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

Author:

Lee Katarina

Abstract

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

Publisher

Cambridge University Press (CUP)

Subject

Law,General Medicine,Health(social science)

Reference23 articles.

1. Cosmopolitan Conceptions in Global Dubai? The Emiratization of IVF and Its Consequences;Inhorn;Reprod. BioMedicine and Soc'y Online,2016

2. The Risk of Major Birth Defects after Intracytoplasmic Sperm Injection and in Vitro Fertilization

3. Mitochondrial DNA mutations in human disease

4. Clinical and ethical implications of mitochondrial gene transfer

5. Psychological Aspects of Infertility;Kumar Deka;Brit. J. Med. Prac.,2010

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