<DOC>
[108 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:89327.wais]
S. Hrg. 108-160
PROMOTING ETHICAL REGENERATIVE MEDICINE RESEARCH AND PROHIBITING
IMMORAL HUMAN REPRODUCTIVE CLONING
=======================================================================
HEARING
before the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
MARCH 19, 2003
__________
Serial No. J-108-7
__________
Printed for the use of the Committee on the Judiciary
89-327 U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2003
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COMMITTEE ON THE JUDICIARY
ORRIN G. HATCH, Utah, Chairman
CHARLES E. GRASSLEY, Iowa PATRICK J. LEAHY, Vermont
ARLEN SPECTER, Pennsylvania EDWARD M. KENNEDY, Massachusetts
JON KYL, Arizona JOSEPH R. BIDEN, Jr., Delaware
MIKE DeWINE, Ohio HERBERT KOHL, Wisconsin
JEFF SESSIONS, Alabama DIANNE FEINSTEIN, California
LINDSEY O. GRAHAM, South Carolina RUSSELL D. FEINGOLD, Wisconsin
LARRY E. CRAIG, Idaho CHARLES E. SCHUMER, New York
SAXBY CHAMBLISS, Georgia RICHARD J. DURBIN, Illinois
JOHN CORNYN, Texas JOHN EDWARDS, North Carolina
Makan Delrahim, Chief Counsel and Staff Director
Bruce A. Cohen, Democratic Chief Counsel and Staff Director
C O N T E N T S
----------
STATEMENTS OF COMMITTEE MEMBERS
Page
Craig, Hon. Larry E., a U.S. Senator from the State of Idaho..... 6
prepared statement........................................... 72
Feinstein, Hon. Dianne, a U.S. Senator from the State of
California..................................................... 4
prepared statement........................................... 76
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah...... 1
prepared statement........................................... 80
Kennedy, Hon. Edward M., a U.S. Senator from the State of
Massachusetts, prepared statement.............................. 101
Kyl, Hon. Jon, a U.S. Senator from the State of Arizona, prepared
statement...................................................... 102
Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont,
prepared statement............................................. 107
WITNESSES
Berg, Paul, Cahill Professor Emeritus of Cancer Research and
Biochemistry, Stanford University Medical Center and Chair,
Public Policy Committee, American Society for Cell Biology,
Palo Alto, California.......................................... 37
Brownback, Hon. Sam, a U.S. Senator from the State of Kansas..... 8
Kass, Leon, M.D., Hertog Fellow in Social Thought, American
Enterprise Institute, Washington, D.C.......................... 23
Kelly, James, Patient Advocate, Granbury, Texas.................. 15
Langevin, Hon. Jim R., a Representative in Congress from the
State of Rhode Island.......................................... 11
Mathews-Roth, Micheline M., M.D., Associate Professor of
Medicine, Harvard Medical School, Boston, Massachusetts........ 33
Murray, Thomas, President, Hastings Center, Garrison, New York... 25
Usala, Anton Lewis, M.D., Clinical Professor and Medical/
Administrative Director, Office for Regulatory Review of
Clinical Trials, East Carolina University, Greenville, North
Carolina....................................................... 31
Varmus, Harold, M.D., President Memorial Sloan-Kettering Cancer
Center, New York, New York..................................... 28
Wasson, Greg, Cotati, California................................. 17
SUBMISSIONS FOR THE RECORD
Alliance for Aging Research, Daniel Perry, Executive Director,
Washington, D.C., letter....................................... 54
Alpha-1 Foundation, John W. Walsh, President and CEO, Miami,
Florida and Alpha-1 Association, John P. Morton, Chair, Board
of Directors, Washington, D.C., joint letter and attachments... 55
American Association for Cancer Research, Margaret Foti, Chief
Executive Officer, Philadelphia, Pennsylvania, letter.......... 58
American Society of Hematology, Ronald Hoffman, M.D., President,
Washington, D.C., letter....................................... 59
Association of American Medical Colleges, Jordan J. Cohen, M.D.,
President, Washington, D.C., letter............................ 60
Association of Reproductive Health Professionals, Felicia H.
Stewart, M.D., Chair, Board of Directors and Wayne C. Shields,
President and CEO, Washington, D.C., letter.................... 61
Berg, Paul, Cahill Professor Emeritus of Cancer Research and
Biochemistry, Stanford University Medical Center and Chair,
Public Policy Committee, American Society for Cell Biology,
Palo Alto, California, prepared statement...................... 62
Bledsoe, Rev. Michael, Pastor, Riverside Baptist Church,
Washington, D.C., statement.................................... 69
Californians for Cure, Don C. Reed, Chair, Fremont, California,
letter......................................................... 70
Children's Neurobiological Solutions Foundation, Fia Richmond,
President, Santa Barbara, California, letter................... 71
Christopher Reeve Paralysis Foundation, Michael Manganiello,
Senior Vice President, Springfield, New Jersey, letter......... 74
Coalition for the Advancement of Medical Research, Michael
Manganiello, President, Washington, D.C., letter............... 75
Hadassah, Bonnie Lipton, National President, New York, New York,
letter......................................................... 79
International Myeloma Foundation, Susie Novis, President, North
Hollywood, California, letter.................................. 84
Kass, Leon, M.D., Hertog Fellow in Social Thought, American
Enterprise Institute, Washington, D.C., prepared statement..... 85
Kelly, James, Patient Advocate, Granbury, Texas, prepared
statement...................................................... 93
Mathews-Roth, Micheline M., M.D., Associate Professor of
Medicine, Harvard Medical School, Boston, Massachusetts,
prepared statement............................................. 108
Members of the religious community, February 5, 2003, joint
letter......................................................... 111
Murray, Thomas, Hastings Center, Garrison, New York, prepared
statement...................................................... 112
National Venture Capital Association, Mark G. Heesen, President,
Arlington, Virginia, letter.................................... 116
Rett Syndrome Research Foundation, Monica Coenraads, VP of
Research, Cincinnati, Ohio, letter............................. 117
Society for Women's Health Research, Roberta Biegel, Director of
Government Relations, Washington, D.C., letter................. 118
Steven and Michele Kirsch Foundation, Susan E. Frank, Director,
Public Policy, San Jose, California, letter.................... 119
Union of Orthodox Jewish Congregations of America and Rabbinical
Council of America, joint statement............................ 120
United Church of Christ, Justice and Witness Ministries, Pat
Conover, Legislative Director, Washington, D.C., letter........ 122
University of California, Richard C. Atkinson, President,
Oakland, California, letter.................................... 125
Usala, Anton-Lewis, M.D., Clinical Professor and Medical/
Administrative Director, Office for Regulatory Review of
Clinical Trials, East Carolina University, Greenville, North
Carolina, prepared statement................................... 127
Varmus, Harold, M.D., President, Memorial Sloan-Kettering Cancer
Center, New York, New York, prepared statement................. 131
Wasson, Greg, Cotati, California, prepared statement............. 139
Wiley, John D., Chancellor, University of Wisconsin-Madison,
Madison, Wisconsin, letter..................................... 146
PROMOTING ETHICAL REGENERATIVE MEDICINE RESEARCH AND PROHIBITING
IMMORAL HUMAN REPRODUCTIVE CLONING
----------
WEDNESDAY, MARCH 19, 2003
United States Senate,
Committee on the Judiciary,
Washington, D.C.
The Committee met, Pursuant to notice, at 10:34 a.m., in
room SD-226, Dirksen Senate Office Building, Hon. Orrin G.
Hatch, Chairman of the Committee, presiding.
Present: Senators Hatch, Craig, Cornyn, Feinstein, and
Durbin.
OPENING STATEMENT OF HON. ORRIN G. HATCH, A U.S. SENATOR FROM
THE STATE OF UTAH
Chairman Hatch. Good morning. Today, the Judiciary
Committee will explore whether and how it might be possible to
draw a line between promoting ethical stem cell research and
prohibiting immoral human reproductive cloning.
I am a cosponsor, along with Senators Feinstein, Specter,
Kennedy, Harkin, Durbin and others, of bipartisan legislation,
S. 303, the Human Cloning Ban and Stem Cell Research Protection
Act of 2003.
Our bill has two goals: first, to stop any attempts to
facilitate the birth of a cloned baby. Virtually everyone in
Congress and among the American public agrees that reproductive
cloning should be criminalized so this practice can be stopped
before it even begins. At a minimum, the 108th Congress should
pass legislation that bans reproductive cloning. That is the
very least we should do.
Second, our legislation allows a promising form of stem
cell research to go forward under strict ethical and moral
guidelines. This research utilizes a cloning technique, and
keep in mind that in biomedical science the term ``cloning''
merely means to make an exact copy of cells, proteins,
molecules, viruses, DNA sequences, and other such entities.
In the cloning technique of somatic cell nuclear transfer,
also called nuclear transplantation, an egg's normal component
of 23 chromosomes is removed and replaced with a full set of 46
chromosomes from a somatic or body cell, such as the skin. This
process does not involve a fertilized egg or any sperm cells.
There are two potential pathways for such engineered non-
fertilized embryonic cells. If introduced into a womb, it is
possible that a cloned human being could be born. Let me repeat
my opposition to reproductive cloning and stress that our bill
would impose severe criminal penalties on anyone participating
in that activity.
It is the other pathway, using nuclear transplantation as a
source to derive stem cells, that has generated so much
excitement in the scientific community and has spawned so much
discussion of the ethical dimensions of this type of research.
I am proud to hold a right-to-life philosophy. I believe
that human life begins in the womb, not in a petri dish. While
I recognize that not everyone agrees with me, I am heartened
that so many of the people that I meet in Utah and throughout
the country, including many fellow right-to-lifers, have
supported me in my views. I believe that as the public studies
and reflects upon these issues, support for the legislation we
have drafted will grow.
Deciding where one stands on this matter is not easy. Among
the difficult questions that must be carefully considered are:
what does it mean to be human, when does life begin, and in our
quest to improve the quality of human life, how can we best
establish ethical safeguards to protect against doing harm to
mankind?
These are not easy questions. Although some are calling for
a moratorium on somatic cell nuclear transfer, I fail to see
how a moratorium will help our society fully consider, debate,
and attempt to resolve the ethical issues.
The cost of delay is real. Some 100 million Americans might
1 day benefit from embryonic stem cell research. We must not
forget them. There is no way to impose a moratorium on their
pain and their suffering. We must also understand that this
avenue of inquiry is still in the very early stages, and we
must conduct basic research before any new tests or treatments
can be developed.
Some argue, including some of those you will hear today,
that adult stem cell research is actually superior to embryonic
stem cell research. I support a vigorous program of adult stem
cell research. I just hope that my colleagues will listen
carefully to our scientific witnesses today, because it appears
that the consensus among most scientists is that embryonic stem
cell research, including stem cells derived through nuclear
transplantation, offers unique and perhaps revolutionary
opportunities.
From my discussions with experts, including Dr. Irv
Weissman, of Stanford, and University of Utah faculty Dr. Mario
Capecchi, a leading mouse stem cell researcher, and Dr. Stephen
Prescott, the Director of the Huntsman Cancer Institute, I
conclude that this line of research merits further
investigation and it merits our support.
At the least, we should all acknowledge that the progress
that there has been with adult stem cells has been largely
attributable to a 20-year head start in Federal funding of this
research. I plan to work with Senators Specter and Harkin as
they develop legislation to expand the number of stem cell
lines derived from embryos no longer needed in the in vitro
fertilization process beyond those lines deemed eligible by the
administration for Federal funding.
The issues we face today are difficult, but not totally
unprecedented. For example, our society successfully addressed
the issues attendant to recombinant DNA research and in vitro
fertilization.
Our bill, along with criminalizing reproductive cloning,
contains a number of strict ethical protections. These include
making this private sector research comply with the Federal
Protection of Human Subjects regulations; separating the egg
collection site from the nuclear transplantation research
laboratory; a prohibition on exporting cloned embryos to any
foreign country that does not ban human reproductive cloning; a
prohibition on conducting nuclear transplantation research on
fertilized eggs for a requirement that each egg donation be
made voluntarily and that there be no profiteering on donated
eggs; and a prohibition similar to the English rule on research
conducted more than 14 days after the nuclear transplantation
has occurred.
These are sound rules. If we adopt these ethical
requirements, it is likely that other countries will follow our
lead. Unless we act to build an environment that encourages the
United States to remain the leader in stem cell research, we
will have lost much.
Failure to enact legislation patterned after S. 303 can
only undermine our Nation's leadership in biomedical research.
Investors and firms will be reluctant to commit the necessary
resources to succeed in this costly, new arena if there is not
a measure of certainty in the legal environment for this
activity.
Andy Grove, CEO of Intel, recently sent me an article that
details how China is attempting to take the lead in this field
of research. If this research is stifled, some of our best
young scientists may feel compelled to move offshore and away
from American patients. Such an outcome will not be good for
the citizens of Utah and our neighbors across the country.
Let me close by sharing with you a letter I recently
received from Nancy Reagan that I think frames the issue in a
helpful way. That letters says, ``Dear Orrin, as you may know,
Ronnie will observe his ninety-second birthday soon. In earlier
times, we would have been able to celebrate that day with great
joy and wonderful memories of our life together. Now, while I
can draw strength from these memories, I do it alone, as Ronnie
struggles in a world unknown to me or the scientists who devote
their lives to Alzheimer's research. Because of this, I am
determined to do what I can to save other families from this
pain. I'm writing, therefore, to offer my support to offer my
support for stem cell research and to tell you I am in favor of
new legislation to allow the ethical use of therapeutic
cloning. Like you, I support a complete ban on reproductive
cloning. However, I believe that embryonic stem cell research,
under appropriate guidelines, may provide our scientists with
many answers that are now beyond our grasp. Orrin, there are so
many diseases that can be cured, or at least helped, that we
can't turn our back on this. We've lost so much time already. I
can't bear to lose anymore. Sincerely, Nancy.''
Well, she is very dear to me, as is her husband. We have
always been very good friends. Nancy Reagan is just one of
thousands and thousands, and millions of people who are hoping
that we might be able to find some breakthroughs that would
help the living to be able to have lives that are more
worthwhile, more healthy, and more resolving of the problems
that they face everyday.
With that, I am going to turn to Senator Feinstein for her
remarks, and then if anybody on our side would care to remark,
we will be glad to have that.
Senator Feinstein?
STATEMENT OF HON. DIANNE FEINSTEIN, A U.S. SENATOR FROM THE
STATE OF CALIFORNIA
Senator Feinstein. Thank you very much, Mr. Chairman, and I
am very proud of your leadership on this issue. I know how hard
you have worked. I know the prayer and soul-searching that you
have gone through to come to the position which you hold today,
and that is a position which I share. I am very proud to
cosponsor with you certain legislation which I will discuss in
a moment. Also, we are joined by Senators Specter, Kennedy,
Harkin, Corzine, Boxer, Lautenberg, and Durbin.
If I may, Mr. Chairman, I would like to introduce a
statement for the record from the ranking member, Senator
Leahy.
Chairman Hatch. Without objection.
Senator Feinstein. Thank you very much.
Mr. Chairman, I hope that this hearing will help convince
people that it is possible to draw a line between human cloning
and valuable nuclear transplantation; that is, so-called stem
cell research or therapeutic cloning.
Many of us were disappointed with the House vote on this
issue last month, and we know that a majority of Senators
appear to disagree with the House's position. I am hopeful that
the Senate will pass our legislation that we introduced to ban
human reproductive cloning, while ensuring that important
medical research can go forward under strict oversight from the
Federal Government.
Simply put, this research offers hope to millions of
Americans suffering from paralysis and debilitating diseases,
including juvenile diabetes, Parkinson's and Alzheimer's. But
let's be very clear: human reproductive cloning is immoral and
unethical. It must not be allowed under any circumstances. But
at the same time, we must not, and we should not, I believe,
prohibit nuclear transplantation research. It holds too much
promise for millions of Americans.
Just this past December, we were told that the Raelians had
cloned a human being. This is almost certainly a hoax. However,
it underscores the point: we must ban human reproductive
cloning now before some unethical scientist is successful in
creating a human clone.
I believe this is a point on which we all agree. Human
reproductive cloning is wrong. It should be banned forever, and
our legislation which we have introduced does just that. But
our legislation also allows medical researchers to continue to
use what appears to be the most promising technique to cure
debilitative diseases--somatic cell nuclear transplantation, a
process used to produce embryonic stem cells. Under our
legislation, though, these researchers will not have a free
hand. They must conduct this research ethically, under strict
guidelines, and with close oversight by the Federal Government.
Now, I also believe that our bill is in the mainstream of
American thinking on this subject. Just this morning, at nine
o'clock, a poll was released that was done by Opinion Research
for the Coalition for the Advancement of Medical Research. It
was conducted on March 6 of this year, and what it shows is
that 67 percent of those surveyed said they favored Congress
allowing therapeutic cloning research to continue, while 30
percent polled wanted to outlaw the research. This was a poll
of 1,012 adult Americans.
So if I may, Mr. Chairman, I would like to place that in
the record, as well.
Chairman Hatch. Without objection.
Senator Feinstein. Mr. Chairman, our legislation will place
tough regulations on scientists conducting nuclear
transplantation research. It would impose a sentence of up to
10 years in Federal prison for anyone attempting to clone a
human being, and establish a minimum civil penalty of $1
million, or three times the gross profits resulting from the
violation, whichever is greater.
It would mandate that eggs used in this research be
unfertilized. We do so so there is no question that it is not a
fertilized egg. We would prohibit the purchase or sale of
unfertilized eggs, including eggs that have undergone nuclear
transplantation. This would prevent so-called embryo farms or
the possible exploitation of women.
We would impose strong ethics rules on scientists,
mandating informed consent by egg donors. We would have any
nuclear transplantation research reviewed by an ethics board,
and we would provide safety and privacy protections. We would
also prohibit any research on an egg cell after 14 days, when
that cell begins to divide and when cell differentiation takes
place. So that egg would have to be disposed of before any of
those things take place. These provisions establish a clear
divide between nuclear transplantation research used only to
produce embryonic stem cells and human reproductive cloning.
I deeply believe that embryonic stem cell research has the
potential to save literally millions of lives and to improve
the quality of life for millions more. The promise of embryonic
stem cells is that they are easily replicated, undifferentiated
cells that can be induced into changing into any cell in the
body--a heart cell, a liver cell, a spinal cord cell, or a
kidney cell.
Talented scientists across the country, and indeed the
world, are conducting research using embryonic stem cells in
the search for new cures and treatments. My point here is that
this research is going to go on and it is going to go in other
countries, and certain countries are establishing headquarters
for this kind of research. So if we don't move, we also risk
the likelihood that we will lose some of our best scientists to
other countries where they can conduct this somatic cell
nuclear transfer research.
In a preliminary study at Washington University, embryonic
cells inserted into rats have led to regeneration of a rat's
spinal cord. The once crippled animals have been able to walk
and bear their own weight. Imagine what this could mean for the
250,000 Americans paralyzed by spinal cord injuries.
Similarly, preliminary findings at the University of
Wisconsin have shown that human embryonic stem cells can
differentiate and actually express the insulin gene. Imagine
what this could mean to 17 million Americans suffering from
diabetes. Much more research and testing needs to be done, but
clearly these findings offer hope to those Americans who suffer
from chronic, debilitating disease.
Now, some have suggested that this research can be done
without nuclear transplantation. They point to research being
done, for example, with adult stem cells. I strongly support
adult stem cell research and other research not involving stem
cells, but I agree with leading scientists who argue that
embryonic stem cell research offers much more promise than
adult stem cell research.
Why? Because the fact remains that adult stem cells are
less versatile than embryonic stem cells. They don't have the
ability to be potentially grown into any organ or any tissue.
They can be grown into certain organs or certain tissues, but
not any.
In addition, I support using nuclear transplantation to
generate embryonic stem cells. Embryonic stem cells generated
through means other than nuclear transplantation are much less
useful. Any new organs or tissues created would not have the
same DNA as the patient, and this is critical, forcing him or
her to take dangerous immunosuppressant drugs and increasing
the chances of rejection.
In America today, there are more than 128 million Americans
who could benefit from embryonic stem cell research. One of
these is Emma Arvedon. Only a few years old, she suffers from
juvenile diabetes. Her father wrote to us and this is what he
said: ``Our family is enormously hopeful that nuclear
transplantation research may play a vital role in finding a
cure for juvenile diabetes. There already exists empirical
evidence that quite possibly this research could yield the
insulin-producing pancreatic cells that my daughter's body
lacks. If research into this process were to be criminalized,
how would I explain to Emma that our Government cares more
about a cloned cell, smaller than a grain of sand, than they do
about her?''
So we today are introducing this legislation for Emma and
the millions like her with the resounding support of the
medical and scientific community. To deprive Emma and her
family of a possible cure, to close the door on nuclear
transplantation research, would be nothing short of tragic.
We can, and should, ban human reproductive cloning, without
hurting Emma and her family and the 127 million families like
her. That is why we are here today, to offer hope to millions
of Americans, and to help turn that hope into reality.
So I am very proud, Mr. Chairman, to join you and to join
Senators Specter, Kennedy, Harkin, Corzine, Boxer and
Lautenberg, and as of yesterday, I believe, Senator Durbin, in
sponsoring this legislation.
Chairman Hatch. Thank you, Senator. We are happy to have
Senator Durbin as a cosponsor.
Senator Craig would like to make a short statement.
STATEMENT OF HON. LARRY E. CRAIG, A U.S. SENATOR FROM THE STATE
OF IDAHO
Senator Craig. Well, thank you very much, Mr. Chairman. I
am anxious to hear the testimony, and I will read most of it
because I am going to have to leave. I will be brief.
Let me ask unanimous consent that my full statement be a
part of the record.
Chairman Hatch. Without objection.
Senator Craig. Let me say that I, like I think most who
have spoken already, you and Senator Feinstein, am opposed to
human cloning. I think morally and ethically I feel that the
use of experimental science in the creation of human life is
unacceptable.
However, I understand that biological research could
provide assistance to burn victims, heart attacks, diabetes,
Parkinson's, leukemia, and the list could go on and on, the
crippling and fatal diseases that many of our citizens face and
experience.
But we must also accept that there is a need for limits
when research goes beyond the boundaries of what is considered
to be ethical, and that is the responsibility of this Committee
and that is the responsibility of this Congress to draw that
line and that is what we are attempting to do here.
I am a cosponsor of S. 245. I am glad to see Senator
Brownback here this morning. He has been an outspoken leader in
this area. I also appreciate the work you are doing, Mr.
Chairman and Senator Feinstein, and others, as we sort this
out. And it really is that business that we are into at this
moment because this is an issue that will be addressed legally
and within the law, I do believe, in a reasonably short period
of time, and it should be.
Again, I do want to stress the importance of advancing
medical research. There are countless people living with
devastating diseases who live with the hope that medical
research will help save their lives. I look forward to learning
more about how we can make those advances in the area without
treading on the sanctity of human life. We have that
responsibility.
Thank you.
[The prepared statement of Senator Craig appears as a
submission for the record.]
Chairman Hatch. Thank you, Senator.
We will begin with two distinguished Members of Congress.
We are honored to have both of you here. Both hold the right-
to-life philosophy. While they agree on the need to ban
reproductive cloning, they have reached opposite conclusions on
the matter of nuclear transplantation for research purposes. At
least that is my understanding.
Senator Brownback is no stranger to this Committee. We miss
you. We wish you were still on the Committee, and on this issue
I am sure you wish you still were on the Committee.
Senator Brownback. Yes, I do.
Chairman Hatch. We welcome you back, Sam. We are grateful
to have you here.
Senator Brownback is the lead sponsor of legislation that
would ban somatic cell nuclear transfer for both reproduction
and research purposes.
We also want to welcome to the Committee Representative Jim
Langevin. Congressman Langevin is from Rhode Island and is in
his second term in the House. We want to thank you for
appearing with us today. It means a lot to us. I know that you
have a commitment on the House side that will require you to
leave as soon as you testify, and we will understand that.
Before we start with Senator Brownback, I want to mention
that due to scheduling conflicts with some of our members, the
Committee will recess this hearing at about 11:30 and then
reconvene at 1:30. We may only be able to get through this
first panel this morning. Maybe if we have enough time, I will
call the fourth panel so that we can do that. We will see how
it goes and maybe we can reach that fourth panel, and then we
will do the others as soon as we get back at 1:30.
So let's start with my friend, Sam Brownback.
Senator Brownback. Mr. Chairman, thank you very for
allowing me to be here. I would be happy to let Congressman
Langevin go first if he has a scheduling conflict.
Chairman Hatch. That is very gracious of you.
Congressman would that help you if you go first?
Representative Langevin. I am fine with waiting for the
Senator. I don't mind waiting. It is up to you, Senator.
Chairman Hatch. Senator Brownback?
STATEMENT OF HON. SAM BROWNBACK, A U.S. SENATOR FROM THE STATE
OF KANSAS
Senator Brownback. Thank you very much. Thank you, Mr.
Chairman, and I would like to be back on the Committee to do a
great deal of very important work. I hope you can clear some
judges on through. I think the Federal bench could sure use it,
and the appellate court bench in particular.
Chairman Hatch. We are doing our best.
Senator Brownback. I know it is a difficult task. I also
have appreciated my association with the Chairman over many
years on many different topics. We have worked closely and
carefully together, and I have always appreciated his great
leadership, his thoughtfulness and his legislative ability. He
is an excellent legislator.
Chairman Hatch. Thank you. We are dear friends, there is no
question about it. We do have our differences on this, but we
can still be dear friends.
Senator Brownback. I hope to persuade you of the
reasonableness of my position.
Chairman Hatch. The error of ways?
Senator Brownback. Yes.
Let me start with the good news, if I could. Senator
Feinstein was talking about the hope and the promise of cloning
and embryonic stem cell research. Let me produce for you a
newspaper articles on cures from adult stem cells. This was in
the Wall Street Journal March 6 of this year. Some of you may
recall this story.
This was about the 16-year-old boy who was shot through the
heart with a nail gun, the other gentleman being charged with
the crime. About a third of his heart was destroyed in this.
The next day after the nail gun was shot through his heart, he
had a heart attack, destroying further areas around it.
They took stem cells from his bone marrow, so these are not
heart stem cells; these are bone marrow stem cells. The first
time in this country--this has been done overseas, but the
first time in this country. They collected them, concentrated
them and injected them back into his heart. He is now walking,
talking, getting bored having to lie around. This has been an
amazing repair procedure that has taken place with adult stem
cells in humans. This isn't about a promise that is taking
place that we might have this taking place with cloning. This
is in humans and it is occurring today, and I would ask that
this full article be submitted into the record.
Chairman Hatch. Without objection, we will put that in the
record.
Senator Brownback. It also shows the malleability, the
pliability of adult stem cells, that were thought previously,
as we haven't really understood these for very long, to be not
particularly pliable, they weren't malleable. But it turns out
that particularly bone marrow stem cells are.
We also learning from the scientific community that we have
these stem cells throughout our bodies, adult stem cells. They
are kind of like repairmen. They go around the building; they
go around the Dirksen Office Building repairing different
things. But if there is a massive attack somewhere, there are
not enough of them to be able to fix the problem that might
blow up, if we have a furnace that blows up, if we have some
other problem. So they have to bring in more, and that is the
idea of concentrating, sending them into a particular spot, and
it is working.
Now, some in the scientific community when adult stem cells
first came out said this is not an answer, this doesn't work;
junk science, some referred to. I would say that this young man
in Ohio would not refer to this as junk science at all. This is
something that is saving his life.
We are seeing this taking place in a broad cross-section of
areas in adult stem cells. I remember when we started this
debate on cloning a couple of years ago, people were saying
adult stem cells really don't work; well, sure, I support it,
but it doesn't really work; they don't have the plasticity to
be able to do it.
Here is a book of the research articles now in adult stem
cells. These are human trials and animal trials that are taking
place in a variety of different areas--brain damage, cancer,
cerebral palsy, diabetes, heart damage, eye diseases, multiple
sclerosis, muscular dystrophy, Parkinson's, spinal cord
injuries, sickle cell anemia, transplants, overall
versatility--and then sources at the end of it.
Chairman Hatch. Senator, would you submit that for the
record?
Senator Brownback. I would be happy to submit these to the
record. We try to get these updated every 2 weeks. There is so
much coming out in the area.
Chairman Hatch. Well, let's keep the record open so that
you can submit whatever comes in, and then we will certainly
look at every bit of that. We are all for what you are talking
about.
Senator Brownback. My point in saying this is as I have
started this debate several years ago, the research and how you
treat the young human and the need to clone is immoral, illegal
and unnecessary, were the three points that we started this
debate with about 3 years ago, maybe a few more.
I wanted to point to the last point on this about the
unnecessary side of this. We have huge findings that are taking
place in humans and in animal trials that these are occurring.
We don't need to go the cloning route because you have to cross
the fundamental issue which we are all struggling with, which
is when does human life begin, and is that youngest of human
life something that is owned by somebody or is its own life? Is
it a person or is it property, which is a point I have posed to
the Chairman numerous times? How are we going to treat this
youngest of human life? Are we going to treat it as a person or
are we going to treat it as a piece of property?
This is a philosophical issue, an issue perfectly suited
for the Judiciary Committee to discuss, but one which we as a
society have been, to date, unwilling to decide. We have been
unwilling to say it is property and therefore it can be
disposed of as its owner chooses, or it is a person and
therefore it has legal rights. We have been unwilling to
decide.
Here, I would quote Ronald Reagan, when he said--and I am
paraphrasing here--if you didn't know if a person was dead yet,
you wouldn't bury him. I would put it in reverse, saying if you
are not sure if it is a life or not, you wouldn't kill it. We
are at one of those similar sorts of questions.
Are we sure or convinced that this is life, or isn't it
human life? Some would say it is clearly human life, it is
genetically defined as human life, it has a full set of
chromosomes, it is human life; all it needs is care and
nurturing and it can become a full human life under anybody's
definition.
There are others who will say, well, without care and
nurturing, without it being in the womb, it cannot be human
life, it cannot grow to a full life expectancy, and therefore
it must be property. We could treat it as such. We could patent
it. We will need to patent these young embryos, we will need to
patent these clones.
We haven't been willing to deal with that, and that is why
I submit to you that we have a procedure and it is working and
it is working brilliantly. It is working wonderfully and it is
producing results today. Why would we kill it if we are not
sure it is alive?
I also want to go into the issue about definition because
this is a debate that is replete with questions about
definition. First, I would submit, and I think this is very
clear from the scientific evidence, that there is only one type
of human cloning and it always results in the creation of a new
human being.
Many of the proponents of human cloning would have society
believe there are two different types, the so-called
reproductive and the so-called therapeutic. Well, these are not
two types of cloning. There is only one and it always results
in the creation of a new human embryo.
There are others who would say we want to do nuclear
somatic cell transfer. That is fine, but that is the name of a
procedure that produces a clone. That is the name of a
procedure and that procedure results in a human clone. Attempts
to put a different label on it or change the intentions of the
researcher by suggesting that are, I think, unhelpful to the
debate.
At the end of the process of somatic cell nuclear transfer,
you end up with a clone, and that is the question about how are
we going to treat clones. Are we going to treat them as a
person or are we going to threat them as property? I would
submit that we should not create this human life just to
destroy it for the research on it.
Recently, in what appears to be attempts to avoid negative
opinion, a new term has been used to describe human cloning,
the term of ``unfertilized egg.'' It is a euphemism that is
being used by people who are proponents of therapeutic cloning.
This term, which is as confusing as can be, I think, needs
closer examination.
Any biology textbook will define a human ovum or egg as a
single cell. Moreover, it is a very unusual cell, a gamete
cell, which means it has only 23 active chromosomes, half the
number. Gender has not yet been determined. An ovum cannot grow
stem cells or otherwise develop because it is just an egg.
However, once an egg contains a complete nucleus, the full
set of chromosomes from any species that is activated and
developing, whether that has occurred by sexual fertilization
or by asexual somatic cell nuclear transfer, then one has a
developing embryo of that species, whether it is a sheep in the
case of Dolly, which was asexual reproduction, or whether it is
a cow or whether it is a homo sapiens.
There is no such thing in biology or in any dictionary as a
human egg or egg cell that has 46 chromosomes, has been
determined to be either male or female and is 5 days old,
consisting of several hundred cells, or 14 days old consisting
of several thousand cells. Calling a 5-day-old or a 2-week-old
human embryo an egg is an attempt really to hide the fact that
this is an embryo and it is the true nature of a human clone,
just as Dolly was at that stage a clone of a sheep.
The phrase ``unfertilized blastocyst'' is likewise being
used in this debate. Now, the term ``blastocyst,'' of course,
refers to a stage of embryonic development, and an egg would
never be a blastocyst. You are at an embryo stage. Human
cloning is human cloning. All human cloning, I would submit to
you, is wrong, no matter what one wants to call it or by what
procedure you get to that clone.
I think these definitions are important because what we
need to deal with is the issue of human clones and what we
intend to do with them as a society. The House has passed a
bill by a large margin saying we should not be researching on
humans and we should not create human clones.
The cloning field is a very less-developed field to date.
We saw Dolly was just put down, put to death, because of
premature problems that she had. I think it is a very dangerous
thing to submit human beings to. I think it is immoral to
research on young humans. I don't think it is right for us to
create life to research on it, and we don't need to; we have
other routes to go. For all those reasons, I am here in
opposition to human cloning either for therapeutic research
purposes or for full reproductive purposes.
I would be happy to take your questions.
Chairman Hatch. Thank you, Senator Brownback.
Congressman Langevin?
STATEMENT OF HON. JIM R. LANGEVIN, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF RHODE ISLAND
Representative Langevin. Thank you, Senator Hatch. I am
honored to be here today and to be seated with Senator
Brownback. I appreciated listening to his thought-provoking
views, and I know they are well-thought-out, though we disagree
on the issue. I enjoyed hearing his perspective.
Senator Hatch, I would like to thank you and Senator
Brownback, Senator Kennedy, Senator Feinstein, and the entire
Judiciary Committee for convening today's hearing on the topic
of cloning.
I feel strongly that it is time to pass a law that will put
this matter to rest. Patient advocacy groups, leading
scientists, lawmakers, and a majority of the American people
agree that human reproductive cloning should not be allowed. It
is clearly the obligation of Congress to pass a law prohibiting
and criminalizing this practice, and to encourage other nations
to follow suit.
In the course of the debate on cloning, we have heard much
discussion about somatic cell nuclear transfer, the procedure
commonly referred to as therapeutic cloning. In the year-and-a-
half since Congress first addressed this matter, I have studied
the principles of nuclear transfer and analyzed the issue from
the perspective of a policymaker, a pro-life Democrat and
Member of Congress, and a devoted advocate of improving the
lives of those with disabilities and diseases.
I particularly want to thank you, Senator Hatch, and
Christopher Reeve and many others on both sides of this issue
for your advice and counsel in helping to arrive at my
position.
After a great deal of thought and discussion and personal
struggle, it is my carefully considered position that we can
and should ban the cloning of human beings without impeding
ground-breaking and promising biomedical research in the area
of somatic cell nuclear transfer. Like Senator Hatch, my pro-
life beliefs include a commitment to defend, extend and improve
the lives of those who are living among us.
As many of you know, in the 107th Congress I became the
first quadriplegic ever elected to the United States House of
Representatives. While my physical condition does not define
me, it does affect me on a daily basis, providing me with a
unique perspective, shaping my pro-life position and my
understanding of the value of the type of research that we are
here to discuss.
At the age of 16, I was in my fourth year of participating
in the Warwick Police Cadet Explorer Scout program. I thought I
was well on my way to realizing my dream of being a police
officer or an FBI agent. But on August 22, 1980, my dream was
shattered and my life was changed forever.
I stood in a locker room with a fellow cadet watching two
members of the SWAT team examining a new handgun. It
accidentally discharged, launching a bullet that ricocheted off
a metal locker and through my neck, severing my spinal cord and
leaving me paralyzed for life.
But perhaps now there is new hope for me and millions of
others. Having come so close to losing my own life, I am
reminded everyday of how precious a gift life truly is, and
that is what has led me to be pro-life. I see my position in
supporting therapeutic cloning as consistent with my pro-life
views.
In somatic cell nuclear transfer, the nucleus of a donor's
unfertilized egg cell is removed and replaced with the nucleus
of a patient's own cell; for example, a skin cell. Doctors are
then able to develop stem cells that will not be rejected by
the patient's own immune system. The cells are never
transplanted into a womb, and to me that is the difference
between ethical regenerative medicine and immoral human
cloning.
Nuclear transfer is the cloning of one's own cells, not the
cloning of any viable form of life. A legal prohibition against
implantation, as provided by the bill offered by Senator Hatch,
provides sufficient assurances that nuclear transfer is ethical
and should be allowed to proceed.
Scientists believe that the knowledge they can gain from
somatic cell nuclear transfer can lead to cures and treatments
for conditions including Alzheimer's, Parkinson's, cystic
fibrosis, diabetes, and even spinal cord injuries. The research
done with cloned cells produces stem cells which have the
potential to yield life-saving and life-enhancing treatments
for millions of people living with diseases and disabilities.
With appropriate safeguards, we can remove the risk of misuse
of this technology and encourage scientific research that is
likely to yield undeniably life-affirming results.
Please understand that I am here to speak today not just
for myself as a lawmaker and as someone living with a
disability, but on behalf of the millions of people who
struggle daily with the pain, suffering and debilitating
effects of disease and disability.
Many lives could be saved, lengthened and dramatically
improved by this research. Large numbers of Americans could
benefit from therapeutic cloning, including 1 million children
with juvenile diabetes, 4 million Alzheimer's sufferers,
230,000 people living with spinal cord injuries, 30,000
children and adults affected by cystic fibrosis, and 30,000 Lou
Gehrig's Disease patients.
Every family in America has been touched by these diseases
and conditions, and through the medical advances such as those
being explored in somatic cell nuclear transfer and stem cell
research, we have the opportunity to offer them real hope.
I must also acknowledge the progress being made on these
issues through other aspects of stem cell research. We do not
yet know which research project might yield the treatment for
Alzheimer's or a cure for diabetes or the many other conditions
and diseases that I have mentioned. We must explore all avenues
of treatment for people living with disease and disability.
In my research that led me to support embryonic stem cell
research, I spoke with one of the foremost experts in adult
stem cell research, Dr. Peter Quisenberry, from my home State
of Rhode Island. He has devoted his career to adult stem cell
research and he believes so strongly in the hope that that
particular research offers. Yet, he acknowledges to me that we
don't yet know where the greatest potential for treatment of
individuals with disabilities and diseases truly lies, whether
it is adult stem cell research or embryonic stem cell research.
Therefore, he believes that we should proceed on both
tracks. In the quest to find new treatments and cures, we must
leave no stone unturned, and it is essential that we continue
to explore both adult and embryonic stem cell research, as well
as somatic cell nuclear transfer.
As legislators, we have a responsibility to protect society
against abuses of technology. We also have an obligation to
maximize its benefits in a responsible and ethical way.
Clearly, human cloning is such an abuse and Congress must take
the necessary measures to protect society from this
exploitation.
The bill offered by Senator Hatch provides these measures
to offer the opportunity to ban human cloning without
concurrently halting critical research in the area of area
somatic cell nuclear transfer which promises a significant
increase in quality of life, and in many cases the promise of
extending and improving life itself for millions of Americans,
and indeed for millions of people around the world.
When we addressed this issue last month in the House of
Representatives, an amendment was offered by Representative
Greenwood containing the provisions protecting somatic cell
nuclear transfer that you see in the Hatch bill. It generated
174 votes, indicating a significant amount of support for
therapeutic cloning. However, it failed to pass the House.
Subsequently, it may now be up to the Senate to make sure
that the door is not closed on promising medical research. It
is my hope that the Senate will pass a bill banning
reproductive cloning, yet encouraging somatic cell nuclear
transfer research, and setting the criteria for it to move
forward in a responsible fashion under the direction and
oversight of credible, trusted entities like the NIH.
To that end, I urge my colleagues in the Senate to support
S. 303, in recognition that it provides appropriate safeguards
against the ethically questionable practice of reproductive
cloning, while maintaining the promise of the best in medical
technology for all Americans.
Mr. Chairman, I thank you for your time here today.
Chairman Hatch. Well, thank you. I want to thank both of
you for your testimonies. They are divergent in some ways, but
both very sincere and dedicated testimonies. So I commend both
of you.
Congressman we will let you go. We know you have got to get
back over to the other side of the Hill, but we are honored to
have you here and we are very appreciative of your testimony.
Representative Langevin. Thank you, Senator.
Chairman Hatch. Thank you so much.
Sam, only one question from me, and that is it may be that
neither bill will pass. But if that is not the case, we ought
to join hands and at least pass a ban on reproductive cloning.
I hope that is the minimum that we do this year. Hopefully, we
can do that. That is all I wanted to say.
Does anybody else have any questions?
[No response.]
Chairman Hatch. We are grateful to have you here.
Senator Brownback. Thank you very much. We will be having a
hearing on the impact of therapeutic cloning on women next week
because, as noted, if we move forward with this, there would be
millions of eggs needed. We are going to look at that procedure
in the Commerce Committee next week because there will be
markets being created.
Chairman Hatch. We will look forward to seeing what your
panels say at that time.
Senator Brownback. Thank you.
Chairman Hatch. We are very close to where we have to get
over to that top-secret meeting.
Senator Feinstein. I beg your pardon?
Chairman Hatch. We are very close to where we need to get
over to that top-secret meeting. Should we try and do the
fourth panel?
Senator Feinstein. If they are here. My understanding was--
I know the signals have changed about this meeting--that there
were going to be these opening comments and then we were going
to recess until 1:30 today. Perhaps that has changed.
Chairman Hatch. Well, I wonder if Jim Kelly and Greg Wasson
are here.
You are Mr. Wasson. Is Jim Kelly here?
Mr. Kelly. Yes.
Chairman Hatch. Well, I wonder if we could take both of
your testimonies at this time. We will try and do it. If you
can limit your testimony to 5 minutes, we can still make our
appointment over in the Capitol. We will start with you so that
you don't have to stick around all day if you don't want to.
This next panel consists of two patient advocates. We want
to thank Jim Kelly and Greg Wasson for traveling here today.
While you both have reached different conclusions with respect
to the best course for public policy with respect to stem cell
research, no one can doubt that you share the ability to
passionately convey your views. So we are pleased to have both
of you before the Committee today. If you can summarize your
remarks within 5 minutes, we will put your full statements in
the record as thought fully delivered.
Mr. Kelly, we will start with you first.
STATEMENT OF JAMES KELLY, GRANBURY, TEXAS
Mr. Kelly. Thank you, Mr. Chairman.
Two years ago while closely researching my own condition, I
blindly accepted media reports claiming embryonic stem cells
were our best hope to cure other conditions. When I realized
the push for cloning was supported by companies that claimed
they had no interest in pursuing the field, I wondered why.
When I read media reports that sharply contrasted with
information I had gathered from medical journals, I became
concerned. When I read of my own condition being used to
justify cloning, I began studying the issue in earnest. This is
what I found.
In embryonic stem cells derived from cloning, chromosomes
transferred in the cloning process retain physical changes that
accrue with age. These age-related changes are known to
contribute to age-related disease. Investors are unwilling to
invest in cloning, since its potential for leading to clinical
treatments, if any, is considered decades away, or as a recent
New York Times articled concluded, ``in the distant future.''
Biotechnology corporate leaders believe its chances of success
are ``vanishingly small.''
The public is being told that therapeutic cloning does not
require the creation and killing of human embryos, when, in
fact, that is exactly what it does. We have been led to believe
that cloning's widespread and variable genetic defects pose no
therapeutic risk. The truth is that researchers don't know how
many genes are affected by cloning, or cloning's potential for
mutation or aberrant imprinting during adult cell mitotic
division, or the long-term consequences of introducing such
cells into adult organs.
Dr. Robert Marcus, Director of the East Anglia Bone Marrow
Transplant Unit, explains the risks: ``Any time you transfer
genes within the cloning process, or change the genetic
material within a cell, there may be defects introduced into a
natural organ or species development. I think I would be quite
cautious there.''
Embryonic stem cells derived from cloning are not expected
to perfectly match the donor. They may face rejection and
require immune suppression. Dr. John Gearhart told the
President's Council on Bioethics there is ``no question'' in
his mind that embryonic stem cells derived from cloning ``could
be rejected.'' ``Absolutely,'' Dr. Gearhart says.
Dr. Irving Weissman explains: ``I should say when you put
the nucleus in from a somatic cell, the mitochondria still come
from the host''--that would be the egg--``and in mouse studies
it is clear that those genetic differences can lead to a mild
but certainly effective transplant rejection and so immune
suppression, mild though it is, will be required for that.''
If custom treatments from cloning could someday exist, they
are expected by leading scientists to be astronomically
expensive. Australia's leading embryonic stem cell expert,
Professor Alan Trounsen, says the pace of stem cell technology
has been so rapid that therapeutic cloning is now unnecessary.
``My view,'' he said, ``is there are at least three or four
other alternatives that are more attractive already.''
In citing the clinical results using adult stem cells to
repair human hearts, the director of a prestigious German
medical journal presents a truth that Americans are not being
told: ``The promises of unscrupulous embryo researchers that
clone without clear clinical goals and experiments are
unsupportable. This remarkable proof has now given us a clear
sign that the Americans with their prohibitions are exactly
right. The biotechnological revolution can take place without
embryonic stem cells if the alternatives are developed.''
Embryonic stem cells from any source are not considered by
most scientists to be the optimal transplantation cell of
choice. This is another truth America is not being told which
further explains why, in New Jersey, science and biotech are
pushing for access to cloned late-term fetuses and newborn
babies.
To summarize, embryonic stem cells derived from cloning do
not perfectly match the patient; contain known and unknown
genetic defects, as well as defective imprinting; are expected
to require immune suppression for immune-sensitive conditions;
retain the genetic age of the donor; are not considered
desirable for transplantation; and may be too expensive for
patients to afford.
Regarding the likelihood that science will overcome just
one of these defects, Dolly's creator predicted in Nature: ``It
should keep a lot of us in business for a long time.''
Moreover, these flaws are in addition to critical defects
already inherent in embryonic stem cells from any source.
Regarding this point, the Institute of Science in Society, an
international organization of 462 scientists from 57 countries,
issued a statement: ``The risks of cancer, uncontrollable
growth, genome instability and other hurdles make ES cells a
bad investment in terms of finance as well as public health
benefits.'' The Institute adds that adult stem cells ``are more
likely to generate affordable therapies that can benefit
everyone.''
In other words, even if cloning's very real practical
concerns could be overcome, including its need for female eggs
and its expected exorbitant costs, and even if rejection issues
and genetic flaws could be addressed, it would still do nothing
more than provide cells known to be genetically unstable, grow
uncontrollably, and cause cancer.
Why then are millions of dollars which could have been used
to develop cures instead being spent on a national campaign to
convince Americans that therapeutic cloning offers the
brightest hope for cures?
The ISIS offers an explanation: ``Commercial imperatives
are the major impetus for ES cell research, much more so than
for adult stem cells. There are more opportunities for
patenting cells and cell lines as well as isolation
procedures.''
The Institute concludes: ``Scientists should stop
manipulating public opinion to promote research that is both
morally and scientifically indefensible. At the same time,
governments need to invest our tax money in scientific research
that can genuinely benefit the health of the nation, and not be
misled by false promises of the next economic boom.''
The exaggerated promise of therapeutic cloning is not a
path to cures in our lifetime, but a dangerous diversion away
from cures. It is in the interest of cures that I urge you to
support S. 245, the Brownback-Landrieu ban on all human
cloning.
Thank you.
[The prepared statement of Mr. Kelly appears as a
submission for the record.]
Chairman Hatch. Thank you, Mr. Kelly.
We will turn to you, Mr. Wasson.
STATEMENT OF GREG WASSON, COTATI, CALIFORNIA
Mr. Wasson. Chairman Hatch, Senator Feinstein, and members
of the Committee, thank you for giving me the opportunity to
testify before you today.
The potential of regenerative medicine is of great
importance to my life. My name is Greg Wasson and I am here on
behalf of the Coalition for the Advancement of Medical
Research, CAMR. CAMR is comprised of universities, scientific
and academic societies, patients' organizations, and other
entities that are devoted to supporting stem cell research.
I, along with CAMR, support every effort to criminalize and
ban human reproductive cloning. It is unsafe and it is
unethical. However, it is imperative that we protect stem cell
research using therapeutic cloning to provide better treatments
and hopefully cures for a number of debilitating and presently
incurable conditions.
Eight years ago, I was diagnosed with Parkinson's disease.
My fiancee, Ann Campbell, who is here with me today, was given
the same diagnosis that year. I was a lawyer. Ann was an editor
and a children's book author. Within 5 years of our diagnosis,
we were both forced to retire on disability. I was later
diagnosed with diabetes, a problem which runs in my family.
An estimated 1 million Americans have Parkinson's, a
progressive, degenerative brain disorder that is presently
incurable, whose cause is unknown, and which slowly robs its
victims of the ability to move properly and eventually to move
at all.
We live with the knowledge that 30 percent of all
Parkinson's patients develop dementia and that we are three
times as likely as the general population to develop
Alzheimer's. We have lesser cognitive problems which plague us
as well.
Eight years after my diagnosis, I take 25 pills per day.
Yet, I have increasing difficulty controlling my symptoms.
These medications do nothing to slow the progress of my
disease. For both Ann and myself, the time will come when our
medications will fail us permanently and we will be totally
functionally disabled. We will leave this world and enter a
twilight world of immobility, encased in our bodies as if
entombed, able to think but not speak, understand but not
communicate. Death will inevitably follow, and by then it may
be welcome.
Parkinson's is just one of the many chronic diseases and
conditions that are fatal, at worst, and leave their victims
permanently disabled at best. These diseases and conditions
affect more than 100 million Americans. Each of us here today
has a loved one or a friend who has a disease such as
Alzheimer's, ALS, diabetes, or Parkinson's.
Time is of the essence in pursuing promising research. Two
years ago, I worked with a number of persons suffering from
ALS. They became my friends. Now, 2 years later, most of them
are dead. John Davis, an Alabama ALS victim and fellow
advocate, fortunately still living, once said of embryonic stem
cell using SCNT, ``this dog will hunt.'' He meant that such
research had the potential for saving countless lives, and he
was right. But this research will hunt only if it is not
leashed and muzzled.
We are not without hope. Regenerative medicine, including
responsibly regulated therapeutic cloning, may lead to a cure
or treatment for Parkinson's disease, ALS, and a host of other
diseases and conditions. As you will hear today from the
scientific panel, human reproductive cloning and cloning for
therapeutic medical purposes are not the same. An unfertilized
ball of perhaps 100 cells the size of a pinhead is not a human
being or anything near to one. The use of SCNT does not destroy
human life; it is an attempt to restore human life.
Ann Campbell and I, along with millions of other Americans,
are human beings, human beings living with terrible diseases
that will kill us unless cures are found. The willingness of
some people to sacrifice our lives, to place less value on our
lives than on a chemically-produced unfertilized mass of cells,
perhaps grown from one of our own hair follicles, is to me the
real shame and the real crime.
Compassion and common sense must prevail. Ignoring the
potential of therapeutic cloning would be a national tragedy
and a huge mistake. But as with other scientific advances, a
vocal and well-organized minority is trying to stop this
research. Galileo, Columbus, and a South African physician
named Christian Barnard all held scientific beliefs that
frightened their contemporaries. But the earth does revolve
around the sun, the earth is not flat, and today heart
transplants are commonplace.
Today, the target of scientific fear is therapeutic
cloning. Opponents argue that legalizing therapeutic cloning
will open the flood gates to a black market industry in
reproductive cloning. But similar claims were once made that
organ transplantations would lead to a huge black market in
harvested organs. This fear was unfounded, and today donation
and transplantation of organs is strictly and effectively
regulated.
Senators we believe that you understand and appreciate the
enormity of the potential for saving human beings from fates
such as Parkinson's, ALS, diabetes and spinal cord injuries. We
believe that, individually and collectively, you will make the
choice to protect and to restore life. What greater legacy
could any government leave its citizens?
So because we have hope and faith that this country will
recognize the value of research into regenerative medicine, Ann
and I will be married this fall. On our wedding day, we will
raise a glass to the promise of a new day when diseases like
Parkinson's are simply a terrible memory. In this Committee, in
the Senate and in Congress, we place our highest hopes and most
sacred trust.
Thank you very much.
[The prepared statement of Mr. Wasson appears as a
submission for the record.]
Chairman Hatch. Well, thank you. We thank both of you for
being here.
Questions, Senator Feinstein?
Senator Feinstein. No, Mr. Chairman, but I did want to read
into the record--I should have done this when Senator Brownback
was here--I would like to read something from Dr. Berg's
statement. For those who don't know, Dr. Berg is the Chair of
the Public Policy Committee of the American Society for Cell
Biology. He is also a Nobel laureate in chemistry and he is
known as, I think, a world expert on this subject.
On page 5 of the testimony he is going to give--and I want
to draw everybody's attention to it--he says, ``Both
Congressman Weldon and Senator Brownback have accepted the
assurances of their advisors that adult-derived tissue-specific
stem cells, that is specialized stem cells that already exist
in many of our tissues, are sufficient for meeting the clinical
needs of repairing damaged or diseased tissue.''
He goes on to say, ``Those assurances contradict the
evidence. The claims on which those assurances rest are largely
anecdotal''--for example, the heart incident that Senator
Brownback mentioned--``relying on experiments that most often
have not been replicated by others and, in some cases, are now
known to be flawed.'' For example, this heart incident had no
science behind it. It was something that was tried, and so far
it has worked and that is just great.
``Indeed, recent experiments have documented that claims
that bone marrow can reconstitute tissues of other organs have
been shown to be artifacts. Moreover, multipotent adult-derived
stem cells have, with few exceptions, not been maintained in
culture for any significant period.''
``It is certainly true that bone marrow harbors rare stem
cells, the so-called hematopoietic stem cells that can
reconstitute the entire blood-forming system. Similar evidence
exists that neural stem cells obtained from embryos can give
rise to different neural cell types. But neural cells obtained
by differentiation of cultured embryonic stem cells''--and this
is the key--``can populate the brain and deliver sufficient
dopamine to alleviate the symptoms of Parkinson's disease in
the mouse.''
So the point I wanted to establish is this is what our
legislation is really going to help develop, this new line of
embryonic stem cells, where these cells can replicate
themselves to be used with minimal rejection in virtually any
part of the body. So I think that that point has to be made and
we have to keep making it.
For somebody like Mr. Wasson who has a problem and needs
help, this is really the one area where he can get that help,
and that is why it is so important. I just want to thank you
for being here today. We are very grateful.
Chairman Hatch. Yes?
Mr. Kelly. Mr. Chairman, I would like to make a request of
you, sir.
Chairman Hatch. Yes, sir.
Mr. Kelly. I would like to address you and Senator
Feinstein on a couple of things.
Senator Feinstein, you made some comments about spinal cord
injury. Before I left last night from Dallas-Forth Worth, I
downloaded the Rutgers University--Dr. Wise Young keeps a
website where he keeps the spinal cord community up to date on
the most promising developments in spinal cord research.
He has a very comprehensive list here of the seven
different areas of spinal cord research, and then he breaks
each area down into whether it is neuro-protective,
regenerative or reparative. It is very comprehensive and it is
very clear and distinct. I would appreciate, sir, if you would
accept this for the Senate record.
Chairman Hatch. We will make that part of the record.
Mr. Kelly. I am sorry. Senator Feinstein, I have to tell
you that what you were told by Dr. Berg is not correct. The
truth of the matter is the heart studies that you were saying
have not been duplicated have been duplicated, Senator. They
were duplicated in Australia, in Germany, in France, and now
this is the first time it has been used in the United States,
and they have been duplicated in humans in all those countries.
The truth of the matter, Senator, is that adult stem cells
are definitely the most promising area of research we have. As
a matter of fact, Senator, I personally am not going to stay in
the United States and wait for biotech to decide that they are
going to try to bring treatments to the American people. This
summer, I am going to Portugal and be treated with olfactory
mucosa from my own nose that has adult neural stem cells that
are already getting people on their feet who have been
chronically paralyzed with spinal cord injury.
I sincerely suggest, Senator Feinstein, that you question
what you are being told because you are not being told the
truth.
Chairman Hatch. Well, I hope you have success in what you
are doing.
Mr. Kelly. Thank you, sir.
Chairman Hatch. Let me just ask one question to both of
you, though. Let's assume that the Brownback bill passes. I
don't think that is going to be the case, but let's assume that
it does. If a therapy that could help you with your respective
difficulties and disabilities were invented overseas with stem
cells derived from a cloned embryo--if that therapy could
actually be developed, would you avail yourselves of your
treatment?
Mr. Wasson. Answering personally, if the Brownback bill
were passed, it is my understanding that I would, upon entry
into this country, be imprisoned for using that therapy.
Chairman Hatch. Well, let's assume that they changed part
of the original bill, which I think they are doing, that would
not make that a crime for you to come back into this country
with a cure or treatment that occurred from embryonic stem cell
research overseas. Would you avail yourself of that treatment?
Mr. Wasson. Certainly.
Chairman Hatch. How about you, Mr. Kelly?
Mr. Kelly. If I understand correctly, you are asking me
would I avail myself of an embryonic stem cell cure using
cloning, if it was possible?
Chairman Hatch. That literally was developed overseas, if
it worked.
Mr. Kelly. If it was possible?
Chairman Hatch. Yes.
Mr. Kelly. I will tell you the truth, sir. A year ago, I
told a Congressman when he asked me the same question that,
yes, I would, because my No. 1 reason for taking the view that
I am taking is I am trying to promote research that can
genuinely lead to cures.
But now, sir, I have to tell you that in the last year I
have come to change my mind on that. The reason why I have
changed my mind is my background is in blue-collar heavy
industry, railroading, and I see things in very clear, black-
and-white simplicity. And when I went to New Jersey to present
what I believe is the pro-cures perspective on this issue and I
saw that in New Jersey they are trying to promote cloning of
not only fetuses for therapeutic cloning, but also newborn
babies, I realized that I myself will not allow a baby to be
killed to get out of this wheelchair. And I swear to you, sir,
nobody wants to be cured more than me, but I draw the line at
killing babies.
Chairman Hatch. Well, that is a principled position. I
don't agree with you, but it is a principled position. I agree
with Mr. Wasson.
You are both excellent people. We appreciate having you
here. We appreciate the testimonies that you have given. We
will let Dr. Berg speak for himself on this issue, because he
will be one of the panelists as we resume this afternoon at
1:30. So we are going to recess until 1:30 because we both----
Senator Feinstein. Mr. Chairman, may I put a number of
letters in the record?
Chairman Hatch. We will, of course, do that, without
objection, and keep the record open.
We just want to thank all the witnesses so far. I am sorry
we have to recess, but this is a very important meeting both of
us have to go to.
Mr. Wasson. Thank you.
Chairman Hatch. Thank you. We will recess until 1:30.
[Whereupon, at 11:44 a.m. the Committee was adjourned, to
reconvene at 1:36 p.m. this same day.]
Chairman Hatch. I am going to ask the two panels to come
together all at once. We were going to have four panels, but we
will put panels two and three together now. I think we had a
good session this morning, and I understand that both Dr. Kass
and Dr. Varmus have travel plans for later this afternoon, so I
think it is best that we consolidate the two panels.
We have two distinguished ethicists with us. Dr. Leon Kass
is on leave from the University of Chicago, where he serves as
Addie Clark Harding Professor in The College and the Committee
on Social Thought. He is also a Fellow of the American
Enterprise Institute. In his spare time, Dr. Kass chairs the
President's Council on Bioethics. I understand that he appears
before us today in his individual capacity and not on behalf of
the Council or the administration. So we welcome you, Dr. Kass.
We are honored to have you here.
We are also fortunate to have with us today Dr. Tom Murray,
who serves as President of the Hastings Center, a non-profit,
non-partisan institution that focuses on ethical issues raised
by health and the environment. Among Dr. Murray's many
accomplishments was his service on the National Bioethics
Advisory Committee that studied the ethical issues attendant to
stem cell research during the previous administration.
We also have with us some respected scientists. Dr. Harold
Varmus is President and CEO of the Memorial Sloan-Kettering
Cancer Center, in New York. He also chairs the Joint Steering
Committee for Public Policy, a coalition that represents 50,000
biomedical research scientists.
Previously, Dr. Varmus served as the Director of the
National Institutes of Health, one of the most important and
prestigious positions in the world. Prior to his 6 years
leading the NIH, he was on the faculty of the University of
California in San Francisco. He was awarded the Nobel Prize in
Medicine in 1989 for his ground-breaking work in discovering
cancer genes called oncogenes.
Next, we will hear from Dr. Anton-Lewis Usala. Dr. Usala
wears two hats. He is Clinical Professor and Medical Director
at the Office of Clinical Trials at East Carolina University.
Dr. Usala is also CEO of Ectocelle, a start-up biotechnology
company that is attempting to develop mechanisms whereby a body
can regenerate its own cells.
Next, we will hear from Dr. Micheline Mathews-Roth. She is
an Associate Professor of Medicine at Harvard Medical School
and a physician at the Brigham and Women's Hospital in Boston.
Much of Dr. Mathews-Roth research has centered on a rare
genetic disease known as EPP. I will let Dr. Mathews-Roth
explain what this acronym means and how she developed an
approved treatment for this disease.
Finally, we will receive the testimony of Dr. Paul Berg,
who won a Nobel Prize in Chemistry for his ground-breaking work
in developing recombinant DNA technology. Dr. Berg is Cahill
Professor of Cancer Research and Biochemistry, and Director
Emeritus of the Beckman Center for Molecular and Genetic
Medicine at Stanford University. In addition, Dr. Berg serves
as the Chairman of the Public Policy Committee of the American
Society for Cell Biology.
Before we begin this panel, I want to urge all of you to
confine your oral presentation to 5 minutes, if you can, so
that we will have time for questions. Of course, we will put
your full, extended comments into the record so that we can
have them.
So we will proceed in the following order: Dr. Kass, Dr.
Murray, Dr. Varmus, Dr. Usala, Dr. Mathews-Roth, and we will
wind up with you, Dr. Berg, in the end.
Dr. Kass, we turn the time over to you, and thank you so
much for giving me your book this afternoon. I really
appreciate it.
STATEMENT OF LEON KASS, M.D., HERTOG FELLOW IN SOCIAL THOUGHT,
AMERICAN ENTERPRISE INSTITUTE, WASHINGTON, D.C.
Dr. Kass. Thank you very much, Mr. Chairman and Senator
Feinstein. I am very grateful to you for this invitation to
present some of my thoughts on human cloning, a topic about
which I have been thinking and writing for 35 years.
Mr. Chairman, I share your views that human cloning is
immoral, as I also share your wish to advance ethical
approaches to regenerative medicine. Human cloning constitutes
unethical experimentation on the cloned child-to-be, confounds
his genetic and social identity, represents a giant step toward
turning procreation into manufacture, and would be a despotic
attempt of parents to select and control the genetic makeup of
their children.
I conclude that human cloning threatens the dignity of
human procreation and that it should be banned. The question is
how best to do it effectively and ethically, with as little
interference as possible to potentially beneficial biomedical
research.
With all due respect, I regret to say that the approach
proposed in Senate bill 303 will not, in my opinion, do the job
that we want to have done. It offers an ineffective and even
counterproductive means of preventing the cloning of children.
It is ethically problematic. It offers inadequate regulatory
safeguards. And, in truth, I think it is unnecessary for
advancing the mainstream of stem cell research, both embryonic
and adult, about which the bill is, in fact, largely silent.
Before trying to back up some of these claims, I want to
speak first about the matter of terminology because the ethical
discussion we need to have is obscured by some confusing
language in the bill.
Whether undertaken for the ultimate purpose of producing
children or for the purpose of extracting stem cells for
research, the deed of nuclear transplantation itself is an act
of cloning. This is the deed that produces the genetic replica
and its product is in both cases identical. The product is a
cloned human embryo. This is the view of the earlier NBAC, and
also of the current President's Council on Bioethics, including
all of the members who actually support the kind of cloning for
research that this bill would endorse.
When identical cloned embryos are grown to the blastocyst
stage, their different fates depend solely on the purposes of
the human users--baby-making or research. The language of the
bill ``unfertilized blastocyst'' is confusing and has no
scientific currency or basis. And its definition as, quote,
``intact cellular structure'' hides the fact that this
structure is a self-developing embryonic human organism.
We should, of course, then have arguments, scientific and
ethical, about why it would be important or permissible to
create such cloned human blastocysts solely for research. But
if we are to have that argument forthrightly, we should not
hide from ourselves or others what we are doing and we should
not try to win this moral argument by definitional sleight of
hand.
Here, then, would be a summary of my reasons for believing
that a ban that tried to block cloning to produce children,
while permitting cloning for biomedical research, is a bad idea
and why I support a comprehensive ban on all human cloning. I
have four arguments. I will summarize the large points. The
details are in the written testimony.
First, I regard this approach as ineffective and
counterproductive. If wants to prevent the development of
anthrax bombs, we do best to block the production of anthrax
spores, not just their transfers to a weapon delivery system.
Similarly, if we mean to be fully serious about stopping
the cloning of human children, we should try to stop the
process before it starts, at the creation of the embryonic
human clones, not merely rely on efforts to prevent their
transfer to women for delivery.
A law such as S. 303 that tried to prevent cloning babies
by banning only implantation of cloned embryos would be
ineffective and unenforceable. It would be difficult to know
when the law had been broken; it would be impossible to enforce
it once it had. Further, by endorsing cloning for research,
such a law would, in fact, increase the likelihood of cloning
to produce children because it would allow the technique that
was required to be perfected in the process.
Second, I regard this approach to be ethically problematic.
Allowing cloned embryos to be produced for biomedical research
and stem cell extraction is highly problematic. It crosses
several important moral boundaries, accelerating our slide down
a slippery slope into a dehumanizing world of genetic control
of offspring and the routine use of nascent human life as a
mere natural resource.
I would single out only one of the subordinate points for
your attention. The use of cloned embryos in research, once
allowed, will be impossible to limit. The arguments that are
now used to justify creating cloned embryos to produce stem
cells will also justify growing these embryos beyond the
blastocyst stage. Experiments already done with cloned cow
embryos have shown the possibly greater therapeutic value of
fetal tissue derived from later stages. Any boundary you now
try to set up here will be overridden by scientific events.
Third, I believe that the regulation that is proposed in
this bill is inadequate, given the unique status and dangers
related to the creation of cloned embryos. They fall far short
of the regulatory recommendations even of those members of the
President's Council on Bioethics who are in favor of doing
cloning for research.
Last, and this would be a long discussion, I think that
cloning for biomedical research is unnecessary for promoting
the mainstream of regenerative medical research. The benefits
of embryonic stem cell research in both knowledge and potential
therapy do not require the creation of cloned embryos or stem
cells from cloned embryos.
The putative benefits of cloning research are at best
speculative at present and it is unlikely to be the solution
for the immune rejection problem. In contrast, a narrowly
constructed yet complete ban on all human cloning would not
interfere with stem cell research, adult or embryonic, using
the cells derived from non-cloned embryos.
In sum, even if no single argument above is by itself
decisive, their cumulative weight leads me to support a
comprehensive an on all human cloning, including the cloning of
embryos for research. Such a ban would be prudent, moral and
virtually cost-free, and it is the only real ban on human
cloning.
In contrast, a ban only on implanting cloned embryos would
be imprudent and morally dubious and would likely yield little
benefit that cannot be obtained by other morally unproblematic
means. Purporting to be a ban on reproductive cloning, it
would, in fact, increase the chances that cloned human beings
would be born, and sooner rather than later.
If I might take 30 seconds to conclude, Mr. Chairman, a
more general point on the current deliberations.
Chairman Hatch. Go ahead.
Dr. Kass. Opposition to human cloning to produce children
in America is overwhelming. 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, Mr. Chairman and Senator
Feinstein, that Congress will rise to the occasion and strike a
blow in defense of human dignity.
Thank you for your attention.
[The prepared statement of Dr. Kass appears as a submission
for the record.]
Chairman Hatch. Thank you, Dr. Kass. We appreciate your
testimony.
Dr. Murray, we will turn to you.
STATEMENT OF THOMAS MURRAY, PRESIDENT, THE HASTINGS CENTER,
GARRISON, NEW YORK
Mr. Murray. Senators Hatch and Feinstein, it is a great
honor to be asked to speak before you today. What I say I will
say with gratitude and respect.
First, briefly, I will address reproductive cloning. In the
6-years since the birth of Dolly the cloned sheep was
announced, the ethical case against reproductive cloning has
grown ever stronger. For one thing, the scientific evidence on
the dangers of reproductive cloning has progressed from
informed speculation to hard evidence.
Scientists are beginning to understand the specific and
powerful obstacles against reproductive cloning in primates.
Indeed, one soon to be published study will indicate that using
all the most advanced techniques in more than twice as many
attempts as were used to make Dolly, there has been no success
in cloning in monkeys. Trying to create a human child by
cloning would be grossly unethical human experimentation. I
think no one on the panel will disagree with that.
Furthermore, the reasons why anyone would want to try to do
reproductive cloning are themselves dubious. The most
sympathetic case for cloning to make a child is to try to bring
back someone, perhaps a child who died. The sad truth is that
this is an illusion. For one thing, reproductive cloning works
poorly when it works at all. Most cloned mammals die before or
shortly after birth. Those that survive are almost certainly
abnormal because of failures to reverse and redo epigenetic
programming or other problems.
If, despite the odds, a healthy child were born, it would
be the same child only genetically. There is little reason to
believe that this child would have the same personality,
temperament, enthusiasms or interests as its progenitor. That
child would live under a suffocating shroud of expectations
that it would be just like the fantasy, really, of the child
who was lost. And the parents would learn that there are no
technical fixes for grief. Grief is a lifelong affliction that
lies beyond the reach of science.
A law to ban human reproductive cloning, such as bill 303,
would be useful not to deal with the plague of human clones.
There is no such plague, and despite the claims of would-be
cloners, we can be virtually certain that there are no human
clones alive or likely soon to be born, no healthy ones at
least.
We need the law to deny all legitimacy to that handful of
entrepreneurs who are growing famous and wealthy with their
ludicrous boasts to protect gullible, desperate, or hopelessly
narcissistic people from exploitation, and most of all to
prevent the almost certain harm befalling any child born
through cloning. Such a law, I think, would be welcome by
almost all Americans.
The ethics of nuclear transplantation in research with
human stem cells presents a very different picture. The
commission of which I was a member, which has now sunsetted,
did a report that was issued in September 1999 on ``Ethical
Issues in Human Stem Cell Research.'' That report recommended
funding for research on human embryonic stem cells derived from
embryos left over after IVF, those embryos destined to be
discarded and explicitly donated for research by the couple.
That commission also proposed very stringent safeguards against
commercialization and coercion largely consistent with, I
believe, the language of 303.
An important point: The National Bioethics Advisory
Commission in its deliberations consulted not merely
philosophers, lawyers, doctors and scientists, but quite a
number of theologians, including from four great religious
traditions--Roman Catholicism, Protestantism, Judaism and
Islam. We found a great range of moral views within some of
those traditions and across them all. So to equate having a
religious view with a particular stance on human cloning or
embryonic stem cell cloning is, I think, a mistake.
The ethical arguments in favor of not criminalizing nuclear
transfer in human stem cells is straightforward. The most
compelling reason is that this research may contribute, in
time, to the relief of suffering and the postponement of
untimely death.
Success is, of course, not certain. It is also possible
that the greatest contributions to human health from research
cloning will come from the basic research it makes possible as
scientists create stem cell lines for an enormous variety of
diseases, cell lines that may allow us to understand and
ultimately treat or prevent those diseases. So nuclear transfer
in human embryonic stem cells is not merely about
transplantation, but a potentially incredibly powerful basic
science model for the study of an enormous range of diseases.
What is sometimes overlooked is the deep human truth that
suffering and death afflicts families, not merely individuals.
Our lives are entwined with the lives of others whom we love.
Their suffering and their death profoundly affects our own
lives. When we minister to suffering, we minister not only to
the individual, but also to all of those who love and care for
her or him. Any one of us who has loved someone who has
suffered or died knows the truth of this.
A second argument in favor of not criminalizing nuclear
transfer in human stem cells appeals to our moral, legal and
political traditions of freedom of speech and freedom of
inquiry. Americans value the quest for new frontiers. Today's
explorers are more likely to wear white coats and inhabit
laboratories than to paddle canoes.
But scientific inquiry is also obliged to respect moral
limits. That principle was resoundingly affirmed in the trials
of Nuremburg and in our own Nation's apology to the subjects of
the Tuskegee syphilis study. But when we have no consensus that
a particular form of research is ethically improper, the wiser
course is to allow people to follow their individual
consciences. This respects the value of freedom of inquiry
without forcing people to violate their own beliefs.
What reasons do people give for criminalizing nuclear
transfer to create stem cells? Well, it is one thing to decide
not to fund an activity because some Americans have moral
objections to it. If we applied that principle broadly, there
would be no funding of research on blood transfusion, or for
that matter on transfusions themselves on the grounds that
Jehovah's Witnesses object to transfusions, which they do. The
same would be true of all research using animals because many
Americans object to any scientific use of animals.
So it is one thing to object to funding and it is quite
another to create a new Federal crime for doing what the
majority of Americans do not find inherently wrong. We must
acknowledge that morally thoughtful Americans are not of one
mind on the moral status of 4- or 6-day-old blastocysts.
In my book, The Worth of a Child, I posed a challenge.
Imagine some entirely new ethical argument or scientific fact
that was introduced into the debate over the moral status of
the embryo that persuaded almost everyone on the other side
that they were wrong; they dropped their objection and they
agreed with you.
Now, notice I didn't say which side of the argument this
came down on because I cannot imagine such a new argument or
new fact. This is, I believe, not because people are impervious
to logic, but because our beliefs about embryos are woven into
a complex tapestry of other beliefs, about what it means to be
a woman, a man, a child, about the value of families, about the
importance of being a nurturing parent. This tapestry of
beliefs and commitments affects everything, from our attitudes
toward sex discrimination in employment, to the importance of
family leave, to education opportunities for women, and to the
moral status of embryos.
Respecting the diversity of sincere and thoughtful beliefs
about families, about women, men, children and embryos honors
our most noble traditions. Where there is a clear and ringing
consensus, as there is against cloning to create a child, let
us act on it. Where there is a profound and principled
disagreement, let our laws respect that.
Declining to fund research can be an honorable choice and a
wise public policy, depending on the circumstances. But sending
scientists to prison for 10 years and subjecting them to fines
of $1 million or more devalues and dismisses the ethical views
of the very many Americans for whom the possibility of
alleviating suffering justifies research cloning.
Just yesterday, I was with Rabbi Elliot Dorff, who is the
chief rabbi at the University of Judaism in Los Angeles. Rabbi
Dorff informed me that the three major strands of American
Judaism--the Reform, Conservative and Orthodox traditions--have
jointly issued a teaching that research on human stem cells is
not merely permitted, but obligatory, if it has any hope of
dealing with human suffering, disease and death. We would be in
a very curious position indeed if we passed a law that sent
someone who was following what they believe their religious
tradition requires them to do to prison for 10 years for doing
so.
Thank you very much.
[The prepared statement of Mr. Murray appears as a
submission for the record.]
Chairman Hatch. Thank you, Dr. Murray.
We will turn to Dr. Varmus now. We welcome you back to the
Committee and look forward very much to hearing your testimony.
STATEMENT OF HAROLD VARMUS, M.D., PRESIDENT, MEMORIAL SLOAN-
KETTERING CANCER CENTER, NEW YORK, NEW YORK
Dr. Varmus. Thank you very much, Mr. Chairman and Mrs.
Feinstein. Thank you for a chance to discuss the contentious
issues that have been raised by the possibilities of human
cloning.
Two bills are now before the Senate which seek to ensure
ethical behavior in this new research arena. Both bills would
ban efforts to create cloned human beings, an appropriate
prohibition given the unsafe nature of the procedure you have
heard detailed by Dr. Murray.
However, the bill by Senator Brownback and his colleagues
would set an unfortunate precedent. It would criminalized
scientists, doctors and patients who pursue the benefits of
some parts of cloning technology, even if those steps were
taken without any intention of making a cloned human being.
Your bill, Mr. Chairman, would allow those benefits to be
pursued under the kinds of regulatory guidelines that have
worked well for medical science in the past.
Now, before returning to the legislation, let me briefly
outline, at your staff's request--I hope this will allow me to
have an extra minute or two--the science involved, beginning
usefully with the widely practiced procedure of in vitro
fertilization, shown on the first chart.
In IVF, as in normal human reproduction, a single sperm
fuses with or fertilizes an egg in a dish, forming a cell that
divides several times to produce an early embryo called a
blastocyst. At this point, the cells are disordered; they lack
any characteristics of specific organs or tissues.
Now, if the blastocyst is transferred into the uterus, a
pregnancy may result, and after a complex process of
development a child might ultimately be born. If, instead of
implanting the blastocyst, its immature cells are grown in a
culture dish, as shown on the far right, they can divide and
under appropriate circumstances can develop into various kinds
of cells and tissues.
Now, these so-called embryonic stem cells are a valuable
by-product of IVF and have enormous potential, as you have
heard, for discovery and therapy. Fortunately, for the hundreds
of thousands of families with children born as a result of IVF,
this procedure was not banned and it was not criminalized when
introduced in the 1970's, even though it was obvious even then
and known in practice now that many blastocysts would remain
unused and might eventually be discarded, as indeed they are
today.
Likewise, it is permissible to derive embryonic stem cells
from blastocysts without imposition of criminal penalties as
long as Federal funds are not used. In fact, some existing stem
cell lines can even be studied with Federal funds, with
regulatory oversight.
Now, unlike IVF which begins with the union of sperm and
egg, cloning begins with the transfer of an intact nucleus from
a mature cell to an egg from which the nucleus has been
removed. That is shown on your left.
As experiments with animals have shown, this procedure can,
surprisingly to all, generate a blastocyst that is similar or
identical to the one produced by fertilization. And if this
unfertilized blastocyst were transferred to a uterus,
development into an infant could conceivably occur, although
judging from animal experiments, as you have heard,
inefficiently and imperfectly.
Embryonic stem cells can also be generated from these
blastocysts for study and therapeutic use, as they would be
after IVF, but with the important advantage that they could
usually be transplanted without rejection to the individual who
donated the nucleus.
So, Mr. Chairman, let me return to the question of why I am
unhappy with the bill proposed by Senator Brownback and happy
with yours. Most importantly, his bill would ban all of the
steps shown in that second chart. Your bill would selectively
and judiciously ban only the transfer of an unfertilized
blastocyst into the uterus, preserving the benefits and
forbidding the abuses of these methods.
But there are also four other issues I would like to
mention briefly. First, I am troubled by the precedent of
imposing criminal penalties on scientists, doctors and
patients, even on patients who might return after treatment
abroad.
In the past, we have had ethically-sensitive science
regulated in a variety of means, by Federal guidelines, for
example, for work on recombinant DNA where Dr. Berg had a major
role, and on gene therapy; regulated by prohibitions on the use
of Federal funds, for example, as we have today with embryo
research; or by classification, as for military research.
Criminalizing the science I have described is unnecessary,
unjustified and unprecedented. Further, by threatening to
impose fines and imprisonment on well-meaning scientists, it
sends a signal that could undermine the confidence of our
remarkable research enterprise in this country.
Second, legislative solutions tend to be inflexible, so
rapidly changing science is a poor target for legislative
remedy or control. The NIH and other Government agencies have
shown repeatedly that they are well-equipped to oversee ethical
conduct in research.
Third, advocates for the Brownback bill, for the complete
ban on all steps in nuclear transfer, have obscured the
profound differences between studying immature human cells in a
culture dish and making a cloned human being. Unlike the
allegations made by Dr. Kass, there is no slippery slope here.
The boundary between the two activities is broad and
unambiguous. Federal rules and medical guidelines can easily
delineate them.
Under your bill, Mr. Chairman, crossing that clear boundary
by trying to introduce cells into a uterus could lead to
prosecution. The regulatory guidelines under your bill would
require responsible Government oversight by the NIH or others,
informed consent by cell donors, a 14-day limit on the growth
of early embryos, physical separation of this activity from IVF
clinics, and other things.
Finally, the draconian legislation proposed by Senator
Brownback and others shows inadequate appreciation for the pace
and difficulty and for the long-range promise of science. Let's
face it, we are just beginning to understand how a fertilized
egg develops into a mature organism. Embryonic stem cells
derived from fertilized and unfertilized blastocysts have
incredible potential to tell us how the instructions for making
an organism are laid down, how they can be reversed, how they
might be reconstituted, for example, to convert liver cells to
nerve cells.
Now, if we pursue such studies, we will discover great
truths, and later use those truths in ways that are now
difficult to predict to benefit patients who suffer from
disease and disability. But if we don't, somebody else
somewhere else surely will.
This year's 50th anniversary of the discovery of the DNA
double helix provides a vantage point for thinking about these
problems. In 1953, it was evident that DNA embodied genes and
that its structure was profoundly significant, but it was very
difficult to know what we would learn by studying it.
Fortunately, no one proposed that studies of human DNA
ought to be banned. But if there had been prohibitions on the
study of DNA, we might not now, 50 years later, have, for
example, a vaccine for hepatitis B virus, drugs to protect the
bone marrow of patients undergoing cancer therapies, tests to
alert people to their risks of certain diseases, or a powerful
new way, Mr. Chairman of the Judiciary Committee, to exonerate
people who have been falsely imprisoned.
With recent advances in the study of cells and the human
genome, we have now, in fact, arrived at the starting line in a
race to understand biology and to help the disabled with that
knowledge. It is too early to know how to get to the finishing
line, whether it is through embryonic stem cells derived from
fertilized or unfertilized blastocysts or from adult stem
cells.
So I must finally ask why should any Member of Congress
wish to punish those who wish to learn and to treat when we
have so much more to learn, and who has such moral authority
that they would impose on our pluralistic society an ethical
standard that only a portion would endorse?
Thank you, Mr. Chairman, for my chance to express these
views and I will be pleased to answer any questions you might
have.
[The prepared statement of Dr. Varmus appears as a
submission for the record.]
Chairman Hatch. Thank you so much, Dr. Varmus. We
appreciate having you here.
Dr. Usala, we will turn to you.
STATEMENT OF ANTON-LEWIS USALA, M.D., CLINICAL PROFESSOR AND
MEDICAL/ADMINISTRATIVE DIRECTOR, OFFICE FOR REGULATORY REVIEW
OF CLINICAL TRIALS, EAST CAROLINA UNIVERSITY, GREENVILLE, NORTH
CAROLINA
Dr. Usala. Thank you, Senator.
In order to replace the function of destroyed patient
tissues in human disease, cellular transplant material obtained
from developing cloned embryos must first overcome the problem
of appropriate integration into the transplant site. Without
such integration, recovery of clinical function is not
possible.
Scientifically, it may make more sense to induce the
patient's own tissues to replicate at the injury site. If the
patient's own tissue could be induced to regenerate the 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 while with my first biotech
company which I left 18 months ago and currently have less than
a 1-percent equity interest in.
My hypothesis was that exposing cells to an environmental
structure similar to that present during natural embryogenesis
would induce the same explosive generation in tissue even in
already mature cells, as the DNA template remains the same from
the point of conception until death.
This injectable material was made from modified naturally-
occurring cow pounds synthetically polymerized to give the
desired structure. The product contained no cells, only
structures that patient cells would bind to upon injection at
the damaged tissue site. The results I am about to show have
been presented at several scientific meetings and have been
recently submitted by the principal investigator from the
University of North Carolina at Chapel Hill to a peer-reviewed
journal.
Shown is an example of the rapid wound healing induced in a
dog that had naturally-occurring diabetes and had developed
multiple full-thickness skin ulcers, similar to foot ulcers
seen in diabetic human patients. 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 wounds healed with regenerated tissue. And as
you can see on the left side of the screen, we injected around
the periphery of the lesion on that particular ulcer which was
full thickness down to the bone. Within 6 days, it had
generated skin and hair follicles. I was excited about the hair
follicles. The new tissue resulting from exposure to the
embryonic-like matrix was determined to be structurally
identical to non-wounded areas.
This photo micro graph shows the result of injecting this
synthetic biopolymer into an adult dog's liver. After 3 weeks,
the section of liver was removed and brought to Dr. Ron Dudek,
a medical embryologist, for interpretation. Shown are cells
that have the appearance of undifferentiated mesenchymal cells
morphologically similar in appearance to stem cells apparently
associated with differentiating fibroblasts and more mature
endothelial cells. Endothelial cells are the cells that make up
blood vessel walls.
Nucleated red blood cells found in large quantities only
during fetogenesis are found in the newly formed blood vessels,
apparently differentiating from the lining of the endothelial
vessel wall. This process occurs only during fetogenesis as red
blood cells, without nuclei, are made in the bone marrow later
in development which does not exist early in fetal development.
Further large and small animal studies confirmed our
finding, and a six-page feasibility study was reviewed by the
Food and Drug Administration to examine the effect of a one-
time injection in patients with chronic diabetes foot ulcers
refractory to conventional therapy.
What we are looking here is the foot ulcer from our first
patient who had diabetes for 20 years, and this ulcer was
present for 4 years. The ulcer is down to the lining of the
bone in the heal. Just to orient the audience, what we are
looking at is the heal down to the middle of the slide and the
toes would be off to the north side of the slide.
This is the appearance of the ulcer 15 minutes after the
one-time injection. And, again, we injected the embryonic-like
scaffolding around the perimeter and then through the center to
try to get the damaged cells exposure to the embryonic matrix.
Within 7 days, we had what we termed explosive generation of
tissue. This has the morphology of fetal-type tissue, with the
soft, glassy appearance.
Over the course of two or 3 months, the tissue continued to
mature. This is at 2 weeks, 4 weeks, 2 months, and 3 months.
Again, this was a man who couldn't really walk for 4 years
because of the ulcer and he had gone every other week for that
time to the University of North Carolina wound treatment
center. Two months after this photo was taken, he was able to
dance at his daughter's wedding.
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.
Because these are human patients, it was unethical for us to
take biopsies, as these ulcers were unhealing before we
injected our matrix. However, in large-animal studies we did
confirm that we had new tissue that was morphologically correct
for that area.
Since the new tissue derived from the patient's own tissue,
there was seamless integration with no evidence of rejection.
It is important to remember, however, that 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.
Shortly after conception, an individual is created with a
new DNA template that begins the process of differentiation
that continues until death. Transplantation strategies, whether
derived from foreign donors or cloned cells from the patients
themselves, are clearly not the only approach to replace
damaged tissues. Such transplantation strategies require
destruction of the newly formed individual DNA template.
Other avenues are further along in clinical trials in human
beings and should be considered as a first approach for study
that do not require destruction of a new human embryo. Indeed,
the patient's existing cells provide the most rational source
for fully integrating replacement tissues, as occurred during
natural embryogenesis.
Thank you, Senators.
[The prepared statement of Dr. Usala appears as a
submission for the record.]
Chairman Hatch. Thank you, Doctor. We appreciate it.
We will now turn to Dr. Mathews-Roth.
STATEMENT OF MICHELINE M. MATHEWS-ROTH, M.D., ASSOCIATE
PROFESSOR OF MEDICINE, HARVARD MEDICAL SCHOOL, BOSTON,
MASSACHUSETTS
Dr. Mathews-Roth. As you were saying, I do work on a
genetic disease called erythropoietic protoporphyria, but since
nobody wants to say erythropoietic protoporphyria, that is why
we call it EPP. I did develop what is the FDA-approved
treatment for EPP, and my collaborators and I have cured the
mouse model of EEP with gene therapy aimed at the bone marrow
stem cells.
I also want to say that I want to make it clear that I am
not speaking as a representative of either Harvard Medical
School or the Brigham, but as an individual physician and
medical researcher. My testimony wants to give you some
scientific facts you should know about therapeutic cloning.
The science of embryology tells us that all human beings
start their lives as one cell which we call the zygote, and I
am sure the gentlemen here know that because they took
embryology. The zygote of a cloned embryo, whether it is made
for reproductive cloning or for therapeutic cloning, is the egg
donor's oocyte whose nucleus was removed and to which the
nucleus of the person to be cloned was added.
So it is scientifically incorrect to say that a human life
begins in the mother's womb. By the time the growing embryo,
cloned or otherwise, implants in its mother's womb, it is
already about 5 days old and at the blastocyst stage of
development.
Embryos growing in a mother or made by IVF or made by
reproductive or therapeutic cloning go through the identical
stages of development. In fact, the publication called
``Scientific and Medical Aspects of Human Reproductive
Cloning,'' put out by the National Academy of Sciences, shows
in a diagram--and I have that as part of the hand-out that I
gave you, and it shows that the development up to the
blastocyst stage of an embryo which is made for reproductive
cloning and an embryo made for therapeutic cloning is exactly
the same. This is science, not philosophy.
At the blastocyst stage, all contain the inner cell mass
which is the group of embryonic stem cells. There is some
differentiation between the inner cell mass and the layer
around the inner cell mass, in that there are some antigens
that are present in the outer layer that are not present in the
inner cell mass. The outer layer of the blastocyst which is
broken open is what is going to become the placenta. So there
is a difference. There is already differentiation between the
inner cell mass cells and the cells around the outside of it.
Now, the important thing for everybody to realize is that
presently the only way that embryonic stem cells can be
obtained from any embryo is to break open the embryo of usually
5 to 7 days of life and remove them. This obviously kills what
we know from science is a growing human being, a very young
human, but nevertheless an individual member of our species.
I want to point out an error in the S. 303 bill which I
think was alluded to by Dr. Kass. There is no such thing as an
unfertilized blastocyst. The somatic cell nucleus of the person
to be cloned which was put into the oocyte was formed by
fertilization. That nucleus has its full component of 46
chromosomes, as does the nucleus of every cell which will form
when the cloned zygote starts to divide.
So a cloned baby or cloned cells for therapeutic cloning
has two genetic parents, the mother and the father of the
nucleus donor. The clone is essentially an identical twin of
the nucleus donor. There is no such thing, as I say, as an
unfertilized blastocyst or an unfertilized egg. If there is an
unfertilized egg, it is got half the number of chromosomes that
you and I have.
Cells and tissues derived from cloned embryonic stem cells
can still cause problems in the recipient of the cloned
material, and this again was pointed out in the National
Academy of Sciences' report. They can cause immunologic
rejection problems, and this is caused by the mitochondria in
the cloned tissue which comes from the egg donor's cell. So
they are foreign to the recipient.
Mutations and imprinting and programming errors occurring
in the early cloned embryo--and they will occur in any early
embryo and these would be transmitted to the cloned cells and
the cloned tissues.
In addition, everybody knows that teratoma formation, these
odd tumors, are very common to embryonic stem cells when you
transplant them into animals, and these still exist with cloned
embryonic stem cells. In fact, there is a recent paper--I think
it is just with embryonic stem cells, though--that they
transplanted some embryonic stem cells into knee joints of a
rat, I believe, and ended up getting whopping teratomas which
made the poor little rat lose its legs.
Physicians are obliged to give complete and accurate
information about treatment options to their patients. So
patients receiving IVF embryo-derived or therapeutic cloning-
derived stem cells will need to be clearly informed that a very
young human, and in the case of therapeutic cloning their very
young identical twin, will need to be killed to obtain the stem
cells needed for this treatment.
I notice that this was not mentioned--informed consent to
the recipients was not mentioned in this bill. Now,
interestingly enough, the society that is concerned with IVF,
the American Society for Reproductive Medicine, has a statement
that says, ``Couples should also know that ES cells research
typically involves deriving cells from the inner cell mass of
an embryo at the blastocyst stage which leads to the embryo's
destruction.''
I will repeat that: ``that ES cells research typically
involves deriving cells from the inner cell mass of an embryo
at the blastocyst stage which leads to the embryo's
destruction.'' So they are saying parents who donate their
embryos should be informed that embryo research kills what we
all know from embryology is a little growing human.
The people who receive cloned tissues should also be
informed of this. If these facts are withheld from the
patients, then the physicians are being intellectually
dishonest and the scientists are being intellectually dishonest
if they don't inform people about the fact that they are
getting products that are being made unfortunately by the
killing of a member of our species. They will have failed in
their obligation to the patients to provide enough information
so that patients can give truly informed consent to their
treatment.
As a physician doing research and dealing with patients
like this, I know, and I am sure Dr. Varmus knows because he
is--you are practicing, aren't you?
Dr. Varmus. No.
Dr. Mathews-Roth. You are not, okay; you are in research.
But those of us who deal with patients know how important
it is to give our patients all the information they need to
make truly informed consent. We can get into trouble if we
don't. In fact, some patients may choose not to undergo stem
cell treatment if they learn that killing a young human is
involved. And if they find out after the fact, if the
scientists weren't honest enough to tell them that, they may be
angry enough to sue their doctors. And if you think we have got
problems with malpractice now, this is going to add to it. So I
think this is a very serious thing.
It is to everyone's advantage that potential patients be
informed that to obtain stem cells, a young growing human being
has to be killed. So are we denying treatment to our patients
if we deny them the use of embryonic stem cells? I don't think
so.
Certain kinds of adult stem cells can be transformed into
many kinds of cells needed to treat serious diseases, not just
stem cells that are characteristically found in one organ.
There are some bone marrow-based stem cells that have indeed
been shown to be able to be transformed into many different
kinds of organs, and this is not fusion and it is not some
little laboratory's strange finding.
For example, Dr. Catherine Verfaillie has discovered what
she calls multipotent adult progenitor cells in human and mouse
bone marrow which can be made to differentiate into cells from
all three embryonic layers. I heard her not too long ago at
Harvard and she really thinks that these have great
possibilities to make a lot of different organs. They don't
form teratomas. They can multiply extensively.
In fact, this was one of her points that they can multiply,
and she showed a comparison slide between them and embryonic
stem cells and they can do, as far as expansion and things are
concerned, just about what embryonic stem cells can do. So they
have this great potential and they multiply a lot, and they do
this without losing their potential to differentiate into
different tissues.
This is one of the problems I have with hematopoietic stem
cells right now, that if I try to expand them, they end up
differentiating to red cells or white cells and I really don't
have enough time to put my gene therapy stuff in. I have a
small window and I can only just transform so many. But with
her MAPCs, you can grow them and make lots and lots of the
undifferentiated cells. So you would have a greater opportunity
to transform them with the gene therapy that you want to do,
with the genes that you want to add. So these are cells that
have a lot of promise to them.
Dr. Eliezer Huberman, for another example, has found a cell
from peripheral blood which can also multiply easily and can be
differentiated into endothelial cells, nerve cells and liver
cells. So here is another example of another kind, and there
are many in the literature. Papers come out everyday. I mean,
it is hard to keep up with the literature. Reviews are being
written, new papers are coming up. It is hard to make definite
statements, oh, embryological stem cells are better than adult
stem cells. Time will tell. But the unbending embryological
fact is if you take an early embryo, you are destroying a human
life. And this is not going to change; this is not philosophy,
it is embryology.
To summarize, do we as a country, and especially people
with diseases who might be helped by stem cell therapy, really
want to sanction the practice of deliberately starting the
lives of members of our own human species for the sole purpose
of killing them to harvest their useful parts, especially when
there exists the alternative of using adult stem cells?
If you check the literature on adult stem cells, you will
find that, at least in animals and starting in humans, one can
make with them the different kinds of cells that people really
want to use in therapy, like heart cells. There are some
examples of pancreas being made; also, blood cells and
different kinds of cells. There are other examples of other
kinds of adult stem cells that you could harvest that will
differentiate. So, again, this is a tough ethical question. Do
we want to justify this?
So I will close with say you, our legislative leaders, had
better think long and hard about this because if you allow, by
law, the production of embryonic stem cells from either extra
IVF embryos or from embryos made by therapeutic cloning, you
are going to be sanctioning this killing of early humans.
Now, it is hard to say at this point whether embryonic stem
cells or adult stem cells are going to be better, but I would
say work with animals, work with primates, see what you can do
in primates, see what you can do in mice, and work like heck
with adult stem cells. But remember that if you do this in
humans, you are killing members of our species.
I know a lot of the scientists who are working with adult
stem cells will just say, oh, but I still think we ought to
keep on working with embryonic stem cells. It is still killing
humans. Do we really want to get into that?
Thank you.
[The prepared statement of Dr. Mathews-Roth appears as a
submission for the record.]
Chairman Hatch. Thank you, Doctor.
Dr. Berg, you have your work cut out for you here, and I
want to know if you differ with Dr. Mathews-Roth.
STATEMENT OF PAUL BERG, CAHILL PROFESSOR EMERITUS OF CANCER
RESEARCH AND BIOCHEMISTRY, STANFORD UNIVERSITY MEDICAL CENTER,
PALO ALTO, CALIFORNIA, AND CHAIR, PUBLIC POLICY COMMITTEE,
AMERICAN SOCIETY FOR CELL BIOLOGY
Mr. Berg. Well, one of the disadvantages of being last on a
panel of six is that everybody has said some of the things that
I wanted to say. I will be brief, but I do want to specifically
address Dr. Mathews-Roth's comments.
First of all, let me just say that the congressional and
public debate about cloning people is, I believe, a non-issue.
Very few, if any, reputable biomedical scientists condone
attempts to produce a cloned human being. A distinguished
National Academy of Sciences panel that considered this issue
concluded that it is dangerous and likely to fail, as we heard
from Dr. Murray.
In short, the risks to the mother and any fetus that would
result from the procedure are unacceptable. If for no other
reason than this, your bill, S. 303, and Senator Brownback's
bill, S. 245, are in agreement in mandating a legally
enforceable ban on reproductive cloning.
Dr. Kass raised the issue of this impasse and allowing us
to continue in a situation where there is no prohibition on
that, and his concern, which is many people's concern, that
this will move ahead if there is no such prohibition. So in one
sense, we have the opportunity to agree on this one issue: We
are all opposed to the cloning of human people and we ought to
then produce legislation that will enforce that claim.
But in contrast to Senator Brownback's proposed
legislation, your bill takes, I believe, a more enlightened
position in permitting the somatic cell nuclear transplant
procedure for research and therapeutic purposes. This research
is supported by overwhelming scientific opinion because the
technology may enable us to develop new forms of therapies for
some of the most debilitating diseases and crippling
disabilities.
Presently, there are only proofs of principle behind this
optimism, but these strongly suggest that if scientists are
permitted to explore these opportunities, their benefits can be
achieved. I believe we are ethically and morally obligated to
pursue them for the benefit of those who suffer.
Now, a particularly promising opportunity that is also
foreclosed by the Brownback bill is the preparation of stem
cells using cell nuclei from individuals with inherited
mutations, particularly ones that pre-dispose them to an
increased probability for developing a variety of life-
threatening and debilitating illnesses in late life.
Examples include breast, colon, prostate and other cancers,
as well as heart, neurological and autoimmune diseases. Such
currently unavailable stem cell lines would provide a new way
to explore how these life-threatening, late-onset diseases
develop, and they could possibly generate clues to their
prevention or cure. Such studies might help reveal the
interrelations between inherited and environmental
contributions that govern much of the balance between health
and disease.
So in the end, I think, as was said earlier, we need
safeguards, not a ban, and I think your bill includes
safeguards as the predominate way to regulate this type of
scientific research.
Both Congressman Weldon and Senator Brownback, and we have
just heard Dr. Mathews-Roth, have accepted the assurances of
their advisers that adult-derived tissue-specific stem cells--
that is, specialized stem cells that already exist in many of
our tissues--are sufficient for meeting the needs for
therapeutic repair of damaged or diseased tissue. Many of these
claims are contentious, for they rely on experiments that often
have not been replicated and in some cases are known to result
from artifacts.
But I believe here is not the place nor the time to debate
the relative therapeutic prospects of adult-derived versus
embryonic stem cells. There are scientific issues, there are
deep issues, there are huge disagreements. Just as in the law
profession, conjecture and hearsay are not considered evidence.
Much of what we have learned and heard about adult-derived stem
cells doing the magic wonders of curing everything are, in my
view, still hearsay and conjecture. And unless they are
replicated on multiple occasions and verified, I would not
accept that adult stem cells can do the entire job.
Having said that, it is quite clear that the people who
support--and I consider myself one of them--going ahead with
embryonic stem cells are not opposed to work on human adult
stem cells. The President, in his address on August 9, 2001,
encouraged research along both lines. It is the people who are
working with adult stem cells who want to prohibit work with
embryonic stem cells.
I believe that most scientists working in this field
recommend strongly, as do I, that research with both adult and
embryonic stem cells should proceed vigorously, so as not to
delay or forgo the benefits for patients. Just such a
recommendation was actually made in a letter to Senator Specter
last year by Dr. Catherine Verfaillie, whom Dr. Mathews-Roth
cited as providing us with cells that are going to obviate the
need for embryonic stem cells.
She writes, ``It is far too early to say whether the adult
stem cells will stack up when compared to embryonic stem cells
in longevity and function. There are still too many unknowns
for researchers or policymakers to begin closing doors to
opportunities of learning.''
Given the present state of our knowledge, I believe it is
premature to choose one line of investigation over the other.
Doing so could prove to be as great a historical embarrassment
as when the Soviets bet on Lysenko's prejudices against
genetics and lost out on improving their own agricultural
productivity and on an entire generation of genetic science and
geneticists and scientists.
One justification for the criminalization of the nuclear
transplant procedure is to guard against rogue attempts, or the
slippery slope argument, to implant the product into a woman's
uterus for the purposes of creating a cloned child.
But like any socially deviant behavior, we can discourage
this with appropriate punishment. We punish murder under
criminal statutes, but we fail to criminalized possession of
the weapons used for the crimes. Prohibit what we all agree is
presently an objectionable practice, but protect the means for
producing life-saving therapies. And we should not be
threatening to put people in prison for seeking cures for
themselves or their children, even if those therapies were
developed elsewhere.
Now, we take considerable pride in being a pluralistic
society, so there must be ample room for differences concerning
the moral and ethical interpretations of early and intermediate
stages of human development. We have heard some of that debate
from Dr. Murray and from Dr. Kass. I think we have to be very
careful in not foreclosing or acknowledging these alternative
and legitimate views because they can mean the difference
between life and death for many of our citizens.
I want to point out that even on the President's Bioethics
Commission which studied this issue for at least half a year,
they still were split in their decision or conclusions. Forty
percent of the members of that commission came down in support
of somatic cell nuclear transplantation being permissible. That
reflects in large part, I think, the kind of diverse views that
exist in society.
I think Harold made an important point that, given that
kind of split, dare we then foreclose for those people who are
in dire need the opportunity to develop the cures? And I hold
out that adult stem cells and embryonic stem cells don't at the
present time tell us which is the better, but we should
certainly not ignore or make a premature bet today on choosing
one and then allowing 5 years to pass before we decide we have
made the wrong bet.
Thank you.
[The prepared statement of Mr. Berg appears as a submission
for the record.]
Chairman Hatch. Well, thank you so much.
Let me ask a question of the two Nobel laureates, Dr.
Varmus and Dr. Berg. Some, including Senator Brownback and
Representative Weldon and Mr. Jim Kelly this morning, suggest
and sometimes assert, as you have said, that the scientific
evidence to date suggests that adult stem cell research is
sufficient or even appears to hold more promise than embryonic
stem cell research.
I would like to know what the prevailing view is among
scientists today--and both of you have as good a handle on that
as anybody--and what, if any, are the unique advantages of
embryonic stem cells, including stem cells that might 1 day be
derived from nuclear transplantation research.
Can we go to you first, Dr. Varmus?
Dr. Varmus. Thank you, Senator. Let me make a few points
about this debate. Fundamentally, I think you have heard from a
few of us already that it is very difficult to say in this very
short time that we have had to work on embryonic stem cells
what will prove to be the most effective as a source of therapy
in the long run. But let me just reflect on a couple of things.
First, it is important to point out that we, as physicians,
have been using adult stem cells in therapy for some time for
treatment, for example, of loss of bone marrow capacity. So we
have known that you can take a cell that has the capacity to
regenerate itself and to make a multiplicity of cell types--for
example, different blood cell types--and use that in therapy.
We know that the adult has cells that regenerate and can
make different kinds of cells, not all kinds of cells and not
appropriate for treating most kinds of diseases, but for some.
So there is a long head start here. There is no doubt that the
study of adult stem cells ought to continue, and in a very
vigorous way.
But let me make the more important point, which is that in
my estimation one of the most remarkable things that has
happened in modern science is the discovery that you can take a
nucleus from an adult cell, put it into the environment of an
egg and basically reprogram it so that it losses its ability to
regulate expression of its genes in a way that was appropriate
for the cell from which it came, wipes the slate clean and has
the capacity to make cells of virtually any type. That is a
fundamentally thrilling point of view that should inspire us to
think about how it happens.
The reason I tried to emphasize the long view here, the
fact that it has taken us 50 years to go from an understanding
of the double-helical nature of DNA to have all these
remarkable accomplishments that followed the study of DNA, is
to point out that we have a long road ahead of us.
My dream is that we learn over the course of the next
decade or two the way in which a cell nucleus can become
reprogrammed, and that we develop very simply tools so that
ultimately we can take a cell from an adult with a disease and
reprogram that cell appropriately. We are not going to learn
how best to do that if we follow only limited leads, restrict
ourselves in our approach to the science and don't give
ourselves adequate time to understand what it takes to make the
kinds of contributions to science and to medicine that are
never accomplished in less than decades.
Chairman Hatch. Thank you.
Dr. Berg?
Mr. Berg. Yes. I would like to just reiterate what Dr.
Varmus just said particularly about the use of the
hematopoietic stem cell. What has been shown is that you can
isolate from bone marrow a specific type of cell which by
itself, injected into animal whose bone marrow has been
destroyed, repopulate the bone marrow and produce all of the
blood cells. So we know the hematopoietic stem cell, which is
an adult-derived stem cell, does, in fact, have the property of
being able to differentiate into all of the blood cells.
But in experiments that have been done now several times,
that cell is incapable of populating any other tissue in the
body. The experiments have been done by introducing just a
single cell into an irradiated animal, repopulating or
reconstituting the bone marrow, and then searching every tissue
in the body for any trace of derivatives of that cell. And the
answer is none have been found.
What has been found is that there are artifacts which can
explain a lot of the data that is out there because sometimes
these derivative cells confuse with existing cells in the
tissue. So when you looked at the fused cell, the occasional
one that occurs, you think it is derived from the original
input cell. But it is, in fact, not derived; it is a product of
fusion. This has now been documented in a number of
laboratories.
So many of the people who work in this field are now
concerned that many of the claims that are out there are, in
fact, artifactual. I think that has to be sorted out just like
any other scientific issue on which there are opposing views or
appears to be opposing evidence. But in the end, the way
science proceeds is verification by duplication and continued
repetition to establish that as a scientific fact.
We can't live with just conjecture and people giving
lectures and claiming this or not, saying there is a paper in
press, or it appears in a newspaper, or my uncle called me and
told me that this is a possible cure. That is not science, and
if we are going to make law on that kind of conjecture, then I
think we would be making a terrible mistake.
Dr. Mathews-Roth. Can I just add to that? I agree that
there have been some papers that have shown cell fusion, but
there have also been recent papers to show that there hasn't
been cell fusion. And you can take indeed one--and it is not a
hematopoietic stem cell; I think it is further back in the stem
cell's evolution, more primitive--that can indeed not only form
hematopoietic tissues, but have been found in other tissues in
the body.
And again going back to our mutual friend, Catherine
Verfaillie, she has shown that her MAPCs, without fusion, can
form cells that are characteristic of tissues of all of three
embryonic layers, what they call endoderm, ectoderm and
mesoderm. And these studies--some of them have been confirmed,
some of them have not. This is true.
Dr. Berg is right. There are some specialized stem cells in
almost each tissue that will only make that tissue, but we have
as adults also non-specialized stem cells which have a
repertoire of being able to make a couple of different tissues.
And it is not fusion; it is just a characteristic of these a
little bit more primitive cells.
And I want to assure Dr. Berg that people who are
interested in stem cells aren't afraid of competition from
embryonic stem cells. I think what should happen is the ideal
situation would be at this time ban embryonic stem cell work on
people; work with the lines that are already available, don't
make new ones. Don't make embryos to kill them, but work with
animals, do the same experiments that you would want to do in
primates, especially primates, because we are primates. Let's
face it, monkeys are our closest relatives. If it is going to
work in a monkey, it will probably work in man.
With all due respect to the animal rights people, I think
it would be better to sacrifice animals than growing little
humans. No matter what you want to do, you have to remember the
basic principle of embryology: you are still killing a growing
human if you are going to work with a blastocysts, with these
early cells.
Chairman Hatch. Dr. Berg, you seem to indicate that you
disagree with some of----
Mr. Berg. I am sorry. I didn't hear that.
Chairman Hatch. Were you in agreement with what Dr.
Mathews-Roth said?
Mr. Berg. She said a lot of things that I am not in
agreement with, but are you saying----
Chairman Hatch. I saw you shaking your head and I thought
you were in disagreement.
Mr. Berg. One of the things which I neglected to mention,
unfortunately, is hematopoietic stem cells which can do this
wondrous thing of repopulating bone marrow cannot be grown at
the present time.
Dr. Mathews-Roth. That is right, they can't.
Mr. Berg. There is no way to propagate them.
Dr. Mathews-Roth. Yes.
Mr. Berg. Most of the so-called adult-derived stem cells
have not been grown. There is no way to amplify them to be able
to even use them for therapeutic purposes. There is good
evidence that some of the cells which reside in the various
tissues are circulating most of the time. So when people take
bone marrow and then use the words ``stem cells,'' they are
using the words to describe a complex mixture which we really
don't have well characterized. I almost likened it one time to
studying sewage and calling it E. coli.
But, in fact, the bone marrow probably contains a variety
of cells that are there transiently. And these may be the ones
that give these very low repopulation results that have been
found, but they can't be propagated. So as a therapy, one would
have to solve the problem of how could you propagate these
adult stem cells so that they could, in fact, be used
therapeutically.
Dr. Mathews-Roth. Well, Catherine Verfaillie has solved
that.
Mr. Berg. Hold on for a moment, please.
Dr. Mathews-Roth. Yes.
Mr. Berg. The virtue of the embryonic stem cells is you can
propagate them virtually indefinitely. You can freeze them
away, you can recover them, and you can invariably
differentiate them, providing the appropriate cues, so they
differentiate into different kinds of tissues.
There are a number of papers that are clearly published
which show that one can, in fact, generate beta islet cells
which can, in fact, treat animals that are diabetic. You can
regenerate a severed spinal cord with embryonic stem cell-
derived neural cells, and you can do the same thing with curing
Parkinson's disease by appropriate neural cells derived from
stem cells. So you can grow stem cells and learn how to
differentiate them into different populations.
Chairman Hatch. Let me interrupt for a minute. I can't
imagine anybody not being willing to go ahead and proceed with
adult stem cell research. Naturally, we all want to do that. I
mean, that is a given.
I asked Senator Brownback to submit for the record his
whole notebook of studies which he relies upon in concluding
that adult stem cell research is the only way to go. I wonder
if all of you would work on helping to coordinate an analysis
of these particular studies by recognized and fair experts, and
compare them to the opportunities for embryonic stem cell
research.
I understand that NIH and NAS have issued similar
assessments in the last few years, but could you help us to be
more certain that we are up to date by looking at and
evaluating the particular information that Dr. Weldon and
Senator Brownback rely upon so that we can be certain that we
have the best knowledge we possibly can?
Mr. Berg. We are in science, Senator. We are not in
certainty.
Chairman Hatch. But to the extent that you can help us----
Mr. Berg. I mean, to ask for certainty today is asking for
something that is not available. They are both promising and we
should be pursuing both. We needn't make a bet today.
Dr. Varmus. Senator, I think it would be appropriate for
people to make an evaluation of that kind, and if we were given
the notebook I am sure we would be able to put together----
Chairman Hatch. We will get that to you.
Dr. Varmus. But I would point out to you that we are not
going to give you an answer that will be ironclad, and that is
the case because these problems are incredibly difficult. The
idea of trying to make a hematopoietic stem cell that can grow
is a big problem. The difficulty of learning how to
differentiate an embryonic stem cell so it becomes all the
tissues we would like it to become has been plaguing science
for the last several years, and indeed being pursued not just
with human stem cells, but also with animal stem cells.
So I think the plea that you are hearing from the
scientific community is we don't know where the best answers
are going to reside and we would encourage you to keep as many
doors open as possible.
Dr. Mathews-Roth. But then again we still have the issue
with the killing and, as I say, do the animal work.
Chairman Hatch. I have that point.
Dr. Kass?
Dr. Kass. Senator, if I might, a lot of this discussion
over the last 10, 15 minutes has been about stem cells,
embryonic versus adult. I wouldn't want you to understand
anything that I said to be taken----
Chairman Hatch. Let me interrupt you just for 1 second.
Dr. Kass. Please.
Chairman Hatch. Where I have always had some problem here
is, first of all, although I agree that the blastocyst is a
living cell, a human cell, I have a real difficult time
believing that it is a human being until it is implanted in the
mother's womb. Now, it has the potential of becoming one. We
all know that, but it doesn't have a chance of becoming a human
being without being implanted in a womb.
I accept that, and I accept Dr. Mathews-Roth's feeling that
she is right on this and you are wrong. I agree with you,
however. I just don't think that we should foreclose what
scientists have told me is the most promising avenue of
research in their lifetimes that might help hundreds of
millions of people in our country, or over 100 million people
in our country, and perhaps billions around the world to
alleviate pain, suffering and difficulties. That is also pro-
life, in my view.
I thought, Dr. Kass, you made some very interesting ethical
remarks in your discussion here today. We have discussed ways
to find common ground on this issue. You and I spoke in my
office about a hypothetical development that, as I recall, you
did find at first blush at least morally troublesome.
One way to maybe test the hypothesis is to just ask you
this question. Of course, you say whatever you were going to
say. I just had to interrupt for this reason and the question
would be this: If an egg could be rendered incapable of
implantation or of implanting in a mother's womb by a chemical
or genetic manipulation of a haploid egg cell, could you
personally view the process of somatic cell nuclear transfer in
another light?
In short, if the cell produced for nuclear transplantation
could not implant due to manipulations made before the somatic
cell nucleus was introduced into the non-implantable egg, are
the ethical concerns bridged under those circumstances?
Dr. Kass. I missed the verb. Are the ethical concerns----
Chairman Hatch. Are the ethical concerns bridged in that
regard? Given the recent reports in the scientific literature
about new insights into how blastocysts affix to the uterine
wall, I think one could imagine the day when scientists would
reverse-engineer--am I on the right track here--and render an
egg incapable of implanting? Now, if that were so, would that
be as ethically troublesome to you, or would that be as
ethically concerning to you?
Dr. Kass. Certainly, some of my concerns having to do with
this matter would be alleviated. I mean, after all----
Chairman Hatch. That is my understanding.
Dr. Kass. Some. Others, I think, might----
Chairman Hatch. But you are still worried about renegades
doing full cloning?
Dr. Kass. Well, what I want to say is that we seem in the
discussion to have gotten the cloning question mixed up with
the stem cell question. The bill, as I see it, is primarily
about cloning for reproduction and what I would prefer to call
cloning for biomedical research. Nothing that I----
Chairman Hatch. One of the problems I have--I keep
interrupting you and I apologize, but this is a matter of great
concern to me. One of the problems I have is if we don't have
NIH involved and we don't set the moral and ethical standards
for this research, then others are going to do it all over the
world. This is going on now, and I would rather have our
country lead the way and set the standards and the parameters
pursuant to which this kind of research can be done. If we
don't do that, then I guarantee you you are going to have the
results that you are talking about that we all would deplore.
Dr. Kass. Senator, we agree on the principle that the
United States has to be not only the leader in biotechnology,
but the leader in the ethical uses of biotechnology. This has
been a big division. Many nations around the world are, in
fact, passing a ban on all cloning even in those countries
where they are encouraging and permitting and funding embryonic
stem cell research. I think it is a mistake to get the
embryonic stem cell research mixed up with cloning.
Chairman Hatch. But how do we get all these other countries
to conform to our point of view without setting the moral and
ethical standards ourselves through the most recognized and
most important research agency in the world, the National
Institutes of Health? The very thing that you are concerned
about ethically is going to happen if we don't do the basic,
necessary things that should be done here.
Dr. Kass. We are in agreement. I am not one of these people
who thinks you have to choose between adult and embryonic stem
cell research. I am in favor of allowing both of these things
to go forward. It is too early to tell which of these lines
will prove most promising.
Chairman Hatch. But, again, on these lines--well, I am
sorry. Go ahead.
Dr. Kass. But I want to distinguish between embryonic stem
cell research from in vitro fertilized embryos and the creation
of cloned embryos for research. They are different.
Chairman Hatch. Okay, they are different and let me tell
you why I find that. It is true that when I got into this, my
major argument was that since these fertilized eggs are going
to be discarded anyway, why wouldn't we utilize them for the
benefit of mankind?
Dr. Kass. Right.
Chairman Hatch. And I think we would have gone a long way
had the President allowed that type of research to go forward
with fertilized eggs that were going to be discarded anyway.
But as I understand it, he limited it to 70 stem cell lines
worldwide, or at least in this country. In practicality, those
are basically Caucasian stem cell lines. They are not diverse
stem cell lines.
I have been led to believe that there may be as few as nine
that are functional because of intellectual property concerns,
patent concerns, and a whole variety of other high-technology
and informational technology concerns. I have also been led to
believe that if we take--and I would like you all to help me
understand this better, but if we take even the somatic cell
nuclear transfer-changed eggs, we actually could reach a point
where you would never have to use a mother's egg again. But
that would take 3, 4 or 5 years of very intensive work to be
able to reach that point.
Dr. Kass. That could be done first in animals, Senators.
Chairman Hatch. What?
Dr. Kass. Proof of that should be done in animals. It
hasn't been shown.
Chairman Hatch. That may be, except for one thing, that the
rest of the world is going ahead with this research and we
could be left behind, with our greatest scientists in this area
leaving this country to go where the research can be done. I am
concerned about that.
Dr. Kass. That is technically not so. I mean, there are a
few countries--Britain, China, Singapore, Sweden, Israel, I
think, are----
Dr. Varmus. Australia.
Dr. Kass. I am sorry?
Dr. Varmus. Australia.
Dr. Kass. Not on cloning. Sorry. The Australians have
imposed a ban, I think, on all cloning, including cloning for
research, so has Norway, so has South Korea, so has France, so
has Germany, so has Spain, so has Italy. The French and the
Germans will probably come back to the UN to try to promote an
international convention trying to stop all cloning, whether
for research or for reproduction. It is true that the world is
not of one opinion here.
See, if you start where I start that we should do whatever
we can to prevent cloning for baby-making, the most secure way
would be to stop that process before it starts. This is not
just creating an embryo; this is creating a genetically-
engineered embryo, the first one. And until somebody does the
research which shows me that it is not just a promise of
something but that there is a real likelihood, either in animal
studies--that there is something for which this is absolutely
necessary, because the matter is so grave I don't want to open
Pandora's box, especially when the technique to practice
cloning for research is going to make cloning for baby-making
much more likely. They are going to perfect this.
Chairman Hatch. Doctor, I have tremendous respect for you.
You know that. It is already opened. I mean, I read an article
called ``The First Cloning Superpower: Inside China's Race to
Become the Clone Capital of the World.'' The Chinese pay an
awful lot of attention to what we do, and so does everybody
else in the world.
There are those, as you have mentioned--France, Germany--I
would have preferred maybe a couple of other countries besides
them.
Dr. Kass. I did.
Chairman Hatch. I know. I am just kidding.
Dr. Kass. South Korea, Australia, Canada.
Chairman Hatch. I would prefer not to use France and
Germany at this time. I am only trying to be humorous.
The fact is that I am concerned that there are countries
that are going ahead with all forms of cloning. And I agree
with you and I agree with everybody on this panel that there
should be no human cloning. That is the least we should do this
year, but because we are involved in a fist-fight here over
this, we may not even get that done.
Go ahead. I have interrupted you so much and I apologize.
Dr. Kass. No. I am enjoying this, Senator, if you don't
mind. I mean, this is dear to me.
Chairman Hatch. You are saying you are enjoying it or you
are----
Dr. Kass. I am enjoying the exchange and I am grateful for
your generosity.
Chairman Hatch. Well, I am, too. I am just sorry I am
interrupting you so much, but I want to go to Dr. Murray.
Dr. Kass. This is a momentous time in lots of ways, but it
is a real question, Senator, whether we have the will and the
capacity to give some direction to where biotechnology is
taking us.
I have the greatest regard for our research. My reputation
isn't that, but that is a mistake. I esteem biomedical research
both in terms of its discoveries and its cures. I think it is a
very bad thing for the most part to have legislative
interference with scientific research, a very bad thing.
Chairman Hatch. I agree with you, but we are pushed into
doing this.
Dr. Kass. But there come occasions where the things which
are at issue and which are being threatened suggest that if we
leave it to business as usual, we might regret it. I would
submit this is one of those cases where we shouldn't simply
hope that if you let this genie out of the bottle, you are
going to be able to control it.
Sure, rogues in China might do this, but they also buy and
sell organs in other parts of the world and we don't follow
suit even though it would save lives. We have the capacity to
set an ethical standard without restricting very much of the
research and allowing the embryonic stem cell research to go
forward.
Chairman Hatch. But how do you do that, Doctor? First of
all, the Brownback bill won't pass the Senate. There is no way
that it has enough votes to pass the Senate. We have close to
the 60 votes to pass this bill which would do away with
reproductive cloning, but would permit the scientific research
to go forward and would set moral and ethical standards for the
NIH. And you would have the Federal Government involved.
Dr. Kass. It doesn't govern the private sector, Senator.
Chairman Hatch. It would have us involved all over the
world, in the World Health Organization and everywhere else, to
make sure that your fears would at least have a chance of being
alleviated.
What we are going to wind up doing here probably is
nothing, which means that the rogue countries where they are
going to do this will be able to get away with it.
Mr. Berg. England is not a rogue country and they have
opted for a regulatory process that oversees the legitimacy of
the work----
Chairman Hatch. Well, I agree with that.
Mr. Berg [continuing]. Which is exactly what I think you
are saying.
Chairman Hatch. Yes.
Mr. Berg. So it is being done and it can be done, and it
can be done ethically and legitimately.
Chairman Hatch. Well, let me go to Dr. Varmus, and then I
have got to get to Dr. Murray. I have been trying to get to
him. He had his hand up here a while ago.
Go ahead, Doctor.
Dr. Varmus. I think that one misconception that Dr. Kass is
portraying here is the idea that if there were no legislation
banning cloning, suddenly there would be a tremendous waterfall
of human reproductive cloning. That is not going to happen.
Even without legislation, it is not going to happen.
We all endorse the idea of having legislation, but the fact
is it would be malpractice. You would have your pants sued off
if you tried to do this because the great likelihood is it
would be almost impossible to do it and if you succeeded, you
would have a child deformed and you would be subject to tort
law.
So the idea that there is going to be a dramatic increase
in human reproductive cloning without a law is frankly in my
mind silly. If there are renegades who want to try this for
publicity sake or something else, they will always be able to
find a place to do this. What worries me about the argument is
it is driving into an illegal state research that could lead to
very important benefits.
I am trying to make the reverse argument, Dr. Kass, that
you are setting up a straw man here that we are going to be
inundated with human cloning exercises, and that that is the
motivation behind a bill such as the Brownback bill that would
cut off important avenues for productive research to help human
beings.
Chairman Hatch. If the bill that we are talking about, the
Hatch-Feinstein-Specter, et al, bill, passes, that bill would
set criminal penalties for reproductive cloning.
Dr. Varmus. Absolutely.
Chairman Hatch. It would set the rule in our country, at
least. It would then designate NIH to set the standards that
are moral and ethically proper in this.
Dr. Kass. It doesn't touch the private sector, Senator.
Chairman Hatch. What?
Dr. Kass. It does not touch the private sector.
Chairman Hatch. No, but nothing touches them now. It does
apply the common rule to the private sector, sure, and we also
touch it from a criminal law standpoint.
Dr. Kass. On the implantation, yes.
Chairman Hatch. Well, yes.
Dr. Kass. But on the research----
Chairman Hatch. We also apply the common rule. Frankly, if
NIH is involved, the private sector can't afford to not work
with NIH. I think your very moral arguments really can be
fulfilled by having a bill that sets parameters, which is what
we have tried to do with this bill and I think we have
accomplished that.
I would like you to read it carefully. I know that you have
studied this as much as anybody.
Dr. Kass. I will do so.
Chairman Hatch. And you have every right to your opinion,
and I happen to respect you so much that the fact that we
differ on this affects our relationship not in the least. But I
can't imagine going another year without having some way of
setting the standards that have to be set here. I can't imagine
the right-to-life community not wanting that done. I can't
imagine anybody who believes that human suffering ought to be
alleviated not wanting to do something here that would benefit
the living.
Dr. Murray, I said I would come to you next. I don't mean
to be preaching to you, but I am just saying it is
flabbergasting to me that this is--go ahead.
Mr. Murray. It is flabbergasting to others as well,
Senator, myself included. It is always dangerous to do
philosophy after 3 p.m. because people fall asleep. I will try
to do it very quickly.
There are really two kinds of arguments being put here
against nuclear transfer and embryonic stem cells. The first is
the argument that Dr. Mathews-Roth has repeated several times
in her testimony, namely that the creation of stem cells--and
this is about all stem cells--is killing them to harvest their
useful parts. That is against all forms of human stem cell
research.
I think I need to grant Dr. Mathews-Roth the sincerity----
Dr. Mathews-Roth. Not adult stem cells.
Mr. Murray. Please don't interrupt me.
I think we need to grant the sincerity of her belief. On
the other hand, you, Senator Hatch, and many others, equally
morally thoughtful people, think that an in vitro blastocyst at
the 4- to 6-day stage is not the same thing, and that the
creation of stem cells from that is not the same thing. So
let's put that argument aside. We have addressed that. I think
criminalizing those who would feel as you do or others would be
disrespectful of the diversity of moral beliefs in the United
States. That is what I tried to say in my testimony.
The other set of arguments were really the ones that Dr.
Kass offered, and he offered four arguments. The fourth one has
really been dealt with, and that was the claim that the claims
that nuclear transfer in embryonic cells that they would be
useful therapeutically or scientifically are putative and
speculative. Well, that is true of all scientific research.
Until we actually do the research and find out whether it
can deliver, all claims of usefulness are putative and
speculative. Scientists make judgments all the time about what
lines of research are more likely to be fruitful than others,
and most knowledgeable scientists about this are very excited
about the possibilities here.
His third argument--I am going to go backwards quickly--was
really about complaints that your current bill may not
adequately regulate all aspects of it. And since that is in
details, I won't go into that one.
Chairman Hatch. We, by reference, pull into the legislation
all of the NIH moral and ethical standards. So I think it is
adequate, as I read it.
Mr. Murray. Yes.
Chairman Hatch. Now, if anybody has suggestions on how we
might make it better, that is one reason we are holding this
hearing. We would be very happy to see what we could do.
Mr. Murray. Yes, and I think clarifying things such as
whether, as Dr. Kass has asked, private research is covered,
which I believe it is, or whether patenting is permitted, and
permitted on the stem cell lines, say, rather than the actual
cloned entity itself--those would be helpful clarifications,
but I don't think they go to the heart of the bill.
The second complaint is that we will be on a slippery slope
if we permit nuclear transfer in human embryonic stem cells,
and that we will end up down at the bottom of a very nasty
hill. Nearly 25 years of working in bioethics has convinced me
that all of life is lived on slippery slopes and the point is
to try to carve out good, firm footing. I believe your bill is
exactly an effort to carve out good, firm footing so that we
can establish ourselves and live a morally decent life at that
point on the hill.
His first argument was that conditions for culturing
blastocysts for stem cells--well, the first argument was that
what we learn from doing nuclear transfer in embryonic stem
cells for research will be immediately and perfectly
transferable to trying to make a human baby by cloning. That is
an empirical claim.
The scientists I speak to who work with human embryonic
stem cells indicate that what they are finding actually is if
you want to develop stem cells of a certain type, say neural
stem cells, it pays from the very beginning to use a culture
medium and a culture procedure that drives them toward becoming
such stem cells.
So, actually, there may be a real divergence between
efforts to create a human baby by cloning, the conditions you
would have to try to do that, versus the conditions you would
have to try to create stem cell populations. So that is an
empirical claim, and the scientists here are better qualified
than I am to say whether it is correct or not. But it may, in
fact, be incorrect, and if the empirical premise is incorrect,
then the conclusion is incorrect.
Chairman Hatch. Well, Dr. Murray, your written testimony
states that you would be pleased to comment on President Bush's
Commission on Bioethics' call for a moratorium on the so-called
cloning for biomedical research. I will bite. Why don't you
make a comment on that?
Mr. Murray. Well, it was a close vote, but a majority did
vote in favor of a moratorium. I disagree. It would be less
interesting to hear that I disagree than it is to hear the
details of the arguments. In fact, what I just did was
basically respond to some of the principal arguments in the
report, but thank you for asking, Senator.
Mr. Berg. Senator Hatch, may I just make a comment?
Chairman Hatch. Yes, Dr. Berg.
Mr. Berg. My one experience with Government regulation of
research goes back 25 years on recombinant DNA.
Chairman Hatch. Right.
Mr. Berg. At that time, one of the interesting arguments
was raised that the best we could was to have the NIH supervise
this regulatory process and it would not apply to the private
sector. As it turned out, the private sector was delighted to
follow the same guidelines that were elicited for the rest of
the scientific community because, in fact, they needed that
guidance themselves.
Rather than go off and do their own thing and go against
what was generally conceded to be a sensible way to approach
this problem of the potential risks of the research, they all
followed it.
Chairman Hatch. And had 4 or 5,000 different directions and
they actually followed what the NIH came up with.
Mr. Berg. Absolutely. I mean, that was an interesting and
unexpected outcome. We were worried about what private industry
would do, but it turned out that they were, as Harold pointed
out, much more concerned about the threats to their integrity,
being picketed outside their research establishment because
they were violating or found to be violating reasonable
regulations. So they all adopted them. They set up internal
review panels and followed exactly the same procedures that
were mandated for the universities or for federally-funded
scientists.
So again, although I think the legislation, as I understand
it, is, in fact, intended to cover all research in this
country, I would not be so fearful whether the private sector
is out looking for some way to get out of it.
Chairman Hatch. Well, let me ask this last question because
we have a vote. I know that a couple of you really have to go,
too, but I am really enjoying this discussion. To have this
quality of science discussion is really uplifting to me. Even
though you disagree, you are all excellent people and I don't
think we could have had a better panel.
Let me just ask the panel this question, and we will start
with you, Dr. Kass. It is a question that Dr. Berg asked
Senator Frist last year at a Health, Education, Labor and
Pensions Committee hearing. Suppose that the United States bans
both reproductive and therapeutic cloning, as has been
suggested by those in opposition to this bill, and a therapy
was developed overseas in a nation that allows such research
that would be very beneficial to a great number of our folks
here in this country.
Now, if you were a treating physician--and I would like
each of you to think this through--if you were a treating
physician, would you have a moral obligation to prescribe such
treatment to your patient, even though such treatment could not
be directly developed or originated in the United States?
If you gave the same answer that Dr. Frist gave, I will be
interested if you would, but wouldn't you be morally obligated
if they came up with a cure or came up with a treatment that
was beneficial to your patients to use that treatment, even
though it was developed through a regenerative medicine
approach?
Dr. Kass?
Dr. Kass. Yes, I would, Senator, and I find the part of the
House-passed bill, if I may say so publicly, that bans the
importation of products regrettable.
Chairman Hatch. I do, too.
Dr. Murray, what would you do?
Mr. Murray. I agree with Dr. Kass.
Chairman Hatch. You would use that therapy?
Mr. Murray. I would recommend it. I would inform my patient
that this was a therapy that was proving itself to be safe and
effective, if that was the evidence. If I felt there was any
chance that my patient might have a moral objection to
receiving embryonic stem cells, I would tell them that is what
it came from. And it would be up to them whether they would
overcome their personal moral qualms about it, but I would do
as Dr. Kass did and tell them.
Chairman Hatch. Dr. Varmus?
Dr. Varmus. Of course, I would do that, but it would be
heart-breaking to have to say that when you return to this
country, you might be subject to possible imprisonment or
fines.
Chairman Hatch. Which is what the Brownback-Weldon bill
calls for.
Dr. Mathews-Roth?
Dr. Mathews-Roth. Well, I would explain the therapy to
them. I would tell them that this does involve killing a very
young human being, if we are using cloned material. I would
tell them that I am personally objecting to it; that I, because
of my personal objection to killing and the Hippocratic Oath I
took when I became a doctor, would not be involved with the
implementation of this therapy; that it is up to them to choose
to do it if they want to and they should go to someone else to
do it.
Chairman Hatch. Thank you.
Dr. Berg?
Mr. Berg. I asked that question of Dr. Frist because he was
a physician.
Chairman Hatch. That is right.
Mr. Berg. And I wanted to see how he would respond to the
issue of having to inform a patient that he had voted against
the implementation of that kind of therapy.
Chairman Hatch. He said basically that he would have to
give his patient the best available treatment.
Mr. Berg. He did say that, and yet at the same time
subsequently he backed the Brownback bill fully even though it
still contained that particular provision.
Chairman Hatch. I was hopeful they would take that
provision out, but even if they took that provision out, there
would still be the feelings of Dr. Mathews-Roth.
Mr. Berg. I think Dr. Mathews-Roth has suggested that the
therapy would be available. It would just be the doctor's
choice. But, in fact, if the bill passes, that therapy is not
available in this country. So the issue comes, as I think was
implied by Dr. Varmus, somebody going to England to have the
therapy having implanted in them cells derived from nuclear
transfer-derived stem cells and coming back.
The question was, in the interpretation of the bill,
whether that person is liable to criminal penalties for
bringing back derivatives of somatic cell nuclear transfer
material. That is probably an arguable question, but the point
was it is saying that we are prepared to prohibit 280 million
from access to therapies that might save their lives because
somebody is offended by the technology that was used to develop
that therapy.
Chairman Hatch. I have to say that Senator Brownback, I
think, did modify his bill to alleviate that provision, in his
defense, but I think the House bill has it in there.
Dr. Usala, I am sorry I have been ignoring you here today,
and yet I found your testimony very interesting.
Dr. Usala. Senator, you are probably the most patient man I
have ever had the pleasure of sitting with for listening to all
of us. Actually, if I could just make a comment----
Chairman Hatch. I am starting to like you a lot.
[Laughter.]
Dr. Usala. I actually think that scientifically most of us
agree with things, and I will answer your question directly in
a second. Dr. Varmus is excited about the possibility of taking
a DNA template, putting it in another environment and having it
reproduce. It is horribly exciting and I agree with it, and I
think that as physician-scientists or scientists, we do see the
potential for making a DNA template replicate and to use it in
therapeutic ways.
But we can't minimize, as has been done, I believe, the
concept that the human being does start shortly after
conception, scientifically speaking, because that is when that
differentiation process--the DNA joins, the template is formed
with all the machinery of the chaperon proteins.
You can't arbitrarily say, well, at this point of
differentiation it is human, and at this point it isn't. It
can't be done.
Chairman Hatch. I acknowledge it is a human cell. The egg
is a living human cell, no question about it. The question is
whether we will utilize that to help the living or we won't. It
is just that simple.
Dr. Usala. And that is where, as a physician, a
pediatrician, I would have to agree with Dr. Mathews-Roth. I
took the Hippocratic Oath. Now, you know, if somebody goes to
China and they execute a prisoner and they get his heart and
transplant it, do we prosecute them here in the United States?
I don't believe so. So that is what it comes down to.
As a physician, I took one of those old Hippocratic oaths.
You know, we don't believe in killing, and there are physicians
in States where assisted suicide is legal in some circumstances
that they do it. In their view, they are doing the best for
their patients. I could not do that because of the oath I took
and because of my understanding as a scientist.
Chairman Hatch. Well, I think this has been one of the most
interesting panels I have ever listened to, and I certainly
want to compliment each of you. I respect each of you very
much, in spite of the fact that I may differ on some matters.
All I can say is that my goal here is to do the very best I
can for mankind, and I think we should help the living as much
as we help anybody. I have to say that I have learned so much
here today and I don't know when we have had a better panel on
any subject. Even though you differ with each other, it has
meant a lot to me that you would take the time to come and try
and enlighten us.
Hopefully, we can resolve this problem in a way that will
bring most of us together. If not, we should resolve it in a
true scientific way, it seems to me. You noticed I used the
word ``true.'' I think that is a very important word in what we
are trying to do with this bill.
So I just want to thank each of you for being here. I have
got to go and vote, and rather than have you wait for me to
come back, I think we have had a good discussion and I will
keep the record open so that if you care to offer any further
written comments about these issues that might help us, I would
be very grateful. That goes for each and every one of you. I
want to thank each of you for being here today.
With that, we will recess until further notice.
[Whereupon, at 3:22 p.m., the Committee was adjourned.]
[Submissions for the record follow.]
[Additional material is being retained in the Committee
files.]
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