Public Comment before the FDA Cellular, Tissue, and Gene Therapies Advisory Committee, 25 February 2014

February 25, 2014 • Posted in Blog

Good afternoon, Members of the Advisory Committee, Ladies and Gentlemen.

I am Dr. D. Joy Riley, the executive director of The Tennessee Center for Bioethics & Culture, an educational not-for-profit organization headquartered in Nashville, TN, dedicated to promoting human dignity in the face of challenges to what it means to be human, and to informing and equipping people to face the vital bioethics issues of the 21st Century.

I am a physician by training, and hold a graduate degree in bioethics as well. I appreciate the opportunity to speak to you today.  I have no conflicts of interest to report.

It is remarkable to note that while more than 40 nations have prohibited germline modification,  we are contemplating stepping over that bright line. It is imperative that we reflect upon the words of philosopher George Santayana, who presciently wrote, “Those who cannot remember the past are condemned to repeat it.”  This applies in several ways.

First of all, consider that this change is being evaluated by the “Cellular, Tissue, and Gene Therapies” Advisory Committee of the FDA. While this is your purview, it is not merely cells, tissues, or genes which are being affected by this decision. No, it is human beings – human beings at their earliest stages – who are the subjects of this research. These are your and my children, grandchildren, nieces, nephews, and cousins being considered here today. Their Petri dish appearance should not confuse us. They are very much human.

We as a nation do not have a good track record recognizing who qualifies as human beings. In fact, in our early years, we counted some adult men and women — of African descent — as less than whole persons; specifically, as 3/5 persons. The 14th Constitutional Amendment was a remedy. “Those who cannot remember the past are condemned to repeat it.”

Secondly, consider codes of international standing:

1) The Declaration of Geneva proclaimed for physicians world-wide, “The health of my patient will be my first consideration,”

2)  The Declaration of Helsinki stated, “In medical research involving human subjects, the well-being of the individual research subject

must take precedence over all other interests.”

Both of these declarations were lessons learned from WWII, in reaction to the human experimentation atrocities uncovered by the Nuremberg Trials and at Unit 731, a prison/experimentation camp conducted by the Imperial Japanese Army.

In the Council of Europe’s Convention on Biomedicine and Human Rights, intervention on the human genome is countenanced “only if its aim is not to introduce any modification in the genome of any descendants.”

Those who cannot remember the past are condemned to repeat it.”

Finally, a major requirement of research on human subjects is that of fully informed consent by the human being whose life, health and posterity will be impacted by the proposed human experiment. How does informed consent work in the research considered today? The women and men from whom the eggs and sperm originate ostensibly would be persons with capacity and able to consent to their gametes being procured. Egg harvesting is not without risk, but we need to understand that the persons who bear the weight of the experimental risk in this proposal are not the women and men giving consent. The humans who bear the weight of experimental risk are not even being treated. No: this is not therapy for the ones undergoing experimentation. Their very formation is the experiment under consideration here. They are not able to give consent; neither are all their descendants who come after them able to give consent, yet the proposal is to experiment on all of them by virtue of altering their germline for all time. Proxy consent is wholly inadequate here.

The FDA jettisoned the Helsinki Declaration several years ago, and substituted new rules of elements of informed consent. Each subject must be informed of

The fact that this is research

Explanation of the purpose(s) of the research

Expected duration of the subject’s participation

Description of the procedures

“Identification of any procedures which are experimental”

Let’s read such a consent form to the next generation, to these grown-up three-parent embryos:

This research project began before you were conceived. It has fashioned
you as we see fit. It will last all of your life. It will affect all of your children,
and their children after them. Have you ever agreed to participate? Sign
here, please.