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Holly Marie Bevagna
PubH 6368: Law, Medicine, Ethics
09/11/17
Final Paper
Political and Ethical Dimension of Therapeutic Cloning
In 1996, in one of the most acclaimed experiments of all time, researchers Ian Wilmut
and Keith Campbell successfully produced the first cloned mammal (Dolly) via somatic cell
nuclear transfer cloning (SCNT) [n.d. 2017]. This would inevitably give rise to much concern
and debate over the feasibility and ethics of human cloning for reproductive and/or therapeutic
purposes. This paper will discuss the legal and ethical implications of therapeutic cloning, in
which stem cells from SCNT cloned embryos are used to treat human afflictions.
What are stem cells?
Stem cells are immature cells that have not undergone differentiation, the process by
which cells acquire specialized functions depending on their location within the body. Unlike
other cells, they are capable of reproducing indefinitely. Stem cells can be classified as either
totipotent, pluripotent or multipotent. Totipotent stem cells can differentiate into any kind of cell
in the body. Pluripotent stem cells are more differentiated than totipotent cells and can be found
in fetal tissue. Lastly, multipotent stem cells can only produce cells that reside in the tissue from
which they are derived (Torrisi, 2007).
Additionally, stem cells may be classified according to source into four categories: adult
stem cells, embryonic stem cells, umbilical cord stem cells and placental stem cells (Torrisi,
2007). Adult stem cells (or somatic stem cells) are present after development and are responsible
for regenerating damaged tissue. Embryonic stem cells derive from the inner cell mass of the
blastula, a pre-implantation embryo that develops 4-5 days after fertilization. Finally, umbilical
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cord blood and placental stem cells have the potential to mature into hematopoietic cells,
including erythrocytes (red blood cells), lymphocytes (white blood cells) and platelets.
Applications of stem cells
Because they are undifferentiated, human stem cells offer a wide variety of promising
therapeutic applications in the field of regenerative medicine. For example, stem cells can
potentially be used to grow pancreatic β cells-which secrete insulin- to cure Type I diabetes
mellitus or to repair areas of the heart damaged by myocardial infarction (heart attack). In fact,
stem cells could be used to remediate virtually any condition involving traumatic injury or
cellular dysfunction, including, though not limited to, diabetes, cancer, arthritis,
neurodegenerative diseases and spinal cord injuries. If theory can be translated into practice, cell-
based therapy could be a panacea for human disease.
How are stem cells derived?
There are a number of ways in which stem cells may be derived. First, they may be
harvested from unused embryos created vis-à-vis in vitro fertilization (IVF). Second, they can be
derived from IVF embryos created for research purposes. Third, they can be produced during
parthenogenesis, in which a female oocyte (egg) is stimulated to divide without being fertilized.
Fourth, adult stem cells can be reverted to embryonic stem cells through applied stimuli; these
cells are known as induced pluripotent stem cells (iPSCs). Finally, they can be synthesized by
means of somatic cell nuclear transfer cloning (NIH website).
What is SCNT cloning?
Somatic cell nuclear transfer cloning refers to the process by which the nucleus of a
somatic cell is inserted into an enucleated ovum and the created cell is stimulated to divide in
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vitro. The newly formed zygote contains DNA genetically identical to the somatic cell DNA
(n.d., 2017).
Therapeutic cloning
The issue of human cloning has sparked significant controversy among policymakers,
researchers and the general public. Whereas some vehemently oppose all forms of cloning on the
grounds that it is inherently wrong and exploitative, others believe that therapeutic cloning will
lead to promising new treatments and scientific innovations and should be allowed, insofar as it
is well-regulated and subjected to intense scrutiny. In therapeutic cloning, scientists harvest stem
cells from the inner cell mass of a blastula produced via Somatic Cell Nuclear Transfer.
Policymakers have voiced their opinion on the issue of therapeutic cloning, passing legislation to
support their convictions. This paper will examine therapeutic cloning from both a legal and
ethical standpoint.
Legislation on Stem Cell Research
Stem cell policy has been largely protean in nature, shifting to reflect the views and
opinions of policymakers. In 1996, Congress passed the Dickey-Wicker Amendment, which
proscribes the use of federal funding for the creation of human embryos for research.
Furthermore, the statute prohibits any research in which an embryo is destroyed, discarded or
deliberately exposed to harm greater than that allowed for research on fetuses in utero (Torrisi,
2007). The National Institutes of Health opined that the moratorium did not apply to stem cell
research, since extant cell lines had already been harvested and, therefore, these stem cells did
not meet the statutory definition of an embryo. To that end, the NIH promulgated its own
guidelines on stem cell research, on August 25, 2000 (Torrisi, 2007). These guidelines proffered
a distinction between embryonic stem cells used for research purposes and embryonic stem cells
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created solely for research purposes. They allowed federal funding for stem cell research using
stem cells derived from embryos created for reproductive purposes via in vitro fertilization with
the caveat that federal funding would not subsidize the destruction of embryos associated with
cell harvesting. Furthermore, they required that the researchers obtain the appropriate donor
consent prior to the use of the surplus embryos.
In 2001, an executive order entitled “Expanding Approved Stem Cell Lines in Ethically
Responsible Ways” (Executive Order 13435) signed by President George W. Bush prohibited the
use of federal funds for research on embryonic stem cell lines created after August 9, 2001.
Unlike legislation enacted by Congress, executive orders can be rescinded by successive
presidential administrations. And that is exactly what transpired. When he formally took office in
2009, President Barack Obama issued an executive order (Executive Order 13505) entitled
“Removing Barriers to Responsible Scientific Research Involving Human Stem Cells”,
nullifying the executive order issued by President George W. Bush. In contrast to the executive
order by President Bush, which emphasized respect for the dignity of human life, the executive
order issued by President Barack Obama promoted biomedical research and the development of
novel technologies that would benefit mankind and reaffirm the United State’s role as a pioneer
of scientific innovation. The stark contrast between the two administrations clearly illustrates the
polemics of stem cell research. A couple months after Executive Order 13505 was signed, the
NIH established a new set of guidelines regulating embryonic stem cell research, including the
derivation of stem cells and procedures for acquiring informed consent.
The most noteworthy court case regarding federal funding of embryonic stem cells was
Shirley v. Sebelius. Subsequent to President Obama’s abrogation of Executive Order 13435,
adult stem cell scientists James Sherley, M.D., Ph.D., and Theresa Deisher, Ph.D. sought
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declaratory and injunctive relief against the National Institutes of Health and the Department of
Health and Human Services, contending that federal funding of embryonic stem cell research
was a direct violation of the Dickey-Wicker amendment. They put forth three main arguments.
First, they contended that stem cell research involved the destruction of human embryos. This
argument was repudiated by the Court of Appeals of the District of Columbia Circuit according
to the law-of-the-case doctrine, which states that the same issue presented at a later time should
lead to the same result. Second, the complainants alleged that the new NIH guidelines knowingly
subjected embryos to risk of injury or death, since the demand for more embryonic stem cell
lines would inevitably result in the destruction of more embryos. On this point, the court held
that the language of the amendment does not ban funding for research that prompts the future
destruction of embryos. Finally, the plaintiffs asserted that the NIH violated the APA by not
responding to comments in opposition to stem cell research. The court found that the agency was
not legally required to respond to all comments. Ultimately, the court ruled in favor of the
government and the NIH guidelines were upheld [Sherley v. Sebelius, 133 S. Ct. 847].
State and Federal Statutes on Cloning
A federal statute governing the use of SCNT derived stem cells, or prohibition thereof,
has yet to be enacted. Given this lack of federal preemption, numerous states have enacted
legislation either prohibiting all forms of cloning (therapeutic and reproductive purposes) or
regulating therapeutic cloning while banning reproductive cloning. In 2002, California passed a
law allowing the “derivation and use of human embryonic stem cells, human embryonic germ
cells, and adult stem cells from any source, including somatic cell nuclear transplantation”
[California S.B. 322, 2003]. The California Health and Safety Code expressly prohibits
reproductive cloning or any cloning that involves the transfer of a nucleus into an enucleated
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human or non-human egg for the purposes implantation in a surrogate mother (California Health
and Safety Code §24185, 2002). The legislature gave the following reasons for supporting
therapeutic cloning: the health burden of debilitating disease, economic costs associated with
healthcare and the United States continued role as a leader in scientific exploration. Conversely,
Arizona’s statutory code categorically prohibits any “attempt to create an in vitro human embryo
by any means other than fertilization through the combining of human egg with human sperm”
[Arizona Revised Statute §36-2312, 2010]. Moreover, the statue disallows a person from
knowingly engaging in embryonic stem cell research involving the destruction of embryos
(implicit in SCNT cloning) [Arizona Revised Statute §36-2313, 2010]. State funding for somatic
cell nuclear transfer cloning is also sanctioned [Arizona Revised Statute §35-196.04, 2005].
While these examples are by no means exhaustive, they highlight the stark differences in
political ideologies between progressive and conservative states.
According to an article published in the New Atlantis, there are seven states that prohibit
cloning for both therapeutic and reproductive purposes (including Arizona) and ten states that
prohibit reproductive cloning yet make allowances for therapeutic cloning. The remaining states
have implemented policies affecting the subsidization of therapeutic cloning research or
providing protections for physicians morally opposed to SCNT (A Report of the Witherspoon
Council on Ethics and Integrity in Science, 2015).
Constitutional protections
There is a dearth of court cases involving stem cells and even more so for therapeutic
cloning. However, a law review by Bellinger, 2002, explores the topic of constitutional
protections for patients who wish to receive stem-cell based therapies derived from SCNT.
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M. Bellinger, 2002, asserts that patients have a “fundamental right” under the Due
Process Clause of the Fifth and Fourteenth Amendments to be treated through therapeutic
cloning, using legal precedent to support his argument, including Griswold v. Connecticut,
Eisenstadt v. Baird, Cruzan v. Director and Roe v. Wade [all covered in class]. I will examine
each of these briefly in turn.
In Griswold v. Connecticut, the Supreme Court of the United States reviewed the
constitutionality of a Connecticut law prohibiting any person from using “any drug, medicinal
article or instrument for the purpose of preventing conception” It held that spouses had a marital
“right to privacy” contained within the penumbras of the 5th and 14th amendments [Griswold v.
Connecticut, 381 U.S. 479 (1965)]. These protections would be extended to unmarried couples in
Eisenstadt v. Baird, in accordance with the Equal Protection Clause of the 14th Amendment,
which states that “no state shall…deny to any person within its jurisdiction the equal protection
of the laws [Eisenstadt v. Baird, 405 U.S. 438 (1972)]. In Roe v. Wade, the Supreme Court
reiterated the rights to privacy and personal autonomy in deciding whether a woman had a
fundamental right to an abortion [Roe v. Wade 410 U.S. 113 (1973)]. Cruzan v. Director
examined the issue of bodily integrity in the context of removal of life-sustaining treatment.
Although the court ruled that the Constitution did not prohibit a state from requiring clear and
compelling evidence of a patients dying wishes, this further affirmed the patient’s right to
autonomy [Cruzan v. Director, Missouri Department of Health, 110 S. Ct. 2841 (1990)].
Based on the common law, therapeutic cloning could plausibly be construed as a
fundamental right, especially if it is deemed necessary to preserve the health of a patient. If this
is the case, the government must have a compelling interest for banning therapeutic cloning. The
potential for human life at the embryonic stage is not sufficient cause to ban access to potentially
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life-saving treatment, even if it involves the destruction of embryos, which are non-viable. That
said, there is no precedent, as of yet, that addresses the creation of human embryos specifically
for research purposes.
The ethics of therapeutic cloning
As mentioned, stem cell research offers a plethora of promising treatments for practically
any tissue that is diseased or damaged, including neurological disorders, hormonal or enzymatic
deficiencies and heart failure. SCNT derived stem cells-in particular- confer the same benefits as
stem cells derived from other methods (i.e. does not require transplant donors and can be used to
regenerate tissue) and eliminate the risk of transplant rejection, since the stem cell’s DNA is
genetically identical to the recipient’s. Because of financial restrictions and moral objections to
cloning, however, most if not all stem cell research is conducted using stem cells derived from
surplus embryos created via in vitro fertilization techniques. Nonetheless, new policies are
constantly being implemented-as evidenced in the preceding paragraphs-and most discoveries
encounter resistance at first (e.g. in vitro fertilization, Darwin’s theory of evolution and the
heliocentric theory). Hence, it is not too premature to discuss the ethical implications of
therapeutic cloning.
Respect for the dignity of life
Some opponents of therapeutic cloning condone the derivation of stem cells from unused
embryos created by means of in vitro fertilization [Gusman, 2005]. Their rational is that, since
the embryos will be disposed of, they might as well be used to benefit mankind. However, the
premise that deriving stem cells from IVF embryos is a morally preferable alternative to
therapeutic cloning is flawed. Both therapeutic cloning and the derivation of stem cells via in
vitro fertilization require the destruction of embryos-the potential for human life.
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Notwithstanding, while it is uncertain whether a human SCNT embryo would survive to term,
the implantation of IVF embryos in a surrogate mother would inevitably result in a viable fetus,
insofar as there are no complications with the pregnancy. A corollary to this is that embryos
produced through SCNT cloning conceivably have less potential for human life (using current-
day methods) than embryos created through IVF. Therefore, is it not more ethical to destroy
SCNT embryos?
Some would argue that there are other means of acquiring stem cells that obviate the
destruction of human embryos, including the use of placental, umbilical cord blood and adult
stem cells and the induction of pluripotent stem cells from adult stem cells [Winter, 2001]. While
alternative sources of stem cells do exist, human embryos have the greatest potential to
differentiate into various cell types. Placental, cord blood and adult stem cells are multipotent
cells and can only produce cells found within the same tissue from whence they originate. In
terms of differentiation, induced pluripotent stem cells are comparable to embryonic stem cells,
yet recent studies indicate that iPSCs are less sustainable than embryonic stem cell lines and
mature at a much slower rate [Hopkins Medicine, 2017]. Despite the benefits of embryonic stem
cells, there is a putative link between the use of embryonic stem cells and the formation of
malignant neoplasms (cancer) [Prentice, 2001]. More studies are needed to confirm or disaffirm
this purported association.
A closer look at the issue suggests that therapeutic cloning is controversial not because it
involves the destruction of embryos, but rather because it creates life only to exploit and destroy
it. Religious leaders and devout Catholics are anathema to human cloning because it interferes
with God’s will. Although similar arguments can be made for in vitro fertilization, the duality of
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creating a human embryo and subsequently destroying said embryo is far more odious to those
who believe in the sanctity of life above all else.
In considering the constitutionality of therapeutic cloning, the right to patient autonomy
will likely be weighed against the embryo’s right to life. Because the embryo is not a viable
organism, as established in Roe v. Wade and similar cases, the needs of the patient will take
precedence, in so far as the benefits of human cloning cannot be attained through other means.
Non-maleficence
Through cell harvesting, therapeutic cloning results in the irrevocable destruction of
human embryos, violating the bioethical principle of non-maleficence. According to legal
precedent, human embryos are to be accorded more respect than mere tissue, but are not entitled
to the same protections as a person who has already been born. The level of respect and dignity
accorded to an embryo or fetus depends on its stage of development. Embryos, regardless of the
means of their inception, are not viable, being comprised of merely a few cells. These embryos
cannot perceive pain, think or breathe. If one assumes that the degree of maleficence is
determined by the viability of the embryo/fetus, the termination of a second-trimester pregnancy
through dilation and extraction does significantly more harm than the destruction of five day old
embryos.
According to legal doctrine, the destruction of an embryo may be justified in order to
save the life of a pregnant woman (e.g. Roe v. Wade). Proponents of this view, contend that the
destruction of an SCNT embryo is not justified, since there is no immediate health threat. I
disagree. Stem cell-therapies can be used to treat diseases refractory to existing treatments. It can
give people their lives back. Although the destruction of embryos is not to be taken lightly, the
benefits of SCNT cloning should be assessed and balanced against the harm it causes.
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Beneficence
Although ample research has been conducted on the biology of stem cells in vitro, there
is a paucity of clinical trials, most likely due to financial and statutory restrictions. Nonetheless,
in clinical trials evaluating the efficacy of stem cell treatment for macular degeneration (Song,
2015) and heart failure (Benetti, 2010), cell-based therapies led to increased visual acuity and
increased ejection fractions, respectively. Researchers cautioned that further studies would be
needed to confirm the results of research. If the efficacy of stem cell therapy can be firmly
established, however, the therapeutic benefits would be considerable enough to justify the
destruction of embryos.
Utility
Therapeutic cloning has the potential to benefit millions of people, demonstrating the
bioethical principal of utility, which is defined as doing the greatest good for the greatest
number. The clinical utility of therapeutic cloning stems from its myriad applications (described
above). Put simply, the number of people who benefit depends on the number of ailments
effectively treated through stem cell therapy. If stem cell therapy only treats one disease, the
benefits might be minimal (depending on the prevalence of the disease), but if it treats numerous
diseases, its utility increases substantially. Furthermore, because SCNT derived stem cells are
autologous (used on the same person), patients will no longer have to wait on transplant lists for
organs or tissues.
Distributive Justice
Depending on the cost of cell-based therapies using SCNT cloned cells, the most
vulnerable groups might not be able to afford treatment. This is cause for concern, as these
groups are disproportionately affected by serious illnesses, such as cardiovascular disease and
12
diabetes. In effect, stem cell therapy could become a form of eugenics that selects for the more
affluent and well-off members of society. The only way to circumvent this is through strict anti-
patent regulation and a universal health care reform bill defining cell-based therapy as an
“essential benefit”.
Final recommendations
A prima facie ban on all human cloning would have severe implications for scientific
advancement in our nation. The United States has long been a pioneer of scientific research. By
not investing in therapeutic cloning, the US is ceding this prominent role to other developed
countries that recognize the full potential of this novel technology. While some countries, like
Germany, strictly prohibit all forms of cloning, the United Kingdom and Japan have adopted
more liberal policies (Winter, 2003). In fact, the U.K. funds research involving therapeutic
cloning (Winter, 2003). If the United States hopes to retain its leadership in scientific
development, members of Congress must pass legislation that preempts state laws banning
therapeutic cloning, provides federal oversight and funds research involving SCNT embryos (the
issue of federalism is beyond the scope of this paper; however Congress may have authority to
enact such legislation under the Commerce Clause).
The federal government should follow California’s suit and enact legislation that
regulates therapeutic cloning while banning reproductive cloning. Because legislation concerning
scientific matters is often ambiguous, an expert panel or agency should be commissioned to draft
regulations on therapeutic cloning and provide oversight. This will allay concerns that
therapeutic cloning will lead to reproductive cloning [The Committee on Bioethical Issues, 2003]
and will ensure the ethical conduct of therapeutic cloning research. Moreover, only labs with the
proper permits and licenses should be allowed to conduct research involving SCNT embryos to
13
guarantee the quality of stem cell products. Quality issues that may arise include poor
manufacturing practices and biological contamination of cells. Informed consent should also be
obtained from anyone participating in research or being treated through SCNT derived stem
cells. Lastly, penalties for engaging in unethical research practices should be punitive enough to
assure that genetic manipulation does not lead to reproductive cloning or the creation of hybrid
organisms.
Citations
1. SCR 1044, Arizona Revised Statutes §36-2312 (2010), http://azleg.gov/ars/36/02312.htm.
2. SCR 1044, Arizona Revised Statutes §36-2313 (2010), http://azleg.gov/ars/36/02313.htm.
3. H.B. 2221, Arizona Revised Statutes §35–196.04 (2005), http://www.azleg.gov/ars/35/00196-
04.htm.
4. S.B. 322, California Health and Safety Code, Chapter 506,
http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=200320040SB322
5. S.B. 1230, California Health and Safety Code §24185 (2002), ftp://www.leginfo.ca.gov/pub/01-
02/bill/sen/sb_1201-1250/sb_1230_bill_20020923_chaptered.html.
6. Copyright 2007 Journal of Health & Biomedical Law Suffolk University Law School Journal of
Health & Biomedical Law, 2007, 3 J. Health & Biomed. L. 143, 9437 words, Note: Embryonic
vs. Adult: The History and Future of the Stem Cell Debate, Caroline P. Torrisi
7. Timeline of major events in stem cell research policy. (2016, December 30). Retrieved September
5, 2017, from http://www.researchamerica.org/advocacy-action/issues-researchamerica-
advocates/stem-cell-research/timeline-major-events-stem-cell
8. George W. Bush: "Executive Order 13435—Expanding Approved Stem Cell Lines in Ethically
Responsible Ways," June 20, 2007. Online by Gerhard Peters and John T. Woolley, The
American Presidency Project.http://www.presidency.ucsb.edu/ws/?pid=75464.
9. Barack Obama:"Executive Order 13505—Removing Barriers to Responsible Scientific
Research Involving Human Stem Cells," March 9, 2009. Online by Gerhard Peters and John T.
Woolley, The American Presidency Project. http://www.presidency.ucsb.edu/ws/?pid=85830.
10. Copyright (c) 2003 Dickinson School of Law, Carlisle, PA Penn State International Law
Review, Winter, 2003, 21 Penn St. Int'l L. Rev. 341, 12469 words, COMMENT:The Difficulty
of Regulating Reproductive and Therapeutic Cloning: Can the United States Learn Anything
from the Laws of Other Countries?, Suzanne H. Rhodes*
11. Copyright (c) 2005 Loyola University Chicago Institute for Health Law Annals of Health
Law,Summer, 2005, 14 Ann. Health L. 361, 17687 words, ARTICLE: An Appropriate
Legislative Response to Cloning for Biomedical Research:The Case Against a Criminal
Ban, Adam Gusman*
12. Sherley v. Sebelius, No. 11-5241, UNITED STATES COURT OF APPEALS FOR THE
DISTRICT OF COLUMBIA CIRCUIT, 689 F.3d 776; 402 U.S. App. D.C. 178; 2012 U.S. App.
LEXIS 17924, April 23, 2012, Argued, August 24, 2012, Decided, US Supreme Court certiorari
denied by Sherley v. Sebelius, 133 S. Ct. 847, 184 L. Ed. 2d 655, 2013 U.S. LEXIS 551 (U.S.,
Jan. 7, 2013)
14
13. Stem Cell Basics. (n.d.). Retrieved September 2, 2017, from
https://stemcells.nih.gov/info/basics.htm
14. Cruzan v. Director,Missouri Department of Health, 110 S. Ct. 2841 (1990)
15. Copyright (c) 2001 Yale Journal of Health Policy, Law and Ethics Yale Journal of Health
Policy, Law and Ethics, Fall, 2001, 2 Yale J. Health Pol'y L. & Ethics 201, 3954 words, CASE
STUDY: The Case Against FederalFunding of Human Embryonic Stem Cell Research, David A.
Prentice,Ph.D.*
16. Copyright (c) 2002 Michigan State University College of Law Journal of Medicine and Law, Fall,
2002, 7 Mich. St. J. Med. & Law 37, 9431 words, ARTICLE: The Constitutional Right to
Therapeutic Cloning, Michael Bellinger
17. Copyright (c) 2005 University of Missouri-Kansas City School of Law UMKC Law
Review, Spring, 2005, 73 UMKC L. Rev. 861, 17705 words, NOTE:TO CLONE OR NOT TO
CLONE: SHOULD MISSOURI ALLOW CLONINGFOR BIOMEDICAL
RESEARCH?, Christopher L. Logan
18. Appendix: State Laws on Human Cloning. (n.d.). Retrieved September 6, 2017, from
http://www.thenewatlantis.com/publications/appendix-state-laws-on-human-cloning
19. (n.d.). Retrieved September 2, 2017, from
http://learn.genetics.utah.edu/content/cloning/clonezone/
20. Huang, A. (2017, June 28). Induced Pluripotent Stem Cells: Not Yet the Perfect Alternative.
Retrieved September 8, 2017, from
http://www.hopkinsmedicine.org/institute_basic_biomedical_sciences/news_events/articles_and_
stories/stem_cells/2010_07_pluripotent_stem_cells
21. Copyright (c) 2003 The Association of the Bar of the City of New York The Record of The
Association of The Bar of the City of New York,2003, 58 The Record 455, 4634 words,
ARTICLE: STATEMENT IN OPPOSITIONTO A FEDERAL LEGISLATIVE BAN ON
THERAPEUTIC CLONING,The Committee on Bioethical Issues
22. Copyright (c) 2005 Duke Law & Technology Review Duke Law & Technology Review, 2005,
2005 Duke L. & Tech. Rev. 26, 7237 words, ARTICLE:Attack of the Clones: Legislative
Approaches to Human Cloning in the United States,ADRIENNE N. CASH n1
23. Song, W. K. (05/2015). Stem cell reports: Treatment of macular degeneration using embryonic
stem cell-derived retinal pigment epithelium: Preliminary results in asian patients. Cell Press.
doi:10.1016/j.stemcr.2015.04.005
24. Benetti F., Peñaherrera E.,Maldonado T., Vera Y. D.,Subramanian V., Geffner L. Direct
myocardial implantation of human fetal stem cells in heart failure patients: long-term results.
Heart Surgery Forum. 2010;13(1):E31–E35. doi: 10.1532/hsf98.20091130.
25. Roe v. Wade 410 U.S. 113 (1973)
26. Griswold v. Connecticut, 381 U.S. 479 (1965)
27. Eisenstadt v. Baird, 405 U.S. 438 (1972)
28. Copyright (c) 2005 Loyola University Chicago Institute for Health Law Annals of
Health Law, Summer, 2005, 14 Ann. Health L. 361, 17687 words, ARTICLE: An
Appropriate Legislative Response to Cloning for Biomedical Research: The Case
Against a Criminal Ban, Adam Gusman
29. Copyright (c) 2001 The Catholic University of America Journal of Contemporary
Health Law & Policy, Winter, 2001, 18 J. Contemp. Health L. & Pol'y 95, 22306
words, ARTICLE: FEDERAL FUNDING OF HUMAN EMBRYONIC STEM CELL RESEARCH
- ILLEGAL, UNETHICAL AND UNNECESSARY*
15
“On my honor as a student of the George Washington
University, I have neither given nor received assistance on this
assignment.
[Signed: HOLLY MARIEBEVAGNA]

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Political and Ethical Dimension of Therapeutic Cloning by Holly Marie Bevagna

  • 1. 1 Holly Marie Bevagna PubH 6368: Law, Medicine, Ethics 09/11/17 Final Paper Political and Ethical Dimension of Therapeutic Cloning In 1996, in one of the most acclaimed experiments of all time, researchers Ian Wilmut and Keith Campbell successfully produced the first cloned mammal (Dolly) via somatic cell nuclear transfer cloning (SCNT) [n.d. 2017]. This would inevitably give rise to much concern and debate over the feasibility and ethics of human cloning for reproductive and/or therapeutic purposes. This paper will discuss the legal and ethical implications of therapeutic cloning, in which stem cells from SCNT cloned embryos are used to treat human afflictions. What are stem cells? Stem cells are immature cells that have not undergone differentiation, the process by which cells acquire specialized functions depending on their location within the body. Unlike other cells, they are capable of reproducing indefinitely. Stem cells can be classified as either totipotent, pluripotent or multipotent. Totipotent stem cells can differentiate into any kind of cell in the body. Pluripotent stem cells are more differentiated than totipotent cells and can be found in fetal tissue. Lastly, multipotent stem cells can only produce cells that reside in the tissue from which they are derived (Torrisi, 2007). Additionally, stem cells may be classified according to source into four categories: adult stem cells, embryonic stem cells, umbilical cord stem cells and placental stem cells (Torrisi, 2007). Adult stem cells (or somatic stem cells) are present after development and are responsible for regenerating damaged tissue. Embryonic stem cells derive from the inner cell mass of the blastula, a pre-implantation embryo that develops 4-5 days after fertilization. Finally, umbilical
  • 2. 2 cord blood and placental stem cells have the potential to mature into hematopoietic cells, including erythrocytes (red blood cells), lymphocytes (white blood cells) and platelets. Applications of stem cells Because they are undifferentiated, human stem cells offer a wide variety of promising therapeutic applications in the field of regenerative medicine. For example, stem cells can potentially be used to grow pancreatic β cells-which secrete insulin- to cure Type I diabetes mellitus or to repair areas of the heart damaged by myocardial infarction (heart attack). In fact, stem cells could be used to remediate virtually any condition involving traumatic injury or cellular dysfunction, including, though not limited to, diabetes, cancer, arthritis, neurodegenerative diseases and spinal cord injuries. If theory can be translated into practice, cell- based therapy could be a panacea for human disease. How are stem cells derived? There are a number of ways in which stem cells may be derived. First, they may be harvested from unused embryos created vis-à-vis in vitro fertilization (IVF). Second, they can be derived from IVF embryos created for research purposes. Third, they can be produced during parthenogenesis, in which a female oocyte (egg) is stimulated to divide without being fertilized. Fourth, adult stem cells can be reverted to embryonic stem cells through applied stimuli; these cells are known as induced pluripotent stem cells (iPSCs). Finally, they can be synthesized by means of somatic cell nuclear transfer cloning (NIH website). What is SCNT cloning? Somatic cell nuclear transfer cloning refers to the process by which the nucleus of a somatic cell is inserted into an enucleated ovum and the created cell is stimulated to divide in
  • 3. 3 vitro. The newly formed zygote contains DNA genetically identical to the somatic cell DNA (n.d., 2017). Therapeutic cloning The issue of human cloning has sparked significant controversy among policymakers, researchers and the general public. Whereas some vehemently oppose all forms of cloning on the grounds that it is inherently wrong and exploitative, others believe that therapeutic cloning will lead to promising new treatments and scientific innovations and should be allowed, insofar as it is well-regulated and subjected to intense scrutiny. In therapeutic cloning, scientists harvest stem cells from the inner cell mass of a blastula produced via Somatic Cell Nuclear Transfer. Policymakers have voiced their opinion on the issue of therapeutic cloning, passing legislation to support their convictions. This paper will examine therapeutic cloning from both a legal and ethical standpoint. Legislation on Stem Cell Research Stem cell policy has been largely protean in nature, shifting to reflect the views and opinions of policymakers. In 1996, Congress passed the Dickey-Wicker Amendment, which proscribes the use of federal funding for the creation of human embryos for research. Furthermore, the statute prohibits any research in which an embryo is destroyed, discarded or deliberately exposed to harm greater than that allowed for research on fetuses in utero (Torrisi, 2007). The National Institutes of Health opined that the moratorium did not apply to stem cell research, since extant cell lines had already been harvested and, therefore, these stem cells did not meet the statutory definition of an embryo. To that end, the NIH promulgated its own guidelines on stem cell research, on August 25, 2000 (Torrisi, 2007). These guidelines proffered a distinction between embryonic stem cells used for research purposes and embryonic stem cells
  • 4. 4 created solely for research purposes. They allowed federal funding for stem cell research using stem cells derived from embryos created for reproductive purposes via in vitro fertilization with the caveat that federal funding would not subsidize the destruction of embryos associated with cell harvesting. Furthermore, they required that the researchers obtain the appropriate donor consent prior to the use of the surplus embryos. In 2001, an executive order entitled “Expanding Approved Stem Cell Lines in Ethically Responsible Ways” (Executive Order 13435) signed by President George W. Bush prohibited the use of federal funds for research on embryonic stem cell lines created after August 9, 2001. Unlike legislation enacted by Congress, executive orders can be rescinded by successive presidential administrations. And that is exactly what transpired. When he formally took office in 2009, President Barack Obama issued an executive order (Executive Order 13505) entitled “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells”, nullifying the executive order issued by President George W. Bush. In contrast to the executive order by President Bush, which emphasized respect for the dignity of human life, the executive order issued by President Barack Obama promoted biomedical research and the development of novel technologies that would benefit mankind and reaffirm the United State’s role as a pioneer of scientific innovation. The stark contrast between the two administrations clearly illustrates the polemics of stem cell research. A couple months after Executive Order 13505 was signed, the NIH established a new set of guidelines regulating embryonic stem cell research, including the derivation of stem cells and procedures for acquiring informed consent. The most noteworthy court case regarding federal funding of embryonic stem cells was Shirley v. Sebelius. Subsequent to President Obama’s abrogation of Executive Order 13435, adult stem cell scientists James Sherley, M.D., Ph.D., and Theresa Deisher, Ph.D. sought
  • 5. 5 declaratory and injunctive relief against the National Institutes of Health and the Department of Health and Human Services, contending that federal funding of embryonic stem cell research was a direct violation of the Dickey-Wicker amendment. They put forth three main arguments. First, they contended that stem cell research involved the destruction of human embryos. This argument was repudiated by the Court of Appeals of the District of Columbia Circuit according to the law-of-the-case doctrine, which states that the same issue presented at a later time should lead to the same result. Second, the complainants alleged that the new NIH guidelines knowingly subjected embryos to risk of injury or death, since the demand for more embryonic stem cell lines would inevitably result in the destruction of more embryos. On this point, the court held that the language of the amendment does not ban funding for research that prompts the future destruction of embryos. Finally, the plaintiffs asserted that the NIH violated the APA by not responding to comments in opposition to stem cell research. The court found that the agency was not legally required to respond to all comments. Ultimately, the court ruled in favor of the government and the NIH guidelines were upheld [Sherley v. Sebelius, 133 S. Ct. 847]. State and Federal Statutes on Cloning A federal statute governing the use of SCNT derived stem cells, or prohibition thereof, has yet to be enacted. Given this lack of federal preemption, numerous states have enacted legislation either prohibiting all forms of cloning (therapeutic and reproductive purposes) or regulating therapeutic cloning while banning reproductive cloning. In 2002, California passed a law allowing the “derivation and use of human embryonic stem cells, human embryonic germ cells, and adult stem cells from any source, including somatic cell nuclear transplantation” [California S.B. 322, 2003]. The California Health and Safety Code expressly prohibits reproductive cloning or any cloning that involves the transfer of a nucleus into an enucleated
  • 6. 6 human or non-human egg for the purposes implantation in a surrogate mother (California Health and Safety Code §24185, 2002). The legislature gave the following reasons for supporting therapeutic cloning: the health burden of debilitating disease, economic costs associated with healthcare and the United States continued role as a leader in scientific exploration. Conversely, Arizona’s statutory code categorically prohibits any “attempt to create an in vitro human embryo by any means other than fertilization through the combining of human egg with human sperm” [Arizona Revised Statute §36-2312, 2010]. Moreover, the statue disallows a person from knowingly engaging in embryonic stem cell research involving the destruction of embryos (implicit in SCNT cloning) [Arizona Revised Statute §36-2313, 2010]. State funding for somatic cell nuclear transfer cloning is also sanctioned [Arizona Revised Statute §35-196.04, 2005]. While these examples are by no means exhaustive, they highlight the stark differences in political ideologies between progressive and conservative states. According to an article published in the New Atlantis, there are seven states that prohibit cloning for both therapeutic and reproductive purposes (including Arizona) and ten states that prohibit reproductive cloning yet make allowances for therapeutic cloning. The remaining states have implemented policies affecting the subsidization of therapeutic cloning research or providing protections for physicians morally opposed to SCNT (A Report of the Witherspoon Council on Ethics and Integrity in Science, 2015). Constitutional protections There is a dearth of court cases involving stem cells and even more so for therapeutic cloning. However, a law review by Bellinger, 2002, explores the topic of constitutional protections for patients who wish to receive stem-cell based therapies derived from SCNT.
  • 7. 7 M. Bellinger, 2002, asserts that patients have a “fundamental right” under the Due Process Clause of the Fifth and Fourteenth Amendments to be treated through therapeutic cloning, using legal precedent to support his argument, including Griswold v. Connecticut, Eisenstadt v. Baird, Cruzan v. Director and Roe v. Wade [all covered in class]. I will examine each of these briefly in turn. In Griswold v. Connecticut, the Supreme Court of the United States reviewed the constitutionality of a Connecticut law prohibiting any person from using “any drug, medicinal article or instrument for the purpose of preventing conception” It held that spouses had a marital “right to privacy” contained within the penumbras of the 5th and 14th amendments [Griswold v. Connecticut, 381 U.S. 479 (1965)]. These protections would be extended to unmarried couples in Eisenstadt v. Baird, in accordance with the Equal Protection Clause of the 14th Amendment, which states that “no state shall…deny to any person within its jurisdiction the equal protection of the laws [Eisenstadt v. Baird, 405 U.S. 438 (1972)]. In Roe v. Wade, the Supreme Court reiterated the rights to privacy and personal autonomy in deciding whether a woman had a fundamental right to an abortion [Roe v. Wade 410 U.S. 113 (1973)]. Cruzan v. Director examined the issue of bodily integrity in the context of removal of life-sustaining treatment. Although the court ruled that the Constitution did not prohibit a state from requiring clear and compelling evidence of a patients dying wishes, this further affirmed the patient’s right to autonomy [Cruzan v. Director, Missouri Department of Health, 110 S. Ct. 2841 (1990)]. Based on the common law, therapeutic cloning could plausibly be construed as a fundamental right, especially if it is deemed necessary to preserve the health of a patient. If this is the case, the government must have a compelling interest for banning therapeutic cloning. The potential for human life at the embryonic stage is not sufficient cause to ban access to potentially
  • 8. 8 life-saving treatment, even if it involves the destruction of embryos, which are non-viable. That said, there is no precedent, as of yet, that addresses the creation of human embryos specifically for research purposes. The ethics of therapeutic cloning As mentioned, stem cell research offers a plethora of promising treatments for practically any tissue that is diseased or damaged, including neurological disorders, hormonal or enzymatic deficiencies and heart failure. SCNT derived stem cells-in particular- confer the same benefits as stem cells derived from other methods (i.e. does not require transplant donors and can be used to regenerate tissue) and eliminate the risk of transplant rejection, since the stem cell’s DNA is genetically identical to the recipient’s. Because of financial restrictions and moral objections to cloning, however, most if not all stem cell research is conducted using stem cells derived from surplus embryos created via in vitro fertilization techniques. Nonetheless, new policies are constantly being implemented-as evidenced in the preceding paragraphs-and most discoveries encounter resistance at first (e.g. in vitro fertilization, Darwin’s theory of evolution and the heliocentric theory). Hence, it is not too premature to discuss the ethical implications of therapeutic cloning. Respect for the dignity of life Some opponents of therapeutic cloning condone the derivation of stem cells from unused embryos created by means of in vitro fertilization [Gusman, 2005]. Their rational is that, since the embryos will be disposed of, they might as well be used to benefit mankind. However, the premise that deriving stem cells from IVF embryos is a morally preferable alternative to therapeutic cloning is flawed. Both therapeutic cloning and the derivation of stem cells via in vitro fertilization require the destruction of embryos-the potential for human life.
  • 9. 9 Notwithstanding, while it is uncertain whether a human SCNT embryo would survive to term, the implantation of IVF embryos in a surrogate mother would inevitably result in a viable fetus, insofar as there are no complications with the pregnancy. A corollary to this is that embryos produced through SCNT cloning conceivably have less potential for human life (using current- day methods) than embryos created through IVF. Therefore, is it not more ethical to destroy SCNT embryos? Some would argue that there are other means of acquiring stem cells that obviate the destruction of human embryos, including the use of placental, umbilical cord blood and adult stem cells and the induction of pluripotent stem cells from adult stem cells [Winter, 2001]. While alternative sources of stem cells do exist, human embryos have the greatest potential to differentiate into various cell types. Placental, cord blood and adult stem cells are multipotent cells and can only produce cells found within the same tissue from whence they originate. In terms of differentiation, induced pluripotent stem cells are comparable to embryonic stem cells, yet recent studies indicate that iPSCs are less sustainable than embryonic stem cell lines and mature at a much slower rate [Hopkins Medicine, 2017]. Despite the benefits of embryonic stem cells, there is a putative link between the use of embryonic stem cells and the formation of malignant neoplasms (cancer) [Prentice, 2001]. More studies are needed to confirm or disaffirm this purported association. A closer look at the issue suggests that therapeutic cloning is controversial not because it involves the destruction of embryos, but rather because it creates life only to exploit and destroy it. Religious leaders and devout Catholics are anathema to human cloning because it interferes with God’s will. Although similar arguments can be made for in vitro fertilization, the duality of
  • 10. 10 creating a human embryo and subsequently destroying said embryo is far more odious to those who believe in the sanctity of life above all else. In considering the constitutionality of therapeutic cloning, the right to patient autonomy will likely be weighed against the embryo’s right to life. Because the embryo is not a viable organism, as established in Roe v. Wade and similar cases, the needs of the patient will take precedence, in so far as the benefits of human cloning cannot be attained through other means. Non-maleficence Through cell harvesting, therapeutic cloning results in the irrevocable destruction of human embryos, violating the bioethical principle of non-maleficence. According to legal precedent, human embryos are to be accorded more respect than mere tissue, but are not entitled to the same protections as a person who has already been born. The level of respect and dignity accorded to an embryo or fetus depends on its stage of development. Embryos, regardless of the means of their inception, are not viable, being comprised of merely a few cells. These embryos cannot perceive pain, think or breathe. If one assumes that the degree of maleficence is determined by the viability of the embryo/fetus, the termination of a second-trimester pregnancy through dilation and extraction does significantly more harm than the destruction of five day old embryos. According to legal doctrine, the destruction of an embryo may be justified in order to save the life of a pregnant woman (e.g. Roe v. Wade). Proponents of this view, contend that the destruction of an SCNT embryo is not justified, since there is no immediate health threat. I disagree. Stem cell-therapies can be used to treat diseases refractory to existing treatments. It can give people their lives back. Although the destruction of embryos is not to be taken lightly, the benefits of SCNT cloning should be assessed and balanced against the harm it causes.
  • 11. 11 Beneficence Although ample research has been conducted on the biology of stem cells in vitro, there is a paucity of clinical trials, most likely due to financial and statutory restrictions. Nonetheless, in clinical trials evaluating the efficacy of stem cell treatment for macular degeneration (Song, 2015) and heart failure (Benetti, 2010), cell-based therapies led to increased visual acuity and increased ejection fractions, respectively. Researchers cautioned that further studies would be needed to confirm the results of research. If the efficacy of stem cell therapy can be firmly established, however, the therapeutic benefits would be considerable enough to justify the destruction of embryos. Utility Therapeutic cloning has the potential to benefit millions of people, demonstrating the bioethical principal of utility, which is defined as doing the greatest good for the greatest number. The clinical utility of therapeutic cloning stems from its myriad applications (described above). Put simply, the number of people who benefit depends on the number of ailments effectively treated through stem cell therapy. If stem cell therapy only treats one disease, the benefits might be minimal (depending on the prevalence of the disease), but if it treats numerous diseases, its utility increases substantially. Furthermore, because SCNT derived stem cells are autologous (used on the same person), patients will no longer have to wait on transplant lists for organs or tissues. Distributive Justice Depending on the cost of cell-based therapies using SCNT cloned cells, the most vulnerable groups might not be able to afford treatment. This is cause for concern, as these groups are disproportionately affected by serious illnesses, such as cardiovascular disease and
  • 12. 12 diabetes. In effect, stem cell therapy could become a form of eugenics that selects for the more affluent and well-off members of society. The only way to circumvent this is through strict anti- patent regulation and a universal health care reform bill defining cell-based therapy as an “essential benefit”. Final recommendations A prima facie ban on all human cloning would have severe implications for scientific advancement in our nation. The United States has long been a pioneer of scientific research. By not investing in therapeutic cloning, the US is ceding this prominent role to other developed countries that recognize the full potential of this novel technology. While some countries, like Germany, strictly prohibit all forms of cloning, the United Kingdom and Japan have adopted more liberal policies (Winter, 2003). In fact, the U.K. funds research involving therapeutic cloning (Winter, 2003). If the United States hopes to retain its leadership in scientific development, members of Congress must pass legislation that preempts state laws banning therapeutic cloning, provides federal oversight and funds research involving SCNT embryos (the issue of federalism is beyond the scope of this paper; however Congress may have authority to enact such legislation under the Commerce Clause). The federal government should follow California’s suit and enact legislation that regulates therapeutic cloning while banning reproductive cloning. Because legislation concerning scientific matters is often ambiguous, an expert panel or agency should be commissioned to draft regulations on therapeutic cloning and provide oversight. This will allay concerns that therapeutic cloning will lead to reproductive cloning [The Committee on Bioethical Issues, 2003] and will ensure the ethical conduct of therapeutic cloning research. Moreover, only labs with the proper permits and licenses should be allowed to conduct research involving SCNT embryos to
  • 13. 13 guarantee the quality of stem cell products. Quality issues that may arise include poor manufacturing practices and biological contamination of cells. Informed consent should also be obtained from anyone participating in research or being treated through SCNT derived stem cells. Lastly, penalties for engaging in unethical research practices should be punitive enough to assure that genetic manipulation does not lead to reproductive cloning or the creation of hybrid organisms. Citations 1. SCR 1044, Arizona Revised Statutes §36-2312 (2010), http://azleg.gov/ars/36/02312.htm. 2. SCR 1044, Arizona Revised Statutes §36-2313 (2010), http://azleg.gov/ars/36/02313.htm. 3. H.B. 2221, Arizona Revised Statutes §35–196.04 (2005), http://www.azleg.gov/ars/35/00196- 04.htm. 4. S.B. 322, California Health and Safety Code, Chapter 506, http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=200320040SB322 5. S.B. 1230, California Health and Safety Code §24185 (2002), ftp://www.leginfo.ca.gov/pub/01- 02/bill/sen/sb_1201-1250/sb_1230_bill_20020923_chaptered.html. 6. Copyright 2007 Journal of Health & Biomedical Law Suffolk University Law School Journal of Health & Biomedical Law, 2007, 3 J. Health & Biomed. L. 143, 9437 words, Note: Embryonic vs. Adult: The History and Future of the Stem Cell Debate, Caroline P. Torrisi 7. Timeline of major events in stem cell research policy. (2016, December 30). Retrieved September 5, 2017, from http://www.researchamerica.org/advocacy-action/issues-researchamerica- advocates/stem-cell-research/timeline-major-events-stem-cell 8. George W. Bush: "Executive Order 13435—Expanding Approved Stem Cell Lines in Ethically Responsible Ways," June 20, 2007. Online by Gerhard Peters and John T. Woolley, The American Presidency Project.http://www.presidency.ucsb.edu/ws/?pid=75464. 9. Barack Obama:"Executive Order 13505—Removing Barriers to Responsible Scientific Research Involving Human Stem Cells," March 9, 2009. Online by Gerhard Peters and John T. Woolley, The American Presidency Project. http://www.presidency.ucsb.edu/ws/?pid=85830. 10. Copyright (c) 2003 Dickinson School of Law, Carlisle, PA Penn State International Law Review, Winter, 2003, 21 Penn St. Int'l L. Rev. 341, 12469 words, COMMENT:The Difficulty of Regulating Reproductive and Therapeutic Cloning: Can the United States Learn Anything from the Laws of Other Countries?, Suzanne H. Rhodes* 11. Copyright (c) 2005 Loyola University Chicago Institute for Health Law Annals of Health Law,Summer, 2005, 14 Ann. Health L. 361, 17687 words, ARTICLE: An Appropriate Legislative Response to Cloning for Biomedical Research:The Case Against a Criminal Ban, Adam Gusman* 12. Sherley v. Sebelius, No. 11-5241, UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT, 689 F.3d 776; 402 U.S. App. D.C. 178; 2012 U.S. App. LEXIS 17924, April 23, 2012, Argued, August 24, 2012, Decided, US Supreme Court certiorari denied by Sherley v. Sebelius, 133 S. Ct. 847, 184 L. Ed. 2d 655, 2013 U.S. LEXIS 551 (U.S., Jan. 7, 2013)
  • 14. 14 13. Stem Cell Basics. (n.d.). Retrieved September 2, 2017, from https://stemcells.nih.gov/info/basics.htm 14. Cruzan v. Director,Missouri Department of Health, 110 S. Ct. 2841 (1990) 15. Copyright (c) 2001 Yale Journal of Health Policy, Law and Ethics Yale Journal of Health Policy, Law and Ethics, Fall, 2001, 2 Yale J. Health Pol'y L. & Ethics 201, 3954 words, CASE STUDY: The Case Against FederalFunding of Human Embryonic Stem Cell Research, David A. Prentice,Ph.D.* 16. Copyright (c) 2002 Michigan State University College of Law Journal of Medicine and Law, Fall, 2002, 7 Mich. St. J. Med. & Law 37, 9431 words, ARTICLE: The Constitutional Right to Therapeutic Cloning, Michael Bellinger 17. Copyright (c) 2005 University of Missouri-Kansas City School of Law UMKC Law Review, Spring, 2005, 73 UMKC L. Rev. 861, 17705 words, NOTE:TO CLONE OR NOT TO CLONE: SHOULD MISSOURI ALLOW CLONINGFOR BIOMEDICAL RESEARCH?, Christopher L. Logan 18. Appendix: State Laws on Human Cloning. (n.d.). Retrieved September 6, 2017, from http://www.thenewatlantis.com/publications/appendix-state-laws-on-human-cloning 19. (n.d.). Retrieved September 2, 2017, from http://learn.genetics.utah.edu/content/cloning/clonezone/ 20. Huang, A. (2017, June 28). Induced Pluripotent Stem Cells: Not Yet the Perfect Alternative. Retrieved September 8, 2017, from http://www.hopkinsmedicine.org/institute_basic_biomedical_sciences/news_events/articles_and_ stories/stem_cells/2010_07_pluripotent_stem_cells 21. Copyright (c) 2003 The Association of the Bar of the City of New York The Record of The Association of The Bar of the City of New York,2003, 58 The Record 455, 4634 words, ARTICLE: STATEMENT IN OPPOSITIONTO A FEDERAL LEGISLATIVE BAN ON THERAPEUTIC CLONING,The Committee on Bioethical Issues 22. Copyright (c) 2005 Duke Law & Technology Review Duke Law & Technology Review, 2005, 2005 Duke L. & Tech. Rev. 26, 7237 words, ARTICLE:Attack of the Clones: Legislative Approaches to Human Cloning in the United States,ADRIENNE N. CASH n1 23. Song, W. K. (05/2015). Stem cell reports: Treatment of macular degeneration using embryonic stem cell-derived retinal pigment epithelium: Preliminary results in asian patients. Cell Press. doi:10.1016/j.stemcr.2015.04.005 24. Benetti F., Peñaherrera E.,Maldonado T., Vera Y. D.,Subramanian V., Geffner L. Direct myocardial implantation of human fetal stem cells in heart failure patients: long-term results. Heart Surgery Forum. 2010;13(1):E31–E35. doi: 10.1532/hsf98.20091130. 25. Roe v. Wade 410 U.S. 113 (1973) 26. Griswold v. Connecticut, 381 U.S. 479 (1965) 27. Eisenstadt v. Baird, 405 U.S. 438 (1972) 28. Copyright (c) 2005 Loyola University Chicago Institute for Health Law Annals of Health Law, Summer, 2005, 14 Ann. Health L. 361, 17687 words, ARTICLE: An Appropriate Legislative Response to Cloning for Biomedical Research: The Case Against a Criminal Ban, Adam Gusman 29. Copyright (c) 2001 The Catholic University of America Journal of Contemporary Health Law & Policy, Winter, 2001, 18 J. Contemp. Health L. & Pol'y 95, 22306 words, ARTICLE: FEDERAL FUNDING OF HUMAN EMBRYONIC STEM CELL RESEARCH - ILLEGAL, UNETHICAL AND UNNECESSARY*
  • 15. 15 “On my honor as a student of the George Washington University, I have neither given nor received assistance on this assignment. [Signed: HOLLY MARIEBEVAGNA]