Although the panel, which advises the federal Food and Drug Administration, did not take a vote, many members questioned the ethics of the procedure, and whether the research into it is as far advanced as some supporters claim.
All people carry two sets of genes in every cell: the 20,000 genes in the cell's nucleus, which determine traits like height, eye color and intelligence; and the 37 genes in the mitochondria, which provide energy for each cell. The mitochondrial transfer procedure would combine the nuclear genes from the mother with the mitochondrial genes of a donor woman. When fertilized, it would lead to babies with genetic material from three "parents."
The procedure promises to help women who carry defective genes that can lead to devastating mitochondrial problems in children, including blindness, organ failure and stroke. It might eventually also help resolve some types of infertility.
The committee considered what scientists would need to do before they could try the technique in people, and whether it would be possible to design a clinical trial to answer the many outstanding questions about the procedure. David Prentice, a cell biologist and senior fellow for life sciences at the Family Research Council, a conservative advocacy group, told the panel he strongly objects to any mixing of genetic material.
"The individuals created are experiments," he said by phone after the meeting ended. "You're actually creating and destroying young human life which we object to. It just seems a very wrongheaded way to proceed."
| Commentary |
Breaking
News...CMDA CEO Dr. David Stevens debated this issue with Ethicist Arthur Caplan on the Fox and Friends national news program, cohosted with Elisabeth Hasselbeck this morning. Dr. Stevens noted the destruction of human embryos in the proposed procedure and non-destructive alternatives to pursuing the cure. He also highlighted the ethical issue of foisting genetic changes, with unknown consequences, on successive generations.
"Germ line manipulation is something that has been prohibited in science all over the world up until the present time," Dr. Stevens noted.
Dr. Caplan replied, "I understand the concern about where we might go. I'm going to worry about that when I get there."
Watch the video here
CMDA CEO David Stevens, MD, MA (Ethics):
“Dr. Caplan is not a scientist so maybe he doesn’t understand the grave dangers
that germ line manipulation can cause. In some mice studies using ‘mitochondrial
replacement therapy,’ there were decreased survival rates, developmental delays,
fertility problems and behavioral changes in progeny. No one knows what will
happen if it is tried in humans, but we do know that if problems occur, they
will continue through every generation. We should be worrying about that now,
not when ‘we get there.’ By then, it will be too late.“As an Ethicist, Dr. Caplan should be concerned that the scientists experimenting on the unborn can’t get informed consent from that child’s granddaughter before doing experiments that will affect her life. He should be concerned that two of the methods of replacing ooplasm require cannibalizing another human embryo causing their death.
“Forty-one years ago, the Supreme Court decided a child could be destroyed if a woman didn’t want it. The FDA is now deciding whether a woman has the right to construct the child she wants. That decision is based on a genetic mutation problem that only causes serious disease in 400 to 600 of the four million babies born each year. If women get this new right, how can society deny them exercising it to correct more serious problems like obesity, diabetes or heart disease, if this ability becomes available through germ line manipulation? Look at all the money society would save on healthcare! Wouldn’t people be happier?
“While the scientist is tinkering, why stop at just making members of that family tree skinny? Why not add making them all six-foot tall, blue eyed and athletic? Welcome to the brave new world of designer babies and two classes of humans, the enhanced and unenhanced.
“As a society, we should not cross the clear line in the sand prohibiting germ line manipulation. It’s science too dangerous to use.”
Executive Director of The Tennessee Center for
Bioethics & Culture D. Joy Riley, MD, MA: (from her testimony
before the FDA, Feb. 25, 2014) – “It is remarkable to note that while more than
40 nations have prohibited germ line 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.
“Secondly, consider codes of international standing:
“The Declaration of Geneva proclaimed for physicians worldwide, ‘The health of my patient will be my first consideration.’
“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.’
“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.’
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. 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 germ line for all time.
Resources:
CMA Letter to FDA on Oocyte Modification in Assisted Reproduction
CMDA Genetics Resources
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