Urgent: Tell the FDA to Prohibit Three-Parent Embryo Technique

Bioethics   |   Rebecca Taylor   |   Feb 17, 2014   |   10:53AM   |   Washington, DC

On February 25th and 26th, the Food and Drug Administration (FDA) will be having a meeting to discuss allowing the technique that creates embryos with three genetic parents to proceed to clinical trials. The “three-parent” embryo technique is also called mitochondrial replacement, maternal spindle transfer, or oocyte modification.

In an effort to “treat” mitochondrial disease, this technique would intentionally modify IVF embryos to have the genetic material from three persons. This modification is also one that will extend beyond the children produced and will be passed onto future generations. (Click here to learn more about “three-parent” embryos.)

threeparent2Over 40 countries have banned such inheritable genetic modifications. Regrettably, the United States has no such laws and it is up the FDA to regulate the practice. They are currently taking written opinions on the subject, but only until this Tuesday, February 18th.  The FDA needs to hear from the public on this issue.

This is a pivotal point in human history. Will we allow the intentional genetic modification of our children and grandchildren? I do not believe I am exaggerating when I say the future of our species depends on how we answer that question.

Please tell the FDA what you think. The contact information given on the advisory panel web page is Gail Dapolito, Fax 301-827-0294, e-mail: gail.dapolito[at]fda.hhs.gov or Rosanna Harvey, Fax 301-827-0294, e-mail: rosanna.harve[at]fda.hhs.gov

Here is the letter I wrote to the committee. Please feel free to use any or all of it.

FDA Cellular, Tissue and Gene Therapies Advisory Committee:

As a concerned citizen of the United States, I urge you to reject attempts to allow oocyte modification, also called mitochondrial replacement or maternal spindle transfer, to advance to clinical trials.

I understand the desire for parents to have genetically-related children, but at some point we must be responsible and limit parental desires, favoring instead the health and well-being of the next generation. Mitochondrial replacement is the intentional modification of children to have the genetic material from three persons. It would also create a germ-line modification; one that would be passed on to future generations.

Many other technically-advanced countries have banned germ-line modifications for good reason. The line that prevents the experimentation on the next generation, and every generation after, without their consent should never be crossed. There are likely many medical advances we could have if we treated human subjects unethically. I believe mitochondrial replacement falls into that category.

Any girl that is conceived with this technique could not help but pass this modification onto her offspring. If there are any deleterious effects, which have been noted in animal studies, she would be placed in the very same position as her mother, struggling with a desire to have genetically-related children, but wary of passing on her modification. The difference is that she would know she was the product of germ-line experimentation sanctioned by the FDA.

Time has proven that the slippery slope in reproductive medicine is very real. IVF, a technique originally designed to help infertile couples conceive, has expanded to a billion dollar industry catering to the desires of the fertile as well, with a menu of choices including sex selection. If you allow mitochondrial replacement to proceed to the clinic, it will only be a matter of time before modifications to nuclear DNA will be attempted. With the lack of federal laws regulating the fertility industry, in a few decades, a similar menu of genetic modifications, no doubt, will be available to prospective parents.



Please keep the focus of mitochondrial disease research on treating patients and not on germ-line genetic engineering. As Americans become more wary of genetically modified organisms in their food supply, understanding that such modifications have unintended and possibly unhealthy side effects, it would be unthinkable to move forward with the genetic modification of our children and grandchildren.

Alternatively, the Center for Genetics and Society has a letter you can sign. They suggest embryo screening as a “safer” alternative which pro-lifers cannot agree with, but overall the content of the letter is excellent. The Center for Genetics and Society is a left-leaning organization. It is important that the FDA hear from all points on the political spectrum. This is one issue that both the left and right can agree on.