[Congressional Record Volume 152, Number 16 (Friday, February 10, 2006)]
[Senate]
[Pages S1050-S1054]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
CLONING
Mr. TALENT. Mr. President, 9 years ago, scientific advances in the
technology of nuclear transfer permitted the cloning of a sheep named
Dolly. The immediate reaction of most Americans, and most Members of
Congress, was to try to make certain that this process was never used
to create a human being, never allowing a human Dolly to be cloned. I
remember thinking at the time that I personally did not want to live in
a world where I was walking down the street and saw myself coming in
the opposite direction.
Why this reaction? After all, cloning is an acceptable thing in the
agricultural world. The difference, of course, is that human beings
have a unique dignity. When parents decide to have a child, they do it
for the benefit of the baby, to nurture that new life to live up to the
potential and live out the plan which God created for him or her. All
of us agree that people should not be cloned because the only reason
you clone something is to use it, and human beings should and do exist
for reasons of greater dignity than simply to be used by others. I
think we all understand that if we were ever to allow a race of clones
to be created as workers or body parts warehouses for society, we would
cheapen the dignity of humanity to the point where none of the rest of
us would be safe in our lives or freedoms.
Yet, despite this shared impulse against cloning, it has been 9 years
since Dolly was created, and no safeguards against cloning have passed
the Congress. Nor are there prospects of any such bill passing in the
near future. The reason is that there is an area of overlap between the
issues of cloning and stem cells. Many scientists believe that stem
cells from a cloned human embryo may have unique advantages for medical
research. This part of the scientific community has resisted the total
ban on cloning which has been introduced each of the last 6 years in
the belief that such a ban would inhibit one important aspect of stem
cell research. Both sides have settled into what has now become a rigid
stalemate, like the Western Front in WWI. Even though the idea of
cloning human beings is morally repugnant to most of us, there is
currently no Federal prohibition or even regulation of any aspect of
human cloning, or for that matter of warehousing body parts and
creating ``fetus farms,'' and no prospect of getting such prohibitions.
I have spent the better part of a year researching this issue,
meeting with people on all sides: groups who oppose cloning embryos to
get stem cells, scientists who support it, parents who don't know who
or what to believe but who are desperate for a cure for their children.
Many to whom I have spoken have strong opinions about the underlying
moral issues. In every case, I respected the sincerity and passion of
those whom I spoke with. I have strong opinions of my own.
I believe human beings are precious. I am concerned about the
tendency of our society to devalue people because they are too old, too
young, or too inconvenient to have around. At the same time, I
understand the desperation of parents whose children are sick
[[Page S1051]]
or dying and who are desperate for treatments that will make them well.
I often tour neonatal units. It breaks my heart to see children there
fighting for life. I also meet with kids who are struggling heroically
with chronic disease. I want to find cures for these children--but I
also want them to grow up in a society that values them for their
inherent dignity, for who they are, regardless of their age, infirmity,
or level of achievement in the world's eyes.
Just because we are deadlocked about what to do in the present is no
reason we cannot agree on what we want the future to be. We find
ourselves at the beginning of a great new era of biology. I believe we
can and should determine what our children's future will look like, and
what objectives we want for our Nation. And, clearly, for all of us
this would include progress in biomedicine built upon a solid
foundation of moral principles in defense of human dignity.
I have come to the floor of the Senate today because there are just
such hopeful prospects for the future. As is so often the case, the
technology that generates the problem may also provide the solution.
Just as recent scientific advancements created a moral dilemma,
discoveries that are even more recent may provide a way out. Within a
short time, it may be possible to get the exact stem cells researchers
say they need without cloning an embryo. This means that we need no
longer argue about such important but difficult questions as whether an
embryo is fully a person or whether and when stem cell research may
actually produce medical cures. The good news is that we can
effectively prohibit human cloning and do it with a consensus that
heretofore has not been possible; we can honorably reconcile our
positions without requiring anyone to compromise their principles--
provided that we are willing to approach the cloning issue humbly and
practically, and provided also that both sides really do want what they
say they want.
Mr. President, one of the difficulties with this issue is that much
depends on understanding at least the basics of the science involved,
and the science is complicated--especially for those of us who limped
through high school biology. So I want to review some of the facts
about stem cells and in particular about how stem cell research
intersects with cloning.
A stem cell is a cell that does not itself perform a physiological or
structural function in the body but instead serves as a source for
cells that do perform such functions. During early development, stem
cells help form the human body; in adult life, stem cells stand in
reserve, to be used as needed to create new blood cells, brain cells,
liver cells, and many other cells with a specific function in the body.
In current scientific language, there are two basic categories of
stem cells: first, adult stem cells and, second, embryonic stem cells,
which are also called pluripotent stem cells.
Adult stem cells exist all over the body. Their purpose is to
maintain and repair damaged tissue. Science has known about, researched
and used adult stem cells for years. To date, adult stem cell research
has resulted in the development of a variety of therapeutic treatments
for diseases: over 60 peer-reviewed treatments using adult stem cells
exist today. These treatments include autoimmune diseases such as lupus
and multiple sclerosis and blood diseases such as sickle cell disease.
A few years ago, American scientists announced that they had isolated
stem cells from human embryos as well. These stem cells, called,
naturally, ``embryonic'' stem cells, are the cells that, during the
first days of life, begin dividing and differentiating, developing into
the various parts of the body. Currently the cells can only be obtained
from embryos created through in vitro fertilization, IVF. Once
isolated, however, embryonic stem cells are self-replicating, which
means an individual embryonic stem cell can produce tens of thousands
of additional stem cells.
There is an important difference between ``adult'' and ``embryonic''
stem cells. Adult stem cells are found in the developed tissue or
organs of the body and they can in general differentiate only to yield
the cell types of the tissue or organ from which they came. In general,
that means that an adult stem cell can become only one kind of tissue.
A heart stem cell, for example, becomes heart tissue; a liver adult
stem cell becomes liver tissue, and so on. Remember, the primary roles
of adult stem cells are to maintain and repair the tissue in which they
are found.
An embryonic stem cell, on the other hand, is considered
``pluripotent.'' That means an embryonic stem cell could develop into
any of the different cell types of the body. They could in theory, if
properly controlled, be commanded to become any one of a number of
different tissues. This is logical, because embryonic stem cells are
derived from the very cells in the embryo that are awaiting genetic
instructions on what organ or other part of the body they will become.
It is important to remember that the major reason science wants
embryonic stem cells is because of this pluripotent quality. The fact
that pluripotent stem cells come from embryos is a problem rather than
a good thing, because of the obvious ethical concerns in extracting a
cell from a human embryo and thereby destroying the embryo.
Whereas the value of adult stem cell research is accepted by
consensus, there is more controversy over the scientific efficacy of
embryonic stem cell research. The pluripotency of embryonic stem cells
gives them more diverse potential, since they can in theory be
``programmed'' to become any kind of tissue. In practice, controlling
pluripotent stem cells enough to produce actual treatments has been
very difficult, and researchers to whom I have spoken, while supporting
research with these cells, have emphasized that cures are likely to be
many years away, if they come at all.
Because of this, some have argued that pluripotent stem cell research
is of negligible value and that we should feel no compunction about
preventing such research. But too many scientists of different
backgrounds have insisted otherwise for me to be certain of that
conclusion. The truth is that it is simply too soon to know whether
science can control pluripotent stem cells well enough to use them for
medical therapies; to the extent there is a consensus on this issue, it
is that such research is speculative but promising.
Even more recently science has determined that a third category of
stem cells may be useful. These stem cells are genetically matched to
the patients who need the cell therapies. For several years, scientists
have believed that it may be possible to derive these genetically
matched stem cells through a process called somatic cell nuclear
transfer or SCNT.
In SCNT the nucleus of an unfertilized human egg, which contains 23
chromosomes, is removed and replaced by the nucleus of an adult body
cell. The new ``transferred'' nucleus would be genetically complete,
containing all 46 chromosomes of the donor cell. This imitates the
effect of normal fertilization in which the sperm's 23 chromosomes add
to the egg's 23 to make the needed 46. The egg with the transferred
nucleus is then stimulated and begins dividing like a naturally
fertilized embryo. If all goes well, in 4 to 5 days it gets to a stage
of development, called the blastocyst, from which embryonic stem cells
would be harvested. These stem cells would be distinct from the
embryonic stem cells derived from IVF in that they would genetically
match the donor. Proponents of SCNT are hopeful that assuming they can
overcome the challenge of controlling the development of any
pluripotent stem cell, and assuming that they can successfully complete
SCNT at all, these genetically matched stem cells would be superior to
other forms of pluripotent stem cells in curing disease.
Again, stem cell research in general has nothing to do with SCNT. It
is only with respect to one particular type of embryonic stem cell--a
stem cell which no one has ever developed but that might have
incremental advantages over other embryonic stem cells--that science
wants to do SCNT. The reason SCNT is controversial is that it is a form
of cloning. In fact, it is the same technique that was used
successfully to create Dolly the sheep.
Both the proponents and opponents of SCNT agree that, if successful,
it would result in the cloning of a human embryo.
Some supporters of SCNT, however, argue that a human embryo does not
[[Page S1052]]
become a human being until it is implanted in a womb, and that unless
researchers intend to implant the cloned embryo, SCNT should be
permitted. The opponents of SCNT believe just as passionately that a
human being does not depend on developmental age, and that a human
embryo is therefore a human being from its beginning. From this
perspective SCNT is the creation of a human being for purely
instrumental use exactly what, in theory, a cloning ban is designed to
prevent. But up until now, both sides have assumed that any nuclear
transfer procedure which would result in the creation of pluripotent
stem cells must first have produced a human embryo.
Yet the most recent scientific developments suggest that this is not
true. In May 2005 the President's Council on Bioethics released a white
paper entitled ``Alternative Sources of Human Pluripotent Stem Cells.''
In this report, the council outlined four specific proposals for a
scientific solution to our current political impasse over stem cell
research. In the months since that report was issued, progress in each
of these approaches has been reported in the leading peer-reviewed
scientific journals. Research on one of these proposals, altered
nuclear transfer, is especially encouraging and suggests that all the
scientific and medical goals of SCNT could be realized without the
cloning or destruction of human embryos.
Remember, with somatic cell nuclear transfer researchers would take
the genetic material out of a human egg, replace it with the complete
genetic code of the donor, and then shock it so that it starts to
divide. In theory, an organism created in such a way--artificially
rather than naturally--could divide and grow until it became an adult
human being. Altered nuclear transfer is a form of somatic cell nuclear
transfer in that it uses nuclear transfer but with a preemptive
alteration of the genetic material. To put it simply, the somatic cell
is altered prior to being transferred. The resultant entity would be
capable of producing pluripotent stem cells but because of the
preemptive alterations during the transfer process it would be
incapable, from its creation, of the organization and developmental
potential that are the defining characteristics of an embryo.
Altered nuclear transfer is a broad umbrella concept with many
possible specific approaches. For example, one proposed approach using
ANT is called ANT-OAR. This form of ANT involves reprogramming the
somatic cell to enter directly into a pluripotent stem cell state,
without going through any of the normal developmental stages. All of
this means that ANT could create genetically matched stem cells without
ever having to produce anything with the capacity to be considered a
human embryo.
This distinction between SCNT and ANT is vital from a moral and legal
perspective. Until the last few months, everyone has assumed that
nuclear transfer which was successful in generating pluripotent stem
cells must first have created a human embryo. The entity which ANT
could create would produce pluripotent stem cells from a laboratory-
constructed cellular source lacking the developmental potential of a
human embryo. In layman's terms, the entity which ANT would create
could only develop for a few days and would then ``close down.'' ANT
thus transcends the moral dilemma which has heretofore prevented any
legislation from passing. It renders moot the question of whether human
life begins at creation or implantation of an embryo since the entity
that ANT could create would not have at its inception the
organizational and developmental capability to be considered a human
life.
Further exploration of the ANT proposal already has the support of a
long list of scientists and ethicists and religious leaders, including
the former chairman of the U.S. Conference of Catholic Bishops
Committee on Doctrine. The author and most vocal champion of ANT is Dr.
William Hurlbut of Stanford. Dr. Hurlbut assured me months ago that ANT
was technologically feasible and would soon be validated through animal
models. And, indeed, just 4 months ago stem cell biologists, Alexander
Meissner and Rudolf Jaenisch, of the Whitehead Institute at MIT, used
altered nuclear transfer to produce fully functional pluripotent stem
cells from a laboratory-construct that is dramatically different in
developmental potential than a natural embryo. In testimony to an
October 2005 Senate hearing on stem cells, Dr. Jaenisch explained that
this procedure is simple and straightforward and does not involve the
creation of an embryo. Dr. Jaenisch said, ``Because the ANT product
lacks essential properties of the fertilized embryo, it is not
justified to call it an ``embryo.'' That was October 19, 2005 testimony
at an Appropriations Subcommittee on Labor, Health and Human Services,
Education hearing on ``An Alternative Method for Obtaining Embryonic
Stem Cells.'' This scientific advance was widely reported precisely
because it signals the end of the ethical dilemma in this area of
research; it suggests that science may soon be able to get this special
kind of stem cell--pluripotent stem cells that genetically match the
donor/patient--without cloning, creating, or destroying a human embryo.
Mr. President, I appreciate the patience of the Senate in bearing
with me as I wound my way through the scientific thicket. I believe it
was necessary to lay this foundation before proceeding, and I suspect
that the Senate may already see the practical suggestion which I see as
the logical result given the latest technological developments and the
current stalemate.
Again, to reaffirm my central point, many scientists have resisted a
total ban on human cloning because they believed it was necessary to
clone human embryos for a narrow purpose: to get pluripotent stem cells
which are a genetic match of the person whom they hope to treat
medically. However, it now appears that it will be possible to get such
stem cells without cloning an embryo.
Some may argue that these alternative forms of nuclear transfer and
other new technologies are unproven and may never produce usable new
discoveries. But the same thing can be said of embryonic stem cell
research in general and SCNT in particular. Bear in mind that science
has yet to succeed in getting pluripotent stem cells from SCNT at all.
Nor, for that matter, is there a single new cure from embryonic stem
cells derived from any source. If researchers cannot learn how to
isolate and control genetic signals, then pluripotent stem cell
research will turn out to have little medical application; if such
control does prove possible, then there should soon be no reason to
have to get the stem cells by a method that clones or destroys a human
embryo.
As I mentioned earlier, we appear to be at a legislative stalemate.
The key to reaching the proper legislative solution, I believe, is to
recognize that the new scientific developments create possibilities for
an honorable reconciliation that simply did not exist at the time
Senators developed and sponsored the various cloning bills that are
currently introduced in the Congress. In effect, the new technology is
rendering the approach of those pieces of legislation out of date.
For example, the main anti-cloning bill, S. 658, of which I am a
cosponsor, would ban the use of nuclear transfer whenever it resulted
in the creation of a human embryo or an organism that was ``virtually
identical'' to a human embryo. This standard satisfies one of the
important principles of the pro-life community, because it recognizes
that the dignity of pre-born human beings doesn't depend on their
gestational age. But it fails to account for the possibility, created
by altered nuclear transfer and some of the other alternative methods,
that an entity may be ``virtually identical'' to an embryo in the sense
that it has a similar external appearance--and can seem to be
developing as it divides--without ever possessing the inherent
organizational capability to be rightly considered a human being.
Because of this, there is a danger that the language of S. 658, which
was adequate when we all assumed that any entity capable of creating
embryonic stem cells must be a human embryo, would outlaw or imperil
precisely those alternatives which hold the greatest promise of
allowing stem cell research while protecting the integrity of human
life. I discussed this problem with Doctor Hurlbut and, in a recent
letter, he expressed concern that S. 658 as drafted might be
misinterpreted to
[[Page S1053]]
outlaw ANT. He pointed out that the term `virtually identical' is vague
and unscientific and, therefore, could be open to misinterpretation
either more broadly or more narrowly than intended by the proponents of
this legislation.
The existence of alternatives like ANT actually strengthens the case
of those of us who oppose the cloning of human embryos, since it
promises another, ethically untroubling way of getting the same
genetically matched stem cells scientists need. But it also shows that
there is much about nuclear transfer that we have yet to discover, and
it cautions against enacting criminal sanctions, like S. 658, that
could have unintended consequences because they presume a scientific
equilibrium that simply doesn't exist. Congress should still move
effectively to prohibit human cloning but the approach of S. 658 needs
to change. At minimum, the ``virtually identical'' language in S. 658
should be discarded, and the bill should specifically define when a
cloned entity has the organizational capability and developmental
potential to be considered a human being. But, I would prefer to enact
a regulatory ban that could be adjusted over time to reflect changes in
the science like ANT, perhaps after consultation with the President's
Council on Bioethics, and I would couple that ban with aggressive
funding of ANT and other alternatives, perhaps in the form of the
competitive incentive program I will discuss in a moment.
The other main cloning legislation, S. 876, should, in light of
recent developments, be equally unsatisfactory to many of its
supporters, although for different reasons. S. 876 does not regulate
the initial nuclear transfer process at all but simply bans implanting
a cloned embryo. This is good as far as it goes, but S. 876 would
provide no protection whatsoever to human life before implantation.
Under generally accepted medical protocols today, science can't even
experiment on animals if other methods of doing the same research are
available, yet S. 876 would permit the cloning of human embryos for any
purpose and under any circumstances, regardless even of whether the
researchers need or intend to use the embryos for stem cell research.
The proponents of S. 876 were almost forced into this position to
protect the stem cell research they thought necessary, because they
believed, as we all did, that the only way to get genetically matched
stem cells was through cloning and that any such cloning would
necessarily produce a human embryo. But the evidence now suggests that
this is not true. I am sure that the supporters of S. 876 are sincere
in their belief that a human embryo does not acquire full personhood
until some point after it is created. But I respectfully suggest that
this view is no longer a reason, given the changing science, to
continue supporting a legal standard that affords no dignity whatsoever
to human life at its earliest stages.
The answer is for both sides to take advantage of scientific changes
to find proposals which they can mutually support and which offer
advantages to each compared to the current stalemate.
To that end, I propose a competition, to be managed by the National
Institutes of Health, which would create incentives for our great
research institutions to get the genetically matched stem cells we need
without risking cloning an embryo. Simply put, the NIH would take
applications from research institutions with research plans to
accomplish the goal. The exact funding and practical details of this
would have to be carefully worked out, but let me put forward a
preliminary proposal. Five institutions would be selected for the
competition and provided $10 million each to conduct their
comprehensive plan. The first institution to successfully harvest
genetically matched stem cells without cloning a human embryo would
receive a prize of $20 million. NIH would develop the boundaries of the
competition with the restriction being that the research could not
violate the terms of the Dickey Amendment. Once ANT or one of the other
alternative methods was successful and we had a proven means to get
genetically matched stem cells without cloning a human being, the NIH
could issue regulations requiring science to use that technology in its
research.
The idea of a competition is not new. They have successfully been
used for centuries to educate, inspire, and motivate. For example,
Charles Lindberg won a $25,000 prize for the first nonstop flight
between Paris and New York in 1927. In 2004, a company called Scaled
Composites won a $10 million prize for the first privately funded
manned suborbital flight from the St. Louis-based X Prize Foundation.
Inspired by the success of the X prize--and with the support of
Congress, the President and his Commission on Implementation of U.S.
Exploration Policy--NASA has begun a federally funded program called
Centennial Challenges that awards prizes to stimulate innovation in
technical areas of interest to space exploration. In fact, the program
manager at NASA, Brant Sponberg, said they expect to spend $80 million
on prizes over the next 5 years.
A proposal of this kind moves us forward in a way both sides should
be able to support. After all, the sole argument for SCNT is that we
need it to get certain kinds of stem cells; the argument against it is
that it involves the cloning of human embryos. If we can get the stem
cells without the cloning, we render the current controversy
scientifically obsolete. Science would have the stem cells it needs in
a morally acceptable way that would allow for full Federal funding of
stem cell research. The pro-life community would have an effective ban
on human cloning. We would turn a zero sum game into a win-win
proposition for everyone.
We are entering a promising new era in biomedical technology, but as
our power over human life increases, so does the seriousness of the
moral issues. It is important to acknowledge that both sides in this
difficult debate are defending something important to all of us. We
should all want to advance biomedical science while sustaining
fundamental principles for the protection of human life.
Biomedical science should be a matter of unity in our national
identity: no one should enter the hospital resentful that positive
possibilities for the best therapies were not explored, or with moral
qualms about the research on which their therapies have been developed.
The revelation that the South Koreans have not succeeded in obtaining
pluripotent stem cells from cloned human embryo returns this research
to square one. This presents to our Nation both a challenge and an
opportunity: a social challenge to seek a way forward as a unified
society, and an opportunity to set a solid scientific and moral
foundation for future generations. The differences within our nation
can be a source of strength as we seek to open a way forward for
biomedical science. Altered nuclear transfer, and the other alternative
approaches put forward by the President's Council on Bioethics offer us
just such a path to progress.
We are at a difficult impasse, but we have extraordinary
possibilities. Our current conflict reflects deep differences in our
personal perspectives, but our wider goals are similar. Any purely
political victory will leave our Nation bitterly divided and erode the
social support that is essential for continuing public funding of
biomedical science. It is with this recognition that I have put forward
this proposal in a spirit of unity. And beneath this spirit of unity
must be a spirit of humility: these are difficult issues and no one of
us has the clarity of understanding or depth of knowledge to answer
them alone. But with mutual good will we can transcend the current
paralysis and find grounds for practical progress in scientific
research. In his presentation on stem cell research last July to the
Senate Appropriations Committee, Dr. Hurlbut said the goal should be to
find ``islands of unity in a sea of controversy.'' We can move from one
such island to another and end up in a world of progress and decency.
There is no reason to continue glaring at each other across the
legislative barricades, when the means are at hand to embrace the
future of developmental biology without moral qualms or political
division?
The PRESIDING OFFICER. The Senator from Massachusetts is recognized
for 30 minutes.
Mr. KENNEDY. Mr. President, will the Chair remind me when I have 5
minutes remaining.
[[Page S1054]]
The PRESIDING OFFICER. The Chair will so advise the Senator.
____________________