Nebraska Coalition for Ethical Research recommends that the FDA deny licensure for the use of mitochondrial techniques in U.S. fertility clinics or research laboratories

Nebraska Coalition for Ethical ResearchAt the end of last month the Board of Directors sent the following letter to the FDA with our position on the use of multi-parent embryos.

27 March 2015

Attn: Michael Berrios
The Committee on Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases
Keck Center
500 Fifth St. NW
Washington, DC 20001

Dear Committee Members:

There are at least five reasons why the Board of Directors of the Nebraska Coalition for Ethical Research recommends that the FDA deny licensure for the use of mitochondrial techniques in U.S. fertility clinics or research laboratories.

• The pronuclear transfer technique of mitochondrial replacement (MR) involves the intentional destruction of human embryos.

With the PNT technique, the first embryo is dismantled or destroyed when its nuclear DNA is removed. The sole purpose of producing the first embryo is for the sake of its nuclear DNA, the nuclear genome that will guarantee the child’s biological relationship to his parents. The sole fate of the first embryo, then, is its destruction through dismantlement. The healthy (second) embryo is only obtained by means of the intentional destruction of the unhealthy (first) zygotic human being. What kind of twisted logic is it that aims to bring life to one human being by deliberately destroying another? Using either the PNT or MST techniques reduces the three-parent embryo to an experiment in genetic modification. In doing that, this crass use of human embryos wields a blow against the dignity and equality of all human beings, born and unborn. In its normative practice, then, the IVF technique of MR is a chosen mode of action by which parents and doctors intentionally deny the child not only his fundamental right to be loved unconditionally, i.e., to be conceived and gestated within his parents’ sexual act of love, but also the child’s basic right to life.

• MR risks endangerment of the human genome.

As Paul Knoepfler, stem cell researcher at the University of California Davis School of Medicine, put it: “[T]he bottom line is that there is an equal or arguably greater chance that [MR] will tragically produce very ill or deceased babies.” And, since MR constitutes germline genetic engineering—genetic modification of the germ cell of the egg or the whole embryo—any or all genetic errors that occur as a result of MR will be inherited, that is passed on through child-bearing females of one generation to the male and female children of the next. The moral tragedy of risking genetic errors is that there is no way for those who use MR today to be accountable to those in future generations harmed by unsuccessful modifications of their predecessors.

• MR, because it has not been adequately studied in animals, is unsafe.

Reputable scientists argue the Achilles heel of doing MR in 2015 is this: It is an attempt to use a technique that involves mtDNA before geneticists have thoroughly studied the mitochondrial genome and before they have sufficiently understood the complex interactions between the mito-genome and the nuclear genome. As Knoepfler argued in his open letter to the UK parliament: “Scientific reality often passed over in this discussion is that while mitochondria have been studied for decades, the field of studying the mitochondrial genome is in its infancy and is far too new to support a major intervention that involves the mitochondrial genome. The interactions between the mitochondrial genome are also only poorly understood today. It would be rash and premature to proceed with human mitochondrial transfer now given how primitive our knowledge is in this area at this time.” Or these reasons, some scientists contend it is irresponsible to pursue MR especially when, given the wide margin for genetic error, mistakes are not reversible.

• MR represents a new form of eugenics.

As Stuart Newman, New York Medical College Professor of Cell Biology and Anatomy, points out: “One factor in placing these MR procedures on the social agenda seems to be the conflation of biological modification of people who do not yet exist with medical treatment of actual sick people. The attempt to improve future people is not medicine, however, but a new form of eugenics. . . . Activities that are clearly covered by the Nuremberg Code prohibiting nonconsensual human experimentation are recast by proponents of gene-altering technologies [such as MR] as within the alleged rights of parents to exert proprietary control over the characteristics of their prospective offspring. It must be emphasized that such hypothetical rights are not at all the same as the inviolable commitment of parents to the health and well-being of their existing children. The genetic design of future offspring, even with the limited objective of making these future children more ‘normal,’ will open the door to attempts to pick and choose other characteristics, because definitions of normality will vary, as will access in technology to take risks with future lives.”

• MR promotion exploits the women who donate their mitochondria.

Women who donate their eggs for IVF techniques such as MR risk adverse health events. Ovarian Hyperstimulation Syndrome is the most immediate and, in the short and long term, memory loss, bone ache, seizures, risk of stroke, organ failure, infection, cancer, and even loss of fertility. Since no agency within the IVF industry is systematically tracking the rate at which any of these health risks occur, the women who donate their eggs are hampered in giving a truly informed consent to the procedure.

Furthermore, many predict the great need for eggs for MR will only lead to increased exploitation of prospective donors. And if, like egg donors in the UK, US donors are offered generous compensation from IVF clinics, they could also become victims of psychological exploitation. How can prospective female donors—especially the economically disadvantaged who are frequently targeted—make prudent medical decisions when the “carrot” of financial reimbursement and healthcare discounts is dangled in front of them?

Thank you for noting our objections in your final consensus statement and in your recommendations to the Food and Drug Administration in respect to the the clinical and research use of mitochondrial replacement techniques in the U.S.

Carol Szczepaniak
Nebraska Coalition for Ethical Research

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