Comments of Enola G. Aird for Mothers for a Human Future
Before the February 25-26, 2014 Meeting
of the Cellular, Tissue, and Gene Therapies Advisory Committee of the United States Food and Drug Administration

Good afternoon. My name is Enola Aird and I represent Mothers for a Human Future, a nonprofit initiative working to promote mothers’ awareness, advocacy, and activism on biotechnologies that could alter the human species. We have no financial conflicts of interest. I thank you for this opportunity to share our views. We very much appreciate efforts to help people with health challenges, but we are deeply concerned about the future for children--should mitochondrial manipulation procedures be approved.

These procedures are forms of human germline modification that would engineer the makeup of future children. These procedures are inherently unsafe. The FDA briefing document speaks to the many known and unknown risks that would be imposed on any resulting children--and their descendants. It is simply too early to know the long-term effects of these manipulations on animals-- let alone human beings.

These procedures would also involve an unprecedented level of experimentation on non-consenting human subjects -- in this case--future generations. You are talking about bringing into existence children whose genes would have been irreversibly changed using high-risk experimental techniques when neither they nor their descendants --whose genes would also have been irreversibly changed--would have been able to give their consent. This raises such grave safety concerns that it--alone--should be sufficient reason not to allow human clinical trials.

Allowing these procedures could also open the door to further germ-line manipulations, to the creation of genetically modified children, and a perversion of the relationship between parents and children--that would treat children more like “objects of design” and “manufactured products”--than human beings with feelings and emotions. Allowing the creation of children with genetic material from three or more parents could open the door to the alteration of the human species and the creation of different biological--Gattaca-like--classes of human beings--and the dissolution of our common humanity.

Because germline modifications could lead to biotechnological eugenics and the alteration of the human species, over 40 countries have adopted policies prohibiting its use. A decision to allow any use of germline modification is of profound consequence to the entire human community-- and should not be made unilaterally by this Committee, the FDA, or any one country. Mitochondrial manipulation technologies raise issues of profound significance to all human beings, but there is little public awareness or debate about them. There is a pressing need to maintain the existing worldwide moratorium on the use of any form of germline modification to allow for broad-based international public education, conversation, and decision-making on the appropriate global regulatory framework to promote responsible uses of these and other biotechnologies that could alter the human species.

Hopefully, this Committee and the FDA will be leaders in the effort to educate and engage the public in the decision-making on this crucial issue. With all due respect, decisions about these technologies are much too important to be left solely to the people in this room.

I urge this Committee and the FDA to consider the moral, ethical, legal, societal, and international implications of its actions--and to say “no,” an emphatic “no”-- to human clinical trials of “mitochondrial manipulation technologies.” It would be irresponsible, at this juncture, to do otherwise.