Human Reproduction
2012—We are
Still Unable to a) Legally Clone Humans and b) Actually Clone Humans
Scientists are still unable to clone humans and so far, have had very limited success with primates:[i]
From a technical perspective, cloning humans and other primates is
more difficult than in other mammals. One reason is that two proteins essential
to cell division, known as spindle proteins, are located very close to the
chromosomes in primate eggs. Consequently, removal of the egg's nucleus to make
room for the donor nucleus also removes the spindle proteins, interfering with
cell division. In other mammals, such as cats, rabbits and mice, the two
spindle proteins are spread throughout the egg. So, removal of the egg's
nucleus does not result in loss of spindle proteins. In addition, some dyes and
the ultraviolet light used to remove the egg's nucleus can damage the primate
cell and prevent it from growing.
More basic
information on cloning can be found at the National Human Genome Research
Project website. http://www.genome.gov/25020028#al-3
Cloned Animals as
Food
á The FDA, as of 2008, has approved cloned as animals as food.
http://www.fda.gov/AnimalVeterinary/SafetyHealth/AnimalCloning/default.htm
á Most Europeans on the other hand, are still unwilling to approve cloned animals as food.
http://www.nytimes.com/2011/03/30/business/global/30clone.html
Artificial Uterus
We are now one step closer to Brave New World. In 2011 scientists birthed baby nurse sharks (which are currently endangered) from an artificial uterus. The embryos, however, only stayed in the artificial uterus for 18 days before being Òbirthed.Ó A video of the birth is available at http://arstechnica.com/science/news/2011/09/baby-sharks-birthed-in-artificial-uterus.ars.
Scientists Closer to Finding a Way to ÒCreate New Eggs in WomenÓ
http://www.npr.org/blogs/health/2012/02/27/147344258/study-suggests-way-to-create-new-eggs-in-women
Preimplantation
Genetic Diagnosis (PGD), Savior Siblings Preimplanation and Genetic Screening
(PGS)
PGD (first introduced in 1990) is the process of creating several embryos in vitro, and removing several (6-10) blastomeres (cells) and testing those cells for certain conditions before transferring them into the woman. PGD is particularly used for testing singular chromosomal disorders such as: Tay-Sachs, muscular dystrophy, cystic fybrosis, chromosomal deletions, inversions and translocations. Although it is a less common usage, PGD, in a more controversial context could be used for sex and trait selection, and screening other medical abnormalities that while not completely disabling are simply undesirable.[ii]
PGD service providers need only follow two ethics committee guidelines: the American Society for Reproductive Medicine (ASRM) and the American Medical Association (AMA). There is little to no regulation of PGD in the United States. Austria, Germany, Ireland, and Switzerland have banned PGD.[iii]
PGS also increases the success rate of couples who are using in vitro to get pregnant. Before PGS physicians and embryologists selected embryos for transfer-back to the uterus based on morphology—the size and shape (typically 8 cells). If the embryo simply ÒappearedÓ healthy it was transferred. Physicians now use PGS to screen for aneuploidy—a condition in which the embryo has too few or too many chromosomes. By screening for and avoiding selection of aneuploidic embryos, physicians and embryologists have increased the success of a viable pregnancy, especially for older women.[iv]
In the near future, physicians, geneticists and embryologists will combine the PGS process with DNA microarray. ÒDNA microarray provides a medium for the orderly arrangement and matching of known and unknown DNA samples.Ó In addition to evaluating chromosomal integrity, DNA microarray will allow physicians to examine other gene variants, which in turn will provide information on Ònon-disease related genetic traits, such as height, hair color, skin color, eye color and possibly some behavioral characteristics.Ó[v]
PGD and PGS have also played an important role in the creation of Òsavior siblings.Ó Savior siblings are as the title tells, children created for the purpose of providing matching tissue, primarily bone marrow and possibly, organs to their living (but dying) sibling. The concept of the savior sibling was popularized by the true story of Lisa and Jack Nash whose first child, Molly, was diagnosed with Fanconi anemia, a deadly genetic disorder characterized by the failure of bone marrow production. Lisa and Jack Nash used PGD to single out an ex utero embryo that they knew would be a match for their dying daughter. The embryo (Adam) was implanted, and immediately after AdamÕs birth, physicians collected stem cells from AdamÕs umbilical cord and infused them into MollyÕs circulatory system. Adam saved MollyÕs life.[vi] The NashÕs story was adapted into a novel, My SisterÕs Keeper and later, a movie staring Cameron Diaz.
Courts tend to employ a substituted judgment standard or the best-interest standard to determine whether the child should be permitted to donate an organ or tissue. Under the substituted judgment standard the court Òstands in the shoes of the minorÓ to decide whether the minor would choose to make the donation if he or she was fully competent. Under the best interest standard, the courts do a cost-benefit analysis to decide what decision would best suit the childÕs needs.[vii]
Legal Status of an
Embryo[viii]
From a Constitutional perspective, the case law on abortion is seemingly the closest source for interpretation. The Supreme Court has yet to discuss the legal status of an ex vivo embryo. WomenÕs rights in relation to abortion are not the same in the ex vivo context. In ex vivo a woman is does not physically Òco-existÓ with the embryo. When embryos are ex vivo or ÒextracorporalÓ courts tend to give equal weight to the rights of both the egg and the sperm donors.[ix]
There is little to no federal law governing the legal status of embryos. The American Society of Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) are two medical societies that oversee the practice guidelines and recommendations related to ART and PGS. Congress enacted the Fertility Clinic Success Rate and Certification Act of 1992, but this was more Òconsumer oriented actÓ which regulated the practice by mandating that physicians report pregnancy success rates to the Secretary of Health and Human Services through the CDC. SART and ASRM both play an active role in ensuring that those rates are reported to the CDC. The data is later made available to the public. [x]
In
2009 President Obama issued an Executive
Order No. 13505 providing that,
Ò ÔThe Secretary of Health and
Human Services, through the director of the National Institutes of Health
(NIH), may support and conduct responsible scientifically worthy human stem
cell research, including human embryonic stem cell research, to the extent
permitted by law.Õ Ó[xi]
In 2010, two scientists brought suit to enjoin the NIH from funding research
using human embryonic stem cells (ESCs) pursuant to NIH's guidelines because
the Guidelines violated the Dickey-Wicker Amendment. The Government prevailed
on the second appeal. The court held that the Dickey-Wicker Amendment, Òdid not
bar funding for a project using an
embryonic stem cell (ESC) that was previously derived because a stem cell was
not an ÒembryoÓ and could not develop into a human being,. . .Ó For more on the
case see Sherley v. Sebelius, 644 F.3d 388 (D.C. Cir. 2011).
The Dickey-Wicker Amendment current prevents the use of federal funds
for any activity that involves the Ò ÔThe creation of a human embryo for
research purposes; or research in which human embryos are destroyed,
discarded, or knowingly subjected to risk of injury or death greater than
that allowed for research on fetuses in utero under 45 C.F.R. ¤ 46.204 and 42
U.S.C.A. ¤ 289g.[xii]
(See below).
42 U.S.C.A. ¤ 289g (Fetal
Research)
(a) Conduct or
support by Secretary; restrictions
The Secretary may
not conduct or support any research or experimentation, in the United States or
in any other country, on a nonviable living human fetus ex utero or a living
human fetus ex utero for whom viability has not been ascertained unless the
research or experimentation--
(1) may enhance the
well-being or meet the health needs of the fetus or enhance the probability of
its survival to viability; or
(2) will pose no
added risk of suffering, injury, or death to the fetus and the purpose of the
research or experimentation is the development of important biomedical
knowledge which cannot be obtained by other means.
(b) Risk standard
for fetuses intended to be aborted and fetuses intended to be carried to term
to be same
In administering the
regulations for the protection of human research subjects which--
(1) apply to
research conducted or supported by the Secretary;
(2) involve living
human fetuses in utero; and
(3) are published in
section 46.208 of part 46 of title 45 of the Code of Federal Regulations; or
any successor to such regulations, the Secretary shall require that the risk
standard (published in section 46.102(g) of such part 46 or any successor to
such regulations) be the same for fetuses which are intended to be aborted and
fetuses which are intended to be carried to term.
45 C.F.R. ¤ 46.204 (Research involving pregnant women or fetuses.)
Pregnant women or
fetuses may be involved in research if all of the following conditions are met:
(a) Where scientifically appropriate, preclinical studies, including
studies on pregnant animals, and clinical studies, including studies on
nonpregnant women, have been conducted and provide data for assessing potential
risks to pregnant women and fetuses;
(b) The risk to the fetus is caused solely by interventions or
procedures that hold out the prospect of direct benefit for the woman or the
fetus; or, if there is no such prospect of benefit, the risk to the fetus is
not greater than minimal and the purpose of the research is the development of
important biomedical knowledge which cannot be obtained by any other means;
(c) Any risk is the least possible for achieving the objectives of the
research;
(d) If the research holds out the prospect of direct benefit to the
pregnant woman, the prospect of a direct benefit both to the pregnant woman and
the fetus, or no prospect of benefit for the woman nor the fetus when risk to
the fetus is not greater than minimal and the purpose of the research is the
development of important biomedical knowledge that cannot be obtained by any
other means, her consent is obtained in accord with the informed consent
provisions of subpart A of this part;
(e) If the research holds out the prospect of direct benefit solely to
the fetus then the consent of the pregnant woman and the father is obtained in
accord with the informed consent provisions of subpart A of this part, except
that the father's consent need not be obtained if he is unable to consent
because of unavailability, incompetence, or temporary incapacity or the
pregnancy resulted from rape or incest.
(f) Each individual providing consent under paragraph (d) or (e) of
this section is fully informed regarding the reasonably foreseeable impact of
the research on the fetus or neonate;
(g) For children as defined in ¤ 46.402(a) who are pregnant, assent and
permission are obtained in accord with the provisions of subpart D of this
part;
(h) No inducements, monetary or otherwise, will be offered to terminate
a pregnancy;
(i) Individuals engaged in the research will have no part in any
decisions as to the timing, method, or procedures used to terminate a
pregnancy; and
(j) Individuals engaged in the research will have no part in
determining the viability of a neonate.
California Health and Safety Code on the
Disposition of Human Embryos ¤ 125315 (selected portions—see
Cal. Health & Safety Code ¤ 125315)
(b) Any individual to whom information is provided pursuant to
subdivision (a) shall be presented with
the option of storing any unused embryos, donating them to another individual,
discarding the embryos, or donating the remaining embryos for research.
When providing fertility treatment, a physician and surgeon or other health
care provider shall provide a form to the male and female partner [. . .] This
form shall indicate the time limit on storage of the embryos at the clinic or
storage facility and shall provide, at a minimum, the following choices for
disposition of the embryos based on the following circumstances:
(1) In the event of the death of
either the male or female partner, the embryos shall be disposed of by one
of the following actions:
(A) Made available to the living partner.
(B) Donation for research purposes.
(C) Thawed with no further action taken.
(D) Donation to another couple or individual.
(E) Other disposition that is clearly stated.
[.
. .] (2) death of both partners [. . .] (3) divorce of partners
(4) In the event of the
partners' decision or a patient's decision who is without a partner, to abandon the embryos by request or a
failure to pay storage fees, the embryos shall be disposed of by one of the
following actions:
(A) Donation for research purposes.
(B) Thawed with no further action taken.
(C) Donation to another couple or individual.
(D) Other disposition that is clearly stated.
(c) [. . .] For any individual considering donating the
embryos for research, to obtain informed consent, the health care provider shall convey all of the following to the
individual:
(1) A statement that the early human embryos will be used to derive
human pluripotent stem cells for research and that the cells may be used, at
some future time, for human
transplantation research.
(2) A statement that all
identifiers associated with the embryos will be removed prior to the
derivation of human pluripotent stem cells.
(3) A statement that donors will
not receive any information about subsequent testing on the embryo or the
derived human pluripotent cells.
(4) A statement that derived cells or cell lines, with all identifiers
removed, may be kept for many years.
(5) Disclosure of the possibility that the donated material may have commercial potential, and a statement
that the donor will not receive financial or any other benefits from any future
commercial development.
(6) A statement that the human pluripotent stem cell research is not
intended to provide direct medical benefit to the donor.
(7) A statement that early human
embryos donated will not be transferred to a woman's uterus, will not survive
the human pluripotent stem cell derivation process, and will be handled
respectfully, as is appropriate for all human tissue used in research.
Patents and
Genetics—Most recent holding on whether isolated DNA sequences can be
patented.
In Ass'n for Molecular Pathology v. U.S. Patent
& Trademark Office the court held that isolated DNA containing breast
cancer susceptibility genes was not patentable subject matter, but that method
claims for screening potential cancer therapeutics was patentable subject
matter.[xiii]
[i]
Cal. Health & Safety Code ¤ 24185
Ò(a) No person shall clone a human being or engage in human reproductive
cloning.Ó
[ii] Judith Daar, Art and the Search for Perfectionism: On Selecting Gender, Genes, and Gametes, 9 J. Gender, Race and Justice, 242, 248, 250-52.
[iii] Amy Lai, To Be To Be or Not to Be My SisterÕs Keeper?, 32 J. Legal Med. 261, 263 (2011).
[iv] Daar, supra at 248-50.
[v] Jaime King, Predicting Probability: Regulating the Future of Preimplantation Genetic Screening, 8 Yale J. Health PolÕy, L. & Ethics, 283, 298-300
[vi] Id. at 260-63.
[vii] Id. at 283-85.
[viii] Daar, supra at 252-57
[ix] Id. at 252-54.
[x] Predicting Probability 319-210
[xi] Thomas Mayo, 1 Health L. Prac. Guide ¤ 15:20 (2011).
[xii] King, supra at 231-22.
[xiii] Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011); 35 U.S.C.A. ¤ 101