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Mike Iasella (mgi4@pitt.edu)
Often times, engineers can find themselves having to make very difficult decisions. These are decisions that have the potential to completely change people’s lives.
They must choose from options of price, affordability, efficiency, safety, risk, and many more important aspects when designing products. Similarly, I currently find myself having to make a tough choice. The results of my actions have the potential to make me a very large sum of money, but at the cost of potentially injuring or even killing those who receive my product. Before I divulge the specifics of my predicament, it is import that one an understanding of cellular connective tissue.
Few things in life can last forever, and the protective cushioning and support that connective tissues provide are no exception. As you may know, the human body is made up of trillions of specialized cells that work together to complete our everyday routines. The cells of the body are not all the same but rather divided into several different kinds of tissues.
These tissues each have varying properties that allow them to serve a particular purpose. Connective tissue consists primarily of tendons and ligaments. “Tendons and ligaments are tough, fibrous bands, made mostly of collagen, that anchor networks of muscle to a bone or link bones and cartilage across crucial joints” [ 1 ]. It is connective tissue that holds the joints together and cushions the bones from grinding against each other. Unfortunately, this cushioning can eventually be worn away or damaged [ 2 ]. Additionally, the tendons and ligaments themselves can become inflamed, sprained, or even torn. Unlike many other tissue types, connective tissue has very poor regenerative ability. This is due to the fact that it is avascular and anural; blood does not flow directly through the tissue but rather the nutrients and cell waste are diffused from elsewhere [ 3 ]. Since a high quantity of nutrients are needed for growth and repair, connective tissue cannot regenerate effectively. Ironically, since this tissue is avascular and anural, it is relatively simple tissue and a good candidate for synthesis. I have been able to make significant progress towards regeneration through laboratory means. Without a network of arteries, veins, or nerves, this tissue is fairly basic and made of only a single cell type. Over 15 years in the making, new treatments offer hope for the many people waiting in pain [ 4 ].
Every joint in the human body is held together with ligaments and tendons. Ligaments are tissues that lead from one bone to the other, while tendons are from bone to muscle.
Both are vital for the proper movement of the body. They are made up of a substance known as collagen. Collagen is a strong and flexible material that is present in two types: type
I and type II. Type I is weaker and less desirable in cartilage regeneration than type II [ 4 ]. Both types are produced by fibroblasts. When a tendon or ligament is damaged the recommended treatment is usually to rest for a period of time.
However, if the ligament is severed, the treatment is to perform surgery, to remove and then replace the ligament.
Since synthetic ligaments have not been successfully produced yet, often times patients must have part of a different ligament repositioned to do the job of the severed ligament. That is the case of the roughly 100,000 people who undergo ACL surgery each year [ 1 ]. Recovery is extensive and can take up to two years before patients may return to full strength. It is for this reason that a way to regenerate ligaments is greatly desired by both patients and medical companies.
Patients want a quick recovery and medical companies want to control the market which is in high demand.
Theoretically, stem cells are capable of regenerating anything in the human body. In the embryonic stages of life, humans are made up of basic cells called stem cells. When a baby develops, the stem cells differentiate and become specific cells which form specific tissues. Therefore applying fresh stem cells in damaged areas of connective tissue should make it possible for tendons and ligaments to be regenerated
[ 4 ]. Unfortunately, I found it is not that simple.
It all began several months ago with a medical breakthrough
I discovered while working for Phyrexor incorporated pertaining to the regeneration of connective tissue. As the preliminary results came back, it was all good news. The mesenchyme stem cells formed fibroblasts in the rabbit’s injured knee which appeared to be actively recreating ligament tissue. This was very promising since after fibroblasts initially create ligaments they only repair damaged tissues, but never repair severed tissues [ 5 ]. I immediately notified my employers. I work in Pennsylvania for Phrexor
Inc., a company based in the Dominican Republic who are well known for their treatment of connective tissue injuries in athletes. Their current treatment is not approved by the FDA so they operate all of their procedures in the Dominican
Republic while maintaining research facilities in the United
States. The current procedure has a high failure rate around
60% which is why my new findings were of great interest to them. Upon hearing my initial results, they prematurely began advertising for this new treatment and demanded I conclude my research on the side effects quickly. I received far too little time to study what happened in the live rabbit test subjects when the order came in to euthanize them, turn in my findings, and begin a new assignment at a promoted position.
University of Pittsburgh, Swanson School of Engineering
2013-10-01

Mike Iasella
Conflicted, I saved one of the rabbits because I wanted to be sure there were no side effects. A month later the rabbit had died and I discovered that the stem cells had formed tumors which spread throughout the body. Alarmed, I was left to reason the best course of action using several tools engineers should rely on.
Sometimes when ethics are in question, a useful tool for deciding what should be done is taking a look at past cases.
These cases can be real and historical or fictional scenarios that provide a look at what others would do in similar situations. One real study I reviewed pertained to a medical device for administering radiation that malfunctioned. It killed three patients and sickened several others [ 6 ]. An investigation determined that the fault was due to an engineering error. Curious as to what legal charges the engineers faced, I was surprised to see that the company was only sued and no charges were filed [ 7] . With this in mind, I may not be held accountable for the side effects of my treatment.
Another study was a fictional case regarding an engineer who noticed a flaw in a water treatment system. Despite warning his superiors, he was threatened with removal from the company if he continued to look into it. The employee remained quiet until the problem resulted in a high pollution leak. The Board of Ethical Review blamed the employee for not doing more stating “…[when] a case may involve a danger to the public safety, the engineer has not merely an “ethical right” but also an “ethical obligation” to report the matter to the proper authorities and withdraw from further service on the project” [ 8 ]. The employee should have contacted state officials when ignored by company superiors. An analysis of this situation shows that reporting the risks and demanding a postponement in treatments would be the ethically approved choice for my predicament. Moreover, there have been reports of stem cells causing more harm than good. Recently, two Filipino politician died following a stem cell treatment
[ 9 ]. As more trials on human subjects occur, the danger of stem cells are becoming more known. What happened to the rabbit was likely no rare occurrence, and if I do not make my findings known, human patients will surely be the next victims.
As an engineer in the United States, there are rules and guidelines set forth by the National Society of Professional
Engineers that must be followed. Their purpose is to ensure the wellbeing of the public and direct engineers into making the best decisions. They are divided into fundamental canons and sub-directives. As I read through the canons, I thought about the situation I found myself in. Several canons and directives stood out among the rest.
Canon one reads “Hold paramount the safety, health, and welfare of the public” [ 10 ]. This is a powerful rule that my product violates. Since I discovered that the treatment may not be as safe as my employers believe, I would be in violation of this canon if I were to say nothing. Furthermore, a subdirective under the first canon states “If engineers’ judgment is overruled under circumstances that endanger life or property, they shall notify their employer or client and such other authority as may be appropriate” [ 10 ]. This would certainly require that I inform my employers. However this could be difficult for several reasons. The lethal side effects I observed only came to light after I disobeyed my orders to euthanize all of the test rabbits. This would reflect badly on myself and potentially lead to my removal from the company.
Even worse, upon hearing of the danger my drug presents,
Phyrexor Inc. could attempt to offer me a bribe so that I remain quiet about my findings and leave them off the records. This offer may be tempting but it too goes against the code of ethics.
Further research lead me to consult the code of ethics set forth by the Engineering in Medicine and Biology Society. I considered several lines under the “research” heading.
“Report research results with scientific integrity… and strive for a balance between benefits and potential harm” [ 11 ].
Damaged connective tissue is by no means life threatening. It may be very painful, but to risk one’s life for a treatment does not seem to be a good balance of safety and risk. As I concluded my analysis on the canons, the thought arose as to why one should follow the ethics code in the first place.
Research showed that many of the rules were not enforced by law but rather guidelines [ 12 ]. Although following the code of ethics isn’t required, doing so will ensure one is always obeying the law. The code should not always be seen as an obstacle but rather a way to protect engineers. As Heinz
Luengenbielh writes in his review on engineering codes,
“…an engineer may be asked to do something which, though profitable to her employer or client, would put other people at risk… Without a professional code, an engineer could not object ” [12 ]. By using the code of ethics this way, engineers can avoid dangerous situations and retain job security.
Considering this information, two possible solutions were apparent to me.
The first option posed the most risk to myself. I would have to alert my bosses that I had continued to look into the stem cells’ side effects despite being told move onto a new project. I would have to admit to stealing one of the rabbits
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Mike Iasella but argue that my new findings cannot be refuted. The side effects are still unknown and the treatment must not be allowed to continue to the next phase. I would have to be willing to risk my position, my job, and my standings in the engineering community. Phyrexor Inc. could respond in one of two ways: accept their error in hastily proceeding by postponing treatments indefinitely or try and cover it up while putting the public at risk. If Phyrexor Inc. decided to do the right thing and delay then proper research could be done and the treatment could be perfected. However if they were to bribe or make an attempt to cover up the findings, I would be forced to resign and contact the authorities. This decision would do me personal damage as I would be out of a job but I could prevent my treatment from harming anyone.
My second option would be one that violates many lines of the code of ethics. I could simply ignore the risk my treatment posed on the public. I could accept my promotion and earn an increased wage. When patients begin to die from the treatment, I could use Phyrexor Inc. as a scapegoat and blame them for ending the research prematurely. I could claim there was little I could do since Phyrexor Inc. is a foreign company, and United States officials have no jurisdiction over their proceedings. This would put my company at fault and reduce my chances of facing charges.
I would be wealthy while my company gets sued and shuts down. All of those employed by Phyrexor Inc. would lose their jobs including myself but I would be fine financially.
In this outcome I would be relatively safe from legal repercussions and profit from the negligence of Phyrexor
Inc.
The code of Ethics provided by engineering societies helps engineers to keep in mind what is ethically right from wrong. An engineer must always hold the safety of the public above any personal gain. To do otherwise would be a negligent and sinful act which could result in criminal prosecution. The choice is easy when considering the canons and sub-divisions. Option one is the best choice because it obeys the guidelines if the ethics codes as well as prevents loss of life. Acting as a whistleblower on Phyrexor
Inc. would be in the best interest of the masses as no one would fall victim to their negligence. It may also even allow me to one day continue my work and finish the project I’ve been endeavoring to achieve.
[1] D. Franklin. (2013). “A Dangerous Game.” Scientific
American.
(Online Article). http://www.scientificamerican
. com/article.cfm?id=a-dangerous-game-athletes-risk-untes ted-stem-cell-treatments
[2] C.H. Chen, C.W. Cheng, Y.P. Chin, M.S. Hsieh, J. Lan,
Y.F. Lin, H.T. Lu, M.T. Sheu. (2013). “Injectable hyaluronic-acid-doxycycline hydrogel therapy in experimental rabbit osteoarthritis.” BMC Veterinary
Research.
(Online Article). http://www.biomedcentral.com/1746-
6148/9/68
[3] C.T Caroom, M.D. Driscoll, M. Horie, D.J. Prockop,
H.W. Sampson, I. Sekiya, D.B. Thomas. (2012).
“Implantation of allogenic synovial stem cells promotes meniscal regeneration in a rabbit meniscal defect model.”
The National Center for Biotechnology Information.
(online
Article).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC332
6686/
[4] N. Mahmoudifar, P. Doran. (2011). “Chondrogenesis and cartilage tissue engineering: the longer road to technology development.” The National Center for Biotechnology
Information. (online article).
http://www.sciencedirect.com
/science/article/pii/S0167779911001673
[5] W. Fernando, M. Han, A. Karapetyan, K. Muneoka, E.
Rugg, J. Simkin, K. Wang, Y. Wu. (2013). “Connective
Tissue Fibroblast Properties Are Position Dependent during
Mouse Digit Tip Regeneration.” PLOS One . (online article). http://web.ebscohost.com/ehost/detail?vid=6&sid=aded40
8a-e3c9-4ccf-881a- 376543416fc8%40sessionmgr114&hid=
113&bdata=JnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d#db=ap h&AN=85383927
[6] N. Leveson, C. Turner. (2006). “An Investigation of the
Therac-25 Accidents.” National Aademy of Engineering.
(online article). http://www.onlineethics.org/Resources
/Cases/therac25.aspx
[7] “A History of the Introduction and Shutdown of Therac-
25.” Computing Cases. (online article). http://computing cases.org/case_materials/therac/case_history/Case%20Histor y.html
[8] Pilat. (2003) “Whistleblowing City Engineer” University of Washington. (online case study). https://courses.washi
ngton.edu/cee440/ETHICS1B.htm
[9] P. Chua. (2013, Aug). “Deaths from stem cell include PH politicians.”
Filipino Reporter . (online article). http://search.proquest.com/docview/1437953788?accountid=
14709
[10] “Code of Ethics for Engineers”
National Society of
Professional Engineers. (online article). http://www.nsp e.org/resources/pdfs/Ethics/CodeofEthics/Code-2007-
July.pdf
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Mike Iasella
[11] “IEEE EMBS Code of Ethics” Engineering in medicine and biology society. (online article).
[12] M. Davis, H. Luegenbiehl. “Engineering Code of
Ethics: Analysis and Applications” Illinois Institute of
Technology. (online article). ethics.iit.edu/publication/CODE--Exxon%20Module.pdf
I would like to thank my orthopedic surgeon, Jan S.
Grudziak, my physical theropists, Brenda and Juilianne, but most of all, my family for taking care of me while I was dependent on the help of others.
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