[Senate Hearing 107-812]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 107-812

  HUMAN CLONING: MUST WE SACRIFICE MEDICAL RESEARCH IN THE NAME OF A 
                               TOTAL BAN?

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

                                HEARING

                               before the

                       COMMITTEE ON THE JUDICIARY
                          UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                               __________

                            FEBRUARY 5, 2002

                               __________

                          Serial No. J-107-55

                               __________

         Printed for the use of the Committee on the Judiciary

83-684              U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2002
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                       COMMITTEE ON THE JUDICIARY

                  PATRICK J. LEAHY, Vermont, Chairman
EDWARD M. KENNEDY, Massachusetts     ORRIN G. HATCH, Utah
JOSEPH R. BIDEN, Jr., Delaware       STROM THURMOND, South Carolina
HERBERT KOHL, Wisconsin              CHARLES E. GRASSLEY, Iowa
DIANNE FEINSTEIN, California         ARLEN SPECTER, Pennsylvania
RUSSELL D. FEINGOLD, Wisconsin       JON KYL, Arizona
CHARLES E. SCHUMER, New York         MIKE DeWINE, Ohio
RICHARD J. DURBIN, Illinois          JEFF SESSIONS, Alabama
MARIA CANTWELL, Washington           SAM BROWNBACK, Kansas
JOHN EDWARDS, North Carolina         MITCH McCONNELL, Kentucky
       Bruce A. Cohen, Majority Chief Counsel and Staff Director
                  Sharon Prost, Minority Chief Counsel
                Makan Delrahim, Minority Staff Director


                            C O N T E N T S

                              ----------                              

                    STATEMENTS OF COMMITTEE MEMBERS

                                                                   Page

Brownback, Hon. Sam, a U.S. Senator from the State of Kansas.....    76
Cantwell, Hon. Maria, a U.S. Senator from the State of Washington    77
Durbin, Hon. Richard J., a U.S. Senator from the State of 
  Illinois.......................................................    85
Feinstein, Hon. Dianne, a U.S. Senator from the State of 
  California.....................................................     1
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah......     3
Kennedy, Hon. Edward M., a U.S. Senator from the State of 
  Massachusetts..................................................    86
Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont.    86
Specter, Hon. Arlen, a U.S. Senator from the State of 
  Pennsylvania...................................................    15

                               WITNESSES

Charo, R. Alta, Professor of Law and Medical Ethics, University 
  of Wisconsin Law School, Madison, Wisconsin....................    30
FitzGerald, Kevin, S.J., Georgetown University Medical Center, 
  Washington, D.C................................................    44
Greely, Henry T., Professor of Law, and Director, Center for Law 
  and the Biosciences, Stanford University, Stanford, California.    25
Greenwood, Hon. James C., a Representative in Congress from the 
  State of Pennsylvania..........................................    12
Gulden, Kris, Coalition for the Advancement of Medical Research, 
  Washington, D.C................................................    34
Kimbrell, Andrew, Executive Director, International Center for 
  Technology Assessment, Washington, D.C.........................    38
Weissman, Irving L., M.D., Chair, National Academies Panel on 
  Scientific and Medical Aspects of Human Reproductive Cloning, 
  and Professor, Stanford University School of Medicine, 
  Stanford, California...........................................    20
Weldon, Hon. Dave, a Representative in Congress from the State of 
  Florida........................................................     6

                         QUESTIONS AND ANSWERS

Questions submitted by Senator Feinstein to the witnesses........    65
Responses of Dr. Weissman to questions submitted by Senator 
  Feinstein......................................................    67
Responses of Mr. Greely to questions submitted by Senator 
  Feinstein......................................................    70
Responses of Ms. Charo to questions submitted by Senator 
  Feinstein......................................................    71

                       SUBMISSIONS FOR THE RECORD

American Society for Cell Biology, Bethesda, Maryland, statement.    75
Citizens' supporting legislation to prohibit cloning, joint 
  statement......................................................    79
CNN.com, article.................................................    83
Coalition for the Advancement of Medical Research, Washington, 
  D.C., statement................................................    84
NewScientist.com, article........................................    87
New York Times:
    editorial, January 19, 2002..................................    88
    Jack M. Balkin, article, January 30, 2002....................    89
St. Louis Post-Dispatch, editorial, December 3, 2001.............    90
United Network for Organ Sharing, Richmond, Virginia, list.......    92
Verfaillie, Catherine, M.D., Professor of Medicine, and Director, 
  Stem Cell Institute, University of Minnesota, Minneapolis, 
  Minnesota......................................................    96
Washington Post, editorial, January 22, 2002.....................    96

 
  HUMAN CLONING: MUST WE SACRIFICE MEDICAL RESEARCH IN THE NAME OF A 
                               TOTAL BAN?

                              ----------                              


                       TUESDAY, FEBRUARY 5, 2002

                                       U.S. Senate,
                                Committee on the Judiciary,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:10 p.m., in 
room SD-226, Dirksen Senate Office Building, Hon. Dianne 
Feinstein presiding.
    Present: Senators Feinstein, Kennedy, Durbin, Hatch, 
Specter, DeWine, and Brownback.

OPENING STATEMENT OF HON. DIANNE FEINSTEIN, A U.S. SENATOR FROM 
                    THE STATE OF CALIFORNIA

    Chairperson Feinstein. I would like to begin by calling the 
hearing together and welcoming the two distinguished Members of 
Congress.
    I would like to begin by making a brief statement and then 
the Ranking Member, who will be for this hearing Senator Hatch, 
will be on his way over and he will make a brief statement.
    Do you gentlemen have a time problem, because if you do, I 
will accommodate you now.
    Mr. Weldon. I am fine.
    Mr. Greenwood. I am not leaving until he leaves.
    [Laughter.]
    Chairperson Feinstein. Cloning seems to be one of those 
words and concepts that seems to inspire a lot of dread in 
people, visions of an apocalyptic world marching lockstep. 
However, as is the case with many medical technologies, it is 
not cloning that is the problem, but some of its potential 
applications. For example, we are all concerned about the sale 
of human organs or the transplant of organs from executed 
prisoners, but few people argue that the solution to these 
potential problems is to ban organ transplantation.
    The truth is that there is bad cloning and good cloning, I 
believe. Bad cloning is human cloning, the creation of carbon 
copies of whole human beings. Good cloning is nuclear 
transplantation to produce stem cells.
    There is broad agreement across our society, in Congress 
and in the scientific, medical and religious communities, that 
we should ban human cloning. Such cloning is scientifically 
unsafe, morally unacceptable, and ethically flawed.
    However, at least to me, it is also clear, and I think to 
the overwhelming majority of the scientific and medical 
community, that we should not ban nuclear transplantation to 
produce stem cells. Many doctors and scientists have argued 
that we must protect our ability to use cloning techniques to 
try to save and improve the lives of those ravaged by disease 
and other ailments.
    In fact, nuclear transplantation offers enormous potential 
for providing cures to diseases such as cancer, diabetes, 
cystic fibrosis, and heart disease, as well as conditions such 
as spinal cord injuries, liver damage, arthritis, and burns.
    This technique could allow the creation of bone marrow for 
transplants to leukemia victims, islet cells for the pancreas 
of a diabetic, heart or liver tissue to repair the damage 
caused by heart attacks or hepatitis, healthy skin for grafts 
for burn victims, and many other potential cures and treatments 
for a variety of diseases and ailments.
    Let me make a few points. First, nuclear transplantation 
could be used to create embryonic stem cells which could be 
used to make tissues, and even organs, for transplant. This 
would help relieve the serious shortage of tissues and organs 
for transplant. Over 50,000 Americans today are waiting for 
organ transplants, while hundreds of thousands more need tissue 
transplants. Tragically, over 5,000 people die a year because 
they can't get the organs or the tissues they need to be 
donated, and many of these are very young children.
    Second, the use of nuclear transplantation to produce a 
tissue or organ could virtually eliminate the danger that the 
patient's body would reject it. Nuclear transplantation 
techniques could allow the implantation of new cells or tissues 
that exactly match those of the person to whom they are 
implanted, greatly reducing the likelihood that the person's 
body would reject those cells or tissues. Such research has the 
potential to save thousands of lives and relieve the pain and 
misery of thousands more.
    Third, nuclear transplantation has many other applications 
as well. It could be used to produce human proteins, such as 
blood-clotting factors that aid in healing wounds. It could 
yield information on stem cell differentiation, providing 
valuable information about the mechanism of aging and the 
causes of cancer. It could even be used to find a cure for 
cancer by teaching us how to reprogram cells.
    Senator Brownback and I both co-chair the Senate Cancer 
Coalition. I am delighted he is here today. We are also both 
part of the National Cancer Dialogue.
    So I believe strongly that it would be a disaster to ban 
this kind of valuable research. Thus, Senator Kennedy and I 
have introduced a bill, S. 1758, that takes a balanced 
approach, we believe, to the cloning issue. This legislation 
would make the cloning of a human being a crime, while allowing 
research involving nuclear transplantation to proceed.
    This is the same approach recommended by a number of blue 
ribbon scientific and medical panels, including the National 
Bioethics Advisory Commission, the National Academies' Panel on 
Scientific and Medical Aspects of Human Cloning, and the 
California Advisory Committee on Human Cloning.
    All of these commissions and panels delved deeply into the 
cloning issue and ended up coming to the same conclusion: ban 
human cloning, but don't interfere with important areas of 
scientific research using nuclear transplantation to produce 
stem cells.
    So I am very pleased that two of the colleagues sponsoring 
this bill are on this committee, Senator Kennedy and Senator 
Durbin. In addition, Senators Boxer, Miller, Corzine, Clinton, 
and Mikulski are cosponsors. I am also happy that the 
Federation of American Societies for Experimental Biology, as 
well as 22 other scientific and medical organizations, have 
endorsed the bill.
    In this letter, they note that S. 1758 is a carefully 
worded bill that should expedite the development of therapies 
for millions of Americans. I would now like to put this letter 
in the record.
    I also want to acknowledge Senator Specter's leadership on 
the cloning issue, as well as on stem cell research generally. 
He and Senator Harkin have introduced legislation, S. 1893, 
that is very similar to our bill, S. 1758, and I look forward 
to working with them on this issue.
    I very much look forward to hearing from the witnesses 
today.
    I would now like to turn to the very distinguished ranking 
member of the full committee, the distinguished Senator from 
the Olympic State, Senator Hatch.

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

    Senator Hatch. Thank you, Madam Chairman. First, I would 
like to inform the Chair that Senator Kyl is managing an 
important amendment on the floor and will unfortunately be 
unable to attend this hearing.
    Today, the committee takes up an important set of issues as 
we explore how considerations of law and ethics affect, and 
should affect, the science of what is commonly and perhaps 
confusingly lumped together under the term ``cloning.''
    In a general sense, cloning merely means making a xerox 
copy, an exact duplicate. There are, in fact, many types of 
entirely unobjectionable, non-controversial, common uses of 
cloning in science. For example, if researchers developed a new 
smallpox vaccine and needed to clone billions and billions of 
copies of a snippet of genetic material as part of this new 
therapy, no one would complain, or at least I believe nobody 
would.
    In the context of this hearing, cloning does raise 
substantial questions. Today, we will examine cloning as a 
technique to produce cells, or even potentially whole 
individuals, with the identical genetic code of one parent 
cell.
    Cloning stands in sharp contrast to normal reproduction, 
the proverbial birds and the bees, in which the father and the 
mother each contribute one-half of the genetic makeup, the DNA, 
of the offspring. While nature in some cases produces twins who 
share the same two parents and virtually identical genetic 
code, cloning technology could conceivably 1 day enable the 
birth of literally a new type of person who springs forth from 
solely the genetic contribution of a single parent.
    The type of cloning we are discussing today revolves around 
the technology of somatic cell nuclear transfer. This consists 
of removing the nucleus of an egg and replacing it with the 
full complement of 46 chromosomes from an adult body cell.
    This, of course, is very different from the time-immemorial 
case in which the egg and spermatozoa contribute 23 chromosomes 
each to the offspring. Theoretically, an embryo produced in the 
test tube through this somatic cell nuclear transfer technique 
could be implanted into a womb and result in a live birth.
    No doubt somewhere, some, such as the Ralians, are trying 
to make a name for themselves and are busy trying to apply the 
techniques that gave us Dolly the sheep to human beings. 
Frankly, I am not sure that ``human being'' would even be the 
correct term for such an individual heretofore unknown in 
nature.
    I am a conservative, and an unabashed pro-life conservative 
at that, or should I say, to be more politically correct, I am 
a faith-based conservative. In any event, I would be extremely 
hesitant to rewrite the Book of Genesis as the story of Adam or 
Eve.
    We know that most everyone at this time opposes so-called 
reproductive cloning, the development and birth of a completely 
new type of individual through what would essentially amount to 
an elaborate form of asexual reproduction.
    The fact is that, today, there is not a simple, 
straightforward Federal law that prohibits reproductive 
cloning. I believe, and I believe that the members of this 
committee and the entire Senate and House believe that it is 
long past time for reproductive cloning to be prohibited by 
Federal law.
    Here is the rub: There is another branch of cloning, termed 
by its proponents as ``therapeutic cloning,'' which I think is 
a lousy name for it, whose motivation is not birth, but the 
development of a broad range of new treatments and diagnostic 
tests for a host of diseases. Through cloning techniques, it is 
possible that the type of highly versatile pluripotent stem 
cells we heard so much about last year could be produced.
    As some of the testimony today reveals, many scientists and 
advocates believe that this line of research is both ethically 
proper and appears extremely promising. Many believe that the 
problem of potential rejection of new stem cell-derived tissues 
could be minimized and perhaps avoided altogether by what I 
would call DNA regenerative therapy.
    Other well-respected experts and groups will tell us that 
not only is the science being over-hyped, but there remain 
fundamental legal and ethical objections to this line of 
research because the very creation and subsequent destruction 
of these new types of cloned embryos is inherently immoral.
    A question with which the Senate struggled in 1998 and with 
which we still struggle today is to see whether we can find a 
way to outlaw the offensive uses of cloning techniques but do 
so in a manner that does not bar potentially life-saving and 
ethically proper scientific research.
    So I commend Senator Leahy and Senator Feinstein for 
holding this hearing today so that we may more fully explore 
these complex issues. The Senator from California, together 
with our colleague Senator Kennedy, has offered legislation on 
this topic. As well, Senator Specter, in partnership with 
Labor-HHS Appropriations Subcommittee Chairman Tom Harkin, has 
held over 12 hearings in this general area, and they have also 
offered both legislation and leadership in the biomedical 
research arena.
    Frankly, I think we all need to take our hats off to 
President Bush and congressional leaders like Arlen Specter and 
Tom Harkin for the bipartisan achievement in doubling our 
Nation's investment in biomedical research at NIH over the past 
5 years.
    My pro-life colleague and good friend, Senator Brownback, 
takes a different view than Senators Feinstein, Kennedy, 
Specter and Harkin on some key aspects of cloning legislation. 
He, too, has offered a bill. It is similar to the measure 
sponsored by one of our most influential witnesses today, 
Representative Dave Weldon, that passed the House last year. We 
also welcome Representative Jim Greenwood here today and 
commend him for his efforts as well.
    I am studying the issues and the proposed legislative 
responses. I have met with experts on all sides of this issue 
from all over the world, and I welcome the opportunity to learn 
more today.
    This debate today will inevitably and ultimately involve 
questions regarding when and under what circumstances life 
begins. As we saw during the debate on the Federal funding of 
certain stem cell research last year, these are difficult 
issues and opinion is unlikely to be monolithic.
    Public education and debate are essential in our 
pluralistic society if we are to reach acceptable compromises 
on contentious issues. Toward this end, I would repeat a 
thought I raised at a Judiciary Committee markup last August, 
when I wondered aloud whether the development of an egg 
incapable of implantation might alter the debate on these 
issues. I intend to ask this question of the witnesses today.
    I hope that today's hearing will help the members of the 
committee gain a better understanding of the science, law, and 
ethics of cloning. It is my hope that this committee and the 
Congress will be able to arrive at a reasonable consensus on a 
policy that fully respects the dignity of humanity with respect 
to reproduction and research.
    So I want to thank you, Madam Chairman. I appreciate being 
with you.
    Chairperson Feinstein. I thank you, Senator.
    Now, we will turn to our two House Members, and I would 
like to introduce them both at one time, beginning with 
Congressman Weldon.
    Congressman Dave Weldon, of Florida, was elected to 
Congress in 1994. He represents Florida's 15th Congressional 
District. He is a practicing physician and an Army veteran. I 
am very pleased to note that he served his internship and 
residency in San Francisco at the Lederman Army Medical Center, 
which is unfortunately no longer there today.
    Mr. Weldon serves on the House Science Committee, the House 
Financial Services Committee, and the Government Oversight and 
Reform Committee. He is the sponsor of H.R. 2505, the House-
passed legislation that would ban both human reproductive 
cloning and therapeutic cloning.
    While I am doing it, I will also introduce, if I may, 
Congressman Jim Greenwood. He was elected to Congress in 1992. 
He represents Pennsylvania's 8th District. He serves on the 
House Commerce Committee and Education and Workforce Committee. 
He served as chairman of the task force charged with reforming 
the Food and Drug Administration, and he has also been active 
on many health care issues, including Medicare and Medicaid. 
Mr. Greenwood sponsored the House substitute to the Weldon 
anti-cloning bill. That legislation would prohibit human 
reproductive cloning, but permit therapeutic cloning.
    So welcome, gentlemen. We are delighted to have you here.
    Mr. Weldon, if we could begin with you, please.

  STATEMENT OF HON. DAVE WELDON, A REPRESENTATIVE IN CONGRESS 
                   FROM THE STATE OF FLORIDA

    Representative Weldon. Thank you, Madam Chairman. I want to 
thank you for the opportunity to be here to testify on this 
very important issue, and I certainly want to commend you and 
the ranking member for taking this issue up. I think the 
American public really would like the Senate to speak on this 
issue. It is very, very obvious that scientists are moving 
ahead and creating cloned human embryos in the lab.
    Let me just start out by saying that I practiced medicine 
for 15 years. I still see patients once a month at the 
veteran's clinic in my district. I have taken care of patients 
with diabetes. My father had diabetes. I have taken care of 
patients with Alzheimer's disease, spinal cord injuries. So I 
do not approach any consideration that would preclude a 
particular avenue of research lightly.
    I would just like to underscore--and I believe both of you 
touched on this issue in your opening statements--the belief is 
that by allowing embryo cloning in the lab, you will somehow be 
able to extract stem cells from this and would be able to treat 
somebody with some type of condition.
    Right now, today, that is purely a theoretical construct. 
It does not exist, nor is there an animal model of such a 
therapy. You cannot take a mouse, for example, with a disease 
and extract stem cells from a cloned embryo of mouse and treat 
that disease.
    It certainly is well worth saying that there are hundreds 
of millions of dollars being spent on all types of research 
modalities to treat these conditions--surgical modalities, 
pharmacologic modalities. I think the important point I would 
like to underscore about this is when we use the terms 
``enormous potential'' and ``tremendous breakthroughs,'' you 
can lead some people who are suffering from these diseases or 
their family members to develop false hopes.
    I just want to underscore that the legislation that we 
passed out of the House and that is very similar to the 
legislation introduced by my friend, Sam Brownback, does not 
preclude animal research in this arena. It would allow it to go 
forward unfettered.
    The real central debate here is are we now going to carry 
the stem cell debate to the place where we are now creating 
human embryos for this purpose. The debate 4 or 6 months ago, 
or a year, 2, 3, 4, years ago was on using excess embryos from 
fertility clinics, and I think many very, very thoughtful 
people believed that that was morally and ethically OK.
    Indeed, it was viewed that these embryos were destined for 
destruction and that it would be inappropriate to just allow 
them to be destroyed without having any redeeming use, and 
therefore this type of embryo stem cell research should be 
allowed to proceed.
    I would just like to point out that many people who put 
forward that argument in the past, including the Washington 
Post in an editorial they did in 1994, and including some 
letters to the President that actually came out of this body, 
underscored the fact that creating embryos for destructive 
research purposes was a direction that we did not want to go 
into. But that is exactly the direction we are heading into 
now.
    Now, some may contend that these embryos are not human or 
that they are not really embryos. I can just tell you from a 
scientific basis there is absolutely no foundation to put 
forward such a claim. This is a human embryo that we would be 
essentially saying it is legal to create this, but only for the 
purpose of exploiting it for research purposes and then it has 
to be destroyed. We would be saying it is illegal to implant it 
into a woman.
    I just want to underscore a couple of additional points. 
One important one is that some people have tried to portray 
this as a pro-life/pro-choice type of debate. While there may 
be some people who may view it in that context, if you actually 
look at what went on in the House, it pretty much transcended 
that, in that there were a lot of people who were very pro-
choice in their outlook, some of whom had a 100-percent 
approval from various groups like NARAL, who voted for the ban.
    Indeed, some pretty vocal feminist groups came out in 
support of banning human cloning, most notably Judy Norsigian, 
with the Boston women's health book group, the coauthor of Our 
Bodies, Ourselves for the New Century. She and Steward Newman 
of the Council for Genetic Responsibility wrote in a Boston 
Globe op ed, ``Because embryo cloning will compromise women's 
health, turning their eggs and wombs into commodities, 
compromise their reproductive autonomy, and with virtual 
certainty lead to the production of experimental human beings, 
we are convinced that the line must be drawn here.''
    The point they are alluding there, of course, is that if we 
are going to allow research labs all over the country to start 
creating these embryos in large quantities for research 
purposes, they are going to have to get female eggs from 
somewhere. Where are they going to get these female eggs from? 
Well, the same place the group in Worcester, Massachusetts, got 
them from; they paid women to do it. So you will be, in my 
opinion--and they agree with me--you will be essentially 
exploiting women by--it will be women who need money who will 
come forward and donate their eggs.
    Another very, very critical point about this relates to the 
recent National Academy of Sciences report that you cited in 
your opening statement, Madam Chairman, in support of embryo 
cloning. They in that report interestingly opposed reproductive 
cloning because they said it would involve the exploitation of 
women.
    But in that report, as you mentioned, they support the so-
called therapeutic cloning or research cloning that we have 
had. And I would have to assert that it involves the same type 
of exploitation of women and women donating their eggs in the 
fashion described.
    Let me just point out several other groups on the left who 
have come out in opposition to this so-called therapeutic 
cloning or embryonic cloning: Friends of the Earth, Council for 
Responsible Genetics.
    Importantly, the bill that passed the House with a strong 
bipartisan majority was not only supported by the Conference of 
Catholic Bishops, but it was supported by the General Board of 
Church and Society of the United Methodist Church, which is, of 
course, a group that has always stood in strong support of 
abortion rights.
    I say all this to just emphasize that this is not an 
abortion debate. I think we have to ask a lot of questions as 
we go through the process of moving this legislation forward in 
the Senate. Do scientists have the moral authority to go 
wherever they wish to go? Should the Congress pass a law that 
would mandate for the first time that a certain class of human 
embryo, if created, must be used for experimental research 
purposes and then has to be destroyed?
    Now, perhaps most importantly, if we have all of these 
research labs all over the country producing hundreds or 
thousands of cloned embryos, will it be possible to prevent a 
physician from implanting one of those embryos in a woman? The 
implantation of a cloned embryo into the womb of a woman would 
occur within the confines of the doctor-patient relationship, 
and it is for that reason, I think, more than any other that 
many people, such as myself, believe that you really cannot 
have both. You cannot have all of this research proceeding and 
prevent reproductive cloning.
    Because the implantation of a clone in a woman would occur 
within the privacy of the doctor-patient relationship, and 
because research labs throughout the world, throughout the 
United States, would be producing large quantities of these 
embryos, it would only be a matter of time before a rogue 
physician, in defiance of the law, would implant one of these 
embryos in a woman.
    Indeed, in the event of that, it would put the Government 
of the United States in a very, very awkward position because 
though it may have been made illegal, you would be getting into 
the issues of reproductive rights and autonomy of the woman, of 
the doctor-patient relationship.
    It is for these reasons and many others that I felt the 
only way to properly prevent human reproductive cloning from 
proceeding was to ban it at the very beginning, at the creation 
of the embryo.
    I would be very happy to field any questions. Thank you.
    [The prepared statement of Mr. Weldon follows:]

 Statement of Hon. Dave Weldon, a U.S. Representative in Congress from 
                          the State of Florida

                              Introduction

    Thank you for your invitation to appear here before you today. I 
appreciate this opportunity to share with the Committee why I am 
concerned about this issue and what led me to introduce in the House, 
along with by good friend, Democrat Rep. Bart Stupak, a bill banning 
human cloning.
    I assume the debate in the Senate will, most likely, follow along 
similar lines as to what occurred in The House. In that body there was 
an almost universal agreement that so called reproductive cloning (an 
attempt to create a live baby using cloning technology) should be 
illegal, but some people would like to allow scientists to be able to 
create human cloned embryos in the lab for research purposes. This 
latter position is defended by its advocate because of the claim that 
such research might lead to treatments for various diseases.
    It also takes us beyond the position many people held by some 
during the debate in support of embryo stem cell research. Destroying 
human embryos was felt justified by some because these embryos in the 
fertility clinics were held to be excess and destined for destruction 
anyway. Now we are debating

        ``. . .creating human embryos specifically to be used for 
        research and then destroyed ``. . . creating embryos for 
        research purposes is entirely different from using spare 
        embryos leftover from infertility treatments. . . '' So wrote 
        13 Senators in a recent letter to the President Bush on July 
        20, 2001.
        Also adopting this ethical principle are 59 Senators who on 
        July 20, 2001 wrote the following to the President regarding 
        embryo stem cell research: ``. . . for we must bear in mind 
        that the embryos used in this research are produced in vitro 
        fertilization clinics and if not used for humanitarian research 
        may otherwise be discarded.''
        A 1994 Washington Post editorial labeled as ``unconscionable'' 
        the notion of allowing embryos to be created solely for 
        research. These Senators, the Post and others saw clearly the 
        great peril of allowing the creation of human embryos, cloned 
        or not, specifically for research purposes. Regardless of the 
        issue of personhood, nascent human life has some value, it's 
        not bacteria, and as these statements suggest, the creation of 
        human embryos for the sole purpose of research is a line which 
        should not be crossed.

                              Terminology

    The term ``therapeutic cloning'' has suffered an image crisis and 
so there has been an effort to come up with a new label. Some call it 
``nuclear transplantation'', others call it ``therapeutic cell 
transplantation''. Is it an embryo. Period. The simple test is, if you 
place the product of nuclear transplantation into a woman's womb could 
it grow into a human baby. The answer is ``yes.'' It is an embryo 
regardless of what name it is given.
   complete ban has broad support/not a pro-life vs. pro-choice issue
Broad Support for Weldon/Stupak Cloning Ban
    By more than a 100 vote majority (265-162) the House passed H.R. 
2505, the Weldon/Stupak bill to ban human embryo cloning for both 
experimental research and human reproduction.
    The House considered and rejected on a 175-251 vote, a bill offered 
by Rep. Greenwood. The Greenwood bill offered a simplistic solution to 
a very complex issue. It allowed for the cloned human embryos to be 
created for research purposes but attempted ban the use of these cloned 
embryos to initiate a pregnancy. This is the very thing that the Post 
called ``unconscionable.'' It is the very thing countless witnesses 
before House Committees called ``unworkable.'' Unfortunately, the bill 
offered by Senator Feinstein is very similar to the Greenwood bill and 
it faces the same problems that the Greenwood bill faced.
    Voting for the full cloning ban which passed the House were pro-
choice and pro-life Members. Some of the most liberal Members in the 
House voted for the complete ban. Why did these Members vote for a 
complete ban on human cloning? Why has such a large and diverse group 
of Americans across political ideologies and religions affiliations 
joined in support of the Weldon/Stupak/Brownback bill? I will shed some 
light on that.

Exploitation of Women
    Judy Norsigian noted feminist of the Boston Women's Health Book 
Group and co-author of Our Bodies, Ourselves for the New Century 
testified in support of the bill that passed the House. She and Stuart 
Newman, Ph.D. of the Council for Genetic Responsibility wrote in a 
Boston Globe Op-ed, ``Because embryo cloning will compromise women's 
health, turn their eggs and wombs into commodities, compromise their 
reproductive autonomy and, with virtual certainty, lead to the 
production of `experimental' human beings, we are convinced that the 
line must be drawn here.'' Any bill that falls short of the complete 
ban enables this exploitation of women and experimentation would go 
forward.
    The National Academy of Sciences (NAS) cited as a reason for 
opposing human reproductive cloning, the increased ``risks to women 
donating eggs.'' The same principle should apply to selling eggs to 
biotech companies for highly speculative human cloning research. For 
every patient, at least one cloned embryo would be required, therefore 
to treat millions of diseased patients, millions of women's eggs will 
be required. Where will they come from?

Environmentalists
    Friends of the Earth President, Dr. Brent Blackwelder, has urged 
the House and Senate to enact the House-passed bill.

The Council for Responsible Genetics,t
    The Nation's oldest organization scrutinizing new genetic 
technologies opposes all human cloning.
Liberal and Conservative Religious Leaders
    The pro-choice General Board of Church and Society of The United 
Methodist Church and the pro-life United States Conference of Catholic 
Bishops support the House passed bill.

             HUMAN CLONING NOT THE MOST PROMISING FOR CURES

New Discovery
    A significant blow was dealt to the advocates of cloning on January 
23, 2002, when it was reported in the New Scientists, that `` ``A stem 
cell has been found in adults that can turn into every single tissue in 
the body. It might turn out to be the most important cell ever 
discovered,''
    Irving Weissman, who is on the next panel, stated in that article, 
``It's very dramatic, the kinds of observations [Verfaillie] is 
reporting. . . .The findings, if reproducible, are remarkable.''
    that a new adult stem cell had been discovered that is can change 
into many other types of human cells. This morning that study is 
published in the peer reviewed scientific Journal of Clinical 
Investigation with an accompanying commentary praising the discoveries 
of Reys, Verfaillie et al.
    These findings are remarkable, and I would urge that we immediately 
thoroughly review these findings and see them duplicated in independent 
studies.
    I think everyone in this room hopes that this finding can be 
independently reproduced. This finding would be one of the most 
dramatic findings ever and would indeed lead us on the path seeking 
cures for diseases without raising the serious moral and ethical issues 
that would otherwise be raised. I would hope that this Committee would 
invite these researchers to appear before your Committee as you 
consider this legislation.

Autoimmune Concerns
    Furthermore, while proponents of research cloning say that human 
embryo cloning is necessary to develop cures and produce 
``immunologically acceptable tissue'' some stem cell researchers 
disagree. In the Journal Science, John Gearhart of Johns Hopkins 
University states that many scientists feel ``there are ways of getting 
around [the rejection problem] without the nuclear transfer [cloning] 
paradigm.''
    One of the most respected members of the Senate, Dr. Bill Frist, 
stated in his November 27, 2001, floor statement urging the Senate to 
take up and pass the House bill that, ``the idea of therapeutic 
cloning, intended to combat the danger of autoimmune rejection, 
something I as a transplant surgeon am very aware of, carries with it 
challenges of its own and does not necessarily solve the problem of 
autoimmune rejection.''

Patients Hopes Raised and Dashed
    As a physician who still sees patients on a regular basis, I find 
it deeply upsetting to see patients suffering from serious diseases 
intentionally used by some in the debate over human cloning. These 
patients' hopes were raised early in the 1 990s over the prospects of 
using tissue from aborted fetuses for curing diseases. Those 
experiments have been disastrous. We saw this again just a few years 
ago with the promises of gene therapy. Nothing could be more cruel than 
to see suffering patients used for the cause of the moment.

Even Biotech Says So. . . 
    Often omitted by the supporters of embryonic stem cell research and 
cloning, are the serious hurdles that must be overcome. The New York 
Times ran several articles on this issue, one on December 11, 2001 and 
another on December 18, 2001. The December 18 article stated ``Though 
not often discussed in public forums, the obstacles are so serious that 
scientists say they foresee years, if not decades, of concerted work on 
basic science before they can even think of trying to treat a 
patient.'' The failure of researchers and biotech companies to filly 
disclose and openly discuss these very serious challenges is prone to 
mislead many of those who suffer from these diseases.
    Most scientists, according to leading scientific journals, now 
regard research cloning as impractical for treating patients. In the 
December 2001 issue of Nature, Peter Aldous (chief editor of news and 
features of Nature) said, ``The idea of 'therapeutic cloning' seems to 
be on the wane.. . most [scientists] now believe this will be too 
expensive and cumbersome for regular clinical use.''
    In Stem Cells, (the first to isolate human embryo stem cells in 
1998), Jamie Thomson of Johns Hopkins University writes, ``[T]he poor 
availability of human oocytes, the low efficiency of the nuclear 
transfer procedure, and the long population-doubling time of human ES 
cells make it difficult to envision this [therapeutic cloning] becoming 
a routine clinical procedure.''
    And a recent New Scientist editorial states, that ``Ministers in 
Britain have too easily swallowed the line that cloning human embryos 
is essential to medical progress. It is not. Like stuck records, 
ministers and policy makers continue to enthuse about therapeutic 
cloning even though the majority of bench scientists no longer think 
it's possible or practicable to treat patients with cells derived from 
cloned embryos.''

Specific Objections and Concerns Raised by Researchers
    University of Colorado biologist Jonathan Van Blerkom said he 
supports a blanket ban on all human cloning until scientists thoroughly 
understand what causes the birth defects that have plagued efforts to 
clone other mammals, such as cows and sheep.
    ``Until you really understand the underlying biology of what you're 
dealing with in a very comprehensive way, it's crazy, it doesn't make 
any sense,'' said Van Blerkom, who works with human embryonic stem 
cells at his Boulder lab.
    The New York Times reported on December 11, 2001, reported that Dr 
Tanja Dominko went to a lab in Oregon to attempt to clone monkeys. 
``She left a year ago, with a cloning portfolio that she calls her 
gallery of horrors.''
    The National Academy of Sciences recently released a report of 
scientists, no bioethicists were involved, in which they supported 
research cloning while calling for a temporary ban on human 
reproductive cloning. ``The greatest benefit we see as scientists is to 
get [human] research models who have real diseases,'' said the panel's 
chairman, Irving Weissman. He continued, ``We are stymied as scientists 
in trying to study these diseases on mouse models.'' In other words, 
the term ``model'' refers to living organisms used in research. It is 
important to realize that regardless of potential clinical 
applications, the panel's recommendation is based on the desire to do 
basic research.

Conclusion
    In conclusion, I suggest that there are several questions before 
the Committee today. These are fundamental questions that deserve 
serious consideration.
    Does science have the moral authority to go wherever it wishes?
    Should Congress pass a law that would mandate for the first time 
ever that a certain class of human embryos if created, can only be 
mined for their cells and then destroyed?
    Is it realistic to think that it is possible to allow the creation 
of cloned embryos and still provide 100% certainty that no rouge 
scientist will take one of these embryos and implant it?
    What would law enforcement do if it is found that a woman is 
carrying a cloned human embryo? If nothing, then why even posit the 
notion that therapeutic and reproductive cloning can be separate? If 
intervention, then aren't we into a whole new realm of civil liberties 
and privacy issues?
    Are federal law enforcement officials going to inject themselves 
into the physician-patient relationship?
    Are women being exploited by biotech companies?
    Are there more promising alternatives? If so, many scientists are 
raising questions about the practicality of research cloning actually 
being used in therapies.
    Are patients' hopes being needless raised once again, only to be 
dashed by scientific reality?
    These just a few of the questions about the Greenwood bill that 
were unresolved during the House debate. And, they remain unresolved in 
the Feinstein bill.
    I appreciate this opportunity to address the members of the 
Committee and would invite any questions you might have either about my 
bill or any of the issues I have raised.
    Chairperson Feinstein. Thanks very much, Mr. Weldon.
    Mr. Greenwood, welcome.

   STATEMENT OF HON. JAMES C. GREENWOOD, A REPRESENTATIVE IN 
            CONGRESS FROM THE STATE OF PENNSYLVANIA

    Representative Greenwood. Thank you, Senator Feinstein, 
Senator Hatch, Senator DeWine, Senator Brownback, for the 
invitation to testify today on the subject of human cloning.
    I am encouraged to see the Senate take up this difficult 
issue as it confronts some of our most basic questions about 
science, the use of technology in improving health care, and 
life itself. These are questions that, however politically 
charged, we must forthrightly address.
    Eighty years ago, Aldous Huxley wrote his literary 
masterpiece Brave New World. In that book, he posited a future 
where genetic engineering is commonplace and human beings, 
aided by cloning, are mass-produced. Controllers and 
predestinators have replaced mothers and fathers as the new 
authors of human life.
    For most of its 80 years, Brave New World was seen as a 
disturbing work of science fiction, but that is no longer the 
case. The cloning of human beings is no longer relegated to the 
world of fiction. On March 28th of last year, I held a hearing 
in the Energy and Commerce Oversight and Investigation 
Subcommittee that found that the science existed and that there 
were sufficiently funded fringe groups that sought to clone a 
human being.
    These fringe groups, combined with the recent announcement 
by a Massachusetts company that it had actually succeeded in 
the effort to grow stem cells for therapeutic purposes, has 
forced each of us to ask what should we do with this science.
    I believe that as policymakers we must not only address the 
problems that come about from the use of the technology, but 
the foregone opportunities, cures for diseases, ailments and 
illness, that well may be lost should we entirely ban every 
aspect of this technology.
    Let me be clear. I oppose human cloning, both the 
implantation of an embryo in a uterus and the creation of these 
embryos for reproductive purposes. Cloning human beings must be 
outlawed, and it must be outlawed in this Congress. But I also 
reject the premise that we are unable to distinguish between 
the dangers of untrammeled scientific experiments, on the one 
hand, and new paradigms in biomedical research on the other.
    Somatic cell nuclear transfer, the science in question, 
holds the very real promise to enable a new kind of therapy, 
known as regenerative medicine. This therapy is one of the 
goals of stem cell research. Stem cells have the potential to 
form any cell in the body, and it can replicate indefinitely.
    Regenerative medicine, when perfected, will use the 
knowledge we will gain in stem cell research to ultimately 
replace damaged or dead cells with transplanted healthy and 
vigorous new cells. These cellular therapies also hold the 
potential to cause an individual's currently malfunctioning 
cells to begin to function properly again.
    Research with these stem cells and regenerative medicine 
holds great promise in the noble struggle to cure and treat 
millions of Americans who suffer from Alzheimer's and 
Parkinson's disease, diabetes, stroke, and spinal cord injury.
    To achieve the goals in regenerative medicine, somatic cell 
nuclear transfer research is essential. This technology will 
help us understand biological properties that enable a 
differentiated cell nucleus to act like an undifferentiated one 
in a pluripotent cell. Scientists are still not sure how this 
reprogramming process works, but research to date supports the 
argument that potentially we could use our own tissue to create 
pluripotent stem cells, reducing the need for immunosuppressive 
drugs as part of the cellular therapy.
    Last year, the House faced a choice of two approaches on 
how to deal with this science. The first, sponsored by 
Congressman Weldon, seeks to provide a simple and 
straightforward solution to this very complex matter of 
science. It seeks to ban all forms of cloning, effectively 
banning the related science of therapeutic cloning, thus 
shutting the door to these potentially life-saving 
technologies. Unfortunately, science will not yield up its 
mysteries in such constricted space.
    The measure that I introduced, which is similar to your 
bill, Senator Feinstein, and to Senator Kennedy's, provides a 
more sophisticated solution to this terribly complex issue. 
Like you both, I wish to outlaw reproductive human cloning, 
while permitting further and carefully circumscribed research.
    Unfortunately, the House chose to yield to fear-mongering 
and voted for the Weldon bill. Now, the Senate asks, what 
should we do with this science? Human reproductive cloning is 
not fiction and we should ban it. At the same time, I urge the 
Senate to enact meaningful legislation that also recognizes and 
responds to the possibilities of therapeutic cloning.
    If I may, I would like to respond to a point or two that my 
colleague has made.
    Chairperson Feinstein. Please.
    Representative Greenwood. First, he referenced or referred 
to false hope, that this science is not yet proven and he 
hesitates to provide false hope to the millions of our fellow 
humans who suffer from these diseases.
    I would hold that hope is at the core of our humanity and 
we should allow our brilliant researchers to tell those who 
suffer from heretofore incurable illnesses and injuries if the 
hope is false or not. We should not legislatively dash their 
hopes.
    A second point that my colleague made was on the question 
of whether this science holds out the potential to exploit 
women, because somehow there has been this notion created of 
embryo farms, thousands of women lining up to donate their eggs 
for this science. This is an incredibly important point in this 
argument.
    What we want to promote is the science that would enable us 
to understand how this transformation occurs between a 
differentiated cell placed in a nucleus, surrounded by the 
contents of the egg--how that becomes an undifferentiated cell, 
and then again specializes in differentiation.
    That science will enable us to identify the chemicals that 
are present at that transformation. When we understand what 
those chemicals are and what those processes are, we no longer 
need a supply of eggs. This is not a process that has to be 
replicated in order to provide the therapy.
    The promise that is held out is that once we understand the 
chemistry of this process at the cellular level, then in the 
relatively near future when the patient comes to the hospital 
with a spinal injury, with the incurable disease, the 
therapist, the doctor, only needs to take that individual's 
somatic cell and then, in combination with these other 
chemicals, allow it to become a pluripotent cell and then a 
specialized cell to repair that spinal cord damage, to repair 
the damaged cells in the other organs, including the brain.
    This vision of embryo farms needs to be removed from the 
debate. There is no such thing. The only way you could create 
this scenario is to have women line up and ask to be put 
through the extraordinarily painful process of super-ovulating 
so that scientists could have these eggs.
    In nature, millions of fertilized eggs are flushed from the 
female body daily. That is, if you will, God's process. In in 
vitro fertilization, we have a surplus of fertilized eggs that, 
in the name of providing couples around the world the 
opportunity to have children when they couldn't otherwise do 
it, are destroyed by the thousands.
    The research that we are talking about, as Senator Hatch 
said, is not about bringing together sperm and egg, but 
allowing the division of a somatic cell, if you would, from the 
inside of a cheek to study the processes that occur when that 
somatic cell is in the environment of the egg, to learn from it 
and then to provide therapy. We are not talking about vast 
quantities of eggs necessary to do that. We are probably 
talking on the order of magnitude of scores.
    Thank you for the opportunity to testify, and I would also 
be pleased to answer your questions.
    [The prepared statement of Mr. Greenwood follows:]

Statement of Hon. James C. Greenwood, a U.S. Representative in Congress 
                     from the State of Pennsylvania

    Senator Feinstein, senator Hatch, thank you for your invitation to 
testify today on the subject of human cloning. I am encouraged to see 
the senate take up this difficult issue, as it confronts some of our 
most basic questions about science, the use of technology in improving 
heatlhcare, and life itself. These are questions that, however 
politically charged, we must forthrightly address.
    Eighty years ago, Aldous Huxley wrote his literary masterpiece, 
brave new world. In that book, he posited a future where genetic 
engineering is commonplace and human beings, aided by cloning, are 
mass-produced. Controllers and predestinators have replaced mothers and 
fathers as the new authors of human life.
    For most of its eighty years, brave new world was seen as a 
disturbing work of science fiction. That is no longer the case.
    The cloning of human beings is no longer relegated to the world of 
fiction. On March 28 last year, I held a hearing in the energy & 
commerce oversight and investigations subcommittee that found that the 
science existed and that there were sufficiently funded fringe groups 
that sought to clone a human being.
    These fringe groups, combined with the recent announcement by a 
Massachusetts company that it had actually succeeded in the effort to 
grow stem cells for therapeutic purposes has forced each of us to ask, 
``what should we do with the science?''
    I believe that as policymakers, we must not only address the 
problems that come about from the use of the technology, but the 
forgone opportunities--cures for diseases, ailments, and illness--that 
may be lost should we entirely ban every aspect of this technology.
    Let me be clear. I oppose human cloning both the implantation of an 
embryo in a uterus and the creation of these embryos for reproductive 
purposes. Cloning human beings must be outlawed. And in this congress. 
But I also reject the premise that we are unable to distinguish between 
the dangers of untrammeled scientific experiments on the one hand and 
new paradigms in biomedical research on the other.
    Somatic cell nuclear transfer, the science in question, holds the 
very real promise to enable a new kind of therapy known as regenerative 
medicine. This therapy is one of the goals of stem cell research.
    Stem cells have the potential to form any cell in the body and can 
replicate indefinitely.
    Regenerative medicine, when perfected, will use the knowledge we 
will gain in stem cell research to ultimately replace damaged or dead 
cells with transplanted healthy and vigorous new cells. These cellular 
therapies also hold the potential to cause an individual's currently 
malfunctioning cells to begin to function properly again.
    Research with these stem cells and regenerative medicine holds 
great promise in the noble struggle to cure and treat millions of 
Americans who suffer from Alzheimer's and Parkinson's diseases, 
Diabetes, Stroke, and Spinal cord injury.
    To achieve the goals in regenerative medicine, somatic cell nuclear 
transfer research is essential. This technology will help us understand 
biological properties that enable a differentiated cell nucleus to act 
like an undifferentiated one in a pluripotent cell. Scientists are 
still not sure how this ``reprogramming'' process works. But, research 
to date supports the argument that potentially, we could use our own 
tissue to create pluripotent stem cells, reducing the need for 
immunosuppressive drugs as part of this cellular therapy.
    Last year, the house faced a choice of two approaches on how to 
deal with this science. The first, sponsored by Congressman Weldon, 
seeks to provide a simple and straightforward solution to this very 
complex matter of science. It seeks to ban all forms of cloning, 
effectively banning the related science of therapeutic cloning, thus 
shutting the door to these potentially life-saving technologies. 
Unfortunately, science will not yeild up its mysteries in such 
constricted space. The measure that I introduced, which is similar to 
your bill, senators Feinstein and Kennedy, provides a more 
sophisticated solution to this terribly complex issue. Like you both, I 
wish to outlaw reproductive human cloning, while permitting further and 
carefully circumscribed research.
    Unfortunately, the house chose to yield to fearmongering and voted 
for the Weldon bill.
    Now the senate asks: what should we do with this science? Human 
reproductive cloning is not fiction--and we should ban it. At the same 
time, I urge the senate to enact meaningful legislation that also 
recognizes and responds to possibilities of therapeutic cloning.
    There is a line from John Keats' work, the fall of hyperion, which 
the late Robert Kennedy once used to describe the burden of public 
service that applies here, where the poet wrote of those ``who feel the 
weight of the world and more like slaves to poor humanity labour for 
mortal good.''
    We are now called upon to labor for the needs of those millions who 
suffer and whose greatest and best hope is in the benefits which can 
only be derived from advances in this remarkable science.
    Thank you very much.
    Chairperson Feinstein. Thanks very much, Mr. Greenwood.
    Do members have questions of this panel?
    Senator Specter. Madam Chairman?
    Chairperson Feinstein. Senator Specter, welcome.

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

    Senator Specter. A comment and a question of sorts. The 
subject matter today is human cloning, and the frequently used 
phrase has been ``therapeutic cloning.'' In hearings which we 
had in the Appropriations Subcommittee for Health and Human 
Services, we called it a nuclear transplant, and I see that 
Senator Hatch today has called it DNA regenerative therapy.
    The word ``cloning'' conjures up reproductive cloning, 
which is generally objected to and has a very, very unpalatable 
connotation. This, of course, is not cloning of another human 
being, but is a process to enable therapy to be applied so that 
the patient does not reject it.
    So my question is, Congressman Greenwood, do you think it 
would be a good idea not to call it therapeutic cloning, but to 
call it something else?
    Representative Greenwood. I do. I think ``somatic cell 
nuclear transfer'' is the appropriate scientific term. And I 
agree with you, Senator Specter, that everyone rejects the 
notion that we should reproduce humans by cloning. I think that 
every child deserves to be the unique process of reproduction 
between a mother and a father, and not someone's duplicate. 
That is the vision that is conjured by the word ``cloning,'' 
and I think it is a misnomer to refer to this somatic cell 
nuclear transfer as cloning and it would be less confusing to 
the public if we dropped that terminology.
    Senator Specter. Well, I thank you, Congressman Greenwood, 
and also Congressman Weldon, for your participation. This is a 
very, very important debate. As already noted, Senator 
Feinstein and Senator Kennedy have introduced legislation, as 
have Senator Harkin and myself. I think Senator Brownback is 
interested in this subject as well.
    Chairperson Feinstein. And Senator Durbin is a cosponsor of 
our bill, as well.
    Senator Specter. And Senator Durbin.
    It is very important to have a thorough debate and I 
compliment you, Madam Chairman, for convening the hearing.
    Chairperson Feinstein. Well, thank you.
    Senator Durbin, any questions of these witnesses?
    Senator Durbin. No.
    Chairperson Feinstein. Any other questions?
    Senator Brownback. I do, Madam Chairman, if I could, 
briefly.
    Chairperson Feinstein. Senator Brownback?
    Senator Brownback. Thank you for holding the hearing. I 
appreciate your doing that and I appreciate looking at the 
topic carefully. I think it is an extremely important topic and 
one that hopefully we are going to take action on this spring. 
The Majority Leader has stated that we would have a vote on 
this sometime in February or March on the floor. So I think it 
is good that we lay the groundwork here.
    I would ask either Congressman Weldon or Greenwood, why are 
we trying to get around this notion of calling the clone an 
embryo.
    Congressman Greenwood, what you are describing in 
therapeutic cloning is, that someone would take the egg, de-
nuclei it; then take a somatic cell from you, and then, put it 
in the egg and start it growing again. Is that correct?
    Representative Greenwood. That is roughly the description 
of the process of somatic cell nuclear transfer, yes, sir.
    Senator Brownback. So we would have a genetic copy of you, 
then, if we did it the way I have just described. Is that 
correct?
    Representative Greenwood. Well, we would have in that cell 
all 46 of my chromosomes, yes.
    Senator Brownback. And they would be identical to your 
genetic makeup. Is that correct?
    Representative Greenwood. That is correct.
    Senator Brownback. And if we are able to perfect the 
system--and I think there is a way to go before we do, but if 
we are able to perfect it the way Dolly the sheep was created, 
at the end of that process if we nurtured that clone, if it is 
able to follow on through, we would have a baby that would come 
forward that would be physically identical to you. Would that 
be correct?
    Representative Greenwood. God forbid.
    [Laughter.]
    Senator Brownback. Or me or anything else like that, but 
that is what would happen at the end of that process. Is that 
correct?
    Representative Greenwood. Yes. Theoretically, if you 
planted that dividing cell into a woman's uterus and it took 
and it came to term, yes, it would be a genetic reproduction of 
the donor of the somatic cell. Of course, that is why we 
expressly prohibit that course of action in our legislation.
    Senator Brownback. You expressly prohibit the implantation, 
correct?
    Representative Greenwood. Correct.
    Senator Brownback. It is not the creation, it is the 
implantation in the Feinstein bill and in your process.
    Representative Greenwood. Correct.
    Senator Brownback. So you would allow the creation, but not 
the implantation of it?
    Representative Greenwood. That is correct.
    Senator Brownback. I think here is, if I could engage 
Congressman Weldon, where the rub on the bill is, that you have 
then created a clone. Now, some may not deem it a clone until 
it reaches a certain age, but the genetic composition in this 
process doesn't change, does it, Congressman Weldon?
    Representative Weldon. No, it doesn't.
    Representative Greenwood. Pardon me. May I be excused? I 
promised to stay longer, but I have been reminded I have a 
television appearance at three.
    Chairperson Feinstein. Please, and thank you very much.
    Senator Brownback. Thank you for being here.
    Representative Weldon. You have created a clone. It begins 
the process of differentiation and it goes through various 
phases. You have the blastocyst phase and then you have the 
embryonic phase, and then it goes into the fetal phase after 
that.
    It is a genetic copy, and that is really why the 
researchers want to use it. The theoretical construct is that 
you develop leukemia, you go into the doctor, he creates a 
clone of you and then he extracts new bone marrow cells from 
the clone, or stem cells that would then become bone marrow 
cells. The clone is then destroyed and the cells that were 
extracted or harvested are then used to treat your condition. 
That is where the term ``therapeutic cloning'' was derived.
    As Senator Specter said, it has very high negative 
connotations amongst the public. So an attempt is being made to 
give it a different name, but it is still the same thing that 
we are talking about.
    Senator Brownback. Madam Chairman, I don't want to belabor 
the discussion here, but I think it is a key part of what the 
discussion is because we are all saying we are opposed to 
cloning because of the repugnance and we don't think that seems 
quite right and a number of other factors that people might 
cite.
    But one bill that several people have put forward bans the 
implantation, not the creation. The Weldon approach and the 
approach I have put forward would ban the creation of the 
clone, and that is, I think, a key distinction that we need to 
understand in the various approaches. Those are basically the 
two approaches that are involved here with the legislation and 
the legislative debate that we are involved in.
    Chairperson Feinstein. Thank you, Senator Brownback.
    Senator Durbin?
    Senator Durbin. If I might ask Congressman Weldon for the 
record, do you suggest that we should prohibit in vitro 
fertilization?
    Representative Weldon. Oh, no, absolutely not, absolutely 
not. That is a totally different issue.
    Senator Durbin. Well, help me with this because you are 
trained in the science and I am not. If I understand in vitro 
fertilization, at the end of the process, if you are 
successful, you may have one implanted embryo that leads to a 
healthy baby and many other fertilized eggs that are ultimately 
discarded.
    If the core of your belief here is that once you have 
joined this sperm and ovum either in a Petri dish or through 
another process that you have a human being, can you explain 
why you would support that process?
    Representative Weldon. Sure, I would be very happy to 
respond to your question. Actually, the technique that is used 
in in vitro fertilization is multiple eggs are usually 
harvested, though in some cases they only get one or two that 
are viable and then they have to do a procedure called twinning 
to get more eggs.
    Then they go through the fertilization phase with the sperm 
and they try to get multiple embryos, and they usually implant 
multiple embryos because it usually requires implanting 
multiple embryos to get one to take. This is why you get the 
high multi-birth incidence in women who have undergone the in 
vitro fertilization.
    The important distinctions in this whole process from a 
moral and ethical perspective, which is I believe what you are 
getting at, are really two- or three-fold. No. 1, it is sexual 
fertilization, so you are not creating a clone and you don't 
get into all the ethical and moral issues associated with 
creating clones. We really didn't get into that, either Mr. 
Greenwood nor I, in our testimony, but there are legal issues 
and there are moral issues associated with that.
    Typically, what happens in the in vitro clinic is after the 
first attempt, there is a 25-percent success rate with the 
first attempt. So 75 percent of the time you get a failure, so 
then you use any of those additional embryos for the second 
attempt. What is true is that 25 percent of the time you get a 
success the first time around and then you will have these 
extra embryos in the freezer, and that is really the issue that 
you bring up.
    How are they different from clones? Well, one of the things 
that makes them very different is they are owned by the mother 
and father, and frequently in a high percentage of cases the 
reason the fertility experts like to keep these in storage is 
the couples come back and they say they want a second child.
    What we really didn't get into in the egg donation issue 
but which is worth mentioning and why I talk about it as being 
exploiting women is there are some hazards associated with the 
egg-harvesting process. You have to give the women a super-
ovulatory drug. There is a certain complication rate. They can 
get ovarian cysts, and it requires an anesthesia to harvest the 
eggs.
    Senator Durbin. I hate to interrupt you, but I am really 
trying to get to the bottom-line question here, not the 
process, but the result. At the end of this process, you end up 
with surplus embryos.
    Representative Weldon. Sometimes, sometimes.
    Senator Durbin. So you are drawing a distinction of 
ownership. If there is ownership of these embryos by a married 
man and woman, then it is morally acceptable to store them, to 
use them. But if they are created through a scientific process 
through cloning, that is where you draw the line? The ownership 
is different?
    Representative Weldon. Well, no, it is not only the 
ownership; it is the purpose and the intent. The purpose and 
the intent when you go to an in vitro clinic is you want to 
have a baby. You are creating these embryos because you want it 
ultimately to result in a child.
    During the natural process, they may insert five embryos 
and only one may take and four are lost. In the other case----
    Senator Durbin. Isn't that a slippery slope? If it is 
intent and I know that my wife and I want one child and we are 
going to end up with surplus embryos that we are never going to 
use, you still think that is morally acceptable to go forward. 
Yet, if there was a cloned embryo coming out of a laboratory 
for whatever purpose, you would say that is morally 
unacceptable?
    Representative Weldon. Well, I think you are comparing 
apples and oranges. What I would object to is if you and your 
wife said we are going to go down to the clinic and she is 
going to donate eggs, and me my sperm, and we are going to 
create embryos and then we are going to give them to this 
research department at the university so that they can extract 
stem cells and then destroy them. I would say then you are 
comparing apples to apples.
    But when you say we are doing this because we want to have 
a baby and, yes, during the process there may be embryos that 
are lost, I think that is an ethically and morally -it is a 
very, very different situation than when you are creating 
embryos for the express purpose of extracting stem cells and 
destroying them.
    Senator Durbin. Thank you.
    Chairperson Feinstein. Thanks very much, Senator.
    Thank you very much, Congressmen, for taking so much time. 
We appreciate it.
    We will move on with the next panel, if we may, and as the 
next panel comes up I am going to begin to introduce them to 
save time.
    The first panelist is Professor Irving Weissman. He is 
Professor of Pathology and Developmental Biology at my alma 
mater, Stanford, School of Medicine. He serves as a member of 
numerous professional societies, institutions, and editorial 
boards. He has been elected to the National Academy of Sciences 
and to the American Association for the Advancement of Science. 
He has also received the Kaiser Award for excellence in pre-
clinical teaching, the Passerow Award, and the Outstanding 
Investigator Award from the National Institutes of Health. 
Professor Weissman is also the Chair of the Panel on Scientific 
and Medical Aspects of Human Cloning, of the National 
Academies. That Panel just issued its long-awaited report and 
recommendations about cloning.
    Professor Weissman, welcome. I am going to observe the 5-
minute rule and we will go right down the line so that we have 
an opportunity to ask questions. I hope that is all right.

    STATEMENT OF IRVING L. WEISSMAN, M.D., CHAIR, PANEL ON 
 SCIENTIFIC AND MEDICAL ASPECTS OF HUMAN REPRODUCTIVE CLONING, 
  THE NATIONAL ACADEMIES, AND PROFESSOR, STANFORD UNIVERSITY 
            SCHOOL OF MEDICINE, STANFORD, CALIFORNIA

    Dr. Weissman. Madam Chair and members of the committee, my 
name is Irv Weissman and I am an M.D. and professor at Stanford 
Medical School. My main research field for the past 20 years 
has been the biology and transplantation of adult cells in mice 
and in humans.
    I am here as Chair of the National Academies' Panel on 
Scientific and Medical Aspects of Human Reproductive Cloning, 
which released its report on January 18 of this year.
    The charge to the panel in June 2001 was to examine the 
scientific and medical issues relevant to human reproductive 
cloning, including the protection of human subjects, and to 
clarify how human reproductive cloning differs from stem cell 
research. Our charge did not extend to an examination of the 
ethical issues related to human reproductive cloning.
    We needed to determine whether current methods for 
reproductive cloning are scientifically feasible and 
reproducible and are medically safe. In addition, we needed to 
examine whether human participants in the process could be 
adequately advised and protected. Society and its leaders will 
need such scientific and medical information if they are to 
address the relevant ethical and public policy issues.
    In reproductive cloning, the nucleus of a body cell is 
transplanted into an egg whose nucleus has been removed, 
stimulating it to divide to produce a blastocyst embryo. The 
blastocyst is then placed into a uterus with the intent of 
creating a newborn.
    In a related but different procedure, cells are isolated 
from a blastocyst derived by nuclear transplantation and the 
cells are used to produce stem cell lines. This is shown here 
in the figure where, from the inner cell mass of a blastocyst 
created by nuclear transplantation, you make an embryonic stem 
cell line. Such stem cells are unspecialized cells and develop 
into almost all kinds of body cells. That is here, all these 
different kinds of cells.
    In what is sometimes called therapeutic cloning, the donor 
of a nucleus for transplantation to produce stem cells can be a 
person in whom the daughter cells of the stem cells are 
transplanted back to regenerate damaged tissue. But there is 
another medical use for nuclear transplantation equally or more 
important, to produce stem cells.
    Stem cells derived from a body cell or a disease cell of a 
patient who has inherited the risk for that disease, and 
therefore whose body cells or whose disease cells have 
completed the process to make the disease and have the life 
history of that process, are transplanted to make stem cell 
lines, and now you can study how this goes wrong in particular 
diseases.
    For example, in breast cancer the body cell often has the 
predilection for the disease, but numerous mutations occur, 
ones that we don't understand, to take it through the rest of 
the process to become a cancer cell. We need to be able to 
study that in a test tube and when we transplant the cells in 
mice.
    We studied the scientific and medical literature and held a 
workshop with world leaders in the relevant technologies. Among 
the participants were persons who planned to clone human 
beings. The data from animal studies of reproductive cloning 
demonstrate that only a small percentage of the attempts are 
successful; that many of the resulting clones die during all 
stages of gestation or pregnancy, late and early; that newborn 
clones often are abnormal or die; and that the procedures carry 
serious risks for the mother. However, the data on nuclear 
transplantation to produce stem cells shows that these cells 
are functional.
    Given those findings, the panel unanimously approved the 
following recommendations.
    Human reproductive cloning should not now be practiced. It 
is dangerous and likely to fail. The panel therefore 
unanimously supports the proposal that there should be a 
legally enforceable ban on the practice of human reproductive 
cloning.
    The scientific and medical considerations that relate to 
this ban should be reviewed within 5 years. The ban itself 
should be reconsidered only if at least two conditions are met. 
The first is that a new scientific and medical review indicates 
that the procedures are likely to be safe and effective, and 
that information must lead to a broad national dialog on the 
societal, religious, and ethical issues to suggest whether a 
reconsideration of the ban is warranted.
    Finally, the scientific and medical considerations that 
justify a ban on human reproductive cloning at this time are 
not applicable to nuclear transplantation to produce stem 
cells. Because of the considerable potential for developing new 
medical therapies for life-threatening diseases and advancing 
fundamental knowledge, the panel supports the conclusion of a 
recent National Academies report that recommended that 
biomedical research using nuclear transplantation to produce 
stem cells be permitted. A broad national dialog on the 
societal, religious, and ethical issues is encouraged in this 
matter.
    Scientists place a high value on the freedom of inquiry, a 
freedom that underlies all forms of scientific and medical 
research. Recommending restrictions of research is a serious 
matter and the reasons for such a restriction must be 
compelling. In the case of human reproductive cloning, we are 
convinced that the potential dangers to the implanted fetus, to 
the newborn, and to the woman carrying the fetus constitutes 
just such compelling reasons. In contrast, there are no 
scientific or medical reasons to ban nuclear transplantation to 
produce stem cells, and such a ban would certainly close 
avenues of promising scientific and medical research.
    The panel stressed that all concerned segments of society 
should examine and debate the broad societal and ethical issues 
associated with human reproductive cloning, as well as those 
associated with nuclear transplantation to produce stem cells. 
We hope that our report will help this committee and President 
Bush's Council on Bioethics in this regard.
    Thank you for the opportunity to testify.
    [The prepared statement of Dr. Weissman follows:]

Statement of Irving L. Weissman, Chair, Panel on Scientific and Medical 
 Aspects of Human Reproductive Cloning, National Academy of Sciences, 
   National Academy of Engineering, Institute of Medicine, National 
   Research Council and Karel and Avice Beekhuis Professor of Cancer 
Biology, and Professor of Pathology and Developmental Biology, Stanford 
                      University, Stanford, Calif.

    Madam Chair and members of the Committee. My name is Irv Weissman. 
I am a professor at Stanford Medical School, and my main research field 
for the last 20 years has been the biology and transplantation of adult 
stem cells in mice and humans. I am here as chair of the National 
Academies Panel on Scientific and Medical Aspects of Human Cloning, 
which released its report on January 18, 2002.
    The charge to the panel in June 2001 was to examine the scientific 
and medical issues relevant to human reproductive cloning, including 
the protection of human subjects, and to clarify how human reproductive 
cloning differs from stem cell research. Our charge did not extend to 
an examination of the ethical issues related to human reproductive 
cloning.
    We needed to determine whether current methods for reproductive 
cloning are scientifically feasible and reproducible and are medically 
safe. In addition, we needed to examine whether human participants in 
the process could be adequately advised and protected. Society and its 
leaders will need such scientific and medical information if they are 
to address the relevant ethical and public-policy issues.
    In reproductive cloning, the nucleus of a body cell is transplanted 
into an egg whose nucleus had been removed, stimulating it to divide to 
produce a blastocyst embryo; the blastocyst is then placed into a 
uterus with the intent of creating a newborn.
    In a related but different procedure, cells are isolated from a 
blastocyst derived by nuclear transplantation, and the cells are used 
to produce stem cell lines. This is shown in the figure. Such stem 
cells are unspecialized cells that can develop into almost all kinds of 
body cells. In what is sometimes called therapeutic cloning, the donor 
of a nucleus for transplantation to produce stem cells can be a person 
in whom stem cell daughter cells will be used to regenerate damaged 
tissues. There is another medical use for nuclear transplantation to 
produce stem cells; stem cells derived from a body cell or a disease 
cell of a patient who had inherited the risk for that disease could be 
powerful tools for medical research and lead to improved therapies.
    We studied the scientific and medical literature and held a 
workshop with world leaders in the relevant technologies. Among the 
participants were persons who planned to clone human beings. The data 
from animal studies of reproductive cloning demonstrate that only a 
small percentage of the attempts are successful, that many of the 
resulting clones die during all stages of gestation, that newborn 
clones often are abnormal or die, and that the procedures carry serious 
risks for the mother. However, the data on nuclear transplantation to 
produce stem cells show that these cells are functional.
    Given those findings, the panel unanimously approved the following 
recommendations Human reproductive cloning should not now be practiced. 
It is dangerous and likely to fail. The panel therefore unanimously 
supports the proposal that there should be a legally enforceable ban on 
the practice of human reproductive cloning.
    The scientific and medical considerations related to this ban 
should be reviewed within five years. The ban itself should be 
reconsidered only if at least two conditions are met: (1) a new 
scientific and medical review indicates that the procedures are likely 
to be safe and effective, and (2) a broad national dialogue on the 
societal, religious, and ethical issues suggests that a reconsideration 
of the ban is warranted.
    Finally, the scientific and medical considerations that justify a 
ban on human reproductive cloning at this time are not applicable to 
nuclear transplantation to produce stem cells. Because of the 
considerable potential for developing new medical therapies for life-
threatening diseases and advancing fundamental knowledge, the panel 
supports the conclusion of a recent National Academies report that 
recommended that biomedical research using nuclear transplantation to 
produce stem cells be permitted. A broad national dialogue on the 
societal, religious, and ethical issues is encouraged on this matter.
    Scientists place high value on the freedom of inquiry--a freedom 
that underlies all forms of scientific and medical research. 
Recommending restriction of research is a serious matter, and the 
reasons for such a restriction must be compelling. In the case of human 
reproductive cloning, we are convinced that the potential dangers to 
the implanted fetus, to the newborn, and to the woman carrying the 
fetus constitute just such compelling reasons. In contrast, there are 
no scientific or medical reasons to ban nuclear transplantation to 
produce stem cells, and such a ban would certainly close avenues of 
promising scientific and medical research.
    The panel stressed that all concerned segments of society should 
examine and debate the broad societal and ethical issues associated 
with human reproductive cloning, as well as those associated with 
nuclear transplantation to produce stem cells. We hope our report will 
help this Committee and President Bush's Council on Bioethics in this 
regard.
    Thank you for the opportunity to testify. I hope that my statement 
and the panel report can be put into the record. I will be happy to 
answer questions.

[GRAPHIC] [TIFF OMITTED] T3684.001

    Chairperson Feinstein. Thank you very much, Dr. Weissman.
    We will now turn to Professor Henry Greely, who also comes 
to us from Stanford University. He is the C. Wendell and Edith 
M. Carlsmith Professor of Law, and Professor, by courtesy, of 
Genetics. He is an expert in health law and health care policy 
and has written extensively on issues concerning genetic 
testing, human cloning, and the ethics of human genetics 
research.
    He is the Chairman of the steering committee of the 
Stanford University Center for Biomedical Ethics. He co-directs 
the Stanford Program on Genomics, Ethics, and Society. He is 
also the Chairman of the Ethics Subcommittee of the North 
American Committee of the Human Genome Diversity Project, and 
serves on the California Advisory Committee on Human Cloning.
    Welcome, Mr. Greely.

 STATEMENT OF HENRY T. GREELY, PROFESSOR OF LAW, AND DIRECTOR, 
   CENTER FOR LAW AND THE BIOSCIENCES, STANFORD UNIVERSITY, 
                      STANFORD, CALIFORNIA

    Mr. Greely. Thank you. Good afternoon, Madam Chairman and 
members of the committee. You have heard who I am. Let me just 
add that I am deeply honored to have the opportunity to speak 
to you today about this important issue.
    I am here for two reasons. As a member of the California 
Advisory Committee on Human Cloning, I am here to report to you 
our committee's results, and then as an individual who has 
studied this area to give you my own views on some of these 
issues, not necessarily that committee's views.
    I have submitted written testimony. I want to use my brief 
time here to highlight some of its more important points. My 
bottom-line conclusion is based on our report, and based on 
that view, I strongly support Senate bill 1758.
    The California Advisory Committee on Human Cloning grew out 
of the fact that California was the first jurisdiction in the 
United States to ban human cloning. California did that in 
1997, shortly after Dolly was announced. It is a 5-year ban on 
reproductive cloning.
    The legislation also required the State to appoint an 
expert committee to advise the Governor and the legislature--
before those 5 years were up--on how that bill should be 
revised. The committee was appointed in early 1999 and has 
spent the last 2\1/2\ years studying this issue, with public 
hearings, with testimony from experts, and with an incredible 
amount of argument.
    We spent 8 months writing our report, debating over 
sentences, words, and the placement of commas. I imagine it 
would be like an 8-month conference committee, not something 
that you particularly want to go through. But I am happy to say 
that at the end, when we finished our negotiations 8 hours 
before we turned in our report, we had five unanimous 
recommendations. They are attached to the testimony as part of 
the executive summary of our report.
    What is important about that is that we all, the 12 of us 
on the committee, came into this process with very different 
views. We left with different views, but not very different 
views. The more we studied it, the stronger our consensus grew.
    Our most important recommendations are that reproductive 
cloning should be banned and that non-reproductive cloning 
should not be banned, but should be regulated. Coming from very 
different positions, we ended up in that same place.
    At least in California, and I think in much of the country, 
there is a latent consensus on this point: ban cloning for 
making babies, allow cloning but regulate it more seriously for 
research purposes. In fact, Madam Chairman, I am authorized to 
say that your opponent in your last election, my law school 
comrade, Tom Campbell, supports your general approach to the 
cloning issue.
    With respect to reproductive cloning, there is not much to 
say. I don't think policy issues get much easier. There are 
compelling safety concerns about the health of any infants 
produced. There are very serious non-safety concerns. There are 
no compelling reasons to produce a baby by cloning. California 
banned this 5 years ago. I agree with Senator Hatch that it is 
long past time for Congress to follow that lead and to ban 
human reproductive cloning.
    Human non-reproductive cloning was a more difficult issue 
for our committee, and clearly is a more difficult issue today. 
Our position was two-fold: California shouldn't ban it, but 
California should impose new regulations on it. One of the 
things I particularly like about S. 1758 is that, mirroring one 
of the California recommendations, it proposes that IRB review 
be required for non-reproductive cloning research. We think 
that is a good idea as well.
    In looking at non-reproductive cloning, it is very 
interesting to start with the arguments against such cloning. 
There seen to be some novel coalitions against such cloning 
research. I don't know whether it is ironic or appropriate that 
an asexual method of reproduction is producing strange 
bedfellows. But we are seeing an unusual, to say the least, 
political coalition opposing non-reproductive cloning.
    Two points. First, most of the arguments about non-
reproductive cloning are arguments about human embryo research 
in general. Those arguments have been around for 10 years. The 
related arguments about human fetal tissue research go back to 
at least 1988. Arguments about the moral status of the embryo 
or the fetus and the arguments about possible exploitation of 
women are not new.
    Our society has not come up with a happy resolution of 
these, but we have come up with a compromise that everyone is 
unhappy with, but everyone lives with: no Federal funding for 
this kind of research, but no Federal ban on privately funded 
such research. I see no reason for it to be different with non-
reproductive cloning.
    The only argument about non-reproductive cloning that is 
not a general argument about human embryo cloning research is 
the argument that once there are cloned embryos for research, 
they will be implanted. Even though the law would criminalize 
such implantation--not require an abortion, but send the doctor 
who implanted the cloned embryo to jail.
    The research institutions that are doing this research for 
developmental biology purposes aren't experts in implanting 
embryos. In vitro fertilization clinics are experts in 
manipulating eggs. It is very unlikely that someone who wanted 
to do this 1) couldn't make the embryo itself, 2) would be able 
to steal an embryo from a research institution that is not an 
in vitro fertilization clinic and, then implant it 
successfully.
    So, in summary, the dangers of human reproductive cloning 
compel responsible legislators to ban it. The promises, as well 
as the dangers, of non-reproductive cloning compel that it be 
permitted, but that it be more extensively regulated along the 
lines of S. 1758.
    Thank you, Madam Chairman.
    [The prepared statement of Mr. Greely follows:]

    Statement of Henry T. Greely, C. Wendell and Edith M. Carlsmith 
Professor of Law, Professor, by Courtesy, of Genetics, Director, Center 
            for Law and the Biosciences, Stanford University

    Madam Chairman and members of the Senate Judiciary Committee, my 
name is Hank Greely. I am a professor of law and a professor, by 
courtesy, of genetics at Stanford University.
    Since early 1999, I have been a member of the California Advisory 
Committee on Human Cloning, which made its statutorily-mandated report, 
entitled Cloning Californians? Report of the California Advisory 
Committee on Human Cloning, to the California legislature on January 
11, 2002. I have made copies of that report available to the 
Committee's staff; I am only attaching its Executive Summary to this 
testimony.
    I am here today both to report the findings of that Committee and 
to provide my own insights into legislation now pending before this 
body concerning human cloning. Except as specifically noted, the views 
I express today are my own and not necessarily those of the California 
Committee or of Stanford University. Those views lead me to support, 
strongly, Senate Bill 1758.
    I want to discuss four things in my testimony: The California 
report, reproductive cloning, non-reproductive cloning, and the 
implementation of any legislation related to human cloning.

                         The California Report

    In 1997 California became the first U.S. jurisdiction to ban human 
reproductive cloning. The ban was to last for five years, until January 
1, 2003. As part of this statute, the legislature required the 
executive branch to appoint a committee to make recommendations back to 
the legislature about appropriate policy on human cloning by December 
31, 2001. The legislature and the governor would thus have a full year 
to consider the report before the existing ban on reproductive cloning 
expired.
    The California Advisory Committee on Human Cloning was appointed in 
early 1999. Its twelve members, identified below, represented a variety 
of professional backgrounds and a wide range of political viewpoints.




Francine Coeytaux, MPH..................................          Public
Prof. Theodore Friedmann, MD............................        Genetics
Dr. David Gollaher, PhD.................................   Biotechnology
Prof. Henry T. Greely, JD...............................             Law
Dr. Roger Hoag, MD......................................        Medicine
Prof. Bernard Lo, MD....................................          Ethics
Dr. Bert Lubin, MD......................................        Medicine
Prof. Margaret R. McLean, MDiv, PhD.....................        Religion
Francis C. Pizzulli, JD.................................             Law
Prof. Radhika Rao, JD...................................             Law
Prof. Larry Shapiro, MD.................................        Medicine
Dr. Tracy Trotter, MD...................................        Medicine



    Under the leadership of Dr. George Cunningham, Chief of the Genetic 
Disease Branch, California Department of Health Services, the Committee 
held five public meetings, beginning in May 1999, and innumerable 
closed meetings. It discussed, debated, negotiated, and argued about 
the subject and about its report up until the day before it delivered 
that report to the State. But, remarkably, the report it delivered 
contained five unanimous recommendations, as the Committee achieved a 
consensus on these very difficult issues.
    The exact recommendations are contained in the Executive Summary of 
the Committee report, attached at the end of this statement. The most 
important recommendations were the first that California should ban 
human reproductive cloning and the second that California should not 
ban, but should regulate, human non- reproductive cloning.
    Those recommendations are not, in themselves, novel. Other groups, 
and other jurisdictions, including the United Kingdom, have reached 
similar conclusions. What was remarkable about the Committee's 
conclusions, I believe, is not what they were but how they were 
reached. The twelve members of this Committee started with very 
different positions on both reproductive and non-reproductive human 
cloning. As we heard more testimony and public comment, read more 
deeply in the literature, and began writing (and arguing about) our 
report, our views began to converge. They never converged completely. 
We have some different reasons for believing human reproductive cloning 
should be banned; although all of us agree more regulation of human 
non-reproductive cloning is needed, we have different ideas for the 
appropriate extent of such regulation. But, in 32 months of study and 
effort, we came much closer together. I believe our experience is 
evidence that, although the issues raised by human cloning are both 
profound and complex, a latent consensus exists, in California and, I 
believe, in the United States, on these issues. Government should not 
allow human cloning to be used to make people; it should allow with due 
care human cloning research to proceed to find ways to relieve diseases 
and conditions that cause suffering to existing people. Senate Bill 
1758, introduced by Senator Feinstein and others, reflects that 
emerging consensus; Senate Bill 790, introduced by Senator Brownback 
and others, does not.

                       Human Reproductive Cloning

    No responsible authority has supported the current use of human 
reproductive cloning. The California Committee was no exception. Every 
member of our Committee concluded that the issues of the physical 
health and safety of any children produced by such cloning compelled 
its prohibition. Every member also had concerns about human 
reproductive cloning even if it were proven safe. A large majority of 
the Committee concluded that other issues would justify a ban on 
reproductive cloning even if it were proven safe, although there was no 
agreement on just which non-safety issues were compelling.
    The safety concerns are not a smoke-screen for the other worries; 
they are only too real. Many strong theoretical reasons cast doubt on 
the safety of this procedure. The empirical results to date with 
reproductive cloning in other mammals are a daunting record of 
miscarriages, still-births, birth defects at ten times the normal rate, 
and at least some possible indications of late onset illness. The 
almost total failure of efforts to clone non-human primates, in spite 
of substantial efforts, is yet another reason for concern. One should 
not demand perfect safety the usual way of making babies has its own 
serious risks for both mother and child but before we should consider 
seriously allowing human reproductive cloning, the procedure should 
have demonstrated, in non-human mammals (and preferably primates), that 
it is as safe or nearly as safe as normal reproduction or in vitro 
fertilization technologies.
    Statutory prohibitions of reproductive cloning, such as exist in 
California and a few other states, would be useful. It is not clear 
that they are essential the unanimous condemnation of the procedure by 
professional groups; the potential for civil liability; the assertion 
by the Food and Drug Administration, no matter how questionable, of 
jurisdiction over cloning; and their own professional duty to ``first 
do no harm'' should stop all but the most reckless physicians. Adding a 
statutory prohibition, with clear and serious penalties, would, 
however, be another useful measure to limit such unjustified 
experiments.

                     Human Non-reproductive Cloning

    The California report's position on human non-reproductive cloning 
is more complicated. We believe that its medical promise meant that it 
should not be banned. At the same time, we do not believe that the 
existing regulation of this research is sufficient. Both parts of that 
recommendation were essential to our unanimous conclusion. Only Senate 
Bill 1758 combines those two crucial points.
    Consideration of human non-reproductive cloning can usefully begin 
with analysis of the arguments against it. Almost every argument about 
human non-reproductive cloning is, in fact, an argument against any 
destructive research with the human embryos. Arguments about the moral 
status of the embryo, the possible commodification of human life, the 
risk of oppression to egg donors have been made for more than a decade 
about human embryo research, as well as human fetal research. Our 
society has not reached a consensus about any of those arguments, but 
our governments have reached a compromise resolution. The federal 
government does not fund research that entails the destruction of human 
embryos; nor does it, under President Bush's August 9, 2001 position, 
fund research on embryonic stem cell lines derived from human embryos 
that were destroyed after that date. But neither the federal government 
nor most states forbid such research if it is privately funded. This 
resolution makes both sides unhappy, but it has proven, to date, an 
acceptable compromise. There is no reason to treat human embryonic 
research differently because the embryo involve was created through 
cloning.
    Only one argument against non-reproductive human cloning is not 
just a recycled argument against human embryo research. Some have 
argued that human non-reproductive cloning must be banned to forestall 
human reproductive cloning. This ``slippery slope'' argument is largely 
silly. One could make the same argument for banning automobiles because 
they might be used for get-aways from bank robberies or banning 
electricity because it might be used to commit a murder. In the case of 
human cloning, the argument requires that someone who is willing to 
violate the law (and incur its penalties) by performing human 
reproductive cloning would not be able to make his own embryos, but 
would be able to beg, borrow, or steal a most likely anonymous cloned 
embryo from a research laboratory and, using an in vitro fertilization 
clinic, implant the transported cloned embryo into a willing woman. If 
the production of cloned human embryos proves possible, it is most 
likely that, as with other cloned mammals, the creation of the cloned 
embryo will be the easy part of the work bringing it successfully to 
term will be the hard part.
    This slippery slope argument does have one good use. It highlights 
the value of increasing the regulation of human non-reproductive 
cloning. The California Committee concluded that the State should 
regulate non-reproductive cloning by at least a) forbidding all 
research with cloned human embryos after the appearance of the so-
called ``primitive streak'' at about 14 days from its creation, b) 
requiring the informed consent of all those who donated cells to the 
process, and, last but most importantly, c) requiring the review and 
approval of any such work by an Institutional Review Board. Such IRB 
review will help ensure that the research is documented, that the 
researchers are accountable, and that the means and goals of the 
research are appropriate. This review is not now generally required for 
research that does not involve federal funding, Food and Drug 
Administration approval, or major research institutions. I am pleased 
that Senate Bill 1758 includes this extension of IRB review to human 
non-reproductive cloning.

                        Issues of Implementation

    Finally, the California Committee discussed not just what policy 
the State should adopt, but how that policy should be implemented. We 
strongly recommended that the legislature delegate the details of 
regulation, including the detailed definition of the covered procedure, 
to an administrative agency. The same concerns clearly exist at the 
federal level.
    It is difficult for a legislature to regulate science effectively, 
particularly in a fast- moving field. Drafters of the legislation, in 
spite of their best efforts, may not understand scientific terms in the 
same way the scientists do. Even if their understanding is correct at 
the time the legislation passes, the science can and will change much 
more quickly and easily than statutory language. I have studied the 
definition of human cloning in the numerous bills introduced and the 
few statutes passed in various jurisdictions after Dolly. See Henry T. 
Greely, Banning ``Human Cloning'': A Study in the Difficulties of 
Defining Science, So. Cal. Interdisc. Law Rev. 8:131-152 (1998).
    Many of those bills would not have achieved their goals because 
their loose use of terms like ``cloning'', ``somatic cell,'' or 
``diploid'' left loopholes that could be exploited. Some used 
definitions that made no sense at all. Several bills would have banned 
``the replication of a human individual by cultivating a cell with 
genetic material through the egg, embryo, fetal and newborn stages into 
a new human individual.'' Unless the term ``replication,'' itself 
undefined and ambiguous, has special meaning, this definition seems to 
describe the age-old method of human reproduction. A bill introduced in 
Florida would have banned human cloning, defined as ``creating a new 
individual by using the complete nuclear genetic material of an 
existing human being to create a second genetic duplicate of that human 
being.'' Presumably the first duplicate would have been permitted. Even 
the California legislation, which, in my professional view, has the 
best definition of human reproductive cloning, could be read to exclude 
some advanced reproductive technologies that involve transfer of a 
nucleus into an egg but do not involve human cloning the resulting egg 
would later be fertilized with sperm.
    Although the Congress is likely to avoid making some of these 
mistakes, it cannot avoid the unpredictability of the future course of 
this science. Any legislation passed, therefore, should define human 
reproductive cloning broadly probably as the intentional creation of a 
fetus or child that is substantially genetically identical to a 
previously existing human and delegate the power to define the subject 
matter more precisely to an administrative agency.

                               Conclusion

    The explosion of our knowledge about biology confronts us all as 
legislators, as citizens, as moral actors with new challenges. It holds 
the promise of unprecedented reductions in human suffering; it also 
holds the threat of unprecedented changes. . .and dangers. . .to our 
humanity. The combination of a science that is both unclear and rapidly 
changing with a host of moral questions of great depth makes perfect 
solutions impossible. We cannot know what is right; we can only act, 
humbly, in ways that, after due consideration, seem right based on what 
we now know. The various dangers of human reproductive cloning, as we 
now understand them, demand that it be banned. The various promises of 
human non-reproductive cloning, with the benefits they now seem likely 
to offer, compel its continuation but with appropriate new regulation. 
This mixed verdict is not the perfect solution to the challenge of 
human cloning; it is merely the best solution we fallible humans can 
come up with today. As such, Congress should enact it into federal law 
through adopting Senate Bill 1758.
    It has been an honor, and a pleasure, to appear before you. Thank 
you for the opportunity to discuss these fascinating and compelling 
issues.

    Chairperson Feinstein. Thanks very much, Professor Greely.
    I will now turn to R. Alta Charo. She is a professor of law 
and medical ethics at the University of Wisconsin at Madison. 
She is on the faculty of both the university's law and medical 
schools. Since arriving at the University of Wisconsin in 1989, 
Professor Charo has served on the University of Wisconsin 
Hospital Clinic Ethics Committee and the university's Bioethics 
Advisory Committee. From 1996 to 2001, she was a member of the 
Presidential National Bioethics Advisory Commission where she 
participated in drafting numerous reports, including ``Cloning 
Human Beings.'' Since 2001, she has been a member of the 
National Academy of Sciences Board on Life Sciences.
    Welcome, Professor.

   STATEMENT OF R. ALTA CHARO, PROFESSOR OF LAW AND MEDICAL 
 ETHICS, UNIVERSITY OF WISCONSIN LAW SCHOOL, MADISON, WISCONSIN

    Ms. Charo. Thank you very much. Madam Chairman, members of 
the committee, first I would like to thank you for the 
opportunity to address you.
    Debates over reproductive cloning, stem cell therapy, and 
even genetic engineering have become hopelessly entangled in 
the last 5 years. Each one is worthy of a policy debate, but I 
deeply believe each one would be better debated if debated 
separately.
    As you have already discussed, there are bills now before 
this Congress that would ban not only the irresponsible use of 
cloning to make babies--a procedure we all agree is dangerous 
at this time--but also the responsible use of non-reproductive 
cloning for research or therapy. Some would even ban the 
importation of proven medical therapies developed abroad if 
their origins were entangled with cloning research.
    Proponents of these bans say this is necessary in order to 
be assured that reproductive cloning to make children cannot 
occur. I disagree.
    The proponents of the bans, for example, fear that once a 
cloned embryo exists in a laboratory, either the embryo or its 
so-called parent may have constitutional grounds to insist that 
pregnancy be permitted. But this makes no sense. It requires 
either that the embryo itself have a constitutional right to be 
born--something that the U.S. Supreme Court has specifically 
rejected and also has been rejected by leading State courts 
hearing disputes over existing frozen IVF embryos in our 
laboratory now--or this argument would require that people be 
considered to have a fundamental right to use these embryos to 
reproduce through cloning--in other words, to have a 
fundamental right to reproduce by cloning, per se, which would 
render the entire ban equally unconstitutional.
    Now, others worry not about a constitutional ground for 
bringing the embryo to term but simply that the cloned embryo 
sitting in a lab will tempt someone to use it illegally. But I 
would note that the criminal penalties in bills such as S. 1758 
are equally effective whether the cloned embryo already exists 
or is merely imagined. The deterrent is clear, and it is not 
strengthened by criminalizing basic research.
    So if criminalizing research is not needed to guard against 
the unfortunate outcome of using cloning to make children, it 
must have another purpose. And indeed the proponents have cited 
the research ban being needed to protect embryos, women's 
health, and even the future of humanity.
    In my opinion, if the purpose is to protect embryos, then 
criminalizing research and so-called therapeutic cloning is an 
odd place to begin. As Senator Durbin has already pointed out 
this afternoon, we know and, indeed, we fully expect that 
embryos will unfortunately be lost by the thousands each year 
at in vitro fertilization clinics, even if IVF is done 
perfectly, even if every woman who wants to adopt an embryo is 
successful.
    Criminalizing research cannot alter the scale of this 
embryo loss, and since almost no one thinks that IVF itself 
could be outlawed, then banning a technique that might involve 
an exceedingly small number of embryos represents, at best, a 
symbolic effort at embryo protection.
    Now, such symbolic efforts are important. They remind us 
that life is a gift to be experienced with awe and gratitude. 
But such symbols can be badly tarnished if they are adopted at 
the expense of pain and suffering. And as Dr. Weissman has 
noted and as the chairman noted when she first opened the 
hearing, reproductive cloning at this time is a danger to 
children but non-reproductive cloning might save their lives. 
Whether by doing research with the cells of those who have 
genetic diseases so we can study in a laboratory dish how the 
defective gene operates and develop drugs to treat, or to use 
it for transplantation without risk of rejection, it is 
potentially life-saving. But most important--and, again, as the 
chairman noted in her earlier remarks--studying research 
cloning allows us to understand how cloning reprograms adult 
cells, which may in the future allow us to reprogram those 
cells directly without cloning and without the use of embryos 
in order to generate tissue that could be used to alleviate 
paralysis or save lives.
    Yes, there are other promising avenues of research, and you 
will hear about them this afternoon. They most certainly should 
be pursued. But that is no argument for criminalizing this 
research. America is not a country in which basic research or 
personal choices are illegal until someone has persuaded the 
government to grant permission. Quite the contrary. We 
celebrate the freedom to think and to act and to inquire into 
the secrets of nature until a compelling case can be made that 
it must be stopped. Identifying complementary areas of research 
falls far short of making that case. In my opinion, at best it 
is an argument for shaping Federal funding priorities in a way 
that affords these alternative avenues every chance of success.
    In my last remaining seconds, I would like to note that 
there are a handful of women's health and environmental 
organizations long known for a particularly great skepticism 
about medical science and biotechnology that have also 
testified against research cloning, saying that it is the first 
step on a slippery slope toward eugenics and the 
commodification of life. I would say that therapeutic cloning 
and research cloning is neither the beginning nor the end of 
that slippery slope, nor is it even the most important 
landmark.
    Our power over human reproduction is as old as ancient 
contraceptive potions, and it was IVF that was the true 
landmark moment at which we were able to manipulate the embryo 
because it now existed outside the body.
    By contrast, cloning research does not engineer or design 
the embryo, and, indeed, precisely because it does not involve 
making babies, it does not design or engineer our children. It 
is not basic research but, rather, our choices about its 
applications that will shape the future.
    A moratorium on attempting pregnancy with cloned embryos is 
an effective and excellent speed bump on the slippery slope 
toward this future so many seem to predict and fear. To ask for 
more and to halt such basic research is to sacrifice the 
diabetic children, paralyzed police officers, and declining 
elderly of the present for a future that is neither certain nor 
imminent.
    Criminalizing research cloning is not the way to protect 
embryos. It is not the way to guard against the future. It 
merely gambles with the hope held by many people today that 
they may live to see that future, whatever it may hold. Thank 
you very much.
    [The prepared statement of Ms. Charo follows:]

   Statement of R. Alta Charo, Professor of Law and Medical Ethics, 
  University of Wisconsin Law School, University of Wisconsin Medical 
             School, Department of the History of Medicine

    Madam Chairman, members of the committee, my name is Alta Charo, 
and I am a professor of law and medical ethics at the University of 
Wisconsin.
    I was a member of the N.I.H. Human Embryo Research Panel in 1993-
94, and the National Bioethics Advisory Commission (NBAC) from 1996-
2001. I participated in drafting NBAC's 1997 report on human cloning, 
but did not participate in drafting its 1999 report on human embryonic 
stem cells, in order to avoid any appearance of a conflict of interest 
due to my affiliation with the university where human embryonic stem 
cells were first isolated and maintained. I also had the privilege of 
testifying for the National Academy of Sciences (NAS) as it prepared 
its recent report on cloning, and have since been appointed to the NAS 
Board on Life Sciences.
    I am pleased to testify in support of legislation that protects 
valuable non-reproductive uses of cloning technology while also 
guarding against its dangerous use to make a baby.
    Such legislation is largely consistent with the recommendations of 
the National Bioethics Advisory Commission (whose reports recommended a 
moratorium on reproductive cloning but federal funding for research on 
stem cells derived from surplus IVF embryos while monitoring on-going 
private sector research on stem cells derived from cloned embryos) and 
with the recommendations in the National Academy of Sciences' two 
reports on stem cell research and reproductive cloning. It is also 
consistent with the provisions of a bill passed last week by the 
Wisconsin State Senate, a bill that is supported by the University of 
Wisconsin--Madison and which is now ready for consideration by our 
State Assembly.
    I am here today to present my own views, however, and do not 
represent NBAC, the NAS or my own university.
    Debates over reproductive cloning, stem cell therapy, and even 
genetic engineering have become almost hopelessly entangled in the last 
five years. Each is worthy of policy debate. But each deserves a clear 
and separate discussion.
    Cloning, that is, somatic cell nuclear transplantation, is 
currently too dangerous for making babies. Medical societies tell their 
members not to try it. The Food and Drug Administration has intervened 
to prevent it. It would be malpractice to attempt it, Florida has a 
bill to hold professionals strictly liable should they do it, and 
Senate Bill 1758 would criminalize it.
    Clearly, there are many ways to stop the small number of publicity-
hungry, irresponsible people who want to risk the health of women and 
children by using reproductive cloning.
    But there are bills now before this Congress that would ban not 
only the irresponsible use of cloning to make babies, but also the 
responsible use of non-reproductive cloning for research or therapy. 
Some would even ban importation of proven medical therapies developed 
abroad, if their origins were entangled with cloning research.
    Their proponents fear that once a cloned embryo exists in a 
laboratory, either the embryo or the so-called ``parent'' may have 
constitutional grounds to insist that pregnancy be permitted. But this 
makes no sense. It requires either that the cloned embryo has its own 
right to be born (a doctrine rejected both by the Supreme Court and by 
leading state courts hearing disputes over existing, frozen IVF 
embryos) or that people have a fundamental right to use these embryos 
to reproduce through cloning, in which case the entire ban on 
reproductive cloning is unconstitutional.
    Others worry that a cloned embryo sitting in a laboratory will 
tempt someone to use it illegally to make a baby. But the criminal 
penalties in Senate Bill 1758 are equally effective, whether a cloned 
embryo already exists or is merely imagined. The deterrent is clear, 
and is not strengthened by criminalizing basic research.
    But if criminalizing research is not needed to deter reproductive 
cloning, then these bills must have another purpose. Indeed, their 
proponents have argued that a research ban is needed to protect 
embryos, women's health, and the future of humanity.
    But if the purpose is to protect embryos, then criminalizing 
research and therapeutic cloning is an odd place to begin.
    We know indeed, we fully expect that embryos will be lost by the 
thousands every year at in vitro fertilization (IVF) clinics. Even if 
IVF is done perfectly, and even if everyone who wants to ``adopt'' an 
embryo is successful, thousands would still be left behind. 
Criminalizing research cloning cannot alter the scale of embryo loss 
that occurs each year. And since almost no one thinks IVF could be 
outlawed, criminalizing a technique that might involve an exceedingly 
small number of embryos represents at best a symbolic effort at embryo 
protection.
    Such symbolic efforts are both powerful and important. They remind 
us that life is a gift that should be experienced with awe and 
gratitude. But a symbol can be badly tarnished if it is adopted at the 
expense of pain and suffering.
    While reproductive cloning at this time is a danger to children, 
non-reproductive cloning could save their lives. Cloning cells from 
someone with a genetic disease could produce tissue in which we study 
how the defective gene malfunctions, and help us develop drug 
treatments, perhaps reducing the number of human volunteers at risk in 
later clinical trials. Used to generate stem cells, it might become the 
fastest route to transplantation without risk of rejection. And perhaps 
most importantly, studying how cloning reprograms adult cells will help 
us learn how to reprogram cells directly, without cloning and without 
the use of embryos, to create tissue for research, transplantation and 
organ regeneration to alleviate paralysis and extend healthy life.
    Yes, there are other promising avenues of research, and they most 
certainly should be pursued. But that is no argument for criminalizing 
this research. America is not a country in which basic research or 
personal choices are illegal until someone has persuaded the government 
to grant permission. Quite the contrary. We celebrate the freedom to 
think and to act and to inquire into the secrets of nature, until a 
compelling case can be made that it must be stopped. Identifying 
complementary areas of research falls far short of making that case. At 
best it is an argument for shaping federal funding priorities in a way 
that affords these alternative avenues every chance of success.
    A handful of women's health and environmental organizations, those 
especially known for great skepticism about medical science and 
biotechnology, have also testified against research cloning, claiming 
it is the first step toward a world that is both unnatural and devoid 
of sentiment.
    These, too, are concerns worthy of independent debate. But FDA 
regulation of cell-based therapies that require women's eggs will 
address issues of risk to women, and markets in eggs, sperm and other 
human tissue can be regulated without criminalizing basic science.
    But most importantly, research and therapeutic cloning is neither 
the beginning nor the end of a slippery slope toward eugenics. It is 
not even the most important landmark.
    Our power over human reproduction is as old as ancient 
contraceptive potions. And the first announcements about IVF were 
greeted with the same chorus of concerns about genetic engineering, 
designer babies, and the commodification of life, because it was IVF 
that first made the embryo amenable to study and manipulation outside 
the body.
    By contrast, therapeutic cloning does not design or engineer the 
embryo, and precisely because it is not about making babies, it neither 
designs nor engineers our children. It is not basic research but rather 
our choices about its applications that will shape the future.
    A moratorium on attempting pregnancy with cloned embryos, or 
perhaps in the future with engineered embryos, is a highly effective 
speed bump on the slippery slope toward the future some people predict 
and fear. To ask for more, to halt basic research, is to sacrifice the 
diabetic children, the paralyzed veterans, the skin-scorched 
firefighters and the declining elderly of the present for a future that 
is neither certain nor imminent.
    In sum, we should deter those who would use cloning for 
reproductive ends despite its dangers. But we shouldn't throw the bath 
water out with the baby. Criminalizing research and therapeutic cloning 
is not the way to protect embryos or to guard against the future. It 
merely gambles with the hope held by many people today that they may 
live to see that future, whatever it holds.
    Thank you.

    Chairperson Feinstein. Thanks very much, Dr. Charo.
    And now we will proceed. I have Kris Gulden next, if I 
might, and we would very much like to welcome her. She is here 
on behalf of the Coalition for the Advancement of Medical 
Research. It represents 60 organizations and associations 
supporting therapeutic cloning. Ms. Gulden, a former veteran 
police officer in Alexandria, Virginia, received several awards 
for her law enforcement work. She also maintained an active 
schedule outside the office, including winning the women's 
triathlon gold medal in August 1996 at the Biannual 
International Police Olympics in Salt Lake City. Tragically, a 
car struck Ms. Gulden while she wa training for the 1998 AIDS 
ride, leaving her with a severe spinal cord injury. That 
accident changed her life. Nine days before the accident, she 
was participating in a triathlon in Memphis. Nine days after 
the accident, ``Just brushing my teeth was exhausting,'' she 
said. Yet Ms. Gulden has made tremendous progress, and I am 
very happy she could be here today to testify.

  STATEMENT OF KRIS GULDEN, COALITION FOR THE ADVANCEMENT OF 
               MEDICAL RESEARCH, WASHINGTON, D.C.

    Ms. Gulden. Thank you, Madam Chairperson, Senator Hatch, 
and members of the committee. I would like to thank you for the 
opportunity to testify today on the value of somatic cell 
nuclear transfer, commonly referred to as therapeutic cloning. 
As you know, the Coalition for the Advancement of Medical 
Research is an organization comprised of universities, 
scientific and academic societies, patients' organizations, and 
other entities that are devoted to supporting stem cell 
research. In addition, I realize that today I am the voice of 
millions of Americans living at ALS, MS, Parkinson's disease, 
spinal cord injuries, and other illnesses that may benefit from 
therapeutic cloning.
    Along with the Coalition for the Advancement of Medical 
Research, I support efforts to prohibit human reproductive 
cloning. However, it is imperative that we protect important 
areas of medical research that offer hope to millions of 
Americans.
    As a person living with paralysis caused by a spinal cord 
injury, I know how urgently a cure is needed. I do not expect a 
cure tomorrow or even next year, and I do not intend to 
overstate the promise of the research. But how can you 
overstate hope?
    On May 26th of 1998, my life was changed when I was struck 
by a vehicle while riding my bike. At the time I set out for 
that bike ride, I was a healthy 31-year-old triathlete, and I 
was employed as a police officer in Alexandria, Virginia. I 
never finished that bicycle ride because I was struck by a car. 
In addition to a traumatic brain injury and a laundry list of 
broken bones, I sustained a spinal cord injury at the T4 level. 
The doctors told me that I had a 20 percent chance of ever 
walking again. My friends and family members had to incorporate 
the word ``paraplegia'' into their vocabularies. In an 
instance, my future changed from adrenaline rushs and thrill-
seeking to wheelchairs and hand controls.
    Six weeks after my accident, I discovered that I could move 
my legs. And in that instant, I discovered hope. I knew that if 
it were only a matter of strengthening the muscles in my legs, 
I would, in fact, walk again. And within 3 months, I was 
walking with a rolling walker.
    In the summer of 1999, I went to the University of Miami to 
go through EMG biofeedback training. This proved to be an 
exciting therapy that gave me even more optimism that I would 1 
day walk again. However, a rare complication of a spinal cord 
injury--a disease called syringomyelia--has caused me to lose 
considerable function. I have not, though, lost hope. I have 
returned to the University of Miami for additional sessions of 
biofeedback, and I remain committed to the idea of walking 
again. Additionally, the potential for new therapies like 
cloning gives hope to so many people.
    I understand that the word ``cloning'' has caused many 
individuals to imagine the worst possible abuses. But allow me 
to make a critical distinction between cloning technology used 
to create a human being--reproductive cloning--and the 
therapeutic cloning techniques that are vital to breakthroughs 
in medicine, diagnostics, and potentially vaccines used to 
treat diseases like Parkinson's, Alzheimer's, cancers, heart 
disease, diabetes, and even paralysis resulting from spinal 
cord injuries. Therapeutic cloning cannot product a whole human 
being. This work should be allowed to move forward.
    Somatic cell nuclear transfer may prove to be a vital tool 
in allowing scientists to fully develop the promise of stem 
cell research. Somatic cell nuclear transfer involves the use 
of a donor's unfertilized egg and a patient's own cells. This 
research could allow a patient's own genetic material to be 
used to develop stem cell therapies specifically tailored to 
that individual's medical condition, thus not triggering an 
immune rejection response. In other words, using somatic cell 
nuclear transfer could repair patients with their own cells.
    Given the scientific potential in this area, we strongly 
opposed any legislative action that would ban research related 
to therapeutic cloning. This would include criminalizing the 
research or the researchers, and prohibiting the importation of 
therapies derived from somatic cell nuclear transfer in other 
countries.
    Madam Chairperson, it is likely that we will continue to be 
confronted with scientific advances that pose difficult social 
and ethical questions. The present momentum in biomedical 
research and the profound implications of what we are learning 
will inevitably raise public concerns. Yet an across-the-board 
ban on human cloning will dash the hopes of many Americans 
living lives that, like mine, are so radically, functionally, 
and emotionally different than what they once were.
    In my dreams, I still walk. I run, I play basketball, and I 
wear the uniform of the Alexandria Police Department. When the 
sun rises each morning, it brings reality with it. I rise to 
the sight of a wheelchair, yet I rise with the hope that maybe 
this will be the morning that I can move my legs.
    And if I could just add one more personal story, my mom 
lives in Pennsylvania, and she is a constituent of Senator 
Arlen Specter. Back in August, my mom attended a town hall 
meeting that Senator Specter held, and she asked him about stem 
cell research. Senator Specter's quote to my mom--and I have 
got the newspaper article here--was, ``We're not going to let 
you down.'' And I wish that Senator Specter was still in the 
room. I hope that he and his colleagues will live up to that 
promise.
    In closing, I just want to thank the committee members for 
having me here today, and on behalf of the Coalition for the 
Advancement of Medical Research, the countless Americans who 
stand to benefit from therapeutic cloning, and the friends and 
family members who love them, I again thank you for having me 
here today.
    [The prepared statement of Ms. Gulden follows:]

     Statement of Kris Gulden, on behalf of the Coalition for the 
                    Advancement of Medical Research

    Good morning Senator Feinstein and Members of the Committee. Thank 
you for the opportunity to testify t oday on the value of somatic cell 
nuclear transfer (SCNT), commonly referred to as therapeutic cloning. 
My name is Kris Gulden, and I am here on behalf of the Coalition for 
the Advancement of Medical Research (CAMR). The Coalition is an 
organization comprised of universities, scientific and academic 
societies, patient's organizations, and other entities that are devoted 
to supporting stem cell research. In addition, I realize that today I 
am the voice of the millions of Americans living with MS, spinal cord 
injuries, ALS, Parkinson's Disease, and many other illnesses that may 
benefit from therapeutic cloning.
    I, along with the Coalition for the Advancement of Medical 
Research, support efforts to prohibit human reproductive cloning. 
However, it is imperative that we protect important areas of medical 
research that offer hope to millions of Americans. As a person living 
with paralysis caused by a spinal cord injury, I know how urgently a 
cure is needed. I do not expect a cure tomorrow, or even next year. And 
I do not intend to overstate the promise of the research. But how can 
you overstate hope?
    On May 26, 1998, I set out on a bicycle ride that would change my 
life. When I began, I was a healthy, 31 year old-triathlete. I was 
employed as a police officer in Alexandria, Virginia. I never finished 
that ride; it was interrupted when I was struck from behind by a motor 
vehicle. In addition to a traumatic brain injury and a laundry list of 
broken bones, I sustained a spinal cord injury at the T4 level. The 
doctors told me that I had about a 20% chance of ever walking again. My 
friends and family had to incorporate the word ``paraplegia'' into 
their vocabularies. In an instant, my future was changed from 
adrenaline and thrill-seeking to wheelchairs and hand controls.
    Six weeks after my accident, I discovered that I could move my 
legs. And in that instant, I discovered hope. I knew that if it were 
only a matter of strengthening my leg muscles, I would in fact walk 
again. And within three months, I was walking with a rolling walker.
    In the summer of 1999 I went to the University of Miami to go 
through EMG biofeedback training. This proved to be an exciting therapy 
that gave me even more optimism that I would one day walk again. 
However, a rare complication of a spinal cord injury a disease called 
syringomyelia - has caused me to lose considerable function.
    I have not, though, lost hope. I have gone back to Miami for 
additional sessions of biofeedback, and I remain committed to the idea 
of walking again. Additionally, the potential for new therapies like 
cloning gives hope to so many people.
    I understand that the word ``cloning'' has caused many individuals 
to imagine the worst possible abuses. But allow me to make a critical 
distinction between the use of cloning technology to create a baby 
reproductive cloning and the therapeutic cloning techniques central to 
the production of breakthrough medicines, diagnostics, and potentially 
vaccines to treat diseases like Parkinson's, Alzheimer's, diabetes, 
heart disease, various cancers, and even paralysis resulting from 
spinal cord injury. Therapeutic cloning cannot produce a whole human 
being. This work should be allowed to move forward.
    Somatic cell nuclear transfer may prove to be a vital tool in 
allowing scientists to fully develop the promise of stem cell research. 
Somatic cell nuclear transfer involves the use of a donor's 
unfertilized egg and a patient's own cells. The research could allow a 
patient's own genetic material to be used to develop stem cell 
therapies specifically tailored to that individual's medical condition, 
thus not triggering an immune rejection response. In other words, using 
somatic cell nuclear transfer could repair patients with their own 
cells.
    Given the scientific potential in this area, we strongly oppose any 
legislative action that would ban research related to therapeutic 
cloning. This would include criminalizing the research or the 
researchers, and prohibiting the importation of therapies derived from 
somatic cell nuclear transfer in other countries.
    Ms. Chairperson, it is likely that we will continue to be 
confronted with scientific advances that pose difficult social and 
ethical questions. The present momentum in biomedical research, and the 
profound implications of what we are learning, will inevitably raise 
public concerns. Yet an across-the-board ban on human cloning will dash 
the hopes of many Americans living lives that, like mine, are so 
radically, functionally, and emotionally different than what they once 
were.
    In my dreams, I still walk. I run, I play basketball, and I wear 
the uniform of the Alexandria Police Department. When the sun rises 
each morning, it brings reality with it. I rise to the sight of a 
wheelchair, yet I rise with the hope that maybe this will be the 
morning I can move my legs.
    On behalf of the Coalition for the Advancement of Medical Research, 
the countless Americans who stand to benefit from therapeutic cloning, 
and the family members and friends who love them, I again thank the 
Committee for its deliberations and for the opportunity to speak to 
this issue.

    Chairperson Feinstein. Thank you very much. Thank you for 
that excellent testimony.
    We will now go to Andrew Kimbrell. He is a public interest 
attorney, activist, and author. In 1994 Mr. Kimbrell founded 
the International Center for Technology Assessment, an 
organization that is devoted to a holistic analysis of 
technology. He continues to serve as the center's executive 
director. He has authored several books and given numerous 
public lectures. In 1994, the Utney Reader named Mr. Kimbrell 
as one of the world's leading 100 visionaries.
    Mr. Kimbrell, welcome.

STATEMENT OF ANDREW KIMBRELL, EXECUTIVE DIRECTOR, INTERNATIONAL 
       CENTER FOR TECHNOLOGY ASSESSMENT, WASHINGTON, D.C.

    Mr. Kimbrell. Thank you, Madam Chairman. I thank the 
committee for the opportunity to speak with you this afternoon. 
I would add, even though I was named one of the 100 leading 
visionaries, I noticed when they got us all together that we 
all wore very heavy lenses. We all had glasses So maybe a 
prerequisite to being a visionary is that you can't really see, 
Madam Chairman, so you should probably take that caveat on my 
testimony today.
    I am here representing myself and also part of the 
Environmental Women's Health and Consumer and Health Coalition 
that Representative Weldon referred to that worked on his bill 
on the House side. I have submitted written testimony. I am 
going to try and summarize it here.
    I am going to try and accomplish two things. One is to put 
this current discussion in sort of a historical context. We all 
remember George Santayana's truism that ``Those who cannot 
remember the past are condemned to repeat it.'' And I think 
that is an important warning that we should take into 
consideration as we discuss this issue today.
    Alta Charo and myself have been dealing with--and so have 
many on this committee--these kinds of issues for many years. 
When I heard Dr. Michael West of ACT say that he was going to 
save 3,000 lives a day, and even a 6-month halt on his embryo 
cloning for stem cells could cost a million and a half lives, I 
realized this was unadulterated hyperbole. And subsequent to 
that, we have seen numerous scientists say that Dr. West's 
claims are completely false, he has completely failed in his 
attempt to do that. So it is important, as Representative 
Weldon has said, that this technology is not working. It is not 
clear when we will be able to garner stem cells from embryos.
    I remember about 12 years ago working with Senator 
Kennedy's staff and then-Senator Gordon Humphrey's staff on the 
gene therapy question, and we were arguing for stringent 
regulations on gene therapy. There were many, many unique 
ethical questions and scientific questions that we felt needed 
to be resolved before we allowed human trials to take place. 
Many in the research community supported us. Many did not.
    Unfortunately, those who wanted a deregulated gene therapy 
industry essentially won the day. Now, over a decade later, 
hundreds of trials, not a single person has been cured with 
gene therapy. Many patients groups call it a big 
disappointment, but for many it has been more than a 
disappointment. Eighteen-year-old Jesse Gelsinger volunteered 
for a gene therapy trial in Philadelphia, and because of 
researcher misconduct, unregulated research, he was killed. 
Investigative reporting by the Washington Post showed that 
perhaps a half-dozen others also have been killed by these 
trials, and over a thousand, over 1,000 adverse reactions in 
this unregulated research, over a thousand reactions, including 
many deaths and serious injuries, were possibly linked. No 
cures. If we had taken a 10-year moratorium at that time, not a 
single disease, however tragic, would have been cured, but many 
lives would have been saved if we had looked at the serious 
questions before we allowed these technologies to be widely 
disseminated.
    I again worked with Senator Kennedy and with Senator 
Hatch's staff and, again, Senator Humphrey's staff to try and 
get adequate regulation of fetal tissue research. We were very 
concerned about the sale of fetal tissue. We were concerned 
that people were going to change the method and manner of 
abortion in order to obtain fetal tissue. We were concerned 
about informed consent in this regard, limitations on how that 
tissue could be used.
    We tried bravely. We got some legislation passed. But, 
basically, there was inadequate regulation, inadequate 
legislation, inadequate enforcement. And what have we found? 
Unfortunately, right now there is a thriving fetal tissue 
market, repugnant, I am sure, to all of us. There are continued 
reports, verified reports of researchers changing the method 
and manner of abortion to get this tissue.
    In the largest trial in Parkinson's disease done up to this 
point--and, by the way, there has been over 400 trials--again, 
no cures. But the side effects, which certainly could have been 
obtained in animal research, were devastating. Absolutely 
devastating, actually. According to Dr. Paul Greene, a 
neurologist at Columbia University College of Physicians and 
Surgeons who oversaw that research, he said, ``It is a real 
nightmare, and we can't selectively turn these fetal cells 
off.'' They put them into brains, and they produce chemicals 
that have his patients, 15 percent of them, twitching 24 hours 
a day, unable to sleep, unable to eat, unable to talk. We 
didn't regulate it adequately. We weren't precautionary. We 
didn't obey the first rule of the Hippocratic oath, ``First, do 
no harm.''
    Now we have the next miracle cure de jour--stem cells. I 
urge you this time, please, do not let this technology go out, 
disseminate it, become an industry without adequately, 
stringently regulating before we do that.
    Now, with stem cells, we have this extraordinary 
unprecedented issue of cloning that is involved. And for the 
progressive community this is not a right-to-life issue. There 
are six major concerns, and I will summarize them very briefly 
in conclusion, and Representative Weldon did mention several of 
them that I think we need to look at.
    At a minimum, before we allow the cloning of human embryos 
for research, we need to have regulations and legislation that 
deals with this, before we allow that. There is a major problem 
with allowing an unregulated market and the production of 
cloned embryos and expect there to be no reproductive cloning. 
Imagine, Madam Chairman and members of the committee, if we 
were to have a drug war where we encourage the production of 
cocaine and other drugs--encouraged it, had an open and 
unregulated industry in it, but also said we were trying to 
make use of drugs illegal. That is essentially what we are 
doing if we encourage an unregulated industry in the production 
of cloned embryos and still say we are against reproductive 
cloning. It is not going to happen.
    The second is that this industry in cloned embryos leads to 
the commodification of life. The Patent Office as announced 
that they will allow the patenting of these embryos. There is 
no bar on the sale of these embryos. If you sell the 
Congressional Medal of Honor, you demean and corrupt that 
medal. If you sell the Nobel Prize, you corrupt and demean the 
Nobel Prize. If you sell children, you corrupt and demean the 
meaning of parenthood. If you sell human embryos and patent 
human embryos, you demean and corrupt what it means to be a 
human.
    Representative Weldon also talked, and I thought rather 
tellingly, about the impacts on women through this technology. 
According to many researchers, there are going to need to be 5 
and 8 million eggs harvested from women in order to make 
therapeutic cloning possible. We all know the impacts on 
women's bodies caused by the operations and drugs required to 
extract eggs. Surely we are not going to let this happen 
without some regulation, some legislation to make sure there is 
not an open industry where poor women sell their eggs to 
researchers for therapeutic cloning, with all of the impacts 
that involves. Not acceptable. I don't think anybody finds that 
acceptable.
    Finally, it is important to view embryo cloning as the 
ultimate choice question. None of us will know whether our 
hair, blood cells, cheek cells are being used to produce these 
research clones. There have been numerous cases, very well-
known litigation, where people's cells have been used to create 
very valuable cell lines, and they didn't know it. None of us 
in this room will have a choice if we allow an unregulated 
industry and the cloning of human embryos for research on 
whether we are being cloned thousands of times, being patented 
and sold without our knowledge. I would view this as the 
ultimate choice question. We cannot preserve choice unless we 
at least have a moratorium or ban on embryo cloning.
    Finally, I do think that it brings up the crucial issue--
and here I understand where Senator Durbin is coming from, but 
I think it is important to note that for the very first time in 
human history, if we do this, if we allow embryo cloning for 
research, we will have produced a human life form solely for 
its destruction, solely for its use as spare parts. Yes, it is 
a question of intention, but as an attorney, we know that 
intention is everything, the difference. Between a non-crime 
and first-degree murder is intention. For the first time, we 
will intentionally as a human race have done this.
    I think at a minimum, at a minimum, this is an ethical 
question that needs tremendous public debate, public hearings 
across the country. And, again, we should have an unlimited 
moratorium or ban on this form of cloning until that 
unprecedented question has been resolved.
    Thank you.
    [The prepared statement of Mr. Kimbrell follows:]

Statement of Andrew Kimbrell, Executive Director, International Center 
                       for Technology Assessment

    At the outset I want too thank you for the opportunity of 
testifying today on this crucial issue. Over the last many months I 
have worked with a coalition of progressive environmental, consumer and 
women's health groups to attempt to ban reproductive human cloning and 
obtain at least a moratorium on human cloning for research, often 
called ``therapeutic cloning.'' While there appears to be little 
disagreement on the need to ban reproductive cloning, the issue of 
halting research human cloning has become quite controversial. In my 
testimony I would like to outline a number of reasons why many in the 
progressive community support a ban or moratorium on human cloning for 
research at this time. However, prior to discussing the current cloning 
controversy, I would like to put our discussion today in the context of 
similar issues we have faced in the last two decades. Sometimes there 
is a tendency to deal with issues like cloning in an historical vacuum 
a kind of technological amnesia. George Santayana's truism ``Those who 
cannot remember the past are condemned to repeat it,'' applies equally 
to technology issues a it does to political ones. Therefore I would 
like to begin by reviewing our past mistakes in assessing and 
regulating two ``miracle'' cures that preceded the current furor over 
stem cell research and human cloning. I fear that if we do not remember 
what happened with these prior technologies we will repeat the mistakes 
that have led to grossly inadequate regulation and real tragedy for 
many patients.

                        Hyperbole Versus Healing

    Last December during a hearing before the Senate Appropriations 
Subcommittee on Labor, Health and Human Services, and Education on the 
controversy over stem cells and human cloning, Michael West of Advanced 
Cell Technology (ACT) predicted that within six months his 
biotechnology company would be ready to create ``magic'' cells that 
would save no less than 3,000 lives a day. West claimed that he would 
soon successfully clone human embryos, and then obtain stem cells from 
those clones which would cure everything from heart disease and 
Alzheimer's, to Parkinson's disease and spinal cord injuries. West 
sternly warned that even a half year halt on his embryo cloning 
research would cost over half a million lives. Horrified by what they 
called ``these real numbers,'' some Senators pronounced themselves 
against any limit on human embryo cloning, and vowed to ``push'' the 
technology in any way they could.
    Of course, West's promise of near term success in obtaining stem 
cells from clones, and the subsequent healing of thousands a day, was 
unadulterated hype. While there have been some preliminary indications 
that adult, fetal and embryo stem cells may some day result in helpful 
therapies, no such cells have ever been obtained from cloned human 
embryos. In fact, West and his Massachusetts company, ACT, had just 
published a paper that revealed that they had completely failed to 
garner stem cells from cloned embryos. Dr. Donald Kennedy, editor of 
the highly esteemed journal Science, summarized the ACT effort, 
stating, ``Everything I have learned about the [ACT] study suggests 
that it is not an advance that would interest us. This scientific 
effort did not succeed by any measure.'' Even more telling was the 
resignation of Dr. John Gearhart, of the Johns Hopkins Medical 
Institutions, from the editorial board of the magazine that published 
the ACT study. Dr. Gearhart, a pioneer in stem cell research, said that 
the experiment"should be considered a failure'' and that the study 
should not even have been published.
    Moreover, the same day West was predicting near term cloning 
success at the Senate hearing, his colleague at ACT, Tanja Dominko was 
explaining the company's failures to a medical conference. She noted 
that there was an unknown, unique characteristic about primates that 
makes them difficult to clone. ``It might be that you just can't make 
humans this way,'' Dominko told the conference.
    Leading experts share this skepticism about cloning and any near 
term success of stem cell technology. Dr. Gail Martin, the co-
discoverer of mouse embryonic stem cells, warns that there are still 
``a gazillion issues'' to be resolved. Another stem cell expert, Dr. 
David Solter who directs the Max Planck Institute of Germany said he 
had ``no idea'' how someone expected injected stem cells to replace 
sick and dying brain neurons in Alzheimer's victims.
    Most of us have experienced the tragedy of disease or disability 
either personally or through family and friends. Facing the crucible of 
disease, we search for some hope when bodies and minds are cruelly 
decimated by illness. Yet however much we want cures, it is essential 
to get the real facts, the full story, about medical advances. 
Unfortunately, in the past we have seen a continuous pattern of 
researchers and companies peddling hype instead of healing. These false 
promises about healing are not merely harmless self promotion by 
research companies eager for venture capital, or benign wishful 
thinking by naive legislators. Researchers' hype cruelly misleads those 
who are suffering into thinking that cures are imminent. Perhaps even 
more disturbing is that this hype is often successful in 
``blackmailing'' legislators and regulators into taking a ``hands off'' 
approach to regulation of these new technologies, lest such regulation 
delay cures. The resulting public policy toward new medical 
technologies has been misguided, inadequate and even dangerous. It has 
resulted in the trampling of some our most important ethical norms, and 
in some cases to increased suffering and mortality among the very 
people we seek to cure.

                          Genetic ``Wizardry''

    A paradigm case of hyperbole over healing is gene therapy. In the 
late 1980s ``gene therapy'' was heralded as the new ``miracle cure.'' 
Researchers were hailed as ``gene wizards'' and the media, policy 
makers and scientist/entrepreneurs predicted cures to cancer and 
virtually every other serious human ailment. Billions of public and 
private research dollars poured into biotechnology companies and human 
clinical trials. Despite public protest by some scientists, and law 
suits by health advocacy groups, human gene therapy trials were 
approved by the federal government with woefully inadequate oversight 
and virtually no enforcement. Unmonitored and virtually unregulated, 
the researchers themselves were relied on to report any adverse results 
in their test. Over the last decade there have been more than 400 gene 
therapy trials on patient groups. Despite all the hype, not a single 
person in any U.S. gene therapy trial has been cured of any disease. 
Abbey S. Meyers, a patients' group advocate noted, ``We haven't even 
taken one baby step beyond the first clinical experiment. It's hardly 
gotten anywhere . . . I have been very disappointed.''
    For many, gene therapy has been far worse than a disappointment. 
Jesse Gelsinger was an active and altruistic 18 year old from Tucson, 
Arizona who suffered from a rare gene disorder. He volunteered to take 
part in a Philadelphia based gene therapy trial study on that genetic 
disorder. He hoped to participate in finding a cure. Instead, the gene 
therapy killed him. The media furor over Gelsinger's death resulted in 
revelations of serious misconduct by researchers in his case and in 
others' trials. Subsequently a half dozen other cases were found where 
patients' deaths were linked to gene therapy experiments. Eventually, 
it was revealed that there were over a thousand serious adverse effects 
potentially attributable to gene therapy trials, including numerous 
deaths. Left on their own, researchers had only reported 37 of these 
adverse events. As the hype about gene therapy held legislators and 
regulators at bay, researchers violated the most basic ethical tenets 
on the use of human subjects, which along with deficiencies in the 
technology, resulting in significant suffering and the death. Wide 
scale reporting of this scandal has led to an attempt to tighten 
regulation of gene therapy trials, but most agree that the new policies 
are far too little, and for the victims of the technology, far too 
late.

                          The Fetal Revolution

    There is a similar and equally disturbing history with the hype 
over fetal tissue research. By the late 1980s fetal transplants were 
being heralded, as the ``ultimate cure of the future.'' An editorial in 
the New York Times warned that ``to interfere with these [fetal tissue] 
experiments is to interfere with progress that could save countless 
lives.'' Fueled by this hype, a moratorium on federally funding of 
fetal tissue transplants was lifted in 1992, and the proponents 
confidently predicted a cure for many of our most pernicious diseases 
and disabilities. Ethical concerns which had led to the moratorium were 
given only cursory attention. Now after 13 years of private and 
publicly funded trials some of the ethicists' worst fears have come to 
pass. There is a thriving market in the sale of various fetal parts 
from clinics to hospitals and researchers. There are also reports that 
clinics are changing the method and manner of abortions, potentially 
creating injury in women, in order to obtain more viable and valuable 
fetal tissue.
    As for the hundreds of patients who have received fetal 
transplants, mainly for Parkinson's disease, there have yet to be 
proven benefits, but as with gene therapy we have seen very real and 
shocking health impacts. As reported last year, the most comprehensive 
study on the use of fetal tissue to treat Parkinson's showed no overall 
benefit, but researchers described side effects of the treatment as 
``absolutely devastating.'' The problem was that in a significant 
percentage of fetal tissue recipients the implanted cells created too 
much of the needed brain chemicals causing uncontrolled movements and 
spasm in the patients. ``They chew constantly, their fingers go up and 
down, their wrists flex and distend,'' reports Dr. Paul E. Greene, a 
neurologist at the Columbia University College of Physicians and 
Surgeons and one of the researchers involved in the federally funded 
fetal tissue study. Greene also described patients as writhing and 
twisting, jerking their heads and flinging their arms about. The spasms 
were so severe in one patient that he could no longer eat and needed a 
feeding tube. For others the spasms made their speech unintelligible. 
Despite these effects, there is no way to remove the transplanted fetal 
cells or stop them from creating these impacts on the patients. ``It 
was tragic, catastrophic,'' Dr Greene explained. ``It's a real 
nightmare, and we can't selectively turn it off.'' As for the near 
future, Dr. Greene at least has seen the light: ``No more fetal 
transplants. We are absolutely and adamantly convinced that there 
should be research only.''

                      Stem Cells and Human Cloning

    As the grim histories of gene therapy and fetal tissue use are left 
generally unexamined, stem cell research, including the cloning of 
human embryos, has succeeded them as the miracle cure du jour. As the 
testimony of West and other researchers indicates, we are once again 
being subjected to a full court press of hype, as companies and 
researchers vie for venture capital and federal research dollars. 
Unfortunately we also continue to witness a continued and 
unconscionable gullibility in many of our policy makers. Once again 
they appear to have become hostages to the hype about healing. This is 
particularly alarming because the stakes in this debate are very high. 
As noted, West and many in the research community are pushing for an 
unregulated and unmonitored industry in cloned human embryos. West and 
his cohorts insist that only cells from cloned human embryos will be 
the panacea for all that ails us. This despite their failure to obtain 
stem cells from embryos, and the current availability of adult and 
placental stem cells for research.
    Besides corporate profits West and some others in the research 
community have another very clear aim. They want to stop the Senate 
from following last year's House action in declaring a ban on human 
embryo cloning, and they may well be succeeding. In the next few months 
the Senate will be debating and voting on the human cloning issue. 
While there is general agreement over banning human embryo cloning to 
create children, there is confusion on halting the cloning of human 
embryos for research. Will our policymakers finally cut through the 
hype and ask the important questions about research cloning?
    A number of those in the progressive community have several major 
concerns about human cloning for research. Environmentalists, consumer 
groups, women's and children's health advocates all want to see 
unprecedented regulatory and ethical questions resolved before and 
human embryo cloning for research is allowed. These issues include:

    1) An unregulated industry and market in the production of cloned 
human embryos will inevitably lead to reproductive cloning. Imagine 
fighting the drug war by banning certain uses of drugs but allowing and 
even encouraging the mass production and dessemination of such drugs 
for 'legal' purposes. This is what those advocating a ban on human 
reproductive cloning but encourging human embryo cloning for research 
are advocating. It is irresponsible legislation. Clearly the time to 
regulate reproductive cloning is at the stage of the creation of the 
cloned embryo. Attempting to enforce a reproductive ban after a cloned 
embryo is implanted into a surrogate mother is a regulatory nightmare. 
Given the slippery slope from embryo cloning to reproductive cloning, 
the only scenario in which embryo cloning for research would be 
acceptable is if a strict regulatory procedure were in place which 
carefully montiored the chain of custody of each and every cloned 
embryo.

    2) An unregulated industry in cloned human embryos will lead to 
unacceptable commodification of life. The U.S. Patent and Trademark 
office has already announced that cloned human embryos would be 
patentable. Additionally there is no bar on the sale of embryos or 
human ova necessary for this technology. Clearly if we sold the 
Congressional Medals of Honor we would degrade the meaning of this 
honor. If the Nobel Prize we up for sale it would cease to have 
meaning. If we buy and sell children we corrupt and demean the meaning 
of parenthood. Just so if we allow the patenting and sale of human 
embryos and human eggs we corrupt and demean what it means to be human.

    3) As currently envisioned cloning of human embryos for research 
represents a serious threat to women's health. In recent testimony a 
researcher stated have stated that they could do up to 1.7 million 
therapies per year. this would require a minimum of 5-8 million eggs--
assuming a very high success rate of 1 out of 3-5 eggs--to accomplish 
the therapeutic cloning required to support these therapies . Where 
will they get theses eggs? From women in this country or abroad. Egg 
donation can have significant health impacts on women including the 
effects of hormone therapies and other drugs administered to facilitate 
extraction and the extraction process itself. Most women who are lured 
into this process are economically disenfranchised and perform this 
operation for money. With research embryo cloning we could see a 
massive expansion in the use of women as paid egg ``factories.'' This 
presents both a real threat to women and an expansion of the repugnant 
commodification of life discussed above.

    4) Human embryo cloning for research could deprive us of our choice 
on when, how and where our genetic heritage will be replicated. 
Researchers may be able to clone ``copies'' of us by using cells from 
our hair, blood, or virtually any other tissue. There have already been 
several legal cases where patients have had their cells turned into 
valuable cell lines without their knowledge. Unless they are carefully 
monitored, how will any of us know if a researcher of company is 
replicating our genetic makeup in any number of human embryos at any 
time. This is a significant ``choice'' issue for all of us, especially 
for those whose religious or moral beliefs find human cloning in any 
form unacceptable.

    5) Does the cloning of human embryos for research divert valuable 
health research dollars away form proven methods into highly 
speculative ones? There are only limited research and health dollars 
available. Diseases such as cancer are complex in origin. Genetic 
predisposition, environmental pollution, diet, stress and social habits 
(such as smoking) all can contribute to this disease. While it is 
tempting to believe that gene therapy, fetal tissue or stem cells form 
cloned embryos will be the 'magic bullet' that will cure cancer, this 
view is hopelessly naive. We have seen in the past that prevention is 
the best policy when dealing with major diseases or disabilities. This 
means significant contribution of resources to cleaning up the 
environment and work places, educating about diet and lifestyle, 
working to reduce poverty and changing some of our unhealthy compulsive 
habits. While prevention may not be a good 'handle'' to raise venture 
capital, it unlike speculative ``miracle'' cures has a proven record of 
success.

    6) Cloning human embryos for research raises the key ethical issue 
of whether we should intentionally create any human life form solely 
for its exploitation and destruction. As a human community we have 
never done this before. Certainly there should be public hearings and 
wide ranging public participation on this key ethical issue before such 
cloning is allowed.
    As we debate the human cloning issues, we must also demand 
responsibility and caution from those making claims about stem cell 
research. Many suffering from serious illnesses or disabilities have 
been misled by the false promises about gene therapy, fetal tissue and 
other medical ``breakthroughs.'' The continued hype about stem cells is 
unconscionable. Moreover, Congress must establish stringent regulations 
that assure that no human trials using stem cells technology take place 
until research fully justifies such trials. Should there eventually be 
human trials, they must be carefully and independently regulated and 
monitored. Researchers cannot be left to regulate themselves. Our 
elected representatives owe nothing less to the families of those who 
have died, and the many now suffering, because of Congress' past 
failures to cut through the hype and appropriately regulate medical 
technology.
    Thank you.

    Chairperson Feinstein. Thanks very much, Mr. Kimbrell.
    I will find my little biography here. Finally, but not 
least, Father FitzGerald. Father Kevin FitzGerald is a research 
associate professor in the Department of Oncology at Georgetown 
University Medical Center. In addition, he is the Chair of 
Catholic Health Care Ethics at the University's Center for 
Clinical Bioethics. Father FitzGerald has received a Ph.D. in 
molecular genetics and a Ph.D. in bioethics from Georgetown 
University. His research has focused on ethical issues in human 
genetics. For the past 10 years, he has served as an ethics 
consultant to the National Society of Genetic Counselors.
    Welcome, Father.

   STATEMENT OF REV. KEVIN FITZGERALD, GEORGETOWN UNIVERSITY 
                MEDICAL CENTER, WASHINGTON, D.C.

    Rev. FitzGerald. Thank you very much, Senator Feinstein, 
and thank you to the committee for this marvelous opportunity 
to join you today in this continuing conversation regarding 
human embryo research, specifically that research which 
involves transferring genetic material from a human somatic 
cell into an egg that has had its nuclear genetic material 
removed--in other words, cloning.
    The key moral issue in research involving cloned embryos 
is, as we have heard, the creation and destruction of a human 
life, an embryo. Though there is no consensus in our society as 
to the value of this nascent human life, there is equally no 
denial that this research is highly contentious and 
controversial in our society. The question before our society 
and this committee is then: How do we make the decision to 
proceed or not proceed with this kind of cloning research?
    We Americans know from our own history with eugenics, 
research on minority, the mentally disabled, and even on our 
own military forces the tragedies that can occur when public 
policies concerning human experimentation are shaped according 
to the dictates of science. When facing the unknown or the 
uncertain, the answer of science is do the research. This is 
perfectly good science. This may not be good public policy nor 
the ethical thing to do.
    In response to the wrongs done in the name of science 
mentioned previously, our society has chosen to limit what 
experiments can be performed on human beings, even though these 
limits may slow scientific progress. If human embryos indeed v 
some significant value to our society, as the National 
Bioethics Advisory Committee concluded, then considering all 
the basic research that still can be done using animal models, 
human tissue culture, non-cloned, non-embryonic stem cells, and 
all sorts of other molecular biology, why is there still a 
continuing clamor for the destruction of human embryos to fuel 
cloning research?
    One reason almost always put forth by proponents of human 
embryo cloning research--and a reason we have heard several 
times today--as justification for the creation and destruction 
of cloned human embryos is the need to bring healing and cures 
to the millions who suffer from illnesses and diseases that may 
otherwise die without this research. Such an argument as this 
is of great significance for it connects to a fundamental 
principle of medicine: treat sickness and heal when you can. 
Yet, as the argument is states, its significance rests in part 
on two assumptions: one, that cloned embryo research will be 
necessary or superior to all other options in the treatment of 
certain diseases; and, two, that the thousands and millions who 
need the treatments will have access to any medical advances 
that might come from such research.
    Addressing the first assumption, we need to recognize that 
the diseases suggested as likely targets for human cloning 
research are also the targets of researchers using other 
approaches, such as genetic therapies, drug development, adult 
stem cells, and other molecular biology approaches. It may well 
be the case that for many patients the treatments for their 
illnesses may come more quickly from research avenues other 
than cloned human embryo research, and that these alternative 
treatments may even be better than any treatment derived from 
human cloning research.
    Regarding the second assumption, we need to acknowledge 
that even if treatments from human cloning research can prove 
to be the best available or are developed first, the vast 
majority of the millions of people who need these treatments 
will not have access to them. For example, no one denies that 
cancer research has generated many significant advances in 
cancer treatment over the past 30 years. This is the war on 
cancer. Yet the President's Cancer Panel in their 2001 report 
conclude that ``a great many people--both the privileged and 
the poor--find that at the very time they need the most 
effective cancer care our research enterprise has devised, the 
health care delivery system of our Nation''--our Nation--
``fails them.''
    Tragically, this reality, considering it, and adding to it 
the fact that millions of children die every year from diseases 
preventable by vaccines, and the fact that some of the most 
effective drugs we have ever developed for certain diseases are 
not mass produced because no one will make a profit, one must 
seriously question any assertion that our society should pursue 
human cloning based on the fact that it will benefit millions. 
This justification for pursuing this socially contentious and 
ethically controversial research is just false. Human embryos 
need not be created and destroyed in order that thousands or 
millions might be saved.
    Indeed, without the continual creation and destruction of 
cloned human embryos, the future of medical advance will still 
be one of great hope. There are many avenues of medical 
research that can be pursued with broad ethical and societal 
support. As a people who value progress and justice, we can 
decide to pursue every avenue of medical research that is 
respectful of human life in all its stages, and we can work 
together to create a system that brings these advances in 
medicine to all those in need.
    Thank you very much for your time and attention.
    [The prepared statement of Rev. FitzGerald follows:]

               Statement of Kevin FitzGerald, S.J., Ph.D.

    We are gathered today to continue the public dialogue regarding 
human embryo research, specifically that research which involves 
transferring genetic material from a human somatic cell into an egg 
that has had its nuclear genetic material removed--i.e. cloning.
    The key moral issue in research involving cloned embryos is the 
creation and destruction of a human life--an embryo. Though there is no 
consensus in our society as to the value of this nascent human life, 
there is no denial that this research is highly contentious and 
controversial in our society. The question before our society and this 
committee is then, ``how do we make the decision to proceed or not 
proceed with this kind of research?''
    We Americans know from our own history with eugenics and with 
research on minorities, the mentally disabled, and even our own 
military forces, the tragedies that can occur when public policies 
concerning human experimentation are shaped according to the dictates 
of science. When facing the unknown or the uncertain, the answer of 
science is always to do the research. This is good science, but it may 
not be good public policy or the ethical thing to do. In response to 
the wrongs done in the name of science mentioned previously, our 
society has chosen to limit what experiments can be performed on human 
beings, even though these limits may slow scientific progress. If human 
embryos do have some significant value in our society, as the National 
Bioethics Advisory Committee concluded, then considering all the basic 
research that still can be done using animal models, human tissue 
culture, and adult stem cells, why is there a continuing clamor for the 
destruction of human embryos to fuel cloning research?
    One reason almost always put forth by proponents of human embryo 
cloning research as justification for the creation and destruction of 
cloned human embryos is the need to bring healing and cures to the 
millions who suffer from illnesses and diseases that may otherwise die 
without this research. Such an argument as this is of great 
significance for it connects to a fundamental principle of medicine: 
treat sickness and heal when you can. Yet, as the argument is stated, 
its significance rests in part on two assumptions: 1) that cloned 
embryo research will be necessary, or superior to all other options, in 
the treatment of certain diseases, and 2) that the thousands and 
millions who need the treatments will have access to any medical 
advances that might come from such research.
    Addressing the first assumption, we need to recognize that the 
diseases suggested as likely targets for human cloning research are 
also the targets of researchers using other approaches, such as genetic 
therapies, drug development, and adult stem cells. It may well be the 
case that for many patients the treatments for their illnesses may come 
more quickly from research avenues other than cloned human embryo 
research, and that these alternative treatments may even be better than 
any treatment derived from human cloning research.
    Regarding the second assumption, we need to acknowledge that even 
if treatments from human cloning research prove to be the best 
available and are developed first, the vast majority of the millions of 
people who need these treatments will not have access to them. For 
example, no one denies that cancer research has generated many 
significant advances in cancer treatment over the past thirty years. 
Yet the President's Cancer Panel in their 2001 report conclude that ``a 
great many people--both the privileged and the poor--find that at the 
very time they need the most effective cancer care our research 
enterprise has devised, the health care delivery system of our Nation 
fails them.'' Considering this tragic reality, and adding to it the 
fact that millions of children die every year from diseases preventable 
by vaccines, and the fact that some of the most effective drugs 
developed for certain diseases are not mass produced because no one 
will make a profit, one must seriously question any assertion that our 
society should pursue human cloning research because millions will 
benefit. This justification for pursuing this socially contentious and 
ethically controversial research is just false. Human embryos need not 
be created and destroyed in order that thousands or millions might be 
saved.
    Indeed, without the continual creation and destruction of cloned 
human embryos the future of medical advance will still be one of great 
hope. There are many avenues of medical research that can be pursued 
with broad ethical and societal support. As a people who value progress 
and justice, we can decide to pursue every avenue of medical research 
that is respectful of human life in all its stages, and we can work to 
create a system that brings the advances in medicine to all those in 
need.
    Thank you for your time and attention.

    Chairperson Feinstein. Thanks very much, Father, and thank 
you, panel. It has been an excellent panel, and I think very 
interesting to hear your respective arguments.
    I would like to begin, if I can, with you, Dr. Weissman. 
This goes to the argument made that, well, there has really 
been no bona fide work in the area of somatic nuclear cell 
transfer. And as I understand it, stem cells injected into mice 
have partially repaired a spinal cord injury and allowed the 
mouse to walk. Human embryonic stem cells have been induced to 
form pancreatic tissue, providing hope that youngsters 
suffering from juvenile diabetes might receive replacement 
insulin-producing cells. And I think just recently scientists 
have announced that they have used cells derived from cloned 
cow embryos that function and are not rejected when implanted 
into adult cows, marking the first time cloning technology has 
been used to grow personalized genetically matched organs for 
transplantation.
    Could you talk a little bit about specific research in the 
area of therapeutic cloning and stem cell research and explain 
what is happening that can make this more real to people other 
than just something very esoteric?
    Dr. Weissman. Sure. Actually, I believe the first paper 
that was published which showed that you could take mouse 
embryonic stem cells, convert them to neural cultures, and then 
use those neural cultures to treat a disease in mice, a 
demyelinating disease, was done by Bressler and Makai and 
published actually several years ago. I am surprised that 
Congressman Weldon didn't know about this. And this led to a 
reinsulating of the neural fibers of these animals that could 
not walk and led to a restoration, at least a partial 
restoration of the function.
    The experiments you talk about with spinal cord injury are 
at the beginning. They are as you reported them. What we like 
to do in science--and I think it is very important for this 
panel to understand--is that we need to have publications that 
are peer-reviewed before we understand what the phenomenon is 
and then independently replicate it. This is a very nascent 
field. It is just at its beginning.
    There are lots of claims that are now coming across in the 
media about substitutes for stem cell research. Most of them in 
the last 2 weeks have come from unpublished papers. So we don't 
understand yet what might or might not be there, and, of 
course, they are not yet verified. So I want to be cautious in 
any claims about whether it works for spinal cord injury or 
other things yet.
    Certainly, you are right. Insulin-producing cells have been 
produced by the same group, Makai's group, from embryonic stem 
cells. There is no doubt about that, and they have also shown 
that they could restore neural function, as I said, in a mutant 
that lacked these insulating fibers. But the only way we are 
going to go forward on this research is if we can do the 
research.
    Chairperson Feinstein. Thank you.
    Dr. Greely, could you explain the difference between 
somatic cell nuclear transfer to produce stem cells and the 
parthenogenic technique used by Advanced Cell Technology?
    Mr. Greely. Can I pass that one back to Dr. Weissman? My 
bachelor's degree from Stanford is in science, but it was 
political science.
    [Laughter.]
    Senator Kennedy. Then you ought to have an answer.
    [Laughter.]
    Mr. Greely. I can, but I am actually old and wise enough 
now to know that he would have a better answer.
    Chairperson Feinstein. Well, let me tell you where I am 
going----
    Senator Durbin. You didn't think that would be on the 
final, did you?
    Chairperson Feinstein. Where I am going is: Is it accurate 
to say that in both somatic cell nuclear transfer and 
parthenogenesis the egg cell is never fertilized by the sperm?
    Dr. Weissman. That is right. And so in parthenogenesis, you 
activate the cell now to start dividing with the nucleus that 
it has. So it is only going to be a replica of that woman's 
egg.
    Chairperson Feinstein. I have one here for Dr. Charo and 
then--I have so many papers here.
    Doctor, in his testimony today, Father FitzGerald, if I 
may, makes one moral argument and two policy statements against 
therapeutic cloning. His first policy argument is that other 
research avenues exist for curing diseases and treating 
ailments besides therapeutic cloning. And a second policy 
argument is that even if therapeutic cloning results in 
promising therapies, many people may not have access to them.
    How do you respond to these two policy arguments?
    Ms. Charo. With regard to the first point, I don't accept 
the premise. I don't believe that adult stem cell research can 
replicate all the areas of research that can be done using 
nuclear transplantation technology, specifically when we are 
looking at the replication of cells from a person with a 
particular genetic disease and we want to study how the 
defective gene operates in tissue that is being studied in the 
laboratory.
    Further, the basic research on the reprogramming of adult 
cells can only be done with embryonic stem--sorry, with nuclear 
transplantation. And, again, for further details I might refer 
back to Dr. Weissman.
    With regard to the question of the actual range of people 
who would obtain a therapy, I share his view that if we are 
going to be arguing based on a balancing of the equities, and 
cures are being held as one important equity, that it is 
important to see how many people would actually obtain those 
cures.
    On the other hand, again, I find both in his testimony and, 
to a large extent, in Mr. Kimbrell's testimony as well, a list 
of very important issues for congressional debate: access to 
health care, regulation of markets in human tissue, improved 
regulation of the protection of human subjects in human 
experimentation generally, FDA regulation of risks to women 
associated with cell-based therapies, and so forth. But none of 
these will be solved by criminalizing research that uses 
nuclear transplantation.
    These are a collection, a pack of very large dogs, and this 
little tail simply can't wag hard enough to answer all of these 
problems and solve all of these dilemmas. And so I think there 
is more than enough evidence that there are enough people and 
enough potential of unknown magnitude to justify the use of 
this kind of research in the hope that it will achieve some 
outcomes for some people and ultimately for everybody.
    Chairperson Feinstein. Thanks, Doctor. My time is up.
    Senator Hatch?
    Senator Hatch. Let me start with the lawyers. Professor 
Greely's testimony characterizes the FDA's assertion of 
jurisdiction over cloning as ``questionable.''
    Mr. Greely. Yes.
    Senator Hatch. From the Federal perspective, what is the 
legal status of cloning, both reproductive and therapeutic, 
vis-a-vis the FDA and its statutes? Do you think that the FDA 
view could prevail in court? Let's start with you, Dr. Greely.
    Mr. Greely. I think the FDA view could prevail in court. I 
think it is most likely not to. In order to be a device under 
the statutory jurisdiction of the FDA, in order to be regulated 
under the statutory jurisdiction of the FDA, human reproductive 
cloning would have to involve a drug, a device, an article, a 
product, a long list of nouns, for none of which human embryo 
seems a good fit.
    On the other side, it also has to be used for the treatment 
of disease or the cure of a medical condition.
    Now, arguably, if it is done for treatment of infertility, 
it is for the treatment of a disease or condition. But if an 
otherwise fertile couple chooses to have a human clone, it is 
very hard to see what medical disease or medical condition is 
being treated.
    There are a couple of law review articles on this--I would 
be happy to provide the citations to your staff--that come to a 
similar conclusion.
    Lurking in the background of this question there is also a 
Commerce Clause issue. Although, frankly, my view is Congress 
does have the power to empower the FDA to regulate this or to 
ban it directly, it just hasn't done so thus far.
    Senator Hatch. Would anybody else care to comment?
    Mr. Kimbrell. Yes, Senator. In 1989, the FDA was asked 
whether it could view fetal tissue as a device and was not 
convinced they could or could not. They decided they basically 
could, but Congress intervened and through the legislation made 
sure that didn't happen.
    I think the real problem is it is very questionable, and 
the last thing we want to see is this thing resolved in court 
when somebody actually litigates against the FDA for being 
arbitrary and capricious and going beyond its statutory 
authority in doing this when the cloning is already in process. 
So I think it is a very risky business indeed to think that the 
FDA could regulate this.
    Ms. Charo. Senator, if I may, of course, ask three lawyers, 
you will get three opinions. I disagree with both my 
colleagues. I think the FDA's jurisdiction here is 
unproblematic, although certainly Congress could help by making 
that easier to understand.
    Senator Hatch. So Congress could pass a law in this----
    Ms. Charo. Congress absolutely could. But what I would like 
to draw to your attention is the distinction between FDA 
jurisdiction over reproductive cloning to make babies versus 
non-reproductive cloning to produce embryos from which cell-
based therapies are derived.
    With regard to reproductive cloning, questions have been 
raised about its jurisdiction, and although Professor Greely 
feels that they might lose in court, my experience looking at 
this field is that courts will be extremely deferential to 
agencies' own interpretations of their authorizing legislation.
    But more to the point, when it comes to non-reproductive 
cloning, its jurisdiction is far clearer because its entire 
Division of Biologics, which regulates a range of cell-based 
therapies and which has been regulating more and more 
aggressively in the last 5 years a variety of therapies and 
markets that involve human tissue, in this area the FDA's 
jurisdiction is, as far as I can see, unproblematic and 
extremely useful in guarding against exactly the kind of 
concerns about retrieval of eggs being risky or markets being 
unduly coercive.
    Mr. Greely. I agree entirely with Professor Charo on that 
second point.
    Senator Hatch. Let me ask Mr. Kimbrell and Father 
FitzGerald this question: Would your views on so-called 
therapeutic cloning--I would call it DNA regenerative therapy. 
I think ``cloning'' is a stupid title, between you and me. I 
heard one of the Congressmen thought that was, you know, just a 
semantic change, but I don't think it is. But would your views 
on therapeutic cloning change if the cloned stem cells were 
derived from an egg that was rendered incapable of implantation 
in a woman's womb?
    Rev. FitzGerald. How would you do this manipulation of the 
egg to make it incapable of implantation?
    Senator Hatch. I am asking the question.
    [Laughter.]
    Rev. FitzGerald. Unfortunately, I mean, I guess it would--
--
    Senator Hatch. I didn't even have political science.
    Rev. FitzGerald. As is the case in a lot of this area, it 
is unfortunate that oftentimes the complexities of the science 
do have direct impact on what particular ethical or public 
policy conclusions one might come to. But I would have to say 
that it might be important how one intends to render that 
inability to be implanted the case. I could think of a variety 
of ways one could do that without necessarily abrogating the 
potential of this entity that is derived once some minor 
manipulation had occurred into be reactivated and being allowed 
to implant.
    Senator Hatch. Let me just ask Dr. Weissman----
    Mr. Kimbrell. I have a quick answer to that, if I could, 
Senator, because I do think it is a very important question. 
With parthenogenesis, people are asking this question more and 
more, and I do think that it resolves a couple of the major 
problems here. One is clearly the only regulatory scheme--and 
England is trying to do this--that would work for cloning of 
human embryos for research that would sort of alleviate the 
problem of having this whole store for people who want to break 
the law would be to have a chain of custody. You wouldn't need 
a chain of custody in the scenario that you talk about, and the 
fear that you would have these research clones available for 
reproductive cloning wouldn't be there. So it would alleviate 
that major concern.
    As far as some of the other concerns, such as, you know, 
commodification and choice, it would not alleviate those 
concerns. But it would deal with that first concern that you 
have a slippery slope and providing so many embryos out there 
in an unregulated way that would lead to reproductive clones.
    Senator Hatch. Dr. Weissman?
    Dr. Weissman. There are two scientific ways that you could 
imagine would be used to render the blastocyst or a pre-
blastocyst stage from being implantable. The first and most 
direct--and it could be done today--is to remove the outer 
lining of trophoblast cells. That would be entirely effective. 
You cannot implant without those cells.
    There is a second and theoretical way--theoretical because 
nobody has done it. We now know the genes, many of the genes 
that are required for making the trophoblast. So one could 
employ current technologies to test whether you could introduce 
into that egg those genes to be expressed during that early 
stage that would prevent the development of the trophoblast.
    So scientifically it could be done.
    Senator Hatch. I have two more questions, if the Chair----
    Rev. FitzGerald. If I could answer--do you want me to 
answer that?
    Senator Hatch. Sure, but I just have a little bit more 
time. The chairman has agreed to give me additional time to ask 
a couple more questions. But go ahead, Father.
    Rev. FitzGerald. I would say, quickly, if one gets to the 
point where you can remove the trophectoderm--that is the cells 
outside the inner cell mass--from the perspective of many 
people you would already be destroying an embryo, so that would 
not necessarily solve the problem I think you are trying to 
solve.
    The second one is if you go in and attempt to render the 
genes inactivated--and one doesn't necessarily have to do that 
at the DNA level; they could do it at an epigenetic level, 
which is slightly different. But then, again, I guess it goes 
to that more legal and philosophical intention discussion that 
we heard earlier, and that is where you would have to have that 
somewhat resolved.
    Senator Hatch. OK. Well, I think this is an area that is 
very intriguing to me.
    Rev. FitzGerald. Just one other issue. Parthenogenesis is 
not therapeutic cloning.
    Senator Hatch. No, no. I understand.
    Rev. FitzGerald. So we wouldn't want to blend the two.
    Senator Hatch. That I do understand.
    Let me ask you, Ms. Gulden, you know, I hope and I will 
pray that you will be able to run again and play basketball and 
be a police person, as you have been in the past. And I want to 
thank you for the courage that you have had in coming here 
today and telling us about yourself and about your views. 
Everyone wants you to get out of that wheelchair and be able to 
do what you want to do. And we all want research, so long as it 
is ethically appropriate.
    Now, this is a tough question, but I think you can probably 
handle it very well, so I feel that I am fair in asking it of 
you. How do you respond to the concerns of those who believe 
that therapeutic cloning entails the killing of another person, 
that is, the cloned embryo? How do you respond to that 
statement?
    Ms. Gulden. I would defer to Dr. Weissman.
    [Laughter.]
    Ms. Gulden. Senator Hatch, in my opinion, another person is 
not being killed. We are talking about a cluster of cells 
perhaps the size of a pencil eraser. I don't think that that is 
a person. I am a real person sitting here before you, and I 
just don't think that the cells we are talking about constitute 
a living human being.
    Senator Hatch. Well, whether they do or not, you seem to be 
saying that, look, they would be helping you and others 
similarly situated to live and to have a better life and to be 
able to do what is good in your life or good for others, that 
you might be able to be even a more productive human being if 
you could resolve these health problems that you have had to 
suffer from.
    These are tough questions for me because, you know, I am 
pro-life, but I also believe we ought to help the living and we 
ought to solve problems of disease and difficulties if we can. 
And it is important that we help people to live. So it has been 
a very, very difficult thing for me.
    If I could just ask one other question, Madam Chairman, and 
that is this--and I would ask it for the panel at large. Cloned 
human beings do not exist in nature. I think that is a fair 
statement. In reproductive cloning, as I understand it, an egg 
is never fertilized with sperm. And while twins share virtually 
identical DNAs, they are the product of haploid gametes, as I 
understand it, of their parents and not from a single diploid 
parental cell.
    Now, would a diploid being created through reproductive 
cloning be a person in the same scientific, legal, and moral or 
religious sense, as we ordinary haploid-haploid mortals? We 
will start with you, Dr. Weissman.
    Dr. Weissman. Well, I think you have made the right 
definition scientifically. I have nothing to add to it. The 
only thing I will say is that from the animal experience, this 
is very important----
    Chairperson Feinstein. Perhaps you would put in lay 
language what he was saying.
    Dr. Weissman. What he is saying is that in nature there is 
no such thing as a diploid cell that has been used to create 
clones, other than twinning, which does occur when two cells 
separate or four cells separate that did have the identical 
nucleus.
    But what I think is important is that the procedure to make 
these is one in which--that is, to make clones is one in which 
you have to add a nucleus in. I have nothing else scientific to 
add to your judgment.
    Mr. Greely. Senator Hatch, I don't have the expertise to 
give a religious answer to that, but as a lawyer, I can tell 
you that should reproductive cloning produce a baby that cries, 
that eats, that sucks, that recycles its nutrition and needs to 
be changed, I as a lawyer would feel very, very confident 
arguing that that baby would be a person for purposes of the 
14th Amendment, entitled to all the rights and liberties of any 
other person, regardless of the way in which it came to be 
born. And although one should never try to predict with 
certainty how courts will react, I feel confident about this 
one. Babies will be held to be people.
    Mr. Kimbrell. I totally agree with Professor Greely. It 
seems to me--and I don't think anybody would seriously argue 
that cloned animals would not be covered under the current 
Animal Welfare Act, that we would make sure that those animal 
were not subject to cruelty and had the basics they needed to 
live. Just because they were cloned animals, I don't think we 
would suspend from them the legislative protections that we 
grant animals, and I am sure the same would be true for people, 
should, God forbid, they ever be cloned.
    Ms. Charo. Senator Hatch, not only do I agree with 
Professor Greely, but I would even take away the suggestion 
that the baby needs to be able to cry and suckle. In the United 
States, if you are human and you are born, you have the equal 
protection of the laws and of the Government, and that is all 
it takes. Nothing more.
    Rev. FitzGerald. I actually very much appreciate your 
question because I think it raises the much deeper issue that 
we are going to wrestle with, not just here but with many of 
the biological advances that are in the pipeline; and that is 
that our concepts such as personhood predate the biological 
information that is coming to us so rapidly, such that our 
philosophical, our theological, and our legal concepts of what 
it means to be human and to be a person do not necessarily 
correspond with the biological data since this is something we 
have only been able to uncover relatively recently in our 
history.
    So we are going to have to continue to struggle with making 
that bridge and understanding the scientific information in 
perhaps ethical and cultural frameworks which are somewhat 
outmoded to integrate it.
    Senator Hatch. I want to thank you all, and I certainly 
want to thank you, Madam Chairman.
    Chairperson Feinstein. Thank you, Senator. Appreciate it.
    Senator Durbin, you are next.
    Senator Durbin. Thank you, Madam Chair, and thank you to 
the panel. I want to thank Kris Gulden for putting a human face 
on this debate. We spend a lot of time talking about scientific 
terminology and law, and you have reminded us what the bottom 
line is in this debate. Thank you for being here.
    And I want to thank Dr. Weissman for serving as the 
lifeline for this panel. Time and again they have called you, 
and your answers have worked out just fine.
    I have listened to this debate and tried to reflect on a 
trip I took several months ago and found to my surprise on the 
South Side of Chicago at the little company of Mary Hospital 
that it was the first hospital in the United States in the 
1950's to have a successful kidney transplant. It was just a 
fluke. It never should have happened. But it did, and they are 
quite proud of that fact.
    And I recall growing up Dr. Christiaan Barnard and heart 
transplantation, and I tried to put myself in the place of 
those who were considering organ transplantation in the 1950's 
and 1960's and listen to the arguments from this panel and 
wonder how that would have come out using the same standards. 
Because I listened to Dr. Kimbrell, and he suggested organ 
transplant--well, I think you could argue organ transplantation 
created many hopes that have not been realized. You said the 
same for gene therapy and other things. Many recipients of 
organ transplants have died, and, of course, that has happened 
with many other therapies that have been tried.
    Allowing organ transplantation was an open invitation to 
commercialization and even murder. It could have happened. 
Maybe it has. I don't know.
    In addressing Father FitzGerald's logic, even successful 
organ transplantation techniques are not available to 
everybody, rich and poor, in America. So using this same logic 
and thinking, I am just curious as to how some of the critics 
of therapeutic cloning would have come down on organ 
transplantation using the same standards. But I think what it 
boils down to is this: Research is research, and it doesn't 
always lead to a cure. The question we have to ask is whether 
we can cross that ethical threshold to justify it.
    Father, I am trying to recall theology courses from a long 
time ago. I think you have a morally consistent position, the 
church does on this, that would even oppose in vitro 
fertilization. Am I correct?
    Rev. FitzGerald. The church's official position, yes.
    Senator Durbin. And I listened earlier to the response from 
Congressman Weldon, and I think, frankly, who owns the sperm 
and the cell and what their intent is should be kind of 
secondary to the moral question if you are going to take the 
church's position. But he thought they made all the difference 
in the world, and I think Dr. Kimbrell and others have agreed 
with him.
    So let me try to pursue this, Dr. Kimbrell, if I can. Do 
you believe that we should prohibit in vitro fertilization as 
some artificial use of science? And how would you draw a 
distinction between in vitro fertilization, if you wouldn't 
prohibit it, and this whole approach that uses nuclear 
transplantation or therapeutic cloning?
    Mr. Kimbrell. I wish Senator Wyden were with us because he 
has been a real courageous leader in trying to regulate one of 
the, to me, most egregious offenders of our ethics, which is 
the IVF industry. It is virtually unregulated.
    My plea was not to ban IVF, but to make sure before we 
disseminate these technologies--and I used a couple of other 
examples, but organ transplantation is as good an example as I 
could ever come up with--you want to make sure that you resolve 
the issues before the technology becomes disseminated, 
commercialized, patented, and there is all this incentive.
    For example, in 1984 and 1985, I was here on the Hill with 
then-Representative Al Gore trying to pass the Organ 
Transplantation Act. In this country, we allowed the sale of 
organs. There were ads in USA Today, in the newspapers, for 
eyes, for kidneys. The World Health Organization has just 
declared this an international emergency as companies go into 
the Third World and take the organs from people. These are live 
donors, Senator.
    You know, certainly before we get that technology out, we 
need to deal with the fundamental commercialization and ethical 
issues. That was the plea I was making, not to get rid of it 
but to make sure for once that we act maturely and take 
legislative and regulatory responsibilities to----
    Senator Durbin. Isn't that what the Feinstein-Kennedy bill 
is all about, to establish some standards for regulation, some 
standards in research, not to ban it in its entirety, to throw 
out all the possible good things that could come from it, if we 
imagine all the bad things that might come from it?
    Mr. Kimbrell. Let me answer that briefly, if I could, and 
Senator Feinstein is a hero of mine. I have an office in San 
Francisco, which is just about my favorite city in the world, 
and I respect her enormously. But I don't think that her bill, 
frankly, does either of these things. Unfortunately -and I 
could submit this to the record; we have done a legal 
analysis--there is some carelessness in the language and 
definitions that would actually allow reproductive cloning, for 
instance, from fetal tissue and from embryos.
    So there are some problems with the bill. What the bill 
does not do is in any way regulate research human cloning, 
human cloning for research. There is no regulation whatsoever. 
Each of the issues that I addressed is completely is 
unaddressed, whether it be the commercialization, whether it be 
sale, whether it be patenting, whether it be a line of custody 
that we would establish through regulation. None of that is 
addressed in the Senator's bill. It is, admittedly, what it is 
supposed to be: a reproductive cloning ban. It is not meant to 
address these other issues at all, and it does not.
    Senator Durbin. Would you agree, then, that if there is 
appropriate regulation, as we put in place for organ 
transplantation, that therapeutic cloning and research in that 
area should go forward?
    Mr. Kimbrell. I believe that if we take the time--and I 
believe there should be an indefinite moratorium until we do 
this. We don't want to, again, provide all of the incentive, 
have a whole industry in place, and then try and retroactively 
-we have seen how impossible that is in the environmental 
field. We know it is impossible trying to retroactively 
regulate successfully. Let's, before we allow this, answer 
these important regulatory and ethical questions so we know 
what we are about when we begin it. We need to have a consensus 
and robust national debate on this before it happens.
    Senator Durbin. But you are not opposed to this research if 
it is regulated?
    Mr. Kimbrell. Not by definition, but by consequence.
    Senator Durbin. Let me ask you, if I have a moment?
    Chairperson Feinstein. Yes, please go ahead.
    Senator Durbin. Dr. Weissman, if I could ask you, could you 
give me an indication, what would the implications of a 
complete ban on therapeutic cloning be for stem cell research 
and what therapeutic interventions specifically might be halted 
or slowed down?
    Dr. Weissman. Sure, so long as we call it nuclear 
transplantation of stem cells. Well, of course, it would end 
all of the research that I described to you that used to be on 
that panel. We could now directly look at how, for example, a 
cancer cell--I think that Dr. FitzGerald should have sympathy 
for this--how the mutations that occur after a woman has been 
born with a heritable predilection for cancer, how it actually 
happens that she gets it and her sister doesn't?
    Senator Durbin. Breast cancer, for example.
    Dr. Weissman. Breast cancer, colon cancer. You can go 
through every one of the cancers. You have heritable 
predilections for this disease, but we still don't understand 
how the disease develops. Mutations develop, and in the unlucky 
cell in the unlucky person, cancer develops. We don't 
understand it yet. We are trying to go very systematically 
through it, but it would be enormously helpful to have the 
nucleus from that cancer cell making a cell line, which we can 
then study in mice, as to what are the true important events 
and which are the unimportant events. So that is just one 
application.
    But I do want to correct, which I have now heard several 
times from other members of the panel and Congressman Weldon, 
that one does not gain from some forms of research important, 
large-scale therapies. So recombinant DNA research--that is, 
putting together two DNAs from different life forms, bacteria 
humans, bacteria mice--was fought on almost exactly the same 
grounds in 1975 to 1980. I was at the first Asilomar Conference 
where scientists say we need to stop for a second and talk 
among ourselves what are the experiments that will allow us to 
go forward or not, and then a regulatory body, the Recombinant 
Advisory Committee was set up, and today it is not false to say 
that hundreds of thousands of lives, people living right now 
are saved or made better by the products of that research: 
erythropoietin, GSCF, interferons, human insulin growth 
hormones, and so on. I can't even go through the list.
    So if we have the same potential, which I believe we do, 
from the kind of research we are talking about, irrespective of 
the therapeutic cloning, just for the research itself, I 
believe it has the same enormous potential as recombinant DNA 
research and, unpredictably, it will come out with the kinds of 
research that leads bright scientists to develop eventually 
therapies.
    Senator Durbin. Thank you, Doctor.
    Thank you.
    Chairperson Feinstein. Thanks, Senator.
    Senator DeWine?
    Senator DeWine. Madam Chairman, let me thank you for 
holding this hearing and thank our panel, and, Ms. Gulden, 
thank you for your testimony. We appreciate it very, very much, 
and I would just echo what everyone else on the panel has said. 
We appreciate you coming in, your courage.
    I don't know that there is much at this point that we can 
add. This panel I think has illuminated very well the national 
debate that we are having, and I think almost all points of 
view are represented on this panel, and you have done a very 
good job, each one of you, of articulating the different 
arguments. In fact, you have added a great deal to those 
arguments.
    My understanding is, as lay person, that the cells that 
develop in an embryo for purposes of therapeutic or 
reproductive cloning are really indistinguishable from that of 
a naturally fertilized egg. That is a basic question. That is 
correct, is it not? What we end up with at this point is 
indistinguishable genetically? Anybody disagree with that? OK--
--
    Rev. FitzGerald. I think you might want to be a little more 
careful. We don't know. I think the answer is--I think that 
would be accurate to say that we could not definitively say one 
way or the other.
    Dr. Weissman. The important data is that with a naturally 
fertilized egg, you have a high probability of going on to a 
blastocyst, and when it implants, even from an IVF clinic, a 
very high probability that it goes through a normal pregnancy. 
All the losses occur in the first few months. But with nuclear 
transfer, to clone, to do reproductive cloning, the 
reprogramming doesn't work very well. You have a much lower 
incidence making the blastocyst, and then you have a 100fold 
loss so that only 1 percent of the implanted embryos make it 
through pregnancy for a live birth, and even after that there 
are many losses. So it's not exactly the same.
    Rev. FitzGerald. Right. But, again, we have to be careful 
because the consequences of the probabilities could be based on 
very similar mechanisms, and what is going wrong 
mechanistically in the cells might not be that distinguishable. 
There could be cells that are the result of the fertilization 
process that, once one looked at them on a molecular level, 
would be difficult to distinguish between some of the cells 
that were created by somatic cell nuclear transfer.
    As Dr. Weissman said, we are very much at the infancy of 
our understanding of all this.
    Senator DeWine. All right.
    [Laughter.]
    Dr. Weissman. But go ahead.
    Senator DeWine. I will try one more time with you, though, 
Dr. Weissman, because what I hear you saying is that the 
process of what will happen in the future may be different. You 
are talking about different odds. It sounds like you are saying 
different odds of survival, is what you sound like you are 
telling me. But the snapshot of what you are looking at or what 
that is at that moment, it sounds like you are saying it looks 
to you, at least, as if it indistinguishable. Now, is that what 
you are saying?
    Dr. Weissman. No. No, I am not.
    Senator DeWine. All right.
    Dr. Weissman. What may look to the naked eye as a 
blastocyst derived from nuclear transfer and a blastocyst 
derived by sperm-and-egg fusion, if it makes it that far, to 
the naked eye you can't tell the difference. But when you look 
at that set of imprinted genes, that is, the gene expression 
profile that normally happens, you can easily tell the 
difference. It has been published before that certain genes 
aren't turned off that should have been turned off. Other genes 
aren't turned on that should have been turned on. And we expect 
that those are the kinds of genes that are important for the 
early development that leads to this high loss during fetal 
life.
    So a sophisticated molecular biologist today could tell the 
difference.
    Chairperson Feinstein. But only that person? Only a 
sophisticated----
    Dr. Weissman. I think that, yes--that is, not just that 
person. You could, of course, develop a laboratory that would 
assay the 42 or more imprintable genes and know whether they 
were appropriately turned on or turned off. A common laboratory 
could do that as easily as the DNA fingerprinting laboratories 
establish identity.
    Senator DeWine. Dr. Weissman, in your testimony before the 
Appropriations Subcommittee, you stated and provided a 
handout--this was your testimony on January 24th--demonstrating 
that the clone used in research is no different in kind or 
nature from one destined for implantation; in other words, 
whether the purpose is going to be for implantation or whether 
the purpose is going to be the, quote, therapeutic, as the term 
is being used.
    Dr. Weissman. At that stage----
    Senator DeWine. At that stage.
    Dr. Weissman. If you were doing an animal cloning 
experiment, because that is the only experience we have, the 
only experience, then that blastocyst could be implanted and 
suffer, as I told you, losses or stem cells could be derived 
from it, which have been done, and you give rise to stem cell 
lines which, on their own, cannot make a whole organism and in 
a test tube cannot make an organ directly.
    Senator DeWine. Well, let me just thank all of you again. I 
found Mr. Kimbrell's testimony, one particular statement, very 
significant. I found a lot of his testimony, frankly, to be 
chilling and give us a lot for thought. But his quote that this 
is the first time that we would have produced a human life form 
with specific intent to destroy it, I think that gives us all 
something to think about.
    Thank you.
    Chairperson Feinstein. Thank you. But as I understand it, 
it isn't. Am I wrong?
    Ms. Charo. In fact, Senator DeWine, I would have to 
disagree with Mr. Kimbrell about that because----
    Senator DeWine. You certainly have the right to do that. 
That is why we have a panel.
    Ms. Charo. Embryos have been created specifically for 
research purposes and then been destroyed for decades, and it 
was exactly how in vitro fertilization was originally 
developed.
    Senator DeWine. So we have done this before.
    Ms. Charo. Yes, for decades. And surveys of laboratories 
around the United States that were done by Government agencies, 
including the National Bioethics Advisory Commission, in fact, 
had documented that fact to some extent.
    Senator DeWine. Doctor? Mr. Kimbrell?
    Mr. Kimbrell. Two issues on that. That is what you were 
getting to, Senator, when you started; you know, Dolly didn't 
just come from a cluster of cells. Dolly came from a sheep 
embryo, so this euphemism of trying to call it a cluster of 
cells, nuclear transplantations, this is just euphemism. This 
is an embryo that would be appropriate for implantation. That 
is what makes it so dangerous as far as being out there.
    Second is that IVF is a rogue industry. There may have been 
those who broke various laws, various things to try and 
accomplish various aims in the IVF industry. But the IVF 
industry is not an industry designed with the intention of 
producing embryos solely for their destruction and the use of 
spare parts. That is new. It is an ethical question. We cannot 
avoid or slip through by thinking it is happening again. For or 
against this technology, it is the ethical question we need to 
deal with, and the public should have a voice in dealing with 
it, not just here at the panel or our legislators. It should be 
a robust public debate, I think.
    Senator DeWine. And, Madam Chairman, I would just again 
call your attention, everyone's attention to the professor's 
comment wherein she said it has been done before. And I guess 
my answer to that is, if it has been done before, it doesn't 
mean it is necessarily right. I think the creation of human 
life for its destruction is not right. And I have the right to 
have that opinion, and she has the right to have a different 
opinion, and that is why we have a debate.
    Thank you.
    Chairperson Feinstein. Senator Brownback, you have shown 
great patience.
    Senator Brownback. It is a great topic, and you have done a 
great job putting together the panel, and I appreciate the 
panel's discussion of it.
    I am very pleased today to be able to announce as well that 
Senator Mary Landrieu is cosponsoring the bill I put forward to 
ban all human cloning. It is modeled after the House bill, and 
so I am pleased that she is going to be the lead Democrat 
cosponsor of the bill and is willing to take a bold, principled 
position on this.
    I think if we back up--this has been a very good panel--and 
look at where the situation and the issue stands today, the 
House has passed a broad-based ban on human cloning. This would 
be both what people refer to as the reproductive and the 
therapeutic cloning ban, total ban, a 100-vote margin in the 
House of Representatives that passed to ban all forms of human 
cloning, whether it is for research, destructive, somatic cell 
nuclear transfer, whatever term you want to use, that has 
passed the House.
    The President has called for a ban on human cloning of all 
forms. He doesn't think we should create life for the purposes 
of destroying it and is now asking the Senate to pass a similar 
ban as to what the House has passed by a broad bipartisan 
margin. And now we need to take the issue up, and a broad-based 
coalition is coming together to do that.
    I would note, I would like permission to enter into the 
record, Madam Chairman, a statement in support of legislation 
to prohibit cloning, cloning of all types--therapeutic cloning, 
and reproductive cloning. It is signed by 77 different people 
of various organizations, including Norman Mailer, a writer; 
Judy Norsigian, who was previously cited, executive director of 
Boston's Women Health Book Collective; and a number of others. 
And I would ask unanimous consent to enter this into the 
record.
    Chairperson Feinstein. Without objection.
    Senator Brownback. I also ask unanimous consent to enter in 
the record and then would like to ask Dr. Weissman about an 
article that appeared about the ultimate stem cell discovery in 
``New Scientist.'' This is about an adult stem cell that is in 
each of our bodies presently that can turn into every single 
tissue in the body, and I am quoting from it. ``It might turn 
out to be the most important cell ever discovered.'' Dr. 
Weissman, you are quoted in this article as well, saying it is 
very dramatic kinds of observations, is reporting the findings, 
if reproducible, are remarkable.
    Then I would note another article that I would ask to be 
put in the record, the Journal of Clinical Investigation, that 
there was reproduced the findings in this study that were in 
the ``New Scientist.''
    The reason I put that forward is, I don't think anybody has 
commented on this yet. I believe, Professor Charo, you were on 
the NBAC Board under Clinton, and you noted in your report, if 
there is another way of doing this without destroying an 
embryo, that is a better way of doing it. And if we have this 
coming about and these now are verified in the adult stem cell, 
that we have adult stem cells that are pluripotent, and can go 
into all forms, can be reproduced outside of the body, I think 
the whole panel would agree that this is a marvelous thing and 
this is the exact way that we could all agree we should pursue.
    Dr. Weissman, since I first put that to you, I----
    Dr. Weissman. Sure, let me respond. That is why--and I 
think it is very important that we all understand. The reason 
that I said what I said just a little bit ago that how 
scientists operate is to publish their results in peer-reviewed 
journals to demonstrate a phenomenon, and then look for 
independent verification. And, Senator, although the ``New 
Scientist'' has made this report, it is not a scientific or 
peer-reviewed journal.
    So the finding by Dr. Catherine Verfaillie at the 
University of Minnesota has not yet been published, and so we 
cannot examine whether her conclusions about her data would fit 
with general scientific ideas. The paper has not been 
published.
    Now, let me just say that I, therefore, asked Dr. Catherine 
Verfaillie to send to you, which you have in your office, and 
to you, Senator Feinstein, and to Senator Kennedy, an exact 
point of what she has and would her findings be important 
enough or even relevant to the issue of nuclear transfer to 
create embryonic stem cell lines. And I could read it to you, 
or you could read it because you have it in your office. I will 
read just a couple small parts.
    She said, ``It is far too early to say whether''--the 
cells--``they will stack up when compared to embryonic stem 
cells in longevity and function. Further, we will not know 
which stem cells, adult or embryonic, are most useful in 
treating a particular disease without side-by-side comparison 
of adult and embryonic cells.''
    And then she went on to say, ``We support studies aimed at 
developing techniques for therapeutic cloning--that is, cloning 
of human embryonic stem cell lines--because they may provide 
immune-compatible cells to treat a number of diseases, and 
because cloning of embryonic stem cells may be critical to the 
study of adult-onset diseases caused, for instance, by mutation 
in the DNA of cells after birth.''
    And there are a lot of qualifications, she goes on, but the 
important point here is the one person who has published the 
only paper where it--not published, who through the media, in a 
pre-publication media blitz, has reported--she didn't do this 
herself. This is the media who has pushed this very hard--that 
there may be such a cell in the body, says no, it does not 
substitute for embryonic stem cell research or nuclear transfer 
research, particularly because she can't make those cells from 
the somatically mutated cells in adults.
    Senator Brownback. Could I ask you, Professor--could I have 
a couple more minutes, Madam Chair?
    Chairperson Feinstein. Of course. Take the time you need.
    Senator Brownback. If we can do what you are desiring to do 
from adult stem cells, would you agree that that is the far 
more preferable way to go?
    Dr. Weissman. You mean to take the nucleus from, say, a 
breast cancer cell or a Lou Gehrig's disease cell and show that 
you can now study for all of the cell differentiation that an 
embryonic stem cell can do, both in vitro and in animal models, 
the development? That is science fiction today.
    Senator Brownback. If we could do with adult stem cells the 
work of curing ALS, of dealing with Alzheimer's, wouldn't you 
agree that that is the better way to go?
    Dr. Weissman. Let me just respond for the scientific part. 
I am committed, as you know, to finding adult stem cells for 
the treatment of human diseases. That is my only commitment. 
That is what I do. I do no research on embryonic stem cells or 
nuclear transfer, have no connections. But even if we could 
treat one disease, or two or five or ten, with adult stem cells 
that are around, I would not block the research, the important 
research that would open up whole fields, like taking disease 
cells or body cells from people with heritable diseases, I 
would not foreclose that because then I would be taking the 
responsibility to slow down the pace of discovery and the loss 
of lives that might have been saved. I could not do that.
    Senator Brownback. Mr. Kimbrell, if I could ask you, what 
is the worst-case scenario if we proceed, no laws in place, no 
regulations, no limitation, United States doesn't act, House 
has said we want a full ban, the President says we want a full 
ban, Senate doesn't act on it or takes another route so no bill 
gets through, so we continue on this unlimited, unregulated 
market situation we are in presently? What is the worst-case 
scenario that could develop in this situation?
    Mr. Kimbrell. As a preface to that, and following along 
with Dr. Weissman, one of the things we do need to be careful 
here--and I will be careful, too--is that we shouldn't have 
science by press release. I think we can all agree with that, 
and we are seeing that more and more often, frankly, to try and 
garner venture capital for these companies. And we can't have 
policy based on that. We cannot have the media do what they do, 
which is aggrandize these things. And talk about science 
fiction. Right now the idea of garnering stem cells from cloned 
human embryos is just that--science fiction.
    Dr. John Gearhart, who is the Senate's consultant on this, 
resigned from the editorship of the journal--excuse me, the 
editorial board of the journal that published Dr. West's study 
because he said it shouldn't have been published. Even as they 
were talking about getting stem cells from cloned embryos, 
numerous scientists were saying this is just not going to 
happen. So it is not just one side that is science fiction, 
Doctor. It is also the whole idea right now of getting stem 
cells from cloned human embryos is definitely science fiction.
    Should it happen, however, I don't think there is any doubt 
that the time and the place to regulate this is at the creation 
of the embryo. If we were to regulate this at the creation of 
the embryo, which I am suggesting, that is a relatively easy 
place to regulate it because you are simply banning the 
creation of these embryos. If we want until implantation to 
regulate, then we already have the embryo implanted; we have 
got a surrogate mother who is bearing this child, and what do 
we do? What is the answer to that? Certainly not abortion.
    Chairperson Feinstein. Sam, would you allow me just to poke 
in here for 1 second with a question?
    Senator Brownback. Yes, if I can continue after you.
    Chairperson Feinstein. Yes, absolutely.
    Mr. Kimbrell, the rest of the world is going to move in 
this direction. European countries are moving in this 
direction. Embryonic stem cells, the nuclear transplantation 
offers so much promise for, you know, remedial efforts with all 
kinds of diseases. Let's say we ban therapeutic cloning and it 
was available in Europe. Ms. Gulden, would you go to Europe? Of 
course you would.
    I don't know how you effectively stop people from looking 
for hope when they have a condition or a disease or a problem 
that might otherwise be changed.
    Mr. Kimbrell. Two quick answers, if I might, Senator. One 
is we want to make sure that they have hope, not hype. As I 
explained in gene therapy and fetal tissues, in the hearings 
very similar to the ones we are having today, it turned out to 
be a lot more hype than healing. Some money was made, but 
people were injured not healed. We need--again, I insist on not 
being technologically amnesia when we look at this.
    But the second thing is look at what England has done. Yes, 
it is true that England has said let's go ahead with this, 
though there has been some legal issues there that have 
actually stopped that and now may continue again, but with 
strict regulation that has a complete line of custody for each 
and every embryo so created to avoid many of the worst-case 
scenarios that I was just discussing with the Senator.
    That kind of regulation, that kind of regulatory system, is 
the only thing that is to prevent at least one of the worst-
case scenarios that we talk about. They realize that. I know 
the German parliament is looking at this, and the United 
Nations is currently looking at this. And I am convinced that 
they will not allow an unregulated--just as England has not, an 
unregulated industry in the creation of cloned human embryos 
for research.
    Chairperson Feinstein. I would very much appreciate it, if 
you would care to--you said there were faults with our bill, 
and I have no doubt, you know, it is an imperfect vehicle right 
now. We admit that. We would like to improve it. I would be 
very happy to receive any of your comments as to how to 
strengthen it or any of the regulatory--we were just reviewing 
them up here, and my staff feels that it is pretty good so far 
that way. Now, you say it isn't.
    So, you know, I for one would love to have your comments, 
if you would care to submit them.
    Mr. Kimbrell. Senator, I have spent hours of my life trying 
to do effective legislative writing, and I realize what a 
humbling process it is, and it is a lot easier to have 20-20 
hindsight. As Senator Hatfield once said to me, where were you 
when the paper was blank? So I realize it is a daunting task, 
and I would be--thank you, I would be very, very happy to give 
you some of the suggestions that we have.
    Chairperson Feinstein. Thank you. I didn't mean to----
    Senator Brownback. No, no, thank you, Madam Chairman.
    I guess, Mr. Kimbrell, what I am asking about is, last 
summer we were engaged in the discussion about embryonic stem 
cell research, and everybody was pointing out, well, these are 
so-called ``leftover'' embryos, which I question the 
designation of ``leftover embryo,'' but they are leftover. They 
are going to be destroyed, and it is just this, and no, we are 
not going to clone human beings, no, we are not going to create 
embryos for research purposes. It was stated by a number of 
people at that time that we are not going to clone, we are not 
going to do this, this is just about the embryonic stem cell, 
period.
    Now here we are 8 months, 9 months later from that point--
not even that far later, and people are now saying we have to 
clone for therapeutic purposes if we are going to cure a number 
of diseases, which I support curing these diseases. I support 
doubling the NIH funding. I am a co-chairman of the Cancer 
Caucus. Cancer runs in my family. I have had it. I mean, it is 
not that I don't have passion for those issues as well. It is, 
OK, now we are on to cloning.
    Then if we don't do anything on this, which may be the 
case, and so it just moves on forward, what is the next step? I 
hear people talk about germ line manipulation in the egg and 
sperm cells of adding outside genetic material or altering the 
material already there to correct defect that may be in there. 
Where are we headed to with all of this? Because it does seem 
like we are on a sequential path that we have continued to 
follow.
    Mr. Kimbrell. There are those--and there is much published 
literature which I would be happy to put into the record on 
this--that are looking toward what they call a post-human 
society, where they very much believe that our carbon bodies 
are not adequate to deal with the slings and arrows of 
outrageous fortune and that we should re-create ourselves in a 
number of different ways through germ line therapy, which part 
of what Dr. Weissman was talking about, the Asilomar Conference 
and others, there has been an informal ban on germ line therapy 
until now. People are talking about rebuilding our cells 
molecule by molecule, and, by the way, we are spending about a 
billion dollars of our taxpayer money on this to rebuild 
ourselves through nano-technology. And MIT and others are 
trying to rebuild us with silicon chip bodies. Senator, you 
would be delighted to know, I know our taxpayer dollars are 
going to that.
    So there really is--and I am not sure how widespread it is, 
to be honest, but there certainly is a rather chilling movement 
called the post-human society which views us as inefficient in 
our current forms, as something that is not a given good at 
all, but somebody can be re-created through technology to 
better deal with the future completely. That is obviously the 
worst-case scenario because, clearly, when we have lost what it 
means to be human, we have lost the ability that all of us have 
to communicate and even discuss these issues. So it is the 
wrong kind of final solution.
    One quick note on that, which is that I have had to deal 
with a great many instances of cancer in my own family, and one 
of the things you learn when all of us who face this with a 
wife and child, we know that it is a very complicated thing. 
Disease is complicated. Is it genetic predisposition? Was it an 
environmental poison that came in? Was it a workplace poison? 
Was it diet? Was it stress? Or did all these combine?
    And I sometimes think that we are a little bit too--and I 
am one--I feel this myself. We are little too prone to a magic-
bullet approach, there is one easy answer, fetal tissue, gene 
therapy, germ line, stem cells, cloning. And rather than say, 
listen, this is a difficult job. Prevention is going to be a 
difficult job. It means environmental cleanup. It means making 
our cars safer. It means the difficult job that it is going to 
take to get rid of all of these resources. It is much more 
tempting, and I think somewhat childish, unfortunately, to say 
we are going to have a magic bullet, particularly if it means 
this post-human society that some would lead us toward, 
Senator.
    Senator Brownback. Thank you. I want to say, Madam 
Chairman, too, I don't challenge anybody's motives or ethics 
that participate in this panel here. I think everybody has a 
wonderful notion in mind of what they want to see in the future 
of there being healing in America and healing around the world 
and that we have got this chance to do this and that we should 
pursue it.
    I don't challenge anybody's motive or ethics, and the Chair 
has been absolutely phenomenal on cancer and dealing with that. 
And I have been pleased to be a part of that. What I do think 
we have to have, as several of you, I think Professor Greely, 
you mentioned it, a robust debate about this. I have one more 
point, let's pause, let's pause and have the robust debate, and 
thoroughly, before we would move forward. I understand a lot of 
other people would say let's move forward and debate as we go. 
But I think we are at a momentous time, and we need to have 
that sort of debate--let's hold up let's really debate this 
before we move forward.
    Madam Chairman, I appreciate your willingness and your 
interest and your holding of this hearing.
    Chairperson Feinstein. Thanks, Senator Brownback.
    As you know, the debate is going on. I mean, we began this, 
what, a year and a half ago, I think. So the debate is going 
on.
    I just want to extend the same offer to Dr. Charo, Dr. 
Greely, anyone else that would like to submit any improvements 
in our bill. We would very much appreciate them.
    I must say I feel very strongly that we should move to ban 
human cloning. I think our Nation should go online and say that 
and be clear about it.
    Now, I am one that very strongly supports the somatic 
nuclear transfer for therapeutic improvements, and I think it 
is going to happen if we do nothing. I think there is a point 
to legislating in a proper way to see that the right protocols 
are there, the right ethics, the right regulations, all of 
that, and that we shouldn't delay.
    You know, I am aware of people leaving universities here, 
going to Europe because they feel there is more opportunity or 
more this or more that. But clearly, our law doesn't relate to 
what is a burgeoning new area, and it is going to burgeon 
without the law, and perhaps more transgressions take place, 
because I think there are people out there who are 
Machiavellian and who will do the wrong thing and want to make 
profit above all things, all the rest of it. And yet there are 
people like Ms. Gulden who look at this as something that, you 
know, really may offer them longer life, better quality of 
life, all of the above. So we have got a lot of challenges on 
our plate.
    I want to thank this panel. It has been one of the best, 
and I really appreciate the different points of view, and thank 
you for coming the distances you did. We will keep the record 
open.
    I would like to submit a statement by the chairman of the 
committee, Senator Leahy.
    Chairperson Feinstein. The meeting is adjourned.
    [Whereupon, at 4:50 p.m., the committee was adjourned.]
    [Questions and answers and submissions for the record 
follow.]
                         QUESTIONS AND ANSWERS

        Questions submitted to Dr. Weissman by Senator Feinstein

    Question 1: As I understand it, nuclear transplantation is a very 
broad technique that need not involve embryos or even stem cells.
         Could you explain some applications of nuclear 
        transplantation that do not involve embryos or stem cells?

    Question 2: I know that DNA regenerative research (also called 
therapeutic cloning) offers enormous potential for providing cures for 
diseases such as cancer, diabetes, cystic fibrosis, and heart disease 
as well as conditions such as spinal cord injuries, liver damage, 
arthritis, and burns.
         Could you explain which diseases and conditions are 
        most likely to be curable or treatable through DNA regenerative 
        research?
         Has anyone been cured or treated yet through DNA 
        regenerative research? If not, when do you expect this could 
        happen?

    Question 3: It was reported recently that, in order to produce stem 
cells, Advanced Cell Technology in Massachusetts has created a monkey 
embryo through parthenogenesis, that is, without the use of sperm. As I 
understand it, unlike embryos created from an egg (oocyte) and sperm, 
parthenogenetic embryos do not go to term if placed in a womb and that 
any stem cells produced could only be used in the women who produced 
the eggs.
         Could you explain the difference between somatic cell 
        nuclear transfer to produce stem cells and the parthenogenetic 
        technique used by Advanced Cell Technology?
         Is it accurate to say that in both somatic cell 
        nuclear transfer and parthenogenesis the egg cell is never 
        fertilized by the sperm?
         What is your view about the medical promise of 
        producing stem cells through parthenogensis?
         Was parthenogenesis to produce stem cells considered 
        by your panel as it was preparing the National Academies 
        report?

    Question 4: There has been much talk about whether adult stem cells 
are as versatile as embryonic stem cells. Some have even said that 
research with adult stem cells shows that we do not need nuclear 
transplantation to produce stem cells.
         Based on your panel's analysis of the medical 
        literature, would you agree that adult stem cells demonstrate 
        sufficient potential that it would be appropriate to stop doing 
        nuclear transplantation?

                                

      Questions submitted to Professor Greely by Senator Feinstein

    Question 1: In U.S. v. Lopez, 514 U.S. 549 (1995), and U.S. v. 
Morrison, 529 U.S. 598 (2000), the Supreme Court held that the Commerce 
Clause gives Congress authority to pass legislation regulating 
intrastate activity where it substantially affects interstate commerce. 
In my view, it seems clear that a federal law banning human 
reproductive cloning would pass muster under Lopez and Morrison. Much 
of the equipment, materials, funding, and personnel required for 
cloning, as well as the individuals seeking cloning services, would 
likely have traveled in interstate commerce.
         Do you agree? Why or why not?

    Question 2: In January 1998, in response to concern over a 
statement by Dr. Richard Seed that he would soon clone himself, the 
Food and Drug Administration (FDA) announced that it had regulatory 
jurisdiction over human cloning under existing federal statutes. The 
FDA also noted that anyone seeking to do human cloning would need to 
get permission from the FDA for such experiments and it suggested that 
it would not give such permission.
         In your view, does the FDA have jurisdiction over 
        human reproductive cloning?
         Does the FDA have jurisdiction over DNA regenerative 
        research (also called therapeutic cloning)?
         To your knowledge, has anyone sought permission from 
        the FDA to attempt to conduct human reproductive cloning?

    Question 3: Some commentators have whipped up a frenzy about 
cloning, raising the specter of a Brave New World of eugenics and 
designer babies. However, others note that, as is the case with many 
medical technologies, it is not cloning techniques that are the problem 
but some of their potential applications. For example, few people would 
argue that we should ban organ transplantation even though we are 
concerned about the sales of human organs or the transplant of organs 
from executed prisoners. Still, there are those who would completely 
ban somatic cell nuclear transplantation. This is in spite of the fact 
that the overwhelming majority of the scientific, medical, and 
patients' advocacy community opposes such a complete ban.
         Is there any precedent for completely banning an area 
        of research against the wishes of the overwhelming majority of 
        the scientific, medical, and patients' advocacy community?
         Would you agree that it is generally appropriate and 
        desirable for the law to discriminate between proper and 
        improper applications of a medical or scientific technique 
        rather than completely ban research into the technique?

    Question 4: You testified that the California Advisory Committee on 
Human Cloning concluded that the state should regulate DNA regenerative 
research by, among other things, ``forbidding all research with cloned 
human embryos after the appearance of the so-called 'primitive streak' 
at about 14 days from its creation.'' I believe that United Kingdom law 
also draws the line at 14 days.
         Can you explain the basis of the committee's 
        recommendation?
         Do you believe that there is an ``emerging consensus'' 
        that DNA regenerative research should be permitted before the 
        two week period but not after?

                                

      Questions submitted to Professor Charo by Senator Feinstein

    Question 1: The right to make decisions about whether to bear 
children is a fundamental liberty protected by the Constitution. A 
federal court has held that the right to make such decisions includes 
medically assisted reproduction, such as in vitro fertilization and the 
use of donated embryos [see Lifchez v. Hartigan, 735 F. Supp. 1361, 
1377 (N.D. Ill. 1990)]. I believe that University of Texas Law 
Professor John A. Robertson has suggested that cloning might be a 
protected constitutional liberty in some instances.
         Do you believe that cloning is protected by the 
        Constitution? If so, under what circumstances?

    Question 2: One of the major arguments put forth by those opposed 
to DNA regenerative research (also called therapeutic cloning) is the 
notion of a ``slippery slope.'' According to adherents of this view, if 
the government banned human reproductive cloning but not DNA 
regenerative research, it would be extremely difficult to prevent 
cloned human embryos from ending up being implanted in women.
         How persuasive is this ``slippery slope'' argument?
         In your view, can the government effectively regulate 
        cloned human embryos? If so, how?
         What lessons have we learned from government's 
        experience with embryos derived from in vitro fertilization?
         How effective has government regulation of these 
        embryos been?

    Question 3: One of the witnesses at the hearing, Father FitzGerald, 
argued that the potential for obtaining benefits from scientific and 
medical research regardless of how significant such benefits may be or 
who may stand to be helped by them does not in itself translate into a 
license to engage in that particular research. However, it is 
undeniable that the potential benefits of DNA regenerative research 
must be considered as a strong argument in favor of such research.
         In your view, how should Congress balance the 
        potential benefits of cures and therapies derived from clonal 
        research with any alleged potential harm?
         What principles should frame the debate?

                                

        Questions submitted to Mr. Kimbrell by Senator Feinstein

    Question 1: As I understand it, there are a number of different 
methods of mammalian cloning, including (1) molecular cloning, which 
involves replicating sections of DNA known as genes and has been useful 
in the production of insulin for diabetes; (2) cellular cloning, which 
involves duplication of somatic cells and allows scientists to test the 
impact of medicines without using actual human subjects; (3) blastomere 
separation, which occurs naturally in the process that results in 
identical twins but can also be induced by scientists; and (4) somatic 
cell nuclear transplantation, in which genetic material is removed from 
a somatic cell of one organism and transferred into the enucleated egg 
of another organism. And recently researchers have begun using 
parthenogenesis getting unfertilized eggs to start dividing as if they 
were embryos which some also consider a form of cloning.
         Do you believe that all forms of mammalian cloning and 
        induced parthenogenesis should be banned, including somatic 
        cell nuclear transfer?
         If so, do you believe that this ban should be 
        permanent or temporary?

                                

Responses of Irving L. Weissman, M.D. to questions submitted by Senator 
                               Feinstein

    Question 1: As I understand it, nuclear transplantation is a very 
broad technique that need not involve embryos or even stem cells.
         Could you explain some applications of nuclear 
        transplantation that do not involve embryos or stem cells?
    Answer: The term ``nuclear transplanation'' has been taken as an 
abbreviation for ``nuclear transplantation for the production of stem 
cells'', which itself could be qualified more precisely in the context 
of the Committee's deliberations to mean ``nuclear transplantation for 
the production of human pluripotent stem cells.'' In that context it is 
specified to be a procedure of transplantation of the nucleus of a 
normal or diseased human body cell into an enucleated human egg for the 
production of pluripotent stem cell lines, these lines being cell 
culture derivates from the inner cell mass of blastocysts that result 
from the procedure. If one takes only the term nuclear transplantation, 
it could mean any procedure involving the transplantation of the 
nucleus from any donor cell into an enucleated cell of any type of host 
cell. By today's technology only the nuclear transplantation of the 
nucleus into an enucleated egg will allow the production of pluripotent 
stem cell lines.

    Question 2: I know that DNA regenerative research (also called 
therapeutic cloning) offers enormous potential for providing cures for 
diseases such as cancer, diabetes, cystic fibrosis, and heart disease 
as well as conditions such as spinal cord injuries, liver damage, 
arthritis, and burns.
         Could you explain which diseases and conditions are 
        most likely to be curable or treatable through DNA regenerative 
        research?
    Answer: There are at least 4 distinct uses for nuclear 
transplantation (in your terms DNA regenerative research) that could 
and should lead to new medical techniques derived form new medical 
knowledge.
        1) To use nuclear transplantation methods to expand the genetic 
        base of human ES lines to be inclusive rather than exclusive. 
        If we assume human ES cells are today limited to the designated 
        approximately 64 human cell lines, and that these derive 
        primarily from in vitro fertilization clinic blastocysts, they 
        represent cell lines solely from infertile couples, and these 
        are a small subset of the ethnic, racial, etc. human groupings. 
        As such, any benefits of studying human developmental biology 
        from these lines will exclude most major segments of U.S. 
        society, and of course could be skewed to humans who are 
        infertile. Thus to provide full potential benefits from this 
        research for all subgroups of our society, nuclear 
        transplantation from diverse donors is the most efficient way 
        to address this limitation.
        2) To use nuclear transplanation methods to create new human ES 
        lines representing humans who not only have an inherited 
        genetic risk for disease, but who are unlucky enough to get one 
        or more of these diseases. These include people with 
        cardiovascular diseases (stoke, aneurysm, coronary artery 
        disease, etc.); autoimmune diseases such as type I (juvenile) 
        diabetes, rheumatoid artritis, multiple sclerosis, systemic 
        lupus erythematosus, hemolytic anemias, ankylosing spondylitis, 
        etc.; neurodegenerative diseases such as Alzheimer's disease, 
        Lou Gehrig's disease (amyotrophic lateral sclerosis), 
        Huntington;s disease, probably Parkinson's disease, Batten's 
        disease, Tay-Sachs disease, Gaucher's disease, the mental 
        retardation of Down's Syndrome, perhaps schizophrenia, etc.; 
        blood disorders such as sickle cell anemia, thalassemia 
        (Mediterranean forms and Korean forms), etc.; allergic 
        disorders; many if not all cancers; hereditary blindness, 
        hereditary deafness, and many, many more.
        3) To use nuclear transplantation methods to produce human 
        lines from the nuclei of cells that underwent somatic (not 
        inherited from parents) mutations as part of the disease 
        process. In these diseases the only body cells that have nuclei 
        that represent the life history of the development of those 
        diseases are the disease cells themselves. these include all 
        cancers, leukemias, and lymphomas, and huntington's disease.
         The study if diseases in categories 2) and 3) involves 
        establishment of the cell lines, study of how they make the 
        cells involved in the disease in test tubes (for example, motor 
        nerves and the muscle cells they can innervate in ALS); and 
        transfer of developing cells into the corresponding tissues of 
        newborn or developing immunodeficient animals to understand how 
        disease develops in the context of the native tissues. in all 
        of these cases, if the disease is replicated, one can use the 
        model to test which genes are involved, and which treatments 
        are possible. These treatments could include ``therapeutic 
        coloning'' (see 4), with dene-corrected cells.
        4) To use nuclear transplantation methods to produce human 
        pluripotent stem cell lines from an individual to treat that 
        individual when his/her own cells or organs have been 
        irreversibly damaged (therapeutic cloning or DNA regenerative 
        research, to use your term). As donor and host are closely 
        similar, minimal immunosuppression should be required. Damaged 
        tissues could include liver failure, stroke, anemia, 
        Parkinson's disease, blood vessel repair, etc.
         Has anyone been cured or treated yet through DNA 
        regenerative research? If not, when do you expect this could 
        happen?

    Answer: Nuclear transfer to produce human pluripotent stem cell 
lines is not currently practiced in the U.S. now, largely due to the 
legal uncertainties and the difficulties in making this potential 
therapy real. In a mouse model of severe combined immunodeficiency 
(SCID), the genetic disorder that the ``bubble boy'' had in Texas, 
scientists from the Whitehead Institute at the Massachusetts Institute 
of Technology produced pluripotent stem cell lines with that disorder 
by nuclear transplantation. They then used gene therapy techniques to 
correct the genetic defect in the pluripotent cell line, and allowed 
the cells to become blood-forming cells. These blood-forming cells were 
modified with another gene to allow them to mature from a primitive 
stage of blood formation suitable for a fetus only to more adult blood-
forming cells suitable for an adult. These adult-type blood-forming 
cells were transferred to the SCID mouse strain, and low levels of 
cells yielding protective immunity resulted. This is the first recorded 
case of ``therapeutic cloning'' in any species. The lessons learned 
look applicable to man, with considerable research required.

    Question 3: It was reported recently that, in order to produce stem 
cells, Advanced Cell Technology in Massachusetts has created a monkey 
embryo through parthenogenesis, that is, without the use of sperm. As I 
understand it, unlike embryos created from an egg (oocyte) and sperm, 
parthenogenetic embryos do not go to term if placed in a womb and that 
any stem cells produced could only be used in the women who produced 
the eggs.
         Could you explain the difference between somatic cell 
        nuclear transfer to produce stem cells and the parthenogenetic 
        technique used by Advanced Cell Technology?
    Answer: In parthenogenesis the egg chromosomes are stimulated to 
duplicate, bring the DNA level in the cell from half the normal amount 
to the normal amount. (Usually the sperm provides half and the egg 
supplies half.) As each egg contains only half the maternal 
chromosomes, when they are duplicated in parthenogenesis they now have 
an unique set of genes, not the same as the mother. However, as the 
mother has 1 copy of each parthenote's genes, an organ or solid tissue 
(e.g., kidney, liver, skin) stem cell transplant from the parthenote 
will usually not be seen as foreign by the mother. But because there 
are an unusual set of immunity cells (natural killer cells) that can 
reject blood-forming tissue transplants, the mother likely would reject 
a blood-forming stem cell transplant from the parthenote. Therefore the 
use of partenogenesis to provide transplants would only be useful for 
the egg donor, and not in all cases.
    F Is it accurate to say that in both somatic cell 
nuclear transfer and parthenogenesis the egg cell is never fertilized 
by the sperm?
     Yes.
     What is your view about the medical promise of producing 
stem cells through parthenogensis?
     It would have the limited use for therapies described above in 
Q2P1. As these cells have only half the genetic diversity of the 
mother, even if the mother had a heritable disease or cancer, her 
parthenogenetic pluripotent stem cells would almost certainly not 
contain the full set of genes to be useful for the other 3 objectives 
of nuclear transplantation research outlined in the answer to Q2.
     Was parthenogenesis to produce stem cells considered by 
your panel as it was preparing the National Academies report?
     Only minimally, as its potential uses were minimal, as described 
above. It does require a blastocyst intermediate.

    Question 4: There has been much talk about whether adult stem cells 
are as versatile as embryonic stem cells. Some have even said that 
research with adult stem cells shows that we do not need nuclear 
transplantation to produce stem cells.
     Based on your panel's analysis of the medical literature, 
would you agree that adult stem cells demonstrate sufficient potential 
that it would be appropriate to stop doing nuclear transplantation?
     Answer: No. There are no peer-reviewed published reports of adult 
stem cells that are pluripotent. Usually public policy should only deal 
with robust phenomena that are independently confirmed. We threrefore 
have no way to assess the properties of such cells, if they exist. 
There are many tissue-specific adult stem cells already discovered 
(e.g., blood-forming, skin, muscle, brain), and pure blood-forming stem 
cells as well as skin cells enriched in stem cells have been used 
successfully in therapies. But we have, as yet, no stem cells for 
pancreatic islets (lost in diabetes), liver, heart, blood vessels, etc. 
They are the focus of promising research. Most adult stem cells have 
properties that make them not useful for most of the goals of nuclear 
transplanation research outlined in the answer to Q2. Specifically, no 
adult stem cells exist for goals 1-3 in Q2, and it is as yet unclear 
whether the full panoply of adult stem cells will be discovered for all 
organs and tissues that need external cells for regeneration.
    Answer: There have been several claims that stem cells are plastic 
in their differentiation potential, e.g. in mouse experiments muscle, 
brain, or fat to blood, blood to muscle, blood to liver, etc. No claims 
for pluripotent or plastic human stem cells have been published. Recent 
evidence shows most of these to be contaminating blood-forming stem 
cells that circulate through all tissues. When the real stem cells from 
muscle or brain were isolated, they could not make blood. And blood-
forming stem cells make little else than blood.
    Given the current status of stem cell research (as of March 20, 
2002), banning nuclear transplantation to produce human pluripotent 
stem cells will not result in comparable research with adult stem 
cells, and so for scientific and medical reasons both kinds of research 
deserve focus and funding. Those responsible for banning such research 
are surely responsible for the lives lost that could have benefited 
from such research done in a timely fashion.
    I hope this aids you in your deliberations.

                                

  Responses of Hank Greely to questions submitted by Senator Feinstein

    Answer 1: The Commerce Clause
    Predicting the Supreme Court's position on the sweep of the 
Commerce Clause seems impossible to do with any confidence. Imagine a 
scenario where the patients, doctors, and most of the equipment for 
human reproductive cloning all came from within one state. This is not 
unlikely; human reproductive cloning, if possible at all, would seem to 
require little equipment. Assume the clinic avoids, as far as possible, 
any interstate advertising or even the use of instrumentalities of 
interstate commerce like the mails or the telephone. Add the fact that 
human reproduction hasn't usually been viewed as an item in interstate 
commerce. And, just to make the scenario as extreme as possible, assume 
further that the cloning is attempted without seeking a profit--perhaps 
even by a non-profit organization.
    Under those circumstances, I can imagine a court, struggling with 
Lopez and Morrison, concluding that the Commerce Clause does not 
stretch to that behavior and I could make that argument with a straight 
face. On the other hand, I think it is more likely a court would hold 
the opposite. Although the conventional method of reproduction has not 
been commercial, in vitro fertilization and other forms of assisted 
reproduction are most certainly been commercial--and a thriving 
commerce at that. Both Lopez and Morrison involved activities that were 
not themselves part of an ongoing business, but that were claimed to 
have effects on interstate commerce. The problem there may have been as 
much ``commerce'' as ``interstate.'' In the case of reproduction--seems 
clear in our society. That makes me think that a court probably would 
distinguish Lopez and Morrison and hold such a statute constitutional--
but I would not predict that outcome with great confidence.
    (Of course, human non-reproductive cloning, aimed at medical 
treatment, would seem much easier to find a part of interstate 
commerce.)

    Answer 2: FDA Jurisdiction
         a. Over Human Reproductive Cloning
    I do not think the Food and Drug Administration currently has 
statutory jurisdiction over human reproductive cloning. I generally 
agree with the conclusions on statutory jurisdiction of two law review 
articles on this subject (although I think the Price article is 
generally somewhat better).
         Elizabeth C. Price, Does the FDA Have Authority to Regulate 
        Human Cloning, 11 Harv. J.L. & Tech. 619 (1998);
         Gregory J. Rokosz, Is the Reach of FDA Authority Too Far a 
        Stretch? 30 Seton Hall L. Rev. 464 (2000)
    The articles focus on two Points: for the FDA to have jurisdiction, 
there must be a drug, device, or biological. This must be an article, 
product, or similar noun, that is either a) applicable to the 
prevention, treatment, or cure of a disease or condition of human 
beings (to meet the definition of a biologic under the Public Health 
Service Act), or b) intended for use in the diagnosis, cure, 
mitigation, treatment or prevention of disease in man [or] to affect 
the structure or any function of the body of man (to meet the 
definition of drug under the Federal Food, Drug, and Cosmetic Act).
    It is quite possible that a court would find that a human embryo is 
not an article or product. It seems to me even more likely that a court 
would find that reproductive cloning (at least where the people 
involved were otherwise fertile) would not meet the second part of the 
definitions--it would neither be for the prevention, treatment, or cure 
of a disease or condition, nor ``to affect the structure or any 
function of the body of man.''
    Of course, the courts give substantial deference to agencies in 
interpreting their empowering statutes. On the other hand, the Supreme 
Court has recently struck down FDA regulation of cigarettes (which 
common sense would seem to group as a device for delivering nicotine, 
an addictive drug). The jurisdiction of the FDA over such cloning under 
existing statutory authority can only be said to be uncertain.
         b. Over DNA Regenerative Research
         It seems clear that cells (or other substances) produced from 
        human non-reproductive cloning would be biologics under the 
        terms of the Public Health Service Act and thus subject to FDA 
        jurisdiction as well as, most likely, drugs under the FFDCA. 
        Note, though, that this jurisdiction is only triggered by their 
        use in human subjects, either experimentally or in human 
        subjects, either experimentally or in treatment. Research short 
        of human trials would not, I believe, be subject to FDA 
        regulation.
         c. Has anyone sought FDA approval for human reproductive 
        cloning?
         Not as far as I know.

    Answer 3: Banning Versus Regulating
         a. Precedent for completely banning an area of research 
        against the wishes of the scientific, medical, and patients 
        advocacy communities?
         No. The closest I can come at the federal level is various 
        restrictions on nuclear fission and fusion information after 
        World War II that had the effect of classifying all weapons-
        related research and concentrating it in the federal 
        government. I suppose bans on chemical and biological weapons 
        also ban some research on those weapons, even under federal 
        government auspices. In neither of those examples was there 
        public support for such research. Several states have laws 
        banning some forms of human embryo research; again, in those 
        states, at the time the laws were passed (usually in the early 
        1980s), such research had no substantial constituency.
         b. It is generally appropriate--and desirable--for the law to 
        discriminate between proper and improper applications of a 
        technique rather than completely ban research into the 
        technique?
         Yes, when the applications can be sufficiently separated. I 
        believe that non-reproductive cloning, a proper application, 
        can be separated entirely from reproductive cloning, an 
        improper application.

    Answer 4: The Primitive Streak
         a. The basis for the California recommendation
         Based on scientific evidence, the development of a ``primitive 
        streak'' seems to mark the first appearance of any precursor to 
        the nervous system. Although the primitive streak itself does 
        not seem to be a nervous system, it is a visible and 
        conservative marker that shows that before its formation, the 
        embryo seems incapable of experiencing any sensation.
         b. Do I believe there is an emerging consensus for a two week 
        research period for DNA regenerative research?
         Yes. The United Kingdom as well as various US advisory bodies 
        have recommended the two week period.

                                

 Responses of R. Alta Charo to questions submitted by Senator Feinstein

    Answer: Your first question concerns my opinion on whether there is 
a fundamental right to use reproductive cloning. I will answer that 
query in this email, and will send answers to the other questions in a 
follow-up email this weekend.
    Your question first asserts that Lifchez v. Hartigan (735 F. Supp. 
1361, N.D. Ill. 1990) holds that the right to make decisions concerning 
whether to bear children includes the right to use IVF and donated 
gamete. The question then asks whether I believe that cloning is 
protected by the Constitution.
    First, I do not agree with your characterization of the Lifchez 
case. Lifchez concerned an Illinois statute that attempted to ban fetal 
experimentation. The statute specifically stated that it was not 
intended to prohibit IVF, and thus the Court's review of the statute 
never required it to reach the question of whether Illinois might 
constitutionally prohibit IVF. Its suggestion that the reproductive 
privacy cases suggest a fundamental right to use technologies that 
bring about pregnancy is not a holding, merely dicta.
    Further, this is no way clarified the view of this federal court, 
let alone the view of other federal courts, on whether the right to 
reproductive privacy also includes a right to make decisions about the 
kinds of children one might have (via gamete selection, embryo 
selection, or in the future, gamete or embryo genetic alteration), a 
right to use donated gametes, or a right to purchase and sell gametes. 
None of these medical and social developments are central to the issue 
of whether or not to become a parent.
    Decisions about gamete and embryo selection concern the scope of 
parental entitlement to shape the parental experience, by influencing 
the kinds of children who will be conceived or brought to term. And use 
of donated or purchased gametes by an individual does not let him or 
her reproduce genetically, thus, again, going beyond the scope of prior 
decisions concerning the right to ``beget'' a child. (Arguably, the use 
of donated or purchased ova does, however, allow a woman to ``bear'' a 
child even though she has no usable ova of her own, and thus this may 
possibly fall squarely within prior cases; those cases, however, were 
written long before it was possible to separate ``bearing'' from 
``begetting'' in the context of female reproduction, so the intent of 
the authors of those legal opinions cannot be determined with any 
precision.)
    More to the point, you ask if I believe cloning is protected by the 
Constitution.
    Before responding, it is essential to note that whether or not 
cloning is protected by the Constitution can be determined only by the 
Supreme Court. Until it has ruled, the issue is unresolved. I would 
predict, however, that if the Supreme Court were presented with this 
question, it would rule that reproductive privacy does not extend to 
cloning.
    First, from a genetic point of view, the donor of a somatic cell 
for cloning will not be conceiving a child but will be conceiving a 
genetic twin. There are no cases that suggest a fundamental right to 
have a sibling. While this may seem semantic or genetic sleight-of-
hand, I believe it is in fact a substantive point, as the earliest 
cases, such as Skinner v. Oklahoma [316 U.S. 435 (1942)], were clearly 
based on a model of vertical genetic transmission across genetic 
generations. This, in turn, appeared to reflect a belief in the 
impermissibility of government interference in an activity that is at 
the center of both personal and human experience throughout human 
history. As cloning represents something sui generis as a form of 
family formation, it would be wrong to assume that these early cases 
would necessarily be extended to apply to this new technology.
    Speaking more broadly, to the spirit of the reproductive privacy 
cases, I believe one finds distinctly different strands of reasoning, 
only some of which would tend to support a fundamental right to use 
cloning as a form of human reproduction. Further, the one strand of 
reasoning that would provide such support, to wit, a liberty interest 
in psychological autonomy, is the very same strand of reasoning that 
the Supreme Court has declined to interpret broadly.
    Various aspects of this reproductive privacy right have been 
articulated in a number of landmark Supreme Court cases, including 
Griswold v. Connecticut [381 U.S. 479 (1965) (striking down statute 
which forbid use of contraceptives on grounds that statute invaded zone 
of privacy surrounding marriage relationship)]; Eisenstadt v. Baird 
[405 U.S. 438 (1972) (striking down statute forbidding distribution of 
contraceptives to unmarried persons on equal protection grounds, but 
observing in dicta that: ``If the right of privacy means anything, it 
is the right of the individual, married or single, to be free from 
unwarranted governmental intrusion into matters so fundamentally 
affecting a person as the decision whether to bear or beget a 
child.'')]; Roe v. Wade [410 U.S. 113 (1973) (establishing unrestricted 
right to an abortion in first trimester)]; and Planned Parenthood of 
Missouri v. Danforth [428 U.S. 52 (1976) (striking down provisions of 
abortion statute requiring spousal consent and parental consent)]. In 
Carey v. Population Services International, 431 U.S. 678 (1977), the 
Court reviewed its prior privacy cases and declared that ``The decision 
whether or not to beget or bear a child is at the very heart of this 
cluster of constitutionally protected choices.''
    What is striking about many of the early contraception cases, which 
laid the ground for the subsequent abortion cases, is their emphasis on 
the marital relationship. It was the intrusion of government policy 
into that marital relationship, and by extension, into the marital bed 
(by virtue of making sexual relations between husband and wife 
difficult or unpleasant due to the need to avoid conception without the 
benefit of contraceptives), that animates the visceral reaction that 
these policies are an intrusion on ``privacy.''
    In Eisenstadt, this concern about marital privacy is combined with 
the Skinner v. Oklahoma concern about impermissible intrusion into the 
realm of an individual's reproductive capacities, resulting in an 
extension of the right to contraception to unmarried individuals. It is 
important to note that, in Skinner, the issue concerned the bodily 
integrity of felons who were faced with forcible sterilization. The 
Eisenstadt case, however, necessarily goes beyond this concern with 
bodily integrity when it extends the right to contraception to men as 
well as women. For women, who are at risk of pregnancy, prohibitions on 
contraception threaten their interest in controlling the state of their 
bodies, as well as their psychological interest in freely deciding 
whether to become a parent. For men, however, the interest is purely 
psychological. Thus, as of 1972, it would appear that the Supreme Court 
was working toward an understanding of reproductive privacy that 
extended to concerns about psychological autonomy, a form of liberty 
that might support a claim of constitutional protection for the use of 
cloning techniques to produce a child.
    But subsequent abortion and right-to-die cases have backed away 
from this regard for psychological autonomy and have emphasized instead 
either gender equality or the liberty interest in bodily autonomy. 
While Justice O'Connor's opinion in Pennsylvania v. Casey does speak to 
the notion that ``at the heart of liberty is the right to define one's 
own concept of existence, of meaning, of the universe, and of the 
mystery of human life, `` her subsequent statements reflect a concern 
more for gender equality in society than for unfettered personal choice 
in all matters touching, no matter how remotely, on human reproduction. 
(``The mother who carries a child to full term is subject to anxieties, 
to physical constraints, to pain that only she must bear. That these 
sacrifices have from the beginning of the human race been endured by 
woman with a pride that ennobles her in the eyes of others and gives to 
the infant a bond of love cannot alone be grounds for the State to 
insist she make the sacrifice. Her suffering is too intimate and 
personal for the State to insist, without more, upon its own vision of 
the woman's role, however dominant that vision has been in the course 
of our history and our culture. The destiny of the woman must be shaped 
to a large extent on her own conception of her spiritual imperatives 
and her place in society.'' )
    The dissenters in that case launched a pointed attack, too, on the 
notion that fundamental rights to privacy bespeak unfettered liberty of 
choice in all personal matters. In a scathing dissent, Justice Scalia 
wrote: ``The best the Court can do to explain how it is that the word 
``liberty'' must be thought to include the right to destroy human 
fetuses is to rattle off a collection of adjectives that simply 
decorate a value judgment and conceal a political choice. The right to 
abort, we are told, inheres in ``liberty'' because it is among ``a 
person's most basic decisions,'' it involves a ``most intimate and 
personal choice,'' it is ``central to personal dignity and autonomy,'' 
it ``originates within the zone of conscience and belief,'' it is ``too 
intimate and personal'' for state interference, it reflects ``intimate 
views'' of a ``deep, personal character,'' it involves ``intimate 
relationships'' and notions of ``personal autonomy and bodily 
integrity,'' and it concerns a particularly ``'important decision.'' 
But it is obvious to anyone applying ``reasoned judgment'' that the 
same adjectives can be applied to many forms of conduct that this Court 
has held are not entitled to constitutional protection--because, like 
abortion, they are forms of conduct that have long been criminalized in 
American society. Those adjectives might be applied, for example, to 
homosexual sodomy, polygamy, adult incest, and suicide, all of which 
are equally ``intimate'' and ``deeply personal'' decisions involving 
``personal autonomy and bodily integrity,'' and all of which can 
constitutionally be proscribed because it is our unquestionable 
constitutional tradition that they are proscribable.'' [citations 
omitted].
    Indeed, the Supreme Court has rejected the notion that a 
psychological autonomy embedded in fundamental liberty interests 
extends to choices about sexual practices such as consensual anal 
intercourse between men [Bowers v. Hardwick, 478 U.S. 186 (1986)]. And 
in Washington vs. Glucksberg, 521 U.S. 702 (1997), the Supreme Court 
rejected the argument that psychological autonomy extends to a right to 
commit suicide, allowing only that when bodily integrity is threatened 
by unwanted medical intervention, there is a fundamental right to 
refuse treatment, even at the risk of death. In these cases, which 
concern sexuality and dying, the Court has declined to announce that 
fundamental liberty interests extend to all aspects of defining one's 
self and controlling one's future, and instead has emphasized 
repeatedly that only those interests that are considered to be central 
to ordered liberty and are historically grounded in common practice 
will be viewed as fundamental.
    Thus, cloning as an exercise of psychological autonomy is unlikely 
to receive the protection of fundamental rights analysis, and as 
prohibitions on cloning neither invade the body nor tread on a 
historically common practice, it is unlikely to gain fundamental rights 
protection on either of those grounds either. Only if it is viewed as 
closely connected to the choice to bear or beget a child is there any 
significant chance that it would be considered protected as a 
fundamental right. And this, of course, returns the discussion full 
circle to the question of whether it should be viewed as a variation on 
human reproduction or as something wholly new unto itself. It is my 
best guess that the Supreme Court would view cloning as something 
wholly new, despite the fact that it could be used as a substitute for 
sexual reproduction through intercourse or even reproduction through 
the use of laboratory techniques to achieve conception by male-female 
gamete combinations in a laboratory dish.
    On a final note, I would like to mention that this analysis of 
Supreme Court decisions does not reflect my personal preferences 
concerning the relationship between liberty and personal choices. I 
must confess that on matters concerning sexuality, marriage, family 
formation, reproduction, dying and death, I would prefer that the 
Supreme Court adopt an expansive vision, so that any state 
encroachments on these choices would be impermissible absent a 
compelling state purpose. I believe that this is not only politically 
preferable, but also that it is a defensible interpretation of these 
cases, all of which acknowledge the importance of liberty interests 
that go far beyond bodily autonomy. Nonetheless, I believe that a fair 
reading of the cases and the jurisprudential theories favored by the 
current Supreme Court make it unlikely that a congressional ban on 
reproductive cloning would be struck down as undue interference in an 
individual's fundamental right to reproductive and familial privacy.
    Answer: Your second question concerns slippery slope arguments and 
the effectiveness of government regulation.
    I do not find the slippery slope arguments persuasive, because 
taken to their most logical conclusion, they would argue most 
strenuously for a ban on in vitro fertilization, as it is IVF that 
allows us to maintain and manipulate embryos outside the body. To the 
extent that slippery slope concerns focus on genetic screening and 
genetic engineering, it is IVF that is the major avenue toward such 
manipulations, not cloning, but it is cloning, and not IVF, that would 
be banned.
    More profoundly, slippery slope arguments are by their nature 
simplistic. In the late 1970s, when concerns were raised about the 
power of recombinant DNA technology, many people called for an 
indefinite moratorium on use of the technique. If that moratorium had 
been adopted, the entire biotechnology industry would have been stopped 
in its tracks.
    Slippery slope arguments are for the timid. The courageous 
recognize the complexity of technology, appreciate that it almost 
always offers both good and bad applications, and fight through the 
uncertainty, confusion and fear in order to develop nuanced policy that 
salvages the good while guarding against the bad.
    Fortunately, there are some governmental mechanisms already 
available to do just that.
    FDA has the authority to regulate medical products, including 
biological products, drugs, and devices. The use of cloning technology 
to clone an embryo for therapeutic purposes would be subject to both 
the biologics provisions of the Public Health Service (PHS) Act and the 
drug and device provisions of the Federal Food, Drug, and Cosmetic 
(FD&C) Act.
    In October 1993, FDA published a notice in the Federal Register, 58 
FR 53248 (October 14, 1993), clarifying the application of FDA's 
statutory authorities to human somatic cell therapy and gene therapy 
products. The notice stated that somatic cell therapy products are 
biological products under the PHS Act as well as drugs under the FD&C 
Act and are subject to investigational new drug (IND) application 
requirements. In the notice, FDA defined somatic cell therapy products 
as ``autologous (i.e., self), allogeneic (i.e., intra-species), or 
xenogeneic (i.e. inter-species) cells that have been propagated, 
expanded, selected, pharmacologically treated, or otherwise altered in 
biological characteristics ex vivo to be administered to humans . . 
..''
    Subsequently, in March 1997, the Agency proposed a more 
comprehensive regulatory approach for cellular and tissue-based 
products that includes somatic cell therapy products (62 FR 9721 March 
4, 1997). In January 2001, after issuing and reviewing comments on a 
proposed rule, FDA issued a final rule that establishes the regulatory 
approach for human cells, tissue, cellular and tissue-based products 
and requires establishments to register with the Agency and list their 
products.
    Thus, clinical research using cloning technology to clone an embryo 
is subject to FDA regulation under the PHS Act and the FD&C Act. Before 
such research could begin, the researcher must submit an IND request to 
FDA, which FDA would review to determine if such research could 
proceed.
    A researcher may not conduct a clinical study unless an IND is in 
effect. Sponsors are required to submit to FDA an IND describing the 
proposed research plan and other pertinent scientific information, to 
obtain authorization from an independent Institutional Review Board, 
and to obtain the informed consent from all participating individuals. 
The sponsor must wait at least 30 days after submitting its proposal to 
FDA before beginning any study. During this time, FDA may take action 
to prohibit a sponsor from conducting the study by placing the study on 
``clinical hold'' for a variety of reasons, including but not limited 
to, situations where the Agency finds that ``human subjects are or 
would be exposed to unreasonable and significant risk of illness or 
injury'' or that ``the IND does not contain sufficient information 
required. . .to assess the risks to subjects of the proposed studies.'' 
(Title 21, Code of Federal Regulations 312.42.)
    On the basis of these powers, FDA could withhold approval of 
studies using cloned embryos if those studies did not ensure that risks 
to egg donors were acceptable, that egg donation was informed and 
voluntary, and that procedures were in place to track the cloned 
embryos so that they could not be diverted to reproductive or other 
unauthorized purposes.
    Government regulation would, of course, be enhanced if federal 
funding were available to a broader range of embryo research projects. 
It is the absence of federal funding for embryo research throughout the 
1980s that accounts for the virtually unregulated and explosive growth 
of clinical applications of IVF and other reproductive technologies. 
Federal funding in the 1980s would have given researchers an incentive 
to proceed in a more measured fashion, and would have permitted 
diffusion of the techniques to be accompanied by a set of social norms 
represented in the federal funding restrictions. Instead, in the 
absence of federal funding, we observed rapid expansion of medical 
indications for reproductive technologies and a relative dearth of 
controlled studies on the safety and efficacy of the techniques. It is 
fortunate that to date there have been so few medical problems 
associated with the techniques, but government funding would have 
ensured that this result was due to planning rather than luck.

                                

                       SUBMISSIONS FOR THE RECORD

           Statement of The American Society for Cell Biology

Somatic Cell Nuclear Transfer Technology is Justified and Essential for 
   Producing Embryonic Stem Cells For Basic Research and Therapeutic 
                              Applications
    Since 1997 The American Society for Cell Biology has stated and 
stood by its strong opposition to the reproductive cloning of human 
beings. Media claims notwithstanding, current scientific information 
suggests that the technology now available will not be able to lead to 
the creation of a cloned human being or to an embryo capable of being 
born as a cloned normal human. Equally important, no responsible 
scientist favors reproductive cloning.
    It is unlikely that current biomedical technology can be used to 
clone adult human beings. But there is substantial justification to 
believe that somatic cell nuclear transfer (SCNT), or what many have 
referred to as therapeutic cloning, will energize scientific progress 
in the fight against the most debilitating illnesses known to man. New 
embryonic stem cell lines, potentially capable of avoiding the 
rejection complications of stem cell therapies for cancer, diabetes, 
spinal cord injury, kidney disease, and Parkinson's disease, may be 
produced by using the genetic material of the prospective transplant 
recipient to generate recipient-matched stem cells. These procedures 
could be vital in solving the persistent problem of a lack of 
genetically matched, qualified donors of organs and tissues that we 
face today. Stem cell research is an essential first step if we are 
ever to be able to achieve the promise of regenerative medicine, a 
wholly new approach for repairing cells and tissues in the treatment of 
currently intractable human diseases. Beside the therapeutic promise, 
the SCNT procedure permits entirely new approaches to the study of the 
earliest phases of human development, of how a single cell is 
transformed into the trillions of different cells and tissues with 
myriad fates and capabilities during embryonic development. By deriving 
embryonic stem cells with defined mutations scientists gain a new 
approach to understanding how such inherited predispositions lead to 
serious disease in adulthood.
    Unfortunately, and onerous cloud has been cast on the term cloning 
because it has been used in the public discourse both to refer to 
attempts to create genetically identical adult humans and to describe 
other procedures that are less controversial. However, cloning is a 
scientific term that describes the preparation of an ``infinite'' 
number of copies of, for example a single molecule, cell, virus or 
bacterium. For example, cloning DNA molecules was essential for solving 
the human gnome sequence. Similarly, Cloning DNA is critical to fight 
against bioterrorism and has already been used in the determination of 
the entire gnome sequences of several organisms identified as 
bioweapons. Furthermore, cloning is integral to modern forensic 
procedures, medical diagnostics, vaccine development, and the discovery 
and production of many of the most promising drugs. Cloning is also 
used to make genetically identical plants and livestock enabling 
continued agricultural breakthroughs necessary to feed a rapidly 
growing and undernourished world population.
    Conflating the term cloning as it is used for the creation of 
genetically identical humans with the valuable and appropriate uses of 
cloning embryonic stem cell lines for basic research and therapeutic 
purposes is inappropriate. The two issues need to be considered 
separately; otherwise we run the serious risk of sacrificing certain 
great benefits to prevent a perceived undesirable practice.

                                

   Statement of Hon. Sam Brownback, a U.S. Senator from the State of 
                                 Kansas

    Thank you.
    First, I would like to thank in particular, the Chairperson, 
Senator Feinstein for calling this hearing. I have nothing but the 
greatest respect for Senator Feinstein. Senator Feinstein and I have 
recently had the opportunity to work very closely together to begin the 
process of building a health care infrastructure that we hope will 
eventually lead the way in finding a cure for cancer and also to ensure 
that Congress commits the resources to finding that cure.
    No matter what disagreement may exist between the members of this 
committee, those who are here to testify, or the public at large on the 
issue of cloning I do not believe there is any disagreement that we 
must all work hard to find a cure for the diseases that plague 
humanity.
    I look forward to the testimony that is about to be presented.
    The Chairperson and I have very different approaches to the very 
important issue of human cloning.
    As most of you know, I am sponsoring the Human Cloning Prohibition 
Act of 2001 which differs from the Chairperson's bill in several 
important ways. And I am proud to announce today, at this hearing, that 
Senator Mary Landrieu has decided to join me, as the Chief Democrat 
sponsor of my legislation to ban all forms of human cloning.
    Senator Landrieu and I believe it is vital that the Senate fully 
consider this issue. The House of Representatives has spoken, and so 
has the President now the Senate must follow suit.
    The issue of human cloning demands the public's attention, in part, 
because it revolves around the meaning of human dignity and the 
inalienable rights that belong to every person.
    Some will argue that the issue simply needs to be studied before 
any research begins, or that cloning be allowed to proceed in a limited 
fashion such a notion clearly does not respect the new life that is 
created through human cloning.
    Some do not want a permanent ban, as you will hear today they want 
a limited ban on ``reproductive'' cloning but not on so-called 
``therapeutic,'' research or destructive cloning.
    The notion that human cloning can be ``therapeutic'' is both 
misleading and disingenuous.
    ``Therapeutic'' cloning, as some of the proponents of cloning in 
the biotech industry refer to it, is really the process by which an 
embryo is specially created for the directly intended purpose of 
subsequently killing it for its cells. Some proponents of human cloning 
claim that an embryo created in this manner will have cells that are a 
genetic match to the patient being cloned, and thus the cells would not 
be rejected by the patient's immune system.
    But to describe the process of destructive human cloning as 
``therapeutic,'' when the intent is to create a new human life that is 
destined for its destruction, is deeply misleading.
    The act of cloning a human being for the purposes of study, to make 
``designer'' replacement cells is wrong. It makes a child into a piece 
of property. The child's sole purpose in creation is to be destroyed 
for someone else's benefit. This is no way to operate in a civil 
society, especially the United States, which leads the world in human 
rights concerns.
    All human cloning is reproductive in that it creates new human 
life. What is done with that life is what the Feinstein bill mandates 
the Feinstein bill mandates that in most cases that life must be 
destroyed for the benefit of others.
    I do not believe that we should create life just to destroy it yet 
that is exactly what is being proposed by those who support cloning in 
limited circumstances; however they might describe those circumstances 
whether it's nuclear transplantation, ``therapeutic'' cloning, 
therapeutic cellular transfer or whatever the latest euphemism. Cloning 
is wrong, period.
    The bill being sponsored by the Chairperson calls for the creation 
of human embryos for the purposes of their immediate destruction.
    Among the obvious concerns that I have just mentioned, I have other 
concerns, which I hope some of the witnesses today will be able to 
discuss.
    The first is that the Feinstein bill seems to put law enforcement 
in a rather difficult position that of having to police intentions, 
rather than actions in particular, in those cases where actions are 
cloaked under the veil of doctor-patient confidentiality.
    I also have some serious concerns regarding the excessively broad 
nature of the definitions sections which would grant exclusions that I 
believe would lead directly to reproductive cloning.
    Finally, I would like to comments from a story that appeared in New 
Scientist, ``A stem cell has been found in adults that can turn into 
every single tissue in the body. It might turn out to be the most 
important cell ever discovered.
    ``Until now, only stem cells from early embryos were thought to 
have such properties. If the finding is confirmed, it will mean cells 
from your own body could one day be turned into all sorts of perfectly 
matched replacement tissues and even organs.
    ``If so, there would be no need to resort to therapeutic cloning - 
cloning people to get matching stem cells from the resulting embryos. 
Nor would you have to genetically engineer embryonic stem cells (ESCs) 
to create a 'one cell fits all' line that does not trigger immune 
rejection. The discovery of such versatile adult stem cells will also 
fan the debate about whether embryonic stem cell research is 
justified.''
    Science continues to prove that destructive embryonic stem cell 
research and so-called, ``therapeutic cloning'' is unnecessary.
    As this debate continues, we need to constantly examine and re-
examine the scientific facts with a fully-informed moral conscience.
    I hope that we can have a full and healthy exchange on these, and 
related issues, and I welcome the panel of witnesses.

                                

  Statement of Hon. Maria Cantwell, a U.S. Senator from the State of 
                               Washington

    Thank you Madam Chairwoman. I am pleased that you have convened 
this hearing today to give all of us the opportunity to learn more 
about the human cloning debate and its implications for medical 
research.
    Every day in this country we learn of exciting new scientific 
discoveries that hold the promise of dramatically improving both our 
daily lives and future medical treatments. There is no doubt that as 
science advances, our country must continually reevaluate and reaffirm 
the legal and ethical guidelines surrounding these advances. As science 
on cloning and stem cell research develops, some have focused on the 
possibility, however distant, that this new knowledge will lead to the 
creation of human clones.
    Last November's announcement of the privately funded cloning of a 
human embryo for therapeutic purposes by Advanced Cell Technology of 
Worcester, Massachusetts has refocused attention on the ethical 
concerns of this emerging science. Researchers described their work as 
an important step toward producing stem cell as treatments for 
diabetes, heart disease, spinal injuries, and many other ailments. But 
the value of this achievement must be balanced against the ethics of 
the means to achieve it.
    In fact, the scientific community has spoken clearly, and often, 
that the pursuit of human clones is unwarranted and probably beyond our 
current technological or biomedical capabilities. Furthermore, as some 
of today's witnesses will describe, such reproductive cloning is unsafe 
and ultimately likely to fail. But scientists have also made it quite 
clear that there are ethical paths of research into therapeutic cloning 
for legitimate biomedical reasons that we should not close with far-
reaching legislation.
    While I strongly oppose cloning for reproductive purposes, I do 
support therapeutic cloning and believe that imposing absolute 
proscriptions on this research would unnecessarily stop valuable 
biomedical research across the country. Finally, I am especially 
concerned that unilateral bans could be read to prohibit DNA 
replication, which is necessary for important biotechnology research.
    Thank you, Madame Chairwoman for convening this hearing so that we 
can learn more about this issue. I look forward to the testimony of our 
distinguished panelists.

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 Article submitted by Jeffrey P. Kahn, Ph.D., M.P.H., Director, Center 
                 for Bioethics, University of Minnesota

       Printed by CNN--On the path to cloning?--November 26, 2001
 cloning is making its way back into the news, with announcements by a 
     massachusetts biotechnology company, advanced cell technology.
    ACT claims it has created ``normal'' cows through cloning and is 
making public the results of its successful human embryo cloning 
effort--and the ``recipe'' for creating cloned embryos. The company 
says it created the clones for research into how it might produce stem 
cells for therapeutic purposes, and has no intention of allowing any of 
the embryos to be implanted into a woman's womb to create a pregnancy.
    But the announcement of a successfully cloned human embryo, even 
for research purposes, rekindles the fear that cloning identical copies 
of humans cannot be far off. The technical reality is still a distant 
prospect but the successful cloning of embryos is another step along 
the path: What are the appropriate limits on stem cell research and the 
application of cloning technologies?
                therapeutic versus reproductive cloning
    ACTs research focuses on so-called therapeutic cloning, where a 
cloned embryo is made using the DNA of a patient who could benefit from 
a stem cell transplant. The cloned embryo would then be allowed to 
divide only a few times, after which the embryonic stem cells would be 
collected and used to grow genetically- matched tissues or specific 
cell type needed to treat the same patient.
    Cloning embryos for their stem cells is controversial for two 
reasons.
    For many people the intention for which embryos are created is 
critically important in thinking about the ethics of their use. For 
them, using embryos that were creating in fertility clinics--originally 
intended for use in reproduction--is more acceptable than creating 
embryos expressly for the purpose of research. In this view, creating 
embryos expressly for research purposes does not treat them with 
adequate respect. But for others, the moral costs of creating early 
stage embryos exclusively for research purposes are outweighed by the 
promise of significant medical benefits.
    While therapeutic cloning is morally very different from trying to 
create an identical copy of a human through reproductive cloning, the 
newly published techniques used to create the embryos would be exactly 
the same. But instead of collecting stem cells, doctors would place the 
cloned embryo in a woman's uterus in the hope that it would result in a 
pregnancy and the birth of a cloned baby. For some, this implies that 
therapeutic cloning will inevitably lead to reproductive cloning.
                      1stopping the slippery slope
    If we believe that the benefits of therapeutic cloning outweigh its 
moral costs, how can we prevent the same technology being used to clone 
humans? As is the case for many medical technologies, it is not cloning 
techniques that are unethical, but some of their potential 
applications. For example, we reject the transplant of organs from 
executed prisoners, but we don't prevent it by banning, organ 
transplantation. The challenge for stem cell research policies is to 
create appropriate parameters to allow its benefits while preventing 
abuses or unethical applications.
    The Bush administration had an important opportunity to set federal 
policy when it considered whether to allow funding for stem cell 
research, and if so, with what limitations.
    Such decisions often have far-reaching implications--even though 
they technically apply only to publicly funded research, they tend to 
set the standard for practice in both publicly- and privately-funded 
research. By limiting funding to only those cell lines that existed as 
of August 2001, the administration was silent about what rules or 
parameters ought apply to the creation of embryos--whether by in vitro 
fertilization or cloning technologies--leaving a gaping policy vacuum.
    We're long overdue for a reasoned public debate on how far stem 
cell research ought to go, and how to limit the creation of embryos to 
ways that our society deems acceptable.
    If we want to realize the benefits of therapeutic cloning but 
prevent reproductive clones, then we'll have to level serious penalties 
against anyone who allows cloned embryos to develop past a certain 
point, or to be implanted in a woman's uterus. This could include 
everything from harsh fines to long prison sentences, or both.
    There is every reason to think we can distinguish therapeutic from 
reproductive cloning and create policies that make the distinction 
stick. Clearly the science will move forward, but with no obvious 
brakes or steering. A workable policy is key to determining how far we 
go and how fast we get there.

                                

Statement of Coalition for the Advancement of Medical Research Position 
               Statement on Somatic Cell Nuclear Transfer

                       (``Therapeutic Cloning '')
    The Coalition for the Advancement of Medical Research (CAMR) 
supports efforts to prohibit human reproductive cloning while 
protecting important areas of medical research, including stem cell 
research.
    Somatic cell nuclear transfer (SCNT), commonly referred to as 
therapeutic cloning, may prove to be a vital tool in allowing 
scientists to fully develop the promise of stem cell research. SCNT 
involves the use of a donor's unfertilized egg and a patient's own 
cells. The research could allow a patient's own genetic material to be 
used to develop stem cell therapies specifically tailored to that 
individual's medical condition, thus not triggering an immune rejection 
response. In other words, using SCNT could repair patients with their 
own cells.
    Given the scientific potential in this area, CAMR strongly opposes 
any legislative or regulatory action that would ban research related to 
SCNT. This would include criminalizing the research or the researchers, 
and prohibiting the importation of therapies derived from SCNT in other 
countries.
    The Coalition for the Advancement of Medical Research is comprised 
of universities, scientific and academic societies, patients' 
organizations, and other entities that are devoted to supporting stem 
cell research.
       Coalition for The Advancement of Medical Research Members
ALS Association

American Association of Neurological Surgeon/ Congress of Neurological 
Surgeons

American College of Obstetricians and Gynecologists

American Diabetes Association

American Foundation for AIDS Research (AMFAR)

American Infertility Association

American Medical Association

American Pediatric Society

American Society for Cell Biology

American Society for Microbiology

American Society for Reproductive Medicine

American Society of Hematology

Association of American Medical Colleges

Association of American Universities

Association of Medical School Pediatric Department Chairs

Association for Research in Vision and Ophthalmology

Association of Reproductive Health Professionals

Biotechnology Industry Organization

Canavan Research Illinois

Cancer Research Foundation of America

Cedars-Sinai Health System

Children's Neurobiological Solutions

Christopher Reeve Paralysis Foundation

Coalition of Patient Advocates for Skin Disease Research

Columbia University

Duke University Medical Center

Genetic Alliance

Hadassah

Harvard University

International Foundation for Anticancer Drug Discovery (IFADD)

International Longevity Center--USA

Jeffrey Modell Foundation

Johns Hopkins Medicine

Juvenile Diabetes Research Foundation (JDRF)

Steven and Michele Kirsch Foundation

Lymphoma Research Foundation of America

Monash University

National Association for Biomedical Research

National Association of State Universities and Land-Grant Colleges

National Coalition for Cancer Research (NCCR)

National Coalition for Cancer Survivorship

National Council on Spinal Cord Injury

National Health Council

Parents of Infants and Children with Kernicterus (PICK)

Parkinson's Action Network

Project A.L.S.

Research ! America

Resolve: The National Infertility Association

Rett Syndrome Research Foundation

Society for Pediatric Research

Society for Women's Health Research

Stanford University

Tuberous Sclerosis Alliance

University of California System

University of Rochester Medical Center

University of Wisconsin-Madison

Washington University in St. Louis

WiCell Research Institution/ Wisconsin Alumni Research Foundation

Wisconsin Association for Biomedical Research and Education

                                

  Statement of Hon. Richard Durbin, a U.S. Senator from the State of 
                                Illinois

    Madam Chairwomen, I want to thank you for holding this important 
hearing. I rise today to give my support to the Human Cloning 
Prohibition Act sponsored by Senators Feinstein and Kennedy.
    The Feinstein-Kennedy bill specifically addresses a course of 
action we all agree on, namely, prohibiting the use of cloning 
technology specifically for the purpose of creating an embryo for 
implantation in a women's uterus. Further, this bill takes the 
important step of outlining significant civil and criminal penalties 
for those who fail to respect this prohibition.
    I would also however like to address a point on which there is some 
disagreement: the banning of therapeutic cloning in addition to 
reproductive cloning. Unlike reproductive cloning, therapeutic cloning 
or somatic cell nuclear transfer aims not to create an identical and 
complete human being but to create a number of genetically identical 
cells which could become an organ or a tissue that one day would be 
used to treat individuals suffering from disease.
    These genetically identical cells can be thought of as similar in 
some respects to someone donating blood for their own use later on 
except with far more potential. Just as is the case with blood 
transfusions, the risks of rejection or other adverse consequences in a 
transplant scenario with cloned cells are greatly reduced because the 
body recognizes itself.
    While I support therapeutic cloning, I strongly believe that 
vigilant oversight will be critical for preventing the improper use of 
this technology. We have heard the argument that such oversight will be 
impossible and therefore only a complete ban on any and all forms of 
cloning will be able to prevent reproductive cloning.
    That once we accept therapeutic cloning, we will never be able to 
prevent reproductive cloning. This is the slippery slope argument and I 
do not accept it. I believe that society has the ability to recognize 
the differences between the harm of reproductive cloning and the 
benefits of therapeutic cloning and to regulate or ban harmful 
applications while still allowing beneficial applications.
    The Feinstein-Kennedy bill outlines significant criminal and civil 
penalties for violators who attempt to carry out reproductive cloning. 
In spite of this, there may be a few bad actors in the world who will 
attempt reproductive cloning out of greed, desperation, or misguided 
beliefs. They will be brought to justice. However, the existence of a 
total ban on cloning will not stop them anymore than a ban on 
reproductive cloning will stop them. It is the researcher looking for 
novel therapies, the researcher searching for cures and treatments, and 
the patients who stand to benefit from this research who will be most 
affected by a complete cloning ban. It is they who have the most to 
lose.
    As a recent article on the creation of kidney-like organs from 
embryonic stem cells shows, this research holds great promise. With 
continuing research, we may be able to use embryonic stem cells to 
repair injured spinal cords or damaged livers or to grow new kidneys or 
hearts for those desperately awaiting transplants. Not, however, if we 
ban this research.
    As J. Benjamin Younger, Executive Director of the American Society 
for Reproductive Medicine has said: ``We must work together to ensure 
that in our effort to make human cloning illegal, we do not sentence 
millions of people to needless suffering because research and progress 
into their illness cannot proceed.''

                                

 Statement of Hon. Edward M. Kennedy, a U.S. Senator from the State of 
                             Massachusetts

    Thank you, Senator Leahy, for holding today's hearing on cloning, 
and thank you, Senator Feinstein, for your important leadership on this 
issue.
    Today's hearing is about hope--hope for millions of Americans who 
face debilitating and life threatening diseases with no known cure. 
It's about our elderly facing Alzheimer's disease. It's about finding 
the cure for cancer. It's about helping children battle leukemia. It's 
about winning the struggle with diabetes.
    I believe that we should ban human cloning. About that, there 
should be no debate. It's one thing to produce Dolly the sheep. It's 
quite another to produce another human life. Human cloning should be 
illegal.
    But the issue today whether to permit another branch of medical 
science to move forward--and that's nuclear transfer. This procedure 
does not produce a new human being. But it does produce new cells that 
hold great promise for the miracle, life-saving cures of tomorrow.
    Just as it's wrong to permit human cloning, it's also wrong to ban 
nuclear transfer research to cure disease and save human life.
    The National Academy of Sciences says yes to nuclear transfer 
research. The National Bioethics Advisory Commission says yes. Major 
medical societies and patients' groups all say yes as well.
    Senator Feinstein has introduced a straightforward bill that 
clearly prohibits the use of cloning to reproduce a human being, and I 
strongly support her legislation. Senator Harkin and Senator Campbell 
have offered similar proposals. I believe that every Member of the 
Senate opposes the use of cloning to reproduce a human being, and 
Congress should enact legislation to make such a practice illegal.
    Yet there are some who are trying to muddy the waters by labeling 
legitimate medical research as ``cloning''. Medical research involving 
the transfer of DNA from one cell to an unfertilized human egg is not 
cloning. It does not produce a child or a pregnancy or a living human 
being.
    But this essential medical research does bring the precious hope of 
a cure to the millions of Americans like Kris Gulden, who are suffering 
from spinal injuries, severe burns, diabetes, and countless other 
illnesses. Nuclear transfer research can unlock the limitless potential 
of stem cell research. With this research, doctors can make stem cells 
that are a perfect genetic match for a patient's own body. Without the 
research, patients may be condemned to a vicious cycle of tissue 
rejection and the renewed onset of disease.
    We must not allow misplaced fears to extinguish the hope that 
nuclear transfer research brings to patients around the nation. We 
should enact sensible legislation to ban the use of cloning to 
reproduce a human being and not prevent doctors from continuing their 
life-saving research.
    I look forward to the testimony of our witnesses today on this 
Issue.

                                

   Statement of Hon. Patrick Leahy, a U.S. Senator from the State of 
                                Vermont

    Earlier generations had the luxury of speculating about human 
cloning when the idea was merely science fiction. We will not have that 
luxury, now that human cloning has arrived on the threshold of becoming 
science fact.
    This is yet another area in which our scientific knowledge and 
technical prowess are outpacing our law and our social consensus. And 
this is yet another instance in which decisions will be needed if we 
are to keep science our servant and not our master.
    This committee has a role in helping to advise the Senate so that 
the Senate's actions are as informed as possible by the facts and by 
the implications of what we choose to do or not to do. I greatly 
appreciate the willingness of Senator Feinstein to chair this important 
hearing and her leadership on this matter. She, and Senator Kennedy, 
have authored a major bill on this issue which is before this 
committee, along with other bills on the cloning issue such as the one 
introduced by Senator Brownback.
    I have been advised that the Democratic Leader has made a 
commitment to take up this issue on the Senate floor to debate these 
matters.
    We are fortunate that our Committee includes as Members several 
Senators who have devoted considerable thought to these issues--
especially Senator Hatch, Senator Kennedy, Senator Brownback, Senator 
Specter, Senator Feinstein and Senator Schumer. This hearings presents 
a great opportunity for all Members to ask the questions and learn more 
about the complex issues raised in the various bills before the 
Committee.
    Last August Senator Hatch and I had a long discussion during an 
executive meeting about the need for the Committee to hold a hearing on 
the issue of cloning. I agreed, and we decided to schedule it, but the 
events of September 11 and its aftermath have delayed this hearing 
until now.
    We can probably all agree on one point: The religious, medical, 
ethical, privacy, Constitutional and scientif1c aspects of cloning are 
controversial. This necessarily will be a debate infused with human 
values and the suffering and the hopes of our fellow human beings.
    One of my values involved in this debate is my strong belief that 
there is constitutional right to privacy which includes reproductive 
rights.
    On the other hand, a guest column in The New York Times from Jan. 
3?0, entitled the Cloning Conundrum, pointed out that two divided 
Rehnquist Supreme Court decisions raised significant federalism issues 
that could be relevant to this hearing.
    The article argues that in U.S. v. Morrison, which struck down a 
federal civil remedy for victims of gender-motivated violence found in 
the Violence Against Women Act, and in U.S. v. Lopez, which struck down 
a federal criminal law regarding gun-free school zones, Chief Justice 
Rehnquist raised issues which suggests a limit on federal authority to 
criminalize or regulate cloning.
    In addition, as Senator Hatch pointed out in August, many are 
hopeful that so-called therapeutic cloning, done in a manner which 
cannot result in creating a cloned human, could produce cures that 
would save lives and perhaps ameliorate life-threatening medical 
disabilities. For example, many scientists hope that therapeutic 
cloning could lead to cures of Parkinson's Disease, Alzheimer's 
Disease, muscular dystrophy, and Lou Gehrig's Disease, as well as allow 
those with spinal chord injuries to walk again.
    Indeed, related assisted reproductive technologies have already 
aided couples in having children which are genetically related to one, 
or both, parents.
    In the United States, and throughout the world, pharmaceutical 
companies and scientists are attempting to develop these life-saving 
cures and solutions to fertility problems and hope that central 
government regulation will not prevent this medical research from being 
completed. This hearing will explore the various arguments for and 
against therapeutic cloning, and related technologies, and also examine 
other aspects of this important issue.
    We should bear in mind as we further study these issues a comment 
by Albert Einstein who noted that ``the right to search for truth 
implies also a duty: one must not conceal any part of what one has 
recognized to be true.''
    The goal of scientific research is to achieve truth, or to develop 
ever more precise answers, but it has never promised mankind peace, 
happiness or redemption.

                                

          Article in NewScientist.com by Sylvia Pagan Westphal

    A stem cell has been found in adults that can turn into every 
single tissue in the body. It might turn out to be the most important 
cell ever discovered.
    Until now, only stem cells from early embryos were thought to have 
such properties. If the finding is confirmed, it will mean cells from 
your own body could one day be turned into all sorts of perfectly 
matched replacement tissues and even organs.
    If so, there would be no need to resort to therapeutic cloning--
cloning people to get matching stem cells from the resulting embryos. 
Nor would you have to genetically engineer embryonic stem cells (ESCs) 
to create a ``one cell fits all'' line that does not trigger immune 
rejection. The discovery of such versatile adult stem cells will also 
fan the debate about whether embryonic stem cell research is justified.
    ``The work is very exciting,'' says Ihor Lemischka of Princeton 
University. ``They can differentiate into pretty much everything that 
an embryonic stem cell can differentiate into.''
                          Remarkable findings
    The cells were found in the bone marrow of adults by Catherine 
Verfaillie at the University of Minnesota. Extraordinary claims require 
extraordinary proof, and though the team has so far published little, a 
patent application seen by New Scientist shows the team has carried out 
extensive experiments.
    These confirm that the cells--dubbed multipotent adult progenitor 
cells, or MAPCs--have the same potential as ESCs. ``It's very dramatic, 
the kinds of observations [Verfaillie] is reporting,'' says Irving 
Weissman of Stanford University. ``The findings, if reproducible, are 
remarkable.''
    At least two other labs claim to have found similar cells in mice, 
and one biotech company, MorphoGen Pharmaceuticals of San Diego, says 
it has found them in skin and muscle as well as human bone marrow. But 
Verfaillie's team appears to be the first to carry out the key 
experiments needed to back up the claim that these adult stem cells are 
as versatile as ESCs.
    Verfaillie extracted the MAPCs from the bone marrow of mice, rats 
and humans in a series of stages. Cells that do not carry certain 
surface markers, or do not grow under certain conditions, are gradually 
eliminated, leaving a population rich in MAPCs. Verfaillie says her lab 
has reliably isolated the cells from about 70 per cent of the 100 or so 
human volunteers who donated marrow samples.
                           Indefinite growth
    The cells seem to grow indefinitely in culture, like ESCs. Some 
cell lines have been growing for almost two years and have kept their 
characteristics, with no signs of ageing, she says.
    Given the right conditions, MAPCs can turn into a myriad of tissue 
types: muscle, cartilage, bone, liver and different types of neurons 
and brain cells. Crucially, using a technique called retroviral 
marking, Verfaillie has shown that the descendants of a single cell can 
turn into all these different cell types--a key experiment in proving 
that MAPCs are truly versatile.
    Also, Verfaillie's group has done the tests that are perhaps the 
gold standard in assessing a cell's plasticity. She placed single MAPCs 
from humans and mice into very early mouse embryos, when they are just 
a ball of cells. Analyses of mice born after the experiment reveal that 
a single MAPC can contribute to all the body's tissues.
    MAPCs have many of the properties of ESCs, but they are not 
identical. Unlike ESCs, for example, they do not seem to form cancerous 
masses if you inject them into adults. This would obviously be highly 
desirable if confirmed. ``The data looks very good, it's very hard to 
find any flaws,'' says Lemischka. But it still has to be independently 
confirmed by other groups, he adds.
                         Fundamental questions
    Meanwhile, there are some fundamental questions that must be 
answered, experts say. One is whether MAPCs really form functioning 
cells.
    Stem cells that differentiate may express markers characteristic of 
many different cell types, says Freda Miller of McGill University. But 
simply detecting markers for, say, neural tissue does not prove that a 
stem cell really has become a working neuron.
    Verfaillie's findings also raise questions about the nature of stem 
cells. Her team thinks that MAPCs are rare cells present in the bone 
marrow that can be fished out through a series of enriching steps. But 
others think the selection process actually creates the MAPCs.
    ``I don't think there is 'a cell' that is lurking there that can do 
this. I think that Catherine has found a way to produce a cell that can 
behave this way,'' says Neil Theise of New York University Medical 
School.

                                

            Articles in the New York Times, January 19, 2002

                       Two Approaches to Cloning
    The National Academy of Sciences called yesterday for a legally 
enforceable ban on human reproductive cloning aimed at creating a 
child--but strongly endorsed cloning to derive stem cells that hold 
great promise for curing a wide range of human diseases. That is 
precisely the distinction that should be drawn by Congress as it 
wrestles with competing bills that would determine whether and how 
cloning research in this country is permitted to advance.
    The academy's report on human reproductive cloning, when coupled 
with an earlier academy analysis that discussed stem cells derived by 
cloning, offers a sound guide through these contentious issues. 
Unfortunately, President Bush, pandering to religious conservatives, 
opposes cloning for any purpose, whether to produce a child or to cure 
disease. The House has passed a bill that would impose a total ban on 
human cloning and subject any violators to criminal penalties and huge 
civil judgments. The Senate will consider both a total ban and a more 
discriminating bill that would allow therapeutic cloning and simply ban 
reproductive cloning.
    Sadly, there seems little chance that a new bio-ethics council 
appointed by the president will do anything to reverse the 
administration's support of a total ban. That panel held its first 
meetings this week under the leadership of Leon R. Kass, an ethicist on 
leave from the University of Chicago, who has publicly urged that both 
therapeutic and reproductive cloning be banned. He will hardly let his 
1 7-member panel do anything that could embarrass the president or 
change his adamant opposition.
    Indeed, Mr. Kass may have signaled his intentions by opening this 
week's meeting with a discussion of a short story by Nathaniel 
Hawthorne, called ``The Birthmark,'' in which a scientist who marries a 
beautiful woman with a blemish on her cheek inadvertently kills her 
while trying to remove it. That sounded as if Mr. Kass was more intent 
on curbing any perceived excesses of science than in facilitating 
medical advances.
    By contrast, the academy's panel of experts reiterated the 
academy's support for therapeutic cloning to produce stem cells that 
are genetically equivalent to a patient's own cells. Such cloned cells 
could help overcome the tendency of the body's immune system to reject 
stem cell treatments it perceives as ``foreign.''
    But the academy agreed with the president and the House on the need 
to prevent cloning to produce a child. It argued persuasively that 
human reproductive cloning would be dangerous for the woman, the fetus 
and any newborn child, and would probably fail in most cases. The 
academy panel took no stand on whether, if the safety problems can be 
overcome, it would be acceptable to clone a child. That contentious 
issue was left to another day.

                                

    Article by Jack M. Balkin, the New York Times, January 30, 2002

                         The Cloning Conundrum

    NEW HAVEN--Human cloning and hate crimes would seem to have little 
in common. But in a series of shortsighted decisions on the 
constitutional limits of Congressional power, the United States Supreme 
Court has managed to create legal precedents that may make it difficult 
for the federal government to ban cloning as well as hate crimes. This 
will no doubt come as a surprise to opponents of abortion, who oppose 
cloning on a moral basis and have been eager to outlaw it.
    Since the New Deal, Congress has been free to regulate any activity 
so long as it had substantial effects on interstate commerce. In the 
last decade, however, the five-person conservative majority on the 
Rehnquist court has created a set of federalism doctrines forbidding 
Congress from regulating what the court calls ``noneconomic'' 
activities. In order to preserve the boundary between what is national 
and local, the court insists, Congress must keep its hands off 
``traditional'' local subjects like crime and the family.
    Thus in 1995 the court said that Congress could not prohibit guns 
in or near elementary and secondary schools, because this usurped local 
authority to make decisions about what activity should be made 
criminal. It also struck down a federal law that let women sue their 
attackers in federal court. Violence against women isn't economic, the 
court said; it's about crime and families. The new states' rights 
doctrines would also
    undermine any future Congressional effort to pass hate-crime 
legislation. Although hate crimes, like domestic violence, clearly have 
an economic impact, under the court's logic they are defined simply as 
assaults.
    In 1994, many conservatives opposed the passage of the Violence 
Against Women Act because they said it infringed upon states' rights; 
today many make the same argument against federal efforts to outlaw 
other hate crimes or to regulate guns. They have cheered the Supreme 
Court's defense of state prerogatives. Now the tables are turned.
    Conservatives who decry the use of cloning to make humans want the 
federal government to make the practice criminal; last year, the House 
passed a ban on cloning for any reason, including for new medical 
therapies.
    But cloning is both an economic activity and a family-related 
issue. In this case, the lines the court has drawn make no sense.
    In the 2000 campaign, President Bush said he admired conservative 
stalwarts like Justice Antonin Scalia and Justice Clarence Thomas, who 
have championed the new restrictions on Congressional power. Now he may 
understand the pitfalls of getting what you wish for.
    This result is hardly surprising. Support for states' rights has 
often been opportunistic, driven by substantive goals like the defense 
of slavery or opposition to women's suffrage, economic regulation or 
civil rights. The standard defense of federalism is that it preserves 
liberty. But the real issue is what sort of liberty we are trying to 
protect.
    tor years liberals have pointed out that the liberty to lynch 
people wasn't worth preserving. Now conservatives may conclude the same 
thing about the liberty to clone. And if a single state-say Oregon-
explicitly permits cloning, they may find the old arguments for 
decentralization ring hollow.
    Congress can use lawyers' tricks to get around these new federalism 
doctrines. It can withhold federal funds from hospitals that perform 
cloning, or require proof that the doctors or the tools they use have 
moved in interstate commerce. And it's entirely possible that the 
Supreme Court will say that cloning is just different and uphold a 
direct criminal prohibition. But if it does so, it won't be because of 
a principled commitment to federalism. It will be because the justices 
wanted a certain political result and stretched the law to get there, 
as they did in Bush v. Gore.
    But there should be no need for Congress to jump through legalistic 
hoops or for the court to engage in doctrinal duplicity. Cloning is an 
issue of national concern, meriting a national debate. It is irrelevant 
whether it can be classified as ``economic'' or ``noneconomic.'' The 
Supreme Court should scrap its ill-considered doctrines and recognize 
that the national government has the power to make all laws that it 
considers to be in the national interest. Then we can focus on the real 
question of our moral responsibilities in a new and difficult age of 
scientific achievement.
    Jack A! Balkin is a professor at Yale Law School and author, most 
recently, of ``What Brown v. Board of Education Should Have Said."

                                

Article by Steven L. Teitelbaum, FASEB President-Elect, St. Louis Post, 
                            December 3, 2001

                               Commentary

                               BIOETHICS

Therapeutice coloning is designed to help people, not create new ones
    Reports of ``human cloning'' experiments conducted by scientists in 
Massachusetts have generated a flurry of debate and widespread concern, 
but many people are still confused about what cloning is.
    The term ``cloning'' describes a process where by a cell is 
replicated many times producing other identical individual cells. 
``Reproductive cloning'' involves the development of a full individual 
from a single body cell ``Therapeutic cloning'' refers to the 
replication of cells for the purpose of repairing damaged tissue or 
replacing malfunctioning cells.
    In reproductive cloning, the nucleus of an adult cell containing 
the DNA and genetic information of an individual is used to replace the 
nucleus of an egg (ovum) cell, and the product is allowed to develop to 
full term. This is the process by which Ian Wilmut created the sheep 
``Dolly.''
    Human reproductive cloning is neither needed nor desirable. Many 
animal studies have shown that cloning tends to produce less healthy 
individuals. There is no medical condition that needs reproductive 
cloning as its cure. Because it is potentially harmful, morally dubious 
and medically unnecessary, most responsible scientific organizations 
have spoken out against doing reproductive cloning. Only fringe 
elements have supported its development. Reproductive cloning should be 
prevented, by force of law if necessary.
    Therapeutice cloning or the replication of cells for cell-based 
therapies, however, has enormous potential for treating disease. 
Therapeutic cloning is not a reproductive process, as no whole organism 
results. Stem cells, because they can grow into a wide range of cells 
and tissues, are an important result of this process. For that reason, 
scientists have been very excited about new developments in this area.
    One very important source of stem cells is embryos because--at the 
current time--they have the most potential to become other types of 
cells. For many people, the use of human embryos in research is morally 
troubling. For others, it is an acceptable option in the search for 
treatment of such illnesses as severe heart conditions, diabetes, 
Parkinson's disease, Alzheimer's disease and spinal cord trauma.
    President George W. Bush found the narrow terrain between these two 
viewpoints with this compromise position on federal funding of human 
embryonic stem cell research. While advocates of neither viewpoint were 
entirely happy, the compromise allows embryonic stem cell research to 
proceed while scientists explore potential uses of stem cells.
    Before stem cells can become the basis for wide spread therapeutic 
application, however, two major scientific problems must be overcome. 
First, we must learn how to ``coax'' stem cells into becoming the types 
of cells and tissue desired. At the same time, we must figure out ways 
to ensure that a recipient's body does not reject the stem cells, if 
they are transplanted into the patient. Both are significant biological 
and scientific challenges.
    To overcome rejection, some scientists have proposed giving the 
stem cells the DNA code of the patient so the resulting cells will be 
perceived as normal by the patient's immune system. One way to 
accomplish this is to take the nucleus from a cell of a patient, which 
contains his or her DNA, and implant it into an egg cell whose own 
nucleus has been removed. This technique is called somatic cell nuclear 
transfer.
    The highly publicized experiments reported by Advanced Cell 
Technologies Corp. in Massachusetts used SCNT to create clusters of 
cells that would then be used to harvest embryonic stem cells. Reports 
of the Massachusetts experiments have unleashed a torrent of criticism, 
some justified and some misinformed. As we consider what was done, we 
must remain cognizant of the fact that they were not cloning human 
beings. Equally important is that their results were to preliminary to 
be claimed as evidence of the production of embryonic stem cells, a 
crucial step in developing cures for many diseases.
    The nation's largest organization of medical researchers, the 
Federation of American Societies for Experimental Biology, is strongly 
opposed to reproductive human cloning, but supports the use of 
therapeutic cloning techniques to produce molecules and cells for 
research and therapeutic use. We fear that hastily crafted legislation 
will prevent these important therapeutic uses of cloning technology and 
block essential biomedical research.
    Research on the most effective and useful ways to derive stem cells 
must continue and should be given federal support so that it can be 
conducted in the open at the nation's leading medical research 
institutions within guidelines established by the National Institutes 
of Health.

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                                    University of Minnesota
                                      Minneapolis, MN 55455
                                                   February 4, 2002

Senator Dianne Feinstein
SH-331 Hart Senate Office Bldg.
Washington, DC 20510

    Subject Stem Cell Research

    Dear Senator Dianne Feinstein:
    In light of recent discussions in the press on work done in the 
Stem Cell Institute at the University of Minnesota, I would, as 
director of like University of Minnesota's Stem Cell Institute, like to 
clarifyour position on our research and its potential as we know it 
today.
    First, as was discussed in the press last week, it is correct that 
we have found adult stem cells in bone marrow of humans as well as mice 
or rats, rats, great growth potential and great versatility, much like 
we've have seen in embryonic stem cells. Parts of these studies have 
been published, and partsare currently being peer-reviewed. That said, 
it is far too early to say whether they will stack up when compared to 
embryonic stem cells in longevity and function. Further, we will not 
know which stem cells, adult or embryonic, are most useful in treating 
a particular disease without side by side comparison of adult and 
embryonic stem cells.
    Second, we support studies aimed at developing techniques for 
therapeutic cloning, i.e. cloning of human embryonic stem cell lines, 
because they may provide immune compatible cells to treat a number of 
diseases, and because cloning of embryonic stem cell lines may be 
critical to the study of adult onset diseases, caused by for instance, 
mutations in the DNA of cells after birth. This does not mean that the 
University of Minnesota's Stem Cell Institute supports reproductive 
cloning.
    Finally, I want to emphasize our belief that stem cell research 
should be done in public, federally funded institutions, such as the 
University of Minnesota. It is in these institutions that the public 
and policymakers can be assured effective and thorough oversight of the 
research and the protocols being explored. While we are excited by our 
adult stem cell findings, it is not our intention to stop here. There 
are still too many unknowns for researchers or policymakers to begin 
closing doors to opportunities of learning.
    I appreciate your attention to these issues and remain at your 
disposal should you have any questions about our research.
            Sincerely,

                                 Catherine Verfaillie, M.D.
            Professor of Medicine and Director, Stem Cell Institure
                                            University of Minnesota

                                

           Editorial in the Washingon Post, January 22, 2002

                        How to Approach Cloning
    AS THE SENATE prepares to plunge anew into the human cloning 
debate, the range of voices in that debate is growing broader. The 
president's new council on bioethics held the first of a projected five 
or six meetings last week designed to produce a report on the topic by 
summer. At the same time, the National Academy of Sciences issued a 
report urging that any attempt to clone an actual human baby be banned 
on safety grounds, but that promising disease research involving the 
cloning of human embryonic cells be allowed to go forward. Meanwhile, 
state legislatures are beginning their own debates. A California panel 
echoed the NAS approach, recommending that the state legislature ban 
human cloning for reproduction but not research. A Florida lawmaker has 
filed a bill that would allow a cloned child to sue the scientist who 
cloned him for parental support and emotional damages.
    The ferment of different approaches could help shed light on the 
central dilemma confronting the U.S. Senate, which is whether to back 
the sweeping ban on all human cloning passed by the House--one that 
would levy harsh criminal penalties on any scientist who cloned a human 
embryo, whatever the purpose, and stop all such research in its 
tracks--or whether to craft a more limited ban that would focus on 
preventing the implantation, gestation or birth of a cloned baby. We 
favor the latter approach. To the prohibition of birthing human clones 
there appears to be little credible opposition. As the academy report 
makes clear, risks to both the cloned fetus and its mother put human 
cloning outside the pale of ethical scientific experimentation barring 
significant further breakthroughs.
    The safety issue makes it proper to ban bringing human clones to 
birth without reaching the knottier ethical questions of whether 
duplicating human genomes transgresses fundamental social values. 
That's more difficult with the sweeping research ban, but proponents 
have likewise offered some practical arguments: Some, among them 
bioethics council chair Leon Kass, have argued that banning the 
creation of cloned embryos for research is the only sure way to avoid 
their implantation in a human womb. Others (including Mr. Kass in other 
contexts) stress the importance of respecting even several-cell forms 
of human life.
    In contrast to the respect-for-life question, the assertion that 
adequate safeguards cannot be drawn to separate research and 
implantation can be challenged and debated on practical and factual 
grounds. Mr. Kass's first council meeting seemed determined to hew to a 
high philosophical line of thought, weighing literature, love and 
ethical boundaries--urged to it by the president, who launched them 
with an exhortation to help clarify ``how to come to grips with how 
medicine and science interface with. . .the notion that life is--you 
know, that there is a Creator.'' But the Senate should take a less 
ambitious approach. Seeking to speak for Americans from all walks of 
life on such ultimately religious matters is a daunting and not 
necessarily advisable task for a legislative body. The Senate debate 
ought to address the pragmatic details of how best to prevent the 
dangerous experimental prospect of human-clone pregnancies and births. 
But it should leave scientists free to work on the experiments that 
offer others great hope.

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