The Roundtable
Welcome to the Roundtable, a forum for incisive commentary and analysis
on cases and developments in law and the legal system.
on cases and developments in law and the legal system.
By Shiven Sharma Shiven Sharma is a senior at the University of Pennsylvania studying Biology with a minor in French Studies. Mitochondrial replacement therapy (MRT) is a revolutionary in vitro fertilisation (IVF) medical technique whereby the defective mitochondrial DNA of a fetus’ cells are replaced by normal, third-party mitochondrial DNA. This is done to prevent mitochondrial disease, a genetic disorder resulting in the loss of bodily energy. Prior to the creation of this prenatal therapy, scientists focused on postnatal treatment options, exploring drug screens using model organisms with a similar mitochondrial genome to find a cure. This proved very difficult since mitochondrial disease arises from a mutation that is irreversible. Thus, the discovery of MRTa—a preventative measure—has proved very beneficial. Under the umbrella of this technique are maternal spindle transfer (MST), maternal genome transfer (MGT), oocyte spindle transfer (OST), and pronuclear transfer (PNT), none of which can be legally undertaken in the USA [1]. The purpose of this article is therefore to explore why MRT is illegal in the USA and to hopefully provide enough information to spark a critical discussion.
MST, MGT, and OST all involve removing the nucleus of an egg with mutated mitochondria and transplanting the nucleus into an enucleated donor egg containing healthy mitochondria. PNT is an “embryo repair” technique in which two embryos are created via IVF [2]. In the UK, PNT has been approved by their national ethics committee and parliament, but not without difficulty because the process does involve the killing of a living human embryo. This is one of the major reasons why human trials in the USA have not been undertaken and why PNT has not been given the opportunity to be approved here [3]. Nonetheless, this is not the most controversial aspect of MRT, since MST, MGT, and OST do not inherently result in death. The real debate stems from the opinions of some experts who consider MRT to be a form of genetic modification. The procedure invariably changes the germline—the heritable characteristics between generations—and it is not really known whether the procedures could cause ailments later on in the child’s life [4]. Employing this line of reasoning, there is a U.S. ban which originates from a bill passed by Congress in December 2015 and contains a section that prohibits the Food and Drug Administration (FDA) from allowing human trials in “in which a human embryo is intentionally created or modified to include a heritable genetic modification” [5]. Just recently, however, the issue has come up again as patient advocates and scientists are trying to lift the ban. In April 2019, a Greek woman who had experienced multiple in vitro fertilization failures gave birth to a healthy baby with DNA from three biological parents using MRT, combining the DNA from the mother, father, and a female donor [6]. As a result of this international recognition of MRT’s merit, many countries—such as Greece and China—have allowed such procedures to take place. This would allow many Americans to seek help out-of-country, but not without negative consequences. Some of the doctors within these countries procure their donor DNA without proper sterilization procedures and in doing so risk the health of both the fetus and the mother. This is what is driving the push for the US to lift the ban; such “transplant tourism” may have irreversible results that would only exacerbate the situation [7]. We have already scene the backlash from organ transplant surgeries that take place overseas, especially from kidney transplants in China. For many hopeful mothers with mitochondrial disease, desperate times calls for desperate measures, which may lead to a heightened risk of infection and possibly even death due to inadequate medical procedures. Accordingly, the USA needs to weigh the benefits against the costs. It is well known that this therapy enables women with mitochondrial disease to produce healthy children of their own. The supposed genetic modification from the substitution is very minimal and does not lead to much change in the child’s morphology. The priority of any medical issue will always be to prevent harm as much as possible; if the ban is not lifted, there will be lives at risk since eager women will undoubtedly be traveling in hopes of returning as mothers. Consequently, our government should lift the ban against MRT and thereby take the stance that it is unethical to refuse a mother the opportunity to reproduce and bring a healthy baby of her own into the world. The opinions and views expressed in this publication are the opinions of the designated authors and do not reflect the opinions or views of the Penn Undergraduate Law Journal, our staff, or our clients. Citation: [1] Pompei, M. & Pompei, F. “ Overcoming bioethical, legal, and hereditary barriers to mitochondrial replacement therapy in the USA.” December 15, 2018. https://link.springer.com/article/10.1007/s10815-018-1370-7. (Accessed October 12, 2019). [2] Pompei, M. & Pompei, F. “ Overcoming bioethical, legal, and hereditary barriers to mitochondrial replacement therapy in the USA.” December 15, 2018. https://link.springer.com/article/10.1007/s10815-018-1370-7. (Accessed October 12, 2019). [3] Asashi, E.Y. & Cohen, I.G. “Preventing Mitochondrial Diseases: Embryo-Sparing Donor-Independent Options.” March 28, 2018. https://www.cell.com/trends/molecular-medicine/fulltext/S1471-4914(18)30048-0. (Accessed October 10, 2019). [4] Mullin, E. “Despite Calls for a Moratorium, More ‘Three-Parent’ Babies Expected Soon.” September 16, 2019. https://onezero.medium.com/despite-calls-for-a-moratorium-more-three-parent-babies-expected-soon-8a2464165423. (Accessed October 11, 2019). [5] National Academies of Sciences, Engineering, and Medicine; National Academy of Medicine; National Academy of Sciences; Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations. “Human Genome Editing: Science, Ethics, and Governance.” February 14, 2017. https://www.ncbi.nlm.nih.gov/books/NBK447260/. (Accessed October 12, 2019). [6] Mullin, E. “Patient advocates and scientists launch push to lift ban on ‘three-parent IVF’” September 16, 2019. https://www.statnews.com/2019/04/16/mitochondrial-replacement-three-parent-ivf-ban/. (Accessed October 12, 2019). [7] Pompei, M. & Pompei, F. “ Overcoming bioethical, legal, and hereditary barriers to mitochondrial replacement therapy in the USA.” December 15, 2018. https://link.springer.com/article/10.1007/s10815-018-1370-7. (Accessed October 12, 2019).
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