The Rutgers Journal of Bioethics, Spring 2015

Journal of Bioethicsthe Rutgers

Volume VI, Spring 2015Genetics loads the gun and environment pulls the trigger.

— Francis Collins, Director, National Human Genome Research Institute, National Institutes of Health, 2006. Qtd. in C.E. Hunt, Arch. Dis. Child. Fetal Neonatal Ed. 96: F428-F429.

The Rutgers Journal of Bioethics

Vol. VI, Spring 2015

1Spring 2015

VOLUME VI, SPRING 2015

JOURNAL STAFF

The Rutgers Journal of BioethicsA project of the students of

Rutgers, the State University of New Jersey Edited, designed and assembled in New Brunswick, NJ

Nile Khan and Sophia TanEditors-in-Chief

Monika Masanam Editing Vandana Apte Outreach Denzel Zhu and Rajvi Shah Design

SOCIETY STAFF

Julia Xia and Olivia Shabash Presidents

Srinayani Marpaka Vice President Krishan Patel Programming ChairAlex Lin Events ChairSuraj Shukla Treasurer

ABOUTThe Rutgers Journal of Bioethics is an undergraduate journal exploring the intersection of ethics, biology, society and pub-lic policy. It has been published each year since 2009. While the journal solicits articles from all persons wishing to par-ticipate in the open discussion on bioethics, it is staffed by students at Rutgers, the State University of New Jersey. The journal is published by Premier Graphics (500 Central Ave., Atlantic Highlands, NJ 07716) and funded through generous contributions from the Rutgers University Student Assembly Allocations Board. The journal welcomes all unsolicited orig-inal essays, book reviews, editorials and art. To submit, please e-mail a copy of your paper or a high resolution image of your

work of art to <[email protected]>. © 2015 The Rutgers Journal of Bioethics. All copyrights to art or essays be-long to their respective authors. All other copyrights belong to The Rutgers Journal of Bioethics. Please send all questions and comments to the above email address. Our sister organiza-tion, the Bioethics Society of Rutgers, the State University of New Jersey, meets every other Wednesday during the academic year at 9:00PM in Rm. 106, Scott Hall (43 College Ave., New Brunswick, NJ 08901). All are welcome to attend. Sometimes we have pizza. Meeting details are available at <https://www.facebook.com/bioethics.ru>. Thanks for reading this far. We hope you enjoy this work.

Ameena Rana Publicity Chairhttps://www.facebook.com/bioethics.ru

Editorial Staff MembersAmeena Rana, Christina Coppola, Ian Berman, Julia Xia,

Olivia Shabash, Srinayani Marpaka and Janice Yang

THANKS

Nils Westergard, Xiao Fu, the Rutgers University School of Environmental and Biological Sciences General Honors

Program and the Rutgers University Student Assembly Allo-cations Board.

2 THE RUTGERS JOURNAL OF BIOETHICS

Editorials

On the importance of scientific literacy for medical autonomy

Peter Nielson

6

Sabah Abbasi

Features

9

The failure of the media’s coverage of Ebola

Donating life:A survey of the ethical consequences of genetic child production by in vitro fertilization in parental versus donor reproductive material

Molly E. Booth

12

The ethics of pre-implantation genetic testing

Jaclyn Estes

20

“Frankenfood” redefined:The necessity of dispelling myths about genetically modified foods

28

Sarah Pfaff

The Rutgers Journal of Bioethics Volume VI, Spring 2015

Spring 2015 3

EssaysCase analysis:Care of an unresponsive patient with a poor prognosisAustin R. Wetmore

37

Possible improvements for off-label drug prescribing

Alexander Yahanda

44

Justifying health care as a feasible ethical right

Samuel H. Jones

52

Guidelines and recommendations regarding the use of deep brain stimulation devices in the treatment of borderline personality disorder

Megan M. Parsons

58

Above: The gyri of the thinker’s brain as a maze of choices in biomedical ethics, Bill Sanderson, 1997. Wellcome Library ICV 51428. Cover: The family of Laocoon entwined in coils of DNA, Bill Sanderson, 1990. Wellcome Library ICV 25416.


Introductions

Letter from the Editors by Nile Khan & Sophia Tan,

Editors-in-Chief

Perhaps the most significant unit in life is the gene. No other biomolecule has the potential to regulate behavior, influence health, control all life processes, and permeate every aspect of our lives. The study of genetics is bidirectional:

it holds the key to our individual identities, as well as our evolutionary histories. Not coincidentally, bioethics parallels this duality—the cases we study are morally ambiguous. Recent epidemics remind us that it is unclear whether certain measures intended to relieve one from harm may exacerbate it in others. Are we to administer placebos to Ebola victims when there is an experimental drug at hand, or ought we risk clinical trial results and further delay drug approval for treatment of a wider set of patients? If doctors do not accept pediatric patients who have not been vaccinat-ed, are their efforts commendable for protecting against the measles outbreak, or are they violating their vow to treat all patients without bias? The ambiguity of bioethical cases is what makes them worth discussing. In this issue of The Rutgers Journal of Bioethics, students representing different universi-ties and fields address some of the most challenging questions faced by the medical community today. Our featured essays highlight the most debated topics in genetics and ethics: we present two papers supporting different views on in vitro fertilization, and an article arguing for the safety of genetically modified organisms. The progress we have made in creating this platform to stimulate conversations regarding bioethical issues is due entirely to our talented team of editors; we are perpetually grateful for their efforts. We would also like to thank our sister organi-zation, the Rutgers Bioethics Society, for driving discussion of current events and hosting the annual bioethics symposium. We encourage you, the reader, to approach this journal issue with an innovation-oriented mindset. What policies can we im-plement to handle ethical concerns arising from unequal healthcare, off-label pre-scribing, deep brain stimulation, and genetic manipulation? Our authors examine creative solutions to solve world hunger, improve healthcare, and prophylactically protect those who are susceptible to disease; it is up to us to mediate a balance to yet another dichotomy—embracing technological advances while practicing responsi-ble science.

—Nile Khan & Sophia Tan, Editors-in-Chief, The Rutgers Journal of Bioethics

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Letter from the Society by Julia Xia & Olivia Shabash,

Presidents

In our time at Rutgers, the Bioethics Society has served as both a ground for ex-perimental thought and a safe space. It is a place where we and other students come to express ourselves while learning about the frontiers of science and med-

icine. The students that come to our meetings are interested in exploring the bridge between science and humanity, and they care deeply about the weight of our choices as responsible citizens. In tackling bioethical issues that inherently lie at the crossroads of science, medi-cine, technology, law, and policy, we inevitably bring together people of all different disciplines. At general body meetings, we host students from majors spanning the natural sciences, social sciences, and humanities, and we team up with numerous other student organizations on campus. This year, we collaborated with the Amer-ican Pharmacy Association to discuss the possibilities of pharmacists with pre-scribing authority. We also joined forces with the Rutgers Astronomical Society to explore the ethics of colonizing on Mars. With the Association of Undergraduate Geneticists, we tackled the issue of three-parent in vitro fertilization and surrogacy. We also expanded our collaborations with Rutgers Robert Wood Johnson Medi-cal School. We hosted medical students who gave us a glimpse of medical ethics in clinical education, and we were delighted to welcome clinician and bioethicist Dr. Eric Singer who took us through the layers of choices a hospital faces in preparation for a nationally feared Ebola case. Through our general body meetings and our annual symposium, the Bioethics Society works to bring thought-provoking questions to young minds across Rutgers. With this journal, we hope to bring carefully articulated ideas and analyses to our readership to show that not only does bioethics have a broad reach but also extreme depth. Finally, we want to acknowledge the executive boards of both the society and the journal for their endless energy and enthusiasm in bringing the organization’s vision to life. It has been a privilege and a joy to work alongside individuals who are as open and sincere as they are, and we invite you all to take the time to appreciate the meticulous and passionate effort that has brought bioethics to Rutgers and this journal to your very hands.

—Julia Xia & Olivia Shabash, Presidents The Bioethics Society at Rutgers, the State University of New Jersey


Editorial

The failure of the media’s coverage of Ebolaby Sabah Abbasi†

While the media frenzy surround-ing the most recent Ebola out-break came and went in a mat-

ter of months, the issue remains one of the deadliest threats to global public health today — although not in the way that the media might have you believe. It did not get nearly as much attention as it should have until the first case arrived here in the United States, where it promptly became an issue of national concern. But much of the coverage of the disease seemed to gloss over or even outright ignore the fact that Ebola was, and still is, a serious threat to thousands of peo-ple throughout affected countries in West Africa.

The mainstream media has blown the issue completely out of proportion and has arguably done more harm than good (if it has even done anything at all), for it has failed to seriously address the issue in a calm, informed, and responsible manner. Ebola quickly became a household topic once there was news that it had reached the United States through an infected patient from Liberia: Thomas Duncan. There has been no shortage of discussion on the mat-ter, although the disease itself has posed no actual threat to most Americans. As of Feb-ruary 2015, there have only been a total of 10 cases in the United States, all of which were closely followed by the media, and there is currently no Ebola in this country at all — eight of these patients fully recovered, and

two died (New York Times). However, it is still important to recognize the implications of the public’s reaction and policymakers’ handling of the situation, as it sets a danger-ous precedent for future potential outbreaks. Without a proper understanding of the dis-ease, its symptoms, its communicability, and the reasons that it is such a widespread epi-demic in West Africa, most people saw Ebo-la as a much larger threat to our immediate health than it actually was, leading to unnec-essary panic.

According to the Centers for Disease Control and Prevention, “Ebola virus dis-ease (Ebola) is a rare and deadly viral illness which is reportable to the National Notifiable Disease Surveillance System in all U.S. states and territories. Early recognition of Ebola is critical for infection control. Health-care providers should be alert for and evaluate any patients suspected of having Ebola.” The virus is communicable, transmitted through direct contact with an infected person’s bodily fluids including blood, sweat, and se-men. With proper medical supplies and pro-tective gear, healthcare workers can success-fully treat Ebola patients without the risk of contracting it themselves. Unfortunately, in West African countries, where the recent Ebola outbreak has claimed nearly 5,000 lives (according to the BBC), these medical supplies are not available. According to the CDC, this year’s Ebola outbreak in West Af-rica was the largest in recorded history, and

† Sabah Abbasi is a Public Health and Political Science undergraduate student, with a minor in Arabic, at the School of Arts and Sciences at Rutgers, the State University of New Jersey, in New Brunswick, NJ. She is the Opinions Editor for The Daily Targum and is an Under-graduate Associate at the Eagleton Institute of Politics. She can be reached at <[email protected]>.

Ebola: A matter of ethics

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the first epidemic of Ebola in the world. Nat-urally, once there was news that Ebola had spread across the globe to the United States, there was a considerable amount of panic. However, many people failed to realize that the circumstances in West Africa’s develop-ing countries are extremely different from the stronger public health infrastructure that we have in the United States. We are equipped to handle Ebola cases that come into the country, and given our physical distance from the outbreak in West Africa and our already carefully controlled travel and immigration policies, the risk of an out-break in the United States is negligible.

The problem is, public opinion in this country can be very powerful, and constit-uents can quite easily influence their repre-sentatives. The media is hugely responsible for the direction of public opinion, and as the main source of information on Ebola for most people, the media had a very neg-ative effect on the perception of the disease and its threat level in this country. When it comes to public health, it is important

to remember that both policymakers and trained health officials must work together to create feasible, effective practices. Scien-tific and medical evidence form the basis of public health, and without an understand-ing of this evidence, there is a danger that the policies implemented hinder actual treatment and prevention efforts. A classic example of the clash between public health and policy was when New Jersey Gover-nor Chris Christie declared that the state would maintain its policy of a mandatory, 21-day quarantine for Nurse Kaci Hickox, even though she tested negative for Ebola. If someone tests negative for Ebola, and if they are not symptomatic, then there is no chance that they are infectious. Hickox was forcibly held at the hospital until the state was pressured by her lawyer to let her go, but her initial quarantine caused consider-able alarm for no reason (since she did not have Ebola) and raised questions about the ethics of mandated quarantines. Christie has remained extremely stubborn on the is-sue with his characteristic no-nonsense per-

The Plague at Ashdod, Nicholas Poussin, 1630. On display at the Louvre Museum, Paris (INV 7276). Photographer: Web Gallery of Art.

Sabah Abbasi


REFERENCES:How many Ebola patients have been treated outside of Africa? (2015, Jan. 26). The New York Times.2014 Ebola outbreak in West Africa. (2015, Jan. 29). Centers for Disease Control and Prevention, <http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/index.html>.Ebola: Mapping the outbreak. (2015, Jan. 23). British Broadcasting Channel, <http://www.bbc.com/news/world-africa-28755033>.

sonality and insisted that his policies are in line with what the American public believes is “common sense.”

While an outbreak of Ebola in the Unit-ed States has proven to be a non-issue, aside from a few isolated cases and one unfortu-nate death, the reality remains that in West African countries, there are hundreds and thousands of people becoming infected and dying from the disease. With all of the atten-tion focused on Ebola’s threat to America, there is not enough emphasis on this issue on the other side of the world. Another un-fortunate byproduct of the unnecessary me-dia-induced panic surrounding Ebola is the discussion of banning flights to and from West Africa. Isolating an entire continent (or part of a continent) will do nothing to address the still-present public health threat that Ebola poses for the world at large if the

disease remains unchecked. Furthermore, addressing the spread of the disease and its consequences on affected populations is a humanitarian issue as well. The importance of proper education and a measured, pro-portionate response to public health threats cannot be underestimated, and this Ebo-la epidemic perfectly illustrates why these things are so important. •

Ebola virus molecular structure, David Goodsell, October 2014. In Ebola Virus Proteins, Molecule of the Month, Research Collaboratory for Structural Bioinfor-matics: Protein Data Bank. To the side is a computer-generated model illustrating the molecular biology of the Ebola virus. Illus-trated in the image is glycoprotein PDB 3CSY, matrix protein PDB 41DD, nucleo-protein PDB 4QB0, and nucleocapsid proteins VP30 (PDB 2I8B), VP24 (PDB 3VNE) and VP35 (PDB 3FKE). Many Ebola vaccines target glycoprotein 3CSY, since antibodies recognize the Ebola virus by binding to the glycoprotein and activating an immune response.

9Spring 2015

Editorial

Public Knowledge and its Relation with Autonomy: A Call to Action

by Peter Nielson†

I think it is time that medical decisions be executed based on fact. There was a time when there were no anatomy labs

or books on the subject. Surgeons who had never seen the inside of a body before were attempting to perform operations. Fortu-nately, those times have past, but the rele-vant medical facts are still not being used to make all medical decisions. Medicine should be evidence-based, and all other “miracle cures” should be shunned. To be convinced of the global popula-tion’s lack of knowledge, you can turn to the research. Various research groups asked a series of scientific questions to people in different areas of the world, and the results were shocking. Most people know that the core of the Earth is hot. Most even know that the Earth orbits around the Sun. However, more than half of the subjects did not know that antibiotics do not kill viruses. Many did not know that the father’s sperm determines the sex of the child (Science and Engineer-ing Indicators, 2008). Furthermore, no sin-gle question was answered correctly by all of the respondents from any study. These facts are so fundamental to our twenty first cen-tury world-view, and I personally remember learning them in elementary school. Nev-ertheless, people may choose not to pay at-tention to the facts that they have learned, or simply do not incorporate these facts in

their decision-making processes. In both cases, objective information is only a simple web search away and is not being utilized. Not everyone needs to have a wealth of sci-entific knowledge, but the global population ought to have some basic level of under-standing. People from our population here in the US become policymakers, activists, elders, and parents—all are leaders who are influential in shaping our communities. We look to these people to make decisions or provide the guidance necessary for making decisions. Living in a deterministic, predict-able universe means that many decisions about the world around us are not right or wrong as matters of opinion; they are right or wrong as matters of fact. The more infor-mation a person has, the better equipped he or she will be to make the correct decision. More importantly, people without an understanding of basic science are given full autonomy in their own healthcare deci-sions—in and out of the doctor’s office. The diet people eat or the activities they partic-ipate in greatly impacts their health. Smok-ing, taking supplements of with untested benefits, eating a poor-quality diet, and par-taking in risky sexual behavior are just a few choices that remain prevalent despite the re-search that shows how detrimental those de-cisions are. Even patients who go to the doc-tor’s office with the expectation of receiving

† Peter Nielson is a biology undergraduate student at the School of Arts and Sciences at Rutgers, the State University of New Jersey, in New Brunswick, NJ (class of ‘15). He can be contacted at <[email protected]>. “While many philosophical questions are interesting, sometimes they are unanswerable or are hypothetical in nature. I am interested in bioethics because often there are actual facts to base decisions off of and there are real life consequences to decisions made.”

Peter Nielson


Trouble comes to the Alchemist, unknown Dutch School painter, 17th-18th century. Chemical Heritage Foundation, Photographer: Will Brown. FA 2000.001.269. Iatrochemists were physicians who believed that health and disease were based off of chemical principles. Above, an iatrochemist conducts a uroscopy, the examination of the com-

position, smell, taste and color of urine to diagnose disease, for a female patient while another person empties her chamber pot onto his head.

Public Knowledge and its Relation with Autonomy: A Call to Action

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a prescription should have a basic level of understanding of the drug. However, with the commercialization of medicine, it seems that drug commercials may be one of the only sources of information a patient has. Now, I do not wish to live in a state where these choices are not autonomous, as free-dom is a wonderful thing. However, I would prefer a world in which everyone recogniz-es that certain decisions are deleterious and consequently people make better choices. Patient autonomy in the doctor’s office is also one of the most important ethical prin-ciples in medicine--and for a good reason, considering some practitioners’ transgres-sions in the past. However, full autonomy currently seems like an imperfect system, as patients often do not have the depth of sci-entific knowledge necessary to make sound medical decisions that often have great con-sequences. Think back to a difficult science or math class, one in which the material was brand-new to you. How well would you have done if there was a test at the end of the first class that could affect you for the rest of your life? How well would you have done if that class was less than 30 minutes and the teacher was only in the room for less than ten of those minutes? This situation is analogous to the length of an average visit to the doctor and corresponding face-to-face time (Dug-dale, Epstein& Pantilat, 1999). The grade on this test is health, and people are simply not doing their homework. There are seemingly two solutions that maintain patient autonomy. Either health care providers can spend more time educat-ing patients about medical procedures and treatments that may need to be performed, as well as lifestyle choices, or the patients can become more knowledgeable themselves. The former solution seems rather unfeasi-ble, considering the stress on efficiency in doctor’s offices and the increasing number of patients seen per day by physicians. How-

ever, my argument for increasing patients’ levels of scientific understanding will solve this problem and may yield a more efficient office visit. Patients will ask better questions and provide more insightful descriptions of symptoms to physicians. The lack of a simple understanding of modern medicine and the scientific method are not necessarily individualistic. Culture and society play a large role in determining to whom and where we turn during times of illness (Cockerham, 2012). Many people self-treat or ask for advice from their social group. A more knowledgeable population could help a number of people who never even make it to the doctor’s office, such as persons without access to health care or for minor ailments that do not require a phy-sician’s treatment. These patients are still seeking some sort of relief from symptoms, and a larger base of knowledgeable people could help them make better decisions on their over-the-counter or folk treatments. A knowledgeable person could further help the doctor by providing useful information that may lead to a more accurate diagnosis.As scientists, perhaps we forget how un-common our knowledge is. We have a hard time explaining useful bits of knowledge in language that is easy to comprehend. How-ever, it is our job to encourage knowledge, promote the use of credible facts, and clear up any misconceptions that people may have about the natural world. It may not al-ways be popular, but it appears to me to be the only thing we can do as individuals. We need to help propagate a culture that relies on evidence to make decisions–especially in a society in which such decisions can direct-ly impact one’s health. •

REFERENCES:Cockerham, W. C. (2012). Medical Sociology. Boston: Prentice Hall.Dugdale, D.C., Epstein, R., Pantilat, S.Z. (1999). Time and the Patient-Physician Relationship. Journal of General Internal Medicine, 14(S1), S34-S40. Science and Engineering Indicators. (2008). [Graphical illustrations of scientific literacy and knowledge acquisition mediums in the U.S. and abroad.]


A survey of the ethical consequences of genetic child production by in vitro

fertilization in parental versus donor reproductive material

Donating Life

by Molly E. Booth†

† Molly E. Booth is a Neuroscience undergraduate student with a minor in Bioethics at the University of Virginia in Charlottesville, VA (class of ‘15). She is very interested in current medical approaches - e.g. stem cells, IVF - and their ethical implications on society. She hopes to further these studies next year in graduate school, specifically with her interest of incor-porating ethical protocols in response to neuroregeneration efforts. She can be reached at <[email protected]>.

Electrodes, David Reeves, 2007. Flickr. A two electrode voltage clamp performing an electrophysiology experiment on Xenopus laevis oocytes.

Donating Life

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Although our constitution states otherwise, we Americans are not all created equally. With current scientific advances, a growing percent of the population has been or will be created in a test tube. Due to these new technologies, children, parents, and society are redefining the family unity and struggling to discern the ethical ramifications of child production. In this paper, I will survey these ethical consequences with regard to in vitro fertilization as a means of child conception by parental or donor reproductive material. I will accomplish this by analyzing the motives of individuals involved in in vitro fertilization (IVF), the impact on family members, and the legal and ethical problems that in vitro fertilization can create for society. Ultimately, I will argue that IVF utilizing parental reproductive material is ethically sound, but that this soundness is lost when genetic material from a nonparental figure is utilized.

BACKGROUNDIn Vitro Fertilization: What Is It and Who Needs It?According to the Centers for Disease Control and Prevention (CDC), the United States alone has 6.7 million women between the ages of 15 and 44 with impaired fe-cundity, equaling about 10.9% of the population. That same survey concluded that a total of 7.4 million women age 15 to 44 have used infertility services (Center for Dis-ease Control and Prevention, 2013). Of the available fertility treatments, this essay will narrow the scope of ethical complications to in vitro fertilization. It will consider the ethical ramifications of using parent or donor samples embryonic transfer into a parental figure.

The Process of Egg and Sperm Retrieval from ParentsWhen parental gametes are used for IVF, fertility centers are paid for the laboratory work involved, but obviously neither parent is paid for their contribution. The cen-ter first performs preliminary blood work and assembles medical histories to find the best medical route for child production. When IVF is chosen, collection of eggs occurs either by the harvest of uterine contents after ovulation or ultrasound-guided oocyte retrieval directly from the ovaries. This can be accomplished with or without hyper-stimulation of a woman’s ovaries via hormonal injection. After collection of eggs, the male sample is collected through a noninvasive masturbatory collection in a fertility center (Centers for Disease Control and Prevention).

ETHICAL CONSIDERATIONS FOR UNNATURAL PREGNANCYIndividualistic Motives for IVFThe motives of hopeful parents for the creation of children depend greatly on the cul-tural norms of their society. In 21st century America, these parents are characterized by a culture of intense individualism, leading to a mental shift from familial needs to the needs of the individual. This culture poses a potential for catastrophic ethical de-cisions, especially in the realm of childrearing. At its core, child production is a fun-damentally individual experience. This, coupled with societal pressures to reproduce, has transformed parenthood into a societal right of passage. Laura Carroll, author of “The Baby Matrix: Why Freeing Our Minds From Outmoded Thinking About Par-

Feature

Molly E. Booth


enthood & Reproduction Will Create a Better World,” described this phenomenon as a subliminal push in American culture that asserts parenthood as the only “path to fulfillment in life”. With the prospect of such a weighty personal experience, parents often want to be involved in the process of making their own children over other more beneficial avenues to society, such as adoption (Carroll, 2012). But in what cas-es should parents’ selfish motives be ethically accepted as reasons to engineer their own children — especially when there is a viable alternative such as adoption? Consider a moderately healthy married woman who has tried for a couple years to have children naturally with her husband to no avail. She has money available to visit a fertility center and finds that her husband has relatively low sperm motility. This condition can be easily overcome by IVF of both parents’ reproductive materials. In this case, this infertility can be considered an easily treatable medical condition, made possible by advances in modern science. Essentially, this form of IVF is just an enhancement of natural pregnancy because the genetic material of two parents is combined without regard for its quality. I would argue that in this situation, IVF is just a mere enhancement of fertility no different than the use of Viagra to aid “nat-ural” sex. In other words, there is not a moral dilemma based upon the location in which the parents’ embryo starts development. Now consider a moderately healthy married couple that is completely infertile. IVF of their genetic material will not result in any viable embryos so they decide to use both an egg donor and sperm donor. In this case, neither of the parents’ genetic material will be passed through the IVF process. Therefore, the potential parents will be just as genetically removed from the manufactured child, as they would be to an adopted child that is already alive and well. This is a problem because the potential

Scanning electron micrograph of methicillin-resistant Staphylococcus aureus and a dead human neutrophil, National Institute of Allergy and Infectious Diseases, 2013.

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parents are no longer being treated for a medical condition, and they are now going out of their way to produce something that already exists: an unrelated child. This issue is a bit more complicated because potential parents would get to play a larger role than child adoption allows. With IVF, they are able to choose the charac-teristics of their child by screening egg and sperm donors for specific characteristics as well as experience pregnancy by carrying the child to term. However, I would ar-gue that the ability to explicitly choose the child’s characteristics should be avoided. It devalues the future child of its humanity by creating a eugenic environment and fostering a parental attitude of child commodification. On the other hand, experienc-ing pregnancy is a valuable gain by the potential parents over adoption, but creating life is an insensitive motive when there are many children that need to be adopted and loved.

Moral Consequences for SocietyFrom these cases, one can ascertain that there is also a third possibility in which only one parent would be able to pass on his or her genetic material to the next generation. This situation would manifest itself if a couple finds that only one of them is infertile, a same sex couple cannot conceive without a single sperm or egg donor, or a single person requires sperm or egg contributions to conceive. In these cases, the parent or parents would be creating a new commodity of familial relation, which is an selfish desire because they cannot adopt a child that shares such relation. Furthermore, this Zona reaction in Porcine Oocytes fertilized in vivo and in vitro as seen with scanning electron microscopy (figure 2), H. Funahashi, H. Ekwall and H. Rodriguez-Martinez, 2000, Biology of Reproduction 63: 1437-1442. (A) Ovulated oocyte. (B) Zygote collected from oviduct. (C) An in vitro maturation oocyte. (D) An in vitro maturation-in vitro fertilization zygote.

Molly E. Booth


is the same selfish desire that drives parents to create children naturally rather than adopting one of the numerous children that need homes. The process of IVF with

only one parental donor, however, still involves strict scrutiny of the other possible donor and therefore a devaluation of that child’s life from a societal perspective. In this regard, the child is again treated as an object that can be cus-tomized, bordering eugenics by the potential parents. This ethical consequence outweighs the positive impact of having a related child because it negatively impacts the attitude of the

family toward that child. The idea that donor scrutiny devalues the life of the child is greatly illustrated by Jessica Cohen’s written experiences as a potential egg donor. As an undergraduate student at Yale, Cohen came across an ad in the school newspaper for an egg donor that was willing to pay an excess of $25,000 for viable eggs. Over the next couple of weeks, the couple screened Cohen with their own criteria. This involved extensive review of her personal pictures and a myriad of personal questions about her educa-tional and health background. This triggered an uneasy feeling in Cohen about the amount of effort the potential parents were putting into screening their child’s donor for potentially unethical selection of traits. Cohen (2002) describes this experience below:

I kept dreaming about all the things I could do with $25,000… But soon, despite [the potential father’s] casual tone and the optimistic attitude of all the classifieds and information I read, I realized that this process was something I didn’t want to be a part of. I understand the desire for a child who will resemble and fit in with the family. But once a couple starts choosing a few characteristics, shooting for perfection is too easy—especially if they can afford it… it would have led to the creation of a child encumbered with too many expectations.

This is a big problem with the commodification of child production. People picking out characteristics of their offspring completely devalues the essential uncertainty that defines the humanity of their child. This idea of a perfect child can lead to a potential situation where egg and sperm donation increasingly replaces natural preg-nancy, so parents can choose the characteristics of their child. Although the specific direction of IVF is not clear, blurring of ethical lines with the commodification of an entire human generation will eventually lead to a world of unethical eugenics, propa-gated mainly by members of the upper class who can afford to do so.

Impact on Family UnityA final ethical consideration in IVF treatment is the impact on family members in-volved. Cohen (2002) touched on this after being rejected as a donor:

I guess I didn’t fit their design; my genes weren’t the right material for their chef d’oeuvre. So I was rejected as a donor. I keep imagining the day when [the po-

People picking out charac-teristics of their offspring completely devalues the essential uncertainty that defines the humanity of their child.

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tential parents]’s child asks where he or she came from. [A potential parent] will describe how hard they both worked on the whole thing, how many pictures they looked at, and how much money they spent.

This is an interesting problem: how will children that are produced by IVF react to that knowledge, whether they contain parental DNA or that of a donor? I would ar-gue that the third party aspect of the conception of IVF children would not trouble them or alter any family dynamics. However, those children made by donor IVF may feel pressured to fulfill their parents’ expectations, leading to higher anxiety through-out their lifetime. This phenomenon is backed by current research on the well-being of donor-produced children. According to a Cambridge University study, which fol-lowed 198 families over the course of seven years, donor children have more emo-tional issues than naturally conceived children. In the first stage of the study, parents were surveyed for their sensitivity toward their children and were asked about their children’s emotional well-being. It was found that parents of donor children were hypersensitive to their child’s needs and tended toward over-involvement, but felt their children had no noticeable emotional deviances from the average child. In the second stage of the study, teachers were asked to describe the emotional states of their children in a blind study — that is, teachers were not told which students were conceived through IVF or natural means. It was reported that donor IVF children expressed higher emotional problems due to higher anxiety from parental oversensi-tivity (Golombok, Murray, Jadva, Lycett, MacCallum, & Rust, 2006). Although parental IVF was not analyzed in this study, I would argue that results from children conceived using parental gametes would correspond to normal anxiety levels in children because parents would not tend toward hypersensitivity since they did not specially design all the characteristics of their child and hold stronger precon-ceived expectations. In support of this argument, the study concluded that families that utilized IVF did not differ from families that used natural reproductive means

De Humani Corporis Fabrica, Andreas Vesalius, 1543. The photo above is found in the first page of one of the most influential books written on the topic of human anatomy by Professor Vesalius of Brussels, Belgium.

Molly E. Booth


in the overall quality of the relationship between parent and child (Golombok et al., 2006). Therefore, only the underlying pressures from the price tag and high expecta-tions on the child—not the actual in vitro process of conception—played a significant role in the mental well-being of all involved. I would further argue that this pressure is due to a societal norm demanding secrecy surrounding the production of children, naturally and unnaturally, which may prevent children from knowing the details of their production.

THE MODEL: PARENTAL IVF AND ADOPTIONParental IVF Treatments: A Viable Ethical Response to InfertilityIVF treatments should be considered a morally viable option when utilized by two parents with less than ideal fertility. This is because IVF acts as a medical treatment to aid the couple in a naturally occurring process, rather than allow the parents to genetically engineer characteristics of their child-to-be. This difference has ethical significance not only for the morality of those involved, but also in the formation of legal and moral precedents for society in general. The largest impact, however, was seen in the well-being of the family members in which donor IVF children exhibited high anxiety in response to overbearing parental figures. Therefore, only parental IVF and not donor IVF is ethically permissible.

Adoption as an Ethical Alternative to Non-Parental IVFTo avoid commodification of a child through donor selection, adoption allows those who cannot naturally conceive the ability to have a family. Some would argue that this is not a viable alternative to IVF child production because adoption offers similar commodification of the child. It is true that the current state of adoption in the Unit-ed States involves a screening process that is not unlike IVF treatment - including the ability of the parents to preliminarily choose characteristics of their child (U.S. Department of Health and Human Services, 2010). However, the actual selection of a child is not wholly within the parents’ control. Parents can adopt only from a finite number of children and get to know their child with occasional meetings before they become a family. I would argue that this reduction of control reduces the parental pressure of high expectations and price tag on the child that was previously stated in the Cambridge study. Additionally, there is a moral good associated with adoption. Parents who adopt children are arguably helping the child they foster because the child’s quality of life would be lower without the parents. With non-parental IVF, par-ents create a child that would not have existed without their initiative, and therefore the child’s quality of life is not improved or worsened.

FURTHER CONCLUSIONSOrgan Donation and Commodification: Is it all Bad?A last big question is whether commodification by IVF is truly bad from an ethical perspective. Recently, there has been a large discussion of the moral concerns for creating a market for organ donation in which human body parts would be treated as commodities to be bought and sold. Although society has not yet decided if this mar-ket is ethically viable, the pro-market argument is well-crafted. The most reputable proposal of this proposed market outlined by Charles Erin (2003) and John Harris

Donating Life

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(2003) in The Journal of Medical Ethics states:

The market would be confined to a self-governing geopolitical area such as a na-tion state or indeed the European Union. Only citizens resident within the union or state could sell into the system and they and their families would be equally eligible to receive organs. Thus organ vendors would know they were contributing to a system, which would benefit them and their families and friends since their chances of receiving an organ in case of need would be increased by the existence of the market…There would be only one purchaser, an agency like the National Health Service (NHS), which would buy all organs and distribute according to some fair concep-tion of medical priority. There would be no direct sales or purchases, no exploita-tion of low-income countries and their populations… Prices would have to be high enough to attract people into the marketplace but dialysis, and other alternative care, does not come cheap. Sellers of organs would know they had saved a life and would be reasonably compensated for their risk, time, and altruism, which would be undiminished by sale.

This type of market system for organs seems ethically viable even though it does pro-vide commodification of human body parts because of the genuine need involved in organ donation. As the Journal of Medical ethics stated, “so long as thousands con-tinue to die for want of donor organs we must urgently consider and implement ways of increasing the supply” (Eric & Harris, 2003). Unlike fertility treatments, organ donation enables commodification of human body parts in order to save lives, and there is no other viable alternative until medicine is able to synthesize organs outside of human bodies. Therefore, commodification of human body parts is acceptable in life-saving efforts, but not in IVF treatments, because there are viable alternatives to the genetic production of children, like adoption. •

REFERENCESBBC News. (2008, July 5). Donor Children ‘Emotionally Well’. Retrieved May 1, 2014, from http://newsvote.bbc.co.uk/mpapps/pagetools/print/news.bbc.co.uk/2/hi/health/7489598 .stmCarroll, L. (2012, August 10). The ‘Biological Urge’: What’s the Truth? The Huffington Post.Center for Disease Control and Prevention. (2013, June). Reproductive Health. Retrieved April 30, 2014, from http://www.cdc.gov/reproductivehealth/Infertility/index.htm#kCohen, J. (2002, December 1). Grade A: The Market for a Yale Woman’s Eggs. The Atlantic.Erin, C., & Harris, J. (2003). An Ethical Market in Human Organs. The Journal of Medical Ethics.Golombok, S., Murray, C., Jadva, V., Lycett, E., MacCallum, F., & Rust, J. (2006). Non-ge netic and non-gestational parenthood: consequences for parent–child relationships and the psychological well-being of mothers, fathers and children at age 3. Human Reproduc tion, 21 (7), 1918-1924.U.S. Department of Health and Human Services. (2010). Adoption. Retrieved May 1, 2014, from <https://www.childwelfare.gov/pubs/f_start.cfm>.


The Ethics of Pre-Implantation Genetic Testing

by Jaclyn Estes†

† Jaclyn Estes is a medical student at Weill Cornell Medical College in New York City (class of ‘16). She holds a bachelor’s degree in Biomedical Engineering from Texas A&M University in College Station, TX, and moved to New York City with her husband in 2012 to pursue a medical degree. She can be reached at <[email protected]>.

Human blood with red blood cells, T cells (orange) and platelets (green), Dennis Kunkel (Dennis Kunkel Microscopy Inc.), 2014. Exhibited at the “Life: Magnified” exhibition, a joint project by the National Institute of General Medical Sciences, American Society for Cell Biology, Metropolitan Washington Airport Authority’s Arts Program and ZEISS Microscopy. Thalassemia is a

genetic disorder that causes abnormally formed hemoglobin, which results in red blood cell disorders.


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Pre-implantation genetic testing is performed on early embryos during in vitro fertilization (IVF) and tests either for specific genetic abnormalities or general chromosomal imbalances like aneuploidy. Currently, it is considered acceptable to test for simple Mendelian diseases such as cystic fibrosis or Huntington’s disease for parents who either have the disease or are carriers. Gender selection and HLA matching are considered more controversial and often involve input from ethics counsels, while phenotypic selection and testing for medical conditions in parents with no history of disease are thought to be inappropriate. This article employs a case scenario based on a real-life example to examine how the ethical principles of autonomy, beneficence, non-maleficence, and justice apply to pre-implantation genetic testing.

Mr. and Mrs. Jeffords have two children – Noah, a 9-year-old healthy boy, and Mark, a 6-year-old boy born with beta thalassemia major, a blood dis-ease characterized by impaired production of hemoglobin which leads to

severe anemia. The Jeffords want another child, but after watching Mark go through countless transfusions and painful aplastic crises, they want to use in vitro fertiliza-tion (IVF) and pre-implantation genetic testing to ensure that their next child does not have thalassemia. After reading about a child with beta thalassemia major who was cured using stem cell transplantation from cord blood, the Jeffords also request Human Leukocyte Antigen (HLA) typing. This method for matching proteins on the surface of red blood cells between donor and recipient would allow Mark to receive a one-time, curative stem cell transplant rather than a lifetime of transfusions. During their discussions, the Jeffords also decide that this will be their final child, and that it would be especially nice to have a girl since they already have two boys and have always wanted “a little princess”. While the Jeffords’ story is fictional, there are many parents with sick children who are struggling with the exact same ethical dilemmas. Advances in reproductive technology over the past few decades have launched this hypothetical scenario from science fiction novels into doctors’ clinics. In vitro fertilization is no longer only for couples who have difficulty conceiving; parents now have the ability to prevent dis-ease, choose HLA types to match those of their current children, and even select the gender of their future children. Taking into consideration the perspectives of parents, children, future children, and society, I will use the principles of autonomy, benefi-cence, justice, and respect for persons to argue that all three of the Jeffords’ requests are ethically sound. Of note, there are a number of other selectable traits such as hair color, height, intelligence, etc. that will not be considered in this argument for pur-poses of brevity. Pre-implantation genetic testing includes two basic categories: pre-implantation genetic diagnosis (PGD) and pre-implantation genetic screening (PGS). Both are performed on early embryos during in vitro fertilization and test either for specific genetic abnormalities (PGD) or general chromosomal imbalances like aneuploidy (PGS). From here on in we will focus on pre-implantation genetic diagnosis, which additionally encompasses selection for gender, chromosomal translocations or inver-sions, HLA type, and other phenotypic traits as previously mentioned. Currently, it

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Jaclyn Estes


is considered acceptable practice to test for simple Mendelian diseases such as cys-tic fibrosis, sickle cell disease, Huntington’s disease, and hemophilia for affected or carrier parents. Sex selection and HLA matching are considered more controversial and often require input from ethics counsels, while phenotypic selection and testing for medical conditions in parents without a history of the disease are thought to be inappropriate (Brezina et al. 2012). To determine the ethics of the Jeffords’ first request – using IVF to make sure that their next child does not have beta thalassemia – we should consider the interests of the unborn child. A child born with thalassemia will undergo a degree of suffering that is above and beyond the normal level expected in those without severe blood disorders. Preventing this suffering would uphold the principle of non-maleficence, which requires not imposing intentional harm. The unborn child should be given a chance at the best life possible, and taking the risk of knowingly allowing him or her to be born with a disease that involves considerable pain would violate the princi-ple of beneficence, which requires protecting the welfare of the child. We must also consider beneficence in the context of the parents. Raising another child with beta thalassemia will impact their psychological welfare, as they may experience a greater level of guilt and burden knowing that they are raising a child with a debilitating disease when this child could have been healthy. Certain medical conditions may also require dependence on caretakers for the extent of the child’s life, forcing an additional cost on other members of society after the parents die. Thus, the Jeffords would be placing undue burden on society by choosing to risk having another child with thalassemia. Besides human labor in the form of a caretaker, more resources

Target cells and sphereocytes, Graham Beards, 2012, Wikimedia Commons. Pictured below are human red blood cells showing the “Mexican Hat Cell” or “Target” cell morphology: cells with a dark center surrounded by a white ring. Target cells are associated with alpha- and beta-thalassemia.


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would have to be spent on the child – resources that could be allocated to better un-derstanding the disease process or advancing medical treatment. Furthermore, the principle of autonomy dictates that it is the parents’ decision to choose how they want to conceive their child and what they want to do with the embryos they create, as long as they are not doing so irresponsibly or in a way that would cause harm to the embryos. Another benefit of allowing the parents to opt for pre-implantation genetic testing is that non-implanted embryos with thalassemia could potentially be utilized as stem cell lines and used to research the underlying mechanisms of disease, which could someday positively impact treatment. Although we assume that a child born with thalassemia would endure more suffering than a child who is disease-free, it is impossible to fully understand the perspective of another person or the relative degree of burden placed on them by a disease. Two people with the same diagnosis of cancer, for example, may range from feeling that life is not worth living to thinking of their disease as a minor irritation. Often, a unique perspective is gained by undergoing tribulation in life, and this should not be undervalued. Learning how to deal with the hardships of life can make us stronger and better-equipped to handle adversity. Still, when given the opportunity to start with a blank slate and choose disease or no disease, avoiding harm to the future child is the most important consideration. Another factor of importance to consider is that if the Jeffords decide to select an embryo without thalassemia, Mark may feel that they are implying his life is not worth living. He could have potential psychological damage several years down the road knowing that his parents did not want to have another child with his disease – that something was so wrong with him that his parents underwent testing and extensive hormonal treatment to prevent a similar sibling from being born. In terms

Human Karyotype 46, XY (man), Josef Reischig, 2014. GLAM Initiative, Wikimedia Czech Republic. Taken using bright field microscopy using 4000x magnification (26cm width).

Jaclyn Estes


of society’s standards, if we decide that it is okay to select against diseases like thalas-semia or achondroplasia or Huntington’s, we are implying that a life with that disease would be better left unlived. On the other hand, choosing to roll the dice and gamble on the chance a child may be born with a debilitating disease when preventive mea-sures can be taken violates the principle of justice, since it results in the inequitable distribution of burden to members of a society. The decision to allow the persistence of a disease that causes considerable anguish places undue burden on those who will suffer from it if their disease could have been avoided. Another argument against PGD for disease is that parents who would otherwise choose to not have any more children are creating extra embryos. If the Jeffords did not have IVF with PGD as an option, they may have not wanted to risk having an-other child with thalassemia. However, since IVF with PGD is an option, the Jeffords could undergo the IVF procedure, yielding healthy embryos that could potentially be destroyed if they are not cryopreserved or donated to another couple. At first glance, the creation of potential lives that will never come into existence seems flippant, even insensitive. It conjures images of future societies throwing away test tube babies on finding an “undesirable” hair color or the presence of freckles. On closer inspection, though, embryos are unconscious which means that they inherently have no interests and that their fate is of no consequence to them. Colin Gavaghan points out that “any decision will have an effect upon the embryos; but this is not the same as saying that the embryos have interests bound by the outcomes of those decisions.” (2007) The second request made by the Jeffords – to select an embryo with an HLA type that matches that of their current son – is a bit more controversial than the first request. Beginning with the perspective of the child, Mark, the parents have an obli-

Studies of Embryos, Leonardo da Vinci, 1510-1512. The embryological drawings of a fetus illustrate Da Vinci’s advanced under-standing of human development during the Early Modern Era.


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gation to do everything in their power to take away the pain and suffering associated with his disease. It would violate the principle of justice if the parents had a cure for his disease but withheld the cure from him. Children who have beta thalassemia major often die of complications from iron overload by age 30 (Muncie et al., 2009), so holding back treatment could be considered passive killing. Even with a non-lethal disease, preventing significant distress is consistent with beneficence. One could also consider the alternative – if they don’t select an embryo at the pre-implantation stage, the Jeffords could decide to have a natural birth and continue terminating their pregnancies until they have an HLA match. This would cause significantly greater harm to the mother and to fetuses of a gestational age greater than just a few days. From Mark’s perspective, there is only upside to his parents selecting an embryo that could save his life, but it is also vital to consider the rights of the unborn child who will donate tissue – often called the “savior sibling”. Is it in their best interest to undergo procedures on behalf of a sibling when they do not have the competence to consent? How does one take into consideration the principle of respect for persons in the case of a child that is not yet born? In the case of the Jeffords, the nature of the procedure to donate tissue from their third child to their second – drawing cord blood – is completely non-invasive and has no risk to the donor, so the benefits for the recipient clearly take precedence. One could argue that more invasive procedures such as bone marrow transfers are unethical since there are risks for the infant donor. Still, a severe disease that poses significant burden and risk of potential death for the older sibling takes priority over a painful procedure that the infant will likely not remember, especially since it involves renewable tissue. However, considering the savior sibling as a means to an end could have deleterious effects on the savior sibling’s self-worth. The thought of being created as a source of healthy tissue is bound to have psychological consequences. A plausible counterar-gument is that as the child ages, he or she may draw great satisfaction and pride from being able to save his or her brother’s life. The brother’s disease is a struggle for the family that the savior sibling has the unique ability of alleviating, providing a better life for the whole group. The Jeffords’ final request – to select the gender of their child for family planning purposes – is easily the most contentious of the three. Sex selection was initially con-sidered as a part of PGD in order to prevent X-linked diseases that are only found in one gender. However, gender has now become a trait parents select because they either have a preference for one gender, or they want to create a more “balanced” family dynamic (e.g., some parents believe having a baby girl will help their current sons become more compassionate). Following the principle of autonomy discussed above, the parents should have the right to choose the gender of their future child. John Robertson (2003) argues that parents have a “reproductive liberty” regarding their decisions surrounding conception, and that liberty is of ultimate importance since the control of reproduction is intricately tied in with personal identity, digni-

It would violate the principle of justice if the parents had a cure for his disease but withheld the cure from him.

Jaclyn Estes


ty, and life’s meaning. Specifically, he claims that the “strongest case for parents is if they persuasively asserted that they would not re-produce unless they could select [a certain] trait.” Indeed, the Jeffords could choose to terminate each pregnancy until they had a girl – a process that would place unnecessary hardship on the mother and potential fetuses. However, simply because parents can termi-nate a pregnancy on the basis of gender does not automatically imply that they should be able to do so. There are several strong arguments against gender selection. The first consideration is the possible increased divide between the upper and lower classes of society. IVF and PGD are expensive procedures that are not always reimbursed by insurance companies. Thus, while wealthy families could create “custom-made” children, impoverished fami-lies would have no such luxury. However, this disparity is not limited to gender selection - IVF used to select against disease is also not typically reimbursed and could lead to the same class inequality. Still, one could argue that reduced disease prevalence is beneficial to society as a whole, whereas selection of

gender on a case-by-case basis does not serve a greater purpose. The second argument is that selecting a child’s gender could be considered sex dis-crimination and could reinforce harmful stereotypes (Bayles, 1984). The preference for one gender may imply that it is superior to the other or may set expectations that restrict the child’s growth. For instance, if the Jeffords do select a female and expect her to be their “princess”, she may feel inadequate or that she is not living up to her parents’ expectations if she ends up liking hunting and monster trucks. However, this could be the case for any family that has certain assumptions based on their child’s gender, and is not restricted to those children born through PGD. Parents’ selection of one gender also implies that the other is somehow less desirable and may make current children feel a sense of failure or disappointment. A third case against sex selection is that it will lead to demographic changes that could alter large-scale societal or economic trends. For instance, if everyone in China who utilized PGD decided to have a son, the gender distribution would be skewed and potentially unsustainable. On the other hand, decisions regarding PGD will not cause rapid changes – these changes would occur over many decades as parents’ choices dictate trends. Thus, the effects of gender selection will become apparent be-fore massive shifts occur and can be dealt with at that time if viewed as problematic. Ultimately, there is no outright or immediate harm done to a child whose sex was

Portraits of Patients from Surrey County Asylum, Hugh Welch Diamond, 1855. National Media Museum, Bradford, UK.

Dr. Diamond was a physician at the Surrey County Asylum, who was the first to systemically use the pseudoscience of

physiognomy to treat mental illness. Physiognomy believed that the face was the mirror into the soul, and Dr. Diamond

proposed that the study of the face could be used to treat and diagnose mental illness (The Public Domain Review).


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selected for him or her – in fact, the parents may be more in-volved in the child’s life if their child is the gender they select-ed, which could lead to happier lives for both the parents and child. It is within the parents’ reproductive liberty and au-tonomy to select the gender of their child. In this hypothetical case, it is in the best interest of the un-born baby, the current children, the parents, and society for the Jeffords to select an embryo that does not have thalassemia and that is Mark’s HLA match. Additionally, the parents have the autonomy to select the gender of their unborn child, though larger demographic and economic trends should be carefully moni-tored if this practice becomes more common in the future. It is tempting to swing to the other extreme on the issue of pre-implantation genetic testing and wonder how far we can go and what traits we can select. If preventing thalassemia is ethi-cal – what about selecting against diabetes, heart disease, or acne? Should selecting for HLA type in order to do a stem cell transfer from cord blood also apply to other procedures like organ donation? Does selecting for gender imply that it is okay to select for eye color, intelligence, or personality? Each of these questions has its own set of unique ethical considerations that are separate from the ones discussed here, but should all be viewed under the lenses of autonomy, beneficence, non-maleficence and justice for all affected parties. • REFERENCESBayles, M. (1984). Reproductive Ethics. New Jersey: Prentice-Hall, p. 36.Brezina, P.R., Brezina, D.S., Kearns, W.G. (2012). Preimplantation genetic testing. BMJ 345:e5908. doi:10.1136/bmj.e5908 Gavaghan, C. (2007). Defending the Genetic Supermarket: Law and ethics of selecting the next generation. New York: Routledge-CavendishMuncie, H.L. & Campbell, J.S. (2009). Alpha and Beta Thalassemia. Am. Fam. Physician. Aug 15; 80(4):339-44. http://www.aafp.org/afp/2009/0815/p339.html Robertson, J.A. (2003). Extending preimplantation genetic diagnosis: medical and non-med ical uses. Comment in: Journal of Medical Ethics 29(4):213-16.

Intracytoplasmic Sperm Injection, Maurisio De Angelis. Intracytoplasmic is a method of in vitro fertilization, done when the male has low sperm count or when sperm motility is low. It involves directly injecting male sperm into the oocyte [egg cell].


† Sarah Pfaff is a Plant Biotechnology undergraduate student at the School of Environmental and Biological Sciences at Rutgers, the State University of New Jersey in New Brunswick, NJ. She currently conducts research on bioremediation and the use of duckweed, an aquatic plant, to clean wastewater in countries where there are few modern wastewater treatment facilities, focusing on Argentina. She can be reached at <[email protected]>.

“Frankenfood” RedefinedThe Necessity of Dispelling Myths About

Genetically Modified Cropsby Sarah Pfaff†

Plate 72, Muscinae, Ernst Haeckel, 1904. In Kunstformen der Natur.

“Frankenfood” Redefined

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What thoughts come to mind when something is said to have been “geneti-cally engineered”? Perhaps it’s scientists in white lab coats mixing chem-icals and examining petri dishes to produce something ‘unnatural’. The

idea of these scientists tucked away in laboratories to experiment with our most staple crop plants, including soybeans, potatoes, and corn, brings anxiety to many. What are they doing? Is it necessary? What are the risks? For more than 20 years, research has been conducted to determine the potentials of genetically modified (GM) crops that can tolerate drought stress, require fewer pesticides, and produce higher yields. Yet misunderstanding of this research and its findings is rampant, leading to significant backlash from the public. In the case of GM crops, the prevalent misinformation about their creation, safety, and immense potential benefits causes unfounded distrust and concern, which can only be com-bated through rebuilding trust and renaming this technology to erase current stigma.

THE SCIENCE BEHIND THE CREATION OF GM CROPSWhen plant breeding began during the First Agricultural Revolution (in 10,000 B.C.), humans initiated intervening with nature by intentionally transferring DNA from one organism to another. The purpose behind these first efforts was to combine desir-able traits into one plant, such as drought tolerance or large kernel size. This new va-riety can then be propagated as a crop. Early humans began “breeding plants through deliberate cross-pollination…mov[ing] and select[ing] genes to enhance the benefi-cial qualities of plants through cross-breeding, without knowing the traits for which the genes coded” (Food Technology, 2000). Because this method is more random than specific, many crosses did not turn out as hoped. But when the crosses showed bene-ficial results, these hybrids would eventually be crossed again with other plants that also had desirable mutations. The accumulation of changes, derived from hundreds of years of individual, intentional cross-pollinations, give us the breeds that are now standard in agriculture. Had this process not been undertaken, there would be very few crops fit for human consumption today. In essence, “We have been tinkering with our food’s DNA since the dawn of agriculture. By selectively breeding plants and animals with the most desirable traits, our predecessors transformed organisms’ genomes, turning scraggly grass into plum-kernelled corn” (Food Technology, 2000). Techniques have advanced greatly since the birth of crop breeding so that our modern methods are much more precise, accurate, and predictable than those first developed. Today, conventional or “naturalized” breeding employs a technique called Marker-Assisted Selection to determine which plant genomes contain the genes that code for a desired trait, such as disease resistance. Rather than examining the phys-ical expression of a trait (the phenotype), Marker-Assisted Selection can be used to quickly pinpoint the desired genes so that breeders know which plants to cross (Cline, 2011). Yet this process can still take many years to complete, as successive generations of crosses are required to ‘weed out’ all of the undesirable traits while maintaining the preferred ones. A more effective method is known as recombinant DNA (rDNA), which isolates and extracts the exact genes required for a trait and splices them into the genome of the plant that will be propagated. In the realm of plant breeding,

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“rDNA technology is the most promising, precise and advanced strategy available today” because it can be used to insert advantageous genes from any living organism into a crop species in order to express desirable traits (Food Technology, 2000). Yet, there are many who are justifiably afraid of the potential side effects of crossing genes between unrelated species. Recombinant DNA is the future of plant breeding because it pinpoints genes that code for desired traits and inserts them precisely and efficiently, but many distrust the safety of this technology. Those who oppose it voice concerns about potentially negative consequences of intervening and allowing foreign genes to interact with one another. rDNA has been described as “completely unnatural and severely disruptive” (Cline, 2011). Dissenters cite scientists who agree that altering natural biochemical pathways within a plant “may affect or interfere with the plant’s own metabolism…by creating an unintended novel protein, or altering or interfering with the production of an existing plant protein,” which in turn would increase the likelihood of unex-pected effects (Greenpeace International 2013). For this reason, many skeptics do not advocate the use of rDNA technology and genetic modification. Yet the National Research Council asserts that “genetic engineering creates DNA that is fundamental-ly the same as that found in nature” (qtd. Amand 2004). Because of the commonality of genetic material between all living organisms, the DNA that is created by inserting genes from one species into another’s DNA will create a recombinant DNA that is exactly like that which came from each donor. Tying two shoelaces together creates one longer shoelace, just as splicing together DNA sequences results in a new strand of DNA, not something entirely novel. The public’s lack of knowledge of genetics and the science behind the experimentation leads to misconceptions and ungrounded fears. Dissenters should note the precision and extensive safety measures employed by scientists working in laboratories creating recombinant DNA. K. V. Prabhu, head scientist of the Indian Agricultural Research Institute, sheds light on this process. “When rDNA is produced, it is within the confines of a highly specialized laboratory

Sennedjem and Ti Harvesting Papyrus, Unknown Egyptian Tomb Artist, Ramesside Period (13th–11th Century BCE). Found in the Tomb of Sennutem, a official, in the village of Deir el-Medina, Egypt. Photographer: Oxford Encyclopedia of Ancient Egypt.


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with skilled scientists and people handling the product who are generally trained to deal with the positive output as well as the negative ones and the unperceived con-sequences, which comprise the major amount of risk involved” (Prabhu 2009). If in fact a biochemical pathway is altered in a way that will not be beneficial for human health upon consumption, there is no way that it will even make it outside of the walls of the laboratory, let alone onto someone’s dinner plate. Hundreds of repetitions of the rDNA experiments are run in order to ensure that the altered pathway is truly harmless to the other functions of the plant and beneficial in the anticipated ways. Years are spent in the process of creating genetically modified crops to ensure their safety upon release. Many who have misgivings about GM crops do not understand the painstaking work and peer-review that have been invested, causing them to be skeptical about the safety of these crops.

SAFETY OF GM CROPS FOR HUMAN CONSUMPTIONThe most prominent misconception about GM crops is that they are unsafe for hu-man consumption and will cause negative health effects. A few studies have been conducted and allegedly show that GM crops cause negative health effects in rats which consumed them. Dissenters, such as Greenpeace, cite these studies to argue against the implementation of GM crops. Without confirming the source and the specifics of the studies, many blindly accept these arguments. Yet the European Acad-emies Science Advisory Council asserts that “statements about the adverse impacts of GM crops have too often been based on contested science” (EASAC Policy Re-port, 2013). Adding to this dismissal of inaccurate scientific claims are a multitude of research projects that together conclude and proclaim the safety of GM crops. At the conclusion of a decade of EU-funded genetically modified organism (GMO) research, the European Union declared that “The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research, and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conven-tional plant breeding technologies” (Economidis et al,. 2010). If it was understood that the studies claiming negative health effects from GM food consumption are few in number, and these studies were conducted in a manner that has caused their re-sults to be questioned by reputable scientists, there would be much less concern over the safety of GM foods. For more than a decade GM crops have been used to make foods consumed by people all around the world. An unrealized reality is the ubiquity of GM foods today, as many would be astonished to hear that about “70 percent of processed foods in the

DNA Extraction II, Patrick Alexander, 2010. Flickr. DNA extraction of ground plant material in a cetyltrimethylammonium bromide buffer. Done in the Kathleen Pryer laboratory, Department of Biology, Duke University in Durham, NC.

Sarah Pfaff


U.S. contain genetically modified ingredients” (Food Technology 2000). Those who oppose the implementation of GM foods on the grounds of potential negative health effects are often unaware that they are already consuming GM foods in large quan-tities without experiencing negative effects. The World Health Organization (WHO) has said that “No effects on human health have been shown as a result of the con-sumption of such foods by the general population in the countries where they have been approved” (WHO 2013). In addition to WHO certifying the safety of GM crops, both the FDA and the USDA examine, test, and approve them. The ways in which GMOs may affect human health is not a hypothetical debate, but rather a tested real-ity that proves them safe to eat.

IMMENSE POTENTIAL BENEFITS OF GM CROPSUnfortunately, the general public is largely uninformed of the repetitious trials and extensive peer-review process and is often unaware of the vast amount of evidence supporting the safety of consuming GMOs. In addition, there is a lack of under-standing of the numerous potential benefits that GM crops hold worldwide. Today, “meeting the demand of a rapidly growing population, reducing the widening social and economic disparities both within and among countries, and at the same time safeguarding…the environment—all represent tremendous challenges... Genetically modified crops have the potential to contribute to solving these challenges” (Skinner et al. 2004). The world’s population is skyrocketing exponentially without any in-crease in available cropland. There are millions starving today because crops do not

Anther of the Thale Cress (Arabidopsis thaliana), Heiti Paves, 2010. Wikimedia Commons. The mustard green A. thaliana is a commonly used model organism in plant biology research. Plasmid DNA is easily incorporated into A. thaliana through the “floral dip” protocol: where flowers are simply dipped into a solution of plasmid, Argobacterium tumefaciens and detergent. See Clough, S.J. & Bent, A.F. (2008). Plant J. 16: 735–743.


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produce enough to sustain those who cultivate them. Biotechnology holds the key to unlocking the potential of our crops to produce the required increase in yield. In many developing countries, not only is food availability a concern, but also the con-sumption of necessary vitamins in adequate quantities. Lack of vitamin A “causes blindness in a quarter-million to a half-million children each year” (Harmon, 2013). The daily requirement of vitamin A comes from fruits and vegetables that are often unavailable to poor families in Third World countries. To com-bat this problem, organizations such as Greenpeace advocate encouraging families to eat a more diverse diet by “in-crease[ing] access to vitamin-rich vegetables” (Greenpeace International, 2013). Just as the option of redistributing food surpluses in order to combat world hunger is not realistic, Greenpeace’s plan will never be executed with the desired effects. Vegetables are much more expensive than rice, and thus, many poor families cannot afford to buy them. Scientists foresaw this problem and the need for an efficient means of providing people with required daily vitamins, and they turned to biotechnology to produce an effective solution. To assess a specific example of a GM crop’s potentially immense benefits, one should consider Golden Rice. After being developed and tested for over 20 years, Golden Rice has been successfully engineered to produce beta-carotene (β-carotene), which is the precursor to vitamin A. Once in the body, biochemical pathways convert β-carotene into vitamin A that can then be used to support normal bodily functions and prevent illness and blindness. After years of research and countless trial strains, a bowlful of Golden Rice will provide an outstanding 60% of the daily requirement of vitamin A for healthy children (Harmon, 2013). If grown in Third World countries, the cost would be no greater than that of traditional white rice, and the dissemination of this crop to the poor, hungry, and malnourished could drastically improve their quality of life. But field trials of the crop are repeatedly torn up by protesters who are unaware of how this rice could save their lives and the lives of their children. Because people are not presented with accurate and accessible information about these crops, they automatically distrust them and act out of this misunderstanding. The only way to reverse this paradigm is to present understandable and objective facts about GM crop’s immense potential benefits to allow the public to make their own educated decisions about whether to trust them or not.

NECESSITY OF A CAMPAIGN TO EDUCATE AND BUILD TRUSTThe plethora of data that supports the safety and necessity of genetically modified crops renders many of these concerns obsolete. The predicament that remains is that people are not presented with the facts in easily understood ways. In many cases, if one really desires to know the truth about a subject, personal research is necessary. Reliance on the media or word of mouth will rarely provide the entire truth. In one

If it was understood that the studies claiming negative health effects from GM food consumption are few in num-ber, and these studies were conduct-ed in a manner that has caused their results to be questioned by reputable scientists, there would be much less con-cern over the safety of GM foods.

Sarah Pfaff


remarkable case, British environmentalist Mark Lynas took part in destroying fields of GM test crops and was a prominent leader in the campaign against their imple-mentation until he took an effort to familiarize himself with the facts. When he ob-jectively assessed the empirical data, he had an “epiphany” and concluded that “his beliefs about biotechnology turned out to be little more than ‘green urban myths’” (Cornett, 2013). This change of heart was only achieved through his efforts to edu-cate himself with the facts about the technology that he instinctively opposed. But Lynas is a scientist, and is thus predisposed to seek out the research. He is also bet-ter equipped to understand the language and draw conclusions from the empirical data and research reports that were crucial in reversing his opinion. Not everyone is equipped with the ability to understand scientists and their jargon, nor do they have access to such information or the desire to seek it out. For the layperson, the means to understand biotechnology and the safety of GM crops is inaccessible.

One effective method that has been used and proven to reap some benefit is to present a community with field trials so that skeptics can come and see the benefits, the potential, and the safety of GM crops. Because “seeing is believing,” making the concept tangible for the public builds trust and thus gains support, which is crucial for eradicating misunderstanding. If you let the evidence speak for itself rather than having it muddled and complicated by the trickle-down from scientist to journalists to the public, a greater sense of trust is achieved. Communities in sub-Saharan Africa were invited to workshops and on ‘farm walks’ to be shown firsthand the compari-son between conventional and GM crops in the field (Ezezika, 2013). The farmers were given bags of seeds to plant themselves. Politicians and media representatives held and tasted the fruit of the crops, envisioning what could be if these crops were implemented across the country. Because of the tangibility of the research and the

A Very Busy Farmer, Jean Marc CÔté, 1899-1910. The Public Domain Review. In France in the XXI (21st) Century, a series of post-cards produced for the 1900 World Exhibition, depicting life in Paris the year 2000. While many of the other postcards were inaccurate (see divers riding on large seahorses or the “aerial police” stopping plane pilots for speeding), the postcards depicting farming are eerily accurate.


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transparency of the researchers, participants and community members experienced a greater trust of the crops and began to grow them.

On the other hand, for city-dwelling consumers who are detached from an ag-ricultural lifestyle, a different approach must be taken in order to demonstrate the safety and necessity of GM foods. A massive educational campaign including pub-lic hearings, online courses, and endorsement from prominent, trusted individuals proclaiming the necessity and safety of genetically adapted crops must be un-dertaken. Through such multifaceted methods, researchers and proponents will be able to go to the public with the truth about the safety and bene-fits of GM crops, rather than allowing them to draw conclusions on their own. Transparent, unbiased risk assessment will be key in communicating to the public why there is no reason to fear or distrust scientists and their work with genetic adaptation of plants. Not only should the potential negative impacts be focused on, but “a complete understanding of the risks must also include the benefits that accompany those risks” (Amand, 2004). Be-cause so many concerns have been voiced from early on, stringent regulations and testing procedures have been put in place. The public’s dissention and mistrust has been healthy for a time, yet it has come to a point where rather than encouraging scientists to perform rigorous tests to be assured of GM crops safety, this dissention has gotten out of hand by frightening the uneducated with ungrounded ‘facts’ and wildly inaccurate claims. The subsequent suppression of life-saving, vital research is becoming ironically unhealthy and must be halted.

Transgenic plants are “already too advanced and present in our lives in the shape of food for the adventure to stop here, in simple indifference and misunderstanding” (Tourte, 2003). If genetically adapted crops are banished to oblivion because of mis-understanding, there will be no time to develop and implement an alternate solution to the world food crisis. Because the “use of genetically modified plants in the pro-duction of foods continues to grow… [as] ‘an estimated two-thirds of the processed foods in U.S. supermarkets contain genetically engineered corn, soybeans or other crops,’” it is obvious that “with this kind of impact on the food industry, it is likely that GM plant products will be part of food production from now on” (Amand, 2004). There is no going back to a time when genetically adapted crops were not part of our lives. The only direction to which we can turn is the future and what it holds for the fate of genetically adapted crops.

Genetically modified crops are too vital and imminent to wait for everyone every individual to do their own research and individually accept their safety and necessity. As previously stated, the anxiety previously created which impedes implementation of GM crops must be reversed by an educational campaign to build trust. If ignored, these fears will fester to a point that a public reversal of opinion may be impossible. If the situation of food deficits is ignored, our population will continue to grow ex-ponentially without an increase in crop yield, resulting in a decrease in standard of

Not everyone is equipped with the ability to understand scientists and their jargon, nor do they have access to such information or the desire to seek it out. For the lay-person, the means to understand biotechnology and the safety of GM crops is inaccessible.

Sarah Pfaff


living for all on the planet. Our future as citizens of this world depends on our trust and acceptance of genetically engineered crops, and only when misconceptions are overturned and fears calmed will we be able to move forward towards a future of sustainability and embrace all the benefits that GM crops will provide. •

REFERENCESSt. Amand, P. (2004). Chapter 14. Risks Associated with Genetically Engineered Crops. In G. H. Liang

& D. Z. Skinner (Eds.), Genetically Modified Crops: Their Development, Uses, and Risks (351-359). Binghamton, NY: Food Products Press.

Cline, H. (2011). Anti-Biotech Crowd Convinced GMO Food is Road to Extinction. Western Farm Press, 33(22): 4.

Cornett, R. (2013). Environmentalist has a Change of Heart about Biotechnology. Western Farm Press, 35(4):12-13.

Economidis, I., Danuta, C., & Högel, J. (2010). A Decade of EU-Funded GMO Research (2001 - 2010). Belgium: Publications Office of the European Union.

EASAC. (2013). Planting the Future: Opportunities and Challenges for using Crop Genetic Improve-ment Technologies for Sustainable Agriculture. European Academies Science Advisory Council Policy Report 21. Brussels, Belgium.

Ezezika, O.C. (2013). Building Effective Agbiotech Partnerships Founded on Trust: A Summary of the Challenges and Practices in Sub-Saharan Africa. Agriculture & Food Security, 1(1) .

Genetically Modified Organisms (GMOs). (2000). Food Technology, 54(1): 42-45. Greenpeace International. (2013). Golden Illusion - the Broken Promises of GE ‘Golden’ Rice. Harmon, A. (2013). Golden Rice: Lifesaver? New York Times.Prabhu, K. V. (2009). Chapter 4: Use of GMOs Under Containment, Confined and Limited Field Trials

and Post-Release Monitoring of GMOs. In Biosafety of Genetically Modified Organisms: Basic Con-cepts, Methods and Issues (157-220). Rome, Italy: Food and Agriculture Organization of the United Nations.

Skinner, D.Z., Muthukrishnan, S., & Liang, G.H. (2004). Chapter 1. Transformation: A Powerful Tool for Crop Improvement. In G. H. Liang and D. Z. Skinner (Eds.) Genetically Modified Crops: Their Devel-opment, Uses, and Risks (1-13). Binghamton, NY: Food Products Press. Tourte, Y. (2003). Genetically Modified Organisms: Transgenesis in Plants. Enfield, NH: Science Publishers.

World Health Organization. (2013). Questions on Genetically Modified (GM) Foods.

Tanzanian Boy Transporting Fodder on his Bicycle to Feed his Family Cattle, Muhammad Mahdi Karim, 2009.

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Essay

Case AnalysisCare of an Unresponsive Patient with a Poor Prognosisby Austin R. Wetmore†

Health care surrogacy used for patients receiving end-of-life care and medical care for homeless persons are two instances that present complex ethical issues to clinicians. This paper analyzes a case vignette that integrates both of these topics. End-of-life medical decision-making respon-sibilities for a homeless man are granted to his legal next of kin, whose substituted judgment is questionable. Ethical values pertaining to the case vignette are analyzed and an ethically ac-ceptable solution of replacing the legal next of kin with a more suitable surrogate is constructed and defended.

† Austin R. Wetmore is a Master of Biological Sciences student at the University of Minne-sota-Twin Cities in Minneapolis, MN (class of ‘16). He previously received a Bachelor of Arts in Chemistry and Biomedical Studies from St. Olaf College in Northfield, MN, in 2012. He is also a research scientist at Innovative Surface Technologies, Inc., a medical device surface chemistry and biomaterials firm in St. Paul, MN. He can be contacted at <[email protected]>.

A case vignette is presented below, which is taken from the interactive feature article “Care of an Unresponsive Patient with a Poor Prognosis,” by Arthur S. Slutsky and Leonard D. Hudson, in the Clinical Decisions section of the New England Journal of Medicine (Vol. 360, Issue 5, January 29, 2009). Following is my analysis of this case vignette from a clinical ethics perspective.

CASE VIGNETTE

A 56-year-old homeless man was found having a seizure and was transported to the hospital. He was found to have a subarachnoid hemorrhage and acute hydrocephalus. He underwent intubation, and mechanical ventilation was

started. A shunt was placed to relieve the hydrocephalus; cerebral angiography re-vealed a ruptured aneurysm of the anterior communicating cerebral artery and an unruptured aneurysm of the posterior cerebral artery. The patient had a score of 5 on the Glasgow Coma Scale. The neurosurgeon stated that without clipping of the aneu-rysm there was a 50% chance of recurrence of bleeding in the next 6 months, should the patient survive. However, the aneurysm was in a location that would be difficult to reach surgically, and the risk associated with the procedure would be high. The patient’s condition did not improve over the next 3 days, and both the neurol-

Austin R. Wetmore


ogist and the neurosurgeon opined that he had a chance of approximately 80 to 90% of being in a long-term persistent vegetative state and a chance of 5 to 10% of any recovery. His prognosis, at best, was to have a severe disability that would leave him dependent on care by others. The patient had not been in contact with his family for several years. He had a son who, under the law of the state, was the legal next of kin for making medical deci-sions if the patient was unable to do so himself. The patient also had a brother and a mother; all three relatives lived 1500 miles away. They were contacted and told of the patient’s situation. They were all in agreement that the patient would not want to live in a state in which he would be largely dependent on others for daily care and would have severely impaired cognition. However, the son described the patient as “a fighter” who would want aggressive care until the prognosis was much more certain.Supportive care, including mechanical ventilation, was continued for the next 3 weeks, without any clinically significant change in the patient’s neurologic state. During this time, it was discovered that the patient had a very close relationship with a counselor at a homeless shelter with whom he had talked at least every couple of weeks. The counselor came to see the patient and related that the patient had told him that he wished to avoid hospitals and that “when his time came” he wanted no aggressive medical care. Placement of a percutaneous endogastric tube for feeding was attempted but was unsuccessful. Upper endoscopy was performed and revealed a large duodenal ul-cer with fungating edges, strongly suggestive of cancer, and partially obstructing the gastric outlet. Biopsy results were inconclusive, but the endoscopist believed that the lesion was probably malignant and that the indeterminate biopsy results were due to

The Interrupted Pilgrimage, Ferdinand Georg Waldmüller, 1858. On display at the Leopold Museum, Wien (LM 481). Photog-rapher: Google Cultural Institute.

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sampling error. Given the lack of improvement in the patient’s neurologic state, the extremely poor prognosis for any meaningful recovery of cognitive function, and the high proba-bility of cancer, the care team strongly believed that all aggressive and supportive measures should be discontinued and the goals of care changed to those of providing comfort. The brother and mother, who had been quick to respond to queries from the beginning, agreed with the shift to comfort care. However, the son, who had become increasingly difficult to contact and rarely returned telephone calls from the caregiv-ers, disagreed. He had hardened his position, wanting full aggressive-care measures to be taken, including clipping of the aneurysm.

CASE ANALYSISOne of the most difficult ethical challenges in clinical medicine is presented in this case (Shalowitz, Garrett-Mayer, & Wendler, 2006). Should the care team discontinue all aggressive and life-sustaining measures, and instead provide comfort care to this incompetent patient? To answer this question, we must consider the unique context of this end-of-life case: the patient is a homeless person. This plays an important role in analyzing the relevancy of the patient’s legal surrogate deci-sion-maker, his son, whose position on proceed-ing with aggressive treatment is in sharp contrast to the positions of the medical team, other family members, and his own initial judgments of the patient’s preferences. To analyze this case, I first identify engaged parties involved in the decision and relevant val-ues that we ought to consider. Subsequently, I sug-gest what ought to be done for the patient from my perspective, incorporating evaluations of sim-ilar precedents.

ENGAGED PARTIES: POSITIONS AND AUTHORITYFor the case presented in the vignette, the main party that we must consider is the patient. Since the clinical decision has the highest implications for the patient, he must be granted the highest lev-el of decision-making authority (Jonsen, Siegler, & Winslade, 2006). However, the patient’s decision-making capacity is diminished as a result of his current neurologic state and this prevents him from expressing his desires for the course of medical treatment. Although the patient verbally expressed his desire to avoid hospitals and not receive aggressive care when his time comes, in the absence of a written advance directive or living will, the implementation of the patient’s instructions as a form of self-initiating consent is not plausible. Therefore, the decision-making authority of other parties involved must be analyzed to communicate his preference. These in-clude the patient’s family members and their relative authorities as dictated by state

Polish-Soviet War, the Anointing of the Sick, Unknown, 1919-1920. Narodowe Archiwum Cyfrowe, Sygnatura 1-H-394. Above, a Polish military chaplain blesses the ill.

Austin R. Wetmore


statutes, and the counselor with whom the patient had a very close relationship.The son is the patient’s legal next of kin and this authorizes him to communicate

the patient’s supposed preferences for the course of treatment. Although the son ini-tially agrees with the patient’s mother and brother that the patient would not want to live in a state of severe cognitive impairment which he is highly dependent on others for daily self-care, he later claims that the patient would rather seek aggressive care in hopes of improving his chance for survival. Contrary to the son’s judgment of the patient’s wishes, the mother and brother of the patient posit that, given the current prognosis, the patient would wish to seek hospice care and avoid further aggressive care. However, they do not hold legal authority to the extent that the patient’s son does.

The counselor at a homeless shelter with whom the patient had a very close re-lationship holds less authority in decision-making than each of the patient’s family members according to the state law. However, this counselor has had the most recent contact with the patient out of all of the parties. He informs the medical team with a recent verbal description of the patient’s preferences for treatment when “his time comes.”

RELEVANT VALUESCentral to this case is the respect for the patient’s autonomy: this is a central value to present-day American society and culture (Miles & August, 1990). Furthermore, Phillips (2012) identifies autonomy as one of three major psychological needs of per-sons and defines it as the ability “for an individual to control [his or her] circum-

Oral Statement by the American Navy Admiral, Unknown, 1854. Library of Congress, call no. LC-USZC4-10708. A Japanese print showing three men, believed to be Cmdr. Anan, Matthew Perry and Henry Adams, who “opened up” Japan to the West. The text being read maybe Pres. Millard Filmore’s letter to the Emperor of Japan. This action marked the beginning of western imperialism within the Far and South East, and challenged the autonomy of many states within Asia.

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stances” (p. 34). Since the patient in this case lacks decision-making capacity, it is an ethical obligation to extend his autonomy onto another individual who can make decisions on behalf of the patient as the patient would have if he held the capacity to do so (American Medical Association, 2011). The most effective and generally ac-cepted method of achieving this is for a sur-rogate to implement the substituted judg-ment standard. The substituted judgment standard guides decision-making based on what the patient would decide if he still held the capacity for decision-making (Shalow-itz et al., 2006). The values of beneficence and nonmaleficence are incorporated into the substituted judgment standard and call for promoting benefit and avoiding harm, respectively.

EVALUATION AND SOLUTION IMPLEMENTATIONSeveral states hold statutes that legally appoint a surrogate decision-maker based on his or her relationship to the patient. In order of decreasing authority, this relational hierarchy generally goes as follows: spouse, adult children, parents, siblings, other relatives, and close friends (Ap-pelbaum, 2007). This hierarchy is based on the idea that an individual’s “family” encompasses the persons who are most familiar with the individual’s lifelong goals and values (Pope, 2010). However, this notion of familial responsibility should not be applied to this case since the patient has not been in contact with his family for several years. Dr. John Song notes that surrogate decision-making for homeless persons is complicated because homeless persons are often isolated from family members and lack social support (Song, 2002; Kushel & Miaskowski, 2006). It is evident that this holds true for the patient in this case. He is in critical condition undergoing life-sustaining treatment, but none of his family members made any attempt to come see him in the hospital before he passes. Rather, they communicate with physicians via telephone. The son is the least interactive of the family members in the course of treatment and, as the patient’s surrogate, he serves as an injustice to the patient. He cannot empathize with the patient as a homeless person, nor can he accurately express the patient’s current interests and values since he had been removed from the patient’s life for several years. Adhering to the substituted judgment standard means that the son, as the patient’s surro-gate, must directly base the patient’s judgment of the decision on previously expressed prefer-ences and values (American Medical Association, 2011). He fails to do this since his demand for aggressive care disregards the patient’s stated preferences for avoiding this, which was expressed through recent verbal conversation with the homeless shelter counselor. Thus, the son is acting out of the scope of his authority as the patient’s surrogate decision-maker and we must look to other individuals who are more suitable for serving the role (Pope, 2010). In order to implement an ethically acceptable solution, it is important to analyze the context of the patient as a homeless person. Homeless persons are the most disadvantaged individuals from the financial and social aspects of life. They are faced with obstacles in meeting the most basic needs of daily living such as having food and finding shelter (Kushel & Miaskowski, 2006). Additionally, many homeless individuals maintain poor health and are burdened with disease, leading to further complications (Song, Wall, Ratner, Bartels, Ulvestad, & Gelberg, 2008). It is plausible that the patient in this case expresses his desire to avoid hospitals as a re-sult of previous poor experiences with hospitals and medical professionals. This is a common perspective among homeless individuals, since they are isolated from the health care system

The counselor at a homeless shelter with whom the patient had a very close relationship holds less authority in deci-sion-making than each of the patient’s family members ac-cording to the state law.

Austin R. Wetmore


for most of their lives (Collier, 2011). The unique and complex challenges faced by homeless persons imply that we must give special consideration to the condition of homelessness and to this patient as a homeless per-son in order to promote justice for him. It is difficult to understand homelessness and the spe-cial needs and struggles of homeless persons without actually having experienced homeless-ness (Song, 2002). The patient’s son had not undergone this experience and it is not evident from the case vignette that he has an understanding of the unique circumstances associated with homelessness. Therefore, in this case, I recommend appointing a replacement surrogate for the patient. The most suitable replacement surrogate is the homeless shelter counselor with whom the patient had a close relationship and continual communication. The counselor had been in recent contact with the patient and likely has a similar understanding of homelessness. Compared to the other parties involved in the decision, the counselor has the best ability to implement the substituted judgment standard on the patient’s behalf and should replace the son as the patient’s surrogate decision-maker. This designation is supported by the Ameri-can Medical Association’s Report of the Council on Ethical and Judicial Affairs on Surrogate Decision-making (2001), since the report extends the notion of “family” to anyone who is closely associated with the patient. Additionally, Song (2002) suggests that in the absence of an appropriate family member, a surrogate who has an understanding of homelessness and interacts with homeless persons on a regular basis should be sought after. Since a contextually knowledgeable surrogate has been identified, the care team or appoint-

ed ethics committee should notify the patient’s son that he is acting out of the scope of his surrogate obligations on the basis of not adhering to the substi-tuted judgment standard (Pope, 2010). They should inform him that there is a homeless shelter counselor involved in

the decision with whom his father has a close relationship and who holds the contextual knowledge for giving an accurate substituted judgment for his father’s decision. It has been documented in literature that informal resolutions similar to this one are very successful, but if the son challenges the decision, the case can be taken to an appellate court to resolve the surrogacy dispute and appoint a suitable surrogate decision-maker for the patient (Pope, 2010).

Homeless Bed (Street Art in Paris), Unknown, 2013. Photographer: Paul Prescott, Paris by Cell Phone.

…We must give special consideration to the condition of homelessness and to this patient as a homeless person in order to promote justice

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CONCLUSIONEnd-of-life care for incompetent patients who lack decision-making skills and need a surrogate decision-maker presents several ethical issues. It is an ethical obligation of the surrogate that he or she communicates the patient’s preferences and values without having his or her own preferences and values influence the decision. The case presented in the vignette has an additional layer of complexity since the patient is a homeless person. Homeless individuals face unique challenges, and surrogates for these individuals should have an accurate understanding of their lifestyle. In the case vignette, it is determined that the patient’s legal next of kin violates ethical obligations as the patient’s surrogate decision-maker and should be replaced by the homeless shelter counselor with whom the patient had a close relationship. • REFERENCESAmerican Medical Association. (2011). Opinion 8.081: Surrogate decision-making.Appelbaum, P. S. (2007). Assessment of patients’ competence to consent to treatment. New England

Journal of Medicine, 357(18), 1834-1840.Collier, R. (2011). Bringing palliative care to the homeless. Canadian Medical Association Journal,

183(6), E317-E318.Jonsen, A. R., Siegler, M., Winslade, W. J. (2006). Clinical ethics: A practical approach to ethical deci-

sions in clinical medicine (p. 219). McGraw Hill, Medical Publications Division.Kushel, M. B., & Miaskowski, C. (2006). End-of-life care for homeless patients: “She says she is there to

help me in any situation”. Journal of the American Medical Association, 296(24), 2959-2966.Miles, S. H., & August, A. (1990). Courts, gender and “the right to die”. Journal of Law, Medicine &

Ethics, 18(12), 85-95.Philipps, K. (2012). Homelessness: Causes, Culture and Community Development as a Solution (Pell

Scholars Thesis). Retrieved from Salve’s Dissertations and Theses at Digital Commons @ Salve Regina. (Paper 88).

Pope, T. (2010). Surrogate selection: An increasingly viable, but limited, solution to intractable futility disputes. Saint Louis University Journal of Health Law & Policy, 3, 183.

Shalowitz, D. I., Garrett-Mayer, E., & Wendler, D. (2006). The accuracy of surrogate decision makers: A systematic review. Archives of Internal Medicine, 166(5), 493-497.

Slutsky, A. S., & Hudson, L. D. (2009). Care of an unresponsive patient with a poor prognosis. New England Journal of Medicine, 360(5), 527-531.

Song, J. (2002, September). Homelessness and clinical ethics. In HEC Forum, 14(3), 209-216.Song, J., Wall, M. M., Ratner, E. R., Bartels, D. M., Ulvestad, N., & Gelberg, L. (2008). Engaging home-

less persons in end of life preparations. Journal of General Internal Medicine, 23(12), 2031-2045.

Snooping, Xiao Fu, 2014. <http://www.fuxiaoart.com/>. From the artist: “My goal in creating art is to allow a viewer the oppor-tunity to observe contemporary social constructs from a distance, providing them with a new perspective.”


Essay

Possible Improvements For Off-Label Drug Prescribingby Alexander Yahanda†

Physicians frequently prescribe drugs for off-label purposes. Off-label drug treatments, however, do not need to be FDA-approved. Moreover, these treatment choices are often supported by poor medical evidence. The relationship between the pharmaceutical industry and physicians may drive some physicians towards certain prescribing practices involving off-label treatments with no proven efficacy. This paper examines the relationship between the pharmaceutical industry and medical professionals and outlines potential situations in which off-label drugs may more reasonably be prescribed.

† Alexander Yahanda is a Master of Biotechnology student at Johns Hopkins University in Baltimore, MD. He previously received a Bachelors of Arts in Biology and Economics and minored in Bioethics from the University of Virginia, in Charlottesville, VA. He became in-terested in Bioethics because of the way in which it intertwines disciplines such as medicine, science, religion, philosophy, and politics. As an aspiring physician, he appreciates how bio-ethics is ubiquitous within the medical field. He can be reached at < [email protected]>.

The pharmaceutical industry, at times, maintains a worrisome relationship with medical professionals. Notably, pharmaceutical companies spend much of their advertising budgets—which collectively amount to billions of dol-

lars—on promoting their products to physicians (D’arcy and Moynihan, 2009). This advertising can lead to superior understanding of a company’s drugs. Yet there are potentially harmful implications about driving doctors towards specific prescribing practices, especially when drugs are being prescribed for “off-label” purposes. It is necessary to assess both how and when pharmaceutical companies should be allowed to promote off-label uses of their products to physicians if we are to create an ideal scenario for off-label usage. Ultimately, companies should only be able to promote off-label uses under certain circumstances—namely, when physicians have distanced themselves from the pharmaceutical industry and when sufficient industry-indepen-dent research has been conducted to determine off-label efficacy and safety. Off-label use is when a physician prescribes a drug for applications beyond those specified by the FDA—perhaps in a different dosage, for a different ailment, or for a different patient population. It is estimated that over 20 percent of all drug prescrip-tions are off-label, with that statistic reaching around 40-50 percent in given subspe-cialties (Wittich, Burkle, and Lanier, 2012; American Society of Clinical Oncology, 2006). However, off-label uses are not FDA-approved and are thus inherently riskier

Possible Improvements For Off-Label Drug Prescribing

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than on-label uses. Unless a drug has been used off-label on patients for years, there will be incomplete knowledge about its possible negative effects. And, alarmingly, low standards of efficacy and safety are accepted for much off-label prescribing (Rad-ley, Finkelstein, and Stafford, 2006). The fact that off-label use is so common does not necessarily indicate that those uses are based on sound medical evidence. In reality, off-label drug use has both benefits and drawbacks. Off-label applica-tions can frequently be helpful to patients. Various hypertension and antimicrobial drugs, for example, have been shown to work on conditions beyond those that they were specifically designed to treat (Radley, Finkelstein, and Stafford, 2006). Similarly, chemotherapy drugs are regularly used on different kinds of cancer in addition to what is actually specified on FDA labels (American Society of Clinical Oncology, 2006.) It would be foolish to strive towards eliminating all off-label prescribing since ideal treatment plans for a number of different medical conditions currently depend on off-label drug uses (American Academy of Pediatrics Committee on Drugs, 2002). That said, more attention could be given to the manner in which pharmaceutical companies convince physicians of a drug’s off-label efficacy. Regrettably, off-label uses do not always yield positive outcomes. There have been many cases in which physicians imprudently encourage off-label use, oftentimes after being persuaded to do so by drug companies. Off-label uses that are based on shoddy or fraudulent evidence can have harmful consequences. This is plainly illustrated by a history of lawsuits against the pharmaceutical industry in which companies have had to pay billions in restitution for putting patients at risk through off-label promotions, physi-cian kickbacks, withholding important safety information, or misleading healthcare providers (Outterson, 2012; Stohr, 2013; Thomas and Schmidt, 2012). Even despite innate uncertainties with the off-label marketing process, doctors are permitted to prescribe drugs off-label for essentially any purpose. This explains why physicians are such prime targets for pharmaceutical companies looking to boost profits, particularly because companies are legally prohibited from advertising off-la-bel uses directly to consumers. Since off-label use is so prevalent, companies realize huge financial gains through unnecessary off-label prescriptions. Indeed, most of the sales for a drug may arise from off-label applications (Schmit, 2004). Physicians, in theory, can act as the missing link between drug companies and consumers for off-la-bel promotion: drug companies may advertise off-label applications to physicians who could subsequently recommend those uses to patients. So, if a company can in-fluence physicians’ prescribing practices then sales of a drug will increase according-ly. This chain of action, of course, may also generate no patient benefit. A fundamen-tal part of doctors’ abilities to work in a patient’s best interest is compromised if their care is based in substandard evidence or the amount of attention they receive from drug reps. It is professionally irresponsible to give patients medication that is of no use or that could actually be harmful. Therefore, before drug companies are allowed to tout off-label advantages of their drugs to physicians, the relationship between the pharmaceutical industry and medical professionals must be amended. Disentanglement between the two sides looks to be the best course of action. To skirt regulations on direct-to-consumer advertising, pharmaceutical companies fre-quently exert influence over physicians by distributing free company paraphernalia and educational material or by labeling doctors as “opinion leaders” for their work

Alexander Yahanda


Tanlac Advertisement, Cooper Medicine Co., Dayton, OH, 1916. An advertisement for Tanlac, a patent medicine made by the Cooper Medicine Company (CMC) of Dayton, OH, in the Atlanta Constitution. CMC claimed that Tanlac was a “tonic and system purifier.” Analysis by the American Medical Association Chemical Laboratory showed that Tanlac was composed of 15.7% alcohol by volume, bitter flavors (gentian), emodin (extracts of rhubarb or buckwheat), licorice ex-

tracts (glycyrrhizic acid), wild cherry and glycerin (a thickening agent/sweetener) (Texas State Journal of Medicine 11: 300).


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in promoting a certain drug (D’arcy and Moynihan, 2009). Furthermore, companies sway some physicians’ prescribing habits via financial benefits, paying for meals, or other incentives. Select states have instituted rules to limit gifts from pharmaceuti-cal companies to physicians. Only one state—Minnesota—has banned almost all gift giving (Grande, 2009). It would be practical for other states to institute similar restrictions on pharmaceutical company-physician interactions. Conceivably, phy-sicians will be more likely to place the patient’s wishes first and foremost once they cannot be as easily targeted by the pharmaceutical industry. Studies indicate that physicians who are strongly intertwined with a pharmaceutical company are affected by that company’s actions even if they believe that they are impervious to propaganda (Grande, 2009). Moreover, if physicians do not receive kickbacks for off-label pre-scriptions, then they could more impartially assess the material they receive from the pharmaceutical industry. Finding the truth in industry-sponsored literature, after all, can be quite difficult. Presently, the government cannot forbid drug companies from distributing infor-mation to physicians on off-label treatments. Challenges to this idea have been struck down by the court system (United States v. Caronia, 2012). To restrict off-label pro-moting would—for better or worse—violate a company’s First Amendment right to commercial free speech (Thomas, 2012). Even though it cannot be legally regulated, the off-label drug use data that pharmaceutical companies spread to physicians is a problem that must be addressed. Pushing for higher standards of proof regarding off-label treatments could help here. Even if physicians do not accept gifts from com-panies, the ‘research’ that they read about a drug’s off-label use could still be unduly influential. In many cases, this material is trustworthy and is actually used to encour-age informed and appropriate off-label drug prescribing. However, pharmaceutical companies have been known to use selective reporting, selective publication, or mul-tiple submission to artificially inflate the significance of off-label treatments (Breen, 2004; Melander, 2003). For instance, British pharmaceutical giant GlaxoSmithKline pleaded guilty in 2012 to promoting off-label uses of three very profitable drugs through nefarious methods, namely covering up safety data and spreading unsup-ported medical claims through fake advisory boards and medical education training courses. For one of the drugs, GSK persuaded physicians to prescribe Paxil, an adult antidepressant, off-label for younger patients by distributing intentionally misleading data. Paxil, in reality, had not been proven to reduce depression in children. GSK also failed to disclose that the drug potentially led to suicidal thoughts when given to adolescents (“GlaxoSmithKline to Plead Guilty,” 2012; Thomas and Schmidt, 2012). GSK’s and similar violations of research ethics cast doubt over the reliability of indus-try-sponsored studies. As the philosophers Radoilska, Scott, and Oliver would say, the pharmaceutical industry has often failed to maintain its truthfulness (Radoilska, Scott, and Oliver, 2005). That is, the information that the industry promotes to phy-sicians may be neither accurate nor sincere: industry reports might highlight incom-plete findings or be used to guide readers away from the truth. Thus, there exists a need for additional, unbiased information about off-label drug use. The biggest upside to more unbiased research would be the ability to perceive fact from fiction. To reiterate, not all off-label prescriptions are misguided. Benefi-cial off-label treatments should be publicized and used to improve patient wellbeing.

Alexander Yahanda


However, this is impossible if there is a lack of credible evidence, which is the case unless a drug has an extensive history of off-label application. When using drugs for on-label purposes, the onus would normally fall on doctors to employ any avail-able information to determine which medications a patient should take. Doing this is harder with off-label treatments, and any uncertainty is exacerbated by untruth-

ful studies that are published by phar-maceutical companies. Patients cannot make informed, autonomous choices if their doctors are presenting treatment options based on incomplete informa-tion. Additional research on off-label drug use would allow patients to take ad-vantage of the most effective treatments and would protect them from those that are unnecessary. To be sure, a higher standard of sci-entific evidence should be the most im-portant condition if drug companies are to continue promoting off-label uses to physicians. At some point, more action must be taken to discern the true benefits or risks posed by popular or well-publi-cized off-label drugs. Finding a definitive solution, though, is a formidable task. One straightforward, albeit incomplete, option comes from the medical com-munity. Hospitals and physicians could start keeping more detailed records of

which patients have received drugs for off-label purposes in order to gather accept-able data on efficacy or side effects. A larger bank of knowledge for off-label uses would help physicians make wiser decisions and would allow the physicians to apply off-label treatments with greater success. The more information on off-label effects that is disseminated among medical professionals—for example, via journals or just between colleagues—the better. Patients, too, would seriously benefit from this in-crease in transparency. Respect for autonomy dictates that it is undesirable for pa-tients to have a dearth of information on the effects and purpose of the drugs they are taking. Indeed, if a physician really wanted to maximize his patients’ autonomy and understanding of their treatments, then he should disclose to patients when partic-ular drugs were being used for off-label purposes. The average patient may be totally unaware of the process by which drugs are marketed and prescribed; they may mere-ly assume that drugs are prescribed only for the conditions they are proven to treat. Unfortunately, evaluating off-label drug use from within the medical community could take years for some drugs and would necessitate many ineffective or adverse outcomes, as well as possibly yielding discrepancies in opinion. To provide help, other institutions could also be used to evaluate common off-label uses in a more timely and definitive manner. The personnel involved in this new research could be scientists and

High Frequency Electric Currents in Medicine and Dentistry, Samuel Howard Monell, 1910. Illustrating a mild vacuum-tube discharge applied to the eyes for tonic effects, using a special bifurcated electrode.


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physicians—presuming that they reject all pharmaceutical industry influence—or a regulatory body like the FDA. The FDA has instituted some regulations since 2007 to address the issue of off-label prescribing, yet those policies only concern off-la-bel drug marketing (not off-label prescribing) and have been met with tepid enthusiasm. Critics point out that the rules are not stringent enough and in no way require companies to get off-label uses FDA approved. The FDA could pivot its efforts somewhat from regulating off-label marketing to focusing on off-label prescribing. However, that would leave doctors more accessible to the pharmaceutical in-dustry, which brings with it all the aforementioned problems. The problem is that it would be extremely difficult—and likely impractical—for the FDA to adopt the role of regulating both off-label marketing and prescribing. The agency currently faces problems with un-derstaffing and a lack of resources (Ventola, 2011). Additionally, the intrinsic ineffi-ciencies and complex legal codes that would accompany an expansion in government bureaucracy would also greatly complicate matters for a while. Seeing as the FDA is already struggling to monitor the pharmaceutical industry, giving it the added re-sponsibility of evaluating off-label prescribing could prove ineffective. Where, then, to turn? Direct FDA testing and oversight of off-label uses does not necessarily have to be the only way to reform off-label drug use. Finding another way to test off-label effects could help quell improper marketing and prescribing, too. Currently, there are outside institutions that help assess some off-label treatments (Dresser and Frader, 2010). These organizations could somehow recruit funding (governmental or private) so that they may serve as additional drug testing outlets. Private funding, obviously, would need to come from outside the pharmaceutical in-dustry. Any negative side effects from off-label drug use could then be reported to ap-propriate regulators, which would confront the relevant manufacturers. Interestingly, the FDA could perchance increase off-label testing stringency requirements with this approach, especially if it could overcome its insufficient resources by outsourcing the testing to private companies. Augmented federal standards of proof for off-label drug marketing would also create less controversy about a company’s right to free speech than an outright ban on promoting off-label uses to physicians. The FDA would not be outlawing a company’s speech; it would be ensuring that doctors also received information from a third-party source. A stricter testing process for off-la-

Atabrine advertisement in Guinea during WW2, Otis Historical Archives of “National Mu-seum of Health & Medicine”, 2013. These men didn’t take their Atabrine, an anti-malaria drug. Sign was posted at the 363rd Station Hospital.

Alexander Yahanda


bel uses would help resolve fraudulent claims being spread by pharmaceutical companies. Physicians could then ad-vocate the best treatments for patients without the risk of being deceived. Pa-tient autonomy would consequently increase since the actual efficacy of an off-label treatment would be known with certainty. Overall, more truthful information on off-label use seems like it would benefit patients and physi-cians alike. None of the solutions outlined here are by any means perfect for solving problems with off-label drug use. Both separating physicians from the phar-maceutical industry and requiring more stringent standards for off-label uses would require additional gov-ernmental legislation. As a result, it is too optimistic to hope that these two improvements will be accomplished anytime soon. Nevertheless, properly addressing those issues would result in a scenario in which it is more permis-

sible for pharmaceutical companies to promote off-label uses to physicians. Doctors must be free from corrupting industry influence to assess company information dis-passionately. And, more medical data compiled on off-label uses would enable doc-tors to double-check the unbiased information as well as their colleagues’ choices to form a stronger consensus on off-label uses from within the medical community. An ideal situation arises when the best off-label drugs are made widely available to those who may benefit from them while those backed by little credibility are debunked and kept from endangering patients. As Edmund Pellegrino says, overall healthcare is not a normal commodity to be bought and sold—“the central feature of health care is the personal relationship be-tween a health professional and a person seeking health” (Pellegrino, 1999). Drug marketing, which toes the line between promoting sales of a commodity and pro-moting health, can place that essential principle in jeopardy. Even though drug com-panies’ marketing strategies may actually be aligned with a physician’s goal of optimal patient care, prescribing deceitfully marketed drugs destabilizes the doctor-patient relationship. Pharmaceutical companies should only be able to market off-label drug uses to physicians when physicians are acting in the patient’s best interest and have the necessary information to separate valuable medical science from a sales pitch. •

A doctor prescribing continuation of treatment to his reluctant patient, Woodward, G. M., 1880.


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REFERENCESAmerican Academy of Pediatrics Committee on Drugs. (2002). Uses of Drugs Not De- scribed in the Package Insert (Off-Label Uses). Pediatrics, 110(1), 181-183.American Society of Clinical Oncology. (2006). Reimbursement for Cancer Treatment: Coverage of Off-Label Drug Indications. Journal of Clinical Oncology, 24(19), 3206-3208.Breen, K. (2004). The medical profession and the pharmaceutical industry: When will we open our eyes? Medical Journal of Australia, 180(8), 409-410.D’arcy, E., & Moynihan, R. (2009). Can the Relationship between Doctors and Drug Com- panies Ever Be a Healthy One? PLoS Medicine, 6(7), E1000075-E1000075.Dresser, R., & Frader, J. (2010). Off-Label Prescribing: A Call for Heightened Professional and Government Oversight. The Journal of Law, Medicine & Ethics, 37(3), 476-486.GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Fail- ure to Report Safety Data. (2012, July 2). Retrieved January 15, 2015, from http://www. justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allega tions-and-failure-report Grande, D. (2009). Limiting The Influence Of Pharmaceutical Industry Gifts On Physicians: Self-Regulation Or Government Intervention? Journal of General Internal Medicine, 25(1), 79-83.Melander, H., Alqhvist-Rastad, J., Meijer, G., & Beermann, B. (2003). Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: Re view of studies in new drug applications. BMJ, 326(7400), 1171-1173.Outterson, K. (2012). Punishing Health Care Fraud — Is the GSK Settlement Sufficient? New England Journal of Medicine, 367, 1082-1085.Pellegrino, E. (1999). The Commodification of Medical and Health Care: The Moral Conse- quences of a Paradigm Shift from a Professional to a Market Ethic. The Journal of Medi- cine and Philosophy, 24(3), 243-266.Radley, D, Finkelstein, S, Stafford, S. (2006). Off-label Prescribing Among Office-Based Phy- sicians. Archives of Internal Medicine, 166(9), 1021-1026.Radoilska, L., Scott, D., & Oliver, A. (2005). Trust in the Pharmaceutical Industry: A Philo- sophical Perspective. The Forum for Philosophy in Business, 1-63. Schmit, J. (2004, August 17). Drugmaker admitted fraud, but sales flourish. Retrieved May 4, 2014, from http://usatoday30.usatoday.com/money/industries/health/drugs/2004-08- 16-neurontin-cover_x.htm?csp=22_thdStohr, G. (2013, December 9). Pfizer Rejected by Top Court on Neurontin Marketing Suits. Retrieved May 4, 2014, from http://www.bloomberg.com/news/articles/2013-12-09/pfiz er-rejected-by-top-court-on-neurontin-marketing-suitsThomas, K. (2012, December 3). Ruling Is Victory for Drug Companies in Promoting Med- icine for Other Uses. Retrieved May 4, 2014, from http://www.nytimes.com/2012/12/04/business/ruling-backs-drug-industry-on-off- label-marketing.html.Thomas, K., & Schmidt, M. (2012, July 2). Glaxo Agrees to Pay $3 Billion in Fraud Settlement. Retrieved May 4, 2014, from http://www.nytimes.com/2012/07/03/business/glaxosmith kline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=allUnited States v. Caronia, 703 F.3d 149 (2d Cir. 2012)Ventola, L. (2011). Direct-to-Consumer Pharmaceutical Advertising Therapeutic or Toxic? Pharmacy and Therapeutics, 36(10), 669-84.Wittich, C., Burkle, C., & Lanier, W. (2012). Ten Common Questions (and Their Answers) About Off-label Drug Use. Mayo Clinic Proceedings, 87(10), 982-990.


Essay

Justifying Health Care as a Feasible Ethical Rightby Samuel H. Jones†

Modern health care as a whole is an enormous and pervasive field of study, and its ethics reflect a multitude of philosophical considerations. Although the scrutiny of particular issues in health care is vital to progress within precise domains of medical ethics, it is equally important to consider issues that span across all of health care. This essay examines the latter by questioning whether individuals in a population have a moral right to health care. After establishing a basis for the philosophical right to health care and its role in populations, several common faults of arguments for such a right are discussed. Finally, this essay concludes by proposing an updated framework for John Rawls’s ideal social contract theory as a method for justifying health care as a feasible ethical right.

† Samuel H. Jones is a medical student at the Weill Cornell Medical College in New York City (class of ‘18). He can be contacted at <[email protected]>.

T he question of whether it is right to provide health care for the masses is not a controversial one. Even when someone is unable to pay for his or her medical treatments, many agree that they are entitled to receive a certain level of care.

In the United States, federal law dictates that anyone can receive emergency treat-ment without regard to his or her social or economic standing. However, while many agree that health care should be provided to everyone regardless of ability to pay, there is vigorous disagreement on the extent to which coverage should realistically be maintained. In other words, to what kind of health care do people have a right? Consideration of theoretical requirements of rights and the practical circumstances of medical care determine the criteria of an individual’s ethical right to health care. A revised version of John Rawls’s ideal social contract theory serves as a guide for the circumstances under which a community is responsible for ensuring a decent minimum of health care.

REQUIREMENTS OF A RIGHT TO HEALTH CAREIn order to determine what features of health care may be properly deemed rights, it is first necessary to define what a right is. In its essence, a right is an ethical prin-ciple supporting an enforceable claim. That is, if the claim of a right is not met, it is acceptable to use reasonable force to meet the requirements of that claim. Further-more, rights may be positive or negative. A positive right requires an action to be taken. For example, if someone has a right to eat, then others have an obligation to ensure that person eats. Conversely, a negative right requires inaction. For example, if someone has a right to live, then others would be obligated to not kill that person.

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Rights may be considered in many issues of ethics, including health care. Given the above definition of rights, under what conditions may health care be considered a right? If it is determined that there is a right to a decent minimum of health care, then there is a shared responsibility to ensure that others receive health care. And, if someone is receiving insufficient medical care according to their right, then those with the power to give them medical care must do so. However, in prac-tice, patients’ rights can conflict with the rights of physicians. For example, in the case of assisted suicide, a patient may claim that he or she has a positive right to die, and that his or her doctor has an obligation to kill them. On the other hand, the patients’ physician may claim a negative right to not be required to kill anyone. A similar relationship may be seen when making health care payments. Whereas a patient may claim a negative right to not have to pay for health care, a doctor may claim a positive right to be paid for his or her services. If health care is a right, then it is acceptable to use reasonable force to ensure that people are able to receive health

Mural at the Sunset Neighborhood Beacon Center, A.P. Giannini Middle School, San Francisco, CA, Nils Westergard, 2013. Pic-tured above is Yuri Kochiyama, a Asian American civil rights activist who was present during the assassination of Malcolm X. Mr. Westergard is an artist in Richmond, VA. His art can be found at <http://nilswestergard.com/>.

Samuel H. Jones


care. However, since the rights of patients and health care professionals can conflict, it is important to develop a health care system that efficiently balances these poten-tially competing interests.

RIGHTS OF POPULATIONSSince conflicts over health care resources arise at the level of the community, rights to health care must be considered in the context of the general population. Practi-cally, health care is managed at the level of medical resources and personnel. Health resource allocation is dependent on a balance between the particular medical needs of individuals in a community and the ability of the community to distribute those resources equally. To justly determine how to allocate health care resources, it is necessary to consider the relationship between rights of the community and rights of individuals. In Remedy and Reaction, Paul Starr addresses the application of rights to an entire population:

[P]ublicly recognized rights imply publicly assumed responsibilities. […] A right to the requirements of human development has no real meaning unless people recognize obligations to one another, mutually and through government, to en-sure that the conditions exist that make it possible for every person to have the opportunity for success in life. (Starr, 2011, p. 248)

Starr acknowledges that the usefulness of a right is dependent on a community’s ob-ligation to action in the case that the right is not fulfilled for a member of the com-munity. If health care is indeed a publicly recognized right, then the public also col-lectively assumes the responsibility of ensuring that everyone is able to receive health care. Furthermore, Starr clarifies that the purpose of a right to health care is to ensure that people have an opportunity to succeed in their own lives. Therefore, it is possible for the general public to estimate the amount of health care to which someone has a right by gauging the influence of the person’s health on his or her ability to succeed. Due to the highly variable nature of medical care receivable by an individual, it is important to note that a right to health care may be better understood as a continu-ous construct, as opposed to a categorical one. The factors that influence a person’s health and medical treatments are so numerous that it is often not practical to com-prehensively describe them; in reality, generalizations about the circumstances of an individual’s health are more useful in a clinical setting. To elucidate the role of an in-dividual’s theoretical right to health care in realistic circumstances, it is important to acknowledge the unwieldy variability of factors contributing to a person’s health and his or her possible subsequent treatments. For this reason, health care may be con-sidered more accurately not as a collection of discrete possible plans, but rather a set of options that is totally modifiable. A proper health care system is not created from a series of options; rather, it is built with regard to many qualitative choices. Therefore, although there is disagreement on the extent to which a right to health care should be maintained by a community, it is theoretically possible to create a health care system that is balanced between polar views of controversial options, allowing for the most possible agreement on plan coverage. In “The Right to a Decent Minimum of Health Care,” Allen Buchanan argues that it is possible to provide a widespread decent minimum of health care without de-claring a right to health care (Buchanan, 1984, pp. 55-78). However, it is necessary


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to grant a right to a decent minimum of health care in order to ensure the adequate health and fair life of individuals in a community. In addition, it is possible to enforce a right to a decent minimum while avoiding the excesses of the strong equal access principle, in which “everyone has an equal right to the best health-care services avail-able” (Buchanan, p. 58). Though Buchanan rightfully rejects the strong equal access principle, his error lies in his position that a right must be “reasonable for everyone to pursue, regardless of his or her physical abilities, skills, and talents” (Buchanan, p. 63). On the contrary, a right does not need to be reasonable for everyone to pursue; rather, an individual’s right is contingent on circumstance—specifically, rights are contingent on the community’s ability to provide them. So, while an ill person has a right to a decent minimum of health care in a setting with readily available medical resources, he or she does not necessarily have that right when medical resources are lacking. This also means that areas with significant resources are not necessarily obligated to provide for all other areas that are lacking. However, ideally, resources should be distributed from resource-rich to resource-poor areas to the extent that provision of services and progress are not impeded in the resource-rich areas. To reinforce such a redistribution of health care resources, it is beneficial to identify a formal ethical framework to identify beneficiaries and support the right to a decent minimum of health care.

A THEORETICAL RIGHT TO HEALTH CAREComparison of existing models of ethical resource distribution makes it possible to identify a foundation for the community-supported right to health care. Ultimately, an updated version of John Rawls’s ideal social contract theory provides the most pragmatic theoretical support for that right. In A Theory of Justice, Rawls argues that a proper liberal ethical framework can be derived from the Original Position and Veil of Ignorance (Rawls, 1970, pp. 102-170). These two principles are used to specify the method for Rawls’s derivation of his contract theory: when all people are situated equally with no knowledge of their society, they would choose societal principles that give equal rights to all (Rawls, pp. 118-122). The Original Position reflects the belief that certain features of people (such as race, congenital disabilities, etc.) are beyond their control and are therefore morally arbitrary; an individual with a morally arbi-trary feature cannot or does not intend for that feature to do harm (Rawls, pp. 15-18). Since such features are morally arbitrary, people should not be subject to segregation based on those features, because others equally could have received those features in

The Vorstadt of Sachsenhausen at the beginning of the 17th Century, Peter Becker, 1889. In the Frankfurt-Archiv, Ergänzungs-Edition (Band 2), Wolfgang KlÖtzer.

Samuel H. Jones


the Original Position (Rawls, pp. 15-18). With the Original Position and Veil of Ignorance, Rawls establishes two principles of justice. First, he derives that each person has an equal right to a set of liberties that is compatible with others’ rights (Rawls, 1970, pp. 214-227). Second, he posits that social and economic inequalities are to be arranged such that they are both (a) reasonably expected to be to everyone’s advantage, and (b) attached to positions and offices open to all (Rawls, pp. 214-227). Given Rawls’s second principle of justice, he outlines the Difference Principle, which states that social order should not secure an advantage for the better-off unless doing so confers an improvement to the least well-off from its original state (Rawls, pp. 65-72). Allen Buchanan argues that Rawlsian ideal social contract theory is ineffective be-cause the Original Position and Veil of Ignorance are not applicable to real-world sit-uations; Buchanan also criticizes this theory by arguing that Rawls does not explicitly list health care as a primary social good (Buchanan, 1984, pp. 61-72). It is appropri-ate to update Rawls’s ideal social contract theory to account for Buchanan’s criticisms. First, Buchanan argues that the Original Position is averse to risk because it au-tomatically distributes resources in a way that is “intuitively unfair to the better off ” (Buchanan, 1984, p. 60). However, this is at least partially remedied by appending to Rawls’s ideal social contract theory the above position that resources should only be distributed in a manner such that their provision to resource-poor areas not impede the health services and progress of the providing, resource-rich area. This is consis-tent with Rawls’s Difference Principle, since research for improving medical proce-dures and technologies implies that resource-rich areas use their selective advantages to produce findings that ideally improve health care in resource-poor areas as well. In addition, it is reasonable to update Rawls’s definition of primary social goods to explicitly include a decent minimum of health care, since health care is often requisite for an agent to fulfill other rights. In A Theory of Justice, Rawls expresses a belief that health (or health care) is not among society’s primary goods:

Making sweet grass medicine, Blackfoot ceremony, Joseph Henry Sharp, 1920. Housed at the Smithsonian American Art Museum in Washington, D.C.


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The chief primary goods at the disposition of society are rights, liberties, and op-portunities, and income and wealth. […] Other primary goods such as health and vigor, intelligence and imagination, are natural goods; although their possession is influenced by the basic structure, they are not so directly under its control. (Rawls, 1970, p. 54)

However, if there is a right to a decent minimum of health care, then health care receives the benefits of Rawls’s primary social goods, since rights are listed among the primary goods. The right to a decent minimum of health care is consistent with Rawls’s argument for primary social goods, and the argument for an ideal liberal social contract supports that right, so it is convenient to revise Rawls’s primary social goods to explicitly include health care. In addition to Buchanan’s counterargument to the Rawlsian ideal social contract, Alasdair Macintyre claims that Rawls’s argument is insufficient because only a ratio-nal agent in the Original Position would actually choose his principles, and not all people are rational. Therefore, Macintyre posits, Rawls’s idea of justice is inherently flawed (Macintyre, 2007, p. 247). However, this objection is insufficient to wholly discredit Rawls’s argument. The aim of any right should be construed as a realistic ideal. For health care, that means that the decent minimum would allow for coverage to the extent that the highest feasible quality of care can be ensured for perpetuity. Additionally, in Rawls’s Original Position, an ideal agent would be a rational one. Therefore, given that the aim of a right should be a realistic ideal, and an ideal agent in the Original Position would be a rational one, a rational agent would choose the principles of health care that most closely represent the realistic ideal. So, although real-world people may not exactly conform to a perfectly rational agent, principles that conform most closely to the realistic ideal would be those chosen by the rational agent. The right to a decent minimum of health care, while rational in theory, becomes muddled in practice. There seems to be agreement that some health care should be provided to everyone, regardless of ability to pay, despite disagreement regarding the existence of a right to health care. By properly analyzing the constitution of rights and the conditions under which health care is a right, it is possible to construct a reasonable framework supporting a right to a decent minimum of health care. Since rights should be ensured by the general population, and health care is a right, then the right to a decent minimum should be ensured by the general population. How-ever, to be effective in practice, the right to a decent minimum of health care is con-tingent on the community’s ability to provide for the individual in the first place. •

REFERENCESBuchanan, A. (1984). The right to a decent minimum of health care. Philosophy & Public Affairs, 13(1), 55-78.Macintyre, A. (2007). After Virtue. Notre Dame, IN: University of Notre Dame Press.Rawls, J. (1971). A Theory of Justice. Cambridge, MS: Harvard University Press.Starr, P. (2011). Remedy and Reaction: The Peculiar American Struggle over Health Care Reform. New Haven, CT: Yale University Press.


Essay

Guidelines and Recommendations Regarding the Use of Deep Brain Stimulation Devices in the Treatment of Borderline Personality Disorderby Megan M. Parsons†

This paper discusses guidelines and recommendations for medical practitioners regarding the use of deep brain stimulation (DBS) devices in the treatment of borderline personality disorder (BPD), as may be demonstrated through DARPA-funded research and approved by the FDA in the next several years. We will use the case of a 16-year-old boy with BPD characterized by dangerous and self-destructive behaviors, who has otherwise exhausted all other approved and available treatment options, as a reference example. We argue that use of DBS devices in treatment of diagnosed, treatment-resistant BPD should be considered in individuals who threaten the well-being of themselves or others because of the pathology, or individuals who suffer significantly decreased quality of life as identified by the individual, a representative (if applicable), and physician.

† Megan M. Parsons is a senior neurobiology concentrator at Harvard University with a secondary concentration in astrophysics and language citation in Mandarin Chinese. She has received national and international recognition for her work in astrophysics and neurosci-ence, and has received numerous grants and fellowships for her research at Harvard Medical School, Harvard-Radcliffe Institute for Advanced Study, and Harvard-Beijing Academy. She can be reached at <[email protected]>.

BACKGROUND

Historically, the brain has been a “black box,” in which input (stimulation) and output (behavioral response) could be measured, but the brain areas involved in the processing of specific stimuli remained a mystery until the

advent of modern imaging techniques (O’Connell, 2011). Despite these powerful im-aging tools, many questions remain about fundamental molecular mechanisms and circuitry involved in psychiatric disorders; however, this does not justify withholding DBS treatment methods from individuals with diagnosed BPD. There are three pri-mary reasons for this: (1) DBS devices will likely be demonstrated (through DAR-PA-funded research) and approved (by the US Food and Drug Administration) for use in the treatment of BPD; (2) modern DBS devices offer several advantages com-pared to traditional surgery (Kuhn et al., 2009); (3) the possibility for DBS device use in psychiatric disorders was first suggested during the highly successful Parkinson’s

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disease DBS trials, and successful DBS treatment has already been reported in similar disorders, such as obsessive compulsive disorder and Tourette’s syndrome (Larson, 2008). We can thus see that there is not only a precedent for treating multisymptom-atic and etiologically ambiguous disorders with DBS devices, but further research exists to demonstrate that the potential benefits of using DBS devices to treat treat-ment-resistant BPD outweigh the risks. In addition, modern DBS techniques are re-versible, and the stimulating electrode can be fine-tuned for individual needs (Kuhn et al., 2009). This is a great advancement compared to traditional techniques, which included invasive, irreversible lobotomies and lesions. It is reasonable, then, for doc-tors to consider use of DBS devices in individuals with treatment-resistant BPD, after all other available treatment options have been exhausted. For our reference patient, this suggests that consideration of a DBS device as a treatment for treatment-resistant BPD is reasonable and merited.

SOCIETAL IMPLICATIONSBroader societal implications for widespread use of DBS in treating personality dis-orders are multifaceted. The manifestation of personality disorders can be disruptive in classroom or work settings, detrimental to the well-being of others, and econom-ically costly. According to the The Diagnostic and Statistical Manual of Mental Disor-ders (5th edition; DSM-5), BPD is characterized by disinhibition and impairments in interpersonal functioning (American Psychiatric Association, 2002). This can lead to behavior that our reference patient has demonstrated, including anger outbursts, drug experimentation and related possession charges, and promiscuous sexual ac-

Typical illustration in a 19th Century book about Physiognomy, Unknown author, 19th century. Photographer: Tom Ordelman, 2006. Wikimedia Commons. Left: “utter despair”, right: “anger mixed with fear.” Physiognomy is the assessment of a person’s character from their face. Invented by ancient Athenian philosopher Zopyrus in 5th century BCE, it was used by 19th century physicians as a technique to diagnose mental illnesses in mental health patients. The use of physiognomy failed to be effective in treating mental illness and was discredited by the mid-20th century as a pseudoscience. Its popularity represents the challenge 19th century scientists and clinicians faced: the lack of useful tools to understand the brain and treat its disorders, a challenge scientists, clinicians and society continues to face today.

Megan M. Parsons


tivity. These symptoms are undoubtedly detrimental to the patient, as well as the patient’s family, school, and communi-ty. Furthermore, it is beyond the scope of parents, school administrators, and conventional treatment options to prop-erly address the problem—the underly-ing BPD pathology. If this patient were to continue on this path, his behavior would likely lead to incarceration. This is unfortunate because it represents both a drain on economic resources, as well as lack of essential treatment of BPD pathology or medical management of symptoms. At the very least, if the pa-tient were fortunate enough to avoid incarceration, his behavior would still put a strain on his family, school, and community, a problem that should be

addressed in a medical setting to increase the patient’s quality of life. Behavior does not have to be explicitly violent to be classified as detrimental; therefore, if a patient is diagnosed with BPD because of

symptoms consistent with those described in the DSM-5, and is a detriment to the emotional or physical well-being of self and others, then the use of DBS devices in populations with personality disorders has the potential to substantially increase the quality of life for both patients and society as a whole.

ETHICAL ISSUESThere are unanswered ethical questions that arise from the aforementioned case. Namely, DBS techniques have the potential to substantially alter personality and emotion. Our personalities and identities are intrinsically linked. We can see this in the example of Phineas Gage, whose traumatic brain injury to the prefrontal cortex changed the way in which he conducted himself, and thereby changed who he was as a person (O’Driscoll et al., 1998). Other people’s perception of who someone is relies heavily on the relationship between personality and interpersonal interaction, so DBS may interfere with identity of the patient, as well as how he or she is perceived by others. It is therefore the responsibility of doctors to set reasonable limits on the use of DBS to treat BPD without causing extensive secondary effects. We suggest that the use of DBS devices be limited to patients who have a definitive diagnosis from a doctor based on the DSM-5, exhausted all other treatment options, understand and fully consent to the procedure (including potential risks associated with this type of surgery), and fully understand the unknown and unforeseen risk that might arise as a direct or indirect result of this procedure. However, doctors must constantly monitor DBS patients. This judgment is based on two points: (1) doctors continue

Tiefe Hirnstimulation bei Morbus Parkinson: Sondenverlauf in Projektion auf den Schädel auf einer Röntgenaufnahme, Hellerhoff, 2011. Wikimedia Commons. Deep brain stimulation probes shown in an X-ray of a skull (the white areas about the jaw represent metallic dentures and are unrelated to deep-brain stimulation).

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to prescribe antidepressants for the treatment of depression, even though some pa-tients experience suicidal thoughts and other dangerous changes in mentality. DBS might have similar effects, but because the treatment is equally reversible, we should not deny patients this treatment option on the basis of this particular risk. (2) If a person’s identity is indistinguishable from a documented pathology, then the role of a physician is to treat the pathology, allowing the patient to re-establish themselves in society as a healthy, fully-functioning individual.

CONCLUSIONIn this paper, we have established the use of DBS in the treatment of BPD as a valid treatment option under very specific circumstances to improve health and quality of life. In doing so, we attempt to find a balance between patients’ health and identity, as well as the common good of society. Guidelines include the following:

1. Physicians may consider use of DBS devices in individuals with treatment-resistant BPD, after all other available treatment options have been exhausted.

2. Patient symptoms must be consistent with those described in the DSM-5 for BPD in order to qualify for this particular treatment option, and it must be docu-mented that patient behavior is a detriment to the emotional or physical well-be-ing of self and others.

3. Patient must understand and fully consent to the procedure (including poten-tial risks associated with this type of surgery), and fully understand the unknown and unforeseen risk that might arise as a direct or indirect result of this procedure.

4. Physicians must consistently monitor patients for alarming changes in person-ality. •

REFERENCESAmerican Psychiatric Association. (2002). [DSM-5] Diagnostic and Statistical Manual of

Mental Disorders (5th ed.). Washington, D.C.: American Psychiatric Publishing.Kuhn, J., Gaebel, W., Klosterkötter, J. & Woopen, C. (2009). Deep brain stimulation as a new

therapeutic approach in therapy-resistant mental disorders: ethical aspects of investiga-tional treatment. European Archives of Psychiatry and Clinical Neuroscience 259, 135-141.

Larson, P.S. (2008). Deep brain stimulation for psychiatric disorders. Neurotherapeutics 5, 50–58.

O’Connell, K. (2011). From black box to ‘open’ brain: Law, neuroimaging and disability dis-crimination. Griffith Law Review, 20(4), 883-904.

O’Driscoll K. & Leach, J. P. (1998). “No longer Gage”: an iron bar through the head. Ear-ly observations of personality change after injury to the prefrontal cortex. The BMJ, 19, 1673–1674.


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