Congressional Record, Volume 144 Issue 9 (Tuesday, February 10, 1998)

[Congressional Record Volume 144, Number 9 (Tuesday, February 10, 1998)]
[Senate]
[Pages S566-S580]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

HUMAN CLONING PROHIBITION ACT

Mrs. FEINSTEIN. Mr. President, I will follow on the comments of the
distinguished Senator from Massachusetts, since the Senate is scheduled
tomorrow to vote on a cloture motion, whether to move Senate bill 1601,
a bill that prohibits the cloning of human beings. I will clarify where
we are and what the issues really are.
Let me be clear at the outset: I support a ban on the cloning of
human beings. There is widespread agreement that the cloning of a human
being should be prohibited. That agreement, I believe, exists in the
Congress. It clearly exists in the scientific community. It exists in
the medical community, in the religious community, and it exists in
virtually every patient and health group that I know of.
I submit, Mr. President, that the cloning of human beings is
scientifically unsafe; it is dangerous; it is morally unacceptable; and
it is ethically flawed. We should enact a ban. We should pass a law
that establishes the illegality of human cloning and sets forth
appropriate penalties.
The argument I make today is not the ban, but how the bill before the
Senate tomorrow, the Bond-Frist bill, would affect scientific research.
I introduced identical bills with Senator Kennedy, Senate bills 1602
and 1611 which would protect research that someday, we believe, is
likely to provide cures for many of the most dreaded diseases.

[[Page S567]]

Some examples are treatments for damaged nerve cells, for spinal cord
injuries, blood cell therapies for leukemia and sickle cell anemia,
liver cell transplants for liver damage, cartilage cells for
reconstruction of joints damaged by arthritis or injuries, the creation
of stem cells to treat burn victims, and the creation of cells to treat
some 5,000 different genetic diseases.
The bill that the leadership is trying to rush through the Senate,
Senate bills 1599 and 1601, would make it a crime with up to 10 years
in prison to conduct that kind of research--research that someday will
save lives and suffering.
Those bills, because they don't have clear scientific terms, they
don't have definitions of critical words which are part of somatic cell
nuclear transfer technology, would submit scientists to prison terms
for treatments using this technique. These penalties would have a
serious, chilling effect on promising scientific research.
Somatic cell nuclear transfer--and I am a newcomer to this so I have
had a crash course, and I still have an awful lot to learn--this
transfer process is its own science. It has a lexicon all of its own.
Scientists tell us that the traditional definitions of reproductive
health--the traditional definitions of reproductive health--do not fit
somatic cell nuclear transfer. There is the rub.
S. 1601 uses these terms but doesn't define them. The bill doesn't
define somatic cell, for example. Now, what I know a somatic cell to be
is a cell in your body. You can take a cell from a mammary gland. In
Dolly's case, the cell was taken from the udder.

Additionally, the bill does not define embryo or preimplantation
embryo. It does not define oocyte. Without clear, scientifically
accurate definitions, we don't know what we are talking about and
scientists will be reluctant to conduct research that might save lives
and alleviate human suffering.
That is the bottom line of asking for a delay, of asking that the
Senate's proper procedures be employed so that the scientific community
can come forward, provide their definitions, explain them, we can
debate them and clearly understand what we are doing.
My father used to tell me that the first tenet of medicine is ``Do no
harm.'' We can do great harm by proceeding without a full understanding
of what this is all about.
According to the Biotechnology Industry Association, Senate bill 1601
would go beyond the issue of human cloning and would outlaw research to
create stem cells. It would make it a crime for doctors to use a
currently effective treatment for mitochondrial disease. The
Biotechnology Industry Association says, ``In this treatment, women who
have this disease have an extreme and tragic form of infertility. The
disease is a disease of the mitochondria 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, endocyst 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 and not cloning.''
So there is no need to rush. The bill we are asked to vote on is one
week old--one week. It was introduced February 3, brought to the full
Senate 48 hours later, on February 5. Now we are asked to vote on
whether to continue consideration and have a vote of the bill. It has
not been referred to committee. There have been no hearings. It has not
gone through the normal deliberative process.
We should not be ramrodding a bill with this potential for harm
through the Senate. It is one of the most profound issues of our time.
This is a difficult area of science. It involves terminology and
technologies few Americans have ever studied, let alone fully
understand, terminology and technologies that few Senators understand.
It poses very serious and fundamental moral, ethical and scientific
questions.
We need not rush a bill to the floor without committee consideration.
That is the other point. The scientific community has imposed a
voluntary moratorium. The Food and Drug Administration has said they
will assert jurisdiction. Many organizations have written urging
caution.
Let me go into some of them right now. Let me begin with the American
Cancer Society, in a letter dated February 9, and I ask unanimous
consent this letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

American Cancer Society,

February 9, 1998.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: The American Cancer Society has
called for your commitment for a renewed war on cancer
through a national investment in biomedical research and
cancer prevention and control programs. The sustained
downturn in cancer mortality and incidence--for the first
time ever--is evidence that our investment in this war is
beginning to make a difference.
The current opportunities in cancer research, including our
understanding of the molecular nature of the disease, are
bringing us closer to the answers we need to prevent and cure
cancer. Congress and the Administration are calling for
unprecedented increases in funding for biomedical and cancer
research which will allow us to exploit scientific knowledge
and bring answers more quickly to the American people.
The American Cancer Society urges you to oppose S. 1601,
legislation that would prohibit the use of somatic cell
nuclear transfer. The American Cancer Society agrees with the
public that human cloning should not proceed at this time.
However, the legislation as drafted would have the perhaps
unintended effect of restricting critical, legal scientific
research. The ability to create therapeutically valuable stem
cell lines from oocytes, therefore promoting genetic
reprogramming of cells to prevent and cure cancer exemplifies
the type of research that could be hindered with overly
restrictive regulations. The current language in S. 1601
could hamper or punish scientists who contribute to our
growing knowledge about cancer.
We urge you to carefully consider all aspects of this
legislation to ensure the continued support for all legal and
ethical modalities of cancer research.
Sincerely,
David S. Rosenthal, MD,
President.

Mrs. FEINSTEIN. Let me quote one part:

The American Cancer Society urges you to oppose S. 1601,
legislation that would prohibit the use of somatic cell
nuclear transfer. . . . The legislation as drafted would have
the unintended effect of restricting critical legal
scientific research. The ability to create therapeutically
valuable stem cell lines from oocytes, therefore promoting
genetic reprogramming of cells to prevent and cure cancer
exemplifies the type of research that could be hindered with
overly restrictive regulations. The current language in S.
1601 could hamper or punish scientists who contribute to our
growing knowledge about cancer.''

The American Heart Association--I ask unanimous consent their letter
be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

American Heart Association, Office of Communications and
Advocacy,
Washington, DC, February 9, 1998.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: On Tuesday, February 10th, the
Senate is expected to initiate a cloture vote regarding a
motion to consider S. 1601, the Prohibition on Cloning of
Human Beings Act of 1998. The American Heart Association
urges you to vote against the cloture petition.
The American Heart Association wishes to make it clear that
we do not support any legislation allowing the cloning of a
human being. However, we fear that this legislation may place
biomedical research at risk and might negatively impact the
use of cloning techniques on human cells, genes and tissue
critical to identifying cures for a host of diseases,
including cardiovascular diseases. The American Heart
Association is concerned that a rush to passage of S. 1601
may inadvertently threaten to restrict critical biomedical
research, which promises to have great impact on disease
prevention and treatment for the American people.
For example, we are concerned that this legislation may
effectively ban research using the generation of stem cells
for treating heart attack victims, as well as blood vessel
endothelial cells for treating atherosclerosis.
The American Heart Association urges the Senate to engage
in a more deliberate debate on this important issue. Please
vote ``no'' on cloture for S. 1601 and allow a more extensive
debate on these complex issues.
Sincerely,
Martha N. Hill, RN, Ph.D.,
President.

Mrs. FEINSTEIN. ``The American Heart Association urges the Senate to
engage in a more deliberate debate on this important issue.''

[[Page S568]]

The Cystic Fibrosis Foundation, I ask unanimous consent their letter
be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Cystic Fibrosis Foundation,

February 9, 1998.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: The current frenzied atmosphere on
Capitol Hill surrounding the issue of human cloning instills
great fear in the scientific community. On behalf of cystic
fibrosis (CF) scientists, researchers, caregivers, and most
importantly patients, the Cystic Fibrosis Foundation (CFF)
asks all members of Congress to take the time to study the
potentially harmful ramifications of prohibitive human
cloning legislation. As America's governing body, Congress
has an unequivocal responsibility to hold public hearings on
this issue in order to fully understand the scope of this
debate. The CFF agrees that the cloning of a complete human
being should not be done. However, we have grave concerns
over current legislation that is crafted in such a way to
restrict the advancement of lifesaving biomedical research.
A voluntary moratorium on human cloning should suffice to
prevent scientists from attempting to clone a complete human
being in the laboratory. Nevertheless, if it is decided that
legislation must be drafted, extreme care should be taken not
to restrict the capacity to pursue cutting edge technologies
which hold great promise. For example, the strategy that may
ultimately be needed to achieve a cure for CF through gene
therapy techniques is called somatic cell/stem cell gene
transfer therapy.
Enactment of the Bond/Frist Cloning Prohibition Act in its
current form and other existing pieces of legislation would
prevent the use of this kind of technology. This would be a
critical set-back in our ability to develop new therapies to
treat individuals with CF and other life-threatening
diseases. To consider the passage of legislation without
appropriate debate from the scientific community, as well as
a public airing of the consequences on future biomedical
research, will do irreparable damage.
For the 30,000 children and young adults with CF in this
country, the message is clear. Do not allow hasty and
capricious action to impede our ability to impact on this
disease. It is equally important to note that until essential
scientific debate has reached completion, the cloning of a
complete human being cannot occur, as the regulatory
safeguards of the FDA already in place prevent such an act.
Your attention to this critical matter is appreciated.
Sincerely yours,
Robert J. Beall, Ph.D.,
President and CEO.

Mrs. FEINSTEIN. They say, ``To consider the passage of legislation
without appropriate debate from the scientific community, as well as a
public airing of the consequences on future biomedical research, will
do irreparable damage.''
The American Association for Cancer Research, I ask unanimous consent
that letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

American Association

for Cancer Research, Inc.,

Philadelphia, PA, February 4, 1998.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: 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
benefitted 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, Ph.D.,
President.

Mrs. FEINSTEIN. They say, ``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.''
The Juvenile Diabetes Foundation International, the Diabetes Research
Foundation, I ask unanimous consent that letter be printed in the
Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Juvenile Diabetes Foundation International,

The Diabetes Research Foundation,

February 9, 1998.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: On behalf of the Juvenile Diabetes
Foundation International (JDFI), we urge you to vote ``no''
on a motion to invoke cloture and proceed to consider S.
1601, a bill to ban human cloning. This vote is scheduled to
come before the Senate on Tuesday, February 10.
We want to be clear: there is no acceptable moral or
ethical justification for making a replica of another human
being. As currently drafted, however, S. 1601 threatens to
restrict future promising stem cell research which could lead
to improved treatments or even a cure for diabetes and many
other serious, chronic illnesses.
Diabetes affects approximately 16 million Americans and is
a leading chronic disease in children. In addition to its
severe human impact, diabetes costs about $137 billion per
year in direct and indirect expenses. Therefore, it is
critical that any federal policies affecting medical research
are crafted so that they do not unnecessarily restrict the
potential for promising future advances in diabetes research.
In the case of type 1, or juvenile, diabetes, the beta
cells of the pancreas which produce insulin are destroyed.
Promising stem cell research could make it possible to
produce pancreatic beta cells that could then be transplanted
into a person with diabetes. As a consequence, a person with
type 1 diabetes would be free of the up to eight daily blood
tests and up to six daily insulin injections that so
significantly reduce the quality of life. More importantly,
this type of cell transplantation could eliminate the
horrible complications of the disease which include: kidney
failure; blindness; amputation; increased risk of heart
disease and stroke; and premature death.
For these reasons, JDFI urges you to vote ``no'' on the
cloture motion for S. 1601, thereby allowing the Senate to
conduct a more thorough debate on this issue. We need to
better understand the impact that legislation in this area
could have on research critical to improving the lives of
people with devastating illness. In order to ensure medical
progress and the attainment of future opportunities, we urge
you to proceed cautiously.
Sincerely,
Robert Levine, MD,
Chairman, Government Relations Committee.
James E. Mulvihill, DMD,
President and CEO, Juvenile Diabetes Foundation
International.

Mrs. FEINSTEIN. They say, ``We urge you to proceed cautiously.''
Resolve, the National Infertility Organization says, ``go slow.''
I ask unanimous consent that letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

[[Page S569]]

Resolve,

Somerville, MA, January 30, 1998.
The Hon. Senator Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: RESOLVE expresses its strong
support for the cloning bill being co-sponsored by you and
Senator Edward M. Kennedy. This bill, consistent with
RESOLVE's position, includes an important provision
specifying that research using somatic cell nuclear transfer
technology should not be banned while recommending a
moratorium on the cloning of a human being until further
review.
RESOLVE is pleased to note that the proposed legislation
does not ban embryo research. Embryo research has been
instrumental in the development of procedures that allow many
couples to overcome the difficulties they experience as they
strive to build families. The emotional and physical
consequences of this struggle can be overwhelming. In vitro
fertilization is an amazing technology which would not have
been possible without the knowledge gained through embryo
research. This effective treatment has brought about the
birth of thousands of much-wanted babies. Continued embryo
research has the potential to further the understanding of
the causes of infertility, including the tragedy of
miscarriage, as well as provide information which can lead to
new breakthroughs.
As a national organization which provides support, advocacy
and education to those experiencing infertility, RESOLVE is
contacted by thousands of people from all walks of life who
are struggling with this disease. The stories about their
struggles can be heart-wrenching. The success stories about
the joy and overwhelming appreciation of the children that
are brought into this world are enormously heart-warming.
Avenues for further research to help couples must not be
halted. RESOLVE joins with many other organizations across
the country in expressing its opposition to any attempts to
ban embryo research. We applaud your efforts to develop
carefully-constructed legislation which will not impact the
potential for medical advances that will help the many
couples struggling to build much-wanted families.
Sincerely,
Diane D. Aronson,
Executive Director.

Mrs. FEINSTEIN. The National Coalition for Osteoporosis and Related
Bone Diseases says, ``Congress needs to be extremely cautious in
drafting legislation too quickly on this very complex issue.''
It is signed by several doctors. I ask unanimous consent this letter
be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

The National Coalition for Osteoporosis and Related Bone
Diseases,
Washington, DC, February 5, 1998.
The Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC
Dear Senator Feinstein: As representatives of the
Osteoporosis and Related Bone Diseases National Coalition,
which consists of scientists and patients, we are writing to
urge you to vote against human cloning legislation which
would ban some types of promising stem cell research.
We support a ban on cloning a human being. We see no
ethical or medical justification for anyone in the public or
private sector, whether in a research or clinical setting, to
create a human child using somatic cell nuclear transfer
technology. However, we are concerned that legislation which
would expedite a ban on cloning would also effectively
eliminate research on ``customized'' stem cell research which
one day could lead to cures for many diseases.
Congress needs to be extremely cautious in drafting
legislation too quickly on this very complex issue. We are
concerned that Congress will not take the time to analyze the
effects on stem cell research already underway or consider
the future benefits of such research. It is our hope that
with input from the scientific community Congress will come
to a consensus which will address the public's concern about
human cloning and yet allow the scientific community to do
their work.
Again, we urge you to protect stem cell research which can
generate cells for the treatment of numerous diseases
including osteoporosis and related bone diseases. If you need
further information about the proposed legislation, please
contact Bente E. Cooney, Director of Public Policy at the
National Osteoporosis Foundation (202) 223-2226.
Sincerely,
Bente E. Cooney, MSW,
Director of Public Policy, National Osteoporosis
Foundation.
Fred Singer, MD,
Chairman, The Paget Foundation.
Stephen Cummings, MD,
Chair, ASBMR Public Affairs Committee, American Society of
Bone and Mineral Research.
Joe Antolini,
President of the Board, Osteogenesis Imperfecta Foundation.

Mrs. FEINSTEIN. The Alliance for Aging Research strongly supports our
bill, the Feinstein-Kennedy bill. They urge a no vote on cloture. They
say this is not a vote for cloning but rather for reasoned debate that
draws upon the wisdom of scientists and medical experts:

Senators should also take time to hear from patients and
their families who yearn for cures and treatments for life-
threatening diseases. A rush to legislate in this area could
have serious consequences for research that could benefit the
lives of millions of Americans.

I ask unanimous consent to have that letter printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Alliance for Aging Research,

Washington, DC, February 9, 1998.
Hon. Dianne Feinstein,
U.S. Senate
Washington, DC.
Dear Senator Feinstein, The Alliance for Aging Research
strongly supports your efforts and those of Senator Kennedy
to legislate responsibly in the area of somatic cell nuclear
transfer technology. You and Senator Kennedy and others have
proposed a ban on human cloning without threatening vital
research efforts into cellular technologies that could
produce cures and valuable therapies for Alzheimers Disease,
Parkinsons, would healing, age-related blindness and many
other medical problems of the elderly. The not-for-profit
Alliance applauds your efforts on behalf of research, and we
urge you to vote ``no'' when a motion to cut off debate on S.
1601 comes to the Senate this week.
The Alliance for Aging Research strongly opposes the
cloning of a human being on moral grounds, as does every
responsible health advocacy organization we know. However,
the Lott-Bond-Frist bill is written so broadly as to halt
cellular technology that could be a significant tool in
developing therapies for scores of age-related diseases and
disabilities.
The Alliance is also concerned there has not been
sufficient discussion and debate to allow reasoned
consideration of this highly technical and complicated issue.
A ``no'' vote on cloture is not a vote for cloning, but
rather for a reasoned debate that draws upon the wisdom of
scientists and medical experts. Senators should also take
time to hear from patients and their families who yearn for
cures and treatments for life-threatening diseases. A rush to
legislate in this area could have serious consequences for
research that could benefit the lives of millions of
Americans.
Respectfully,
Daniel Perry,
Executive Director.

Mrs. FEINSTEIN. The National Health Council states, ``We urge careful
consideration of the issue and a vote against cloture so a more
thorough debate can occur.''
I ask unanimous consent that be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

National Health Council,

Washington, DC, February 9, 1998.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: Early this week the Senate will
decide whether to begin debate on legislation to ban the
cloning of a human being. The National Health Council, which
represents the Nation's leading patient organizations, agrees
with the American public that the cloning of a human being
should be prohibited. However, we urge careful consideration
of the issue and a vote against cloture, so a more thorough
debate can occur within the committees of jurisdiction before
consideration by the full Senate.
Current advances in medical research are, for the first
time, holding true promise of curing some of the most well-
known diseases: cancer, diabetes, and paralysis. In the past,
scientific gains have provided patients with novel
treatments, allowing us to manage disease more effectively.
But cures have eluded us.
Cloning, the duplication of scientific material, such as
cells or genes, has allowed scientists to more efficiently
study biological processes, and has led to many recent
medical advances. The technique which created the sheep Dolly
was a new approach to producing duplicate material. This
novel process, called somatic cell nuclear transfer, may hold
the key not only to understanding the function of all human
cells but also to identifying new avenues to repair damaged
cells.
By gaining a greater understanding of how cells develop and
differentiate we may be able to replace damaged pancreatic
cells with healthy cells, therefore curing diabetes. Combined
with gene therapy, cloning may also make it possible to
eliminate the transmission of such inherited diseases as
Huntington's Disease.
We appreciate your concerns regarding the issues relating
to cloning, but it is critical

[[Page S570]]

that we have a better understanding of all the implications
of the various approaches aimed at banning the cloning of
human beings. I am certain that you share our interest that
important medical research is protected. In order to ensure
medical progress and the attainment of future opportunities,
we urge you to proceed cautiously.
Thank you for your consideration of this important issue.
Sincerely,
Myrl Weinberg, CAE,
President.

Mrs. FEINSTEIN. The National Patient Advocate Foundation says,
``There is no rush to legislate.''
I ask unanimous consent their letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

National Patient

Advocate Foundation,

Newport News, VA, February 6, 1998.
Dear Senator: The National Patient Advocate Foundation
urges you to vote ``no'' on the cloture vote next Tuesday,
February 10, regarding the motion to proceed to consider S.
1601, the legislation to ban human cloning. A vote ``no'' is
a vote to protect biomedical research. It would also call for
more deliberate debate on this complicated scientific issue.
As an organization that continues to seek insurance
reimbursement for cancer therapies, therapeutic devices and
agents that hold promise of improved quality of life after a
cancer diagnosis, life extension and improvement in
preventing cancer, bio-medical research presents significant
hope for improvement in preventing, detecting and treating
cancer. We have been involved with this issue since early
last summer when the anti-cloning discussion first emerged
when the Ehler's bills was introduced. Our position then and
now is the same. Though we are in full support of no cloning
of human beings, we value the progress being made in bio-
medical research and can not support any initiative that
threatens continued research in this area. Zygotes, diploid
cells and somatic cell nuclear transfer are issues that are
complicated and present myriad opportunities for
misinterpretation without thorough discussions relative to
the impact on bio-medical research that this anti-cloning
legislation poses. We urge your no vote on cloture February
tenth, so that this matter may be addressed in detail in
hearings.
There is no need to rush to legislate. The Food and Drug
Administration has full jurisdiction to ensure that no one
will clone human beings at this time. We urge careful and
deliberate consideration of this legislation to ban cloning.
It should be carefully reviewed by key Committees, which has
not occurred. S. 1601 raises serious questions about its
scope and impact on critical biomedical research seeking
cures for deadly and disabling diseases.
This bill is not confined to``cloning'', which is the
creation of a child genetically identical to another
individual.
It would halt research to develop ``customized'' stem cells
which promise potential new treatments for many diseases and
conditions.
It would outlaw a current medical procedure to treat
infertility which uses eggs which are fertilized and contain
the genetic traits of two individuals, not the clone of one
individual.
Again, we urge you to vote ``no'' on Tuesday's cloture vote
on S. 1601 to protect biomedical research.
Sincerely,
Nancy Davenport-Ennis,
Founding Executive Director.

Mrs. FEINSTEIN. The California Biomedical Research Association,
signed by 40 or 50 major companies, urges us ``to support continuing
debate about the potential negative impact of Senator Trent Lott's
legislation.''
I ask unanimous consent that be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

California Biomedical

Research Association,

Sacramento, CA, February 9, 1998.
Hon. Dianne Feinstein,
U.S. Senate, Hart Senate Office Building, Washington, DC.
Dear Senator Feinstein: On behalf of the CBRA Governing
Board, I am writing to encourage your ``no'' vote on the
cloture vote on S. 1601 scheduled for Tuesday, February 10,
1998. The Association urges you to support continuing debate
about the potential negative impacts of Senator Trent Lott's
legislation.
Somatic cell transfer technology is essential to continuing
research into cures for some of our greatest human health
threats--Parkinson's Disease, leukemia, diabetes, Alzheimer's
disease and spinal cord injuries. Unintended consequences of
this bill as currently written could threaten the future
health of millions of Americans.
Please feel free to contact our office if you should need
further information.
Sincerely,
Suzanne Ness,
President.

members (partial list)

Allergan
Alliance Pharmaceutical
ALZA Corporation
American Association for Laboratory Animal Science:
Northern, Orange County, San Diego, Southern and Palms to
Pines Branches
American Cancer Society, California Division, Inc.
American Diabetes Association, California Affiliate
American Heart Association (Western States Affiliate and
Greater L.A. Affiliate)
American Lung Association of California
Amgen
Bayer Corporation
Berlex Bio Sciences
BioDevices
Buck Center for Research in Aging
California Institute of Technology
California Medical Association
California State University: Long Beach, Pomona, Office of
the Chancellor
California Veterinary Medical Association
Cedars-Sinai Medical Center
Charles River Laboratories
Children's Hospital Oakland Research Institute
Children's Hospital of Orange County
Chiron Corporation
City of Hope
Genentech
J. David Gladstone Institutes
Good Samaritan Hospital
Harbor UCLA Medical Center, Research and Education
Institute, Inc.
Heartport
Huntington Medical Research Institutes
Isis Pharmaceuticals
Lawrence Berkeley Laboratory
Loma Linda University
NASA Ames Research Center
Palo Alto Medical Foundation
Roche Biosciences
Salk Institute for Biological Studies
San Diego State University
San Jose State University
Scripps Research Institute
Stanford University
The Parkinson's Institute
University of California: Berkeley, Davis, Irvine, Los
Angeles, Riverside, San Diego, San Francisco, Santa Barbara,
Santa Cruz, Office of the President
University of Southern California
Veterans Administration Medical Centers at: Loma Linda,
Long Beach, Palo Alto, San Diego, San Francisco, Sepulveda,
West Los Angeles.

Mrs. FEINSTEIN. The AIDS Action Council, the Allergy and Asthma
Network, the Alliance for Aging Research, the Alzheimers Aid Society,
the American Academy of Optometry and the American Academy of
Pediatrics urges that we ``proceed with extreme caution and adhere to
the ethical standards for physicians, `first do no harm'.''
I ask unanimous consent that the letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

January 26, 1998.
Re legislation to ban cloning of human beings.

Dear Member: We are writing to express our concern about
legislation pending in the Congress to ban the cloning of
entire human beings.
Let us be clear. We oppose the cloning of a human being. We
see no ethical or medical justification for the cloning of a
human being and agree with the conclusions of the National
Bioethics Advisory Commission (NBAC) that it is unacceptable
at this time for anyone in the public or private sector,
whether in a research or clinical setting, to create a human
child using somatic cell nuclear transfer technology. We
recognize that this application of the technology raises
fundamental ethical and social issues. This technology is not
currently safe to use in humans.
The American Society for Reproductive Medicine, the
Biotechnology Industry Organization, and the Federation of
American Societies of Experimental Biology have all stated
that their members will not seek to clone a human being.
These three associations include essentially every researcher
or practitioner in the United States who has the scientific
capability to clone a human being.
We agree with NBAC in its report on cloning that: ``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.'' Poorly crafted
legislation to ban the cloning of human beings may put at
risk biomedical research, such as the use of cloning
techniques on human cells, genes and tissues, which is vital
to finding the cures to the diseases and ailments which our
organizations champion. Cancer, diabetes, allergies, asthma,
HIV/AIDS, eye diseases, spinal cord injuries, Guillain-Barre
syndrome, Gaucher disease, stroke, cystic fibrosis, kidney
cancer, Alzheimer's disease, tuberous sclerosis, tourette
syndrome, alcoholism, autoimmune diseases, osteoporosis,
Parkinson's disease, infertility, diseases of aging, ataxia
telangiectasia and many other types of research will benefit
from the advances achieved by biomedical researchers.
We urge the Congress to proceed with extreme caution and
adhere to the ethical standard for physicians, ``first do no
harm.'' We believe that there are two distinct issues here,
cloning of a human being and the healing which comes from
biomedical research.

[[Page S571]]

Congress must be sure that any legislation which it considers
does no harm to biomedical research which can heal those with
deadly and debilitating diseases.
Please keep patients' concerns in mind as you proceed in
analyzing this very complicated issue.
Sincerely,
AIDS Action Council.
Allergy and Asthma Network/Mothers of Asthmatics, Inc.
Alliance for Aging Research.
Alzheimer Aid Society.
American Academy of Optometry.
American Academy of Pediatrics.

Mrs. FEINSTEIN. The Biotechnology Industry Organization, which
represents literally hundreds of biotech organizations, says, ``We are
very concerned about the rushed process to pass legislation on this
complex subject and the possibilities for unintended consequences.''
I ask unanimous consent to have the letter printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Statement of the Biotechnology Industry Organization (BIO) 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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 create a 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 of 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 diabetics; 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 treatment 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 ``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 types 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 power approaches involving cultured stem cells. Studies
of these cells obtained from a mouse's stem cells show that
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 adults 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 differentiated 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

[[Page S572]]

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) or
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 it
a crime to provide this treatment even though the nucleus
which is transferred is the product of fertilization, not
cloning.

customized stem cells

If the current Bond bill was limited to somatic 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, 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 be 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--if 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 transferred 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 focused 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
and 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
ares 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 ``mitochondrial'' 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 disease
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 produce insulin) for transplantation''
(NBAC report at 30). The Clinton Administration proposed law,
like the Feinstein bill, avoids the peril identified by 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

[[Page S573]]

perform this ongoing review. The Feinstein bill calls on NBAC
to conduct the reviews.

Mrs. FEINSTEIN. Finally, there are hospitals and universities, the
University of California Medical Center in San Francisco, the
Reproductive Genetics Unit, also sent a letter.
I ask unanimous consent to have that printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

University of California,

San Francisco, CA, February 4, 1998.
Hon. Senator Kennedy,
U.S. Senate, Washington, DC.
Dear Senator Kennedy: I am writing to express my deep
concern about the negative impact of impending legislation
introduced by Senators Bond, Frist et al. (S. 1599) intended
to regulate cloning of a human being. As an active researcher
in the scientific field of the discovery leading to Dolly, I
understand its implications for basic science and human
health. Dolly's existence proves for the first time that the
genetic material of an adult body cell can be completely
reprogrammed by the egg, thus totally restoring the genetic
potential for specializing into all possible cell types. This
discovery that genetic reprogramming is possible in mammals
is as important to human health as the discovery of
penicillin. Basic research on genetic reprogramming will
likely lead to novel transplantation therapies for numerous
human disease, including heart disease, diabetes,
neurodegenerative diseases (such as Parkinson disease),
genetic diseases and birth defects. I believe that imprecise,
hastily-written legislation against human cloning, such as S.
1599, will hinder these important research opportunities for
understanding genetic reprogramming of adult cells. Excessive
regulation as specified by S. 1599, including civil penalties
and criminalization, in the areas of this new discovery is
likely to thwart the momentum of basic research on genetic
reprogramming and deter the enthusiasm and ability of
researchers poised to make new contributions in applying
their findings to human health problems.
In no conceivable instance would research on genetic
reprogramming involve cloning of human beings. Indeed,
active, credible researchers and clinicians overwhelmingly
regard cloning a human being as an unethical and
reprehensible act. Last year, working through the Society for
Developmental Biology, I spearheaded a voluntary moratorium
on cloning human beings. This moratorium unequivocally states
that we have no intention to clone human beings, where this
is defined as ``duplication of an existing or previously
existing human being by transferring the nucleus of a
differentiated, somatic cell into an enucleated human oocyte,
and implanting the resulting product for intrauterine
gestation and subsequent birth.'' To date, 15 additional
scientific and medical societies, including the Federation of
American Societies for Experimental Biology, the American
Society for Reproductive Medicine, and the Society for the
Study of Reproduction, together representing more than 60,000
reproductive, developmental, cell and molecular biologists,
have endorsed this moratorium. Historical precedent (with
recombinant DNA technology) indicates that a voluntary
moratorium can deter activities that are potentially unsafe
for humans. It is evident from recent events that anyone who
advocates cloning human beings for any purpose will be
subjected to ostracism and discredited scientifically.
Therefore, I believe that the existing voluntary moratorium
against cloning human beings is an effective means of
regulating the behavior of U.S. scientists and physicians.
Presently, the fields of developmental biology and human
genetics are at an exciting juncture, where many novel genes
are being identified through the Human Genome Project and
their functions during normal development are being
understood for the first time. In addition, an understanding
of how these genes interact with the internal and external
environment of the cell is emerging for studies such as those
giving rise to Dolly. Deriving the full benefits of these new
insights for human health will require a dedicated and
cooperative research effort by many scientists, including
those who conduct research on human cells and tissues.
In conclusion, there is a great risk that anti-cloning
legislation would deprive the American people of
unprecedented human health benefits. I thus urge extreme
caution in any legal sanctions, such as those included in S.
1599, which would have lasting detrimental effects on our
ability to alleviate human diseases, and would also undermine
the competitive abilities of U.S. scientists in our field.
Respectfully yours,

Roger A. Pedersen, Ph.D.,

Professor and Research Director, Reproductive Genetics
Unit,
Department of Obstetrics, Gynecology and Reproductive
Science.

Mrs. FEINSTEIN. Let me move for a moment to think tanks. I must say,
Mr. President, that one of the most interesting letters to me is one
from the CATO Institute, dated February 6.
They attach to their letter a very interesting article from Science
magazine which really casts major doubts on the conclusions drawn from
the Dolly experiment.
The letter says that the new information indicates that there is no
need to rush legislation, and it can be accorded the time and
deliberation appropriate to legislate that can have a lasting impact on
biological research in this country.
The article from Science magazine questions whether Dolly originated
from adult cell DNA. Interesting. And it suggests that she might have
resulted from the cloning of an embryonic cell. ``Scientists have
cloned embryonic cells for years, and those activities have raised no
public concern. The last sentence in the first paragraph of the Science
news article sums up the significance of the new information. If Dolly
isn't the product of DNA from a mature cell, `it would mean that human
cloning, which for most conceivable purposes would start with adult
cells, is not the immediate threat some worry about.' ''
And CATO goes on and says:

With this new information in hand, there appears to be no
need to rush legislation, and at a minimum there is ample
time for hearings with knowledgeable and respected
scientists, ethicists, theologians, and others testifying
about the proposed legislation and its ramifications.

The CATO letter continues,

Many scientists, including the Director of the NIH, worry
that hastily drafted and loosely drawn legislation directed
against cloning will foreclose research that promises new
drugs and the capacity to replace or repair nerves, skin, and
muscle lost to injury or disease. The information from
Science indicates that legislative haste is not necessary.
I ask unanimous consent that the CATO letter be printed in the
Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Cato Institute,

Washington, DC, February 6, 1998.
Hon. Dianne Feinstein,
Washington, DC.
Dear Senator Feinstein: As you are well aware, the uproar
over Dolly and the perils that many people see in the
possibility of human cloning have resulted in the
introduction of legislation to prohibit research into human
cloning. A letter and news article from this week's Science
magazine (enclosed) cast doubt on the conclusions drawn from
Dolly. The new information indicates that there is no need to
rush legislation and that it can be accorded the time and
deliberation appropriate to legislation that can have a
lasting impact on biological research in this country.
Few biological results have excited as much attention as
the announcement of Dolly's birth eleven months ago. Dolly
was important and surprising because, it was claimed, she was
produced from the DNA of an adult sheep.
Mammalian life begins with a ``totipotent'' fertilized egg
that can multiply and differentiate into all the diverse
types of cells--skin, nerves, bones, muscle, etc.--that make
up a mature animal. As cells differentiate into specialized
cells, they lose the capacity to carry out the functions of
other cell types; they are no longer totipotent. A skin cell
cannot produce a nerve, bone, or muscle cell, for example.
Dolly was a surprise because she was, apparently, the
product of DNA from a differentiated, specialized cell from
the udder of a mature sheep. The DNA was introduced into a
DNA-less egg, and the egg was implanted into the uterus of a
sheep where it developed into Dolly.
Dolly, at the time the experiment was announced last year,
appeared to open up the possibility of human cloning. In
theory, DNA could be taken from a woman or man and inserted
into a DNA-less egg, and the egg, which now contained the
genetic information from the donor, could be introduced into
the uterus of a woman. If a child resulted from the process,
she or he would be genetically identical to the woman or man
from whom the DNA came.
The enclosed letter from Science questions whether Dolly
originated from adult cell DNA, and it suggests that she
might have resulted from the cloning of an embryonic cell.
Scientists have clonsed embryonic cells for years, and those
activities have raised no public concerns. The last sentence
of the first paragraph of the Science news article sums up
the significance of the new information. If Dolly isn't the
product of DNA from a mature cell, ``it would mean that human
cloning, which for most conceivable purposes would start with
adult cells, is not the immediate threat some worry about.''
With this new information in hand, there appears to be no
need to rush legislation. At a minimum, there is ample time
for hearings with knowledgeable and respected scientists,
ethicists, theologians, and others testifying about the
proposed legislation and its ramifications.
Human cloning, if it is ever accomplished, will offer the
promise of a child to love and cherish to couples who
otherwise would be childless. Although cloning has been
greeted very negatively, it is also true that negative

[[Page S574]]

reactions met almost every advance in human reproduction
technologies--artificial insemination, in vitro
fertilization, ``fertility drugs,'' prenatal diagnoses. Those
technologies became accepted when they gave healthy children
to couples that otherwise would have been childless.
Many scientists, including the Director of the National
Institutes of Health, worry that hastily drafted and loosely
drawn legislation directed against cloning will foreclose
research that promises new drugs and the capacity to replace
or repair nerves, skin, and muscle lost to injury or disease.
The information from Science indicates that legislative haste
is not necessary.
I will be happy to talk with you or your staff and to
provide additional information.
Sincerely,
Michael Gough, Ph.D.

Mrs. FEINSTEIN. Mr. President, there are also brand new letters that
I did not enter into the Record my last time on the floor speaking
about this issue. They are from the American Society for Biochemistry
and Molecular Biology, from the professor and chairman of the
Department of Developmental Biology at Stanford University School of
Medicine, the American Society for Cell Biology, which interestingly
enough is signed by more Nobel laureates than I have ever seen signing
one letter. And this is truly amazing. There are 27 Nobel laureates on
this letter.
What they say, in summing up, is:

If legislation is deemed to be necessary, we respectfully
urge you to be sure that it be limited to the cloning of
human beings and not include language that impedes critical,
ongoing, and potential new research.

And I have letters from the American Society for Cell Biology, the
American Society for Human Genetics, the National Association for
Biomedical Research, a telegram from the Federation of American
Societies for Experimental Biology. I ask unanimous consent that these
letters be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

American Society for Biochemistry and Molecular Biology,
Bethesda, MD, February 10, 1998.
Hon. Christopher Bond,
U.S. Senate, Washington, DC.
Dear Senator Bond: We are writing to express a number of
concerns regarding your bill, S. 1601, the Human Cloning
Prohibition Act, which would prohibit the use of ``Somatic
cell nuclear transfer technology for purposes of human
cloning.'' Our main concern is that harm not be done to
biomedical research through your well-intentioned effort to
prevent disreputable individuals or companies from attempting
to clone a human being. We recognize it is not your intent to
harm biomedical research. However, we respectfully point out
that this would be the likely result if the bill were to
become law in its current form.
Our first concern is that few of the scientific terms used
in the bill are defined. The bill defines the broad term
``human somatic cell nuclear transfer technology,'' but the
definition is flawed in several ways. The use of the word
``technology'', for example, implies that it is the physical
tools needed to carry out human somatic cell nuclear transfer
that are banned, not the process itself. The technology
needed to carry out such a nuclear transfer is readily
available in any modern biological laboratory dealing with
reproductive biology; surely it is not your intention to ban
these tools.
The definition also includes as banned the production of
``an embryo (including a preimplantation embryo)''. This
inclusion would clearly interfere with work needed to develop
a variety of therapies described below for burn victims,
diabetes sufferers, and others suffering from more rate
genetic diseases.
The bill also does not define the term ``oocyte,'' which
many members of the Senate may not understand. It would be
useful to define term so these senators know what is being
discussed. The same could be said for the terms ``nuclear'',
``nuclear transfer,'' ``cell,'' ``somatic cell,'' and
``cloning.'' The point of this discussion of definitions is
that this whole area of biology is extremely complex, and the
process itself is only now beginning to be understood by
people who have devoted years of study to the subject. It is
thus premature to attempt to define in legislation a process
that is still evolving.
Second, we are concerned by the bill's permanent
prohibition of human somatic cell nuclear transfer. While no
responsible member of the life sciences community is in favor
of cloning humans at this time, there may come a time, after
further research and study, when it will be viewed as less
egregious. For example, infertile couples might appreciate
the availability of human somatic cell nuclear transfer, as
it might someday enable them to experience the joys and
rewards of parenthood.
Third, cloning is a widely used technique in modern biology
to produce large numbers of cells and other biological
materials scientist need to carry out modern biomedical
research. The National Institutes of Health has produced a
paper called ``Cloning: Present Uses and Promises'', which
discusses all of these issues in clear and useful detail.
This paper explains that human somatic cell nuclear
transfer can have profound benefits for human health if
research is allowed to proceed using the technique. For
example, a burn victim often needs skin grafts. Current
grafting techniques require taking undamaged skin from the
victim and grafting it onto the patient's burned areas. Skin
from other humans cannot be used because it would be rejected
by the victim's immune system. However, if adult cells can be
taken from the victim, treated in such a way as to return
them to an embryonic state and then made to grow into skin
cells, virtually unlimited quantities of the victim's own
skin could be grown and used as grafts. This skin would not
be rejected since it would be genetically identical to the
victims' original skin.
The NIH paper also discusses the potential use of somatic
cell nuclear transfer in attacking diabetes, and other, more
rare genetic diseases. Of course, these therapies are not
available now--but they might be in the future, if biomedical
research on the uses and limits of somatic cell nuclear
transfer is not permanently banned, as it would be under the
provisions of your bill.
Even though your bill notes that ``Nothing in this Act . .
. shall be construed to restrict areas of scientific research
that are not specifically prohibited . . .'' section 2
declares that ``. . . it is right and proper to prohibit the
creation of cloned human embryos that would never have the
opportunity for implantation and that would therefore be
created solely for research that would ultimately lead to
their destruction.'' This language, plus the way your
definition of ``human somatic cell nuclear transfer
technology'' is phrased, makes it impossible for research to
continue on these therapies using somatic cell nuclear
transfer. We respectfully note that we cannot support such a
broad prohibition.
A fourth matter to consider is that history is replete with
examples of bad law that were primarily the products of undue
haste. In our view, human cloning is not going to occur soon
enough to justify taking this bill directly to the floor of
the Senate without hearings at the subcommittee and committee
level. Such hearings would develop the points we raise above
as well as many more, and explore the consequences (both
positive and negative) of the bill's provisions. There is no
need at this point to short-circuit the normal hearing
process, which serves our country and the Congress very well.
Finally, all of the above notwithstanding, it is not
absolutely clear that the now famous sheep Dolly was cloned
using an adult cell and not a fetal cell in the first pace.
One prominent researcher, Dr. Norton Zinder, of Rockefeller
University, believes that it has not been proven that Dolly
was created using the nucleus of a somatic cell. In a recent
letter to Science, he notes that so far, Dolly has not been
replicated, and that it took 400 tries to create her in the
first place. One success in 400 ``Is an anecdote, not a
result,'' he writes. Thus, since it has not been definitely
proven that an adult cell was used to clone Dolly, it is
possible that Dr. Wilmut's announcement approximately a year
ago was mistaken, and that a fetal cell was used by accident
(the sheep from which the cell was taken was pregnant at the
time, and fetal cells circulate throughout the body in such
situations).
Thus, it may be that there is no danger of somatic cell
nuclear transfer being used to clone a human being because it
cannot be done! We simply don't know at this point. It would
therefore be unfortunate if this technique, which has promise
in so many other biological applications, was placed ``off
limits'' to researchers before its promise and pitfalls were
thoroughly explored. This is yet another reason why haste is
not desirable.
Let me make it clear that the ASBMB does not support human
cloning. This is why the ASBMB Public Affairs Advisory
Committee supports the National Bioethics Advisory
Commission's call for a 5-year moratorium. The committee
adopted the following resolution in September 1997:
``The ASBMB Public Affairs Advisory Committee supports the
declaration of a voluntary five-year moratorium on cloning
human beings, where `cloning human beings' is defined as the
duplication of an existing or previously existing human being
by transferring the nucleus of a differentiated, somatic cell
into an enucleated human oocyte, and implanting the resulting
product for intrauterine gestation and subsequent birth.''
Numerous life sciences organizations, such as the Society
for Developmental Biology, the Federation of American
Societies for Experimental Biology, the American Society for
Cell Biology, and the Association of American Medical
Colleges, have indicated their support for a voluntary
moratorium on human cloning. We are confident that such a
moratorium will be effective in preventing the act you fear
from occurring. It would also allow the issue to be revisited
later, after further research and deliberation.
We hope you will take all these thoughts into consideration
before moving ahead with a bill that is well-intentioned but
which could also do serious harm to biomedical research
unless it is modified. We would be pleased to provide you
with further information on these issues in the days and
weeks ahead.
For your information, the American Society for Biochemistry
and Molecular Biology,

[[Page S575]]

founded in 1906, is a scientific and educational organization
with a membership of 10,200 life scientists who teach or
conduct research at most of our country's colleges and
universities, nonprofit research institutions, in industry,
and for the federal government. We publish the Journal of
Biological Chemistry, one of our nation's premiere peer-
reviewed journals in the life sciences. Our headquarters are
on the campus of the Federation of American Societies for
Experimental Biology, in Bethesda, Maryland.
Sincerely,
I. Robert Lehman,
President.
____

Beckman Center,

Stanford, CA, February 4, 1998.
Hon. Connie Mack,
U.S. Senate, Washington, DC.
Dear Senator Mack: The Congress is moving rapidly, indeed
precipitously, to legislate a ban on attempts to produce a
human being by somatic cell nuclear transfer (SCNT)
technology. The bill sponsored by Senators Bond, Frist, Gregg
and others, if passed, would be the first to ban a specific
line of research. I believe this is a serious mistake, one
that we could regret because of its unintended implications
for otherwise valuable biomedical research.
Extending the President's moratorium to the private sector
would provide an interim solution to preventing any and all
attempts to produce a human being by SCNT until a
congressional commission determined whether and what kind of
legislation would be appropriation.
I call to your attention a position statement supported by
many scientific societies which recommends a course of action
you should consider.
At the request of the National Bioethics Advisory
Commission, the American Society for Cell Biology recommended
in the Spring of 1997 a voluntary international moratorium on
human nuclear transfer for the purpose of creating a new
human being. This would allow scientists and the public the
opportunity to determine the safety and appropriateness of
such experimentation.
The ASCB continues to support such a moratorium as a
constructive interim response to the concerns raised by the
cloning of an adult sheep. However, recent events in the U.S.
have escalated and infused new urgency into this debate,
resulting in increased demands for regulatory legislation.
The ASCB urges that if legislation is needed, it should
specifically be concerned with the reproduction of a human
being by nuclear transfer. At the same time, any legislation
should not impede or interfere with existing and potential
critical research fundamental to the prevention or cure of
human disease. This research often includes the cloning of
human and animal cell lines and DNA, but not whole human
beings.
The National Biomedical Advisory Commission did recommend a
three to five year moratorium on human nuclear transfer for
the purpose of creating a new human being in order to allow
time to evaluate the safety of and public views about such
procedures. The ASCB urges that the Commission's
recommendation be the basis for any federal legislation.
Very sincerely yours,
Paul Berg,
Nobel Laureate, Chemistry, 1980.
____

The American Society for

Cell Biology,

Bethesda, MD, February 9, 1998.
To the President of the United States and Members of the
United States Congress:
There is a broad consensus supporting the President's
National Biomedical Ethics Advisory Commission's proposal to
ban the creation of a human being by somatic nuclear
transplants. The Commission urged that such a ban should not
deliberately or inadvertently interfere with biomedical
research that is critical to the understanding and eventual
prevention of human disease. To that end, we the undersigned
endorse the statement on cloning from the American Society
for Cell Biology. If legislation is deemed to be necessary,
we respectfully urge you to ensure that it be limited to the
cloning of human beings, and does not include language that
impedes critical ongoing and potential new research.
Sincerely,
Sidney Altman, Sterling Professor of Biology, Professor
Chemistry, Yale University, Nobel Prize in Chemistry,
1989; Kenneth J. Arrow, Joan Kenney Professor of
Economics Emeritus, and Professor of Operations
Research Emeritus, Stanford University, Nobel Prize in
Economics, 1972; David Baltimore, President, California
Institute of Technology, Nobel Prize in Physiology or
Medicine, 1975; Paul Berg, Cahill Professor of Cancer
Research, Department of Biochemistry, Stanford
University School of Medicine, Nobel Prize in
Chemistry, 1980.
J. Michael Bishop, University Professor, University of
California, Director, the G.W. Hooper Research
Foundation, University of California, San Francisco
School of Medicine, Nobel Prize in Physiology or
Medicine, 1989; Stanley Cohen, Distinguished Professor
of Biochemistry, Vanderbilt University School of
Medicine, Nobel Prize in Physiology or Medicine, 1986;
E.J. Corey, Sheldon Emery Professor of Chemistry,
Department of Chemistry & Chemical Biology, Harvard
University, Nobel Prize in Chemistry, 1990; Peter
Doherty, Department of Immunology, St. Jude Children's
Research Hospital, Nobel Prize in Physiology or
Medicine, 1996.
Gertrude B. Elion, Research Professor of Pharmacology and
Medicine, Nobel Prize in Physiology or Medicine, 1988;
Walter Gilbert, Carl M. Loeb University Professor,
Department of Molecular and Cellular Biology, Harvard
University, Nobel Prize in Chemistry, 1980; Alfred G.
Gilman, Regental Professor and Chair, Department of
Pharmacology, University of Texas Southwestern Medical
Center, Nobel Prize in Physiology or Medicine, 1994;
Donald A. Glaser, Professor of Physics and Neurobiology
in the Graduate School, University of California at
Berkeley, Nobel Prize in Physics, 1960.
Joseph L. Goldstein, Professor and Chairman, Department
of Molecular Genetics, University of Texas Southwestern
Medical Center at Dallas, Nobel Prize in Physiology or
Medicine, 1985; Roger Guillemin, Distinguished Research
Professor, The Salk Institute for Biological Studies,
Nobel Prize in Physiology or Medicine, 1977; Dudley
Herschbach, Baird Professor of Science, Harvard
University, Nobel Prize in Chemistry, 1986; Edwin G.
Krebs, Professor Emeritus, Department of Pharmacology,
University of Washington, Nobel Prize in Physiology or
Medicine, 1992.
Joshua Lederberg, Professor Emeritus, The Rockefeller
University, Nobel Prize in Physiology or Medicine,
1958; Leon M. Lederman, Pritzker Professor of Science,
Illinois Institute of Technology, Director Emeritus,
Fermi National Accelerator Laboratory, Nobel Prize in
Physics, 1988; Edward B. Lewis, Thomas Hunt Morgan
Professor of Biology, Emeritus, Nobel Prize in
Physiology or Medicine, 1995; Daniel Nathans, Senior
Investigator, Howard Hughes Medical Institute,
University Professor, The Johns Hopkins University
School of Medicine, Nobel Prize in Physiology or
Medicine, 1978.
Marshall Nirenberg, Laboratory Chief, Laboratory of
Biochemical Genetics, The National Institutes of
Health, National Heart Lung & Blood Institute, Nobel
Prize in Physiology or Medicine, 1968; Douglas D.
Osheroff, J.G. Jackson and C.S. Wood Professor of
Physics, Stanford University, Nobel Prize in Physics,
1996; Phillip A. Sharp, Professor and Head, Department
of Biology, Massachusetts Institute of Technology,
Nobel Prize in Physiology or Medicine, 1993; Susumu
Tonegawa, Amgen Professor of Biology and Neuroscience,
Director, Center for Learning and Memory, Massachusetts
Institute of Technology, Investigator, Howard Hughes
Medical Institute, Nobel Prize in Physiology or
Medicine, 1987.
James D. Watson, President, Cold Spring Harbor
Laboratory, Nobel Prize in Physiology or Medicine,
1962; Eric F. Wieschaus, Squibb Professor of Molecular
Biology, Investigator, Howard Hughes Medical Institute,
Nobel Prize in Physiology or Medicine, 1995; Torsten
Wiesel, President, The Rockefeller University, Nobel
Prize in Physiology or Medicine, 1981.

The American Society for Cell Biology Statement on Cloning January,
1998

At the request of the National Bioethics Advisory
Commission, the American Society for Cell Biology recommended
in the Spring of 1997 a voluntary international moratorium on
human nuclear transfer for the purpose of creating a new
human being. This would allow scientists and the public the
opportunity to determine the safety and appropriateness of
such experimentation.
The ASCB continues to support such a moratorium as a
constructive interim response to the concerns raised by the
cloning of an adult sheep. However, recent events in the U.S.
have escalated and infused new urgency into this debate,
resulting in increased demands for regulatory legislation.
The ASCB urges that if legislation is needed, it should
specifically be concerned with the reproduction of a human
being by nuclear transfer. At the same time, any legislation
should not impede or interfere with existing and potential
critical research fundamental to the prevention or cure of
human disease. This research often includes the cloning of
human and animal cell lines and DNA, but not whole human
beings.
The National Bioethics Advisory Commission did recommend a
three to five year moratorium on human nuclear for the
purposes of creating a new human being in order to allow time
to evaluate the safety of and public views about such
procedures. The ASCB urges that the Commission's
recommendation be the basis for any federal legislation.
____

The American Society

of Human Genetics,

Bethesda, MD, February 5, 1998.
Hon. Dianne Feinstein,
U.S. Senate, Washington, DC.
Dear Senator Feinstein: Senators Kit Bond (R-TN) and Bill
Frist (R-TN) have introduced S. 1601, ``to prohibit the use
of somatic cell nuclear transfer technology for purposes of
human cloning.'' While the majority of the scientific
community and the public supports a ban on human cloning, the

[[Page S576]]

bill's language would effect other important areas of medical
and scientific research.
As President of The American Society of Human Genetics
representing over 6,000 researchers in the field human
genetics, I want to go on record as opposing this bill.
Congress must make sure that any bill would not restrict or
inhibit stem cell research which is being used to create a
whole new type of therapy--cell therapy. Congress must also
make sure that research is not restricted into the pathology
of disease, gene therapy research, research into the ways
genes operate in the cell and other basic biomedical research
which gives hope that we can find and develop cures and
therapies for deadly and disabling diseases.
Thank you for allowing us to go on record as opposing S.
1601.
Sincerely yours,
Arthur Beaudet, MD,
President, ASHG.
____

National Association for

Biomedical Research,

Washington, DC, February 5, 1998.
Hon. Dianne Feinstein,
U.S. Senate, Washington, DC.
Dear Senator Feinstein: The NABR membership respectfully
requests that you vote ``no'' next Tuesday, February 10, when
a motion to invoke cloture and proceed to consider S. 1601, a
bill to ban human cloning, is scheduled to come before the
Senate. There is virtually unanimous agreement that human
beings should not be cloned. However, as currently drafted S.
1601 threatens to restrict research efforts far beyond those
which could involve cloning human beings. The proposal is
going to the floor without the customary committee
consideration and recommendation. The result is a well-
intentioned, but ill-defined, measure that will destroy
promising new research avenues that might provide long-
awaited solutions to untold human suffering. Your ``no'' vote
is needed to protect responsible biomedical research and
allow this legislation to receive the full deliberation it
deserves.
We all fear a disastrous outcome of new cloning
technologies; however, S. 1601 is not focused on outcomes.
Rather, for the first time, the government would ban a
specific research technique and process. To prevent a real or
imagined future calamity, approval of this bill would mean
the public must also forego all the beneficial fruits of
``somatic cell nuclear transfer,'' including the possible
cloning of cells or tissue to cure and treat cancer,
diabetes, Alzheimer's and many other illnesses. (Please see
enclosed Time article for further discussion.) For this
reason, Congress certainly should take the time to carefully
consider S. 1601 and other proposals dealing with human
cloning. Surely, the people whose healthy futures depend on
more and better research must have the opportunity to
understand and participate in the decisions Congress is
facing. The current rush to pass imprecise, misunderstood
legislation to ban human cloning is much more dangerous to
the pubic than the remote chance a mad scientist might
actually attempt it in the near future.
Until the moral, ethical and medical questions surrounding
the possibility are fully explored and satisfactorily
answered, no one should try to duplicate a human being by
cloning. The nation's leading scientific, medical,
pharmaceutical and biotechnology organizations agree and have
already subscribed to a voluntary moratorium to this effect.
In addition, the Food and Drug Administration has announced
it will exercise regulatory authority over human cloning
should any irresponsible individual try to ignore the
mainstream scientific community. Therefore, it is not
necessary to act hastily in the absence of all the facts.
Should you or your staff require additional information,
please contact NABR. Thank you for your consideration of this
urgent matter.
Sincerely,
Frankie L. Trull,
President.
____

Federation of American Societies

for Experimental Biology,

Bethesda, MD, February 3, 1998.
Hon. Dianne Feinstein,
U.S. Senate, Washington, DC.
The Federation of American Societies for Experimental
Biology (FASEB) urges the Senate to proceed extremely
cautiously as it considers legislation regarding human
cloning. While the Federation considers the cloning of human
being to be reprehensible, dangerous, and unethical, we are
concerned that overly restrictive legislation could
unintentionally preclude critical research of great benefit
to the American people. We believe that S. 1599, currently
pending consideration by the Senate, would be damaging to
worthwhile research. By flatly banning all use of human
somatic cell nuclear technology for any purpose, this
legislation would close off key areas of research which do
not involve the creation of humans. We urge that the Senate
not approve this legislation in its current form as it does
not balance appropriate ethical considerations with the
health needs of the American people.

Ralph G. Yount, Ph.D.,

President.

Mrs. FEINSTEIN. And academics. I have a letter from the University of
California at San Diego, from the professor of the Division of Cellular
and Molecular Medicine, the Department of Pharmacology, University of
California; another one from Dr. Bishop, Nobel laureate, University of
California; a letter from the Whitehead Institute; another letter from
the University of California from the Vice President of Health Affairs
and the Vice Provost of Research; a letter from Dr. Roger Pedersen,
professor and research director of the Reproductive Genetics Unit,
University of California, San Francisco; and a letter from the Nobel
laureate of chemistry to Senator Mack. In 1980, he won the Nobel prize.
I ask unanimous consent that these be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

University of California,

San Diego, CA, February 10, 1998.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: I am writing to urge you to
continue working to protect basic biomedical research in any
proposed human cloning legislation. While we all agree that
``cloning'' a complete human being is undesirable and
unethical at present, it is very important that any
legislation that is passed not inadvertently block important
research into regenerative technology, or into the creation
of artificially grown human organs for transplantation and
other purposes. For example, as you know the recently
proposed Bond/Frist cloning bill, S. 1599 in the Senate is
far too broad and would ban many related and valuable
research and medical activities. Your bill S. 1602 with
Senator Edward Kennedy (D-MA) bans the implantation of the
product of somatic cell nuclear transfer into a woman's womb.
The language in S. 1602 appears much more reasonable and with
minor modification could be recommended for support by the
scientific community.
For your information, I have reproduced below a statement
from the American Society for Cell Biology on cloning, which
clearly delineates principles that many scientists feel are
most useful in thinking about this important legislative
challenge.

``The American Society for Cell Biology Statement on Cloning, January,
1998

``At the request of the National Bioethics Advisory
Commission, the American Society for Cell Biology recommended
in the Spring of 1997 a voluntary international moratorium on
human nuclear transfer for the purpose of creating a new
human being. This would allow scientists and the public the
opportunity to determine the safety and appropriateness of
such experimentation.
``The ASCB continues to support such a moratorium as a
constructive interim response to the concerns raised by the
cloning of an adult sheep. However, recent events in the U.S.
have escalated and infused new urgency into this debate,
resulting in increased demands for regulatory legislation.
``The ASCB urges that if legislation is needed, it should
specifically be concerned with the reproduction of a human
being by nuclear transfer. At the same time, any legislation
should not impede or interfere with existing and potential
critical research fundamental to the prevention or cure of
human disease. This research often includes the cloning of
human and animal cell lines and DNA, but not whole human
beings.
``The National Bioethics Advisory Commission did recommend
a three to five year moratorium on human nuclear transfer for
the purpose of creating a new human being in order to allow
time to evaluate the safety of and public views about such
procedures. The ASCB urges that the Commission's
recommendation be the basis for any federal legislation.''
It is very important that our citizens and legislators
think calmly and carefully about what legislation is passed
in this area. We must ensure that we do not inadvertently
hold back important and valuable medical research. I am sure
that simple and temporary legislation, which doesn't seek to
be too broad in its scope, and introduce many unintended
consequences would be the best strategy. I hope that you will
proceed with great caution.
Sincerely,
Lawrence S.B. Goldstein, Ph.D.
____

Whitehead Institute,

Cambridge, MA, February 5, 1998.
Hon. Edward M. Kennedy,
Russell Senate Office Building, Washington, DC.
Dear Senator Kennedy: I am very concerned about efforts to
bring Senate Bill 1599, the Bond bill, to an immediate vote.
While I agree that there should be a national ban on human
cloning, it is essential that any such law protect areas of
critical research that can benefit human health. The Bond
bill's generic ban on the use of ``human somatic cell nuclear
transfer technology,'' would, in fact, be quite damaging to
medical research progress in the United States.
The Bond bill would seriously limit our ability to develop
new cell-based strategies to fight cancer, diabetes, and
Alzheimer's disease. It would also prevent vital research on
the repair of spinal cord injuries and severe burns.
I urge you to convey to your colleagues that the Bond bill
would cause us to lose ground in the battle against deadly
and disabling human diseases. In contrast, Senate

[[Page S577]]

Bill 1602 (the Feinstein/Kennedy bill) focuses on the
implantation of the product of somatic cell nuclear transfer.
By banning implantation, the Feinstein/Kennedy bill would
permit life-saving research to continue and still prohibit
the cloning of human beings.
All major advances in technology raise new ethical, legal,
and social issues. The cloning issues are particularly
complex. I appreciate your efforts to promote widespread and
careful public deliberation and, at the same time to foster
important advances in human health.
Sincerely,
Gerald R. Fink,
Director.
____

University of California,

Oakland, CA, February 10, 1998.
Hon. Dianne Feinstein,
U.S. Senator, Hart Senate Office Building, Washington, DC.
Dear Senator Feinstein: We are writing on behalf of the
University of California to urge you to vote against the
upcoming cloture motion for S. 1601, the cloning bill. While
we recognize the sensitivity and importance of this issue,
the University is concerned that premature legislation on
cloning, however well intentioned, may prove to be too
inclusive, with resulting negative consequences on future
advances in biomedical research.
The current opportunities in biomedical research are
unparalleled. Thousands of experiments are carried out each
day in the university laboratories using routine molecular
and cellular research approaches involving human tissues,
cells and molecules. Over the past two decades, this research
has contributed to major advances in our understanding of the
molecular and cellular basis of human disease. It has led to
important new medical advances, including the production of
human insulin, hepatitis vaccine, and sensitive diagnostics
for AIDS. The scientific techniques involved in cloning
research are very promising in terms of our ability to treat
and manage myriad diseases and disorders, ranging from cancer
to heart disease, to Parkinson's and Alzhemier's, to
infertility and HIV/AIDS. These advances have saved hundreds
of thousands of lives and dramatically reduced health care
costs.
We urge you to vote no on the motion to invoke cloture on
S. 1601, so that there is more time to consider the
implications of cloning legislation. If Congress chooses to
enact legislation, we urge you to make certain that any
legislative language does not prohibit legitimate and
worthwhile scientific research that has the potential to
provide enormous health benefits. We would be happy to offer
our resources as the legislative debate continues.
Thank you for considering our views.
Sincerely,
Cornelius L. Hopper,
Vice President, Health Affairs.
Robert N. Shelton,
Vice Provost, Research.
____

University of California,

San Francisco,

San Francisco, CA, February 4, 1998.
Hon. Connie Mack,
U.S. Senate,
Washington, DC.
Dear Senator Mack: I understand that the U.S. Senate is
considering several bills related to human cloning. One of
these bills, introduced by Senator Bond and others, prohibits
human somatic nuclear transfer to be used for the purpose of
creating an embryo. Although this bill, as I understand it,
protects many areas of science, the specific prohibition on
somatic nuclear transfer is unwarranted and potentially
detrimental to medical research.
The fundamental flaw in this legislation is the prohibition
of a technology irrespective of its application. Such
prohibition forecloses on any benefit from the technology,
even if that benefit were in no way objectionable. Many well-
intentioned people fail to understand that somatic cell
nuclear transfer is not limited to cloning an organism. There
are many examples of possible future applications of this
technology to produce healthy tissue for therapeutic
purposes, such as skin grafts for burn patients, or even to
create insulin-producing cells for diabetics. There may also
be applications for cancer patients who need a bone marrow
transplant for whom a match cannot be found.
The Senate should instead address its attention to specific
applications of this technology that are unwanted in our
society, such as creating a new human being.
I hope that you will work to ensure that research on this
promising technology is allowed to continue.
Sincerely,
J.M. Bishop,
Nobel Laureate.
____

February 4, 1998.
Hon. Senator Kennedy,
U.S. Senate,
Washington, DC.
Dear Senator Kennedy: I am writing to express my deep
concern about the negative impact of impending legislation
introduced by Senators Bond, Frist et al. (S. 1599) intended
to regulate cloning of a human being. As an active researcher
in the scientific field of the discovery leading to Dolly, I
understand its implications for basic science and human
health. Dolly's existence proves for the first time that the
genetic material of an adult body cell can be completely
reprogrammed by the egg, thus totally restoring the genetic
potential for specializing into all possible cell types. This
discovery that genetic reprogramming is possible in mammals
is as important to human health as the discovery of
penicillin. Basic research on genetic reprogramming will
likely lead to novel transplantation therapies for numerous
human diseases, including heart disease, diabetes,
neurodegenerative diseases (such as Parkinson disease),
genetic diseases and birth defects. I believe that imprecise,
hastily-written legislation against human cloning, such as S.
1599, will hinder these important research opportunities for
understanding genetic reprogramming of adult cells. Excessive
regulation as specified by S. 1599, including civil penalties
and criminalization, in the area of this new discovery is
likely to thwart the momentum of basic research on genetic
reprogramming and deter the enthusiasm and ability of
researchers poised to make major new contributions in
applying their findings to human health problems.
In no conceivable instance would research on genetic
reprogramming involve cloning of human beings. Indeed,
active, credible researchers and clinicians overwhelmingly
regard cloning a human being as an unethical and
reprehensible act. Last year, working through the Society for
Developmental Biology, I spearheaded a voluntary moratorium
on cloning human beings. This moratorium unequivocally
states that we have no intention to clone human beings,
where this is defined as ``duplication of an existing or
previously existing human being by transferring the
nucleus of a differentiated, somatic cell into an
enucleated human oocyte, and implanting the resulting
product for intrauterine gestation and subsequent birth.''
To date, 15 additional scientific and medical societies,
including the Federation of American Societies for
Experimental Biology, the American Society for
Reproductive Medicine, and the Society for the Study of
Reproduction, together representing more than 60,000
reproductive, developmental, cell and molecular
biologists, have endorsed this moratorium. Historical
precedent (with recombinant DNA technology) indicates that
a voluntary moratorium can deter activities that are
potentially unsafe for humans. It is evident from recent
events that anyone who advocates cloning human beings for
any purpose will be subjected to ostracism and discredited
scientifically. Therefore, I believe that the existing
voluntary moratorium against cloning human beings is an
effective means of regulating the behavior of U.S.
scientists and physicians.
Presently, the fields of developmental biology and human
genetics are at an exciting juncture, where many novel genes
are being identified through the Human Genome Project and
their functions during normal development are being
understood for the first time. In addition, an understanding
of how these genes interact with the internal and external
environment of the cell is emerging for studies such as those
giving rise to Dolly. Deriving the full benefits of these new
insights for human health will require a dedicated and
cooperative research effort by many scientists, including
those who conduct research on human cells and tissues.
In conclusion, there is a great risk that anti-cloning
legislation would deprive the American people of
unprecedented human health benefits. I thus urge extreme
caution in any legal sanctions, such as those included in S.
1599, which would have lasting detrimental effects on our
ability to alleviate human diseases, and would also undermine
the competitive abilities of U.S. scientists in our field.
Respectfully yours,
Roger A. Pedersen, Ph.D.,
Professor and Research Director, Reproductive Genetics
Unit, Department of Obstetrics, Gynecology, and
Reproductive Science.

Mrs. FEINSTEIN. There are new letters from industry groups. There is
a very interesting letter from Genentech. Genentech is a huge biotech
firm. Actually, biotechnology was spawned out of San Francisco and
Genentech was one of the very first companies in the Nation to enter
this area. They have a very cogent letter that states well their
opposition. They point out, ``. . . deliberate and exercise caution and
restraint in legislating this issue.''
I ask unanimous consent that the February 9 letter from the
Biotechnology Industry Organization be printed in the Record.
There being no objection, it has been ordered to be printed in the
Record, as follows:

Regarding Human Cloning Legislation Tuesday Cloture Vote: S. 1601,
Bond/Lott

February 9, 1998.
Dear Senator: Tomorrow the Senate is scheduled to vote on
cloture on S. 1601, the Bond/Lott human cloning bill. The
Biotechnology Industry Organization (BIO) urges you to vote
``no'' on the cloture petition. BIO represents 760
biotechnology companies throughout the world engaged in
research on diseases, the immune system, cell therapy,
vaccines, drugs/biologics, antibiotics, and gene therapy.
The Bond/Lott bill is not ripe for consideration by the
Senate. It was introduced on Wednesday of last week, no
hearings have

[[Page S578]]

been held on it and no mark-up in the two committees with
jurisdiction have been held on it. Most important, the bill
as drafted would have a dire impact on biomedical research
completely unrelated to human cloning.
This is not a human cloning bill. This is a bill which bans
the use of biomedical technology even if that use has nothing
whatever to do with human cloning.
A ``no'' vote is a vote to protect biomedical research on
deadly and disabling diseases.
There is no rush to legislate. The FDA has jurisdiction
over Dr. Seed and any others. Violations of the FDA
regulatory requirements carry draconian penalties. A ``no''
vote is a vote to proceed with caution to make sure that
biomedical research is not harmed.
A ``no'' vote is a vote to restrict this bill to the human
cloning issue.
A ``no'' vote is a vote to permit the Senate Labor and
Senate Judiciary Committees, which have jurisdiction over the
bills to take care to draft the legislation and confine it to
the human cloning issue.
BIO believes that a human cloning experiment would be
utterly unethical and unsafe. What we are writing about here
is our views on the terms of the Bond/Lott bill, not the
larger debate about human cloning.
Attached is a more detailed statement outlining our
concerns about the Bond/Lott bill which was printed in the
Congressional Record on Thursday. If you have any questions
about our position, please feel free to call at 857-0244.
Sincerely,
Nancy Bradish,
Director, Federal Government Relations.
Charles E. Ludlam,
Vice President for Government Relations.

Mrs. FEINSTEIN. Mr. President, I ask unanimous consent that the
January 28 letter from the Pharmaceutical Research and Manufacturers of
America be printed in the Record.
There being no objection, the letter was ordered to be printed in the
Record, as follows:

Pharmaceutical Research and,

Manufacturers of America,

Washington, DC, January 28, 1998.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: I urge you to consider any
legislative proposals to ban the cloning of an entire human
being with great caution. The research-based pharmaceutical
industry appreciates the widespread ethical and moral
concerns about the possibility of creating a genetic
duplicate of an existing (or previously existing) human
being. We also share the view expressed by the National
Bioethics Advisory Commission that such a procedure is
unsafe.
For equally valid ethical, moral and safety reasons, we are
concerned that some pending proposals would inadvertently
harm patients with unmet needs and their families. The member
companies of the Pharmaceutical Research and Manufacturers of
America support the President's call for a voluntary
moratorium on any cloning of an entire human being. However,
the best help and heal patients, biomedical researchers need
to be able to continue to clone human genes, cells and
tissues. If not drafted with laser-precision, legislation to
ban ``human cloning'' could--unintentionally, but
heartbreakingly--stop life-saving and health-enhancing
medical research.
The Food and Drug Administration has announced it will
prevent any cloning of an entire human being. The FDA's
assertion of regulatory authority eliminates any need for
well-intended but risky haste. In your consideration of any
legislative proposals, we urge you to protect patients and
their families from unintended impediments to ethical, moral
and safe biomedical research that does not involve any
cloning of an entire human being, but does involve cloning
human genes, cells or tissues.
Sincerely,
Alan F. Holmer,
President.

Mrs. FEINSTEIN. The California Biomedical Research Organization ``. .
. urges you to support continuing debate about the potential negative
impact of Senator Trent Lott's legislation.''
This is accompanied by, I would have to say, 30 campuses and
companies. Ligand Pharmaceuticals, two letters for the Record. I ask
unanimous consent that these letters be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Genentech, Inc.

San Francisco, CA, February 9, 1998.
Hon. Connie Mack,
Hart Senate Office Building, Washington, DC.
Dear Senator Mack: I am writing with regard to legislative
proposals currently pending in the Senate relating to cloning
entire human beings. This vexing topic needs to be put into a
larger perspective before the Senate votes on a bill, S.
1601, which was introduced only last week.
The biotechnology and research community has been very open
and public about its support for the President's request for
a voluntary moratorium on activities that could lead to the
cloning of entire human beings. This exercise of
responsibility in science is consistent with our long history
of restraint in the pursuit of basic biomedical research. We
do not plan or seek to clone entire human beings. In
addition, we fully recognize the existence of various federal
laws setting out the jurisdiction of the Food and Drug
Administration which, when taken together, would bar the
commercialization of cloning of entire human beings. Because
of this moratorium and existing legal limitations on action,
it is possible to deliberate and exercise caution and
restraint in legislating this issue.
The reality of modern biomedical research is that it is
difficult to predict in advance exactly how specific, even
esoteric, areas of research will produce breakthroughs. As
Michael Bishop (cancer researcher, Nobel laureate in medicine
and my colleague from the University of California, San
Francisco) spoke of this issue recently, in 1968 his work
with Dr. Harold Varmus, and Professor Herb Boyer would have
never been foreseen as leading to breakthroughs in
recombinant DNA research and cancer genetics. Similarly, work
done in the 1980s on transgenic animals by Dr. Phil Leder, of
Harvard, and others, would not have easily been understood as
being essential to the development of animal models that
could facilitate dramatic advances in our ability to test new
AIDS therapies.
It is also the case that with virtually every scientific
advance there are voices that seek to delay legitimate, if
misunderstood, advances in science. In the early 1970s, some
government officials sought to vary virtually all recombinant
DNA research out of exaggerated fears about the safety of the
technology. Researchers and companies voluntarily adopted a
moratorium on some research until more information was
obtained. Fortunately, the calls for more radical local or
federal regulation were rejected. The self-regulatory efforts
by industry and the research community worked, and there were
no significant safety issues to arise out of that research.
In the 1980s some critics advocated bans on transgenic
animal research out of fear of science. These requests for a
halt to research were often based on assertions of
pseudoscience. Again, we are fortunate that Congress did not
act to bar the creation of transgenic animals, which are now
so commonly used in drug development, especially in AIDS
research. In addition, transgenic animals may someday be used
for the actual production of pharmaceutical compounds. This
hope for pure protein production at a lower cost is yet to be
realized, but if Congress had acted in the 1980s to end
research, patients would have had that hope foreclosed.
Now Congress is faced with difficult decisions about how to
react to a single experiment in sheep. Each side of the
current debate has sincere motivations and convictions about
its legislative approach. Senators Bond, Frist and others
have bona fide concerns about cloning human beings and hope
that their bill would not affect biomedical research. Yet,
determining how to prohibit the act of cloning an entire
human being has proven to be a daunting task. For a set of
reasons outlined below, we prefer the approach taken in the
bill, S. 1602, to that found in the bill currently pending,
S. 1601.
Most importantly, in considering restrictions on scientific
research in the private sector (as opposed to previously
enacted limitations on the expenditure of federal funds),
great care must be exercised. In addition to the legal rights
of persons to free expression and inquiry in the private
market, there is little precedent for imposing limitations on
research except for reasons of safety or other narrowly
crafted circumstances.
In this instance, there are multiple possibilities of
promising research with somatic cells. Our hope in the
research community is that this branch of research will lead
to discoveries that permit us to develop new cures and
treatments for serious and unmet medical needs. Some of our
colleagues in academe have already begun exploring questions
of how to turn on and off these somatic cells so that new
biological material could be generated for transplantation
and for other therapeutic purposes. At this point in the
discovery process, it is not known exactly how to accomplish
this therapeutic goal, but one possible way is to use the
technique known as somatic nuclear cell transfer. Such
research could, in some circumstances, involve conduct that
would be permitted under S. 1602 and would be criminalized
under S. 1. This difference (among others noted below) is the
reason we prefer your bill.
There seems to be little dispute within the Congress about
the current inappropriateness of using somatic nuclear cell
transfer technology to create an embryo which is implanted
into the uterus, with the goal being reproductive in nature.
On the other hand, it is hard to understand why scientists
should become criminals if they pursue legitimate new
therapies for heart disease, cancer, diabetes, and other
diseases, and if their research has no prospect or intent of
creating an entire cloned human being.
Given our current state of knowledge, there is no
reasonable prospect for creating a new human being unless an
embryo is implanted into the uterus of a woman. Thus, the
approach should be to adopt a bill that effectively bars what
the political consensus

[[Page S579]]

wants to prohibit, while simultaneously retaining the option
of research that is aimed at new therapies, not at
reproductive ends.
There are several other reasons to support the approach
taken in S. 1602:
S. 1602 preempts inconsistent state laws. Given the rush to
judgment in various states, the high likelihood for
overlapping and inconsistent standards, and the clearly
negative effect on interstate commerce, a federal standard is
appropriate.
S. 1602, unlike S. 1601, uses a civil penalty structure
that will be sufficient to deter unwanted conduct. If
criminal penalties or asset forfeiture are threatened for
research activities, there is likely to be a chilling effect
on research in this entire area. Moreover, there are
additional sanctions available under the Food, Drug and
Cosmetic Act to address human cloning.
S. 1602 appropriately requires that Congress should review
these limitations on research after a set period of time.
This review could be facilitated if, using carefully drawn
criteria, there was a balanced review of this area of
research by a nonpolitical entity.
The suggestion in S. 1602 for international cooperation on
this topic is welcome, as is the ratification of the
authority of the jurisdiction of the Food and Drug
Administration.
One final point, S. 1601 would establish a commission that
could approach the bioethics questions associated with
certain limited new somatic cell nuclear transfer
technologies. This concept is worthy of serious
consideration. As we approach scientific advances, it is
important that we make sure that science reflects our basic
human and ethical values.
The work done by existing entities, such as the Recombinant
DNA Advisory Committee of the NIH, and the NIH-DOE Working
Group on Ethical, Legal, and Social Implications of Human
Genome Research, has advanced the public discussion. In this
regard, the work already done by the President's Commission
on the topic of cloning entire human beings has materially
assisted the national debate on this topic. We leave to the
political process questions of whether any such bioethics
commission should be situated in the Executive Branch and who
should exercise the appointment authority.
There are several caveats worth noting, however:
Past history, here and in Europe, suggests that there is a
real risk that any such commission could inadvertently begin
to function as a new regulatory entity and serve to delay the
approval of new treatments for patients. This temptation
should be avoided at all costs by explicitly limiting the
role of the commission.
There is a risk that any new commission will be led by
other political agendas into discussions that do not advance
progress on improving human health. This temptation should
also be avoided by narrowly circumscribing the commission's
charter.
The composition of any commission should broadly reflect
the best available thinking in science, law, and ethics. The
mere prohibition on political officials serving on such a
panel is not likely sufficient to prevent the politicization
of the appointment process. There are, I understand,
precedents that permit certain relevant professional
societies to offer lists of nominees to an appointing
authority. This approach would appear to mitigate the risk of
an overly political appointment process.
In closing, let me thank you for having the special
sensitivity and commitment to biomedical research to ask for
greater deliberation and for crafting a more precise bill
that seeks a uniform consensus about how to ban the cloning
of entire human beings.
The issue before the Senate is: Can we simultaneously
advance science and the search for cures for serious diseases
while also barring the cloning of entire human beings? We
believe that to foster further dialogue and deliberation can
help achieve that common goal.
Sincerely,
Art Levinson,
President.
____

California Biomedical

Research Association,

Sacramento, CA, February 9, 1998.
Hon. Dianne Feinstein,
U.S. Senate, Hart Senate Office Building, Washington, DC.
Dear Senator Feinstein: On behalf of the CBRA Governing
Board, I am writing to encourage your ``no'' vote on the
cloture vote on S. 1601 scheduled for Tuesday, February 10,
1998. The Association urges you to support continuing debate
about the potential negative impacts of Senator Trent Lott's
legislation.
Somatic cell transfer technology is essential to continuing
research into cures for some of our greatest human health
threats--Parkinson's Disease, leukemia, diabetes, Alzheimer's
disease and spinal coral injuries. Unintended consequences of
this bill as currently written could threaten the future
health of millions of Americans.
Please feel free to contact our office if you should need
further information.
Sincerely,
Suzanne Ness,
President.

members (partial list)

Allergan
Alliance Pharmaceutical
ALZA Corporation
American Association for Laboratory Animal Science
Northern, Orange County
San Diego, Southern and Palms to Pines Branches
American Cancer Society, California Division, Inc.
American Diabetes Association, California Affiliate
American Heart Association (Western States Affiliate and
Greater L.A. Affiliate)
American Lung Association of California
Amgen
Bayer Corporation
Berlex Bio Sciences
BioDevices
Buck Center for Research in Aging
California Institute of Technology
California Medical Association
California State University: Long Beach, Pomona, Office of
the Chancellor
California Veterinary Medical Association
Cedars-Sinai Medical Center
Charles River Laboratories
Children's Hospital Oakland Research Institute
Children's Hospital of Orange County
Chiron Corporation
City of Hope
Genentech
J. David Gladstone Institutes
Good Samaritan Hospital
Harbor UCLA Medical Center, Research and Education
Institute, Inc.
Heartport
Huntington Medical Research Institutes
Isis Pharmaceuticals
Lawrence Berkeley Laboratory
Loma Linda University
NASA Ames Research Center
Palo Alto Medical Foundation
Roche Biosciences
Salk Institute for Biological Studies
San Diego State University
San Jose State University
Scripps Research Institute
Stanford University
The Parkinson's Institute
University of California: Berkeley, Davis, Irvine, Los
Angeles, Riverside, San Diego, San Francisco, Santa Barbara,
Santa Cruz, Office of the President
University of Southern California
Veterans Administration Medical Centers at: Loma Linda,
Long Beach, Palo Alto, San Diego, San Francisco, Sepulveda,
West Los Angeles.
____

Ligand Pharmaceuticals,

San Diego, February 2, 1998.
Hon. Dianne Feinstein,
U.S. Senate, Hart Senate Office Building, Washington, DC.
Dear Senator Feinstein: Ligand Pharmaceuticals Inc. of San
Diego and its more than 300 employees, like other responsible
members of the biomedical community, deplore the recent
announcement by Dr. Richard Seed of his intention to clone a
human being. We regard such an effort to be medically
irresponsible and ethically abhorrent. Nevertheless, we are
concerned that Congress and State legislatures, in
understandable zeal to prevent Dr. Seed and anyone of a like
mind from actually attempting to clone a human, will enact
legislation that fails to distinguish between vital medical
research and misguided human cloning. Therefore, we ask that
you and other members of Congress carefully consider both the
need for and the scope of any legislation addressing this
issue before acting upon it.
With respect to whether legislation is needed, Ligand
suggests a careful review of existing legislation to
determine whether the U.S. Food and Drug Administration (FDA)
already has the authority to regulate research related to and
the actual cloning of a human being. Many, including the
Biotechnology Industry Organization to which Ligand belongs,
believes the FDA has this authority.
If legislation is deemed to be necessary, it should achieve
two important ends. The first is that it should be drafted
narrowly to deal with the cloning of a human being and not
contain broad or even ambiguous prohibitions on cloning which
would halt or disrupt vital medical research based upon
widely accepted cloning techniques. Secondly, it should be
preemptive of State laws governing cloning. Biomedical
research is carried out, often with Federal funding,
throughout the United States. This research occurs in public
and private universities and in big and small companies. Much
of this research is done on a collaborative basis involving
entities in more than one state. Furthermore, every advance
paves the way for further progress. The individual states
should not, therefore, be allowed to erect a maze of law and
regulation which unnecessarily regulates this area of
research.
Congress, unlike the states, has ready access to the
expertise of NIH, NSF, FDA and other sources of expertise
that should be drawn upon before the drafting of appropriate
legislation. That fact, and the interlocking nature of
biomedical research, suggests that preemption is in the best
interests of the country with respect to dealing with the
issues raised by Dr. Seed. We believe this to be the case
even though our Federal system rightly contemplates that the
fifty states can exercise sovereignty in most areas, either
in concert with, or in the absence of legislation at the
national level.
Should you, therefore, have the opportunity to shape the
debate on this important, and even emotional issue, we ask
that you support hearings which address first whether new
legislation is required. If a reasoned analysis of current
law suggests that FDA is not able to effectively regulate,
then

[[Page S580]]

and only then should legislation carefully drawn based on
input from the biomedical community be enacted.
Very truly yours,
William L. Respess,
Senior Vice President.
____

Ligand Pharmaceuticals,

San Diego, February 5, 1998.
Hon. Dianne Feinstein,
U.S. Senate, Hart Senate Office Building, Washington, DC.
Dear Senator Feinstein: I am writing on behalf of Ligand
Pharmaceuticals Inc. asking that you oppose Senator Bond's
Bill S. 1599 concerning human cloning. It is my understanding
that this bill is to come up for a vote without hearings or
mark-up. We believe that is an action that is too precipitous
and could result in legislation which will adversely impact
the biomedical industry.
I wrote to you on February 2, 1998 expressing opposition to
the announcement by Dr. Richard Seed to engage in an effort
to clone a human being. However, legislation or regulation to
ban such activity must be carefully drawn so as not to
inhibit legitimate research. Therefore, it is essential that
hearings be held on any bill to permit testimony by
scientists, representatives of the biomedical industry, and
others potentially affected by such legislation to be heard
on the specifics of any bill. This is not the time for a
justifiable rush to judgment on Dr. Seed's announced
intention to result in hastily conceived legislation which
may do as much harm as good. Research on cloning and the use
of cloning techniques are important to the progress of
medical science. While Congress should move with deliberate
speed, this is not the occasion to act outside of the usual
congressional scheme of engaging in hearings before
appropriate committees before taking action on matters of
such import.
In my letter of February 2, 1998, I suggested that Congress
first look to determine whether the FDA already has the
authority to regulate in this area and, only if it is
persuaded that the FDA lacks such authority, to undertake to
draft legislation. I still believe that is the most
appropriate process.
Very truly yours,
William L. Respess,
Senior Vice President.

Mrs. FEINSTEIN. Mr. President, let me be very clear. Every letter
that is coming in says: Stop, consider, proceed cautiously; this bill
would be harmful; it would stop vital research. What is the rush, since
the FDA has asserted jurisdiction and the scientific community has
engaged in a moratorium? Why proceed like this in such haste, straight
to the floor?
Only two letters have come in saying, proceed like this: One from the
Christian Coalition, and the other one is from the National Right to
Life Committee, two letters. The entire scientific community says, go
slow, define your terms, know what you are doing.
Let me share with you what I understand this technology is. Let's say
a somatic cell were taken out of my tissue. The nucleus of that cell is
removed and is entered into an egg cell and fused. That cell, once
fused, begins to divide and create more cells. The only way that cell
can produce a human being is if it is put into a human uterus.
Otherwise, it cannot produce a human being. We don't even know if it
will produce a human being if it is put in a uterus. There is only one
known instance in an animal, Dolly, which now Science magazine has
challenged in a major way. But what we do know is that those stem
cells, because of their DNA, can clone tissue.
For example, a third-degree-burn patient who may reject a skin graft
may some day get a skin graft made from his or her own cells and will
not reject it. My husband, Bert Feinstein, died of colon cancer and
liver cancer. What a miracle if those cells could have been used to
come up with a cancer treatment that would have prevented his death.
That is really where we are. That is what we hope for.
There are no definitions in the bill. We don't know what they call a
somatic cell. We don't know what they call an embryo. The bill does not
define oocyte. But the point is, we have to know, and these terms have
to be spelled out in the legislation.
The bill says, if there is this stem tissue research, it is illegal,
and the scientists have a 10-year sentence.
So what we are begging, imploring, respectfully asking the
distinguished majority leader is, please, let's not proceed tomorrow.
Let's observe the regular order. Let's go to committee. Let Senator
Kennedy and I have an opportunity to present our bill. Let's have the
majority leader, Senators Bond and Frist, whom I respect, have an
opportunity to present their bill. Let's discuss it and see what is
best. Then at least we have heard everybody with knowledge.
Let me be clear. I want a bill. I want a carefully crafted bill. I
want this Congress to act to ban the cloning of human beings.
I thank the Chair. I yield the floor.
Mr. GRAMS addressed the Chair.
The PRESIDING OFFICER. The Senator from Minnesota.
Mr. GRAMS. Mr. President, I ask unanimous consent to be able to speak
as if in morning business for 10 minutes.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. GRAMS. Thank you very much.

____________________