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GERM LINE THERAPY: AN ETHICAL DEBATE
Chris DiPasquale (cjd65@pitt.edu)
WHERE IT ALL BEGINS
My name is Christopher DiPasquale, and I am a
Bioengineer working at the University of Pittsburgh. I
currently conduct my own research under Doctor Aleksandar
Rajkovic in the Center for Research in Reproductive
Physiology Lab. My research is focused on the genetic
transfer of heritable diseases, passed down from mother to
child, through germ cells commonly known as sex cells. All
of my work done in the lab is based on theoretic principle and
individual cellular testing due to ethical concerns surrounding
the use of germ line gene therapy. Germ line gene therapy is
the alteration of genetic material of a germ cells in an
organism, so that when reproduction occurs no heritable
diseases are passed down to the next generation as well as any
prior generation in that lineage [1].
Recently throughout my days researching, I have begun to
think more and more about the possible exploration and use
of germ line therapy in the real world, with human testing. As
an engineer broaching this situation I am not allowed to be
rash in my decision making when dealing with an ethically
concerning subject. I must consult the National Society of
Professional Engineers Code of Ethics, as well as my specific
engineering ethical codes given by the Biomedical
Engineering Society. These ethical codes will layout to me
how I am professionally governed as a bioengineer. Just as
well I need to research other ethical based scenarios that deal
with my field and see how they have been handled to better
gauge the mindset I should have on this issue. Another
methodology I will use will be my peers, who conduct
research with me, and by consulting with them I will be able
to work out the scenario with professionals who have,
carefully thought out perspectives on this subject too. I will
also consult with Doctor Aleksandar Rajkovic, a veteran in
the field of Reproductive Physiology, and use his advice as a
resource to analyze this ethical scenario.
CODES FOR ENGINEERS TO LIVE BY
In this situation as I work as a practicing Bioengineer in
a Lab I, like all other engineers working in the United States,
am governed by the National Society of Professional
Engineers Code of Ethics [2]. Within this code there are three
specific canons of engineering that apply, more directly then
the rest, to the idea of integrating germ line therapy into
society. These canons are the first, the third and the sixth. The
first fundamental canon states that, “Engineers shall hold
paramount the health and welfare of the public” [2]. This
canon on public health helps me realize what I can and cannot
do related to the public. By introducing this new form of
therapy to the public, by the nature of the treatment, I may be
University of Pittsburgh, Swanson School of Engineering 1
2013-10-29
endangering the welfare of the public unwittingly. This is
because of the still unforeseen consequences of germ line
therapy [3]. If genes are altered and homogenized throughout
society by the passage from generation to generation, by the
time it is seen that an altered gene is faulty it may be too late
to reverse the affects [4]. Faulty genes can lead to the
unraveling of the genome which leads to even worse
conditions then what the initial gene transfer was designed to
prevent [5]. On the other hand this canon has me being pushed
toward this therapy because if it were completely successful
then all human heritable disease would seize, and with that
public health concerns would drop drastically.
The next two canons are applicable on the same train of
thought. They are centered on this idea of not knowing where
the therapy will take society [2]. The third canon states that
engineers may only issue public statement in a truthful manor.
This draws me to ethical issues surrounding the future effects
of germ line therapy. How can I issue a completely truthful
statement of the effects this therapy will have on humanity if
some consciences are unforeseen? What if twenty years after
this gene therapy is implemented as a treatment to eradicate
all maternally passed down mitochondria DNA diseases, a
strand of mutated DNA is seen to form from the initial altered
gene [6]. Then that gene in society begins to afflict the
population greatly due to its homogenized presence in people.
From this standpoint how am I supposed to issue a public
address, in present day, with complete “competence in the
subject matter” [2]. I would assume from this canon that to
fully address the public I would need to alert them of the pros
and cons of this treatment as well as have many clinical test
to display my own confidence on the ethics of germ line gene
therapy.
Canon six is about the professional obligations of an
engineer [2]. The main point of relation, to my question on
germ line therapy in this canon, is about how engineers shall
have the “highest standards of honesty and integrity” that will
guide them in their work [nspe]. According with this I must
advise clients when I believe a project will not be successful
[2]. This ethical standard lends me help in my decision
making because it shows me I must not push for germ line
therapy in process until it has been completely stripped clean
of side effects that could hurt individuals or society. The
canon will hold me accountable for any misleading actions
[2]. This will prevent me from, say, pushing the experimental
germ line therapy on a mother, who is indicated to have a
heritable disease, before the therapy has been perfected and
before it has a high enough success rate in accordance with
United States law. It will also push me to always think of
public interest before my own research benefits, which will
have me more aware of my research methods and testing [2].
Chris DiPasquale
the extent to which design can reach [8]. Due to the
multifaceted ethical nature of my profession I have to take
into account many ideas beyond the scope of just my principle
codes. One of the main concepts I have to consider is
medicine ethics, specifically concerning the limits of therapy,
safety and risk, and individual cases versus societal benefits
[8]. In the case of germ line gene therapy this make me ask
myself the question, is it rational to attempt to completely
prevent genetic diseases while at the same time possibly
sacrificing the health of the general public? I have to think
about if the risks out way the safety in this situation. I need to
see if genetic transfer of disease is prevalent enough to
outweigh the possible harm. But, even before all that I must
concern myself with one question, do I as an individual have
the right to alter the future history of humanity?
Within the scope a job as a bioengineer I intervene with
natural processes, and likewise I “must take into
account…conflicting values involved in different views of
nature” as to properly form concepts around what I am
morally able to do [8]. This concept ties back to the idea that
if I were to start human trials of germ line therapy, would I
really have the ethical standpoint to create a genetically
modified person without giving them any chance to be born
as an unaltered miracle. From the view of a utilitarian, I do
not have the right, for I am not deriving my “cure” from
nature, I am creating a preventative process to eradicate
disease [8]. On the other hand as a doministic, I would believe
that any and all nature is supposed to be controlled and used
to the benefit and aid of mankind, which would lead me to the
conclusion of altering traits for the sake of human survival
[8].
BIOMEDICAL CODE OF ETHICS
Professionally, I am obligated to uphold principles held in
the Biomedical Engineering Society Code of Ethics. These
ethics correspond with some of the same guidelines as the
National Society of Professional Engineers, but they add onto
them and increase the importance of their canons. As a part of
the Biomedical Engineering Society I must use my
knowledge to “enhance the safety, health, and welfare of the
public” [7]. This is very similar to the first canon of the
National Society of Professional Engineers Code of Ethics,
but the key difference here is the word enhancement.
Enhancement defines that I should find ways in which create
a healthier public. The statement directs me more towards
pursuing the development of human centered testing for germ
line therapy then the first canon from my Engineering Code
of Ethics. This is because if human centered trials were
invoked the rate to which success would be achieved through
the process of germ line therapy would increase. Increasing
the success rate would make the viability of a healthier
population in closer reach then if the testing was just in
laborites, as it is in present day.
The second applicable canon from the Biomedical
Engineering Society Code of Ethics is about the larger
consequence of my work in regard to “cost, availability, and
delivery of health care” [7]. Canon two makes me consider
the instalment of germ line gene therapy because once the
treatments began, then the delivery method of the health care
would no longer be in control by an official system, but would
be controlled by people who possess the altered genes. This
could bring up more issues because with the cost of
experimental treatments today, there is the possibility of a
divide forming between those who have the ability to be
treated and those who do not. Separation by monetary income
could then set up greater social lines, formed by those who are
untreated and can pass down genetic diseases and those who
are treated and cannot, creating social disparity.
Another ethical guideline I need to follow is complying
with “legal, ethical, institutional, governmental, and other
applicable research guild lines,” when doing testing for germ
line therapy [7]. This canon will force me to stay on point in
my analysis of my data and allow me to see if human testing
for germ line therapy is allowed in any form. This canon
prevents me from falsifying my research and tweaking
evidence so that I begin human trials prematurely.
Germ Line Therapy
Just as there are ethical questions to be brought about in
the general nature of bioengineering, there are also ethical
questions directly concerning gene therapy. As a moderately
young process, only being approved by the United States in
1990, there are still ethical concerns surrounding the action of
the alteration of the human genome [9]. The most prominent
ethical concern surrounding gene therapy ethics is the idea
that a human being, “both as an individual and as a member
of the human species,” must be treated with dignity and
respect [9]. This pertains to germ line therapy because the
process itself can make human beings into commodities by
having people with manufactured genes [9]. These people
would not have to deal with the “inconvenience” of having
normally genetic mixed reproduction, but as a consequence
they would be inadvertently diluting the evolutionary gene
pool [9]. The ethical concerns surrounding germ line therapy
have helped me make my decision on human testing of germ
line therapy by giving me incite to the social concern that I
had not thought of before.
RESEARCH INTO ETHICAL SITUATIONS
Bioengineering General
Now that I have considered the ethical codes I must follow
as a Bioengineer, I need to delve into some research on
general ethics and on my current situation with germ line gene
therapy. As a bioengineer, my discipline combines both the
ethics surrounding medical practices as well as ethics about
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Chris DiPasquale
INTERVIEWS WITH WORK AFFLIATES
REFERENCES
My final ground with which to base my ethical decision
off of will be to talk about it with my peers and then my
supervisor. These interviews will allow me to talk out all of
the knowledge I have acquired through my research. They
will allow me to express my concerns with the ethics of the
situation in a personal scenario, and will allow me to come to
a final deliberation on whether it would be ethically sound to
move forward in human trial testing for germ line therapy.
When reviewing the ethics with my coworkers I was able to
identify one more ethical flaws with germ line therapy, that
being the difficulty in the work place with which to enact such
a treatment [10]. By being able to talk to my coworkers, I was
also able to derive a mockup of how society would view the
human trial of germ line therapy, and the conclusion of that
was not positive [10]. They did not like the idea of all other
treatment being undermined by the preface of a genetically
modified gene [10].
Next when consulting with my boss about the ethical
implication of human trails, we had a very long methodical
debate which ultimately came to the conclusion of it not being
a good idea. He was first enthused by my interest in the
matter, and liked seeing the technique pursued but, he judged
from his own experience and my depth of research into the
subject matter that human trails in present day would not be
ethical. The reason he gave me was that there has not been
enough conclusive evidence to point us in the direction a risk
ratio that had benefits that could out way the possible
catastrophic impact on humanity [11]. By both talking to my
peers and my supervisor I was able to talk out all the ethical
possibilities that I had researched, and in doing so I am now
better apt to make a conclusive decision on germ line gene
therapy [11].
[1] S. Ginn, I. Alexander. (2011). “Gene therapy: Progress in
childhood disease.” Journal of Paediatrics and Child Health.
(Online article). DOI: 10.1111/j.1440-1754.2011.02204.x.
pp. 466-471
[2] (2007). “Code of Ethics for Engineers.” National Society
of Professional Engineers. (Online website)
[3] H. Grankvist. (2010). “Gene Therapy.” Encyclopedia of
Science and Technology Communication. (Online article).
http://knowledge.sagepub.com/view/scienceandtechnology/n
118.xml
[4] A. Sutton. (2013). “A case against germ-line gene
therapy.” Ethics & Medicine: an international journal of
bioethics.
(Online
article).
http://go.galegroup.com/ps/i.do?action=interpret&id=GALE
%7CA320422617&v=2.1&u=upitt_main&it=r&p=AONE&
sw=w&authCount=1
[5] Kara Rogers. (2013). “gene therapy.” (Online article).
http://www.britannica.com/EBchecked/topic/681974/genetherapy
[6] (2010). “Gene Therapy.” Black's Medical Dictionary.
(Online
article).
http://www.credoreference.com/entry/blackmed/gene_therap
y
[7] (2004). “Code of Ethics.” Biomedical Engineering
Society. (Online website)
[8] Bugliarello, George. "Bioengineering Ethics."
Encyclopedia of Science, Technology, and Ethics. (Online
article).
http://go.galegroup.com/ps/i.do?action=interpret&id=GALE
%7CCX3434900093&v=2.1&u=upitt_main&it=r&p=GVRL
&sw=w&authCount=1
[9] Gene Therapy: Ethics and Regulation. (2003). In
Encyclopedia of the Human Genome. (Online article).
http://www.credoreference.com/entry.do?ta=wileyhg&uh=g
ene_therapy_ethics_and_regulation
[10] J. Smith, J. Doe, D. Williams. (2013, October 25).
Interview
[11] A. Rajkovic. (2013, October 25). Interview
CONCLUSION
After reviewing the multiple aspects of ethics that I must
follow I have come to the conclusion that bridging the gap
between my laboratory research and the real world would not
be a good idea at this point in time. I have come to this
standpoint mainly because as an Engineer, I do not have the
right to endanger the public in any situation, especially in a
situation where the chance of succeeding to prevent all
disease has the potential ramifications of causeing the public
even worse diseases. These disease are genetically caused and
would result from the unavailing of a human beings genome,
creating a defective cell in the body that could replicate and
cause severe illness or death. As an engineer I must uphold
the integrity of my profession and make a decision of
Maximum professional integrity and I have by subsiding from
pursing human trials of germ line therapy.
ADDITIONAL SOURCES
K. Hana. (2006). “Germline Gene Transfer.” National Human
Genome
Research
Institute.
(Online
article).
http://www.genome.gov/10004764
ACKNOWLEDGMENTS
I would like to thank my mother who always taught me to
do what I know is right and stick to my moral conviction no
matter what the circumstance.
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Chris DiPasquale
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