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From Embryo Research to Therapy Bernard Baertschi, Marc Brodin, Christine Dosquet, Pierre Jouannet, Anne-Sophie Lapointe, Jennifer Merchant, Grégoire Moutel

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From Embryo Research to Therapy Bernard Baertschi, Marc Brodin, Christine Dosquet, Pierre Jouannet, Anne-Sophie Lapointe, Jennifer Merchant, Grégoire Moutel From Embryo Research to Therapy Bernard Baertschi, Marc Brodin, Christine Dosquet, Pierre Jouannet, Anne-Sophie Lapointe, Jennifer Merchant, Grégoire Moutel To cite this version: Bernard Baertschi, Marc Brodin, Christine Dosquet, Pierre Jouannet, Anne-Sophie Lapointe, et al.. From Embryo Research to Therapy. 2017. inserm-02946989 HAL Id: inserm-02946989 https://www.hal.inserm.fr/inserm-02946989 Submitted on 23 Sep 2020 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. From Embryo Research to Therapy Inserm Ethics December Committee “Embryo and Developmental 2017 Research” Group Embryo and Developmental Research Group: Bernard Baertschi, Marc Brodin, Christine Dosquet, Pierre Jouannet, Anne-Sophie Lapointe, Jennifer Merchant, Grégoire Moutel A child of one’s own It was Aristotle who said that human beings, like all living beings, have “a natural desire to leave behind them an image of themselves”.1 A desire that he considered to be the natural foundation of the conjugal union – a natural foundation to which many social foundations are, of course, added. While our conception of what is natural has changed considerably since the age of Aristotle, this desire remains visible in our modern societies – with assisted reproductive technology (ART) being evidence of this. The majority of couples want children, children of their own2, meaning that in the event of infertility, many of those affected turn to medicine rather than adoption3 to help them overcome the obstacles thrown in their path by nature – paradoxically opposing a desire that in itself is partially natural. For a long time, ART was limited to artificial insemination, with donor or partner sperm. But with the birth of Louise Brown in 1978, the technology has undergone an extraordinary expansion, considerably opening up the realm of possibilities. In order to develop in vitro fertilization (IVF), research on human embryos was necessary. Research that continues to remain necessary if we are to improve and evaluate these techniques, not just for the benefit of infertile individuals but also that of children. According to a 2016 study conducted on children born using ART, they presented a more or less high risk of developmental disorders at 5 years of age, depending on the culture medium used for the IVF. 4 It is therefore necessary to intensify research in this area for the development of even safer media. 1. Aristote, La Politique, Paris, Vrin, 1970, p. 25. 2. The parents also wish to procreate, with all that it implies in terms of personal investment, including for gestation and delivery. 3. If they do not turn to adoption, it is also for reasons of feasibility. While around 800 children are declared adoptable each year in France, around 25,000 couples or individuals are estimated to be approved, that is to say they have gone through all the relevant processes. 4. Céline Bouillon & al., Does Embryo Culture Medium Influence the Health and Development of Children Born after In Vitro Fertilization?, Plos One, 2016, DOI:10.1371/journal.pone.0150857. 2 Treat not destroy Parents do not just wish to have a child but one in good health. When a couple is known to have a disease of genetic or chromosomal origin, it has since the 1990s been possible to diagnose it in embryos created from its gametes prior to implantation and to avoid transferring affected embryos to the uterus. Therefore, once the serious disease in question is detected in an embryo using pre-implantation genetic diagnosis (PGD), the embryo is not transferred to the uterus. In parallel, and for a long time now, many parents decide to terminate the pregnancy should prenatal diagnosis detect a chromosome abnormality or severe malformation syndrome in the gestating fetus. As far as embryos are concerned, we often refer to “screening”, a term that carries an implicit negative moral evaluation. There are several reasons for this, which are themselves subjects for debate, but one is that the embryo is then discarded: because of some of its characteristics, it is destroyed or donated to research. Indeed, the embryo is not considered a person under French law. Consequently, the French National Consultative Ethics Committee (CCNE) has defined it as a “potential human person” (PHP),5 thereby emphasizing that it is not a person. On a philosophical level, we could say that all French citizens are potential Presidents of the Republic, which means that they are clearly not Presidents of the Republic. However, destroying an embryo that is liable to become a human being is never an optimal solution and can cause suffering for the couple in question. All the more so if the embryos obtained are all affected, which can unfortunately sometimes happen. A better solution would, of course, be to treat or even cure them. A certain number of current studies are heading in this direction, and the benefits they suggest form strong justification for the research performed on embryos that can in some way be said to be for their benefit. This assertion appears paradoxical, given that in order to develop embryo therapies, invasive studies are required in which some lead to the destruction of embryos. But we must not lose sight of the fact that it is for the benefit of other embryos that could lead to the birth of healthy children who, for their part, are people. It must be emphasized here that treating an embryo does not make it a person: all living beings are liable to receive treatment, but few living beings are people. Furthermore, the fact that the embryo is a particularly vulnerable living being does not make it a person either, although as a potential person it requires solicitude and respect.6 In this way, research on embryos can benefit the embryos themselves, directly and indirectly.7 It indirectly benefits future embryos and it directly benefits the embryo itself when 5. CCNE, Opinion on sampling of dead human embryonic and fetal tissue for therapeutic, diagnostic, and scientific purposes (Opinion no. 1), May 22, 1984. 6. To the question asked by Pierre Jouannet: “Does comparing a days-old embryo to a patient imply that it is a person? “ (L’embryon sujet: patient d’une médecine de l’embryon ? L’embryon objet: quelle recherche et pour qui ?, in Pierre Jouannet and Catherine Paley-Vincent, L’embryon, le fœtus et l’enfant, Paris, Eska, 2009, p. 78), the answer, of course, is no. “Being a patient” does not imply “being a person”. 7. Pierre Jouannet, ibid., p. 83. 3 it can be subsequently transferred to the uterus for gestation as provided for by law since 2016 (French Public Health Code, L 2151-5), which was confirmed by the French Constitutional Council considering that these clinical trials do not lead to the embryo being placed at a risk out of proportion to the expected benefit.8 Several therapeutic approaches in favor of the embryo are currently in development and are subject to much research. At least two of them have already been used in the clinical setting with the aim of bringing a child into the world – namely mitochondrial replacement therapy and treatment of triploidy, which are the subject of this document. Before examining them in more detail, it must be noted that four scenarios must in general be distinguished: 1. Embryo screening, when it is decided to not transfer an embryo and to destroy it because it is considered abnormal (for example, it is triploid) or unsuitable for development (for example, it has morphological abnormalities). Screening is also performed when, in an embryonic cohort, it is chosen to transfer some embryos rather than others, because their characteristics offer better chances of pregnancy. 2. Embryo destruction, which primarily concerns embryos with diseases, and sometimes also normal embryos to fulfill the decision of people not wishing to continue to store frozen embryos as part of a parental project. 3. Embryo treatment, which concerns embryos with treatable diseases. 4. Embryo reconstitution from multiple embryo sources. Restoration of diploidy is an actual treatment (3), whereas mitochondrial replacement therapy still involves the reconstitution of an embryo (4).9 One question that immediately arises when it comes to treating embryos is whether germline gene therapy is involved. Given that the latter is forbidden and that these two approaches have already been used, it is evident that it had not been judged in this way. This is because they do not involve modifying the structure of the genes themselves, whether at nuclear (nuclear genes) or mitochondrial level, but this could be contested if, like certain authors, we consider that “the goal of germ-line gene therapy [consists of introducing] transgenic cells into the germ line as well as into the somatic cell population. Not only should this therapy achieve a cure of the person treated, but some gametes could also carry the corrected genotype”.10 8. The French Constitutional Council considers that “subjecting to clinical trials techniques in development that are intended to improve the efficacy of ART methods or to prevent or treat embryo diseases” is necessary and “that these clinical trials, conducted for the benefit of the embryo itself or for ART research, do not lead to the embryo being placed at a risk out of proportion to the expected benefit” (Constitutional Council decision no. 2015-727, DC of January 21, 2016).
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