0011 Schaub 4:00 L07 ETHICS IN THE USE OF STEM CELLS IN MODERN MEDICINE Peter Shilowich (pes44@pitt.edu) INTRODUCTION: A POSSIBLE ETHICAL SCENARIO In the field of engineering one of the most important things to pay attention to is the ethics of a situation. Engineers in all fields have to pay attention, legally and morally, to a specific code of ethics. Whether it’s a medical engineer developing new car technology or a bioengineer researching and implementing stem cells. In the following scenario, the head engineer in a stem cell research lab must come to decision that is within the bioengineering code of ethics. To further understand the reasons behind the engineer’s solution to this scenario, you must be informed about the basics of stem cell research and use. WHAT ARE STEM CELLS AND HOW ARE THEY USED? The research that is currently being conducted on stem cells is future of modern medicine. “Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth” [1]. A stem cell divides and when this occurs it has the option to continuing being a stem cell or it can change itself into another type of cell with a specific function, for instance a red blood cell or brain cell. Also stem cells do not have a limit to how many times they can divide so they can also serve as an internal repair system but only as long as the organism is living. In the realm of stem cells there are two different types: adult stem cells and embryonic stem cells. An adult stem cell are stem cells that exist in already developed tissue, but it can also be found in infants and children. “These stem cells can act like a repair system, dividing regularly to provide new specialized cells to take the place of those that die or are lost” [2]. But research with adult cells has been limited because scientists have found difficulty growing and differentiating the cells in the conditions of a lab. Embryonic stem cells on the hand are produced when a newly fertilized egg begins to divide, which is usually about three to five days into the development of the zygote. In the following scenario, the embryonic stem cell is one that is being used. Obtaining the stem cells can both a simple and nearly harmless process as well as a more in-depth process. The collection of adult stem cell is the easier of the two. They can be removed from adult tissues with little harmful effect on the patient meanwhile embryonic stem cells are University of Pittsburgh, Swanson School of Engineering 2014-10-26 created from multicellular embryos that have been cultured in the a lab [2]. There are also other ways that scientists produce stem cells because there is limited about of them from research. Some of the current and potential sources are early embryos created by in vitro fertilization, germ cells or organs from an aborted fetus, early embryos created by somatic (body) cell nuclear transfer (SCNT), and reprogramming mature adult tissue cells to behave like stem cells [2]. In today’s medicine stem cells have been used to provide life-saving treatments to patients with lymphoma, leukemia, other blood disorders, as well as solid tumors. Also stem cells have been used in bone marrow transplants, where healthy, matching donor cells replace the patient’s bone marrow. “While most blood stem cells reside in the bone marrow, a small number are present in the bloodstream. Peripheral blood stem cells can be obtained from drawn blood, making them easier to collect than bone marrow stem cells. However, PBSCs are sparse in the bloodstream, so collecting enough to perform a transplant can pose a challenge” [2]. Scientists have recently discovered another place to find stem-cell-rich blood, umbilical cords. The blood found in the umbilical cord can be used to treat patients with the same health problems as those treated using bone marrow cells and PBSCs. Another use of stem cells is in the field of therapeutic cloning. Therapeutic cloning is a procedure to create versatile stem cells independent of fertilized eggs. The nucleus is removed from the unfertilized egg as well as the nucleus of the somatic cell of a donor. The donor nucleus is then injected into the egg, creating a line of stem cells that is genetically identical to the donor’s, a clone [3]. THE SCENARIO The head engineer in an embryonic stem cell research lab in UPMC has been working on the most efficient way to create large quantities of embryonic stem cells. In order to create even a single embryonic stem cell, a human embryo is required and must be at the blastocyst stage which is about three to five days post fertilization at which time they consisted of about fifty to one hundred and fifty cells, and the inner cell mass must be removed. But with this process moral and ethically issues arise which raises a red flag in the engineer’s research. These moral issues that our engineer faces are the duty to prevent or alleviate suffering and the duty to respect the value of human life. In order for our hypothetical engineer to make a decision and plan a course of action, he must consult the WMA Declaration of Helsinki- Ethical Principles for Peter Shilowich Medical Research Involving Human Subjects along with the Biomedical Engineering Society Code of Ethics. Another option that our engineer has is that he can continue to perform the normal process without worrying about the value of life and thoughts of those people who care if the embryo is considered a human or not because the production of stem cells with prevent and alleviate suffering. With these two options a problem does come with the process and how it’s conducted. Researchers are seeking out eggs from young woman at an increasing rate. But the process that is used to harvest multiple eggs often involves the administration of drugs that have not been approved for this purpose. As well as the drugs used have not been adequately studied for their long-term effects on women despite research providing some evidence of significant harm to women in both short and long term [6]. So an easy solution to that issue is to remove the use of those drugs from the process but that would increase the difficulty of the process in addition to possibly increasing the pain that the women would endure during the process. But for the decision of whether to choose to respect the value of human life or prevent and alleviate suffering our engineer needs to refer to specific codes of ethics. POSSIBLE SOLUTIONS TO THE SCENARIO Our hypothetical engineer’s possible solutions when it comes to facing these red flags in his research is to try and decided which moral issue is more important to satisfy. The research lab will continue to create embryonic stem cells by destroying an early embryo. But this continues to bring up a moral dilemma that has two moral principles to it: the duty to prevent or alleviate suffering and the duty to respect the value of human life. But our engineer can only satisfy one of the two principles. The first option is to attempt to satisfy the moral principle of respecting the value of life. This is a big issue because almost anyone can have an option on this topic. But the main discussion is over what moral status does a human embryo have. Some believe that the embryo has full moral status from the instant it is fertilized while others believe that it has no moral status at all. There also others in the middle that believe that around the 14 th day after fertilization is when the embryo gains moral status and finally some believe that the embryo’s moral status increases as it develops. The main question that needs to be answered in order for this solution to be acceptable is to determine when a human being begins to exist. It is nearly impossible to please the people that believe that an embryo has a moral status upon fertilization. The only way to satisfy them is to not perform the procedure. So our engineer’s best option is to destroy the embryo before the 14th day after fertilization occurs. Before day 14, the embryo has no central nervous system and therefore has no sense. The argument that arises is that if we can remove organs from a patient who is pronounced brain dead then why can’t we take hundred-cell embryos that have no nervous system. Fertilization is a process and an embryo in the earliest stages is not defined as an individual so in that case it couldn’t possibly have a moral status [4]. “An individual who is an identical twin cannot be numerically identical to the one-cell zygote, since both twins bear the same relationship to the zygote, and numerical identity must satisfy transitivity. That is, if the zygote, A, divides into two genetically identical cell groups that give rise to identical twins B and C, B and C cannot be the same individual as A because they are not numerically identical with each other. This shows that not all persons can correctly assert that they began their life as a zygote. However, it does not follow that the zygote is not a human being, or that it has not individuated.”[5]. Another argument that would provide strength to the side of continuing research and the current procedure. CODES OF ETHICS The codes of ethics provide a guideline to people in certain fields to make decisions that will be the moral and ethical ones. In the case of our engineer and his stem cell research, he’ll use the Biomedical Engineering Society Code of Ethics and WMA Declaration of Helsinki- Ethical Principles for Medical Research Involving Human Subjects. According to Biomedical Engineering Professional Obligations it states that biomedical engineers should “Use their knowledge, skills, and abilities to enhance the safety, health, and welfare of the public” [7]. Which in this case would mean to continue with process as is because the creation of stem cells with in turn save lives by curing health problems. But it also states that engineers should “Regard responsibility toward and rights of patients, including those of confidentiality and privacy, as their primary concern” [7]. And with that the patient could be explained the process with full detail and allow them to make the decision if they believe the process is morally sound or not. The WMA states that “In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects” [8]. In this scenario clearly the importance of the objective carries a lot of weight because it would save lives but there are always risks and burdens with each and every patient. And similarly the WMA also states that “Participation by individuals capable of giving informed consent as subjects 2 Peter Shilowich in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees” [8]. Both codes of ethics provide similar and knowledgeable information about what is required to make a decision in the field of bioengineering. But before our engineer can make a final decision he needs to take a look at some case studies that explain hypothetical situations with solutions. an embryonic stem cell. Possibly using an egg cell from another animal so people would not be up in arms about the destruction of a human embryo and the value of life. RESOURCES [1] (2002). “Stem Cell Basics: Introduction.” Stem Cell Information (Website). National Institutes of Health, U.S. Department of Health and Human Services. http://stemcells.nih.gov/info/basics/pages/basics1.aspx [2] “Basics of Stem Cell Research.” American Medical Association. (Website). http://www.amaassn.org/ama/pub/physician-resources/medicalscience/genetics-molecular-medicine/related-policytopics/stem-cell-research/basics-stem-cellresearch.page?# CASE STUDIES Jim and the Forgotten Embryos This case study comes from the State University of New York at Buffalo. The goal of this study is to expose students to the basics of embryonic stem cell and their therapeutic use, and they do this through the story of a college student, Jim Allison. Jim is paralyzed in a car accident and Jim is approached by doctors to participate in a study where patients are injected with embryonic cells in the hope that these cells will regenerate damaged nerve cells. The purpose of the study is to show how a family and patient decided to participate in the destruction of embryos or not. They have to decide what the moral status of an embryo is and whether they are ok with destroying the possibility of life. [9] [3] Mayo Clinic Staff. (2013). “Stem Cell Transplant.” Mayo Clinic. (Website). http://www.mayoclinic.org/testsprocedures/stem-cell-transplant/in-depth/stem-cells/art20048117?pg=1 [4] K. Hug. (2011). “Embryonic Stem Cell Research: An Ethical Dilemma.” Euro Stem Cell. (Online Article). http://www.eurostemcell.org/factsheet/embyronic-stemcell-research-ethical-dilemma [5] Siegel. A. (2013). “Ethics of Stem Cell Research.” In Stanford Encyclopedia of Philosophy. http://plato.stanford.edu/entries/stemcells/#WheDoeHumBeiBegExi CONCLUSION AND FINAL DECISION [6] D. Beeson, A. Lippman. (2006). “Egg Harvesting for Stem Cell Research: Medical Risks and Ethical Problems.” RBM Online. (Online Article). Along with all the of the information that was presented throughout with paper, our engineer decided to take a poll around his place of work of people who were not involved in the research. He asked them to answer with the morals in mind. And what he found was that majority of the people he polled believed that the process of destroying an embryo in order to make embryonic stem cells was morally ok because of the power and usefulness of these embryonic stem cells. When our engineer puts all of the facts and information together the best solution to the scenario at hand is for our engineer to continue research as is but when a procedure is to occur the patient must have full disclosure of what occurs. And at that point if the patient is accepting with how the stem cells were produced then the process can happen but if don’t then the patient needs to seek other treatment. For future engineers a way to fix this entire scenario would be to discover a way to genetically create [7] “Biomedical Engineering Society Code of Ethics.” (2004). Biomedical Engineering Society. (Website). http://bmes.org/files/2004%20Approved%20%20Code%2 0of%20Ethics(2).pdf [8] “WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.” (2002). World Medical Association. (Website). http://www.wma.net/en/30publications/10policies/b3/inde x.html [9] Segura-Totten, M. (2012). Jim and the Forgotten Embryos. National Center for Case Study Teaching in Science: SUNY Buffalo. [Case Study]. ADDITIONAL SOURCES 3 Peter Shilowich YouTube. (2012, October 18). The Ethical Questions of Stem Cell Research [Video file]. Retrieved from http://www.youtube.com/watch?v=f5d0ieWfKlI Members of Forbes Floor 3 (personal communication, October 27, 2014) Zenios, S., Denend, L., Boeing, W., Majumdar. R., Riskin, D. A Problem of Understanding. Stanford Biodesign. [Case Study]. Honesty’s Always the Best Policy. Web Guru: Guide for Undergraduate Research. [Case Study]. ACKNOWLEDGEMENTS I would like to thank Nicole Faina for coming into our class and explaining in great detail how this paper should go. 4