Embryo stem cell research: Ten years of controversy

Journal of Law, Medicine and Ethics

Volumn 38, Issue 2, 2010, Pages 191-203

  Robertson, John A ^a  

^a UNIVERSITY OF TEXAS AT AUSTIN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; CONFLICT; CONSENSUS; EMBRYO RESEARCH; EMBRYONIC STEM CELL; ETHICAL THEORY; ETHICS; FINANCIAL MANAGEMENT; FORECASTING; GOVERNMENT; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; MASS COMMUNICATION; PLURIPOTENT STEM CELL; POLITICS; SCIENCE; SOCIOECONOMICS; UNITED STATES;

CONSENSUS; DIFFUSION OF INNOVATION; DISSENT AND DISPUTES; EMBRYO RESEARCH; EMBRYONIC STEM CELLS; ETHICAL THEORY; FEDERAL GOVERNMENT; FORECASTING; GOVERNMENT REGULATION; HUMANS; PLURIPOTENT STEM CELLS; POLITICS; RESEARCH SUPPORT AS TOPIC; SCIENCE; STATE GOVERNMENT; UNITED STATES; VALUE OF LIFE;

EID: 77954923316     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2010.00479.x     Document Type: Conference Paper

References (64)

1. Lo B. " Case-Based Reasoning in Stem Cell Clinical Trials: The Case of Parkinson's Disease," Journal of Law Medicine & Ethics 2010, 38(no. 2). http://www.genengnews.com/specialreports/sritem.aspx?oid=61364204, The FDA has also approved Phase I stem cell clinical trials for Batten Disease and Pelizaeus-Merzbacher Disease, which are much rarer than spinal cord injury, Since approving Geron's clinical trial, the FDA has put the study on hold pending more data on cyst formation and immunosuppression in the animal studies used to support Geron's application. P. F. Dimond, " Special Report, Geron's Setback with Testing Its hESC Therapy in Humans Points to FDA's Continued Cautionary Stance," August 28, 2009,, last visited April 7, 2010
2. Thomson J A. " Embryonic Stem Cell Lines Derived from Human Blastocysts," Science 1998, 282(no. 5391):1145-1147. M. J. Shamblott et al., " Derivation of Pluripotent Stem Cells from Cultured Human Primordial Germ Cells," 95, no. 23 (1998): 13726-13731
3. This is a conflict over the methods used to obtain the cells used in research. Concerns about research methods, however, can arise at any stage of a science. Research methods can be directly harmful, as with the release of toxic agents or microbes into the biosphere. Or they could use animals in cruel ways or human subjects without consent. The creation of chimeras may also be contentious. See note 47.
4. Debates over embryo status and ESC research are complicated further by their connection with cloning, assisted reproduction, and other technologies at the beginning of life. The announcement of lab culture of human ESCs came a year after Ian Wilmut's announcement of nuclear transfer cloning of a sheep had roiled the world with the possibility of reproductive cloning and genetic control over progeny. Somatic cell nuclear transfer (SCNT) cloning has been thought necessary to generate ESCs with particular genomes to model disease and to produce histocompatible replacement tissue, and has played a central role in ESC policy debates.
5. George R P, Tollefsen C. Embryo: A Defense of Human Life 2008, New York, Doubleday
6. Brock D W. " Creating Embryos for Use in Stem Cell Research," Journal of Law, Medicine & Ethics 2010, 38(no. 2). For an analysis of this issue, See
7. http://www.leg.State.co.us/lcs/initrefr/0708initrefr.nsf/89fb842d0401c52087256cbc00650696/16f403e0c19126f98725744b0050fd4d/$file/amendment%2048.pdf, Efforts at state constitutional amendments or legislation protecting all fertilized eggs and embryos have usually failed. In Colorado such an amendment made it to the ballot but failed. See Amendment 48 (2008),, last visited April 8, 2010
8. Poll Gallup. " Six in 10 Americans Favor Easing Restrictions on Stem Cell Research," 2007, http://www.gallup.com/poll/27898/Six-Americans-Favor-Easing-Restrictions-Stem-Cell-Research.aspx, last visited April 8, 2010
9. Sometimes they distinguish research embryos created by fertilization from those created by SCNT. In Massachusetts and Missouri, for example, it is illegal to create embryos for research by fertilization but not by SCNT.
10. Robertson J A. " Symbolic Issues in Embryo Research,": Hastings Center Report 1995, 25(no. 1):37-38. I have argued that the difference is a symbolic one - the line is a place to symbolize or mark a person's firm commitment to respect for human life. The benefits of that symbolic position, however, should be weighed against the loss in knowledge that results by not having this method of obtaining embryos for research available
11. Robertson J A. " Embryo Culture and the Culture of Life: Constitutional Issues in the Embryonic Stem Cell Debate," University of Chicago Legal Forum 2006, 2006:1-40.
12. 410 U.S. 113 (1973)
13. 505 U.S. 833 (1992)
14. Robertson J A. " Assisting Reproduction, Choosing Genes, and the Scope of Reproductive Freedom," George Washington Law Review 2008, 76(no. 6):1490-1513.
15. Robertson J A. " Embryo Culture and the Culture of Life: Constitutional Issues in the Embryonic Stem Cell Debate," University of Chicago Legal Forum 2006, 2006:1-40. at 31-38
16. A relevant case here is , 512 U.S. 662 (1994) (more than minimal rational basis required for First Amendment restriction)
17. 445 F.3rd 470 (D.C. Cir. 2006); reversed en banc, 495 F.3d 695 (C.A.D.C. 2007); cert. den. 128 S. Ct. 1069 (2008)
18. Green R M. Political Interventions in U.S. Human Embryo Research: An Ethical Assessment," Journal of Law, Medicine & Ethicis 2010, 38(no. 2). The EAB recommended that IVF research go forward and then no embryo research occur without EAB approval
19. President Clinton immediately said he would not permit funding of research embryos. See Green, .
20. The first version of it was Pub. L. No. 104-99, 110 Stat. 26 (1996). For later cites, see President's Bioethics Council, , 2004, at note 8, page 49.
21. See H. Raab, Memorandum to Harold Varmus, M.D., Director, NIH, Federal Funding for Research Involving Human Pluripotent Stem Cells, January 15, 1999.
22. Guenin L M. The Morality of Embryo Use 2008, L. Guenin has argued that ESC research is research in which embryos are destroyed because it is necessary to destroy them to get the ESCs, but has failed to convince lawmakers of his position, New York, Cambridge University Press, L. M. Guenin, " A Proposed Stem Cell Research Policy," 23, no. 8 (2005): 1023-1027. If the Dickey-Wicker rider had said " research involving embryos," there might have been a different outcome
23. National Institutes of Health Guidelines for Research Involving Human Pluripotent Stem Cells. Federal Register August 25, 2000, 65:51975-51981. The National Bioethics Advisory Commission, (Rockville, MD: U.S. Government Printing Office, 1999
24. Remarks by President George W. Bush on Stem Cell Research, August 9, 2001, reprinted in President's Bioethics Council, , Appendix B, 181-185, 2004.
25. His administration claimed that more than 60 lines fit that bill, but in time only between 15-20 lines were available. Some could not be verified. Some had onerous licensing restrictions, and some sources were not set up to become suppliers throughout the world. Interestingly, it is cells from a Bush-approved line at the University of Wisconsin that led to the first clinical trial with ESC therapy.
26. Robertson J A. " Assisted Reproduction in Germany and the United States: An Essay in Comparative Bioethics," Columbia Journal of Transnational Law 2004, 43(no. 1):189-227. Germany also used a cut-off time. ESC lines cannot be legally derived in Germany, but German researchers could import lines that had been derived legally in other countries before January 1, 2002. See, at 212. See also J. A. Robertson, " Causative vs. Beneficial Complicity in the Embryonic Stem Cell Debate," 36, no. 4 (2004): 1099-1113 (arguing that Bush's complicity standard would also support federal funding of those lines that had been derived in the private sector after the Bush announcement)
27. This required separate equipment, accounting, and even buildings for use of cell lines outside the Bush cut-off. If frozen embryos being stored for use to derive new lines in a separate facility had a freezer shutdown, they could not switch them to the federally funded freezer without disqualifying any embryos there stored.
28. The Director of the NIH actually testified before Congress that the Bush administration funding policy was hurting the progress of ESC science. R. Weiss, " Stem Cell Policy Hampering Research, NIH Official Reports," , January 20, 2007.
29. See note 31 for an account of Prop 71. New Jersey, Illinois, Wisconsin, Maryland, and New York also made significant commitments, though none as great at that of California.
30. Korobkin R. " Embryonic Histrionics: A Critical Evaluation of the Bush Stem Cell Funding Policy and the Congressional Alternative," Jurimetrics 2006, 47(no. 1):1-29.
31. Obama Barack. " Removing Barriers to Responsible Scientific Research Involving Human Stem Cells," Federal Register March 11, 2009, 74:10667-10668. Executive Order No. 13,505
32. Federal Register July 7, 2009, 74:32170-32175. Those lines will still have to meet the strict standards for consent of donors, including their consent to use in the particular kind of research in which they will be used. While this will disqualify some lines from federal funding, enough other lines have been created to meet the needs of researchers. See, Editorial, " Consent Issue Dogs Stem Cell Approval," 462, no. 7275 (December 17, 2009): 837 (embryos donated for diabetes research may not be used for other purposes)
33. 45 CFR 46.101 et seq.
34. Berg P. " Potential Biohazards of Recombinant DNA Molecules," Science 1974, 185(no. 4148):303. This was the classic case with the Berg letter that led to Asilomar and the NIH's Recombinant DNA rules, Letter
35. " Guidelines for Human Embryonic Stem Cell Research," 2005, http://www.nap.edu/catalog.php?record_id=11278, National Research Council, , last visited April 8, 2010) [hereinafter " NAS Guidelines"
36. Critics may question whether such guidelines have enough bite to get the job done. Sometimes professionally developed guidelines are window-dressing. But this does not appear to be the case with the NAS stem cell rules. With the ESC field so eager to move forward and the source so authoritative (the NAS is not merely another professional interest group), they have earned widespread respect and support.
37. The guidelines of the International Society of Stem Cell Researchers (ISSCR) overlap substantially with those of the NAS, but there are differences. Some ISSCR members have pointed out that the NAS guidelines were drafted without international representation: " To hold that the U.S. guidelines can simply be lifted and imported to other international settings ignores the differing political, cultural, and religious perspectives that shape research policy." I. Hyun, P. Taylor, and G. Q. Daley, " Letter," , February 8, 2007.
38. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research, 2007. Human Embryonic Stem Cell Research Advisory Committee, National Research Council, The changes to the guidelines involved clarifying the phrase " provenance of the cell lines" (changes to Section 1.2); use of the hESCs approved for use in federally funded research (addition to Section 1.4); importation of hESC lines into an institution or jurisdiction (addition of Section 1.5); and allowing ESCRO committees to serve multiple institutions (changes to Section 2.0 and addition of Section 2.1). , at 3-4
39. " National Institutes of Health Guidelines for Human Stem Cell Research," Federal Register July 7, 2009, 74(no. 128):321470. Department of Health and Human Services
40. Lo B, Parham L, Cedars M. " NIH Guidelines for Stem Cell Research and Gamete Donors," Science February 19, 2010, 327(no. 5968):962-963.
41. Cohen C B, Majumder M A. " Future Directions for Oversight of Stem Cell Research in the United States," Kennedy Institute of Ethics Journal 2009, 19(no. 1):79-103.
42. Robertson J A. " Compensation and Egg Donation for Research," Fertility and Sterility 2006, 86(no. 6):1573-1575.
43. Statement of the Empire State Stem Cell Board on the Compensation of Oocyte Donors, June 11, 2009. L. Nelson, " New York State Allows Compensation in Egg Donations for Research," , June 26, 2009, at A18.
44. Strictly speaking the research occurring was not " research with a human subject" under the HHS guidelines. 45 CFR 46.101 et seq. See also M. Cho and D. Magnus, " Issues in Oocyte Donation for Stem Cell Research," 308, no. 5729 (2005): 1747-1748.
45. See NAS Guidelines, note 36, at 100.
46. See Cohen and Majumder, note 42, at 91.
47. The Obama guidelines also deny funding for such research. See 74 (2009): 32170-32175, at 32175 (" Chimera ban" )
48. See Lo, note 1; B. Lo, A. Kriegstein, and D. Grady, " Clinical Trials in Stem Cell Transplantation: Guidelines for Scientific and Ethical Review," 5, no. 5 (2008): 517-522.
49. Special problems may arise here that require sham surgery, so that all patients will think that they are getting the new therapy. See Lo, note 49.
50. Mathews D J H. " Cell-Based Interventions for Neurologic Conditions," Neurology 2008, 71(no. 4):288-293.
51. ISSCR 608 commentary.
52. See Lo, note 49.
53. The willingness to travel abroad to uncertified clinics for untested but highly touted and expensive treatments is an example of the ease with which consent can be obtained. See Hyun, note 61.
54. Guidelines for the Clinical Translation of Stem Cells. December 3, 2008, International Society for Stem Cell Research
55. Magnus D. " Translating Stem Cell Research: Challenges at the Research Frontier," Journal of Law, Medicine & Ethics 2010, 38(no. 2). See discussion of therapeutic misconception in
56. The Johns Hopkins group argues that researcher and oversight bodies should ensure that the consent process is above reproach, and that it provides few opportunities for even misguided criticism because of the sensitivity and political ramifications of ESC research. See Mathews et al., note 51, at 291.
57. Sugarman J. " Reflections on Governance Models for the Clinical Translation of Stem Cells," Journal of Law, Medicine & Ethics 2010, 38(no. 2). Bernard Lo and Jeremy Sugarman also make these points. See Lo, note 49 and
58. Hyun I. " Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges," Journal of Law, Medicine & Ethics 2010, 38(no. 2). Several papers in this symposium address the issue of innovative therapy. See, page numbers coming); P. L. Taylor, " Overseeing Innovative Therapy Without Mistaking It for Research: A Function-Based Model Based on Old Truths, New Capacities, and Lessons from Stem Cells," 38, no. 2 (2010
59. I do not mean to underestimate the problems that even people with insurance have in getting standard care. Some of those same problems could prevent access to stem cell therapies just as they do to other treatments.
60. " Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law; Final Rule," Federal Register December 19, 2008, 73(no. 425):78072-78101. Department of Health and Human Services, CFR version at 45 CFR 88
61. Takahashi K, Yamanaka S. " Induction of Pluripotent Stem Cells from Mouse Embryonic and Adult Fibroblast Cultures by Defined Factors," Cell 2006, 126(no. 4):663-676. J. Gearhardt, E. Pashos, and M. Prasad, " Pluripotentcy Redux - Advances in Stem-Cell Research," 357, no. 15 (2007): 69-72; J. Shaw, " Tools and Tests: The Evolution of Stem-Cell Research," 112, no. 3 (January-February 2010): 24-29
62. Yamanaka S. " Elite and Stochastic Models for Induced Pluripotent Stem Cell Generation," Nature 2009, 460(no. 7251):49-52.
63. See references listed in Cohen and Majumder, note 42, at 94-95.