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REGENERATIVE MEDICINE & ETHICAL ISSUES: THE KIDNEY
Emily Youwakim (eay17@pitt.edu)
INTRODUCTION: BIOENGINEERING AND
ETHICAL MATTERS: PRESSING ISSUES
Introductory Information: The Basics of Ethics
The field of bioengineering has progressed substantially
within the last twenty years and is steadily growing in both
interest and size. Scientists are collaborating worldwide to
cure diseases and other physiological problems within the
human body. With the increase in health problems plaguing
humans, it is pertinent that we apply our rapidly increasing
technology to save lives. One aspect in this field under
constant scrutiny is the issue of organ failure and what can
be done to rectify this problem. I presently work for
Organovo Holdings, Inc. dealing with the research and
development of genetically engineered organs. The
technology we develop creates a plethora of ethical issues,
one of which I am currently dealing with. I have to look to
our codes of ethics in order to make a decision based on
what I see as right, in comparison to what I am instructed to
do. Engineers deal with these types of issues everyday and
we all look to the National Society of Professional
Engineers’ (NSPE) codes of ethics and our own discipline’s
codes such as the bioengineering ones in my case to decide
what course of action to pursue.
My Ethical Predicament: Explained
My company has now finally advanced the technology of
3D bio printing to the point where we have successfully
engineered the complete reconstruction of a kidney. We
have been in the process of conducting trials with patients
and I have been recording all information pertinent to these
tests and processes. I am responsible then for analyzing how
well the genetically engineered kidney made by my
company functions post-transplantation. We have done a
clinical test series of one hundred trials thus far where we
grow the complete kidney using the latest 3D printing
technology, which is then transplanted back into the patient.
The kidney is modified and grown from his/her own cells, so
it contains the same genetic composition and virtually
eliminates any risk of rejection from the patient. Out of the
trials that were conducted, 64% of the kidneys transplanted
into the patients were successful and after two months
continued to function productively. The other 36% of the
time the transplantation was successful, but the actual
function of the kidney dropped to significantly less than
optimal, or in some cases, even failed. My findings do not
suggest this technology is ready yet for use in hospitals, but
my superiors are pressuring me to tamper with the results in
University of Pittsburgh, Swanson School of Engineering 1
2013-10-29
order to scale the numbers and give the impression that this
technology is ready for widespread clinical use. I am even
being offered a substantial amount of money to fix my
results and not report the inconsistencies. I am currently
looking back to my codes of ethics and other resources in
order to make a decision. To better understand what decision
to make and to see the dilemma I’m being faced with,
background needs to be established regarding the resources I
will refer to as well as my project and the aspects that are
actually involved.
RESOURCES USED TO FORMULATE A
DECISION
In order to make a competent decision on how I should
proceed in my present situation, I need to refer back to my
general NSPE codes of ethics, but also the specific
bioengineering codes of ethics as well. When I refer back to
my general codes a few different codes and objectives that
may help stand out in my mind. The first code that resonates
states, “Engineers shall issue public statements only in an
objective and truthful manner. Engineers shall be objective
and truthful in professional reports, statements, or
testimony” which is significantly applicable in my problem
[1]. This code and subsection specifically states that doing
anything such as altering medical reports and findings would
be highly unethical and is unacceptable as outlined in the
NSPE codes of ethics. Another general directive that rose to
the forefront of my mind in regards to honesty is stated,
“Engineers shall not promote their own interest at the
expense of the dignity and integrity of the profession” which
shows again the immorality of a situation such as that [1]. I
then looked to the bioengineering codes of ethics and a few
other directives stood out at well. The first states that
bioengineers should, “Consider the larger consequences of
their work in regard to cost, availability, and delivery of
health care” which applies in connection with my company
[2]. The other states that biomedical engineers should,
“Publish and/or present properly credited results of research
accurately and clearly,” another code I promised to uphold
as an engineer [2]. These four main principles are the ones
that resound most clearly to me when trying to make the
decision whether I should listen to my superiors, or not. The
next step in my decision-making process is to think more
about the project I have dedicated my time and effort to and
establish the implications of whichever action I choose
according to my codes.
Emily Youwakim
printing might be one of the most revolutionary techniques
developed thus far, and the sooner this technology is
released for widespread use, the more people can receive a
transplant without requiring a lifetime supply of
immunosuppressive drugs that will eventually do more harm
[8]. After reviewing the current treatments and importance
of this specific organ, I am reminded of how much of a
necessity it is to find another solution to this problem and
save lives.
BACKGROUND INFORMATION: THE
KIDNEY & IMPORTANCE IN
ADVANCEMENTS
Primary Role of the Kidney and Its Importance
In order to understand more about my dilemma, the
background of the research I have done on kidneys needs to
be established. The kidney has many functions that are vital
to ensuring a healthy life. It is responsible for maintaining
blood pressure, emptying the body of waste and excess
fluids, and also maintaining healthy levels of salt and other
chemicals in the blood [3]. When damage is done to the
kidneys, a buildup of fluids and waste products occurs. If the
process continues for long periods of time, it can lead to
many other complications. Depending on the severity of
these complications, this can result in the need for a
transplant and if not that, the prognosis eventually ends in
death. Since the kidney is such a vital organ in the human
system, it is imperative that decisions made that will affect
the general public are ethically sound and will do no harm to
innocent citizens.
NEW TECHNOLOGIES: 3D
BIOPRINTING
The technology that has emerged in the bioengineering
field is the technique I have been referencing of 3D bio
printing. 3D bio printing involves a process aiming to create
layers of living tissue that can be implanted back into the
body to function as sort of “replacement cells” for the
damaged tissue. The process starts with a water-based
hydrogel on the printing surface, which is then surrounded
by clusters of cells. The same process is repeated until a
finished stack of sheets of cells remains, which becomes the
artificial biomaterial used. In use with the kidney, we have
have been utilizing a micro-valve to build layers of human
embryonic stem cells, which then have the capability to turn
into any type of tissue that we need [9]. The goal of 3D bio
printing was to be able to extract a cell from a patient, create
the appropriate new tissues to form an entire organ, and then
implant that functional organ back into the patient. Since the
generated cells stem from the patient’s existing cells,
virtually any immune responses or tissue rejection is
eliminated [9]. As Jason King, of Roslin Celllab, said of this
new technology in its infancy, “This is a scientific
development which we hope and believe will have
immensely valuable long-term implications for reliable,
animal-free drug testing and, in the longer term, to provide
organs for transplant on demand without the need for
donation and without the problems of immune suppression
and potential organ rejection” and his statement has now
turned into a reality [9]. Now that we have successfully met
this goal, there are many gray areas that have to be
addressed such as whether or not the technology should be
held until it is completely functional and the success ratio
increases significantly. After reviewing my research and
background on this project, I now need to refer back to
applying my main ethical codes of conduct so that I can
make my decision.
Previous Treatments
The treatments being used now for kidney disease that
would be replaced by our 3D bio printing technology are
dialysis and organ donor transplants. Dialysis is used if a
patient has acute kidney failure and no option is available for
a transplant procedure. During dialysis, all kidney functions
are artificially performed through a machine. A problem
with this form of treatment though, is that it is never a
solution to the problem. The other technology implemented
is transplantation of the kidneys. In 1955, the kidney was the
first organ to be transplanted into a patient, and since then,
we have made significant progress in the field of organ
transplantations [4]. Every year though, hundreds of people
still die without a kidney transplant. In the U.S. there are still
nearly 100,000 patients awaiting a transplant a year and the
numbers continue to grow [5]. Transplants have been the
best available option, but there are still problems that
accompany the procedure. The most prevalent problem with
transplants is still the shortage of donors. Also, there is
always a chance that the recipient’s body may reject the
kidney after transplantation. Even if the body does not reject
the transplant, the patient has to take a lifelong combination
of immunosuppressive drugs in order to help ensure their
body will not reject the organ. Unfortunately, long-term side
effects to taking these rigorous drug regiments can arise,
such as cancer and infections [6]. Both of these current
technologies are sufficient, but the problem of kidney
disease has continued to grow every year. As an engineer it
is my responsibility to aid in creating solutions to problems
while maximizing public benefits and minimizing harm [7].
This new technology I have been working on with 3D bio
ETHICAL CODES OF CONDUCT: MY
THOUGHTS
My primary concern with making this decision is about
whether or not I will be able to make the correct and most
beneficial choice for all parties involved. It is said that as a
general code for engineers, you have to make your own
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Emily Youwakim
decisions without outside influence and cannot hesitate or
waver in your choice once it is made [10]. My first thought
goes back to what some of the general public’s opinions
have been on this issue ever since the emergence of 3D bio
printing. Traditionalists would claim that creating living
material artificially to implant back into the human body is
wrong because the use of human embryonic stem cells as
well as therapeutic cloning is implemented to grow the new
tissue [11]. Although that is one ethical aspect researchers
have dealt with since the beginning, the other ethical
concerns lead back to whether or not it is okay for me to
accept the money and scale the results up. Companies such
as the one that I work for only care about the money and
competing with other similar firms. This clashes with my
role as a researcher since the health profession is supposed
to solely be about the general welfare of the public and
healing [11]. If I change my reports in order to get the
product onto the market faster, I would be going against both
the general NSPE code and the bioengineering code that
says as an engineer all reports must be accurate and truthful.
Also, if I were to ever accept a monetary bribe to fix testing
results, I would be in complete violation of the ethical codes
engineers adhere by. In reference to the other code I thought
applied well to this situation that talked about considering
the consequences in regards to cost and delivery, the
implications of delivery and cost will be much greater if I
accept the deal and conform to what my boss wants me to
do. These codes all are ones that I promised to adhere by
when I became an engineer, so violating any one of them
would be an unethical practice.
in their own ethical dilemmas. I can confidently say now that
I cannot in good faith do what my superiors want me to do.
REFERENCES
[1]“NSPE Code of Ethics for Engineers.” (2007). NSPE.
(Website).
http://www.nspe.org/Ethics/codeofethics/index.html
[2]“Biomedical Engineering Society Code of Ethics.”
(2004). Bmes.org. (Website).
http://bmes.org/files/2004%20Approved%20%20Code%20o
f%20Ethics(2).pdf
[3] Boomkey, J. Dankers, P. Meijer, E.W. Popa, E. Van
Luyn, M. (2011). “From kidney development to drug
delivery and tissue engineering strategies in renal
regenerative medicine.” Journal of Controlled Release.
(Online
article).
http://www.sciencedirect.com/science/article/pii/S01683659
1100040X
[4] S.V. Murphy, A. Atala. (2013). “Organ engineering combining stem cells, biomaterials, and bioreactors to
produce bioengineered organs for transplantation.”
Bioessays.
(Online
article).
http://onlinelibrary.wiley.com/doi/10.1002/bies.201200062/f
ull
[5] (2013). “Top-Down and Bottom-Up, Artificial Organs
Progress.” LexisNexis Academic. (Online article.)
http://www.lexisnexis.com/lnacui2api/api/version1/getDocC
ui?lni=58CH-0GT1-DXX0P28M&csi=365372&hl=t&hv=t&hnsd=f&hns=t&hgn=t&oc
=00240&perma=true
[6] L. Perin, S. Da Sacco, S. De Filippo. (2010).
“Regenerative medicine of the kidney.” Advanced Drug
Delivery
Reviews.
(Online
article).
http://www.sciencedirect.com/science/article/pii/S0169409X
10002887
[7] Gutmann. (2011). “The Ethics of Synthetic Biology:
Guiding Principles for Emerging Technologies.” Hastings
Center
Report
41.
http://muse.jhu.edu/journals/hastings_center_report/v041/41.
4.gutmann.html
[8] “Stem Cell Research; Engineering whole organs: Closing
in on a potential solution to the organ donor shortage?”
(2012).
LexisNexis
Academic.
http://rt4rf9qn2y.search.serialssolutions.com/?ctx_ver=Z39.
88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF8&rfr_id=info:sid/summon.serialssolutions.com&rft_val_fm
t=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=
Engineering+whole+organs%3A+Closing+in+on+a+potenti
al+solution+to+the+organ+donor+shortage%3F&rft.jtitle=In
vestment+Weekly+News&rft.date=2012-0331&rft.issn=1945-8177&rft.eissn=19458185&rft.spage=945&rft.externalDocID=Investment_Weekl
y_News_2012_03_31_945_Stem_Cell_Research_Engineeri
CONCLUSION: MY FINAL DECISION
In conclusion, the field of bioengineering is ever
changing and technology such as 3D bio printing is rapidly
developing. With the increasing number of health issues that
need to be addressed, such as kidney failure, there is a
crucial need for solutions. As an engineer, I am faced with
ethical issues constantly and I need to always be able to
make a clear and focused decision based on the guidelines
all engineers adhere by. I have two options in my current
situation. I can go against many of the codes in order to
appease my boss and falsify reports of the technology that
just quite is not foolproof enough for me to be comfortable
releasing it. The other option is to refuse to do what the
company wants and risk losing my job and all the research I
have worked so hard on. I could never risk disgracing the
dignity of the profession I worked so hard to be a part of,
and if that means risking losing a job and so much work,
then that will be the consequence I will have to live with.
Ernest Hemingway stated, “So far, about morals, I know
only that what is moral is what you feel good after, and
immoral is what you feel bad after” which is a quote I live
by [12]. The decision is mine, just as is any other engineers’
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Emily Youwakim
ng_whole_organs_Closing_in_on_a_potential_solution_to_t
he_organ_donor_shortage&paramdict=en-US
[9] (2013). “3D printing brings artificial human organs
closer to reality.” LexisNexis Academic. (Online article).
http://www.lexisnexis.com/lnacui2api/api/version1/getDocC
ui?lni=57NS-2VR1-JDJN606V&csi=344861&hl=t&hv=t&hnsd=f&hns=t&hgn=t&oc
=00240&perma=true
[10] J.M. Basart, M. Serra. (2011). “Engineering Ethics
Beyond Engineers’ Ethics.” Springer. (Online article).
http://download.springer.com/static/pdf/594/chp%253A10.1
007%252F978-1-4614-69131_4.pdf?auth66=1383091666_8f9fbee1dd65f2f6ca30d97b88
f02c41&ext=.pdf
[11] D. Kwok-Wing Tam, O. Faust. (2013). “Ethics of
Biomaterials for Implants.” Springer. (Online article).
http://download.springer.com/static/pdf/594/chp%253A10.1
007%252F978-1-4614-69131_4.pdf?auth66=1383091666_8f9fbee1dd65f2f6ca30d97b88
f02c41&ext=.pdf
[12] E. Hemingway. (1932). Death In The Afternoon. Good
Reads. (Website). http://www.goodreads.com/quotes/2955so-far-about-morals-i-know-only-that-what-is
ADDITIONAL SOURCES
Gojo, S. Toyoda, M. Umezawa, A. (2011). “Tissue
engineering and cell-based therapy toward integrated
strategy with artificial organs.” Springer. (Online article.)
http://link.springer.com/article/10.1007%2Fs10047-0110578-4/fulltext.html
A. Trafton. (2012). “Tissue engineering: Growing new
organs, and more.” MIT News. (Online article).
http://web.mit.edu/newsoffice/2012/engineering-healthtissue-engineering-growing-organs-1214.html
ACKNOWLEDGEMENTS
I would like to thank people that provided me with
support throughout writing this paper. I want to thank my
engineering professor, everyone at the writing center that
takes their time to grade all of our papers, and my mother for
being the one who piqued my interest in not only
engineering, but the bioengineering aspect. I also want to
thank Bridget Csongradi, Iman Basha, and Adam Fritz, two
of my fellow engineering peers, who I worked alongside
with and aided me in storming and proofreading my paper.
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