I am writing concerning the Food and Drug Administration’s (FDA) October 22-23, 2013, meeting of the Cellular, Tissue and Gene Therapies Committee on “oocyte modification in assisted reproduction for the prevention of mitochondrial disease or treatment of infertility.”
I am the founder and director of Mothers for a Human Future, a nonprofit initiative focused on promoting awareness, advocacy, and activism about human biotechnologies that could alter the human species. We are working to preserve our humanity in the face of technologies that are pushing us toward what has been called the “post human” future.
It is our understanding that the FDA meeting will consider whether or not to allow human clinical trials of mitochondrial replacement techniques (MRT). MRT raises serious unresolved questions of safety and efficacy, as well as profound ethical, social, and legal concerns. Because pre-implantation genetic diagnosis (PGD) offers a safer, less extreme alternative to MRT, we urge the FDA to reject the request now before it.
MRT is designed to help a small number of women affected by a rare form of mitochondrial disease to have biologically-related children who are unaffected by the disease. As a mothers’ organization, we certainly understand and empathize with women whose desire is to have healthy children. We are also deeply concerned, however, about the use of MRT, a biologically extreme procedure, to achieve this goal.
MRT would work by inserting the nucleus of an egg of a woman who has unhealthy mitochondria into an enucleated egg (with healthy mitochondria) from another woman. This constructed egg would then be fertilized with sperm and the result would be a genetically modified “three-parent” baby.
MRT is a form of human inheritable genetic modification (IGM), which manipulates genes to try to determine the traits of future children. The technique is more like cloning than it is like in vitro fertilization. There are complex interactions between nuclear and mitochondrial DNA that are not yet fully understood. Mixing and matching DNA seems an extremely dangerous thing to do. The only research group that has used MRT to produce live primates, the Oregon Health and Science University, has created four macaque monkeys who are only three years old. There are therefore no studies of the effects of this technique on subsequent generations. In addition, human zygotes created using the University’s technique developed abnormalities that were not observed in the macaques, suggesting that human eggs are more sensitive to manipulations than the eggs of monkeys. Any mistakes made would not be limited to the children whose genes had been modified. They would be passed on to all descendants of the girls in which the genetic alterations had been made–possibly introducing new genetic diseases into the human population.
Authorizing MRT could also open the door to the use of IGM to create genetically modified “designer babies.” We cannot know all the consequences that could flow from the use of IGM. But among the concerns that have been raised are:
1. as researchers try out these new untested technologies, there would be an unprecedented level of unsafe, unethical experimentation on children yet to be born and their descendants, who would be unable to give consent to these techniques;
2. the use of these techniques could usher in an era of consumer eugenics in which parents pursue their own personalized visions of the “perfect” children;
3. children could come to be treated more like “objects” and manufactured products than human beings with feelings; and
4. if some children have genetic material from two parents, as has been the case up until now, and other children have genetic material from three or perhaps more parents, we would be creating different genetic classes of human beings–leading to what has been called a “post human” future, and the dissolution of our common humanity.
For these and other reasons, there has been a long-standing international consensus that biotechnologies are to be used–with appropriate safeguards–to treat medical diseases, but are not to be used to manipulate the traits of future children. IGM is prohibited by the Charter of Fundamental Rights of the European Union, the Council of Europe’s Oviedo Convention on Biomedicine and Human Rights, the United Nations Education, Scientific, and Cultural Organization’s Universal Declaration on the Human Genome and Human Rights, and other instruments of international law. Because it could fundamentally alter the human species, no one country or regulatory authority should unilaterally violate the international consensus against the use of IGM.
Mothers for a Human Future has been working to raise the level of public awareness about potentially consequential new human biotechnologies such as “oocyte modification,” among mothers, fathers, and advocates for children in the United States and Europe, and I can attest that there is a striking lack of public knowledge about these technologies and their implications. They raise issues of profound significance to all human beings, but there is relatively little public awareness, dialogue, or debate about them. There is a pressing need for a worldwide moratorium on the use of any and all forms of IGM to allow for international public education, conversation, and decision-making on the appropriate global regulatory framework for IGM and other biotechnologies that could alter the human species.
Accordingly, we urge the FDA not to allow MRT to be used in human clinical trials.
Please do not hesitate to contact me should you have any further questions about our position on this matter.