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Untangling the Promises of Human Genome Editing

Published online by Cambridge University Press:  01 January 2021

Abstract

This article traces the rapid progression of policy pertaining to human genome germline modifications using genome editing. It provides an overview of how one fertility physician implemented and advertised experimental techniques as part of his fertility clinic services, examines US law and policy, and assesses the impact of rhetoric influencing global policy and interpretation of the law. This article provides an in-depth examination of the medical rationale driving the acceptance of genome editing human embryos in two contexts: to cure disease and treat infertility. It describes complexities in genomics and outlines risks currently associated with genome editing, asserting the available evidence fails to demonstrate genome editing constitutes a curative therapy.

Type
Independent Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

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References

Travis, J., “Breakthrough of the Year: CRISPR Makes the Cut,” Science 350, no. 6358 (2015): 14561457.Google Scholar
Califf, R. and Nalubola, R., “FDA's Science-based Approach to Genome Editing Products,” FDA, January 18, 2017, available at <https://blogs.fda.gov/fdavoice/index.php/2017/01/fdas-science-based-approach-to-genome-edited-products/> (last visited November 16, 2018). (last visited November 16, 2018).' href=https://scholar.google.com/scholar?q=Califf,+R.+and+Nalubola,+R.,+“FDA's+Science-based+Approach+to+Genome+Editing+Products,”+FDA,+January+18,+2017,+available+at++(last+visited+November+16,+2018).>Google Scholar
Corrigan-Curay, J. et al., “Genome Editing Technologies: Defining a Path to the Clinic,” Molecular Therapy 23, no. 5 (2015): 796806.Google Scholar
See Regalado, A., “Engineering the Perfect Baby,” MIT Technology Review, March 5, 2015, available at <https://www.technologyreview.com/s/535661/engineering-the-perfect-baby/> (last visited November 16, 2018); T. Lewis, “Congress Just Put a Massive Roadblock in the Way of Genetically Editing Human Embryos,” Business Insider, December 16, 2016, available at <http://www.businessinsider.com/congress-bans-funding-for-embryo-gene-editing-2015-12> (last visited November 16, 2018).+(last+visited+November+16,+2018);+T.+Lewis,+“Congress+Just+Put+a+Massive+Roadblock+in+the+Way+of+Genetically+Editing+Human+Embryos,”+Business+Insider,+December+16,+2016,+available+at++(last+visited+November+16,+2018).>Google Scholar
This article will focus on clinical as opposed to research applications.Google Scholar
Hamzelou, J., “World's First Baby Born With New ‘3 Parent’ Technique,” New Scientist, September 27, 2016, available at <https://www.newscientist.com/article/2107219-exclusive-worlds-first-baby-born-with-new-3-parent-technique/> (last visited November 16, 2018); J. Couzin-Frankel, “Unanswered Questions Surround Baby Born to Three Parents, Science, September 27, 2016, available at <http://www.sciencemag.org/news/2016/09/unanswered-questions-surround-baby-born-three-parents> (last visited November 16, 2018); see also K. Drabiak, “Emerging Governance of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence and Policy Outcomes,” DePaul Journal of Health Care Law, forthcoming 2018 (hereinafter “Drabiak MRT.”) (last visited November 16, 2018); J. Couzin-Frankel, “Unanswered Questions Surround Baby Born to Three Parents, Science, September 27, 2016, available at (last visited November 16, 2018); see also K. Drabiak, “Emerging Governance of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence and Policy Outcomes,” DePaul Journal of Health Care Law, forthcoming 2018 (hereinafter “Drabiak MRT.”)' href=https://scholar.google.com/scholar?q=Hamzelou,+J.,+“World's+First+Baby+Born+With+New+‘3+Parent’+Technique,”+New+Scientist,+September+27,+2016,+available+at++(last+visited+November+16,+2018);+J.+Couzin-Frankel,+“Unanswered+Questions+Surround+Baby+Born+to+Three+Parents,+Science,+September+27,+2016,+available+at++(last+visited+November+16,+2018);+see+also+K.+Drabiak,+“Emerging+Governance+of+Mitochondrial+Replacement+Therapy:+Assessing+Coherence+Between+Scientific+Evidence+and+Policy+Outcomes,”+DePaul+Journal+of+Health+Care+Law,+forthcoming+2018+(hereinafter+“Drabiak+MRT.”)>Google Scholar
Id.; Ossola, A., “FDA Expected to Approve Technique to Create ‘The Three-Parent Babies,’” Popular Science, February 3, 2016, available at <http://www.popsci.com/fda-approves-technique-to-create-three-parent-babies> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Untitled Letter from Mary Malarkey, Director of Office of Compliance and Biologics Quality, Federal Food and Drug Administration, to John Zhang, Darwin Life, Inc. and New Hope Fertility Center, FDA, August 4, 2017, available at <https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM570225.pdf> (last visited November 16, 2018)(hereinafter “Zhang Letter”).+(last+visited+November+16,+2018)(hereinafter+“Zhang+Letter”).>Google Scholar
21 CFR § 1271 (2017); Letter to Sponsors/Researchers-Human Cells Used in Therapy Involving the Transfer of Genetic Material By Means Other Than the Union of Gamete Nuclei, FDA, July 6, 2001, available at <https://wayback.archive-it.org/7993/20170404210748/ https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm105852.htm> (last visited December 13, 2018); National Academies of Sciences, Engineering, and Medicine, Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations (Washington D.C.: National Academies Press, 2016) at 22 (hereinafter “NAS MRT Report.”)+(last+visited+December+13,+2018);+National+Academies+of+Sciences,+Engineering,+and+Medicine,+Mitochondrial+Replacement+Techniques:+Ethical,+Social,+and+Policy+Considerations+(Washington+D.C.:+National+Academies+Press,+2016)+at+22+(hereinafter+“NAS+MRT+Report.”)>Google Scholar
Zhang Letter, supra note 9.Google Scholar
Article 13, Convention on Human Rights and Biomedicine, Council of Europe (1997), available at <https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=090000168007cf98> (last visited November 16, 2018); M. Araki and T. Ishii, “International Regulatory Landscape and Integration of Corrective Genome Editing Into In Vitro Fertilization,” Reproductive Biology and Endocrinology 12, no. 108 (2014): 1-12 at 9; R. Isasi et al., “Editing Policy to Fit the Genome?” Science 351, no. 6721 (2016): 337-339; United Nations Scientific Educational, Scientific, and Cultural Organization, Report of the IBC on Updating Its Reflection on the Human Genome and Human Rights (2015), available at <http://unesdoc.unesco.org/images/0023/002332/233258E.pdf> (last visited November 16, 2018); United Nations Scientific Educational, Scientific, and Cultural Organization, Universal Declaration on the Human Genome and Human Rights (1997), available at <http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genome-and-human-rights/> (last visited November 16, 2018).+(last+visited+November+16,+2018);+M.+Araki+and+T.+Ishii,+“International+Regulatory+Landscape+and+Integration+of+Corrective+Genome+Editing+Into+In+Vitro+Fertilization,”+Reproductive+Biology+and+Endocrinology+12,+no.+108+(2014):+1-12+at+9;+R.+Isasi+et+al.,+“Editing+Policy+to+Fit+the+Genome?”+Science+351,+no.+6721+(2016):+337-339;+United+Nations+Scientific+Educational,+Scientific,+and+Cultural+Organization,+Report+of+the+IBC+on+Updating+Its+Reflection+on+the+Human+Genome+and+Human+Rights+(2015),+available+at++(last+visited+November+16,+2018);+United+Nations+Scientific+Educational,+Scientific,+and+Cultural+Organization,+Universal+Declaration+on+the+Human+Genome+and+Human+Rights+(1997),+available+at++(last+visited+November+16,+2018).>Google Scholar
National Academy of Sciences, Engineering, and Medicine, International Summit on Human Gene Editing: A Global Discussion (2015), available at <https://www.nap.edu/catalog/21913/international-summit-on-human-gene-editing-a-global-discussion> (last visited November 16, 2018)(hereinafter “International Summit”); NAS MRT Report, supra note 11; National Academies of Sciences, Engineering, and Medicine, Human Genome Editing: Science, Ethics, and Governance (Washington D.C.: National Academies Press, 2017) at 86, available at <https://www.nap.edu/catalog/24623/human-genome-editing-science-ethics-and-governance> (last November 16, 2018)(hereinafter “NAS Human Genome Editing Report.”)+(last+visited+November+16,+2018)(hereinafter+“International+Summit”);+NAS+MRT+Report,+supra+note+11;+National+Academies+of+Sciences,+Engineering,+and+Medicine,+Human+Genome+Editing:+Science,+Ethics,+and+Governance+(Washington+D.C.:+National+Academies+Press,+2017)+at+86,+available+at++(last+November+16,+2018)(hereinafter+“NAS+Human+Genome+Editing+Report.”)>Google Scholar
Drabiak, K., “Engineering Consensus in the Development of Genome Editing Policy,” Hasting Center Bioethics Forum, March 14, 2017, available at <http://www.thehastingscenter.org/engineering-consensus-development-genome-editing-policy/> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Estreich, G., “On Embryos and Spin,” Center for Genetics and Society, August 1, 2017, available at <https://www.genetic-sandsociety.org/biopolitical-times/embryos-and-spin> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
The Science and Ethics of Genetically Engineered Human DNA, Hearing Before the Subcommittee on Research and Technology, 114th Congress (2015).Google Scholar
Ball, P., “Designer Babies: An Ethical Horror Waiting to Happen?” The Guardian, January 8, 2017, available at <https://www.theguardian.com/science/2017/jan/08/designer-babies-ethical-horror-waiting-to-happen> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Specter, M., “The Gene Hackers,” The New Yorker, November 16, 2015, available at <https://www.newyorker.com/magazine/2015/11/16/the-gene-hackers> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Begley, S., “Do CRISPR Enthusiasts Have Their Head in the Sand About the Safety of Gene Editing?” STAT News, July 18, 2016, available at <https://www.statnews.com/2016/07/18/crispr-off-target-effects/> (last visited December 13, 2018); see also M. Porteus and C. Dann, “Genome Editing of the Germline: Broadening the Discussion,” Molecular Therapy 23, no. 6 (2015): 980-982.+(last+visited+December+13,+2018);+see+also+M.+Porteus+and+C.+Dann,+“Genome+Editing+of+the+Germline:+Broadening+the+Discussion,”+Molecular+Therapy+23,+no.+6+(2015):+980-982.>Google Scholar
Id., at 981; Tang, L. et al., “CRISPR/Cas9-Mediated Gene Editing in Human Zygotes Using Cas9 Protein,” Molecular Genetics and Genomics 292, no. 3 (2017): 525533.Google Scholar
Barnett, S.A., “Regulating Human Germline Modification in Light of CRISPR,” University of Richmond Law Review 51, no. 2 (2017): 553591.Google Scholar
NAS Human Genome Editing Report, supra note 14.Google Scholar
Ajunwa, I., “Genetic Coercion,” Data and Society Databite # 41, June 11, 2015, available at <http://opentranscripts.org/transcript/databite-ifeoma-ajunwa-genetic-coercion/> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Comfort, N., “Can We Cure Disease Without Slipping Into Eugenics?” The Nation, July 16, 2015, available at <https://www.thenation.com/article/can-we-cure-genetic-diseases-without-slipping-into-eugenics/> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
“The New Technologies of Human Genetic Modification: A Threshold Challenge for Humanity,” Center for Genetics and Society (2002), available at <https://www.geneticsandsociety.org/article/threshold-challenge-new-human-genetic-technologies> (last visited November 16, 2018)(quoting Evelyne Schuster in the Report on the Conference Beyond Cloning: Protecting Humanity from Species Altering Procedures) (hereinafter “The New Technologies.”)+(last+visited+November+16,+2018)(quoting+Evelyne+Schuster+in+the+Report+on+the+Conference+Beyond+Cloning:+Protecting+Humanity+from+Species+Altering+Procedures)+(hereinafter+“The+New+Technologies.”)>Google Scholar
Editorial, “Scientific Buzzwords Obscure Meaning,” Nature 538, no. 7624 (2016): 140 (stating “buzzwords are Orwellian and obfuscate even as they pretend to enlighten.”)Google Scholar
NAS Human Genome Editing Report, supra note 14, at 8. NAS Human Genome Editing Report specifically sets forth a list of governance principles including responsible science, due care, and transparency; see generally Drabiak MRT, supra note 6.Google Scholar
Bangay, T., “Gene Editing: Can the Law Keep Up?” International Bar Association Business Insights, March 22, 2017, available at <https://www.ibanet.org/Article/New-Detail.aspx?ArticleUid=FC0BD200-63E1-472F-A6B9-C86440859B83> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Drabiak MRT, supra note 6, at 14-22.Google Scholar
Annas, G., Some Choice: Law, Medicine and the Market (New York: Oxford University Press, 1998) at 140152, 163-169.Google Scholar
Estreich, supra note 16.Google Scholar
Regalado, supra note 4; Lewis, supra note 4.Google Scholar
Lewis, supra note 4.Google Scholar
Knoepfler, P., “Steven Pinker Interview: Case Against Bioethocrats & CRISPR Germline Ban,” The Niche: Knoepfler Lab Stem Cell Blog, August 10, 2015, available at <https://ipscell.com/2015/08/stevenpinker/> (last visited November 16, 2018); J. Savulescu et al., “The Moral Imperative to Continue Gene Editing Research on Human Embryos,” Protein Cell 6, no. 7 (2015): 476-479; S. Pinker, “The Moral Imperative for Bioethics”, The Boston Globe, August 1, 2015, available at <https://www.bostonglobe.com/opinion/2015/07/31/the-moral-imperative-for-bioethics/JmEkoyzlTAu9o-QV76JrK9N/story.html> (last visited November 16, 2018).+(last+visited+November+16,+2018);+J.+Savulescu+et+al.,+“The+Moral+Imperative+to+Continue+Gene+Editing+Research+on+Human+Embryos,”+Protein+Cell+6,+no.+7+(2015):+476-479;+S.+Pinker,+“The+Moral+Imperative+for+Bioethics”,+The+Boston+Globe,+August+1,+2015,+available+at++(last+visited+November+16,+2018).>Google Scholar
NAS Human Genome Editing Report, supra note 14, at 85-88.Google Scholar
See Frequently Asked Questions About Genetic Disorders, National Human Genome Research Institute, available at <https://www.genome.gov/19016930/faq-about-genetic-disorders/> (last visited December 1, 2018).+(last+visited+December+1,+2018).>Google Scholar
Genes and Human Disease, World Health Organization, available at <http://www.who.int/genomics/public/geneticdiseases/en/index2.html> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
NAS Human Genome Editing Report, supra note 14, at 87-88; Ishii, T., “Germ Line Genome Editing in the Clinics: The Approaches, Objectives, and Global Society,” Briefings in Functional Genomics 16, no. 1 (2017): 4656 at 50 (stating the prevention of monogenic diseases before childbirth appears to be a “reasonable application”); E. Juengst, “Crowdsourcing the Moral Limits of Human Gene Editing?” Hasting Center Report 47, no. 3 (2017): 15-23 (stating there appear to be “clear cut cases that enjoy international endorsement.”)Google Scholar
See Barrangou, R. and Doudna, J., “Applications of CRISPR Technologies in Research and Beyond,” Nature Biotechnology 34, no. 9 (2016): 933941 at 938; Lander, E., “Brave New Genome,” New England Journal of Medicine 373, no. 1 (2015): 5-8.Google Scholar
Savulescu et al., supra note 36, at 876.Google Scholar
Id.; Enriquez, P., “Genome Editing and the Jurisprudence of Scientific Empiricism,” Vanderbilt Journal of Entertainment and Technology Law 19, no. 3 (2017): 603695 at 637; Grant, E., “FDA Regulation of Clinical Applications of CRISPR-CAS Gene Editing Technology,“ Food and Drug Law Journal 71, no. 4 (2016): 608-633, at 613-614.Google Scholar
Enriquez, supra note 43, at 637 (discussing prophylactic measures and protective mutations); Ishii, supra note 40, at, 53; Ishii, T., “Germline Genome-Editing Research and Its Socioethical Implications,” Trends in Molecular Medicine 21, no. 8 (2015): 473481 at 479 (comparing preventive editing to preventive medicine); Juengst, supra note 40, at 18 (likening genome editing as similar to other public health measures designed to prevent disease and promote health).Google Scholar
Ajunwa, supra note 25; see also Comfort, supra note 26 (asserting that proponents of technology are publicly advocating for the new eugenics couched in technology.)Google Scholar
Ishii, T., “Reproductive Medicine Involving Genome Editing: Clinical Uncertainties and Embryological Needs,” Reproductive Biomedicine 34, no. 1 (2017): 2731 at 28.Google Scholar
Infertility, Centers for Disease Control and Prevention, available at <https://www.cdc.gov/reproductivehealth/Infertility/> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Global Prevalence of Infertility, Infecundity, and Childlessness, World Health Organization, available at <http://www.who.int/reproductivehealth/topics/infertility/burden/en/> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Gregorio, J., “Hatching A Plan Toward Comprehensive Regulation in Egg Donation,” DePaul Law Review 65, no. 4 (2016): 12831319, at 1285-1286.Google Scholar
Diamanti-Kandarakis, E. et al., “Endocrine Disrupting Chemicals: An Endocrine Society Scientific Statement,” Endocrine Reviews 30, no. 4 (2009): 293342.Google Scholar
See generally Skakkebaek, N. et al., “Male Reproductive Disorders and Fertility Trends: Influences of Environment and Genetic Susceptibility,” Physiological Reviews 96, no. 1 (2016): 5597 at 68; R.S. Tavares et al., “The Non-Genomic Effects of Endocrine Disrupting Chemicals on Mammalian Sperm,” Reproduction 15, no. 1 (2015): R1-R13.Google Scholar
Bergman, A. et al. (eds.), State of the Science on Endocrine Disrupting Chemicals, World Health Organization and United Nations Environment Program (2012)(hereinafter “State of the Science on EDCs”); Skakkebaek et al., supra note 51, at 80-81; see also P. Ghosh, “Sperm Count “Could Make Humans Extinct,’” BBC News, July 25, 2017, available at <http://www.bbc.com/news/health-40719743> (last visited November 16, 2018).Google Scholar
Skakkebaek et al., supra note 52, at 80-81.Google Scholar
International Summit, supra note 14.Google Scholar
Gene Editing: CBER's Perspective, supra note 55.Google Scholar
Baylis, F., “Human Genome Germline Editing and Broad Societal Consensus,” Nature Human Behavior 1, no. 0103 (2017): 13.Google Scholar
21 CFR § 1271.3(d) (2017); Grant, supra note 43, at 615, 624-625; NAS MRT Report, supra note 11, at 25-38, 99-100.Google Scholar
21 CFR § 1271.150 (2017).Google Scholar
See Drabiak MRT, supra note 6, at 25.Google Scholar
21 CFR § 1271.151 (2017); see also Grant, supra note 43, at 624-625.Google Scholar
Grant, supra note 43, at 624-625; NAS MRT Report, supra note 11, at 25-38, 99-100.Google Scholar
Grant, supra note 43, at 614-615.Google Scholar
See NAS MRT Report, supra note 11, at 59, 67.Google Scholar
Section 736, Consolidated Appropriations Act, Public Law No. 115-31, 115th Congress (2016-2017); see also Castro, R., “Mitochondrial Replacement Therapy: The UK and US Regulatory Landscapes,” Journal of Law and Biosciences 3 no. 3 (2016): 725735.Google Scholar
NAS Human Genome Editing Report, supra note 14, at 6.Google Scholar
Id. at 102-103.Google Scholar
Genome Editing: An Ethical Review, Nuffield Council on Bioethics, September 2016, available at <https://nuffieldbio-ethics.org/wp-content/uploads/Genome-editing-an-ethical-review.pdf> at 5152 (last visited November 16, 2018)(hereinafter “Nuffield Council Genome Editing Report”); NAS Human Genome Editing Report, supra note 14, at 90.+at+51–52+(last+visited+November+16,+2018)(hereinafter+“Nuffield+Council+Genome+Editing+Report”);+NAS+Human+Genome+Editing+Report,+supra+note+14,+at+90.>Google Scholar
NAS Human Genome Editing Report, supra note 14, at 90 and 102-103.Google Scholar
Barnett, supra note 23, at 553; see also NAS Human Genome Editing Report, supra note 14, at 85.Google Scholar
NAS Human Genome Editing Report, supra note 14, at 89-94.Google Scholar
Id. at 89, 93-95.Google Scholar
Id. at 93-95.Google Scholar
Chen, Y. et al., “Functional Disruption of the Dystrophin Gene in the Rhesus Monkey Using CRIPSR/Cas9,” Human Molecular Genetics 24, no.13 (2015): 37643774 at 3765. Chen and colleagues used 179 rhesus monkey embryos and implanted them in 59 surrogates, which resulted in eight miscarriages, four full term still births, and only fourteen live birth rhesus monkeys. See also U. Midic et al., “Quantitative Assessment of Timing, Efficiency, Specificity, and Genetic Mosaicism of CRISPR-Cas9-Mediated Gene Editing of Hemoglobin Beta Gene in Rhesus Monkey Embryos,” Human Molecular Genetics 26 no. 14 (2017): 2678-2689 at 2684 (finding a 10% survival rate from embryo to full term birth).Google Scholar
Id.; Isasi et al., supra note 13; Ishii, T., “Potential Impact of Human Mitochondrial Replacement on Global Policy Regarding Germline Gene Modification,” Reproductive Biomedicine Online 29, no. 2 (2014): 150155 at 152-153; Araki and T. Ishii, supra note 13, at 9.Google Scholar
Article 13, Convention on Human Rights and Biomedicine, Council of Europe (1997), available at <https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=090000168007cf98> (last visited November 16, 2018); United Nations Scientific Educational, Scientific, and Cultural Organization, Report of the IBC on Updating Its Reflection on the Human Genome and Human Rights (2015), available at <http://unesdoc.unesco.org/images/0023/002332/233258E.pdf> (last visited November 16, 2018); United Nations Scientific Educational, Scientific, and Cultural Organization, Universal Declaration on the Human Genome and Human Rights (1997), available at <http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genome-and-human-rights/> (last visited November 6, 2018).+(last+visited+November+16,+2018);+United+Nations+Scientific+Educational,+Scientific,+and+Cultural+Organization,+Report+of+the+IBC+on+Updating+Its+Reflection+on+the+Human+Genome+and+Human+Rights+(2015),+available+at++(last+visited+November+16,+2018);+United+Nations+Scientific+Educational,+Scientific,+and+Cultural+Organization,+Universal+Declaration+on+the+Human+Genome+and+Human+Rights+(1997),+available+at++(last+visited+November+6,+2018).>Google Scholar
Article 13, Convention on Human Rights and Biomedicine, Council of Europe (1997), available at <https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=090000168007cf98> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Article 9, Directive 2001/20/EC, Council of Europe (2001), available at <http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Assisted Human Reproduction Act s. 5 (2004); Assisted Human Reproduction Act s. 60 (2004).Google Scholar
Embryo Protection Act, Federal Law Gazette, Part I, No.69 (1990).Google Scholar
Research on Embryos, Bioethics Law, Code of Public Health. Article L2151-5 (2011); Absolute Prohibition on Creating Transgenic Embryos and Chimeras, Bioethics Law, Code of Public Health. Article L2151-2 (2011); see also Beaumont, S. and Tripathi, S., “France's Loi du 7 Julliet 2011 Clarifies The Human Embryonic Research System,” Life Sciences Bulletin, Fasken Martineau, August 2, 2011, available at <http://www.fasken.com/files/Publication/ad92fa84-d869-497e-80d7-071bfef919e5/Presentation/PublicationAttachment/f3b681c6-78fc-4379-aa6d-19456049955c/Life%20Sciences%20Bulletin%20-%20Beaumont-Tripathi%20-%20August%202%202011.pdf> (last visited December 1, 2017).Google Scholar
Article 35, Federal Act on Medically Assisted Reproduction, Federal Assembly of the Swiss Confederation (1998).Google Scholar
See Sections 3-4, The Genetic Integrity Act, Swedish Code of Statutes no.2006:351 (2006).Google Scholar
Article 13, Rules of Medically Assisted Procreation, No. 40 (2004).Google Scholar
Some laws prohibit germline modification to any embryo, some prohibit modification for implantable embryos. See Isasi et al., supra note 13.Google Scholar
Drabiak MRT, supra note 6, at 8-12.Google Scholar
Id. at 11.Google Scholar
McCaughey, T. et al., “A Global Social Media Survey of Attitudes to Human Genome Editing,” Cell Stem Cell 18, no. 5 (2016): 569–529 at Document S1.Google Scholar
See Genome Editing: Scientific Opportunities, Public Interests and Policy Options in the European Union, European Academies Scientific Advisory Council, March 2017, available at <https://www.easac.eu/fileadmin/PDF_s/reports_statements/Genome_Editing/EASAC_Report_31_on_Genome_Editing.pdf> (last visited December 1, 2018) at 5 (hereinafter “European Academies”); B. Friedrich, Human Genome Editing: Scientific and Ethical Considerations, German National Academy of Sciences, European Experts Meeting, March 16, 2016, available at <https://www.inserm.fr/sites/default/files/media/entity_documents/Inserm_ComiteEthique_Atelier_201603_Presentation2_BFriedrich_0.pdf> (last visited December 1, 2018) at 20; H. Chneiweiss, Fostering Responsible Research With CRISPR-Cas9, INSERM Ethics Committee, European Experts Meeting, March 16, 2016, available at <https://www.inserm.fr/sites/default/files/media/entity_documents/Inserm_ComiteEthique_Atelier_201603_Presentation1_HChneiweiss_0.pdf> (last visited December 1, 2018).+(last+visited+December+1,+2018)+at+5+(hereinafter+“European+Academies”);+B.+Friedrich,+Human+Genome+Editing:+Scientific+and+Ethical+Considerations,+German+National+Academy+of+Sciences,+European+Experts+Meeting,+March+16,+2016,+available+at++(last+visited+December+1,+2018)+at+20;+H.+Chneiweiss,+Fostering+Responsible+Research+With+CRISPR-Cas9,+INSERM+Ethics+Committee,+European+Experts+Meeting,+March+16,+2016,+available+at++(last+visited+December+1,+2018).>Google Scholar
European Academies, supra note 95, at 6.Google Scholar
Friedrich, supra note 95, at 19, 22; Chneiweiss, supra note 95, at 7, 18, 19.Google Scholar
European Academies, supra note 95; Chneiweiss, H. et al., “Fostering Responsible Research With Genome Editing Technologies: A European Perspective,” Transgenic Research 26, no. 5 (2017): 709713.Google Scholar
Id., at 713.Google Scholar
Callahan, D., “Gene Editing: Hope, Hype, Caution,” Hasting Center Bioethics Forum, December 8, 2015, available at <http://www.thehastingscenter.org/gene-editing-hope-hypeand-caution/> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Isasi et al., supra note 13, at 338.Google Scholar
Araki and Ishii, supra note 13, at 8-9; Ishii, supra note 44, at 478-479.Google Scholar
“If you tell a big enough lie, and tell it frequently enough, it will be believed.” –quote attributed to Joseph Goebbels. See Stafford, T., “How Liars Create the Illusion of Truth,” BBC News, October 26, 2016, available at <http://www.bbc.com/future/story/20161026-how-liars-create-the-illusion-of-truth> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Newman, S., “CRISPR Will Never Be Good Enough to Improve People,” Gene Watch 30, no.1 (2017): 56; G. Annas et al., “Protecting the Endangered Human: Toward An International Treaty Prohibiting Cloning and Inheritable Alterations,” American Journal of Law & Medicine 28, no. 2-3 (2002):153-178 at 157-160; S. Jasanoff et al., “CRISPR Democracy: Gene Editing and the Need for Inclusive Deliberation,” Issues in Science and Technology, Fall 2015, available at <http://issues.org/32-1/crispr-democracy-gene-editing-and-the-need-for-inclusive-deliberation/> (last visited November 16, 2018).Google Scholar
See The New Technologies, supra note 27, at 34-35; Lanphier, E. et al., “Don’t Edit the Human Germline,” Nature 519, no. 7544 (2015): 410411 at 411.Google Scholar
Liang, P. et al., “CRISPR-Cas9-Mediated Gene Editing in Human Tripronuclear Zygotes,” Protein Cell 6, no.5 (2015): 363372 at 366.Google Scholar
Midic et al., supra note 79, at 2685; Ma, H. et al., “Correction of a Pathogenic Gene Mutation in Human Embryos,” Nature 548, no. 7668 (2017): 413419.Google Scholar
Midic et al., supra note 79, at 2684.Google Scholar
Id. at 2685; NAS Human Genome Editing Report, supra note 14, at 56.Google Scholar
Midic et al., supra note 79, at 2679.Google Scholar
Id. at 2682; see also Ma et al., supra note 108, at 416.Google Scholar
59th Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee, FDA, February 25, 2014, available at <https://wayback.archive-it.org/7993/20170113010721/ http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesAdvisoryCommittee/UCM390945.pdf> (last visited December 1, 2018) at 203 (hereinafter “FDA Meeting”); see also Report on the Safety of “Mitochondrial Replacement” Techniques: Epigenetic Issues, Human Genetics Alert, March 2013, available at <http://www.hgalert.org/Report%20on%20the%20safety%20of%20mitochondrial%20transfer.pdf> (last visited December 1, 2018) at 5-6 (hereinafter “Human Genetics Alert.”)+(last+visited+December+1,+2018)+at+203+(hereinafter+“FDA+Meeting”);+see+also+Report+on+the+Safety+of+“Mitochondrial+Replacement”+Techniques:+Epigenetic+Issues,+Human+Genetics+Alert,+March+2013,+available+at++(last+visited+December+1,+2018)+at+5-6+(hereinafter+“Human+Genetics+Alert.”)>Google Scholar
NAS MRT Report, supra note 11, at 94-95.Google Scholar
Corrigan-Curay et al., supra note 3.Google Scholar
NAS MRT Report, supra note 11, at 94-95.; Carroll, D. and Charo, R.A., “The Societal Opportunities and Challenges of Genome Editing,” Genome Biology 16, no. 242 (2015): 19. Carroll and Charo specifically assert: “Because editing is performed in a hit-and-run fashion – the nucleases do their job and then are degraded in the cells — no traces of the reagents remains in the organism.” See also Ishii, supra note 40, at 49 (stating “the safety of unprecedented introduction of genome editing nucleases into human embryo deserves special scrutiny.”)Google Scholar
Kang, X. et al., “Introducing Precise Genetic Modifications Into Human 3PN Embryos for CRISPR/Cas-Mediated Genome Editing,” Journal of Assisted Reproduction and Genetics 33, no. 5 (2016): 581588 at 587.Google Scholar
Annas el al., supra note 105, at 157.Google Scholar
Id.; Newman, S., “Averting the Clone Age: Prospects and Perils of Human Developmental Manipulation,” Journal of Contemporary Health Law & Policy 19, no. 1 (2003): 431463; see also Ishii, supra note 40, at 49.Google Scholar
Newman, supra note 120, at 451.Google Scholar
Newman, S., supra note 105; Newman, S., “The Hazards of Human Developmental Gene Modification,” Gene Watch 13, no. 3 (2000): 1012.Google Scholar
Kang et al., supra note 118, at 587.Google Scholar
Human Genetics Alert, supra note 114.Google Scholar
NAS Human Genome Editing Report, supra note 14, at 90-95.Google Scholar
Id. at 56; Evitt, N. et al., “Human Germline CRISPR-CAS Modification: Toward a Regulatory Framework,” American Journal of Bioethics 15, no.12 (2015): 2529 at 26; E. Hosman, “CRISPR Gene Editing: Proofreaders and Undo Buttons, But Ever Safe Enough?” BioPolitical Times, The Center for Genetics and Society, November 19, 2015, available at <https://www.geneticsandsociety.org/biopolitical-times/crispr-gene-editing-proofreaders-and-undo-buttons-ever-safe-enough> (last visited November 17, 2018).Google Scholar
Newman, supra note 120, at 451.Google Scholar
Knoepfler, supra note 36.Google Scholar
Kang et al., supra note 118, at 585, 587; Midic et al., supra note 79, at 2684; Liang et al., supra note 107, at 364, 366; Chen et al., supra note 79, at 3765.Google Scholar
NAS Human Genome Editing Report, supra note 14, at 89.Google Scholar
Midic et al., supra note 79, at 2684; Chen et al., supra note 79, at 3765.Google Scholar
Kang et al., supra note 118, at 585.Google Scholar
Connor, S., “First Human Embryos Edited in the U.S,” MIT Technology Review, July 26, 2017, available at <https://www.technologyreview.com/s/608350/first-human-embryos-edited-in-us/> (last visited November 17, 2018).+(last+visited+November+17,+2018).>Google Scholar
Chen et al., supra note 79, at 3765.Google Scholar
See generally Campbell, I. et al., “Somatic Mosaicism: Implications for Disease and Transmission Genetics,” Trends in Genetics 31, no. 7 (2015): 382392; J. Vigg et al., “Somatic Mutations, Genome Mosaicism, Cancer and Aging,” Current Opinion in Genetics and Development 26 (2014): 141-149.Google Scholar
NAS Human Genome Editing, supra note 14, at 89; Ishii, supra note 44, at 29.Google Scholar
NAS Human Genome Editing, supra note 14, at 50; Ishii, supra note 46, at 49-50; Ishii, supra note 44, at 29.Google Scholar
Corrigan-Curay et al., supra note 3, at 801; Lander, supra note 41.Google Scholar
Ishii, supra note 44, at 29.Google Scholar
Corrigan-Curay et al., supra note 3, at 799, 805; Kang et al., supra note 118, at 586; see also Begley, S., “Do CRISPR Enthusiasts Have Their Head in the Sand About the Safety of Gene Editing?” STAT News, July 18, 2016, available at <https://www.statnews.com/2016/07/18/crispr-off-target-effects/> (last visited November 17, 2018).+(last+visited+November+17,+2018).>Google Scholar
Id.; but see Midic et al., supra note 79, at 2681. Midic and colleagues concluded their modifications produced no off target effects, but they examined only the two most common loci where they predicted off target effects would occur.Google Scholar
Ishii, supra note 44, at 29.Google Scholar
Id.; Callaway, E., “Doubts Raised About CRISPR Gene-Editing Study in Human Embryos,” Nature News, August 31, 2017, available at <https://www.nature.com/news/doubts-raised-about-crispr-gene-editing-study-in-human-embryos-1.22547> (last visited November 17, 2018); D. Egli et al., “Inter-Homologue Repair in Fertilized Human Eggs?” Pre-print (2017), available at <https://doi.org/10.1101/181255> (last visited November 17, 2018).+(last+visited+November+17,+2018);+D.+Egli+et+al.,+“Inter-Homologue+Repair+in+Fertilized+Human+Eggs?”+Pre-print+(2017),+available+at++(last+visited+November+17,+2018).>Google Scholar
NAS Human Genome Editing, supra note 14, at 89-90; Midic et al., supra note 79, at 2681; Ishii, supra note 44, at 474.Google Scholar
Schaefer, K. et al., “Unexpected mutations after CRISPR–Cas9 editing in vivo,” Nature Methods 14, no. 6 (2017): 547548 [Retracted]; see also K. Brown, “A Controversial Study Is Tearing the CRISPR World Apart,” Gizmodo, June 12, 2017, available at <https://gizmodo.com/a-controversial-study-is-tearing-the-crispr-world-apart-1796026251> (last visited December 13, 2018).Google Scholar
See Spicer, C., “Biotech Companies Criticise CRISPR Mutation Study,” BioNews, June 27, 2017, available at <https://www.bionews.org.uk/page_96057> (last visited November 17, 2018).+(last+visited+November+17,+2018).>Google Scholar
Kosicki, M. et al., “Repair of Double-Strand Breaks Induced By Crispr-CAS9 Leads to Large Deletions and Complex Rearrangements,” Nature Bioetechnology 36, no. 8 (2018): 765771; see also S. Begley, “Potential DNA Damage From CRISPR Has Been ‘Seriously Underestimated,’ Study Finds,” STAT News, July 16, 2018, available at <https://www.stat-news.com/2018/07/16/crispr-potential-dna-damage-underestimated> (last visited November 17, 2018).Google Scholar
See Drabiak MRT, supra note 6, at 34-37; see also Hunter, P., “The Long Term Health Risks of ART,” EMBO Reports 18, no. 7 (2017): 10611064.Google Scholar
I have referred to this clinical decision-making model as the “Unified Composite Risk Benefit Analysis.” See Drabiak, K., “The Impact of a Developing Regulatory Framework Governing LDTs in Precision Oncology: Re-Envisioning the Clinical Risk Assessment Paradigm,” Journal of Health & Biomedical Law 13 (2017): 189 at 83-88.Google Scholar
Id.; Lu, Y. et al., “Long Term Follow-up of Children Conceived Through Assisted Reproductive Technology,” Journal of Zhejiang University Biomedicine and Biotechnology 14, no. 5 (2013): 359371 at 361; J. Seggers et al., “Congenital Abnormalities In the Offspring of Subfertile Couples: A Registry Based-Study in the Northern Netherlands,” Fertility and Sterility 103, no. 4 (2015): 1001-1010; D. Kissin, “Association Of Assisted Reproductive Technology (ART) Treatment And Parental Infertility Diagnosis With Autism In ART-Conceived Children,” Human Reproduction 30, no. 2 (2016): 454-465; ESHRE Capri Workshop Group, “Birth Defects And Congenital Health Risks In Children Conceived Through Assisted Reproduction Technology (ART): A Meeting Report,” Journal of Assisted Reproduction and Genetics 31, no. 8 (2014): 947–958.Google Scholar
Kissin, supra note 153.Google Scholar
Lu et al., supra note 153.Google Scholar
Hart, R., “Physiological Aspects of Female Infertility: Role of the Environment, Modern Lifestyle, and Genetics,” Physiological Reviews 96, no. 3 (2016): 873909 at 889; see also M. Szalaviz, “The Link Between Infertility Treatments and Birth Defects,” Time, May 7, 2012, available at <http://healthland.time.com/2012/05/07/the-link-between-infertility-treatments-and-birth-defects/> (last visited November 17, 2018).Google Scholar
Amirian, E.S. and Bondy, M., “Assisted Reproductive Technology and Risk of Cancer in Children,” Pediatrics 137, no. 3 (2016): e20154509; M. Reigstad el al., “Risk of Cancer in Children Conceived by Assisted Reproductive Technology,” Pediatrics 137, no. 3 (2016): e20152061.Google Scholar
FDA Meeting, supra note 114, at 77, 88; NAS MRT Report, supra note 11, at 58.Google Scholar
FDA Meeting, supra note 121, at 87, 172; “Experts Warn of IVF Timebomb,” U.K. Daily Mail, available at <https://www.dailymail.co.uk/health/article-195627/Expert-warns-IVF-timebomb.html> (last visited December 13, 2018).+(last+visited+December+13,+2018).>Google Scholar
FDA Meeting supra note 114, at 203, 232-233; NAS Human Genome Editing Report, supra note 14, at 58; Cellular, Tissue, and Gene Therapies Advisory Committee, “FDA Briefing Document: Oocyte Modification in Assisted Reproduction for the Prevention of Transmission of Mitochondrial Disease or the Treatment of Infertility,” FDA, February 25-26, 2014 at 14-15, 20 (hereinafter “FDA Brief.”)Google Scholar
“Human Genetic Engineering on the Doorstep,” Human Genetics Alert, November 2012, available at <http://www.hgalert.org/Mitochondria%20briefing.pdf> (last visited November 17, 2018) at 4-5 (hereinafter “Genetic Engineering on the Doorstep”); Science and Technology Committee, “Mitochondrial Donation: Correspondence Received Relating to the Evidence Hearing on 22 October 2014,” House of Commons, 2014, available at <https://www.parliament.U.K./documents/commons-committees/science-technology/Mitochondrial%20donation/MITCorrespondence.pdf> (last visited November 17, 2018) at 39-49.+(last+visited+November+17,+2018)+at+4-5+(hereinafter+“Genetic+Engineering+on+the+Doorstep”);+Science+and+Technology+Committee,+“Mitochondrial+Donation:+Correspondence+Received+Relating+to+the+Evidence+Hearing+on+22+October+2014,”+House+of+Commons,+2014,+available+at++(last+visited+November+17,+2018)+at+39-49.>Google Scholar
FDA Brief, supra note 160, at 15.Google Scholar
Id. at 20; NAS MRT Report, supra note 11, at 58; FDA Meeting, supra note 114, at 104-105; Human Genetics Alert, supra note 114, at 3.Google Scholar
FDA Brief, supra note 160, at 19; Human Genetics Alert, supra note 114, at 3; Genetic Engineering on the Doorstep, supra note, 161 at 5.Google Scholar
FDA Brief, supra note 160, at 19; NAS Genome Editing, supra note 14, at 53.Google Scholar
Midic and colleagues found human embryo efficiency at 52%, but only 10% rhesus monkey zygotes developed to full term. See Midic et al., supra note 79.Google Scholar
I have similarly issued a call to assess the inconsistency between evidence demonstrating grave risks and NAS recommendations pertaining to MRT. See Drabiak MRT, supra note 6, at 37.Google Scholar
Lek, M. et al., “Analysis Of Protein-Coding Genetic Variation In 60,706 Humans,” Nature 536, no. 7616 (2016): 285291; Editorial, “Genetic Reckoning,” Nature 538, no. 7624 (2016): 140.Google Scholar
Id.; Hayden, E.C., “Seeing Deadly Mutations in a New Light,” Nature 538, no. 7624 (2016): 154157; D. Goldstein et al., “Sequencing Studies in Human Genetics: Design and Interpretation,” Nature Review Genetics 14, no. 7 (2013): 460-470.Google Scholar
Goldstein et al., supra note, 169, at 465; Genetic Reckoning, supra note 168.Google Scholar
Goldstein et al., supra note 169, at 465.Google Scholar
Id. at 465.Google Scholar
Drabiak, K., “The Impact of a Developing Regulatory Framework Governing LDTs in Precision Oncology: Re-envisioning the Clinical Risk Assessment Paradigm,” Journal of Health and Biomedical Law 13, no. 2 (2018): 157 at 10-11; C. Holman, “The Critical Role of Patents in the Development, Commercialization, and Utilization of Innovative Genetic Diagnostic Tests and Personalized Medicine,” Boston University Journal of Science and Technology Law 21, no. 2 (2015): 297-316 at 302-303.Google Scholar
Id.; see also Peres, J., “Breast Cancer Screening Offers Vital Information, Uncertainty,” The Chicago Tribune, September 25, 2014, available at <http://www.chicagotribune.com/lifestyles/health/breastcancer/sc-health-0924-bc-genetic-mutations-20140925-story.html> (last visited November 16, 2018).+(last+visited+November+16,+2018).>Google Scholar
Goldstein et al., supra note 169, at 463; see also Lander, supra note 41.Google Scholar
Lostrumbo, L. et al., “Prophylactic Mastectomy for the Prevention of Breast Cancer,” Cochrane Database of Systematic Reviews 11, Article No. CD002748 (2010): 193 at 3.Google Scholar
Goldman, S., “Environmental Toxins and Parkinson's Disease,” Annual Review of Pharmacology and Toxicology 54 (2014): 141164 at 142.Google Scholar
Pacchierotti, F. and Spano, M., “Environmental Impact of DNA Methylation in the Germline: State of the Art and Gaps of Knowledge,” BioMed Research International (2015), Article ID 123484 (2015): 123.Google Scholar
Rothstein, M. et al., “The Ghost in Our Genes: Legal and Ethical Implications of Epigenetics,” Health Matrix: Journal of Law-Medicine 19, no. 1 (2009): 162 at 4-11.Google Scholar
Pacchierotti and Spano, supra note 183.Google Scholar
Sears, M. and Genius, S., “Environmental Determinants of Chronic Disease and Medical Approaches: Recognition, Avoidance, Supportive Therapy, and Detoxification,” Journal of Environmental and Public Health 2012, Article ID 356798 (2012): 115.Google Scholar
See Drabiak, K., “Dying to Be Fresh and Clean? Regulatory Shortcomings Governing Toxicants in Personal Care Products, the Impact on Cancer Risk, and Epigenetic Damage,” Pace Environmental Law Review 35, no. 1 (2017): 75107 at 102-104 (discussing environmentally mediated epigenetic damage) (hereinafter Drabiak EDCs).Google Scholar
Paraskevaidi, M. et al., “Underlying Role in Mitochondrial Mutagenesis in the Pathogenesis of Disease and Current Approaches for Translational Research,” Mutagenesis 32, no. 3 (2017): 335342 at 341. Paraskevaidi and colleagues suggest simple low risk measures such as exercise and nutrition carry the potential for positive impact because they encourage mitochondrial formation.Google Scholar
See supra note 38.Google Scholar
Cooper, D. et al., “When Genotype Is Not Predictive of Phenotype: Towards an Understanding of the Molecular Basis of Reduced Penetrance of Human Inherited Disease,” Human Genetics 132, no. 10 (2013): 10771130.Google Scholar
Nahhas, F. et al., “An Intergenerational Contraction of Fully Penetrant Huntington Disease Allele To A Reduced Penetrance Allele: Interpretation of Results and Significance for Risks Assessment and Genetic Counseling,” American Journal of Medical Genetics 149A, no. 4 (2009): 732736 at 734; C. Kay et al., “Huntington Disease Reduced Penetrance Alleles Occur at High Frequency in the General Population,” Neurology 87, no. 3 (2016): 282-288.Google Scholar
Reiner, A. et al., “Genetics and Neuropathology of Huntington's Disease,” International Review of Neurobiology 98 (2011): 325372.Google Scholar
Learning About Huntington's Disease, National Human Genome Research Institute, available at <https://www.genome.gov/10001215/learning-about-huntingtons-disease/> (last visited November 17, 2018). (last visited November 17, 2018).' href=https://scholar.google.com/scholar?q=Learning+About+Huntington's+Disease,+National+Human+Genome+Research+Institute,+available+at++(last+visited+November+17,+2018).>Google Scholar
Nahhas et al., supra note 192, at 734. Nahhas and colleagues cite two figures for intermediate allele penetrance arising from two different studies. A study by Langbhen and colleagues 10-53% penetrance for 36-39 CAG repeats, while Quarrell and colleagues estimated 67% penetrance. Nahhas and colleagues cite another study that intermediate alleles affect 1-3.9% of the general population. But see Kay et al., supra note 192. Kay and colleagues estimated intermediate allele occurrence in the general population at only 1/400.Google Scholar
Nahhas et al., supra note 192; see also Cooper et al., supra note 191, at 1084.Google Scholar
Cooper et al., supra note 191, at 1077; see also Gallati, S., “Disease Modifying Genes and Monogenic Disorders: Experience in Cystic Fibrosis,” Application of Clinical Genetics 7, no. 2014 (2014):133146.Google Scholar
Gallati, supra note 197, at 134; Cooper et al., supra note 191, at 1077-1078.Google Scholar
Id. at 134; Id. at 1084, 1086.Google Scholar
Id. at 134; Id. 1101-1102.Google Scholar
Id. at 134; Id. at 1101.Google Scholar
Id. at 1102.Google Scholar
Id. at 1078-1078, 1102.Google Scholar
Cooper et al., supra note 191, at 1077; see also Gallati, S., “Disease Modifying Genes and Monogenic Disorders: Experience in Cystic Fibrosis,” Application of Clinical Genetics 7, no. 2014 (2014):133146.Google Scholar
Goldman, supra note 180, at 145-150.Google Scholar
Olejniczak, M. et al., “The Role of the Immune System in Triplet Repeat Expansion Disorders,” Mediators of Inflammation 2015, Article ID 873860 (2015): 111.Google Scholar
Stein, R., “Breaking Taboo, Swedish Scientist Seeks To Edit DNA Of Healthy Human Embryos,” NPR, September 22, 2016, available at <https://www.npr.org/sections/health-shots/2016/09/22/494591738/breaking-taboo-swedish-scientist-seeks-to-edit-dna-of-healthy-human-embryos> (last visited November 17, 2018).+(last+visited+November+17,+2018).>Google Scholar
Colburn, T. et al., Our Stolen Future (New York: Penguin Books, 1996); State of the Science on EDCs, supra note 52; C. Guerro-Bosagna and M. Skinner, “Environmentally Induced Epigenetic Transgenerational Inheritance of Male Infertility,” Current Opinion in Genetics and Development 26 (2014): 79-88; Diamanti-Kandarakis et al., supra note 50; Fertility and Infertility and the Environment, National Center for Environmental Health, centers for disease control and prevention, available at <https://ephtracking.cdc.gov/showRb-FertilityInfertilityEnv> (last visited November 17, 2018).Google Scholar
See generally Diamanti-Kandarakis et al., supra note 50 (discussing reproductive disorders, structural abnormalities, and reduced fertility); Skakkebaek et al., supra note 51 at 3-4 (discussing between impaired semen motility, low sperm count, and testicular cancer); Hart, supra note 156, at 873 (discussing premature ovarian failure and subfertility) and 891 (discussing the connection between obesity and reduced fertility).Google Scholar
See supra, notes 47-48.Google Scholar
Groskop, V., “The Fertility Industry is One That Sells Hope-Sometimes That Hope Is False,” The Guardian, June 1, 2015, available at <https://www.theguardian.com/lifeand-style/2015/jun/01/fertility-industry-sells-hope-false-delay-having-baby> (last visited November 17, 2018).+(last+visited+November+17,+2018).>Google Scholar
Hart, supra note 156, at 888-889.Google Scholar
Id. at 884.Google Scholar
Skakkebaek et al., supra note 51, at 3-4, 13, 25; Diamanti-Kandarakis et al., supra note 50, at 309-312; State of the Science on EDCs, supra note 52, at vii, 57, 65, 74.Google Scholar
Levine, H. et al., “Temporal Trends in Sperm Count: A Systematic Review and Meta-Regression Analysis, Human Reproduction Update” Human Reproduction Update 23, no. 6 (2017):646659 at 6-7; Skakkebaek et al., supra note 57, at 68.Google Scholar
Levine et al., supra note 215, at 6-7.Google Scholar
Guerro-Bosagna and Skinner, supra note 208, at 80-83; see also Sharma, R. et al., “Lifestyle Factors and Reproductive Health: Taking Control of Your Fertility,” Reproductive Biology and Endocrinology 11, no. 66 (2013): 115.Google Scholar
Id.; Skakkebaek et al., supra note 51, at 14; Hart, supra note 156, at 887.Google Scholar
Id.; Diamanti-Kandarakis et al., supra note 50; see generally State of the Science on EDCs, supra note 52.Google Scholar
Marques-Pinto, A. and Carvalho, D., “Human Infertility: Are Endocrine Disruptors To Blame?” Endocrine Connections 2 no. 3 (2013): R15R29 at R21.Google Scholar
Skakkebaek et al., supra note 51, at 3-6; Tavares et al., supra note 51; State of the Science on EDCs, supra note 52, at vii (discussing the connection between the decrease and fertility and increase in occurrence of endocrine and reproductive disorders).Google Scholar
Huo, X. et al., “Bisphenol A and Female Infertility: A Possible Role of Gene-Environment Interactions,” International Journal of Environmental Research and Public Health 12, no. 9 (2015): 1110111116 at 11105-11106.Google Scholar
Id. at 11101, 11102; Skakkebaek et al., supra note 51, at 22-24; Tavares et al., supra note 51, at 2 (discussing he potential for environmental factors to exert non genomic effects such as inducing oxidative stress and mitochondrial dysfunction.)Google Scholar
Skakkebaek et al., supra note 51, at 11-12 (asserting the overall decline in male fertility cannot be explained by lifestyle alone); at 14 (discussing the impact of sedentary lifestyle, sleep, stress, and nutrition on fertility); Sharma et al., supra note 217, at 2 (discussing the impact of diet on fertility), at 3 (discussing the role of obesity on fertility), at 3-4 (discussing the role of physical activity on fertility).Google Scholar
State of the Science on EDCs, supra note 52, at 65 (discussing the impact of fetal exposure on PCBs and dioxin), at 189-200 (discussing the impact of exposure to endocrine disrupting chemicals present in plasticizers, pesticides, and personal care products); Tavares et al., supra note 51, at 3-5 (discussing endocrine disruption from pesticides, phthalates, and PBCs), at 9 (discussing endocrine disruption from PVC products such as raincoats, toys, food packaging, medical devices); Skakkebaek et al., supra note 51, at 6 (discussing how pesticides, fungicides, phthalates, and dioxin exert anti-androgenic influence).Google Scholar
State of the Science on EDCs, supra note 52, at vii.Google Scholar
State of the Science on EDCs, supra note 52, at viii; See Drabiak EDCs, supra note 188, at 27-28 (discussing the critical window of development.)Google Scholar
Guerro-Bosagna and Skinner, supra note 208, at 81-82.Google Scholar
Id. at 83-84.Google Scholar
Drabiak MRT, supra note 6, at 52-53; see also Regalado, A., “Who Owns the Biggest Biotech Discovery of the Century?” MIT Technology Review, December 4, 2014, available at <https://www.technologyreview.com/s/532796/who-owns-the-biggest-biotech-discovery-of-the-century/> (last visited November 17, 2018). (discussing the billions of dollars at stake over CRISPR related patents); Annas, supra note 32, at 4, 11.+(last+visited+November+17,+2018).+(discussing+the+billions+of+dollars+at+stake+over+CRISPR+related+patents);+Annas,+supra+note+32,+at+4,+11.>Google Scholar
Id.; Comfort, supra note 26.Google Scholar
Both the U.S. and the U.K. have addressed genome editing as a strategy for enhancing capabilities in military personnel. See Nuffield Council Genome Editing Report, supra note 72, at 101; see also Jacobsen, A., “Engineering Humans for War,” The Atlantic, September 23, 1015, available at <https://www.theatlantic.com/international/archive/2015/09/military-technology-pentagon-robots/406786/> (last visited November 17, 2018).+(last+visited+November+17,+2018).>Google Scholar
International Summit, supra note 14, at 4.Google Scholar
Annas et al., supra note 105, at 153, 157, 159-161; see also Drabiak MRT, supra note 6, at 58.Google Scholar
See Annas et al., supra note 105.Google Scholar