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Remember the three-parent babies I told you about in December?  The ones made with genetic material from two different women?  Well, the United States might be moving a step closer to their creation.

A Food and Drug Administration (FDA) Advisory Committee will hold a public meeting on February 25 and 26 regarding clinical trials of mitochondrial transfer procedures (MT).  I’ve submitted a written statement and received FDA permission to present my arguments at the meeting. I’ll be there to oppose the use of such procedures because they would permanently change the genes passed down to future generations.

A quick reminder of what’s at stake.  The Advisory Committee will consider whether to allow human clinical trials of “oocyte modification in assisted reproduction for the prevention of the transmission of mitochondrial disease or treatment of infertility.” That’s a long way of referring to a form of genetic modification that would alter an embryo’s genetic structure in such a way that the changes would be passed down to all future generations of the same line.

To accomplish this sci-fi sounding task, scientists would employ cloning-like techniques and other procedures to, in effect, “engineer” children by including in their makeup genetic material from more than two biological parents.  The aim, according to researchers, is to help women with certain mitochondrial diseases have genetically related children unaffected by these diseases. That is a laudable goal. But the number of women who would be candidates for these procedures is very small, and there are safer, less biologically radical alternatives.

I’ll be at the meeting not in my capacity as a lawyer but in my role as a mother.  The question of whether to allow human clinical trials of MT techniques raises issues that should be of profound concern to all of us who care about the well-being of children and the human future.

Here are three reasons to forego this kind of experimentation:

    [1] These procedures are inherently unsafe.

Scientists do not know enough about the complicated interactions between different kinds of DNA.  A recent essay in Science, written by evolutionary biologists, called it “premature” to proceed to clinical trials without far more extensive preclinical work, and noted in particular that “results from mice and invertebrates suggest that many deleterious effects of [these procedures] would not be revealed until adulthood.”  And the health risks would be borne not just by the resulting children, but by all future generations as well.

    [2] These procedures would require an unprecedented degree of unethical experimentation on human subjects.

Everyone agrees that it’s wrong to perform experiments on human subjects without their consent.  Think for a minute about what MT would do.  It would bring into existence children whose genes had been irreversibly changed using high-risk experimental techniques, and neither they nor their descendants would have been able to give their consent.   A child born a century from now of the same germ line would still carry the altered genes – and all of the risks that they entail. This level of experimentation on children would be unprecedented in human history.  The process would wind up treating children like consumer products: mere things to be designed, manipulated, controlled, objectified, discarded.

    [3]  These procedures could open the door to biotechnological eugenics.

Scientists have for many years been using biotechnologies to breed what they consider to be “better” plants and animals.  Authorizing MT could open the door to a new brand of eugenics in which parents pursue the project of creating “better” children.  According to cell biologist Stuart Newman, “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…”

In a March 2013 letter to the editor in the London Times, bioethicists from around the world, addressing regulatory actions aimed at authorizing the use of MT in Britain, noted that “because of the implications for all humanity, intentional germ-line interventions are prohibited in every national jurisdiction that has considered the issue.”  They urged “the British government to consider its international responsibilities. This is because persons created through germ-line interventions, which may subsequently be revealed to be detrimental, will be able to travel and have their own children abroad. For the UK to isolate itself from its duties by allowing ‘mitochondrial replacement’ to take place without consulting its international partners would create a very serious precedent.”

The same can be said of the United States.  That’s why I have joined with other advocates to sign a letter asking the FDA not to allow the use of any form of MT. And that’s why I’m going to the FDA meeting: because no country or regulatory authority should take it upon itself to unilaterally violate the international consensus against making inheritable changes in children’s genes.


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