Budny 10:00 L10 ARTIFICIAL LUNG TRANSPLANTATION: DO WE VALUE ETHICS OR HUMAN LIFE? Piyusha Sane (pms44@pitt.edu) TERMINALLY ILL PATIENT’S STRUGGLE TO LIVE Gasping for air, a seventy year-old woman finds herself being rushed out of an ambulance on a stretcher. Her family members hurry behind. The scene in the Emergency Department of the city’s largest hospital is rather chaotic: paramedics, nurses, doctors, and surgeons, running from one room to another gathering materials, all on a mission to save another life. After diagnosis, the professionals determine that the patient has acquired a rare lung disease that cannot be cured with the equipment present in the hospital. The physicians estimate that the woman will have only four weeks to live, unless a miracle should occur. The aged woman would be added to the list for lung transplant. Meanwhile, the news upsets the entire family of the patient. The doctors advise the family that it should not count on the transplant since the waiting list for organ donors is extensive. A physician adds that “an average of 18 people die each day waiting for transplants that can’t take place because of the shortage of donated organs” [1]. Hearing this alarming statistic, the son firmly rises and poses a request to the surgeon: he would like to offer $100,000 to the engineers who could construct an artificial lung for his mother. The surgeon contacts me, a bioengineer at the University of Chila Pulmonary Research Institute, with the request. I approach the head of our lab team and, we set up a lab meeting with my team members to discuss the situation. This was the first time the world would hear of a long-term artificial lung transplant. First we consider the possible processes we could employ to design and build the organ. Then, the lab team deliberates over the techniques used in the past to manufacture artificial organs including the trachea, bladder, and heart. Following the reflection, the members realize that although the lung could be made in the four weeks, there most likely would not be enough time to perform the required testing certifying the lung for transplantation. After a few minutes of thought, the head of the lab team decides that the testing is not necessary; he suggests we should regard the monetary award with utmost importance. Moreover, the woman is terminally ill. Even if the transplanted lung had defects, would it not be better to try to save a life with the time and resources we have? The head remarks that he can get the certification made by a friend who is part of the Bioengineering Board of Certification. The team would simply have to pay $1000 to obtain certification that approves the untested lung for transplantation. We must vow to secrecy, University of Pittsburgh, Swanson School of Engineering 1 2013-10-01 because the physicians, patient, and family members will be told that the certification is official. I sit there puzzled. How could we misinform the patient, misinform the physicians, misinform the world? At the same time, was it not better to try to save a life than leave the woman to her terminal illness? Mystified, I start planning the construction of this organ, reconsidering the procedure and past successes of organ transplantation. Would there any way to build and test the lung in four weeks and obtain official certification for the transplant? Would it acceptable to transplant the lung without official certification? Would the artificial lung transplant even help rectify her terminal illness? THE PROCESS OF ORGAN TRANSPLANTATION To answer the questions running through my mind, I explore the practice of organ transplantation. Through experimentation, bioengineers have been able to consider three main techniques to acquire organs for transplantation. The oldest method involves direct replacement by a donor organ. Unfortunately, this system carries a major drawback: “the foreign tissue can be rejected by the recipient” [2]. To challenge this issue, researchers discovered the practice of reseeding, in which a donor’s organ is reseeded with the patient’s own cells [2]. In this case, although there is no foreign tissue which can be rejected, several other problems persist. According to the New York Times, “A donated organ may not be the right size; it has to be stripped of its cells and reseeded while the recipient waits; and the procedure still requires donor organs, which are in short supply” [2]. Even if a donor organ is available, this time-consuming process could prove to be too lengthy for the patient’s survival. Attacking the difficulty of obtaining donor organs, today’s engineers are discovering a third formula to procure organs for transplantation: construction of artificial organs using stem cells. This technique uses a synthetic scaffold made with templates of the patient’s own organ. This not only ensures that the organ will be accepted by the patient’s body, but also that it will be of the perfect size for the patient [2]. And best of all, the patient will not have to wait for a donor organ. In the case of our task, the woman would not be able to attain a donor organ in the four weeks considering the overwhelming discrepancy between patients and donors: “There are currently 118,617 people waiting for lifesaving organ transplants in the U.S.” compared to the 14,630 donors [2] [3]. Consequently, we cannot approach the situation with direct donor organ transplantation or use the technique of reseeding donor organs. Ultimately, building an artificial Piyusha Sane organ using the patient’s own stem cells remains our only option. It is important to review prior achievements in the bioengineering division of artificial organs. These would guide us in our project. Heart Beats to Life As seen above, engineers have been fruitful in producing hollow organs, “a visceral organ that is a hollow tube or pouch or that includes a cavity which serves a vital function,” such as the trachea and the bladder [6]. But now, the focus lies in creating more complex organs, which could change the scene of transplants forever. Currently, many research teams around the world are working to construct an artificial heart. The French company Carmat recently developed an artificial heart devised from cow tissue (animal stem cells) [7]. According to the New York Times, “the device, soon to be tested in patients with heart failure, is regulated by sensors, software, and microelectronics. And its power will come from two external, wearable, lithium-ion batteries” [7]. The next step in this project is to eliminate the batteries and sensors to have a heart pumping on its own. Then, the heart will be tested again before widespread use [7]. Such discoveries are on their way to guiding engineers into shaping more efficient and practical solutions to organ dysfunction. A critical point in this case is that this heart is taken through gradual stages of development and is tested multiple times before its integration into the human body. In the four weeks, we would not have time to perform repeated tests to achieve precision and accuracy in the making of the lung. ACCOMPLISHMENTS: YESTERDAY, TODAY, AND TOMORROW An Extra Breath of Air As of now, engineers have been able to build a few organs from patient stem cells, the most prevalent method of artificial organ construction. One of the first artificial organ transplants was that of a trachea: “Surgeon Paolo Macchiarini has made his name by successfully transplanting bioengineered stem cell-based trachea, composed of both artificial and biological material” [4]. In 2011, Andemariam Beyene, a patient in Sweden, found a tumor growing in his windpipe that could not be contained through surgery. He was on his death bed, when Dr. Macchiarini considered the idea of building a windpipe for Beyene [2]. Dr. Macchiarini, a doctor at the Karolinska Institute, was determined “to harness the body’s repair mechanisms so that it [could] make a damaged organ on its own” [2]. In June 2011, he showed the world that he could design, construct, and transplant a windpipe through Beyene’s own stem cells. The doctor emphasizes the significance of using the features of the human body to treat itself: “The human body is so beautiful, I’m convinced we must use it in the proper way,” as he aims on building more complex tissues and organs, such as the esophagus, diaphragm, heart and lungs, for transplants [2] [4]. As we attempt to construct the lung, we must apply a similar technology, using the patient’s own stem cells as our building blocks. This way, we can be sure that her body will not reject the tissue. ETHICAL CONCERNS The main issue with our project is time. Designing and constructing the lung would take four weeks based on previous experience. So, obtaining a valid, genuine certification would not be possible in the given time. But my boss’s solution of faking the certification would not be tolerated as per the National Society of Professional Engineers (NSPE) Code of Ethics and the Biomedical Engineering Society’s (BMES) Code of Ethics! As engineers, we are expected and required to follow these guidelines in our research, design, and implementation. The Bladder’s Rebirth Along with the trachea, bioengineers have successfully constructed and transplanted bladders also fabricated from the patients’ own cells. At Wake Forest University School of Medicine, the Institute for Regenerative Medicine conducted a study to build new bladders for “patients four to nineteen years old who had poor bladder function because of a congenital birth defect that causes incomplete closure of the spine” [5]. This process involved conducting a biopsy of the children to obtain cells that were then grown and placed into a biodegradable scaffold in the shape of a bladder. Smooth transplantation of the bladder has shown successful results in several patients [5]. Here, we see that the scaffold is one of the most important parts of design. Learning from this case, it is vital that we manufacture a scaffold that perfectly supports the woman’s internal network of tissues and vessels, eliminating any possible sources of rejection. Considering the NSPE Code of Ethics The NSPE Code of Ethics is established as a part of the engineering profession, in which integrity and honesty are two of the respected principals of conduct. If we would have a counterfeit certification made, this would clearly violate the fifth canon of the Code of Ethics: “Engineers shall avoid deceptive acts” [8]. The code explicitly states that engineers should not “falsify their qualifications” [8]. The lab team cannot accept credit for the production of the lung if it has not passed official regulations. Considering the BMES Code of Ethics The BMES Code of Ethics highlights the responsibilities of professionals in the department of biomedical engineering, incorporating “engineering, science, technology, and 2 Piyusha Sane medicine” [9]. It divides its code into four sections, “professional practice, research, patient care, and training,” each designated to a particular subsection of the biomedical engineering field [9]. As a biomedical engineering lab team, we strive to use our “knowledge, skills, and abilities to enhance the safety, health, and welfare of the public” [9]. Additionally, we must regard the greater consequences of our work, and how they affect our health care delivery [9]. In our attempt to design the lung, we would surely be attempting to encourage the health and wellbeing of the patient, but we cannot guarantee our success without testing the lung, ultimately risking the safety of the individual. And even though on a larger scale we are attempting to save a life, it remains unethical to risk the welfare of the patient, thus negatively affecting our health care delivery. everything possible to construct the lung and certify it for transplantation. But several questions remain unanswered. Provided we do not have the time to test the artificial lung, should we obtain a fake certification to follow through with the transplant? Should we hide the uncertainty of the transplantation results from the patient, the family members, and the physicians? Should we value ethics or human life? I consider it my responsibility to abide by the ethical codes of conduct and avoid deception. Only with approval from the Bioengineering Board of Certification shall we proceed with the lung transplantation. REFERENCES [1] “The Need is Real: Data.” U.S. Department of Health and Human Services. (2013). (Website). organdonor.gov/about/data.html [2] H. Fountain. (2012, November 15). “A First: Organs Tailor-Made With Body’s Own Cells.” New York Times. (Online article). www.nytimes.com/2012/09/16/health/research/scientistsmake-progress-in-tailor-madeorgans.html?pagewanted=all&_r=0 [3]“Organ Donation and Transplantation Statistics.” National Kidney Foundation, Inc. (2013). (Website). www.kidney.org/news/newsroom/factsheets/OrganDonation-and-Transplantation-Stats.cfm [4] “Stem Cell-Based Bioartificial Tissues and Organs.” Science Daily. (2013, February 18). (Online article). www.sciencedaily.com/releases/2013/02/130218103026.htm [5] “Wake Forest Physician Reports First Human Recipients of Laboratory-Grown Organs.” Wake Forest Baptist Medical Center. (2013, April 18). (Online article). www.wakehealth.edu/NewsReleases/2006/Wake_Forest_Physician_Reports_First_Hum an_Recipients_of_Laboratory-Grown_Organs.htm [6] “Hollow Organ.” Merriam Webster (2013). (Website). http://www.merriam-webster.com/medical/hollow%20organ [7] A. Eisenberg. (2013, July 13). “The Artificial Heart is Getting a Bovine Boost.” New York Times. (Online article). www.nytimes.com/2013/07/14/business/the-artificial-heartis-getting-a-bovine-boost.html?_r=0 [8] “NSPE Code of Ethics for Engineers.” NSPE (2013). (Online article). http://www.nspe.org/Ethics/CodeofEthics/index.html [9] “Biomedical Engineering Society Code of Ethics.” Biomedical Engineering Society (February 2004). (Online article).http://bmes.org/files/2004%20Approved%20%20Co de%20of%20Ethics(2).pdf [10] A. Steinberg. (2012) “The Terminally Ill Patient” The First International Colloquium. (Online article). http://www.hods.org/pdf/Steinberg%20Terminally%20ILL %20Patient2.pdf [11]The IAHPC Manual of Palliative Care. (2013). (Online article). Ethics in Terminally Ill Patients Since we are confronted with a terminally ill patient, it is necessary for the lab team to consider the ethics pertaining to that dispute in addition to the Engineering Codes of Ethics. According to Professor Avraham Steinberg, a pediatric neurologist at the Shaare Zedek Medical Center, we find terminally ill patients to be “people whose quality of life seems greatly reduced, and whose survival is expected to be short” [10]. But what does that mean? The professor discusses the ethical concerns of terminally ill patients emphasizing that the term possesses a very vague definition. He states: “in effect, we are all terminal. The most serious and dangerous disease that a person can contract is called life, because it is the one thing that we know for certain will lead to our death” [10]. This argument poses the idea that the case cannot simply be considered as a “terminal illness”: just because this woman has a fatal illness does not mean it is acceptable to “try and see” if the organ functions in her body. The truth is, we are not even sure of whether this lung transplant would save the woman’s life. The IAHPC Manual of Palliative Care stresses that “terminally ill patients should not be subjected to futile therapies” [11]. In our case, the team members cannot not predict whether this transplant would be futile or successful! How could we proceed to building and transplanting an organ without knowing its potential effects and consequences on the human body? CHALLENGE TO RESPONSIBILITY As a bioengineer, I feel that it is my duty to support the growth of the engineering discipline. I should accept the challenge as a responsibility and construct the first artificial lung. Engineers now have the capabilities of designing and producing artificial organs, and I must take advantage of the emerging technology. Meanwhile, the lab team must reflect upon the ethical concerns of the situation. I will meet with the head of the lab team to decide what would be in the best interest of both the lady and the engineers. In the four weeks given, we would do 3 Piyusha Sane http://hospicecare.com/uploads/2013/9/The%20IAHPC%20 Manual%20of%20Palliative%20Care%203e.pdf ACKNOWLEDGEMENTS I would like to thank Dr. Budny for giving me a chance to explore the bioengineering world in action. Also, I appreciate Ms. Katy Rank Lev’s guidance in explaining the project with clarity. Additionally, I sincerely thank my writing instructor, Ms. Janine Carlock, who directed me in the process of writing a coherent and focused paper. 4