(Excerpted from "FDA raises concerns about three-parent embryo procedure,"
USA Today, February 26, 2014) - In two days of hearings
ending Wednesday, a federal committee proved quite skeptical about research that
might help some patients birth healthy children — but might also open the door
to human gene manipulation. The procedure being considered, called mitochondrial
transfer, would mix the genes of two women in hopes of creating a healthy
baby.
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."
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
ReproductionCMDA
Genetics Resources