Mahboobin 10:00
R08
3D BIOPRINTING FOR KIDNEY TRANSPLANTATION ETHICAL DILEMMA
Timothy Bowers (teb50@pitt.edu)
University of Pittsburgh, Swanson School of Engineering 1
Submission Date 2015-11-03
Timothy Bowers
to comply fully with legal, ethical, institutional,
governmental, and other applicable research guidelines,
respecting the rights of and exercising the responsibilities to
colleagues, human and animal subjects, and the scientific
and general public. I am obligated to publish and/or present
properly credited results of research accurately and clearly.
(LINK4)
Project Frankenstein at first proved to meet these
requirements but with the increased stress of rushed
production, many of these obligations were bypassed.
ABSTRACT
It has come to my attention that my company’s new
venture, Project Frankenstein, has decided to begin human
trials of our new method of kidney transplantation. This
method consists of 3D-bioprinting an artificial kidney to
replace a patient’s failing diseased kidney. However, our
previous trials on our ape subjects only proved to be 90%
effective. My team has been tasked to find another possible
way to improve the scaffold kidney’s vascularity since the
main cause of our prototype’s lack of functionality was due
to low blood pressure in the area of insertion. My company
believes that our new method must be put to use soon, as one
of our rivals are anticipated to release their own method of
artificial kidney transplantation within the next few months.
With the lack of time for research, recent modification of
vascularity in the organ, and limited resources I have come
to a crossroads in my decision on how to proceed with my
situation. Should I potentially endanger patients’ lives
because of our lack of preparation? Should I allow our
method to undergo human trials with the hope that it will
prove effective and give my company a large payout? I
believe the only true way to approach this decision is to
confront the ethical guidelines of my professional field,
observe case studies that relate to my situation, evaluate the
media impact of this decision, and most importantly
understand my own morality in this ethical dilemma.
CASE STUDIES
I have come across three separate case studies that
may prove influential to my decision. The first study I have
observed was the Ethical and Policy Problems in Synthetic
Biology: Emergent Behaviors of Integrated Cellular Systems
(EBICS).
The goal for a team of engineers was to engineer biological
machines – biological systems that do not occur in nature –
to perform human directed functions. The range of
applications for these machines is vast. The National Science
Foundation (NSF) is funding the research team with $25
million for a 5-year Science and Technology Center (STC)
in Emergent Behaviors of Integrated Cellular Systems
(EBICS). The different biological machines are: 1.
Cellular systems that sense the level of substances,
such as glucose, in the human blood stream, and then
instruct other cellular systems to produce and secrete drugs,
such as insulin. 2. Test-bed cellular systems that mimic the
behavior of human organs, such as the heart or liver, to be
used in screening drugs for safety and efficacy, reducing or
eliminating the need for animal testing in drug development.
3. Cellular systems that sense the level of neurotoxins in
water and signal other cellular systems to produce
substances that eliminate the neurotoxins. The two methods
of approaching the production of these machines are
engineered systems or emergent systems. An engineered
system is produced by inducing stem cells to differentiate
into particular cell types, such as nerve or muscle cells,
which are then assembled into machines to perform a desired
function. An emergent system is produced by interventions
to steer the differentiation and evolution of stem cells into
different components that interact naturally to perform a
desired function. For example, an emergent system mimics
how embryos develop into adults by nature. The interactions
and communication among stem cells, result in
differentiation in interacting clusters of cell types.
(LINK 1)
I have been charged with investigating and
providing real-time ethical and policy analysis and
recommendations to the EBICS STC, by selecting one of the
three different biological machines and a system to
implement it. For my ethical standpoint, I decided the best
approach to create cellular systems that sense the level of
CODE OF ETHICS
As a biomedical engineer it is my obligation to
follow the code of ethics established not only by the
National Society of Professional Engineers (NSPE) but also
the code of ethics of the Biomedical Engineering Society
(BMES). The NSPE rules of practice state that engineers
shall hold paramount safety, health, and welfare of the
public. Engineers shall perform services only in the areas of
their competence. Engineers shall issue public statements
only in an objective and truthful manner. Engineers shall act
for each employer or client as faithful agents or trustees.
Engineers shall avoid deceptive acts. (LINK 5) Many of the
procedures my company is utilizing to implement our
method in a timely matter is disregarding these rules of
practice. The paramount safety, health, and welfare of our
patients are being risked as we are not producing our most
thorough job due to the rushed development. We are not
being faithful to our clients as this forced method is not the
best we can do. My company is truly deceiving our patients
in order to beat out our competition.
My health care obligation as being a part of the
BMES is to regard responsibility toward the rights of my
patients, including those of confidentiality and privacy, as
my primary concern. I must consider the larger
consequences of my work in regard to cost, availability, and
delivery of health care. My research obligations require me
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Timothy Bowers
top journals in the field, so it didn’t seem like it could have
been fabricated or manipulated in anyway. She was
concerned that if she brought this up to her research mentor,
she might be perceived as incredibly narcissistic or
incredibly stupid. (LINK 3)
I have been tasked with answering the following
questions: 1. What is the action or inaction that is the cause
for concern? 2. Who or what may be affected? 3. How will
they be affected? 4. Are there any laws, regulations written
or unwritten that may apply? 5. What actions might be taken
and what would the consequences of these actions be? 6.
Can anything be done to prevent this from reoccurring or to
minimize the severity of the consequences?
The action that is a cause of concern is the found
instance of scientific misconduct, through the fabrication of
data in a published technical article. All of the authors on the
paper, other members of the research laboratories, and
anyone in the field depending on the authenticity of the work
will be affected. The authors’ professional reputation will
suffer greatly as well as the integrity of all of those involved
in the project. Many universities usually investigate alleged
instances of scientific misconduct very carefully, but if the
research was funded by the U.S. government, then The
Office of the Inspector General might investigate. The
consequences could prove to be quite severe, such as, the
loss of professional credibility, loss of research funding,
termination of employment, fines, and even imprisonment.
(LINK 3) Unfortunately, there is no real way to stop this
type of fraud from ever happening again.
This case study has given me insight on the
possibility of invalid production of data due to my
company’s rushed research. Data shall always be credible
and if the fast-tracking of research produces undesirable data
we must present it, even if it prolongs our process of
development in our new method of artificial kidney
transplantation.
substances such as glucose in the human blood stream, and
then instruct other cellular systems to produce and secrete
drugs such as insulin must be produced by an emergent
system. The emergent system would act similarly to my
company’s method of artificial kidney transplantation as the
communication between stem cells will be the driving force
of its function. It would provide a natural approach to a
biological machine that will have a similar functionality to
that of the human liver. The criticism of disrupting nature
will be dismissed as we would be creating another natural
system within the body.
The second study I have observed was the case
“Clinical Trial Headaches”. My idea for a new device for the
treatment of congestive heart failure symptoms is beginning
to transfer from just a concept to an actual product. I have
taken it to a venture-capital-funded small “start up”
company that I helped create. My product’s animal studies
were very encouraging, but there has not been a good model
for human trials. During a single center study, the device
proved to have apparent safety despite one death among the
very ill patients. A multicenter trial has been designed in
collaboration with several of the primary investigators
participating in the trial. However, two of the six
investigators will not participate without full access to the
trial data from all of our company’s sites. They also wish to
keep the primary data from their patients in a database they
control on their own site. The CEO believes they will not
give proper care to the data if they keep it locally on their
own site. It might lead to differing data between the sites
because of the lack of continuous updating. She thinks one
might publish the data early without going through the
company, as one investigator said he will want to publish
data from his center separately even if our device ends up
not being developed for production. Because medical centers
want to have their personnel overlooking the data, the CEO
believes its best for the company to have the data itself, as
the future of the company depends on regulatory approval of
the product. (LINK 2)
I have been tasked with giving the CEO advice in
dealing with this situation involving the company’s data. I
would advise the CEO that in order to protect the company it
is best to maintain the data in our company’s site. This will
maintain the reliability of the data for the scientific
community and add to its worth. Although two investigators
will then drop out of the trial studies there are still four more
willing to proceed with the trials. It is our ethical duty as
engineers to provide valid data for products especially ours
which involves the treatment of human subjects.
The third study I observed was the case study “It’s
All the Same….” In this case, an undergraduate research
student was viewing an image of the gel featured in the
research article in the current issue of Cell. The image
appeared to be identical to the established success of the
pulse-chase experiment down to the same size, shape and
tailing of each and every band shown on the gel. The student
couldn’t believe that this had been published in one of the
PORTRAYAL OF ETHICAL APPROACH IN
THE MEDIA
My decision may greatly impact the view of 3Dbioprinting in the media. If our method is to fail and prove
not only to be ineffective but potentially cause the deaths of
some people, it may put funding of research back a few
years. However, if we are successful, it may advance the
field in numerous ways.
Garter Inc. predicts that 3D-bioprinted human
organs will soon be readily available and will spark a variety
of political, moral, and financial interests. The use of many
animal cells in the development of these organs may raise
questions for concern. Some major challenges in 3Dbioprinting involves the creation of the connective tissue or
scaffolding-like structures that support the functional tissue
in a human organ and the vascular structure to support tissue
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Timothy Bowers
with oxygen and nutrients. Traditionally, tissues created in a
lab dies before leaving the petri dish.
Clinical trials and testing of organs for transplants
in the U.S. could take up to a decade because of stringent
reviews by the U.S. Food and Drug Administration (FDA).
However, 3D-bioprinting is advancing in other countries
with less-restrictive government oversight. (LINK6)
It has become one of the latest developments in
personalized medicine. 3D-bioprinting allows orthopedic
surgeons to print artificial bone from a scan of the patient,
printing existing surgical materials to precisely the right
shape to replace missing or damaged bone. Due to this
advanced development, three ethical issues are being raised.
The first issue is justice in access to health care.
Should these treatments only be available to those who can
pay the additional cost? It can be cost effective for cases
such as children that have lost limbs. Due to quick
production, new prosthetics can be made as the child grows.
It can avoid the criticism that personalized medicine
inevitably increases the cost of health care and puts effective
personalized treatments out of the reach of many patients.
The second issue is testing for safety and efficacy.
How can we test that the treatment is safe and effective
before it is offered as a clinical treatment? Unlike the case of
developing a new drug, a stem cell therapy can’t be tested on
a sizeable number of healthy people prior to being tested on
patients and then, finally, being made available as a standard
treatment. Regulatory bodies that give approval for new
treatments need to establish new standards of testing for
regulatory approval before these treatments can become
readily available.
The third issue is whether these technologies should
be used to enhance the capacity of individuals beyond what
is “normal” for humans. If the technology can be used to
develop replacement organs and bones, couldn’t it also be
used to develop human capacities beyond what is normal for
human beings? For example, we could give one stronger
artificial bones, muscle tissue that gets less fatigued, and
new lungs that oxygenate blood more efficiently to
ultimately make a more evolutionary advanced human
being. This enhancement could also be associated with
sports or military use of the technology. Unfortunately,
although military usage will create more durable and
stronger soldiers, it could lead to a new type of arms race.
With stronger defenses other armies will create stronger
weapons that in turn will put more civilians into danger.
(LINK 7)
Advancement in the field of 3D-bioprinting proves
to have both numerous positives and negatives with no direct
answer to whether it is the right thing to. As my method of
kidney transplantation could possibly save the lives of many,
it could also put the lives of others in danger.
MY PERSONAL ETHICAL DILEMMA
This decision has challenged not only my
professional morality but also my personal morality. As
being a strong Catholic, my morals have begun to be
challenged. Is the act of creating something artificial for the
betterment of the person an act against God’s creation? Is
the quest for wealth in a company more important than the
health of the people we are trying to help?
I have looked to the Holy Bible for guidance. "Now
this I say, brethren, that flesh and blood cannot inherit the
kingdom of God; neither doth corruption inherit
incorruption." - 1st Corinthians 15:50. If the implementation
of a new organ can save a person, I believe this should not
make that person less of who they are just because the new
part of them is artificial. For when we die our bodies do not
join us in the afterlife. Our physical being is left behind as
our spiritual self moves on. "It is the spirit that quickeneth;
the flesh profiteth nothing: the words that I speak unto you,
they are spirit, and they are life." – John 6:63. (LINK 8)
My company’s quest for wealth goes against my
belief of the betterment of man. Greed is causing those
above me to forget what this project was intended to do. Just
because they want to beat out our competition for the
prospect of attaining more money they have forgotten that
the intended purpose of our idea was to help those in need.
“But those who desire to be rich fall into temptation, into a
snare, into many senseless and harmful desires that plunge
people into ruin and destruction.” – 1 Timothy 6:9. (LINK 8)
I also decided to explore how people’s lives have
benefitted from other forms of artificial transplantation.
Through ENABLING THE FUTURE, volunteers all over
the world have been 3D-printing different prosthetics to help
those without limbs to live a “normal” life. (LINK 9) The
people seem overjoyed and it shows how much potential this
field provides.
CONCLUSION
In conclusion, by confronting the ethical guidelines
of my professional field, observation of case studies,
studying the impact the media would have on my decision,
and understanding my own morality, I have been able to find
an answer to my ethical dilemma. I have decided to sit down
with my superiors to explain to them the great possibilities
Project Frankenstein will have on those that are affected by
kidney disease if we continue our approach to the situation
as initially intended, rather than rush to beat out our
competitors. If they disregard my attempt to give the project
more time, then based on my ethical understanding of the
situation, I must remove myself from the project as it not
only breaks the ethical codes of the NSPE and the BMES but
also my own moral stance on the subject.
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Timothy Bowers
REEFERENCES
[1] (2013). “Ethical and Policy Problems in Synthetic
Biology: Emergent Behaviors of Integrated Cellular Systems
(EBICS)” Online Ethics Center For Engineering and
Science. (website).
http://www.onlineethics.org/Resources/Cases/27581.aspx
[2] “Ethics Case Studies in Biodesign” Stanford Biodesign.
(website).
http://biodesign.stanford.edu/bdn/ethicscases/8clinicaltrialda
ta.jsp
[3] “It’s All the Same…” WebGuru. (website).
http://www.webguru.neu.edu/professionalism/casestudies/its-all-same
[4] (2004). “Biomedical Engineering Society Code of
Ethics” Biomedical Engineering Society. (website).
http://bmes.org/files/2004%20Approved%20%20Code%20o
f%20Ethics(2).pdf
[5] (2015). “Code of Ethics” National Society of
Professional Engineers. (website).
http://www.nspe.org/resources/ethics/code-ethics
[6] L. Mearian. (2014). “Bio-printing human parts will spark
ethical, regulatory debate” ComputerWorld. (online article).
http://www.computerworld.com/article/2486998/emergingtechnology/bio-printing-human-parts-will-spark-ethical-regulatory-debate.html
[7] S. Dodds. (2015). “3D printing raises ethical issues in
medicine” ABCScience. (online article.) .
http://www.abc.net.au/science/articles/2015/02/11/4161675.
htm
[8] (2015). St. John’s Bible. (book.)
[9] (2015). “Enabling the Future” Enabling the Future.
(website). http://enablingthefuture.org/tag/3d-printedprosthetics/
ACKNOWLEDGEMENTS
I would like to thank my mother, father, and brother
for initially getting me interested in the field of
bioengineering and for providing me with outstanding
discussions on the topic of this paper.
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