[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
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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.
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\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.
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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.
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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.
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\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.]