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An Ethical and Legal Analysis of Ovascience – A Publicly Traded Fertility Company and its Lead Product AUGMENT

Published online by Cambridge University Press:  06 January 2021

Katarina Lee
Katarina Lee*
Affiliation:
Department of Family Medicine, University of Manitoba and Clinical Ethicist at St. Boniface General Hospital in Winnipeg, Manitoba
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Extract

In May 2015, the first baby created through an emerging ova technology called AUGMENT, was born in Canada.1 Developed by OvaScience, AUGMENT essentially introduces mitochondria sourced from the genetic mother into her own ovum in order to revitalize the ovum.2 This technology is controversial because OvaScience is a publicly traded company, and it is driven by short-term results, such as earnings;3 and (2) OvaScience did not complete adequate clinical trials before offering AUGMENT to the public.4 Moreover, in its 2014 annual report, OvaScience declared that it was intentionally offering its products in countries where clinical trials are not required.5 The lack of adequate clinical trials is the primary reason underlying the Food and Drug Administration's (“FDA”) prohibition of the technology in the United States.6 Finally, as of August 2018, OvaScience has shifted its research away from AUGMENT, and it only offers it through an “exclusive license to IVF Japan Group in Japan.”7

Type
Articles
Information
American Journal of Law & Medicine , Volume 44 , Issue 4 , November 2018 , pp. 508 - 528
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2018

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Footnotes

This article benefited from helpful comments received by Professor June Carbone, colleagues at Baylor College of Medicine and participants at Harvard Medical School's Center for Bioethics Conference: The Ethics of “Making Babies.

References

1 Zain Rajani Is the 1st Baby Born Using Augment IVF Treatment, CBC News, (May 8, 2015, 10:57 PM), http://www.cbc.ca/news/canada/toronto/zain-rajani-is-the-1st-baby-born-using-augment-ivf-treatment-1.3067637 [https://perma.cc/V4W3-TF6V].

2 Id.

3 Dallas, Lynne L., Short-Termism, the Financial Crisis, and Corporate Governance, 37 J. Corp. L. 265, 267-68 (2012)Google Scholar.

4 Eur. Soc'y of Human Reprod. & Embryology, Energizing Eggs with a Patient's Own Mitochondria Offers No Benefit in Assisted Reproduction, EurekAlert! (July 3, 2018), https://www.eurekalert.org/pub_releases/2018-07/esoh-eew062818.php [https://perma.cc/R8TL-N895] (reporting that results from the only published randomized trial show that AUGMENT “offer[s] no benefit in terms of pregnancy or live birth rate.”); Karen Weintraub, Turmoil at Troubled Fertility Company Ovascience, MIT Tech. Rev. (Dec. 29, 2016), https://www.technologyreview.com/s/603274/turmoil-at-troubled-fertility-company-ovascience/ [https://perma.cc/Y5L7-SGZ9] (OvaScience halted clinical trials.).

5 OvaScience, Inc., Annual Report (Form 10-K), at 17 (Mar. 16, 2015).

6 Id.

7 Pipeline and Treatments, OvaScience, https://ovascience.com/treatments/ [https://perma.cc/V78P-CC4U].

8 See Press Release, OvaScience, Improved Pregnancy Rates and Healthy Births with OvaScience's AUGMENT Fertility Treatment to be Published in Peer-Review Journal (Aug. 10, 2015, 4:15 PM), https://www.businesswire.com/news/home/20150810006135/en/Improved-Pregnancy-Rates-Healthy-Births-OvaScience%E2%80%99s-AUGMENT [https://perma.cc/DQV5-5WQX].

9 See OvaScience, Inc., Annual Report (Form 10-K) (Mar. 2, 2017).

10 See OvaScience, supra note 7.

11 See Press Release, OvaScience, Publication of OvaScience's AUGMENT Fertility Treatment Shows Statistically Significant Improvements in Embryo Selection and Transfer Compared to Standard IVF (Aug. 26, 2015, 10:44 AM), https://www.businesswire.com/news/home/20150826005800/en/Publication-OvaScience%E2%80%99s-AUGMENT-Fertility-Treatment-Shows-Statistically [https://perma.cc/YZG7-AA5T]. TCART no longer exists independently. In 2015 LifeQuest Centre for Reproductive Medicine and TCART Fertility Partners merged. Our Medical Team, TRIO, http://triofertility.com/our-medical-team/ [https://perma.cc/FP8C-G89W] (“TRIO was established in 2015 when the experienced teams of fertility specialists from LifeQuest Centre for Reproductive Medicine and TCART Fertility Partners merged to form the new clinical practice TRIO Fertility.”).

12 Michael H. Fakih et al., The AUGMENTSM Treatment: Physician Reported Outcomes of the Initial Global Patient Experience, J. Fertilization: In Vitro: IVF-Worldwide, Reprod. Med., Genetics & STEM Cell Biology, Aug. 14, 2015, at 1, 2; About Us, OvaScience, https://ovascience.com/about-us/ [https://perma.cc/2WHM-SF6W].

13 A clinical trial was commenced in Spain; however, was not completed. See Press Release, OvaScience, OvaScience Announces Business Update, (Dec. 21, 2016, 4:04 PM), https://www.businesswire.com/news/home/20161221005882/en/OvaScience-Announces-Business-Update [https://perma.cc/ZQ55-SQPA] (“The Company is reassessing the ongoing IVI-sponsored clinical study in Spain ….”).

14 Motluk, Alison, IVF Booster Offered in Canada but Not US, 187 Can. Med. Ass'n J. E89, E89 (2015)CrossRefGoogle Scholar

15 Taryn Hillin, Why an Incredible New Method to Extend Fertility Is Off Limits in the U.S., Splinter (Aug. 4, 2015, 8:54 AM), https://splinternews.com/why-an-incredible-new-method-to-extend-fertility-is-off-1793849708 [https://perma.cc/R7RZ-LLEW]

16 Navot, Daniel et al., Age-Related Decline in Female Fertility Is Not Due to Diminished Capacity of the Uterus to Sustain Embryo Implantation, 61 Fertility & Sterility 97, 99-100 (1994)CrossRefGoogle Scholar.

17 Hillin, supra note 16; Why Augment, Augment, https://augmenttreatment.com/#why-augment [https://perma.cc/3UGG-RUHY].

18 Augment, supra note 18.

19 Id.

20 See Fakih et al, supra note 13, at 2.

21 See Robert F. Casper et al., TCART Fertility Partners, Preliminary Results with Autologous Egg Precursor Cell Mitochondrial Injection During Intracytoplasmic Sperm Injection (ICSI) in Women with Previous Poor Embryo Development (Mar. 26, 2015), http://ovascience.com/files/SRI_Poster_Casper_March_2015_FINAL.pdf [https://perma.cc/GBF6-ERRA].

22 See Augment, supra note 18.

23 Jennifer Couzin-Frankel, Controversial Fertility T reatments Focus on Eggs' Power Plants Science (Mar. 30, 2015, 6:30 PM), https://www.sciencemag.org/news/2015/03/controversial-fertility-treatments-focus-eggs-power-plants [https://perma.cc/V2XZ-PU3M].

24 Press Release, Ovascience, OvaScience AUGMENT Fertility Treatment Shows Improved Pregnancy Rates in Women with Prior Failed IVF Cycles (Mar. 26, 2015, 1:05 PM), https://www.businesswire.com/news/home/20150326006099/en/OvaScience-AUGMENT-Fertility-Treatment-Shows-Improved-Pregnancy [https://perma.cc/X553-34KM].

25 Fakih et al., supra note 13, at 3-4.

26 Id. at 4.

27 Id. at 4 tbl.2

28 Id.

29 Id. at 5.

30 Eur. Soc'y of Human Reprod. & Embryology, supra note 4.

31 Id.

32 Press Release, OvaScience, OvaScience Reports Fourth Quarter and Year End 2014 Financial Results (Mar. 16, 2015, 4:22 PM), https://www.businesswire.com/news/home/20150316006351/en/OvaScience-Reports-Fourth-Quarter-Year-2014-Financial [https://perma.cc/NW9M-67D6].

33 Press Release, Ovascience, OvaScience Completes Enrollment of 70 Patients in OvaPrime Clinical Study in Women with Primary Ovarian Insufficiency or Poor Ovarian Response (June 13, 2017, 7:00 AM), https://www.businesswire.com/news/home/20170613005535/en/OvaScience-Completes-Enrollment-70-Patients-OvaPrime-Clinical [https://perma.cc/FQG9-3JXL].

34 OvaScience, Inc., Quarterly Report (Form 10-Q), at 16 (Aug. 3, 2017).

35 Id. at 6.

36 Id. at 15.

37 Id.

38 Press Release, Intrexon, Joint Ventures: OvaXon – Improving Human and Animal Health (Dec. 19, 2013), https://investors.dna.com/2013-12-19-OvaScience-and-Intrexon-Collaborate-to-Accelerate-Development-of-OvaScience-s-OvaTure-Technology-for-InfertilityTreatments [https://perma.cc/W9AR-RXWF].

39 Id.

40 OvaScience, Inc., Annual Report (Form 10-K), at 5 (Mar. 16, 2015).

41 Toronto Fertility Clinic Offers Controversial Egg Treatment for Women That Can Extend Child-Bearing Years, Nat'l Post (Jan. 30, 2015, 8:48 AM), https://nationalpost.com/news/canada/toronto-fertility-clinic-offers-controversial-egg-treatment-for-women-that-can-extend-child-bearing-years. See also Aging Eggs: Exciting Research Is on the Horizon, Fertility Auth., https://www.fertilityauthority.com/articles/aging-eggs-exciting-research-horizon [https://perma.cc/87DX-Y5GJ] (The technique was developed by embryologist Jacques Cohen); Kim Tingley, The Brave New World of Three-Parent I.V.F., N.Y. Times Mag. (June 27, 2014), http://www.nytimes.com/2014/06/29/magazine/the-brave-new-world-of-three-parent-ivf.html?_r=0.)

42 Steve Connor, Three-Parent Babies: ‘As long as she's healthy, I don't care’, Says Mother of IVF Child, Th e Indep. (Aug. 25, 2014, 9:07 PM), https://www.independent.co.uk/news/science/three-child-babies-the-mothers-view-as-long-as-she-s-healthy-i-don-t-care-9690059.html [https://perma.cc/XGH8-AAA3]; Tingley, supra note 42

43 Tingley, supra note 42.

44 Id.

45 Erika Check Hayden, Regulators Weigh Benefits of ‘Three-Parent’ Fertilization, Nature (Oct. 15, 2013), https://www.nature.com/news/regulators-weigh-benefits-of-three-parent-fertilization-1.13959#Box [https://perma.cc/W7MZ-GCQS].

46 James Gallagher, UK Approves Three-Person Babies, BBC News (Feb. 24, 2015), http://www.bbc.com/news/health-31594856, [https://perma.cc/CX5C-VXBF].

47 See Tingley, supra note 42.

48 3-Person IVF: A Resource Page, Ctr. for Genetics & Soc'y, https://www.geneticsandsociety.org/internal-content/3-person-ivf-resource-page [https://perma.cc/6ZG6-M7U3].

49 Id.

50 See Nat'l Post, supra note 42.

51 OvaScience, Inc., supra note 5, at 17.

52 See id. at 18.

53 See Connor, supra note 43.

54 Nat'l Post, supra note 42. Note, while AUGMENT was provided in Canada for several years, it is unclear whether AUGMENT is being offered in Canada as of August 2018. As noted in footnote 9, TCART merged to create TRIO. It appears that at some point TRIO was offering AUGMENT as there was a webpage in existence (triofertility.com/augment/); however, the link no longer provides any information.

55 See Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans, Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/guidance-document-preparation-clinical-trial-applications-use-cell-therapy-products-humans.html [https://perma.cc/PX4T-8F44].

56 Id.

57 See id.

58 Id.

59 See id.

60 See id.; Motluk, supra note 14, at E89.

61 Motluk, supra note 14, at E89.

62 Katarina Lee, A Comparison of Canadian and American ART Law, Voices in Bioethics (Oct. 14, 2015), http://voicesinbioethics.org/2015/10/14/a-comparison-of-canadian-and-american-art-law/ [https://perma.cc/N65E-DPXT].

63 Assisted Human Reproduction Act, S.C. 2004, c 2 (Can.).

64 See generally, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans: Section 9 – Researching, Involving Human Gametes, Embryos or Fetuses, Panel on Research Ethics, http://www.pre.ethics.gc.ca/eng/archives/tcps-eptc/section9-chapitre9/#9A [https://perma.cc/8FHJ-P2SU].

65 See id. at art. 9.1.

66 Id. at art. 9.4.

67 Id.

68 Id. at art. 9.2.

69 Id. at art. 9.3.

70 See id. at art. 9.4.

71 Sharon Kirkey, Canadian C linic First to Offer Controversial New Form of IVF, Canada.com (Jan. 29, 2015, 4:50 PM), https://o.canada.com/health-2/fertility-treatment-that-seeks-to-extend-womens-child-bearing-years-raises-debate.

72 mtDNA from the mother is the same regardless if the mother has a son or daughter. See FAQs: Mitochondrial DNA Explained, Phillips DNA Project, http://phillipsdnaproject.com/faq-sections/144-mitochondrial-dna-explained [https://perma.cc/PZD4-VFEC].

73 Taylor, Robert W. & Turnbull, Doug M., Mitochondrial DNA Mutations in Human Disease, 6 Nature Rev. Genetics 389, 389 (2005)CrossRefGoogle ScholarPubMed.

74 See Ilona Miko, Mitosis, Meiosis, and Inheritance, Nature Educ., https://www.nature.com/scitable/topicpage/mitosis-meiosis-and-inheritance-476 [https://perma.cc/DGD2-964T]. Note, the typical arguments permitting therapeutic genetic manipulation are not relevant to this discussion as (1) most genetic manipulation occurs once an individual is born and (2) adding mitochondria to facilitate successful pregnancy is not a form of treatment. In fact, it could be argued that the addition of mitochondria is a form of enhancement technology as it is meant to enhance an ovum in order that it can facilitate fertilization and sustain pregnancy. See World's First Genetic Modification of Human Embryos Reported: Experts Consider Ethics, Sci. Daily (April 24, 2015), http://www.sciencedaily.com/releases/2015/04/150424122312.htm [https://perma.cc/G77E-QUHB].

75 See Inhorn, Marcia C., Cosmopolitan Conceptions in Global Dubai? The Emiratization of IVF and Its Consequences, 2 Reprod. BioMedicine & Soc'y Online 24, 25 (2016)Google ScholarPubMed.

76 Law No. 11 of 2008 (Concerning Licensing of Fertilization Centers in the State), 16 Dec. 2008, art. 8 (U.A.E).

77 Alison McMeans, IVF Restrictions Force Women Abroad, The Nat'l (Aug. 30, 2008), https://www.thenational.ae/uae/ivf-restrictions-force-women-abroad-1.560181 [https://perma.cc/U5PT-KC95].

78 Id.

79 Cabinet Decision No. 36 of 2009 (Issuing the Implementing Regulation of Federal Law No. (11) of 2008 Concerning the Licensing of Fertilization Centers in the State), 9 Oct. 2009 (U.A.E); Surbhi Veer, IVF Law in the UAE, LinkedIn (Dec. 11, 2014), https://www.linkedin.com/pulse/ivf-law-uae-surbhi-veer [https://perma.cc/HBQ3-QPNP].

80 Veer, supra note 79.

81 Experts in Egg Health: Advancing Fertility Patient Care, OvaScience 79 (2015), http://www.ovascience.com/files/ESHRE_Symposium_2015_Final_For_Website_Posting_FINAL-2.pdf [https://perma.cc/W86K-VZW8].

82 Law No. 11 of 2008 (Concerning Licensing of Fertilization Centers in the State), 16 Dec. 2008, art. 14 (U.A.E).

83 Susuki, Masakuni, In Vitro Fertilization in Japan – Early Days of In Vitro Fertilization and Embryo Transfer and Future Prospects for Assisted Reproductive Technology, 90 Proc. Japan. Acad. Series B, Physical & Biological Sci. 184, 195 (2014)Google Scholar.

84 Id. at 196.

85 Mayumni Mayeda, Present State of Reproductive Medicine in Japan – Ethical Issues with a Focus on Those Seen in Court Cases, BMC Med. Ethics, Apr. 5, 2006, at 8.

86 Id.

87 Skye Gould & Kevin Loria, This Map Shows Where Researchers Might Design the First Genetically Engineered Baby, Bus. Insider (Oct. 20, 2015, 12:48 PM), http://www.businessinsider.com/what-countries-allow-researchers-to-edit-human-embryos-2015-10 [https://perma.cc/68FY-BD6P].

88 Human Genome Editing, Japan Times (Sept. 26, 2016), https://www.japantimes.co.jp/opinion/2016/09/26/editorials/human-genome-editing/#.Wah7ka0ZNE4 [https://perma.cc/94XX-39S7].

89 See Sci. Council of Japan, Genome Editing Technology in Medical Sciences and Clinical Applications in Japan 3-4 (2017), http://www.scj.go.jp/ja/info/kohyo/pdf/kohyo-23-t251-1-en.pdf [https://perma.cc/PJ6B-DFUU].

90 Ratner v. Ovascience, Inc. 134 F.Supp.3d 621, 624 (D. Mass. 2015).

91 Id. at 625; see also 21 C.F.R. § 1271.10(a).

92 Ratner, 134 F.Supp.3d at 627.

93 Id.at 625.

94 Id. at 625-26; see also Zeba Siddiqui, FDA Demands OvaScience Apply for Product Approval; Shares Slump, Reuters (Sept. 10, 2013), http://www.reuters.com/article/2013/09/10/us-ovascience-fda-idUSBRE9891HE20130910 [https://perma.cc/B2MN-GLD6].

95 See Hillin, supra note 16; Alice Park, Exclusive: Meet the World's First Baby Born with an Assist from Stem Cells, Time (May 7, 2015), http://time.com/3849127/baby-stem-cells-augment-ivf/ [https://perma.cc/PKJ2-H89S]; Siddiqui, supra note 95.

96 Siddiqui, supra note 95; Rob Stein, Fertility Clinic Courts Controversy with Treatment That Recharges Eggs, NPR: Shots (Mar. 5, 2015, 3:43 AM), https://www.npr.org/sections/health-shots/2015/03/05/389284225/toronto-infertility-clinic-offers-controversial-treatment [https://perma.cc/7VQM-43HA].

97 What We Do, FDA, http://www.fda.gov/AboutFDA/WhatWeDo/ [https://perma.cc/AP5Z-NFV9].

98 The most controversial ART are IUI, IVF, and surrogacy. Hormonal treatments and reparative techniques do not pose the same ethical quandaries.

99 Marko Ahteensuu, University of Turku, Rationale for Taking Precautions: Normative Choices and Commitments in the Implementation of the Precautionary Principle, Risk & Rationalities Conference Proceedings at Queens' College, Cambridge, UK (2007), https://www.kent.ac.uk/scarr/events/ahteensuu.pdf [https://perma.cc/QP4V-HJNJ].

100 See Griel, Arthur L., Infertility and Psychological Distress: A Critical Review of the Literature, 45 Soc. Sci. & Med. 1679, 1694 (1997)Google Scholar; Wang, Jeff & Sauer, Mark V., In Vitro Fertilization (IVF): A Review of 3 Decades of Clinical Innovation and Technological Advancement, 2 Therapeutics & Clinical Risk Mgmt. 355, 355 (2006)CrossRefGoogle ScholarPubMed.

101 See Kumar Deka, Prasanta & Sarma, Swarnali, Psychological Aspects of Infertility, 3 Brit. J. Med. Prac. 32, 32-33 (2010)Google Scholar; Verhaak, C.M. et al., A Longitudinal, Prospective Study on Emotional Adjustment Before, During and After Consecutive Fertility Treatment Cycles, 20 Hum. Reprod. 2253, 2253-54, 2257 (2005)CrossRefGoogle ScholarPubMed.

102 See generally Vulliemoz, N.R. & Kurinczuk, J., In Vitro Fertilisation: Perinatal Risks and Early Childhood Outcomes, 15 Hum. Fertility 62 (2012)Google ScholarPubMed.

103 Am. Soc'y for Reprod. Med., In Vitro Fertilization (IVF): What Are the Risks? (2014), https://www.reproductivefacts.org/globalassets/rf/news-and-publications/bookletsfact-sheets/english-fact-sheets-and-info-booklets/in_vitro_fertilization_ivf_what_are_the_risks_factsheet.pdf [https://perma.cc/TM7S-28QU].

104 Peter Henriksson et al., Incidence of Pulmonary and Venous Thromboembolism in Pregnancies After In Vitro Fertilization: Cross Sectional Study, Brit. Med. J., Jan. 15, 2013, at 1, 3.

105 de Melo-Martin, Inmaculada, Ethics and Uncertainty: In Vitro Fertilization and Risks to Women's Health, 9 Risk: Health, Safety & Env't 201, 207-08 (1998)Google Scholar; Carrie L. Williams et al., Risks of Ovarian, Breast, and Corpus Uteri Cancer in Women Treated with Assisted Reproductive Technology in Great Britain, 1991-2010: Data Linkage Study Including 2.2 Million Person Years of Observation, Brit. Med. J., July 18, 2018, at 1, 8.

106 de Melo-Martin, supra note 106, at 208.

107 Am. Soc'y for Reprod. Med., supra note 104

108 Id.

109 Inst. of Med. & Nat'l Res. Council, Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report 32 (Linda Giudice et al. eds., 2007).

110 Id. at 34.

111 Id. at 36-37; Jain, Divya et al., Anaesthesia for In Vitro Fertilisation, 53 Indian J. Anaesthesia 408, 408 (2009)Google ScholarPubMed.

112 Dolmans, Marie-Madeleine et al., A Review of 15 Years of Ovarian Tissue Bank Activities, 30 J. Assisted Reprod. & Genetics 305, 310 (2013)CrossRefGoogle ScholarPubMed.

113 Imbert, T. et al., Safety and Usefulness of Cryopreservation of Ovarian Tissue to Preserve Fertility: A 12-Year Retrospective Analysis, 29 Hum. Reprod. 1931, 1938 (2014)CrossRefGoogle ScholarPubMed.

114 Id. at 1934.

115 Embarrassing Questions, Tex. Fertility Ctr., https://txfertility.com/patient-resources/embarrassing-questions [https://perma.cc/SQ5Y-3GSW].

116 de Melo-Martin, supra note 106, at 209.

117 Id.

118 See Sara Manti & Amelia Licari, How to Obtain Informed Consent for Research, 14 Breathe 145, 145 (2018); Informed Consent, AMA, https://www.ama-assn.org/delivering-care/informed-consent [https://perma.cc/79KX-2R5R].

119 See Voigt, Kristin, Paternalism and Equality, in New Perspectives in Paternalism and Health Care 87, 87 (Thomas Schramme ed., 2015)CrossRefGoogle Scholar.

120 See Nana Matoba, What Should IVF Practitioners Disclose to Expectant Patients?, Sci. Am. (Jan. 10, 2018), https://blogs.scientificamerican.com/observations/what-should-ivf-practitioners-disclose-to-expectant-parents/ [https://perma.cc/6V6T-PU46].

121 Jennifer L. Marino, Perinatal Outcomes After Infertility Treatment, Plos One, Jan. 8, 2014, at 1, 8.

122 Gina Kolata, Picture Emerging on Genetic Risks of IVF, N.Y. Times (Feb. 16, 2009), http://www.nytimes.com/2009/02/17/health/17ivf.html.

123 Sandin, Sven et al., Autism and Mental Retardation Among Offspring Born After In Vitro Fertilization, 310 JAMA 75, 83 (2013)Google ScholarPubMed.

124 Id.

125 Hansen, Michèle et al., The Risk of Major Birth Defects After Intracytoplasmic Sperm Injection and In Vitro Fertilization, 346 New Eng. J. Med. 725, 727 (2002)CrossRefGoogle ScholarPubMed.

126 Id. at 729.

127 See, e.g., Special Protections for Children as Research Subjects, U.S. Dep't of Health & Hum. Servs., https://www.hhs.gov/ohrp/regulations-and-policy/guidance/special-protections-for-children/index.html [https://perma.cc/P349-65Z2].

128 Lydia Ramsey, What 3-Parent Babies Mean for the Future of Reproductive Medicine, Popular Sci. (Feb. 10, 2015), http://www.popsci.com/uk-one-step-closer-using-dna-3-people-make-babies [https://perma.cc/4ZBG-X9LE].

129 See generally Dresser, Rebecca, First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless, 37 J. of L., Med. & Ethics 38 (2009)CrossRefGoogle ScholarPubMed (Explaining some of the ethical concerns with first-in-human research).

130 See, e.g., Sally Howard, Fear and Infertility Research, The BMJ, Feb. 1, 2018, at 1, 1 (detailing a controversial, experimental cytoplasm replacement treatment that was abandoned when the FDA required the developers to apply for an investigational new drug application).

131 U.S. Food & Drug Admin., Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND (2013).

132 What Does FDA Regulate?, U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm [https://perma.cc/VA4C-J7C6].

133 Id.

134 What is the Approval Process for a Biological Product?, U.S. Food & Drug Admin., http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194562.htm [http://wayback.archive-it.org/7993/20171114204644/ https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194562.htm] [hereinafter Approval Process]

135 What Does FDA Regulate?,, supra note 132.

136 Approval Process, supra note 134.

137 Id.

138 Edwards, Sarah, Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside, 13 Am. J. Bioethics 3, 4 (2013)CrossRefGoogle Scholar.

139 Id.

140 Id. at 4-5

141 Id. at 4.

142 Clinical Trials, Stan. U. Res. Compliance Off., https://researchcompliance.stanford.edu/hs/new/resources/participants/clinical_trials.html [https://perma.cc/8DWU-QZ6C]; Id.

143 Step 3: Clinical Research, U.S. Food & Drug Admin., http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm [https://perma.cc/MQ3U-J3HH].

144 Learn About Clinical Studies, Nat'l Inst. of Health, U.S. Nat'l Libr. of Med., https://www.clinicaltrials.gov/ct2/about-studies/learn#ObservationalStudies [https://perma.cc/Y6PF-J27G].

145 See Garattini, Silvio et al., Placebo or Active Control? Either, as Long as it is in the Patient's Interest, 17 WHO Drug Info. 253, 253-54Google Scholar

146 See Jim Hughes, Univ. of Wash., Dep't. of Biostatistics, Cluster Randomized Trials and the Stepped Wedge Design 11-12 (Jan. 26, 2005), http://faculty.washington.edu/peterg/Vaccine2006/lectures/JimHughesSteppedWedgeslides.pdf [https://perma.cc/QX3N-RY3R].

147 Markus MacGill, What is a Randomized Controlled trial in Medical Rresearch?, Med. News Today, https://www.medicalnewstoday.com/articles/280574.php [https://perma.cc/ZY3A-ZXFF].

148 OvaScience, supra note 82, at 43.

149 Eur. Soc'y of Human Reprod. & Embryology, supra note 4.

150 OvaScience, supra note 82, at 93

151 Id. at 47.

152 Id.

153 See Ramsey, supra note 127.

154 See Bracken, Michael B., Why Animal Studies Are Often Poor Predictors of Human Reactions to Exposure, 101 J. Royal Soc'y Med. 120, 120 (2008)Google Scholar.

155 Mitalipov, Shoukhrat & Wolf, Don P., Clinical and Ethical Implications of Mitochondrial Gene Transfer, 25 Trends Endocrinology & Metabolism 5, 5-6 (2014)CrossRefGoogle ScholarPubMed.

156 Judy Norsigian & Miriam Zoll, Big Business in Babies: First IVF Company Now Being Traded on the Stock Market, Ctr. for Genetics & Soc'y (Aug. 6, 2013), https://www.geneticsandsociety.org/biopolitical-times/big-business-babies-first-ivf-company-now-being-traded-stock-market?id=7074 [https://perma.cc/7QXJ-VYKY].

157 OvaScience Reveals Plans to Go Public, FierceBiotech, (Aug. 30, 2012, 12:18 PM), http://www.fiercebiotech.com/story/ovascience-reveals-plans-go-public/2012-08-30 [https://perma.cc/26QY-9TWZ].

158 OvaScience Grabs $37 M B Round for Fertility Treatments, FierceBiotech, (April 3, 2012, 5:21 PM), http://www.fiercebiotech.com/story/ovascience-grabs-37m-b-round-fertility-treatments/2012-04-03 [https://perma.cc/HDG9-AUQV].

159 John Carroll, OvaScience Shares Blitzed After FDA Steps in to Supervise Lead Product, FierceBiotech (Sept. 11, 2013, 8:11 AM), http://www.fiercebiotech.com/regulartory/ovascience-shares-blitzed-after-fda-steps-to-supervise-lead-product/2013-09-11 [https://perma.cc/N5TG-GA3A].

160 Stacy Lawrence, OvaScience Off by More than 50% As It Says It Won't Meet 2015 Fertility Treatment Goal, FierceBiotech, https://www.fiercebiotech.com/medical-devices/ovascience-off-by-more-than-50-as-it-says-it-won-t-meet-2015-fertility-treatment [https://perma.cc/MVC7-TTZV].

161 Ratner, 134 F.Supp.3d at 623-24.

162 Id. at 633.

163 OvaScience Inc, Nasdaq.

164 See Victor Katch, Industry Funding: Pros and Cons, Mich. Today (Jan. 18, 2016) http://michigantoday.umich.edu/industry-funding-pros-cons/ [https://perma.cc/8CSX-DXPY]; Private Funding for Science, Nature Methods (June 29, 2016), https://www.nature.com/articles/nmeth.3923#article-info [https://perma.cc/ELP7-TH86].

165 15 U.S.C. § 78d (2012).

166 12 U.S.C. § 5511 (2012).

167 Olga Oksman, Drug Companies May Not be Able to Justify the Cost of Medicines, Gizmodo (Oct. 5, 2015, 10:00 AM), http://gizmodo.com/drug-companies-may-not-be-able-to-justify-the-cost-of-m-1733610990 [https://perma.cc/9QDF-CB6M].

168 CBC News, supra note 1.

169 See Eur. Soc'y of Human Reprod. & Embryology, supra note 4 (finding a 41percent live birth rate in mitochondrial transfer patients and a 39 percent live birth rate in the control group).

170 Sonya Norris & Marlisa Tiedemann, Parliamentary Info. & Research Serv., No. 2011-82-E, Legal Status at the Federal Level of Assisted Human Reproduction in Canada i (2011).

171 See Human Fertilisation & Embryology Act 2008, c. 22, § 26 (Eng.); See also About Us, Hum. Fertilisation & Embryology Authority, https://www.hfea.gov.uk/about-us/ [https://perma.cc/U3B6-MBUV].

172 Alex Keown, Beleaguered OvaScience is Absorbed in Reverse Merger by Michigan-based Millendo Therapeutics (Aug. 09, 2018), https://www.biospace.com/article/beleaguered-ovascience-is-absorbed-in-reverse-merger-by-michigan-based-millendo-therapeutics-/ [needs perma cc]