• Our sample letters to the FDA re: three-parent babies.

    Posted on October 14, 2013 by Editor in News.

    Below are two sample letters to the FDA. Please adapt these to your own style and personalize your comments as you see fit. Comments are due by Tuesday, October 15, 2013.

    Email your letter to Bryan Emery at the FDA: bryan.emery@fda.hhs.gov
    Thank you,
    Mothers for a Human Future
    Sample #1
    Dear Mr. Emery:
    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.”
    As I understand it, this meeting will consider possible human clinical trials of mitochondrial replacement techniques (MRT), which would involve combining DNA from three biological parents. This issue raises many serious questions and concerns which have not yet been adequately addressed and which must be resolved before any decision is made. I am therefore writing to ask that the FDA reject the request now before it.
    MRT is designed to help women affected by a rare form of mitochondrial disease to have biologically related children who do not have the disease. As a mother, I very much empathize with the plight of women who are affected by mitochondrial diseases. I am, however, also deeply concerned about the safety of these techniques.
    MRT is a form of human inheritable genetic modification (IGM), which manipulates genes to try to determine the characteristics of future children; this seems extremely dangerous to me. The Oregon Health and Science University, the only research group that has used MRT to produce live primate babies, has created four macaque monkeys. They are only three years old, so there are no studies of the effects on subsequent generations. When the Oregon group used its technique to create human zygotes, they found that the human zygotes developed abnormalities that were not observed in the macaques. This suggests that human eggs are more sensitive to manipulations than the eggs of monkeys. And what if mistakes are made? They 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.
    I am equally concerned that MRT could open the door to the creation of genetically modified designer babies–and a new kind of eugenics. Going down that road could fundamentally alter the human species by creating different classes of human beings. 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, and the policies of over 40 countries. I don’t think that any one country or regulatory authority should unilaterally violate this international consensus.
    This is an issue of great significance to the whole human community, but there is relatively little public awareness, dialogue, or debate about it. In my opinion, the FDA should not allow MRT to be used in human clinical trials. We should maintain existing prohibitions on the use of any and all forms of IGM.
    Sincerely,
    Your Name. Add address or state.
    Sample # 2
    Dear Mr. Emery:
    I am the mother of _(please indicate how many)___ children. I live in _________. 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.”
    As I understand it, this meeting will consider possible human clinical trials of mitochondrial replacement techniques (MRT), which would involve combining DNA from three biological parents. This seems extremely dangerous to me. As a mother I am concerned about the many serious questions raised by this technology which have not yet been adequately addressed and which must be resolved before any decision is made. I am therefore writing to ask that the FDA reject the request now before it.
    As a mother, I very much empathize with the plight of women who are affected by mitochondrial diseases. I am, however, also deeply concerned about the safety of these techniques. In my opinion, the FDA should not allow MRT to be used in human clinical trials.
    Sincerely,
    Your Name. Add address or state
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