[Senate Hearing 108-160]
[From the U.S. Government Publishing Office]



                                                        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



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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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