[Congressional Record Volume 144, Number 7 (Thursday, February 5, 1998)]
[Senate]
[Pages S425-S433]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
HUMAN CLONING PROHIBITION ACT--MOTION TO PROCEED
Mr. BOND. Mr. President, I ask unanimous consent that the Senate now
turn to the consideration of Calendar No. 304, S. 1601, regarding human
cloning.
The PRESIDING OFFICER. Is there objection?
Mrs. FEINSTEIN. I object.
The PRESIDING OFFICER. Objection is heard.
Mr. BOND. In light of the objection from the other side of the aisle,
I now move to proceed to S. 1601.
The PRESIDING OFFICER. Is there debate on the motion?
Mrs. FEINSTEIN. Mr. President, I wish to debate the motion.
The PRESIDING OFFICER. The Senator from California may proceed.
Mrs. FEINSTEIN. Mr. President, this is a rush to judgment on one of
the most fundamental issues of the 20th century. Mr. President, this is
not renaming National Airport Ronald Reagan Airport.
Mr. President, I submit respectfully to the distinguished Senators on
the other side of the aisle that this is a major debate that has
scientific implications, moral implications and ethical implications.
It is a debate, also, that involves one of the most difficult areas of
science involving human genetics, with a vocabulary and a lexicon that
is not understood by the great bulk of the American people and
certainly not by many of us in the U.S. Senate.
Both the Bond-Frist bill and the Feinstein-Kennedy bill dealing with
the subject of human cloning were introduced less than 48 hours ago--48
hours. No hearings have been held on either bill, no floor debate has
been held on either bill. The medical community, the research
community, patients with currently incurable diseases whose cure we
might affect by both of these bills have barely read the bills, much
less analyzed them.
As a matter of fact, the letters are now beginning to pour in. I ask
unanimous consent to have printed in the Record a 9-page statement of
the Biotechnology Industry Organization regarding legislation
introduced to ban human cloning and a letter to Senator Mack from the
American Association for Cancer Research.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Statement of the Biotechnology Industry Organization Regarding
Legislation Introduced To Ban Human Cloning
The Biotechnology Industry Organization (BIO) believes that
it is both unsafe and unethical to even attempt to clone a
human being. BIO strongly supported the review of this issue
by the National Bioethics Advisory Commission (NBAC) and the
moratorium on cloning imposed by President Clinton. We
believe that the FDA has clear authority and jurisdiction and
will, as they have stated, prohibit any attempt to clone a
human being.
BIO is concerned about the scope and impact of legislation
introduced to make it a crime with a ten year prison sentence
to conduct biomedical research which may or may not have any
relevance to the cloning of a human being. We are very
concerned about the rushed process to pass legislation on
this complex subject and the possibilities for unintended
consequences. The scientific and legal issues with respect to
any legislation regarding biomedical research are exceedingly
technical, and a hastily drafted bill could advertently and
inadvertently damage biomedical research on deadly and
disabling diseases.
The Senate needs to adhere to the standard for doctors,
``first, do no harm.'' Biomedical research into deadly and
disabling diseases is far too important to rush to enact
legislation which would unequivocally undermine promising
research and therapies. The Senate should be extremely
cautious before it starts sending scientists to jail when the
purpose of their research meets the highest moral and ethical
standards and holds such promise for relieving human
suffering.
analysis of pending bills and the science at risk
Several bills have been introduced in the Senate regarding
human cloning. They vary widely in focus and precision. The
three principal bills are S. 368, S. 1599, and S. 1602 and we
have analyzed each of them here.
The first bill introduced by Senator Bond last year, S.
368, is one of the better drafted bills introduced in either
body. It uses reasonably accurate terms to describe the
applicable science and limits Federal funding for the cloning
of a human being.
The new bill introduced by Senator Bond, S. 1599, would
impose a ten year prison sentence for any individual for the
act of ``producing an embryo (including a preimplantation
embryo)'' through the use of a specified technology,
``somatic cell nuclear transfer,'' even if the production of
such an embryo is for purposes unrelated to the cloning of a
human being and even if the embryo does not contain nuclear
DNA which is identical to that of an existing or previously
existing human being (cloning). The bill goes beyond the
issue of cloning to make it a crime to use somatic cell
nuclear transfer of a nucleus derived from normal sexual
union of an egg and sperm, which is obviously not cloning. It
would also make it a crime to conduct some research seeking
to generate stem cells to treat a wide range of deadly and
disabling diseases, treatments which have nothing whatever to
do with human cloning.\1\
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\1\ An identical bill has been introduced by Senator Lott as
S. 1601 and this may be the bill which is called up for the
Senate debate.
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The third bill, introduced by Senator Feinstein, S. 1602,
would impose heavy civil fines for any entity that would
``implant or attempt to implant the product of somatic cell
nuclear transfer into a woman's uterus . . .'' This sharply
focuses the bill on an attempt to clone a human being and
would not imperil biomedical research.
impact of bills on stem cell research
The current bill introduced by Senator Bond would, because
it goes well beyond the issue of human cloning, imperil
promising biomedical research, including research to generate
stem cells. Instead of focusing on cloning, it makes it a
crime to zygote or embryo through the use of a new
technology, somatic cell nuclear transfer, even if the use of
this technology is essential for the generation of stem cells
to treat disease and where there is no intention or attempts
through use of this technology to clone a human being.
Basically the current bill would make it a crime to conduct
research if it could possibly be related to the cloning of a
human being even if it is not, in fact, conducted for that
purpose.
This approach in S. 1599 goes beyond the issue of human
cloning and would outlaw some research to create stem cells,
including stem cells for the following types of treatments:
cardiac muscle cells to treat heart attack victims and
degenerative heart disease; skin cells to treat burn victims;
spinal cord neuron cells for treatment of spinal cord trauma
and paralysis; neural cells for treating those suffering from
neurodegenerative diseases; pancreas cells to treat diabetes;
blood cells to treat cancer anemia, and immunodeficiencies;
neural cells to treat Parkinson's, Huntington's and
Amyotrophic Lateral Sclerosis (ALS); cells for use in genetic
therapy to treat 5,000 genetic diseases, including Cystic
Fibrosis, Tay-Sachs Disease, schizophrenia, depression,
and other diseases; blood vessel endothelial cells for
treating atherosclerosis; liver cells for liver diseases
including hepatitis and cirrhosis; cartilage cells for
treating of osteoarthritis; bone cells for treatment of
osteoporosis; myoblast cells for the treatment of Muscular
Dystrophy; respiratory epithelial cells for the treatment
of Cystic Fibrosis and lung cancer; adrenal cortex cells
for the treatment of Addison's disease; retinal pigment
epithelial cells for age-related macular degeneration;
modified cells for treatment of various genetic diseases;
and other cells for use in the diagnosis, treatment and
prevention of other deadly or disabling diseases or other
medical conditions.
To be precise, the current bill introduced by Senator Bond,
S. 1599, would make it a crime to generate stem cells, for
the above uses, where somatic cell nuclear transfer
technology is used. It would not ban stem cell research where
the stem cell is generated without the use of somatic cell
nuclear transfer. It is not possible to say how much of this
promising research will or might involve the use of somatic
cell nuclear transfer. As described below, the bill would
clearly ban the generation of any stem cells
[[Page S426]]
``customized'' to an individual where somatic cell nuclear
transfer must be used.
This stem cell technology is exciting and potentially
revolutionary. Scientists are developing a new approach for
treating human diseases that doesn't depend on drugs like
antibiotics, but on living cells that can differentiate into
blood, skin, heart, or brain cells and can potentially treat
various cancers, spinal cord injuries, and heart disease. For
example, this stem cell research has the potential to develop
and improve cancer treatments by gaining a more complete
understanding of cell division and growth and the process of
metastasis. This could also lead to a variety of cancer
treatment advances.
The type of cells that make up most of the human body are
differentiated, meaning that they have already achieved some
sort of specialized function such as blood, skin, heart or
brain cells. The precursor cells that led to differentiated
cells come from an embryo. The cells are called stem cells
because functions stem from them like the growth of a plant.
Stem cells have the capacity for self-renewal, meaning that
they can reproduce more of themselves, and differentiation,
meaning that they can specialize into a variety of cell types
with different functions. In the last decade, scientists
studying mice and other laboratory animals have discovered
new powerful approaches involving cultured stem cells.
Studies of these cells obtained from a mouse's stem cells
show they are capable of differentiating, in vitro or in vivo
into a wide variety of specialized cell types. Stem cells
have been derived by culturing cells of non-human primates.
Promising efforts to obtain human stem cells have also
recently been reported.
Stem cell research has been hailed as the ``[most]
tantalizing of all'' research in this field, because adults
do not have many stem cells. Most adult cells are fully
differentiated into their proper functions. When
differentiated cells are damaged, such as damage to cardiac
muscle from a heart attack, the adult cells do not have the
ability to regenerate. If stem cells could be derived from
human sources and induced to differentiate in vitro, they
could potentially be used for transplantation and tissue
repair.
Using heart attacks as an example, we might be able to
replace damaged cardiac cells, with healthy stem cells, that
could differentiate into cardiac muscle. Research using these
stem cells could lead to the development of ``universal donor
cells,'' and could be an invaluable benefit to patients. Stem
cell therapy could also make it possible to store tissue
reserves that would give health care providers a new and
virtually endless supply of the cells listed above. The use
of stem cells to create these therapies would lead to great
medical advances. We have to be sure that this legislation
concerning human cloning would not in any way obstruct this
vital research.
Bond Bill Application to Non-Identical Nucleus
The purpose of a bill to ban human cloning is supposedly to
ban the cloning of an individual and the essence of this is
the duplication of the DNA of one individual in another. The
term ``somatic cell,'' however, is not limited in the current
Bond bill to somatic cells with DNA which is the same as that
of an existing or previously existing human being. If it is
not limited to cases where the DNA is identical, human
cloning is--by definition--not involved.
The current Bond bill goes beyond cloning because it does
not define the term ``somatic cell'' or limit to cases where
the DNA is identical. It only defines the term ``somatic cell
nuclear transfer,'' but it does not define the term ``somatic
cell.'' We need a brief glossary of terms to define what
constitutes a ``somatic cell.''
``Zygote'' means a single celled egg with two sets (a
diploid set) of chromosomes as normally derived by
fertilization;
``Egg'' and ``oocyte'' mean the female gamete;
``Gamete'' means a mature male or female reproductive cell
with one set (a haploid) set of chromosomes;
``Sperm'' means the male gamete;
``Somatic cell'' means a cell of the body, other than a
cell that is a gamete, having two sets (a diploid set) of
chromosomes.
So a ``somatic cell'' is any cell of the body other than a
gamete, and it includes a fertilized egg. This means that the
current Bond bill would make it a crime to use somatic cell
nuclear transfer even in cases where the somatic cell
contains a nucleus derived from sexual reproduction, which is
obviously not cloning. This means that even though the
nucleus is not a clone, the current Bond bill makes it a
Federal crime to create it. This means that the current Bond
bill goes beyond the issue of cloning.
Because of this coverage of all ``somatic cells'' the
current Bond bill would make it a crime for doctors to use a
currently effective treatment for mitochondrial disease.
In this treatment women who have the disease have an
extreme and tragic form of infertility. The disease is a
disease of the mitochondria, which is an essential element
of any egg. The treatment for this disease involves the
use of a fertilized nucleus which is transferred through
the use of somatic cell nuclear transfer to an egg from
which the nucleus has been removed. The new egg is a
fresh, undiseased egg. The current Bond bill would make a
crime to provide this treatment even though the nucleus
which is transferred is the product of fertilization, no
cloning.
customized stem cells
If the current Bond bill was limited to sometic cells with
nuclear DNA identical to that of an existing or previously
existing human being, i.e., to a cloned nucleus, it would
make it a Federal crime to conduct one especially promising
type of stem cell research, into generating ``customized''
stem cells.
A researcher or doctor might want to create a human zygote
with DNA identical to that of an existing or previously
existing person through the use of somatic cell nuclear
transfer, the act prohibited in the bill, in order to create
a customized stem cell line to treat the individual from whom
the DNA was extracted. By using the same DNA, the stem cell
therapy would more likely to compatible with, and not be
rejected by, the person for whom the therapy is created. By
starting with the patient's own nuclear DNA, the therapy is,
in effect, custom made for that person. It is like taking the
patients blood prior to surgery so that it can be infused
into the patient during surgery (avoiding the possibility of
contamination by the use of blood of another person).
Because the current Bond bill makes it a crime to use the
technology--somatic cell nuclear transfer--it would make it a
crime to develop a therapy with the equivalent of the
patient's personal monogram on it a customized treatment
based on their own nuclear DNA.
Because the bill introduced by Senator Feinstein requires
the implantation of an embryo, it does not curtail stem cell
research, and the bill provides that the transfer nucleus
must be that of an ``existing or previously existing human
child or adult,'' precisely the limitation not present in the
current Bond bill. None of the issues we have raised
regarding the current Bond bill apply to the Feinstein bill,
which is narrowly focuses on the act of cloning, or
attempting to clone an individual.
Protecting biomedical research
The current Bond bill and the Feinstein bill both contain
clauses for the protection of biomedical research. There is a
critical difference between them.
At the press conference announcing introduction of his bill
Senator Bond distributed a document entitled ``Current
Research Untouched by the Bond/Frist/Gregg Legislation.'' The
title of this document was followed by a list of such
research, including ``In Vitro Fertilization,'' ``Stem Cell
Research,'' ``Gene Therapy,'' ``Cloning of Cells, Tissues,
Animals and Plants,'' ``Cancer,'' ``Diabetes,'' ``Birth
Defects,'' ``Arthritis,'' ``Organ Failure,'' ``Genetic
Disease,'' ``Severe Skin Burns,'' ``Multiple Sclerosis,''
``Muscular Dystrophy,'' ``Spinal Cord Injuries,''
``Alzheimer's Disease,'' ``Parkinson's Disease, and ``Lou
Gehrig's Disease''. Unfortunately, the title is followed by a
critical qualification, an asterisk. The asterisk
qualification states, ``The current Bond bill would not
prohibit any of this research, even embryo research, as long
as it did not involve the use of a very specific technique
(somatic cell nuclear transfer) to create a live cloned human
embryo.''
In the ways described above this asterisk qualification
acknowledges that the bill would, in fact, make it a crime to
conduct some types of stem cell research and other research.
Given the importance of the asterisk, the document's title
the list of supposedly protected research could be considered
misleading. The document should more accurately have been
entitled ``Only Some Research Regarding the Following
Diseases is Outlawed.''
The current Bond bill contains a Section 5 entitled
``Unrestricted Scientific Research.'' This section provides
that ``Nothing in this Act (or an amendment made by this Act
shall be construed to restrict areas of scientific research
that are not specifically prohibited by this Act (or
amendments).'' This provision is circular. It states that the
bill does what it does and does not do what it does not do.
The provision does nothing to modify the prohibitions on
research and does nothing to protect ``scientific research.''
In contrast the Feinstein bill includes a provision
regarding ``Protected Research and Practices'' which provides
that ``Nothing in this section shall be construed to restrict
areas of biomedical and agriculture research or practices not
expressly prohibited in this section, including research or
practices that involve the use of--(1) somatic cell nuclear
transfer or other cloning technologies to clone molecules,
DNA, cells, and tissues; (2) mitochondrial, cytoplasmic or
gene therapy; or (3) somatic cell nuclear transfer techniques
to create nonhuman animals.'' This is a ``savings'' clause
with meaning and content. Its reference to the cloning of
``cells'' and to ``mitrochondrial'' therapy are laudatory and
meaningful.
NBAC Recommendation and Clinton Administration Bill
The National Bioethics Advisory Commission (NBAC) cautioned
that poorly crafted legislation to ban human cloning may put
at risk biomedical research on the following types of
diseases and conditions: ``Regeneration and repair of
diseased or damaged human tissues and organs'' (NBAC report
at 29); ``assisted reproduction'' (NBAC report at 29);
``leukemia, liver failure, heart and kidney disease'' (NBAC
report at 30); and ``bone marrow stem cells, liver cells, or
pancreatic beta-cells (which product insulin) for
transplantation'' (NBAC report at 30). The Clinton
Administration proposed law, like the Feinstein bill, avoids
the peril identified by
[[Page S427]]
NBAC and focuses only on the issue of human cloning and does
not imperil biomedical research.
sunset and preemption
NBAC proposed that any law include both sunset review and
preemption provisions.
Regarding a sunset review provision, NBAC stated in its
report: ``It is notoriously difficult to draft legislation at
any particular moment that can serve to both exploit and
govern the rapid and unpredictable advances of science. Some
mechanism, therefore, such as a sunset provision, is
absolutely needed to ensure an opportunity to re-examine any
judgment made today about the implications of somatic cell
nuclear transfer cloning of human beings. As scientific
information accumulates and public discussion continues, a
new judgment may develop and we, as a society, need to retain
the flexibility to adjust our course in this manner. A sunset
provision . . . ensures that the question of cloning will be
revisited by the legislature in the future, when scientific
and medical questions have been clarified, possible uses have
been identified, and public discussion of the deeper moral
concerns about this practice have matured.'' NBAC report at
101.
President Clinton has proposed a five year sunset in his
bill. The Feinstein bill includes a ten year sunset and the
current Bond bill includes no sunset review.
BIO supports inclusion of a sunset review provision, but
the most important issue is whether the terms of the
prohibition in any law focuses only on the issue of human
cloning. A sunset review provision will not undo the damaged
which a poorly crafted, over broad law would do to biomedical
research prior to the sunset date.
The Feinstein bill, but not the current Bond bill, includes
a clause which preempts inconsistent state laws. NBAC
strongly supported a preemption of state laws: ``The
advantage to federal legislation--as opposed to state-by-
state laws--lies primarily in its comprehensive coverage and
clarity. . . . Besides ensuring interstate uniformity, a
federal law would relieve the need to rely on the cooperation
of diverse medical and scientific societies, or the actions
of diverse IRBs, to achieve the policy objective. As an
additional benefit, federal legislation could displace the
varied state legislative efforts now ongoing, some of which
suffer from ambiguous drafting that could inadvertently
prohibit the important cellular and molecular cloning
research described . . . in this report.'' NBAC report at
100.
Numerous bills introduced in state legislatures, some of
which are very poorly crafted and over broad.
BIO supports inclusion of a preemption clause. Again, the
key issue is whether the prohibition in any law focuses only
on the issue of human cloning and does not imperil biomedical
research. A poorly drafted, over broad Federal law which
preempts state laws might do even more damage.
nbac role and commission
NBAC performed a public service with its quick and
thoughtful analysis of the human cloning issue. The current
Bond bill would set up an entirely new body to review the
human cloning issue rather than rerefer the issue back to
NBAC for further review. NBAC is well qualified and
positioned to perform this function and it may be wasteful
and expensive to establish another body to perform this
ongoing review. The Feinstein bill calls on NBAC to conduct
the reviews.
____
American Association for
Cancer Research, Inc.,
Philadelphia, PA, February 4, 1998.
Hon. Connie Mack,
U.S. Senate, Washington, DC.
Dear Senator Mack: Medical research, conducted in the
United States over the last 20 years, has opened up
tremendous opportunities to make progress against many
devastating diseases. The scientific community does not
desire to make human beings, or modify or genetically mark
any portion of our population. However, to deny the
application of molecular biology, made possible through the
use of cloning technologies, to patients who could be
benefited would be a great injustice.
A litany of beneficial applications of cloning technology
was enumerated in this weeks TIME Magazine. Several of these
applications are at the core of cutting-edge cancer research,
and there are many more potential benefits that are unknown
at this time. These applications, as well as any future
progress, would be eliminated by broad legislation setting
back progress and potential in our conquest to develop
effective approaches to the prevention, detection, and
treatment of cancer.
The American Association for Cancer Research (AACR), with
over 14,000 members, is the largest professional organization
of basic and clinical cancer researchers in the world.
Founded in 1907, its mission is to prevent, treat, and cure
cancer through research, scientific programs, and education.
To accomplish these important goals it is essential that
scientists vigorously pursue all promising lines of
investigations against cancer.
The AACR feels strongly that an ethical and just compromise
can be reached that will protect the public and the
scientific community from the irresponsible application of
cloning technology while permitting meaningful and ethical
research to move forward. The medical and cancer research
community feels that the present rush to enact legislation
without proper consideration or deliberation is a serious
mistake, and the unfortunate result would be irresponsible
legislation.
As scientists we clearly see the tremendous advantages of
cloning technology as well as its potential problems, which
we, also, have reason to fear if it is applied in an
unreasonable manner.
The AACR, therefore, appeals to all Members of Congress to
establish and honor a moratorium of at least 45 days on
enacting any legislation until definitions and implications
of legislation can be determined in a more reasonable and
thoughtful manner, and in an open and public process. This
would be a service to humanity, science, and millions of
individuals who are now suffering, or will suffer in the
future, from catastrophic and crippling diseases such as
cancer. We appeal to all members of Congress to give this
important moral and scientific issue very careful
consideration and deliberation. Clearly a rush to judgment on
this complex issue could be a major setback for cancer and
medical research.
Sincerely,
Donald S. Coffey,
President.
Mrs. FEINSTEIN. Mr. President, the Biotechnology Industry Association
analyzes both the Bond-Frist bill and the Feinstein-Kennedy bill, which
is a second bill that addresses cloning. This interesting analysis,
representing the entire biotechnology industry of the United States,
makes a very important point, that whatever we do here impacts on human
research in a multitude of different areas, and most particularly it
affects cancer research. Mr. President, I will comment on this paper
and also comment on a number of other items.
The American Association for Cancer Research's letter to Senator
Connie Mack urges that there be a 45-day delay in enacting any
legislation until definitions and implications of legislation can be
determined in a more reasonable and thoughtful manner and in an open
and public process. They are calling for reason, they are calling for
thoughtful deliberation, they are calling for a public process. Who can
deny that on a very complicated subject?
The Whitehead Institute--and specifically Gerald R. Fink, a Director
of the American Cancer Society, Professor of Genetics--in his letter
talks about the limited ability to develop cell-based strategies, which
will take place if the Bond-Frist bill is ramrodded through this body.
The American Society for Reproductive Medicine has written a letter
urging this body to vote no on the Bond-Frist legislation.
The American Psychological Association has written to us urging that
we delay, that there be discussion and debate, and they point out that
we need to protect research efforts in this area.
The American Association for the Advancement of Science has said that
they are deeply concerned about the ethical and scientific issues. They
warn us: ``Use great caution in moving with this legislation.''
Even the College of Veterinary Medicine from the University of
Missouri, Colombia, has written to this body urging caution.
The University of California at San Francisco, Roger A. Pederson,
Professor and Research Director of the Reproductive Unit of the
Department of OB/GYN and Reproductive Science, has written to this body
urging caution and restraint as well.
I ask unanimous consent that these letters be printed in the Record.
There being no objection, the letters were ordered to be printed in
the Record, as follows:
American Society for
Reproductive Medicine,
Birmingham, AL, February 5, 1998.
Dear Senator Kennedy: The American Society for Reproductive
Medicine (ASRM) urges you not to allow the Bond Human Cloning
Prohibition Act (S. 1601) to be brought to the floor for a
vote today, and if it is, to vote against it.
ASRM is very concerned that in the rush to make human
cloning illegal, Congress will inadvertently outlaw very
serious and promising medical research that may uncover cures
to some of the most deadly diseases. Cloning is a highly
technical area that cannot easily be understood and should
not be hastily legislated.
Scientists engaged in legitimate medical research are not
interested in cloning a human being. Since October,
professional organizations representing more than 64,000
scientists have announced their participation in a voluntary
five year moratorium on human cloning. Efforts led by the
scientific community, rather than legislative prohibitions,
have worked before, and will work this time.
When we first discovered how to duplicate DNA at any level,
there were cries to outlaw it. Luckily your predecessors did
not take that step, instead allowing the scientific
community's voluntary moratorium to slow
[[Page S428]]
research while we explored its implications. Today millions
of Americans are alive thanks to drugs made using recombinant
DNA.
This bill prohibits not just the creation of a human clone,
but any attempt to understand how somatic cell nuclear
transfer could be used to improve our understanding and
treatment of disease.
We urge you and your colleagues to carefully consider any
human cloning legislation and to proceed through the proper
legislative channels so that a hastily drafted bill does not
get passed, sentencing millions of Americans to needless
suffering.
Sincerely,
J. Benjamin Younger, M.D.,
Executive Director.
____
American Psychological Association,
February 2, 1998.
Senator Dianne Feinstein and
Senator Edward Kennedy,
Committee on Labor and Human Resources,
U.S. Senate, Washington, DC.
Dear Senators Feinstein and Kennedy, I write to support the
proposed ``Prohibition on Cloning of Human Beings Act of
1998'' introduced by both of you. There appears to be
considerable confusion on this topic which apparently has
resulted in an effort by some to restrict various areas of
biomedical and agricultural research dealing with
reproduction and embryo research. It is important to
differentiate between human cloning and other types of
research. My understanding also is that the FDA has indicated
that they are the federal agency responsible for monitoring
any possible attempts at cloning research.
I do want to emphasize again that we need to protect
researchers efforts at research which does not include ``the
production of a precise genetic copy of a molecule (including
DNA), cell, tissue, organ, plant, animal or human''.
Let me also add that the American Psychological Association
took the stand that it is human behavior, in all its aspects
which should ultimately serve as the focus of scientific and
bioethical inquiry, not simply the techniques which initiate
the process. After all, just think if nature had not beaten
us to the development of twins. Wouldn't there be a huge cry
about how we ought not to have identical twins because it
would be unnatural to have two people so similar to each
other?
Thank you for permitting me to express my viewpoints. I am
sure they are shared by many scientists in this country.
Sincerely,
Norman Abeles, Ph.D,
Professor and Immediate Past President.
____
American Association for the
Advancement of Science,
February 2, 1998.
Hon. Christopher S. Bond,
U.S. Senate, Senate Russell Office Building, Washington, DC.
Dear Senator Bond: The American Association for the
Advancement of Science (AAAS) has followed with interest the
developments of the past year related to cloning, including
current and proposed legislation regarding the possible use
of somatic cell nuclear transfer to clone a human being.
Throughout its 150-year history, AAAS has been a pioneer
among American scientific organizations in addressing the
moral and ethical issues related to scientific developments.
We are deeply concerned about the scientific and ethical
issues raised by the possibility of cloning human beings and
believe that a much more complete understanding of these
issues is essential before such experiments are even
considered. At the same time, however, we are also concerned
that well-intentioned legislation in the area of human
cloning may inadvertently impede vital research in
agriculture, biotechnology, pharmaceuticals, and genetics.
We urge that congressional leaders use great caution in
drafting legislation to ban human cloning. Congress should
consult with leading researchers in genetics and other areas
of the life sciences in crafting language so that definitions
of scientific and technical terms are well understood and the
resulting laws do not impede important research that may use
similar techniques but do not raise the same kinds of moral
and ethical concerns. Such related research can yield great
benefits, for example, in increasing agricultural production,
generating new products through biotechnology, finding cures
for genetic disorders, and reducing the costs of
pharmaceuticals. It is essential that these legitimate and
socially-important areas of research not be adversely
affected by legislation aimed at restricting human cloning.
AAAS, founded in 1848, is the world's largest
multidisciplinary scientific association, with 145,000
individual members and nearly 300 affiliated scientific and
engineering societies. Our Committee on Scientific Freedom
and Responsibility has been a powerful voice for ethics in
science and, in collaboration with our Program of Dialogue
Between Science and Religion, held a major public forum in
Washington last June that explored scientific, moral,
ethical, and religious implications of human cloning. We are
eager to assist in promoting a responsible and constructive
dialogue between scientists, policymakers, and the public in
this area, and stand ready to assist you in any manner that
would be useful.
Sincerely,
Richard S. Nicholson.
____
College of Veterinary Medicine,
University of Missouri-Columbia,
Columbia, MO, February 4, 1998.
To: Ms. Adira Simon, Senator Kennedy's Office.
From: R. Michael Roberts, Curators' Professor and Chair,
Veterinary Pathobiology.
Subject: Feinstein/Kennedy (S1602) versus Bond (S1599).
I am sending you a copy of my letter to Senator Bond, which
addresses some of the same scientific issues raised in your
comparison.
I have read S1602 and believe that it would be well
accepted by scientists, including members of the Society for
the Study of Reproduction, and the Developmental Biologists.
What is important is criminalization of any intent to produce
a baby and not to ban a possibly desirable outcome of the
technology, which is the generation of replacement cells and
tissues for an individual. The Feinstein/Kennedy Bill also
creates a moratorium rather than a difficult-to-reverse ban
on cloning of human beings. Again, most scientists would find
this comforting.
I should point out that the term ``somatic cell nuclear
transfer technology'' has much broader meaning than the way
it is defined in either bill. Nuclear transfer between
somatic cells is a common technique and has been used for
decades. I would be happier if the wording of both bills made
it clear that it is the transfer of a somatic cell nucleus to
an oocyte to create a human baby that is the issue.
What I found contradictory about S1601 is that it creates
an elaborate commission to report on cloning (and other
issues), yet the very technique that could allow future
discourse will have been criminalized.
In summary, I judge the Feinstein/Kennedy Bill likely to
accomplish what most scientists and the lay public support, a
ban on cloning human beings. It will not prohibit the
legitimate use of somatic nuclear transfer to oocytes to
create replacement tissues, and it places a time limit on the
ban, which can be extended as public and scientific sentiment
dictates.
____
University of California,
San Francisco,
January 30, 1998.
Hon. Senator Kennedy,
U.S. Senate, Washington, DC.
Dear Senator Kennedy, I am writing to express my profound
appreciation and support for your efforts to preserve the
opportunities for continuing research in the United States on
the earliest stages of human development. I can provide you
with the names and histories of several patients in our
experience who have benefited directly from prior research
and diagnostic procedures leading to healthy pregnancies and
births. In addition, I can provide you with one or more names
of families whose health misfortunes could have been or could
be avoided through research on early products of human
conception.
Please tell me if this additional information will be of
value to you. I applaud your efforts to achieve a responsible
bill on the subject of human cloning prohibition that does
not impede the benefits of basic and clinical research for
the American people.
Sincerely yours,
Roger A. Pedersen, Ph.D.,
Professor and Research Director, Reproductive Genetics
Unit, Department of Obstetrics, Gynecology and
Reproductive Sciences.
Mr. BOND. Mr. President, may I inquire of the distinguished Senator
from California how long she will be? We have not had an opportunity
for an opening statement. I would like to know how long she proposes to
proceed in opposition.
Mrs. FEINSTEIN. I would like to respond to the distinguished Senator
from Missouri. I think the Senator is right. I do have a very lengthy
presentation to make, and it is going to be quite involved. I would be
very happy to yield to him to make his opening statement if he would
see that I have the floor regained directly following his statement.
Mr. BOND. Mr. President, I would be happy to ask unanimous consent
that when my remarks are finished, the Senator from California be
recognized.
The PRESIDING OFFICER. Without objection, it is so ordered.
The Senator from Missouri is recognized.
Mr. BOND. Mr. President, I thought before we got into a full-fledged
debate saying this is bad, perhaps my colleagues would like to know
what it is that we propose to do, speaking for the sponsors of this
measure. It is obviously one that is going to take some discussion and
debate, and it's very helpful to know some of the objections that are
raised to it. Again, for the sake of the Record, let me say what this
is.
This measure is a very carefully and narrowly targeted provision that
places an outright ban on the use of somatic cell nuclear transfer for
human cloning purposes. It defines one technique, the technique that
was used to
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create, by cloning, the sheep Dolly and says that you shall not do that
for human beings --quite simply.
Why is this necessary? Why is it necessary that we move forward on
this? Well, frankly, recent reports show that a Chicago-based scientist
is prepared to move forward with human cloning experimentation. I think
this forces an immediate debate on how far out on a moral cliff we are
willing to let science proceed before we as a nation insist on some
meaningful constraints. We no longer have the luxury of waiting around
for this morally reprehensible act to occur.
That scientist is proposing to raise huge sums of money and promise
infertile couples that he can clone human beings for them. The time for
the debate and action is now. If creating test tube babies by cloning a
human embryo is morally, ethically, and practically wrong, as I
strongly believe it is, we need to stop it now. To delay it, to
filibuster it, to postpone it means that not only this scientist and
others who, perhaps, are not holding news conferences, can go forward
with a process that I believe the overwhelming majority of American
people believe is wrong, as I believe it is. To those who say we have
not studied this or debated this, I only say that since we had this
story about the cloning of Dolly the sheep, and stories of
organizations and individuals pursuing human cloning, they have kept
the debate alive. The American public is asking if similar techniques
can be used to clone human beings, and they are concerned very deeply
whether something which was thought only to be science fiction is now
closer to reality.
Now, there are some distinguished books that oppose a prohibition on
human cloning. They suggest that we cannot put the genie back in the
bottle and we cannot stop progress. I suggest that we have come to the
point where our technological capability may be outrunning our moral
sense. We have, in this body, carried a prohibition against Federal
funding of cloning human embryos. We have prohibited the research and
experimentation with Federal funding because we thought it was way down
the line. We didn't want to see money used. Last year, after the
cloning of Dolly the sheep, we held hearings; tremendous amounts of
testimony were presented. I personally testified before Senator Frist's
subcommittee. This is not a new debate. The reason this debate is
important, and the reason that action is important is that now we are
faced with scientists of, I believe, questionable judgment, who would
go forward with something that is morally reprehensible.
This measure is targeted narrowly to one specific process that was
used to clone the sheep Dolly. It is the somatic cell nuclear transfer
to create a human embryo. In addition to prohibiting that, we have, at
the urging of my distinguished cosponsor, Senator Frist, provided for a
commission to study the ethical implications of related technologies.
And I believe we have made it clear that ongoing legitimate activity,
short of this one specific process, cleaning out a human embryo and
putting in a nuclear cell transfer, and starting the process of
differentiation of the cell toward creating a test tube baby is
unacceptable.
The ethical implications of human cloning are staggering. I believe
that we would have the overwhelming understanding and support of the
American people that we should never create human life for spare parts,
as a replacement for a child who has died, or for unnatural or selfish
purposes. How many embryos or babies would we tolerate being created
with abnormalities before we perfect human cloning? It took Dr. Wilmut,
the Scottish scientist, 276 tries before creating Dolly, and we still
do not even know if Dolly is the perfect sheep. For humans, those
results are unacceptable--creating tremendously deformed human embryos
or human beings. Dr. Ian Wilmut, the lead Scottish scientist who
created Dolly, himself stated that he can see no scenario under which
it would be ethical to clone human life. And he is right.
In September of 1994, a Federal human embryo research panel noted
that, ``Allowing society to create genetically identical persons would
devalue human life by undermining the individuality of human beings.''
Further, the panel concluded that there are moral concerns about the
deliberate duplication of an individual genome, and that making carbon
copies of a human being is repugnant to members of the public. ``Many
members of the panel share this view and see no justification for
Federal funding of such research.''
I emphatically argue that those statements apply to private sector
research as well. That is what we are trying to reach. It is important
to note that the legislation is narrowly drafted, and its sole
objective is to ban the use of somatic cell nuclear transfer for human
cloning purposes. We worked overtime to ensure that this language was
specific so that it would ban only the technique used to create Dolly.
This technique has also been criticized by a representative of the
pharmaceutical industry, who in a prepared statement for Members of
Congress, dated January 13, 1998, stated:
While conventional cloning technology has been used
extensively worldwide to meet global medical needs, nuclear
transfer technology is fraught with untold failures for each
partial success and has major scientific and significant
ethical issues associated with it. Furthermore, it has no
strong therapeutic or economic-based need driving it at this
time. The concept that it is a viable alternative to
infertile parents is cruel and completely unjustified. I
would challenge you not to confuse the two as the Congress
considers its options here.
Well, Mr. President, myself, Senator Frist, Senator Gregg, and
others, have met with and consulted with representatives of the
pharmaceutical industry, researchers, representatives of patient
groups, and we have told them what we are proposing to do, and we have
listened to them discuss all of the implications. We know that in vitro
fertilization, plant and animal cloning, cloning of DNA cells and
tissues, stem cell research, gene therapy research, and other
activities taking place at the Human Genome Center offer great hope in
addressing how to prevent, diagnose, and treat many devastating
diseases. These types of research will continue to thrive, that is
clear, because we have targeted our ban so narrowly, and we intend only
to prohibit, by cloning, the creation of the human embryo.
This is a technique characterized by industry, researchers,
theologians, ethicists, and others, as fraught with failures and
lacking therapeutic value. This bill, however, does allow the important
and promising research to continue. I have long been a supporter of
biotechnology. I have supported biotechnology efforts. I continue to
support everything from human genome mapping to all of the other human
research efforts. We have no problems with and support cloning of
animals. But there is a bright line between those activities and human
cloning, and we must draw that line. There is a line, Mr. President,
and that line is clear.
You can do all the research you want. You can create organs, you can
do all kinds of experimentation. But you should not be able to create a
human embryo by cloning, starting a test tube baby. Now, there are some
who say that it is all right so long as you don't implant that cloned
human embryo, so long as you destroy it. Once you start the process of
creating this test tube baby, it is OK to destroy it. As a matter of
fact, they would have us believe that we would start all these human
embryos, start the cell differentiation, and then wipe them out. Well,
I think that raises serious questions with many people, and I am
included in that. But it also raise also the prospect that once you
start cloning these human embryos--they are very small --they can be
transported very easily, picked up and taken from this country to
someplace else in the world in large numbers, where there may be no ban
on implementation. The difficult science is creating the human embryo.
Once you do that, you have opened a whole area. And to say we are just
going to prevent them from being implanted so a baby is brought to
term, that won't get it because that is too late. I have heard the
arguments of those who oppose this bill. And, quite frankly, let me
tell you what those arguments are.
They are that some scientists would like to be able to create human
embryos, play with them, and experiment with them, experiment with a
human embryo that is differentiating and starting to grow, and say,
``OK. Time is
[[Page S430]]
up. We will toss this one away and we will start playing with another
one.'' Once you get into that process, Mr. President, you have stepped
over the moral and ethical line. There is a clear line. There is a very
clear line.
We are ready to have the argument because I believe a significant
majority of the Members of this body reflect a significant,
overwhelming view of the American people that that is unacceptable.
There may be well-intentioned scientists who say we need to play with
human embryos and start these embryos growing and let us play with
them. They may get something. They may develop some scientific
knowledge. But the statements I have already presented show that there
is no really legitimate, scientific need, and, in fact, there are grave
moral and ethical reasons not to. I strongly hold the belief that all
human beings are unique and created by God. And I think billions of
people around the world share it. Human cloning, a man's attempt to
play God, will change the very meaning of life, of human dignity, and
what it is to be human. Are we ready for that? I don't think so.
Mr. President, the Washington Post in October of 1994 in an editorial
said:
The creation of human embryos specifically for research
that will destroy them is unconscionable. Viewed from one
angle this issue can be made to yield endless complexities.
What about the suffering of individuals and infertile couples
who might be helped by embryo research? What about the status
of a brand new embryo? But before you get to these questions,
there is a simpler one. ``Is there a line that should not be
crossed even for scientific, or other gain, and, if so, why
is it?"
That is the quotation from the Washington Post. In case you missed
it, let me give you the first sentence again. ``The creation of human
embryos specifically for research that will destroy them is
unconscionable.''
That is a simple, straightforward statement with which I agree, and I
believe when the Members before the body have an opportunity to reflect
on it and consider it, they will agree that is right.
Let me quote President Bill Clinton, 1994.
The subject raises profound ethical and moral questions as
well as issues concerning the appropriate allocation of
Federal funds. I appreciate the work of the committees that
have considered this complex issue, and I understand that
advances in in vitro fertilization research and other areas
could be derived from such work. However, I do not believe
that Federal funds should be used to support the creation of
human embryos for research purposes.
That is the President. He said don't create human embryos by cloning
for research.
That is the question. Those who would delay and filibuster want to
avoid that question and delay it. I know they are well-intentioned. I
know they may have great reservations. They may not agree with that
simple moral standard. But there are people out there who want to start
that process, who may as we speak be engaged in that process.
We have debated whether cloning of human embryos is a good idea. I
think there is a clear consensus. We have drafted a narrow bill, a
targeted one that I hope we can move forward to enact. There is a lot
of smoke and mirrors, and there are a lot of discussions about a whole
range of other options. These are very technical. That is why we set up
a commission to review all of these things. What we are targeting right
now is the one procedure that has been used with sheep, and could be
used, if it is not stopped, to start creating human embryos. For those
people who want to create human embryos for research purposes and
destroy them or implant them, I say you are going across the line. I
don't care what your motives are. I don't care whether it is
profitable. I don't care what you think might come out of it. At this
point we are saying, ``No, you cannot cross the line.''
Mr. President, that is what this debate is all about. I believe that
we may have an opportunity, if discussion continues, to bring this
debate to a close. At such time I will be back on this floor to say, if
you want to allow the scientific community and some people with
different sets of standards and different sets of judgments to go ahead
and attempt to create human embryos by cloning by a somatic cell
nuclear transfer, go ahead and support the extended discussion. Vote no
against cloture. But, by doing so, you are providing a green light. You
are saying, go ahead and use this technique that I believe is
unacceptable and should be made illegal in this country as it is in the
United Kingdom, Germany, Canada, and many of the other developed and
leading countries in the world.
Mr. President, I appreciate very much the Senator from California
allowing me to explain what the bill is and what it is not. I yield the
floor.
Mrs. FEINSTEIN addressed the Chair.
The PRESIDING OFFICER. The Senator from California.
Mrs. FEINSTEIN. Mr. President, I thank the distinguished Senator from
Missouri. I appreciate his comments. And I must tell him that in the
main I agree with him.
We have submitted an alternative bill to Bond-Frist. It is Feinstein-
Kennedy.
I am opposed to human cloning. I believe human cloning is
scientifically dangerous, it is morally unacceptable, it is ethically
flawed, and we should outlaw it. That is not the issue.
The issue is we are dealing with a complex subject. The bill at hand
is a bill that uses words and does not define those words. There is the
rub.
So the issue here today is whether we go ahead and ramrod through
legislation with virtually no consideration by this body, legislation
that would impose a permanent ban forever with prison terms of up to 10
years, and we will not understand fully what that bill will do. That is
why the medical and the scientific research community have asked us to
proceed with caution.
Let's say that you don't believe me. Would you believe the
Biotechnology Industry Association representing the entire
biotechnology community? Let me quote from page 4 of their 9-page
statement to us.
The current Bond bill goes beyond cloning because it does
not define the term ``somatic cell'' or limit to cases where
the DNA is identical. It only defines the term ``somatic cell
nuclear transfer,'' but it does not define the term ``somatic
cell.'' We need a brief glossary of terms to define what
constitutes a ``somatic cell.''
``Zygote'' means a single celled egg with two sets (a
diploid set) of chromosomes as normally derived by
fertilization;
``Egg'' and ``oocyte'' mean the female gamete;
``Gamete'' means a mature male or female reproductive cell
with one set (a haploid) set of chromosomes;
``Sperm'' means the male gamete;
``Somatic cell'' means a cell of the body, other than a
cell that is a gamete, having two sets (a diploid set) of
chromosomes;
Here is the point.
So a ``somatic cell'' is any cell of the body other than a
gamete, and it includes a fertilized egg. This means that the
current Bond bill would make it a crime to use somatic cell
nuclear transfer even in cases where the somatic cell
contains a nucleus derived from sexual reproduction, which is
obviously not cloning. This means that even though the
nucleus is not a clone, the current Bond bill makes it a
Federal crime to create it. This means that the current Bond
bill goes beyond the issue of cloning.
Because of this coverage of all ``somatic cells'' the
current Bond bill would make it a crime for doctors to use a
currently effective treatment for mitochondrial disease. In
this treatment women who have the disease have an extreme and
tragic form of infertility. The disease is a disease of the
mitochondria, which is an essential element of any egg. The
treatment for this disease involves the use of a fertilized
nucleus which is transferred through the use of somatic cell
nuclear transfer to an egg from which the nucleus has been
removed. The new egg is a fresh, undiseased egg. The current
Bond bill would make it a crime to provide this treatment
even though the nucleus which is transferred is the product
of fertilization, not cloning.
This is the Biotechnology Industry Association's statement.
It goes on into other areas that would be prohibited. But let me say
what I think the major problem here is.
The key terms in this bill are undefined, and the full scope of the
bill is unknown by anyone in this body. It is just 48 hours old. We
don't understand the impact of it. The bill is not ready for rushing to
the full Senate for immediate consideration.
The Bond-Frist bill fails to define the following terms: somatic
cell, oocyte, embryo, and preimplantation embryo.
These are all technical, scientific, state-of-the-art terms that need
definition. The bill actually drops the definitions that were in
earlier versions of it.
Undefined key terms will chill vital medical research and treatment.
The medical and scientific community has
[[Page S431]]
overwhelmingly stated that this bill would chill important scientific
and health research. The bill criminalizes that research. Scientists
will refuse to do that research. Venture capitalists will refuse to
fund it when faced with possible prison terms.
The Bond bill bans somatic cell nuclear transfer technology, and, as
a result, the Bond bill may ban production of genetically identical
tissues for treatment of disease and transplantation, including blood
cell therapies for diseases, such as leukemia and sickle cell anemia;
nerve cell therapy for neurodegenerative diseases such as Alzheimer's,
Parkinson's and Lou Gehrig's; multiple sclerosis; nerve cell therapy
for spinal cord injury; insulin transplants for diabetes; skin cell
transplants for severe burns; liver cell transplants for liver damage;
muscle cell therapy for muscular dystrophy and heart disease; and
cartilage-forming cells for reconstruction of joints damaged by
arthritis or injury.
Let me say what I think the problem is.
Senator Kennedy and I have another bill. We approach this
differently. Rather than banning all somatic cell nuclear transfer,
period, the end, we say you can't use this technology if you are going
to implanting it in a human uterus. You cannot grow a baby by
implanting it in a human uterus.
Let me restate that.
You cannot grow a baby using this technology unless it is implanted
in a human uterus. I have confirmed that, to my knowledge,
scientifically at this stage, there is no way of doing it. However, you
can use this somatic nuclear cell transfer for the tissue research, the
other areas of research that I am talking about. Once you ban the
technology, you cannot use it for these other areas of research.
That is why we feel that the place to ban it is with implantation in
the female uterus or womb. That stops the production of a baby. It is
dangerous. It took 277 implants in Dolly before they got it to work.
And there is a lot we do not know about the procedure. It is terribly
dangerous because you are taking a cell at a certain degree of
maturity, not an infant cell. You are taking a mature cell, and you
don't know what the impact of that cell is going to be on developmental
disabilities and the rest of human development.
So scientifically it is dangerous to clone a human. Morally, we say
it is unacceptable, and there are a lot of reasons for this: Who would
clone? What rules do you set up in cloning? Do you permit the cloning
of Adolf Hitlers and the other less favorable characters of history,
history past and history future.
So there are many, many questions to discuss. I think everyone in
this body believes that human cloning should be made illegal, but we
should not attack the technology from which so much good can come. For
example, using this technology scientists believe that it will be
possible to treat third-degree burns, to provide skin grafts because
the DNA would be the same. We may that be able to clone their skin,
grow that skin and transfer that skin without rejection. The same thing
may be true of diabetes, and particularly in juvenile diabetes which is
so recalcitrant and so difficult to handle.
This technology may offer a cure. And with respect to cancer, this
technology is what is used in the mass production of anticancer drugs.
It would stop all of this particular technology.
So the key is not to stop the technology. The key is to stop the
implantation of the embryo produced by this technology in a human
uterus. That is what we do in our bill. And that is why I can say
virtually all of the scientific community supports Feinstein-Kennedy
and opposes Bond-Frist.
Now, I am aware of the fact our staffs met earlier this morning. We
all want the same thing. Let me beg this body, do not do something in a
rush that is going to mean one day someone is not going to have a cure
for cancer or diabetes or somebody lying in a burn unit at St. Francis
Hospital in San Francisco or anywhere else is not going to make use of
this technology to produce tissue that the body will not reject.
That is really the issue. Why does this have to be done in 48 hours?
The FDA says it will prevent human cloning. Why are we rushing to do
something and use terms like somatic cell and we do not define in the
legislation what a somatic cell is. How many people do we condemn to
death because we shut off research because anybody that does any
research will have a 10-year Federal prison sentence, a 10-year Federal
prison sentence if you do research on somatic nuclear cell transfer to
try to develop a skin graft for a third-degree burn that will not be
rejected?
That is essentially what we are talking about here today, Members of
the Senate. The Bond bill additionally could ban noncloning treatments
for diseases carried in the cytoplasm. The cytoplasm is the nonnuclear
material in a cell. So parents whose children inherit cytoplasmic
diseases can have healthy children by using a variation on somatic cell
nuclear transfer. This isn't cloning. It is curing a disease. And I am
as sure as I am standing here the Bond-Frist bill bans this kind of
therapy.
So let's have hearings. These bills should go to committee and be
considered thoroughly. Let's have the biotechnology community testify.
Let's have the scientific community testify. Let's have a glossary of
terms that we all agree upon. And let's put those definitions into a
bill. Yes, let's ban human cloning. Let's say you cannot implant a
uterus with somatic cell nuclear transfer. Then there are no babies.
Then there is no human cloning. But the rest of the research, research
to cure diseases, can move ahead.
I am aware of the fact that the distinguished Senator from Florida is
in the Chamber and may wish to make a statement. If I could regain the
floor, I would be happy to yield to him for the purpose of that
statement.
Mr. BOND. Mr. President, I think there are others in the Chamber as
well. I do not believe that we have any agreement at this time to go
back and forth with proponents and opponents. The Senator from
California has the floor, and if she wishes to yield I suggest the
Senator from New Hampshire has been here for some time.
Several Senators addressed the Chair.
The PRESIDING OFFICER (Mr. Hagel). The Senator from California has
the floor.
The Senator from California.
Mrs. FEINSTEIN. Yes, I would like to continue if I can then, and if
there is any message that I might be able to deliver on behalf of the
distinguished Senator from Florida, who probably knows more about
research into areas involving cancer than many of us in this body, I
would be happy to deliver it for him.
I say to the distinguished Senator, I do not want to yield the floor
and lose the floor because it is my intention to slow down Senate
consideration today in this rushed manner in hopes that we will be able
to send it to committee, have a hearing and follow the normal
deliberative process, including sending it back to the Senate soon for
thoughtful consideration.
Mr. MACK. I wonder if I might----
Mrs. FEINSTEIN. I am afraid to yield the floor because I may well
lose the floor and not get it back again. So I will continue, if I may.
Mr. President, just yesterday, Dr. J. Benjamin Younger, the Executive
Director of the American Society For Reproductive Medicine, wrote:
``I urge you and your colleagues to carefully consider any
human cloning legislation and to proceed through the proper
legislative channels so that a sloppily drafted bill does not
get passed and sentence millions of Americans to needless
suffering.
Mr. President, once again, I say we should not charge ahead at full
throttle on a bill that legislates issues as profound as those
surrounding human cloning. There is simply too much at stake.
I would like to give you just a quick side-by-side comparison of the
two bills under consideration that ban cloning, Bond-Frist and
Feinstein-Kennedy.
Feinstein-Kennedy, as I have said, bans the implantation of the
product of somatic cell nuclear transfer into a woman's uterus. It
makes unlawful the shipping of the product of somatic cell nuclear
transfer in interstate or foreign commerce for the purpose of
implanting into a woman's uterus. And it prohibits the use of Federal
funds for implanting the product of somatic cell nuclear transfer into
a woman's uterus. I recognize that is current in the fiscal year 1998
appropriations law, but we reinforce it in our bill.
The Bond bill, as I understand it, bans human somatic cell nuclear
transfer period. It is defined as taking the
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nuclear material of a human somatic cell and incorporating it into an
oocyte from which the nucleus has been removed or rendered inert and
producing an embryo, including a preimplantation embryo. Again, it
defines none of these terms. And it makes unlawful the importation of
an embryo produced through human somatic cell nuclear transfer
technology. It is silent on the use of Federal funds, probably because
the authors know that a prohibition on human embryo research is already
in place.
The length of the ban in our bill is 10 years. It is a permanent ban
in the Bond bill.
The reason it is a temporary ban or a moratorium of 10 years is
largely because a voluntary moratorium has been put in place by the
entire American scientific community, and to the best of my knowledge,
what they were requesting a 5-year moratorium which the President's
bill contained. We felt the 5-year moratorium was too short. We prefer
the longer period so that it can be reviewed at the end of 10 years.
The Feinstein-Kennedy bill protects and allows biomedical and
agricultural research on practices which are not expressly prohibited.
That would include research or practices involving somatic cell nuclear
transfer or cloning technologies, mitochondrial, cytoplasmic or gene
therapy or somatic cell nuclear transfer to create animals. We do not
interfere with that. The Bond bill protects or allows areas of
scientific research not specifically prohibited. It is silent on
mitochondrial, cytoplasmic or gene therapy. And that is part of our
problem here, and that is one of the reasons why we think it needs to
go to committee and we need to know at the end of the hearing exactly
what it is we are doing.
On the issue of a national commission, Feinstein-Kennedy authorizes
the current National Bioethics Advisory Commission for 10 years, from
the date of enactment. The current commission terminates in 1999. Our
would continue it and we require reports and recommendations from the
commission in 4\1/2\ years and in 9\1/2\ years. The Bond bill would
establish a new national commission to promote a national dialogue on
bioethics of 25 members appointed by the Senate and House majority and
minority leadership by December 1, 1998, to conduct a discourse on
bioethical issues, including cloning, and to report to Congress by
December 31, 1999 and annually thereafter.
On the issue of penalties, the Feinstein-Kennedy bill has a civil
penalty of $1 million or three times the gross pecuniary gain or loss
resulting from the violation, in other words, a very stringent civil
penalty. If an individual uses somatic cell nuclear transfer and
implants the product into a woman's uterus, we subject that individual
to forfeiture of any property derived from or used to commit a
violation or attempted violation. This would get at the lab or hospital
where an implantation into a human uterus would take place. Obviously,
it has to be done somewhere, and I think this is in a sense a fail-safe
major penalty because that entire lab could be forfeited.
The Bond bill has 10 years in prison or a civil penalty if pecuniary
gain is derived of not more than twice the gross gain or both. We think
10 years in prison, when definitions are not included to clearly show
what we are talking about, 10 years in prison for someone who might use
somatic cell nuclear transfer to create the DNA in a cell that could
produce a skin graft or another tissue culture, a skin graft that would
heal a burn patient, that that individual should not be subject to 10
years in prison.
On the issue of preemption, there is a difference between the two
bills as well. Feinstein-Kennedy preempts any State or local law that
prohibits or restricts research or practices constituting somatic cell
nuclear transfer, mitochondrial or cytoplasmic therapy or the cloning
of molecules, DNA cells, tissues, organs, plants, animals or
humans. So, we would set a national standard so that the States could
not pass legislation and say it's OK to insert a somatic cell in a
woman's uterus. We preempt the area.
Internationally, there are some differences in the two bills, too.
Feinstein-Kennedy has a sense of the Congress that the President should
cooperate with foreign countries to enforce mutually supported
restrictions. The Bond bill has a sense of the Congress that the
Federal Government should advocate for and join an international effort
to prohibit the use of human somatic cell nuclear transfer technology
to produce a human embryo.
I think we could easily come to agreement on many of these,
particularly this last one. I think we want the same thing.
The major difference is that the Feinstein-Kennedy bill would allow
the technology to proceed in medical research as long as it does not
involve human cloning.
Mr. President, the successful cloning of a sheep--
Mr. GREGG. Will the Senator from California yield for a question?
Mrs. FEINSTEIN. I will be happy to yield.
Mr. GREGG. Will the Senator entertain a unanimous consent request
that I be allowed to speak without taking the floor from the Senator,
so the Senator can regain the floor after I finish speaking? I will not
offer any amendments.
Mrs. FEINSTEIN. I will be happy to, again, if I can regain the floor.
Mr. GREGG. I ask unanimous consent I be allowed to speak for 5
minutes and at the end of the statement the floor return to the Senator
from California.
The PRESIDING OFFICER. Without objection, it is so ordered.
The Senator from New Hampshire.
Mr. GREGG. Mr. President, I thank the Senator from California because
I wish to address this issue, also. I, unfortunately, have a meeting
that starts at 1 o'clock.
Mr. President, I think we are all actually concerned about the issue
of human cloning, and certainly the representations by the doctor from
Chicago who stated he intends to pursue a course of commercializing
human cloning has caused us to need to accelerate addressing this as a
public policy matter. It is appropriately an issue that should be
addressed at the level of the Congress of the United States. It should
be spoken to by the people's representatives and not left to a
regulatory environment such as the FDA for a determination, because it
is a matter of dramatic import to our culture and to our scientific
community.
There is no question but that the concept of cloning a human is
unethical, inappropriate and wrong. We don't have to delve very far
into the history of this century to see the horror that can result from
a society which allows itself to pursue a course of creating humans or
designing a human race not based on God's will but based on the
determination of a political decision or a scientific community.
Obviously, the Nazi government, in its seeking of a master race,
represents one of the true horrors of the history of mankind.
So, the need to debate the issue of whether or not humans should be
cloned I think is not necessary. There should be and I believe there is
almost unanimity on the need not to allow human cloning to go forward
in our society or any other civilized society. I think it is
interesting to note that the European Community has also banned human
cloning. The question becomes how should we proceed and whether we
should proceed with a bill that has been designed by Senator Bond,
Senator Frist and to some part myself, or whether we should proceed in
some other manner. I for one strongly support the initiative that is
put forward by the bill which we are presently considering because it
addresses the core issue of human cloning, which is the creation of an
embryo through the process of somatic cell nuclear transfer. That is
really the question here.
In order to clone a human, you produce an embryo and as a result you
get a human if you follow the next scientific steps. What we have done
is limited dramatically and really focused the question specifically on
the necessary scientific acts to produce a cloned human and then said,
``No, you cannot proceed in that direction.'' That is the way it should
be addressed.
This bill was structured in order to respond to the very legitimate
concerns of the scientific community for further research in all the
areas the Senator from California has outlined. This bill does not, in
my opinion, in any way limit the research into those areas because this
bill is purely directed at the embryo issue and the creation of a
cloned human being as a result of taking that step. The scientific
[[Page S433]]
issues are further protected by the commission which is in this bill,
which says essentially that we have in place, or will have in place, a
bioethical commission which will be able to evaluate science as it
evolves and make a determination as to when science needs to have more
leverage or needs to have more flexibility and then can come to the
Congress and say what changes should occur in order to allow for that
flexibility. So there is in place a commission which is not only
scientifically based but is theologically based and which is
politically based, in the sense that it represents, not politicians,
but the community at large and which will have the capacity to review
what is happening in the area of cloning technology so that we can stay
ahead of the curve and be sure we are not limiting the scientific
experience and expansion in this very critical area.
So this bill allows for cloning in the area of agriculture and it
allows for cloning in the area of animal husbandry. It also allows for
cloning for the production of organs. It allows for cloning in stem
cell research technology. It allows for cloning in a whole variety of
places. Where it does not allow cloning is in the production of a human
being, and that is what we should be saying. As a matter of ethics, as
a matter of policy, as a matter of a nation which must stand up and
define its purposes and ideas, we should be saying humans shall not be
cloned.
I yield my time.
The PRESIDING OFFICER. Under the previous order, the Senator from
California is recognized.
Mrs. FEINSTEIN. Mr. President, I know there are others on the floor.
The distinguished Senator from Texas and my friend and colleague from
Massachusetts wished to speak on this issue. I would just like to wrap
up very rapidly.
This whole issue was really galvanized with the cloning of the sheep
Dolly. Let me reinforce the fact that it took 277 attempts before this
cloning was successful. The impact of the cloning is not yet known.
The second point is that the science is such that huge disabilities,
real problems can result from human cloning. It is unsafe.
And my third point is, the circumstances to not require us to rush.
Chicago physicist Dr. Richard Seed propelled the debate into full force
last month when he told the media that he intended to clone human
beings. And he said that there were 10 clinics in the United States
interested in offering cloning services and that he believed the demand
would be for 200,000 cases per year. That's according to the American
Medical News.
Since that time, as you know, the scientific community itself has
exercised a self-imposed moratorium on human cloning. I know of no
legitimate lab, hospital, or facility that will permit human cloning
today. I also would like to add that the FDA has said that they are
asserting jurisdiction in this area and will not permit human cloning.
So I respectfully submit to those who feel there is time pressure that
forces us to proceed to the Senate today, that is not correct. There is
time for us to take time to consider this issue, to hear the testimony,
to go over the scientific terms, to really debate whether the
Feinstein-Kennedy approach or the Bond-Frist approach or perhaps a
third or fourth approach is the right way to go.
So I would like to end my comments today, Mr. President, by thanking
you for your discretion and by appealing to the majority side of this
body. You have an opportunity to do some good. But you also have an
opportunity to do enormous harm that could cost tens of thousands of
lives needlessly if we do not legislate carefully. So let's do it
right.
I thank the Chair and I yield the floor.
The PRESIDING OFFICER. The Senator from Texas.
Mr. GRAMM. Mr. President, I ask unanimous consent that I might speak
for 10 minutes as in morning business.
The PRESIDING OFFICER (Mr. Kyl). Without objection, it is so ordered.
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