Volume II Issue ii

Penn Bioethics Journal 2006 Faculty Advisors Connie Ulrich, RN, PhD Paul R. Wolpe, PhD Founder Andrew J. Rosenthal Associate Editors Ian Barrett Katryn Bowe Claire Chang Julietta Chang Chava Cogan Sheri Halpern Benjamin Himes Stephanie Joco Justin Masterman Rajini Murthy Charles Robinson Victoria Tsai Kavita Vinekar Associate Publishers Claire Chang Bo Peng Jules Shen Kavita Vinekar Business Manager Alix Rogers Cover Design Chava Cogan Julietta Chang Webmaster Xin Luo Managing Editors Erin Cho Rachel Han Bo Peng Alix Rogers Jules Shen Executive Editor and Publisher Jennifer Rha

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

Volume II, issue ii: Bioethics Without Borders

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

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

A deep understanding of the issues, insightful exploration and writing style are just some of the qualities by which prospective articles will be judged. Submissions are considered without regard to home institution. The recipients of the award will be announced in the early winter of 2006.

inside this issue...

Exclusive PBJ Interview

01

with Paul Farmer coming soon

Winning Articles

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First Award: Methods to Identify and Address the Ethical Issues Associated with Managed Care COURTNEE LUNDY, University of Pennsylvania

Second Award: The Role of Bioethics in the International Prescription Drug Market: Economics and Global Justice SHELBY E. NEWLAND, University of Pennsylvania

Feature Articles

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The Moral Implications of Prenatal Genetic Testing

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Justified Paternalism: The nature of beneficence in the care of dementia patients

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PETER CHIPMAN, Dalhousie Univeristy, Canada

KASHINA GROVES, University of Washington

The Ethics of Placebo-Controlled Studies on Perinatal HIV Transmission and its Treatment in the Developing World SHI (MARK) GU, Duke University

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PERSPECTIVES from abroad: Abortion: Pro and Contra

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Kant’s Assessment of Motivation in the Fulfillment of Social Obligations

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Childbirth in Modern Athens: The Transition from Homebirth to Hospital Birth

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Xenotransplantation: A Rational Choice?

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LAURA (PAUNCU) JEBEREANU, University of Medicine and Pharmacy “Victor Babes’ Timisoara, Romania

JACKIE KNUPP, University of Richmond

JULIE NUSBAUM, University of Pennsylvania

OLOLADE OLAKANMI, Grinnell College

For Your First Born Child: An Ethical Defense of the Exploitation Argument Against Commercial Surrogacy BRENDAN OSBERG, Dalhousie University, Canada

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The Two-Faced Angel: Do Phase I Clinical Trials Have a Place in Modern Hospice?

DANIEL S. ROSS, University of Pennsylvania

Bioethics Without Borders

Interview with Paul Farmer, MD, PhD, to come soon: Founding Director of Partners in Health; Medical Anthropologist and Physician Author: Jules Shen 10 April 2006, University of Pennsylvania

Paul Farmer is a physician who has truly demonstrated that Bioethics can go beyond the borders of nations, professions, and societies. With the origins of his organization Partners in Health (PIH), he showed that modern medical facilities can function in the countryside of the poorest nation of the Western hemisphere. His research proved that anthropology could lend a critical lens of context to successful clinical practice and research. This extraordinary work was organized around the guiding principle that fundamental inequalities, whether in Harlem or Haiti, should be no more accepted as unfixable underlying conditions as the contagion of infectious disease, anywhere, for anyone.

When conceptualizing the field of Bioethics, we typically think of the philosophical conundrums raised by cutting-edge technologies. We think about the role of autonomy in deciding the edge between life and death and reproduction and what it means to be human, or even about problematic nature of certain policy structures, like health insurance. These are important questions.

Nonetheless, we should not forget that we have the luxury of sometimes thinking hypothetically about Terri Schiavo or stem cells because we do not have to think literally day-to-day about where our potable water is coming from, or about losing our bodies as means of self-support in the future because we can’t afford the medicine for it today.

The disease with which Farmer is most famous for engaging—tuberculosis—has long been “cured.”

Except that for the vast majority of those infected with TB, the benefits of known treatments aren’t available in any meaningful sense whatsoever, certainly not for most of the 5,000 victims who die everyday. Until PIH’s groundbreaking work in introducing directly observed therapy, short-course (DOTS), experts had long dismissed the cost-efficiency of treating patients with multiple drug resistant strains, a phenomenon becoming more and more prevalent as struggling public health infrastructures around the world left indigent patients with incomplete medication regimens and worse prognoses. Farmer proved that it was possible to cure the poor with a more intensive, though costly, approach, arguing adeptly for its ultimate value given the Penn Bioethics Journal Vol. II, Issue ii Spring 2006

ramifications of a pandemic.

Moreover, however, Farmer and PIH stand for the principle that any treatment possible in the modernized “West” should be considered practical for every citizen of the world. As stated while speaking at Villanova’s nearby campus, Farmer does not want to accept the “double, triple, quadruple standards” that apply in most health policymaking for the “developing” countries of the world. Working in Haiti, Peru, Russia, and most recently Rwanda, PIH have insisted upon one standard of care, the highest possible, for each and every patient, regardless of their country’s GDP or lack thereof.

Insisting upon a flexible model that holds communitybased health care as the gold standard of improving health, PIH embodies a hand up, not a handout: “The work that we do in Haiti is done by Haitians.” Moreover, Farmer emphasized the solidarity of their approach based not on a sense of compassion alone, but a firm right to justice. Noting the criticism of a renovated Rwandan pediatric ward with non-necessities of nice floor tiles and flowers, he retorted that the democratic government had reflected its citizens’ right to allocate resources as they saw fit rather than projects done on the cheap. “I’m not saying there should be a right to flowers, although I don’t know that that would be a bad thing… but a country building its own health infrastructure is not just philanthropy,” surely not one directed from the outside by foreign “experts.”

Farmer exhorted that to comprehend current health conditions, historical awareness is crucial: The disparity of black versus white children in asthma outcomes requires understanding the history of American discrimination, which in turn shares a common origin with the difference that makes certain children prone to landmine injuries in Africa. Societal factors are reflected everywhere in the “structural violence” of war, politics, money, and geography; the burden of illness for most of the world is inherited with intergenerational poverty.

These gaps in access are ones that bioethicists today and in the future would do well to address. As part of the medical and human rights communities along with Farmer, Bioethics should lend a critical voice about the fundamental problem of entitlement to, not just

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availability of, the fruits of modern medicine, whether research or practice. After all, for all the usefulness of thought experiments involving hypothetical conundrums or reviews of emerging ones, there stands an even greater amount of gain to be made by advocating for the billions of people who have tangibly suffered as patents expire and after technologies retire, their persistent illness as

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great a dilemma as any.

At the Penn Bioethics Journal, we hope that hearing from Dr. Farmer, one of the leading voices on the forefront of facing this challenge, will lend perspective to working out the problem. Please look for our exclusive interview in an updated version of Vol II, iss ii to come out by early May: www.bioethicsjournal.com.

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Penn Bioethics Journal Vol II, Issue ii Spring 2006

Award for Excellence in Undergraduate Bioethics: First Prize

Bioethics Without Borders

Methods to Identify and Address the Ethical Issues Associated with Managed Care Author: Courtnee Lundy, University of Pennsylvania Faculty Sponsor: Theresa A. Walls, DO, MBE Abstract There are many benefits of managed care, such as its focus on disease prevention and health promotion, its integration of healthcare services to minimize inefficiencies, and its ability to restrict healthcare costs; however, there are also some ethical concerns that arise from managing care. In the context of managed care, ethics is a method for examining conflicts of values and obligations where there are competing interests, each of which presents a reasonably justified position. The principles of procedural, commutative, and general justice are particularly applicable to the ethical issues associated with managed care. Through a review of relevant literature, this paper will examine different methods and principles of justice to consider in establishing an ethical managed care organization and it will offer some examples of plans that have established policies to meet their ethical goals. By setting common goals, plans and enrollees can minimize ethical conflicts and collaborate to ensure that plans consistently use just procedures to ensure that quality care is available.

The Shift to Managed Care In response to employer and government demands for cost containment, enhanced access, and improved quality, the managed care system of healthcare has grown tremendously in the United States. With the previously open-ended reimbursement policies of the post-World War II period that gave doctors incentives to provide unnecessary care, the costs of health care inflated at a rapid pace. Under the payment system of indemnity insurance, spending more healthcare dollars did not appear to be improving America’s health, (Bodenheimer, 1993, p.

376) and public concern with healthcare quality increased.

Pressure from politicians and interest groups to reform the nation’s healthcare system ultimately fueled managed care’s rapid growth in the late 1980s and early 1990s. However, even with the healthcare dollars saved by managing care, the ethical implications associated with managing care still exist.

Courtnee Lundy is a Senior at University of Pennsylvania and is majoring in Health and Societies with a concentration in Health Policy.

Email: clundy@sas.upenn.edu Theresa A. Walls, DO, MBE, is the faculty sponsor for this submission. She is a Lecturer in History and Sociology of Science at the University of Pennsylvania.

Address: 630 Apple Roach, Lancaster, PA 17601 Email: theresa.walls@verizon.net Penn Bioethics Journal Vol. II, Issue ii Spring 2006

Managed care refers to various healthcare coverage products and services that attempt to reduce costs by encouraging more efficient healthcare delivery. The purpose of managing care is to “eliminate choices that are wasteful, harmful, or too expensive” (Mariner, 1995, p. 237). Thus, in the managed care system, a limited number of contracted physicians provide healthcare at reduced rates of reimbursement. Managed care works to shift some of the financial risk from payers (e.g. insurance companies) to healthcare providers, through financial rewards and penalties, in attempts to influence providers’ clinical decisions. Managed care plans direct members to these contracted providers and, in theory, patients save money (e.g. lower insurance premiums) by receiving care that is more efficient. There are many benefits of managed care, such as its focus on disease prevention and health promotion, its integration of healthcare services to minimize inefficiencies, and its ability to restrict healthcare costs; (Mariner, 1995, p. 239) however, there are also some ethical concerns that arise from managing care.

Justice and Mangaged Care In the context of managed care, ethics is a method for examining conflicts of values and obligations where there are competing interests, each of which presents a reasonably justified position (Randel, et al., 2001, p. 46). “The principle of justice, which governs resource allocation, is especially relevant to managed care organizations because the very nature of managed care requires allocating resources for the benefit of all members of a group” (Mariner, 1995, p. 240). Three types of justice are particularly applicable to the ethical issues associated with managed care. They are procedural justice, commutative justice, and general justice.

Procedural Justice Dr. Marjorie Chan, professor of management at the College of Business Administration, California State University at Stanislaus, describes procedural justice as “the fairness of process with which outcomes are delivered” (Chan, 2002, p. 316). A managed care organization (MCO) concerned with upholding procedural justice principles will create clear policies that are consistent, unbiased, and accurate. Members should have full access to all plan policies and procedures that may affect their ability to receive quality care. This also means that members should have the ability to uncomplicatedly challenge coverage denials. In addition, internally, a plan maintaining procedural justice will have

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standardized mechanisms in place to resolve any financial and/or ethical issues.

Commutative Justice Commutative justice pertains to medical relationships and that which is owed to patients that enter into professional relationships with providers (Bondeson, 2002, p. 3). In a managed care setting, determining the proper ethical actions that providers should undertake suggests a need to balance obligations to patients (of providing the best care) against responsibilities due to a health plan and its members (of managing limited financial and medical resources). Concerns may be greater in some forms of managed care than others; yet, changes in the physicianpatient relationship, changes in standards of appropriate care, and changes in the locus of decision-making will always raise commutative justice issues.

General Justice Relating closely to managed care’s responsibility of rationing resources, general justice pertains to that which individuals owe to the common good in their uses of healthcare resources (Bondeson, 2002, p. 8). In managed care, general justice concerns not only the particular patient, but also the other plan members. Without general justice guidelines, plan members would suffer from what Garret Hardin, biologist from the University of California, Santa Barbara, termed “the tragedy of the commons,” in which overuse depletes all resources (Hardin, 1968, generally).

Embracing the principles of general justice in managed care means proper usage of scarce medical resources; thus, maintaining general justice requires that healthy plan members do not demand wasteful care and that sick members comply with prescribed therapeutic measures.

Ethical issues arise when a plan denies access to certain services that members (or their healthcare provider) deem necessary or when a plans will not pay for members to receive care from the members’ choice provider.

A quality managed care system could avoid many justice conflicts with close attention to the ethical concerns inherent to the managed care industry. While creating and maintaining an ethical MCO would require vigilant monitoring and continuous consideration of new ethical issues, there are examples of managed care organizations that have taken on the challenges of managing care ethically.

This paper will examine different methods to consider in establishing an ethical managed care organization and it will offer some examples of plans that have implemented policies to meet their ethical goals.

Tax-Exempt Status and General Justice Along with shifting financial risk to physicians, MCOs in effect have the authority to make some medical decisions that previously had been reserved for healthcare providers (Bodenheimer, 1993, p. 374). “MCOs perform

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both medical and business functions, taking actions to provide or withhold care that touch the traditional sphere of medical ethics, and, at the same time, acting like ordinary business enterprises with no moral obligations or, at least, obligations that have little to do with traditional medical ethics” (Mariner, 1995, p. 240). As businesses, corporate values (such as efficiency, cost-reduction, competition, and profit) influence MCOs, which may differ from the traditional ethics and values of practicing medicine.

To reduce the conflicts between providing care and running a business, MCOs should minimize disagreements by focusing on providing quality care to their members. For this to happen, truly ethical managed care organizations should be nonprofit. Investor-owned MCOs have dual, often conflicting, obligations: they have a financial duty to increase profits and shareholder dividends, while also maintaining a contractual responsibility of providing members needed medial services. Nonprofit MCOs, on the other hand, have the analogous duties of providing members healthcare while only using its income to support its charitable operations and stated purposes. Thus, nonprofit plans allocate any profit to benefit their members (or perhaps provide subsidized coverage for new, lowincome members).

Holy Cross Health System (HCHS) represents a healthcare plan that successfully uses its mission to justly serve all members at the forefront of major medical decisions. HCHS has a strong faith-based mission that emphasizes fidelity, excellence, stewardship, and empowerment. It established a process called “mission discernment,” whereby potentially conflicting business and clinical decisions are evaluated for both their financial and strategic implications but also for their ethical implications.

HCHS uses a systematic list of questions that plan clinicians and administrators discuss to determine the impact of all major decisions on achieving the ethical norms essential to the organization’s stated purpose.1 While the mission discernment process is not intended to yield a yes or no decision, it is a process through which the organization can openly work to better ensure that policies or decisions are restructured to realize the plan’s mission.

Traditionally, healthcare delivery remained in the nonprofit realm, with providers offering more charity care with lower administrative costs than for-profit organizations (Bodenheimer, 1993, p. 376). Because nonprofit organizations are required to have mission statements that stress the organizations’ charitable purposes, nonprofit managed care organizations’ business structures,

1 Randel, 52. The questions covered in the mission discernment process are as follows: What considerations make this decision important in the mission and values of HCHS? How will the quality of services be determined and maintained? How will care for the poor be addressed with this development? What is the community benefit from this development?

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Penn Bioethics Journal Vol II, Issue ii Spring 2006

Managed Care

policies, and practices allow for the provision of better quality care than profit-seeking MCOs.2 In fact, some studies have indicated that for-profit status is associated with lower quality and satisfaction performance levels.

In a recent study using survey responses from Medicare beneficiaries, Landon et al reported that “for-profit and nationally affiliated health plans scored lower for almost all of the outcomes they examined” (Landon, et al., 2001, p. 282). Thus, nonprofit MCOs are able to uphold their medical responsibilities and business values with fewer ethical conflicts in providing healthcare and higher customer satisfaction.

Patient Choice and Procedural Justice Limits on choice of physician and access to specialists are inherent to the managed care system; however, choice is a component of the central ideal of self-determination that Americans value dearly. Consequently, there is often a conflict between plans’ structures, which only authorize use of contracted physicians, and enrollees’ wishes to receive care from out-of-network providers. It is important that patients feel comfortable with their primary care physician.

Patients are more likely to adopt healthy habits (such as quitting smoking) or bear painful but efficacious therapies if recommended by a trusted physician (Emanuel, 2000, p. 324). To facilitate patients’ willingness to use physicians under contract with their MCO, plans must explain carefully the terms of contracts and the basis of the types of limitations they will impose.

Patients need to understand that plan membership may allow for lower out of pocket costs but only in return for accepting some limitations on choice and the type and amounts of care provided. However, “full disclosure is necessary, but insufficient to foster a fair contractual relationship” (Mariner, 1995, p. 242). Ezekiel Emanuel, MD, PhD suggests two conditions for fairness in imposing restraints on enrollees’ choice of providers: the first is that the policies for limiting access to treatments and physicians should be accessible to the public and plan members.

Secondly, doctors and enrollees should be able to challenge plan decisions and argue for revisions through set, accessible mechanisms (Emanuel, 2000, 324). Dr. Ronald Duska, a business ethics professor at American College, conducted research of the 10 largest national plans. 3 His research revealed that member grievances concerning limited access to health services often were attributed falsely to plans Monroe, 181. An example of a nonprofit MCO’s mission statement is that of California HealthCare Foundation, whose mission is “to expand access to affordable quality healthcare for underserved individuals and communities and to promote fundamental improvements in the health status of the people of California.”

2

3 The ten largest plans in the study covered the lives of over half the U.S. population.

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denying claims, whereas the limited access to care was more accurately the result of a lack of knowledge of the methods to gain access to care (Duska, 2000, p. 70). To avoid these misconceptions, plans should provide complete information to their members and healthcare providers that articulate the plan’s policies and how access conflicts can be resolved.

In 1999, BlueCross BlueShield of Tennessee (BCBST) attempted to actively inform its members by making its medical policies available to clinicians, members, and the public. BCBST made all relevant information available through a link on the company’s website that is updated on a monthly basis. The site explains the process that BCBST generally uses to determine “medical necessity” and it offers the rationale for its policies (Randel, et al., 2001, p. 52). This includes a list of in-network doctors and covered procedures, as well as medical literature supporting the plan’s decisions not to reimburse for certain procedures.

“By presenting its reasoning as well as its conclusions, BCBST encourages trust and creates the possibility of constructive debate with its key stakeholders” (Randel, et al., 2001, p. 53). Although members and physicians may disagree with the plan’s decision-making process, BCBST provides them with the appropriate information and clear guiding principles to appeal or protest a coverage decision in a focused manner.

Medical Decision-Making and Commutative Justice In general, the law recognizes that anytime a person receives advice or counseling from a professional, they enter into a contractual relationship where the professional is morally (and often legally) obligated to put the client’s wellbeing ahead of any other motivating factors. “Bioethics and law both have long regarded physicians as having a fiduciary relationship with their patients. Thus, the physician is supposed to put the patient’s interest first, ahead of any others” (Rosoff, 2001, p. 3). However, as physicians also have contractual obligations with managed care organizations, there is a potential ethical conflict because physicians have incentives to compromise patient advocacy in order to limit healthcare costs. MCOs require physicians to make decisions based on utilization and economic goals determined by the health plan and these goals could compromise a doctor’s duty to patients.

Physicians that have to make medical decisions that are not in accordance with MCO reimbursement structures often have to show that the treatment prescribed has been proven to be cost-effective. Managed care is structured around a variety of incentives to encourage the practice of efficient medicine and to minimize variation in clinical practice patterns. This means providing a healthcare product while minimizing unnecessary resources to treat each patient. Often, increasing productivity and fixing costs maximizes efficiency. Hence, managed care may

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create pressure to do more with less: less time per patient, less costly medicines, and fewer costly diagnostic tests and treatments.

One of the most powerful managed care driven initiatives to reduce waste is its focus on evidence-based decision making. Evidence-based medicine applies scientific research findings to the practice of medicine. It is the process of using relevant scientific and statistical data to formulate medical decisions. Although evidence-based medicine has helped to verify and refute the effectiveness of certain medical practices, it has also created many ethical and legal issues within managed care. As evidence-based medicine, uses aggregate data to make medical decisions for individual patients, managed care organizations and plan practitioners cannot easily manage individual variation.

“When working with numbers there may be tendencies to focus on the aggregate, with insufficient regard for the people those numbers represent” (Robbins, 1998, p.

33). These variations are inevitable; however, an MCO’s duty is to provide care even to those outlier patients that require unique treatment. The true ethical issue arises in determining whether a prescribed treatment is futile or appropriately deviates from standard plan guidelines.

Supporting principled standards and sponsoring an ethics program can help to foster commutatively just procedures to resolve the issue of needed versus wasteful treatment. While an ethics committee should not explicitly make coverage decisions, it could serve as a consulting body that provides suggestions based soundly on bioethical principles. In 1991, Community Health Plan (CHP) established an exemplary MCO ethics committee that addressed sub-acute and outpatient oriented issues.

The 18-member multidisciplinary group was comprised of representatives from the medical, legal, nursing, and behavioral health communities, as well as clergymen and plan administrators. The committee, which had direct access to the plan’s Board members, had a stated mission to (1) identify significant ethical issues affecting CHP, (2) serve as a consulting body on bioethical issues which affect a patient’s individualized care or a specific component of CHP’s program, and (3) actively educate CHP staff, healthcare providers, and members (Felder, 1997, p. 358).

There are many noteworthy elements of CHP’s ethics committee. The goals and purposes of the ethics committee are clearly stated, which aid in determining appropriate ethical issues for the group to evaluate. By functioning as a forum for discussion of ethical issues, the committee establishes itself as a deliberative group and consulting resource that can influence but not explicitly make coverage decisions. In undertaking the mission of educating the plan staff and members, the ethics committee works towards creating a coordinated system under which all the plan takes all participants’ concerns into consideration.

CHP’s committee is just one example of how ethics

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committees can serve as a medium for reconciling ethical conflicts, assuring honesty, maintaining minimum standards of quality, and preventing the wasteful or inadequate use of health care funds.

Conclusion Managed care offers the United States’ healthcare system real and potential benefits and challenges. As long as healthcare expenditures continue to rise, providing efficient services that lower consumer costs will play a pivotal role in making care more economical and accessible.

Market-driven principles in managed care control costs and encourage the supply of high quality healthcare that meets or exceeds consumer demands. Nonetheless, MCOs’ financial motivations in providing care could potentially damage the traditional physician-patient relationship and undermine plans’ obligations to members.

MCOs, by definition, work to integrate the inherently opposing principles of business and medicine. To effectively address significant issues associated with managing care and to protect patients, a health plan should minimize competing corporate and medical obligations by creating ethical guidelines that mediate these conflicting interests. A managed care organization that focuses on its responsibility to provide the best care possible can refocus plan policies, ensuring members’ best interests are at the forefront of all major business decisions.

In order to successfully manage and allocate limited medical resources, managed care organizations and members must understand and be committed to the justice principles as ethical guidelines. It is essential that all plan participants (enrollees, contracted physicians, staff, and administration) actively and collectively engage in the formulation and evaluation of its mission and policies. A health plan and its members can minimize conflicts by setting common goals and establishing just procedures that ensure quality care is available to all enrollees. Ultimately, with conscientious examinations of their structure, processes, and policies, plans can manage healthcare ethically.

References 1. Bodenheimer, T. (1993). The health reform game: the major players start dealing. The Nation, 256(11), 374-377. Retrieved December 10, 2005, from EBSCOHOST MegaFILE database.

2. Chan, M. (2002). Violations of service fairness and legal ramifications: The case of the managed care industry. Journal of Business Ethics, 36(4), 315-336. Retrieved December 10, 2005, from ABI/INFORM database.

3. Chernew, M. E. (2004). Barriers to constraining health care cost growth. Health Affairs, 23(6), 122-128. Retrieved December 10, 2005, from ABI/INFORM database.

4. Duska, R. F. (2000). Managed care and insurance: Some ethical considerations. Journal of Financial Service Professionals, 54(5), 683-690. Retrieved December 10, 2005, from ABI/INFORM database.

5. Emanuel. E.J. (2000). Justice and managed care: Four principles for the just allocation of health care resources. Hastings Center Report, 30(3), 8. Retrieved December 10, 2005, from EBSCOHOST MegaFILE database.

6. Felder, M. (1997). Bioethics and the HMO. HEC Forum, 9(4), 355-

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Managed Care 364. Retrieved December 10, 2005, from SpringerLINK database.

7. Frakes, J. T. (1997). Managed care. evolution and distinguishing features. Gastroenterology Clinics of North America, 26(4), 703714. Retrieved December 10, 2005, from MDConsult Core Collection Ejournals database.

8. Hardin, G. (1968). The Tragedy of the Commons. Science, 162, 1243-1248. Retrieved December 10, 2005, from www.sciencemag. org.

9. Landon, B. E., Zaslavsky AM, Beaulieu ND, Shaul JA, Cleary PD. (2001). Health plan characteristics and consumers’ assessments of quality. Health Affairs, 20(2), 274-286. Retrieved December 10, 2005, from ABI/INFORM database.

10. Mariner, W. K. (1995) Business vs. medical ethics: conflicting standards for managed care. Journal of Law and Medical Ethics, 23(3), 236-246.

11. Mechanic, D. (2000). Managed care and the imperative for a new professional ethic. Health Affairs, 19(5), 100-111. Retrieved December 10, 2005, from ABI/INFORM database.

12. Monroe, A. (2002). Consumer involvement—a vital piece of the

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quality quilt: The california HealthCare Foundation’s strategy for engaging California consumers. Quality and Safety in Healthcare, 11, 181-185. Retrieved December 10, 2005, from on qhc. bmjjournalscom.

Bondeson WB, & Jones JW (Eds.). Ethics of managed care: Professional integrity and patient rights. Boston: Kluwer Academic Publishers.

Randel, L. Pearson, S. D. Sabin, J. E. Hyams, T. Emanuel, E. J., (2001). How managed care can be ethical. Health Affairs, 20(4), 43-56. Retrieved December 10, 2005, from ABI/INFORM database.

Robbins, D. A. (1998). Integrating managed care and ethics : transforming challenges into positive outcomes. New York: McGraw-Hill.

Rosoff, A. J. (2001). Breach of fiduciary duty lawsuits against MCOs. Journal of Legal Medicine, 22(1), 55-76. Retrieved December 10, 2005, from EBSCOHOST MegaFILE database.

Weber, D. O. (1997). Second thoughts: can managed care be ethical? Healthcare Forum Journal, 40(4), 17-29. Retrieved December 10, 2005, from EBSCOHOST MegaFILE database.

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Award for Excellence in Undergraduate Bioethics: Second Prize

Bioethics Without Borders

The Role of Bioethics in the International Prescription Drug Market: Economics and Global Justice Author: Shelby E. Newland, University of Pennsylvania Faculty Sponsor: Angelique M. Reitsma, MD, MA Abstract In terms of health care access, bioethics has an important role to inform and shape policy issues and develop interdisciplinary ideas and interventions. The rising price of prescription drugs presents one of the most looming barriers to health care access in the world today. Including both theoretical and practical features of the pharmaceutical industry’s behavior is necessary to find ethical solutions towards increasing access.

Bioethics can evaluate global justice by weighing human rights theory and future innovation at the macro level, and by addressing market forces and responsibilities at the micro level.

Inherent structural features of pharmaceuticals, such as its reliance on research and development, cause the industry to employ pricing strategies that seem counter-intuitive to conventional wisdom, but that result in producing a just allocation as defined by market forces. Parallel trade and drug exportation/ reimportation threaten the saliency of the industry’s differential pricing scheme; a case-study of a single “Euro-price” within the European Union illustrates how this will actually create harm to the most needy member states.

This complex situation requires solutions weighing arguments from human rights theory with those from economic theory to arrive at the most globally just allocation of prescription drugs in the global marketplace, as well as to ensure future innovation and scientific progress. Bioethicists as well as economists need to partake urgently in this discourse for the betterment of the global injustices in the international prescription drug market.

Health care access is a major problem confronting many around the world. In the context of access, bioethics has important role to inform and shape policy issues and develop interdisciplinary ideas and interventions.

The rising costs of health care provide one of the most looming barriers to health care access in the world today; one of the driving forces being pharmaceutical prices. The Shelby E. Newland, BA in Economics and Political Science, was a Post-Baccalaureate at University of Pennsylvania at the time of writing this submission. She will be entering the Master of Bioethics Program at the University of Pennsylvania in the Fall of 2006.

Email: shelby.newland@gmail.com Angelique M. Reitsma, MD, MA, is the faculty sponsor for this submission. She is a Visiting Professor in the Department of Bioethics at the University of Pennsylvania.

Address: 3401 Market St, Suite 320, Philadelphia, PA 19104 Email: ar6j@virginia.edu

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price of prescription drugs has been growing faster than other elements of health care, which therefore directly affects health care access to products such as life-saving, life-prolonging, and life-enhancing medication (KFF, 2004, p. 1).1 In dealing with the implications that arise from disparities in health care access through drugs, it is important to understand both theoretical and practical explanations of the pharmaceutical industry’s behavior when looking for ethical solutions. Access to medication involves evaluating both social and private responsibilities (Ryan, 2005, p. 544). Bioethics must therefore weigh the elements found in global justice and future innovation at the macro level, while addressing market forces and responsibilities at the micro level.

Global Justice and Human Rights Theory This analysis applies the principle of justice, as posited

by Beauchamp and Childress (1994, p. 225), to the analysis of prescription drug access. Justice involves determining the proper allocation according to certain standards, and the two main philosophies guiding the principle of justice are comparative and distributive (Daniels, 1981, p.

147). Comparative justice assumes an inherently scarce environment with a finite amount of money and resources that can be spent on health care, which posits that health care should be allocated based on existing needs and conditions. Distributive justice focuses on the use of doctrines to decide what is just rather than turning to elements found in the current state of affairs. Using welfare and difference measures of justice, the starkest injustice in pharmaceuticals involves the poorest countries in the world.

The two most pressing features of low-income individuals in the drug market are affordability of medication and research into diseases endemic to poor countries (Frank, 2001, p. 116). An analysis into the current allocation of pharmaceuticals on the global market involves an in-depth look at the role of justice in theory and practice.

Literature on human rights theory discusses health care both explicitly and implicitly. In the United Nations Declaration of Human Rights (1948, Article 25), the enumerated rights present a stark contrast between positive and negative rights; that is, those that must be actively provided versus passively allowed. Article 25.1 states,

“National prescription spending increased 15% from 2001 to 2002, compared to an 8% increase for physician and clinical services and a 10% increase for hospital care [in the United States].”

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Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care, necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control. (Emphasis added.)

While the doctrine discusses the right to a standard of living with some level of health care, it does not go so far as to demand positive intervention from a governmental body in order to provide care. Creating a minimum standard of health care might refer to creating a public health environment with proper water and sanitation, rather than an imperative to provide citizens access to all available health care and regimens. However, ambiguity arises in determining the burden of care that should apply to the pharmaceutical industry.

Pharmaceutical Industry Structure Economic Theory Economic theory is helpful to analyze the global pharmaceutical industry and the corresponding allocation of drugs. There are four main models used in microeconomic theory: perfect competition, monopoly, monopolistic competition, and oligarchy. These models differ based on assumptions such as the symmetry of information between the buyer and seller, and whether the firm is a price-maker or price-taker. Inherent features of the pharmaceutical industry exist that most resemble the assumptions in the monopolistic competition model (Danzon and Towse, 2003, p. 188). In normal commodity markets, i.e. the perfect competition model, consumers benefit from the presence of competition. Businesses target consumers by developing and advertising new products to attempt to find a niche.

The result begets new brands and nuances within brands, with the ensuing competition helping to drive down the price of close substitutes. However, inherent structural differences exist in the pharmaceutical industry in which competition (and lower prices) does not benefit consumers in the same manner as most other normal commodity markets. Two prime examples of the structural differences are the existence of patents and the use of differential pricing.

Patents The World Trade Organization, which is the international organization that regulates the rule of trade between 149 nations, established an international patent life of 20 years in its 1995 charter. Patents and other intellectual property rights, which are utilized for reasons such as encouraging innovation and regulating competition in the global market, are governed by the WTO’s Trade Related Intellectual Property Rights (TRIPS) agreement (WTO, Penn Bioethics Journal Vol II, issue ii Spring 2006

2006). The TRIPS agreement affords pharmaceutical companies the right to hold exclusive access to its product for a set amount of time and provides a standardized mechanism to license its products in other countries.

The justification behind patents is two-fold: to encourage innovation and to recover R&D costs (Sykes, 2002, p. 57).

If the company were not afforded the promise of patent protection, no company with heavy R&D focus would enter the pharmaceutical business. (This analysis reflects the current scenario in which drug R&D and manufacturing are linked.) Although critics argue that the patent period is too long and allows drug companies to make high profits, there does not seem to be a way to privately develop pharmaceuticals without the patent system (Gilbert, 1990, p. 112). Difficulties arise in trying to estimate R&D costs and a time frame in which to recover these costs. The R&D costs to be recovered not only include those for the drug in question, but also for other drugs that were lost in different stages of development. In one analysis of 68 drugs that entered the US market between 1980 and 1999, three health economists concluded that the average pre-FDA-approval price to the company was $802M (DiMasi et. al, 2003, p.

180). A high rate of attrition exists in potential products through the stages of laboratory, animal, and human trials, as well as trials needed for regulation (Barton and Emanuel, 2005, p. 2076). According to the DiMasi (2002, p. 298), only 21% of drugs that begin in human testing receive final approval. Due to the complexity of the estimation, pharmaceutical firms argue that it is better to err on the side of higher profits than lower in order to ensure future innovation.

Differential Pricing Differential pricing, also known as price discrimination or market segmentation, occurs when a company charges different prices to different consumers for the same product. An intuitive interpretation would conclude that charging different prices to different individuals would be an indisputable injustice; that is, those paying a higher price would be more justly served by paying the low price.

However, market segmentation in price-sensitive industries actually increases access and lowers prices to the poorest without raising the prices to the richest. An oft-cited example is the price of movie theatre tickets. Adults pay the regular price while students and senior citizens pay a discounted rate. The theory is that students and seniors are price-sensitive – students have less money to spend than adults, and seniors have a smaller percentage to devote to entertainment on a fixed budget – so each might not attend a cinema if they had to pay full price. Charging everyone full price would restrict access to the show as the pricesensitive audience would not attend. Conversely, charging all patrons a discounted rate would not allow the theatre, and by extension the movie industry, to pay back the high costs of production, which would lead to negative consequences

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for the entire industry. The best situation then, and the one that is in fact practiced, is to charge different prices to different markets. Therefore, access is expanded while the costs of production are paid back to those who fronted the costs.

This example is analogous to the pharmaceutical industry, except that price-sensitivity is, in theory, segmented by country rather than by age. Countries with high incomes per capita are analogous to the adult in the movie theatre example – they have relatively more money than citizens of poor countries and therefore more money to potentially devote towards drug expenditures. The students and seniors are in the movie example represent the poorer states in the world. De George (2005, p. 563) argues that using global differential pricing is in fact an ethical obligation in that it increases access. According to one analysis, price discrimination increases access by a factor of 4-7 times, which illustrates the economic concept that pharmaceutical companies accomplish the goals of expanding affordability and access by implementing a system of differential pricing (Dumoulin, 2001, p. 322).

Differential pricing occurs only because markets can be properly segmented to assure that lower prices do not erode into the general marketplace. In the theatre example, this transpires by forcing seniors and students to show proof of age or affiliation when purchasing tickets. The industry wants proof that only students and seniors are using their discounted prices and not purchasing tickets for use by full-fare adults. Likewise, when poor countries receive price discounts, it becomes imperative that some mechanism protects these discounts from spilling over into other markets; markets made up of those who in fact have the money to pay the initial price.

The manner in which markets are be segmented affects access. For instance, poor and/or uninsured citizens living within a country with high income will be unable to access the drugs at relatively high prices assigned to the country; this is the case in the United States and India. The best situation in terms of access for these individuals as well as sales for the pharmaceutical industry is to segment the

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markets even further, such as by income. The downside to price discrimination is that those facing higher prices may look for other opportunities to acquire medication, which can lead to an implosion of the differential pricing scheme.

Duty to Shareholders By virtue of the market mechanism, companies have a duty to their shareholders to provide them with a reasonable return for assuming risk as well as a profit margin to entice more capital (Dukes, 2002, p. 1682).

Industries that produce products with a long time lag between research and appearance on the market involve an extra cost that economists refer to as the “opportunity cost of capital.” Basically, if the investors had chosen a typical industry (i.e. shorter time lag), they would have seen a return much sooner, and this implies more opportunity for interest and investment. Therefore, to attract capital in the pharmaceutical industry, companies must be able to entice investors by offering the potential for larger returns.

Contrary to popular belief, the pharmaceutical industry does not consistently churn out exorbitantly high profits, as Table provided below illustrates.

Many reports focus on the high percentages of sales dollars spent on marketing compared to research in the pharmaceutical industry. Experts argue that the market itself has created an imbalance between research and marketing dollars (Barton and Emanuel, 2005, p. 2077; Angell, 2004, p. 1452). They suggest that, by reinvesting the marketing money back into R&D, more new drugs can be created and/or prices can be lowered. While this logic is valid, it does not account for the possible increase in demand caused by the marketing, which could affect the volume of drugs sold. Marketing is an important mechanism in which to promote scientific advancements in medicine, but the magnitude of marketing dollars is in need of further research and dialogue. This leads to the conclusion that if, like critics contend, marketing money was redirected toward R&D, the problem becomes the opposite – without sales in the first place, there will be no

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money available to support R&D. Research incentives The structure of the pharmaceutical industry creates incentives only for drugs with potentially large markets in high-income countries. The market mechanism lacks incentives for R&D into pediatric cures, preventive interventions, vaccines, and rare diseases in developed countries, as well as ailments that affect persons predominantly in developing countries (Danzon and Towse, 2003, p. 184). Human rights theory necessitates the reconciliation of research priorities to resemble elements of justice, and the market mechanism fails in this regard.

A flawed private market leaves the governments with some underlying notion to intervene and regulate to strive for a more just equilibrium.

Euro-Price The “Euro-price” case study for pharmaceuticals is an example of how supranational governments can directly intervene in the market for prescription medications, but in this case causing more harm than good. The European Union, by virtue of free trade within the member states, has advocated for a single “Euro-price” to be charged to all states.

This ideal of “parallel trade” can be achieved by importing drugs from those states with lower incomes and therefore paying lower prices than those charged by pharmaceutical companies. This appears to be an empowering solution to cut prices across EU countries. However, Ganslandt and Maskus (2004, p. 1036) discuss the theory behind parallel trade and why it does not produce positive outcomes specifically in the pharmaceutical industry, based on the differential pricing scheme discussed previously. When this pricing system is upset by parallel trade, i.e., when countries pay a lower price than originally mandated, manufacturers are left with the task to somehow cover their R&D costs (Towse, 1998, p. 273). Since addressing these cost deficits by raising prices on the rich countries is useless since they are already bypassing pharmaceutical pricing under a Euro-price, it forces the industry to increase the previously-discounted drugs, being those afforded to the poorest countries. A Euro-price, though a bargain for rich EU countries, ends up hurting the poorest members by raising prices of discounted drugs.

Possible solutions Once short-comings of global pharmaceutical access are acknowledged, solutions and interventions need to be discussed and developed. Three areas in which interventions can be directed include drug prices and exportation/ reimportation, industry structure, and development incentives (Barton and Emanuel, 2005, p. 2078). Although the global differential pricing scheme does provide discounts and access to lower-income countries, higherincome markets could increase access by further segmenting Penn Bioethics Journal Vol II, issue ii Spring 2006

the market by income. In this manner, the poor residing in rich countries can benefit from differential pricing and lower prices. The 2001 and 2003 conferences of the WTO confirmed the ability of countries to deny exports in order to prevent parallel trading (i.e. if a low-income country were being charged a low price, this discount would be assured by legal regulation that denies pharmaceutical exportation to richer countries that pay full-price) (Scherer and Watal, 2002, p. 939; WTO Doha, 2001, 01-5860). Parallel trade would force the pharmaceutical industry to intervene and raise prices to the poorest countries, but introducing stricter international regulations can be structured to address this problem sufficiently.

In terms of changing industry structure, one solution is the buy-out price system. In this model, the government pays a pharmaceutical company a lump sum payment equal to their R&D costs and a certain profit target. The idea is that the costs of R&D can be more evenly spread across the globe, and consequently the company will charge the world markets only the marginal cost of the pills. However, this creates a free-rider problem, whereas if a state does not donate to the buy-out, is will still reap the benefits of a pill or vaccine priced only at marginal cost.

The final solutions involve changing development incentives. In line with reconciling the research priorities justly, governments can change the incentive structure to create drugs to benefit developing nations or rare diseases in developed nations. Some examples include funding a prize for innovation or creating a pricing scheme based on social value rather than market demand (Barton and Emanuel, 2005, p. 2080). This would overhaul the current marketbased pricing system, but the ramifications are beyond the scope of this paper.

The image of the pharmaceutical industry has been tarnished by recent examples of adverse effects in drugs, efforts to thwart the dissemination of negative results, abuses of patents, and conflicts of interest in the industry.

Companies maintain they are only acting as economists and industry analysts would expect, i.e., as profit maximizing firms, and that they did not create the global economic injustices so should not have to change their practices in an attempt to correct them (Leisinger, 2005, p. 588).

In the end, all of these solutions pose the same conundrum: what must be the trade-off between current prices, future innovation, and global justice. Organizations or governments must intervene to determine a cut-off point at which the speed of new drugs entering the market no longer equals the societal costs of price increases.

Government has a duty to correct market failures, ideally guided by bioethical theories reconciling notions of justice with access and affordability, as well as the economic theory governing market behavior. This complex situation requires interventions weighing arguments from human rights theory with those from economic theory to arrive at the most just

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allocation of prescription drugs in the global marketplace, as well as ensuring future innovation and scientific progress.

Bioethicists as well as economists need to partake urgently in this discourse for the betterment of the global injustices in the international prescription drug market.

Acknowledgment The authors wish to thank Jon Merz, PhD, MBA, for his valuable comments.

References 1. Angell, M. (2004). Excess in the pharmaceutical industry. CMAJ : Canadian Medical Association Journal, 171(12), 1451-1453.

2. Barton, J. H., & Emanuel, E. J. (2005). The patents-based pharmaceutical development process: Rationale, problems, and potential reforms. JAMA: The Journal of the American Medical Association, 294(16), 2075-2082.

3. Beauchamp, T. & Childress, J. (1994). Principles of Biomedical Ethics. New York: Oxford University Press.

4. Daniels, N. (1981). Health-care needs and distributive justice.

Philosophy and Public Affairs, 10(2), 146-179.

5. Danzon, P. M., & Towse, A. (2003). Differential pricing for pharmaceuticals: Reconciling access, R&D and patents International Journal of Health Care Finance and Economics, 3(3), 183-205.

6. De George, R. T. (2005). Intellectual property and pharmaceutical drugs: An ethical analysis. Business Ethics Quarterly, 15(4), 549575.

7. DiMasi, J. A. (2001). Risks in new drug development: Approval success rates for investigational drugs. Clinical Pharmacology & Therapeutics, 69(5), 297-307.

8. DiMasi, J. A., Hansen, R. W., Grabowski, H. G. (2003). The price of innovation: new estimates of drug development costs. Journal

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of Health Economics, 22, 151-185.

9. Dukes, M. N. (2002). Accountability of the pharmaceutical industry.

Lancet, 360(9346), 1682-1684.

10. Dumoulin, J. (2001). Globalization and public health: Doha, a reversal? Sante Publique, 13(4), 321-323.

11. Frank, R. G. (2001). Prescription drug prices: Why do some pay more than others do? Health Affairs, 20(2), 115-128.

12. Ganslandt, M., & Maskus, K. E. (2004). Parallel imports and the pricing of pharmaceutical products: Evidence from the European Union. Journal of Health Economics, 23(5), 1035-1057.

13. Gilbert, R., Shapiro, C. (1990). Optimal Patent Length and Breadth.

Rand Journal of Economics, 21, 106-112.

14. Leisinger, K. M. (2005). The corporate social responsibility of the pharmaceutical industry: Idealism without illusion and realism without resignation. Business Ethics Quarterly, 15(4), 577-594.

15. KFF - Kaiser Family Foundation (2004). Prescription Drug Trends.

October 2004 Update, Fact Sheet #3057-03.

16. Ryan, M. P. (2005). Introduction: Ethical responsibilities regarding drugs, patents, and health. Business Ethics Quarterly, 15(4), 543547.

17. Scherer, F. M. & Watal, J. (2002). Post-TRIPS options for access to patented medicines in developing nations. Journal of International Economic Law, 5, 913-939.

18. Sykes, A. O. (2002). TRIPS, pharmaceuticals, developing countries, and the Doha “solution”. Chicago Journal of International Law, 3(1), 47-68.

19. Towse, A. (1998). The pros and cons of a single ‘euro-price’ for drugs. PharmacoEconomics, 13(3), 271-276.

20. United Nations Declaration of Human Rights (1948). Available at: http://www.un.org/Overview/rights.html 21. WTO – World Trade Association, Website (2006). Available at: http://www.wto.org.

22. WTO Doha – World Trade Association, Doha Declaration (2001).

Ministerial Declaration. Available at: http://www.wto.org/english/ thewto_e/minist_e/ min01_e/min01_e.htm

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Bioethics Without Borders

The Moral Implications of Prenatal Genetic Testing Author: Peter Chipman, Dalhousie University, Canada Faculty Sponsor: Ms. Meredith Schwartz Abstract The advance of medical technology now permits many genetic tests to be administered to a fetus in the womb. The goal of this testing is to determine the potential for genetically based disorders and disabilities.

The use of these tests has major implications on the decision of a parent to abort a child based on what information they find in the prospective child’s genes.

Advocates of prenatal testing argue that it enables the families of these prospective children to make an informed decision when faced with the possibility of disability.

I argue that this choice is drastically limited by social coercion through a discriminatory and stereotyped perception of the disabled community.

Permitting an uncontrolled barrage of prenatal genetic tests will further promote the stereotype of a disabled life, and thus hinders our societal goal to recognise and promote equality and individuality. Which disabilities to test for, or what genes to search for, is a judgement that should be made only through extensive consultation with members of the disabled community, including individuals who have suffered from or who have been directly associated with the disability which is to be tested.

Rapid advances in medical technology coupled with the recent completion of the Human Genome Project provide unprecedented insight into the genetic basis of many human diseases and disabilities. There are currently many technologies that allow early diagnosis and prediction of the probability of onset of particular diseases, malformations, defects and disabilities in an unborn child. As these technologies advance, the scope of accurate prenatal testing is seemingly limitless and has a future where the identification of any disorder or trait with a genetic basis becomes increasingly plausible. It is assumed that most Peter Chipman was an undergraduate at Dalhousie University at the time of writing this submission. After graduating with a BS in Neuroscience in 2005, Peter Chipman began working with disabled children in the regional school system as a substitute Educational Program Assistant. He will be attending Dalhousie University in the fall of 2006 to obtain a Masters in Anatomy and Neurobiology.

Email: pchipman@dal.ca Ms. Meredith Schwartz is the sponsor for this submission.

She is currently a PhD student and Teaching Assistant of Philosophy at Dalhousie University.

Address: 2234 Maynard St. Apt 9, Halifax, Canada, NS, B3K3T5 Email: meredith.schwartz@dal.ca Penn Bioethics Journal Vol. II, Issue ii Spring 2006

prospective parents will be concerned with ensuring the birth of a healthy child and will likely adhere and succumb to the pressures of providing standard of prenatal care in order to be ensured of the fetus’ good health. In the event that a genetic or potential genetic disorder is detected, prenatal diagnosis provides the prospective parents with several different options, including both mental and financial preparation for the birth of an abnormal child, the use of fetal treatments against the detected disease or termination of the pregnancy. Currently, the reality of prenatal testing is that the most widely used fetal treatment is the outright termination of the pregnancy. For the purposes of this discussion, I will assume that it is morally and legally acceptable that women have the right to terminate any unwanted pregnancies.

In this essay I address the problem posed by social influences that pressure parents toward a barrage of prenatal genetic tests, as well as what restrictions can be imposed upon the availability of these tests to counteract these pressures. In specific, I suggest that tests other than those that would identify a fetus with high probability of infant fatality, severe and chronic pain or severe cognitive impairment should be withheld from use.

One must assess what sorts of prenatal tests and genetic screening are currently available and what sorts will eventually be possible. Analysis of fetal genetic information or chromosomal abnormalities can be accomplished through procedures such as amniocentesis, chorionic villi sampling (CVS), maternal serum alpha-foetal protein assay (MSAFP), and preimplantation genetic diagnosis (PGD).

Structural and anatomical abnormalities can be assessed through imaging techniques such as ultrasound, magnetic resonance imaging and fetal echocardiography (Cunniff, 2004, p.889). Ultrasound is currently the standard of care for health assessment in all pregnant women regardless of age, family history and health, while amniocentesis and CVS are utilized most commonly in pregnancies with woman over the age of 351, and as second round of testing when a disease is suspected. New medical genetic technology allows for identification of many genes known to be associated with particular abnormalities and provides the option of using the above procedures to screen for these particular genes. Although many diseases do indeed have a genetic component, the expression of these diseases does not These tests are meant to follow an ultrasound diagnosis of potential problems, but are increasingly being used by many pregnant woman regardless of the potential for disease.

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rely solely on the presence of the genes, but also on an interaction of the genes and the child’s environment. In addition, many diseases and malformations result in factors completely unrelated to the genetic code; such as trauma incurred during pregnancy or birth, maternal drug use in early pregnancy or malnutrition in early development. It should be noted that in many cases, genetic tests identify only those genes that are associated with a particular disorder and in no way directly contribute to the development of the disorder.2 The advancement of testing procedures, including a reduced cost and easier access will increase the number of tests routinely administered during pregnancy and will compromise a woman’s autonomy in regards to which tests are necessary and which are desired.

The pressures placed upon expecting mothers are not necessarily imposed directly through coercion by the genetic counsellor3 or family, but generally through what is socially perceived to be an acceptable level of care required during pregnancy. It is assumed that parents are concerned with having a healthy child and ensuring the proper care for that child.4 As technologies advance, the meaning of proper care may encompass certain procedures that accomplish little more than to warn the pregnant woman of a potential for a fetal disability or abnormality. The perceived burdens of raising a disabled child pressures expecting parents to request a particular test (Lippman, 1991, p. 402). Should the fetus exhibit traits that promote a particular disability, the parents may seem to have little choice but to abort the pregnancy. The increased use of unnecessary tests will further perpetuate the unfounded societal belief that these tests are necessary to produce a healthy child and may subsequently perpetuate ignorance and discrimination toward the disabled community. People may start to wonder why these individuals were not identified and aborted, and would thus perceive them as reproductive errors or oversights. The perpetuation of these beliefs is ultimately detrimental to efforts in society to promote equality.

It is a disturbing perception that the disability is the primary defining feature of a disabled individual (Asch, 1999, p. 1653). Those women who receive prenatal tests only to discover that their child may be disabled tend to focus on the disability rather than the possibility of giving birth to a caring and loving child who will potentially develop their own personality and provide their own contributions to society.5 The point of emphasis is that the potential of a 2 There are single genes that have been directly linked to disorders, such as the case for Huntington’s disease and muscular dystrophy (Chan & Chan, 1997, p.173).

3 Genetic counsellors are in fact instructed not to provide any sort of direction in regards to decisions about termination of the pregnancy (Cunniff et al. 2004, p.889) 4 It is not through a concern for the health of the child that termination is considered, but rather a chance for the parents to produce a child with a socially acceptable level of health.

5 An infant or fetus can only be measured by its potential, although those affected by different levels of severity will show differing levels of social aptitudes as well.

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disabled fetus is no different from the potential of an ‘abled’ fetus. The only difference arises from the ideals imposed in society as to what constitutes meaningful potential as a human being. For instance, emphasis is placed upon those who are intelligent, attractive and athletic. A disabled person may be none of those, but may be more caring, considerate, and thoughtful than an individual with the qualities above.

Which qualities are more important and valued in society should be carefully assessed and reconsidered – although this is much easier said than done.

Many argue that prenatal testing enables the families of prospective children to make an informed decision6 when faced with the possibility of disability. Jeffrey Botkin, a proponent of prenatal testing argues that, “parents in this circumstance are not harmed by the suffering of the child… but rather by their time, efforts, and expenses to support the special needs of an individual with Down syndrome…”

(Botkin, 1995, p. 36). Although Botkin acknowledges that the affected individual does not personally suffer from the disability, he emphasizes that a large burden is imposed upon the family. He defines a burden as the amount of time, effort and expenses provided by the family to support the child with a disability. Adrienne Asch (1999, p. 1653) argues that although the amount of support needed to raise a child who suffers from a particular disability is not questioned, it is interesting that the benefits received through this level of involved care are not assessed or weighed against the burdens. Caring for a disabled child is a difficult task, but such a difficult task must reap rather large emotional rewards. Additionally, Botkin does not address the dichotomy between those burdens imposed by gifted children and those imposed by disabled children (Asch, 1999, p. 1653). According to Botkin’s criteria, a child who becomes interested in pursuing a career in professional hockey may impose much more of a burden upon their family than does a disabled child.7 The dichotomy lies in the appreciation society has of each of the two individuals. The fault is placed on a society that skews the perception of an ability and disability. Abby Lippman (1991, p. 404) argues that instead of creating additional social support programs to care and provide for those disabled persons, society expects to solve these ‘problems’ through medical and technological interventions. Interestingly, social programs that accommodate to the needs of gifted individuals are not difficult to come across.

An additional argument in support of prenatal genetic screening relates to the difficulties and pressures imposed upon the prospective disabled child. Proponents argue that 6 A decision in this sense would mean whether or not to abort a disabled fetus.

7 Supporting a child’s interest in such an expensive sport and one of such high competition demands the investment of countless dollars and hours into providing expensive equipment, timely delivery to early morning practices and games, and the potential for lengthy hospital visits.

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these difficulties would far exceed the benefits one may experience in such a life. By this description, it would be unfair to bring into the world a child who would outright be denied the “right of an open future” (Asch, 1999, p.1652).

Numerous problems arise out of this argument, namely the distinction between a life with a disability versus no life at all, or non-existence. Differing levels of disability would undoubtedly generate different arguments. For instance, non-existence would likely be preferable to a life full of chronic, inescapable physical pain and anguish.8 Physical pain may be reduced through drug programs, but may not altogether eradicate it. A life dominated by drug use seems less than desirable, but is this sufficient to justify non-existence? Who, but the individual affected, can decide the value of a life? Here it is important to identify the difference between a life completely plagued by burdens and one perceived to be plagued by burdens.9 I argue that it is not the individual that determines dissatisfaction, but the structure of society in which the individual lives that ultimately determines the ability and willingness of an individual to live with his/her disability.

Mental anguish is essential in quality of life assessments, although the level of social contribution towards this anguish is difficult to illustrate and determine. Individuals with similar disabilities may report a wide range of personal experiences, depending upon their environment and subsequently their expectations of living with their disability. These expectations are constructed through social experiences with not only the individual’s parents and family, but through interactions with peers and the general public. Obvious physical abnormalities and mental retardation may be criticised in certain social environments, and such an individual may suffer low self-esteem and may consequently have negative expectations of living a life with his or her disability. However, if these individuals were raised in an environment where they are integrated and accepted regardless of their apparent disability, then these individuals would likely report a higher level of selfesteem and have more positive expectations of a life with a disability. Expectations would affect how an individual weighs the burdens of his or her life.

Considering the above arguments, there are certain foreseeable circumstances when a disability is not worth the life or risks associated with it to the mother and prospective child. If the chances for a live birth are slim, the fetus may be aborted in favour of the potential risks to the mother associated with carrying a severely defected child to term.10 However, this case represents one extreme end of a continuum.

Herein lies the fundamental problem of a perceptive reality, where an individual creates their reality based on their perceptions of what a particular life is to be. Such perceptions are based on social influences.

10 If such an action is so desired. Many woman suffer mentally even from aborting a doomed fetus due to the nature of abortion.

Some prefer to let nature take its course rather than actively killing 8 9

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A disease, which carries with it chronic and uncontrollable pain, or severely impaired cognitive development to those affected, may nullify the chance for an enjoyable life. These cases likely justify abortion of the affected fetus, and thus screening for these disorders may be permitted. The decision of which disabilities fit these criteria should only be made by those who have been personally affected by the disability in question.11 It is only through consultation with the disabled community that the true quality of life associated with the disease may be assessed and a decision about whether or not to allow screening can be made. If individuals with the disorder cannot communicate the degree of their quality of life,12 then the decision may pass to the parent, geneticist or obstetrician where a consensus can be made.

Variations in social experiences arise mainly due to what is considered normal13 in society. The public may regard individuals that are different as either inferior or as threats or may simply generalise to encompass a further difference in human characteristics such as thoughts, feelings and emotions. Thus, the problem arises from the general societal view that disabled is different, and different infers a level of difficulty and subsequent dissatisfaction in life. Here there must be a distinction made between what is dissatisfaction and what is difficulty. Certain difficulties are part of life for everyone and it is how people deal with these difficulties that determines the quality of their lives and their overall level of satisfaction. Indeed there are some people who do report that their lives may be complicated by disability, but these individuals consider it simply as a personal quality they must use to navigate throughout life.

Additionally, the difficulties encountered by the disabled are largely socially rather than biologically imposed (Asch, 1999, p. 1653). Most disabled people report that their only dissatisfaction in life arises due to their unemployment and associated problems with income, and health insurance (US), encountered as a result of discrimination. A mother may feel pressured to abort an ‘abnormal’ fetus because it may encounter difficulties and discrimination as a result of his/her disability. The decision to abort a fetus with such a disadvantage thus completes the vicious circle. It will only compound the perception that disability is undesirable.

Several lines of research indicate that the ‘abled’ population perceives the quality of life of the disabled population as significantly less desirable than do those Understandably, the level of severity by which an individual suffers from the disability will affect his/her opinion on the morality of prenatal testing. An individual who suffers considerably from a particular disease would be more likely to support prenatal testing for it (Gollust et al., 2005, p.39).

12 Inability to communicate entails an inability to comprehend due to severe cognitive impairment or early death resulting form the disease. It does not imply those with language disorders.

13 Definitions of normalcy vary, but may be considered as being those combinations of traits that are found in the majority of the population.

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living with disabilities. A study preformed by Ray & West (1984, p.83) indicated that individuals living with spinal cord injury reported an increase in positive self image after becoming disabled. Several other groups of disabled people seem to be satisfied with their lives and report the quality of life as being better than unaffected individuals perceive it to be. In fact, a certain group of deaf individuals have been reported to not only prefer having a deaf child, but would use prenatal screening to selectively terminate those fetuses that can hear (Dennis, 2004, p.894). Certain individuals maintain that their exclusion from the hearing world enables them to create closer, more intimate bonds between themselves and other deaf individuals, and prefer to share these experiences with their children. Although this is an extreme and seemingly isolated case, it clearly illustrates that certain disabled individuals do not lead difficult and painful lives but may in fact lead lives that they perceive as being superior to those without their ‘disability’.

Aborting a disabled fetus solely due to a disability in which no valid or justifiable harm can be proven to the future individual may be considered a form of discrimination against individuals with the disability. Many individuals in the disabled community fear that uncontrolled genetic tests will eventually reduce the number of individuals in their population and thus create a higher level of discrimination (Gollust et al., 2005, p.37). Women who refuse prenatal tests or abortion after a positive test could be held financially responsible for their ‘irrational’ decisions.

Support programs for a disabled child may not be as readily available if the option to avoid having the child is present.

However, it must be kept in mind that many diseases do not have a genetic basis and the elimination of disability through prenatal screening is impossible. While screening would not eliminate disability, it would undoubtedly propagate the social stigma against the acceptance of those individuals.

The propagation of negativity towards a certain group is always an undesirable consequence.

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The goals of prenatal testing primarily intend to prevent the hardships and burdens of a life with disabilities for both the mother and the prospective child. Secondary to the benefits obtained from these tests are the moral implications that result on a society that is already distanced from, and discriminates against, the disabled community. This could then be considered a step in the wrong direction in a society that seems to want to promote equality. Widespread uses of prenatal testing will primary affect and worsen the discrimination and distance which is already present in the disabled community. Providing a woman with a barrage of prenatal tests does not allow for a sufficient level of choice in regards to whether or not a disabled child should be carried to term, as social pressures drastically limit this choice. The only way to limit social coercion to abort a disabled fetus is to limit the use of prenatal tests and impose certain restrictions through consultation with members of the disabled community.

References 1. Asch, A. (1999) Prenatal Diagnosis and Selective Abortion: A Challenge to Practice and Policy, American Journal of Public Health; 89(11):1649-1657 2. Botkin J. (1995) Fetal Privacy and Confidentiality, Hastings Center Report; 25(3); 32-39 3. Cunniff C. et al. (2004) Prenatal Screening and Diagnosis for Pediatricians, Pediatrics; 114; 889-894 4. Dennis, C. (2004) Deaf by Design, Nature; 431; 894-896 5. Gollust SE. et al. (2005) Community Involvement in Developing Policies for Genetic Testing: Assessing the Interests and Experiences of Individuals Affected by Genetic Conditions, American Journal of Public Health; 95(1); 35-41 6. Lippman A. (1991) Prenatal Genetic testing and Screening: Constructing Needs and Reinforcing Inequities, American Journal of Law and Medicine; 17; nos.1&2; 15-50. Reprinted in Health Care Ethics in Canada (2004), eds. Baylis F et al. with the permission of the American Society of Law, Medicine & Ethics and Boston University 7. Ray C & West J. (1983) Social. Sexual and Personal Implications of Paraplegia, Paraplegia; 22; 75-86 8. V Chan J& TK Chan J. (1997) Prenatal Diagnosis of Common Single Gene Disorders by DNA Technology, Hong Kong Med J; 3(2);173-178

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Penn Bioethics Journal Vol II, Issue ii Spring 2006

Bioethics Without Borders

Justified Paternalism: The nature of beneficence in the care of dementia patients Author: Kashina Groves, University of Washington Faculty Sponsor: Sara Groering, PhD Abstract The issue of patient autonomy in cases of permanent dementia has recently received a great deal of philosophical attention. Specifically, many have worried about ethical issues surrounding advance directives in which people specify how they shall be treated when they are no longer competent to make their own medical decisions. Ronald Dworkin has been a staunch defender of what he calls precedent autonomy in these cases, believing persons have a right to control, to some degree, how their lives will end, despite the common intuition that the principle of beneficence requires us to improve the experiential quality of patients’ lives. Objections have been brought against Dworkin on a number of fronts, including worries about personal identity theory and informed consent. Here, I offer an objection to Dworkin’s assessment of the nature of paternalism as it relates to cases of permanent dementia.

Introduction Traditional bioethics holds respect for patient autonomy as one of its basic guiding principles. Some patients however, are considered medically incompetent and are not permitted to make decisions about the course of their medical care. These groups typically include children, some developmentally disabled individuals, and some individuals with advanced dementia. Each group has special characteristics that will lead to unique ethical principles designed to guide medical decision-making, but they each present a similar problem. When one person is, for some reason, not able to exercise autonomy over a certain area of life, a rational individual or group of rational individuals must take on the responsibility to make decisions in the person’s best interest. There has been some question as to who should make these decisions, but the most controversy arises in the latter case of dementia.

Ronald Dworkin has weighed in on this issue, arguing that individuals who don’t yet have dementia should be their own future guardians through the system of advanced directives. Rebecca Dresser has explained a number of objections to Dworkin’s theory. I will examine Dworkin’s Kashina Groves is a Senior at the University of Washington and is double majoring in Philosophy and Environmental Studies.

Email: kashinadawn@gmail.com Dr. Sara Goering is the faculty sponsor for this submission. She is an Assistant Professor of Philosophy at the University of Washington.

Address: 345 Savery, Box 353350, Seattle, WA 98195 Email: sgoering@u.washington.edu Penn Bioethics Journal Vol. II, Issue ii Spring 2006

argument, Dresser’s objections to it, and then present my own objection to Dworkin.

Both Dresser and Dworkin consider the case of Margo, a hypothetical person based on an actual case. Margo is a patient with dementia (not medically competent) who seems quite happy to outside observers, but who signed an advanced directive saying she would prefer to be allowed to die once afflicted with dementia, should she need life-saving medical treatment.

In Ronald Dworkin’s 1993 book, Life’s Dominion: An Argument about Abortion, Euthanasia, and Individual Freedom, he argues that (competent) individuals should be allowed full authority to determine what the course of their lives shall be if they somehow become incompetent (Dworkin, 1993, p. 226). In other words, healthy individuals should be able to create documents with explicit instructions for what healthcare providers should do in specific instances which could not ethically be breached in most cases regardless of their own future expressed desires. He supports this conclusion by prioritizing what he calls a person’s “critical interests,” or meaningful life goals and projects, over “experiential interests,” or desires to have enjoyable experiences, even if the individual is made unaware of her critical interests (Dworkin, 1993, p.

230). According to Dworkin, people should be granted the autonomy to pursue the kind of death they feel fits in with their life story and the character they have cultivated throughout life. Competent individuals, as opposed to experts who claim to know what is in the best interests of persons, should be able to decide for themselves what they want in a future situation because we value the “integrity view of autonomy,” the view that persons should be granted the freedom to make choices that are their own, even if they may not in fact be in their best interest (Dworkin, 1993, p.

224).

Although it may appear to even highly experienced psychologists that Margo is still enjoying life to some degree given the fulfillment of her experiential interests, Dworkin would argue that her living with dementia is necessarily opposed to her own critical interests (that she had while competent) and therefore undermines any quality of life she might have even though she is not nor will ever again be aware of those critical interests. According to Dworkin, this treatment ignores the basic bioethical principle of beneficence, because those caring for her are not making decisions that comply with caring for the whole person (which to Dworkin includes her previously expressed wishes) or that lead to the fulfillment of her critical interests

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(Dworkin, 1993, p. 231).

In her article “Dworkin on Dementia: Elegant Theory, Questionable Policy,” Rebecca Dresser makes a number of objections to Dworkin’s suggestions about advanced directives and dementia patients. Many of these objections are empirical or practical in nature, while others are theoretical. My interest here is more in the theoretical objections, though the others are worth noting as well.

For example, Dresser wonders if in fact Americans do generally place a high value on how they die and whether the integrity of their characters is maintained through the end of life. Additionally, she worries that people do not have sufficient knowledge of the course of dementia and what the experience of a dementia patient is like, and the advance directives will not be specific about when during the course of the disease the person wishes to stop treatment (Dresser, 1999, p. 52).

One of Dresser’s large concerns is that persons may not be able to accurately predict what dementia will be like and whether it would be acceptable for them to live in such a condition (Dresser, 1999, p. 52). In fact, competent persons often have trouble imagining themselves with any sort of disability (including physical disability); compared with imagined satisfaction with disabilities among the non-disabled, satisfaction is quite high among competent physically disabled individuals. Dresser’s concern is that the same discrepancy might exist between competent people and those suffering from dementia, if we accurately measure the satisfaction of the latter group. Dworkin would be able to dismiss this concern on two accounts. First, he acknowledges the epistemic problem of measuring the satisfaction of dementia patients by saying that although we cannot know the level of satisfaction of a dementia patient, the best person to judge this is the same patient while she is still competent (Dresser, 1999, p. 49). Second, the conscious satisfaction of the dementia patient, even if it could be accurately assessed, is of little importance no matter how high it may be. What matters to Dworkin is that the critical interests of the person have been compromised simply in virtue of the fact that she is living with dementia.

Because Dworkin’s argument rests on the premise that one’s interests can be meaningfully neglected without the person’s knowledge, Dresser’s worry here is not an adequate objection.

Another concern Dresser raises is the issue of whether identity persists through drastic changes in an individual’s character and personality. If identity does not persist, a competent individual designing an unalterable advance directive would be making the decision to place a different future person into a binding contract based on her own desires and worldview. No reasonable system of ethics allows for this sort of practice (Dresser, 1999, p. 52). This is a common objection to Dworkin’s argument, and is very troubling in light of predominantte contemporary views

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of personal identity holding that “psychological continuity is (at least) a necessary condition for personal identity” (Buchanan, 1988, p. 280). Dworkin’s case rests on the dubious falsity of this claim. However, given Dworkin’s commitment to strong personal freedom, it seems he would not be worried by such a concern; this is not his view of personal identity. Furthermore, Dworkin would say that the primary reason for having advance directives for dementia at all is the inability of dementia patients to make competent decisions about their medical care. Someone, or some group of people, needs to make medical decisions for the person with her best interests in mind. Dworkin believes that, more than any doctor, counselor, or family member, the decision should be left to the pre-dementia individual to which this treatment will be given (or withheld). Despite the fragility of Dworkin’s argument given the debate surrounding personal identity, his argument is still open to objection even if he is granted his assumption that identity persists throughout dementia.

Dresser’s objections will not worry Dworkin because the two philosophers fundamentally disagree on basic assumptions about dementia patients. I will present an additional objection to Dworkin that does not appear in Dresser’s work. Dworkin is very much worried about paternalism. He mentions that not allowing Margo’s stated wishes to be carried out would be an “unacceptable form of moral paternalism” (Dworkin, 1993, p. 231), implying that he sees some forms of paternalism as acceptable. Moral paternalism is acceptable in cases in which it enhances the future fulfillment of critical and experiential interests of a temporarily incompetent person or in some cases in which it enhances the future fulfillment of a permanently incompetent person’s experiential interests. Temporary incompetence includes childhood (in which there is focal incompetence for certain kinds of decisions) and altered states (that are related to sleep or mind-altering substances).

Permanent incompetence includes dementia (and other neurological diseases) and cases in which developmental disabilities render persons focally or completely incompetent to make decisions for their well-being.

I wish to make a distinction regarding my objection to Dworkin’s views of beneficence and autonomy in these cases. Others, most notably Seana Shiffrin, have contested Dworkin’s assumption that whatever the dementia patient should express should be ignored in making decisions about her care. For Dworkin, the dilemma is between respecting the wishes the patient expressed while competent and giving agency to caretakers, family members, counselors, and physicians. Shiffrin takes this to be a false dilemma, making an analogy between the permanently demented and terminally ill children. She notes that our intuition is to respect the expressed desires of terminally ill (but not yet fully competent) children insofar as these wishes are not dangerous even though we cannot claim we are

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Justified Paternalism

helping the children to develop their autonomy (Shiffrin, 2004, p. 206). I do not take this case to be analogous to the permanently demented, and do not wish to challenge Dworkin’s assumption that the apparent expressed will of the permanently demented be ignored. Except for the very young, children have a higher degree of competence than the seriously demented and can be expected to retain this competence until death. Additionally, because these children have greater access to their memories than the permanently demented, they are able to engage in developing meaningful life projects, even if to a lesser extent than competent adults. Our intuitions in the case of terminally ill children should not inform the argument about permanently demented adults.

In Life’s Dominion, Dworkin makes an analogy between permanent dementia and temporary incompetence using the example of a Jehovah’s Witness who asks in advance not to receive a blood transfusion even if he pleads for one when it becomes a medical necessity (Dworkin, 1993, p. 227). I do not find this example to be as obvious as Dworkin intends it to be, but another analogy will suffice in leading to the same end. If, as a student, studying keeps me awake until quite late, I might ask a friend to wake me up in the morning and be sure I leave for work on time.

I might say something like: “I know I’ll be temporarily incompetent in the morning, and I’ll tell you I don’t want to get up and possibly try to convince you that I don’t need to go to work. No matter what I say or do then, carry out only the instructions I give you now, for they are derived from what I actually want.” My friend would be obligated to do as I say, ignoring whatever desires I seem to have in the morning, knowing that paternalistically getting me to work is the best way to maximize the fulfillment of my critical interests that I may temporarily be unaware of. In other words, heeding my previous orders is required by beneficence. Dworkin would say this example is analogous to advance directives, but I will show why it is not.

My friend’s use of paternalism by ignoring my apparent current interests and acting only on my previous orders in order to get me to work in the morning is permissible because I am temporarily unaware of what my critical interests are, or I am temporarily unable to use my rational capacities to act in ways to maximize the fulfillment of those interests. After becoming fully conscious, I will once again be fully aware of my entire spectrum of interests and will be competent enough to make decisions to those ends. The justification for paternalism in these cases rests upon the future competence of the individual. There is no reason to promote critical interests that a person cannot ever possibly be aware she has. Our only obligation is to act to maximize the fulfillment of the incompetent person’s current and future interests as far as we can tell what they are, which in the case of dementia can only include experiential interests.

The paternalism used in caring for a dementia patient Penn Bioethics Journal Vol II, issue ii Spring 2006

and ignoring her now vacant critical interests is, in fact, acceptable. This is not to say that the advance directive is not evidence of the patient’s previous critical interests at the time it was signed. It is evidence that these interests existed, but is not sufficient for proving they still exist. If any critical interests about Margo’s life still exist, it is only because other people now hold them, just as people might take on the critical interests of the dead as their own to ensure the completion or continuation of the projects of a deceased person.

Given Dworkin’s strong commitment to personal autonomy and narrative coherence in one’s life, he might give another analogy to show why I am mistaken. Suppose a competent person has the critical interest of raising her children in a manner so that they will flourish. Now suppose the children are adults who have moved away and only see the parent rarely and communicate via telephone. The children tell the parent that they are quite successful, happy, and fulfilled, when in fact they are miserable, lonely, and depressed. They lie about jobs, friends, and experiences that do not exist because they know about the parent’s interest in their happiness. Dworkin would call this unacceptable paternalism because the parent is made to believe her critical interests have been fulfilled when in fact they have not, and I would agree with him. The parent’s critical interests will not be fulfilled, and she does not have the ability to become aware of that. Dworkin might say this example is analogous to the unacceptable paternalism in the case of Margo, because in both cases someone is stopping the person’s critical interests from being fulfilled, and the person is unable to become aware of it.

I would respond to such an objection by saying that it is not the person’s ability to know whether their critical interests have been fulfilled that matters, nor is it their ability to affect the fulfillment that morally distinguishes acceptable paternalism from unacceptable paternalism.

Rather, it is the person’s ability (or future ability) to know that she even has critical interests that distinguishes Margo from the misinformed parent. The parent desires her critical interests to be fulfilled (and not simply to believe they have been), while Margo is completely unaware that she even has or ever had critical interests. It is not wrong to ignore critical interests that a person will never have a way of knowing exist.

While Dresser makes many objections, both practical and theoretical, to Ronald Dworkin’s theory of precedent autonomy surrounding advance directives and dementia, her theoretical objections would not worry Dworkin given the differences in basic assumptions between the two philosophers. I would object to Dworkin by questioning whether the paternalism present in making decisions for a patient with dementia based solely on her present condition is morally unacceptable. It is, I think, more analogous to cases in which paternalism is acceptable than it is to cases

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in which it is unacceptable. Given this acceptability, I would recommend healthcare workers and families make decisions for dementia patients with the goal of bettering their current condition, rather than honoring their former wishes.

Bernstein and Weiner (1996, p. 268-269) admit that sometimes some studies seeking to explore the pathogenesis and clinical outcomes of a disease offer no therapeutic benefit to the research subject. Known as phase 1 studies, they administer medication to the subject in small doses, gradually increasing the dosage to test for the toxicity of the drug. In such cases, there is a potential for a tremendous amount of benefit on many levels. If a new drug is developed as a result of research, the researchers and institution gain recognition, while the drug companies amass profit. The research subject, however, gains no immediate benefit from his or her participation, save the fulfillment of altruistic motives.

Such a phenomenon whereby the benefit of research unduly favors the interests of the researchers rather than the subjects may be considered a “conspiracy of silence.�

If the proxy decision makers or the subjects themselves

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were consistently informed that phase 1 studies offer no therapeutic benefits, one would presume that enrollment in such studies would sharply decline.

Ostensibly, the issue of clinical research on cognitively impaired older adults is controversial. Kapp (2002) concludes that excluding older adults with mental impairments from the participant pool would unfairly limit research, a process that is necessary for clinical medicine to advance. However, Kapp also acknowledges the value of protecting the rights of those who are unable to protect themselves.

References 1. Buchanan, Allen. (1988). Advance Directives and the Personal Identity Problem. Philosophy and Public Affairs, 17(4) pp. 277302.

2. Dresser, Rebecca. (1999). Dworkin on Dementia: Elegant Theory, Questionable Policy. In J. Lindemann Nelson and H. Lindemann Nelson, (Eds.) Meaning and Medicine: A Reader in the Philosophy of Health Care, (pp. 47-56). New York: Routledge.

3. Dworkin, Ronald. (1993). Life’s Dominion: An Argument about Abortion, Euthanasia, and Individual Freedom. New York: Alfred A. Knopf.

4. Shiffrin, Seana. (2004). Autonomy, Beneficence, and the Permanently Demented. In Justine Burley (Ed.) Dworkin and His Critics (pp. 195-217). Malden, MA: 2004.

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Penn Bioethics Journal Vol II, Issue ii Spring 2006

Bioethics Without Borders

The Ethics of Placebo-Controlled Studies on Perinatal HIV Transmission and Its Treatment in the Developing World Author: Shi (Mark) Gu, Duke University Faculty Sponsor: Amy Sayle, PhD Abstract Perinatal HIV transmission in the United States has been greatly reduced since the 1993 discovery of zidovudine, known as protocol 076. However, a feasible treatment in developing countries has not yet been found due to the high cost and medical standards needed to implement protocol 076. This presents an ethical question: whether placebo or active control should be used in testing new treatments. Proponents of a placebo control argue that a placebo control is the only method that provides definitive evidence of efficacy and side-effects, especially important given the scarce financial resources present in developing countries. Critics, however, argue that the use of a placebo controlled study when an effective treatment exists would be jeopardizing the health of individuals in developing countries. The key to resolving this debate is realizing that protocol 076 would not necessarily be effective when transplanted to developing countries due to the lack of adequate medical infrastructure, malnutrition, prevalence of disease, and low standard of living—it is not certain that protocol 076 would be better than placebo at all. Following this line of reasoning, quite a few placebo-controlled studies on perinatal HIV treatment have already been performed.

Upon examination of this accumulated evidence, one finds that protocol 076, and shortened courses of it, are indeed effective in non-breastfeeding participants in developing countries; however, no treatment has been proven effective for breastfeeding populations.

Therefore, it would be ethical to conduct placebocontrolled studies on breastfeeding populations, but not on non-breastfeeding populations.

In 1993, an effective treatment, protocol PACTG 076, was discovered to significantly reduce perinatal transmission of HIV (Connor et al, 1993). This protocol was a breakthrough in stemming the transmission of HIV; however, it was both costly and difficult to implement in areas without established medical facilities. A more costeffective and practical treatment is still necessary to treat Shi (Mark) Gu is a Freshman at Duke University and is double majoring in Biomedical Engineering and Electrical Engineering.

Email: sg58@duke.edu Dr. Amy Sayle is the faculty sponsor for this submission.

She is a Mellon Lecturing Fellow in the University Writing Program at Duke University.

Address: Box 90025, Durham, NC 27708-0025 Email: sayle@duke.edu Penn Bioethics Journal Vol. II, Issue ii Spring 2006

the bulk of HIV infections, which take place in developing countries. Unfortunately, an ethical dilemma presents itself: should new treatment options be tested against a placebo or against active controls such as protocol PACTG 076, the current standard of treatment? The answer to this question hinges primarily on whether the current standard of treatment would be effective when transplanted to developing countries. If it is not proven to be effective, then placebo-controlled studies are warranted to find effective treatments. Once definitive proof of the efficacy of the treatments in developing countries is obtained, however, the use of placebo as a control would put the health of the individual taking the placebo at unnecessary risk. This would be unacceptable because it would be unethical to sacrifice the individual for societal gain—especially when the sacrifice is unnecessary.

The original study that is the focus of this ethical debate was conducted in 1993 by Conner, et al. This study, known as the Pediatric AIDS Clinical Trials Group (PACTG) Protocol 076, used zidovudine to try to prevent the perinatal transmission of HIV. The results were unprecedented: zidovudine, otherwise known as AZT and ZDV, was shown to be 67.5% more effective than placebo at preventing the transmission of HIV from mother to newborn. Moreover, this study was a double-blinded, placebo-controlled trial and was therefore considered definitive proof of the effectiveness of zidovudine—at least in the developed world. Subsequent “epidemiologic data have […] extended this efficacy to children of women with advanced disease, low CD4+ T-lymphocyte counts, and prior ZDV therapy” (“PHS Taskforce,” 2005, p. 2).

Therefore, with slight modifications, the current treatment against perinatal transmission of HIV remains nearly identical to the protocol 076 treatment used in the 1993 study, at least in developed countries.

In developing countries, however, there has been a significant amount of research due to the fact that PACTG protocol 076 is unfeasible in these countries. Although PACTG protocol 076 was recommended by the US Public Health Service for widespread use in 1994 (“PHS Taskforce,” 2005, p. 3), it remains out of reach and unfeasible for implementation in the most AIDS-devastated regions of the world due to the medical infrastructure and financial commitment needed for such large-scale implementation of the program. In particular, protocol 076 stipulates that the mothers take 100mg of zidovudine orally, five times

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a day, from 14 to 34 weeks before the expected due date.

During birth, zidovudine is injected intravenously, which may be inconvenient in locations lacking adequate medical facilities. Finally, the infant is given oral zidovudine every 6 hours for 6 weeks. The total cost of this full regimen is “estimated to be in excess of $800 per mother and infant, an amount far greater than most developing countries can afford to pay for standard care” (Varmus, 1997, para 8).

The goal, therefore, is to find a treatment that is both effective and feasible in developing countries. In the process of achieving this goal, one is faced with the question of whether placebo-controlled or active-controlled studies should be used to affirm the effectiveness of alternative treatments. Proponents of using placebo-controlled tests have several reasons for supporting placebo controlled trials, even when proven treatment exists.

First, they argue that the standard of care in a developing country is so minimal that giving placebo doesn’t jeopardize the health of a subject beyond the type of care that they would have received otherwise. Second, they argue that the support of the host country for studies on their own people is what matters, not the ethicality of the study from the sponsoring countries’ viewpoint. Third, they argue that using an active-control presents the risk that the new treatment will be less effective than the control and thus render the study irrelevant since the active control is too difficult to implement. The fourth, and most solid reason, is the fact that the placebo-controlled tests can provide definitive proof of whether a treatment is effective in a particular population and can definitively provide evidence of side-effects. In the case of PACTG 076, they claim that just because PACTG 076 has been shown to be effective and feasible in industrialized nations doesn’t mean that it has the same effect in developing countries. In particular, they speculate that the lower standard of living in developing countries may affect the safety and effectiveness of zidovudine: Zidovudine is a powerful drug, and its safety in the populations of developing countries, where the incidences of other diseases, anemia, and malnutrition are higher than in developed countries, is unknown. Therefore, even though the 076 protocol has been shown to be effective in some countries, it is unlikely that it can be successfully exported to many others. (Varmus, 1997, para. 7) The first three arguments are easily shown to be invalid.

The first reason, which argues that subjects would not be treated anyway and therefore are available for use as placebo controls, has disastrous implications. It would be akin to a doctor refusing a patient treatment on the grounds that the patient wouldn’t have received treatment anyway. Incidents of this type of reasoning have occurred in the past, most

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notably in the Tuskegee Syphilis Study where several hundred syphilitics were not given treatment because “these African-American men probably would not have been treated anyway, so the investigators were merely observing what would have happened if they were not in the study” (Angell, 1997, para. 4). Thus, it would be unethical for placebo-controlled studies to be conducted when proven treatments exist on the grounds that the subjects were not going to be treated anyway.

The second argument that proponents make in support of placebo-controlled trials in developing countries is that there is local support. Yet, the studies are conducted with the participation of US agencies and funded by US money.

Thus, the ethicality of the studies is important to the US because the US is the country sponsoring the studies. If a study is unethical in the United States, then any study conducted or supported by the US should also be unethical.

Otherwise, one could exploit study participants by simply moving the study outside of the US It is critical to note, however, that keeping the same ethical guidelines does not necessitate the same treatment or procedure in and outside of the US The standard of treatment in the US may be different from the standard elsewhere, depending on factors such as medical facilities and living conditions, yet the determination of these standards of treatment should be made based on the same ethical guidelines. Overall, studies supported by the United States must follow the same ethical guidelines regardless of where they are conducted.

The third argument, made by Varmus (1997) is that “if the affordable intervention is less effective than the 076 regimen—not an unlikely outcome—this information will be of little use in a country where the more effective regimen is unavailable” (para 13). This argument is flawed.

In testing new treatments in developing countries, the intention is not to find treatments that are more effective than protocol 076, although it would be great if researchers happened on one. Rather, the intention is to find a more feasible treatment. If a treatment was found to be somewhat less effective yet much more feasible, it would be a success since it provides the greatest benefit to the greatest number of people without sacrificing the individual.

Thus, we are now left with the fourth and final argument, that the placebo-controlled trial is the only definitive proof of an effective treatment in a particular environment, and is also able to provide definitive evidence of side-effects. Whereas the previous three arguments are disputed, this final argument has merit and is backed by the World Medical Association in the Declaration of Helsinki (2004): “[…] a placebo-controlled trial may be ethically acceptable, even if proven therapy is available […] where by compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method” (Note of clarification on paragraph 29). The key here

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Placebo-Controlled Studies on Perinatal HIV Transmission

is that placebo-controlled studies can be conducted if there are legitimate methodological and scientific reasons, including differences in the study environment and sample population that warrant further study. Indeed, the treatment of perinatal HIV transmission may fit under this category since the standard of treatment in developing countries, protocol 076, has only been proven effective in developed countries with high standards of healthcare. Furthermore, it is important to note that the ethicality of using placebo controlled tests is directly affected by the quality of scientific data collected through studies in the field. If current studies find that a particular treatment is indeed effective in developing countries, then placebo-controlled studies would be unethical. In lieu of such a discovery, placebocontrolled studies are ethical and necessary. Thus, in order to determine if placebo controlled studies for treatment against perinatal transmission of HIV are ethical in the present, we must examine the wealth of information that has been generated by placebo-controlled studies conducted up to now and see if there has been definitive findings on successful treatments.

As reasoned above, studies begun in the mid-1990s were justified in the use of placebo-controlled trails of shortened courses of protocol 076 in developing countries such as in Thailand and Africa. These studies have yielded a wealth of evidence concerning the efficacy of different treatments against perinatal transmission of HIV in developing countries. The primary problem, it appears now, is the inability of mothers in developing countries to refrain from breast feeding because of the lack clean water for baby formula. There is also social stigma surrounding not breast feeding because to do so would reveal one’s HIV positive status. These problems dramatically affect the efficacy of zidovudine, as shown by recent studies.

For example, placebo-controlled studies of zidovudine in Thailand and Africa, in which mothers agreed not to breast feed showed that zidovudine was quite effective: “A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother to child HIV-1 transmission by half ” (Shaffer, 1999, Interpretation). This is similar to the results of the PACTG protocol 076 study (Connor, 1993), in which participants did not breastfeed. Moreover, this study indicated that shortened forms of the zidovudine treatment that required only oral medication was still effective in developing countries, which dramatically improves the feasibility of implementing widespread zidovudine treatments against perinatal transmission of HIV. Furthermore, recent studies in the United States also indicate that shortened courses of protocol 076 can be nearly as effective as a full course. According to a study conducted by Wade (1998), “When treatment was begun in the prenatal period, the rate of HIV transmission was 6.1 percent […] when begun within the first 48 hours of life, Penn Bioethics Journal Vol II, issue ii Spring 2006

the rate was 9.3 percent […] when begun on day 3 of life or later, the rate was 18.4 percent […] In the absence of zidovudine prophylaxis, the rate of HIV transmission was 26.6 percent” (p. 1). This shows that even if zidovudine was given 48 hours after delivery, there is not a substantial decrease in efficacy. Although larger and more detailed studies need to be conducted, these results show that it is highly probable that zidovudine is effective in shortened course forms both in the United States and in developing countries, provided that there is no breast feeding. Taken together, these two studies indicate two important points: first, shortened courses of zidovudine would be more feasible than the original protocol 076, and second, shortened zidovudine courses can be used as activecontrols in developing countries for non-breastfeeding populations.

However, breast feeding is a seemingly unavoidable problem in most developing countries. This drastically lowers the effectiveness of protocol 076 and shortened courses of it, to the point at which it may not necessarily be more effective than placebo, ruling out zidovudine as an active-control for studying breastfeeding populations.

According to the Petra Study Team (2002), “The bad news from our trial is that when a combined endpoint of HIV-1 infections and child mortality is taken, very little benefit remains after 18 months of follow-up [for short-course zidovudine and lamivudine treatments]. This may be ascribed to continued breastfeeding with resultant HIV1 transmission and to high infant mortality rates in East Africa” (Discussion).1 There is hope, however, in the possibility of a new treatment in the form of nevirapine, a significantly cheaper drug that appears to be much more effective than zidovudine. In an active-controlled study known as the HIVNET 012 randomized trial conducted from 1997 to 1999 in Uganda, nevirapine treatment was shown to have a transmission rate of 15.7% compared to a 25.8% transmission rate for short course zidovudine at 18 months (Jackson, 2003, Interpretation). This finding contains two important indications. First, nevirapine is far more effective than zidovudine in breast feeding populations and is also more feasible because it is given in only two doses: one to the mother during labor and another to the newborn 72 hrs after birth. Second, it is important to note that the zidovudine effectiveness of 25.8% is not much better than placebo treatment in other studies. Although one should be wary about cross-comparing results from different studies, this large transmission percentage supports the idea 1 It may be of interest to note that the ethicality of the placebocontrolled Petra study was questioned before its results were revealed due to its use of a placebo control. The ethical issues debated were similar to the ones discussed in this paper. In hindsight, the authors note that “it is worth drawing attention to the difficulties that would have been incurred in interpretation of

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that zidovudine treatment in a breastfeeding population is ineffective.

So what do all of these studies mean? Do they show conclusively that there is an effective standard of treatment for developing countries, and therefore require that all future studies use it as a control instead of placebo? The answer depends on what kind of study one is conducting.

If one were to conduct studies in which subjects are not allowed to breastfeed, then it would be unethical to use a placebo control because it has been shown conclusively that short course zidovudine is an effective standard treatment.

However, studies involving breast feeding subjects are still ethical because the evidence is not so conclusive. Zidovudine has been shown to be ineffective, and nevirapine needs to be tested against placebo.2 Therefore, efforts should be made to affirm the effectiveness of nevirapine in breastfeeding women, when tested against placebo. If such tests do in fact show that nevirapine is effective, then placebo-controlled trials would become unethical.

Overall, the use of a placebo-controlled study can not be justified by the low standard of care in the study location, by local support without ethical approval in the sponsoring country, or by the infeasibility of implementing the active-control in the country. Indeed, the World Medical Association states in the Declaration of Helsinki (2004) that a placebo-control, “in general […] should only be used in the absence of existing proven therapy” (Note of clarification to paragraph 29). In the case of protocol 076, there has been substantial evidence in recent years indicating that the breakthrough protocol that works effectively in industrialized countries can be shortened and still be effective in developing countries for non-breastfeeding populations. These recent studies used placebo controls and did so ethically because there was a state of equipoise—of uncertainty that protocol 076 or modified forms of it were superior to placebo. However, that state of equipoise no longer exists because of the results of these studies. Future studies, in non-breastfeeding populations, therefore, can

not be justified on the grounds of equipoise. Studies of breastfeeding populations using placebo-controls, however, are still ethical because of the lack of a proven treatment i.e., a genuine state of equipoise still exists. Once an effective treatment is found however, all subsequent studies must be tested against an active control.

References 1. Angell, M. (1997). The ethics of clinical research in the third world [Electronic version]. New England Journal of Medicine, 337, 847849.

2. Connor, E.M., Sperling, R. S., Gelber, R., Kiselev, P., Scott, G., O’Sullivan, M. J. et al. (1994). Reduction of maternalinfant transmission of Human Immunodeficiency Virus type 1 with zidovudine treatment [Electronic version]. New England Journal of Medicine, 331, 1173-1180.

3. Jackson J.B., et al. (2003). Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-tochild transmission of HIV-1 in Kampala, Uganda: 18-month followup of the HIVNET 012 randomised trial. The Lancet [Electronic Version], 362: 859-868.

4. Lurie, P., Wolfe, S. M. (1997). Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries [Electronic version]. New England Journal of Medicine, 337, 853-856.

5. Petra Study (2002). Efficacy of three short-course regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (Petra study): a randomised, double-blind, placebo-controlled trial. The Lancet [Electronic Version], 359: 1178-1186.

6. PHS Taskforce (2005). Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. Retrieved March 05, 2006 from http://aidsinfo. nih.gov/ContentFiles/PerinatalGL.pdf 7. Shaffer N., et al. (1999). Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. The Lancet [Electronic Version], 353:773-80.

8. Varmus H., Satcher D. (1997). Ethical complexities of conducting research in developing countries [Electronic version]. New England Journal of Medicine, 337, 1003-1005.

9. Wade, N.A. (1998). Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the Human Immunodeficiency Virus. New England Journal of Medicine [Electronic Version] 339, 1409-1414.

10. World Medical Association (2004). Declaration of Helsinki: ethical principles for medical research involving human subjects.

Retrieved February 20, 2006, from http://www.wma.net/e/policy/ pdf/17c.pdf.

The HIVNET 012 nevirapine trial started out with a placebo control, but when the Thai trials of zidovudine showed that zidovudine was effective 6 months after birt¬¬¬h, the placebo control was dropped due to ethical reasons similar to the ones discussed in this paper.

Subsequent trials, as explained in this paper, showed that zidovudine was actually not effective when extended to 18 months after birth in breastfeeding populations.

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Penn Bioethics Journal Vol II, Issue ii Spring 2006

Bioethics Without Borders

PERSPECTIVES: Empirical Research from Romania Abortion: Pro and Contra First Author: Laura Jebereanu, University of Medicine and Pharmacy “Victor Babes,” Romania Collaborating Authors: Diana Jebereanu, Roxana Alaman, Andra Tofan, Sorin Jebereanu, Sebastian Pauncu Faculty Sponsor: Enache Alexandra, MD, PhD Abstract To kill a new life before it’s born, to do an abortion. This is a problem of many generations. In the evolution of human civilization, the attitude concerning abortion was different in different cultures, periods, societies. The aim of our study is to evaluate the actual opinion and attitude about abortion of young persons, students, and residents in medicine in Timisoara city, and the situation of the whole country. We performed a questionnaire for 400 people between the ages of 19 and 28 with superior studies. The group is composed of 320 (80%) women and 80 (20%) men. We accepted for recording and analyzing all the completed questionnaires. The questions referred to the topic of abortion in the antecedents, and asked if they had had one, how it affected the life of the women and her family, the circumstances of acceptance of abortion today, religious aspects and different other aspects.

Introduction: General Data The social and political changes in Romania after 1989 created new concepts about female, family, pregnancy, solitary mother, abortion.

Abortion is purposeful termination of pregnancy with intentions to not produce a live born infant or to remove a dead fetus; or the purpose of the abortion is to avoid becoming a parent, for different reasons.

Romania has the highest rate of mortality after abortion, five times higher than the medium rate from European states. In the last years the rate of abortion has decreased, but on the international scale, Romania continues to be in the top of the list referring to the number of abortions, recording a rate of 3 abortions for every birth.

(Among 1 million of pregnancies per year, more then 2/3 are ended with an abortion.)

Laura (Pauncu) Jebereanu is the first author of this submission. She is a student at the University of Medicine and Pharmacy “Victor Babes” Timisoara, Romania.

Email: paunculaura@yahoo.com Enache Alexandra, MD, PhD, is the faculty sponsor for this submission. She is the Senior Fellow at the Center of Bioethics and an Associate Professor of Legal Medicine at the University of Medicine and Pharmacy “Victor Babes” Timisoara, Romania.

Address: Square Eftimie Murgu no. 2, Timisoara, Romania Email: esanda2000@yahoo.com Penn Bioethics Journal Vol. II, Issue ii Spring 2006

This happens because the older women didn’t accept the idea of contraception; which was illegal before 1989 (BMJ). In that period many women died because of the illegal abortion. They where exposed to infections, septicemia, hemorrhage, embolism, sterilizations, coma.

A study of Romanian Population Services shows that 97% of the Romanians heard about a contraceptive method. However, for every 1.000 new born children with approximation there are 1.200 abortions. This data is only that which is centralized in state clinics and hospitals.

A good part of women preferred to do the abortion in particular clinics.

In 1990 Romania had 1 million abortions. Romanian Population Services confirmed that there were 11 million abortions between 1989 and 2000, but the number does not include the abortions from the particular clinics.

From 1992, the government started sexual education in schools and familial planning units. The number of abortions is decreased from 980.000 in 1990 at 254.855 in 2001, and the maternal mortality caused by abortion has decreased from 280 in 1989 at 35 in 2001.

The population of Romania decreased by 1.400.000 from 1990 since 2002. There are recorded about 22 deaths caused by abortion per 100.000 births. Alarming is the fact that 20.000 girls aged 15 years old had an abortion in 2002.

In 2003 the statistics recorded 224.807 abortions and in 2004 their number was 200.000.

About 20% of women are infertile secondary of an abortion. The mortality caused by abortion represents more than 50% from the total maternal deaths. Romanian female has 3-4 abortions, versus Occidental Europe women where is recorded less than one abortion in a woman’s lifetime.

The number of the women who has had sexual contact before the wedding has risen from 77% in 1999 to 90% in 2004. More than 50% persons who are sexually active and can have children didn’t want to become parents (2004).

The total fertility rate remains at 1.3 births per woman.

The specific rate of fertility has been raised by almost 80% for those aged 30-34 years, remained stable for the 25-29 age bracket, and decreased for the 20-24 age bracket.

The prevalence rate of contraception methods has been tripled for women of about 15-44 years old. The most used method is the contraceptive pill which is used

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by 16% of women. 36% are still using the traditional methods like coitus interrupts, and 34% are not using any of contraceptive methods.

In Timis County the rate of abortion is high compared to other counties. In 1991 there were 27.066 abortions and they are decreasing over the years at 6886 in 1998.

There exist new opportunities, but all are they favorable for a healthy society?

We conducted a study to evaluate the actual opinion and attitude about abortion of young persons, students, and residents in medicine in Timisoara city.

Because physical and social aspects differ between sexes, we tried to analyze data in accord with these parameters.

Our research is a part of a larger ongoing study.

Methods We performed a questionnaire about abortion. We performed a questionnaire for 400 people between the ages of 19 and 28 with superior studies. They were young medical students (312 persons) and residents in medicine (88 persons). We want to analyze aspects about abortion just for young persons, who were children in 1989, without past influences, and who have sexual life developing in a “normal” society. The group was formed by 320 (80%) women and 80 (20%) men. The mean age is 23.3 years (SD=3.7 years).

The data were collected by anonymous questionnaires with the acceptance of collaboration. Incomplete answers were excluded. The initial number of participants was 423.

We do not have data on: how many of them started their sexual life, whether they have a regular sexual life or not, what contraceptive methods are used, and what their social status is.

For these questions we did obtain pertinent data or they refused to answer.

The analysis of the results was performed in EPI 6 Info Program of the WHO (frequencies, Odds Ratio, Relative Risk, Chi-squares, p-values). It was used with 95% confidence interval.

Results All of the participants know what the abortion is. Most of the questioned persons consider that it is important to keep the pregnancy (258). Just 92 females agree with the idea of abortion, but the number of males was 50. More than 35% of all questioned persons accept it, motivation that can be a necessity.

280 (70%) would regret if it they were personally being implicated in the decision of making an abortion.

Abortion is a considerate solution

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Answered ”YES FOR ABORTION, BECAUSE…”

in some cases like fetal malformation (but no significance between sexes) and pregnancy resulting from rape or incest, by 380 (95%) persons. Females believe that abortion is rightly motivated in the second situation.

Abortion is seen to be a necessity by 356 of them in the case of parents’ exposure to mutagen agents, without differences between sexes.

If the parents were exposed to mutagen agents the child can be born with malformations or different incurable diseases. In many cases the parents choose to do an abortion. They do not accept the risk.

Pregnancy after rape or incest is considered a necessity (309 female versus 71 male). In this situation many women have an abortion because of a psychiatric cause: they see in the new born child the person that abused on them. If she keeps the baby, it is very difficult to get attached to him.

And the child will grow in an incomplete family.

Men seem to be more attentive if the woman’s health

Attitude concerning abortion

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PERSPECTIVES: Abortion

is in danger if the pregnancy continues. 72 of them voted of the future 310 (77.5%), education 280 (70%) and religion for abortion in this situation. And men are not prepared 220 (55%) are not strong motives to avoid the abortion. to be “father” at a young age (42 persons, more than half At the question “Imagine that you have done an of them), in non-legitimate relationship (45% man versus abortion, would you repeat it?” 303 (75,75%) persons 23.75% women). Men are not dreaming of a big family, answered that they won’t do that mistake again, and 97 with many children. 33 of them prefer abortion.

(24,25%) would repeat it if it is necessary. Two of them were Female are more courageous than males, in the face afraid to repeat it because of the possible complications. of unplanned pregnancy in a non-legitimate relation.

292 (73%) believe that they won’t make an abortion More of them accept the child if they are too young, if because they are sure that contraception is a sure method. the baby is too The rest of Motivation of the opposition for abortion early, or if their them 108 (27%) parents oppose would do it if to maintain the the mother is ch i l d . W h e n in dang er or t h e f e m a l e ’s if there are parents do not some fetal agree with the malformations. pregnancy it is very difficult for her to avoid an abortion, According to the medical ethics, a doctor can deny especially when she depends on them and lives with them. to interfere in the process of reproduction, pregnancy Some parents understand their daughter and they try to interruption and abortion if this is his opinion; inviting help and support her decisions. the persons to ask for the advice of other doctors (The It is better for a child to grow in a complete family.

International Conference of Orders and Organisms with The mother needs the support of her partner because it is similar attributions Paris, January 1987 art.18). difficult to raise a child all by herself. Taking care of a baby Our data was obtained questioning young medical implies love, time, affection, financial support and the most students and residents. important: to be prepared to be a parent.

Our conclusion is that young medical students and The young age of parents is not an impediment for having residents are not well prepared to face to an unplanned a baby if they know what to expect. If they are prepared pregnancy. They do not have the theoretical knowledge, they physically and were not interested mentally, they can in documenting raise a child. the topic of Sometimes abortion, and in t h e w o m a n ’s general they think health is in danger that this cannot if the pregnancy be their problem. continues, and in Some of these situations it them consider is rational to avoid the loss of the mother and to perform abortion like “the last way” to follow, in some specific an abortion. cases, motivated by subjective reasons.

The birth of a child is a moment of joy and happiness, We have no answers for such a complex problem. But but sometimes when the baby is malformed, or he has birth we know that the new generation in Romania have the defects or severe medical problems, the sadness is bigger right to choose for themselves and in general they fight for than the joy. The malformations make a harder life for the child and for his parents. The child feels that something is References not right with him; he can’t do things like other children his 1. Harrison, The Principle of Internal Medicine, 14th Edition (2003): age, others laugh and look strangely at him. He needs a lot 1164-1165 2. D.Caprioara , Obstretics (1976): 166-171 of attention, special care and medicine. It is very difficult 3. Vladimir Belis, Legal Medicine (1995): 169-170 to see your child in this situation, to know that all you can 4. http://www.gandul.info/2005-11-07/social/romania_in_continuare, do is not enough, to bring him to normal. You can’t know British Medical Journal: România, An 1, 161, în continuare în topul rilor cu cele mai multe avorturi, C lina BERCEANU, 7 what is going to happen to him. The family is forced to noiembrie 2005, take the hard decision to make the abortion if the child to 5. http://www.9am.ro/revistapresei/Social/22707/Romania-este-pelocul-I-in-Europa-la-avorturi, Curentul, Cosmin Anghel, 16 be born has this kind of problems.

Noiembrie 2005 The reason they don’t agree with the abortion is 6. http://www.y4y.ro/sanatate/studii/, Studiu asupra s n t ii especially their conscience 280 (70%) persons. To be afraid reproducerii România, 2004, Fundaia Tineri pentru Tineri Penn Bioethics Journal Vol II, issue ii Spring 2006

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7. http://www.hotnews.ro/articol_17511-Un-sfert-de-milion-deavorturi-pe-an.htm, Lica Manolache, Emilian Isaila, Evenimentul Zilei, 16 mar 2005 Romania este tara cu cele mai multe chiuretaje din Europa, Un sfert de milion de avorturi pe an 8. www.primulpas.ro.org/avortul/statistici.html, Numarul total de

avorturi pe judete, in Romania 1970 - 1990 9. http://www.primulpas.ro.org/avortul/legiro.html, Reglementarea institutiei avortului in Romania, Asociatia Primul Pas Iasi, Bd. T Vladimirescu Nr. 89 10. http://abortion.brainsip.com

Editor’s note: Pursuant to PBJ policy regarding submissions in a language other than the author’s primary one, this article has been edited for clarity. No major changes were made, nor original meanings altered. We worked with the author to alter some usage and structure and to clarify the original submission. For more information on PBJ policies regarding submissions and the editorial process, please visit our website or contact the Executive Editor by emailing editors@bioethicsjournal.com.

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Penn Bioethics Journal Vol II, Issue ii Spring 2006

Bioethics Without Borders

Kant’s Assessment of Motivation in the Fulfillment of Social Obligations Author: Jackie Knupp, University of Richmond Faculty Sponsor: Terry Price, PhD Abstract This paper explores the motivations of physicians who promote the health of their communities through the fulfillment of social obligations beyond the boundaries of their own patients. Based on the assumption that physicians do have social obligations, this paper looks at the normative, motivational question, namely “How should physicians be motivated to fulfill social obligations?” The paper traces the Kantian view of morality and motivation. The distinctions between required, merely permissible, and forbidden actions is drawn. Furthermore, Kant’s view that required actions done in accordance with duty are of no moral worth is critiqued from three stand points. First, it is argued that just because motivations outside of Kantian-based duty are not as good, it does not follow that these motivations are of no moral worth. Second, it is argued that there are some motivations behind required actions that are clearly better than other motivations. Third, it is argued that required actions done in accordance with duty are clearly better than those actions done without relevance to duty. The paper concludes that many required actions done in accordance with duty are performed from motivations that do have moral worth.

Many physicians in the medical community embrace their social obligations as healthcare experts by providing indigent care, engaging in clinical research, and leading public health projects. In fact, a recent survey of family physicians indicated that as many as 52% of physicians fulfill their social obligations by providing 40% or more of their care to the underserved (Medicare, Medicaid and indigent patients) (Eliason et al, 2000, p. 229). These physicians enhance the dignity of the suffering and neglected by improving the health of their communities. Examples of such publicly minded physicians abound in health care practice as well as in other health-related areas such as clinical research, education, ethics, and public health.

Jackie Knupp is a Senior at the University of Richmond and is double majoring in Biology and Leadership Studies.

Email: jackie.knupp@richmond.edu Dr. Terry Price is the faculty sponsor for this submission.

She is an Associate Professor of Leadership Studies in the Jepson School of Leadership Studies at the University of Richmond.

Address: Jepson School of Leadership Studies, Jepson Hall, University of Richmond, VA 23173 Email: tprice@richmond.edu Penn Bioethics Journal Vol. II, Issue ii Spring 2006

When physicians volunteer their medical services in a community, their interactions are not contractual in nature. These non-contractual engagements include such interactions as when physicians provide indigent or emergency care,, serve on hospital committees, train new physicians, and affect health policy in government. Though non-contractual, these interactions contribute to the high standard of well-being enjoyed by society. Furthermore, these interactions may be even more pivotal in a capitalistic society where issues of health-care access are rife.

In a recent study, the U.S. Census Bureau quoted an estimated 43.6 million Americans without health insurance and many more without proper health care access (Geller et al., 2004, p. 48). In response to this need, there are well over 1000 clinics in the U.S. that provide charity care. Many of these clinics are staffed by the voluntary services of physicians. As research on free clinics in the Midwest has concluded, we “should recognize the important role that free clinics are playing in helping to patch the health care safety net” (Geller et al., 2004, p. 49-50). The pivotal role these free clinics play in providing health care access further supports the importance of voluntary medical services given by physicians.

These physician volunteers challenge common conceptions of the duties of physicians. Are physicians only responsible for elevating health in the context of the contractual physician-patient relationship? Is there a boundary between a physician’s patients and the rest of the community? And with respect to motivation, what should inspire these physicians to work beyond the boundaries of their patients in contributing to quality health care?

When asked what motivates them to fulfill social obligations, many physicians might respond that they are motivated out of a sense of duty or that they act because they feel it is the right thing to do. Motivations of this type are not unlike the Kantian ethic which prescribes that acts of moral worth must be done out of duty as defined

by Kant’s categorical imperative. This paper explores Kant’s views on how physicians should be motivated in the fulfillment of social obligations.

Kant’s first categorical imperative states: “Act only according to that maxim by which you can at the same time will that it should become a universal law” (Kant, 1969, p.

44). For Kant, when actions are performed according to a principle that one could will to be applied universally, duty is fulfilled. Kant further distinguishes between strict duties, such as the duty to fulfill promises, and broad duties, such as

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the duty to help others. While strict duties must be kept at all times, Kant allows for greater flexibility in the time and manner in which broad duties are fulfilled. The broad duty to help others can be derived from an application of Kant’s first categorical imperative. First, we must try to imagine a world in which no one helped anyone else. Because we all need the help of others at some point in our lives, we cannot will that others help us and simultaneously will to live in a world in which no one helps anyone else. Since this world is unimaginable, we see that we have a duty to help others. By the same logic, one also cannot will the non-contractual help of a physician and simultaneously will a world in which no physicians assisted anyone beyond their patients. The question then becomes, must physicians will the non-contractual help of other physicians?

One might argue that those individuals such as physicians with the economic means to pay for medical services do not need non-contractual help from other physicians, and thus could will a world in which physicians do not meet social obligations. However, even those of high socio-economic status benefit from fulfilled social obligations of physicians with regards to their own medical care. The quality of care that these patients receive is dependent in part on the voluntary medical knowledgesharing that occurs between physicians, public health research, medical ethics decisions and the education of future physicians. Thus, application of Kant’s first version of the categorical imperative demonstrates that physicians have general social obligations as part of the Kantian duty to help others. But what ought to motivate these physicians as they meet their social obligations as medical professionals?

Kant is universally interpreted as holding reason supreme and as defining the moral worth of an action by its direct dependence upon the sense of duty behind it. Kant asserts that other motivations are of no moral worth: “To duty every other motive must give place, because duty is the condition of a will good in itself, whose worth transcends everything” (Kant, 1969, p. 23). For Kant, motivation based on inclination has no moral worth, and in cases where actions line up with both inclination and duty, the test of moral worth is whether or not one would still act even if one was not inclined to do so. In other words, moral worth for Kant means that the action was performed solely out of duty.

To apply a Kantian ethic to the behavior of physicians, one might first ask, did the physicians do what duty required of them? Assume physicians did meet their social obligations, perhaps by volunteering in a free clinic, lobbying politicians, or engaging in clinical research. What would Kant say ought to motivate these physicians as they meet these broad duties? The Kantian question then becomes, why did they do it? And more specifically, did they do it from duty (as opposed to self-interest, compassion, or

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religion, for example, in which case their actions would be in accordance with duty, not from duty)?

Kant would say that physicians who are motivated because of these other influences are acting on a hypothetical imperative, not a categorical imperative. Acting on a hypothetical imperative does not produce actions of moral worth. In other words, motivations such as the glory of God, self-interest, or the good of others cannot be the reason why one might do the moral thing. Rather, the imperative on which one acts must be categorical. That is, if the action is to have moral worth, morality must be considered an end in itself. For example, Kant states, “the categorical imperative alone can be taken as a practical law, while all the others may be called principles of the will but not laws” (Kant, 1969, p. 43). Principles of the will are transient; what is moral cannot be determined by the results actions produce. Clearly, Kant is not a consequentialist, for he states: “What is essentially good in it [the categorical imperative] consists in the intention, the result being what it may” (Kant, 1969, p. 38). Here intention means the motivation behind the act, and good intention refers to motivations of duty based on reason.

Kant also speaks of the dangers of heteronomous influences on the autonomous reason. For example, he defines heteronomy as “every case in which an object of the will must be assumed as prescribing the rule which is to determine the will” (Kant, 1969, p. 71). Under such heteronomous influences, the autonomy of reason is bypassed because an outward object of the will prescribes the rule rather than the will itself, as in the example of action done because it is the will of God. According to this rule, physicians who fulfill social obligations for religious reasons are not performing acts of moral worth.

Furthermore, Kant states that the will in heteronomous cases “never determines itself directly by the conception of the action itself but only by the inventive which the foreseen result of the action incites in the will—that is, ‘I ought to do something because I will something else’” (Kant, 1969, p. 71). Accordingly, heteronomous influences also include consequential motivations such as physicians fulfilling social obligations from the sole motive of elevating the health of the community. From Kant’s perspective, it is clear that physicians ought only to be motivated to fulfill their obligations out of duty in order to perform acts of moral worth.

A Critique of Motivation According to Kant While Kant’s ethical framework provides a compelling justification for the grounds of the social duties that physicians hold, his absolutist position on the motivation behind acts of moral worth disregards many beneficial motivations in physicians’ fulfillment of social obligations.

For example, according to Kant, providing charity care is of no moral worth if the physician is motivated out of

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Kant’s Assessment of Motivation in the Fulfillment of Social Obligations

enjoyment, compassion, religion, or a desire to produce the best outcomes. Is it problematic to discount the moral worth of providing charity care based on the above motivations simply because the provision of care is not based solely on the autonomous reason’s determination of duty?

The above examples pinpoint actions committed from a wide variety of motivations which are self-interested, compassionate, or religious in nature. Physicians are also motivated by duty, but in a broader sense than the Kantian definition of duty. Contemporary ideas of “duty” are based upon much broader influences than the Kantian-based duties determined through application of the categorical imperative. Physicians, like everyone else, might talk about performing actions out of a sense of duty. However, it is unlikely that they mean duty in the same way that Kant does.

For example, when a physician says she is motivated out of a sense of obligation, she might mean she has a duty as defined by tradition, religion, or social forces including the law, all of which Kant would discount as heteronomous.

Rather than acknowledging a duty based on the categorical imperative, an individual might acknowledge an obligation because he believes it is God’s will, as when a Christian defines his obligations based on the Bible. In contrast, Kant defines actions done from duty in the narrow sense.

Compared to Kant’s conception of duty, these other, socalled duty-based motivations are heteronomous and thus can hold no moral worth in Kant’s framework.

Kant’s view allows for three types of actions in the assessment of morality: those which are required, those which are merely permissible, and those which are forbidden (Table 1). Clearly, forbidden actions have no moral worth as they contradict duty, and merely permissible actions cannot be morally worthy because they fail to fulfill duty. One can further distinguish motivations behind forbidden actions as having negative moral worth, whereas motivations behind merely permissible actions simply have no moral worth.

However, when it comes to the motivation behind required actions, Kant asserts that those actions done in accordance with duty also have no moral worth; only those required actions performed from duty have moral worth.

There are three reasons why Kant’s determination of morality is inadequate with respect to the morality of required actions done in accordance with duty. First of all, just because some motivations may not be as good as Kantian duty, it does not follow that these other motivations have no moral worth. Second, within required actions committed in accordance with duty, there are some motivations which are clearly better than others. Third, motivations in accordance with duty are clearly better than morally neutral motivations. In this case, required actions done in accordance with duty should have a different moral worth when compared to merely permissible actions.

First of all, Kant objects to all motivations other than Kantian-duty when distinguishing actions of moral worth. For example, he claims that the physician providing indigent care out of a sense of duty even though he is not inclined to do so is completing an act of great moral worth. In contrast, the physician providing indigent care out of compassion is fulfilling a duty but nonetheless, completing an act of no moral worth. The former physician’s fulfillment of his social obligations may be considered more admirable since he is doing the right thing even though he is not inclined to do so. However, comparatively it does not seem that the other physician’s similar actions are void of moral worth simply because his inclination is aligned with the required action.

Undoubtedly, some motivations can undermine the morality of an act, and thus it could be problematic to claim that any motivation leading to the completion of duty is of moral worth. However, this does not mean that all motivations outside of Kantian duty undermine the morality of an act. While Kantian duty might be the best motivation, it does not follow that all required actions outside of those done from duty have no moral worth.

Secondly, within the category of required actions done in accordance with duty, it is clear that some motivations are definitively different from clearly poor motivations such as the distinction between caring for the indigent out of compassion as compared to caring for the indigent to pad a resume. Take another example of providing charity care in order to make colleagues feel guilty or to get in the

Applying Kant’s theory—Action, Motivation, and Morality.

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good graces of a political representative. These motivations might undermine the moral worth of the act of providing charity care. In contrast, moral theory ought to reflect the fact that motivations such as compassion for the uninsured or concern for the elevation of health are morally different from clearly poor motivations.

Thirdly, Kant’s determination of the morality of required actions done in accordance with duty is also inadequate because he does not make a clear distinction between actions which are assessed to be of no moral worth because they are merely permissible and actions which are of no moral worth because they are done in accordance with duty. Based on our contemporary view of morality, most of us would be uncomfortable placing actions committed out of compassion in the same moral category as actions committed without relevance to duty.

For example, it seems incongruous to evaluate the charity care of a physician based on compassion as morally equal (in its quality of having no moral worth) to another physician’s participation in an exercise class at the gym. There is a sense in which actions done in accordance with duty appear to be of greater moral worth than other merely permissible actions because the motivations behind these actions inspire the fulfillment of duty.

It seems insufficiently discriminating to evaluate motivations behind the fulfillment of duty in the same way we evaluate motivations behind merely permissible actions, and for good reason. If we are concerned about physicians’ social obligations, we ought also to care about their fulfillment. One cannot care about the fulfillment of duties without considering the motivations that lead to their fulfillment. Certainly the moral worth of motivations behind required actions merits greater consideration than that of merely permissible actions for the former lead to the fulfillment of duty.

Clearly, motivations outside of Kantian duty,

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although perhaps not as good, can still have moral worth.

Furthermore, there are some motivations behind required actions which are better than others. Finally, required actions done in accordance with duty are distinctly separate from permissible actions and thus should be of greater moral worth. From these arguments it follows that many required actions done in accordance with duty are performed from motivations that do have moral worth.

But how might this understanding of morally worthy motivations according to Kant be helpful in promoting the fulfillment of social obligations by physicians? Specifically, the model of motivation presented in this paper would assign moral worth to physicians who provide charity care in free clinics. In promoting the non-contractual interactions of physicians, these interactions should be seen as duties and many of the motivations behind these actions ought to be viewed as morally worthy. With respect to duty, the identity of the physician should be linked to non-contractual interactions, and individuals training to become physicians ought to be educated as such. With respect to motivation, the moral worth of motivations outside of duty such as compassion or religious motivation ought to be recognized in promoting non-contractual interactions. Beyond the need to establish non-contractual interactions as part of the duties of physicians, many motivations which inspire the fulfillment of duty ought to be encouraged as morally worthy reasons to inspire physicians to act.

References 1. Eliason, B.C., Guse, C., & Gottlieb, M.S. (2000). Personal Values of Family Physicians, Practice Satisfaction, and Service to the Underserved. Arch Fam Med, 9(3), 228-32.

2. Geller, S., Taylor, B.M., & Scott, H.D. (2004). Free Clinics Helping to Patch the Safety Net. Journal of Health Care for the Poor and Underserved, 15(1), 42-51.

3. Kant, I. (1969) Foundations of the Metaphysics of Morals.

In R.P. Wolf (Ed.), Kant: Foundations of the Metaphysics of Morals: Text and Critical Essays (pp. 3-94). New York: Macmillan Publishing Co.

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Bioethics Without Borders

Childbirth in Modern Athens: The Transition from Homebirth to Hospital Birth Author: Julie Nusbaum, University of Pennsylvania Faculty Sponsor: Janet Tighe, PhD Abstract The transition of birthing practices in Greece from a homebirth culture, in which women deliver at home surrounded by family and under the supervision of a typically female birth attendant, to a biomedical birth model, in which women deliver in a hospital with numerous forms of medical intervention and under the control of a physician, has been unusually rapid. Today, Western biomedicine not only dominates the health care system in Greece but has an essential hegemony on women’s health care. My research examines whether the pervasive utilization of biomedical environments for birthing can be explained by a lack of alternatives or by women’s satisfaction with the technology and care available in hospitals. I also examine how women retain control over their experience of pregnancy and childbirth within the biomedical context and attempt to explain the emerging construction of a “natural” discourse on pregnancy and childbirth in Athens.

Major themes that emerged from interviews with Athenian women were the lack of consent for medical intervention during birth, limited infrastructure to support women who seek non-medical alternatives, and limited emotional support and collective education for mothers in the urban environment of Athens. Also, women described choosing the right caregiver as essential to maintaining a sense of control over their pregnancy and, more generally, over their life. In light of women’s apparent interest in improving women’s experience of pregnancy and childbirth in Athens, it is recommended that researchers further explore the interaction of medical and non-medical discourses on pregnancy and childbirth.

Introduction and Methodology Note: All names and identifying information have been altered to protect the identity of informants.

During the course of my four-month study abroad program in Greece in the fall of 2005, my interest

Julie Nusbaum is a Senior at the University of Pennsylvania and is majoring in Health and Societies.

Email: julie.nusbaum@gmail.com Dr. Janet Tighe is the faculty sponsor for this submission. She is Adjunct Professor of History and Sociology of Science at the University of Pennsylvania, Dean of Freshman and Director of Academic Advising, College of Arts and Sciences.

Address: Suite 120 Logan Hall, 249 S. 36th Street, Philadelphia, PA 19104 Email: jtighe@sas.upenn.edu Penn Bioethics Journal Vol. II, Issue ii Spring 2006

in women’s health and my background in medical anthropology evolved into an ethnographic research project on the medical and non-medical discourses on pregnancy and childbirth in Athens. As women began to share story after story of highly technological hospital births, I began to wonder how a country known for its strong affinity for tradition could so universally have wiped out any remnants of “natural” homebirth in favor of the Western model of hospital birthing.

The transition of birthing practices in Greece from a homebirth culture, in which women deliver at home surrounded by family and under the supervision of a typically female birth attendant, to a biomedical birth model, in which women deliver in a hospital with numerous forms of medical intervention and under the control of a physician, has been unusually rapid. As late as 1960, Greece’s homebirth rate was at sixty percent (Mikkola, 1997, p. 46).

Today, the vast majority of women in Greece give birth in technologically advanced hospitals, with the percentage of homebirths as low as six tenths of one percent (Georges, 1996, p. 160). Western medicine not only dominates the health care system in Greece but has an essential hegemony on women’s health care. My research examines whether the pervasive utilization of biomedical environments for birthing can be explained by a lack of alternatives or by women’s satisfaction with the technology and care available in hospitals. I also examine how women retain control over their experience of pregnancy and childbirth within the biomedical context, and I attempt to explain the emerging construction of a “natural” discourse on pregnancy and childbirth in Greece.

Over the course of three months, I interviewed eight people in Athens – five mothers, two midwives, and one Ob/Gyn. All are middle-class, live in Athens, and have spent significant time abroad, mostly in England or the United States. One woman is German, two women are American (one of whom is Greek-American), and all the rest are Greek-born and raised. The Ob/Gyn was the only male informant. I conducted one interview in English with each person, and most interviews lasted about an hour. I took hand notes during my interviews and typed up the transcript as soon after the interview as possible. My sampling method was generally a snowball sample, since each woman I was referred to would refer me to her friends and her doctors who would then refer me to their friends and their doctors, and so forth.

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The Medical Discourse The socially prescribed ways in which human reproduction takes place serve to generate official power and authority over birth (Lazarus, 1994, p. 25). Medical knowledge, like most knowledge, is inseparable from social relationships and social experiences. Because medical knowledge is unequally distributed (with doctors perceived to have more and patients less), it is inherently linked to matters of power and control (Lazarus, 1994, p.

26). Through clinical encounters, during which doctors monitor women’s behavior and provide biomedical lessons, and through such popular sources as magazines, television, videos, childbirth classes, and pregnancy guides, women learn to conceive of pregnancy as a biomedical event (Fox, 1999, p. 331).

The dominant model of birth in Greece is medical, founded on the assumption that birth is a potentially pathological condition in which something could go wrong at any time (Lazarus, 1994, p. 27). Katerina, an environmentalist in her late 30s who sells handcrafted clothes and gifts, said, “In Greece, a pregnant woman is treated like a sick person. When you’re pregnant, it’s acceptable to complain as much as you want, to eat as much as you want... because people think you have a condition or a sickness.”

Researchers in a variety of disciplines, including medicine, public health, psychology, sociology, and anthropology, have put forth a strong critique of the medical management of pregnancy, labor, and delivery (Fox, 1999, p. 327). The main argument that emerges from this canon of research is that the medical management of childbirth decreases the control of the birthing woman, fails to improve the physical and emotional outcome of the birth, and alienates women from a potentially empowering experience (Fox, 1999, p. 327).

Throughout Greece, pregnancy, birth, and abortion have been fully medicalized for at least a generation, and in urban areas, even longer (Georges, 1996, p. 160).

Furthermore, the technological discourse of biomedicine is continually displacing old explanations and practices, including local knowledges of the pregnant body (Georges, 1996, p. 160). Today, births in Greek hospitals include routine use of pubic shaving, enemas, IV drips, pitocin to augment labor, electronic fetal monitors, episiotomies, the lithotomy position with arms and legs strapped to the delivery table, and cesarean section for a growing number of women (Georges, 1996, p. 160).

Birthing at home has become unthinkable (Georges, 1996, p. 160). Eleni, a Greek midwife, said, “I just met a young woman who said that she will lose status when people on her island find out she had a homebirth – the more expensive the birth, the more status one has. If she has a homebirth, people will assume she couldn’t afford a hospital birth.” Dr. Makriyianni, an Ob/Gyn in his thirties who works at a private maternity hospital in Athens, reported,

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“Home childbirth is almost unacceptable. It’s considered [socially irresponsible] and risky... Truthfully, people would think you were a hippie if you wanted a homebirth.”

The Natural Discourse In response to the rapidly growing dominance of medical childbirth, a discourse on “natural” childbirth emerged. “Natural childbirth” cannot be easily defined by women, and medical professionals alike have differing perspectives on what defines “natural.” For the purposes of this paper, “natural childbirth” is interchangeable with “non-medical approach to birth” and refers to a birthing experience in which the mother’s desire for limited intervention, often in the form of the prohibition of an epidural, episiotomy, labor induction, and cesarean section, is respected by the birthing attendants. Influenced by the consumer and feminist movements, proponents of “natural” childbirth argue that women gain power through access to information and control over personal choices. At one end of the discourse on natural childbirth are advocates of homebirth who seek to achieve a “natural” experience by delivering in the comfort of their home, able to move about as they wish, and without the interference of technological machinery. At the other end of the spectrum of “natural childbirth” are women who deliver in a hospital under the direction of a doctor, but still seek to limit medical intervention.

An interest in non-medicalized approaches to birth has become apparent in Athens only in the last decade. A number of vocal, yet limited, groups have emerged to offer information and services to women who seek alternative or complementary perspectives on birth. The groups’ sphere of influence is mainly in and around Athens, but a breastfeeding advocacy and support group had established chapters in Thessaloniki and throughout northern Greece.

Moreover, there seems to be an increasing number of Ob/ Gyns, largely foreign-born, whom are known to be more open to “natural birth.”

Critics argue that the flaw in much of the literature on natural childbirth is its uncritical acceptance that unmedicated birthing and hands-on mothering is superior to other forms of birthing and mothering (Browner, 1982, p. 8). Moreover, critics suggest the literature implies that women should assume control over their labors and deliveries and ignores what women may gain from medical intervention (Fox, 1999, p. 330). Evidence is mounting that, although some women are alienated by their experience of medicalized birth, many women across social classes welcome medical intervention and are quite satisfied with hospital deliveries (Fox, 1999, p. 328).

Discussion As the biomedical model of birth has gained dominance, the definition of natural childbirth by medical professionals has broadened to “include any birth in which

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Childbirth in Modern Athens: From Homebirth to Hospital

the mother is awake and delivers vaginally” (Brozan, 1988, p.14). The changing conception of what defines “natural” can lead to misunderstandings between women and their doctors. For example, Gabby said, “I told [my doctor] that I wanted natural childbirth, and he agreed. But, at the time of the birth, it became clear that his conception of ‘natural’ meant not a C-section; whereas, my conception of ‘natural’ meant no medicines and less intervention.”

Like Gabby, many of the women I interviewed were motivated to seek a more “natural” childbirth after first having had a negative experience during a hospital birth.

Contrary to my expectations, these women often did not seek a midwife but stayed within the biomedical setting and sought, sometimes relentlessly, a physician who they could trust to respect their wishes.

A woman’s interest in natural childbirth was not of itself a predictor of whether she would seek a doctor or a midwife to assist in her delivery. Instead, the women I interviewed seemed to be highly influenced by their pre-existing attitudes towards hospitals, their body, and pregnancy. Katerina, who had a homebirth, remarks, “I was never fearful. I was very convinced since I was young that I wanted to have a homebirth. I helped out with two homebirths that were beautiful. And, I never felt safe in hospitals.”

The women who sought midwife-assisted births believed that they could have more trust in a midwife than a doctor to use as little intervention as possible. These women talked about retaining the responsibility of birthing, rather than passing off this responsibility to a physician.

Katerina says, “It’s easier to lay responsibility in the hands of a doctor... The family prefers to put the responsibility on a doctor. Homebirth acknowledges that a lot of birth is your own work.”

A recurrent theme that emerged from the interviews was the importance women placed on their choice of birth attendant. Lazarus (1994, p. 27) finds that women’s interest in maintaining control over the course of their pregnancies and over childbirth influences their choice of physician, and that choosing a doctor agreeable to their views increased women’s control over their pregnancy and delivery. Women’s definition of control varied. To some women, control was a general notion of being involved in decision-making and exercising some power over what happened during birth.

For other women, their definition of control was more particular, relating to their views on specific technologies, such as anesthesia or episiotomy. For all of the women, choosing the right caregiver was essential to maintaining control. Women’s interest in maintaining control over their pregnancy related to a more general control over their lives.

Their resistance to submit to doctors’ authority, or at least to retain some power in the decision-making process, related to a larger refusal to submit to dominant authorities.

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capacity of medical intervention and were willing to accept birth as a biomedical event, although to varying degrees. The women with the strongest feelings on natural childbirth were willing to accept medical intervention as a last resort, while women with less strong views on natural childbirth were willing to resort to medical intervention at an earlier point. For all of the women, in the case of a medical emergency, saving the life of their baby was their primary concern. However, women who sought a natural childbirth viewed a positive emotional experience of birth as a primary factor in the future health of their baby and in the formation of the mother-child relationship.

A common theme of the interviews was that mothering in the urban environment of Athens was individualizing and alienating. Numerous women suggested that Athenian society offered little emotional support to mothers and that the experiences of motherhood were no longer shared collectively among women, as it had been in the villages.

(Rapid urbanization has resulted in over one third of Greece’s population living in Athens. Therefore, people commonly refer to village life as symbolic of the past.)

Eleni said: “I think the key is that Greek women until recently have lived in rural society as a collective: living, working and raising their children together, women of all ages and levels of experience moving in and out of each others’ homes and lives in a continual flow, sharing their experiences and helping each other. In urban Greece, that is now lost: young women as housewives and mothers are largely left on their own to learn by trial and error, without the example and collective experience of other women – having lost the feeling of being connected to that tradition, or being able to draw on it.”

Katerina said: “We are social beings but we no longer see other women give birth or breastfeed. I remember when I was trying to nurse, I was using information from a book. I thought, ‘I should know how to breastfeed.’ But, I had never seen anyone breastfeed before. It’s not in the social structure anymore.”

The women in this study all discussed the lack of power they felt in the medical setting and emphasized how little support existed for women interested in nonmedical approaches to childbirth. Dr. Makriyianni points out, “There’s no infrastructure to support women for homebirths... In rural areas, maybe there might be an old midwife who might be able to assist, but, generally, people go to cities.” Within the hospital, women who challenge hospital policy or doctor’s judgment are often deemed crazy and irresponsible by hospital staff. Sarah relates the following story of the birth of her second baby, who was born with jaundice: “Here, they start treating jaundice at level 12; whereas, in the U.S. they don’t start treating jaundice until level 18. I refused to have

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the baby treated under the lights. They tried to persuade me.

They made me feel like a criminal! I had to be the crazy foreigner.

I persisted and asked them to give me a waiver to sign. I knew the baby would be fine and that her jaundice level was not dangerously high. After the doctor heard I signed the waiver to refuse treatment, he came in and tried again to convince me I was crazy.

The level did eventually go down and I brought the baby home.”

In response to women’s apparent feeling of disempowerment within the medical setting of birthing, the primary breastfeeding advocacy group in Athens encourages women to trust their instinct and question medical authority. Sarah said, “Through our group, you realize warning signs [that your doctor doesn’t share your point of view or won’t accommodate your wishes] and you get the courage to change doctors. We’ve had women who change doctors at 9 months pregnant!... We encourage women to trust themselves [because] friends will say, ‘you’re crazy!’”

Lazarus (1994, p. 37) suggests that knowledge alone does not give women power within the medical system.

Issues of consent proved to be a major reason why women who felt prepared prior to labor to refuse what they deemed “unnecessary” medical interventions never had the chance to express their wishes during labor. Katerina had more resolve and preparation than perhaps any of the other women I interviewed, and, yet, a number of medical interventions were used in her homebirth without her consent. Katerina recounts: “The doctor forced me to lie on a bed. This was not the most comfortable position for me, but he insisted. He puts his hand in my vagina, which rips me. And I needed just one stitch, but I still feel that one stitch today. He admitted his mistake later.

That he didn’t really need to be as forceful. I still feel that stitch during sex... I argued with the doctor not to cut the umbilical cord until it stopped pulsating. But I really think he cut it before then. Also, I know he must have given me a drug to help the placenta to drop. In Greece, women are never asked about this. Because I read so much, I was ready to fight. But, if I were pregnant again, I would just move to another place where I knew I could easily have the kind of birth I want.”

Irini, a German-born woman in her early 40s, had discussed her interest in a natural childbirth with her doctor, but describes the many medical interventions that were used on her either without her consent or as the doctor’s override of her refusal: “The nurses wanted to shave me. But, I didn’t see why they should have to do that. We had a battle about it and eventually came to a compromise of a ‘half shave.’ Then, I had an enema, while I was in all this pain... Then, amidst all of this pain and trouble, they fingerprinted me! Then they told me to lie down so they could insert an IV. I said, ‘No, I don’t want any medicines.’ ‘This is routine,’ they said, ‘You must do this.’

So, I finally agreed, and they attached the IV as well as a fetal heart monitor. Still, there was no dilation. So, they gave me medicine. Then, the periodic pains became one long pain... I

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eventually fainted. Then, the doctor was called to administer an epidural. Because I wasn’t conscious, I couldn’t respond to him when he told me to turn over for the epidural. So they eventually turned me over and administered the epidural.”

Because women have unequal access to knowledge and differing degrees of desire for such knowledge (Lazarus, 1994, p. 36), it seems essential for multiple discourses on birth to coexist. Demand for natural childbirth services remains limited in Greece, but the voice of the women seeking non-medical approaches to birth is becoming more audible. Although women involved in the natural childbirth movement have made little headway in diminishing doctors’ skepticism of natural birthing, they have succeeded in creating a more organized support network for women interested in non-medical approaches to childbirth and have established a number of practical resources, including a natural birthing center and an educational center.

While it is clear that natural childbirth is not the desired model for all, or even most, women, the wishes of women interested in natural childbirth have yet to be met with respect from medical professionals or support from within the birthing infrastructure. Whether women can affect fundamental changes in childbirth practices within the physician-dominated health care system or must seek non-medical alternatives is a subject of considerable debate.

Because the amount of institutional and societal support given to the medical perspective is far greater than that given to individual women seeking non-mainstream childbirth, it is unclear whether individual coping strategies will be sufficient or if broader social reforms are necessary for the varying beliefs of women to be respected during pregnancy and delivery. Eleni describes the lack of support felt by some mothers in Athens: “A [mother with AIDS] expressed this very well when, not sure how to care for her infant, she cried out, ‘There should be someone here, with me, some mother or grandmother, someone who knows and could tell me.’ She meant, a continual presence, until she ‘got it right.’ I could only say, ‘Yes, you’re right. Someone should be here.’”

In light of women’s apparent interest in improving women’s experience of pregnancy and childbirth in Athens, it is essential that researchers more thoroughly examine the interaction of medical and non-medical discourses on childbirth within Greek society.

References 1. Arnold, M. S. (1985). Childbirth among rural Greek women in Crete: use of popular, folk, and cosmopolitan medical systems.

Ph.D. dissertation. Philadelphia: University of Pennsylvania.

2. Brozan, N. (1988, November 13). Women gain as technology becomes part of natural birth. New York Times, pp. 1, 14.

3. Fox, B., Worts, D. (1999). Revisiting the critique of medicalized childbirth: a contribution to the sociology of birth. Gender and Society 13, 326-346.

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Childbirth in Modern Athens: From Homebirth to Hospital 4. Georges, E. (1996). Fetal ultrasound imaging and the production of authoritative knowledge in Greece. Medical Anthropology Quarterly, 10, 157-175.

5. Lazarus, E. S. (1994). What do women want?: issues of choice, control, and class in pregnancy and childbirth. Medical Anthropology Quarterly, 8, 25-26.

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6. Lefkarites, M. P. (1992). The sociocultural implications of modernizing childbirth among Greek women on the island of Rhodes. Medical Anthropology Quarterly, 13, 85-412.

7. Mikkola, C. (1997). At the heart level. International Midwife, Spring, 46-48.

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Bioethics Without Borders

Xenotransplantation: A Rational Choice?

Author: Ololade Olakanmi, Grinnell College Faculty Sponsor: Johanna Meehan, PhD Abstract There are many potential benefits that xenotransplantation (cross-species transplantation) might afford us, but there are also many weighty biological hurdles which must be surmounted if this procedure is ever to become a clinical reality. Many of these biological concerns are being addressed by specific and novel therapies; however, we must still determine the point at which xenotransplantation could be considered safe enough for clinical implementation. Many members of the scientific community believe that we should strive to make xenotransplantation products as safe and effective as possible, whereas others argue that we should not need to optimize the safety and efficaciousness of xenotransplantation products for them to be deemed acceptable for human use. In this paper I take the latter position, I argue that “the scientific community should move from the paradigm of…trying to indicate to society optimal solutions to that of…trying to help society in finding ‘satisficing’ solutions” which, although not necessarily optimal, are, nevertheless, good enough (Giampietro, 2002, p. 466).

The Case for Xenotransplantation Although organ transplantation saves thousands of lives every year, the worldwide demand for organs has always exceeded the supply. As a result, in 2005, over 6000 patients died while on the waiting list for an organ transplant. Tens of thousands died before they could even be placed on the donor waiting list. In the coming years, this organ shortage is only expected to worsen (USPHS guideline, 2001). In light of these dismal statistics, scientists are once again exploring xenotransplantation, defined here as the transplantation, implantation or infusion of cells, tissues, organs, or body fluids from animals (primarily pigs) into humans.

Xenotransplantation products (e.g. hearts, valves, kidneys, livers, and bone marrow) are able to support and sustain human life for extended periods of time (Deschamps et al., 2005; Michler, 1996; Mollnes and Fiane, 1999, p. 269276; Reemtsma et al., 1964, p. 384-410). For instance, in 1998, Autumn Tate, a dying 16-year-old girl from Lincoln, Nebraska, received an extracorporeal perfusion through a Ololade Olakanmi is a Senior at Grinnell College and is double majoring in Biology and Philosophy.

Email: olakanmi@grinnell.edu Dr. Johanna Meehan is the faculty sponsor for this submission. She is a Professor of Philosophy at Grinnell College.

Address: Steiner Hall 208, Grinnell College, Grinnell, IA 50112 Email: meehan@grinnell.edu

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pig liver before a human liver could be found (Reeves, 1998).

If properly developed, xenotransplantation promises to be one of the most revolutionary medical technologies of the twenty-first century. To be sure, its scope of potentiallytreatable conditions is noticeably wide, ranging from organ failure, to diabetes mellitus, to Parkinson’s disease, to Huntington’s disease, and many others.

H o w e v e r, d e s p i t e i t s p o t e n t i a l b e n e f i t s, xenotransplantation also carries many risks, the most critical being the possible transmittance of infectious diseases across species lines. Several potentially pathogenic infections have been detected in and eliminated from source animals through diagnostic testing and selective breeding (Chmielewicz et al., 2003, p. 349-356). Yet, virologists are still concerned with diseases that have not been identified or characterized, which may escape the screening process.

Of particular concern are endogenous retroviruses (viruses embedded within DNA), which may recombine and/or sustain prolonged incubation periods before disease symptoms appear. Meanwhile, if the virus could evade detection, the patient might inadvertently transmit the disease(s) through sexual contact or to those who have come into “transient but close contact with the carrier of the agent” such as doctors, nurses and family members (Cooper, 2003, p. 557). If this were to continue in an uncontrolled manner an epidemic—or possibly a pandemic—could result. To minimize this danger, the U.S. Public Health Service requires that xenograft recipients, as well as those who come in contact with the recipient, consent to frequent clinical examinations, postmortem autopsies, travel restrictions, and the use of barrier contraception, just to name a few precautions (see USDHHS/FDA/CBER report, 2003).

Xenotransplantation and Rational Choice Theory At present, the scientific community believes that the risks of disease transmittance are low; however, many commentators assert that laboratory work should continue until we have learned more about the pathogenic potential of xenotransplantation products. Indeed, researchers and ethicists generally agree that, prior to a clinical trial of xenotransplantation, preclinical experimentation in animal models (e.g., pig-to-primate) should offer compelling evidence that xenotransplantation products are both safe and effective. At what point, though, can we justifiably say “that [the physician-investigator’s] work with laboratory animals has solved the conceptual, empirical, and technical problems presented by a therapeutic innovation sufficiently to warrant trying it on human subjects?” (Fox and Swazey,

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Xenotransplantation

1974, p. 67-68). The relevant ethical question at work here is, “How much safety is enough safety?” Or put another way, “How much risk are we, as a society, willing to tolerate in order to reap the benefits of this technology?”

On the one hand, many commentators believe that we should strive to make xenotransplantation products as safe and effective as possible; on the other hand, several individuals argue that we should not need to optimize the safety and efficaciousness of xenotransplantation products for them to be deemed acceptable for human use. In this paper I take the latter position, I will argue that “the scientific community should move from the paradigm of…trying to indicate to society optimal solutions to that of…trying to help society in finding ‘satisficing’ solutions” which, although not necessarily optimal, are, nevertheless, good enough (Giampietro, 2002, p. 466).

As a first step in theorizing about safety and efficacy, it is necessary that we recognize the point at which we have successfully achieved an acceptable degree of safety and efficacy. Without specifically outlined expectations for safety and survival time, for instance, safe will never be safe enough, survival time will never be long enough.

But how should we go about defining this notion of safe enough? When dealing with decisions that involve evaluations of safety, researchers typically utilize formalanalytical decision theories such as risk analysis. “[T]he central question in risk…analysis is determining the point at which risk has been sufficiently reduced” (Rowe, 1977, p. 962). In risk analysis, the relationship between an act and the probability and utility of its intended consequences are subjected to a risk calculus and the resulting assessment is expressed in a formal and quantitative manner.

This approach to risk is preferable insofar as it is fairly straightforward, standardized, and non-arbitrary.

Unfortunately, xenotransplantation is not amenable to any formal method of risk assessment (Tackaberry and Ganz, 1998, p. 41-43). In order to estimate and assign expected utility values to potential consequences, one needs empirical data. This requisite places us in a somewhat perplexing and ironic position: In order to proceed with clinical trials we must first establish that xenotransplantation is safe enough.

And in order to determine when safe is safe enough we must first have empirical data, which would ultimately come from clinical trials. Thus, it appears that formal risk assessment is bankrupt when dealing with xenotransplantation. We must find another way to justifiably establish an acceptable level of safety. I suggest we turn to rational choice theory.

Rational choice theory has been used in economics, political science, and cognitive psychology for decades.

Rational choice theory suggests that our decisions, for the most part, are rational, ordered, and predictable to some degree (Etzioni, 1988). Most readers will be acquainted with rationality and rational behavior, so I will not dwell on the topic. Briefly, classical and neoclassical economists hold that Penn Bioethics Journal Vol II, issue ii Spring 2006

the actions of all rational agents are aimed at a particular end and our goal as rational actors is to choose the action that maximizes the expected utility of that end (Gibbard, 1990). Rational choice theorists regard this choice strategy as an optimizing/maximizing strategy. With regard to ethics and moral agents, this is tantamount to the statement: the right action is the best action, that is, the one that maximizes the good or expected good (Schmidtz, 1995). If applied to xenotransplantation, we would have to submit that our desired level of safety ought to be optimized, and only an optimal level of safety ought to be tolerated and deemed ethically acceptable. This sounds all well and good, but perhaps we should analyze this position a bit further. When considering scientific innovations like xenotransplantation, what constitutes optimal safety? Should we require that xenografts survive indefinitely? Transplanted human organs cannot survive indefinitely and require the indefinite use of aggressive immunosuppressant drugs. Should we require that no casualties result from xenotransplantation?

Casualties occur in the development of many novel technologies, especially invasive procedures such as this.

Furthermore, the patients generally selected for transplants are individuals who are in such dire need for a treatment that they have no reasonable alternative but to seek a xenograft.

These often include patients who are not eligible for the donor waiting list (e.g., patients with autoimmune disorders like AIDS). Correspondingly, it does not come as a surprise that these patients frequently suffer from numerous healthrelated problems. Should we require that xenogeneic organs pose no threat of cross-species infection? We can excise viral genes directly from the germ line – a very non-trivial task – but there still might exist undiscovered infections. In short, xenotransplanation will never be considered risk-free.

In fact, no medical intervention (especially an experimental one such as this) is ever risk free We in the scientific and philosophical community are going to have to come to the realization that risk will be an unavoidable artifact of xenotransplantation research.

We cannot be rid of it and neither can we minimize it in order to optimize a xenotransplantation product’s level of safety. If we place the burden of safety optimization on xenotransplantation, we will never reap any of its potential benefits. From a traditionally rational perspective, laboratory research would continue ad infinitum because increasing safety will always be the more rational choice procedure.

However, what immediately strikes me as irrational in this behavior is the lack of any clearly defined stopping point for one’s inquiry, the incessant insistence on the better option. This method of decision-making offers no point at which laboratory research can cease and clinical trials may commence, and is thus of no pragmatic use to us.

Optimization is, nonetheless, our prevailing mode of thinking with respect to xenotransplantation. This mindset is, in part, due to advances in the science of public health

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and, in part, a result of changes in the social climate of many Western societies. In the case of the former, the rise of the precautionary principle in the last few decades has placed more pressure on the developers of technology to explore the potential adverse effects of using the technology before entering the market. In the case of the latter, medical technologies like stem cell research, for instance, are increasingly touted by the media along with many physicians-investigators as “miracle therapies” with seemingly endless therapeutic potential. Thus, there is an increasing pressure to live up to those expectations.

So where are we to go from here? How are we to proceed with xenotransplantation? Characteristic of ethical situations like this is the moral dilemma, the fact that there are several alternative answers to a moral question. In situations that involve uncertainty, like scientific innovation, it may not be feasible to obtain sufficient information in order to optimize a decision. Also, the decision climate may be dynamic, with new options constantly emerging.

These are some of the problems that are inherent to xenotransplantation. The extent to which animal models can mimic the human condition is uncertain. High doses of the immunosuppressant cyclosporine A do not elicit adverse effects in non-human primates, but are toxic in humans (Deschamps et al., 2005, p. 91-109). No one knows the disease-causing potential of porcine endogenous retroviruses, if any; or if an unknown infection might unprecedently rear its ugly head. And it is impossible to predict how and to what extent xenotransplantation technology will improve in the future. We must, nonetheless, find a way by which we can make decisions in the face of such uncertainties. In my opinion, we should appeal to “bounded rationality.”

Bounded rationality was initially described by the Nobel laureate, Herbert A. Simon, and employs a satisficing strategy rather than an optimizing/maximizing strategy.

Satisficing states that it is at times permissible and necessary to make decisions that deliberately do not maximize expected utility; particularly, in situations where there is no clearly-defined right answer, where there is limited time, knowledge, or technical capacity (Simon, 1957). Satisficers pre-establish an aspiration level or threshold level for expected utility, such that the first option that equals or exceeds that level is immediately selected. This option is considered the right option inasmuch as it is good enough to satisfy one’s expectations. However, at the same time, the option may not maximize expected utility (Simon, 1979, p.

493-513). Therefore, moral actors, in some situations, need not maximize the good of their actions in order for their actions to be considered morally right. The moral satisficer need only choose options that s/he deems good enough (Slote, 1984, p. 139-163, 1989).

In keeping with the bounded rationality model, it follows that xenotransplantation should not need to

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maximize safety to be considered morally permissible. I even go as far as saying maximizing safety is an irrational and impracticable decision procedure for this technology.

Researchers merely need to establish that the technology is safe enough. In order to determine this safety level, researchers, ethicists, and other representative members of the scientific community must outline an acceptable aspiration level for safety, such that a therapeutic option that equals or surpasses this level would immediately be chosen.

In my view, the decision process would likely resemble the following scheme: (1) Investigators initially specify an aspiration level for safety which identifies (a) The number of days a xenograft should be able to support a non-human primate (b) The identity of viral genes that need to be removed, if any (c) Expectations for the absence of infections during these experiments (d) How reproducible the experiments should be (2) With these safety expectations put in place, laboratory research is conducted in non-human primate models (3) Once the contingencies of the aspiration level have been satisfied, proceed to clinical trials Clinical trials could only be justified if a decision stratagem such as the one put forth above is employed. Moral satisficing is the only method of ethical justification by which laboratory experiments can be compared to an acceptable standard.

In conclusion, xenotransplantation is a technique burdened by a specter of risk. Therefore, divorcing risk from this technique is a practical impossibility. However, the mere presence of risk should not automatically deter us from making decisions. Indeed, decisions must often be made in the face of uncertain risks. I submit that Simon’s theory of satisficing could be adopted in order to facilitate decision making with regard to xenotransplantation research. Satisficing acceptable risk is not a novel concept in and of itself, and it may not be the most appropriate decision strategy in every instance. However, many cognitive psychologists believe that satisficing closely resembles how most individuals deal with life’s complexities. And its usefulness to the field of cross-species organ transplantation is evident.

References 1. Chmielewicz et al. No new pig herpesviruses exist that might create unknown xenotransplant risk. Heart Disease Weekly (August 24, 2003): 71-72. Reprinted in Xenotranplantation 2003, 10(4): 349-356.

2. Cooper, DKC. Clinical xenotransplantation-How close are we?

The Lancet 362 (2003): 557-559.

3. Deschamps, JY; Roux, FA; Sai, P; Gouin, E. History of xenotransplantation. Xenotransplantation 12 (2005): 91-109.

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Xenotransplantation 4. Etzioni, A. The Moral Dimension: Toward a new economics. New York, The Free Press, 1988.

5. Fox, RC; Swazey, JP. “The experiment-therapy dilemma.” The Courage to Fail. Chicago: University of Chicago Press, 1974, 6083.

6. Giampietro, M. The precautionary principle and ecological hazards of genetically modified organisms. Ambio 31(6) (2002): 466-470.

7. Gibbard, A. Wise Choices, Apt Feelings. Cambridge: Harvard University Press, 1990.

8. Michler, R. “Xenotransplantation: Risks, clinical potential, and future prospects.” CDC Commentary. 1996. 23 December 2002.<http://www.cdc.gov/ncidod/EID/vol2no1/michler.htm> 9. Mollnes, TE; Fiane, AE. “Xenotransplantation: how to overcome the complement obstacle?” Molecular Immunology 36 (1999): 269-276.

10. Reemtsma, K; McCracken, GH; Schlegel, JU; Pearl, MA; Pearce, CW; DeWitt, CW; Smith, PE; Hewitt, RL; Flinner, RL; Creech, O. Renal heterotransplantation in man. Annals of Surgery 160 (1964): 384-410.

11. Reeves, B. Pig liver helped save Lincoln girl’s life. Lincoln Journal Star (1998) http://net.unl.edu/newsFeat/med_eth/me_xeno2.html 12. Rowe. Governmental regulations of societal risks. George

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Washington Law Review 45 (1977b): 944-968.

13. Schmidtz, D. Rational Choice and Moral Agency. Princeton: Princeton University Press, 1995.

14. Simon, HA. Models of Man. New York: John Wiley and Sons, Inc., 1957.

15. Simon, HA. Rational Decision Making in Business Organizations.

American Economic Review 69(4) (1979): 493-513.

16. Slote, M. Satisficing consequentialism I. Proceedings of the Aristotelian Society suppl. 58 (1984): 139-163.

17. Slote, M. Beyond Optimizing: A Study of Rational Choice.

Cambridge: Harvard University Press, 1989.

18. Tackaberry, ES; Ganz, PR. Xenotransplantation: assessing the unknowns. Canadian Medical Association Journal 159(1) (1998): 41-43.

19. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research.

Guidance for industry: Source animal, product, preclinical and clinical issues concerning the use of xenotransplantation products in humans. (April 2003). http://www.fda.gov/cber/guidelines.htm 20. US Public Health Service guideline on infectious disease issues in Xenotransplantation. (August 24, 2001). http://www.cdc.gov/ mmwr//preview/mmwrhtml/rr5015a1.htm

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Bioethics Without Borders

For Your First Born Child: An Ethical Defense of the Exploitation Argument Against Commercial Surrogacy Author: Brendan Osberg, Dalhousie University, Canada Faculty Sponsor: Susan Sherwin, PhD Abstract In this essay I explore two arguments against commercial surrogacy, based on commodification and exploitation respectively. I adopt a consequentialist framework and argue that commodification arguments must be grounded in a resultant harm to either child or surrogate, and that a priori arguments which condemn the practice for puritanical reasons cannot form a basis for public law. Furthermore there is no overwhelming evidence of harm caused to either party involved in commercial surrogacy, and hence Canadian law (which forbids the practice) must (and can) be justified on exploitative grounds.

Objections raised by Wilkinson based on an ‘isolated case’ approach are addressed when one takes into account the political implications of public policy. I argue that it is precisely these implications that justify laws forbidding commercial surrogacy on the grounds of preventing systematic exploitation.

“A free race cannot be born of slave mothers.”

—Margaret Sanger

Recent advances in medical technology have brought the advent of many new ethical concerns regarding how, if at all, we may take the liberty of tampering with life. As scientists busily forge the frontiers of what can be done, the more opaque, and problematic task of determining what should be done is left to ethicists and governments. To this end, in 2004 the Canadian Liberal government passed Bill C-13, the Assisted Human Reproduction Act which prohibits--among other things--the paid commission of surrogate mothers.

In this essay I will outline the objections of Anderson (1993) Brazier et al (1997) and van Niekerk et al (1995) who argue that commercial surrogacy (CS) corrupts the natural bond between mother and child by commodifying the surrogate and/or the prospective child. I will ultimately argue that these writers have come to the right answer for the wrong reasons. I will then outline the objections to CS based on exploitative arguments, and the various objections Brendan Osberg is a Senior at Dalhousie University and is majoring in Physics and Engineering.

Email: bosberg@dal.ca Dr. Susan Sherwin is the faculty sponsor for this submission. She is a Professor of Philosophy at Dalhousie University.

Address: Dept of Philosophy, Dalhousie University, Halifax, NS, B3H4P9 Email: ssherwin@dal.ca

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to them. I will show that, again, these arguments fall somewhat short of the mark, and that the missing element to a compelling exploitation-based argument against CS lies in a sort of ‘feedback’ effect that exists between policy makers and the general public. The relationship between law-makers and society is not a one-way street, as is tacitly assumed by CS proponents such as Wilkinson (2003).

Because of this reciprocal relationship, I will argue in favour of the legal prohibition of CS, using the framework of both a welfarist, and a consequentialist, Finally, I will defend this position against objections based on paternalism and discrimination. Total prohibition, I will show, is necessary for such a potentially exploitive market.

Commercial surrogacy, in this paper, is defined as an arrangement in which a woman (the ‘surrogate’) is paid more than a compensatory fee for bringing a fetus (possibly, though not necessarily her own genetic offspring) to term, and for subsequently giving up that child –and all parental rights to it--to another party (the ‘commissioning parents’) (Wilkinson, 2003, p.169-170). Altruistic surrogacy, by contrast, is defined as a similar arrangement wherein the surrogate receives, at maximum, a compensatory reimbursement for expenses directly related to pregnancy (such as medical bills, etc.).

There are many ethical lenses through which we may appreciate surrogate motherhood and laws regarding this practice. From a conservative, legal moralist perspective it may seem like an abomination to trade in human life in this way. Because of its tendency to separate the physical and emotional unification of men and women that are ‘inseparable in the laws of nature,’ Pope Paul IV (1968) condemned surrogate motherhood of any kind, a position the catholic church has maintained since 1968.1 In a pluralistic society comprised of a wide variety of religious backgrounds, however, we cannot permit just one religious doctrine to determine government policy unless that doctrine is grounded in a more universally accepted value system. That something is unconventional, or seems ‘unnatural,’ does not make it unethical. Still, there may be valid commodification arguments against CS. Anderson, for example, argues that CS degrades children and debases their inherent moral worth as human beings (Anderson, 1993, p.170-175).

It is, perhaps, fortunate that this doctrine was not yet promulgated at the time of the birth of Christ!

1

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For Your First Born Child

We are then forced to consider the following question: ‘is it always wrong to treat people as commodities?’ I will answer ‘no’ for reasons that are well illustrated by an example taken from Mclachlan et al (2000, p. 5.)

In the era of slavery, Africans were kidnapped against their will and taken to North America to be sold as property.

The fact that white land owners purchased these slaves as mere commodities for manual labour now seems barbaric and woefully unjust.

However, if purchasing a particular slave (and subsequently giving him his freedom) was the only possible way to free him, the very act of purchasing him involves treating him, in part, as a commodity. Is it then wrong? I think not. What this example illustrates is that treating a person as a commodity is not itself unethical, but rather, when treating people as commodities becomes an adopted practice, it is the implications of this practice which make it unethical due to its harmful effects on the individuals themselves (i.e. the loss of autonomy, the subjugation to potential abuse, etc.). Note that my intention here is to illustrate precisely why slavery is so unethical, and to separate its effects from the isolated act of treating people as commodities. It seems evident that the consequentialist effects of slavery are what prompt condemnation since purchasing a human being, I would argue, is a moral imperative in this case to prevent such injustice.

Similarly, I will consider the commodification argument a valid one if -and only if- the (supposed) dehumanizing aspect of CS can be associated with unjust treatment of the children or surrogates concerned, or with a wider social attitude of indifference or callousness and inhumanity.

From a consequentialist perspective, we must ascertain how people will treat one another, and how society will behave given the total repercussions of changing social norms.

From a humanist, consequentialist perspective, it seems that the discussion surrounding the ‘value’ and ‘intrinsic worth’ of a person is somewhat abstract and intangible, unless it influences policy-making in such a way as to have concrete impact on individuals or groups in society. For this reason we must assess whether CS will contribute to poor treatment of children or surrogates.

Mclachlan and Swales point out that people who pay money to purchase kittens, or expensive pedigree dogs do not, in general, treat their animals worse than people who acquire their pets as stray’s or as gifts (Mclachlan et al., 2000, p. 5). Indeed, purchased animals may well be treated better than adopted strays as they are brought into a household that is able to provide for their needs. What Mclachlan and Swales overlook, however, is the tendency for affluent parents to spend money, rather than time, on their children.

Parenting is a time-consuming obligation that requires attentive, responsive parents. Children whose parents see them as ‘investments’ may mature in an environment with more expensive toys than any of their peers, but without Penn Bioethics Journal Vol II, issue ii Spring 2006

the sort of nurturing comfort that children require. If commissioning parents of CS can be shown to exhibit this type of trend in parenting, then the commodification argument might have merit.

This prospect, however, is not limited to affluent parents; poor parents can be just as emotionally negligent as any others. Drug abuse, and crime are often associated with poverty, and if CS systematically prefers affluent parents, then their respective children may, in fact, be better off than other children. Furthermore, there is no available evidence to show that commissioning parents of CS are generally emotionally inattentive. Indeed, commissioning parents most likely have tried many alternatives to achieve pregnancy and are eager, if not desperate, for a bundle of joy to dote on.

The burden of proof, then, must lie with opponents of CS to show that the concerned children tend to be neglected. Since Canadian law currently forbids the practice, a domestic study is not possible, and there is no other compelling evidence to attest to this claim. Arguments based on the commodification of children, I argue, are somewhat unsubstantiated.

The commodification of surrogates, however, may be somewhat different. Anderson suggests that applying commercial norms to a woman’s reproduction diminishes the woman’s status to that of an object for mere use (Anderson, 1993, p. 175-182).

If commercial surrogates are, however, performing a role for pay, and if this role supposedly dehumanizes them, then we must ascertain exactly what differentiates a surrogate from, say, a worker performing manual labour.

The implication, it seems, is that pregnancy involves a sort of deep, intimate devotion that is debased by trading in the common market.

As a crude analogy, however, great artists, such as Leonardo da Vinci are renowned for investing the deepest aspects of their personal passion in their work, baring their soul in the art they create. Does it then follow that da Vinci himself is dehumanized when the Mona Lisa is bought and sold?

Admittedly this example lacks the element of human kinship that is demonstrated in surrogate pregnancy, however we have already considered arguments regarding commodification of the child/fetus. We are now focused on determining whether the investment of deep, heartfelt love (by the surrogate) into a task renders it unethical for sale. I would argue that the intimate human bond inherent in pregnancy is not cheapened by commercial sale, and hence I am not persuaded by arguments against CS based on commodification. However, I intend to show that CS should remain illegal for other, more compelling reasons.

Does CS exploit women?

To answer this question we must first determine what is meant by exploitation. What is often implied in the word

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is an act of coercion and manipulation by one individual onto another for the purposes of personal gain. Wilkinson (2003, p.173) proposes the following: A transaction between A and B amounts to A’s exploiting B if and only if a) the distribution of benefit and harm between A and B is (other things being equal) unjust (in A’s favour); and, b) B does not validly consent.

The reason this definition is particularly useful in this context is that it does not require an overt, active coercion on the part of A. If B is stranded in the desert, dying of thirst, and A happens to come along with a canteen full of water, a compassionate person would say that A has an obligation to provide B with water (assuming A is not also in danger of dehydration.) If A insists that B promise to pay her a huge sum of money for a small amount of water then clearly B has no choice but to agree, and her consent is invalid.

The salient point in this definition of exploitation is that it does not necessarily involve A making B worse off than she was originally, (B would surely have died in the desert had A not stumbled upon her) but may involve merely a threat not to take action in situations of dire need.

Even though CS has the potential for ommissive coercion (and hence exploitation by the above definition) there remain objections to legal prohibition.

Wilkinson argues that surrogate mothers are bound to benefit from CS if they are choosing to engage in it, rather than the alternative, which (however terrible a scenario it might be) is something the commissioning parents are acting to prevent. Therefore, he argues, the commissioning parents are acting to improve the welfare of the surrogate, and hence, regardless of what alternatives are available to the surrogate, CS cannot be coercive or exploitative.

To label CS as unethical or unjust in these instances then requires making an assumption central to welfarist ideology, namely that either the commissioning parents or (more likely) society has an obligation to bring the surrogate up to a certain standard of welfare so that she can exercise free choice.

Even then Wilkinson argues against the criminalization of CS. If a surrogate has no other means of obtaining the money she needs, he argues, and if the court has no power to alleviate the plight she is in, is it right to deny her the opportunities that paid surrogacy might afford in order to save her from exploitation? This absurd conclusion –in an isolated case--makes a weighty objection to prohibition measures on CS. The flaw in this argument, however, is that we must consider the implications of public policy beyond isolated cases.

What the above argument overlooks is that the political system does have the power to alleviate the poor surrogate’s

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plight. Supposing government law has a causal influence on society’s circumstances, and further supposing that there exists no causal relation in the reverse sense then it would indeed be absurd to deny women the option of surrogacy for their own benefit, (since the choice they make is surely done to better their situation) and Wilkinson’s objection would be well-founded.

In our society, however, there is an abundance of feedback mechanisms that serve to influence the decision making of those in political power. It is the role of journalists to expose injustice and to document matters of interest to the public. It is the role of public interest groups to rally political support around issues and lobby government officials to take action. As long as government politicians are beholden to voters for their jobs, the needs of society will dictate its laws.

When destitute women resort to the income that CS provides, they become no longer poverty stricken (or at least less so) and the surrogate’s financial gain may appear to many to be an indication of free choice. Consequently, the dire nature of this woman’s poverty has now been hidden behind what may be ostensibly perceived as valid consent to CS. (Although the logic of this inference is deeply flawed, it is quite likely reflective of widespread public perception.)

As a result, governments are alleviated of a certain amount of pressure to resolve the conditions of poverty that have led to this problem (and may consider reducing child-care funding and other social services). Hence, the problem in effect is quietly swept under the rug, and citizens will be inclined to think that there are no longer any poor, childless women in the world. If we are to agree that having people in our society near starvation is morally unacceptable, and if it is also unacceptable (though possibly less so) for women to part with their newborn children for financial reasons, then we cannot permit one injustice to become the solution for another.

The harsh reality confronting unwilling surrogate mothers must be made clear to society so that political support may be galvanized to change their conditions. In the long run of national policy, we must aim at a just society, not a ‘less unjust’ one.

There remains one other objection to the prohibition of CS in Bill C-13, and that is its paternalistic nature.

The decision of the Canadian parliament (an 80% male dominated institution) to deny women the right to choose to engage in paid surrogacy can be seen as an assault on the autonomy of women and their reproductive rights. Even if the bill is motivated by the most genuinely well-intentioned goal of protecting women from exploitation, the denial of free choice on the issue may serve to subordinate women and perpetuate the perception of women as weak, and in need of male protection. In many countries, men are often paid money for the donation of sperm, a transaction most people regard as benign –even comical.

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A woman who carries a fetus to term, and is then told she can never hold this baby again, however, is no laughing matter. The difference in these cases is clearly the emotional impact, and harm of the transaction on the concerned parties.2 Furthermore, it may be difficult for a woman to forsee the difficulty that is inherent in the agreement she is making while pregnant. From a consequentialist stand point, neither the donation of sperm, nor ova, result in the dramatic post-partum effects that are often experienced by women after birth. According to Anderson (1993, p.

178), most surrogate mothers (commercial and altruistic) experience grief upon giving up their children – in 10% of cases seriously enough to require therapy.

The laws against CS then can be seen as somewhat parallel to laws against the sale of organs. The potential for ommissive coercion in these cases is enormous, and society has a duty to ensure that nobody falls to such a level of financial ruin that these sorts of alternatives become necessary (because of the devastating losses that these alternatives result in.) Laws regarding the sale of human tissue apply to everyone, and by analogy, it seems reasonable that laws regarding CS apply to women for no reason other than the simple fact that only women are ever pregnant.

Systematic discrimination and paternalism, then, do not seem to be reasonable objections to Bill C-13.

As we have seen, the objections to CS are many and diverse. Arguments proposed by Brazier that paid surrogacy is an a-priori debasement of human worth are unfounded as they do not reflect the diverse range of values in society. On the other hand, arguments to the effect that the commodification of parties concerned results in their mistreatment or harm do not present an overwhelming basis of evidence. The potential for harm to children due to CS seems no more credible than the prospect that genetic parents may be abusive, or negligent. Furthermore, the connection between paying a woman for pregnancy, and the lowering of this woman’s moral worth in the eyes of

society is a possible, but highly speculative one. It does not seem immediately clear that CS should be banned on the basis of such conjectural guesswork.

The exploitative argument against CS is ultimately the most sound reason to prohibit CS when one considers the long term effect that public welfare has on government policy making. Wilkinson’s objection to the exploitation argument is then addressed and the exploitation argument is redeemed. For this reason, the component of the Assisted Human Reproduction Act regarding commercial surrogacy should be maintained in order to prevent the exploitation of financially destitute women. Commercial surrogacy should remain illegal in Canada.

References 1. Anderson, E., (1993). Value in Ethics and Economics. Cambridge, Mass.: Harvard University press.

2. Brazier, M., (1997). Surrogacy: Review for the UK Health Ministers of Current Arrangements for Payments and Regulation. Human Reproduction Update, 3(6), 623-628 3. Callman, J., (1999). Surrogacy – a case for normalization. Human Reproduction, 14(2) 277– 278 4. The Canadian department of Justice (2006). Updates to Justice Laws Web Site. Retrieved March 13th 2006 from the justice department homepage: http://laws.justice.gc.ca/en/A-13.4/2389. html 5. Pope Paul IV.(1968). Humanae Vitae (On the Regulation of Birth), Encyclical letters. Retrieved March 11th 2006, from The Catholic Encyclopedia homepage: http://www.newadvent.org/library/docs_ pa06hv.htm.

6. Heard, A. (2006). Women and Elections. Retrieved February 26th 2006 from web site: http://www.sfu.ca/~aheard/elections/women. html 6. H. Mclachlan and J.K. Swales. (2000). Babies, Child Bearers, and Commodification: Anderson, Brazier et al., and the Political Economy of Commercial Surrogate Motherhood., Health Care Analysis, 8, 1-18 7. van Niekerk A. and van Zyl, L. (1995). Commercial Surrogacy and the commodification of children, an ethical perspective. Med Law 14(3-4), 163-170 8. Wertheimer, A.. (1996). Exploitation. Princeton: Princeton University Press 9. Wilkinson, S. (2003). The exploitation argument against commercial surrogacy. Bioethics, 17(2), 169-187.

2 It should be noted that in Canada, Bill C-13 forbids, equally, the purchase of ovum and sperm – a policy that I do not endorse.

This issue, however, will not be addressed here as it is somewhat tangential.

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Bioethics Without Borders

The Two-Faced Angel: Do Phase I Clinical Trials Have a Place in Modern Hospice?

Author: Daniel S. Ross, University of Pennsylvania Faculty Sponsor: Joseph Straton, MD, MSCE Abstract Increasingly, bioethicists have been exploring the possibility of making phase I clinical trials available to hospice patients. Phase I clinical trials are designed to test a drug’s safety and dosage, not its effectiveness. Participants in these studies generally do not understand that the purpose of the investigation is not to benefit them, thus challenging the notion of informed consent. But furthermore, the idea that patients believe experimental drugs will help them is contrary to the principles of hospice. Also, the very nature of the research in phase I conflicts with hospice’s methods. For these reasons, this paper finds that the two models must remain distinct.

Death is an angel with two faces: To us he turns A face of terror, blighting all things fair; The other burns With glory of the stars, and love is there.

—Theodore Chickering Williams

The appalling work of “Dr.” Josef Mengele was probably the lowest point in the history of medical research. A “physician” at Nazi Germany’s infamous Auschwitz concentration camp, Mengele contributed to the executions of 400,000 people—a flick of his wrist meant the difference between life and death—while at the same time directing the suffering of countless others over the course of his notorious investigation. Gruesome experiments to his name include tolerance studies of electric shock and radiation exposure on live subjects who were either killed instantly or left severely scarred. Mengele never expressed remorse for his actions, citing the fact that all of his human Guinea pigs were amongst the walking dead, already condemned by Hitler. Who cares what we do to people who are going to die anyway? For his “contributions” to Dan Ross is a Freshman at the University of Pennsylvania.

Email: rossds@sas.upenn.edu Joseph Straton, MD, MSCE, is the faculty sponsor for this submission. He is an Assistant Professor of Family Practice and Community Medicine at the University of Pennsylvania.

Address: Penn Family Care at St. Leonard’s Court, Penn Presbyterian Medical Center, Suite 205, 3819 Chestnut St, Philadelphia, PA 19104 Email: joseph.straton@uphs.upenn.edu

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medical knowledge, this “doctor” lives on by way of his well-known pseudonym, the “Angel of Death” (Pence, 1990).

But in contrast, while Mengele and his experiments define “a face of terror, blighting all things fair,” modern American medicine has a care model that “burns/ With glory of the stars”: hospice. Unlike the Nazi, whose shocking exploits evoke images of the Grim Reaper, hospice reminds us of Hermes, the Greek god whose charge was to lead the souls of the dead to Hades. According to the National Hospice and Palliative Care Organization (2002), hospice is “support and care for persons in the last phase of an incurable disease so that they may live as fully and comfortably as possible.” It functions as a comforting guide to the ill and their families as they progress through the process of dying, respecting life though understanding death as its natural terminus. Hospice patients have chosen to accept their fate, forego curative treatment, and thus spend their final days in palliative care, attending only to the comfort of themselves and those close to them—“and love is there.” This brand of healthcare clearly is a different side of the angel of death.

But what happens when we attempt to look at both of the seraph’s faces simultaneously. What happens when we attempt to conduct research on the dying, particularly those who have made the hospice decision, who have therefore accepted that they are “going to die anyway?” Truth be told, the initial juxtaposition of Mengele and hospice is unfair to the scientist’s perspective, but bringing the sociopath into this discussion is not wholly inappropriate in that researchers do want to use hospice patients to test treatments, not for efficacy, but for toxicity and dosage— they want to execute phase I clinical trials on these subjects (Byock, 2005). Ethically, this could not be more askew.

As we will see, enrolling hospice patients in phase I trials compromises and contradicts the goals of palliative care and is thus an unethical medical practice.

Interestingly, both early clinical tests of pharmaceuticals and hospice are linked by a common goal: altruism. Phase I trials are most often associated with oncology and chemotherapy, and “agents and interventions that are tested in phase I may have substantial side effects” (Casarett et al., 2002, p. 1601). In these situations scientists have discovered a compound that might be a Holy Grail, a miraculous cure for cancer. But their invention might also be dangerous, so researchers conduct a Phase I trial, defined by the

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The Two-Faced Angel

FDA as “initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness” (ClinicalTrials.gov, 2005). As an ethical necessity, participants are informed that their involvement “offers no meaningful chance of direct medical benefit”— the purpose of their participation is to test a therapy’s safety, not its value (Casarett et al., 2002, p. 1601-1602).

A survey of hospice patients conducted by Dr. David Casarett, Dr. Cordt Kassner, and Dr. Jean S. Kutner (2004) indicated that this perception of selflessness is the most popular motivation for which they would consider joining a clinical trial: 66% of those who expressed willingness to be approached about research said they desired this to “help others” (p. 857).

The modern hospice is founded on a separate sense of this same humanity. In a pamphlet provided by the Hospice Association of America, the organization describes its model of care as “[reaffirming] the right of every person and family to participate fully in the final stage of life” (Hospice Association of America, 2002). Hospice focuses on palliative care and symptom management, providing services that support the medical, social, emotional, and spiritual needs of the dying and their loved ones. Since 1982, Medicare has offered a hospice benefit, subsidizing all costs for those who enter certified hospice programs, subject to the condition that their prognosis be terminal within six months or less and that they terminate curative care, including Phase I clinical trials. This new policy, through its financial incentive to enroll in and provide hospice care, drove the number of registered hospice program in the United States from 31 in 1984 to 2,265 in January 2002 (Hospice Association of America).

But besides economics, key to the success of hospice is the understanding reached by all parties that life-sustaining treatment will cease—besides “comfort first,” do-notresuscitate (DNR) is the golden rule in hospice care. This principle is the root of the first major ethical conflict between hospice and research: researchers have a stake in the life and death of their subjects. More data can be collected if the subject is kept alive longer, thus doctors might be inclined to override a DNR order in order to elongate their study. Margaret Edson’s Wit, a play turned HBO movie, highlights this distressing possibility. Vivian Bearing, the main character, is a former English professor diagnosed with terminal ovarian cancer. At the behest of a doctor at her university, she decides to enroll in what was most likely a phase I trial, but after eight months of suffering through a volatile course of chemotherapy, she decides that if her heart stops, she’d like it to stay that way.

The last scene, however, portrays one of the researchers violating this decision, calling in a “code blue” to bring her back because “she’s research.” Fortunately in the end, the blue team leaves Dr. Bearing in peace, but this fictional Penn Bioethics Journal Vol II, issue ii Spring 2006

picture is not so far from reality (Nichols, 2001).1 In another study by Dr. Casarett (1999), this time with Dr. Carol Stocking and Dr. Mark Siegler, a survey of 358 physicians showed that the 29% of them “certainly would” resuscitate a patient who had experienced a cardiopulmonary arrest if the arrest was due to a complication in treatment.

Furthermore, on a 7-point Likert scale, with 1 being “certainly would not” and 7 being “certainly would”, the mean response to that question was 5.24, “likely” (Stocking et al., 1999, p. 36). Consider that phase I clinical trials are those most likely to exhibit the types of complications that would cause heart stoppage—in the movie, as Vivian whispers with her characteristic wit, it’s not her cancer has so ravaged her body that she is required to be in immunonological isolation—it’s her treatment (Nichols, 2001). How, then, would a researcher react to a cardiac arrest when faced with the inherent DNR of hospice, the therapeutic misconception, and the fact that his research depended on his subject living as long as possible—which of the angel’s masks would he wear? The truth is that no one can be trusted to make the ethical decision under these circumstances, and for this reason alone, it’s clear that research ethics and the hospice model don’t mix well.

It’s also apparent, revisiting Mengele, that research on those “are going to die anyway” raises some complicated moral questions. In an August 2000 article in the Journal of Pain and Symptom Management, Dr. Casarett and Dr. Jason Karlawish outlined and discussed four considerations that are particular to research in hospice: that “these patients are especially vulnerable,” that “investigators must obtain consent from patients and families,” that “balancing research and clinical roles is particularly difficult,” and that “the risks and benefits of palliative research are difficult to assess” (p. 131). The first concern is acknowledged by the National Institutes of Health, the principal research regulatory body in the United States, which “defines people near the end of life as a ‘special class’ of research subjects” because of their lack in decision-making capacity and questionably voluntary choices (Karlawish et al., 2000, p.

131). . This issue is clearly related to the second concern regarding informed consent, and the combined problem is fairly sticky: can terminal patients reasonably give consent to enroll in clinical trials?

The answer is no: dying people enrolled in phase I research do not understand that the purpose of the investigation is not their own benefit. In a study on Phase I research participants at the University of Chicago, surveyors found that 85% of patients decided to participate because of possible therapeutic benefit and that 93% said that they understood all (33%) or most (60%) of the information 1 At many points in the film, her physicians indicate their surprise that she lasted as long as she did, acknowledging that the drug was being tested for safety.

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given to them; the same study found that only 33% could actually state the purpose of the trial: dose-escalation and dose-finding studies (Daugherty, 1999, p. 1607). Also, in the same study in which Dr. Casarett (2004) observed that two thirds of hospice patients would participate in research for altruistic reasons, 55% also responded that they’d participate to in an attempt to help themselves (p. 857). Unfortunately, these views are horribly misguided because, according to the Mayo Clinic (2005), 30% of experimental therapies aren’t even safe enough to make it out of phase I, and only 6% eventually come before the FDA for approval.2 Clearly these statistics, coupled with the results of both surveys, indicate a surprising amount of ignorance amongst those participating in studies for which they are supposed to have given “informed” consent. This is because the consent they have given is not truly informed. To present terminal patients with the option to enroll in phase I research is to tantalize them with a terribly false hope for their own survival. And unfortunately there’s no better way to say that this hope is completely contrary to the idea of hospice other than to state it bluntly: hospice patients have accepted their impending deaths, and those enrolled in phase I clinical trials cling to the thought that their participation will cure them.

Thus it is absolutely unethical to offer a hospice patient the opportunity to enter a phase I clinical trial because doing so would undermine the basis of the palliative model.

While the false hope of patients enrolled in phase I trials contradicts the foundations of hospice, the other two ethical concerns enumerated by Dr. Casarett and Dr. Karlawish compromise its goals. Hospice care’s approach is primarily focused on providing comfort for both patient and family, and the difficulties that arise in defining the roles of caregivers and in assessing the perils and profits of research directly inhibits this end (Karlawish et al., 2000 p. 134-135). First of all, enrolling a patient in both research and hospice involves constant contact with quite a few physicians, each with a different agenda. Who, then, helps patient and family make the important decisions that arise at the end of life? Adding a research team into the mix makes the already stressful process of dying all the more hectic for all parties by giving voice to perspective that might not necessarily have the best interests of patient and family in mind. That said, the same criticism could be charged against hospice practitioners, but the very possibility of such confusion in an already nerve-racking situation demonstrates that the natural tension that would exist between the two healthcare teams would be a barrier to good end-of-life care. Second of all, the side effects of

these drugs are counter-productive to the goal of alleviating physical pain. That nearly a third of phase I therapies are too dangerous to continue testing indicates just how volatile these substances can be. A disease that puts a person in hospice is obviously bad enough as it is; do caregivers really need the added responsibility of controlling the symptoms of something that can so easily be avoided? Finally, the very nature of a phase I trial is to assess the hazards of a drug, an end that also opposes to the goal of comfort.

Researchers want to know how uncomfortable the drug makes the subject: how much vomit heaved, how many pounds lost, or how few hairs left (Nichols, 2001). Doctors whose objective is to measure pain have a most unfortunate aim that opposes the fundamentals of palliative care, and for this reason it seems that their presence can do nothing but hinder the hospice course. For these reasons, phase I research trials have, intrinsically, no place in a true hospice program.

Still, it seems rather unfair to deprive participants in phase I research trials of the hospice’s resources. In fact, it seems rather ludicrous that any person would be denied the means of attaining a more comfortable healthcare experience. But this is the status quo in American medicine. For example, at the Hospital of the University of Pennsylvania, the 14th best hospital in the country according to U.S. News and World Report, only 1.5 nurse practitioners provide only 20 of 680 (3%) patients with palliative care, while 20-30% could be assisted by their expertise (McMamamen, 2005). This is general symptom management, not just for the dying, to which everyone should have access.

Therefore, the objections to allowing hospice patients to enroll in phase I research outlined in this paper are not grounded in the notion that participants in clinical trials should be restricted from the services of hospice— everyone should have those. Rather, the goals of the two approaches are so divergent that to utter “experimental drug” and “hospice” in same breath seems sacrilegious. The government’s current policy on the matter is thus correct: those participating in clinical trials should not be eligible for Medicare’s benefit. But a happy-medium paradigm for care should be established that permits those who partake in phase I trials access to the suffering management resources that make hospice so popular. Currently, phase I research and hospice characterize the two-faced angel of dying in America. But death should be an angel with only one expression, a gaze that “burns/With glory of the stars, and love is there.”

According to the website, 20% of all treatments make it from phase I to FDA approval, but after analysis of the other statistics provided, this is impossible. 70% of drugs pass phase I, 33% of those pass phase II, and 25-30% of those pass phase III. Multiplying those odds yields 6%, and that doesn’t even factor in the odds of receiving FDA approval after phase III.

References 1. Byock, Ira. “Palliative Care and the Ethics of Research: Medicare, Hospice, and Phase I Trials.” Journal of Supportive Oncology 1 (2003): 139-141. 17 Dec. 2005 <http://www.supporitveoncology. net>.

2. Casarett, David J., and Jason H. T. Karlawish. “Are Special Ethical Guidelines Needed For Palliative Care Research?” Journal of Pain and Symptom Management 20 (2000): 130-139.

2

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The Two-Faced Angel 3. Casarett, David J., Carol B. Stocking, and Mark Siegler. “Would Physicians Override a Do-Not-Resuscitate Order When a Cardiac Arrest is Iatrogenic?” Journal of General Internal Medicine 14 (1999): 35-38.

4. Casarett, David J., Cordt T. Kassner, and Jean S. Kutner.

“Recruiting for Research in Hospice: Feasibility of a Research Screening Protocol.” Journal of Palliative Medicine 7 (2004): 854859.

5. Casarett, David J., Jason H. T. Karlawish, Michelle I. Henry, and Karen B. Hirschman. “Must Patients with Advanced Cancer Choose between a Phase I trial and Hospice?” Cancer 95 (2002): 1601-1604.

6. “Clinical Trials: A chance to try evolving therapies.” Cancer. 8 July 2005. Mayo Clinic. 18 Dec. 2005 <http://www.mayoclinic.com/ health/clinical-trials/DI00033>.

7. “Data Element Definitions.” ClinicalTrials.gov. 8 December 2005.

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United States Library of Medicine. 4 April 2006.

8. Daugherty, Christopher A. “Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective.” Journal of Clinical Oncology 17 (1999): 1601-1607.

9. “Hospice Facts and Statistics.” Hospice Association of America.

Nov. 2002. Hospice Association of America. 7 Nov. 2005 <http://www.nahc.org/consumer/hpcstats.html>.

10. McMamamen, Erin. Personal interview. 7 Nov. 2005.

11. “National Hospice and Palliative Care Organization Definition of Hospice.” Center to Advance Palliative Care Manual. 20 Feb. 2002. Center to Advance Palliative Care. 3 April 2006.

12. Pence, Gregory E. Classic Cases in Medical Ethics. New York: McGraw-Hill, Inc., 1990.

13. Wit. Dir. Mike Nichols. Perf. Emma Thompson. Videocassette.

HBO, 2001.

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