```

[Senate Hearing 108-891]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 108-891
 
                  SCIENCE AND ETHICS OF HUMAN CLONING

=======================================================================

                                HEARING

                               before the

             SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE

                                 OF THE

                         COMMITTEE ON COMMERCE,
                      SCIENCE, AND TRANSPORTATION
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                               __________

                            JANUARY 29, 2003

                               __________

    Printed for the use of the Committee on Commerce, Science, and 
                             Transportation

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       8SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                     JOHN McCAIN, Arizona, Chairman
TED STEVENS, Alaska                  ERNEST F. HOLLINGS, South Carolina
CONRAD BURNS, Montana                DANIEL K. INOUYE, Hawaii
TRENT LOTT, Mississippi              JOHN D. ROCKEFELLER IV, West 
KAY BAILEY HUTCHISON, Texas              Virginia
OLYMPIA J. SNOWE, Maine              JOHN F. KERRY, Massachusetts
SAM BROWNBACK, Kansas                JOHN B. BREAUX, Louisiana
GORDON SMITH, Oregon                 BYRON L. DORGAN, North Dakota
PETER G. FITZGERALD, Illinois        RON WYDEN, Oregon
JOHN ENSIGN, Nevada                  BARBARA BOXER, California
GEORGE ALLEN, Virginia               BILL NELSON, Florida
JOHN E. SUNUNU, New Hampshire        MARIA CANTWELL, Washington
                                     FRANK LAUTENBERG, New Jersey
      Jeanne Bumpus, Republican Staff Director and General Counsel
             Robert W. Chamberlin, Republican Chief Counsel
      Kevin D. Kayes, Democratic Staff Director and Chief Counsel
                Gregg Elias, Democratic General Counsel
                                 ------                                

             Subcommittee on Science, Technology, and Space

                    SAM BROWNBACK, Kansas, Chairman
TED STEVENS, Alaska                  JOHN B. BREAUX, Louisiana
CONRAD BURNS, Montana                JOHN D. ROCKEFELLER IV, West 
TRENT LOTT, Mississippi                  Virginia
KAY BAILEY HUTCHISON, Texas          JOHN F. KERRY, Massachusetts
JOHN ENSIGN, Nevada                  BYRON L. DORGAN, North Dakota
GEORGE ALLEN, Virginia               RON WYDEN, Oregon
JOHN E. SUNUNU, New Hampshire        BILL NELSON, Florida
                                     FRANK LAUTENBERG, New Jersey

                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on January 29, 2003.................................     1
Statement of Senator Brownback...................................     1
Statement of Senator Ensign......................................    15
Statement of Senator Fitzgerald..................................    16
Statement of Senator Nelson......................................    30
Statement of Senator Wyden.......................................    14

                               Witnesses

Gulden, Kris, Coalition for the Advancement of Medical Research..    57
    Prepared statement...........................................    59
Feinstein, Hon. Dianne, U.S. Senator from California, prepared 
  statement......................................................     9
Hatch, Hon. Orrin G., U.S. Senator from Utah.....................     2
    Prepared statement...........................................     6
Kass, Dr. Leon R., Chairman, The President's Council on Bioethics    33
    Prepared statement...........................................    37
Specter, Hon. Arlen, U.S. Senator from Pennsylvania..............    10
    Prepared statement...........................................    10
Toomey, Hon. Patrick J., U.S. Representative from Pennsylvania...    21
    Prepared statement...........................................    22
Usala, Dr. Anton-Lewis, Medical and Administrative Director, 
  Office of Regulatory Review of Clinical Trials, East Carolina 
  University.....................................................    60
    Prepared statement...........................................    62
Weldon, Hon. Dave, U.S. Representative from Florida..............    16
    Prepared statement...........................................    19

                  SCIENCE AND ETHICS OF HUMAN CLONING

                              ----------                              

                      WEDNESDAY, JANUARY 29, 2003

                                       U.S. Senate,
    Subcommittee on Science, Technology, and Space,
        Committee on Commerce, Science, and Transportation,
                                                    Washington, DC.
    The Subcommittee met, pursuant to notice, at 2:35 p.m. in 
room SR-253, Russell Senate Office Building, Hon. Sam 
Brownback, Chairman of the Subcommittee, presiding.

           OPENING STATEMENT OF HON. SAM BROWNBACK, 
                    U.S. SENATOR FROM KANSAS

    Senator Brownback. Good afternoon. We are glad to have 
everybody here. Thank you for joining us. The committee room 
will come to order.
    This is the first hearing of the Commerce Science, 
Technology, and Space Subcommittee. We will have a number of 
them through this next 2 years. Senator Wyden chaired the 
Committee for the past year-and-a-half, did an excellent job, 
the working, ranking member.
    I am looking forward to engaging in a number of different 
topics. This is the first up. It is a very timely topic, a very 
important topic for us to consider, to consider the issue of 
human cloning.
    As I understand, we have--obviously, we have four members 
here. We are delighted to have all four of you here today. I 
understand from Senator Specter that he is really under a time 
crunch, and Senator Wyden and--oh, Senator Hatch is under the 
real time crunch, OK.
    Senator Hatch. Mr. Chairman, I am conducting, or should be 
conducting, a hearing over in the Judiciary Committee on six 
judicial nominees, and it is a very hotly contested----
    Senator Brownback. If it would be OK with the other 
members, we would like to go----
    Senator Specter. So am I, Mr. Chairman.
    Senator Brownback. If we could, let Orrin go first for a 
few minutes of his comments and then go ahead, and then you 
could be dismissed, if you would like, to chair the Judiciary 
Committee. And then we will go ahead with our opening 
statements after that, if that would be OK with the other 
Members of the Committee, or----
    Senator Specter. If I might ask, Mr. Chairman, if I might 
be permitted to use just a couple of minutes when Senator Hatch 
finishes?
    Senator Brownback. That will be fine, and then we will go 
ahead with our opening statements here at that point. We will 
try to accommodate you on the hearing schedule that you are on. 
I know you have an important Judiciary Committee markup.

               STATEMENT OF HON. ORRIN G. HATCH, 
                     U.S. SENATOR FROM UTAH

    Senator Hatch. Thank you so much, Mr. Chairman and Members 
of the Committee. That means a lot to me.
    As you can imagine, this hearing is the first one, and it 
is a very tough hearing. But I did want to be with you today, 
and I want to commend you, Mr. Chairman and others on the 
Committee, for holding this hearing today.
    And while it is no secret that we may differ somewhat on 
all of the matters under discussion today, I want to make sure 
that everybody knows that I am a great admirer, friend, and 
supporter of my friend from Kansas. And I appreciate his 
sincerity and his honesty in the way he serves, as well as all 
of you who serve on this Committee. As a fellow right-to-life 
Senator, I can tell you that I will miss you on the Judiciary 
Committee, Mr. Chairman.
    I am here today, though, to speak to the Subcommittee about 
how to stop the offensive practice of human reproductive 
cloning while at the same time allowing vital biomedical 
research to go forward under strict moral and ethical 
guidelines and protections.
    It is my hope that the 108th Congress will be able to come 
to agreement on some key matters. At the least, I hope we can 
pass legislation that will help derail the Raelians and the 
other fringe groups in their ill-advised attempt to clone human 
beings. I believe that there is virtual unanimity within 
Congress and among the public that society should prevent, 
through strong Federal criminal sanctions, attempts to 
interfere with the traditional means of reproduction in the 
form of this new form of asexual reproduction.
    Let me briefly explain what reproductive cloning means, 
because some confusion about the facts may still persist. In 
normal reproduction, including in vitro fertilization, a female 
egg, with a full complement of 23 chromosomes, is united with a 
male sperm cell that also contains 23 chromosomes. The cell 
resulting from this union of the female and male reproductive 
cells contains the complete set of 46 chromosomes that each of 
the specialized cells in our body contain, except for 
reproductive cells like the sperm and egg. Through the process 
of sexual reproduction, each of us is the shared product of our 
parents' genetic material.
    In contrast, through a technique still under development, 
it might be possible for some unscrupulous scientists to 
facilitate the birth of an asexually developed cloned baby. 
Here is how: Through the new technology of somatic cell nuclear 
transfer, it appears that it may one day be possible to remove 
the normal 23 chromosomes present in a human egg cell and 
replace them with the full complement of 46 chromosomes that 
are present in all normal human cells other than the egg and 
sperm cells. This nuclear transplantation takes place without 
the fertilization of the egg and without sperm.
    If the cellular product of such nuclear transplantation 
were implanted in a woman's womb, it is theoretically possible 
that an asexually reproduced person could be born. The 
unsubstantiated claims of Raelians notwithstanding, scientific 
experts tell us that it would be very difficult to succeed in 
bringing to birth a cloned human baby. After all, it took 377 
failures before Dolly, the cloned sheep, was born.
    At present, there is no unambiguous Federal law in the 
United States that prevents the birth of cloned human beings. 
The best way to stop reproductive cloning in its tracks in the 
United States is for Congress to pass a tough Federal criminal 
law banning reproductive cloning. That is something we could do 
today. And I believe that if our country took this action, many 
other nations would follow suit.
    Now, I recognize that there are very heartfelt views on 
both sides of this issue, Mr. Chairman, and where I part 
company with the type of legislation that you and our right-to-
life colleagues--Representative Dave Weldon, an advocate, of 
course--is on some important aspects of the new science of 
regenerative medicine and stem-cell research.
    Regenerative medicine concerns itself with the study of 
healthy and diseased cells and tissues and the attempt to 
devise interventions to repair damaged, or prevent diseased 
cells and tissues. Perhaps the most promising avenue for 
regenerative medicine is the study of stem cells. Stem cells 
are those various flexible cells that appear to have the 
ability to transform themselves into the more than 200 types of 
specialized cells that form the tissues that comprise the human 
body. There is broad agreement that research into mature adult 
stem cells should proceed full speed ahead.
    Please make no mistake about it, I am fully supportive of 
adult stem cell research. But let me hasten to add a word of 
caution. Many leading scientific experts tell us that this 
branch of stem cell research is not as promising as embryonic 
stem cell research at this time.
    In addition to adult tissue cells, such as bone marrow 
cells, there are two other promising sources of stem cells. 
First, stem cells derived from embryos produced for, but no 
longer needed in, fertility treatment. Second, stem cells 
derived through the somatic cell nuclear transport process for 
research, not reproductive, purposes.
    This first source, stem cells derived from the excess 
embryos left over from the in vitro fertilization process, is 
the type of embryonic stem cells that President Bush made 
eligible for limited Federal funding in the year 2001. Only 
those stem cells lines that were derived before the date of the 
President's speech on August 9th, 2001, qualified for Federal 
funding. Those embryos were formed in the laboratory of 
fertilization clinics. While these types of embryos were 
created in the laboratory, they all contained the normal 23 
chromosomes from a woman's egg cell and 23 chromosomes from a 
male's sperm cell.
    Now, I respect the fact that many hold the view that life 
begins at the moment the egg and sperm are united, even if this 
occurs outside the womb, in a laboratory. After many 
conversations with scientists, ethicists, patient advocates, 
and religious leaders, and many hours of thought, reflection, 
and prayer, I reached the conclusion that human life does not 
begin in the petri dish. I believe that human life requires and 
begins in a mother's nurturing womb.
    In June of 2001, I wrote to President Bush and also to 
Secretary of Health and Human Services Tommy Thompson 
explaining my views on this matter and urging them to allow 
Federal funding of research on stem cell lines derived from the 
thousands of embryos left over in the in vitro fertilization 
process each year. While I would have preferred the President 
to have gone further in this area, I applauded the President 
for his decision to make a limited member of stem cells lines 
eligible for federally funded research.
    I recognize the role that Dr. Leon Kass has played in 
acting as a trusted sounding board and advisor and helping the 
President reach a decision that was disappointing to many of my 
colleagues and friends in the right-to-life community, such as 
you, Mr. Chairman. Each year, thousands of laboratory-
facilitated embryos no longer needed in the treatment of 
fertility are routinely discarded. Many, including many of us 
with a pro-life philosophy, do not understand why it is 
permissible, and has been accepted for many years, to destroy 
these spare embryos, but it is somehow improper and unethical 
to use these cells to benefit mankind.
    Last fall, the Labor-HHS Appropriations Subcommittee held a 
hearing that shed light on some of the major deficiencies of 
the Administration's policy. And I commend the leadership of 
that subcommittee, and particularly the leadership of Senators 
Specter and Harkin for their long and distinguished record on 
this issue.
    And, by the way, I do have a statement by Senator Feinstein 
that I would ask, through unanimous consent, be placed in the 
record immediately following my----
    Senator Brownback. Without objection.
    Senator Hatch. While the number of eligible stem cell lines 
has grown from about 60 cells lines right after the President's 
speech to more than 70 cells lines, at the hearings, scientists 
pointed out that due to intellectual property restrictions and 
other issues such as logistics, the reality is that only about 
ten or so stem cell lines are practically available for 
research purposes.
    All of these facts led me to conclude that I must support 
efforts to increase the number of stem cell lines derived from 
spare IVF embryos eligible for federally funded research. More 
stem cell lines are needed to reflect adequately the ethnic and 
gender composition of the public, and that is sorely lacking in 
the current stem cell lines. We must recognize the importance 
of making more stem cell lines available to government-funded 
researchers, because a great deal of basic biomedical research 
conducted in this country largely occurs through resources 
provided by the formidable 27-billion-dollar budget of the 
National Institutes of Health. Those who applaud the promise of 
adult stem cell research--although it is unjustifiably believed 
to be superior over embryonic stem cell research in the eyes of 
many experts--should at least acknowledge that whatever 
progress that has been made in this area was possible, in large 
part, by the 20-year head start in the Federal funding of this 
type of research.
    I plan to work with Senators Specter, Harkin, and 
Feinstein, and others, to expand the number of embryonic stem 
cell lines eligible for Federal research funding by seeking 
greater use of spare embryos from IVF clinics.
    In addition to increasing federally funded research on the 
sexually-produced spare IVF embryos, I favor continuing to 
permit research on whether stem cells may be derived through 
the somatic cell nuclear transfer process.
    Let me repeat my opposition to any attempt to use nuclear 
transplantation to facilitate the birth of a cloned baby. If, 
on the other hand, nuclear transplantation can lead to another 
source of stem cells, I think we should take advantage of this 
technique, so long as we develop adequate ethical standards. 
Nuclear transplantation does not use a fertilized egg. And 
unless the asexually produced cell is implanted into a woman's 
womb, a baby cannot be born. I do not consider the laboratory-
created product of nuclear transplantation, the unfertilized 
enucleated egg injected with a somatic cell nucleus, to be a 
person.
    Frankly, I think even those who believe that life begins at 
conception, even if the unison of sperm and egg takes place in 
the lab, need to consider carefully whether the joinder of an 
enucleated egg with a somatic cell nucleus accompanied by 
chemical or electrical stimulation should fairly be thought of 
as the same process as conception. The man-made technology of 
nuclear transplantation is certainly a far cry from the natural 
world of birds and bees.
    I believe that criminalizing any attempt to implant the 
product of nuclear transplantation into a woman's womb, 
together with the appropriate protections in areas such as 
informed consent, make it possible to conduct ethical stem cell 
research through the transfer--or through the technique of 
somatic cell nuclear transfer.
    Scientists believe that there are unique advantages of 
using the DNA of one person, rather than the combined DNA of 
two parents, to study disease progression, and, in particular, 
the disease progression of a certain person. In addition, it 
may be possible to develop therapies that will be less likely 
to be rejected by the immune system if such therapies are 
derived from the patient's own DNA.
    Forty-one American Nobel laureates have told Congress of 
their strong belief that the emerging science of nuclear 
transplantation offers great hope in combatting many currently 
life-threatening, but essentially untreatable diseases. We are 
talking about cancer, heart disease, diabetes, Alzheimer's, 
Parkinson's, multiple sclerosis, ALS, and so many more.
    It is estimated that over 100 million Americans suffer from 
diseases that stem cell research may 1 day help cure or 
prevent. A critical feature of being pro-life, in my opinion, 
is helping the living. Helping those millions of American 
families struggling with the challenges of debilitating 
diseases is exactly what stem cell research with spare embryos 
from fertility treatment and from nuclear transplantation 
promises. It is my hope that Congress will enact legislation 
that will ban the birth of cloned babies, but will allow stem 
cell research through nuclear transplantation to go forward.
    I am working with a bipartisan group of Senators, including 
Senators Specter, Harkin, Feinstein, and Kennedy, to craft such 
legislation, and we hope to introduce such legislation within 
the next few weeks.
    Senator Brownback. If we could wrap it up, we were trying 
to accommodate you to be able to get back to your committee.
    Senator Hatch. You were wonderful and I certainly 
appreciate it; I am sorry to have taken this long. Let me just 
wrap it up.
    Failure to act on legislation to ban the birth of cloned 
babies only emboldens such irresponsible groups such as the 
Raelians. Failure to enact legislation that sanctions nuclear 
transplantation research, accompanied by stringent ethical and 
moral safeguards, undermines America's role as a leader in 
biomedical research and may result in the potentially 
revolutionary fruits of this research as well as some of our 
leading researchers in moving offshore and away from the 
American public. I think that outcome should be avoided, for a 
simple reason--the patients are waiting.
    And let me close by saying that for Kris Gulden, who 
testified before the Judiciary Committee 2 years ago and will 
speak to you today, and millions of others, the wait has 
already been too long.
    Thank you, Mr. Chairman. I thank you for your great 
courtesy to me. And I will leave Senator Feinstein's statement.
    Senator Brownback. And her statement will be entered into 
the record.
    [The prepared statement of Senator Hatch follows:]

   Prepared Statement of Hon. Orrin G. Hatch, U.S. Senator from Utah

    Thank you, Mr. Chairman.
    I want to commend you for holding this hearing today.
    While it is no secret that you and I do not see eye-to-eye on all 
of the matters under discussion today, I also want to be sure that it 
is no secret that I am a great admirer, friend, and supporter of my 
friend from Kansas.
    As a fellow Right to Life Senator, I can tell you that I will miss 
you on the Judiciary Committee.
    I am here today to speak to the Subcommittee about how to stop the 
offensive practice of human reproductive cloning while, at the same 
time, allowing vital biomedical research to go forward under strict 
ethical protections.
    It is my hope that the 108th Congress will be able to come to 
agreement on some key matters.
    At the least, I hope that we can pass legislation that will help 
derail the Raelians and other fringe groups in their ill-advised 
attempts to clone human beings.
    I believe that there is virtual unanimity within Congress, and 
among the public, that society should prevent--through strong federal 
criminal sanctions--attempts to interfere with the traditional means of 
reproduction in favor of a new form of asexual reproduction.
    Let me briefly explain what reproductive cloning means because some 
confusion about the facts may persist.
    In normal reproduction, including in vitro fertilization, a female 
egg with the full complement of 23 chromosomes is united with a male 
sperm cell that also contains 23 chromosomes. The cell resulting from 
this union of the female and male reproductive cells contains the 
complete set of 46 chromosomes that each of the specialized cells in 
our body contain except for reproductive cells like the sperm and egg. 
Through the process of sexual reproduction, each of us is the shared 
product of our parents genetic material.
    In contrast, through a technique still under development, it might 
be possible for some unscrupulous scientists to facilitate the birth of 
an asexually developed, cloned baby.
    Here is how.
    Through the new technology of somatic cell nuclear transfer, it 
appears that it may one day be possible to remove the normal 23 
chromosomes present in a human egg cell and replace it with the full 
complement of 46 chromosomes that are present in all normal human cells 
other than egg and sperm cells. This nuclear transplantation takes 
place without the fertilization of the egg with sperm.
    If the cellular product of such nuclear transplantation were 
implanted in a woman's womb it is theoretically possible that an 
asexually reproduced person could be born. The unsubstantiated claims 
of the Raelians notwithstanding, scientific experts tell us that it 
would be very difficult to succeed in bringing to birth a cloned human 
baby. After all, it took 377 failures before Dolly the Sheep was born.
    At present , there is no unambiguous federal law in the United 
States that prevents the birth of cloned human beings. The best way to 
stop reproductive cloning in its tracks in the United States is for 
Congress to pass a tough federal criminal law banning reproductive 
cloning. That is something we could do today. And, I believe that if 
our country took this action many other nations would follow suit.
    I recognize that there are very heartfelt views on both sides of 
this issue, Mr. Chairman. Where I part company with the type of 
legislation that you and our Right to Life colleague, Representative 
Dave Weldon, advocate, is on some important aspects of the new science 
of regenerative medicine and stem cell research. Regenerative medicine 
concerns itself with the study of healthy and diseased cells and 
tissues and the attempt to devise interventions to repair damaged or 
prevent diseased cells and tissues. Perhaps the most promising avenue 
for regenerative medicine is the study of stem cells.
    Stem cells are those flexible cells that appear to have the ability 
to transform themselves into the more than 200 types of specialized 
cells that form the tissues that comprise the human body.
    There is broad agreement that research into mature, adult stem 
cells should proceed full speed ahead. Please make no mistake about it. 
I am fully supportive of adult stem cell research.
    But, let me hasten to add a word of caution. Many leading 
scientific experts tell us that this branch of stem cell research is 
not as promising as embryonic stem cell research at this time.
    In addition to adult tissue cells such as bone marrow cells, there 
are two other promising sources of stem cells:
    First, stem cells derived from embryos produced for, but no longer 
needed in, fertility treatment.
    Second, stem cells derived through the somatic cell nuclear 
transfer process for research, not reproductive, purposes.
    This first source--stem cells derived from excess embryos left over 
from the in vitro fertilization process--is the type of embryonic stem 
cells that President Bush made eligible for limited Federal funding in 
2001. Only those stem cell lines that were derived before the date of 
the President's speech on August 9, 2001 qualified for federal funding. 
Those embryos were formed in the laboratory of fertilization clinics. 
While these types of embryos were created in the laboratory, they all 
contain the normal 23 chromosomes from a woman's egg cell and 23 
chromosomes from a male's sperm cell.
    I respect the fact that many hold the view that life begins at the 
moment the egg and sperm are united even if this occurs outside the 
womb in a laboratory.
    After many conversations with scientists, ethicists, patient 
advocates, and religious leaders and many hours of thought, reflection, 
and prayer, I reached the conclusion that human life does not begin in 
the petri dish. I believe that human life requires and begins in a 
mother's nurturing womb.
    In June of 2001, I wrote to President Bush and also to Secretary of 
Health and Human Services Thompson explaining my views on this matter 
and urging them to allow federal funding of research on stem cell lines 
derived from the thousands of embryos left over in the in vitro 
fertilization process each year.
    While I would have preferred the President to have gone further in 
this area, I applauded the President for his decision to make a limited 
number of stem cell lines eligible for federally funded research.
    I recognize the role that Dr. Kass played in acting as a trusted 
sounding board and adviser in helping the President reach a decision 
that was disappointing to many of my colleagues and friends in the 
Right to Life Community such as you, Mr. Chairman.
    Each year, thousands of laboratory-facilitated embryos no longer 
needed in the treatment of fertility are routinely discarded. Many, 
including many of us with a Pro-Life philosophy, do not understand why 
it is permissible--and has been accepted for many years--to destroy 
these spare embryos but it is somehow improper and unethical to use 
these cells to benefit mankind?
    Last fall, the Labor-HHS Appropriations Subcommittee held a hearing 
that shed light of some major deficiencies of the Administration's 
policy. I commend the leadership of that Subcommittee and particularly 
the leadership of Senators Specter and Harkin for their long and 
distinguished record on this issue.
    While the number of eligible stem cells lines has grown from about 
60 cell lines right after the President's speech to more than 70 cell 
lines, at the hearing scientists pointed out that due to intellectual 
property restrictions and other issues such as logistics, the reality 
is that only about 10 or so stem cell lines are practically available 
for research purposes.
    All of these facts led me to conclude that I must support efforts 
to increase the number of stem cell lines derived from spare IVF 
embryos eligible for federally funded research.
    More stem cell lines are needed to adequately reflect the ethnic 
and gender composition of the public. We must recognize the importance 
of making more stem cells lines available to government funded 
researchers because a great deal of basic biomedical research conducted 
in this country largely occurs through the resources provided by the 
formidable $27 billion budget of the National Institutes of Health.
    Those who applaud the promise of adult stem cell research--although 
it is unjustifiably believed to be superior over embryonic stem cell 
research in the eyes of many experts--should at least acknowledge that 
whatever progress that has been made in this area was possible in large 
part by the 20-year head start in the federal funding of this type of 
research.
    I plan to work with Senator Specter and Senator Harkin and others 
to expand the number of embryonic stem cell lines eligible for federal 
research funding by seeking greater use of spare embryos from IVF 
clinics.
    In addition to increasing federally funded research on the sexually 
produced, spare IVF embryos, I favor continuing to permit research on 
whether stem cells may be derived through the somatic cell nuclear 
transfer process.
    Let me repeat my opposition to any attempt to use nuclear 
transplantation to facilitate the birth to a cloned baby.
    If, on the other hand, nuclear transplantation can lead to another 
source of stem cells, I think we should take advantage of this 
technique so long as we develop adequate ethical safeguards.
    Nuclear transplantation does not use a fertilized egg and, unless 
the asexually produced cell is implanted into a woman's womb, a baby 
cannot be born.
    I do not consider the laboratory-created product of nuclear 
transplantation--the unfertilized, enucleated egg injected with a 
somatic cell nucleus--to be a person. Frankly, I think even those who 
believe that life begins at conception, even if the unison of sperm and 
egg takes place in the lab, need to consider carefully whether the 
joinder of an enucleated egg with a somatic cell nucleus, accompanied 
by chemical or electrical stimulation, should fairly be thought of as 
the same process as conception. The man-made technology of nuclear 
transplantation is certainly a far cry from the natural world of the 
birds and the bees.
    I believe that criminalizing any attempt to implant the product of 
nuclear transplantation into a woman's womb, together with appropriate 
protections in areas such as informed consent, make it is possible to 
conduct ethical stem cell research through the technique of somatic 
cell nuclear transfer.
    Scientists believe that there are unique advantages of using the 
DNA of one person, rather than the combined DNA of two parents, to 
study disease progression, and in particular, the disease progression 
of a certain person. In addition, it may be possible to develop 
therapies that will be less likely to be rejected by the immune system 
if such therapies are derived from the patient's own DNA.
    Forty-one American Nobel Laureates have told Congress of their 
strong belief that the emerging science of nuclear transplantation 
offers great hope in combating many currently life-threatening but 
essentially untreatable diseases. We are talking about cancer, heart 
disease, diabetes, Alzheimer's, Parkinson's, multiple sclerosis, ALS, 
and so many more. It is estimated that over 100 million Americans 
suffer from diseases that stem cell research may one day help cure or 
prevent.
    A critical feature of being pro-life is helping the living. Helping 
those millions of American families struggling with the challenges of 
debilitating diseases is exactly what stem cell research with spare 
embryos from fertility treatment and from nuclear transplantation 
promises.
    It is my hope that Congress will enact legislation that will ban 
the birth of cloned babies but will allow stem cell research through 
nuclear transplantation to go forward. I am working with a bipartisan 
group of Senators, including Senators Specter, Harkin, Feinstein and 
Kennedy, to draft such legislation and we hope to introduce such 
legislation in the next few weeks.
    Failure to act on legislation to ban the birth of cloned babies 
only emboldens such irresponsible groups like the Raelians.
    Failure to enact legislation that sanctions nuclear transplantation 
research accompanied by stringent ethical safeguards undermines 
America's role as a leader in biomedical research and may result in the 
potentially revolutionary fruits of this research--as well of some of 
our leading researchers--in moving off-shore and away from the American 
public. This outcome should be avoided for a simple reason--the 
patients are waiting.
    Let me close by saying that for Kris Gulden--who testified before 
the Judiciary Committee two years ago and will speak to you today--and 
millions of others, the wait has already been too long.

    [The prepared statement of Senator Feinstein follows:]

             Prepared Statement of Hon. Dianne Feinstein, 
                      U.S. Senator from California

``The Senate Should Ban Human Cloning, But Permit Promising Medical 
        Research to Continue''
    Mr. Chairman, thank you for holding this hearing and inviting me to 
testify.
    At the dawn of this new era in medicine, we have mapped the human 
genome, we have discovered drug therapies for cancer that work at the 
cellular level, and we are unlocking the promise of nuclear 
transplantation.
    We are now poised between two choices.
    We can continue under the current status quo with no regulations on 
cloning and with the certain knowledge that, sooner or later, we will 
be faced with reproductive cloning.
    Or, we can simply and reflexively ban all cloning, including the 
valuable biomedical research field of somatic cell nuclear 
transplantation which may well lead to cures for diseases such as 
cancer, Parkinson's, and Alzheimer's afflicting tens of millions of 
people.
    In my view, both of these choices are morally unacceptable.
    I believe that we should adopt a balanced, common-sense approach to 
this issue: ban human cloning--that is, creating a whole-body, carbon 
copy of a human being--but permit valuable stem cell research to 
continue, with strong and strict regulatory oversight.
    I will shortly be introducing legislation with Senators Hatch, 
Kennedy, Specter, Harkin, and others to do just that.
    There is broad agreement across our society that human reproductive 
cloning should be prohibited. Such cloning is unsafe, immoral, and 
unacceptable.
    Our bill bans human reproductive cloning.
    Under our bill, anyone who even attempts to clone a human being 
will face a 10-year prison term and a minimum $1 million fine.
    But there is also wide-scale support in our society to continue 
research that may yield cures, treatments, and diagnoses for many 
diseases and illnesses. And our bill allows this important research to 
continue.
    Nuclear transplantation research has nothing to do with cloning 
humans. Rather, it has everything to do with saving lives and 
alleviating suffering.
    Somatic cell nuclear transplantation is a technique that offers 
enormous potential for providing cures for diseases such as cancer, 
diabetes, cystic fibrosis, and heart disease as well as conditions such 
as spinal cord injuries, liver damage, arthritis, and burns.
    For example, a blue-ribbon National Academies' Panel concluded that

        ``Because of its considerable potential for developing new 
        medical therapies for life-threatening diseases and advancing 
        fundamental knowledge . . . biomedical research using nuclear 
        transplantation to produce stem cells be permitted.''

    I believe that any bill to ban cloning should allow this valuable 
research to continue under strict safeguards to prevent abuse. The 
legislation that we will introduce will include such safeguards.
    I am pleased that virtually every leading medical, scientific, and 
patients' advocacy group opposes legislation that would ban nuclear 
transplantation research and supports our approach.
    These organizations include the American Medical Association, 
National Health Council, Parkinson's Action Network, Juvenile Diabetes 
Research Foundation, and Federation of American Societies for 
Experimental Biology, which represents over 600,000 medical researchers 
around the country.
    In my view, it would be a great setback for millions of patients 
with catastrophic medical conditions to prohibit medical research that 
offers them the possibility of a cure.
    These are real people, with real diseases and real suffering. They 
are the ones whose hopes would be dashed if we ban nuclear 
transplantation.
    Let me read from a letter I received last year from Richard Avedon, 
the father of five-year-old Emma:

        ``Our five year old daughter suffers from Juvenile diabetes. We 
        were lucky. We discovered her condition during a check-up when 
        she was a year old. When the disease develops in infants, it's 
        usually discovered only when the child lapses into a coma and 
        is rushed to the emergency room, often in critical condition.
        Emma `s pancreas produces no insulin. On her belt, that she 
        wears twenty-four hours a day, there is an insulin pump that is 
        attached to her backside and that delivers insulin to her body 
        through surgical tubing.
        By pricking her finger for blood, as often as every two hours 
        throughout the day and night, we determine her current level of 
        blood sugar and then use the pump to adjust her insulin 
        accordingly.
        What we have learned about Emma's particular condition, 
        referred to as `brittle' or unpredictable diabetes, is that 
        despite all our efforts to control the progressions of the 
        disease and all the efforts she will make as she grows older, 
        Emma can look forward to a lifetime of potential complications, 
        including blindness, kidney failure, limb amputation and a 
        substantially shortened life expectancy, unless a cure if 
        found.
        Our family is enormously hopeful, however, that therapeutic 
        cloning research may play a vital role in finding a cure for 
        juvenile diabetes. There already exists empirical evidence 
        that, quite possibly, [somatic cell nuclear transplantation] 
        could yield the insulin producing pancreatic cells that my 
        daughter's body lacks.
        If research into this process were to be criminalized, how 
        would / explain to Emma that our government care more about a 
        cloned cell, smaller than a grain of sand, than they do about 
        her.''
        Thank you.

    Senator Brownback. Senator Specter, if you could give your 
brief comments so we could go to the opening statements here by 
the panel that is on the dais.

               STATEMENT OF HON. ARLEN SPECTER, 
                 U.S. SENATOR FROM PENNSYLVANIA

    Senator Specter. Mr. Chairman, I shall be very brief. I ask 
unanimous consent that my statement be made a part of the 
record.
    Senator Brownback. Without objection.
    [The prepared statement of Senator Specter follows:]

               Prepared Statement of Hon. Arlen Specter, 
                     U.S. Senator from Pennsylvania

    Mr. Chairman and Members of the Committee. Thank you for calling 
this hearing.
    As we prepare to debate the cloning issue, I wanted to share with 
you what I have learned about stem cell research and cloning.
    As Chairman of the Appropriations Subcommittee on Labor, HHS and 
Education, I have taken part in 14 hearings where scientists, patients 
and ethicists described the promise--and the challenges--associated 
with stem cell therapy and therapeutic cloning, or what some are 
calling ``nuclear transplantation.'' As stem cell research progresses, 
one of the biggest challenges that we will face is finding a way to 
ensure that the patient's body does not reject the implanted stem 
cells. A way to do that is by giving the stem cells the DNA code of the 
patient, so that the cells will not be rejected. This would be 
accomplished by a technique commonly referred to as therapeutic 
cloning. However, for many Americans, mere mention of the word 
``cloning'' conjures up grotesque images from a bad science-fiction 
movie: mad scientists, bubbling test tubes and row after row of zombie-
like characters.
    Evidently, those images were shared by members of the U.S. House of 
Representatives, who passed H.R. 2505, the Human Cloning Prohibition 
Act. Unfortunately, that legislation was written so broadly that it 
would also put a halt to promising research on therapies for a number 
of diseases that plague society.
    The problem is that the word ``cloning'' is scientific shorthand 
for a complex process that can be used to achieve different ends--some 
bad and some good. But like any shorthand expression, its meaning is 
easily misunderstood by those who are unfamiliar with all the facts 
involved, the most important being that there are actually two types of 
cloning: reproductive cloning and therapeutic cloning. The difference 
between the two is like night and day. One serves no useful purpose and 
is ethically and morally wrong. The other holds the potential to save 
lives and avoid human suffering.
    Reproductive cloning involves the development of a full individual 
from a single body cell, the same process which Scottish scientists 
used in 1997 to create Dolly the sheep, and Texas scientists recently 
used to create CC the cat. All of us abhor human reproductive cloning 
and agree that it should be banned. To address this issue I, along with 
Senator Hatch and others, introduced S. 2439, a bill that provides 
criminal and civil penalties for any person who performs or attempts to 
perform human cloning.
    Therapeutic cloning, on the other hand, refers to creating 
embryonic stem cells that are genetic matches to the patient for the 
purpose of repairing damaged and diseased tissue. In 1998, scientists 
first reported that embryonic stem cells have the ability to transform 
into any type of cell in the human body. If the scientists' theories 
are accurate, human embryonic stem cells, or tissues derived from them, 
could be transplanted to any part of the body to replace tissue that 
has been damaged by disease, injury or aging. It is this remarkable 
adaptability that leads scientists to believe that one day, stem cells 
could be the basis for an entire field of regenerative medicine.
    As an example of the way this could work, let's say that a patient 
has heart damage resulting from a heart attack. The genetic material 
from one of his mature cells would be transplanted to an egg, which has 
been donated by a woman and had its own genetic material removed. This 
nuclear transplantation would create an entity that has never before 
existed in nature, but is related to a ``pre-implantation embryo.'' 
This pre-implantation embryo, or ``activated oocyte'' as others have 
called it, is stimulated to divide in a Petri dish. After five to seven 
days, it would form a ball of about 100 cells called a blastocyst. At 
this stage, embryonic stem cells can be derived from within the 
blastocyst. These stem cells continue to divide in an undifferentiated 
state for an indefinite period of time. Stem cells, or heart tissue 
derived from these cells, would then be transplanted into the damaged 
heart of the patient where they would take up residence and work 
alongside the patient's original heart cells. Because the cells are the 
identical genetic match of the patient, no rejection would ever occur.
    In 2001, President Bush announced his support for limited 
federally-sponsored embryonic stem cell research. While I prefer wider 
availability of stem cells than the President calls for, his compromise 
at least allows stem cell research to proceed. But scientists will 
never be able to explore the full potential of stem cells if 
legislation like H.R. 2505, the House-passed ban, is enacted into law.
    Many say that we should ban medical research related to therapeutic 
cloning because it is unproven and may lead to unintended consequences. 
We have heard these arguments before, and we should heed the lessons 
learned. Twenty five years ago a debate raged regarding the potential 
of a new biotechnology called recombinant DNA. Members of Congress 
argued about whether to ban the use of this controversial technology 
completely, or to draft regulations that would allow scientists to move 
forward slowly. Many believed that the new technology could be used to 
cure diseases, and should therefore be fostered. Others believed that 
the technology was unproven, unsafe and would lead to Aldous Huxley's 
nightmarish vision of a Brave New World, and should therefore be banned 
completely. A debate was engaged whose conclusion was far from certain. 
In the end, the scientists identified ethical and safety guidelines and 
the Congress allowed them to create techniques using recombinant DNA. 
Today, this technology forms the backbone of an entire industry that 
has led to the development of recombinant vaccines, insulin for 
diabetics, drugs to fight AIDS, cancers, and many of our most 
debilitating diseases and afflictions. A ban on recombinant DNA 25 
years ago would have resulted in the early deaths of hundreds of 
thousands, if not millions of Americans.
    Today, we stand on the threshold of another era of scientific 
advances that, with the proper ethical guidelines, may revolutionize 
the way medicine is practiced. Dr. Bert Vogelstein, a prominent cancer 
researcher at Johns Hopkins University chaired a National Academies of 
Sciences Panel that investigated the potential of stem cells and 
nuclear transplantation to produce stem cells. Dr. Vogelstein's panel 
found that nuclear transplantation and stem cell-based therapies could 
be used to treat diseases and injuries that afflict over 100 million 
Americans. These maladies include cancer, diabetes, osteoporosis, 
cardiovascular diseases, autoimmune diseases, Alzheimer's disease, 
Parkinson's disease, burns, spinal-cord injuries and birth defects. Dr. 
Vogelstein estimates ``that 170,000 Americans a year might be spared 
disease-related deaths through stem cell therapies.'' This is an 
astounding figure from an experienced cancer researcher.
    Lest someone think our country's scientists have no moral compass, 
when news accounts first surfaced that some individuals planned to 
conduct human cloning experiments, the prestigious National Academy of 
Sciences was quick to call for a legal ban on reproductive cloning. The 
Federation of American Societies for Experimental Biology, which 
represents over 60,000 of our nation's scientists, followed suit by 
emphatically denouncing human reproductive cloning. But both 
organizations were quick to make the distinction that, unlike 
reproductive cloning, therapeutic cloning holds enormous life-saving 
potential and should therefore be pursued.
    Why is all this important? Because unless we take the time to 
understand the distinction between reproductive and therapeutic 
cloning, we risk losing one of the brightest hopes we have for treating 
and curing maladies like cancer, Alzheimer's, diabetes, spinal cord 
injury, and heart disease.
    We must not tie the hands of our scientists. There are already 
reports of a ``reverse brain drain,'' in which scientists are leaving 
the United States or choosing not to come here in the first place 
because of restrictions on stem cell, and now therapeutic cloning, 
research. More importantly, we risk delaying scientific and medical 
breakthroughs that can save lives.
    We should ban human reproductive cloning, and the legislation that 
I and others have introduced will do so. But, before we close off the 
opportunity to save lives, we owe it to ourselves and future 
generations to look beyond the word cloning and engage in a substantive 
debate regarding regenerative therapies that could revolutionize the 
practice of medicine.

    Senator Specter. Senator Hatch has outlined the issues 
very, very well, and I will just supplement with a couple of 
comments.
    During my 23 years on the Senate Appropriations 
Subcommittee for Health and Human Services, I have promoted the 
funding for the National Institutes of Health, which has done 
remarkable work. When stem cells burst upon the scene in 
November 1998, in my capacity as chairman of that subcommittee, 
I convened the first of some 14 hearings on the subject.
    I am totally opposed to human cloning. The word ``cloning'' 
has been used with reproductive cloning, which is a misnomer. 
It is really nuclear transplantation. There are enormous 
advances possible on the most dreaded maladies around. If the 
embryos could be used to produce life, that would be their 
highest use, and I would be all for it. But--and, Senator 
Hatch--and this is the only thing I will repeat--said he cannot 
understand why you should destroy embryos instead of using 
them. And I think that is the consideration, in a nutshell.
    Last year, I took the lead in putting up $1 million--or the 
appropriations process did--for embryo adoption. And if there 
are enough people who are willing to adopt embryos, we ought to 
give them tax breaks. That would be the best use. But rather 
than discard them, let us use them. Let us work together to ban 
human cloning, but not mistake that it is not cloning when you 
talk about nuclear transplantation, which has the capacity to 
save many, many lives.
    President Bush acknowledged the importance of stem cells on 
August the 9th in his famous speech where he authorized Federal 
funding for stem cell lines in existence at that time. Let us 
permit science to go forward.
    That is three-and-a-half minutes, Mr. Chairman, and I thank 
you.
    Senator Brownback. Thank you, as well, Senator Specter.
    Thank you all for coming today. We will have opening 
statements at this point in time. I wanted to accommodate other 
members. And we will get back to the rest of the panel, then, 
after that.
    Today we will investigate the science and the ethics of 
human cloning. The world was stunned when a cult claimed to 
have produced the first live-born human clone over the 
Christmas holidays, and whether or not the Raelian claim of a 
live-born human clone is, in the end, proven to be true or 
false, we all know, at a minimum, that a live-born human clone 
is either already among us, or is, at least, a likely reality.
    Of course, what the Raelians claim to have done is build on 
work that some in the biotech community are attempting to do. 
Work has already begun in biotechnology laboratories for the 
mass production of made-to-order human clones. Some want to 
begin cloning humans, some want--they just do not want anyone 
to call it that. Some who support human cloning would have 
society believe that there are two different types of cloning--
so-called ``reproductive cloning'' and so-called ``therapeutic 
cloning.'' Science, however, tells us that there is only one 
type of cloning, and, when successful, always results in the 
creation of a young human--initially a human embryo; 
eventually, a live birth. All cloning is reproductive, then, by 
nature. By that, I mean all human cloning produces another 
human life.
    Now, so-called ``therapeutic cloning'' is the process by 
which an embryo is specially created for the directly intended 
purpose of subsequently killing it for its parts or for 
research purposes. Some proponents of human cloning claim that 
an embryo created in this manner will have cells that are a 
genetic match to the patient being cloned and, thus, would not 
be rejected by the patient's immune system. This claim is 
overstated, at best. In fact, there are some scientific reports 
that show the presence of mitochondria DNA in the donor egg can 
trigger an immune-response rejection in the patient being 
treated.
    To describe the process of destructive human cloning as 
therapeutic when the intent is to create new human life that is 
destined for its virtual immediate destruction is certainly 
misleading. However one would like to describe the process of 
destructive cloning, it is certainly not therapeutic for the 
clone who has been created and then disemboweled for the 
purported benefit of its adult twin.
    I, along with the President and the vast majority of 
Americans, do not believe that we should create human life just 
to destroy it. Yet that is exactly what is being proposed by 
those who support cloning in some circumstances. And however 
they might name the procedure--whether they call it ``nuclear 
transplantation,'' ``therapeutic cloning,'' ``therapeutic 
cellular transfer,'' ``DNA regenerative therapy,'' or some 
other name--it is simply human cloning.
    Now, let us be clear, the Raelians and those interested in 
human cloning research seek to create human life through a 
process of human cloning that a vast majority of Americans 
clearly oppose. The threat presented to us by the Raelians is 
one that should refocus our attention on the immediacy of 
passing a permanent and comprehensive ban on all human cloning. 
The need for a permanent and comprehensive ban is pressing.
    Six states have already passed laws that outlaw human 
cloning, and several more are beginning to follow suit. In 
fact, just yesterday the Indiana State Senate voted 47 to 3 to 
ban all human cloning.
    Clearly, the Congress must address this issue during the 
108th Congress. Later today, Senator Mary Landrieu and I, along 
with several of our Senate colleagues, will introduce the Human 
Cloning Prohibition Act of 2003.
    The President has already stated his unequivocal support 
for a permanent and comprehensive ban on all human cloning 
numerous times, including in his annual State of the Union 
Address just last night. And during the 107th Congress, the 
House voted, in an overwhelmingly bipartisan majority, to ban 
it.
    The time for action in the Senate is now. Hopefully through 
this hearing, and with some of the hearings to come over the 
next several months, we will be able to better understand the 
implications of human cloning for our society.
    And I would note, as some of you have noticed already, the 
whole issue is going to be in the definition of ``What is a 
human clone?'' Last night, when the President said he supported 
banning all human cloning, virtually everybody stood up and 
applauded. I thought that to be a very good sign. Then you 
find, ``Well, what does the parsed word mean here? And when is 
a human clone a clone?'' And that is the definition of what 
Senators Hatch and Specter were talking about, as well.
    I hope we can focus in on human cloning--What is a human 
clone?--that we can ban that procedure and ban the creation of 
human clones, and I hope we can have a good discussion of that. 
This is not about embryonic stem cells from embryos that are 
currently in existence, as some have already testified. This is 
about the creation of a human clone, and it is primarily the 
issue of the creation of that human clone for research 
purposes. So hopefully we can have a good hearing and 
discussion on that point.
    I now turn to the ranking member, Senator Wyden.

                 STATEMENT OF HON. RON WYDEN, 
                    U.S. SENATOR FROM OREGON

    Senator Wyden. Thank you, Mr. Chairman. I am certain we are 
going to have a good hearing, because you have always been very 
fair. I will tell you, having chaired this Subcommittee in the 
last Congress, and I wish I did not have to turn over the gavel 
right now, but I look forward to working with you. I know we 
are going to find common ground on a host of issues. I do not 
think there is a more exciting Subcommittee in the U.S. Senate 
than this one, and I wish you well.
    Mr. Chairman and colleagues, first and foremost, with the 
hopes and aspirations of millions of suffering Americans, I 
just hope that Congress will follow the route of careful 
science here, rather than create roadblocks of resistance when 
our scientists try to come up with breakthrough cures.
    I think it is especially important to reflect on another 
matter that we faced about 30 years ago, which has an awful lot 
of parallels to what we are dealing with today. In the late 
1970's, when recombinant DNA technology was being developed, 
Congress was pushed then to consider a ban on all research in a 
field that was considered new and controversial. There was a 
debate, and much of the same set of questions we are faced with 
now was raised then. Fortunately, the research was allowed to 
go forward. It was done carefully. As I have suggested, 
therapeutic research must be done now, but the benefits have 
just been extraordinary. I will just mention a few of them, a 
few of the 66 recombinant DNA products have helped tens of 
millions of patients worldwide--Humulin and Humalog serve human 
insulin, for over 4 million diabetes patients worldwide. 
Herceptin treats breast cancer, is now being treated in Phase 3 
clinical trials. Epogen has been used since 1989 to fight 
anemia in kidney-dialysis patients. Endro works with the body's 
immune system to control inflammation. Pulmozyme has prevented 
childhood deaths from cystic fibrosis.
    I think when you look at these kind of complicated 
scientific questions, where passions do run very high and 
people have differences of opinion, it is important to look at 
these historical models. I am convinced that making sure that 
we did not stop scientists in the 1970's was critical, the 
decisions we make about whether to stop or not stop scientists 
now is just as critical.
    Last session, the Senate looked at two very different 
approaches to regulating yet another unfamiliar line of 
research. One of them would have banned reproductive cloning 
while allowing scientists to continue promising research on 
somatic cell nuclear transfer. The other approach would have 
been not only reproductive cloning, but also nuclear transfer 
and the importation of medical advances made through this 
research.
    I favor the first approach. I think it is absolutely 
critical if we are to unlock the next generation of life-saving 
medical treatments. I hope that this Congress will not turn a 
blind eye to the therapeutic potential of the research that can 
lead to these breakthroughs.
    I know that with strong differences of opinion, Chairman 
Brownback is going to handle a difficult issue fairly, and I 
look forward to working with him and our colleagues.
    Senator Brownback. Thank you, Senator Wyden.
    Senator Ensign, would you have any opening comments?

                STATEMENT OF HON. JOHN ENSIGN, 
                    U.S. SENATOR FROM NEVADA

    Senator Ensign. Just very briefly, Mr. Chairman.
    I thank you for calling this hearing. I think in the bigger 
scope of things, I do not know that we could be dealing, as far 
as future is concerned, with a more important issue. It really 
does get to how we view ourselves as human beings. When we are 
starting to mess with the genetic makeup of people, the 
potential for evil is so great it is--it is almost 
unimaginable. And so this issue coming before us, it is so 
important that we deal with it, and we deal with it in a very 
logical, systematic manner, and we get as much scientific 
testimony as possible so that we know--we all know what we are 
dealing with.
    There is a lot of confusion out there. I mean, it sounds so 
good to say ``therapeutic cloning.'' I mean, you know, it is 
not reproductive cloning, it is therapeutic cloning. That is 
why, Mr. Chairman, when you mentioned how important it is going 
to be to have the definition of terms, just the difference 
between those two terms right there, it tells you, you know, 
whoever wins the battle of the definition will probably win 
this debate.
    And so it is very important that we establish that cloning 
is cloning. Dolly was a clone. I think that everybody 
recognizes that Dolly was a clone. Somatic cell nuclear 
transfer, that is the way Dolly was created. Everybody would 
recognize that that was a clone. A clone, as Senator Hatch was 
talking about, you would not define that as a clone, but that 
certainly, in my book, is a clone.
    And so I think that it is important, as we get testimony, 
that we educate ourselves and we educate all of our colleagues 
about truly what we are dealing with here, because I really 
believe that this is one of the fundamental questions of our 
age, and future generations will be looking back at what we do 
now, depending on which direction we go.
    So thank you very much for holding this hearing, and I look 
forward to the testimony of the witnesses.
    Senator Brownback. Thank you.
    Senator Fitzgerald, do you have any comments?

              STATEMENT OF HON. PETER FITZGERALD, 
                   U.S. SENATOR FROM ILLINOIS

    Senator Fitzgerald. Well, I just want to thank the Chairman 
for his leadership on the cloning issue, and I am proud to be a 
co-sponsor of your legislation.
    And I want to welcome Representatives Toomey and Weldon to 
the Committee, and we will take--do some questions later.
    Thank you.
    Senator Brownback. You both have been very patient. 
Congressman Weldon, I believe we will go with you first, if 
that is OK. And I very much appreciate both of you being here 
to testify here today.
    Dave Weldon.

                STATEMENT OF HON. DAVE WELDON, 
                U.S. REPRESENTATIVE FROM FLORIDA

    Dr. Weldon. Thank you, Mr. Chairman, for the opportunity to 
testify.
    It is critically important that the Senate act and enact a 
complete ban on human cloning. There is a huge bipartisan 
majority of Americans that want to see the procedure of human 
cloning banned, both for reproductive purposes and for 
experimental research. The failure to act is not only confusing 
and disappointing to the American people, but it also sends out 
a very wrong signal to the world community.
    The United States remains the world's leader in the arenas 
of biomedical technology development and research, but, as 
well, in the areas of ethics involving the applications of 
these technologies. Many countries that have banned all human 
cloning remain amazed that the United States has not enacted a 
similar ban and that today in America, it remains legal to 
perform human cloning.
    For this reason, I would like to confine my comments to the 
principal issue that is responsible for the failure of the 
Congress to act. All human cloning begins with the production 
of a cloned embryo. Reproductive cloning involves implanting a 
cloned embryo into a woman's uterus; while cloning research, 
therapeutic cloning, somatic cell nuclear transfer, nuclear 
transfer, or whatever you choose to call it, involves taking 
that same embryo, using it, and then destroying it after the 
cells have been extracted.
    The question before us is whether we should ban human 
cloning at its beginning, or whether we should allow the 
creation of cloned embryos for experimental research and the 
inevitable implantation.
    Many advocates for research cloning have advanced the 
notion that we need to allow it because of the so-called 
``potential'' of therapeutic cloning. This potential has been 
based on speculation, exaggeration, and with no scientific 
facts. There are not even animal models to back up the claims 
that are promised. Cloning advocates say they need cloning to 
cure diseases. We were all promised, just last year, that 
embryonic stem cell research will cure all our ills. Now, a few 
months later, those same people are telling us that we need to 
accept human cloning experiments to address the tissue 
rejection issues.
    I would like to remind you that transplant surgeon and now-
Senate Majority Leader Frist made it clear on November 27th, 
2001 in a Senate-floor speech that cloning does not resolve the 
tissue rejection issues. In fact, the real successes and 
advances being made are in the area of adult stem cells. Adult 
stem cells can be harvested from many areas of our body, such 
as the marrow, fat tissue, even the nose. There are no immune 
rejection issues with their use, no moral or ethical 
objections, and they have been used successfully in clinical 
practice for over 20 years to treat a host of serious 
conditions. Adult stem cells have been used successfully in 
over 45 human clinical trials, treated thousands with bone 
marrow transplants, and cured--cured a 59-year-old man of 
Parkinson's Disease. Furthermore, today's medical literature 
abounds with publications demonstrating successful new human 
clinical applications of adult stem cells.
    Mr. Chairman, I still see patients, and I still read the 
medical journals. For the record, I submit a list of over 80 
recent articles I was able to obtain from the medical 
literature demonstrating the successful use of human stem 
cells.
    Senator Brownback. Those will be submitted to the record 
without objection. *
---------------------------------------------------------------------------
    * The information referred to has been retained in Committee files.
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    Dr. Weldon. Researchers have found it very difficult to 
move embryo stem cells beyond the petri dish. Their robust 
tendency to duplicate and differentiate has shown them to be 
unstable in animal trials, with a tendency to form cancer-like 
tumors. Today, not only is there no example of embryo stem 
cells being used successfully to treat diseases in humans, 
there is not even a good animal model where this can be done.
    What Senator Hatch and others are proposing we do is to go 
down the same path with cloned human embryos. Mr. Chairman, 
these are not minor issues. These are major issues, and there 
are obstacles we face--and the obstacles faced with embryo stem 
cells and cloned stem cells, we do not face with adult stem 
cells.
    Both my bill and your bill, Mr. Chairman, allow unfettered, 
ongoing research in the fields of animal cloning. Cloning of 
animals is permissible under our legislation. Cloning of 
tissues is permissible. Cloning of DNA is permissible. Mr. 
Chairman, we do not allow drug companies to go out there and 
start experimenting on human subjects with their drugs until 
they have first demonstrated success in animal models. I think 
the gentleman from Nevada can testify to this. He is a former 
veterinarian.
    Why some would want to skip this process and go directly to 
human cloning is beyond me. I say to these researchers, ``Go 
out and conduct your animal experiments and then come back to 
us, and do not skip the process and start experimenting with 
humans.'' Too much is at stake.
    If we pass anything short of the bill such as the one I 
have introduced, and the bill that you and Senator Landrieu 
would introduce, we will be forced to confront some very 
serious issues. If we go down the path Senator Hatch and 
Senator Specter have proposed, I think there are some very 
serious challenges that we will open up.
    We will usher in an era where women will be exploited by 
experimental research cloning by corporations in order to get 
their eggs. Millions of women's eggs will be purchased for use 
in cloning experiments. This commodification of women is one of 
the reasons that leading feminists, like Judy Norsigian, have 
come out against research cloning. We have already seen the 
disturbing ads in college newspapers offering to pay women for 
their eggs for research. I find it hard to believe that some 
would embrace exposing women to serious--a serious medical 
procedure in order to harvest their eggs for these questionable 
experiments.
    I would further assert that if the approach that Senator 
Hatch is advocating were allowed to move forward, eventually 
these companies will go to Central and South America and 
exploit poor women in Third World countries to get their eggs. 
The failure to approve our bill will allow there to be hundreds 
of labs all over the country creating cloned human embryos, 
which will ultimately usher in reproductive cloning. It will be 
impossible to police a reproductive cloning ban alone. The U.S. 
Department of Justice said so in testimony they presented to a 
House committee last year.
    And, Mr. Chairman, I would like to introduce that testimony 
for the record in this Committee.
    Senator Brownback. Without objection.
    [The information referred to follows:]

        Dr. WELDON. But you kind of leave the door open. That's the 
        impression I get. You say, at this time, until there are better 
        results in animals; I can't help but conclude that at least in 
        your opinion and the position of many members of your 
        professional association that you may come out ultimately in 
        support of Dr. Zavos' position that we should allow 
        reproductive cloning.
        Dr. COWAN. Yes, sir. It is a difficult position. Certainly, at 
        this time though, we don't recommend it; but times can change. 
        Times have changed for all of us, and we may very well see the 
        position for reproductive cloning in the future. Rather than 
        close this door, we would prefer to say, leave it open until we 
        know more about it.

    Dr. Weldon. Once cloned embryos are available in the 
laboratory, the implantation of a cloned human embryo into the 
womb of a surrogate mother would occur in the privacy of the 
doctor-patient relationship. Once implanted, what would the 
proponents of research cloning suggest we do? How could we 
possibly enforce their bill?
    On May 15th, 2002, Dr. Bryan Cowan, representing the 
American Society for Reproductive Medicine, testified before 
the House that they opposed reproductive cloning at this time. 
I questioned him, asking him whether his professional 
organization may come out ultimately in support of reproductive 
cloning, as Dr. Zanos Panos wants to do. He responded, and I 
quote, ``Yes, sir, it's a difficult position.'' Their position 
is that when the safety issues are resolved, they want to 
engage in reproductive cloning. So research cloning will pave 
the way for reproductive cloning. Therefore, the only way to 
effectively stop this from occurring is to ban cloning from the 
start.
    Finally, let me say that if we allow research cloning to be 
legal in the U.S., we are opening the door to a whole host of 
additional moral/ethical dilemmas. The artificial womb is 
currently under development, and it is possible now to place 
cloned embryos in an artificial womb environment and allow them 
to develop beyond the embryonic stage into the fetal stage of 
development.
    Mr. Chairman, artificial wombs will be available in the 
near future. I will suggest to you that you will see these same 
people knocking on your door next year saying, ``Please just 
let us grow these embryos for a few more weeks in the 
artificial womb so we can now get the differentiated cells.'' 
The question remains, How far will they go? To what age would 
they like to allow these cloned embryos to develop? How much do 
they want to exploit them?
    Mr. Chairman, again, thank you for inviting me to be here, 
and I would be happy to answer any questions during the 
question period.
    [The prepared statement of Dr. Weldon follows:]

                Prepared Statement of Hon. Dave Weldon, 
                    U.S. Representative from Florida

    Thank you for the opportunity to testify. It is critically 
important that the Senate enact a complete ban on human cloning. There 
is a huge bipartisan majority of Americans that want to see the 
procedure of human cloning banned, both for reproductive or 
experimental research purposes. The failure to act is not only 
confusing and disappointing to the American people, but it also sends 
out a very wrong message to the world.
    The United States remains not only the world's leader in the arenas 
of biomedical technology development and research, but as well in the 
areas of the ethics involving the applications of these technologies. 
Many countries that have banned all human cloning remain amazed that 
the United States has not enacted a similar ban, and that today in 
America it remains legal to perform human cloning.
    For this reason, I would like to confine my comments to the 
principle issue that is responsible for this failure to act. All human 
cloning begins with the production of a cloned embryo. Reproductive 
cloning involves implanting a cloned embryo into a women's uterus; 
while cloning research, therapeutic cloning, somatic cell nuclear 
transfer, nuclear transfer, or whatever you choose to call it, involves 
taking that same embryo and destroying it to take its cells rather than 
implanting it.
    The question before us is whether we should ban human cloning at 
its beginning, or whether we should allow the creation of cloned human 
embryos for experimental research and the inevitable implantation.
    Many advocates for research cloning have advanced the notion that 
we need to allow it because of the so-called potential of therapeutic 
cloning. This potential has been based on speculation, exaggeration and 
with no scientific facts. There are not even animal models to back up 
the claimed promises.
    Cloning advocates say they need cloning to cure diseases. We were 
all promised just last year that embryonic stem cell research will cure 
all our ills. Now a few months later those same people are telling us 
that we need to accept human cloning experiments to address tissue 
rejection issues. I would like to remind you that transplant surgeon, 
and now Senate Majority Leader Frist, made it clear on November 27, 
2001, in a Senate floor speech, that cloning does not resolve the 
tissue rejection issues.
    In fact, the real successes and advances are being made in the area 
of adult stem cells. Adult stem cells can be harvested from many areas 
of your body such as the marrow, fat tissue, even your nose. There are 
no immune rejection issues with their use, no moral or ethical 
objections, and they have been used successfully in clinical practice 
for over twenty years to treat a host of serious conditions. Adult stem 
cells have been used successfully in over forty-five human clinical 
trials, treated thousands with bone marrow transplants, and cured a 59 
year old man of Parkinson's disease.
    Furthermore, today's medical literature abounds with publications 
demonstrating successful new human clinical applications of adult stem 
cells. Mr. Chairman, I still see patients and I still read the medical 
journals. For the record I submit a list of over 80 recent articles I 
was able to obtain from the medical literature demonstrating the 
successful use of adult stem cells.
    Researchers have found it very difficult to move embryo stem cells 
beyond the petri dish. Their robust tendency to duplicate and 
differentiate has shown them to be unstable in animal trials with a 
tendency to form cancer like tumors. Today, not only is there no 
example of embryo stem cells being used successfully to treat disease 
in humans, there is not even a good animal model where this can be 
done. What Senator Hatch and others are proposing we do is to go down 
this same path with cloned human embryos. Mr. Chairman, these are not 
minor issues. These are major issues, and they are obstacles we do not 
face with adult stem cells.
    Both my bill and your bill, Mr. Chairman, allow unfettered, ongoing 
research in the field of animal research in the area of cloning. 
Cloning of animals is permissible under our legislation Cloning of 
tissues is permissible. Cloning of DNA is permissible. Mr. Chairman we 
do not allow drug companies to go out there and start experimenting on 
human subjects with their drugs until they have first proven successes 
in animal models. Why some would want to skip this process with human 
cloning is beyond me. I say to the researchers, go out and conduct your 
animal experiments and then come back to us, but do not skip that 
process and start experimenting with humans. Too much is at stake.
    If we pass anything short of the bill that Rep. Bart Stupak and I 
have introduced in the House, and the bill that you and Senator Mary 
Landrieu are introducing in the Senate, we will be forced to confront 
some very serious issues.
    Absent our bill, we will usher in an era where women will be 
exploited by experimental research cloning corporations for their eggs. 
Millions of women's eggs will be purchased for use in cloning 
experiments. This commodification of women is one of the reasons that 
leading feminists like Judy Norsigian have come out against research 
cloning. We have already seen the disturbing ads in college newspapers 
offering to pay women for their eggs for research. I find it hard to 
believe that some would embrace exposing these women to serious medical 
procedures in order to harvest their eggs for experiments.
    Second, the failure to approve our bill will allow there to be 
hundreds of labs all over the country creating cloned human embryos 
which will usher in reproductive cloning. It will be impossible to 
police reproductive cloning. The U.S. Department of Justice said so in 
testimony they presented in a House Committee last year. (Mr. Chairman 
I would like to submit their testimony for the record.) Once cloned 
embryos are available in the laboratory, the implantation of a cloned 
human embryo into the womb of a surrogate mother would occur in the 
privacy of the doctor-patient relationship. Once implanted, what would 
the proponents of research cloning suggest we do? How could they 
possibly enforce their bill?
    On May 15, 2002 Dr. Bryan Cowan, representing the American Society 
for Reproductive Medicine, testified before the House that they opposed 
reproductive cloning ``at this time.'' I questioned him asking whether 
his professional organization ``may come out ultimately in support of 
Dr. Zavos' position that we should allow reproductive cloning.'' He 
responded, and I quote: ``Yes, sir. It is a difficult position.'' Their 
position is that when the safety issues are resolved they want to 
engage in reproductive cloning. So, research cloning will pave the way 
for reproductive cloning. Therefore, the only way to effectively stop 
this from occurring is to ban cloning from the start.
    Finally, let me say that, if we allow research cloning to be legal 
in the U.S., we are opening the door to a whole host of additional 
moral and ethical dilemmas. The artificial womb is currently under 
development and it is possible to place the cloned embryos in an 
artificial womb environment and allow them to develop beyond the 
embryonic stage well into the fetal stage of development.
    Mr. Chairman, artificial wombs will be available in the near 
future. I'll suggest to you that you'll see these same people knocking 
on your door next year, saying please just let us grow these embryos 
for a few more weeks in the artificial womb so we can get the 
differentiated cells. The question remains, how far will they go, to 
what age would they like to grow these smallest of humans in order to 
exploit them.

    Senator Brownback. Thank you, Dr. Weldon. I appreciate your 
testimony. Being a physician adds another level of credibility.
    Senator Ensign, though, noted to me that he remains a 
veterinarian. You said he ``was.'' But he remains a 
veterinarian.
    Dr. Weldon. My deepest apologies, Doctor.
    Senator Brownback. Next, we have Congressman Patrick 
Toomey. He is a Congressman from Pennsylvania's 15th District, 
serving in the House of Representatives. We are glad to have 
you with us, Congressman Toomey.

             STATEMENT OF HON. PATRICK J. TOOMEY, 
             U.S. REPRESENTATIVE FROM PENNSYLVANIA

    Mr. Toomey. Thank you, Mr. Chairman and Members of the 
Committee, for allowing me to testify today.
    As you all know, during the last Congress, the House of 
Representatives overwhelming passed H.R. 2505, a bill 
introduced by my colleague from Florida, Dr. Weldon, which 
would ban all human cloning. As a strong supporter and one of 
the 265 House members who voted for this bill, I am here today 
to urge my Senate colleagues to do likewise. As the President 
stated last night, because no human life should be started or 
ended as the object of an experiment, I ask you to set a high 
standard for humanity and pass a law against all human cloning.
    I am certainly very sympathetic to all those who suffer 
from incurable or chronic afflictions. I think we all are. And 
we are all committed to helping find cures. I understand the 
good intentions of those who advocate human cloning and the 
hope that research on these clones might yield cures for major 
illnesses. But for a variety of reasons, both technical and 
ethical, I believe it is wrong to pursue this approach.
    On the technical level, although I am neither a doctor nor 
a scientist, the evidence suggests to me that cloned human 
embryos are not likely to yield cures for major illnesses. 
Hopes to the contrary are not well-founded and may be false 
hopes for the afflicted.
    As just one example, according to Thomas Okarma, the chief 
executive officer of Geron Corporation, a leading bio-
pharmaceutical company, quote, ``The odds favoring success are 
vanishingly small, and the costs are daunting. It would take 
thousands of human eggs on an assembly line to produce a custom 
therapy for a single person. The process is a nonstarter, 
commercially,'' end quote.
    Furthermore, as Dr. Weldon has explained, despite years of 
research with animal cloning, no successful treatment has been 
developed using cells derived from cloned embryos, for either 
animals or people.
    The process that would be required to produce large 
supplies of cloned human embryos is, itself, ethically 
problematic. Super-ovulatory drugs are necessary for producing 
large supplies of eggs for harvesting. These drugs have been 
linked to an increased risk of ovarian cancer. In addition, 
this process inherently treats a woman's eggs as a commodity.
    Supporters of human cloning for research purposes have 
proposed limitations that are both arbitrary and, I believe, 
unworkable. To avoid the dilemma of creating a cloned child, 
they would require that the cloned embryo be destroyed after a 
specified period of time. Some have suggested 14 days. Clearly, 
this is an arbitrary point in time. If scientists were to 
determine that the embryo would be of more scientific value 
after 21 days or 51 days, what rationale would keep the 14-day 
limit in force?
    In addition, a specified deadline for experimenting upon 
and destroying a cloned human embryo would be almost impossible 
to enforce. The Justice Department concluded that, quote, 
``Enforcing a modified cloning ban would be problematic and 
pose certain law enforcement challenges that would be lessened 
with an outright ban on human cloning.'' The statement went on 
to say, ``There does not seem to be any reliable means for 
determining the difference between a fertilized embryo and a 
cloned embryo,'' and concluded by stating that, ``Once a 
pregnancy were established, any government-directed attempt to 
terminate a cloned embryo in utero would create problems 
enormous and complex.'' In other words, if a cloned human 
embryo were to be implanted and a viable pregnancy established, 
it would be virtually impossible to detect or differentiate 
from a routine pregnancy. And if detected, the only way to 
prevent the cloned child would be a forced abortion, which is 
obviously unacceptable to all of us.
    As daunting as all of the technical challenges are, Mr. 
Chairman, perhaps the strongest arguments against human cloning 
are the ethical arguments. The process of transferring a 
somatic cell nucleus into an enucleated egg produces a human 
embryo that has the potential to be implanted in utero and 
developed to term. In other words, the embryo produced for the 
purpose of therapeutic cloning, as some would call it, is 
biologically indistinguishable from an embryo intended for 
reproduction. It is a human life--at a very early stage of 
development, of course, but entirely human, nevertheless.
    Thus, creating cloned human embryos for research purposes 
means creating human life for the purpose of research and with 
the intent of destroying it. This commodification and 
exploitation strikes me as a profound undermining of our 
society's sense of human dignity. And in doing so, I believe it 
undermines our very humanity.
    Mr. Chairman, I thank you for holding this hearing today. I 
thank you for your support for a ban on all human cloning, and 
I thank you for allowing me to testify this afternoon.
    [The prepared statement of Mr. Toomey follows:]

Prepared Statement of Hon. Patrick J. Toomey, U.S. Representative from 
                              Pennsylvania

    Thank you, Mr. Chairman and Members of the Committee for allowing 
me the opportunity to testify today.
    As you know, during the last Congress, the House of Representatives 
overwhelmingly passed H.R. 2505, a bill introduced by the gentleman 
from Florida, Dr. Weldon, which would ban all human cloning. As a 
strong supporter and one of the 265 House members who voted for it, I 
am here today to urge my Senate colleagues to do likewise. As the 
President stated last night, ``because no human life should be started 
or ended as the object of an experiment, I ask you to set a high 
standard for humanity, and pass a law against all human cloning.''
    I am certainly very sympathetic to all those who suffer from 
incurable or chronic afflictions--we all are--and we all are committed 
to helping to find cures. I understand the good intentions of those who 
advocate human cloning in the hope that research on these clones might 
yield cures for major illnesses. But for a variety of reasons, both 
technical and ethical, I believe it is wrong to pursue this approach.
    On the technical level, although I am neither a doctor nor a 
scientist, the evidence suggests to me that cloned human embryos are 
not likely to yield cures for major illnesses. Hopes to the contrary 
are not well founded, and may be false hopes for the afflicted.
    According to Thomas Okarma, Chief Executive Officer of Geron 
Corporation, ``The odds favoring success are vanishingly small, and the 
costs are daunting. It would take thousands of [human] eggs on an 
assembly line to produce a custom therapy for a single person. The 
process is a nonstarter, commercially.''
    Furthermore, despite years of research with animal cloning, no 
successful treatment has been developed using cells derived from cloned 
embryos for either animals or people.
    The process that would be required to produce large supplies of 
cloned human embryos is itself ethically problematic. Superovulatory 
drugs are necessary for producing large supplies of eggs for 
harvesting. These drugs have been linked to an increased risk of 
ovarian cancer. In addition, this process inherently treats a woman's 
eggs as a commodity.
    Supporters of human cloning for research purposes have proposed 
limitations that are both arbitrary and unworkable. To avoid the 
dilemma of creating a cloned child they would require the cloned embryo 
to be destroyed after a specified period of time--some have suggested 
14 days. Clearly this is an arbitrary point in time. If scientists were 
to determine that the embryo would be more scientifically valuable 
after 21 days or 51 days, what rationale would keep the 14-day limit in 
force?
    In addition, a specified deadline for experimenting upon and 
destroying a cloned human embryo would be almost impossible to enforce. 
A Justice Department statement concluded that ``enforcing a modified 
cloning ban would be problematic and pose certain law enforcement 
challenges that would be lessened with an outright ban on human 
cloning.'' The same statement went on to say, ``there does not seem to 
be any reliable means for determining the difference between a 
fertilized embryo and a cloned embryo'' and concluded by stating ``once 
a pregnancy were established, any government-directed attempt to 
terminate a cloned embryo in utero would create problems enormous and 
complex.'' In other words, if a cloned human embryo were to be 
implanted and a viable pregnancy established it would be virtually 
impossible to detect or differentiate from a routine pregnancy. And if 
detected, the only way to prevent a cloned child is a forced abortion, 
which is obviously unacceptable to all of us.
    As daunting as all of the technical challenges are, perhaps the 
strongest arguments against human cloning are the ethical arguments. 
The process of transferring a somatic cell nucleus into an enucleated 
egg produces a human embryo that has the potential to be implanted in 
utero and developed to term. In other words, the embryo produced for 
the purpose of ``therapeutic cloning'' as some call it, is biologically 
indistinguishable from an embryo intended for reproduction. It is a 
human life-at a very early stage of development of course-but entirely 
human nevertheless. Thus creating cloned human embryos for research 
purposes means creating human life for the purpose of research with the 
intent of destroying it. This commodification and exploitation strikes 
me as a profound undermining of our society's sense of human dignity. 
And in doing so, it undermines our very humanity.
    Mr. Chairman, I thank you for holding this hearing today, I thank 
you for your support for a ban on all human cloning and I thank you for 
allowing me to testify this afternoon.

    Senator Brownback. Thank you very much, and thank you for 
your patience, too, on the panel because you have been here 
quite a while sitting and waiting.
    I have just a couple of questions. Dr. Weldon, you have 
looked at a lot of the research. I have had people in my office 
look at the research. One thing that I have noted was a number 
of the claims that were made that this was going to cure a 
number of diseases--Parkinson's, ALS, a whole host of 
diseases--are the same claims that were made about fetal tissue 
research, were the same claims that were made about embryonic 
stem cell research, are now being made about cloning. As a 
matter of fact, we have gone back to the actual debates and 
pulled statements from people.
    And of course, we all want to cure these diseases. We want 
to see that take place. But what I have seen of the research, 
particularly on fetal tissue, which has now been going on about 
10 years, those claims have not proven valid, that they were 
going to cure all of these ailments. Indeed, in some cases, the 
fetal tissue research has had terrible impact on the actual 
patient when it has been used.
    And I wanted to just enter into the record this--I ran 
across last week--in Rheumatology Journal, embryonic stem cells 
injected into the mouse knee joint formed teratomas and 
subsequently destroyed the joint.
    This is the first research paper I know of at this point in 
time on embryonic stem cells forming tumors and destroying the 
joint, which is something that we saw taking place in the fetal 
tissue research area.
    And I want to enter this into the record and would ask you 
to comment on what you have seen in the fetal tissue and the 
embryonic stem cell scientific work to date.
    [The information referred to follows:]

    Rheumatology 2003; 42: 162-165, British Society for Rheumatology
Embryonic stem cells injected into the mouse knee joint form teratomas 
        and subsequently destroy the joint
    S. Wakitani, K. Takaoka, T. Hattori \1\, N. Miyazawa \2\, T. 
Iwanaga \2\, S. Takeda \2\, T. K. Watanabe \2\ and A. Tanigami \3\, 
Department of Orthopaedic Surgery, Shinshu University School of 
Medicine, Matsumoto,
---------------------------------------------------------------------------
    \1\ Department of Orthopaedic Surgery, Osaka-Minami National 
Hospital, Kawachinagano and
    \2\ Otsuka GEN Research Institute, Otsuka Pharmaceutical Co. Ltd, 
Tokushima and
    \3\ Fujii Memorial Research Institute, Otsuka Pharmaceutical Co. 
Ltd, Otsu, Japan.
---------------------------------------------------------------------------
    Objective. To determine whether the joint space is a suitable 
environment for embryonic stem (ES) cells to grow and form cartilage.
    Method. We transplanted ES cells into the knee joint and a 
subcutaneous space of mice with severe combined immunodeficiency.
    Results. Teratomas formed in both areas. Those in the joints grew 
and destroyed the joints. The incidence of cartilage formation was the 
same in the knee joint and subcutaneous space, but the ratio of 
cartilage to teratoma was higher in the knee joint than in the 
subcutaneous space. The teratomas were proved to have been derived from 
the transplanted ES cells by detection of the neomycin-resistance gene 
that had been transfected into the ES cells.
    Conclusions. It is currently not possible to use ES cells to repair 
joint tissues. Further optimization of donor ES cells to differentiate 
as well as inhibit tumour growth may help to meet these challenges.

    Dr. Weldon. Well, you really got to the heart of the issue. 
And let me just say, in response to this, before I say anything 
else, you know, I am a physician. I took care of hundreds of 
patients with Parkinson's Disease, paralysis, diabetes. Indeed, 
I had an uncle I was very close to, died of Parkinson's 
Disease. My father died of the complications of diabetes. And 
so I just want to set the record straight. I do not pursue this 
in a trivial fashion. If it were scientifically valid to make 
the claims that there are all these great promises of cloning, 
I would very, very seriously look at that.
    The facts are the facts. And facts are stubborn things; but 
they are, nonetheless, the facts. There is no evidence in the 
scientific literature that cloning can actually be used, even 
in an animal model of any form of disease.
    And might I also add that the way we went down this whole 
path was, you know, we got started with the embryo stem cell 
lines. And adult stem cells, mind you, they have been used for 
20 years, and there are no rejection issues.
    And as I said, I have got--I am introducing, for the 
record, 80--eighty--research articles using adult stem cells. 
And I broke it down by tabs. I have got adult stem cell 
successes for brain damage. I have got adult stem cell 
successes for cancer. I have got adult stem cell successes for 
cerebral palsy, adult stem cell successes for diabetes, adult 
stem cell successes for eye disease, adult stem cell successes 
for heart disease. I mean, it is not like, if you take the time 
and look at the medical literature, there is not a lot of 
evidence here.
    There is zero using embryonic stem cells, zero--zero. Zero 
using embryonic stem cells in humans. Zero using cloned models 
in humans. For animal models, it is the same number.
    I have been challenging scientists at NIH and all these 
institutions, ``Show me your data that there's all this 
promise,'' and they have yet to do it. Occasionally you see 
these articles appearing where the claims are made. But then, 
when you actually stop and read the article--in the two--the 
two publications I have seen, when you actually read the 
research article, they were actually using adult stem cells, 
and they were trying to claim, in the press, that these were 
embryonic stem cells, or these were cloned stem cells.
    And so, in my opinion, there are lots of technical 
problems, and I do not want to get too deep into the science 
here, but I would be very, very happy to do that. There are 
some real bona fide problems. And probably the biggest one is 
the one you touched on in the example you described where the 
embryo stem cells ate away the joint.
    The cell biologists love embryo stem cells because they are 
very robust, so when you play with them in a petri dish and a 
test tube, they grow very, very nicely and they differentiate 
very easily into different cell lines. But that very property 
of growing robustly and differentiating easily makes them 
extremely problematic when you try to do clinical applications 
with them.
    I am sorry for that very lengthy answer to your question.
    Senator Brownback. It is a good answer, and very 
knowledgeable. You have spent a lot of time on this.
    Senator Wyden?
    Senator Wyden. Thank you, Mr. Chairman. I will be brief.
    The first thing I would like to do, Mr. Chairman, is ask 
unanimous consent to enter into the record a set of letters 
from a whole host of scientific and medical organizations that 
are in support of therapeutic research, and make that part of 
the record.
    Senator Brownback. Without objection. *
---------------------------------------------------------------------------
    * The information referred to has been retained in Committee files.
---------------------------------------------------------------------------
    Senator Wyden. Gentlemen, thank you. And I know you both 
have spent a lot of time on this issue. And as I indicated in 
my opening statement, I know that views run passionately on 
this subject.
    And I think my question, and I have just one, would be for 
your, Mr. Toomey, on this question of, well, the science is not 
going anywhere and it is not going to produce any big gains--
let me just read you a sentence from just one of the letters 
from physician and scientific groups that I am putting in the 
record today.
    This is from the American Society of Hematology. It was 
written just a few days ago. And I will quote here. It says, 
``As an organization of physicians who care for desperately ill 
patients and scientists devoted to understanding the basic 
mechanisms of disease and discovering new therapies, ASH is 
excited about the enormous potential of all avenues of stem 
cell research and related scientific mechanisms, such as 
SCNT.''
    Now, this is from a very renowned organization, a group of 
physicians who are considered leaders in the field. And my 
question to you is, when a group like this says that the 
research is very promising--and also in the letter, they talk 
about how important it is to have rigorous oversight and 
careful procedures to make sure that the work goes forward--why 
is it appropriate for the U.S. Congress to say that that 
research should not go forward when they are talking about the 
need for rigorous oversight, careful scientific procedures so 
as to not promote abuse? Why should the Congress not let the 
scientific research go forward when there are the kind of 
safeguards and--they are against human cloning, as I am, as 
well--why should that science not go forward, Congressman 
Toomey?
    Mr. Toomey. Well, Senator, thank you for that. And the 
fact--the opinion of these physicians needs to be carefully 
considered. That is an important part of this discussion. But I 
think that their opinion does not--and even their hope for 
rigorous oversight--does not change some fundamental features 
here, some fundamental facts, and that is that the product, the 
pursuit of what they are advocating means creating human life 
with the intent to learn from it and then destroy it at some 
period of time. And that is very troubling, on an ethical 
level, for many of us, and I think it is quite appropriate for 
Congress to make a judgment as to whether or not that ethical 
consideration outweighs the potential, the possibility, that 
there may, although there may not, be medical benefits from 
this.
    And we also have an obligation, I think, to weigh carefully 
whether it is really, truly possible to provide the oversight 
that they say they would like to see. As I cited in my 
testimony, I think there are some very serious technical 
hurdles that may not be possible to overcome, in terms of 
preventing the kinds of abuses that I think, and many of us 
think, would inevitably occur.
    Senator Wyden. I would also put into the record at this 
point, Mr. Chairman, a piece in The Wall Street Journal, by 
Virginia Postrel, that talks about why it would be a mistake to 
impede medical progress. She would certainly be considered a 
conservative, in terms of her political perspective, and she 
also talks about the need for rigorous oversight. She says, in 
response to what Congressman Toomey said, ``The small 
possibility of reproductive cloning does not justify making 
nucleus transfer a crime,'' and goes on to say how virtually 
anything in science, and these are her words, ``could be 
translated into evil at some point.'' But I think good people, 
like you and Senator Brownback and I, can find ways to minimize 
that prospect.
    And I thank you all. I know you are very sincere in your 
views and I look forward to working with you.
    Thank you, Mr. Chairman.
    Senator Brownback. That will be entered into the record.
    [The information referred to follows:]

               The Wall Street Journal, December 5, 2001.

                   Yes, Don't Impede Medical Progress

                          By Virginia Postrel

    To many biologists, the recently announced creation of a cloned 
human embryo was no big deal. True, researchers at Advanced Cell 
Technology replaced the nucleus of a human egg with the genetic 
material of another person. And they got that cloned cell to start 
replicating. But their results were modest. It took 71 eggs to produce 
a single success, and in the best case, the embryo grew to only six 
cells before dying. That's not a revolution. It's an incremental step 
in understanding how early-stage cells develop.
    And it's far from the 100 or so cells in a blastocyst, the hollow 
ball from which stem cells can be isolated. Scientists hope to coax 
embryonic stem cells into becoming specialized tissues such as nerve, 
muscle, or pancreatic islet cells. Therapeutic cloning, or nucleus 
transplantation, could make such treatments more effective.
    In theory, it would work like this: Suppose I need new heart tissue 
or some insulin-secreting islet cells to counteract diabetes. You could 
take the nucleus from one of my cells, stick it in an egg cell from 
which the nucleus had been removed, let that develop into stem cells, 
and then trigger the stem cells to form the specific tissue needed. The 
new ``cloned'' tissue would be genetically mine and would not face 
rejection problems. It would function in my body as if it had grown 
there naturally, so I wouldn't face a lifetime of immunosuppressant 
drugs.
    But all of that is a long way off. ACT and others in the field are 
still doing very basic research, not developing clinical therapies. 
Indeed, because of the difficulty of obtaining eggs, therapeutic 
cloning may ultimately prove impractical for clinical treatments. It 
could be more important as a technique for understanding cell 
development or studying the mutations that lead to cancer. We simply 
don't know right now. Science is about exploring the unknown and cannot 
offer guarantees.
    Politics, however, feeds on fear, uncertainty, and doubt, and the 
word ``cloning'' arouses those emotions. While its scientific 
importance remains to be seen, ACT's announcement has rekindled the 
campaign to criminalize nucleus transplantation and any therapies 
derived from that process. Under a bill passed by the House and 
endorsed by the president, scientists who transfers a human nucleus 
into an egg cell would be subject to 10-year federal prison sentences 
and $1 million fines. So would anyone who imports therapies developed 
through such research in countries where it is legal, such as Britain. 
The bill represents an unprecedented attempt to criminalize basic 
biomedical research.
    The legislation's backers consider the fear of cloning their best 
hope for stopping medical research that might lead to gene-level 
therapies. Opponents make three basic arguments for banning therapeutic 
cloning.
    The first is that a fertilized egg is a person, entitled to full 
human rights. Taking stem cells out of a blastocyst is, in this view, 
no different from cutting the heart out of a baby. Hence, we hear fears 
of ``embryo farming'' for ``spare parts.''
    This view treats microscopic cells with no past or present 
consciousness, no organs or tissues, as people. A vocal minority of 
Americans, of course, do find compelling the argument that a fertilized 
egg is someone who deserves protection from harm. That view animates 
the anti-abortion movement and exercises considerable influence in 
Republican politics.
    But most Americans don't believe we should sacrifice the lives and 
well being of actual people to save cells. Human identity must rest on 
something more compelling than the right string of proteins in a petri 
dish, detectable only with high-tech equipment. We will never get a 
moral consensus that a single cell, or a clump of 100 cells, is a human 
being. That definition defies moral sense, rational argument, and 
several major religious traditions.
    So cloning opponents add a second argument. If we allow therapeutic 
cloning, they say, some unscrupulous person will pretend to be doing 
cellular research but instead implant a cloned embryo in a woman's womb 
and produce a baby. At the current stage of knowledge, using cloning to 
conceive a child would indeed be dangerous and unethical, with a high 
risk of serious birth defects. Anyone who cloned a baby today would 
rightly face, at the very least, the potential of an enormous 
malpractice judgment. There are good arguments for establishing a 
temporary moratorium on reproductive cloning.
    But the small possibility of reproductive cloning does not justify 
making nucleus transfer a crime. Almost any science might conceivably 
be turned to evil purposes. This particular misuse is neither 
especially likely--cell biology labs are not set up to deliver 
fertility treatments--nor, in the long run, especially threatening.
    Contrary to a lot of scary rhetoric, a healthy cloned infant would 
not be a moral nightmare, merely the not-quite-identical twin of an 
older person. (The fetal environment and egg cytoplasm create some 
genetic variations.) Certainly, some parents might have such a baby for 
bad reasons, to gratify their egos or to ``replace'' a child who died. 
But parents have been having children for bad reasons since time 
immemorial.
    Just as likely, cloned babies would be the cherished children of 
couples who could not have biological offspring any other way. These 
children might bear an uncanny resemblance to their biological parents, 
but that, too, is not unprecedented. Like the ``test tube babies'' born 
of in vitro fertilization, cloned children need not be identifiable, 
much less freaks or outcasts.
    Why worry so much about a few babies? Because, say opponents, even 
a single cloned infant puts us on the road to genetic dystopia, a 
combination of Brave New World and Nazi Germany. A cloned child's 
genetic makeup is too well known, goes the argument, and therefore 
transforms random reproduction into ``manufacturing'' that robs the 
child of his autonomy. This is where the attack broadens from nucleus 
transfer to human genetic engineering more generally. An anti-
therapeutic cloning petition, circulated by the unlikely duo of 
conservative publisher William Kristol and arch-technophobe Jeremy 
Rifkin, concludes, ``We are mindful of the tragic history of social 
eugenics movements in the first half of the 20th century, and are 
united in our opposition to any use of biotechnology for a commercial 
eugenics movement in the 21st century.''
    But the ``eugenics'' they attack has nothing to do with state-
sponsored mass murder or forced sterilization. To the contrary, they 
are the ones who want the state to dictate the most private aspects of 
family life. They are the ones who want central authorities, rather 
than the choices of families and individuals, to determine our genetic 
future. They are the ones who demand that the government control the 
means of reproduction. They are the ones who measure the worth of human 
beings by the circumstances of their conception and the purity of their 
genetic makeup. They are the ones who say ``natural'' genes are the 
mark of true humanity.
    Winners in the genetic lottery themselves, blessed with good health 
and unusual intelligence, they seek to deny future parents the chance 
to give their children an equally promising genetic start. In a 
despicable moral equivalency, they equate loving parents with Nazis.
    Biomedicine does have the potential to alter the human experience. 
Indeed, it already has. Life expectancy has doubled worldwide in the 
past century. Childbirth is no longer a peril to mother and infant. 
Childhood is no longer a time for early death. The pervasive sense of 
mortality that down through the ages shaped art, religion, and culture 
has waned.
    Our lives are different from our ancestors' in fundamental ways. We 
rarely remark on the change, however, because it occurred 
incrementally. That's how culture evolves and how science works. We 
should let the process continue.

    Senator Brownback. Any comment?
    Senator Ensign?
    Senator Ensign. Thanks, Mr. Chairman.
    Just very briefly, for either one of you. The debate is 
whether or not this is cloning. When we are talking about--I 
talked about that briefly in my opening research--the various 
definitions that we talk about. And maybe start with you, Dr. 
Weldon. They are saying that they are not creating life and 
destroying it with therapeutic cloning. Could you just address 
that, from a technical standpoint?
    Dr. Weldon. Yes, I would be very, very happy to do that. 
And you know, a lot of people are trying to put lipstick on the 
pig here, and----
    [Laughter.]
    Dr. Weldon.--you know, the--when people say things like 
that, I have to say to them, ``Well, explain to me, then, why 
Dolly is not a sheep.'' From a--you know, my background, you 
know, I practiced medicine for 15 years before I came here. And 
my undergraduate degree, I did research in molecular genetics, 
and my degree was in biochemistry. And I tend to look at this 
from a biological perspective, OK? And when we take a nucleus 
out of one of your body cells and put it in a female egg and 
zap it with electricity and it starts to duplicate--from a 
biological perspective, that is a human embryo with the full 
potential, if there are no genetic defects in it, to fully 
develop into a twin, an identical twin, of you. And to try to 
say that this is not the creation of human life, that this is 
not cloning, that this is not this, and this is not that, is 
really trying to do damage control, in my opinion.
    The overwhelming--notwithstanding the assertions of some 
professional societies that this is ethically and morally OK, 
the overwhelming opinion of the American people that--is that 
it is not and that it is very, very problematic.
    And the point I have just been trying to stress over and 
over again is, Where is the data? You know? It is like, 
``Where's the beef?'' You know? Show me the information that 
this has all the supposed promise that you claim.
    And might I also add that in the bill that we passed in the 
House, and the bill the Senator introduced in the last term--
and I assume it is going to read the same way--the animal 
research can move ahead unfettered. And if it really does show 
all the supposed promise, we can revisit this issue. But to 
allow this to move ahead with humans, in my opinion, will--
exploiting women, what it would entail--I think it is extremely 
disturbing. And I do not----
    Mr. Toomey. I would just add, very briefly, Senator, that I 
think that some folks are attempting to create a distinction 
that does not exist based on the intended application, but 
based on the intended use of the embryo that is being created. 
And it seems to me, as a matter of logic, that regardless of 
the intended application or intended use of the embryo, since 
it is biologically indistinguishable, a so-called therapeutic 
clone or a reproductive clone, I think that is a false 
distinction.
    Dr. Weldon. Can I just add one important point, if I may, 
Mr. Chairman?
    If the positions of Senators Specter and Hatch and others 
move forward, what I would predict, as a scientist, as a 
physician who has read the literature, there will be no 
therapeutic applications of this technology. But what has the 
potential to happen is the development of human laboratory 
models of disease.
    You could have a situation where if you had a child with 
cystic fibrosis, you could clone that child, you could make 
dozens of embryos of that child, and then sell those embryos to 
research labs all over the country and allow those embryos to 
develop in the lab and study cystic fibrosis that way. And that 
is a potential application of all of this.
    But other than that, I do not--I think it is highly likely 
there would ever be any clinical utility in this kind of 
research. And what I have just described, which is an eventual 
outcome if we do not ban this, I think is morally and ethically 
extremely objectionable, to have biotechnology companies with 
shelves of human embryos representing all these different 
diseases that they are selling and making out of, and that 
these embryos are just going to be exploited in the lab and 
then thrown away when they are done.
    And mind you, the place they will go next is beyond the 
embryonic stage into the fetal development stage. Who on earth 
would want to go through all the trouble of extracting stem 
cells and have to deal with all that manipulation of the stem 
cells when you could just drop it in some broth and it would 
develop into a fetus, and then you could just get the tissue 
that you want?
    Senator Ensign. Well, Mr. Chairman, unfortunately, I have 
to excuse myself from the hearing. Just one last comment that I 
would like to make.
    When you become a new physician, become a new veterinarian, 
one of the things that they teach is, ``Above all, do no 
harm.'' And as you mentioned, animal cloning can go forward, 
animal research can go forward. I think that it would be very, 
very wise of us, as an institution, to ban all human cloning at 
this point.
    Once again, it could--I do not think that we should ever 
legalize it, even if it--from a utilitarian point of view, that 
it turns out to be actually useful. I am skeptical whether it 
will be useful, but even if it does, it is still fundamental to 
me that creating human life just because can you utilize it 
devalues human life.
    We should be in the business of making a moral statement 
that we value human life in America, that we value each 
individual, that fundamentally we were a nation that valued the 
individual because we felt that we were created and that we had 
certain inalienable rights in each individual. And I think that 
we should, as a nation, continue to value each individual 
instead of devaluing life by looking at us as purely 
utilitarian.
    Thank you, Mr. Chairman.
    Senator Brownback. Thank you for that statement.
    Senator Nelson, did you have any questions or comments?

                STATEMENT OF HON. BILL NELSON, 
                   U.S. SENATOR FROM FLORIDA

    Senator Nelson. Thank you, Mr. Chairman.
    I would love to have your opinion on the two procedures 
compared to each other, one in the production of stem cells 
from a fertilized egg, as well as the production of stem cells 
from the procedure known as SCNT.
    Dr. Weldon. The embryonic stem cell issue first came up 
when--you know, there were all these fertility clinics, and 
many of them have leftover embryos, and it was Dr. Thompson 
back in 1998 who showed that you could extract stem cells from 
those embryos and that they divide robustly and they 
differentiate into other tissues.
    The procedure involving somatic cell nuclear transfer is 
really--from a stem cell perspective, is not that different; it 
is just a difference in the source. You know, in SCNT, you are 
taking the egg, and, rather than uniting it with a sperm and 
getting a new, unique human individual, you are taking that 
egg, removing the nucleus that was in the egg, which is 23 
chromosomes, and you are taking a cell from, say, your body or 
somebody else's body, taking the nucleus out and putting it in 
there. But once it starts dividing, you get the same kind of 
stem cells out of it that have the same characteristics--not 
exactly; I mean, there are a whole bunch of huge biological and 
medical issues that separate the two. But I think, from the 
layperson's perspective, it is basically the same thing.
    Senator Nelson. So for the process of producing stem cells, 
of which the President has approved a certain process of 
certain existing stem cells, those of which were derived from 
fertilized eggs, from an ethical standpoint, you do not see any 
difference in deriving stem cells from the procedure of SCNT, 
as opposed to the procedure through the fertilized egg.
    Dr. Weldon. Oh, well, no, there is a huge difference. In 
the case of the fertilized egg, you are looking at a situation 
where a man and a woman, you know, came together and created 
that, had some babies, and then decided they did not want to 
use it, and so they turned it over for--either to be discarded 
or to be exploited for research purposes and then destroyed, 
which I think, morally and ethically, is a very different 
issue, from a moral and ethical perspective, from saying, 
``We're going to create these human embryos for the purpose of 
exploiting them and then destroying them.'' In the one 
situation, you had an embryo that was going to be destroyed 
anyway, and you are trying to take advantage of it for 
utilitarian purposes. In the other scenario, you are 
specifically creating these things to take advantage of them.
    And my position--and you were not here when I gave my 
testimony earlier--is that this is unnecessary and unethical. 
Unethical, we can debate. The reason I say it is unnecessary--
and I was showing this earlier--this is just the recent medical 
literature, in the last 12 or 14 months, on adult stem cells. 
Eighty-eight studies I have here. In humans, not in animals.
    Senator Nelson. Do you--and Mr. Toomey, chime in--do you 
approve the method of extracting stem cells from the fertilized 
egg that you said that was going to be discarded anyway?
    Dr. Weldon. Well, my personal position on this issue is 
that the eggs belong to the mother and father. OK? And that if 
they do not want to implant them in the mother--if they have 
had their family, they have their three or four kids--then they 
are presented the option to either adopt them out or give them 
over to research.
    My position on embryo stem cells was always that I did not 
want to see it funded. The debate in this city was over the use 
of taxpayer dollars. Because when you extract a stem cell, you 
kill the embryo, there are many people who are pro-life who 
feel that our taxpayer dollars should not be going for that 
purpose, and I agree with that position. But I never took the 
position that I wanted to make that illegal.
    What I would like to make illegal is the special creation 
of human embryos for the purpose of exploiting them and 
destroying them through the process of cloning.
    Senator Nelson. At the end of the day, what I am trying to 
get at--and, Mr. Toomey, maybe you want to--if we find that 
there is promise in curing diseases through stem cells, then we 
have to get them some way. And as I understand the description 
here, there is one of two ways. There is either through the 
fertilized egg that you have just described, or there is 
through the procedure of SCNT. So if you are trying to combat 
disease with a stem cell, part of the process which has been 
approved already by the President--what is the best way? And 
why do you feel that way? And obviously, it is a matter of 
ethics, as you have explained your feeling on the----
    Mr. Toomey. I would just briefly suggest that there is, 
perhaps, a third way. There are the existing lines of stem 
cells, which are already in existence and for which research is 
continuing, with Federal funding, as you know.
    It is my view that the question of what to do with the 
``leftover,'' if you will, embryos from in vitro fertilization 
does pose its own unique set of ethical questions that we need 
to wrestle with. But I share Dr. Weldon's view. That is a--it 
is a distinct case. It is a separate set of issues. And it is 
reasonable for us to separate them and address them separately.
    Dr. Weldon. Can I just add to that? If there is--your body 
is teeming with stem cells, Bill. I mean, they are in your 
nose, they are in your skin, they are in your fat tissue, they 
are in your blood. And those stem cells are called adult stem 
cells, and those stem cells have been studied in human clinical 
trials and have been found useful in treating a whole host of 
medical conditions.
    The debate is over using embryo stem cells. And you are 
right, there are two places you can get them. You can get them 
from fertilized eggs through sexual fertilization and through 
cloning. And those stem cells have been shown to be useful in 
zero clinical trials in humans. They have been shown to be 
useful in zero animal models in humans.
    And so, to me, the promise is in using these adult stem 
cells. And why would we want to go down the path of allowing 
human cloning when the embryo stem cells are just really not 
proven to be very effective at all?
    Senator Nelson. And of course, this is the beginning of a 
very interesting debate. My predecessor, Senator Connie Mack, 
is someone who has come to me and pleaded the case of allowing 
the SCNT procedure to proceed, because he is very convinced 
that it will have the result of a number of medical 
breakthroughs.
    So thank you for your opinion.
    Senator Brownback. Thank you very much. You have been a 
very patient and excellent panel. We appreciate your coming 
here.
    The next panel will be Dr. Leon Kass. He is a native of 
Chicago. Dr. Kass was educated at the University of Chicago, 
where he earned his BS and MD degrees, and at Harvard, where he 
took a Ph.D. in biochemistry. He then did research in molecular 
biology at the National Institute of Health, while serving the 
United States Public Health Service.
    Shifting directions from doing science to thinking about 
its human meaning, he has been engaged for over 30 years with 
ethical and philosophical issues raised by biomedical advance 
and, more recently, with broader moral and cultural issues.
    And I would note, as well, he is chairman of the 
President's Council on Bioethics, appointed by President George 
W. Bush.
    Dr. Kass, we are delighted to have you. I think we intended 
initially to have you on the program by 3 o'clock, maybe a 
little earlier. We are a quarter to 4, so we are running right 
on time. Delighted to have you. The floor is yours.

           STATEMENT OF DR. LEON R. KASS, CHAIRMAN, 
              THE PRESIDENT'S COUNCIL ON BIOETHICS

    Dr. Kass. Thank you very much, Mr. Chairman, Members of the 
Committee. On behalf of the President's Council on Bioethics, I 
want to thank you for this opportunity to present the council's 
findings and recommendations on the vexing subject of human 
cloning.
    Senator Brownback. Dr. Kass, pull that microphone down a 
little bit more forward, if you would.
    Dr. Kass. Is that better?
    Senator Brownback. Yes, thank you.
    Dr. Kass. Also speaking personally, as someone who has 
written on the subject of the ethics of human cloning for 35 
years, I want to thank you, Senator Brownback, for your vision 
in recognizing the momentous choice now before us, and for your 
courage and for your leaderships in seeking effective means to 
protect us from a dangerous assault on human dignity.
    For the first 6 months of the year 2002, the President's 
Council on Bioethics met to consider the moral, biomedical, and 
human significance of human cloning in order to advise 
President Bush on the subject. The council's report, ``Human 
Cloning and Human Dignity and Ethical Inquiry,'' was issued 
last July. I am submitting, as part of my testimony, the 
executive summary of the report, and we have provided here 
today fresh copies of the report, which I hope will be 
distributed to all Members of the Committee.
    Senator Brownback. That will be made part of the record 
without objection.
    Dr. Kass. Right. I want to summarize, to begin with, the 
findings of the report in five points.
    First, the council sought to examine the subject of human 
cloning in full by considering the human goods that cloning 
might serve or endanger, not just whether the technique is 
today feasible or safe. We regard it as of prime importance to 
put cloning in its proper place, both in its relation to human 
procreation and also in the context of other biotechnical 
powers now gathering for manipulating the human body and mind.
    Second, the council worked to develop fair and accurate 
terminology, a point that has turned out to be crucial, 
beginning with the idea of human cloning, itself. And if I 
could recommend anything--one single thing in the report, it is 
the chapter on terminology, which is unanimously approved by 
all members of the council whether they support cloning for 
biomedical research or not. That is the third chapter----
    Senator Brownback. Very good.
    Dr. Kass.--and I think it would be very help to your 
deliberations.
    Whatever the purpose for which human cloning is undertaken, 
the act that produces the genetic replica is the very first 
step in the process, the creation of an embryonic clone. 
Accordingly, the council has insisted that we what we mean by 
``human cloning'' is the production of cloned human embryos, 
the earliest stage of developing human life.
    This act of cloning may be undertaken with the intention of 
either transferring these embryos to a uterus in order to 
initiate a pregnancy, or taking them apart in order to obtain 
stem cells for research. But whatever the purpose, it is the 
same act, and the results--and it results in the same initial 
product, a cloned human embryo.
    In popular discussion, the first use has been called 
``reproductive cloning,'' the second, ``therapeutic cloning,'' 
``research cloning,'' ``nuclear transfer for stem cells.'' The 
council has rejected these terms and has--instead chose to call 
these uses, respectively, ``cloning to produce children,'' or 
``cloning for biomedical research.'' The terms are accurate. 
They allow us to debate the moral questions without deciding 
them terminologically and without Orwellian speech.
    The third point has to do with the ethics of cloning to 
produce children. The council unanimously held that cloning to 
produce children should be opposed both morally and legally. 
Not only is the technique demonstrably unsafe, but it can never 
be safely and ethically attempted. We oppose this practice, not 
only because it is unsafe, but because it would imperil the 
freedom and dignity of the cloned child, the cloning parents, 
and the entire society.
    And in its report, the council also argues that by enabling 
parents for the first time to predetermine the entire genetic 
makeup of their children, we would be taking a major step 
toward turning procreation into manufacture.
    Cloning to produce children would also confound family 
relations and personal identity, create new stresses between 
parents and offspring, and might open the door to a new 
eugenics where parents or society could replicate the genomes 
of individuals whom they deemed to be superior.
    Fourth, the ethics of cloning for biomedical research. 
Here, the council was not of one mind, for the issue is 
complicated. On the one hand, we all acknowledge that the 
research offers the prospect, though entirely speculative at 
this moment, of gaining some valuable knowledge and treatments 
for many diseases. On the other hand, as the previous witnesses 
have already testified, this practice would require the 
exploitation and destruction of nascent human life created 
solely for the purpose of research and, by creating cloned 
embryos, would make the cloning of children that much more 
likely.
    Individual council members weighed these moral concerns 
differently, yet all members of the council agreed that each 
side in this debate has something vital to defend, not only for 
itself, but for us all. All of us understand that we cannot 
afford to be casual about human suffering, to be cavalier 
regarding how we treat nascent human life, or to be indifferent 
about how we decide among the alternatives.
    Finally, our recommendations. The majority of the council, 
myself included, recommended that no human cloning of any kind 
be permitted at this time. We proposed that Congress enact a 
ban on all attempts, both publicly and privately funded, at 
cloning to produce children and a 4-year Federal moratorium on 
human cloning for biomedical research, beginning with the act 
of the production of cloned human embryos.
    We argued for this moratorium on a number of grounds. It 
would give us more time to debate whether we should cross this 
crucial moral boundary, that of creating cloned human life 
solely as a resource for research. It would allow time for 
other areas of stem cell research, both adult and embryonic, to 
proceed and to find out whether they will live up to their 
promise. It would allow time for those who believe cloning for 
biomedical research can never be ethically pursued to make 
their case, and for those who disagree to design a responsible 
system of regulation and public oversight, which they have no 
incentive to design in the absence of some kind of temporary 
ban. Perhaps most important, the moratorium on all cloning 
offers us the only effective way to prevent cloning to produce 
children while this deliberation continues and while no 
regulatory system is in place.
    Also, a national moratorium on cloning for research would 
allow the debate on the question of research on cloned embryos 
to be taken up in the larger context where it belongs, namely 
in the context of embryo research generally, and in the context 
of future possibilities of genetic engineering of human life.
    Pending such debate, the majority of the council held that 
no law should now be enacted that approves or authorizes any 
cloning. A minority of the council recommended that we do 
proceed with such potentially valuable research, but only if 
and when significant regulations are in place, including 
Federal licensing of all cloning research, oversight that would 
keep track of the uses and fates of all cloned embryos 
produced, and strict limits on how long cloned embryos may be 
allowed to develop outside the body.
    To this point, Mr. Chairman, I have merely summarized the 
report of the council, emphasizing what I take to be its major 
achievements and conclusions.
    I would ask for a few minutes, if I might, to elaborate 
briefly the ethical objections to human cloning to produce 
children, because most people--many people think that the major 
objection is simply a matter of safety and, beyond that, it 
rests on irrational repugnance.
    Senator Brownback. Please take the time you need.
    Dr. Kass. Thank you, sir.
    In order of increasing seriousness, I offer four objections 
to human cloning to produce children. One, it involves 
unethical experimentation on the unborn. Two, it threatens 
identity and individuality. Three, it turns procreation into 
manufacture. And four, it means despotism over children and 
perversion of parenthood.
    And I won't rehearse all these arguments. These are 
arguments made in the report, though I make them here in my own 
name. Let me just touch on the third and the fourth.
    Human cloning would represent a giant step toward turning 
begetting into making, procreation into manufacture, a process 
that was already begun with in vitro fertilization and genetic 
testing of embryos. With cloning, not only is the process in 
hand, but the total genetic blueprint of the cloned individual 
is selected and determined by the human artisans. We are here 
making a--taking a major step into making man, himself, simply 
another one of the manmade things.
    How does begetting differ from making? In natural 
procreation, human beings come together complementarily, male 
and female, to give existence to another being who is formed 
exactly as we were by what we are. But in clonal reproduction, 
and in the more advanced forms of manufacture to which it will 
lead, we give existence to a being, not by what we are, but by 
what we intend and design. As with any product of our making, 
no matter how excellent, the artificer stands above it, not as 
an equal, but as a superior, transcending it by his will and 
creative powers. In human cloning, scientists and prospective 
parents adopt a technocratic attitude toward human children. 
Human children become their artifacts, and such an arrangement 
would be profoundly dehumanizing, no matter how good the 
product.
    Next and most important, the practice of cloning by nuclear 
transfer would enshrine and aggravate a profound and mischief-
making misunderstanding of the meaning of having children and 
of the parent-child relation. When a couple normally chooses to 
procreate, the partners are saying yes to the emergence of a 
new life in its novelty, are saying yes not only to having a 
child, but also to having whatever child this child turns out 
to be. The genetic distinctiveness and independence of the 
child is a natural foreshadowing of the deep truth that this 
child has his own and never-before-enacted life to live. Though 
sprung from a past, children take an uncharted course into the 
future.
    In contrast, overbearing parents take a step that 
contradicts this entire meaning of the open and forward-looking 
nature of procreation and parent-child relations. The child is 
given a genotype that has already lived, with the full 
expectation that this blueprint of a past life ought to be 
controlling of the life that is to come. A wanted child now 
means a child who exists precisely to fulfill parental wants. 
Cloning is thus inherently despotic, for it seeks to make one's 
children after one's own image, and their future according to 
one's will.
    For all these reasons, I conclude that human cloning 
threatens the dignity of human procreation, giving one 
generation unprecedented control over the next and marking a 
major step toward a eugenic world in which children become 
objects of manipulation and products of will. The same 
concerns, I would submit, even more than the concerns about 
embryo destruction, should lead us also to oppose cloning for 
biomedical research.
    And I would like to wind up with just two more minutes, if 
I might.
    Senator Brownback. Please.
    Dr. Kass. All human cloning must be seen in the context of 
our growing powers over human reproduction augmented by new 
knowledge of the human genome. Science already permits us to 
screen human embryos in vitro for thousands of human genes, not 
only to find markers for dread diseases, but also soon genes 
responsible for other human traits, not just sex, height, or 
skin color, but even intelligence, temperament, or sexual 
orientation. Genetic selection of embryos is today a growing 
industry, and some experts hail assisted reproduction as the 
route, not to the treatment of infertility, but to finding 
genetically sound babies.
    While directed genetic change of human embryos may be a 
long way off, it has already been accomplished in primates in 
the laboratory, and it would be naive to think that cloning 
children will be confined to infertile couples, or that cloning 
research would be confined to the study to disease.
    Once we view this in this larger context, the production of 
cloned embryos for any purposes--for any purpose--marks a 
significant leap in transforming procreation into a form of 
manufacture. The embryo created by cloning would be the first 
human embryo to have its genetic identity selected in advance, 
the first embryo whose makeup is not the unpredictable result 
of uniting egg and sperm. It is precisely this genetic control 
that makes cloned embryos appealing and useful.
    We should not be deceived. Saying yes to creating cloned 
embryos, even for research, means saying yes, at least in 
principle, to an ever-expanding genetic mastery of one 
generation over the next. Once cloned embryos exist in 
laboratories, the eugenic revolution will have begun. And of 
course, it will be virtually impossible to prevent them from 
being used to produce cloned babies.
    The failure of the last Congress to enact a ban on human 
cloning, notwithstanding the widespread agreement across the 
country that it should be prohibited, casts grave doubt on our 
society's ability to govern the unethical uses of biotechnology 
even when it threatens things we hold dear. If Congress fails 
to act this time around, human cloning is likely to happen 
here, and we--``we''--will have acquiesced in its arrival.
    It is my profound hope, Mr. Chairman, that Congress will 
rise to the occasion and strike a blow in the defense of human 
dignity.
    [The prepared statement of Dr. Kass follows:]

   Prepared Statement of Dr. Leon R. Kass, Chairman, the President's 
                          Council on Bioethics

    Mr. Chairman and Members of the Committee. My name is Leon R. Kass, 
and I appear before you as Chairman of the President's Council on 
Bioethics. On behalf of the Council, I wish to thank you for this 
opportunity to present the Council's findings and recommendations on 
the vexing subject of human cloning. I am also Hertog Fellow in Social 
Thought at the American Enterprise Institute and the Addie Clark 
Harding Professor (on leave) in the Committee on Social Thought and the 
College at the University of Chicago. In my own scholarship, I have 
been thinking and writing about the ethics of human cloning for thirty-
five years. Thus, speaking personally, I would like to thank you, 
Senator Brownback, for your vision in recognizing the momentous choice 
now before us and for your courage and leadership in seeking effective 
means to protect us from a dangerous assault on human dignity.
    For the first six months of last year, the President's Council on 
Bioethics met to consider the moral, biomedical, and human significance 
of human cloning, in order to advise President Bush on the subject. The 
Council's report, Human Cloning and Human Dignity: An Ethical Inquiry, 
\1\ was issued in July, 2002; I am submitting the Executive Summary of 
the report as part of my written testimony.
---------------------------------------------------------------------------
    \1\ U. S. Government Printing Office, 299 pp., 2002. A commercial 
paperback edition, Human Cloning and Human Dignity: The Report of the 
President's Council on Bioethics, 350 pp., was published in 2002 by 
Public Affairs.
---------------------------------------------------------------------------
    I want to summarize the contents of the report in five points. 
First, the Council sought to examine the subject of human cloning in 
full by considering the human goods that cloning might serve or 
endanger--not just whether the technique is feasible or safe. We sought 
also to assess the impact of growing biotechnical powers over human 
life and their effect on human procreation, on the goals and limits of 
biomedical science, and on the meaning of the activity of healing. It 
is of prime importance to put cloning in its proper place, both humanly 
speaking and also in the context of other biotechnical powers now 
gathering for manipulating the human body and mind.
    Second, the Council worked to develop fair and accurate 
terminology. Human cloning is a subject that has been bedeviled by 
confusing speech and manipulative speech. Our goal was to clarify the 
terminology that confounds this discussion, beginning with the idea of 
human cloning itself. Whatever the purpose for which human cloning is 
undertaken, the act that produces the genetic replica is the very first 
step in the process, the creation of an embryonic clone. Accordingly, 
the Council has insisted that what we mean by ``human cloning'' is the 
production of cloned human embryos, the earliest stage of developing 
human life. This act of cloning may be undertaken with the intention of 
either transferring these embryos to a uterus in order to initiate a 
pregnancy or taking them apart in order to obtain stem cells for 
research.
    In popular discussion, the first use has been called ``reproductive 
cloning'' or just ``cloning.'' The second has come to be called 
``therapeutic cloning,'' ``research cloning,'' or ``nuclear transfer 
for stem cell research.'' The Council, instead, chose to call these 
uses respectively ``cloning-to-produce-children'' or ``cloning-for-
biomedical-research.'' These terms are accurate. And they allow us to 
debate the moral questions without euphemistic distortion or Orwellian 
speech. Whether one favors or opposes cloning to produce children; 
whether one favors or opposes cloning for biomedical research, the 
Council insists that we must acknowledge that both uses of cloning 
begin with the same act, the production of cloned human embryos. \2\
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    \2\ Despite efforts to obscure this fact, this is true for what 
scientists have preferred to call ``nuclear transfer to produce stem 
cells.'' The act of nuclear transfer does not directly produce stem 
cells. It produces, as a primary product, a cloned human embryo, which, 
once grown to the blastocyst stage (about 5-6 days), may then be 
dissected for its stem cells. It is not true, as Stanford University 
originally claimed when it recently announced its intention to do 
``nuclear transfer to produce stem cells'' (= ``cloning for biomedical 
research''), that the President's Council endorses this terminology or, 
moreover, approves the use of human cloning for this purpose.
---------------------------------------------------------------------------
    The third point concerns the ethics of cloning-to-produce-children. 
Regarding cloning-to-produce-children, the Council is in agreement with 
majority opinion both in America and the Congress. The Council was 
unanimous, in fact, that cloning-to-produce-children should be opposed, 
both morally and legally. Not only is the technique demonstrably 
unsafe, but it can never be safely and ethically attempted. And the 
Council opposes this practice not only because it's unsafe, but because 
it would imperil the freedom and dignity of the cloned child, the 
cloning parents, and the entire society. In its report, the Council 
also argues that by enabling parents for the first time to predetermine 
the entire genetic makeup of their children, we would be taking a major 
step toward turning procreation into manufacture. Cloning-to-produce-
children would also confound family relations and personal identity, 
create new stresses between parents and offspring, and might open the 
door to a new eugenics where parents or society could replicate the 
genomes of individuals whom they deem to be superior.
    The fourth point concerns the ethics of cloning-for-biomedical-
research. Here the Council, like the nation, was divided. On the one 
hand, we acknowledge that the research offers the prospect, though 
speculative at the moment, of gaining valuable knowledge and treatments 
for many diseases. On the other hand, this practice would require the 
exploitation and destruction of nascent human life created solely for 
the purpose of research.
    Individual Council members weighed these moral concerns 
differently. Yet all members of the Council--and I am delighted about 
this--agreed that each side in this debate has something vital to 
defend, not only for itself but for all of us. Each side understood 
that we cannot afford to be casual about human suffering, to be 
cavalier regarding how we treat nascent human life, or to be 
indifferent about how we decide among the alternatives. Each side 
recognized that we must face up to the moral burden of either approving 
or disapproving this research: namely, on the one hand, that some who 
might be healed more rapidly might not be; and on the other hand, that 
we will become a society that creates and uses some lives in the 
service of others.
    Finally, the Council offered two policy recommendations, a majority 
recommendation and a minority recommendation, each of them distinct 
from the most prominent legislative proposals considered in the last 
Congress. Both recommendations called for a permanent ban on cloning-
to-produce-children, thus giving public force to the nation's strong 
ethical verdict against this practice. Where the Council differed was 
on how to approach cloning-for-biomedical-research.
    A minority of the Council recommended that we proceed with such 
potentially valuable research, but only once significant regulations 
are in place, including federal licensing of all cloning research, 
oversight that (among other things) would keep track of the uses and 
fates of all cloned embryos produced, and strict limits on how long 
cloned embryos may be allowed to develop outside the body.
    A majority of the Council, myself included, recommended that no 
human cloning of any kind be permitted at this time. We proposed that 
Congress enact a ban on all attempts--both publicly and privately 
funded--at cloning-to-produce-children, and a four-year federal 
moratorium on human-cloning-for-biomedical-research, beginning with the 
act of the production of cloned human embryos.
    We argued for this moratorium on a number of grounds. It would give 
us more time to debate whether we should cross this crucial moral 
boundary--that of creating human life solely as a resource for 
research. A moratorium would allow time for other areas of stem cell 
research, both adult and embryonic, to proceed. It would allow time for 
those who believe cloning-for-biomedical-research can never be 
ethically pursued to make their case, and for those who disagree to 
design a responsible system of regulation and public oversight. \3\ 
And, perhaps most important, a moratorium on all cloning offers the 
only effective way to prevent cloning-to-produce-children while the 
deliberation continues and while no regulatory system is in place.
---------------------------------------------------------------------------
    \3\ The Council majority also believed, that, in the absence of a 
ban or temporary moratorium, scientists and industrial researchers who 
want no restriction or regulation of their activities, would have no 
incentive whatsoever to design a regulatory scheme of the sort favored 
by the Council's minority.
---------------------------------------------------------------------------
    A national moratorium on cloning-for-biomedical-research would also 
allow the debate on the question of research on cloned embryos to be 
taken up in the larger context, where it belongs, in the context of 
embryo research generally, and in the context of the future 
possibilities of genetic engineering of human life. Pending such 
debate, the majority of the Council held that no law should now be 
enacted that approves or authorizes any human cloning.
    To this point, I have summarized the report of the Council, 
emphasizing what I take to be its major achievements and conclusions. 
In what follows, I wish to elaborate the ethical objections to human 
cloning-to-produce-children. I do so because some people think that, 
beyond the issue of safety, the popular opposition to cloning children 
rests wholly on irrational feelings such as repugnance, while others, 
ignoring what it might mean to be a cloned child, focus exclusively on 
the desires and putative rights of the adults who would wish to 
practice cloning. Though all the points that follow are made in the 
Council report, I will be speaking here in my own name and formulating 
the arguments in my own manner.
    In order of increasing seriousness, I offer four objections to 
human cloning-to-produce-children: (1) it involves unethical 
experimentation; (2) it threatens identity and individuality; (3) it 
turns procreation into manufacture; and (4) it means despotism over 
children and perversion of parenthood.
    First, any attempt to clone a human being would constitute an 
unethical experiment upon the resulting child-to-be. As the animal 
experiments indicate, there are grave risks of mishaps and deformities, 
even to those clones that are born alive. Conducting the experiments in 
humans in efforts to make cloning safer would violate the ethical norms 
for experimenting with human subjects. Shall we just discard the 
defective children? Moreover, because of what cloning means, one cannot 
presume a future cloned child's consent to be a clone, even a healthy 
one. Thus, we cannot ethically even get to know whether or not human 
cloning is feasible.
    Second, cloning creates serious issues of identity and 
individuality. The clone may experience concerns about his distinctive 
identity not only because he will be in genotype and appearance 
identical to another human being, but, in this case, because he may 
also be twin to the person who is his ``father'' or ``mother''--if one 
can still call them that. What would be the psychic burdens of being 
the ``child'' or ``parent'' of your twin? What will happen when the 
adolescent clone of Mommy becomes the spitting image of the woman Daddy 
once fell in love with? In case of divorce, will Mommy still love the 
clone of Daddy, even though she can no longer stand the sight of Daddy 
himself? In addition, unlike ``normal'' identical twins, a cloned 
individual will be saddled with a genotype that has already lived. He 
will not be fully a surprise to the world: people are likely always to 
compare his performances in life with that of his alter ego. True, his 
nurture and circumstance will be different; genotype is not exactly 
destiny. But one must also expect parental efforts to shape this new 
life after the original--or at least to view the child with the 
original version always firmly in mind. For why else did they clone 
from the star basketball player, mathematician, and beauty queen--or 
even dear old Dad--in the first place?
    Since the birth of Dolly, there has been a fair amount of 
doublespeak on the matter of genetic identity. Experts have rushed in 
to reassure the public that the clone would in no way be the same 
person or have any confusions about his identity: they are pleased to 
point out, as previously noted, that the clone of Mel Gibson would not 
be Mel Gibson. Fair enough. But genotype obviously matters plenty. 
That, after all, is the only reason to clone, whether human beings or 
sheep. The odds that clones of Shaquille O'Neal would play in the NBA 
are, I submit, infinitely greater than they are for clones of Danny 
DeVito.
    A cloned child is deliberately deprived of a normal bio-social 
identity. He or she has (at most) but one biological ``parent''; the 
usually sad situation of the ``single-parent child'' is here purposely 
planned, and with a vengeance. In the case of self-cloning, the 
``offspring'' is, in addition, one's twin: The dreaded result of 
incest--to be parent to one's sibling--is here brought about 
deliberately, albeit without any act of coitus. Moreover, all other 
relationships will be confounded: what will father, grandfather, aunt, 
cousin, or sister mean, and who will bear what ties and burdens? To 
this it is no answer to say that our society, with its high incidence 
of broken families and non-marital childbearing, already confuses 
kinship and responsibility for children, unless one also wants to argue 
that this, for children, is a preferable state of affairs.
    Third, human cloning would represent a giant step toward turning 
begetting into making, procreation into manufacture (literally, 
something ``handmade''), a process already begun with in vitro 
fertilization and genetic testing of embryos. With cloning, not only is 
the process in hand, but the total genetic blueprint of the cloned 
individual is selected and determined by the human artisans. To be 
sure, subsequent development is still according to natural processes; 
and the resulting children will be recognizably human. But we here 
would be taking a major step into making man himself simply another one 
of the man-made things.
    How does begetting differ from making? In natural procreation, 
human beings come together, complementarily male and female, to give 
existence to another being who is formed, exactly as we were, by what 
we are--living, hence perishable, hence aspiringly erotic, hence 
procreative human beings. But in clonal reproduction, and in the more 
advanced forms of manufacture to which it will lead, we give existence 
to a being not by what we are but by what we intend and design. As with 
any product of our making, no matter how excellent, the artificer 
stands above it, not as an equal but as a superior, transcending it by 
his will and creative prowess. In human cloning, scientists and 
prospective ``parents'' adopt a technocratic attitude toward human 
children: human children become their artifacts. Such an arrangement is 
profoundly dehumanizing, no matter how good the product.
    Mass-scale cloning of the same individual makes the point vividly; 
but the violation of human equality, freedom, and dignity is present 
even in a single planned clone. And procreation dehumanized into 
manufacture is further degraded by commodification, a virtually 
inescapable result of allowing baby-making to proceed under the banner 
of commerce.
    Finally, and perhaps most important, the practice of human cloning 
by nuclear transfer--like other anticipated forms of genetically 
engineering the next generation--would enshrine and aggravate a 
profound and mischief-making misunderstanding of the meaning of having 
children and of the parent-child relationship. When a couple normally 
chooses to procreate, the partners are saying yes to the emergence of 
new life in its novelty, are saying yes not only to having a child but 
also to having whatever child this child turns out to be. In accepting 
our finitude and opening ourselves to our replacement, we tacitly 
confess the limits of our control. Embracing the future by procreating 
means precisely that we are relinquishing our grip, in the very 
activity of taking up our own share in what we hope will be the 
immortality of human life and the human species. This means that our 
children are not our children: they are not our property, they are not 
our possessions. Neither are they supposed to live our lives for us, 
nor anyone else's life but their own. To be sure, we seek to guide them 
on their way, imparting to them not just life, but nurture, love, and a 
way of life. To be sure, they bear our hopes that they will surpass us 
in goodness and happiness, enabling us in small measure to transcend 
our own limitations. But their genetic distinctiveness and independence 
are the natural foreshadowing of the deep truth that they have their 
own and never-before-enacted life to live. Though sprung from a past, 
they take an uncharted course into the future.
    Much mischief is already done by parents who try to live 
vicariously through their children. Children are sometimes compelled to 
fulfill the broken dreams of unhappy parents. But whereas most parents 
normally have hopes for their children, cloning parents will have 
expectations. In cloning, such overbearing parents will have taken at 
the start a decisive step that contradicts the entire meaning of the 
open and forward-looking nature of parent-child relations. The child is 
given a genotype that has already lived, with full expectation that 
this blueprint of a past life ought to be controlling of the life that 
is to come. A wanted child now means a child who exists precisely to 
fulfill parental wants. Cloning is thus inherently despotic, for it 
seeks to make one's children after one's own image (or an image of 
one's choosing) and their future according to one's will.
    For all these reasons, I conclude that human cloning threatens the 
dignity of human procreation, giving one generation unprecedented 
control over the next, and marking a major step toward a eugenic world 
in which children become objects of manipulation and products of will. 
We rightly worry about this threat when we oppose cloning-to-produce-
children, yet the same concerns (even more than concerns about embryo 
destruction) should lead us also to oppose cloning-for-biomedical-
research.
    All human cloning must be seen in the context of our growing powers 
over human reproduction augmented by new knowledge of the human genome. 
Science already permits us to screen human embryos in vitro for 
thousands of human genes: not only to find markers for dread diseases, 
but also soon genes responsible for other human traits; not just sex, 
height, or skin color but even intelligence, temperament, or sexual 
orientation. Genetic selection of embryos is today a growing industry. 
Some experts hail assisted reproduction as the route to genetically 
sound babies. While directed genetic change of human embryos (even for 
therapeutic purposes) may be a long way off, it has been accomplished 
in primates in the laboratory. It would be naive to believe that 
cloning children will be confined to infertile couples or that cloning 
research will be confined to studies of disease.
    Viewed in this larger context, the production of cloned embryos for 
any purpose marks a significant leap in transforming procreation into a 
form of manufacture. The embryo created by cloning would be the first 
human embryo to have its genetic identity selected in advance, the 
first embryo whose makeup is not the unpredictable result of uniting 
sperm and egg. It is precisely this genetic control that makes cloned 
embryos appealing and useful. But we should not be deceived: saying yes 
to creating cloned embryos, even for research, means saying yes, at 
least in principle, to an ever-expanding genetic mastery of one 
generation over the next. Once cloned human embryos exist in 
laboratories, the eugenic revolution will have begun. And, of course, 
it will be virtually impossible to prevent them from being used to 
produce cloned babies.
    Opposition to human cloning-to-produce-children is practically 
unanimous in America: the vast majority of our fellow citizens, 
including most scientists, would like to see it banned. Nearly every 
member of Congress has condemned it. Yet despite this near-unanimity, 
and despite the fact that bans on all human cloning are being enacted 
in many nations around the world, we have so far failed to give 
national public force to the people's strong ethical verdict. The 
failure of the last Congress to enact a ban on human cloning casts 
grave doubt on our ability to govern the unethical uses of 
biotechnology, even when it threatens things we hold dear. If Congress 
fails again to act this time around, human cloning will happen here, 
and we will have acquiesced in its arrival. It is my profound hope that 
Congress will rise to the occasion, and strike a blow in defense of 
human dignity.

    Excerpted from: The President's Council on Bioethics, Human Cloning 
and Human Dignity: An Ethical Inquiry (Washington, D.C.: Government 
Printing Office, 2002): xxi-xxxix.

Executive Summary
    For the past five years, the prospect of human cloning has been the 
subject of considerable public attention and sharp moral debate, both 
in the United States and around the world. Since the announcement in 
February 1997 of the first successful cloning of a mammal (Dolly the 
sheep), several other species of mammals have been cloned. Although a 
cloned human child has yet to be born, and although the animal 
experiments have had low rates of success, the production of 
functioning mammalian cloned offspring suggests that the eventual 
cloning of humans must be considered a serious possibility.
    In November 2001, American researchers claimed to have produced the 
first cloned human embryos, though they reportedly reached only a six-
cell stage before they stopped dividing and died. In addition, several 
fertility specialists, both here and abroad, have announced their 
intention to clone human beings. The United States Congress has twice 
taken up the matter, in 1998 and again in 2001-2002, with the House of 
Representatives in July 2001 passing a strict ban on all human cloning, 
including the production of cloned human embryos. As of this writing, 
several cloning-related bills are under consideration in the Senate. 
Many other nations have banned human cloning, and the United Nations is 
considering an international convention on the subject. Finally, two 
major national reports have been issued on human reproductive cloning, 
one by the National Bioethics Advisory Commission (NBAC) in 1997, the 
other by the National Academy of Sciences (NAS) in January 2002. Both 
the NBAC and the NAS reports called for further consideration of the 
ethical and social questions raised by cloning.
    The debate over human cloning became further complicated in 1998 
when researchers were able, for the first time, to isolate human 
embryonic stem cells. Many scientists believe that these versatile 
cells, capable of becoming any type of cell in the body, hold great 
promise for understanding and treating many chronic diseases and 
conditions. Some scientists also believe that stem cells derived from 
cloned human embryos, produced explicitly for such research, might 
prove uniquely useful for studying many genetic diseases and devising 
novel therapies. Public reaction to the prospect of cloning-for-
biomedical-research has been mixed: some Americans support it for its 
medical promise; others oppose it because it requires the exploitation 
and destruction of nascent human life, which would be created solely 
for research purposes.

Human Cloning: What Is at Stake?
    The intense attention given to human cloning in both its potential 
uses, for reproduction as well as for research, strongly suggests that 
people do not regard it as just another new technology. Instead, we see 
it as something quite different, something that touches fundamental 
aspects of our humanity. The notion of cloning raises issues about 
identity and individuality, the meaning of having children, the 
difference between procreation and manufacture, and the relationship 
between the generations. It also raises new questions about the 
manipulation of some human beings for the benefit of others, the 
freedom and value of biomedical inquiry, our obligation to heal the 
sick (and its limits), and the respect and protection owed to nascent 
human life.
    Finally, the legislative debates over human cloning raise large 
questions about the relationship between science and society, 
especially about whether society can or should exercise ethical and 
prudential control over biomedical technology and the conduct of 
biomedical research. Rarely has such a seemingly small innovation 
raised such big questions.

The Inquiry: Our Point of Departure
    As Members of the President's Council on Bioethics, we have taken 
up the larger ethical and social inquiry called for in the NBAC and NAS 
reports, with the aim of advancing public understanding and informing 
public policy on the matter. We have attempted to consider human 
cloning (both for producing children and for biomedical research) 
within its larger human, technological, and ethical contexts, rather 
than to view it as an isolated technical development. We focus first on 
the broad human goods that it may serve as well as threaten, rather 
than on the immediate impact of the technique itself. By our broad 
approach, our starting on the plane of human goods, and our open spirit 
of inquiry, we hope to contribute to a richer and deeper understanding 
of what human cloning means, how we should think about it, and what we 
should do about it.
    On some matters discussed in this report, Members of the Council 
are not of one mind. Rather than bury these differences in search of a 
spurious consensus, we have sought to present all views fully and 
fairly, while recording our agreements as well as our genuine diversity 
of perspectives, including our differences on the final recommendations 
to be made. By this means, we hope to help policymakers and the general 
public appreciate more thoroughly the difficulty of the issues and the 
competing goods that are at stake.

Fair and Accurate Terminology
    There is today much confusion about the terms used to discuss human 
cloning, regarding both the activity involved and the entities that 
result. The Council stresses the importance of striving not only for 
accuracy but also for fairness, especially because the choice of terms 
can decisively affect the way questions are posed, and hence how 
answers are given. We have sought terminology that most accurately 
conveys the descriptive reality of the matter, in order that the moral 
arguments can then proceed on the merits. We have resisted the 
temptation to solve the moral questions by artful redefinition or by 
denying to some morally crucial element a name that makes clear that 
there is a moral question to be faced.
    On the basis of (1) a careful analysis of the act of cloning, and 
its relation to the means by which it is accomplished and the purposes 
it may serve, and (2) an extensive critical examination of alternative 
terminologies, the Council has adopted the following definitions for 
the most important terms in the matter of human cloning:

   Cloning: A form of reproduction in which offspring result 
        not from the chance union of egg and sperm (sexual 
        reproduction) but from the deliberate replication of the 
        genetic makeup of another single individual (asexual 
        reproduction).

   Human cloning: The asexual production of a new human 
        organism that is, at all stages of development, genetically 
        virtually identical to a currently existing or previously 
        existing human being. It would be accomplished by introducing 
        the nuclear material of a human somatic cell (donor) into an 
        oocyte (egg) whose own nucleus has been removed or inactivated, 
        yielding a product that has a human genetic constitution 
        virtually identical to the donor of the somatic cell. (This 
        procedure is known as ``somatic cell nuclear transfer,'' or 
        SCNT). We have declined to use the terms ``reproductive 
        cloning'' and ``therapeutic cloning.'' We have chosen instead 
        to use the following designations:

   Cloning-to-produce-children: Production of a cloned human 
        embryo, formed for the (proximate) purpose of initiating a 
        pregnancy, with the (ultimate) goal of producing a child who 
        will be genetically virtually identical to a currently existing 
        or previously existing individual.

   Cloning-for-biomedical-research: Production of a cloned 
        human embryo, formed for the (proximate) purpose of using it in 
        research or for extracting its stem cells, with the (ultimate) 
        goals of gaining scientific knowledge of normal and abnormal 
        development and of developing cures for human diseases.

   Cloned human embryo: (a) A human embryo resulting from the 
        nuclear transfer process (as contrasted with a human embryo 
        arising from the union of egg and sperm). (b) The immediate 
        (and developing) product of the initial act of cloning, 
        accomplished by successful SCNT, whether used subsequently in 
        attempts to produce children or in biomedical research.

Scientific Background
    Cloning research and stem cell research are being actively 
investigated and the state of the science is changing rapidly; 
significant new developments could change some of the interpretations 
in our report. At present, however, a few general points may be 
highlighted.

   The technique of cloning. The following steps have been used 
        to produce live offspring in the mammalian species that have 
        been successfully cloned. Obtain an egg cell from a female of a 
        mammalian species. Remove its nuclear DNA, to produce an 
        enucleated egg. Insert the nucleus of a donor adult cell into 
        the enucleated egg, to produce a reconstructed egg. Activate 
        the reconstructed egg with chemicals or electric current, to 
        stimulate it to commence cell division. Sustain development of 
        the cloned embryo to a suitable stage in vitro, and then 
        transfer it to the uterus of a female host that has been 
        suitably prepared to receive it. Bring to live birth a cloned 
        animal that is genetically virtually identical (except for the 
        mitochondrial DNA) to the animal that donated the adult cell 
        nucleus.

   Animal cloning: low success rates, high morbidity. At least 
        seven species of mammals (none of them primates) have been 
        successfully cloned to produce live births. Yet the production 
        of live cloned offspring is rare and the failure rate is high: 
        more than 90 percent of attempts to initiate a clonal pregnancy 
        do not result in successful live birth. Moreover, the live-born 
        cloned animals suffer high rates of deformity and disability, 
        both at birth and later on. Some biologists attribute these 
        failures to errors or incompleteness of epigenetic 
        reprogramming of the somatic cell nucleus.

   Attempts at human cloning. At this writing, it is uncertain 
        whether anyone has attempted cloning-to-produce-children 
        (although at least one physician is now claiming to have 
        initiated several active clonal pregnancies, and others are 
        reportedly working on it). We do not know whether a transferred 
        cloned human embryo can progress all the way to live birth.

   Stem cell research. Human embryonic stem cells have been 
        isolated from embryos (produced by IVF) at the blastocyst stage 
        or from the germinal tissue of fetuses. Human adult stem (or 
        multipotent) cells have been isolated from a variety of 
        tissues. Such cell populations can be differentiated in vitro 
        into a number of different cell types, and are currently being 
        studied intensely for their possible uses in regenerative 
        medicine. Most scientists working in the field believe that 
        stem cells (both embryonic and adult) hold great promise as 
        routes toward cures and treatments for many human diseases and 
        disabilities. All stem cell research is at a very early stage, 
        and it is too soon to tell which approaches will prove most 
        useful, and for which diseases.

   The transplant rejection problem. To be effective as long-
        term treatments, cell transplantation therapies will have to 
        overcome the immune rejection problem. Cells and tissues 
        derived from adult stem cells and returned to the patient from 
        whom they were taken would not be subject (at least in 
        principle) to immune rejection.

   Stem cells from cloned embryos. Human embryonic stem cell 
        preparations could potentially be produced by using somatic 
        cell nuclear transfer to produce a cloned human embryo, and 
        then taking it apart at the blastocyst stage and isolating stem 
        cells. These stem cells would be genetically virtually 
        identical to cells from the nucleus donor, and thus could 
        potentially be of great value in biomedical research. Very 
        little work of this sort has been done to date in animals, and 
        there are as yet no published reports of cloned human embryos 
        grown to the blastocyst stage. Although the promise of such 
        research is at this time unknown, most researchers believe it 
        will yield very useful and important knowledge, pointing toward 
        new therapies and offering one of several possible routes to 
        circumvent the immune rejection problem. Although some 
        experimental results in animals are indeed encouraging, they 
        also demonstrate some tendency even of cloned stem cells to 
        stimulate an immune response.

   The fate of embryos used in research. All extractions of 
        stem cells from human embryos, cloned or not, involve the 
        destruction of these embryos.

The Ethics of Cloning-to-Produce-Children
    Two separate national-level reports on human cloning (NBAC, 1997; 
NAS, 2002) concluded that attempts to clone a human being would be 
unethical at this time due to safety concerns and the likelihood of 
harm to those involved. The Council concurs in this conclusion. But we 
have extended the work of these distinguished bodies by undertaking a 
broad ethical examination of the merits of, and difficulties with, 
cloning-to-produce-children.
    Cloning-to-produce-children might serve several purposes. It might 
allow infertile couples or others to have genetically-related children; 
permit couples at risk of conceiving a child with a genetic disease to 
avoid having an afflicted child; allow the bearing of a child who could 
become an ideal transplant donor for a particular patient in need; 
enable a parent to keep a living connection with a dead or dying child 
or spouse; or enable individuals or society to try to ``replicate'' 
individuals of great talent or beauty. These purposes have been 
defended by appeals to the goods of freedom, existence (as opposed to 
nonexistence), and well-being--all vitally important ideals.
    A major weakness in these arguments supporting cloning-to-produce-
children is that they overemphasize the freedom, desires, and control 
of parents, and pay insufficient attention to the well-being of the 
cloned child-to-be. The Council holds that, once the child-to-be is 
carefully considered, these arguments are not sufficient to overcome 
the powerful case against engaging in cloning-to-produce-children.
    First, cloning-to-produce-children would violate the principles of 
the ethics of human research. Given the high rates of morbidity and 
mortality in the cloning of other mammals, we believe that cloning-to-
produce-children would be extremely unsafe, and that attempts to 
produce a cloned child would be highly unethical. Indeed, our moral 
analysis of this matter leads us to conclude that this is not, as is 
sometimes implied, a merely temporary objection, easily removed by the 
improvement of technique. We offer reasons for believing that the 
safety risks might be enduring, and offer arguments in support of a 
strong conclusion: that conducting experiments in an effort to make 
cloning-to-produce-children less dangerous would itself be an 
unacceptable violation of the norms of research ethics. There seems to 
be no ethical way to try to discover whether cloning-to-produce-
children can become safe, now or in the future.
    If carefully considered, the concerns about safety also begin to 
reveal the ethical principles that should guide a broader assessment of 
cloning-to-produce-children: the principles of freedom, equality, and 
human dignity. To appreciate the broader human significance of cloning-
to-produce-children, one needs first to reflect on the meaning of 
having children; the meaning of asexual, as opposed to sexual, 
reproduction; the importance of origins and genetic endowment for 
identity and sense of self; the meaning of exercising greater human 
control over the processes and ``products'' of human reproduction; and 
the difference between begetting and making. Reflecting on these 
topics, the Council has identified five categories of concern regarding 
cloning-to-produce-children. (Different Council Members give varying 
moral weight to these different concerns.)

   Problems of identity and individuality. Cloned children may 
        experience serious problems of identity both because each will 
        be genetically virtually identical to a human being who has 
        already lived and because the expectations for their lives may 
        be shadowed by constant comparisons to the life of the 
        ``original.''

   Concerns regarding manufacture. Cloned children would be the 
        first human beings whose entire genetic makeup is selected in 
        advance. They might come to be considered more like products of 
        a designed manufacturing process than ``gifts'' whom their 
        parents are prepared to accept as they are. Such an attitude 
        toward children could also contribute to increased 
        commercialization and industrialization of human procreation.

   The prospect of a new eugenics. Cloning, if successful, 
        might serve the ends of privately pursued eugenic enhancement, 
        either by avoiding the genetic defects that may arise when 
        human reproduction is left to chance, or by preserving and 
        perpetuating outstanding genetic traits, including the 
        possibility, someday in the future, of using cloning to 
        perpetuate genetically engineered enhancements.

   Troubled family relations. By confounding and transgressing 
        the natural boundaries between generations, cloning could 
        strain the social ties between them. Fathers could become 
        ``twin brothers'' to their ``sons''; mothers could give birth 
        to their genetic twins; and grandparents would also be the 
        ``genetic parents'' of their grandchildren. Genetic relation to 
        only one parent might produce special difficulties for family 
        life.

   Effects on society. Cloning-to-produce-children would affect 
        not only the direct participants but also the entire society 
        that allows or supports this activity. Even if practiced on a 
        small scale, it could affect the way society looks at children 
        and set a precedent for future nontherapeutic interventions 
        into the human genetic endowment or novel forms of control by 
        one generation over the next. In the absence of wisdom 
        regarding these matters, prudence dictates caution and 
        restraint.

    Conclusion: For some or all of these reasons, the Council is in 
full agreement that cloning-to-produce-children is not only unsafe but 
also morally unacceptable, and ought not to be attempted.

The Ethics of Cloning-for-Biomedical-Research
    Ethical assessment of cloning-for-biomedical-research is far more 
vexing. On the one hand, such research could lead to important 
knowledge about human embryological development and gene action, both 
normal and abnormal, ultimately resulting in treatments and cures for 
many dreaded illnesses and disabilities. On the other hand, the 
research is morally controversial because it involves the deliberate 
production, use, and ultimate destruction of cloned human embryos, and 
because the cloned embryos produced for research are no different from 
those that could be implanted in attempts to produce cloned children. 
The difficulty is compounded by what are, for now, unanswerable 
questions as to whether the research will in fact yield the benefits 
hoped for, and whether other promising and morally nonproblematic 
approaches might yield comparable benefits. The Council, reflecting the 
differences of opinion in American society, is divided regarding the 
ethics of research involving (cloned) embryos. Yet we agree that all 
parties to the debate have concerns vital to defend, vital not only to 
themselves but to all of us. No human being and no society can afford 
to be callous to the needs of suffering humanity, or cavalier about the 
treatment of nascent human life, or indifferent to the social effects 
of adopting one course of action rather than another.
    To make clear to all what is at stake in the decision, Council 
Members have presented, as strongly as possible, the competing ethical 
cases for and against cloning-for-biomedical-research in the form of 
first-person attempts at moral suasion. Each case has tried to address 
what is owed to suffering humanity, to the human embryo, and to the 
broader society. Within each case, supporters of the position in 
question speak only for themselves, and not for the Council as a whole.

A. The Moral Case for Cloning-for-Biomedical-Research
    The moral case for cloning-for-biomedical-research rests on our 
obligation to try to relieve human suffering, an obligation that falls 
most powerfully on medical practitioners and biomedical researchers. We 
who support cloning-for-biomedical-research all agree that it may offer 
uniquely useful ways of investigating and possibly treating many 
chronic debilitating diseases and disabilities, providing aid and 
relief to millions. We also believe that the moral objections to this 
research are outweighed by the great good that may come from it. Up to 
this point, we who support this research all agree. But we differ among 
ourselves regarding the weight of the moral objections, owing to 
differences about the moral status of the cloned embryo. These 
differences of opinion are sufficient to warrant distinguishing two 
different moral positions within the moral case for cloning-for-
biomedical-research:
    Position Number One. Most Council Members who favor cloning-for-
biomedical-research do so with serious moral concerns. Speaking only 
for ourselves, we acknowledge the following difficulties, but think 
that they can be addressed by setting proper boundaries.

   Intermediate moral status. While we take seriously concerns 
        about the treatment of nascent human life, we believe there are 
        sound moral reasons for not regarding the embryo in its 
        earliest stages as the moral equivalent of a human person. We 
        believe the embryo has a developing and intermediate moral 
        worth that commands our special respect, but that it is morally 
        permissible to use early-stage cloned human embryos in 
        important research under strict regulation.

   Deliberate creation for use. We believe that concerns over 
        the problem of deliberate creation of cloned embryos for use in 
        research have merit, but when properly understood should not 
        preclude cloning-for-biomedical-research. These embryos would 
        not be ``created for destruction,'' but for use in the service 
        of life and medicine. They would be destroyed in the service of 
        a great good, and this should not be obscured.

   Going too far. We acknowledge the concern that some 
        researchers might seek to develop cloned embryos beyond the 
        blastocyst stage, and for those of us who believe that the 
        cloned embryo has a developing and intermediate moral status, 
        this is a very real worry. We approve, therefore, only of 
        research on cloned embryos that is strictly limited to the 
        first fourteen days of development--a point near when the 
        primitive streak is formed and before organ differentiation 
        occurs.

   Other moral hazards. We believe that concerns about the 
        exploitation of women and about the risk that cloning-for-
        biomedical-research could lead to cloning-to-produce-children 
        can be adequately addressed by appropriate rules and 
        regulations. These concerns need not frighten us into 
        abandoning an important avenue of research.

    Position Number Two. A few Council Members who favor cloning-for-
biomedical-research do not share all the ethical qualms expressed 
above. Speaking only for ourselves, we hold that this research, at 
least for the purposes presently contemplated, presents no special 
moral problems, and therefore should be endorsed with enthusiasm as a 
potential new means of gaining knowledge to serve humankind. Because we 
accord no special moral status to the early-stage cloned embryo and 
believe it should be treated essentially like all other human cells, we 
believe that the moral issues involved in this research are no 
different from those that accompany any biomedical research. What is 
required is the usual commitment to high standards for the quality of 
research, scientific integrity, and the need to obtain informed consent 
from donors of the eggs and somatic cells used in nuclear transfer.

B. The Moral Case against Cloning-for-Biomedical-Research
    The moral case against cloning-for-biomedical-research acknowledges 
the possibility--though purely speculative at the moment--that medical 
benefits might come from this particular avenue of experimentation. But 
we believe it is morally wrong to exploit and destroy developing human 
life, even for good reasons, and that it is unwise to open the door to 
the many undesirable consequences that are likely to result from this 
research. We find it disquieting, even somewhat ignoble, to treat what 
are in fact seeds of the next generation as mere raw material for 
satisfying the needs of our own. Only for very serious reasons should 
progress toward increased knowledge and medical advances be slowed. But 
we believe that in this case such reasons are apparent.

   Moral status of the cloned embryo. We hold that the case for 
        treating the early-stage embryo as simply the moral equivalent 
        of all other human cells (Position Number Two, above) is simply 
        mistaken: it denies the continuous history of human individuals 
        from the embryonic to fetal to infant stages of existence; it 
        misunderstands the meaning of potentiality; and it ignores the 
        hazardous moral precedent that the routinized creation, use, 
        and destruction of nascent human life would establish. We hold 
        that the case for according the human embryo ``intermediate and 
        developing moral status'' (Position Number One, above) is also 
        unconvincing, for reasons both biological and moral. Attempts 
        to ground the limited measure of respect owed to a maturing 
        embryo in certain of its developmental features do not succeed, 
        and the invoking of a ``special respect'' owed to nascent human 
        life seems to have little or no operative meaning if cloned 
        embryos may be created in bulk and used routinely with 
        impunity. If from one perspective the view that the embryo 
        seems to amount to little may invite a weakening of our 
        respect, from another perspective its seeming insignificance 
        should awaken in us a sense of shared humanity and a special 
        obligation to protect it.

   The exploitation of developing human life. To engage in 
        cloning-for-biomedical-research requires the irreversible 
        crossing of a very significant moral boundary: the creation of 
        human life expressly and exclusively for the purpose of its use 
        in research, research that necessarily involves its deliberate 
        destruction. If we permit this research to proceed, we will 
        effectively be endorsing the complete transformation of nascent 
        human life into nothing more than a resource or a tool. Doing 
        so would coarsen our moral sensibilities and make us a 
        different society: one less humble toward that which we cannot 
        fully understand, less willing to extend the boundaries of 
        human respect ever outward, and more willing to transgress 
        moral boundaries once it appears to be in our own interests to 
        do so.

   Moral harm to society. Even those who are uncertain about 
        the precise moral status of the human embryo have sound 
        ethical-prudential reasons to oppose cloning-for-biomedical-
        research. Giving moral approval to such research risks 
        significant moral harm to our society by (1) crossing the 
        boundary from sexual to asexual reproduction, thus approving in 
        principle the genetic manipulation and control of nascent human 
        life; (2) opening the door to other moral hazards, such as 
        cloning-to-produce-children or research on later-stage human 
        embryos and fetuses; and (3) potentially putting the federal 
        government in the novel and unsavory position of mandating the 
        destruction of nascent human life. Because we are concerned not 
        only with the fate of the cloned embryos but also with where 
        this research will lead our society, we think prudence requires 
        us not to engage in this research.

   What we owe the suffering. We are certainly not deaf to the 
        voices of suffering patients; after all, each of us already 
        shares or will share in the hardships of mortal life. We and 
        our loved ones are all patients or potential patients. But we 
        are not only patients, and easing suffering is not our only 
        moral obligation. As much as we wish to alleviate suffering now 
        and to leave our children a world where suffering can be more 
        effectively relieved, we also want to leave them a world in 
        which we and they want to live--a world that honors moral 
        limits, that respects all life whether strong or weak, and that 
        refuses to secure the good of some human beings by sacrificing 
        the lives of others.

Public Policy Options
    The Council recognizes the challenges and risks of moving from 
moral assessment to public policy. Reflections on the ``social 
contract'' between science and society highlight both the importance of 
scientific freedom and the need for boundaries. We note that other 
countries often treat human cloning in the context of a broad area of 
biomedical technology, at the intersection of reproductive technology, 
embryo research, and genetics, while the public policy debate in the 
United States has treated cloning largely on its own. We recognize the 
special difficulty in formulating sound public policy in this area, 
given that the two ethically distinct matters--cloning-to-produce-
children and cloning-for-biomedical-research--will be mutually affected 
or implicated in any attempts to legislate about either. Nevertheless, 
our ethical and policy analysis leads us to the conclusion that some 
deliberate public policy at the federal level is needed in the area of 
human cloning.
    We reviewed the following seven possible policy options and 
considered their relative strengths and weaknesses: (1) Professional 
self-regulation but no federal legislative action (``self-
regulation''); (2) A ban on cloning-to-produce-children, with neither 
endorsement nor restriction of cloning-for-biomedical-research (``ban 
plus silence''); (3) A ban on cloning-to-produce-children, with 
regulation of the use of cloned embryos for biomedical research (``ban 
plus regulation''); (4) Governmental regulation, with no legislative 
prohibitions (``regulation of both''); (5) A ban on all human cloning, 
whether to produce children or for biomedical research (``ban on 
both''); (6) A ban on cloning-to-produce-children, with a moratorium or 
temporary ban on cloning-for-biomedical-research (``ban plus 
moratorium''); or (7) A moratorium or temporary ban on all human 
cloning, whether to produce children or for biomedical research 
(``moratorium on both'').

The Council's Policy Recommendations
    Having considered the benefits and drawbacks of each of these 
options, and taken into account our discussions and reflections 
throughout this report, the Council recommends two possible policy 
alternatives, each supported by a portion of the Members.
    Majority Recommendation: Ten Members of the Council recommend a ban 
on cloning-to-produce-children combined with a four-year moratorium on 
cloning-for-biomedical-research. We also call for a federal review of 
current and projected practices of human embryo research, pre-
implantation genetic diagnosis, genetic modification of human embryos 
and gametes, and related matters, with a view to recommending and 
shaping ethically sound policies for the entire field. Speaking only 
for ourselves, those of us who support this recommendation do so for 
some or all of the following reasons:

   By permanently banning cloning-to-produce-children, this 
        policy gives force to the strong ethical verdict against 
        cloning-to-produce-children, unanimous in this Council (and in 
        Congress) and widely supported by the American people. And by 
        enacting a four-year moratorium on the creation of cloned 
        embryos, it establishes an additional safeguard not afforded by 
        policies that would allow the production of cloned embryos to 
        proceed without delay.

   It calls for and provides time for further democratic 
        deliberation about cloning-for-biomedical research, a subject 
        about which the nation is divided and where there remains great 
        uncertainty. A national discourse on this subject has not yet 
        taken place in full, and a moratorium, by making it impossible 
        for either side to cling to the status-quo, would force both to 
        make their full case before the public. By banning all cloning 
        for a time, it allows us to seek moral consensus on whether or 
        not we should cross a major moral boundary (creating nascent 
        cloned human life solely for research) and prevents our 
        crossing it without deliberate decision. It would afford time 
        for scientific evidence, now sorely lacking, to be gathered--
        from animal models and other avenues of human research--that 
        might give us a better sense of whether cloning-for-biomedical-
        research would work as promised, and whether other morally 
        nonproblematic approaches might be available. It would promote 
        a fuller and better-informed public debate. And it would show 
        respect for the deep moral concerns of the large number of 
        Americans who have serious ethical objections to this research.

   Some of us hold that cloning-for-biomedical-research can 
        never be ethically pursued, and endorse a moratorium to enable 
        us to continue to make our case in a democratic way. Others of 
        us support the moratorium because it would provide the time and 
        incentive required to develop a system of national regulation 
        that might come into use if, at the end of the four-year 
        period, the moratorium were not reinstated or made permanent. 
        Such a system could not be developed overnight, and therefore 
        even those who support the research but want it regulated 
        should see that at the very least a pause is required. In the 
        absence of a moratorium, few proponents of the research would 
        have much incentive to institute an effective regulatory 
        system. Moreover, the very process of proposing such 
        regulations would clarify the moral and prudential judgments 
        involved in deciding whether and how to proceed with this 
        research.

   A moratorium on cloning-for-biomedical-research would enable 
        us to consider this activity in the larger context of research 
        and technology in the areas of developmental biology, embryo 
        research, and genetics, and to pursue a more comprehensive 
        federal regulatory system for setting and executing policy in 
        the entire area.

   Finally, we believe that a moratorium, rather than a lasting 
        ban, signals a high regard for the value of biomedical research 
        and an enduring concern for patients and families whose 
        suffering such research may help alleviate. It would reaffirm 
        the principle that science can progress while upholding the 
        community's moral norms, and would therefore reaffirm the 
        community's moral support for science and biomedical 
        technology.

    The decision before us is of great importance. Creating cloned 
embryos for any purpose requires crossing a major moral boundary, with 
grave risks and likely harms, and once we cross it there will be no 
turning back. Our society should take the time to make a judgment that 
is well-informed and morally sound, respectful of strongly held views, 
and representative of the priorities and principles of the American 
people. We believe this ban-plus-moratorium proposal offers the best 
means of achieving these goals.
    This position is supported by Council Members Rebecca S. Dresser, 
Francis Fukuyama, Robert P. George, Mary Ann Glendon, Alfonso Gomez-
Lobo, William B. Hurlbut, Leon R. Kass, Charles Krauthammer, Paul 
McHugh, and Gilbert C. Meilaender.
    Minority Recommendation: Seven Members of the Council recommend a 
ban on cloning-to-produce-children, with regulation of the use of 
cloned embryos for biomedical research. Speaking only for ourselves, 
those of us who support this recommendation do so for some or all of 
the following reasons:

   By permanently banning cloning-to-produce-children, this 
        policy gives force to the strong ethical verdict against 
        cloning-to-produce-children, unanimous in this Council (and in 
        Congress) and widely supported by the American people. We 
        believe that a ban on the transfer of cloned embryos to a 
        woman's uterus would be a sufficient and effective legal 
        safeguard against the practice.

   It approves cloning-for-biomedical-research and permits it 
        to proceed without substantial delay. This is the most 
        important advantage of this proposal. The research shows great 
        promise, and its actual value can only be determined by 
        allowing it to go forward now. Regardless of how much time we 
        allow it, no amount of experimentation with animal models can 
        provide the needed understanding of human diseases. The special 
        benefits from working with stem cells from cloned human embryos 
        cannot be obtained using embryos obtained by IVF. We believe 
        this research could provide relief to millions of Americans, 
        and that the government should therefore support it, within 
        sensible limits imposed by regulation.

   It would establish, as a condition of proceeding, the 
        necessary regulatory protections to avoid abuses and misuses of 
        cloned embryos. These regulations might touch on the secure 
        handling of embryos, licensing and prior review of research 
        projects, the protection of egg donors, and the provision of 
        equal access to benefits.

   Some of us also believe that mechanisms to regulate cloning-
        for-biomedical-research should be part of a larger regulatory 
        program governing all research involving human embryos, and 
        that the federal government should initiate a review of present 
        and projected practices of human embryo research, with the aim 
        of establishing reasonable policies on the matter.

    Permitting cloning-for-biomedical-research now, while governing it 
through a prudent and sensible regulatory regime, is the most 
appropriate way to allow important research to proceed while insuring 
that abuses are prevented. We believe that the legitimate concerns 
about human cloning expressed throughout this report are sufficiently 
addressed by this ban-plus-regulation proposal, and that the nation 
should affirm and support the responsible effort to find treatments and 
cures that might help many who are suffering.
    This position is supported by Council Members Elizabeth H. 
Blackburn, Daniel W. Foster, Michael S. Gazzaniga, William F. May, 
Janet D. Rowley, Michael J. Sandel, and James Q. Wilson.

    Senator Brownback. Thank you very much, Dr. Kass. That was 
a very profound statement, and I appreciate your thoughtfulness 
over the past 30 years on this topic and your willingness to 
serve the country at this time as we go through this.
    I want to get the definition accurate. And you have stated 
it in your testimony, but I want to cover it one more time so 
that we are clear on it.
    The SCNT, somatic cell nuclear transfer, as frequently 
people refer to human cloning, by your definition--by the 
board--the President's Council on Bioethics--you deemed that to 
be human cloning. Is that correct?
    Dr. Kass. Cloning for biomedical research. It is cloning, 
because the act that produces the clone--the only act that 
produces the genetic replica--is the very first act.
    Senator Brownback. Past that, you are just letting it grow.
    Dr. Kass. Past that, you let it grow. You let it grow up to 
about 5 days, when it is a ball of about a hundred cells, and 
it is at that point that your two different intentions decide 
whether you are going to try to produce a child with it or 
whether you are going to use it for biomedical research.
    Somatic cell nuclear transfer is the name of the technique. 
It does not really name the act. The name of the act is the 
production of a cloned human embryo. That is why you did it, 
because that is what you want.
    Senator Brownback. OK. But as far as you are concerned, as 
the President's Bioethics Council, the process of SCNT is human 
cloning. Now, it is either for reproductive or biomedical 
research, but it is the process of human cloning. Is that 
correct?
    Dr. Kass. SCNT is the ``how'' human cloning is done, yes. 
It is----
    Senator Brownback. OK.
    Dr. Kass.--it is human cloning, exactly.
    Senator Brownback. Because I think one of the things that 
has been the big struggle in this debate is the debate about 
the term. And you have put it--and you have defined that term 
here, and I think it is important that we have that out there, 
about what is human cloning and what is not human cloning.
    Dr. Kass. I think if--you are holding the text of the 
Council's cloning report in front of you--and I can refer you 
and colleagues later--page 54 has the conclusion of the 
terminological discussion. ``Human cloning (what it is)'' is 
``the asexual production of a new human organism that is, at 
all stages of development--that is, beginning at the first 
one--genetically virtually identical to the existing one. ``How 
it is done'' is by somatic cell nuclear transfer. And ``why it 
is done'' will either be to produce children, or to--for 
biomedical research.
    Senator Brownback. OK. I think that is a good way of 
putting it. What it is--but SCNT is just simply how----
    Dr. Kass. It is just the----
    Senator Brownback.--it is done.
    Dr. Kass.--it is just the technique.
    Senator Brownback. The technique----
    Dr. Kass. Right.
    Senator Brownback.--for doing it. And that was the process 
used for Dolly.
    Dr. Kass. That was the process used for Dolly. And when 
people say ``somatic cell nuclear transfer to produce stem 
cells,'' you do not produce stem cells directly by somatic cell 
nuclear transfer; you produce an embryo, which you then have to 
grow up and then you get the stem cells out.
    So the primary product of the technique of somatic cell 
nuclear transfer is an embryo. It is a cloned embryo. And if it 
is in the human species, it is a cloned human embryo.
    Senator Brownback. OK. And this is the same process that is 
being used now not only in Dolly, but in cats--well, what all 
has this been used--this same process been used in?
    Dr. Kass. It has been used successfully in, I think, eight 
or nine mammalian species--sheep, cows, pigs, cats, mice, rats, 
goats. I have left out one or another, but----
    Senator Brownback. And if the Raelians----
    Dr. Kass. By the way, the rate of success in some of these 
other species now goes up. It is no longer one in 277, as with 
Dolly.
    Senator Brownback. What is it now?
    Dr. Kass. I do not have the latest data, but it is up to 4-
5 percent in mice and the technique is being perfected by by 
practice.
    Senator Brownback. So that that one in nearly 300 is going 
down to--substantially as people learn more and are able to 
perfect the technique.
    Dr. Kass. Yes.
    Senator Brownback. Now, the technique that the Raelians 
would have used if they did produce a human would be this SCNT 
procedure?
    Dr. Kass. As--I assume so. With the Raelians, I think all 
bets are off, but----
    [Laughter.]
    Dr. Kass.--if--but, yes.
    Senator Brownback. Now, if--one of the things that you 
argued, as I understand it, is that if you allow this technique 
to develop, the SCNT technique of developing an embryo--and now 
we are past the issue of whether it is a human clone, but of 
developing that--but you just do it in research purposes, it is 
going to be very hard to hold that as a research topic, that 
you have created a human clone just for research purposes, that 
that is going to move on forward.
    Dr. Kass. Well, I think it will in two ways, Senator. 
First, as Dr. Weldon, I think, has already amply testified, the 
belief that one can effectively establish a ban on only the 
transfer of such embryos to initiate a pregnancy is, I think, 
very problematic. If these are--if these embryos are produced 
commercially in laboratories under protection of industrial 
secrecy, no one will know what is being done with them. They 
could be bought and sold with impunity. They could be--find 
their way, just as the embryos now in in vitro clinics produced 
for one purpose, namely the treatment for infertility, now wind 
up in laboratories. So the same embryo produced originally for 
research could wind up in an infertility clinic and, under the 
privacy of the doctor-patient relationship, be used to produce 
a baby.
    And as Dr. Weldon has pointed out, clonal pregnancy would 
be hard to find. A clonal pregnancy does not look any different 
from any other, and there would be no enforceable remedy should 
it be discovered.
    So once the cloned embryos exist and once one gets a lot of 
practice at perfecting this technique, it will hasten the day 
that cloning for baby-making will arrive, and I do not think an 
effective ban could be erected in the way in which Senators 
Specter and Hatch and Feinstein and Kennedy think it can be.
    But second, more importantly, if the justification for 
creating these embryos is that we need these embryos in order 
to pursue knowledge of disease and remedies for diseases and 
disabilities, that principle knows no limit at the five- to 6-
day-old blastocyst stage. Already there has been one experiment 
with cloning of animals in which a cloned embryo--a cloned cow 
embryo--was put back into the cow's uterus, grown up to a 
couple of months, and then aborted, and that fetus had its 
kidney tissues removed.
    And as, again, Dr. Weldon said, differentiated tissue, is 
much more valuable than stem cells, which are much harder to 
handle and the potential that some of them would remain 
undifferentiated and cause tumors would persist.
    I am not sure about artificial uteruses, but one could put 
human embryos into pig uteruses and grow them up to much more 
valuable stages than they are at five or 6 days. And one can 
well expect that if we start down this road and the potential 
of differentiated tissue turns out to be realized, there will 
be great pressures to push all the way down.
    Senator Brownback. Because there has been no boundary 
really drawn that has any significance in----
    Dr. Kass. There has no boundary that has any significance 
here at all, Senator.
    Senator Brownback.--and I also--I mean, I just--as Senator 
Ensign was saying, there is a profound issue here of human 
dignity, which I know you have written and thought about for a 
number of years. But just--when you start to research on 
humans, that is a profound issue and a place that we have 
crossed over of saying that humans can be used by other humans.
    Dr. Kass. No, indeed. I think it is--a year ago, people 
were saying that--in the summer of 2001, people were saying, 
``Look, these embryos are going to die anyhow. Why should their 
death not be redeemed by putting them to use for the benefit of 
others? But no, it would be unthinkable to create them 
specially for research purposes.'' But within 6 months, we now 
have a call to say, ``It's all right. Since there's really no 
difference between taking the ones that are spare and killing 
them and actually creating embryos explicitly for use, why 
don't we go the next step down the road?''
    In addition to the harm that is potentially done to these 
little embryos, we have to think about the harm that is done to 
us as a society for coming to regard nascent human life as a 
natural resource for our own benefit. You do not have to think 
that the embryo--the 5-day-old embryo--is a person--and I am an 
agnostic on this question; I just do not know enough to know--
but you do not have to think that it is a person to be very 
disquieted by what it would mean to start to instrumentalize 
and commercialize and turn nascent human life into a natural 
resource and treat it as if it were something to be mined so 
that you and I and our children could be benefited. This is a 
cost. This is a deep cost.
    And I should say, by the way, that it is--there are--to 
disentangle this question from the stem cell question, which I 
hope we could, to some extent, disentangle--you were very 
careful in your bill, and Dr. Weldon in his, to limit this to 
cloning, not to regular stem cell research.
    Many, many countries around the world, an increasing 
number, have banned all human cloning--not just cloning to 
produce children, but cloning for biomedical research--even 
some of them that permit research on in vitro embryonic stem 
cells--to proceed--Australia, South Korea, Norway. The Canadian 
Government is now hearing, in the third reading, a bill that 
will allow embryonic stem cell research but would ban all human 
cloning.
    Cloning is different because it is--in addition to embryo 
destruction, this is genetic manipulation.
    Senator Brownback. Very good.
    Senator Wyden?
    Senator Wyden. Thank you, Mr. Chairman, and thank you, Dr. 
Kass. I know you have done considerable work in this field, and 
I think you know I have an interest in this, as well, stemming 
from having authored the fertility clinic legislation, which is 
still the only Federal law on the books now with respect to 
fertility.
    My first question, I just want to be clear on one point. 
The U.S. Senate, by my calculus, is going to have a vote on the 
floor of the Senate before too long on an outright ban on 
cloning for biomedical research. That is what the vote is going 
to be. Now, you are the chairman of the President's Council on 
Bioethics. My assessment is that a majority of the President's 
Council on Bioethics does not now support an outright ban on 
human cloning--or, excuse me, on cloning research. Is that 
correct?
    Dr. Kass. It is a close call, Senator. On one way of 
reading the evidence, I think you are right. That table that 
has been--is--you are pointing to is a table which--is a table 
which reports the views of the individuals if the--if the 
question were on that issue alone. It is a subtle point.
    The question is--if the question was only what--would we 
approve or disapprove cloning for biomedical research, seven 
were in favor of allowing it to go forward, but only under very 
severe restrictions; seven were in favor of banning it; and 
three were in favor of a--would be in favor of a moratorium. 
There is no--there is no specific count in there on what people 
think with respect to the packaged bill, where, for reasons 
that have something to do with the likelihood of increasing the 
risk of cloning to produce children, from allowing that 
research to go forward, where the count would be. That was on 
the ethics of the matter, not on the final question.
    I think the only thing you can go on with respect to the 
final opinion is that at least the majority, ten to seven, 
favors a ban, permanent ban, on cloning to produce children and 
says that there should be no human cloning of any sort at this 
time, at least for 4 years.
    Senator Wyden. I just want to make it clear that I think 
when you read this, and I would like to make this--it is part 
of the President's Council on Bioethics Report, Mr. Chairman, 
July 2002, at page 202--it is very clear to me that a majority 
of the President's Council does not support an outright ban. 
Dr. Kass has made a point to put it in the context that he 
thinks is appropriate.
    Dr. Kass. Senator, could I just ask you--just to read the--
the paragraph before it indicates it is--the restriction. I 
will just refer you to point (e), and it has got the 
stipulations.
    Senator Wyden. Fair enough.
    Doctor, recently several important congressional supporters 
of an outright ban have made an important change with respect 
to their proposal, and they have indicated that they now are 
willing to allow the importation of products from SCNT research 
coming from overseas. Now, in my view, this just undermines a 
basic proposition of the supporters of the ban's case. They 
have been saying again and again this is not going to produce 
any great scientific dividends, and yet now they have made this 
major change, I gather to pick up support. Is this change not 
an admission that there are potential medical breakthroughs and 
they want to get the products from overseas?
    Dr. Kass. Three points. First of all, you could read that 
entirely the other way; there being some great doubt as to 
whether there are going to be any benefits, there is no point 
to stand in the way of importing them. Second, I think the--I 
think that the provision was a piece of--I had better be 
careful--I think it was a misguided provision of the previous 
law. I think it was--I think--sufficient unto the day.
    The important thing is not to aid and abet immoral 
research. And if you regard this as immoral research, 
sufficient unto the day is not allow the immediate products, 
which is to say the cloned embryos, to be made somewhere else 
and then used here.
    Senator Wyden. But that is exactly what they are doing. To 
me, it makes a mockery out of the exercise.
    Dr. Kass. No, no--I am sorry, I do not--I have not seen the 
new text, Senator. I do not think--I think the importation 
provision of the last--of the bill that passed the House was 
not about the immediate product, but it had to do with even any 
kind of derivative drugs or things like that that someone might 
someplace produce. And it seemed to me--it would seem to be--to 
say that you would, 50 years from now, or a hundred years from 
now, not import a drug that might, in fact, aid juvenile 
diabetes because it came from a cell line that, 50 years 
earlier, had been created from a cloned embryo would not be 
regarded as somehow having been complicit in or aided and 
abetted in or encouraged the original evil. So I do not think 
that provision was necessary.
    I am happy to--if it is really going out, I am happy to see 
that this provision is out. And I do not think it is an 
undermining of the principle that--that led people to oppose 
it.
    Look, the most important thing that would be--to me, is 
something like this. You want to stop cloning to produce 
children. What is the most effective way to do that? What is 
the only effective way to do that? You stop that process before 
it starts.
    Now, as Dr. Weldon said, if it should turn out, after 
extensive work in animals, about which I think we have to 
remain very skeptical--if after decades--and it is going to 
take decades to produce any evidence--they show us that there 
is a unique benefit, ``a unique benefit,'' from stem cells from 
cloned embryos, we can revisit this question.
    Senator Wyden. Well----
    Dr. Kass. But for the time being--for the time being, we 
are opening Pandora's box in the direction of genetic 
manipulation of nascent life, we are allowing the creation and 
the perfection of techniques of cloned embryos with the hope 
that we can then somehow stand in the way of keeping cloned 
babies from being--for what? For a pipe dream.
    Senator Wyden. Well----
    Dr. Kass. For a pipe dream.
    Senator Wyden. You are saying ``revisit it,'' and all of 
these suffering Americans say they cannot afford to wait. All 
of those with Parkinson's and Alzheimer's and other diseases 
want to see the Federal Government get behind them. They want 
to see the Federal Government go out and push as hard as it 
possibly can to find these cures. I have enormous respect for 
you--and I would like, if I could, Mr. Chairman, to ask about 
one other question that Dr. Kass is familiar with, in terms of 
in vitro. I think to have someone like yourself say, ``We can 
revisit it sometime down the road,'' when people like myself, 
will meet you more than halfway with respect to safeguards--
there is no debating the need for the safeguards, and there is 
no debating the fact that we are going to support a ban on 
human cloning--but with that ban, plus the safeguards, to tell 
all of those who are suffering that they should have to wait 
and we can revisit it some other time, I think is very 
unfortunate.
    Dr. Kass. Senator, I am glad for the opportunity to 
respond, if I might.
    Look, I do not think I take second place in the concern for 
the needs of suffering humanity. I trained as a physician. I 
also have personal reasons--I will not recite the details--but 
most of these dread diseases that are talked about have been in 
my family, are in my family. I know about them.
    But there are--first of all, one runs a terrible risk of 
cruelly exploiting the needs and wishes of patients with the 
promise that the cures are just around the corner. We do not 
know--I grant you, we do not know which line of research is 
going to produce which benefits for which diseases. And I think 
that a fair-minded person will say not just adult stem cells, 
but embryonic stem cells should be tried. I am in favor of 
that.
    Senator Wyden. OK.
    Dr. Kass. But--but, we will also set certain kinds of 
limits around things that, if we release those limits, lives 
would be saved. We do not allow the buying and selling of 
organs for transplantation, even though lives might be saved if 
we allowed that to open up.
    Similarly, it seems to me--look, we have the example of 
other kinds of countries. They are going ahead with embryonic 
stem cell research, they are going ahead with adult stem cell 
research. But they, for their own good reasons--and the 
European Parliament, by a huge margin--called for a ban on all 
human cloning. Cloning.
    The chances that you are going to get something out of the 
cloned embryos for research, as opposed to ordinary embryos for 
research, that is going to help these people I think are very 
small--show me the data first. It is going to be decades before 
you will have any, if at all.
    Senator Wyden. One last question. I appreciate the 
Chairman's indulgence.
    Again, with so much of this having parallels to debates we 
had years ago, I am curious about the differences you see 
between this and IVF, the in vitro research in the 1970's. In 
the New England Journal of Medicine article back in the 1970's, 
you talked at that time about how there is no ethical way to 
proceed with in vitro fertilization research. But, to your 
credit, you did not call for a ban on all governmental 
research. You said, ``Let's have the profession do internal 
oversight and scrutiny''--intraprofessional scrutiny, as you 
called it. And of course, there have been enormous gains, 
several hundred thousand babies born in the United States. 
Parents who carry genetic diseases are better able to avoid 
passing it along to their children.
    Given the fact that we were careful then not to ban that 
research--why would we not say the same thing now with respect 
to therapeutic research that I and others want to do? What is 
different?
    We have almost exactly the same concerns. We are in 
agreement that there are certainly potentials for abuse, in 
terms of the most egregious cases, human cloning. There is 
tremendous unanimity in the Congress on human cloning and the 
potential abuse. What is different now that requires this 
outright ban that is different from what we faced in the 
1970's, when, to your credit, you and other leaders, 
recognizing there was potential, said, ``Let's make sure 
there's vigorous oversight,'' but did not ban it by government?
    Dr. Kass. I think the difference, Senator--there are a 
number of differences. I am not sure I can collect them all 
here. And I--you know, with permission, if--when I formulate my 
thoughts----
    Senator Wyden. Of course.
    Dr. Kass.--more carefully, I will send them in. But a 
couple of differences are striking.
    Nobody knew before the first in vitro experiments were done 
whether that was going to be safe or not. And only recently are 
we beginning, in fact, to discover that maybe there are certain 
problems after hundreds of thousands of babies born. But the 
difference is, as I indicated, there, the child that is 
produced and the research that was taking place, although it 
paved the way for this--and in my early writings, one of the 
reasons I worried about that was that it was going to lead us 
down the road in the direction of ever-greater intervention, 
ever-greater genetic manipulation and the like--the difference 
there is that you are mixing an egg and a sperm, and the 
product is a product of chance.
    Here, you have got the deliberate genetic manipulation and 
the creation of an embryo that is a genetic copy of another 
one. We are now crossing a border, both in the direction of 
cloning children as well as acquiring the technologies to 
intervene, to exercise growing genetic control over the next 
generation. That is different.
    As long as you have got a--as long as you are mixing egg 
and sperm, it is out of the body, but it is still sex. Here, 
you have got intervention into the genotype, and that is a 
major watershed, and we should not cross it doing business as 
usual. If we are going to cross it, it should only be after 
there are powerful reasons which say we must cross it.
    It is not enough in something like this to say ``it could 
cure something.'' This is a major watershed. This is a major 
watershed. And the burden of proof, it seems to me, lies on 
those who say we should abandon our restrictions at this point. 
Show us why it is necessary, rather than say, ``Why not?''
    Now, scientists do not like any restrictions. And it is 
dangerous to interfere with basic research. But this is not 
just basic research; this is an action.
    Senator Brownback. And if we could move onto the next panel 
so we can wrap up.
    Dr. Kass, thank you very much----
    Dr. Kass. Thank you very much.
    Senator Brownback.--for your very clear testimony and 
service to the country. Appreciate it.
    The final panel will be Dr. Anton-Lewis Usala, who is the 
medical and administrative director, Office of Regulatory 
Review of Clinical Trials, East Carolina University, and also 
serves as CEO and CSO of Ectosella, Incorporated; and Ms. Kris 
Gulden, who is a member of the Alexandria Virginia Police 
Department and received several awards for her law enforcement 
work. In addition, she won the Women's Triathlon Gold Medal in 
August 1996 at the Biennial Police Olympics in Salt Lake City. 
She was paralyzed after her bicycle was tragically struck from 
behind by a motor vehicle, leaving her with severe spinal cord 
injury. And both of these individuals are with us today to be 
able to testify and illuminate us on the issue of human 
cloning.
    Dr. Usala, thank you very much. You are first up. And 
please give us your testimony.
    Dr. Usala. I am going to see if we can get the PowerPoint 
presentation to actually work, Senator.
    Senator Brownback. All right.
    (Pause.)
    Senator Brownback. If you need to move that so you can see 
it, that would be just fine. If it is going to take you some 
time, we could go to Ms. Gulden's----
    Dr. Usala. That would be great.
    Senator Brownback.--testimony. Would you mind going ahead 
of Dr. Usala?
    Ms. Gulden. Not at all.
    Senator Brownback. That would facilitate him.
    Ms. Gulden, thank you very much for joining us here today.

          STATEMENT OF KRIS GULDEN, COALITION FOR THE 
                ADVANCEMENT OF MEDICAL RESEARCH

    Ms. Gulden. Thank you, Senator Brownback.
    I would like to testify this afternoon about the issue of 
somatic cell nuclear transfer, commonly referred to as 
``therapeutic cloning.'' My name is Kris Gulden, and I'm here 
on behalf of the Coalition for the Advancement of Medical 
Research.
    The coalition is composed of more than 75 patient 
organizations, universities, scientific societies, foundations, 
and other entities advocating for the advancement of 
breakthrough research and technologies in the field of 
regenerative medicine. The goal, of course, is to cure disease 
and alleviate human suffering. Today, I consider myself the 
voice of hope for the millions of Americans who may benefit 
from this research.
    Along with the Coalition for the Advancement of Medical 
Research, the National Academies of Science, 41 Nobel 
laureates, and the vast majority of the American public, I 
support a ban on human reproductive cloning. However, it is 
important that we protect important areas of medical research 
that offer hope to so many of our citizens.
    As a person living with paralysis caused by a spinal cord 
injury, I know how urgently a cure is needed. I do not expect a 
cure tomorrow or even next year. But we may have before us our 
greatest chance to cure diseases like ALS, Alzheimer's, 
Parkinson's, cancer, diabetes, and even paralysis resulting 
from spinal cord injury.
    Everything about my life changed on May 26th, 1998, when I 
began a bicycle ride that I never completed. I started my ride 
as a 31-year-old triathlete. I was employed as a police officer 
in Alexandria, Virginia. I had been on my bike for an hour when 
I was struck from behind by a motor vehicle. In addition to a 
traumatic brain injury and numerous broken bones, I bruised and 
displaced my spinal cord at the T4 level.
    As a result of that accident, I have been forced to 
surrender my career as a public servant, robbed of the hobbies 
that sustained me, and left unable to perform some of the daily 
personal freedoms that able-bodied people take for granted. It 
should not be difficult to understand why I feel so 
passionately about furthering research into nuclear 
transplantation, a technique that has been called ``the most 
promising advance in the history of medicine.''
    Within a few months of my injury, I had regained enough 
strength in my legs that I was able to walk with a rolling 
walker. However, a rare complication of a spinal cord injury, a 
disease called syringomyelia, has caused me to lose 
considerable function. I have not, though, lost hope. I ride a 
stationary bike that uses electrical stimulation to power my 
leg muscles 3 days a week for an hour at a time. I take 
therapeutic horseback-riding lessons, use a Nordic-Track-like 
device for standing and additional aerobic exercise, and I 
spend a month in Miami each year going through biofeedback 
training. The biofeedback shows that my brain is sending 
signals out to my leg muscles. This is evidence that my spinal 
cord is still healing.
    I am doing my part, even 5 years post-injury, to maximize 
my potential for a return of function. But I cannot do it 
alone. With help from medical researchers who are exploring new 
technologies, there exists a possibility that I will not be 
forever reliant on this wheelchair.
    I understand that the word ``cloning'' causes many people 
to imagine the worst-possible abuses. But there is a critical 
difference between cloning to make a baby, reproductive 
cloning, and therapeutic cloning techniques to create stem 
cells. While I am not a scientist, I am aware of the process of 
therapeutic cloning.
    Dr. Joanne Baufman, executive vice president of the 
American Society for Human Genetics, is with us today and will 
answer questions pertaining to the science.
    As a layperson, though, I find it unconscionable that the 
U.S. Congress would choose to prohibit this research knowing 
that it could lead to cures and therapies for many devastating 
diseases and disabilities.
    I recognize that no area of research, be it adult stem 
cells, embryonic stem cells, or nuclear transplantation, comes 
with a guarantee. But they should all continue.
    Although I did not include this in my written testimony, I 
would like to remind you that on September 25th, 2002, at a 
Senate Labor, Health and Human Services, Education, and Related 
Agencies hearing, Dr. Elliott Sarahuni, director of the 
National Institutes of Health, said, quote, ``NIH continues to 
believe that research on both embryonic stem cells and adult 
stem cells must be pursued simultaneously in order to learn as 
much as possible about the potential of these cells to treat 
human disease,'' end of quote.
    To me, the creation of embryonic stem cells through nuclear 
transplantation is a reasonable step in the quest to free 
people from the inescapable medical conditions with which they 
live. For me, the only escape from paralysis occurs when I 
dream. In my dreams, I still walk, I run, I play basketball, 
and I wear the uniform of the Alexandria Police Department. 
When the sun rises each morning, it brings reality with it. I 
rise to the sight of a wheelchair. Yet I rise with the hope 
that maybe this will be the morning I can move my legs.
    On behalf of the Coalition for the Advancement of Medical 
Research, the countless Americans who stand to benefit from 
therapeutic cloning, and the friends and family members who 
love them, I am asking you to please carefully consider our 
futures as you deliberate this issue.
    Thank you very much.
    [The prepared statement of Ms. Gulden follows:]

         Prepared Statement of Kris Gulden, Coalition for the 
                    Advancement of Medical Research

    Good afternoon Senator Brownback and Members of the Committee. 
Thank you for the opportunity to testify today on the value of somatic 
cell nuclear transfer (SCNT), commonly referred to as therapeutic 
cloning. My name is Kris Gulden, and I am here on behalf of the 
Coalition for the Advancement of Medical Research. \1\ The Coalition is 
comprised of more than 75 patient organizations, universities, 
scientific societies, foundations, and other entities advocating for 
the advancement of breakthrough research and technologies in 
regenerative medicine in order to cure disease and alleviate suffering. 
Today, I consider myself the voice of hope for the millions of 
Americans who may benefit from therapeutic cloning.
---------------------------------------------------------------------------
    \1\ The Coalition is comprised of nationally-recognized patient 
organizations, universities, scientific societies, foundations, and 
individuals with life-threatening illnesses and disorders, advocating 
for the advancement of breakthrough research and technologies in 
regenerative medicine--including stem cell research and somatic cell 
nuclear transfer--in order to cure disease and alleviate suffering.
---------------------------------------------------------------------------
    Along with the Coalition for the Advancement of Medical Research, 
the National Academies of Science, 41 Nobel laureates, and the vast 
majority of the American public, I support a ban on human reproductive 
cloning. However, it is imperative that we protect important areas of 
medical research that offer hope to so many of our citizens. As a 
person living with paralysis caused by a spinal cord injury, I know how 
urgently a cure is needed. I do not expect a cure tomorrow, or even 
next year, but we may have before us our greatest chance to cure 
diseases like ALS, Alzheimer's, Parkinson's, cancer, diabetes, and even 
paralysis resulting from spinal cord injury. I do not intend to 
overstate the promise of the research, but you can't overstate the hope 
that it offers people like me.
    Everything about my life changed on May 26, 1998, when I began a 
bicycle ride that I never completed. I started my ride as a 31 year-old 
triathlete. I was employed as a police officer in Alexandria, Virginia. 
I'd been on my bike for an hour when I was struck from behind by a 
motor vehicle. In addition to a traumatic brain injury, four broken 
vertebrae, two broken ribs, a broken breastbone and clavicle, I bruised 
and displaced my spinal cord at the T4 level. As a result of that 
accident, I have been forced to surrender my career as a public 
servant, robbed of the hobbies that sustained me, and left unable to 
perform some of the daily, personal freedoms that able-bodied people 
take for granted. It should not be difficult to understand why I feel 
so passionately about furthering research into nuclear 
transplantation--a technique that has been called the most promising 
advance in the history of medicine.
    Within a few months of my injury, I began to follow research that 
was being conducted at the Miami Project to Cure Paralysis. At about 
the same time, I was experiencing tremendous healing and discovered 
that I could move my legs. I rapidly progressed to walking with the 
rolling walker. However, a rare complication of a spinal cord injury--a 
disease called syringomyelia, has caused me to lose considerable 
function. I have not, though, lost hope.
    I ride a stationary bike that uses electrical stimulation to power 
my legs three days a week, for an hour at a time. I take therapeutic 
horseback riding lessons, use a Nordic track--like device for standing 
and additional aerobic exercise, and I spend a month each year doing 
biofeedback in Miami. The biofeedback shows that my brain is sending 
signals out to my leg muscles. My spinal cord is still healing. My 
commitment to getting out of this wheelchair is unwavering. I am doing 
my part--even five years post-injury, to maximize my potential for 
return of function. But I can't do it alone. I need medical researchers 
to continue exploring new technologies that could forever rid me of my 
wheelchair.
    Five years ago, I was excited when I learned about the restorative 
potential of Schwann cells that were being studied in Miami. When stem 
cells were isolated--especially embryonic stem cells, I became even 
more convinced that there would be a medical breakthrough to help me 
reclaim the life I left behind. Now we're talking about nuclear 
transplantation--a technique to create embryonic stem cells that could 
be used to treat a myriad of diseases and disabilities. With each 
additional discovery, my hopes soar. In the five years since my injury, 
I've come to accept that scientists are making progress, and that the 
question of a cure is no longer a matter of ``if'', but ``when''.
    I understand that the word ``cloning'' causes many people to 
imagine the worst possible abuses. But there is a critical difference 
between cloning to produce a baby--reproductive cloning--and 
therapeutic cloning techniques to create stem cells. While I am not a 
scientist, I am aware of the process of therapeutic cloning. It is 
unconscionable to me that the United States Congress would choose to 
prohibit research that could lead to cures and treatments for many 
devastating diseases and disabilities.
    I recognize that none of these areas of research--adult stem cells, 
embryonic stem cells, and nuclear transplantation--comes with a 
guarantee, but they should all continue. I also understand that the 
limited potential of adult stem cells makes working with embryonic stem 
cells preferable. One may argue that there are already existing lines 
of embryonic stem cells available for research. But that number is 
dwindling. The creation of embryonic stem cells through nuclear 
transplantation seems to me a reasonable step in the quest to free 
people from the inescapable medical conditions with which they live.
    For me, the only escape from paralysis is to dream. In my dreams, I 
still walk. I run, I play basketball, and I wear the uniform of the 
Alexandria Police Department. When the sun rises each morning, it 
brings reality with it. I rise to the sight of a wheelchair, yet I rise 
with the hope that maybe this will be the morning I can move my legs.
    Please don't take away the hope of countless Americans who could 
benefit from therapeutic cloning and the family members and friends who 
love them and care for them. On behalf of the Coalition for the 
Advancement of Medical Research I again thank the Committee for its 
deliberations and for the opportunity to speak to this issue.

    Senator Brownback. Thank you very much, and thank you for 
your powerful and passionate testimony.
    Dr. Usala, are we ready to go?
    Dr. Usala. We are up and going, Senator, thank you.
    Senator Brownback. Thank you.

        STATEMENT OF DR. ANTON-LEWIS USALA, MEDICAL AND 
         ADMINISTRATIVE DIRECTOR, OFFICE OF REGULATORY 
      REVIEW OF CLINICAL TRIALS, EAST CAROLINA UNIVERSITY

    Dr. Usala. Destruction of specific cells results in many 
chronic disease states, such as type-one diabetes, Parkinson's 
Disease, and spinal cord injury. Replacement of these tissues 
with replacement of their specific function would provide an 
effective cure for the diseased state.
    Two theories to replace damaged tissue involve the use of 
transplanted human embryonic tissues or tissues derived from 
cloned individuals. Tissues obtained from donor human embryos 
have different DNA than the recipient patient and will, thus be 
rejected as foreign material by the patient; while tissue 
obtained from cloned human embryos have the same DNA as the 
patient and, thus, would theoretically have fewer rejection 
problems. Neither of these human embryonic tissue sources are 
able to form effective communication with the recipient's 
existing tissue. Without such connections, the transplanted 
tissue will not be functional.
    No large-animal studies have successfully demonstrated 
functional recovery from embryonic stem cell transplantation 
experiments, although many successful experiments have been 
published utilizing the patient's own adult stem cells.
    Cellular transplantation material obtained from developing 
embryos must overcome the problem of appropriate integration 
into the transplant site in order to replace the function of 
the destroyed tissue. Scientifically, it may make more sense to 
induce the patient's own tissues to replicate at the desired 
sites. If the patient's own tissue could be induced to 
regenerate at the desired site of injury, the communication and 
integration networks are already in place.
    I would like to share with the Committee the preliminary 
results of a product I developed to induce regeneration of a 
specific kind of tissue in animal and human patients. My 
hypothesis was that exposing the cells to an environmental 
structure similar to that present during natural embryogenesis 
might induce the patient's cells to behave as they did during 
embryogenesis and thereby induce explosive generation of 
tissue.
    This artificial embryonic scaffolding was made from 
modified naturally occurring compounds synthetically 
polymerized to give the desired structure. This product 
contained no cells--no adult stem cells, no embryonic stem 
cells, no cloned cells--only structures for the patient's own 
cells to bind to at the damaged site.
    The results I am about to show have been presented at 
several scientific meetings and have recently been submitted to 
a peer-review journal.
    Shown is an example of the rapid wound-healing induced in a 
dog that had naturally occurring diabetes and developed 
multiple full-thickness skin ulcers, as are seen in patients 
with diabetes. The dog had undergone multiple courses of 
antibiotics and surgical closure procedures, but the ulcers 
would not heal because of the chronic destruction of blood 
vessels commonly seen with longstanding diabetes.
    After a one-time injection of the artificial embryonic 
scaffolding, the dog's wounds healed with regenerated tissue. 
And what we did was, we injected around the periphery of the 
ulcer, as seen on the left, and through the center. And what 
you see is, within 6 days we had total closure with newly 
generated skin, newly generated blood vessels.
    The new tissue resulting from exposure to the embryonic-
like matrix was determined to be structurally identical to non-
wounded areas. And those studies were performed at the request 
of the Food and Drug Administration.
    Further large and small animal studies confirmed our 
finding, and a six-patient feasibility study was reviewed by 
the Food and Drug Administration to examine the effect of a 
one-time injection in patients with chronic diabetic foot 
ulcers which did not respond to any conventional or to any 
other experimental therapy.
    Shown here is the heel of a patient with 20 years of 
longstanding diabetes. This man had a ulcer that was refractory 
to all kinds of therapy for 4 years. Every 2 weeks, he went to 
the University of North Carolina's Wound Healing Center and had 
appropriate treatment applied. He was not able to heal this 
wound because his blood vessels had degenerated around it. As 
with the dog, what we did was, we injected around the periphery 
and then through the center of the lesion. This allows the 
artificial scaffolding we developed to bind to the patient's 
own tissues.
    Now, remember, what we were trying to do was provide an 
embryonic environment that would induce the same kind of 
generation that occurs during embryogenesis. There were no 
cells involved at all.
    This is study-day one. Here we are a week later. This is 
very, very exciting to the patient, obviously. What you see 
there is the very fine, delicate, gelatinous-almost-like tissue 
that you see during fetal development. The blood that you see 
is the result of the surgical debridement procedure where the 
surgeon poked the tissue and blood spurted out, indicating that 
new blood vessels had explosively regenerated as they do during 
embryogenesis.
    This is 14 days out. Remember, this wound was here for 4 
years. Here, it is closed. And again, you are starting to see 
now the generation of all the appropriate structures.
    A month out, you start to see the epidermis, the outer 
layer of the skin, growing. This is 2 months later, and this is 
3 months later. Three months after this photo was taken, the 
patient who was not able to walk for 4 years, danced at his 
daughter's wedding.
    Senator Brownback. Here, here.
    Dr. Usala. Transplantation strategies, whether derived from 
foreign donors or cloned cells from the patients themselves, 
are clearly not the only approach to replace damaged tissues. 
Other avenues are further along in clinical trials. The results 
that I showed you were obtained with my first biotech company, 
which I am no longer with and own less than .1 percent of the 
company's stock. I have no financial interest in showing this 
to the Committee. We did this study on six patients, and I 
understand that the company is now engaged with a large 
pharmaceutical company to do the next phase of testing.
    While other avenues are further along in clinical trials, 
it should be considered as a first approach for study that does 
not use human embryonic or cloned cells. Indeed, the patient's 
existing cells provide the most rational source for fully 
integrating replacement tissues, as occurred during all of our 
own embryogenesis.
    Thank you.
    [The prepared statement of Dr. Usala follows:]

Prepared Statement of Dr. Anton-Lewis Usala, Medical and Administrative 
Director, Office of Regulatory Review of Clinical Trials, East Carolina 
                               University

    Chronic disease states such as Type 1 Diabetes, Parkinson's 
Disease, and Spinal Cord Injury result from the destruction of specific 
cells. Replacement of these tissues may provide immense relief, and 
possibly cure, of the disease.
    One approach to replace these tissues is to find acceptable 
transplantation sources and implant donor cells into a patient. If 
these cells are derived from a source other than the patient, there 
will be problems with rejecting the ``foreign'' transplant material. 
Cloned patient cells (cells that are induced to replicate with the same 
DNA template as the patient) do not have many of foreign markers and 
theoretically would not be rejected. However, cloning by the transfer 
of somatic nuclei into unfertilized eggs requires a dramatic remodeling 
of chromosomal architecture. Many proteins are specifically lost from 
nuclei and others are taken up from the egg cytoplasm. These proteins 
determine which DNA genes are promoted and expressed, and which DNA 
genes are repressed.
    The specialization of cells for specific function occurs during 
embryogenesis, fetal development, and continues throughout adult life. 
The microenvironment that developing cells are exposed to plays a major 
role in determining which factors of the DNA are expressed, and which 
factors are not expressed. We all have met identical twins, which have 
the same DNA template, but have quite different personalities and even 
different physical appearances. These differences are largely 
determined by differences in environment that the differentiating cells 
are exposed.
    Since cellular transplant material obtained from developing embryos 
must overcome the problem of appropriate integration into the 
transplant site in order to replace the function of the destroyed 
tissue, scientifically it may make more sense to induce the patient's 
own tissues to replicate at the desired site. If the patient's own 
tissue could be induced to regenerate at the desired site of injury, 
the communication and integration networks are mostly in place. 
Embryonic stem cell transplantation has repeatedly been shown to be 
ineffective in large animal models largely because they are not capable 
of integrating into mature host structures. Even if the stem cells are 
obtained from cloned embryos, and subsequently are not rejected on the 
basis of major immunologic compatibility, the transplanted stem cells 
are still not capable of forming the complex integrative network that 
many structures require.
    The developing embryo is surrounded by unique proteins and 
environmental factors. Once the embryo reaches a more mature fetal 
stage, the cells are surrounded by more mature proteins and growth 
factors, leading to more highly differentiated cell functions. 
Throughout this process, the DNA template that codes for the expression 
of all cell functions remains the same. One hypothesis states that if 
the correct embryonic environment could be duplicated, a patient's 
cells may be able to be induced to regenerate in a given site, as they 
rapidly did earlier in the patient's life during embryogenesis. This 
would result in totally compatible, integrated, replacement tissue for 
the disease being treated.
    I would like to share with the Committee the preliminary results of 
a product I developed to induce regeneration of a specific kind of 
tissue in animal and human patients. My hypothesis was that exposing 
cells derived from a specific embryonic germ layer (the mesoderm) to an 
environmental structure similar to that present during natural 
embryogenesis, might induce the patient cells to behave as they did 
during embryogenesis, and induce explosive generation of tissue. 
Mesodermally derived cells give rise to such differentiated structures 
as blood vessels, deep skin structures, bone and cartilage. The 
artificial embryonic scaffolding I invented was made from modified long 
chain, naturally occurring coumpounds that were synthetically 
polymerized to give the desired structure. This embryonic scaffolding 
contained no cells, only structures for the patient's cells to bind to. 
If the hypothesis were correct, after exposing the patient's damaged 
tissue to this synthetic biopolymer, the patient's tissues should be 
induced to rapidly regenerate according to the direction of the 
patient's own DNA template.
    The results I am about to show have been presented at several 
scientific meetings, and have recently been submitted for review in a 
peer reviewed journal. Shown is an example of the rapid wound healing 
induced in a dog that had naturally occurring diabetes and developed 
multiple full thickness skin ulcers. The dog had undergone multiple 
courses of antibiotics and surgical closure procedures, but the ulcers 
would not heal because of the chronic destruction of blood vessels 
commonly seen with long standing diabetes. After a one-time injection 
of the artificial embryonic scaffolding, the dog's wound's healed with 
regenerated tissue. The new tissue resulting from exposure to the 
embryonic like matrix was determined to be structurally identical to 
non-wounded areas, without the usual scarring that is normally seen 
with healing lesions. Further large and small animal studies confirmed 
our finding, and a six patient feasibility study was reviewed by the 
Food and Drug Administration to examine the effect of a one-time 
injection in patients with chronic diabetic foot ulcers refractory to 
conventional therapy.
    Within days of a one-time injection, all the patients experienced 
rapid diminution of ulcer size, with apparent regeneration of skin, 
blood vessels, and surrounding structures. Since the new tissue derived 
from the patients' own tissue, there was seamless integration with no 
evidence of rejection. Further study is required to determine if this 
particular product is safe and effective, but clearly the large animal 
and human patient studies suggest cellular transplantation is not 
necessarily required to replace damaged tissue.
    Destroying a human embryo to obtain cellular material does in fact 
destroy a human life, not a potential human life. Shortly after 
conception, a human being has a DNA template from which ALL other cells 
are generated. The process by which cells become specialized is called 
differentiation. A differentiated heart cell has the same DNA template 
as a differentiated skin cell, and they both have the same DNA template 
as the undifferentiated cells early in embryogenesis.
    The mass of cells that begins this replication and differentiation, 
either shortly after conception or induction through nuclear transfer, 
defines the beginning of any mammal's life. This differentiation 
process continues until death. The continuum of human life thus starts 
at the beginning of the complex, explosive process of cellular DNA 
differentiation during embryogenesis and ends at death. One cannot stop 
the continuum at any one point and say it is not human life because it 
lacks the ability to do certain functions. When the mass of cells has 
feelings or reason is subject to debate. When it begins as human life 
is a biologic fact.
    All laws are based on precedent. The difference between a just and 
an unjust society is the precedent the society accepts to base its 
jurisprudence upon. In my view, the United States is a uniquely just 
society because it is the first government in the history of humankind 
in which the right of the individual supersedes the perceived right of 
the state, thus defining the individual as society's most valued 
entity. The first ten amendments to our constitution explicitly 
prevents government, even if so desired by the majority, from violating 
these individual rights. As a developing embryo, whether cloned or 
naturally created, is scientifically a human being, the United States 
must not set the precedent of allowing individuals to be sacrificed for 
the illusion of a greater good.
    Transplantation strategies, whether derived from foreign donors or 
cloned cells from the patient themselves, are clearly not the only 
approach to replace damaged tissues. Other avenues are further along in 
clinical trials, and should be considered as a first approach for 
study. Indeed, the patient's existing cells provide the most rationale 
source for fully integrating replacement tissues, as occurred during 
embryogenesis.

REFERENCES
    Usala AL. Methods for increasing vascularization and promoting 
wound healing. US Patent #6,261,387; issued July 17, 2001.
    Hansen M, Kurinczuk JJ, Bower C, and Webb S: The risk of major 
birth defects after intracytoplasmic sperm injection and in vitro 
fertilization. N Engl J Med. 2002 Mar 7;346(10):725-30.
    Hill RS, Klann RC, Lloyd WH, Lacy SA, Pitts JD, Penland SL, Dudek 
R, Marston W, Usala AL: Improved wound healing of diabetic foot ulcers 
following treatment with a novel biopolymer. Abstract submitted to the 
ADA Annual Meeting, 2002.
    Kikyo N, Wade PA, Gushin D, Ge H, and Wolffe AP: Active remodeling 
of somatic nuclei in egg cytoplasm by the nucleosomal ATPase 
ISWI.Science. 2000 Sep 29;289(5488):2360-2.
    Usala AL, Klann R, Bradfield J, Ray S et al: Rapid Induction of 
Vasculogenesis and Wound Healing Using a Novel Injectable Connective 
Tissue Matrix. Diabetes 49 (Supplement 1): Abstract 1664 PO, 2000.
    Usala AL, Dudek R, Lacy S, Olson J, Penland S, Sutton J, Ziats NP, 
Hill RS: Induction of Fetal-Like Wound Repair Mechanisms In Vivo with a 
Novel Matrix Scaffolding. Diabetes 50:(Supplement 2)A488, #2048-PO, 
2001.
    Usala AL. On the Horizon: Current Research into Advanced Therapies 
for the Diabetic Foot Ulcer. Wound Management Symposium 2000, UNC 
Chapel Hill School of Medicine, Chapel Hill, NC, September 22, 2000.
    Usala AL. Current Research and Future Products. Wound Management 
Symposium 2001, UNC Chapel Hill School of Medicine, Chapel Hill, NC, 
September 29, 2001.

    Senator Brownback. Thank you very much. That's exciting to 
see.
    Ms. Gulden, I think you have testified before at the Labor 
Subcommittee on Appropriations, Appropriations Subcommittee.
    Ms. Gulden. It was the Judiciary Committee.
    Senator Brownback. The Judiciary? Good. I remember hearing 
you testify at another place, and I was not quite sure where. 
It is good to see you again.
    Ms. Gulden. Thank you.
    Senator Brownback. The groups--the patient groups that you 
work with, have they stated a date that they would like to see 
the clone--or the somatic cell nuclear transfer, being, however 
you would want to refer to it--live up until before it would be 
destroyed? You mentioned you represent a number of different 
patient groups. Have they identified a date by which they would 
not want it to live any longer than?
    Ms. Gulden. My understanding is that the five-to-seven-day 
period is what is practiced. I have not heard anything 
officially from CAMR, though.
    Senator Brownback. They have not taken an official position 
that, OK, we want to--when we create this--I realize we have 
a--differences of terminology, but we want to create a clone or 
an entity, and we want it to live for a certain period of time 
to be able to then harvest the stem cells that are there? But 
is the period of time in the five to 7 days, are they set firm 
on that, or is there----
    Ms. Gulden. My understanding is five to 7 days is their 
position.
    Senator Brownback. OK. You heard the testimony earlier 
about--that if this happens, and--but it turns out that you 
could get differentiated cells by letting the entity--the 
clone--the somatic cell nuclear transfer body, whatever you 
want to refer to it as--live for a longer period of time, or 
you could get the differentiated cells that may be more useful, 
how do you--how do you react to that sort of statement, that if 
you do not--if you can say five to 7 days, what is to keep you 
from going to 14 days or to 21 days or to 35 days, if it turns 
out that would be a more useful body of cells?
    Ms. Gulden. How do I respond, personally, to that?
    Senator Brownback. Yes.
    Ms. Gulden. I think that the sooner you can get them, that 
is--you know, I am more comfortable with cells coming out 
sooner rather than later.
    Senator Brownback. Would you have any objection if it were 
later if it proved that it could be valuable usefulness for the 
cells, if it could be more useful in research?
    Ms. Gulden. At this point, when the cells are useful is 
when I would like to see them come out. And that, to me--it 
would be preferable for them to come out sooner rather than 
later.
    Senator Brownback. But you do not have a firm number of 
saying there is something special about five to 7 days--the 
groups do not have anything firm about what is special about 
the five-to-seven-day time period?
    Ms. Gulden. Not that I am aware of.
    Senator Brownback. OK. I mean, that--that has a part of the 
issue. I think you have--as you have heard the other 
testimony--you were very good at being patient about being here 
for it--but that we wanted to--people were curious, ``Well, 
what's magical in the five-to-seven-day time period?'' But--and 
I think that is, you know, a point that there is some concern 
about, that that could slip to a further period of time.
    Ms. Gulden. Dr. Baufman might be able to better explain the 
five-to-seven-day period, or whatever that time window is.
    Senator Brownback. OK.
    Dr. Usala, let me refer to your testimony. And this is work 
that you have done. You keep referring to an ``embryonic 
matrix,'' but you did not use embryonic stem cells, is that 
correct--in doing this?
    Dr. Usala. That is correct, Senator. Basically, it was some 
long-chain proteins that I derived from skin taken from pigs 
and polymerized that with some other long-chain compounds to 
try to replicate the molecular structure of certain 
scaffoldings that are present during the time of embryogenesis.
    Senator Brownback. And you were able to get, then, that 
structuring to take place to heal these gaping ulcerated type 
of wounds.
    Dr. Usala. Yes, Senator, that is correct.
    Senator Brownback. And the point being that you do not have 
use embryonic stem cells to get the body to react in a way to 
build an embryonic-type of growth medium and structure, then.
    Dr. Usala. Right. I think the idea of taking something that 
is less differentiating and putting it into a patient and 
thereby hoping that it will assume the properties of the tissue 
that you are trying to replicate has been shown to be naive.
    As was mentioned earlier, the--taking of fetal tissue, 
which--I remember in the late 1980's and early 1990's--I have 
had type-one diabetes since I was a year old, and I remember 
all of these things--they wanted to cure type-one diabetes by 
taking fetal pancreatic cells and implanting them into people, 
thereby thinking, because they were less differentiated, they 
would take better.
    I was involved with all kinds of transplantation 
experiments. And what we found was this, that when you take a 
cell out of its natural environment, whatever it is, and you 
put it someplace else, things happen. And what I mean by that 
is, the DNA in the nucleus is very much influenced by the 
environment. And so if you pluck it out of where it--that cell 
started to grow up, and put it in a different area, it does not 
make the connection it needs to be functional.
    Knowing that, what I did was, I made--I brought the 
mountain to Mohammed--what I did was, I brought the structural 
scaffolding that we all see during embryogenesis, and I put it 
in the patient's own tissues. The connections are already made. 
The environment calls for the tissue to become what is needed. 
And so, thereby, we have demonstrated, and I believe we are the 
only people that have thus far demonstrated, the ability to 
induce that kind of regeneration.
    There are such scientific hurdles involved with trying to 
make all of these billions of connections work just by taking 
something that is not differentiated. It is mind-boggling. It 
is easier to raise money that way at the NIH, because everybody 
knows there is a lot of work to be done, so it is easy to get 
20-, $30 million thrown at something if it holds great promise 
but there is not much data, because everybody understands a lot 
would be required.
    What I am suggesting is that there are many, many reasons 
why we should not be destroying a human life. And where I take 
exception with Senator Hatch and agree with Dr. Weldon, human 
life starts at conception. That is a scientific fact.
    Now, what I heard Senator Hatch saying was, you know, there 
may be philosophic and other ethical reasons to suggest that 
that is not worthy of the protections provided by the law, but 
human life does start when the differentiation process 
commences, when the sperm and the egg DNA merge. You cannot 
stop it at any point after that, because that differentiation 
and replication continues until you die.
    So I think that it is not wise for us to shake the 
foundation of the republic and, for a greater good, sacrifice 
individuals. That would be the first time in the history of the 
United States where the government chooses to sacrifice 
individuals for the benefit of someone else without that 
individual's consent.
    Senator Brownback. Ms. Gulden, if you wanted to solicit 
information from any of the people that you work with to 
clarify your answer earlier--I have got another question for 
Dr. Usala, but if you would like to get some information from 
them while I ask this, I would sure be happy to receive that.
    Ms. Gulden. Thanks.
    Senator Brownback. Well, thank you for being here.
    Dr. Usala, what happens when we focus our research--let us 
say we put millions of dollars into human cloning because it 
seems interesting. We might find something here, but then it 
does not go into places like the research you have shown us 
here or adult stem cells. There is a finite set of dollars. We 
all want to cure these diseases. I am sure, in your case, with 
diabetes, you wanted to see that cured in the most profound 
ways, as we all want to see these things cured. But what 
happens in the research community when we take off on areas 
that may have the--may have a general image to them, but that 
do not have the real data behind them to be able to produce 
results?
    Dr. Usala. It is like throwing a pebble in the water. What 
happens is that efforts, like my effort, which was funded 
almost entirely with private funds--that was funded by a 5-and-
a-half-million-dollar venture capital round. Why? Because this 
was an out-of-the-box kind of idea. It would have no chance at 
all of being funded by the NIH.
    What happens when we say, OK, this is an exciting 
proposition. Billions of dollars are invested in investigating 
it. Well, what the standard of the researcher is held to is--is 
not the production of a therapeutic entity. The standard is 
publishing papers. And I am absolutely certain many, many 
papers will be published with the research. But what will also 
happen is that people will have to--if they take a different 
route, will have to get the funding totally separately, from 
private sources, and demonstrate it in human beings before the 
rest of the scientific community will look at it. And that is, 
in fact, what happened here.
    It is not just that there is not enough money to fund all 
ideas like this. It seems that what would make the most sense--
if what the Congress is interested in is creating effective 
medical therapy, let us go with those things that are closer to 
being executed than--rather than a fishing expedition.
    So in addition to the money, it has to do with things like 
publication, it has to do with grant submissions to other non-
government sources. It has a profound effect on the conduct of 
research, in general.
    Senator Brownback. It is, to me, to try to go where you can 
be most productive in getting the yield of the cures that you 
are looking for on injuries, on ALS, all these particular 
areas.
    My time is up, but, Ms. Gulden, I would hope Senator 
Wyden--if you have explanation on that--the question I had, I 
would be happy to receive that.
    Ms. Gulden. Thanks. I hope this will clarify it.
    At--between the fifth and seventh day, there appears to be 
enough cells that cells can be extracted to create the stem 
cell lines. However, I understand there is other wording in the 
Senator Hatch bill. It says by 14 days, you either must 
implant, or the blastocyst will die. So five to 7 days is the 
period we tend to focus on, because that is when stem cells can 
be extracted and cell lines can be obtained.
    Senator Brownback. OK. So your distinction is based 
strictly upon the physiology of the actual cell, and it is not 
on any, ``We think there's an important developmental stage, 
that human life begins after 7 days,'' or anything of that 
nature. It is based upon the physiology of the clone or of the 
SCNT, as others would refer to it. Is that correct?
    Ms. Gulden. Before the differentiation begins.
    Senator Brownback. OK. If--and if you do not want to answer 
this, you do not have to, but I just--I want to try to get it 
from the patient advocacy groups--if it is shown that once 
differentiation takes place, you have more opportunities to get 
the type of replacement tissues, cells that you are looking at 
at the 14-day stage, rather than the five-to-seven, is your 
group supportive of that, or in opposition, or have they not 
taken any stand?
    Ms. Gulden. I will choose not to answer that.
    Senator Brownback. OK. All right. I just--I think it is an 
important issue for us to get at. And the more we go into this 
debate, I think we need to get to the sharpness of the point 
of, you know, what period of time are we talking about here of 
being able to let the clone grow to? Because I think that is 
going to be, I think, a very key issue as we get focused in 
more on--if we are going to have human cloning, we are going to 
do this research technology, how many days, and what is the 
ethical line as to why you would draw it, or what is the 
physiological line that you would draw, and why do you draw it 
there? And that is why I hope you would see this--and other 
people have problems with the whole issue, because some of 
these lines can shift pretty easy, based upon needs or desires 
and--but not--there is not a clear philosophical reason of why 
five to 7 days is any different than 14 or 30.
    Senator Wyden?
    Senator Wyden. Well, thank you, Mr. Chairman.
    And I want you to know, first, Ms. Gulden, I am going to do 
everything I can, as a United States senator, to not foreclose 
scientific options for progress and opportunity for people like 
yourself. I think that is what your government owes you.
    I appreciate the fact that you have come today, and you 
have made it clear you are not a scientist. We are going to 
have various kinds of complicated questions. We have talked 
about some of them here today. I think it would be especially 
sad if options were foreclosed here, in this country, and then 
similar cures were available overseas. What we would have said 
to our citizens here is that we did not make the effort. We did 
not try. And I am going to work with those who do not share my 
views to set in place the kind of rigorous safeguards, because 
I think that is important. And you have made it clear you 
support safeguards. We are going to do everything we can to 
find the cures, because there are too many people in this 
country suffering and hurting, and we owe it to them. So I 
thank you for coming.
    And I have just one question for you. What do you make of 
the--this change from so many of the influential sponsors, that 
they are now going to remove the ban on the importation of 
SCNT-derived technologies? To me, that is a clear admission 
that there is tremendous scientific progress here. What do you 
think?
    Ms. Gulden. I was not aware that that had been removed.
    Senator Wyden. Well, that is what is being discussed. What 
has been widely reported in the news media is that--at the 
request of the Senate Majority Leader, that would be removed by 
the sponsors. And perhaps you could get back to us when you 
have had a chance to reflect on it.
    But I think it is a major, a very significant, development. 
I think it undermines one of the basic propositions that 
supporters of the outright ban have been making. They have been 
saying it does not have great scientific promise, there are not 
great opportunities for breakthroughs, and yet they are willing 
to say that they will change their position on importation.
    So we will look forward--we will get your response in 
writing. And mostly thanks for coming. You are a powerful voice 
for making sure we are not foreclosing scientific options. We 
sure need that right now, and I thank you for it.
    I have one question, just for you, if I might, Dr. Usala, 
with respect to your research. And it is certainly interesting 
and important. My question would be, how effective would this 
kind of work be in conditions, various medical problems, such 
as genetic disorders, like Parkinson's or Alzheimer's?
    The reason I ask the question is, it would seem to me that, 
in one sense, you are, in effect, reintroducing the genetic 
disorder with regeneration. Is that an issue in your mind? And 
how would you react to that?
    Dr. Usala. There certainly would be some conditions, 
Senator, where you are absolutely right. Alzheimer's, 
Parkinson's are not two of them. All diseases probably have 
some genetic basis for predisposition. But, for instance, in 
diabetes, remember, before 1992, everybody at the NIH believed 
that the complications associated with diabetes were genetic 
and that blood-sugar control made no difference. And this was 
the cognoscenti of the medical/scientific community. And those 
that believed that blood-sugar control did make a difference 
were viewed as extremist and not quite right.
    Well, in 1992, after those extremists really pushed the 
issue, we found out that the extremists were right, and the NIH 
and the ADA, American Diabetes Association, were wrong, at the 
cost of hundreds of thousands of lives.
    My point here is that, for things like Alzheimer's, there 
are still tissues. If we took that person's brain tissue and 
replicated it from the--as it was during embryogenesis, you 
would still have another 60, 70 years of functional utility 
before the Alzheimer's again became a problem.
    So I do agree that in certain very aggressively lethal 
genetic problems, like Tay-Sachs Disease, this would not be of 
any help. But neither would therapeutic cloning or embryonic 
stem cell implantation.
    Senator Wyden. Mr. Chairman, I think this has been an 
important hearing. As I said, I guess, 2 hours ago, you and I 
are going to agree on plenty of issues in the course of this 
Subcommittee's work, and I think it is fair to say this is one 
where we do have differences, and we are going to talk about 
them in a reasonable fashion, without the decibel level 
breaking the building.
    But I will tell you and those who are here, I just hope we 
can find a way to make sure that we send the message to all of 
those families and all of those Americans who are suffering 
today that we are going to stand by them. We are going to pick 
up on the excellent ideas of Dr. Kass here, Senator Brownback, 
who is an authority on this subject, to make sure that every 
reasonable precaution is in place.
    But when we are dealing with heart disease and stroke and 
diabetes and Parkinson's and spinal cord injuries, let us do 
what those organizations, the letters of which I have put into 
the record, are urging, and that is--they are saying, ``Let us 
pursue the route of careful science, rather than putting up 
roadblocks of resistance.''
    And Sam, I thank you. I wish you well as you begin your 
service as Chairman of the Subcommittee. I wish I did not have 
to give it up, but I am looking forward to working with you.
    Senator Brownback. Thank you.
    And I want to thank the panel. And I also want to add my 
statements to what Senator Wyden was saying about our search 
and push for answers. I think we have got some great 
opportunities, and we are pushing them. I have supported 
strongly the doubling of the NIH budget, because I thought we 
had some great opportunities and still think we have got a 
number of them out there--very important to do.
    I do think, as well, you have to consider the dignity of 
each and every person. And we could learn a lot by 
researching--maybe even researching on me, you could learn 
something. I do not know, I may be too old and broken-down at 
this point to do that.
    But there is a dignity to each and every person, and I hope 
we never forget that, whether we agree or disagree on topics, 
that there is a great dignity to each and every person.
    I do want to answer, Senator Wyden, your comment about the 
change of the bill on the international issue. And that was 
raised a number of times last year, that people said, well, if 
you find a cure overseas, it comes here, you will get penalized 
for that. It is not because of any findings that we are finding 
anything of success in the cloning field. Far be it--actually, 
the research work is all what Dr. Weldon has said, we are not 
finding that, but to take away that area of argument, because 
our desire is not to limit--not to address things overseas; it 
is to address things in the United States. And so we put that 
change in the bill to say we are addressing what is going on in 
the United States, not what is going on in other places. That 
is where our legislation should focus, we hope.
    And there are ongoing international negotiations at the 
U.N. A number of countries, as Dr. Kass has pointed out, have 
already banned, totally, all forms of human cloning, because 
they see the route of where this is going to.
    But it was to raise that and deal with that argument that 
some had raised. It was not an admission that there is promise 
here, because we still have not seen that in animal models, and 
certainly not in humans.
    Thank you all. Excellent hearing, excellent panel. And we 
will have further discussions on the topic. The hearing is 
adjourned.
    [Whereupon, at 5 p.m., the hearing was adjourned.]

                                  
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