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

Š   The FDA, as of 2008, has approved cloned as animals as food.

http://www.fda.gov/AnimalVeterinary/SafetyHealth/AnimalCloning/default.htm

http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052469.pdf

Š   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 “birthed.” 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 “Create New Eggs in Women”

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 “appeared” 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. “DNA microarray provides a medium for the orderly arrangement and matching of known and unknown DNA samples.” In addition to evaluating chromosomal integrity, DNA microarray will allow physicians to examine other gene variants, which in turn will provide information on “non-disease related genetic traits, such as height, hair color, skin color, eye color and possibly some behavioral characteristics.”[v]

 

PGD and PGS have also played an important role in the creation of “savior siblings.” 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 Adam’s birth, physicians collected stem cells from Adam’s umbilical cord and infused them into Molly’s circulatory system. Adam saved Molly’s life.[vi] The Nash’s story was adapted into a novel, My Sister’s 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 “stands in the shoes of the minor” 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 child’s 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. Women’s rights in relation to abortion are not the same in the ex vivo context. In ex vivo a woman is does not physically “co-exist” with the embryo. When embryos are ex vivo or “extracorporal” 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 “consumer oriented act” 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,           “ ‘The 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.’ ”[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, “did not bar funding for a project using an embryonic stem cell (ESC) that was previously derived because a stem cell was not an “embryo” and could not develop into a human being,. . .” 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 “ ‘The 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 “(a) No person shall clone a human being or engage in human reproductive cloning.”

[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 Sister’s 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 Pol’y, 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