are obese with a dietary restrictive menu, their autonomy is not contravened. Furthermore, it is not necessary for healthcare professionals to ask the patient’s consent to provide them with this menu. Dietary restriction should only be implemented if the patient’s liberty to refuse to eat what is offered to them or to purchase an alternative is preserved. This ensures that the rare inpatient, whose authentic wellbeing is genuinely promoted by being obese, is not any worse off as a result of the intervention’s existence. Moreover, it ensures a clear and consistent message is imparted from the health service to the public about what it means to eat healthily, with a view to lose weight. It also prevents any dietary advice that is given to patients being undermined or diluted by a double standard, which may be perceived as hypocrisy on the part of healthcare professionals. If patients are to trust healthcare professionals, the healthcare system should follow the advice it endorses its employees to impart to their patients. Finally, as we should only restrict diet of patients who are obese if it increases their authentic health assessment, we must avoid stigmatizing them in our practices as this is unlikely to increase their wellbeing, and will almost certainly lower it.

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About the Author Maximilian Peluso is a fourth-year undergraduate at the University of Bristol Medical School in the United Kingdom and has earned his B.Sc. in Bioethics with Honors.

Dr. Kerry Gutridge at the University of Bristol served as the faculty sponsor for this article. Gutridge is a Lecturer in Biomedical Ethics and Law for the Centre for Ethics in Medicine.

Master of Bioethics

Imposing Dietary Restrictions for Obese Inpatients

University of Pennsylvania www.med.upenn.edu/mbe

bioethicsjournal.com

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