Bursic, 2:00 R14 AN ETHICAL DILEMMA IN BIOPRINTED ORGANS Edward Skorpinski (ejs96@pitt.edu) GROWING HEALTH CRISIS The United States faces a health crisis that continues to grow. Each year, thousands of people die who could have been saved by an organ transplantation. According to the National Kidney Foundation, an average of 12 people die every day awaiting a lifesaving kidney donation. [1] Adding on to the difficulty of the situation, the number of transplants needed in the United States continuously increases. Longer life spans due to the effects of modern medicine unfortunately contain the side effect that organs are more likely to deteriorate over time. As the length of the average American life increases, so does the possibility of an organ failure. Figure 1 shows how the organ shortage has grown over time. a patient. How would a responsible, ethical engineer go about solving these problems? BIOENGINEERING WITH 3D PRINTING Additive engineering Additive engineering is a manufacturing method of producing extremely precise parts, while additionally eliminating much of the waste produced by standard manufacturing practices. The procedure of 3D printing involves the layering of material to form objects of any shape or size. Products are formed after the application of numerous layers, which can be as thin as 0.05 mm. [3] Many different materials can be utilized in additive engineering such as multiple resins, plastics, metals, and ceramics. 3D printing allows for advanced precision and the ability to create unique shapes. Manufacturers gained the ability to create complex products with relative ease as compared to traditional engineering methods. [4] Additive engineering also cuts down on the amount of waste produced during the manufacturing process. In traditional manufacturing methods, products are often made through the removal of material to form a desired shape. Advances in 3D Printing FIGURE 1 [2] The number of organs needs for donation increases steadily every year while the number of organs available remains stagnant. In order to combat the problem, doctors need a drastically increased supply of organs, and biomedical engineers have found a possible solution. Currently the technology to produce artificial organs through additive engineering is in development. Engineers working with biomaterials have made great strides in developing 3D printing organs available for transplantation. The ability to readily produce artificial organs will effectively end the organ donation crisis. However, the situation also could lead to ethical dilemmas. Artificial organs would be an extremely lucrative industry; an industry in which an entrepreneurial businessperson could earn a fortune. When a person’s live is at stake, one must be careful not to cross the fine line between business and extortion. Also, the consequences of failure could be fatal to University of Pittsburgh, Swanson School of Engineering 1 2014-10-28 In 2011, the industry experienced a 30% growth after starting the year valued at around $1.9 billion. [5] Additive engineering spread very quickly around numerous industries. Industries such as health care and aerospace engineering are especially involved in the development of 3D printing because of its high precision. According to the World 3D Printing to 2017 report, the market is anticipated to continue to grow at a rate of over 20% per year to reach a net worth of over $5 billion in 2017. [6] As the industry continues to grow, the number of applications will only continue to grow. One such advancement in the industry is the ability to print human tissue and organs. Bioengineering Process The concept of creating functional living organs adds a unique and challenging aspect to the regular additive engineering process. Similar to regular 3D printing, bioprinting involves the layering of material in succession in order to produce a finished product. However, the material used in bioprinting must be compatible with natural living tissue while also containing all of specified tissue’s structural and operational properties. This requirement is known as biocompatibility. Certain types of materials need to be used, Edward Skorpinski such as polymers derived from human or animal specimen or specifically designed synthetic molecules. Natural polymers are advantageous in the aspect of easy compatibility with the human body, and some examples of natural polymers used are alginate, gelatin, and hyaluronic acid. Synthetic polymers can be designed for specific uses depending on their use in the body. However, they are harder to make biocompatible. [7] 3D bioprinting is comprised of three major aspects: biomimicry, autonomous self-assembly, and mini-tissue building blocks. The purpose of biomimicry is to create exact replicas of living human tissue. In order to achieve this, engineers must develop the polymers on a microscopic scale. Then the polymers must organize themselves as a standard group of human tissue cells. Known as autonomous selfassembly, the 3D printed cells must be able to control their own function, structure, and future growth. The third strategy of bioprinting involves using mini-tissues as building blocks to construct a cellular structure. Engineers recreate the biological design of a cell and construct its components one by one. Typically, the construction of a complex biological object involves a combination of the three approaches. [7] potential and releasing it before our competitor would give my company the upper hand. Individually, my career would take a huge leap forward with this product’s financial success. Unfortunately, failure of the product could prove deadly to my clientele. As an engineer, I need to evaluate how to ethically solve the situation. ETHICS IN ENGINEERING Engineering for the greater good As professionals and servants of the public good, engineers are bound to follow a strict code of ethics. In 2007, the National Society of Professional Engineers (NSPE) released a revised version of their code of ethics. The code is meant to govern the engineering community as a whole with a set of standard practices. Through following it, engineers uphold the integrity of the profession. First and foremost, as described in the opening canon of the NSPE Code of Ethics for Engineers, is that engineers must “hold paramount the safety, health, and welfare of the public.” [8] In this context, the public should be the primary concern for every engineer. The general public’s wellbeing shall take precedence over any other concern. The NSPE Code of Ethics outlines the general principles of how engineers are meant to take responsibility for the effects of their actions on society. Nonetheless, engineering covers such a diverse range of disciplines that one broad code could not cover the whole spectrum. In response, different areas of engineering have developed their own specific codes of ethics. For example, the Biomedical Engineering Society developed their own code of ethics. It is meant specifically for engineers who work in the areas of “engineering, science, technology, and medicine.” [9] Through consultation of the general and any specific codes of ethics, an engineer has the resources necessary to make an ethical decision. ETHICAL DILEMA I work for a bioengineering company called B.E.D., which stands for Biomedical Engineering Design. We have recently developed an artificial kidney produced through 3D bioprinting. I am the lead engineer on the design team, so I take a large portion of the responsibility for the development of the product. The kidney shows initial promise, but remains largely untested on human subjects. The initial tests acquired inconclusive results and showed that the kidney is not consistently stable. Thousands of Americans are in dire need of a kidney transplant, and the number is continuously growing. An artificial kidney which can be easily produced would make millions of dollars. Clients for the kidney would not hesitate for a potentially life-saving operation. However, another rival company is also developing an artificial kidney and they are very close to completion. The executives at B.E.D. want to push the kidney onto the market as soon as possible in order to release it before our competitor. I am being pressured by my superiors to rush through the testing process as soon as possible. They want me to ensure that the kidney will pass through testing no matter the cost, even if I have to fabricate data. I am hesitant to put a product on the market that might not be completely ready. The kidney would drastically improve lives and solve the donation shortage crisis for the United States. B.E.D. would earn enormous profits and as lead engineer on the project, I would likely receive a large promotion. However, a dysfunctional product would lead to horrific results. Any patient who receives a faulty kidney would face an enormous health risk. Releasing the kidney as soon as possible would be hugely beneficial to B.E.D. financially. If we wait too long and our competitor releases their product before us, we would lose a large portion of our expected profits. The kidney has enormous market Examining Ethics in Developing Artificial Organs Introducing an artificial kidney to the public would provide an immense service to humanity. The lack of kidneys available for transplant stands out as one of America’s largest problems in modern medicine. With 3D printed kidneys, the situation would be almost completely resolved. For example, look at the situation presented by Dr. Anthony Atala in his TED talk “Printing a human kidney.” In the lecture, Dr. Atala explains how a procedure involving a transplant of a 3D printed bladder drastically improved the health of a young patient named Luke Massella. Through receiving this new artificial organ, the patient’s livelihood significantly improved. [10] Due to the success of the procedure, Dr. Atala took great strides forward in the field of bioengineering. He exemplifies the professional obligation of a biomedical engineer to “strive by action, example, and influence to increase the competence, prestige, and honor of the 2 Edward Skorpinski biomedical engineering profession,” set forth in the first canon and second directive of the BMES Code of Ethics. [9] Biomedical engineers are not only encouraged, but obliged, to further the development of their field. In accordance with my code of ethics, I would be obligated to work on the advancement of an artificial kidney when presented with the opportunity. As an engineer, one must work in conjunction with numerous other fields of study as well as other disciplines of engineering. To quote Josep Basart and Montse Serra in their paper on the complexities of engineering ethics, engineers must be able to “exist and operate as a node in a complex network of mutual relationships with many other nodes. [11] In the field of bioengineering, professionals must also assume the responsibility of a health care provider. The products which bioengineers create directly influence the health of a patient as well as the physician who implements the aforementioned product. In doing so, they assume the responsibilities of a patient’s health and wellbeing. I consulted a physician, Dr. Edward W. Skorpinski, MD, on the responsibilities of his profession. He responded: more easily evaluate a current dilemma or scrutinize it from a different viewpoint. Also, engineers can view past precedents through studying previous ethical situations. Through reference and comparison to previous cases, an engineer can make a much more highly educated decision. To Release, or Not to Release: An Engineer’s Perspective The case study presents a hypothetical situation where a company known as X Medical wants to introduce a new medical device to the market. However, not every qualitycontrol procedure was followed correctly and the product may not be completely ready for commercial use. [15] The case presents the questions of the potential consequences of a dysfunctional product and how the situation should be addressed. The Health Care Obligations section of the BMES Code of ethics states the patient health is the foremost priority and the overall consequences of one’s work must always be in consideration. [9] Under the circumstances, the engineer’s ethical duty should be to ensure the safety of the new product. If the device requires greater confirmation that it will be effective, the engineer is responsible for it. If the product is unsafe for the public, then the engineer must take responsibility in ensuring that the device is not prematurely released. Those in the medical profession have been entrusted with the responsibility of putting the needs of their patients first, and while it is important to bring new medical developments to light one must also be certain that it is done in a manner which guarantees that due diligence has been performed and that patient safety is foremost. As stated in the physicians’ Hippocratic Oath, “I will take care that they suffer no hurt or damage. [12]” [13] Overly Ambitious Researchers – Fabricating Data The case study recounts two scenarios in which students fabricated experimental data in order to achieve quick, accurate results without having actually completed the work. Each student’s misconduct was discovered and any significance placed upon their work was removed. In addition, each student’s respective reputation was tarnished. [16] The falsification of data is strictly forbidden in both the NSPE (I.1.a.) [8] and BMES (Research Obligations, 2) codes of ethics. [9] Under no circumstances is the fabrication considered ethical, as the faulty research could lead to a dysfunctional product. In the medical field especially, such a product could prove extremely harmful to the public. Dr. Skorpinski explained the medical profession’s responsibility to prioritize patients’ needs. Similarly, the second canon, second directive of the BMES Code of Ethics defines an engineer’s duty to “Regard responsibility toward and rights of patients, including those of confidentiality and privacy, as their primary concern.” [9] This similarity with engineering and medical ethics exemplifies the multidimensionality of engineering and how ethics from different professions blend together. Challenger Disaster The Space Shuttle Challenger Disaster unfortunately resulted in the deaths of seven astronauts and exemplifies the consequences of not following ethical procedure. Prior to the shuttle launch, engineers brought crucial information about a possible launch failure to mission directors. The engineers warned that low air temperatures could cause malfunctions in the O-rings of the solid rocket boosters, but the directors disregarded their warnings as negligible. [17] The consequential rocket explosion shows that negative side effects of an ignorance of ethics. The engineers who revealed the possible failure were following section III.1.b of the NSPE Code of Ethics, “Engineers shall advise their clients or ANALYZATION OF CASE STUDIES Benefit of case studies “Case studies give young engineers an opportunity to see ethical precepts at work in actual situations and, through, discussion, to benefit from the views and experiences of other professionals,” says Tara Hoke, assistant general counsel for the American Society of Civil Engineers. [14] She was commenting on the effectiveness analyzing ethical situations through the use of case studies. Case studies can be used to 3 Edward Skorpinski employers when they believe a project will not be successful.” However the executives who ignored the advice then as a result violated the first fundamental canon of the code by not prioritizing the safety of the public. The case study exemplifies the possibilities of engineers who do not follow ethical procedure. Engineers are responsible for the consequences of their actions. Since the ramifications of an engineer’s work can prove dire, the importance of following ethical code should always be an engineer’s top priority. and earn massive profits, I cannot ethically do so. I hold an obligation to my profession as an engineer to provide the best service to the public as I possibly can. REFERENCES [1] (2014) “Organ Donation and Transplantation Statistics.” National Kidney Foundation. (online article). http://www.kidney.org/news/newsroom/factsheets/OrganDonation-and-Transplantation-Stats [2] (2014) “The Need is Real: Data.” Organdonor.gov. (online article). http://www.organdonor.gov/about/data.html [3] (2014). “3D Printing Materials, Terminology, and Specifications.” Genesis Framwork. (online article). http://3dprototypesandmodels.com.au/3d-printingterminology-specifications/ [4] (28 Feb. 2013). “Additive Manufacturing and 3D Printing.” Chemical Industry Digest. (online article). http://go.galegroup.com/ps/i.do?id=GALE%7CA320677245 &v=2.1&u=upitt_main&it=r&p=AONE&sw=w&asid=b329 71350b2f0fb46c6fa48d1b18b30b [5] (28 Feb. 2013). “Additive Manufacturing and 3D Printing.” Chemical Industry Digest. (online article). http://go.galegroup.com/ps/i.do?id=GALE%7CA320677245 &v=2.1&u=upitt_main&it=r&p=AONE&sw=w&asid=b329 71350b2f0fb46c6fa48d1b18b30b [6] (Dec. 2013). “World 3D Printing to 2017.” ReportsnReports. (online article). www.reportsnreports.com/reports/272154-world-3dprinting-to2017.html [7] S. Murphy, A. Atala. (5 August 2014). “3D bioprinting of tissues and organs.” Nature Biotechnology. (online article). DOI: 10.1038/nbt.2958 [8] (2007). “NSPE Code of Ethics for Engineers.” National Society for Professional Engineers. (online article). http://www.nspe.org/sites/default/files/resources/pdfs/Ethics/ CodeofEthics/Code-2007-July.pdf [9] (February 2004). “Biomedical Engineering Society Code of Ethics.” Biomedical Engineering Society. (online article). http://bmes.org/files/2004%20Approved%20%20Code%20o f%20Ethics(2).pdf [10] (March 2011). “Anthony Atala: Printing a human kidney.” TED. (online video). http://www.ted.com/playlists/144/should_we_redesign_hum ans [11] J. Basart, M. Serra. (15 July 2011). “Engineering Ethics Beyond Engineers’ Ethics.” Science and Engineering Ethics. (online article). http://link.springer.com/article/10.1007/s11948-011-9293z/fulltext.html [12] (28 August 2014). “Hippocratic Oath (Modern Version).” Johns Hopkins Sheridan Libraries. (online article). http://guides.library.jhu.edu/bioethics [13] E. Skorpinski. (26 October 2014). Interview COMPARISON TO CASE STUDIES AND ETHICAL DECISION After analyzing the precedents set forth by the case studies, I can make comparisons between them and my current ethical predicament. The case study in which an engineer is being pressured to push a product to the commercial market to early shares a current resemblance to my current situation. It established that I must follow the Health Care Obligations of the BMES Code of Ethics by placing my patients’ health care as my number one priority. Therefore, I should take all measures necessary to confirm that B.E.D.’s artificial kidney is completely ready for patient use before the product is released. Also if the company plans to release the kidney anyway before my confirmation, I am obliged by section III.1.b of the NSPE Code of Ethics to “advise my client or employers when I believe a project will not be successful.” [8] I must be responsible for only releasing quality products to the public. Therefore, I must pledge to keep B.E.D. from selling a questionably finished product. In addition, I must resist the pressure put upon me by my superiors to possibly falsify data. As seen in the case study about the students’ fabricated lab results, any falsified scientific data is not permitted by the BMES Code of Ethics. Therefore, I may not publish any deceitful and dishonest reports for the purpose of releasing the kidney to the commercial market sooner. Thirdly, the potential causes of transplanting malfunctioning kidneys into patients parallels the ethical dilemma of the Challenger case. When an engineer makes a mistake, he must take responsibility for that mistake. I may not allow any harm to come to the public because I allowed them to use an unsafe product. The Space Shuttle Challenger disaster stands as an example of how an irresponsible engineering mistake can lead to casualties. If B.E.D. decides to proceed with releasing a possibly dysfunctional artificial kidney, it is my duty to try and ensure the company takes an ethical approach. CONCLUSION I will in my best effort attempt to benefit my company by releasing the artificial kidney as soon as possible. However, it must be done in a thorough manner. Despite the temptation to sell an unfinished product to gain a jump on the competition 4 Edward Skorpinski [14] T. Hoke. (May 2012). “The Importance of Understanding Engineering Ethics.” Civil Engineering. (print article). Vol. 82, no. 5. pp.40-41. 2p [15] M. Pritchard. (26 October 2014). “Case Study 1: Overly Ambitious Researchers – Fabricating Data.” National Academy of Engineering. (online case study). http://www.onlineethics.org/Education/precollege/sciencecla ss/sectone/chapt4/cs1.aspx [16] “To Release, or Not to Release: An Engineer’s Perspective.” Stanford Biodesign. (online case study). http://biodesign.stanford.edu/bdn/ethicscases/21releasequesti on.jsp [17] “Engineering Ethics: The Space Shuttle Challenger Disaster.” Texas A&M University Department of Philosophy and Department of Mechanical Engineering. (online case study). http://ethics.tamu.edu/Portals/3/Case%20Studies/Shuttle.pdf ADDITIONAL SOURCES S. Glenn. (15 Mar. 2013). “Developments in 3D printing and additive manufacturing.” Advanced Manufacturing Technology. (online article). http://go.galegroup.com/ps/i.do?id=GALE%7CA337816638 &v=2.1&u=upitt_main&it=r&p=AONE&sw=w&asid=8b90 7c8550826ccd3e2c1fa2b2e6239a D. Richards, Y. Tan, J. Jia, H. Yao, Y. Mei. (2 October 2013). “3D Printing for Tissue Engineering.” Israel Journal of Chemistry. (online article). http://onlinelibrary.wiley.com/doi/10.1002/ijch.201300086/p df ACKNOWLEDGEMENTS Foremost, I would like to thank Ben Bucks, my high school CAD teacher who first introduced me to 3D printers. Thank you to Dr. Edward Skorpinski for taking time out of his busy schedule for an interview. Thank you to Starbucks and Monster Energy for providing me with the energy with which to write. Thank you to the Hillman Library staff for creating an excellent work environment. Finally, thank you to the residents of Forbes Hall, fourth floor, who aided in my writing process through peer advisement and editing. 5