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For as children tremble and fear everything in the blind darkness, so we in the light sometimes fear what is no more to be feared than the things children in the dark hold in terror and imagine will come true .
—Lucretius 1
I NTRODUCTION
At present, “excess” embryos 2 from in vitro fertilization (IVF)
* Professor of Law, New England School of Law and the Chair of the Committee on
Bioethics, Real Property, Probate & Trust Section of the American Bar Association.
The author would like to thank Kate E. Hutson, J.D. New England School of Law
2005 (expected), for her exceptional work on this project. Her ideas and energy helped make this article possible. The author also wishes to thank New England
School of Law and Dean, John F. O’Brien for research support through the James R.
Lawton Summer Stipend Program.
1 . L UCRETIUS , D E R ERUM N ATURA [T HE N ATURE OF T HINGS ] bk. 1, l. 87, in J OHN
B ARTLETT , F AMILIAR Q UOTATIONS 100, 100-01 (Emily Morison Beck ed., 1980).
2 . The term embryo has various meanings and interpretations regarding the timeline of fetal development. See Eric S. Surrey et al., The Menstrual Cycle, Ovulation,
Fertilization, Implantation, and the Placenta (Calvin J. Hobel ed.), in E SSENTIALS OF
O BSTETRICS AND G YNECOLOGY 59, 69-70 (Neville F. Hacker & J. George Moore eds.,
3d ed. 1998); Adam Ratner, Fetal Development , at http://health.allrefer.com/ health/fetal-development-info.html (May 31, 2002).
The following is a brief summary of the stages of development of the embryo:
Once a single sperm has fertilized an egg, a single cell consisting of half the mother’s
DNA and half the father’s DNA results. Id.
This “single cell is called a zygote.” Id.
The cells begin to divide, creating both inner and outer masses of cells. Id.
The developing entity at this stage is called a blastocyst. Id. The entity then travels down the fallopian tubes and into the uterus, and, on approximately day six, implants into
583
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584 NEW ENGLAND LAW REVIEW [Vol. 39:583 procedures can be used by scientists to extract stem cell lines 3 for research.
Federal funding for such research, however, is prohibited.
4 The clear weight of current evidence suggests that embryonic stem cell lines are superior to adult stem cell lines.
5 However , if the research conducted on these stem cell lines is to prove optimally useful for gene therapy, cloned embryos (embryos created by scientists from Somatic Cell Nuclear
Transfer (SCNT) 6 or similar methods) should be used. Such embryos are optimal because if the “sick” patient is cloned and an embryo produced, the the uterine wall. Id.
From implantation until approximately the end of the eighth week, the entity is now termed an embryo. After the eighth week, the entity is called a fetus until delivery. Id. For purposes of this article, the term embryo will be used for all stages of development after an egg has been fertilized (either by traditional intercourse or through in vitro fertilization procedures), or after the creation of a clone. This term may be qualified in order to assure that the reader is clear about which stage of development is being discussed.
3 . Stem cells are cells that have the ability to become any type of cell in the body. The natural course of development instructs the cells to differentiate into all types of cells in the body; however, scientists can also compel differentiation of the stem cells to become the cells that they desire in a Petri dish. Jonathan Shaw, Stem-Cell Science ,
H ARV .
M AG ., July-Aug. 2004, at 36, 40.
In this article, the terms stem cells and stem cell lines will refer to embryonic stem cells and lines; that is, stem cells derived from an embryo. While adult stem cells do exist, they will not be discussed in the text of this article. See generally David
Prentice, Adult Stem Cells , 19 I SSUES L.
& M ED . 265 (2004) (discussing the identity of adult stem cells, the mechanisms inspiring their differentiation and possible therapeutic and research uses); N AT
’
L I NSTS .
OF H EALTH , Stem Cell Basics , at http://stemcells.nih.gov/info/basics/ (last modified June 10, 2004) (discussing adult stem cells, where they come from, what they do and various uses for them).
4 . Address to the Nation on Stem Cell Research, 2 P UB .
P APERS 953 (Aug. 9, 2001), available at http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html.
President George W. Bush announced that he would allow federal funds to be used for research on the sixty embryonic stem cell lines in existence at that time. Id. He also announced, however, that federal funds could not be used to create additional stem cell lines. Id. For the stem cell lines in existence, the President commented that research should go forward since “the life and death decision has already been made.”
Id.
5 . See infra
note 18 and accompanying text.
6 . For this article, a cloned embryo is one that is created by SCNT or related processes.
In the SCNT process, an adult, differentiated somatic cell (such as a skin cell) is starved, rendered dormant, and is returned to the state where it may be differentiated to become any type of cell. See Ronald Chester, Cloning for Human Reproduction:
One American Perspective , 23 S YDNEY L.
R EV . 319, 321-22 (2001). It is then fused with an enucleated egg to create a single entity called a clone. See id. The resulting clone carries the DNA of the donor of the somatic cell, and a tiny portion of the inactive mitochondrial DNA from the donor of the egg cell. See id. The clone is genetically identical to its somatic cell donor. See id.
726932737 15.04.2020
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2005] CLONING EMBRYOS FROM ADULTS 585 patient’s immune system is less likely to reject the therapy made possible by its own cloned embryo’s stem cells.
7
While there is considerable agreement among scientists that embryos left over from fertility treatments should be used to extract new stem cell lines beyond those allowed by President Bush, 8 creating a cloned embryo in order to destroy it for its stem cells, as the South Koreans have just done, 9 is not as widely accepted. However, if the medical research involving stem cells from excess embryos proves as fruitful as many
7 . Production of a cluster of cells from which stem cell lines can be extracted can now be achieved by a process other than cloning; a process which may raise fewer ethical questions than cloning—parthenogenesis. Parthenogenesis is a process by which a female egg is chemically instructed not to release half of its chromosomes (as it would normally) and is stimulated to start developing normally, even though it has not been fertilized. S
EAN
H
ENAHAN
, A
CCESS
E
XCELLENCE
Asexual Stem Cell
Production , at http://www.accessexcellence.org/WN/SU/parthenogenesis.html (Feb.
5, 2002). While this is a normally occurring process in some reptiles and insects, until recently, it was not believed that mammals could reproduce in this way. Id. In 2003, researchers were able to grow parthenogenetic human embryos to the blastocyst stage, at which time stem cells could be harvested. Sylvia Pagán Westphal, ‘Virgin Birth’
Method Promises Ethical Stem Cells , N
EW
S
CIENTIST
, Apr. 28, 2003, at 17, available at http://www.newscientist.com/article.ns?id=dn3654. This was originally an attractive alternative to cloning, because it was not believed that mammalian parthenogenetic embryos had the ability to develop into mammals—thus, if they never had the potential to be a life, then there would be no ethical problem with removing stem cells. See H ENAHAN , supra . However, with the recent discovery that scientists can create mammals (most notably mice which have similar biological structures to humans) through parthenogenesis, the ethical problem remains. Rick
Weiss, Who Needs Men? Japan Produces Mice with Two Mommies , C ENTRE D AILY
T IMES , Apr. 23, 2004, at 11. There are, however, still some possible advantages to utilizing parthenogenesis. The resulting offspring from this process creates a unique individual—not a clone of the egg. Id.
Thus, those who oppose reproductive cloning because they feel the child would not be unique or an individual would not be able to use that as an excuse. The resulting child would have his own DNA, and would not be a mere replication of one of her parents. Unfortunately, parthenogenesis, created by female eggs and chromosomes, can only create female offspring. See Westphal, supra . Additionally, the stem cell lines that would be derived may be useful for research purposes, but the therapeutic uses are limited because only female stem cell lines can be produced. See id.
For more information on parthenogenesis, see generally
Daniel Loebel & Patrick Tam, Mice Without a Father , 428 N ATURE 809 (2004);
Weiss, supra ; Westphal, supra .
8 . See Address to the Nation on Stem Cell Research, supra
9 . Rick Weiss, Mature Human Embryos Cloned , W ASH .
P OST , Feb. 12, 2004, at A1. On
February 12, 2004, South Korea announced that it had created the world’s first mature, cloned, human embryo. Id.
Researchers also managed to extract an embryonic stem cell colony from one of the embryos, marking the first in time in history such a procedure was successful.
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586 NEW ENGLAND LAW REVIEW [Vol. 39:583 suspect and leads to successful drug or gene therapy, the utilitarian argument 10 for cloning such embryos can be expected to overwhelm the deontological argument 11 for not creating them.
While the utilitarian arguments for reproductive use of cloned embryos may not be as strong as those for the therapeutic uses, they do exist. Couples who cannot conceive by any other means, 12 lesbian
10 . Utilitarianism is the philosophical doctrine that actions should be directed towards achieving the greatest good for the greatest number of people. W EBSTER
’
S T HIRD N EW
I NT
’
L D ICTIONARY 2525 (3d ed. 1986). When evaluating a new procedure or practice, the utilitarian view requires that one weigh the benefits of the procedure/practice against its possible harms. If the benefits outweigh the harms, the procedure/practice is said to have utility. Baroness Mary Warnock, Philosophy and Ethics , in E POSIUM
1992: G
ENETIC
E
NGINEERING
—T
HE
N
EW
C
HALLENGE
67 (Clive Cookson et al. eds.,
European Patent Office 1993). The utilitarian outlook is a cost-benefit calculation that is unaffected by moral or ethical considerations. See Roger Brownsword, Bioethics
Today, Bioethics Tomorrow: Stem Cell Research and the “Dignitarian Alliance ,
”
17
N
OTRE
D
AME
J.L.
E
THICS
& P
UB
.
P
OL
’
Y
15, 16-17 (2003).
11 . Deontology is the study of moral obligation and therefore a deontological argument is a morally based argument. W EBSTER
’
S T HIRD N EW I NT
’
L D ICTIONARY , supra
at 603. In the embryonic stem cell debate, one deontological argument often discussed is the human dignity as constraint argument. Human dignity as constraint requires that the human embryo be respected in and of itself as a member of the human species.
See Brownsword, supra
not like a rock or a stone.” Id.
at 42.
It does not matter if the embryo can experience pain, suffering or distress. The embryo should be respected, and thus not destroyed, based on the “overarching value of respect for human dignity.” Id.
Brownsword also distinguishes a second deontological argument—human dignity as empowerment. This philosophy is closely linked with modern human rights thinking, and requires that every human being has inherent dignity and that this inherent dignity means that he has the right to do whatever he wants. Each individual has the capacity to decide what is best for him to do, and it is not up to the other members of society to make such decisions. Id.
at 21-25.
12 . In vitro fertilization (IVF) procedures and other assisted reproductive technologies are available for many couples who wish to reproduce children with DNA from both parents. If either parent cannot produce viable sperm or eggs, however, they are unable to have children that are genetically their own. Reproductive cloning may be able to assist these couples in producing children that are genetically linked to one of the parents, without requiring the intrusion of a third party, who may later reappear to try and claim the child as their own. C AL .
A DVISORY C OMM .
ON H UMAN C LONING ,
C
LONING
C
ALIFORNIANS
?
R
EPORT OF THE
C
ALIFORNIA
A
DVISORY
C
OMMITTEE ON
H UMAN C LONING , reprinted in 53 H ASTINGS L.J. 1143, 1169 (2002) [hereinafter
C ALIFORNIA C OMMITTEE R EPORT ]; Alexandra Hawkins, Comment, Protecting Human
Dignity and Individuality: The Need for Uniformity in International Cloning
Legislation , 14 T RANSNAT
’
L L AW . 243, 257 (2001); John A. Robertson, Why Human
Reproductive Cloning Should Not in All Cases Be Prohibited , 4 N.Y.U.
J.
L EGIS .
&
P UB .
P OL
’
Y 35, 37 (2000); Lee Silver, Public Policy Crafted in Response to Public
726932737 15.04.2020
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2005] CLONING EMBRYOS FROM ADULTS 587 couples, 13 and individuals who want to reproduce without a partner 14 would all be benefited by reproductive cloning.
15
Once the cloning of embryos for research and therapy becomes widely accepted, it is probably true that nothing can stop the use of such clones for reproduction.
16 At the same time, the deontological argument for reproductive use may even be stronger than the argument for therapeutic and research uses because we do not destroy the embryo in reproductive cloning; we use it as an end in itself to create sustainable life. It is my purpose in this paper to argue that the deontological reasons for reproductive cloning, coupled with the significant utilitarian reasons for such cloning, make the argument for reproductive use of such clones at least as strong as those for research or therapeutic uses. Furthermore, the
Ignorance is Bad Public Policy , 53 H
ASTINGS
L.J.
1037, 1041 (2002) (predicting that the individuals most likely to utilize reproductive cloning will be single women wishing to have a genetically-related child without using a sperm donor).
For an article discussing the risks to women from egg extraction for use in either
IVF or cloning, see Judy Norsigian, Risks to Women in Embryo Cloning , B OSTON
G LOBE , Feb. 25, 2005, at A13.
In instances of male gametic infertility, it is possible for both parents to contribute to the genetic makeup of the child by using reproductive cloning. By inserting the father’s DNA into the mother’s enucleated egg and implanting the embryo inside the mother, the child has a biological link to both parents—through the father’s nuclear DNA and the mother’s mitochondrial DNA (as well as through her gestation of the embryo). C ALIFORNIA C OMMITTEE R EPORT , supra , at 1169; see also
Hawkins, supra , at 257; Robertson, supra , at 37.
13 . Lesbian couples may seek to produce offspring without the intrusion of a third party sperm donor. One partner may donate the nuclear DNA, and the enucleated egg cell and may gestate the embryo herself; or one partner may donate the nuclear DNA and the other may donate the enucleated egg cell and gestate the egg. In this second circumstance, both partners have at least a small genetic link to the child. See
C ALIFORNIA C OMMITTEE R EPORT , supra note 12, at 1169.
14 . Some individuals may choose to reproduce without a partner if both partners are carriers of genetic recessive disorders. Robertson, supra note 12, at 38. Diseases such as Tay-Sachs, sickle cell anemia, and cystic fibrosis are transferable to a child only if both of the genetic parents are carriers of the defective gene. Id.
To reduce the risk that the child would be born with one of these diseases, an individual may choose to reproduce by cloning, thereby eliminating the possibility that two defective genes could be transferred to the child. Id.
15 . In therapeutic cloning, once the embryo has been cloned, the stem cells are extracted and the embryo destroyed. In reproductive cloning, on the other hand, the cloned embryo is implanted in the uterus where (theoretically) it will grow and develop into a human being. June Mary Zekan Makdisi, The Slide from Human Embryonic Stem Cell
Research to Reproductive Cloning: Ethical Decision-Making and the Ban on Federal
Funding , 34 R UTGERS L.J. 463, 496 (2003).
16 . See id.
at 505.
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588 NEW ENGLAND LAW REVIEW [Vol. 39:583 argument for the relative merits of reproductive cloning versus research or therapeutic cloning may be strengthened if embryonic stem cell research proves less fruitful then expected.
Ultimately, I will argue that legislation and regulation should permit the cloning of embryos via SCNT and that there is no real need for lawmakers to try to prohibit the use of such embryos for reproductive purposes while allowing it for research and therapy. Once the clone is created, it can, and should, be used in any of these ways; prohibition of any of the uses will not work.
17 Thus, lawmakers should allow cloning by
SCNT and related procedures and not worry about trying to ban one use of the clones (reproduction) while allowing others (research and therapy).
There are sufficient reasons to allow any of the mentioned uses.
I.
C LONING F OR R ESEARCH AND T HERAPY
It is not a purpose of this paper to enter the dispute over whether stem cells from adults can supplant embryonic stem cells. Rather, for purposes of this argument, I will assume that embryonic stem cells are clearly superior.
18 Once the need for embryonic stem cells is accepted, preference
17 . The distinction between embryos used for therapeutic versus reproductive purposes is discussed in length by June Mary Zekan Makdisi. Id.
Makdisi examines the multiple bills that came through Congress during 2001 and 2002. Id. While much of the language between various bills and drafts appears to be similar, one recurring problem was trying to distinguish between embryos used for therapy and embryos used for reproduction. Id.
at 499. She believes that once cloning is allowed for research and therapy, clones will eventually be used for reproduction. Id.
Makdisi also examines the California Legislature’s attempt to regulate cloning on the state level. Id.
at 493-97. California has attempted to distinguish between clones created for reproduction and clones created for stem cell research. Id.
at 493.
In 1997, legislation was passed that prohibited reproductive cloning. Id. Subsequent legislation indicates that the clones, though they may be created by the same SCNT process, are to be distinguished from each other based on the user’s intent to use them for either therapeutic or reproductive purposes. The “reproductive” clones are prohibited from being created, while the “therapeutic” clones are permitted and accepted, and may be used for stem cell research. For a more complete description of the bills before Congress and the California Legislature, see id.
at 493-95, 497-502.
18 . Only one adult stem cell has been well-characterized by scientists and can be used to treat patients—the hematopoietic stem cell (HSC). Shaw, supra
Although HSCs can create many cell types that make up blood and the immune system, they cannot create other organs. Id.
Adult stem cells are thought to only be able to generate specific tissues. Id.
Conversely, embryonic stem cells may be manipulated to become any tissue in the body. Id.
Additionally, scientists are almost certain that not every organ has an adult stem cell associated with it. Id.
So, for certain diseases or failing organs, the only possible way to repair the damaged organ would be to utilize cloned embryonic stem cells. Id.
While adult stem cells are useful,
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2005] CLONING EMBRYOS FROM ADULTS 589 for cloned embryos over IVF embryos requires explanation.
Initially, I believe it is necessary to separate research uses of embryos from therapeutic uses. Research uses have created present demand for such embryos, while the therapeutic uses are largely speculative, though their projected benefits are spectacular.
The general idea behind the therapeutic uses of cloned embryos is as follows: Take a patient’s healthy somatic cell and create a clone; then retrieve the stem cells from this cloned embryo that can be used to repair a patient’s failing organ without fear of rejection by the patient’s immune system.
19 Excess IVF embryos would not have this feature. According to
Rick Weiss of the Washington Post:
[T]his potential to regenerate ailing organs [through a cloned embryo’s stem cells] has been a powerful—though so far unsuccessful—selling point as scientists and advocates have tried to persuade Congress and the Bush administration to loosen restrictions that preclude the use of federal funds for work involving cloned embryos.
20
An important reason for this lack of success is that therapeutic cloning, even if perfected, faces “technical and regulatory hurdles so high that it could be a decade before the first proposal is ready for consideration by a
Food and Drug Administration.” 21 The FDA has already said it will want answers to questions such as the following: “Will the stem cells go where they’re supposed to go in the body? Could they turn into the wrong kinds of cells once they’re in the body? Will they start multiplying uncontrollably and do not pose the ethical questions that embryonic stem cells do, there does not seem to be a consensus claiming that they can be used as effectively as embryonic stem cells. Id .; see also N AT
’
L I NSTS .
OF H EALTH , supra
difference between adult stem cells and embryonic stem cells and their various uses);
Allison B. Newhart, Note, The Intersection of Law and Medicine: The Case for
Providing Federal Funding for Embryonic Stem Cell Research , 49 V ILL .
L.
R EV . 329,
331 (2004) (discussing the reasons researchers prefer embryonic stem cells to adult stem cells); Makdisi, supra
note 15, at 468-72 (analyzing the public perception of the
usefulness of adult stem cells versus embryonic stem cells).
19 . Rick Weiss, Cloned Embryos Could Help Explain Basis for Diseases , W ASH .
P OST ,
Feb. 23, 2004, at A8.
It should be noted that Harvard University, which has established a stem cell research institute with private funds, is, after a year of ethical review, about to announce that the institute will clone embryos for research and therapeutic purposes.
Gareth Cook, Harvard Provost OKs Procedure , B OSTON G LOBE , Mar. 20, 2005, at
A29.
20 . Id.
21 . Id.
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590 NEW ENGLAND LAW REVIEW [Vol. 39:583 and form cancers?” 22
Because of the futuristic nature of therapeutic cloning, and Congress’s recent unresponsiveness to its potential, scientists are beginning to talk about the more immediate research uses of cloned embryos:
Instead of making cloned embryos a source of healthy stem cells for transplantation into patients, scientists are proposing to make cloned embryos that explicitly bear the genetic glitch or glitches at the root of a patient’s disease…. [For example] they would start with … a degenerating nerve cell … from a person with
Lou Gehrig’s disease, a neurological disorder that robs people of control over their muscles. Using cloning techniques, scientists would transform that cell into an embryo, which … would produce stem cells … [bearing] the genetic roots of the disease….
23
Since “[r]esearchers already know how to force stem cells to become nerve cells[,] … they would do so with stem cells taken from a cloned Lou
Gehrig’s embryo and watch those cultured nerves as they degenerate in a laboratory dish.” 24 Then, they could watch the disease unfold outside a person and test whether chemicals or drugs might somehow alter the process. Or, they could inject these fresh, but degenerating neurons into the brain of a mouse or rat and watch how they develop, die and/or respond to various drugs.
25
So the fact is that there is considerable utility in cloning embryos whether or not the therapeutic uses trumpeted in the media come to pass soon or at all. The ethical problem remains, however, that even though early embryos are not generally considered “human life” (except by the religious right), there is some consensus, as the court said in Davis v.
Davis, that embryos fall into an interim category, between persons and property, and are thus entitled to a measure of “respect,” which is not welldefined.
26 Thus, when we create embryos by cloning we are creating an
22 . Id.
; see also F OOD & D RUG A DMIN ., BRMAC Meeting: Human Stem Cells as Cellular
Replacement Therapies for Neurological Disorders—Discussion Questions , at http://www.fda.gov/ohrms/dockets/ac/00/questions/3629q2.pdf (last modified July 10,
2000).
23 . Weiss, supra
24 . Id.
25 . Id .
(discussing other uses cloning has to offer the research community such as introducing different environmental factors to defective clones and examining the contributions of nuclear and mitochondrial genes); N AT
’
L I NST .
OF H EALTH , supra
note 3 (describing uses for stem cell research such as gene therapies, determining how
genes are turned “on” and “off” and creating muscles and tissue for transplants).
26 . Davis v. Davis, 842 S.W.2d 588, 597 (Tenn. 1992) (upholding Hamby v. McDaniel,
726932737 15.04.2020
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2005] CLONING EMBRYOS FROM ADULTS 591 entity in this interim category solely to destroy it for its stem cells, so that experimentation and, later perhaps, therapy can take place. It might be argued that these embryos are being cloned as a means to an end, not as ends in and of themselves (as would occur if cloned for reproductive, rather than experimental, purposes).
27
II.
C LONING F OR R EPRODUCTION
The utility of cloning for reproduction receives very little attention in the media. Perhaps this is partly because controversial groups, like lesbians and single parents wishing to reproduce, would derive much of this utility.
Another group that might want to use the technology for reproduction would be those unable to produce children by conventional means or other forms of reproduction; however, this group seems rather limited.
28 There also appears to be a concern that cloned embryos, left to develop into children, would produce children with physiological and perhaps psychological defects. Society would not be burdened by such potentially damaged children if cloned embryos were destroyed early to extract their stem cells.
Some opponents of reproductive cloning argue that creating a cloned child is creating a child destined to be burdened with psychological problems. One such problem is that the child may suffer from a loss of identity and individuality since he is technically a delayed twin and not a unique child.
29 Others have posited that the cloned child may endure biological and familial problems due to the fact that the cloned child is a
559 S.W.2d 774 (Tenn. 1977)). The Davis court ultimately stated that the IVF embryos (that had been frozen at less than 14 days old) were not “persons” under
Tennessee law or under federal law. Id .
However, the Court did not officially declare the status of an embryo, but instead just said that the embryo deserved “special respect because of its potential for human life.” Id . Additionally, the court stated that the parents did not maintain a true property interest in the embryos, although they do have an ownership interest, to the extent that they may dictate the disposition of the embryos within the scope of the law. Id .
27 . See President’s Council on Bioethics, The Moral Case Against Cloning for
Biomedical Research , 18 I SSUES L.
& M ED . 261 (2003). But see Roger H. Taylor, The
Fear of Drawing the Line at Cloning , 9 B.U.
J.
S
CI
.
& T
ECH
. L. 379, 398 (2003)
(arguing that cloning and extracting stem cells for therapy may be different than using excess IVF embryos for their stem cells because IVF embryos were originally intended to create human life, while cloned-for-therapy embryos were never intended to become a human life, but were only intended to have their stem cells harvested).
28 . See supra
notes 12-14 and accompanying text.
29 . President’s Council on Bioethics, Human Cloning and Human Dignity: An Ethical
Inquiry , 18 I SSUES L.
& M ED .
167, 175 (2002), available at http://www.bioethics.gov/ reports/cloningreport/index.html.
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592 NEW ENGLAND LAW REVIEW [Vol. 39:583 virtual twin of his parents—is the clone a child or a sibling?
30 Finally, some speculate that the child may suffer from an “expectations problem.” Since the child will grow up with the same DNA as one of his parents, will the parent saddle the cloned child with expectations and forced desires that the parent had (or wished they had) when they were younger?
31
The psychological problems a cloned child might encounter seem overblown.
32 A child produced by SCNT would actually be less genetically similar to its “parent” than an ordinary “identical” twin would be to its sibling because the clone can carry the different mitochondrial DNA of the host egg.
33 The mitochondrial DNA would be from a different source than would the donor nucleus unless, of course, a female did the cloning all by herself and carried the resultant child.
34 Also, the “expectations” problem would seem less severe than with identical twins.
35 A clone would typically be a generation or two younger than its “parent.” 36 Unlike the identical twin, the clone would hardly be expected to look like the entity with its same DNA. In fact, it might develop into a substantially different adult than its parent due to various environmental influences.
37 As far as the clone becoming “enslaved” to the expectations of its parent, there seems little reason to distinguish any parental expectations for the clone from those a parent might have for a conventionally conceived child.
38
On the other hand, there are serious risks that the cloned child may have physiological damage, at least initially. Animal studies show that
30 . See Taylor, supra note 27, at 402.
31 . See Radhika Rao, What’s So Strange About Human Cloning?
, 53 H ASTINGS L.J. 1007,
1010-11 (2002). For more information on potential psychological harms, see Taylor, supra
note 27, at 402; President’s Council on Bioethics,
supra
Robertson, supra note 12, at 40-41.
32 . See supra
notes 29-31 and accompanying text.
33 . See Chester, supra
34 . Nathan A. Adams, IV, Creating Clones, Kids & Chimera: Liberal Democratic
Compromise at the Crossroads , 17 N OTRE D AME J.L.
E THICS & P UB .
P OL
’
Y 71, 84 n.86 (2003).
35 . Some studies have shown that parents of twins tend to expect that the twins will act the same, perform the same and learn at the same rate, due to the fact that their gene configurations are exactly alike. Judith Rich Harris, Where is the Child’s
Environment? A Group Socialization Theory of Development , 102 P SYCHOL .
R EV .
458, 459 (1995).
36 . See Robertson, supra note 12, at 40-41.
37 . See John A. Robertson, Liberty, Identity and Human Cloning , 76 T EX .
L.
R EV . 1371,
1413 (1998).
38 . See Robertson, supra note 12, at 40-41; see also Robertson, supra note 37, at 1416;
Ronald Chester, To Be, Be, Be … Not Just to Be: Legal and Social Implications of
Cloning for Human Reproduction , 49 F LA .
L.
R EV . 303, 305 n.7 (1997).
726932737 15.04.2020
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2005] CLONING EMBRYOS FROM ADULTS 593 cloned individuals tend to be “defective” in some way.
39 For example,
Dolly the sheep, the first cloned animal, did not live to the age of a
“normal” sheep.
40 While Robertson, among others, has argued that an individual with such physical problems is “better off” than if it had not been born at all, this might depend on how serious the physical anomalies are.
41
Thus, the “safety” issues for clones that are allowed to develop into children appear to be real ones at present—or at least, so the preliminary evidence suggests. It does, however, seem somewhat “circular” for us to deny funding to, or even to block research about, human reproductive cloning due to fear for the clone’s health. This stymies research and clinical trials that might ensure healthier outcomes for cloned children. One problem is surely that developing embryos and maybe even resulting children would be lost in experiments to improve “safety.” 42 It is likely that such embryos would be significantly further along developmentally than the minute ones destroyed for their stem cells. This reality engenders greater ethical concerns. If the embryos are implanted, the mother’s safety also becomes a factor.
If the United States continues to stymie research into reproductive cloning, it is to be expected that researchers in other countries will “pick up the slack.” Eventually, we may find that cloning for reproduction is nearly as safe as normal reproduction, or at least as safe as other means of assisted
39 . While scientists have successfully cloned pigs, cattle, goats, cats, monkeys and mice, there are studies that suggest that the animals suffer from defects and/or abnormalities. Since a clone is created from a mature (or at least not brand new) animal cell, although the cell is returned to its primitive state, the chromosomes in the cell are “old” and so the animal may begin life genetically older then he appears to be.
These clones may suffer from shortened life spans or from health problems associated with old age. Taylor, supra note 27, at 382. Additionally, some cloned mice have suffered from obesity. Narumi Ogonuki, Early Death of Mice Cloned from Somatic
Cells , 30 N ATURE G ENETICS 253, 254 (2002). Others have been found to have organ deformities. Lori B. Andrews, Is There a Right to Clone: Constitutional Challenges to
Bans on Human Cloning , 11 H ARV .
J.L.
& T ECH . 642, 652 (1998). Finally, the success rate for producing viable cloned offspring is small—Dolly the sheep was the 277th implanted egg. Taylor, supra
40 . Cameron Simpson, Cloning Fears as Dolly the Sheep Dies , H ERALD (Glasgow), Feb.
15, 2003, at 1. Dolly was put to sleep at age six after doctors discovered signs of progressive lung disease. Id. The average sheep lives to approximately eleven or twelve, and while lung disease is not uncommon, it usually only strikes sheep in the later stages of life. Id.
41 . For a complete discussion of the moralities of creating a child with known anomalies, see Robertson, supra
42 . Adams, supra
note 34, at 85. In cloning trials, ninety-seven percent of the simplest
cloned animals die prior to a live birth. Id.
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594 NEW ENGLAND LAW REVIEW [Vol. 39:583 reproduction.
43 If the safety issues are resolved, those who would ban reproductive cloning must squarely face the reasons for their unease.
44 If there is utility for some from the procedure, why ban it?
Opponents of the procedure might then be forced into weak arguments such as the “yuck” factor, psychological speculations and disgust with “asexual” as opposed to sexual reproductions.
45 These can be countered on an ethical basis by noting that embryos cloned for such a purpose are being used to produce life, not to destroy, at least a preliminary form of life. The opposite is true when embryos are cloned for research or therapeutic purposes. Since this reality may make the deontological argument for reproductive cloning stronger than that for research or therapeutic cloning, the considerable utility from such a procedure, at least to some groups, would seem to tip the balance in favor of reproductive use.
III.
C OMPARING R EPRODUCTIVE C LONING WITH R ESEARCH AND / OR
T HERAPEUTIC C LONING
If a strong argument can be made for allowing human reproductive cloning once the physical safety issue is removed, where does that leave cloning for research and/or therapeutic uses? Obviously, once human cloning through SCNT is allowed and perfected for any purpose, it will be practically impossible to prevent its use for another.
46 The biology is the
43 . Despite the fact that ARTs have been in existence for quite some time, recently, some studies have shown that children born as the result of ARTs may not be as healthy as originally thought. John A. Robertson, Procreative Liberty and Harm to Offspring in
Assisted Reproduction , 30 A M .
J.L.
& M ED . 7, 9-10 (2004). Complications and disorders associated with ART births include: increased risks for low birth weight; increased risk for birth defects; increased risks of neurological disorders; and, increased risk of sex chromosome difficulties and imprinting disorders. Id.
Evidence of these problems is relatively new, and more studies are being conducted to try to formulate reliable and comprehensive conclusions regarding birth defects on ART children. Id .; see also
IVF Babies “Face Birth Problems”
, BBC N EWS , Jan. 23, 2004, at http://news.bbc.co.uk/1/hi/health/.
44 . Roger Brownsword, Stem Cells and Cloning: Where the Regulatory Consensus Fails ,
39 N EW E NG .
L.
R EV . 535, 538 (2005) (stating that once safety fears are eliminated, those opposed to cloning on the basis of such reasoning may “change their tune”).
45 . Defending the “yuck” argument, Leon Kass compares human cloning to the likes of rape, bestiality, cannibalism, and incest. For a complete explanation of the “it’s icky” argument, see generally Leon R. Kass, The Wisdom of Repugnance: Why We Should
Ban the Cloning of Humans , 32 V AL .
U.
L.
R EV . 679 (1998).
46 . Since the process (either SCNT or a similar process) is the same whether one is creating a clone for therapy or reproduction, the only difference between these processes lies in the decision to implant the clone or to extract its stem cells for research or therapy. See Makdisi, supra
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2005] CLONING EMBRYOS FROM ADULTS 595 same: all that is involved is a change in human will.
47 The current excitement over possible therapeutic cloning has made commentators like
Professor Makdisi confident that cloning for such a purpose is likely to be allowed due to its supposedly great utility.
48 I have argued that the deontological argument for such cloning may actually be weaker than that for reproductive cloning—at least once the safety concerns about the latter are resolved. But perhaps the battle over which uses of cloned embryos to permit will be fought on the grounds of utility, with the optimistic biotech companies initially prevailing over lesbian couples or others wanting or needing to reproduce by cloning.
Currently, those advocating cloning for research or therapy tend to argue that the two-day-old embryo has little or no moral status and can be destroyed for its stem cells without serious ethical difficulty.
49 Many of them would attach moral status to the embryo only when it reaches the fourteen-day mark at which the “primitive streak” (neural tube) first appears.
50 The reasoning is that the embryo could not be until it has at least the most primitive means of experiencing sensations. Since the embryos used for research are destroyed well before they develop the “primitive streak”, 51 many advocates see no ethical problem in this destruction. If pressed, they may respond that the “cluster of cells” being destroyed has no more potential for life than a single human cell since such a cell itself can divide and eventually become a human being.
52
47 . Id.
48 . Id. at 504.
49 . See, e.g.
, Richard W. Momeyer, Embryos, Stem Cells, Morality and Public Policy:
Difficult Connections , 31 C AP .
U.
L.
R EV . 93, 94 (2003); Newhart, supra
350.
50 . The primitive streak first appears at approximately the fourteen or fifteen day mark.
Prior to the appearance of the primitive streak, the embryo consists only of the embryonic sac, the umbilical cord, and the placenta. “The embryo cannot experience pain, is not sentient and has no brain activity.” Taylor, supra note 27, at 400 (quoting
June Coleman, Comment, Playing God or Playing Scientists: A Constitutional
Analysis of State Laws Banning Embryological Procedures , 27 P AC .
L.J. 1331, 1335
(1996)).
The primitive streak as a demarcation line as to when stem cells may be harvested is also the test used in Great Britain. Enforced by the Human Fertilization and Embryology Act, the appearance of the primitive streak marks the end of the period within which stem cell harvesting and/or research may occur. See
Brownsword, supra
note 10, at 34-35 (citing Human Fertilization and Embryology
Act (1990) (Eng.)).
51 . Embryonic stem cells are generally extracted at four or five days after cloning or fertilization occurs. N AT
’
L .
I NSTS .
OF H EALTH , supra
see also Shaw, supra
52 . No one is seriously arguing that each cell should legally be protected. Taylor points
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However, it is possible to differentiate a single human cell that must be made to divide from the tiny cluster of cells that has already begun to divide and will continue to do so, and if attached to the female uterus may become a human being. While many scientists believe that after the appearance of the primitive streak, the embryo may experience pain, 53 we really have no way of assessing whether the embryo experiences any sensations. Thus, picking fourteen days as the point at which protectible life begins is as much a political choice as choosing the time of fertilization or conception to begin such protection.
54 There is no biological necessity for the choice to protect life at fourteen days as opposed to some other point such as fertilization, or, in the case of the clone, its creation. The choices society has made about when to protect “life” also vary with the issue under discussion.
55
Drawing the line at or before the appearance of the primitive streak is critical to those who would argue that research and therapeutic cloning are ethically permissible.
56 If we are not creating (either by IVF or cloning) a human life form, but just a cluster of cells, then these may be destroyed for their stem cells without pause.
57 Thus, the “primitive streak” dividing line between a cluster of cells (entitled to no protection) and an embryo
(entitled to some, undefined protection) is a very convenient one for those who wish to destroy these “pre-primitive streak” entities for their stem cells. The choice of an earlier developmental point as the demarcation line would, of course, open cloning for research or therapy to ethical out however, that these pre-primitive streak cells only seem to have significance because of their environment, and if isolated from that environment, they would have little or no protection. Taylor does note that after the formation of the primitive streak, when the cells have changed qualitatively, the embryo should be entitled to more protection. Taylor, supra note 27, at 400.
53 . See id.
at 405; Heather L. Fowler, Note, Misapplied Ethical Considerations: U.S.
Federal Stem Cell Mandates Lack Global Focus and Market Foresight , 36 C ORNELL
I NT
’
L L.J. 521, 534 (2004).
54 . See Jed Rubenfeld, On the Legal Status of the Proposition that “Life Begins at
Conception ,
”
43 S TAN .
L.
R EV . 599 (1990), for a discussion of the proposition that life’s beginnings are a matter of political, not judicial choice. Legislatures are constantly determining “matters of profoundly contested personal and moral beliefs.”
Id. at 615. They are often called upon to make the determination of when an individual has received the status of “personhood” or “adulthood”—be it for purposes of abortion, inheritance, or to have criminal charges brought against him. Having the legislature decide when an embryo should be protected is no different from other political choices the legislature has made in similar circumstances.
55 . See id.
at 599 .
56 . See Taylor, supra
57 . See id.
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58 If it is really society’s choice whether to protect the cloned embryo at creation, then such cloning is at least morally questionable.
59
In cloning an embryo for strictly reproductive purposes, other ethical issues are presented. Once the embryo attaches to the uterine wall, it is clearly on its way to becoming a human being. At first blush, this might seem to make the implanted embryo more entitled to protection than the unattached, pre-implantation embryo. However true this would be if we viewed the implanted embryo in isolation, we now must consider the rights of a full juridical person—the mother—as well. In the event that the mother wants an abortion, her rights trump those of the fetus before the fetus is judged viable 60 and gradually give way to those of the fetus as it develops further.
61
Because of the competing rights of the mother, it may fairly be argued that the two-day-old cloned embryo (pre-primitive streak) is in a stronger position ethically than the implanted embryo, at least pre-viability. If we choose creation of the cloned embryo as the point at which we would protect it, then the tiny bundle of cells, viewed in isolation has at least some rights 62 —and arguably is entitled to greater protection—than the pre-viable
58 . This is because, if we choose to protect the embryo immediately at fertilization, there is no time to extract the stem cells from the embryo before protection begins. Thus, therapeutic and research cloning would be impossible.
59 . See Rubenfeld, supra
60 . The viability of an embryo is defined as the time when it has the potential to “live outside the mother’s womb, albeit with artificial aid.” Roe v. Wade, 410 U.S. 113,
160 (1973). However, since the detection of viability is not an exact science, the
Supreme Court of the United States has said that the exact time of viability cannot be determined by statute, but should be determined by the attending physician in a particular case. Planned Parenthood v. Danforth, 428 U.S. 52, 64-65 (1976).
61 . A woman has the right to “choose to have an abortion before viability and to obtain it without undue interference from the State. Before viability, the State’s interests are not strong enough to support a prohibition of abortion or the imposition of a substantial obstacle to the woman’s effective right to elect the procedure.” Planned
Parenthood v. Casey, 505 U.S. 833, 846 (1992).
62 . The most fundamental right of the “embryo is the right to be valued at each stage of development, as an end and not as an instrumental means toward another’s end.”
Makdisi, supra
note 15, at 507 (citing Juan de Dios Vial Correa,
P ONTIFICIA
A CADEMIA P RO V ITA (R EFLECTIONS ON C LONING ), available at http://www.vatican.va/ roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_30091997_c lon_en.html (last visited Aug. 27, 2004)). Likewise John Kunich notes: “[T]he case for treating the early-stage embryo as simply the moral equivalent of all other human cells . . . is simply mistaken: it denies the continuous history of human individuals from the embryonic to fetal to infant stages of existence; it misunderstands the meaning of potentiality; and it ignores the hazardous moral precedent that the routinized creation, use, and destruction of nascent human life would establish.” J OHN
C HARLES K UNICH , T HE N AKED C LONE : H OW C LONING B ANS T HREATEN O UR
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598 NEW ENGLAND LAW REVIEW [Vol. 39:583 implanted embryo (whose mother’s rights may be in competition with its own). This may be true even though the implanted embryo is clearly
“further along” in becoming a human being than, say, a two-day-old nonimplanted embryo.
If the intention behind the cloning is reproduction, it must be admitted that the embryo is being used as an end in itself, rather than being sacrificed for the good of others (as in research or therapeutic cloning). On the other hand, one may argue that cloned embryos, as opposed to “excess”
IVF embryos, may not have been created for reproductive purposes in the first place—they may have been created simply to extract their stem cells.
When seen in this way, they could be viewed as being used for their intended purposes of research or therapy and not as a means to an end.
63
The strength of this seemingly plausible argument ultimately depends on whether we view the embryo as having as its inherent purpose
(regardless of human intentions for it) development into a human being. If the moral status of the embryo is neutral—if this tiny cluster of cells has no inherent purpose—it is only human intention that directs its use.
64
However, if this cluster is inherently human (exhibiting the potential for life), destroying it in hopes of benefiting others is an action in opposition to the intended purpose of these cells. In this case, the creation of these cells can be viewed as simply a means to an end, whereas using it for reproduction would be utilizing it for its intended purpose. By contrast, if the cluster of cells has no purpose until human will acts on it, cloning for either research or therapy (just as for reproduction) would represent use of this entity for its end purpose, not merely as a means to that end.
IV.
S UMMARY OF THE A RGUMENT
In attempting to prevent or to regulate human cloning by SCNT or
P
ERSONAL
R
IGHTS
102 (2003) (quoting President’s Council on Bioethics, supra note
63 . Taylor, supra
note 27, at 398-99. Taylor argues that IVF embryos and embryos
cloned specifically for research are inherently different and should be treated differently. Id. Excess IVF embryos were created with the purpose of creating a new life; thus, to use them as research subjects would not comport with this purpose.
However, research clones are created solely to extract their stem cells. Thus, they are not being used as a means to an end, but rather they are being used for the express purpose for which they were created. See id. at 398. Additionally, Taylor argues that if legislatures want to protect embryos from research, the excess IVF embryos should be more protected than others—that is, they should not be used for research, since to do so would be contrary to the express purpose of their creation. Id.
64 . See Brownsword, supra
note 44, at 551-52 (discussing whether or not an embryo is a
rights-holder and, if so, to what degree those rights need to be respected and whether consent is or is not required).
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2005] CLONING EMBRYOS FROM ADULTS 599 similar processes, lawmakers have had difficulty deciding whether to differentiate cloning for reproductive purposes on one hand, from cloning for research and therapeutic purposes on the other.
65 While a number of lawmakers would like to ban reproductive cloning outright, some of these would like to permit other uses. In either case, the clone produced is exactly the same; it is only the purpose for which the clone is used that varies.
66 It may thus be practically impossible to stop one use of cloning and permit another.
67
There has been much public pressure for therapeutic cloning generated because of the notion that afflictions such as those suffered by
Ronald Reagan 68 and Christopher Reeve 69 might be cured by gene therapy and replacement using the stem cells from cloned embryos. As we have noted, any real success along these lines may be a decade away.
70
However, scientists have delineated various ways that such embryos can be used immediately for research into diseases and other afflictions.
71 If, on one hand, both research and therapeutic cloning appear to have strong utility, their appeal seems grounded in the popular belief that it may be
65 . See Makdisi, supra
note 15, at 497-502 (discussing several of the bills that have been
brought before Congress to combat cloning questions, propositions and dilemmas).
66 . Id.
at 505.
67 . See id.
68 . Ronald Reagan died on June 5, 2004 from Alzheimer’s disease. See, e.g.
, Diane C.
Lade, Reagan’s Fight Brought Alzheimer’s into the Open; Groups Say Calls Flood in for Tests, Help , S
UN
-S
ENTINEL
(Ft. Lauderdale), June 11, 2004, at 17A. Although
Alzheimer’s disease is considered by some to be a candidate for stem cell therapy, recent studies suggest otherwise. See infra
note 70 and accompanying text.
69 . Christopher Reeve was paralyzed by a spinal-cord injury and vigorously advocated for stem cell research that could uncover therapies to help regenerate his damaged spinal cord cells. See Lade, supra note 69, at 17A. He died on October 10, 2004 after suffering for nine years from his injuries. CNN Entertainment News, Christopher
Reeve Dies at 52 (Oct. 11, 2004), available at http://www.cnn.com/2004/SHOWBIZ
/Movies/10/11/obit.reeve/.
70 . Jonathan Amos, Scientists Clone 30 Human Embryos , BBC O NLINE N EWS , at http://news.bbc.co.uk/go/em/fr/-/1/hi/sci/tech/3480921.stm (last updated Feb. 12,
2004). Scientists have recently discovered that, while many potential therapies for
Alzheimer’s are in the works, Alzheimer’s disease may not be the best candidate for stem cell therapy. Rick Weiss, Stem Cells an Unlikely Therapy for Alzheimer’s ,
W
ASH
.
P
OST
, June 10, 2004, at A3. Alzheimer’s differs from diabetes and Parkinson’s disease in that it occurs due to the loss of hundreds of billions of brain cells (of varying types) as well as the synaptic loss between brain cells, and is not concerned with mere malfunctions of cells, or loss of a few types of cells. Id. Neither the complex nature of the brain nor the amount of cell loss during the disease supports the likelihood that stem cell therapy will be very effective in helping to cure Alzheimer’s disease. Id.
71 . See supra notes 23-25 and accompanying text.
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600 NEW ENGLAND LAW REVIEW [Vol. 39:583 acceptable to sacrifice a tiny two-day-old embryo for the perceived greater good of many afflicted persons.
While one might question the utility of largely futuristic uses of cloning for therapy, there is little reason to question its strength when the cloning is for basic research into diseases. While the public appeal of therapeutic cloning is clear, the public case is just beginning to be made for research cloning.
72 When weighed against the lingering question of the morality of cloning for either research or therapy, the case for the strong utility of research cloning will have to be convincingly made.
The ethical problem for research cloning is essentially the same as that for therapeutic cloning: What moral or legal status will be given to the two-day-old embryo before we decide whether to destroy it for its stem cells?
73 On one hand, the rights of this tiny embryo can be considered without regard to the rights of an adult human; the latter consideration would be necessary if the embryo were implanted for reproductive purposes. On the other hand, many do not believe this tiny cluster of cells has any moral or legal status at all until the primitive streak (or neural tube) first appears in the embryo at about fourteen days.
74
I have argued that the choices of when to begin protecting the embryo are essentially political and are not biologically determined.
75 A starting point for making these choices is whether one believes the tiny embryo has an inherent purpose: Is it meant to be a human being? If we decide yes on this question, then this entity, if destroyed for its stem cells, is not being used for its intended purpose and is therefore but a means to an end. On the other hand, if we believe this tiny cluster of cells has no inherent purpose— is morally neutral—then creating it by SCNT in order to extract its stem cells is precisely to use it for its intended purpose, and not as a means to an end.
Of course, excess IVF embryos were originally created for the purpose of reproduction, and thus destroying them for their stem cells would be using them merely as means to the end of research or therapy.
But, a cloned embryo might well be intended for some purpose other than reproduction (e.g. research). If so, then the cloned embryo’s destruction for its stem cells might not be ethically suspect.
76
I am sure that many who view reproductive cloning with horror would find this latter view a comfortable one, particularly if they argue for stem cell research. However, since the tiny cloned embryo has already
72 . See Weiss, supra
73 . See supra
74 . See supra
note 50 and accompanying text.
75 . See supra
notes 54-55 and accompanying text.
76 . See supra
note 57 and accompanying text.
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2005] CLONING EMBRYOS FROM ADULTS 601 begun cell division—that if allowed to progress normally may create a human child—it is equally plausible to regard it as having its essential purpose, which is the creation of human life. This view is worthy of some respect, and perhaps the embryo should be protected so that it may ultimately reach its goal of a viable life form.
Although the argument may thus be made that to use the embryo to create a life is ethically superior to destroying it, those advocating reproductive cloning must then turn to utilitarian arguments to advocate its acceptance. Certainly, utility exists for childless couples for whom traditional assisted reproduction methods do not work, for lesbian couples wanting to have a child involving no one else who is related to one of the partners, and for single parents wishing to have a child genetically related to them.
77 Although many in society currently would not weigh these desires very highly in the utilitarian calculus, it is easy to see that reproductive cloning does have great utility for some in the population.
In the end, there are reasonable deontological and utilitarian arguments that can be made for both reproductive cloning and for research and therapeutic cloning. Since many will disagree on the relative merits of these arguments, it would seem that the best choices for society’s lawmakers are to: (1) permit cloning in the first place, and perhaps encourage it in some cases; (2) not try to ban reproductive use of the cloned embryo; and (3) devise regulations for all types of cloning. I suggest that the difficulty in proscribing one use of the clone while allowing another could be avoided by simply allowing cloning for any of the purposes described in this article. Once lawmakers are out of the “banning” business, they can concentrate on regulating reproductive, research, and therapeutic uses of those embryos cloned via SCNT or similar procedures.
78 In addition, they may decide to affirmatively support some of these uses with funding. The next section of this article briefly describes present American attempts to regulate in this area and how these might be modified and strengthened in light of the arguments made herein.
V.
R EGULATION
If there are plausible arguments, both ethical and utilitarian, for allowing cloning from SCNT, what regulatory schemes, if any, should be put in place around its several uses? On the federal level, the Food and
77 . See supra
78 . Attempts by the government and government agencies to regulate cloning have not been to regulate cloning, but rather to prohibit or ban cloning. See Gail H. Javitt &
Kathy Hudson, Regulating (for the Benefit of) Future Persons: A Different
Perspective on the FDA’s Jurisdiction to Regulate Human Reproductive Cloning ,
2003 U TAH L.
R EV . 1201, 1202 n.4 (2003).
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602 NEW ENGLAND LAW REVIEW [Vol. 39:583
Drug Administration (FDA) has already asserted authority over cloning procedures, and the NIH 79 will be able to exercise the power of the purse over various research and therapeutic uses of these procedures. In March
2001, the FDA sent a letter to organizations to “remind” them that the FDA possessed jurisdiction over cloning technologies to create a human being.
The letter also reminded the organizations that the FDA exhibited its jurisdiction pursuant to the Public Health Service Act and the Federal
Food, Drug, and Cosmetic Act, though the FDA did not specify how those acts granted this asserted authority. Additionally, it was reiterated that organizations wishing to experiment in cloning technologies were required to complete an investigational new drug application (IND) and were required to follow FDA procedures.
80
Although the FDA has taken it upon itself to declare its jurisdiction over cloning procedures, it has skipped several steps in legitimizing its assertion of jurisdiction. The Administrative Procedure Act (APA), enacted in 1946, was created to ensure that those people affected by actions of an administrative agency would be protected from arbitrary and abusive decisions.
81 If any agency, including the FDA, does not comply with the
APA requirements, that failure could be the basis for invalidating the agency’s action.
82
79 . The NIH, as an agency under the Department of Health and Human Services, acts primarily as a funding agency. The NIH is responsible for funding research projects in the United States to protect and improve the health of its citizens. N AT
’
L I NST .
OF
H
EALTH
, The NIH Almanac , at http://www.nih.gov/about/almanac/index.html (last visited Feb. 5, 2005). The FDA, should it choose to do so, may request funds from the
NIH to support research projects regarding human cloning; indirectly, therefore, the
NIH could be either aiding or hindering cloning efforts.
80 . Katherine C. Zoom, Letter from Dept. of Health and Human Services: Public Health
Service Food and Drug Administration to Associations , (Mar. 28, 2001) at http://www.fda.gov/cber/ltr/aaclone.htm.
81 . See Sandra B. Zellmer, The Devil, the Details, and the Dawn of the 21st Century
Administrative State: Beyond the New Deal , 32 A
RIZ
.
S
T
.
L.J. 941, 963 (2000)
(discussing Administrative Procedures Act, 5 U.S.C. §§ 551-59 (1994 & Supp. IV
1998)).
82 . Javitt & Hudson, supra
note 78, at 1209. Since administrative agencies are not
comprised of elected officials, the public seemingly had no recourse for actions taken by administrative agencies until the Administrative Procedure Act (APA). See
Zellmer, supra
note 81, at 963. Additionally, the APA wanted to ensure
accountability to the public, and thus required agencies to engage in formal rulemaking processes and to include the public in these decisions. See Javitt &
Hudson, supra
note 78, at 1209 n.48. Even if the FDA truly believes that it has the
legal authority to exercise jurisdiction over human cloning, the fact that it has not completed the requirements pursuant to the APA standards should render any such assertions of jurisdiction invalid. Id.
Additionally, if the FDA is requiring organizations dabbling in the cloning industry to follow regulatory procedures (such
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Since a few states are funding stem cell research (because of the federal government’s current hesitancy on these matters), their own regulatory processes will be brought to bear, at least on research and therapeutic cloning.
83 If reproductive cloning becomes accepted, courts at both state and federal levels will undoubtedly get involved in issues surrounding new procedures, access to it, surrogacy and parentage. If experience with other assisted reproductive technologies is any guide, regulation by the courts and at the state level will be sporadic and contradictory.
84
It should be faced at the outset that the United States, with its fragmented and complex legal system, has often “left it to the market” to sort out issues involving emerging technologies. This tendency seems to stem both from a strong laissez-faire attitude among many lawmakers and an inability and/or unwillingness to try to keep abreast of the fast pace of technological change. Thus, the current American approach contrasts with the United Kingdom’s approach in the area of assisted reproduction and this approach is likely to be repeated in the area of human cloning. Despite the FDA’s attempted intervention, no centralized authority such as the
Human Fertilisation and Embryology Authority (HFEA), which regulates assisted reproduction in the United Kingdom, 85 is likely to emerge in the as filling out administrative forms), shouldn’t the FDA be required to follow its own procedures?
83 . See C ALIFORNIA C OMMITTEE R EPORT , supra
note 12, at 1161 (describing the state
legislative action regarding bans on reproductive cloning and, in some states, allowing research cloning). New Jersey recently passed legislation allowing for embryonic stem cell derivation and research. N.J.
S TAT .
A NN
. §§ 26:2Z-1–2Z-2 (West
1996 & Supp. 2004). Its legislature enumerated its findings on diseases that may be candidates for stem cell therapies, and detailed what types of research may be conducted. The New Jersey statute also lists prohibitions on the sale of embryonic tissues and the penalties that such sale incurs. Finally, the statute advises that the public funding of stem cell research will aid tremendously in realizing the promise of stem cell research.
During the 2004 presidential election, Democratic nominee, Senator John Kerry, announced that he favored overturning President Bush’s ban on federally funding stem cell research. John Kerry, Supporting Stem Cell Research to Find Cures for
Millions of Americans Suffering from Debilitating Diseases , at http://www.johnkerry. com/issues/health_care/stemcell.html (last visited Feb. 6, 2005). Kerry said that he believes that embryonic stem cell research should be permitted, encouraged and if elected, he would have allowed “doctors and scientists to explore their full potential with the appropriate ethical oversight.” Id.
84 . See Chester, supra
note 38, at 335-36 (discussing the conflicting views of many state
legislatures and courts regarding assisted reproductive technologies); Chester, supra
85 . The Human Fertilisation & Embryology Authority was created under the Human
Fertilisation and Embryology Act of 1990 to oversee licensing and to monitor fertility
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604 NEW ENGLAND LAW REVIEW [Vol. 39:583
United States to regulate all aspects of human cloning.
86
If one is untroubled ethically by SCNT, or at least sees arguments on both sides, utilitarian concerns reflected in the market may well guide the uses of cloning technology. Those who are alarmed by reproductive cloning, when it is viewed in the abstract, may eventually come to terms with it when they realize the market for it should be quite limited.
87 If we simply allow those who want to exercise their human dignity 88 to clone, what will be the likely result? First, coital reproduction to create offspring, supplemented by already accepted ARTs, will no doubt be the chosen method of reproduction for most. Although a market economy allows the taking of risks by individuals, I believe that relatively few will want to take the risks of reproductive cloning, if some other safer method is available.
Furthermore, relatively few people are so enamored with their own DNA, that they will want to replicate it, rather than to join it with that of another.
89 However, if some want to try it, don’t the overriding principles of this society encourage them to go ahead?
After all, cloning to reproduce your genotype or mine, is highly unlikely to produce the vanguard of a “master race.” 90 Rather, it is genetic manipulation, whether from cloned or uncloned embryos, that may concern us on that score. However, those who have weighed the possibility of genetic enhancement, while not liking it at all, seem to feel that once the
“cat is out of the bag,” it will require Herculean efforts, if we want to exert them, to keep it in check. I believe that our resources should be directed at treatment clinics in the United Kingdom. The HFEA has strict guidelines for all aspects of reproductive medicine—from infertility treatments, to egg, sperm and embryo storage, to developing more effective means of contraception. See Human
Fertilisation & Embryology Act, 1990 c. 37 (Eng.), available at http://www.hmso.gov
/uk/acts/acts1990/ukpga.htm (prepared Sept. 20, 2002). For a detailed look at the status of cloning regulations in other countries, see Denise Stevens, Comment,
Embryonic Stem Cell Research: Will President Bush’s Limitation on Federal Funding
Put the United States at a Disadvantage? A Comparison Between U.S. and
International Law , 25 H OUS .
J.
I NT
’
L L. 623 (2002).
86 . See supra
notes 80-81 and accompanying text.
87 . See supra
notes 12-14 and accompanying text.
88 . In this instance, we are referring to human dignity as empowerment. See supra note
89 . See K UNICH , supra note 63, at 40 (stating that the likelihood of world-wide cloning is a very remote possibility—”the stuff of nightmares or pipe dreams”); see also
Brownsword, supra
90 . Roger Brownsword distinguishes macro-cloning (cloning on a large-scale, as in a
Brave New World type scenario) from micro-cloning (cloning on a relatively small, individualized scale). He also differentiates cloning from genetic manipulation, admiring the former, and disapproving of the latter. For more detailed information, see Brownsword, surpa
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2005] CLONING EMBRYOS FROM ADULTS 605 controlling such manipulation of genotypes, rather than at the mere replication or reproduction of them through cloning.
91
While cloning for research and therapy raises the moral hackles of some because of its destruction of tiny embryos, these concerns can be allayed to a certain extent by the realization that a cloned embryo, in contrast to an excess IVF embryo, does not necessarily have a reproductive purpose that is being defeated by its destruction. Besides, the utilitarian arguments for the use of SCNT technology to alleviate human suffering are strong and popular indeed.
In sum, once SCNT cloning becomes generally accepted, I think that what we can expect in the United States is basically a laissez-faire regime, coupled with attempts to regulate some of cloning’s uses.
92 Although the
FDA, as presently constituted, may ultimately want to ban, rather than regulate these uses, under future Administrations this predilection may change. Ultimately, attempts to ban cloning will likely meet the same fate as Prohibition. Market forces, coupled with some regulation, will likely determine the long-term uses of cloning technology. Reproductive uses will probably be limited by low demand, 93 while the scope of various research and therapeutic uses will be determined largely by the efficacy of each in the market.
It is never easy to accept change, particularly rapid change. Fear of
91 . Cloning may not pose the same problems as genetic enhancement does. Cloning, IVF and other assisted reproductive technologies are all aimed at creating a child who will have a naturally created genome. Maxwell J. Mehlman & Kirsten M. Rabe, Any DNA to Declare? Regulating Offshore Access to Genetic Enhancement , 28 A M .
J.L.
&
M ED . 179, 182 (2002). By contrast, genetic enhancement is improving the genes of a person past the point of “normal” (where genetic therapy terminates) by creating unnatural “super” DNA. See id . While cloning replicates the DNA of a person already in existence—it is just that—a replication of a naturally occurring genome, not a specially altered and created genome hand-selected by man. Id .
Regulatory efforts (promulgated by the FDA or by whomever assumes jurisdiction) seem to be more likely to survive in the area of genetic enhancement than for cloning. While the authority of the FDA to regulate cloning is unclear, the
FDA could present a reasonably solid case for regulating genetic enhancement under the Federal Food, Drug and Cosmetic Act. Forms of genetic enhancement would likely be considered a drug or device (per the FDCA definition of such) and would therefore be within the jurisdiction of the FDA. Federal Food, Drug & Cosmetic Act,
21 U.S.C. § 321(g)(1)(B) (2000 & Supp. 2004). For a thorough discussion of the regulation of genetic enhancement, see generally Mehlman & Rabe , supra ; Maxwell
J. Mehlman, How Will We Regulate Genetic Enhancement?
, 34 W AKE F OREST L.
R EV . 671 (1999).
92 . This limited role for regulation assumes that the FDA is not successful in its attempts to regulate the area in its entirety.
93 . See supra
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606 NEW ENGLAND LAW REVIEW [Vol. 39:583 the unknown is a well understood human reaction. But once the unknown becomes better known, and fear subsides, we look to the utility of a novel procedure in the marketplace. For better or worse, this is the American way.
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