[House Hearing, 107 Congress]
[From the U.S. Government Printing Office]





                ISSUES RAISED BY HUMAN CLONING RESEARCH

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

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 28, 2001

                               __________

                            Serial No. 107-5

                               __________

       Printed for the use of the Committee on Energy and Commerce


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house

                               __________

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                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio                RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania     EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California          FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma              BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa                    ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia             BART STUPAK, Michigan
BARBARA CUBIN, Wyoming               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               TOM SAWYER, Ohio
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING,          KAREN McCARTHY, Missouri
Mississippi                          TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia                  BILL LUTHER, Minnesota
ED BRYANT, Tennessee                 LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland     MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana                 CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California        JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska

                  David V. Marventano, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

              Subcommittee on Oversight and Investigations

               JAMES C. GREENWOOD, Pennsylvania, Chairman

MICHAEL BILIRAKIS, Florida           PETER DEUTSCH, Florida
CLIFF STEARNS, Florida               BART STUPAK, Michigan
PAUL E. GILLMOR, Ohio                TED STRICKLAND, Ohio
STEVE LARGENT, Oklahoma              DIANA DeGETTE, Colorado
RICHARD BURR, North Carolina         CHRISTOPHER JOHN, Louisiana
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
  Vice Chairman                      JOHN D. DINGELL, Michigan,
CHARLES F. BASS, New Hampshire         (Ex Officio)
W.J. ``BILLY'' TAUZIN, Louisiana
  (Ex Officio)

                                  (ii)


                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Boisselier, Brigitte, Scientific Director, Clonaid...........    52
    Cameron, Nigel M. de S., Principal, Strategic Futures Group..   103
    Caplan, Arthur L., Director, Center of Bioethics, University 
      of Pennsylvania............................................    95
    Eibert, Mark D., the Law Offices of Mark Eibert..............   107
    Hanson, Jayde, Assistant General Secretary, General Board of 
      Church and Society, the United Methodist Church............   129
    Jaenisch, Rudolph, Professor of Biology, Massachusetts 
      Institute of Technology....................................    44
    Murray, Thomas H., National Bioethics Advisory Commission....    81
    Okarma, Thomas B., President and CEO, Geron Corporation......    34
    Pence, Gregory, Professor of Philosophy, School of Medicine 
      and Humanities, University of Alabama at Birmingham........   100
    Rael, Leader, Raelian Movement...............................   132
    Soules, Michael R., President, American Society of 
      Reproductive Medicine......................................   120
    Terry, Sharon F., Genetics Alliance, Inc.....................   118
    Westhusin, Mark E., Associate Professor, Texas A&M 
      University, College of Veterinary Medicine.................    38
    Wicker, Randolfe H., Founder, Clone Rights United Front, 
      spokesman for the Human Cloning Foundation.................   124
    Zavos, Panos Michael, Founder, Director and Chief 
      Andrologist, Andrology Institute of America................    47
    Zoon, Kathryn C., Director, Center for Biologics Evaluation 
      and Research, Food and Drug Administration.................    78
Material submitted for the record by:
    Best, Robert A., President, Culture of Life Institute, 
      prepared statement of......................................   145
    Mitchell, C. Ben, prepared statement of......................   148

                                 (iii)

  

 
                ISSUES RAISED BY HUMAN CLONING RESEARCH

                              ----------                              


                       WEDNESDAY, MARCH 28, 2001

                  House of Representatives,
                  Committee on Energy and Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10 a.m., in 
room 2123, Rayburn House Office Building, James C. Greenwood 
(chairman) presiding.
    Members present: Representatives Greenwood, Stearns, 
Largent, Burr, Whitfield, Bass, Tauzin (ex officio), Deutsch, 
Strickland, DeGette, John, and Rush.
    Staff present: Alan Slobodin, majority counsel; Julie 
Corcoran, majority counsel; Ray Shepherd, majority counsel; 
Robert Simison, professional staff member; Chris Knaur, 
minority investigator; and John Ford, minority counsel.
    Mr. Greenwood. All right, the hearing before the Oversight 
and Investigations Subcommittee will now come to order. We 
thank the witnesses for their indulgence and the Chair 
recognizes himself for 5 minutes for the purposes of an opening 
statement.
    Nearly 80 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 replaced mothers and fathers. The words 
themselves considered smut.
    As the new authors of human life in an uncompromising 
search for human happiness and stability, the possibility of 
human individuality had been entirely jettisoned. For most of 
its 80 years, Brave New World could be seen as a disturbing 
work of science fiction. That is no longer the case. The 
possible cloning of human beings is now relegated to the 
world--not relegated to the world of fiction. The question we 
must now ask is this: what should we do with this science? That 
is what brings us here today.
    Several scientists claim that they are poised to take the 
fateful next step and actually produce a human clone. We in 
this subcommittee will focus not only on the scientific, but on 
the moral and ethical questions raised by the astonishing 
possibility that an exact copy of a human being might be cloned 
in the near future.
    What then is cloning? The World Book Encyclopedia describes 
cloning as a process that involves ``destroying the nucleus of 
an egg cell of the species to be cloned. The nucleus is then 
removed from a body cell of an animal of the same species. This 
donor nucleus is injected into the egg cell. The egg, with its 
new nucleus, develops into an animal that has the same genetic 
makeup as the donor.''
    Just 4 years ago, the Scottish researcher Ian Wilmot and 
his colleagues, announced that they had successfully cloned a 
lamb they called Dolly from a single cell of an adult sheep. 
Since then various other mammals have been cloned. Recently, 
however, two groups of scientists have announced their 
intention to manufacture the first human clone. One group, the 
Raelians, a Canadian-based religious cult, announced late last 
year that it had found an American couple willing to pay 
$500,000 to clone their deceased child. The Raelians claim to 
be conducting experiments in a laboratory in the United States. 
Several publications including Wired Magazine and the New York 
Times, have published in-depth stories which take the Raelians 
announcement quite seriously.
    The other group, an international consortium of scientists 
led by Dr. Panos Zavos, a reproduction researcher, and his 
partner, Severino Antinori, an Italian fertility doctor, have 
stated their intent to develop clones for infertile couples. In 
January of this year, Dr. Zavos' group announced that within 2 
years it intends to clone the first human being at a site 
outside the United States.
    Capitalizing on the fascination with human cloning, other 
groups have established websites offering cloning services. We 
have a demonstration of that.
    Although federally funded human cloning research is 
prohibited, such privately funded research is not. In fact, no 
definitive Federal statute governs privately funded human 
cloning experiments. Experimentation in science has outpaced 
the law on the underlying issues raised by human cloning.
    As one of our witnesses, Dr. Arthur Caplan recently put it, 
``the science horse ran out of the barn, jumped over the fence 
and has gone down the highway and the law is still hanging 
around the barn.''
    The FDA has asserted that it has jurisdiction over human 
cloning, based on the Public Health Service Act and the Food, 
Drug and Cosmetic Act. Is this a sufficient safeguard?
    Although there is no Federal ban on human cloning, a number 
of states, 26 other countries and the United Nations have seen 
the need to enact some form of ban on human cloning. But to 
craft a meaningful and reasonable statute that is both sound in 
its science and consistent with human dignity, the Congress 
needs to ask the hard questions posed by human cloning 
research.
    The technique to clone other mammals has proved difficult 
and dangerous. Before scientists successfully produced Dolly, 
there were 276 failures. Last week, my staff and I met with Dr. 
Simon Best, a member of the Dolly research team. Extrapolating 
from its results, he told us the data suggests that it might 
take a thousand surrogate mothers to successfully clone a human 
being at the cost of 990 miscarriages, still births and infants 
born with serious and unpredictable birth defects.
    The rate of failure in animal cloning should serve as a 
fire bell in the night. Behind the headlines of apparent 
success in animal cloning lies a failure rate as high as 95 to 
97 percent.
    Would human cloning lessen the worth of individuals and 
diminish respect for human life by turning procreation into a 
manufacturing process?
    Is there a bright line between the joining of a man and a 
woman's reproductive cells and the replication of just one 
person's genetic material?
    Is the one creation and the other mere construction?
    The Christian philosopher G.K. Chesterton wrote, ``The 
whole difference between construction and creation is exactly 
this, that a thing constructed can only be loved after it is 
constructed, but a thing created is loved before it exists.''
    We also, in fairness, need to listen to the arguments in 
favor of human cloning. There are those who argue that 
reproductive freedom includes human cloning, perhaps as a means 
to address the problem of male infertility. Others advocate 
cloning as a means to replicate a deceased loved one. For yet 
others, human cloning is justified because it may provide 
important advances in scientific knowledge.
    In examining these arguments, I believe we must exercise a 
substantial degree of healthy skepticism and we would do well, 
I think, to keep in mind the powerful message contained in the 
simple saying that hung in Albert Einstein's office at 
Princeton, ``Not everything that counts can be counted and not 
everything that can be counted counts.''
    This committee has a responsibility to ask these difficult 
questions because we are dealing with the most profound of 
human responsibilities, the future of our species.
    The witnesses we have assembled represent a broad cross 
section of opinions and expertise on these complex issues. We 
will hear from experts in animal cloning research and 
bioethics, the FDA and the National Bioethics Advisory 
Commission, among others. The NIH, National Institutes of 
Health was invited to participate in this hearing, but 
deferred, owing to a lack of expertise in this area.
    We will also hear from controversial witnesses. We hope to 
learn from their testimony whether the projects they envision 
are credible scientifically.
    Other esteemed bodies can hold meetings and write reports 
and issue voluntary guidelines, but only the Congress can write 
the laws for our nation. It is said that Huxley borrowed the 
title for his book from these lines found in Act V of 
Shakespeare's play The Tempest: ``Oh brave new world that has 
such people in it.'' And he compounded the irony by envisioning 
a world in which Shakespeare himself was outlawed. In fact, 
when one of the characters asks, ``But why is it prohibited?'' 
he is told ``because it is old. That's the chief reason. We 
haven't any use for old things here.'' ``Even when they are 
beautiful?'' he then asks. ``Particularly when they are 
beautiful'' comes the reply.
    But if we are wise, before we open the floodgates to a new 
kind of human being, we might recall the lines in The Tempest 
that preceded the ones Huxley used in his title. ``How many 
goodly creatures are there here? How beauteous is mankind.'' I 
want to express my appreciation to the subcommittee ranking 
minority Congressman Peter Deutsch for working with me on this 
hearing. I'm also grateful to the full committee Chairman Billy 
Tauzin for his support of this hearing. I thank all of the 
witnesses for participating in this hearing and I look forward 
to their testimony.
    I recognize the ranking member, Mr Deutsch for 5 minutes 
for an opening statement.
    Mr. Deutsch. Thank you, Mr. Chairman. I have a statement 
that I'd like to submit for the record. I'm anxious to hear the 
witnesses' testimony.
    Mr. Greenwood. Without objection.
    Mr. Deutsch. And I'll just maybe summarize a couple of 
points. One is I think it's important that we're having this 
hearing, obviously. I appreciate the chairman's work in setting 
this up and his staff work as well.
    I would make one comment that as you are well aware, no one 
from NIH is here today and I find that lacking in the sense 
that the Nation's premiere health organization is not here, but 
hopefully if we follow up in additional hearings that's 
something that we can basically rectify.
    I also believe that it's imperative that we go about our 
work in this important matter in a manner that does not curtail 
or chill research in other fields and I know that the 
biotechnology industry is concerned about this and I'm glad 
that they're here today.
    As you know, there are some tremendously important fields 
that are not human cloning. These fields are recombinant 
technology that hold out the hope for prevention, treatment and 
cure for a host of diseases and conditions. These include 
Parkinson's, diabetes, Alzheimer's, leukemia and other cancers, 
heart disease, liver failure and many others. Anything that we 
do in the name of prohibiting the cloning of humans should not 
delay or deny the important work that is being done with stem 
cells and related fields of science.
    Finally, I would also mention that if we are talking about 
the FDA itself being the agency that theoretically would be 
enforcing the ban that arguably exists, there's a question 
about not providing additional resources to the FDA we're 
talking about providing additional responsibilities and in 
terms of the President's budget, there's no acknowledgement of 
this additional research or this additional enforcement by the 
FDA. And I think that's a real concern I have.
    But finally, and really in a sense, I have spent time 
reading through testimony, reading through projects and I would 
say to you and I think it's important to say even at the start 
of this hearing that I agree with you completely, that it is 
our job to legislate and we are the only entity able to 
legislate and I think it is imperative, in fact, that we make 
clear that human cloning is not legally acceptable in the 
United States of America. And I look forward to working with 
you to create legislation that would, in fact, do that, 
balancing the concerns that I think both of us share not to 
interfere with some of the incredibly significant research that 
can be done regarding other issues here. And I believe that we 
will be able to craft legislation to that effect and I yield 
back the balance of my time.
    Mr. Greenwood. The Chair thanks the gentleman and 
recognizes the chairman of the full committee, Mr. Tauzin.
    Chairman Tauzin. Thank you, Mr. Chairman, let me first 
congratulate and salute you, Mr. Chairman, Congressman James 
Greenwood for holding this hearing and for shining the light on 
this issue of great public concern, that of human cloning.
    This hearing is a great example of how Congress, especially 
the House of Representatives, serves as both a voice and a fact 
finder for the American people.
    As you saw in the film, a religious sect called the Raelian 
Movement and an international group of scientists have recently 
announced their intent to conduct experiments on human beings 
to create a cloned baby. As far as we can tell, one of these 
experiments has already started and both are being conducted 
outside the scrutiny of government regulatory bodies and 
institutional review boards.
    The issue of human cloning and these announced experiments 
raise scientific, medical, ethical, moral and ultimately policy 
questions that we as a country must confront. Cloning may 
literally threaten the character of our human nature. We are 
all imperfect beings as we often find out. All of us. And that 
requires us to learn and develop certain traits such as 
forgiveness and understanding and love and character. How is 
all that threatened when we produce perfect human beings 
through this cloning technology?
    Other institutions can issue reports and hold hearings and 
announce voluntary policy, but only the Congress, particularly 
through this committee can write the laws that could regulate 
or even ban the cloning of human beings. This oversight hearing 
can be the start for an honest appraisal of the science behind 
human cloning, a fair inquiry to hear from the parties 
themselves on how they plan to conduct their human cloning 
experiments and a thoughtful discussion of the issues.
    While we all should withhold judgment on whatever 
legislation may come forward, I personally feel there are 
problems with human cloning from a safety, legal, and ethical 
standpoint. I believe the burden is going to be on the 
proponents of human cloning to make the moral and scientific 
case for these experiments. The question is why do we need 
human cloning?
    This hearing must also address whether current Federal law 
and regulation is adequate for monitoring human cloning 
experiments. The Food and Drug Administration has asserted its 
authority over human cloning intended to create a human being 
and we support the FDA and want to assist them in the 
considerable skills they have in overseeing the matter. 
However, the jurisdictional claim of the FDA may suffer from 
being a square peg in a round hole.
    FDA says it can regulate human cloning because the agency 
has interpreted old Federal laws to cover new cloning 
activities. The FDA argues that old Federal laws regulating new 
drugs cover a human cell or human fetus. I frankly do not find 
it obvious that a human fetus is a drug. And while a court may 
find this argument facially plausible, I would not want to rely 
upon the single reed of Federal regulation to address 
experiments intended to create a baby from cloning technology.
    In addition, FDA's authority is based only on safety 
concerns, not on ethical or moral concerns. This leaves open 
the question of whether FDA would permit the cloning of human 
beings, if it became satisfied that it was safe. And since FDA 
generally does not have the authority to ban cloning on moral 
and ethical grounds, we should all be concerned that 1 day the 
FDA may simply approve the process on a safety basis.
    Congress may need to pass legislation to ban human cloning 
or take other actions to firm up FDA's policies or grant 
enforcement authority to another agency. We will deliberate 
carefully and thoughtfully. We'll hear some very distinguished 
scientists and ethicists today. We'll also have controversial 
witnesses, including those from the Raelian Movement. The 
media, including Time Magazine and the TV show 60 Minutes, as 
you saw, covered the Raelians' announced efforts to clone a 
human being. If the Raelians are to be believed, they are only 
weeks away from implanting a human embryo into a surrogate 
mother. Through this hearing, the public will hopefully learn 
whether the Raelian experiment is a hoax or whether as Time 
Magazine reported, ``this group may even be further along in 
human cloning than the competition.''
    If the facts and the consensus emerge to support 
legislation to ban the cloning experiments intended to make 
babies, we are going to have to be prepared to act. I will work 
with Chairman Greenwood and every member of the committee, 
Democrats and Republicans to legislate on a good bill. I 
welcome the witnesses and look forward to their testimony and I 
thank again the chairman for this very important hearing.
    Mr. Greenwood. The Chair thanks the chairman of the full 
committee and yields 3 minutes to the gentle lady, Ms. DeGette, 
for her opening statement.
    Ms. DeGette. Thank you, Mr. Chairman. The questions posed 
by human cloning span the range of legal, ethical and medical 
frontiers. Who is responsible for a wrongful birth or an 
abnormal human being born as the result of the cloning 
procedure, the parent, the cloners or the physician who 
supervises the pregnancy? Can a dead person be cloned without 
giving pre-death consent? Can a loved one clone a relative in a 
coma without consent, and if so, who is responsible for the 
complications that may arise out of the procedure?
    As the science and medical communities continue to make 
incredible strides in the areas of genetic discovery as 
recently occurred with the mapping of the human genome, it's of 
paramount importance that we carefully examine the issues 
surrounding human reproductive cloning.
    As we've heard, human cloning will receive a lukewarm at 
best reception today in this committee. However, the complexity 
of the issues, moral, scientific and ethical argues for a 
thoughtful and complete discussion of the issue before we pass 
legislation.
    This analysis must examine the impact any new legislation 
would have on work currently underway by scientists across the 
globe whose goal is to further medical therapies to eradicate 
disease. To be clear, these two types of research are very 
different.
    As co-chair of the Congressional Diabetes Caucus, I'm a 
strong advocate of medical research as the prevention and 
treatment of many diseases have been achieved through 
university, private sector and government-funded research. In 
particular, I'm interested in the advancement of research in 
the areas of stem cell therapy and cell therapy and beta cell 
development as one means of further reducing or eliminating 
dependence on insulin for Type 1 diabetes. This research not 
only has implications for diabetes, but may provide profound 
breakthroughs for the millions of people affected by genetic 
diseases such as sickle cell anemia, Parkinson's, Cystic 
Fibrosis and Alzheimer's Disease.
    A concern for people involved in medical research has also 
led me to introduce the Human Subject Protections Act which 
would, of course, apply to anyone involved in private research 
on human cloning and I intend to reintroduce this bill soon in 
the 107th. I hope I can count on co-sponsorship from the 
chairman and many members of this committee.
    Over the years, clinical research has become increasingly 
complex. Human cloning adds to the complexity. Before any 
humans are cloned in the United States, I know we all want to 
ensure the ramifications of this project are fully known and 
that all medical and research guidelines and safeguards have 
been carefully followed.
    Most scientists, however, tell us that today neither animal 
nor human reproductive cloning can be done safely, 
efficaciously, reliably or frankly, morally. We cannot and 
should not proceed without those safeguards.
    Mr. Chairman, I look forward to hearing from the witnesses 
today and learning more about human cloning, including whether 
really cloning is on the horizon or if it's just a lot of talk.
    I'd like to hear the process and the legal and regulatory 
issues surrounding it and with that, I yield back the balance 
of my time.
    Mr. Greenwood. The Chair thanks the lady for her statement 
and recognizes the vice chairman of the subcommittee, the 
gentleman from Kentucky, Mr. Whitfield for 3 minutes for his 
opening remarks.
    Mr. Whitfield. Thank you very much, Mr. Chairman. In 
preparation for this hearing I went back to 1998 and read the 
transcript of the hearing we held at that time on this very 
subject matter, even though it was not the Oversight Committee 
and in reading that material I came across a statement from 
Cardinal William Keeler, Archbishop of Baltimore, and I might 
add that I'm certainly not a member of the Catholic faith, but 
I thought he touched on some very important issues that we need 
to think about as we proceed in the discussion of this 
important issue.
    He stated that ``cloning is presented as a means for 
creating life, not destroying life. Yet it shows disrespect 
toward human life and the very act of generating it. Cloning 
completely divorces human reproduction from the context of a 
loving union between man and woman, producing children with no 
parents in the ordinary sense. Here, human life does not arise 
from an act of love, but is manufactured to predetermined 
specifications. A developing human being is treated as an 
object, not as an individual with his or her own identity and 
rights.''
    I don't think there is any subject that this Congress can 
be taking up that is more important than this issue and the 
many complex aspects to it.
    I know we have a distinguished panel of witnesses today, 
three panels, and while I find myself agreeing with the 
Cardinal's testimony in 1998, I am still approaching this with 
an open mind and do look forward to the testimony here today. I 
yield back the balance of my time.
    Mr. Greenwood. The chairman thanks the gentleman for his 
opening remarks and recognizes the gentleman from Illinois, Mr. 
Rush for 3 minutes for his opening remarks.
    Mr. Rush. Thank you, Mr. Chairman. Mr. Chairman, I want to 
commend you and thank you for holding this hearing on this 
very, very important and critical issue. I do have some 
statements that I will enter into the record at a later date 
and I'll attempt to summarize my position right now.
    With the Scottish scientist Ian Wilmot's cloning of an 
adult sheep, Dolly, in February 1997, we all knew that it only 
was a matter of time before attempts would be made to clone a 
human. I am indeed an ordained Baptist minister and based on my 
calling, my personal, moral and religious views, I know that 
human cloning raises serious ethical, religious and moral 
concerns. However, as the co-chair of the House Biotech Caucus, 
I'm well aware of the amazing advances science and technology 
have made in both the medical and agricultural fields to 
prolong and improve the quality of human life.
    As an African-American, I'm keenly aware of racist 
prejudices and biases. The expansion of science can never be an 
end unto itself. The expansion of science must be viewed in the 
light of the agenda of those who espouse it and the impact it 
has on our public, on our way of life and on our God.
    Efficacy is also a major concern. Even if we simply view 
cloning from a purely scientific perspective, devoid of moral 
considerations, there are major problems. Many prominent 
scientists have reported that cloning has resulted in 
development delays, heart defects, lung problems and 
malfunctioning immune systems in mammals. Also, the errors 
created by a cloning are random and may not surface, indeed, 
until the cloned individual is much older, later in the cloned 
individual's life.
    Thus, until long term research is done on cloning, we will 
not know the impact of cloning as cloned species age. The FDA 
would not release a drug for human consumption which causes 
major birth defects in lab animals and could therefore harm 
humans. Based on this same logic, cloning should not be 
considered for humans, not now, and never in the future. The 
danger of cloning as a public health concern reaches beyond the 
cloned infant. The physical and genetic abnormalities of a 
cloned infant poses serious threats to all concerned, 
particularly a surrogate mother.
    While it is clear that there are serious problems with 
human cloning due to moral and public health concerns, I don't 
think that prudence is warranted. As noted, science and the 
biotech field has brought us great successes. We must not take 
action which will impede the legitimate and safe use of 
biotechnology. Many argue that Congress is slow to act or react 
to changes in science and technology. However, I would argue 
that we must act with caution to ensure that future scientific 
successes which will make this world healthier and more 
productive while tightly regulating and indeed banning those 
practices which pose a clear threat to the health, the safety 
and the moral condition of our citizens. Human cloning must be 
banned now and forever.
    Thank you and I yield back the balance of my time.
    Mr. Greenwood. The Chair thanks the gentleman for his 
statement and recognizes for 3 minutes the gentleman from 
Florida, Mr. Stearns for his opening statement.
    Mr. Stearns. Thank you, Mr. Chairman. No mother, no father, 
no parents, no family. That's what will happen if we allow 
human cloning. Human cloning is a form of playing God, since it 
intervenes with the natural order of creation. We have reached 
that point in our human history where human cloning is an 
unethical use of technology. Ever since the world was made 
aware of Dolly, and the infamous Dr. Seed and the possibility 
of cloning human beings, significant actions have been taken to 
outlaw this practice.
    Mr. Chairman, in the 105th and 106th Congresses, I 
introduced legislation to prohibit the expenditure of Federal 
funds to conduct or support research on the cloning of humans 
and to express the sense of Congress that other countries 
should establish substantially equivalent restrictions.
    Even though the President called for a ban on the use of 
Federal funds for research on cloning of human beings, I 
believe legislation to ban Federal funding of research on human 
cloning is still necessary. Let me explain why.
    Currently, in the United States, four states prohibit 
cloning and eight more States have legislation pending to ban 
human cloning. But let's take a look at the California law for 
a moment. It imposes a 5-year moratorium on cloning of an 
entire human being. The word ``entire'' is key because some of 
us consider an embryo to be a human being. That is why we must 
be very cautious in the terminology that is used because you 
will hear the words ``entire human'' being used frequently in 
debates about cloning. That is just one of many problems 
associated with technology that may be used to clone humans.
    I would like to share with my colleagues what Lori B. 
Andrews who teaches the legal aspects of genetics at Chicago 
Kent College has to say about the bans on human cloning. She 
has analyzed the bans under consideration in 20 states. Here's 
what she has to say. ``Once again, technology may be running 
circles around the law. At least seven States ban and prohibit 
transferring the nucleus from a human cell into a human egg, 
but that doesn't address the possibility of transferring a 
human nucleus into a non-human egg.''
    There are many issues raised by the possibility of cloning 
humans. There are lots of risk as my colleagues have talked 
about. Of the 273 tries to develop Dolly, 272 were failed, 
either aborted, destroyed or maimed. Obviously, we cannot go 
down that line.
    There are also compelling and serious ethical and moral 
implications involved with cloning of humans. Theologians have 
raised three broad objections. Cloning humans could lead to a 
new eugenics movement where even if cloning begins with a 
benign purpose, it could lead to the establishment of 
scientific categories of superior and inferior people. Cloning 
is a form of playing God since it interferes with the natural 
order of creation. Cloning could have long-term effects that 
are unknown and harmful. People have a right to their own 
identity and their own genetic makeup which should not be 
replicated.
    So Mr. Chairman, I look forward to this hearing. We have a 
lot to learn and also the Food and Drug Administration's role 
is something we should explore. Also, Mr. Chairman, by 
unanimous consent, I'd like to place the testimony of Attorney 
Clark D. Forsythe who is President of Americans United for Life 
in the record. Mr. Forsythe's testimony discusses the 
constitutional issues related to cloning of human beings which 
is an important part of the debate surrounding this complex 
subject.
    Mr. Greenwood. Without objection, the testimony so 
referenced will be included in the record.
    [The prepared statement of Clarke D. Forsythe follows:]
         Prepared Statement of Clarke D. Forsythe 1
---------------------------------------------------------------------------
    \1\ B.A. Allegheny College (1980); J.D., Valparaiso University 
(1983); President, Americans United for Life (AUL). Copies of two of my 
professional articles have been submitted to the Subcommittee: Clarke 
D. Forsythe, Human Cloning and the Constitution, 32 Val. U.L. Rev. 469 
(1998); Clarke D. Forsythe, Homicide of the Unborn Child: The Born 
Alive Rule and Other Legal Anachronisms, 21 Val. U.L. Rev. 563 (1987).
---------------------------------------------------------------------------

                           EXECUTIVE SUMMARY

    Substantive due process does not restrict governmental prohibitions 
on human cloning. There is no constitutionally-protected right to non-
coital, asexual reproduction. This is due to (1) the demonstrated 
authority of the state and federal governments to protect human life at 
every stage of development, (2) the limits of substantive due process, 
and (3) the compelling interests in prohibiting human cloning, which 
are addressed in order below.
    The history of legal protection of developing human life is 
important because it shapes substantive due process, informs the limits 
of Roe v. Wade, 410 U.S. 113 (1973), and undergirds protection for the 
developing human being in non-abortion circumstances today. 
Governmental authority to protect human life at every stage of 
development is deeply rooted in English and American history, and--at 
least outside the context of abortion--is broadly and increasingly 
exercised today. Throughout American history, legal protection of human 
life has grown as medical knowledge has grown. State protection of 
human life at every stage of development has grown in criminal law and 
civil (tort) law throughout the 20th century. In particular, at least 
38 states have affirmed, as a matter of public policy, that human life 
begins at fertilization (conception). There are only two exceptions to 
this general trend: abortion jurisprudence and state judicial decisions 
relating to custody decisions involving cryopreserved human embryos.
    Throughout the development of Anglo-American law protecting 
developing human life, legal protection required medical knowledge of 
the existence of a human life. The common law relied on two types of 
medical evidence: quickening--the first sign of fetal movement--and the 
location of the developing child inside or outside the womb (birth). 
Human cloning--a byproduct of in vitro fertilization (IVF)--is 
conducted extracorporeally, outside the human body, in vitro. As with 
IVF, only after the cloned human embryo is allowed to divide would the 
embryo be implanted in a woman's uterus. There is no ``pregnancy'' to 
be terminated, and no right to ``terminate pregnancy'' is affected by 
state protection of the extracorporeal human zygote or human embryo. 
Since extracorporeal human embryos are outside the womb they are, for 
all intents and purposes, born, and as developing human beings, are 
entitled to the full protection of the law.
    The constitutional right of privacy--or substantive due process 
more specifically--does not prevent legal prohibitions or regulations 
on human cloning. There is no fundamental right to human cloning. 
Supreme Court privacy cases preceding Roe v. Wade protect family 
interests related to coital reproduction. In 1973, in Roe v. Wade, the 
Supreme Court created a right to ``terminate pregnancy.'' In the 
discrete area of abortion, the Supreme Court has broadly prohibited 
governmental regulation, as exemplified by Planned Parenthood v. Casey, 
505 U.S. 873 (1992), and Stenberg v. Carhart, 120 S.Ct. 2597 (2000). 
But this has never been expanded beyond abortion into a broad right of 
``procreative liberty.'' Nothing in Supreme Court case law establishes 
non-coital reproduction, much less asexual reproduction, as a 
constitutionally protected right. None of the values deeply rooted in 
the nation's history and tradition or implicit in the concept of 
ordered liberty--such as marital intimacy, marital sexual relations, 
bodily integrity--are implicated by non-coital, asexual reproduction 
like cloning.
    Finally, there are compelling reasons to prohibit human cloning. In 
addition to the pervasive destruction of human life inevitably caused 
by cloning research, cloning: (1) creates confusion of identity and 
individuality, (2) represents a giant step toward ``transforming 
procreation into manufacture,'' (3) represents a form of despotism of 
the cloners over the cloned and thus is a blatant violation of the 
inner meaning of parent-child relations, and (4) would constitute an 
unethical experiment upon the resulting child.

                   I. LEGAL PROTECTION OF HUMAN LIFE

    The legal issues surrounding human cloning research in the United 
States are the grandchild of the Supreme Court's 1973 decision in Roe 
v. Wade, which legalized abortion for any reason, at any time of 
pregnancy, in every state. Legalized abortion fostered in vitro 
fertilization (IVF) and embryo experimentation, which now have led to 
(reported) attempts at human cloning. IVF technology was first widely 
publicized in 1978 with the birth of Louise Brown, the first ``test 
tube baby,'' in Britain.2 IVF typically involves the 
fertilization of a number of eggs resulting in several human embryos in 
hopes of successfully implanting at least one in a woman's uterus, and 
IVF researchers conduct embryo experimentation in order to increase the 
success rates of IVF. Human cloning, in a sense, is a type of IVF and 
will inevitably involve embryo experimentation. Hence, the legal status 
of the human embryo is directly relevant to constitutional issues 
affecting human cloning.3
---------------------------------------------------------------------------
    \2\ Gina Kolata, Clone: The Road to Dolly and the Path Ahead 180 
(1998).
    \3\ For purposes of this testimony, I adopt Congress' definition of 
``human embryo'' in Pub. L. No. 106-554, sec. 510(b) (``any organism--
that is derived by fertilization, parthenogenesis, cloning, or any 
other means from one or more human gametes or human diploid cells'').
---------------------------------------------------------------------------
    For much of the public and for many scholars, the legal and moral 
status of the developing human being begins and ends with Roe v. Wade, 
410 U.S. 113 (1973), the Supreme Court's decision which legalized 
abortion nationwide for any reason, at every stage of gestation, a 
quarter of a century ago. Much public discussion today about the unborn 
revolves around the issue of abortion. Legal commentators who write on 
the legal status of the embryo commonly demonstrate only the most 
superficial understanding of the history of legal protection of the 
developing human being.4 For example, in justifying human 
cloning and ``the manipulation and destruction of embryos that cloning 
research, if not the procedure itself, will inevitably cause,'' 
Professor John A. Robertson, a leading advocate of reproductive 
technologies including cloning, contends that there is a ``prevailing 
moral and legal consensus that views early embryos as too rudimentary 
in neurological development to have interests or rights.'' 5 
Whether such a consensus exists in fact and history requires a detailed 
review of American legal history and contemporary legislation and 
caselaw. Hence, the history of the legal protection of developing human 
life is important because it shapes substantive due process, informs 
the limits of Roe v. Wade, and undergirds protection for the developing 
human being in non-abortion circumstances today.
---------------------------------------------------------------------------
    \4\ See e.g., John A. Robertson, Embryos, Families, and Procreative 
Liberty: The Legal Structure of the New Reproduction, 59 S. Cal. L. 
Rev. 942, 973 (1986) (``With the exception of former laws that 
prohibited abortion, the law has never regarded fetuses as rights-
bearing entities''); John A. Robertson, In the Beginning: The Legal 
Status of Early Embryos, 76 Va. L. Rev. 437, 450 n.38 (1990) (citing 
four articles for legal background, all of which contain only a 
sketchy, incomplete, and superficial review of the history of the legal 
protection for the unborn: Lori B. Andrews, The Legal Status of the 
Embryo, 32 Loyola L. Rev. 357, 361 (1986) (citing Roe v. Wade for the 
legal status of the human embryo in history); Patricia A. King, The 
Juridical Status of the Fetus: A Proposal for Legal Protection of the 
Unborn, 77 Mich. L. Rev. 1647 (1979); Robertson, Embryos, 59 S. Cal.; 
Marcia Joy Wurmbrand, Note, Frozen Embryos: Moral, Social, and Legal 
Implications, 59 S. Cal. L. Rev. 1079 (1986) (citing Robertson, 
Embryos, supra, and John A. Robertson, Procreative Liberty and the 
Control of Conception, Pregnancy, and Childbirth, 69 Va. L. Rev. 405 
(1983)).
    \5\ Robertson, The Question of Human Cloning, Hastings Ctr. Rep. 
Mar.-Apr. 1994, at 6.
---------------------------------------------------------------------------
A. Common Law Protection of Human Life
    Anglo-American law has always considered human beings and the human 
species special. There has always been an important distinction in 
American law between the human species and all other species. The basic 
law protecting the inviolability of human life--the law of homicide--is 
reserved for human beings. The principle of the natural rights of human 
beings, the equal creation of human beings, and the inalienability of 
the right to life is deeply imbedded in the American political and 
legal tradition. The founding political document of the United States, 
the Declaration of Independence, proclaims that all are created equal, 
endowed by their Creator with certain inalienable rights, including a 
right to life, and that government is instituted to secure (not create) 
that right. These were considered--by Jefferson, Madison, Adams, 
Franklin and the entire founding generation--to be ``self-evident'' 
truths.
    At common law, the basic law protecting human life was the law of 
homicide. The protection of the law of homicide was very broad--
extending its protection to ``the killing of any human creature,'' 
according to Blackstone, the leading authority on the common 
law.6 Contemporary debate over the moral status of the human 
embryo, however, forgets that the homicide law, by definition, protects 
human beings, not persons. This confuses the 14th Amendment (and the 
Court's discussion of ``person'' in Roe v. Wade) with the criminal 
code.7 Even if a human being is not considered by the courts 
to be a person under the 14th Amendment, that human being still may be 
protected under state homicide law. Homicide law does not protect only 
mature or developed persons, but all human beings as human beings--all 
offspring of human parents. It is species-directed. Roe v. Wade merely 
created a constitutional exception to the general rule when it 
stipulated that that protection may not interfere with a woman's right 
to ``terminate pregnancy.''
---------------------------------------------------------------------------
    \6\ 4 William Blackstone, Commentaries on the Laws of England 177 
(U. Chicago Reprint 1979) (hereafter Blackstone). See also 4 Blackstone 
188 (``Felonious homicide'' defined as ``the killing of a human 
creature''); 6 The New Encyclopaedia Britannica 26 (15th ed. 1995) 
(``homicide, the killing of one human being by another'').
    \7\ See e.g., Robertson, 76 VA L. Rev. at 444 n.24 (``The abortion 
debate has often been confused by loose use of terms such as person, 
human life, human being, etc. Clearly the fertilized egg, embryo, and 
fetus are human and are living. The question is whether they merit the 
moral protection accorded to clearly defined persons.'').
---------------------------------------------------------------------------
    The common law protected unborn human life to the greatest extent 
possible given contemporary medical knowledge. The law was informed by 
medicine, and legal protection was extended as medical knowledge 
progressed. The right to life was ``a right inherent by nature in every 
individual; and it begins in contemplation of law as soon as an infant 
is able to stir in the mother's womb.'' 8 But what was most 
important was not ``personhood'' but its status as a ``human 
creature.'' In the face of the limitations of primitive medical 
knowledge, every consideration was given to protect the life and rights 
of the unborn child. Thus, as Blackstone wrote, ``An infant in ventre 
sa mere, or in the mother's womb, is supposed in law to be born for 
many purposes.'' 9 The common law protection of the unborn 
child had direct antecedents in the Roman civil law's protection of the 
unborn child from the time the mother was known to 
conceive.10
---------------------------------------------------------------------------
    \8\ 1 Blackstone 125.
    \9\ 1 Blackstone 126. See also Stemmer v. Kline, 19 N.J.Misc. 15, 
17 A.2d 58, 59 (1940) (``At common law, a child en ventre sa mere was 
separate entity entitled to recognition and protection by courts and 
recognized as a 'person'.'').
    \10\ See e.g., Dennis J. Horan, Clarke D. Forsythe & Edward R. 
Grant, Two Ships Passing in the Night: An Interpretavist Review of the 
White-Stevens Colloquy on Roe v. Wade, 6 St. Louis U. Pub. L. Rev. 229, 
276 & n.276 (1987) (citing writings of Paulus and Marcianus in Corpus 
Juris Civilis).
---------------------------------------------------------------------------
    That English medical-legal authorities considered abortion at any 
stage of gestation to be the taking of human life, and thus a crime, 
influenced the development of English legislation.11 As 
Glanville Williams observed, with Lord Ellenborough's Act of 1803, 
Parliament ``made not merely a legal pronouncement but an ethical and 
metaphysical one, namely that human life has a value from the moment of 
impregnation.'' 12 Why these laws arose in the nineteenth 
century and not before is clear: Parliament only then learned of the 
medical evidence concerning human development.13
---------------------------------------------------------------------------
    \11\ John Keown, Abortion, Doctors and the Law 26-48 (1988).
    \12\ Glanville Williams, The Sanctity of Life and the Criminal Law 
227 (1957); Keown, supra note 10, at 20.
    \13\ Keown, supra note 10, at 26-48.
---------------------------------------------------------------------------
    Anglo-American society's consideration of the unborn human being is 
also seen in legal reference to the unborn human being as a ``child'' 
or ``unborn child'' stretching back over centuries. At common law, the 
unborn human being was commonly called a ``child.'' 14 The 
term has been used by legal commentatories for centuries, by Fleta, 
Staunford, Lambarde, Dalton, Coke, Blackstone, Hawkins, and 
Hale.15 This is also seen in the common phrase, being ``with 
child.'' 16 Early texts on midwifery, medicine, and 
jurisprudence used the term ``child'' at any time of 
pregnancy.17
---------------------------------------------------------------------------
    \14\ 1 Blackstone 450 (``his child, either born or unborn'')
    \15\ Horan, Forsythe & Grant, 6 St. Louis at 289-90 & nn.359-378.
    \16\ 1 Blackstone 446 (``declares herself with child'')
    \17\ Horan, Forsythe & Grant, 6 St. Louis at 290 n.369; 1st Cite 
Forsythe, 21 Val. U.L. Rev. at 563.
---------------------------------------------------------------------------
    Though limited by contemporary medicine, American law incorporated 
a general rule of protection. Thus, the Massachusetts Supreme Judicial 
Court stated, ``[t]o many purposes, in reference to civil rights, an 
infant in ventre sa mere is regarded as a person in being.'' 
18 Or, as the New Jersey Supreme Court stated as long ago as 
1849 in State v. Cooper, ``[i]t is true, for certain civil purposes, 
the law regards an infant as in being from the time of conception . . 
.'' 19
---------------------------------------------------------------------------
    \18\ Parker, 50 Mass. at 266 (citing 1 Blackstone 129).
    \19\ 22 N.J. 52, 56-57 (1849). The court finished this statement by 
saying that ``yet it seems no where to regard it as in life, or to have 
respect to its preservation as a living being.'' Id. The answer here is 
the difference between different burdens of proof in civil and criminal 
law, as well as the evidentiary issues involved.
---------------------------------------------------------------------------
    The centuries during which legal protection was burdened by the 
limitations of medical knowledge dwarf the relatively few, recent years 
during which heightened medical knowledge has allowed treatment and 
surgery in utero. The novelty of medical technology that allows 
treatment and visualization of the unborn human being was highlighted 
by the famous Swedish photographer, Lennard Nilsson. ``New technology 
has made it possible to see the actual events surrounding fertilization 
and to visualize the growing fetus more clearly. At the same time, new 
medical knowledge has reduced the risks of pregnancy . . .'' 
20
---------------------------------------------------------------------------
    \20\ Lennart Nilsson, A Child Is Born 15 (1990).
---------------------------------------------------------------------------
B. Quickening As An Evidentiary Line
    Quickening was established centuries ago as the most reliable 
medical line showing evidence of life. From the fourteenth through the 
nineteenth centuries, quickening was the only reliable evidence that a 
woman was pregnant or that the unborn human being was alive. As late as 
1800, a standard text on midwifery (the forerunner to obstetrics) 
concluded that ``there appears to be no unequivocal sign, whereby that 
state [pregnancy] can with certainty be determined, till between the 
fourth and fifth months,when the child quickens, that is, when its 
motions are distinctly felt.'' 21 Texts of midwifery 
typically contained chapters on the ``signs of pregnancy,'' in which 
quickening was emphasized.22 Thomas Denman, a widely cited 
authority on the subject, expressed the developing understanding of 
quickening in his 1829 text:
---------------------------------------------------------------------------
    \21\ Valentine Seaman, The Midwives Monitor and the Mothers Mirro 
70-72 (1800).
    \22\ See Forsythe, 21 Val. U.L. Rev. at 571 n.42, 572-73.
---------------------------------------------------------------------------
          The changes which follow quickening have been attributed to 
        various causes. By some it has been conjectured, that the child 
        then acquired a new mode of existence; or that it was arrived 
        to such a size as to be able to dispense with the menstrous 
        blood, before retained in the constitution of the parent, which 
        it disturbed by its quantity or malignity. But it is not now 
        suspected, that there is any difference between the aboriginal 
        life of the child, and that which it possesses at any period of 
        pregnancy, though there may be an alteration in the proofs of 
        its existence, by the enlargment of its size, and the 
        acquisition of greater strength.23
---------------------------------------------------------------------------
    \23\ Thomas Denman, An Introduction to the Practice of Midwifery 
287 (3d ed. 1829).
---------------------------------------------------------------------------
Beck, in his Elements of Medical Jurisprudence--one of the primary 
authorities in the 19th century--emphasized the same understanding:
          It is important to understand the sense attached to this word 
        [quickening] formerly, and at the present day. The ancient 
        opinion, on which indeed the laws of some countries have been 
        founded, was, that the foetus became animated at this period--
        that it acquired a new mode of existence. This is altogether 
        abandoned. The foetus is certainly, if we speak 
        physiologically, as much a living being immediately after 
        conception, as at any other time before delivery; and its 
        future progress is but the development and increase of those 
        constituent principles which it then received.24
---------------------------------------------------------------------------
    \24\ 1 John Beck, Elements of Medical Jurisprudence 276 (11th ed. 
1860).
---------------------------------------------------------------------------
Wharton and Stille emphasized the same point:
          This symptom [quickening] was formerly given much weight, 
        because at that time the child was supposed to receive its 
        spiritual nature--to become animate. Such ideas have now become 
        entirely obsolete in the scientific world. The time perfecting 
        the child is at its conception. After then, in all ways, it is 
        merely a question of growth and development.25
---------------------------------------------------------------------------
    \25\ 3 Wharton and Stille, Medical Jurisprudence 7 (5th ed. 1905).
---------------------------------------------------------------------------
    Based on the primitive medical knowledge of the day, the common law 
adopted the presumption that the fetus first became alive at 
quickening.26
---------------------------------------------------------------------------
    \26\ 6 St. Louis at 279-280 (collecting authorities); 21 Val. U.L. 
Rev. at nn. 39-53 (collecting authorities).
---------------------------------------------------------------------------
    At the earliest time of the common law, in the thirteenth century, 
Bracton and Fleta held that the killing of a ``quickened child'' in the 
womb was homicide without any explicit requirement of live 
birth.27 However, there is substantial common law authority 
that abortion was a crime at common law without regard to quickening 
and without regard to the time of gestation. As the highest court in 
Maryland stated in 1887, ``[A]s the life of an infant was not supposed 
to begin until it stirred in the mother's womb [quickening], it was not 
regarded as a criminal offense to commit an abortion in the early 
stages of pregnancy. A considerable change in the law has taken place 
in many jurisdictions by the silent and steady progress of judicial 
opinion; and it has been frequently held by Courts of high character 
that abortion is a crime at common law without regard to the stage of 
gestation.'' 28
---------------------------------------------------------------------------
    \27\ 6 St. Louis Pub. L. Rev. at 285 & n.338. For a description of 
the common law history of abortion, see Horan, Forsythe & Grant, 6 St. 
Louis at 278-300; Robert Bryn, An American Tragedy: The Supreme Court 
on Abortion, 41 Fordham L. Rev. 807 (1973); Robert Destro, Abortion and 
the Constitution: The Need for a Life-Protective Amendment, 63 Cal. L. 
Rev. 1250 (1975); Joseph Dellapenna, The History of Abortion: 
Technology, Morality and Law, 40 U. Pitt. L. Rev. 359 (1979); Shelley 
Gavigan, The Criminal Sanction as it Relates to Human Reproduction: The 
Genesis of the Statutory Prohibition of Abortion, 5 J. Legal Hist. 20 
(1984).
    \28\ Lamb v. State, 10 A. 208, 208 (Md. Ct. App. 1887).
---------------------------------------------------------------------------
    Prior to this Maryland decision, two of the most prestigious 
criminal law scholars of the 19th century, Bishop and Wharton, also 
criticized the quickening rule, concluding that abortion was a crime at 
common law regardless of the stage of gestation.29 Wharton's 
discussion revealed the dynamic between medical evidence and increasing 
protection for unborn human life:
---------------------------------------------------------------------------
    \29\ Joel Prentiss Bishop, Bishop on Statutory Crimes sec. 744, at 
447 (2d ed. 1883); Frances Wharton, American Criminal Law secs. 1220-
30, at 210-218 (6th rev. ed. 1868).
---------------------------------------------------------------------------
          There is no doubt that at common law the destruction of an 
        infant unborn is a high misdemeanor, and at an early period it 
        seems to have been deemed murder. If the child dies 
        subsequently to birth from wounds received in the womb, it is 
        clearly homicide, even though the child is still attached to 
        the mother by the umbilical cord. It has been said that it is 
        not an indictable offense to administer a drug to a woman, and 
        thereby to procure an abortion, unless the mother is quick with 
        child, though such a distinction, it is submitted, is neither 
        in accordance with the result of medical experience, nor with 
        the principles of the common law. The civil rights of an infant 
        in ventre sa mere are equally respected at every stage of 
        gestation; and it is clear that no matter at how early a stage 
        he may be appointed executor, is capable of taking as a 
        legatee, or under a marriage settlement, may take specifically 
        under a general devise, as a ``child''; and may obtain an 
        injunction to stay waste . . . It appears, then, that 
        quickening is a mere circumstance in the physiological history 
        of the foetus, which indicates neither the commencement of a 
        new stage of existence, nor an advance from one stage to 
        another--that it is uncertain in its periods, sometimes coming 
        at three months, sometimes at five, sometimes not at all--and 
        that it is dependent so entirely upon foreign influences as to 
        make it a very incorrect index, and one on which no 
        practitioner can depend, of the progress of pregnancy. There is 
        as much vitality, in a physical point of view, on one side of 
        quickening as on the other, and in a social and moral point of 
        view, the infant is as much entitled to protection, and society 
        is as likely to be injured by its destruction, a week before it 
        quickens as a week afterwards.30
---------------------------------------------------------------------------
    \30\ Wharton, supra note 28, at secs. 1220-1230 (cit. omit.).
---------------------------------------------------------------------------
Today, for obvious reasons, quickening ``provides only corroborative 
evidence of pregnancy and itself is of little diagnostic value.'' 
31
---------------------------------------------------------------------------
    \31\ J. Pritchard, P. MacDonald & N. Gant, Williams Obstetrics 218 
(17th ed. 1985).
---------------------------------------------------------------------------
C. The Evidentiary Meaning of the Born Alive Rule
    The born alive rule was a rule of medical 
jurisprudence.32 It was an evidentiary rule, a bright-line 
rule of evidence used to eliminate cases of uncertain evidence in the 
killing of a child.33 As a leading 19th century legal 
authority described the purpose of the born alive rule:
---------------------------------------------------------------------------
    \32\ See generally, Forsythe, Homicide of the Unborn Child: The 
Born Alive Rule and Other Legal Anachronisms, 21 Val. U.L. Rev. 563 
(1987).
    \33\ 21 Val. U.L. Rev. 563; 6 St. Louis Pub. L. Rev. at 285-88.
---------------------------------------------------------------------------
          It is well known that in the course of nature, many children 
        come into the world dead, and that others die from various 
        causes soon after birth. In the latter, the signs of their 
        having lived are frequently indistinct. Hence, to provide 
        against the danger of erroneous accusations, the law humanely 
        presumes that every newborn child has been born dead, until the 
        contrary appears from medical or other evidence. The onus of 
        proof is thereby thrown on the prosecution; and no evidence 
        imputing murder can be received, unless it be made certain by 
        medical or other facts, that the child survived its birth and 
        was actually living when the violence was offered to 
        it.34
---------------------------------------------------------------------------
    \34\ A. Taylor, Medical Jurisprudence 411 (7th ed. 1861).
---------------------------------------------------------------------------
It was generally recognized at common law that pre-viable children 
could be born alive.35 The medical purpose of the born alive 
rule 400 years ago has been completely eliminated by modern medical 
science and technology. It is outmoded, and its existence no longer 
makes sense in the law.36
---------------------------------------------------------------------------
    \35\ Forsythe, 21 Val. U.L. Rev. at 568 & n.28.
    \36\ See Forsythe, 21 Val. U.L. Rev. 563.
---------------------------------------------------------------------------
    The Supreme Court in Roe v. Wade misconstrued the born alive rule 
and converted it from an evidentiary rule dependent on location (in or 
out of the womb) into a gestational rule (fullterm). This is indicated 
by the Court's statement that the rights of persons do not begin until 
term birth, after the third trimester. 37
---------------------------------------------------------------------------
    \37\ 410 U.S. at 161-162, 163.
---------------------------------------------------------------------------
    The evidentiary nature of the born alive rule is also seen in the 
congruence between injury in the womb and death after birth outside the 
womb. As a renowned 19th century commentator stated the rule: ``If a 
person intending to procure abortion does an act which causes a child 
to be born so much earlier than the nature time that it is born in a 
state much less capable of living, and afterwards dies in consequence 
of its exposure to the external world, the person who by her misconduct 
so brings the child into the world, and puts it thereby into a 
situation in which it cannot live, is guilty of murder.'' 38 
If the born alive rule was a gestational rule and a moral rule, both 
the injury and death would have had to occur after birth. Russell's 
explication shows both the evidentiary nature of the born alive rule 
and the irrelevance of viability. Modern courts have increasingly 
recognized this congruence.39 This demonstrates that the 
born alive rule recognized biological and existential continuity 
between the unborn child (at any stage of gestation) and the born 
child.
---------------------------------------------------------------------------
    \38\ 2 Walter Russell, A Treatise on Crimes and Misdemeanors 671-72 
(Garland Pub. reprint 1979) (1865).
    \39\ State v. Cotton, 197 Ariz. 584, 5 P.3d 918, 922 (Ariz.App. 
2000) (adopting rule that ``the death of an infant who is born alive 
from injuries inflicted in utero constitutes homicide,'' citing United 
v. Spencer, 839 F.2d 1341 (9th Cir. 1988); Ranger v. Georgia, 249 Ga. 
315, 290 S.E.2d 63 (1982); Illinois v. Bolar, 109 Ill.App.3d 384, 440 
N.E.2d 639 (1982); Williams v. Maryland, 316 Md. 677, 561 A.2d 216 
(1989); New Jersey v. Anderson, 135 N.J.Super. 423, 343 A.2d 505 
(1975), reversed on other grounds, 173 N.J.Super. 75, 413 A.2d 611 
(1980); People v. Hall, 158 A.D.2d 69, 557 N.Y.S.2d 879 (1990); Cuellar 
v. State, 957 S.W.2d 134 (Tex. Ct. App. 1997); Wisconsin v. Cornelius, 
152 Wis.2d 272, 448 N.W.2d 434 (1989)).
---------------------------------------------------------------------------
    What the common law demonstrates is that law and medicine had a 
dynamic relationship with regard to the unborn child. As medical 
knowledge of fetal development increased, legal protection increased. 
The law considered the offspring of human parents to be a human being, 
and the law considered the unborn child to be a human being whenever it 
could be determined to be alive. Evidence of life--a living human 
being--was what was important for legal protection, not personhood. The 
modern debate about ``personhood'' began with the Supreme Court's 
consideration of the 14th Amendment liberty clause (protecting 
``persons'') in Roe v. Wade in 1973 and subsequent philosophical 
discussions about Roe. The common law protected unborn human life to 
the greatest extent possible given contemporary medical 
knowledge.40 The common law protection encompassed living 
members of the human species.
---------------------------------------------------------------------------
    \40\ Mark Scott, Quickening in the Common Law: The Legal Precedent 
Roe Attempted and Failed to Use, 1 Mich. Law & Pol. Rev. 199, 261 
(1996) (legal protection extended to ``a living member of the human 
species''); Forsythe, 21 Val. U.L. Rev. at 265ff.
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D. The Irrelevance of Viability
    The common law placed significance on quickening and live birth. 
Viability, was not a concern of the common law.41 It played 
no role in the development of the common law and its protection of the 
unborn child.42 A leading 19th century legal authority 
confirmed this:
---------------------------------------------------------------------------
    \41\ See Horan, Forsythe & Grant, 6 St. Louis at 281-82 n.306-311 
(collecting authorities).
    \42\ Forsythe, 21 Val. U.L. Rev. at 569 & n.33.
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          The English law does not act on the principle that a child, 
        in order to become the subject of a charge of murder, should be 
        born viable, i.e., with the capacity to live . . . The capacity 
        of a child continuing to live has never been put as a medical 
        question in a case of alleged child murder; and it is pretty 
        certain, that if a want of capacity to live were actually 
        proved, this would not render the party destroying it 
        irresponsible for the offense.43
---------------------------------------------------------------------------
    \43\ A. Taylor, Medical Jurisprudence 413 (7th ed. 1861).
---------------------------------------------------------------------------
    In American law, viability first began as a judicially-imposed 
gloss on the law, with Oliver Wendell Holmes' 1884 opinion in Dietrich 
v. Inhabitants of Northampton 44 for the Massachusetts 
Supreme Judicial Court. Dietrich denied recovery for the death of a 
child born alive but premature from a miscarriage and created a 
viability requirement for civil recovery that had no basis in statute 
or common law.45
---------------------------------------------------------------------------
    \44\ 138 Mass. 14, 16 (1884).
    \45\ See generally, Clarke D. Forsythe, The Legacy of Oliver 
Wendell Holmes, 69 U. Det. Mercy L. Rev. 677, 685-89 (1992).
---------------------------------------------------------------------------
    As the ``dean of torts,'' William Prosser made clear, some American 
courts followed Dietrich for about 50 years, but with developing 
medical knowledge in the 20th century and the 1946 decision in Bonbrest 
v. Kotz, 65 F.Supp. 138 (D.D.C. 1946), Americans courts increasingly 
rejected the viability rule until the Supreme Court's decision in 1973 
in Roe v. Wade placed such great emphasis on viability. Relying on Roe, 
some state courts limited legal protection for the unborn to viability. 
More recently, other courts have recognized that Roe--and its emphasis 
on viability--does not apply outside abortion law.
F. Modern Criminal and Tort Law Developments
    1. Tort Law--Until modern scientific advances allowed greater 
knowledge of human life in utero, abortion law was the primary--but not 
exclusive--legal field for the protection of unborn human life. Until 
nearly the 20th century, homicide and abortion law proceeded on two 
different, evidentiary tracks based on location of the child--homicide 
law applied to human beings outside the womb, abortion law applied to 
human beings inside the womb.
    Dean Prosser explained both the evidentiary reasons for the born 
alive rule in tort law and the advancements in medical science that 
eliminated its rationale:
          When a pregnant woman is injured, and as a result the child 
        subsequently born suffers deformity or some other injury, 
        nearly all of the decisions prior to 1946 denied recovery to 
        the child. Two reasons usually were given: First, that the 
        defendant could owe no duty of conduct to a person who was not 
        in existence at the time of his action; and second, that the 
        difficulty of proving any causal connection between negligence 
        and damage was too great, and there was too much danger of 
        fictitious claims.
          So far as duty is concerned, if existence at the time is 
        necessary, medical authority has recognized long since that the 
        child is in existence from the moment of conception, and for 
        many purposes its existence is recognized by the law . . . So 
        far as causation is concerned, there will certainly be cases in 
        which there are difficulties of proof, but they are no more 
        frequent, and the difficulties are no greater, than as to many 
        other medical problems. All writers who have discussed the 
        problem have joined in condemning the old rule, in maintaining 
        that the unborn child in the path of an automobile is as much a 
        person in the street as the mother, and in urging that recovery 
        should be allowed upon proper proof.46
---------------------------------------------------------------------------
    \46\ William Prosser, Law of Torts 335-36 (4th ed. 1971) (emphasis 
added); Prosser & Keeton on Torts 367-72 (5th ed. 1984); Prosser Wade & 
Schwartz, Torts 421-36 (9th ed. 1994).
---------------------------------------------------------------------------
The Court in Roe cited Prosser to support its erroneous description 
that courts had granted recovery for prenatal injuries only where the 
fetus was viable or at least ``quick.'' 47 But Prosser 
stated just the opposite, pointing out that, in fact, most states 
permitted recovery for prenatal injuries regardless of the stage of 
gestation in which the injuries are inflicted:
---------------------------------------------------------------------------
    \47\ 410 U.S. at 161 162.
---------------------------------------------------------------------------
          Most of the cases allowing recovery have involved a fetus 
        which was then viable . . . Many of them have said, by way of 
        dictum, that recovery must be limited to such cases, and two or 
        three have said that the child, if not viable, must at least be 
        ``quick.'' But when actually faced with the issue for decision, 
        almost all of the jurisdictions have allowed recovery even 
        though the injury occurred during the early weeks of pregnancy, 
        when the child was neither viable nor quick.48
---------------------------------------------------------------------------
    \48\ Prosser, Law of Torts, at 337 (4th ed. 1971) (emphasis added).
---------------------------------------------------------------------------
As Professor David Louisell summarized the law two years before Roe:
          [T]he progress of the law in recognition of the fetus as a 
        human person has been strong and steady and roughly 
        proportional to the growth of knowledge of biology and 
        embryology. For centuries the law of property has recognized 
        the unborn as living persons and the criminal law, although 
        unevenly, has accorded them substantial protection. The law of 
        torts, because of biological misconceptions among judges and 
        practical difficulties of medical proof, was something of a 
        laggard, but since World War II there has been an explosive 
        recognition ``that the unborn child in the path of an 
        automobile is as much a person in the street as the mother.'' 
        Judicial adknowledgment ``that the unborn child is entitled to 
        the law's protection'' has resulted in ordering blood 
        transfusion necessary to save his life, over the cogent 
        countervailing claims to the free exercise of religion. In a 
        word, the unborn child is a person to be protected in his 
        property rights and against negligence, and to be afforded the 
        reach of equity's affirmative arm for support and 
        sustenance.49
---------------------------------------------------------------------------
    \49\ David W. Louisell, Biology, Law and Reason: Man as Self-
Creator, 16 Am. J. Juris. 1, 19-20 (1971).
---------------------------------------------------------------------------
    Although abortion law was virtually abolished by the Supreme Court 
in 1973, Roe did not touch assaults on the unborn child outside the 
context of abortion. Roe may have stifled an ongoing process of 
increasing state protection for unborn human life in the field of 
criminal and tort law, 50 but that process has progressively 
continued outside the immediate context of abortion despite 
Roe.51 The upshot of this progressive protection has been a 
gradual abolition of the artificial born alive rule and a growth in 
protection of the unborn child, even if stillborn, and without regard 
to the stage of gestation.
---------------------------------------------------------------------------
    \50\ Some courts concluded that Roe prevented protection of the 
unborn child even outside the context of abortion. See e.g., Bopp & 
Coleson, The Right to Abortion: Anomalous, Absolute, and Ripe for 
Reversal, 3 B.Y.U. J. Pub. L. at 256-57 (citing cases). But that 
erroneous understanding has been abandoned in recent years. See e.g., 
People v. Davis, 7 Cal.4th 797, 30 Cal.Rptr.2d 50 872 P.2d 591 (1994).
    \51\ See e.g., People v. Davis, 7 Cal.4th 797, 30 Cal.Rptr.2d 50 
872 P.2d 591 (1994); State v. Merrill, 450 N.W.2d 318 (Minn. 1990), 
cert. denied sub. nom. Merrill v. Minnesota, 496 U.S. 931 (1990). For 
various surveys of the current status of legal developments protecting 
the unborn child in criminal and tort law, see Forsythe, 32 Val. U.L. 
Rev. at 494-501; Bopp & Coleson, The Right to Abortion: Anomalous, 
Absolute, and Ripe for Reversal, 3 B.Y.U. J. Pub. L. 247-261; Horan, 
Forsythe & Grant, 6 St. Louis Pub. L. Rev. at 307-309.
---------------------------------------------------------------------------
    In tort law today, virtually all states allow suits for prenatal 
injuries for children later born alive. (Obviously, if the child is not 
born alive, the suit would be for wrongful death.) Today, at least 
thirty-six jurisdictions allow wrongful death actions for a stillborn 
child, while a dwindling minority of eight to ten states reject the 
cause of action.52 A majority of state courts have expressly 
or implicitly rejected viability as a limitation for liability for 
nonfatal prenatal injuries.53 As recently as 1993, the 
Pennsylvania Supreme Court pointed out that ``no jurisdiction accepts 
the . . . assertion that a child must be viable at the time of birth in 
order to maintain an action in wrongful death'' (where the child is 
born alive and dies thereafter).54
---------------------------------------------------------------------------
    \52\ See generally, Sheldon R. Shapiro, Annotation, Right to 
Maintain Action or to Recover Damages for Death of Unborn Child, 84 
A.L.R.3d 411 (1978 & Supp. 1997).
    \53\ Paul B. Linton, Planned Parenthood v. Casey: The Flight from 
Reason in the Supreme Court, 13 St. Louis U. Pub. L. Rev. 15, 47-48 
n.141 (1993) (citing 28 states).
    \54\ Hudak v. Georgy, 634 A.2d 600, 602 (Pa. 1993).
---------------------------------------------------------------------------
    2. Criminal Law--Progressive development has continued in criminal 
law as well. At the time of Roe, several states treated the killing of 
an unborn child as a homicide at some stage of gestation without regard 
to live birth. The born alive rule, created as a bright line 
evidentiary rule in a time of primitive medicine, became illogical when 
medical science advanced to the point that the elements of homicide 
could be reliably demonstrated even if the child died before birth 
(stillborn). The born alive rule has been discarded by an increasing 
number of states at some stage of gestation. Today, more than half of 
the states treat the killing of an unborn human being as a form of 
homicide, even though not born alive (stillborn), at some stage of 
gestation. Eleven states, including Illinois and Minnesota, define (by 
statute) the killing of an unborn child as a form of homicide, 
regardless of the stage of pregnancy.55 One state defines 
(by statute) the killing of an unborn human being after eight to ten 
weeks gestation as a form of homicide.56 Eight states define 
(by statute) the killing of an unborn child after quickening as a form 
of homicide.57 Five states define (by statute or caselaw) 
the killing of an unborn human being after viability as a form of 
homicide.58 Constitutional challenges to statutes of this 
type, include statutes applying throughout gestation, have been 
rejected in several decisions.59
---------------------------------------------------------------------------
    \55\ Ariz. Rev. Stat. 13-1103(A)(5) (West 1989 & Supp. 1995); Ill. 
Comp. Stat. ch. 720, 5/9-1.2, 5/9-2.1, 5/9-3.2 (1994); Ind. Code Ann. 
35-42-1-6 (Burns 1994) (feticide); La. Rev. Stat. Ann. tit. 14, 32.5-
32.8 (read in conjunction with tit. 14, 2(11) (West 1996 Supp.); Minn. 
Stat. Ann. 609.266, 209.2661-609.2665, 609.268(1) (1987 & Supp. 1996); 
Mo. Rev. Stat. 1.205, 565.024 (Vernon 1996 Supp.)(see State v. Knapp, 
843 S.W.2d 345 (Mo. 1992); N.D. Cent. Code 12.1-17.1-01 to 12.1-17-04 
(1995 Supp.); Ohio Sub. Senate Bill No. 239 (1996); PA Senate Bill No. 
45 (1997); S.D Cod. Laws Ann 22-17-6 (1988); 22-16-1, 22-16-1.1, 22-16-
4, 22-16-15, 22-16-20, 22-16-41, read in conjunction with 22-1-2(31), 
22-1-2(50A) (1996 Supp.); Utah Code Ann. 76-5-201 (1995). Prosecutions 
under the Illinois law, without regard to time of gestation, are 
common. See e.g., Steven J. Stark, ``Boyfriend, 21, is charged in 
pregnant teen's slaying,'' Chicago Tribune, Sunday, March 8, 1998, sec. 
4, p. 3, col. 5 (defendant charged with ``intentional homicide of an 
unborn child'').
    \56\ Cal. Pen Code 187(a) (1988). See People v. Davis, 7 Cal.4th 
797, 30 Cal.Rptr.2d 50, 872 P.2d 591 (1994).
    \57\ Fla. Stat. Ann. 782.09 (West 1992); Ga. Code Ann. 16-5-80, 40-
6-393.1 (Harrison 1994), 52-7-12.3 (Harrison 1996 Supp.); Mich. Comp. 
Laws Ann. 750.322 (West 1991)(limited by judicial decision to 
viability, Larkin v. Cahalan, 389 Mich. 533, 208 N.W.2d 176 (1973); 
Miss. Code Ann. 97-3-37 (1994); Nev. Rev. Stat. 200.210 (1995); Okla. 
Stat. Ann. tit. 21, 713 (West 1983); Wash. Rev. Code Ann. 
9A.32.060(1)(b) (1988); Wis. Rev. Stat. 940.04(2)(a) (West 1996).
    \58\ Iowa Code Ann. 707.7 (West 1993) (as amended by H.F. 2109 
(1996)); Commonwealth v. Cass, 392 Mass. 799, 467 N.E.2d 1324 (1984), 
Commonwealth v. Lawrence, 404 Mass. 378, 536 N.E.2d 571 (1989); State 
v. Horne, 282 S.C. 444, 319 S.E.2d 7093 (1984); Tenn. Code Ann. 39-13-
201 (Michie 1991 & Supp. 1995); R.I. Gen. Laws 11-23-5 (Michie 1994).
    \59\ People v. Davis, 7 Cal.4th 797, 30 Cal.Rptr.2d 50, 872 P.2d 
591 (1994); Hughes v. State, 868 P.2d 730 (Okla. Crim. App. 1994); 
Brinkley v. State, 253 Ga. 541, 322 S.E.2d 49 (1984); Smith v. Newsome, 
815 F.2d 1386 (11th Cir. 1987); People v. Ford, 221 Ill.App.3d 354, 581 
N.E.2d 1189 (1991); People v. Campos, 227 IllApp.3d 434, 592 N.E.2d 83 
(1992); People v. Shum, 117 Ill.2d 317, 512 N.E.2d 1183 (1987), cert. 
denied sub nom. Shurn v. Illinois, 484 U.S. 1079 (1988); State v. 
Merrill, 450 N.W.2d 318 (Minn. 1990), cert. denied, 496 U.S 931 (1990); 
State v. Bauer, 471 N.W.2d 363 (Minn.App. 1991); State v. Knapp, 843 
S.W.2d 345 (Mo. 1992); State v. Black, 188 Wis.2d 639, 526 N.W.2d 132 
(1994).
---------------------------------------------------------------------------
    As medical science has developed, and the cause of the death of the 
unborn human being is more easily determined, the born alive rule has 
come under increasing criticism and has been increasingly rendered 
meaningless. It is important to remember that even under the 
application of the born alive rule, the killing of an early developing, 
human being was still counted as a homicide if the assault on the 
mother resulted in a miscarriage that produced expulsion from the womb 
and death after that expulsion, at any stage of development. In the 
course of things, the unborn human being might not survive the initial 
assault or the miscarriage, but if it did, it did not matter to the law 
of homicide how premature the human being was, as long as it survived 
expulsion from the womb and was observed outside.
    By eliminating the born alive rule in the 20th century, state 
homicide law has abandoned the arbitrary matter of location (outside or 
inside) because location no longer matters to medical determination. 
This has allowed the law to focus on the cause of death at any stage of 
development, without regard to location. As a result, cases like the 
Merrill case in Minnesota have followed.60 Merrill involved 
a double homicide, when a man killed his estranged girlfriend when she 
was pregnant with a 28-day-old embryonic human being, who died in the 
womb. The assailant was charged with a double homicide and that 
indictment was upheld on appeal. Many similar cases involving previable 
unborn human beings have arisen in Illinois, another state with a 
similar law that has abandoned the born alive rule without establishing 
arbitrary gestational limitations.
---------------------------------------------------------------------------
    \60\ State v. Merrill, 450 N.W.2d 318 (Minn. 1990), cert. denied, 
496 U.S 931 (1990).
---------------------------------------------------------------------------
    In California, because of the supreme court's May, 1994 decision in 
People v. Davis 61 a charge of homicide can be brought for 
the killing of an unborn human being at any time after 8-10 weeks 
gestation. The court arrived at this result from a strict, biological 
reading of the legislative term, ``fetus,'' even though the term 
``fetus'' is commonly used to denote a developing human being at any 
stage of development.62
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    \61\ People v. Davis, 7 Cal. 4th 797, Cal. Rptr. 2d 50, 872 P. 2d 
591 (1994).
    \62\ See e.g., J.M. Tanner, Fetus into Man: Physical Growth from 
Conception to Maturity (Harvard University Press 1978) (where 
conception and fertilization are properly treated as equivalent, and 
``true foetal age'' is counted as beginning with fertilization (p.38-
39)).
---------------------------------------------------------------------------
    These developments in homicide law continue. Recently, Indiana 
became the 26th state to treat the killing of an unborn human being as 
a homicide at some stage of gestation when it enacted a law, over the 
Governor's 1997 veto, to treat the killing of a unborn child as a 
homicide, whether born alive or not.63 Because the 
publicized incidents that gave rise to the legislation involved the 
shooting of a pregnant woman carrying a presumably viable child, the 
legislation contained a viability limitation. In addition, Michigan 
enacted legislation to protect the unborn child (``embryo'' and 
``fetus'') at all stages of gestation. Legal protection of the unborn 
human being throughout gestation is a dynamic process that continues. 
Outside the context of abortion, there is a remarkable legal and 
legislative consensus across at least thirty-eight states that the life 
of a human being is considered to begin at fertilization 
(conception).64
---------------------------------------------------------------------------
    \63\ Indiana House Bill 1160.
    \64\ Paul Linton, 13 St. Louis U. Pub. L. Rev. at 120 (Appendix B, 
collecting legislation and caselaw from 38 states).
---------------------------------------------------------------------------
             II. THE LIMITS OF ROE V. WADE AND ITS PROGENY

A. The Limits of the Supreme Court Privacy Cases Before Roe
    Whether human cloning is a constitutional right involves an 
application of, as Michael McConnell has phrased it, ``the most 
fundamental question of modern constitutional theory: when, and under 
what conditions, may courts invalidate duly enacted state or federal 
laws on the basis of unenumerated constitutional rights?'' 
65 The Supreme Court's 1973 decision in Roe v. Wade has 
spawned 25 years of litigation, legislation, scholarship, cultural 
change, and public discussion concerning sexual reproduction and the 
scope of a constitutional right to sexual reproduction. Proponents of a 
expansive right to sexual reproduction have given it various names and 
descriptions, among them ``procreative liberty,'' ``a right of the 
couple to reproduce,'' ``a right to form a family.'' Professor John A. 
Robertson, one of the foremost advocates of a broad ``procreative 
liberty,'' claims that ``reproductive freedom'' has traditionally been 
a right taken for granted. Of course, this begs a definition of 
``reproductive freedom.'' ``Procreative freedom'' is too broad a 
description of what the Supreme Court has actually held to be 
constitutionally protected from popular, democratically-approved limits 
and constraints.
---------------------------------------------------------------------------
    \65\ Amicus Brief for Senator Orrin Hatch et al. at 1, Vacco v. 
Quill, 117 S.Ct. 2293 (1997) (No. 95-1858), 1996 WL 657755. See also 
Michael W. McConnell, The Right to Die and the Jurisprudence of 
Tradition, 1997 Utah L. Rev. 665 (1997).
---------------------------------------------------------------------------
    The Supreme Court's substantive due process decisions of the 
twentieth century do not support a broad right to ``procreative 
liberty'' that encompasses using technology for non-coital, asexual 
reproduction like cloning. Prince v. Massachusetts 66 
involved traditional family relationships. Two other cases relating to 
parenting rights are deeply based in the common law: Meyer v. Nebraska 
67 dealt with the education of children, and Pierce v. 
Society of Sisters 68 concerned the decision of parents to 
send their child to a private school. Skinner v. Oklahoma 69 
dealt with liberty against coerced sterilization of ``habitual 
criminals,'' a negative liberty that could be based in deeply-rooted, 
common law principles involving battery and informed consent. Loving v. 
Virginia 70 dealt with marriage, a union deeply based in 
Anglo-American law. Eisenstadt v. Baird 71 involved the use 
of contraceptives and emphasized their use by individuals, not married 
couples.
---------------------------------------------------------------------------
    \66\ 321 U.S. 158 (1944).
    \67\ 262 U.S. 390 (1923).
    \68\ 268 U.S. 510 (1925).
    \69\ 316 U.S. 535 (1942).
    \70\ 388 U.S. 1 (1967).
    \71\ 405 U.S. 438 (1972).
---------------------------------------------------------------------------
    In sum, it may be said that Skinner (a case sometimes referred to 
as involving ``procreation'' broadly 72) is to cloning as 
Cruzan v. Director, Missouri Dept. of Health 73 is to 
assisted suicide. Both Skinner and Cruzan involved negative liberties 
of refusing treatment that are based in concepts of battery and 
informed consent; they did not involve positive liberties to an 
activity or power. In this regard, it diminishes the strength of a 
``right'' to cloning that cloning does not alleviate infertility, but 
rather circumvents it, and that cloning cannot be said to be 
therapeutic.
---------------------------------------------------------------------------
    \72\ See e.g., Justice Stewart's reference to Skinner as involving 
``procreation'' in a footnote in Harris v. McRae, 448 U.S. at 312 n.18.
    \73\ 497 U.S. 261 (1990).
---------------------------------------------------------------------------
    The substantive due process cases that preceded Roe in the area of 
family law and reproduction are distinquishable in a number of 
ways.74 First and foremost, with the exception perhaps of 
Eisenstadt v. Baird, the rights recognized there have historical 
antecedents deeply rooted in American law and were explicitly 
recognized as such.75 It is also important to point out that 
Justice Harlan's opinion in Poe v. Ullman was limited to marital use of 
contraception. (Justice Souter's concurrence in Washington v. 
Glucksberg ignores the limitations of Poe, enormously expands its 
implications and thereby seriously distorts Harlan's 
opinion.76) Nothing in the substantive due process cases 
preceding Roe provides any basis for a right to non-coital, asexual 
reproduction.77
---------------------------------------------------------------------------
    \74\ Pierce v. Society of Sisters, 268 U.S. 510 (1925); Meyer v. 
Nebraska, 262 U.S. 390 (1923); Skinner v. Oklahoma, 316 U.S. 535 
(1942); Griswold v. Connecticut, 381 U.S. 479 (1965); Eisenstadt v. 
Baird, 405 U.S. 438 (1972).
    \75\ Meyer v. Nebraska, 262 U.S. 390, 399 (1923) (``to enjoy those 
privileges long recognized at common law as essential to the orderly 
pursuit of happiness by free men''); Pierce v. Society of Sisters, 268 
U.S. 510, 534-35 (1925) (``the liberty of parents and guardians to 
direct the upbringing and education of children under their control'', 
``engaged in a kind of undertaking . . . long regarded as useful and 
meritorious''); Moore v. City of East Cleveland, 431 U.S. 494, 503-04 
(1977) (``the Constitution protects the sanctity of the family 
precisely because the institution of the family is deeply rooted in 
this Nation's history and tradition'').
    \76\ Michael W. McConnell, The Right to Die and the Jurisprudence 
of Tradition, 1997 Utah L. Rev. 665 (1997).
    \77\ See also Marc Lappe, Four reasons to step back from cloning, 
Chicago Tribune, March 8, 2001, sec. 1, p. 21 (``No one has an 
inalienable right to reproduce, much less perpetuate her own genetic 
makeup, no matter how unique.''); Lori Andrews, 11 Harv. J.L. & Tech. 
643, 666 (1998) (quote); George Annas, Human Cloning: A Choice or an 
Echo?, 23 U. Dayton L. Rev. 247, 254 (1998) (``Asexual cloning by 
nuclear substitution represents such a discontinuity in the way humans 
reproduce . . . This discontinuity means that although the 
constitutional right not to reproduce would seem to apply with equal 
force to a right not to replicate, to the extent that there is a 
constitutional right to reproduce if one is able, no existing liberty 
doctrine would extend this right to replication by cloning.''); George 
Annas, Human Cloning: Should the United States Legislate Against It?, 
A.B.A.J. at 80 (May 1997) (``Cloning is replication, not reproduction, 
and represents a difference in kind, not in degree, in the way humans 
continue the species.).
---------------------------------------------------------------------------
    Professor Robertson's vision of parenthood is the ``wish to 
replicate themselves, transmit genes, gestate, and rear children 
biologically related to them.'' 78 Robertson posits a right 
to ``produce a child for rearing that is genetically or gestationally 
related to one or both partners.'' 79 Entailed in such a 
right would be ``discretion to create, freeze, donate, transfer and 
discard embryos, because these maneuvers are necessary to overcome 
coital infertility.'' He argues for ``the right of persons to use 
technology in pursuing their reproductive goals'' 80 and for 
``presumptive moral and legal protection for reproductive technologies 
that expand procreative options.'' 81 But Robertson's 
argument is declaratory and conclusory, not reasoned: ``If the moral 
right to reproduce presumptively protects coital reproduction, then it 
should protect noncoital reproduction as well.'' 82
---------------------------------------------------------------------------
    \78\ John A. Robertson, Children of Choice: Freedom and the New 
Reproductive Technologies 32 (1994).
    \79\ 28 Jurimetrics Journal 285, 292 (1988).
    \80\ John A. Robertson, Children of Choice at 42.
    \81\ John A. Robertson, Children of Choice at 220.
    \82\ Id. at 32.
---------------------------------------------------------------------------
    Quite clearly, a constitutional right to cloning cannot be 
logically derived from the two sets of two sets of substantive due 
process cases that Professor Robertson posits as a basis for a right to 
non-coital reproduction.83 The first line of cases involves 
contraception and abortion, both of which involve a person's physical 
integrity against a physical imposition by a third-party and a right to 
avoid procreation. These involve a right not to procreate, as Robertson 
points out. From these, Robertson states that a positive right to 
procreate by non-coital techniques exists, but without any reasoning: 
``This well-established right [not to procreate] implies the freedom 
not to exercise it and, hence, the freedom to procreate.'' The right to 
use contraception, as developed by American courts, may well assume a 
right not to use contraception, but this leads only to coital 
reproduction, nothing more.
---------------------------------------------------------------------------
    \83\ Robertson, 69 VA L. Rev. at 415.
---------------------------------------------------------------------------
    The second line of cases involves rearing children, or the 
``assignment of rearing rights,'' in Robertson's words, from which he 
infers ``a right to bring children into the world.'' Parental rights, 
however, are deeply rooted in American law and tradition and the common 
law, involving relationships between living parents and living 
children. There are several limitations on these rights that do not 
imply any right to non-coital, asexual reproduction. First, the 
parental relationship is founded in duty, not ownership. Second, these 
rights presume the existence of children from coital reproduction and 
nothing more. Third, parental rights are limited by the interests of 
the children, and while Roe establishes a right to end the life of a 
child conceived but not yet born, it says nothing about ending the life 
of children conceived in vitro. Roe involves a right to be free of the 
physical burden of pregnancy.
    Hence, nothing in Supreme Court case law jumps the gap between 
coital and non-coital reproduction--to say nothing of the gap from 
sexual to asexual reproduction--and the reliance of the cases involving 
coital reproduction on physical integrity cannot be extended to the 
extracorporeal use of germ cells to achieve in vitro fertilization. 
Finally, it is apparent in Robertson's construction of his procreative 
liberty that the essence of this parental right is the exertion of 
parental will and desire, a notion of ownership, the imposition of 
personal will, a conditional love or care. It is exactly this notion 
that characterized the complete autonomy of the Roman father and was 
repudiated by the common law.
B. The Limits of Roe's Right to ``Terminate Pregnancy''
    Roe v. Wade, properly understood on its own terms, dealt with a 
right to ``terminate pregnancy'' and nothing more.84 It was 
entirely based on the physical impact of pregnancy on a woman and her 
desire to rid herself of the pregnancy.85 To use Professor 
Robertson's words, Roe involved ``the physical burdens of bearing and 
giving birth.'' 86 As the Court noted in Harris v. McRae, 
``the Court in Wade emphasized the fact that the woman's decision 
carries with it significant personal health implications--both physical 
and psychological.'' 87 Roe created a negative right to 
terminate a pregnancy without social (governmental) limits; it did not 
establish a positive liberty to procreation or a positive liberty in 
non-coital reproduction. Roe created a right to avoid procreation, not 
a right to procreate. This characterization was reaffirmed in Carey v. 
Populations Services International, 88 and Planned 
Parenthood v. Casey.89 The central discussion of 
``terminating pregnancy'' in Casey is concluded by a reference to 
``these considerations of the nature of the abortion right . . .'' 
90 Likewise, when the Court in Eisenstadt v. Baird refers to 
``the decision whether to bear or beget a child,'' 91 it was 
understood to refer to the literal physical burden of 
pregnancy.92 ``Terminating pregnancy'' is the concept of the 
Roe liberty held by Justice Blackmun himself.93
---------------------------------------------------------------------------
    \84\ See 410 U.S. at 170 (Stewart, concurring) (``the right of a 
woman to decide whether or not to terminate her pregnancy'').
    \85\ Roe, 410 U.S. at 150 (discussing the risk to the woman, state 
has interest in protecting the woman's own health and safety; 153 
(detailing ``detriment'' to pregnant woman by ``denying this choice''), 
162 (``the rights of the pregnant woman at stake''). See also Casey, 
112 S.Ct. at 2807 (``The mother who carries a child to full term is 
subject to anxieties, to physical constraints, to pain that only she 
must bear''), 2816 (``the urgent claims of the woman to retain the 
ultimate control over her destiny and her body'').
    \86\ Robertson, 69 VA L. Rev. at 416.
    \87\ 448 U.S. at 316.
    \88\ 431 U.S. 678, 688 (1977) (``an individual's right to decide to 
prevent conception or terminate pregnancy . . .'').
    \89\ 112 S.Ct. at 2804 (``the legitimate authority of the State 
respecting the termination of pregnancies by abortion procedures''), 
Id. (referring to ``essential holding'' of Roe as including ``right of 
the woman to choose to have an abortion''), 2806 (``the profound moral 
and spiritual implications of terminating a pregnancy''), 2807 (``the 
woman's interest in terminating her pregnancy''), 2810 (describing Roe 
as ``a rule . . . of personal autonomy and bodily integrity''), 2816 
(``freedom to terminate her pregnancy''), 2816 (``the right of the 
woman to terminate her pregnancy''), 2816 (``the woman's liberty to 
determine whether to carry her pregnancy to full term''), 2816 (``a 
right to choose to terminate her pregnancy''), 2817 (``[t]he woman's 
right to terminate her pregnancy''), 2818 (``a right to choose to 
terminate or continue her pregnancy''), 2820 (``the right to decide 
whether to terminate a pregnancy'').
    \90\ 112 S.Ct. at 2819.
    \91\ 405 U.S. 438, 453 (1972).
    \92\ See Casey, 112 S.Ct. at 2819 (quoting passage from 
Eisenstadt).
    \93\ See e.g., Casey, 112 S.Ct. at 2486-87 (``a woman's right to 
terminate her pregnancy'') (``continue pregnancies they might otherwise 
terminate'') (``the right to terminate pregnnacies'').
---------------------------------------------------------------------------
    Under the regime of Roe v. Wade, it is enough that legislation 
intervenes to protect human beings--the traditional function of the 
criminal law and homicide law. It is not necessary that the human 
beings be ``persons'' within the meaning of the 14th Amendment. 
Legislation does not need any other justification, if the exercise of 
legislative authority does not interfere with woman's right to 
abortion. The states can protect any extracorporeal human being under 
the homicide code. Protecting that extracorporeal embryo or human being 
does not interfere with the Court's limited abortion right. The right 
to ``procreative liberty'' is a negative right and does not extend to 
power over extracorporeal embryos or human beings.
    The limits of Roe are seen as well in the abortion-funding line of 
cases. In Maher v. Roe,94 the Court held that ``the right 
protects the woman from unduly burdensome interference with her freedom 
to decide whether to terminate her pregnancy.'' 95 In Harris 
v. McRae,96 the Supreme Court again referred, more than 
once, to the Roe liberty as ``the freedom of a woman to decide whether 
to terminate a pregnancy.'' 97 The funding cases demonstrate 
that the states may ``make a value judgment favoring childbirth over 
abortion'' and ``implement that judgment'' by the use of public 
funding.
---------------------------------------------------------------------------
    \94\ 432 U.S. 464, 473-74 (1977) (``the right protects the woman 
from unduly burdensome interference with her freedom to decide whether 
to terminate her pregnancy'').
    \95\ 432 U.S. at 473-74.
    \96\ 448 U.S. 297 (1980).
    \97\ 448 U.S. at 312. See also Id. at 316 (``the freedom of a woman 
to decide whether to terminate her pregnancy'') (three times on the 
same page).
---------------------------------------------------------------------------
    The Roe abortion liberty is also severely limited by the fact that 
it expressly and forcefully excludes men, even married men, from any 
right whatsoever in the abortion decision. The father of ``the 
developing child'' (as Casey used the phrase 98), even the 
woman's husband, has no right to consent (Danforth) or even notice 
(Casey). Many efforts by men to intervene in and stop abortions have 
been summarily rejected by the courts.99 Men have no legal 
right to be involved in abortion decisionmaking. Formally, the decision 
is the woman's. Roe saw the decisionmaking as between the woman and her 
doctor only, 100 and, as the plurality stated in Casey, 
``what is at stake is the woman's right to make the ultimate 
decision.'' 101 The plurality in Casey went on, at great 
length, describing the total exclusion of the father or spouse from 
decisionmaking.102 Legal commentators rejecting legal 
regulation of in vitro fertilization are inclined to wax eloquent over 
the involvement of ``couples'' in ``decisions about whether and when to 
bear children'' but fathers (and spouses) are strictly and absolutely 
excluded from the Roe framework and abortion decision 
making.103
---------------------------------------------------------------------------
    \98\ 112 S.Ct. at 2817.
    \99\ See e.g., Conn v. Conn, 525 N.E.2d 612 (Ind. Ct. App), aff'd, 
526 N.E.2d 958 (Ind.), cert. denied, 488 U.S. 955 (1988); Smith v. Doe, 
530 N.E.2d 331 (Ind. Ct. App. 1988), cert. denied, 492 U.S. 919 (1989).
    \100\ 410 U.S. at 156.
    \101\ 112 S.Ct. at 2821.
    \102\ 112 S.Ct. at 2826-31.
    \103\ See e.g., Lori Andrews, The Legal Status of the Embryo, 32 
Loyola L. Rev. 357, 359 (1986).
---------------------------------------------------------------------------
    The limits of Roe are fairly admitted even by proponents of a broad 
right of non-coital procreation. Thus, such a familiar advocate as John 
Robertson states:
          In the United States, the right to avoid reproduction by 
        contraception and abortion is now firmly established. Whether 
        single or married, adult or minor, a woman has a right to 
        terminate pregnancy up to viability 104 and both men 
        and women have the right to obtain and use contraceptives. The 
        right to procreate--to bear, beget and rear children--has 
        received less explicit legal recognition . . . [N]o cases (with 
        the possible exception of Skinner v. Oklahoma) turn on the 
        recognition of such a right. However, dicta in cases ranging 
        from Meyer v. Nebraska to Eisenstadt v. Baird clearly show a 
        strong presumption in favor of marital decisions to found a 
        family . . . What then about married couples who cannot 
        reproduce coitally? . . . The values and interests that 
        undergird the right to coital reproduction clearly exist with 
        the coitally infertile. Their interest in bearing, begetting or 
        parenting offspring is as worthy of respect as that of the 
        coitally fertile. It follows that restrictions on noncoital 
        reproduction by an infertile married couple should be subject 
        to the same rigorous scrutiny to which restrictions on coital 
        reproduction would be subject.105
---------------------------------------------------------------------------
    \104\ This misrepresents the scope of the Roe-Casey liberty. Roe 
did not limit the abortion liberty to viability. Instead, with the 
companion decision of Doe v. Bolton, 410 U.S. 179 (1973), Roe 
established a right to a ``health'' abortion throughout pregnancy 
(defined as ``all factors--physical, emotional, psychological, 
familial, and the woman's age--relevant to the well-being of the 
patient. All these factors may relate to health''). Id. at 192. Several 
federal courts have given such a broad reading to the ``health'' 
exception after viability. See e.g., Women's Med. Prof. Corp. v. 
Voinovich, 130 F.3d 187 (6th Cir. 1997), cert. denied, 118 S.Ct. 1347 
(1998) (Thomas, J., dissenting from the denial of certiorari); American 
College of Obstetricians and Gynecologists v. Thornburgh, 737 F.2d 283, 
298-99 (3d Cir. 1984), aff'd, 476 U.S. 747 (1986); Margaret S. v. 
Edwards, 488 F.Supp. 181 (E.D. La. 1980); Schulte v. Douglas, 567 
F.Supp. 522 (D.Neb. 1981), aff'd per curiam, sub nom. Women's Servs., 
P.C. v. Douglas, 710 F.2d 465 (8th Cir. 1983). The breadth of this 
``health'' exception after viability was not altered in the Casey 
decision. Planned Parenthood v. Casey, 505 U.S. 833, 846 (1992) 
(reaffirming ``State's power to restrict abortion after fetal 
viability, if the law contains exceptions for pregnancies which 
endanger a woman's life or health''), Id. at 878 (reaffirming Roe's 
holding ``that subsequent to viability, the State . . . may . . . 
regulate, and even proscribe, abortion except where it is necessary, in 
appropriate medical judgment, for the preservation of the life or 
health of the mother.''), Id. at 871 (``when the fetus is viable, 
prohibitions are permitted provided the life or health of the mother is 
not at stake'').
    \105\ John A. Robertson, Decisional Authority over Embryos and 
Control of IVF Technology, 28 Jurimetrics J. 285, 290 (1988).
---------------------------------------------------------------------------
Again, Robertson has noted the limits to Roe elsewhere, referring to 
``a woman's decision not to conceive or bear a child.''
          Even though the Court has eliminated most of the legal 
        limitations on the right to avoid pregnancy, the freedom not to 
        procreate is still circumscribed by a number of restrictions. 
        One such restriction derives from the negative nature of 
        constitutional protections, which shield individuals from state 
        interference with their liberty but do not guarantee them the 
        means to exercise those rights.106
---------------------------------------------------------------------------
    \106\ Robertson, Procreative Liberty and the Control of Conception, 
Pregnancy, and Childbirth, 69 VA L. Rev. 405, 405 n.3 (1983).
---------------------------------------------------------------------------
In sum, as one scholar has phrased it, ``to characterize some or all of 
the cases on which the Court relies in reaffirming Roe [in Casey] as 
standing for an abstract right to 'personal autonomy' simply creates an 
artificial common denominator among a very disparate and largely 
unrelated group of cases while at the same time denying what makes 
abortion unique.'' 107
---------------------------------------------------------------------------
    \107\ Linton, 13 St. Louis U. Pub. L. Rev. at 31.
---------------------------------------------------------------------------
    The issue, though, is not coital versus noncoital as much as 
corporeal versus extracorporeal reproduction (occurring outside the 
living body). The negative liberty that has been recognized by the 
Supreme Court is grounded in personal physical integrity, and the Court 
has on several occasions explicitly disavowed a right to use one's body 
in whatever way desired.108 The ``values and interests'' of 
the ``coitally infertile'' may be conceded, but it does not follow that 
these may be pursued by whatever means or ``techniques'' possible. Some 
techniques may be legitimate, while others are wholly illegitimate. And 
it does not follow that any of the techniques are necessarily of a 
constitutional dimension that overrides other social and ethical 
judgments made by society through the democratic process. Still less is 
it clear that the judiciary is empowered to override the authority and 
decisions of society through the democratic process.
---------------------------------------------------------------------------
    \108\ Roe, 410 U.S. at 154 (``it is not clear to us that the claim 
asserted by some amici that one has an unlimited right to do with one's 
body as one pleases bears a close relationship to the right of privacy 
previously articulated in the Court's decisions''); Jacobson v. 
Massachusetts, 197 U.S. 11 (1905) (vaccination).
---------------------------------------------------------------------------
    Robertson's analysis begs all of these questions by focusing on one 
consideration to the exclusion of all others. Richard McCormick has 
mounted an insightful critique of Robertson's utilitarian approach to 
the status of the human embryo and ethical defense of human cloning by 
blastomere separation (despite McCormick's use of the term ``pre-
embryo'' and his general agreement that a human embryo is not a 
person).109 In McCormick's words, Robertson's defense is 
``breathtaking in the speed with which it subordinates every 
consideration to its [cloning by blastomere separation] usefulness in 
overcoming infertility. [Robertson's] thesis can be summarized as 
follows: if it aids otherwise infertile couples to have children, it is 
ethically acceptable . . . anything that is useful for overcoming 
infertility is ethically acceptable.'' 110 McCormick points 
out that Robertson is trying to create a consensus, not protect an 
existing one.
---------------------------------------------------------------------------
    \109\ Cf. Robertson, The Question of Human Cloning, 24 Hastings 
Center Report No. 2 at 6 (1994), with McCormick's response, Richard A. 
McCormick, Blastomere Separation: Some Concerns, 24 Hastings Center 
Report No. 2 at 14 (1994).
    \110\ McCormick, supra note 82, at 14.
---------------------------------------------------------------------------
    The limits of Roe are apparent, as well, from the Joint Opinion in 
Casey, where the plurality of Justices O'Connor, Kennedy and Souter 
shifted the basic rationale of the abortion liberty from privacy to the 
sociological grounds of abortion as a backup for failed contraception 
and the ``reliance interests'' of Americans.111 The Joint 
Opinion again put the emphasis on terminating pregnancy, a backup to 
contraception, not a positive liberty to ``procreate'' by any means, 
much less a liberty in extracorporeal reproduction.
---------------------------------------------------------------------------
    \111\ 112 S.Ct. at 2809 (``for two decades of economic and social 
developments, people have organized intimate relationships and made 
choices that define themselves and their places in society, in reliance 
on the availability of abortion in the event that contraception should 
fail'').
---------------------------------------------------------------------------
    It may be said that American law establishes a privacy interest in 
marital coital reproduction. But even this is limited to marriage. The 
precedents leading to Roe fairly establish this. Harlan's specific 
emphasis in Poe v. Ullman was that the state statute in question 
criminalized marital use of contraception.112 While there 
may be a right to the use of contraceptives, even by minors, there is 
still no established liberty in premarital or extramarital sexual 
relations.113
---------------------------------------------------------------------------
    \112\ 367 U.S. 497, 554-55 (Harlan, J., dissenting from dismissal 
on jurisdictional grounds). See also Griswold v. Connecticut, 381 U.S. 
479, 499 (Harlan, J., concurring in the judgment).
    \113\ Indeed, in Eisenstadt v. Baird, the Court implicitly 
acknowledged the state's authority to prohibit ``extramarital and 
premarital sexual relations.'' 405 U.S. at 448. And Eisenstadt was 
based on the Equal Protection Clause, not the Due Process Clause. 
Likewise, Carey v. Population Services Inter'l, 431 U.S. 678 (1977), 
decided after Roe, did not create a right to premarital or extramarital 
sexual activity. 431 U.S. at 688 n.5, 694 & n.17. See also Id. at 702 
(White, J., concurring in part and concurring in the judgment), Id. at 
713 (Stevens, J., concurring in part and concurring in the judgment).
---------------------------------------------------------------------------
    Roe itself identified abortion as unique and ``inherently different 
from marital intimacy, or bedroom possession of obscene material, or 
marriage, or procreation, or education, with which Eisenstadt and 
Griswold, Stanley, Loving, Skinner, and Pierce and Meyer were 
respectively concerned.'' 114 The courts have not gone 
beyond Roe's formulation since 1973. As Casey demonstrates, Roe and 
abortion have both been treated as ``sui generis.'' 115 In 
fact, the Casey plurality frankly stated that ``abortion is a unique 
act.'' 116
---------------------------------------------------------------------------
    \114\ 410 U.S. at 159.
    \115\ 112 S.Ct. at 2810.
    \116\ Id. at 2807 (``the liberty of the woman is at stake in a 
sense unique to the human condition and so unique in the law'').
---------------------------------------------------------------------------
    No court has held that there is a constitutional right to in vitro 
fertilization. Two lower federal courts have struck down fetal 
experimentation statutes, but on vagueness grounds alone, while a third 
has upheld a fetal experimentation statute.117
---------------------------------------------------------------------------
    \117\ Lifchez v. Hartigan, 735 F.Supp. 1361 (N.D.Ill.), aff'd, 914 
F.2d 260 (7th Cir. 1990), cert. denied, 498 U.S. 1069 (1991); Margaret 
S. v. Edwards, 794 F.2d 994 (5th Cir. 1986); Jane L. v. Bangerter, 794 
F.Supp. 1537 (D. Utah 1992).
---------------------------------------------------------------------------
    The broader formulation of a positive liberty in ``procreation'' by 
various scholars is based on contemporary moral philosophy, rather than 
caselaw, or legal or constitutional history. Some would ground the 
procreative liberty and its scope on the subjectivity of the ``choice'' 
rather than physical integrity. For example, John Robertson has written 
that ``[t]he personal importance of a decision or activity, rather than 
its secrecy from the gaze of others, determines its status as part of 
protected privacy (or liberty, to be more precise.).'' 118 
The Supreme Court expressly rejected such a formulation in Washington 
v. Glucksberg.
---------------------------------------------------------------------------
    \118\ Robertson, 28 Jurimetrics J. at n.16.
---------------------------------------------------------------------------
C. Differentiating Cruzan, Vacco, Glucksberg
    Proponents of an unlimited procreative autonomy have relied on the 
expansive language of autonomy in Planned Parenthood v. 
Casey,119 sometimes called the ``mystery'' passage. There, 
the plurality opinion stated: ``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. Beliefs about these matters could not 
define the attributes of personhood were they formed under compulsion 
of the State.'' 120 But it was aptly argued by scholars that 
this passage must be considered within the context of the plurality's 
entire opinion and its emphasis on stare decisis.121 Within 
that context, the passage should be most accurately understood as 
rhetorical and not as prescriptive of any specific rights.
---------------------------------------------------------------------------
    \119\ 505 U.S. 833 (1992).
    \120\ 505 U.S. at 851.
    \121\ See e.g., Yale Kamisar, Against Assisted Suicide--Even a Very 
Limited Form, 72 U. Det. Mercy L. Rev. 735, 765-68 (1995); Richard S. 
Myers, An Analysis of the Constitutionality of Laws Banning Assisted 
Suicide from the Perspective of Catholic Moral Teaching, 72 U. Det. 
Mercy L. Rev. 771, 777-78 (1995).
---------------------------------------------------------------------------
    The scope of Casey was demonstrated to be narrow in the Supreme 
Court's landmark decision in Washington v. Glucksberg,122 
where the Court held that the Due Process Clause does not protect any 
right to assisted suicide. First, the Court in Glucksberg specified the 
two strict requirements of substantive due process. The Due Process 
Clause protects ``those fundamental rights and liberties which are, 
objectively, `deeply rooted in this Nation's history and tradition' 
[cit. omit.] and `implicit in the concept of ordered liberty,' such 
that `neither liberty nor justice would exist if they were sacrificed.' 
'' And a ``careful description'' of ``the asserted fundamental liberty 
interest'' is required.123 It must first be established that 
an asserted interest is fundamental so as to ``avoid[] the need for 
complex balancing of interests in every case.'' 124
---------------------------------------------------------------------------
    \122\ 117 S.Ct. 2258 (1997).
    \123\ 117 S.Ct. at 2268.
    \124\ Id. at 2268.
---------------------------------------------------------------------------
    Second, the Court specifically emphasized the limited nature of the 
passage from Casey. Referring to this passage, the Court stated:
          By choosing this language, the Court's opinion in Casey 
        described, in a general way and in light of our prior cases, 
        those personal activities and decisions that this Court has 
        identified as so deeply rooted in our history and traditions, 
        or so fundamental to our concept of constitutionally ordered 
        liberty, that they are protected by the Fourteenth Amendment. 
        The opinion moved from the recognition that liberty necessarily 
        includes freedom of conscience and belief about ultimate 
        considerations to the observation that `though the abortion 
        decision may originate within the zone of conscience and 
        belief, it is more than a philosophic exercise.' [cit. omit.] 
        That many of the rights and liberties protected by the Due 
        Process Clause sound in personal autonomy does not warrant the 
        sweeping conclusion that any and all important, intimate, and 
        personal decisions are so protected [cit. omit.], and Casey did 
        not suggest otherwise.125
---------------------------------------------------------------------------
    \125\ 117 S.Ct. at 2271.
---------------------------------------------------------------------------
Two of the three Justices who joined the Casey plurality opinion joined 
this opinion in Glucksberg (O'Connor and Kennedy).
    The Court in Glucksberg also reaffirmed the limits of Cruzan v. 
Director, Missouri Dept of Health.126 The right recognized 
by the Supreme Court in Cruzan was a right to ``refuse unwanted medical 
treatment,'' not a ``right to treatment'' and not a ``right to die.'' 
127 The right is properly seen as a right to refuse medical 
treatment, based in bodily integrity and the common law doctrine of 
informed consent, and not a right to ``bodily expression.'' As the 
Court stated in Glucksberg, ``[t]he right assumed in Cruzan . . . was 
not simply deduced from abstract concepts of personal autonomy. Given 
the common-law rule that forced medication was a battery, and the long 
legal tradition protecting the decision to refuse unwanted medical 
treatment, our assumption was entirely consistent with this Nation's 
history and constitutional traditions.'' 128
---------------------------------------------------------------------------
    \126\ 497 U.S. 261 (1990).
    \127\ 117 S.Ct. at 2270.
    \128\ Id. at 2270.
---------------------------------------------------------------------------
    In addition, the Court stated in Cruzan, and reaffirmed in 
Glucksberg, that the states have an ``unqualified interest in 
preservation of human life.'' 129 As the Court stated in 
response to the suicide advocates' argument in Glucksberg that the 
state's interest in life only applies to ``those who can still 
contribute to society and enjoy life'':
---------------------------------------------------------------------------
    \129\ 117 S.Ct. at 2272 (quoting Cruzan, 497 U.S. at 282 and the 
Model Penal Code ``The interests in the sanctity of life that are 
represented by the criminal homicide laws are threatened by one who 
expresses a willingness to participate in taking the life of an 
other'').
---------------------------------------------------------------------------
          Washington, however, has rejected this sliding-scale approach 
        and, through its assisted-suicide ban, insists that all 
        persons' lives, from beginning to end, regardless of physical 
        or mental condition, are under the full protection of the law. 
        [citing United States v. Rutherford, 442 U.S. 544, 558 (1979) 
        (``. . . Congress could reasonably have determined to protect 
        the terminally ill, no less than other patients, from the vast 
        range of self-styled panaceas that inventive minds can 
        devise''] As we have previously affirmed, the States 'may 
        properly decline to make judgments about the 'quality' of life 
        that a particular individual may enjoy. [citing Cruzan, 497 
        U.S. at 282] This remains true, as Cruzan makes clear, even for 
        those who are near death.130
---------------------------------------------------------------------------
    \130\ 117 S.Ct. at 2272.
---------------------------------------------------------------------------
Although in Glucksberg, this interest applies to the end of life, there 
is no reason--outside the strict constraints of Roe and bodily 
pregnancy--that this unqualified interest does not apply equally to 
both ends, or all stages, of human life. Thus, just as the states can 
decline to ``make judgments about the ``quality'' of life that a 
particular individual may enjoy,'' and enjoin assisted suicide despite 
an individual ``interest'' in assisted suicide, so too the states may 
protect extracorporeal human embryos despite varying notions about 
``personhood'' or the interests of infertile individuals.
    Since Roe, defenders of the abortion liberty have sometimes shifted 
from the Due Process Clause to the Equal Protection Clause to sustain 
Roe.131 To the extent that this is persuasive, it cuts 
against any right to human cloning. And it is instructive that Justice 
O'Connor, at oral argument in Vacco and Glucksberg, emphasized that 
suicide (and death and dying) did not affect women uniquely but 
affected men and women equally. In this context, a ban on human 
cloning--and the protection of extracorporeal human embryos--would fall 
equally on women and men. A prohibition on somatic cell nuclear 
transfer applies equally to the cells of men and women. For these 
reasons, as well, Roe and its progeny could not encompass a right to 
human cloning or somatic cell nuclear transfer.
---------------------------------------------------------------------------
    \131\ See e.g., Richard Posner, Sex and Reason 339-40 (1992) 
(noting such a shift).
---------------------------------------------------------------------------
                   III. LEGAL LIMITS ON HUMAN CLONING

A. The Interests in Human Cloning
    There are clear, compelling state interests that justify a ban on 
human cloning and outweigh any supposed ``right'' to human cloning. 
These can be grouped into three categories: preventing the extensive 
destructive of human life that human cloning would clearly involve, 
preventing injury to the child-to-be, and preventing the degradation of 
the parent-child relationship.
    There are obvious utilitarian benefits to be gained from animal and 
plant cloning. The utilitarian considerations that are appropriate for 
plants and animals, however, cannot be extended to humans. To do so 
violates a basic principle of human rights--to treat human beings as 
ends and not as means.132
---------------------------------------------------------------------------
    \132\ See e.g., Tom L. Beauchamp & James F. Childress, Principles 
of Biomedical Ethics 7 (1979).
---------------------------------------------------------------------------
    Perhaps the three most compelling reasons for human cloning 
research are the production of children for infertile couples, possible 
enhancement of the ability to do prenatal diagnosis and detect genetic 
defects in the embryo leading to eugenic abortion, and the knowledge 
derived from cloning embryos that may result in new therapies (such as 
transplantation) to treat disease.133 Among the interests 
that might support human cloning, the NBAC referred to ``important 
social values, such as protecting the widest possible sphere of 
personal choice, particularly in matters pertaining to procreation and 
child rearing, maintaining privacy and the freedom of scientific 
inquiry, and encouraging the possible development of new biomedical 
breakthroughs.'' 134
---------------------------------------------------------------------------
    \133\ See e.g., Robert Edwards, Ethics and embryos: the case for 
experimentation, in Anthony Dyson & John Harris, Experiments on Embryos 
42, 50 (1990); John Harris, Embryos and hedgehogs: on the moral status 
of the embryo, in Anthony Dyson & John Harris, Experiments on Embryos 
75-76 (1990).
    \134\ National Bioethics Advisory Commission, Cloning Human Beings: 
Report and Recommendations of the National Bioethics Advisory 
Commission ii (1997) (hereinafter NBAC Report).
---------------------------------------------------------------------------
    One of the most commonly argued reasons for human cloning is 
infertility. Cloning will be a handmaiden to IVF. As Robertson states, 
``scientific zeal and profit motive combine with the desire of 
infertile couples for biologic offspring to create an enormous power to 
manipulate the earliest stages of human life in infertility centers 
across the country.'' 135 Some couples undergoing IVF who 
``cannot produce enough viable embryos to initiate pregnancy'' might 
arguably seek cloning by blastomere separation or somatic cell nuclear 
transfer.136 Human cloning, it has been argued, is justified 
as just an ``incremental step beyond what we are already doing with 
artificial insemination, in vitro fertilization, fertility enhancement 
drugs and genetic manipulation.'' 137 While the anquish of 
infertile women and couples may be great, it does not logically follow 
that they may seek any means to counteract that infertility or seek any 
means to have a particular child to their liking. There is no ``right'' 
to a ``perfect child,'' as demonstrated by the long legal tradition 
against infanticide, or a right to perpetuate one's lineage. It follows 
that there is no right to a genetically perfect or identical child. At 
some point, there are simply ethical limits to available solutions to 
infertility.
---------------------------------------------------------------------------
    \135\ Robertson, Hastings Center Rep. at 7.
    \136\ Jerome P. Kassirer & Nadia A. Rosenthal, Should Human Cloning 
Research Be Off Limits?, 338 New Eng. J. Med. 905, 905 (1998).
    \137\ Laurence Tribe, Second Thoughts on Cloning, New York Times, 
Dec. 5, 1997, p. A23.
---------------------------------------------------------------------------
    There are times when scientific knowledge is greatly desired but 
not morally obtainable. At those times, it is necessary to pursue other 
avenues or to wait. There are alternatives to cloning, and to embryo 
experimentation in general, such as obtaining stem cells from other 
sources, such as umbilical cord blood. Alternative avenues that are 
morally permissible must be pursued. A ban on human cloning would 
create appropriate incentives to invest in alternative areas of 
research, which--though perhaps more difficult or expensive--do exist.
B. The Interests Protected by Prohibiting Human Cloning
    Many ethical objections have been leveled against human cloning by 
Leon R. Kass, a biochemist and bioethicist from the University of 
Chicago, and others. These include the following: (1) cloning creates 
confusion of identity and individuality, (2) cloning represents a giant 
step toward transforming procreation into manufacture, that is, toward 
the increasing depersonalization of the process of generation, the 
production of human children as artifacts, products of human will and 
design, (3) cloning represents a form of despotism of the cloners over 
the cloned and thus is a blatant violation of the inner meaning of 
parent-child relations, of what it means to have a child, and (4) any 
attempt to clone a human being would constitute an unethical experiment 
upon the resulting child because of the lack of any consent by the 
child produced.138 The common law born alive rule provides a 
solid legal basis for these arguments: any human being injured before 
birth can claim injury after birth. There is congruence between the 
human entity before and after birth.
---------------------------------------------------------------------------
    \138\ See Kass, The Wisdom of Repugnance: Why we should can the 
cloning of humans, The New Republic, June 2, 1997, at 17. See also Leon 
R. Kass, The Wisdom of Repugnance, 32 Val. U.L. Rev. 679. See also, 
Marc Lappe, Four reasons to step back from cloning, Chicago Tribune, 
March 8, 2001, sec. 1, p. 21 (``According to the original Nuremberg 
Code developed at the end of WWII to prevent future abuses of medical 
research subjects, every experimental subject should have the right to 
terminate his experiment. How would we ever get an acceptable consent 
from future generations?'').
---------------------------------------------------------------------------
    1.Preventing Experimentation On and Death of Unborn Human Beings--
Human cloning, and the process of developing it, will inevitably 
involve creating, manipulating, and killing individual members of the 
human species, i.e., human beings. (Killing is not a rhetorical word, 
simply the straight-forward use of the dictionary 
definition.139 We may ``discard'' things, because things do 
not die, but we ``kill'' living beings by causing their death. The very 
use of the term ``discard''--as is typical in most ethical discussions 
of embryo experimentation--reduces the living human embryo to a thing.) 
Congressional testimony and debates indicate that it is precisely the 
ambition of scientists to do research on such developing human 
entities, with the ``disposal'' of many or most. John Robertson vividly 
describes the casual treatment of ex utero embryos.140
---------------------------------------------------------------------------
    \139\ See e.g., Webster's Ninth New Collegiate Dictionary 661 
(1987) (``Kill merely states the fact of death caused by an agency in 
any manner.''); American Heritage Student Dictionary 546 (1994) (kill: 
``To cause the death of; deprive of life'').
    \140\ See e.g., John A. Robertson, The Question of Human Cloning, 
Hastings Ctr. Rep. Mar.-Apr. 1994 at 7. See also Margaret Talbot, A 
Desire to Duplicate, New York Times Magazine, February 4, 2001, at 140 
(``Cloning mammals is a wildly inefficient process that can require 
hundreds of attempts both to create an embryo and to implant it 
successfully.'').
---------------------------------------------------------------------------
    Cloning will inevitable involve non-therapeutic experimentation on, 
and killing of, human embryos.141 Several international 
codes of medical ethics avoid any distinction between human beings and 
persons by addressing the interests of ``human beings'' and ``human 
subjects.'' For example, the Nuremburg Code (1947) limited 
experimentation on the ``human subject'' by requiring that ``voluntary 
consent'' is ``absolutely essential.'' Experimentation is not permitted 
on ``human subjects'' without ``legal capacity to give consent'' and 
cannot be continued if ``a continuation of the experiment is likely to 
result in injury, disability, or death to the experimental subject.'' 
142 Likewise, the Declaration of Geneva [1948] declares: ``I 
will maintain the utmost respect for human life from conception.'' 
Similarly, the United Nations Declaration on the Child (November 20, 
1959) states: ``The child by reason of his physical and mental 
immaturity needs special safeguards and care, including appropriate 
legal protection before as well as after birth.'' By these 
contemporary, authoritative ethical standards, human cloning cannot be 
justified.143 This is most clearly true with intentionally 
cloning human beings for research without intending to implant them.
---------------------------------------------------------------------------
    \141\ NBAC Report, supra note 134, at 63-64. See e.g., Marc Lappe, 
Four reasons to step back from cloning, Chicago Tribune, March 8, 2001, 
sec. 1, p. 21 (``Much of the more subtle damage in animal clones has 
shown up only one ore more generations after the first one was 
cloned.'').
    \142\ Warren Thomas Reich, ed., Encyclopedia of Bioethics 2763 
(Rev. ed.) (vol. 5, Appendix).
    \143\ See e.g., Marc Lappe, Four reasons to step back from cloning, 
Chicago Tribune, March 8, 2001, sec. 1, p. 21 (``According to the 
original Nuremberg Code developed at the end of WWII to prevent future 
abuses of medical research subjects, every experimental subject should 
have the right to terminate his experiment. How would we ever get an 
acceptable consent from future generations?'').
---------------------------------------------------------------------------
    It is precisely the prerogative of society to give respect to the 
dignity of these developing human beings and to require that equal 
dignity and respect be given by other individuals. Anglo-American law 
has always treated human beings, and the human species as special, and 
uniquely protected it through homicide law.
    2. Preserving Human Freedom and Dignity--It is obvious that human 
cloning by any means (by somatic cell nuclear transfer or blastomere 
separation) is intended to use unborn human beings, who would be 
treated as means, not ends, who would be evaluated and valued precisely 
because of their attributes. The NBAC referred to ``a possibly 
diminished sense of individuality and personal autonomy.'' 
144
---------------------------------------------------------------------------
    \144\ NBAC Report, supra note 134, at ii. See Kass, 32 Val. U.L. 
Rev at 694-95.
---------------------------------------------------------------------------
    It would extend the degree of control over shaping human lives and 
in ways that are highly subjective. Clearly, human cloning is not 
therapeutic, either to the mother or the human being cloned, and is 
elective. Cloning is only the most recent and highly publicized example 
of the admonition that technology always involves the power of some 
people over other people.145 As the Oxford scholar, C.S. 
Lewis has written, ``For the power of Man to make himself what he 
pleases means . . . the power of some men to make other men what they 
please.'' 146 Of course, education--to a greatly limited 
extent--has always involved a similar power. But, as C.S. Lewis points 
out, ``in the older systems both the kind of man the teachers wished to 
produce and their motives for producing him were prescribed by the 
Tao--a norm to which the teachers themselves were subject and from 
which they claimed no liberty to depart. They did not cut men to some 
pattern they had chosen.'' 147
---------------------------------------------------------------------------
    \145\ See generally, Paul Ramsey, Fabricated Man: The Ethics of 
Genetic Control (1970); C.S. Lewis, The Abolition of Man (1950).
    \146\ C.S. Lewis, The Abolition of Man 72 (1950).
    \147\ Id. at 73-74.
---------------------------------------------------------------------------
    Perhaps the most sympathetic case for cloning a human being--the 
genetic replacement of a lost child--shows instead the 
depersonalization of children. The notion that genetically cloning the 
child will replace the child suggests that children are their genes. We 
know that children are at least their genes, but they are more than 
their genes. Children are not fungible and cannot simply be 
``replaced.''
    3. The Diminution of Parental Responsibility--A third result of 
human cloning is a coarsening of the relationship between parents and 
cloned children. The NBAC referred to a ``concern about a degradation 
in the quality of parenting and family life.'' 148 With 
cloning, children will be manufactured in ways that are highly 
subjective and particular. Because of highly subjective criteria, 
cloned children will be conditionally accepted; in fact, if the 
conditions are not satisfied, they will most likely not be born at 
all--the embryos will be ``discarded.'' Such conditional acceptance 
treats children as commodities or possessions. Consequently, ``family 
relations are necessarily diminished, turned into merely contractual 
relationships between autonomous individuals.'' 149
---------------------------------------------------------------------------
    \148\ NBAC Report, supra note 134, at ii. See Kass, 32 Val. U. L. 
Rev at 697-98.
    \149\ Allen Verhey, Theology after Dolly, Christian Century, March 
19-26, 1997, at 285.
---------------------------------------------------------------------------
    As Leon Kass has testified:
          Cloning also represents a giant step (not the first) toward 
        transforming procreation into manufacture, children into 
        artifacts and commodities, products of human will and design. 
        Cloning, like other nontherapeutic genetic engineering, is a 
        form of despotism, an attempt to make children in our image and 
        to control in advance their future. It thus represents in 
        blatant form a deep violation of the meaning of parent-child 
        relations, of the meaning of procreatively saying yes to our 
        own demise and ``replacement.'' 150
---------------------------------------------------------------------------
    \150\ Leon Kass, supra note 134, at 21. A version of this testimony 
has been published as Leon R. Kass, The Wisdom of Repugnance: Why We 
Should Ban the Cloning of Humans, 32 Val. U.L. Rev. 679 (1998).
---------------------------------------------------------------------------
    A resulting detachment between parent and child is not speculative. 
We see it already in sperm and egg donation, as exemplified by the 
California Court of Appeals' decision in Jaycee Buzzanca.151 
Buzzanca was conceived from anonymous sperm and egg donors and born in 
1995 to a surrogate mother (with her husband's consent), contracted by 
John and Luanne Buzzanca. The Buzzancas separated shortly after Jaycee 
was conceived and subsequently divorced. Luanne Buzzanca, who had 
custody of Jaycee since birth but had not adopted her, sued John 
Buzzanca for child support, and was ``the only one of the six people 
who helped create her to claim parental rights.'' 152 A 
California Superior Court judged ruled that Jaycee had no legal 
parents, but the court of appeals reversed. Advocates for Jaycee argued 
that the court should focus on what is best for the child and not on 
the biological status of the Buzzancas, and the ACLU contended that the 
child has a ``right to have parents'' that overrules the lack of legal 
precedent in California. The way to give meaning to a ``the child's 
right to have parents,'' however, is by preserving biological links and 
preventing detached, asexual reproduction through cloning, not by 
imposing parental responsibilities, after the fact, on people who do 
not have a biological link with the child. The California court of 
appeals explicitly urged the state legislature to address the situation 
through legislation because ``[t]hese cases will not go away.'' 
153
---------------------------------------------------------------------------
    \151\ Buzzanca v. Buzzanca, 72 Cal. Rptr. 2d 280 (Cal. App. 1998).
    \152\ Ann Davis, Artificial-Reproduction Arrangers Are Ruled 
Child's Legal Parents, Wall Street Journal, March 11, 1998, at B2.
    \153\ Buzzanca, 72 Cal. Rptr. 2d at 293.
---------------------------------------------------------------------------
    Cloning would overturn the traditional rule of Anglo-American 
jurisprudence that limits parental authority over the life and health 
of the child. The protection of vulnerable human life is reflected in 
the common law's clear repudiation of the absolute power of the Roman 
father over the life of the child and the common law's elevation of 
legal protection for human life. Blackstone pointed out this 
contrast.154 Justice James Wilson, one of the first 
associate justices of the Supreme Court, emphasized the common law 
protection for the unborn and newborn child:
---------------------------------------------------------------------------
    \154\ 1 Blackstone 440.
---------------------------------------------------------------------------
          I shall certained by excused from adducing any formal 
        arguments to evince, that life, and whatever is necessary for 
        the safety of life, are the natural rights of man. Some things 
        are so difficult; others are so plain, that they cannot be 
        proved. It will be more to our purpose to show the anxiety, 
        with which some legal systems spare and preserve human life; 
        the levity and cruelty which others discover in destroying or 
        sporting with it; and the inconsistency, with which, in others, 
        it is, at some times, wantonly sacrificed, and, at other times, 
        religously guarded . . .
          [I]n Sparta, if any infant, newly born, appeared, to those 
        who were appointed to examine him, ill formed or unhealthy, he 
        was, without any further ceremony, thrown into a gulph near 
        mount Taygetus . . . At Athens, the parent was empowered, when 
        a child was born, to pronounce on its life or its death . . . 
        [A]t Rome, the sone held his life by the tenure of her father's 
        pleasure . . .
          With consistency, beautiful and undeviating, human life, from 
        its commencement to its close, is protected by the common law. 
        In the contemplation of law, life begins when the infant is 
        first able to stir in the womb. By the law, life is protected 
        not only from immediate destruction, but from every degree of 
        actual violence, and, in some cases from every degree of danger 
        . . .155
---------------------------------------------------------------------------
    \155\ 2 The Works of James Wilson 596-97 (R.G. McCloskey ed. 
(1967). See also Adam Smith, Lectures on Jurisprudence 172-75 (R. Meek, 
D. Raphael, P. Stein, eds. 1978) (Liberty Classics Reprint 1982) 
(quote).
---------------------------------------------------------------------------
Wilson concluded that ``[t]he formidable power of a Roman father is 
unknown to the common law. But it vests in the parent such authority as 
is conducive to the advantage of the child.'' 156 This 
sentiment was apparently familiar to lawyers during the Founding era, 
because it is reflected as well in the legal training of John Quincy 
Adams, who observed that the common law ``has restrained within proper 
bounds, even the sacred rights of parental authority, and shewn the 
cruelty, and the absurdity of abandoning an infant to destruction for 
any deformity in its bodily frame.'' 157 To paraphrase 
Justice Harlan, this is a tradition from which we have broken.
---------------------------------------------------------------------------
    \156\ 2 Works of James Wilson at 604.
    \157\ 2 JQA, Diary of John Quincy Adams 193 (March 1786-December 
1788) (entry of April 2, 1787).
---------------------------------------------------------------------------
    Based on the common law principle that parental authority must be 
consistent with the life and health of the child, states have limited 
parental control that threatens the life or health of the child. For 
example, parental beliefs against medical treatment can be overriden to 
preserve the life and health of the child. Parents may be held 
responsibility for the death of the child if medical treatment is not 
provided. Based on this principle, the states have a related interest 
in limiting parental control over the genetic destiny of a child.
    The interests against human cloning cannot be protected short of a 
prohibition on the practice. Once cloned, the embryo's genetic identity 
is formed and controlled and, while subject to further possible 
experimentation, it cannot be unaltered. Once cloned, it is not 
possible to effectively protect the life of the extracorporeal embryo. 
Requiring implantation is inconceivable, and placing them for 
``adoption'' would entail freezing techniques carrying a high risk of 
death or injury. The only effective way to protect the human embryo is 
to prevent cloning altogether.
    Each of these concerns independently justifies a ban on human 
cloning. Each supports state action outside the context of abortion to 
protect human life.

                               CONCLUSION

    As the Professor Gilbert Meilaender testified to the National 
Bioethics Advisory Commission (NBAC) on human cloning, ``sometimes we 
may only come to understand the nature of the road we are on when we 
have already traveled fairly far along it.'' 158 Human 
cloning is the logical outcome and most recent extension of 20 years of 
embryo experimentation and manipulation and may be the most subtle 
extension of that technique and philosophy in its denigration of the 
dignity of the human being. It proceeds on a cramped, artificial, and 
impersonal view of human beings and reflects the dehumanizing spirit of 
Aldous Huxley's Brave New World. The impersonal instinct that leads to 
controlling the genetic destiny of one's progeny comes from the same 
instinct that treats the human embryo as just a clump of cells. 
Hopefully, the publicity and analysis given to human cloning will 
illuminate and education Americans on the entire misguided effort of 
human embryo experimentation and manipulation.
---------------------------------------------------------------------------
    \158\ Reprinted as Gilbert Meilaender, ``Begetting and Cloning,'' 
First Things 41, 43 (June/July 1997). See also Gilbert Meilaender, 
Cloning in Protestant Perspective, 32 Val. U.L. Rev. 707 (1998).
---------------------------------------------------------------------------
    At important junctures in this century, scientists have recognized, 
as a basic tenet of medical ethics, that protection of the human being 
is more important than the interests of science or society. That is the 
essence of the Nuremburg Code, which reaffirmed limits on research on 
human subjects. As the 1975 Helsinki Declaration of the World Medical 
Association stated, ``Concern for the interests of the subject must 
always prevail over the interest of science and society.'' 
159 Twenty-seven years ago, Nobel Prize-winning biologist 
James Watson noted that ethical decisions about human cloning could not 
be left to science:
---------------------------------------------------------------------------
    \159\ Declaration of Helsinki, World Medical Association (1989), 
reprinted in 5 Warren T. Reich, Encyclopedia of Bioethics 2766 (Rev. 
ed. 1995). See also id at 2767 (``In research on man, the interest of 
science and society should never take precedence over considerations 
related to the well-being of the subject.''). See also Declaration of 
Geneva, World Medical Association (1948) (``I will maintain the utmost 
respect for human life from the time of conception.''), reprinted in 5 
Warren T. Reich, Encyclopedia of Bioethics 2646-47 (Rev. ed. 1995).
---------------------------------------------------------------------------
          This is a matter far too important to be left solely in the 
        hands of the scientific and medical communities. The belief 
        that surrogate mothers and clonal babies are inevitable because 
        science always moves forward, an attitude expressed to me 
        recently by a scientific colleague, represents a form of 
        laissez-faire nonsense dismally reminiscent of the creed that 
        American business, if left to itself, will solve everybody's 
        problems. Just as the success of a corporate body in making 
        money need not set the human condition ahead, neither does 
        every scientific advance automatically make our lives more 
        ``meaningful.'' No doubt the person whose experimental skill 
        will eventually bring forth a clonal baby will be given wide 
        notoriety. But the child who grows up knowing that the world 
        wants another Picasso may view his creator in a different 
        light.160
---------------------------------------------------------------------------
    \160\ James Watson, Moving Toward the Clonal Man, 227 The Atlantic 
50, 53 (May, 1971).
---------------------------------------------------------------------------
It is necessary for society through civil government to establish 
limits. As Paul Ramsey pointed out, some scientific knowledge, however, 
interesting or valuable, cannot be obtained by moral means. When that 
happens, we must seek it by other means or wait until it can be 
obtained by appropriate means.
    Roe v. Wade and its progeny created a woman's ``liberty interest'' 
in ``terminating a pregnancy.'' The Supreme Court limited state 
protection of unborn human life only when balanced against the woman's 
personal abortion liberty. In that context, a physician is only an 
agent of the mother and has no personal constitutional liberty interest 
at stake. Outside that limited context, when the woman's interest in 
terminating pregnancy is not at stake, the states are free to protect 
the unborn human being from homicide at every stage of gestation, 
including fertilization, as some states have done. When extracorporeal 
human embryos are at stake, no woman is pregnant, and the 
considerations of Roe are absent. This state interest has a long 
tradition that is actively exercised by states today. Scientists and 
doctors, as third parties, have no personal constitutional liberty to 
deprive an unborn human being of life or dignity. No broader 
constitutional liberty in ``procreation'' encompasses a right to use 
technology to clone in vitro human embryos. Accordingly, the 
Constitution leaves broad authority to the representative branches to 
ban or regulate the practice of human cloning.

    Mr. Greenwood. The Chair recognizes for 3 minutes for his 
opening statement, the gentleman from Ohio, Mr. Strickland.
    Mr. Strickland. Thank you, Mr. Chairman. I want to thank 
you for holding the hearing today on this important issue. We 
know that scientists have made tremendous strides in recent 
years with technologies that were the stuff of science fiction 
novels just a few years ago. Much of this research is very 
exciting and its potential heal the sick and to improve the 
quality of life of patients around the world.
    I am hopeful that in the coming months, researchers will 
learn more about the unique properties of stem cells and what 
they can do for patients with Parkinson's Disease, Lou Gehrig's 
Syndrome and other diseases of the brain. Nearly every great 
scientific advance brings with it accompanying ethical issues 
which society must consider and resolve. Too often, I am 
afraid, that the resolution of these ethical issues tends to 
lag behind the rapid pace of scientific development. So I am 
pleased that the subcommittee is holding this hearing today so 
that we can hear some of the arguments for and against the 
prospect of human cloning.
    I want to make one observation and then listen to the 
debate. It seems to me that research into human cloning is a 
great departure from other more traditional forms of medical 
research. Traditional medical research focuses on preventing 
disease, curing disease, slowing the progress of disease, 
lengthening of life or the easing of pain. We may have ethical 
disagreements about the methods used to conduct this research, 
but I think we all agree that the goals of this type of 
research are laudable and good.
    Research into human cloning has a vastly different goal, 
the copying of a human being. While there may be collateral 
medical benefits to cloning, I understand that the goal of 
those scientists who are attempting to clone humans are not 
related, the goal is not related to improving the health of 
individuals, but is rather about making copies of existing 
humans. Given this great departure from traditional research, I 
think that our debate should start not with questions of safety 
and efficacy, although these are very important, but with 
whether this pursuit is something that we as a society should 
permit to continue.
    Again, I thank the Chair for holding this important hearing 
and I look forward to hearing the testimony of our witnesses 
and I relinquish the balance of my time.
    Mr. Greenwood. The Chair thanks the gentleman and 
recognizes for 3 minutes for his opening statement, the 
gentleman from Oklahoma, Mr. Largent.
    Mr. Largent. Thank you, Mr. Chairman, for holding this 
important subcommittee hearing. I'm looking forward to hearing 
the testimony of our witnesses this afternoon and would just 
make a few brief remarks.
    Human cloning represents the first footstep into a dark 
wilderness from which we may never emerge. University of 
Chicago professor, Leon Kass, has written that human cloning 
would be a fateful step toward ``making man himself simply 
another one of the man-made things. Human nature becomes merely 
the last part of nature to succumb to the technological project 
which turns all of nature into raw material at human 
disposal.''
    In our vain quest for immortality, will we simply regard 
cloned babies as meaningless blobs of cells and tissue mass 
that we can dispose of without any burden on our conscience? 
The last century and a half is blood soaked with examples of 
what happens when men are subjugated to the will of other men. 
We know from our own Nation's experience that slavery not only 
chained the body of the slave, but it also hardened the heart 
of the slavemaster to unspeakable brutalities.
    It was a small step for German physicians in the 1930's 
from believing that there was such a thing as a life not worth 
living to embrace the mass murder of their neighbors. If you 
had a chance in human history to prevent slavery, would you 
have taken it? If you had a chance to prevent genocide, would 
you have taken it? Congress has a chance to prevent the ills 
that will follow human cloning. Will we take that chance?
    The future of the human race is the issue before us. I'm 
afraid that if human cloning proceeds as a mainstream 
scientific endeavor, that we may find out what C.S. Lewis meant 
when he observed that ``man's conquest of nature would result 
in the abolition of man.''
    Thank you, Mr. Chairman.
    Mr. Greenwood. The Chair thanks the gentleman and 
recognizes for 3 minutes for the purposes of an opening 
statement, the gentleman from Louisiana, Mr. John.
    Mr. John. Thank you, Mr. Chairman. Thank you for holding 
this hearing to address, I think, the numerous and myriad 
issues around the science of human cloning and I'll be very 
brief in my remarks.
    As you've heard from many of my other colleagues, the 
cloning of the sheep in Scotland occurred just a mere 4 years 
ago, but the speed in which medical research has produced 
findings that call us now to address the possible ramifications 
of human cloning. I think it is absolutely imperative that we 
have an open and in-depth debate in order to determine the most 
appropriate role that the Federal Government or should not play 
in regarding this complex issue as far as and related to legal 
and ethical matter.
    Congress has made it clear that Federal tax dollars cannot 
be used in the promotion of human cloning research, however, as 
you've heard from some of my colleagues today and of course, we 
will hear from some of the panelists, it is only a matter of 
time, it will only be a matter of time before someone tries to 
clone, if it hasn't actually started to happen.
    I believe it is imperative that we are fully aware of the 
potential ramifications of human cloning and what the causes 
beyond will be. Beyond the ethical and moral questions about 
whether we should even be performing cloning, the data 
available from the animal cloning shows that we have a very, 
very long way to go before we have a reliable source of 
information for safe human cloning. Simply put, I believe 
Congress and Americans, we must be responsible for the results 
of these actions or our actions and at this point the 
consequence of human cloning, I believe, are very unclear.
    A few states, including my home State of Louisiana, have 
issued a ban on human cloning. Some of the other states have 
issued or is in the process of reviewing this. Also, many 
countries have already implemented laws limiting or prohibiting 
human cloning research and just to list a few of them, it may 
surprise you: Ireland, Israel, Italy, France, Argentina, Spain, 
are nations that have prohibited human cloning. Nations with 
current legislative process on the way are Korean, Canada, New 
Zealand and Russia.
    So I think it is imperative that this U.S. Congress step up 
to the plate and responsibly respond to the scientific 
community. Therefore, I'm very anxious to hear from our 
distinguished and experienced panel here, their thoughts on the 
current scientific status of human cloning and the legal issues 
surrounding the individuality, the identity, reproduction 
rights and also privacy of this issue.
    I think that the United States, if we fail to address the 
scientific questions facing us today, I think it will pale in 
comparison to the questions that we will face tomorrow.
    I thank the chairman and I look forward to the testimony to 
follow.
    Mr. Greenwood. The Chair thanks the gentleman and for 
purposes of an opening statement recognizes the gentleman from 
New Hampshire, Mr. Bass.
    Mr. Bass. No opening statement.
    Mr. Greenwood. The Chair thanks the gentleman and 
recognizes for 3 minutes for purposes of his opening statement 
the gentleman from North Carolina, Mr Burr.
    Mr. Burr. I thank the chairman. I won't take the full 3 
minutes. I want to thank the chairman for this hearing. I want 
to thank the witnesses.
    Clearly, there's been a lot said about the witnesses 
because they vary greatly. The fact is that we're a very 
diverse world and the Congress should welcome as many different 
views on a particular subject as they can find because I think 
it displays to the American people, (1) the reason that we're 
here; and (2) the urgency that many of us feel compelled to 
inject into this debate.
    We've heard today the number of countries around the world 
that have banned human cloning, that the U.N. is ahead of the 
U.S., that the Catholic Church is ahead of the Congress. We've 
read quotes that deal with words like ``abort spontaneously'', 
``abnormality rates'', ``congenital defects'', that deal with 
the cloning of animals and potentially the cloning of humans.
    We have the experience of individuals who have participated 
in animal cloning. One such Michael Bishop, the President of 
Infogen where he said ``that's still a scientific blackbox that 
we're trying to unravel. We won't be able to tell which embryos 
can grow to a calf and which cannot. We're getting there.''
    Where getting there? Where we are today is we have reached 
a point where I personally believe and I hope it's the belief 
of my colleagues, that when a male and female DNA don't meet, 
implantation in a woman's uterus should be banned. I hope, in 
fact, this committee will listen very carefully to the 
information our witnesses bring to us today, but I do 
desperately hope that that's the initiative that comes out of 
this and that we can pass it on to the relevant committees of 
this Congress to move legislation.
    I thank the chairman and I yield back.
    [Additional statement submitted for the record follows:]

    PREPARED STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN 
                  CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Chairman, the subject of today's hearing is enormously 
important.
    Because of this significance, I am disappointed that we will not 
hear today from the premier voice in basic science, the National 
Institutes of Health (NIH). They are a valuable resource on the matters 
before us, even though NIH is barred from using federal funds for 
cloning humans.
    I also urge caution as the Committee approaches this subject, 
because a clumsy, ideologically driven effort would chill or curtail 
some of the most important research being conducted in the life 
sciences. This research holds promise for so many who suffer from a 
number of diseases, including Parkinson's, diabetes, cancer, and 
Alzheimer's. I know that the biotechnology industry is concerned about 
this and I am glad they are here today.
    Finally, Mr. Chairman, some may suggest that the Food and Drug 
Administration (FDA) lacks both the authority and the resources to 
police a ban on cloning. If we want FDA to do more, I ask, how? What 
personnel and what facilities should now become subject to FDA 
jurisdiction? How often, and under what standards, should anyone with 
the theoretical ability to clone a human be inspected? And where is FDA 
going to find the resources to take additional steps to police a ban on 
cloning? I don't see anything in the President's budget that would 
allow FDA to enhance its efforts to stop the cloning of humans. Would 
existing programs, such as new drug approvals and food safety, be 
adversely affected? If we place more obligations upon FDA without 
providing additional resources, then we will be at fault.
    I urge the Committee to address this topic thoughtfully, carefully, 
and responsibly.

    Mr. Greenwood. The Chair thanks the gentleman. The Chair 
now calls our witnesses and thanks the first panel of witnesses 
and thanks all of them for their patience.
    I would call Dr. Thomas B. Okarma, Ph.D. and M.D. who is 
the President and CEO of Geron Corporation and is testifying on 
behalf of the Biotechnology Industry Organization. Also, Dr. 
Mark E. Westhusin, Ph.D., Associate Professor of Texas A&M 
University, College of Veterinary Medicine; Dr. Rudolph 
Jaenisch, Ph.D., Professor of Biology, Massachusetts Institute 
of Technology; Dr. Panos Michael Zavos, Ed.S., Ph.D., Founder, 
Director and Chief Andrologist, Andrology Institute of America; 
and Dr. Brigitte Boisselier, Scientific Director of Clonaid. 
Welcome, thank you for coming.
    You are aware that the committee is holding an 
investigative hearing and when doing so has had the practice of 
taking testimony under oath.
    Do you have any objections to testifying under oath? Very 
well.
    The Chair then advises you that under the rules of the 
House and the rules of the committee, you are entitled to be 
advised by counsel, if you desire to be advised by counsel 
during your testimony today.
    I see no affirmative responses.
    In that case, if you would please rise and raise your right 
hand, I will swear you in. Do you swear that the testimony you 
are about to give is the truth, the whole truth and nothing but 
the truth? Thank you.
    [Witnesses sworn.]
    Witnesses may be seated in the order in which I introduced 
them, we'll begin with Dr. Okarma. For the benefit of all of 
the witnesses, you probably have noticed these little black 
boxes on the table. When you begin your testimony, you'll see 
the green light. You have 5 minutes for your testimony. You'll 
get the yellow light at 2 minutes, that's your 2 minute warning 
and at the red light we would ask you to please quickly 
summarize and desist.
    Dr. Okarma, you are recognized for 5 minutes.

   STATEMENTS OF THOMAS B. OKARMA, PRESIDENT AND CEO, GERON 
 CORPORATION; MARK E. WESTHUSIN, ASSOCIATE PROFESSOR OF TEXAS 
    A&M UNIVERSITY, COLLEGE OF VETERINARY MEDICINE; RUDOLPH 
  JAENISCH, PROFESSOR OF BIOLOGY, MASSACHUSETTS INSTITUTE OF 
 TECHNOLOGY; PANOS MICHAEL ZAVOS, FOUNDER, DIRECTOR AND CHIEF 
   ANDROLOGIST, ANDROLOGY INSTITUTE OF AMERICA; AND BRIGITTE 
           BOISSELIER, SCIENTIFIC DIRECTOR OF CLONAID

    Mr. Okarma. Good afternoon. I am Tom Okarma, the President 
and Chief Executive Officer of Geron Corporation in Menlo Park, 
California. Geron is a biopharmaceutical company focused on 
commercializing therapeutic and diagnostic products for 
applications in oncology----
    Mr. Greenwood. Dr. Okarma, could you pull the microphone a 
little closer to yourself?
    Mr. Okarma. Geron is a biopharmaceutical company focused on 
discovering and commercializing therapeutic and diagnostic 
products for applications in oncology, drug discovery and 
regenerative medicine.
    I'm testifying today on behalf of my company and the 
Biotechnology Industry Organization known as BIO. BIO 
represents more than 950 biotechnology companies, academic 
institutions, State biotechnology centers and related 
organizations in all 50 U.S. states and 33 other nations.
    Mr. Chairman and members of the subcommittee, thank you for 
the opportunity to testify today at this important hearing on 
cloning. Let me start by making our position perfectly clear. 
BIO opposes human reproductive cloning. It is simply too 
dangerous technically and raises far too many technical and 
social questions.
    That's why BIO wrote to President Bush last month and urged 
him to extend the voluntary moratorium on human reproductive 
cloning which was instituted in 1997. I would respectfully ask 
for this letter to be included in the hearing record.
    It would be extremely dangerous to attempt human 
reproductive cloning. In fact, in most animals reproductive 
cloning has no better than a 3 to 5 percent success rate, that 
is, very few of the cloned animal embryos implanted in a 
surrogate mother animal survive. The others either die in 
utero, sometimes at very late stages of pregnancy or die soon 
thereafter. It is simply unacceptable to subject humans to 
those risks.
    The Food and Drug Administration has publicly stated that 
it has jurisdiction over human reproductive cloning experiments 
and that it would not approve them. BIO supports that view.
    It's critical, however, to distinguish use of cloning 
technology to create a new human being (reproductive cloning) 
from other appropriate and important uses of the technology, 
such as cloning specific human cells, genes and other tissues 
that do not and cannot lead to a cloned human being, so called 
therapeutic cloning. These techniques are integral to the 
production of breakthrough medicines, diagnostics and vaccines, 
to treat heart attacks, various cancers, Alzheimer's disease, 
diabetes, hepatitis and other diseases. This type of 
therapeutic cloning could also produce replacement skin, 
cartilage and bone for burn and accident victims and result in 
ways to regenerate retinal and spinal cord tissue.
    My company, Geron, as well as many other companies and 
academic laboratories, use cloning technology for many 
beneficial purposes. Let me explain how we use it to develop 
products that could revolutionize medicine and improve the 
lives of people suffering from serious illnesses.
    Many diseases result in the disruption of cellular function 
or destruction of tissue. Heart attacks, stroke and diabetes 
are examples of common conditions in which critical cells are 
lost to disease. Today's medicine is unable to completely 
restore this loss of function. Regenerative medicine, a new 
therapeutic paradigm, holds the potential to cause an 
individual's currently malfunctioning cells to begin to 
function properly again or even to replace dead or irreparably 
damaged cells with fresh, healthy ones, thereby restoring organ 
function.
    At Geron, therapeutic cloning technology is one of the 
techniques we use to create pure populations of functional new 
cells that can replace damaged cells in the body. For example, 
we're learning how to turn undifferentiated human pluripotent 
cells into neurons, liver cells and heart muscle cells. Thus 
far, these human replacement cells appear to function normally 
in vitro, raising the possibility for their application in the 
treatment of devastating chronic diseases affecting these 
tissue types. This would, for instance, allow patients with 
heart disease to receive new heart muscle cells that would 
improve cardiac function. Cellular cloning techniques are a 
critical and necessary step in the production of sufficient 
quantities of vigorous replacement cells for the clinical 
treatment of patients.
    Let me conclude. In addition to the scientific obstacles, 
human reproductive cloning raises numerous ethical and social 
concerns. When the moratorium was imposed in 1997, scientists, 
ethicists and policymakers believed that the various ethical 
issues raised by human cloning had not been resolved. At the 
time, the National Bioethics Advisory Commission called human 
cloning morally unacceptable.
    Mr. Chairman, that is still true today. Now only is there 
no consensus in our society about how to resolve the ethical 
concerns implicated by human reproductive cloning, these issues 
have not even been adequately discussed. In my personal view, 
reproductive cloning would devalue human beings by depriving 
them of their own uniqueness.
    Mr. Chairman, human reproductive cloning remains unsafe. 
Moreover, the ethical issues it raises have not been fully 
debated throughout our society, therefore the voluntary 
moratorium on human reproductive cloning should remain in place 
and no Federal funds should be used for human reproductive 
cloning.
    Thank you.
    [The prepared statement of Thomas Okarma follows:]

    PREPARED STATEMENT OF THOMAS OKARMA, PRESIDENT AND CEO OF GERON 
    CORPORATION ON BEHALF OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION

    Good afternoon. My name is Thomas Okarma. I am the President and 
CEO of Geron Corporation in Menlo Park, California. Geron is a 
biopharmaceutical company focused on discovering, developing, and 
commercializing therapeutic and diagnostic products for applications in 
oncology, drug discovery and regenerative medicine. Geron's product 
development programs are based upon three patented core technologies: 
telomerase, human pluripotent stem cells, and nuclear transfer.
    I am testifying today on behalf of my company and the Biotechnology 
Industry Organization (BIO). BIO represents more than 950 biotechnology 
companies, academic institutions, state biotechnology centers and 
related organizations in all 50 U.S. states and 33 other nations. BIO 
members are involved in the research and development of health care, 
agricultural, industrial and environmental biotechnology products.
    Mr. Chairman, and members of the Subcommittee, thank you for the 
opportunity to testify today at this important hearing on cloning. Let 
me start by making our position perfectly clear: BIO opposes human 
reproductive cloning. It is simply too dangerous technically and raises 
far too many ethical and social questions.
    That's why BIO wrote to President Bush last month and urged him to 
extend the voluntary moratorium on human reproductive cloning which was 
instituted in 1997. I would respectfully ask for this letter to be 
included in the hearing record.
    It would be extremely dangerous to attempt human reproductive 
cloning. In fact, in most animals, reproductive cloning has no better 
than a 3-5% success rate. That is, very few of the cloned animal 
embryos implanted in a surrogate mother animal survive. The others 
either die in utero--sometimes at very late stages of pregnancy--or die 
soon after birth. Only in cattle have we begun to achieve some 
improvements in efficiency. However, scientists have been attempting to 
clone many other species for the past 15 years with no success at all. 
Thus, we cannot extrapolate the data from the handful of species in 
which reproductive cloning is now possible to humans. This underlines 
that this would be an extremely dangerous procedure.
    It is simply unacceptable to subject humans to those risks.
    The Food and Drug Administration (FDA) has publicly stated that it 
has jurisdiction over human reproductive cloning experiments and that 
it would not approve them. BIO supports that view.
Beneficial Uses of Cloning Technology--Therapeutic Cloning
    It is critical to distinguish use of cloning technology to create a 
new human being (reproductive cloning) from other appropriate and 
important uses of the technology such as cloning specific human cells, 
genes and other tissues that do not and cannot lead to a cloned human 
being (therapeutic cloning). These techniques are integral to the 
production of breakthrough medicines, diagnostics and vaccines to treat 
heart attacks, various cancers, Alzheimer's, diabetes, hepatitis and 
other diseases. This type of therapeutic cloning could also produce 
replacement skin, cartilage and bone tissue for burn and accident 
victims, and result in ways to regenerate retinal and spinal cord 
tissue.
    My company, Geron, as well as many other companies and academic 
laboratories, use cloning technology for many beneficial purposes. Let 
me explain how we use it to develop products that could revolutionize 
medicine and improve the lives of people suffering from serious 
illnesses.
Regenerative Medicine
    Many diseases result in the disruption of cellular function or 
destruction of tissue. Heart attacks, strokes, and diabetes are 
examples of common conditions in which critical cells are lost to 
disease. Today's medicine is unable to completely restore this loss of 
function. Regenerative medicine, a new therapeutic paradigm, holds the 
potential to cause an individual's currently malfunctioning cells to 
begin to function properly again or even to replace dead or irreparably 
damaged cells with fresh healthy ones, thereby restoring organ 
function.
    The goal of Geron's regenerative medicine program is to produce 
transplantable cells that provide these therapeutic benefits without 
triggering immune rejection of the transplanted cells. This could be 
used to treat numerous chronic diseases such as diabetes, heart 
disease, stroke, Parkinson's Disease and spinal cord injury.
    At Geron, therapeutic cloning technology is one of the techniques 
we use to create pure populations of functional new cells that can 
replace damaged cells in the body. For example, we are learning how to 
turn undifferentiated human pluripotent stem cells into neurons, liver 
cells and heart muscle cells. Thus far, these human replacement cells 
appear to function normally in vitro, raising the possibility for their 
application in the treatment of devastating chronic diseases affecting 
these tissue types. This would, for instance, allow patients with heart 
disease to receive new heart muscle cells that would improve cardiac 
function. Cellular cloning techniques are a critical and necessary step 
in the production of sufficient quantities of vigorous replacement 
cells for the clinical treatment of patients.
Predictive Toxicology/Drug Discovery
    Geron is also developing research tools to facilitate the safe 
development of new drugs. The use of normal, cloned human liver cells 
to test new drugs under development for certain toxic metabolites would 
reduce the danger of human clinical trials by eliminating such 
compounds before human testing. This process could streamline and make 
safer the drug development process, thereby reducing by several years 
drug development time, bringing drugs to patients sooner and with 
greater safety, and reduce the reliance upon animal testing.
Agriculture
    Geron uses cloning technology for applications in agriculture as 
well. These include producing animals with desirable qualities such as 
disease resistance, longevity, or improved product quality. Animals can 
also be cloned to produce proteins for human therapeutic use such as 
human antibodies, allowing for large-scale production of vaccines.
Ethical Concerns of Reproductive Cloning
    In addition to the scientific obstacles, human reproductive cloning 
raises numerous ethical and social concerns. When the moratorium was 
imposed in 1997, scientists, ethicists, and policy makers believed that 
the various ethical issues raised by human cloning had not been 
resolved. At the time, the National Bioethics Advisory Commission 
(NBAC) called human cloning ``morally unacceptable.''
    Mr. Chairman, that is still true. Not only is there no consensus in 
our society about how to resolve the ethical concerns implicated by 
human reproductive cloning, these issues have not yet even been 
adequately discussed. Many of these issues strike at the heart of 
beliefs and values that are inherent in the human condition. What does 
it mean to be an individual? How should we view our parents, brothers, 
sisters, and children? How does the world around us influence our 
intellectual, physical and spiritual development? These are just a few 
of the questions raised by human cloning. In my view, reproductive 
cloning would devalue human beings by depriving them of their own 
uniqueness.
    To allow human reproductive cloning without a full and fair 
discussion of these and other moral issues would be irresponsible. 
Worse yet, it could lead to a backlash that would stifle the numerous 
beneficial applications of therapeutic cloning technology--some of 
which I have described today--that could lead to cures and treatments 
for some of our most deadly and disabling diseases.
Conclusion
    Mr. Chairman, human reproductive cloning remains unsafe. Moreover, 
the ethical issues it raises have not been fully debated throughout our 
society. Therefore, the voluntary moratorium on human reproductive 
cloning should remain in place and no federal funds should be used for 
human reproductive cloning.
    Thank you. I'd be happy to answer any questions.

    Mr. Greenwood. Thank you, Dr. Okarma for your testimony.
    Dr. Westhusin, you're recognized for 5 minutes.

                 STATEMENT OF MARK E. WESTHUSIN

    Mr. Westhusin. Thank you. Thank you for the opportunity to 
come here and visit about this issue. I start off by saying 
that I'm currently an Associate Professor at Texas A&M 
University and I've been working with animal cloning since 
1987, so I've literally been involved with tens of thousands of 
nuclear transfer procedures and experiments in science that 
related to nuclear transfer and cloning all the way ranging 
from just studying and trying to understand developmental 
biology all the way up to actually producing live animals.
    There are really just three points that I want to focus on. 
A lot of us know the benefits from cloning animals and 
therapeutic cloning of humans, but there are three points that 
really I would like to focus on. One is basically just the 
risks that are involved with cloning even animals that we have 
to deal with today. And I'll give you some examples of some 
data. I'd also like to talk a little bit about this idea that 
you could potentially screen for embryos or fetuses and pick 
out those that were abnormal and abort those. And then finally, 
I just might make a few comments on some ethical concerns.
    But what I wanted to do is part is I'm just going to read 
from my testimony.
    Although animals can be cloned by nuclear transfer using 
somatic cells as nucleus donors, the efficiency is still 
extremely low. In cattle where the majority of the work has 
been completed, problems with early embryonic development do 
not seem to be a factor affecting development. Material 
recognition is not a factor and in fact, you can produce a 
reasonable pregnancy rate if you go check animals at 35 days of 
gestation. The problem is that after 35 days of gestation or 
during the first trimester, approximately 90 percent of the 
pregnancies are lost or abort.
    The most common developmental malformation observed to date 
is just problems with the placental development which leads to 
all kinds of other problems that include developmental 
abnormalities such as immature lungs, cardiovascular disease, 
pulmonary hypertension and a number of things that we've, in 
fact, documented.
    I wanted to give you just some examples of just so you have 
an idea about the efficiency of this 4 or 5 different cases. In 
one case, we had a bull that we cloned that was 21 years old. 
We collected cells. We produced 26 blastocysts from those, 
transferred those into 11 recipients and got 6 pregnancies and 
o1 calf that went to term. When that calf went to term, we 
spent the first 2 to 3 weeks in intensive care with that calf, 
really trying to keep him alive. He developed also Type 1 
dependent diabetes which we don't understand at all why that 
happened because you just don't see that in cattle and he also 
had some immune problems.
    In a second case, we cloned a Charolais cow or attempted to 
do that. To cut to the chase we transferred 37 embryos into 13 
recipients. Six of there were diagnosed pregnant at 30 days. 
Only four remained pregnant past 60 days. We got two calves, 
but both of them died, and died, obviously, due to 
complications related to the cloning.
    In another case, we had a Brangus cow that we worked on. We 
produced 43 embryos in that case where we transferred embryos. 
We produced only three pregnancies and none of those went to 
term.
    And the point that I want to bring out with that, by giving 
you some of these different examples, is that in not every case 
is every animal easily clonable. There are big differences 
between one animal might work better than another, but in every 
case they seemed to show these abnormalities.
    I'm running out of time here, I'm sure, so I won't talk 
about the last part, but there's just case after case of this.
    I wanted to show--these are just some slides that show 
these kinds of things I've talked about, so this just shows the 
efficiency where it dropped of dramatically. This is the 
gestation loss that we see between 30 and 90 days which is just 
horrendous and then these are some of the kinds of things that 
we see and so the top is the bull calf that we actually saved 
and he's in ICU and he's on respirator just to keep him alive 
and in the lower right is obviously one that didn't make it.
    I wanted to talk to you about, you know, the one on the 
lower right and then relate it to those six clones. I guess one 
could almost think about too, what's going to happen if you get 
more than one?
    This is another one that I think was every interesting that 
we studied a group of 13 pregnancies that went into the third 
trimester. From these, only 8 calves were born alive. Four were 
stillborn. Three of the cows that actually were carrying the 
pregnancies also died within 7 days and then we ended up with 
actually six calves, but we had tremendous amount of loss.
    Now I want to, and these are just some examples, I wanted 
to talk about the aberrant plastintation so I'm running out of 
time here and the different things that we see. But I wanted to 
bring this up also and talk that there'd been some issues that 
one might be able to screen these embryos and really is not the 
case.
    We're not going to be able to screen embryos for anything 
to tell whether they're abnormal or not. The reason is because 
if you look at the karyotype, for instance, of cloned embryos, 
they all have normal karyotypes and they have the normal number 
of genes. They also have aberrant gene expression of various 
genes and we don't really have a clue what those genes are at 
this time. It could be any of 30,000 genes or more and we 
really don't have a clue. You can't do genetic analysis of 
30,000 genes and you can't do pre-implantation diagnostics of 
PDG to try and determine if those genes are abnormally 
expressed. It's just something that can't be done. We don't 
have the technology available to do that yet and you couldn't 
do it on pre-implantation. The closest you could get to, as 
referred to is you could get to something like ultrasound, but 
at that case you're basically going say the fetus is dead, the 
calf is dead, it's dying, it has problems.
    So this concept that you're going to be able to screen 
pregnancies and embryos, there's just no basis for that in 
terms of how we would actually be able to do it because the 
technology is simply not available.
    I guess I'll quit there, since I've run out of my time.
    [The prepared statement of Mark E. Westhusin follows:]

 PREPARED STATEMENT OF MARK E. WESTHUSIN, ASSOCIATE PROFESSOR, COLLEGE 
              OF VETERINARY MEDICINE, TEXAS A&M UNIVERSITY

    Man has long been interested in nuclear transplantation both as a 
tool to study developmental biology and as a means for producing 
genetically identical animals. The basic technique involves the 
transfer of a nucleus from one cell to another cell which has had its 
own nucleus removed. For cloning animals this entails transferring the 
nucleus of a cell obtained from the individual to be cloned into an 
unfertilized ovum that has had its chromosomes removed. If successful, 
the transferred nucleus is re-programmed so to direct development of a 
new embryo that is genetically identical to the animal from which the 
cell was obtained. This embryo can then be transferred into a surrogate 
mother for gestation to term and birth of a clone.
    In recent years, nuclear transplantation has been employed to clone 
a number of different animals. The most acclaimed example is of course 
the report by Wilmut et al (1997), which was the first to demonstrate 
cloning of adult mammals was possible. Nuclei of cultured mammary 
epithelial cells derived from an adult ewe were transferred into 
enucleated sheep ova, ultimately resulting in the birth of a cloned 
lamb (Dolly). The demonstration that adult cells could be used for 
cloning mammals sparked enormous new interest in exploring the 
potential of cloning animals. As a result, in just the past three 
years, cloned cattle, sheep, goats, pigs, and mice have been reported.
    The potential benefits animal cloning will afford mankind are far-
reaching, and undoubtedly, many more applications and benefits are yet 
to be imagined. A current utility includes the production of transgenic 
animals for use as living bioreactors to produce pharmaceuticals. 
Several products produced in milk of transgenic sheep and goats are 
already in clinical trials (Factor IX, P.P.L., Inc.; anti-thrombin III, 
Genzyme Inc.; and the estimated market value of pharmaceutical 
production in the milk of transgenic animals currently exceeds $3 
billion per year. A number of other products are targeted for 
production in milk from transgenic livestock including both 
nutriceuticals and vaccines. Genetic engineering animals for protein 
production in milk promises to result in a wide variety of products for 
human use, many of which will be less expensive and more effective. 
Other applications of cloning to produce transgenic animals include the 
production of livestock that are that are genetically resistant to 
devastating diseases such as those currently causing major concern 
throughout the world i.e. Mad Cow Disease and Foot and Mouth disease. 
Agricultural applications of animal cloning will result in increased 
quality and decreased costs for food and fiber. In addition, animal 
cloning provides for rapid genetic gain in animal breeding programs and 
could potentially have a great beneficial impact on the conservation, 
preservation and propagation of endangered species.
    Anticipated future applications of cloning procedures are nothing 
short of phenomenal. These include such things as the production of 
human embryonic stem cells for tissue transplantation and/or gene 
therapy and treatments for mitochondrial diseases, just to name a few. 
Human cells could potentially be utilized as nuclear donors for 
transplantation into oocytes, resulting in cell lines that may be 
useful for human therapy to treat conditions such as Alzheimer's or 
Parkinson's disease.
    With animals representing 5 different mammalian species now having 
been produced by somatic cell nuclear transfer, cloning has been 
proposed as a tool for assisted reproduction in humans i.e. a means for 
producing a human baby. Experiments from our laboratory and others 
provide strong evidence that the current procedures used for mammalian 
cloning are not safe and many times result in abnormal development. 
This can ultimately lead to death of the cloned offspring and the 
surrogate mother. Based on these observations and evidence from studies 
in mice which demonstrate incompatibilities between nucleus and 
cytoplasm from different strains, cloning as an approach to human 
assisted reproduction is at present both risky and extremely 
irresponsible.
    Although animals can be cloned by nuclear transplantation using 
somatic cells as nucleus donors, the efficiency of the technique is 
still extremely low. In cattle where the majority of the work has been 
completed, problems with early embryonic development do not seem to be 
a major factor affecting the efficiency of cloning, as development 
rates to the blastocyst stage in vitro are similar to those of normal 
embryos produced by in vitro fertilization. Maternal recognition and 
the establishment of pregnancy as indicated by pregnancy rates at 35 
days of gestation are also similar between normal embryos and those 
produced by nuclear transplantation. However, after 35 days of 
gestation, pregnancy loss is dramatic and very few fetuses survive to 
term. Approximately 90% of the pregnancies are lost and abort between 
days 35 and 90 of gestation (the first trimester). The most common 
developmental malformation observed to date is aberrant placentation. 
Of those calves that do survive, most exhibit placental edema and a 
reduced number of enlarged placentomes. These placental abnormalities 
pose serious health risks not only to the developing fetus and 
offspring but also to the surrogate mothers carrying the pregnancies. 
In several cases involving cattle, both the surrogate mother and the 
bovine fetuses have died during late gestation due to a variety of 
complicated health issues related to the abnormal pregnancy. Moreover, 
even if the cloned offspring survive to term, many of the resulting 
calves exhibit developmental abnormalities and die at birth or shortly 
thereafter, normally a result of cardiopulmonary abnormalities. In 
general, regardless of the species, only 1%-5% of cloned embryos 
survive to term.

    In our laboratory we have utilized nuclear transfer to try and 
reproduce the genotypes of several different animals, selected for 
cloning based on their inherent genetic value. Results we have obtained 
to date are similar to those reported by other laboratories regardless 
of the species involved. The first case involved a Brahman steer named 
``Chance'', known to be at least 21 years old. Adult fibroblasts were 
obtained from a skin biopsy and expanded in culture using standard 
methods for tissue culture prior to being frozen and stored in liquid 
nitrogen. When nuclear transfer was performed using the fibroblast 
cells derived from Chance, 28% of the fused couplets (53 of 190) 
developed into blastocysts in culture. Twenty-six of these were 
transferred into 11 recipient cows resulting in 6 pregnancies. Three of 
these continued to develop through 90 days of gestation but only one 
survived to term. ``Second Chance'' is now over a year old and appears 
normal and healthy for his age. However during the first week of life 
he required intensive monitoring and therapy to treat lung dysmaturity 
and pulmonary hypertension. At 7 days of age he was also diagnosed and 
treated for Type 1 insulin-dependent diabetes, which is extremely rare 
in cattle. He also lacked the expression of an important T-cell antigen 
CD45, indicating his immune system was in some way abnormal (Hill et 
al, 2000).
    The second and third attempts at reproducing desired genotypes by 
cloning involved two middle-aged cows, one Brangus and one Charolais. 
These were selected based on being top performers in the herd. 
Fibroblasts were again obtained from skin biopsies. Development rate to 
the blastocyst stage following nuclear transfer and embryo culture 
averaged 16%. Thirty-seven blastocysts derived from the Charolais cow 
were transferred into 13 recipients. Six of these were diagnosed as 
pregnant at 30 days of gestation but only 4 remained pregnant through 
60 days. One of these pregnancies was subsequently lost. In two cases 
the fetus was removed for research purposes. The final pregnancy was 
allowed to proceed to term resulting in twin heifers. However, both 
calves died between 7-10 days after birth due to complications related 
to the cloning procedure. Forty-three blastocysts derived from the 
Brangus cow were transferred into 14 recipients resulting in 3 
pregnancies. However none of these survived past 90 days of gestation.
    Our most recent attempt at cloning a specific animal has involved a 
deceased Black Angus bull previously shown to be naturally 
(genetically) resistant to Brucellosis. Of the oocyte-fibroblast 
couplets fused and cultured, 44% developed to the blastocyst stage. 
Thirty-nine blastocysts were transferred into 20 recipients resulting 
in 10 pregnancies at 35 days of gestation. One of these survived to 
approximately 150 days of gestation and was then lost. Another single 
pregnancy survived to term resulting in a healthy bull calf.
    Prior to any attempt to use nuclear transplantation/cloning as a 
means of human assisted reproduction, it is imperative that many 
additional animal studies evaluating the safety of somatic cell cloning 
be carried out. These studies should also include efforts to evaluate 
the safety of applying nuclear transplantation procedures for treatment 
of human disease or infertility by manipulating oocyte cytoplasm and/or 
genetically modifying human cells prior to cloning. Proponents of human 
cloning as a means of assisted reproduction have pointed out that even 
with accepted practices of assisted reproduction such as in vitro 
fertilization, success rates are low and pregnancy losses higher than 
in natural reproduction. This is indeed the case, but hardly to the 
extent seen in cloning where only 1-5% of the procedures performed 
result in offspring, and a significant number of these either die at 
birth or require intensive care for several weeks to keep them alive.
    Moreover, the claim that cloned embryos could be screened prior to 
embryo transfer so to select those that will develop normally is simply 
not a possibility at this time. Research conducted in our laboratory 
and several others now points very strongly to the fact that problems 
seen in cloned embryos/pregnancies are likely epigenetic effects 
brought on by the cloning techniques themselves and causing abnormal 
expression of important developmental genes. Techniques to evaluate for 
these abnormalities are simply not yet available and it will likely be 
years before such diagnostics do become available. Procedures to 
determine whether cloned embryos and fetuses appear to have normal and 
the right number of chromosomes are woefully inadequate as there is no 
indication to date that abnormal karotypes are a problem i.e. 
chromosomes in cloned embryos appear normal. If one wanted to screen 
for abnormal gene expression, which of the tens of thousands of genes 
would one screen for? There is no solid data yet to point to one gene/
cause for developmental failure. In addition, given the small size and 
few cells available, current techniques will not allow any type of 
adequate analyses of an embryo so to determine in fact that it is 
normal. At best, with ultrasound, one could determine that the fetus is 
dead, which based on animal studies is likely to be the situation in 
90% of the cases during the first trimester of pregnancy.
    Finally, even the apparently healthy animals that are produced by 
cloning should be studied and observed for a number of years to 
evaluate their long-term health status prior to any applications in 
humans. Considerable evidence has now been accumulated to suggest that 
insults occurring during the critical period of embryo and fetal 
development may have long-term effects on the health of offspring and 
resulting adults. Cloned animals produced to date have not yet lived 
long enough to evaluate this potential risk. Undoubtedly it would be a 
devastating case to produce cloned humans only to find out that they 
all developed serious disease/health problems and/or died during 
childhood or adolescence or even early in their adult life. At this 
point it is simply impossible to eliminate this potential disastrous 
outcome.
Ethical Concerns Involving Human Cloning:
    I have previously been quoted in the popular press as saying that 
while there are enormous beneficial applications to cloning animals, 
``I have never met a human worth cloning.'' Although my wife may take 
some exception to this statement, I still stand behind it. In part, 
this is due to the fact that as human beings, none of us are perfect. 
Also, expectations of what a human clone would be or do are many times, 
exaggerated. Cloning animals by nuclear transplantation is simply a 
technology that can be used to produce another individual with the same 
genetic make up. What cloning absolutely is not, is a means of 
resurrection. I think it best we leave this business to God as we have 
enough problems to deal with just trying to be decent human beings. It 
is indeed extremely troubling to me however, that with the successful 
cloning of animals, many people in society still seem to have no 
understanding of the difference between ``reproduction'' and 
``resurrection''. A significant number of requests for human cloning 
involve the utilization of cells from ``beloved family members'' that 
are in fact deceased. Undoubtedly, those requesting such services, 
whether they would admit it to themselves or not, in some way believe 
cloning is a form of resurrection, not reproduction. It is deeply 
concerning that individuals offering human cloning services could take 
advantage of highly emotional situations involving the death of a loved 
one by selling resurrection vs reproduction.
    With time and education, society will eventually understand the 
difference between resurrection and reproduction. I will also predict 
that given the current state of various assisted reproduction 
techniques that are already being utilized by humans and readily 
accepted as ethical, such as in vitro fertilization and 
intracytoplasmic sperm injection, cloning by nuclear transplantation 
will eventually also be thought of as simply another form of assisted 
reproduction, and individuals employing techniques of nuclear 
transplantation will not be accused of ``playing God.'' In short, I 
predict that humans will someday be cloned. When this happens, the sky 
will not fall and the world will not come to an end. Scenarios such as 
that seen in ``The Boys from Brazil'' and armies of clones will remain 
in the movies. The number of human babies that would ever be produced 
by cloning will be infinitesimally small compared to children born by 
natural reproduction, and will hardly be noticed. The person (s) that 
come into this world by way of cloning will be new and unique 
individuals. Moreover, I have confidence and a personal faith in God 
that they will be blessed with a unique spirit and soul. To think 
otherwise is to suspect that God hasn't blessed the thousands of babies 
already born by other forms of assisted reproduction with a soul, and 
neither the tens-of-thousands of genetically identical twins that live 
in this world. This begs the question, what is it that really makes 
human cloning so (as it is often referred to) repugnant? Is it the word 
``clone'' itself and/or the horrendous stories that have been written, 
or movies that have been made that always depict cloning as a terrible 
thing leading to a terrible outcome? Would it be impossible to write a 
story about human cloning that had a happy ending, or is it just the 
fact that it wouldn't sell and therefore no profit would be gained? 
Surely it is not the fact that a clone would have a genetically 
identical copy, either still alive or deceased? How would this be that 
much different than an identical twin?
    Consider the following scenario. A skin cell from a human male is 
inserted into an enucleated human ovum (nuclear transplantation) so to 
create a cloned human embryo. However, instead of transplanting this 
embryo into a surrogate mother, the embryo is placed into culture and 
treated in such a way that it develops into embryonic stem cells. Given 
the enormous and promising success that has been achieved in recent 
years involving the production of human embryonic stem cells, it is 
easily conceivable that in the not to distant future, these stem cells 
could then be directed in culture to undergo gameteogenesis and develop 
into cell types that represent gametes (sperm and eggs) containing a 
haploid number of chromosomes (half of that in a normal somatic cell), 
and the genes will have been rearranged, as occurs during normal gamete 
development. Once this has occurred, two of the gamete cells could be 
selected and using nuclear transfer a second time, placed into another 
enucleated ovum resulting in a normal embryo that could then be 
transferred into a surrogate mother for development to term. While this 
scenario may be difficult for some to follow, here's the punch line. It 
is entirely conceivable that a single cell originally derived from a 
single male, with the aid of technology, could be used to produce a new 
human baby. This new human being would not at all be a clone, because 
of the natural process of gene rearrangement that occurs during gamete 
development, and in fact, could turn out to me a girl!
    If cloning a human being is unethical, would this procedure also be 
unethical even though the new baby would not be a clone at all but 
simply derived from an elaborate assisted reproductive technology? 
Given the state of currently accepted practices for treating human 
infertility, I doubt it, but with one caveat. It would certainly be 
considered highly unethical and completely irresponsible if 90% of the 
pregnancies resulted in abortions, the surrogate mother was put in 
serious health risk, and a significant portion of the offspring that 
resulted were developmentally abnormal and many died.
    So we are back to square one. Is nuclear transfer to produce a 
human clone a reasonable thing to consider attempting at this time? In 
my opinion absolutely no! Ethical issues and moral issues aside, at 
present, cloning is just too risky, many times resulting in serious 
health problems and/or death the developing fetus, surrogate mother, 
and resulting offspring.

                              References:

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Cammuso C, Williams JL, Nims SD, Porter CA, Midura P, Palacios MJ, 
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WG, Overstrom EW, Echelard Y, 1999. Production of goats by somatic cell 
nuclear transfer. Nat Biotechnol 17:456-461.
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nuclear transfer from a cultured cell line. Nature 380:64-66
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Ponce de Leon A, Robl J. Cloned transgenic calves produced from 
nonquiescent fetal fibroblasts. Science 1998; 280:1256-1258.
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characteristics of calves produced by nuclear transfer cloning. 
Theriogenology 45:141-152.
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Thompson JA, Looney CR, Westhusin ME, Robl JM, Stice SL. 1999. Clinical 
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H, Tsunoda Y.1998. Eight calves cloned from somatic cells of a single 
adult. Science 282:2095-2098.
    Kruip TAM, Daas JHG den, Den Daas JHG. 1997. In vitro produced and 
cloned embryos: effects on pregnancy, parturition and offspring. 
Theriogenology 47: 43-52.
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mammalian genome during development. Curr.Top.Dev.Biol. 43:1-49:1-49.
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H, Perry ACF. Pig Cloning by Microinjection of fetal fibroblast nuclei. 
2000 Science 289:1188-1190.
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Boone J, Walker S, Ayatres D, Colman A, Campbell K. 2000. Cloned pigs 
produced by nuclear transfer from adult somatic cells. Nature 407:86-
90.
    Renard JP, Chastant S, Chesne P, Richard C, Marchal J, Cordonnier 
N, Chavette P, Vignon X. 1999. Lymphoid hypoplasia and somatic cloning. 
The Lancet 353:1489-1491.
    Schnieke AE, Kind AJ, Ritchie WA, Mycock K, Scott AR, Ritchie M, 
Wilmut I, Colman A, Campbell KH. 1997. Human factor IX transgenic sheep 
produced by transfer of nuclei from transfected fetal fibroblasts. 
Science 278:2130-2133.
    Stice SL, Strelchenko NS, Keefer CL, Matthews L. 1996. Pluripotent 
bovine embryonic cell lines direct embryonic development following 
nuclear transfer. Biol Reprod 54:100-110.
    Stice SL, Robl JM, Ponce de Leon FA, Jerry J, Golueke PJ, Cibelli 
JB, Kane JJ. 1998. Cloning: new breakthroughs leading to commercial 
opportunities. Theriogenology 49:129-138.
    Wakayama T, Perry AC, Zuccotti M, Johnson KR, Yanagimachi R. 1998. 
Full-term development of mice from enucleated oocytes injected with 
cumulus cell nuclei. Nature 394:369-374.
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future. Theriogenology 45:57-68.
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Viable offspring derived from fetal and adult mammalian cells. Nature 
385:810-813.
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lambs from an established embryonic cell line: a comparison between in 
vivo- and in vitro-matured cytoplasts. Biol Reprod 57:385-393
    Wells DN, Misica PM, Forsyth JT, Berg MC, Lange JM, Tervit HR, 
Vivanco WH. 1999a. The use of adult somatic cell nuclear transfer to 
preserve the last surviving cow of the Enderby Island cattle breed. 
Theriogenology 51:217.
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Biol Reprod 60:996-1005.
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McCalla DF. 1995. Comparison of birth weight and growth characteristics 
of bovine calves produced by nuclear transfer (cloning), embryo 
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    Mr. Greenwood. Thank you, Mr. Westhusin. Thank you for your 
testimony. For the benefit of the members, we're not going to 
recess during this vote, but try to allow members to vote, go 
and vote and then return.
    Next we'll turn to Dr. Rudolf Jaenisch.
    Thank you for being here and we look forward to your 
testimony, sir.

                  STATEMENT OF RUDOLF JAENISCH

    Mr. Jaenisch. I am Professor of Biology at MIT and the 
Whitehead Institute in Boston. It's clear from the five 
different species which have been cloned, you can make common 
phenotypes observed. The great, great majority of clones die 
very early, some die later. Some make it to birth and they are 
abnormal at birth. What are the abnormalities? They're very 
often overweight. They have large placentas and they die within 
minutes. They have heart problems, circulatory problems, they 
can't inflate their lungs, the immediate cause of death. Some 
live longer. They may die after days or after weeks. At 
autopsies one sees problems in the kidney, brain abnormalities, 
dysfunction of the immune system, you just heard it.
    So some reach adulthood and appear normal, but they may not 
be. I believe there's probably not a normal clone around and I 
will come to why that is. So what is the problem?
    We believe programming of the genome is the main problem, 
so let me explain what it is. When you take let's say a nucleus 
of the skin and try to make a clone out of this, then you have 
to look at the nucleus what it is. The nucleus of a skin 
expresses those genes which are important for skin function, 
let's say hair growth, but not those genes which are important 
for embryonic developments. Those genes are there, but they are 
silent. They're not needed any more. So what has to happen for 
cloning to succeed? The nucleus is transplanted into the old 
site and now this embryonic program has to be activated 
hundreds of critical genes and that's where things go wrong. 
This fails.
    So I think it's very useful to compare this what happens in 
normal development. In normal development also reprogramming 
has to occur. It occurs during egg maturation and sperm 
maturation. These are very complex processes which take years 
or months in humans. So when the two gametes, the egg and the 
sperm come together at fertilization, they are poised, they are 
reprogrammed to activate the embryonic genes and then things go 
normal. That's how evolution designed gametogenesis.
    Now what happens in clones? In clones, this nucleus comes 
in and now it's to reprogram its genome probably within 
minutes, at most hours, because the egg has to divide and 
that's where things go wrong. Most clones die.
    It's very interesting in the way they die. We don't know 
exactly why, but we believe the ones, the majority of the ones 
that die very early because it cannot activate the key early 
genes. Others die later, because they did activate the early 
ones, but not the later ones. And the ones which go to birth, 
probably did those okay, but now the other problems are there 
which affect kidney, brain, whatever.
    So in principle, I think any of the 30,000 genes we have is 
a target for reprogramming errors. So even apparently healthy 
adult clones may have subtle defects which are beyond to detect 
easily in an animal.
    So let me come to what I mentioned before, these cloning 
activists have announced they can do embryo grading, genetic 
screening, quality control, so they imply they are able to 
employ routine diagnostic procedures which are used in the 
clinic to screen out bad and good clones. This is a false 
statement. They cannot do this. The routine prenatal tests are 
designed to take chromosomal operation or single gene defects, 
but they cannot and I really emphasize this, they cannot detect 
reprogramming errors because reprogramming errors do not 
involve gene changes. The genes are normal, the sequence has 
not changed. It's the state of the gene which argues it's 
either expressed or not. So I think this is a really false 
statement. So the argument by the activists again, they have 20 
years' experience with IVF, so they're good in cultivating 
embryos, better than the embryo clonists, yes, that might be 
true. They might avoid physical damage to the egg of the 
nucleus, so they might get the first steps, better than we get 
in mice, but the basic problem, the basic biological problem 
has not changed a bit. That is reprogramming. It's the same 
thing so what they will do is they will produce more embryos 
which implant. They may get more out of it at the other end, 
but the ratio of normal, apparently normal to abnormal clones 
will not change a bit by this. It's more efficient in the early 
stages.
    So I agree, they probably can use ultrasound to detect 
malformed fetuses, sure, but this is not important because 
malformed fetuses will die anyway. The problem are the ones 
which are apparently normal, but are not and I really 
reemphasize there's no way to screen the available technology 
or with any technology in the foreseeable future to do that.
    Now for summarizing from the experience with animals, we 
can clearly predict how a few cloned humans would look like. 
The great majority will be abnormal. Some may live, but they 
may be not normal. They may have subtle defects like in the 
brain. So, for example, Dolly, I believe is not normal. You 
don't need much brain to graze on the fields, so we really 
don't know, we have no tests to check that.
    So what will we do with the abnormal clones when they are 
born? With animals, this is an easy thing, the animals will 
die. We can study them. We can learn something. What can we do 
with humans? They will be kept alive with medical intervention 
for probably not happy lives.
    You can ask do I know this for sure? Of course, I don't 
know because humans have not been cloned. But five mammalian 
species, mice, goats, sheep, cows and pigs have been cloned. 
They're all mammals and humans are mammals. So I think it's a 
very safe prediction that this will happen.
    Should we find out whether humans are more efficient, maybe 
than pigs or mice, I think the answer is very clear. We should 
not find out because humans are not guinea pigs. They're not 
experimental organisms and we're particularly at the stage when 
we haven't really solved the basic fundamental problems in 
animals.
    So the conclusion is from the scientific point of view that 
it's inappropriate and irresponsible to attempt cloning at this 
point.
    I want to make just a final point if I may which is the 
public, I'm afraid, may associate the activities of these 
cloning activists with serious stem cell research as it was 
mentioned before. This would be extremely unfortunate. You've 
heard the benefits of this research, so I want to make very 
clear what the differences between reproductive cloning, 
reproductive cloning and embryos implanted, the goal is a new 
person, to copy a person. And yes, embryo stem cell research, 
the embryo is never implanted, it grows in the petri dish. The 
embryo stem cell is derived from this, will always be 
manipulated in a petri dish and the problems obviously are very 
different here.
    So I think there are very serious areas that these ill-
conceived cloning attempts at humans would get mixed up with 
this very serious and potentially very beneficial research and 
I think this would be of great concern.
    Thank you.
    [The prepared statement of Rudolf Jaenisch follows:]

    PREPARED STATEMENT OF RUDOLF JAENISCH, WHITEHEAD INSTITUTE FOR 
                          BIOMEDICAL RESEARCH

    Recently, cloning of humans by nuclear transplantation has been 
proposed. In this testimony I will focus on the scientific concerns 
about human cloning that have resulted from the experience with animal 
cloning.
    1. To date, five mammalian species (sheep, mice, goats, cows and 
pigs) have been cloned, however, survival of the nuclear clones has 
been uniformly low. The great majority of all clones (of all five 
species) die either at various stages of embryonic development, at 
birth, or soon after birth. Most newborn clones are overweight and have 
an increased and dysfunctional placenta. Those that survive the 
immediate perinatal period may die within days or weeks after birth 
with defects such as kidney or brain abnormalities, or with a defective 
immune system. Even apparently healthy adult clones may have subtle 
defects that cannot be recognized in the animal.
    2. The most likely cause of abnormal clone development is faulty 
reprogramming of the genome. This may lead to abnormal gene expression 
of any of the 30,000 genes residing in the animal.
    3. Faulty reprogramming does not lead to chromosomal or genetic 
alterations of the genome, so methods that are used in routine prenatal 
screening to detect chromosomal or genetic abnormalities in a fetus 
cannot detect these reprogramming errors. There are no methods 
available now or in the foreseeable future to assess whether the genome 
of a cloned embryo has been correctly reprogrammed.
    4. The experience with animal cloning allows us to predict with a 
high degree of confidence that few cloned humans will survive to birth 
and of those, the majority will be abnormal.
    The arguments given in this outline have been summarized in more 
detail in an article by Jaenisch and Wilmut that will be published in 
Science magazine on March 30, 2001. A copy of the article will be 
available at the Committee meeting.

    Mr. Greenwood. Dr. Jaenisch, thank you for compressing what 
would have been a fascinating 2 hour lecture into 5 minutes.
    We are going to recess for just 10 minutes so the last of 
us can run over and make this vote and then we'll return to Dr. 
Zavos as soon as we reconvene.
    [Brief recess.]
    Mr. Greenwood. The hearing will come to order. I ask the 
guests to please be seated. Again, to the witnesses, thank you 
for your patience. You've been more than patient and now we 
turn to Dr. Zavos for his testimony. Let me particularly thank 
you because as you and I know, you had a very hectic weekend 
and I implored you to come and present your testimony today and 
you agreed. I thank you for that. And I recognize you for 5 
minutes to present your testimony.

                STATEMENT OF PANOS MICHAEL ZAVOS

    Mr. Zavos. Thank you, Mr. Chairman, and I thank the 
committee for inviting me. I am Dr. Panos Zavos. I am a 
Professor Emeritus, University of Kentucky. I'm the Director of 
the Andrology Institute of America and I have other titles, of 
course, which----
    Mr. Greenwood. Dr. Zavos, if you could just pull that 
microphone in. It's fairly directional, so if you could pull it 
in as close as possible and then maybe lift it up a little bit. 
Everyone is eager to hear your testimony.
    Mr. Zavos. Can you hear me better now? Thank you. Over the 
last 25 years, I have been involved in the area of reproductive 
physiology andrology and assisted reproductive medicine. I have 
received extensive formal education by obtaining four college 
degrees in biology, chemistry, general physiology and 
reproductive physiology. I have published quite generously in 
the areas of reproductive medicine and reproductive physiology 
as well.
    I'd like to say something about the current events in the 
ART market, that's the assisted reproductive technology market. 
With the advent of IVF and all other advances in assisted 
reproductive technologies, we're able today to perform 
incredible maneuvers and offer the infertile couples options 
that give them hope for having a healthy child. Never before in 
the history of mankind have we ever been so lucky to treat the 
infertility epidemic so incredibly well with such high 
probabilities for success. We all know that when an infertile 
couple comes to us for treatment of infertility, they want two 
things. They want a child yesterday, if at all possible, and 
they want a healthy child.
    In all the years that Professor Antinori and myself have 
been involved in the diagnosis and treatment of both male and 
female infertility, have we ever been involved in taking risks 
to humans. This same principle will remain in place as we 
venture into the development of new frontiers in infertility 
medicine. The current status of animal cloning, a variety of 
mammalian species have been cloned utilize somatic cell nuclear 
transfer, this we have heard before. These include sheep, 
cattle, mice, goats and pigs. As for implantation and prenatal 
chromosomal and genetic screening was not performed in any of 
the aforementioned animal cloning experiments, a small but 
significant proportion of the resulting offspring exhibited 
development abnormalities and/or perinatal death. To avoid the 
developmental abnormalities observed in the unscreened animal 
experiments, we proposed to conduct a variety of screening 
protocols on the nuclear transfer or transplant of embryos.
    Comprehensive embryo screening, although expensive would 
ensure that only healthy developmentally normal embryos would 
be conceived. This is the fundamental aspect of the 
consortium's proposal as producing developmentally abnormal 
human children is clearly not ethically acceptable by us.
    The current status of human cloning, although no one has 
claimed as yet that a human clone has been produced, the rumors 
that are out there indicates that cloning is just around the 
corner. And I think the 60 Minute footage that you just played 
for us, Mr. Chairman, indicate that very well.
    The technology for cloning a human being exists and it 
almost exists in every high tech laboratory across the world 
today. There are 55 such IVF labs in New York City alone today. 
So the questions that we must and we should be answering today 
is or are, who should develop this technology and then 
furthermore, what quality controls will be necessary to be 
developed and/or applied in order to make this technology safe 
with minimal risks to those using it and most importantly, to 
those that will be born from such efforts?
    Who should develop this technology? The human therapeutic 
cloning technology should be developed by a group of scientists 
and medical experts that understand this type of work and the 
seriousness of its development. Furthermore, such teams should 
be focused on this effort and work with leaders in government 
to see that this technology can be made safe and be 
disseminated properly.
    As you know, Mr. Chairman, I have just returned from a 
great country from a visit to a great country, the country of 
Israel, where I have visited with the chief spiritual leader of 
Rabbi Kaduri and the President of Israel and others that 
obviously have given us a great deal of support and a great 
deal of endorsement although obviously we're approaching those 
kinds of steps very cautiously.
    What quality controls are necessary? As stated before, 
during animal experimentation with cloning, no implantation of 
prenatal chromosomal and genetic screening was performed in any 
of the animal cloning experiments which brought about small, 
but significant proportion of the resulting offspring 
exhibiting developmental abnormalities and/or perinatal death. 
All animal experiments carried out today were done with 
unscreened embryos. This, according to the CHTC principles is 
totally inhumane and irresponsible for those that carry those 
experiments and gave the world this horrible picture, an 
impression that cloning cannot be offered and made to be safe 
in humans.
    On the contrary, this Consortium, in order to avoid the 
developmental abnormalities observed in the unscreened animal 
experiments wishes to develop and apply a variety of screening 
protocols and for that I am submitting as Exhibit 2 to this 
testimony a whole array of write ups for those kinds of 
screening tests that are in existence and we will be developing 
as we go along.
    Also, I need to mention something for this committee to be 
aware of is that our Consortium has no intentions of developing 
this technology within the continental USA.
    As a closing remark, I must say to you the following that 
those that say ban it, those would not be the Neil Armstrongs 
that would fly us to the moon and walk us on it. Those that 
stop it, those would not be the Columbuses that would take the 
bold step to discovery America. Those that say do not do it, 
they would definitely not be the Steptoes and the Edwards that 
changed the world by their innovative technologies of IVF. We 
are talking, Mr. Chairman, about the development of a 
technology that can help people. We are talking about the 
development of a technology that can give an infertile and 
childless couple the right to reproduce and have a child and 
above all complete its life cycle. This is a human right and 
should not be taken away from people because someone or a group 
of people have doubts about its development. We have no 
intentions and I emphasize that, we have no intentions to step 
over dead bodies or deformed babies to accomplish this. We 
never did in the past and have no intentions of doing it while 
we attempt to develop this revolutionary and yet magnificent 
technology. Thank you.
    [The prepared statement of Panos Michael Zavos follows:]

PREPARED STATEMENT OF PANOS MICHAEL ZAVOS, FOUNDER, ANDROLOGY INSTITUTE 
                               OF AMERICA

                              INTRODUCTION

    Over the last 25 years I have been involved in the area of 
reproductive physiology, andrology, and assisted reproductive medicine. 
I have received extensive formal education by obtaining four College 
degrees in Biology, chemistry, general physiology and reproductive 
physiology. I have also received extensive training in the areas of 
gamete physiology, manipulation, cell culture and in-vitro gamete 
manipulation. I have been involved in the development of various 
technologies and products and I have published on those subjects quite 
extensively. I have developed technologies in gamete culture and 
manipulation, cryopreservation and others (See short biography; Exhibit 
1).
    Recently, I was involved with a scientific group in Yonago, Japan 
in the development of ROSNI during which immature spermatozoa 
(spermatids) were harvested from the testes of infertile men and their 
nuclei were transferred into nucleated oocytes and electrofusion was 
applied and pregnancies were achieved. This clinical service is 
available to infertile couples all over the world.
    I own several US patents and have developed products that are 
currently in use in ART centers throughout the world. Both my wife, who 
is an OB/GYN and REI board eligible (Director of KCRM and IVF) and my 
self as Director of the Andrology Institute of America are involved in 
the infertility market and we also own a company that markets 
infertility products throughout the world. In my family, we are totally 
dedicated towards the treatment of infertility and we regard our 
patients as our primary target for offering them the best infertility 
service available.
    It is because of our total dedication and belief in those 
principles that I have decided along with Prof. Antinori to undertake 
the great effort and to offer our infertility patients that have 
exhausted all options available to them to bear a biological child of 
their own the option of human therapeutic cloning.

                    CURRENT EVENTS IN THE ART MARKET

    With the advent of IVF and all the other advanced assisted 
reproductive technologies (ART) we are able today to perform incredible 
maneuvers and offer the infertility couple options that can give them 
hope for having a healthy child. Never before in the history of mankind 
have we been so lucky to treat the infertility epidemic so incredibly 
well and with such high probabilities for success. We all know that 
when our infertile couple comes for a visit they want two things:

1. A child, yesterday if possible, and
2. A healthy child.
    These incredible developments in the ART market today are no pure 
accident but rather the end result of various forces that come into 
play. These come about because of the abilities and the freedom that 
scientists and clinicians have to develop such efforts and work 
together in organized groups such as ASRM, ESHRE MEFS and others 
throughout the world. I have been and continue to work with such groups 
because it is essential that those efforts should continue towards the 
development of safe and effective treatments for infertility diagnosis 
and treatment. In all the years that both Prof. Antinori and I have 
been involved in the diagnosis and treatment of both male and female 
infertility have we ever been involved in taking risks to humans. This 
same principle will remain in place as we venture into the development 
of new frontiers in the infertility medicine.

                    CURRENT STATUS OF ANIMAL CLONING

    A variety of mammalian species have been cloned utilising S.C.N.T. 
(somatic cell nuclear transfer). These include sheep, cattle, mice, 
goats, and pigs. As pre-implantation and pre-natal chromosomal and 
genetic screening was not performed in any of the aforementioned animal 
cloning experiments, a small but significant proportion of the 
resulting offspring exhibited developmental abnormalities and/or 
perinatal death. On the 9th of March 2001 our international consortium 
of scientists announced that they intended to perform human S.C.N.T. to 
allow infertile couples have children. To avoid the developmental 
abnormalities observed in the unscreened animal experiments, we 
proposed to conduct a variety of screening protocols on the nuclear 
transplant embryos. Comprehensive screening, although expensive, would 
ensure that only healthy developmentally normal embryos would be 
conceived. This is a fundamental aspect of the Consortium's proposal, 
as producing developmentally abnormal human children is clearly not 
ethically acceptable. This report is a review of the scientific 
literature, results and protocols regarding somatic cell nuclear 
transfer (S.C.N.T.) and contemporary morphological, chromosomal and 
genetic screening procedures. It is anticipated that the Consortium 
will utilize a range of screening protocols similar to (if not the same 
as) those discussed in this report.

                    CURRENT STATUS OF HUMAN CLONING

    Although no one has claimed as yet that a human clone has been 
produced, the rumors are that the development of cloning technology for 
application in humans may not be too far off. If one examines other 
events by studying historical data one can conclude that the 
development of human cloning is inevitable. In a recent report by 60 
Minutes during which a group of scientists and others participated, it 
was concluded that the recent developments are in tune with the trends. 
Human cloning is around the corner and more accurately as I stated over 
and over, where it comes to human cloning ``the genie is out of the 
bottle''. The technology for cloning a human being exists and it almost 
exists in everyone IVF high tech laboratory across the world. They are 
55 such IVF labs in New York City alone. So the questions that we 
should be answering today are:

1. Who should develop this technology, and
2. What quality controls will be necessary to be developed and/or 
        applied in order to make this technology safe with minimal 
        risks to those using it and most importantly to those that will 
        be born from such effort.

                  WHO SHOULD DEVELOP THIS TECHNOLOGY?

    The human therapeutic cloning technology should be developed by a 
group of scientists and medical experts that understand this type of 
work and the seriousness for its development. Furthermore such team 
should be focused on this effort and work with leaders and governments 
to see that this technology can be made safe and be disseminated 
properly. This technology like others can have catastrophic 
ramifications if it is not developed properly and it is allowed to end 
in the hands of the exploiters and the ``pushers''. It is because of 
those possible developments that our government along with others joins 
in and participates in the constructive dialogue and have something to 
say about its development and dissemination rather than taking the 
attitude that ``I don't want to play''. I believe that our government 
recent attitude with similar situations has adopted the principle of 
establishing a dialogue with hostile groups and governments throughout 
the world and it did pay off great dividends. This is not to imply 
however that the CHTC is either hostile or has any hostile tendencies 
towards anyone or any government in the world.

                  WHAT QUALITY CONTROLS ARE NECESSARY?

    As stated before, during animal experimentation with cloning no 
pre-implantation or pre-natal chromosomal and genetic screening was 
performed in any of the animal cloning experiments which brought about 
a small but significant proportion of the resulting offspring exhibited 
developmental abnormalities and/or perinatal death. This according to 
the CHTC principles is totally inhumane, and irresponsible for those 
that carried those experiments and gave the world this ``horrible'' 
picture and impression that cloning can not be offered and made to be 
safe in humans.
    On the contrary this Consortium in order to avoid the developmental 
abnormalities observed in the unscreened animal experiments wishes to 
develop and apply a variety of screening protocols on the nuclear 
transplant embryos that could ensure that only healthy developmentally 
normal embryos would be transferred to produce only healthy children. 
This is a fundamental of this Consortiums proposal, as producing 
developmentally abnormal human children is clearly not ethically 
acceptable. The Consortium has developed such array of testing 
procedures and wishes to make them available to this Committee for 
review and as part of this testimony (See Exhibit 11).
    For this committee's benefit, I would like to make the following 
comments before I proceed further:
    1. Our Consortium (the Consortium for Human Therapeutic Cloning) 
has no intentions of developing this technology within the continental 
USA. I am saying this to you Mr. Chairman at this time so that this 
Committee will not have to worry about this Consortium breaking any 
rules, laws, or having to be legislated out of extinction by this 
Congress.
    2. That name calling is not in our cards and those that do because 
they believe that they are better medically, scientifically or 
ethically they serve no constructive purpose by doing so and the public 
is not served in any positive fashion at all.
    3. We have received several offers by people to pay to have them 
cloned to have their own biological child. Such offers are not accepted 
by us because we have no technology to offer to anyone. It is still at 
its experimental stage.

                            CLOSING REMARKS

    Those that say ban it, those would not be the Neil Armstrongs that 
would fly us to the moon and walk us on it. Those that say stop it, 
those would not be the Columbus's that would take the bold step to 
discover America. Those that say don't do it, they would definitely not 
be the Steptoes and the Edwards that changed the world by their 
innovative technologies of IVF. Ironically, Mr. Chairman, those that 
say don't do it, they may be the ones, that enjoy the fruits of 
Professor Edwards and his team's efforts by doing IVF and getting 
compensated for. This is hypocritical and this has to stop. We are 
talking Mr. Chairman, about the development of a technology that can 
help people. We are talking about the development of a technology that 
can give an infertile and childless couple the right to reproduce and 
have a child and above all complete its life cycle. This is a human 
right and should not be taken away from people, because someone or a 
group of people have doubts about its development. We have no 
intentions to step over dead bodies or deformed babies to accomplish 
this. We never did it in the past and have no intentions of doing it 
while we attempt to develop this revolutionary and yet magnificent 
technology.

    Mr. Greenwood. Dr. Zavos, thank you for your testimony. We 
appreciate it.
    Now we would turn to Dr. Brigitte Boisselier, and you are 
recognized, ma'am, for 5 minutes for your testimony.

                STATEMENT OF BRIGITTE BOISSELIER

    Ms. Boisselier. Thank you, Mr. Chairman. Thank you for this 
invitation. I represent Clonaid, as you know, and this is a 
private company based in the United States that sets its goal 
to produced the first human clone. I'd like to remind you that 
when we talk about the first human clone, we are talking about 
a baby, a very healthy one and that's what we want and that's 
what we will produce. By the same time, I'd like you to 
recognize that this baby should be treated as a human being and 
I've heard a lot of words like monster, a bunch of cells and 
things like that. This is terrible. We are talking about 
parents who would like to be called to have this baby and I 
will address that issue after.
    But first of all, you talk about harms and I heard a lot 
about defects and that this has been in the press for weeks 
now. Based on scientific publication, I will give you a few 
figures. First of all, if you look at the publication regarding 
cattle cloning in the year 2000, if you look at the numbers 
that were published there, they have success rate, an average 
success rate between 15 and 20 percent. The usual success rate 
in in vitro fertilization clinics, the best ones, are between 
30 and 40 percents, meaning that today, 15 to 20 percent 
implantation of calves, of embryos for cattle cloning are 
bringing perfectly healthy clone. This is very comfortable to 
the success rate of in vitro fertilization in human.
    Now when we talk about the defects observed with the cows 
and you have seen all these pictures and so on, I'd like to 
tell you to look at the results of in vitro fertilization of 
cows because the same defects have been observed in in vitro 
fertilization. They do have a problem in imprinting of the 
embryos in cattle. It's not a problem of cloning, it's a 
problem of this species, the cattle.
    We heard a lot about defects also on mice. The mice have 
also indeed some defects, but I'd like to remind you that mice 
are inbred from generation to generation they have been mating 
between sisters and brothers, so they don't have any gene 
diversity and that's why they are not resistant to any defect. 
We are not inbred, we are outbred. Human beings are more 
resistant to these kind of defects and will not lead to these 
outcomes. So I'd like you to consider these defects that have 
been sensational all over the press today as elements that 
should be considered for these species. They have been 
researched on in vitro fertilization of humans. We know how to 
deal with these embryo, human embryo today and we have enough 
knowledge to proceed since cloning is actually using the 
technology of in vitro fertilization.
    Now I'd like to talk about benefits and about the people 
who would like to be cloned, who are they? They are homosexual 
couples. They are infertile couples. They are also parents who 
have lost a child. And I'd like to read very quickly, if I have 
time, a letter from my partner, I have founded a company with 
this man. He is the father of a baby who died at the age of 10 
months. And that's what he says. ``Dear Chairman Greenwood, who 
am I and why do I support human cloning? I am a successful 
attorney, a former State Legislator, a current elected 
official, a husband, a son, a brother, but most importantly, I 
am a father. At the age of thirty-eight I was blessed with a 
perfect baby boy. My wife and I were not expecting this 
miracle; as a matter of fact, I never even considered having 
children. The day our son was born was both the happiest and 
saddest day of my life.'' And then he goes on and explains how 
he loved this child and he learned that his child had a random 
birth defect that had to go through surgery for his heart. And 
then, ``when our son was 10\1/2\ months old my wife and I took 
our angel to a children's hospital to have his heart repaired. 
The doctors told us he had a 94 percent chance of full 
recovery. After 17 days of misery and struggle, with my wife 
and I, our family and friends sleeping on the floor beside our 
child, praying, crying, our hearts and souls dying, our sweet 
baby succumbed to the insult on his body and we lost him. We 
didn't know what to do and I couldn't accept that it was over 
for our child and for the first time in human history I/we 
didn't accept death as the end. Not since our Lord and Savior, 
Jesus Christ, spoke to Lazarus and told him to 'come forth' 
from the grave has a human been able to bridge the great gulf 
of death. I hoped and prayed that my son would be the first; I 
could do no less for him. He deserves a chance to live, to 
grow, to learn, to walk, to talk, go to school, to listen to 
music, to drive a car, to make a difference in this world; all 
these things he would never have the chance to do if this were 
the end, because of the failure of a heart operation with a 94 
percent success rate. How could this be, how could a father 
accept this outcome? I decided then and there that I would 
never give up on my child. I would never stop until I could 
give his DNA--his genetic makeup a chance. I knew that we only 
had one chance, human cloning. To create a healthy duplicate, a 
twin of our son. I set out to make it happen. We saved the 
appropriate cells'' and then he explained how we built that and 
how we met and how he will support that.
    ``I must withhold my identity until after the project is 
successful. However our commitment to human cloning and to 
duplicating our child is unlimited, whether in the United 
States or abroad, we will never quit or give up on our child. 
Hopefully 1 day we can all celebrate our family and friends, my 
wife and our son, Dr. Grigitte and the brave new world. Until 
then, I am respectfully, a father.''
    He mentioned a brave, new world and I'd like to finish this 
with just a remark about that. You mentioned that Brave New 
World novel and Huxley to me didn't despite cloning. He 
actually described how a State controlled science could produce 
controlled individuals who would think the same, act and behave 
the same. Thus, it's not cloning that might lead to social 
harms, but for a social structure that allow any form of 
enforced control over people thoughts and behavior by their 
rulers. These are the harms I am concerned about. The ones that 
I suffered from in France in my country of origin when I first 
declared that cloning was right. As a result of this 
declaration, I was denied the right to work and the right to 
have custody of my younger child.
    For all these reasons, and on behalf of the couples who 
have hopes, on behalf of the scientists who are told not to 
proceed, I'm respectfully asking you to secure two basic 
freedoms, the freedom of scientific inquiry and the freedom to 
make personal reproductive choices.
    [The prepared statement of Brigitte Boisselier follows:]

      PREPARED STATEMENT OF BRIGITTE BOISSELIER, DIRECTOR, CLONAID

    Ghairman Greenwood, how could a baby, not even born yet, have 
created so much fear around the world and in this country in the past 4 
years?
    Since the day the announcement of his potential birth was made, all 
the possible unfavorable outcomes have been predicted:

 A shortened lifespan due to shorter telomeres
 A high-risk of birth defect
 A high-probability of not having a soul
 Plagued with insurmountable identity crises
 A difficult relationship with the ``gene'' parent
 The possibility of having been desired for reasons other than 
        for him.
    How could a baby generate so much fear, so much disgust, and so 
much aversion?
    Why is he announced as a monster, and why are we, scientists at 
CLONAID, regarded as monsters?
    Why do people only talk about armies of clones, fading copies, and 
high-risks of defects when today, there are hundreds of cloned mammals 
that are alive and perfectly healthy?
    The ``YUK effect'' and the ``Defect Syndrome'' are terms that are 
used as a deterrent and are the result of a collective fear that is 
constantly fed by movies, novels, and reports that are hungry for 
sensationalism. The fact of the matter is that every time a new theory 
or a new technique is introduced to the public it is always scrutinized 
with the same level of apprehension, following the so-called 
``precautionary principle''. This was true for other reproductive 
methods, such as:

 artificial insemination
 in vitro fertilization
 the freezing of human embryos
 surrogate motherhood
    All went through this same ``condemnation'' phase and, with time, 
have come to be accepted techniques.
    So despite the fact that a large number of people curse this new 
technology and condemn cloning, using the same arguments that were used 
for previous techniques, despite the fact that they claim ``this time 
it's different and it's gone too far'', it is important for society to 
realize that it will happen soon regardless. The question is: where. 
Furthermore, most researchers agree that it will soon be common 
practice and likely to be an option at many fertility clinics.
    The purpose of my being public about our activities at Clonaid is, 
and has always been, to prepare our society for this new science, and 
to welcome this little baby. It is, and has always been, about 
educating people and reminding them that, unlike nuclear weapons, this 
pro-life technology does not represent a threat to the survival of the 
Human race and that reproductive cloning is not a new drug nor does it 
involve any gene modification. This technique just involves the 
creation of a new baby, the belated twin of an individual that has 
given full consent to the procedure.
    I think it is important for people to go past their emotions and 
examine the rationale behind such a practice.
    In order to do so, let us examine the harms and the benefits of 
human cloning in relation to the people cloned, their families and our 
society.

                                BENEFITS

    Benefits related to stem cell research and cloning for organ 
repair, organ growth, ageing studies, and cancer studies have been 
extensively reported, therefore, I will only concentrate on the 
benefits of reproductive cloning.
Who wants a cloned baby?
    For the past few years, and particularly the past 6 to 8 months, 
CLONAID has received thousands of requests from individuals or couples 
who are eagerly waiting for the public announcement of our success. 
These individuals are homosexual couples, individuals without a 
partner, and mainly infertile couples who have been through all 
possible fertility methods and who cannot have a baby with their own 
genes except through the cloning method. These requests are not 
geographically concentrated, they come from every continent, every 
culture, and every religion. The desire to give birth to a child 
bearing our genes is probably written in our genes.
    A huge amount of requests have also been expressed by people who 
have lost a child or a close relative. Every day, more and more people 
are calling and currently, we are working on cells of a baby who died 
at 10 months of age.
    A letter from his father is attached to the present testimony. It 
calls to us all and tells us about his motivation, his commitment, and 
about mine and the one from scientists at Clonaid. We will do all that 
is humanely possible to bring the belated twin of this boy back to life 
and healthy. If it becomes impossible to do it in this country, Clonaid 
will go elsewhere. And if no country on this planet allows it, we will 
do it on a boat in international waters, and we know that the number of 
people willing to help us will grow exponentially once they realize 
that we are only trying to give birth to a baby.
Having the best of death.
    The belated twin of a dead child will not replace the first one, 
but it will be one way to have this unique genetic code express itself 
again, a first step towards eternal life. Further steps are needed 
before we reach that level but this is one of the most probable outcome 
of this research.

                            POTENTIAL HARMS

Low success rates.
    The success rate announced for Dolly was very poor: only one viable 
offspring for 29 implantations. However, for the past 4 years, success 
rates have greatly increased (as could be expected for a new 
technology) and the average success reported in the 2000 publications 
range from 15 to 20% for cattle as an example. This means that 15 to 20 
% of the implanted embryos produced healthy offspring. We should recall 
that the best IVF clinics have a success rate of 30 to 40 %. We should 
also recall that, 22 years ago, the success rate for IVF techniques 
when it first started was less than 1%.
    These numbers tell us that, in animal cloning, we have already 
reached a level of reproducibility that compares well with human IVF.
Possible Defects
    The reported defects have been different depending on the species 
studied.In regards to mouse problems, we should remember that the ones 
that showed defects were inbred which means they don't have any genetic 
diversity in their genome . . . each individual human being, on the 
other hand, is outbred and has full genetic diversity which makes us 
very resistant to genetic defects and abnormalities . . . (inbred 
means: brother-sister mating for many generations which makes the two 
copies of all their genes the same, therefore no genetic diversity).
    Regarding problems of large offspring observed in cattle, we should 
recall that the same defects have been observed in calves resulting 
from IVF. These defects have never been observed in humans born through 
IVF.
    Those who are familiar with the human Assisted Reproductive 
Technologies (ART) and the progress that has been made in growing human 
embryos in culture in IVF clinics in the last 15 years, know that our 
knowledge of human reproduction is far more advanced than that of other 
mammals . . . 
    Clonaid scientists are well-trained and have been perfecting the 
egg enucleation and heteronuclear transfer which makes us very 
confident about the outcome of this endeavor.
Miscarriages and possible problems for surrogate mothers
    Miscarriages are common in pregnancy resulting from IVF but also in 
natural reproduction and do not constitute any potential harm to the 
mothers.
Psychological problem for the cloned individual
    All kinds of problems have been announced for the first test tube 
baby, Louisa Brown and she is so normal . . . 
    Identity crises or genetic identity, neither means nor entails 
personality identity. The belated twin will have his own identity . . . 
And hopefully will be told how precious life is since the alternate 
choice for him would be not to exist. What is best for them, to exist 
or not?
    Too much pressure, too many expectations . . . Would the belated 
twin be expected to behave like his gene donor? Isn't this what's 
already done with children today in many families. Aren't they expected 
to perform as well as dad or even better than dad?
    While we are spending time wondering about this child who is 
desired and will be loved and cherished, 13,000 other children are 
dying every day from starvation and abuse, sometimes in their own 
families . . . Which children should we be more concerned about?
Armies of clones
    Armies are not created by individuals but by governments . . . 
Among the thousands of couples or individuals who requested to be 
cloned, none ever asked to get more than two clones.
Gene trade
    While it is our basic freedom to reproduce our genes as we want, it 
is not acceptable to use the genes of someone who is alive and 
reproduce them without his consent. This is common sense and should be 
regulated.
    Again, I should emphasize that no one ever came to Clonaid with 
cells of famous personalities asking to get a cloned baby with these 
genes . . . and Clonaid does its own sampling to prevent such abuses.
    Looking at all these potential harms, I do not see why we should 
deny scientists the right to perform these practices nor why we should 
deny these parents from having the baby they have dreamed about for so 
long.

                         MYSTERIOUS OBJECTIONS

    During the debate that have been conducted the past years, 
mysterious objections have been raised and they really need to be 
addressed.
Playing God, Hubris . . . 
    Depending on the cultures and religions, different approaches have 
been taken. While Christians, in their majority, believe that we 
shouldn't head in that direction, Buddhists have expressed no concerns 
and some Jewish Rabbis have declared that if God has given us the brain 
to imagine it, then this is how it's meant to be.
    This last attitude is very close to Raelian's, who believe that 
life on Earth was the result of the creativity of advanced and 
brilliant scientists. These creators were mistaken for Gods in ancient 
times and today, we ourselves are on the verge of also becoming 
creators . . . or Gods. Is this hubris? I believe it is only a natural 
cycle of creations.
    The same emotional objection was given for most new technologies . 
. . 
Cloning is unnatural . . . 
    It must be painful for identical twins to hear that they are 
considered to be unnatural and, therefore, that their existence is 
morally undesirable. Centuries ago they were already feared and chased 
. . . 
Human dignity
    Both, the World Health Organization and the European Parliament, 
have stated that such cloning endeavor would be an offense to human 
dignity.
    The definitions of human dignity offered by major ethics 
dictionaries didn't help to explain how cloning would be a violation.
    If this means, as I understand it, that we shouldn't treat other 
people merely as means to an end but always as ends in themselves, then 
I assume it refers to the production of embryos that may or should not 
be implanted. This philosophical problem is not unique to human cloning 
but is also part of the debate regarding IVF and abortion.
    If it refers to the parent's choice to have a cloned child, then I 
want to testify how conscious these parents-to-be are. In this process, 
they conceive their baby with care, patience, determination and the 
baby will be one of the most loved child. Can we say the same for all 
naturally conceived children today?
Selfishness . . . 
    I often hear comments such as: ``These parents are selfish. They 
want to have a child with their genes while there are so many children 
to adopt'', or ``They want to have the belated twin of a dead son to 
ease their grief.''
    First of all, we should remember that life is the most wonderful 
gift.
    Now, are we going to have to examine the reasons why parents are 
having a child, whatever the reproductive method is used? Do they want 
it instinctively or for other reasons such as: they feel like it, they 
want a heir, someone to take over their business, someone to help them 
when they are old . . . There are all sorts of selfish reasons that can 
be involved in the decision to have a child, whatever technique is 
used.
What world do we want to live in??
    In his novel ``A Brave New World'', Huxley didn't despise cloning. 
He actually described how a state controlled science could produce 
controlled individuals who would think the same, act and behave the 
same. Thus, it is not cloning that might lead to social harms but 
rather social structures that allow any form of reinforced control over 
people's thoughts and behaviors by their rulers. These are the harms I 
am concerned about, the ones that I suffered from in France, my country 
of origin, when I first declared that cloning was right. As a result of 
this declaration, I was denied the right to work and the right to keep 
the custody of my younger child . . . 
    For all these reasons, and on behalf of the couples who have hopes, 
on behalf of the scientists who are told not to proceed, I am 
respectfully asking you to secure two basic freedoms:

 The freedom of scientific enquiry
 The freedom to make personal reproduction choices.

    Mr. Greenwood. Thank you for your testimony.
    The Chair recognizes himself for 5 minutes. Before I do, as 
a matter of housekeeping, the letter recommended by Dr. Okarma, 
a letter written on the stationery of Biotechnology 
Organization, by Mr. Carl Feldbaum, will be entered into the 
record without objection.
    Dr. Boisselier, first of all, let me comment to you that in 
a Brave New World as you describe it, the bravery would not be 
required of those who replicate others. The bravery would be 
required of the replica, who must live his or her life without 
a singular identity and that's what concerns me. You reference 
in your letter this father, who had the happiest and saddest 
day of his life when his child was born genetically defective. 
And then that child died in a surgical procedure that you said 
had about a 96 percent likelihood of succeeding. What concerns 
the members of this committee is that in order to use the DNA 
from that deceased child to replicate it, would be to use a 
procedure that we've already been told here is 96 to 97 percent 
ineffective, has a failure rate of 96 and 97 percent. It would 
seem to me that the odds are overwhelmingly in favor of the 
reality that were you to try to bring such a baby into 
existence, that you would give this poor couple yet another 
happiest and saddest day of their life as they witness the 
birth of yet another seriously ill child with serious birth 
defects. Now a question for you is how on earth is it that you 
and I would like Dr. Zavos respond to this and I would like Dr. 
Jaenisch to respond to this and any others on the panel that 
would like to. How on earth can you possibly screen this 
process so that you provide anything like the degree of 
certainty that we can expect from normal procreation that the 
child would be born healthy?
    Ms. Boisselier. Of course, I understand your point and we 
will do all we can to proceed so that we can check these 
embryos.
    Mr. Greenwood. The question is what can you do?
    Ms. Boisselier. Yes. Today, it was mentioned that the 
preimplantation diagnosis that are known today are not 
sufficient. It's true, if we consider the results of cattle 
cloning, but I'm telling you it's a problem of cattle 
reproduction. They don't know how to imprint that----
    Mr. Greenwood. How do you know that? You are a scientist. 
You use the scientific method. It seems to me that your 
assertion requires some level of scientific support which I've 
not yet heard from you.
    Ms. Boisselier. Okay, I'm just telling you what was 
published and what has been published by experts in this arena. 
So that's how I am--I'm just telling you what they published 
and that's completely available in the literature today. They 
do have the same problem in in vitro fertilization of cattle.
    Now when you look at the knowledge we have today on human 
reproduction, we have enough knowledge on how to deal with 
embryo, how to screen viable embryos and I think Dr. Zavos will 
explain that to you too. In in vitro fertilization clinics, 
they do these kind of screening. It might not be enough for 
what you think is good. I believe that we have--the trained 
scientists that are on my team are well-trained to address 
these issues.
    Mr. Greenwood. Dr. Zavos, would you respond? I'm sorry, I 
have limited time. I'd like Dr. Zavos to respond to the 
question.
    Mr. Zavos. We do hear you, Mr. Chairman, that you do have 
concerns just as much as every member of this committee. We 
need to point out several things that the basic scientists on 
this panel pointed out that they worked with animals, different 
animal models with different genetic makeup and therefore the 
susceptibility of those animal models is different and also one 
of the scientists indicated that there was a species to species 
variation or animal to animal species variation, that some can 
take the heat and stay in the kitchen and some cannot. In other 
words, we can do cloning with some, but others we cannot. 
Therefore this genetic diversity brings a very important issue 
here, that we have no standards as such as Congressman Rush 
just indicated a while ago about the FDA when they introduce a 
new drug, they do use some standard procedures via which they 
can scrutinize that drug and use different animal models to 
scrutinize that, and as of today, none of the animal models 
that have been created and have been studied have been 
scrutinized enough in order to be standardized and can be used 
as projections or predictors of an IVF or a human cloning 
effort as such.
    Now I need to point out here that we've been doing IVF and 
oocyte retrieval and embryo manipulation in this world for 23 
years now. And they just started animal cloning research and 
embryo manipulation as such for only very few years and I know 
I worked as a full Professor at the University of Kentucky and 
I operated such an effort for 22 years in the Animal Science 
Department. Therefore, I am quite knowledgeable as to what the 
standards for the animal industry to either clone or do IVF or 
do embryo transfer or whatever that might be, versus my wife 
and operating an IVF laboratory today and IVF clinic, an 
infertility clinic, the Kentucky Center for Reproductive 
Medicine and IVF. We have a success rate of almost 50 plus 
percent per embryo transfer. Now that is a significant 
difference between the animal species and the human species, 
therefore, when we retrieve 5 to 10 million oocytes per year in 
the human and we've been doing that for 23 years, we have a 
track record that is second to none. And therefore those 
experiences cannot be diluted by just a few dead cattle out 
there in Texas that they have been obviously cloned or 
reproduced under almost nonsterile conditions and in the case 
of their embryo transfer, they have never been scrutinized or 
screened properly in order for those embryos to be transferred 
in utero and expect a decent pregnancy to be established. So 
those are very serious concerns that we have when we talk about 
animal models versus the human species.
    There is a significant difference between a mouse and a 
human. There is a significant difference between a cow and a 
woman.
    Mr. Greenwood. I think that is the difference we're 
interested in here, as a matter of fact. Yes sir?
    Mr. Jaenisch. I think there are really serious factual 
errors and serious misstatements in both of the speakers which 
have to be corrected and I'm surprised to hear this from a 
Professor of Biology.
    So first of all, it is just not correct that you can do 
prenatal screening for chromosomal operations. Chromosomal 
operations are not the problem in cloning. A chromosomal 
operation may occur and is of no great concern because these 
embryos will die very early as they do in normal human 
reproduction.
    This is really not the point. The point is reprogramming 
which is not a genetic change. The genes are normal. There's no 
change. I think it's very important for them to understand 
that. There's a basic difference between IVF, in vitro 
fertilization and cloning. In vitro fertilization, the sperm 
and the egg have gone through the reprogramming. There's no 
problem with that. So to compare now in vitro fertilization 
rates to be high or low with cloning, low or high, that means 
comparing like apples with oranges. It has no--it is not 
usefulness in this comparison.
    Then it was said that mice are inbred and that's why 
cloning is a problem. Again, I want to correct, these are all 
factual errors. When you try to clone inbred mice, it doesn't 
work at all. But when you clone mice which are not inbred, 
they're called F-1 animals, they're very happy to clone. They 
have all these malformations and they're actually quite well to 
be cloned as with probably similar efficiencies as you see in 
cows.
    Now then comes the species--so the idea would be well, 
there's species variation. Yes, there is, because we understand 
the in vitro development of embryos to a different extent in 
these different species. There are clear differences, but this 
is not the problem. The problem is the basic biological problem 
of reprogramming. All mammals in this problem is the same. I 
can really say this with quite some conviction. I am really 
sure about this.
    And then finally, 15 to 20 percent success rate in cloning 
of cattle, I just wonder where these data come from and I think 
my neighbor can really address this. I think this is very 
obscure sources, probably, and of course 15 to 20 percent 
success. What do they call success? Abnormal cattle? They don't 
know whether they're normal. As I said before, I don't believe 
there's a single normal clone in existence. All clones have 
some subtle defects. If the defects are serious, they die early 
in development. If they're less serious they go to birth and 
die at birth. The ones which have less serious ones go later 
and die after week or 2 and then Dolly made it to adulthood. 
Dolly is not normal. Dolly is overweight. They don't know why 
it's overweight. Dolly may have other problems which are beyond 
our ability to analyze in an animal. We cannot animal as easily 
what the brain function is. We can only do this in humans 
unfortunately and they're socialized and go to school. Then we 
have an abnormal person. So I think it's totally irresponsible 
and totally misleading to use scientific data which are plenty 
there and select certain data to make a statement which is 
false.
    Mr. Greenwood. Dr. Westhusin?
    Mr. Westhusin. I'd like to make a few comments also. I can 
point you to another reference also where the success rate was 
80 percent, 8 calves were born and then 4 of those died within 
a day after they were born. So you can pick out isolated cases 
where the efficiency of cloning is higher and you don't have 
these problems, but when you look over across the averages of 
all the papers and put them all together, it's an extremely 
serious problem.
    The other issue that was brought up about in vitro 
fertilization, the whole basis and background of human in vitro 
fertilization, what they do today, was brought on by animal 
research and it suggests that they can produce humans with in 
vitro fertilization better than we can even with cattle, if we 
had an interest with it today, is ridiculous. We're much better 
at producing babies by in vitro fertilization in cattle using 
all the nonsterile techniques we must use to do it than they 
are in humans, our pregnancy rates are much higher, our 
development to blastocyst rates are much higher and we're a lot 
better at it than in humans and there's a whole industry in in 
vitro fertilization in cattle that has much better record than 
humans do.
    The other issue is I don't quite follow the logic to say 
that of all these animals that have shown these different 
problems we can't use those as an example of the human because 
they don't represent good models of the human, so does that 
mean we don't use any example and we just jump out and go try 
it? I don't follow the logic of that thought process of trying 
to argue that these are not good animals or models and we can 
do better in humans because we're so much better in the 
techniques and the things we have. I just doesn't make any 
sense.
    Mr. Greenwood. Thank you. Dr. Okarma.
    Mr. Okarma. I have little to add technically other than to 
confirm the comments you've heard from my two colleagues to the 
left. In my opinion there is serious misrepresentation of fact 
and a tenor of confidence that the data, in fact, in human IVF 
and embryonic screening do not support.
    It is true that when couples with a known genetic defect 
desire to have children through IVF in limited cases where the 
genetic defect is absolutely known, samples of the embryos that 
are created by IVF can be obtained and screened for the 
presence or absence of that single abnormality, when it is 
known as there it is, but the notion that this technology is 
capable of screening all of our 30,000 genes is absolutely 
specious. And I too am surprised at these kinds of statements 
made from a former faculty person in biology.
    Ms. DeGette. Mr. Chairman, if the chairman would yield, I'd 
like to ask unanimous consent, we clearly have some scientific 
disagreement on this panel. I'd like to ask unanimous consent 
if all of the doctors on the panel, they've all referred to 
studies, if they could present to the panel in writing their 
studies and the sources of their claims and where they came 
from. I think that would be helpful.
    Mr. Greenwood. Without objection, we ask each of the 
witnesses to the extent that you have referred in your 
testimony or referred in your written comments, in your oral 
comments and can recall them and reference studies that would 
be helpful in our decisionmaking. We would be delighted to have 
you submit copies of those.
    The Chair recognizes the ranking member, Mr. Deutsch for 5 
minutes for his inquiry.
    Mr. Deutsch. Thank you, Mr. Chairman, and obviously there 
is a great disagreement amongst the five of you and I think 
it's very helpful for us and also for our jobs in terms of 
trying to shape policy.
    I'm going to ask you to do something somewhat unusual. If 
you would like to, just dialog each other, you know in terms of 
some of the statements that were made in terms of the efficacy 
of the safety of cloning directly. I mean I've heard 180 degree 
different opinions from the two people on the right and the 
three people on the left from our vantage point on this panel. 
I don't want to be confrontational, but I think people are 
making statements in a public setting, citing scientific data 
directly opposite each other. And I think one of the things 
that does is highlight the role that the FDA conceivably could 
play in terms of determining what is, in fact, best science. 
It's not just someone with a Ph.D. or an M.D. behind their name 
saying something, but some type of independent arbiter who 
doesn't have a vested interest, who has legal standards in 
which they have to be responsive to.
    I don't know if anyone wants to take a response to that, 
but I'd be happy--it's kind of unusual, but I'd be happy to 
open it up that way.
    Mr. Westhusin. I'll ask a single question to Dr. Zavos and 
it's along this line of we've been talking about screening.
    There are at least half a dozen papers out there now that 
are documenting probably at least 6 to 8, probably more genes 
because the work is just starting to be really, it's just 
coming to the forefront of trying to do genetic comparisons 
between cloned animals and normal animals at the blastocyst 
stage through the field stage, all the way up through 
development. There are at least probably 6 to 7 genes that have 
been compared to normal and have been shown to be abnormally 
expressed and what that means if you're going to measure those 
is you have to do gene expression analysis which can't be done 
on a single cell from a few embryos or you can't do a biopsy to 
do those kinds of things, so how would you propose that you 
would screen for those 6 or 7 genes and then how would you have 
the thought process to the idea that those were the only 6 or 7 
genes that were important of the 30,000 that could possibly be 
screwed up in expression?
    Mr. Zavos. I think you just mentioned the key word, 
possibly, and the ``mays'' that you're using in your statements 
obviously do obviously bring a great deal of dismay to me 
because I think that we need to understand here that those 
impossibilities that they're talking about are only 
impossibilities and I don't want to be too philosophical on 
answering his question but if Columbus, for instance, would 
just even think that the winds are too troublesome or Mr. Neil 
Armstrong would think for a moment that he may not be able to 
climb on the ladder back onto this shuttle to get back to the 
world, back to this earthly world, I should say, he would 
probably never take that bold step to get there and come back. 
So those are possibilities.
    Now as a scientist I have to ask my people, my scientific 
colleagues on the right here as to have they ever cloned a 
human clone embryo and have they ever been able to study that? 
I want to ask them that question because I think that if you've 
never been to the moon you can't talk about the life and the 
environment on the moon, that's why we went there, we found out 
and came back and we said all about it and we have written 
books about it. And this is the story that they're trying to 
extrapolate the animal modeling that they have done and I have 
to challenge them about the numbers and the standards that they 
have established because there are no standards. I know as a 
faculty for 22 years and claim to be a full professor with 
tenure, I know the pressures that exist on a college campus to 
produce a paper or two in order to get the promotions and the 
financial compensations that go there. And therefore, I need to 
ask them those kinds of questions because we can debate this 
issue all day long about those six genes they may be obviously 
in trouble and you need to screen for. Have they ever cloned a 
human embryo and have they scrutinized that human embryo?
    Mr. Deutsch. Let me just interject and again I think at 
some level of science I think it's appropriate, but let me try 
to respond to what you said. I think two things and again, just 
to get a feel for it. I don't know if you would suggest that 
the first time NASA sends something to the moon it would be 
humans on a ship. Clearly before we sent Neil Armstrong to the 
moon, we had lunar exploration and even though a human had not 
been on a moon, clearly we had done a great deal of scientific 
or societally as the United States of America, we had done a 
great deal of scientific exploration of the moon and what to 
expect in that environment.
    I think there's two issues that I see. One is just the 
practical issue. I think that there is a scientific standard 
that's out there. I don't think whether you say philosophy or 
not philosophy to throw that out.
    Dr. Jaenisch, it seems you were struggling to respond, so I 
want to give you that opportunity to respond.
    Mr. Jaenisch. I have a couple of responses to that. So one, 
I would like to know from Dr. Zavos whether he has cloned a 
human, what his experience. I would like to know that.
    But let me say clearly that humans are not guinea pigs. So 
if you do experiments with humans, it's application, but it's 
not experimentation to find out science the thing you do with 
animals and it's clear in animals this has not been resolved 
and therefore it's just out of the question to my opinion and 
it's totally irresponsible to even attempt to consider doing 
these experiments with cloning.
    So one thing I wanted to come to this letter back of this 
father. This didn't make any sense at all, because apparently 
this boy had a genetic defect, so they want to reclone this 
boy? Of course, the clone would have the same genetic defects 
and these parents would have in addition to the existing 
problem all the problems coming from cloning. This seems to be 
not a very attractive proposal and I think these parents are 
really misled badly by misstatements as we heard which totally 
distort, I think, the scientific literature and I think there's 
an enormous body of experience and knowledge now which I think 
underscore what my colleagues to the right have said and myself 
included.
    Mr. Westhusin. I would also like to comment that one of the 
real misconceptions that I think and later on this afternoon I 
think some of the ethicists will be here to talk more about 
ethics and stuff, but one of the real issues that bothers me 
about this also is the concept of the difference between 
resurrection and reproduction. This is not resurrection. It is 
not resurrection. Okay? It's a reproductive technology and 
whether or not you want to say you know whatever side you take 
on it, it should take, it simply is another form of assisted 
reproductive technology and we can talk about the ethical 
issues aside as to whether we should be doing it, but you can 
think up scenarios that you could take single cells from single 
individuals and create people that weren't clones and you could 
create--figure out huge technologies of people that couldn't 
have children where you could take one cell from each side, 
there was a skin cell and do things in the laboratory to where 
they would not be clones, but you still wouldn't do that if 90 
percent of the babies died, if it put the surrogate mothers in 
risk and if you have these potentials for developmental 
problems to begin with. There's a real ethical issue, I think, 
and a real danger that this can be thought of as resurrection 
when it absolutely is not and in fact, a clone wouldn't even be 
as similar as an identical twin because it would have a new 
mitochondrial genotype.
    Ms. Boisselier. If I may answer to some of the questions 
there. First of all, it was not a genetic defect that this 
baby. It was a random birth defect and was proven not to be 
genetic from what I know and what is said and what his doctors 
said.
    When you talk about the success rates, I'd like to remind 
all of us that when we started in vitro fertilization the 
success rate was 1 percent, okay? So also that's something that 
we should keep in mind and improving it to 50 percent. It means 
that there have been a lot of embryos that never went through 
these implantation pregnancies. So we should remember that.
    I also think that we should know we could go on and on with 
pig and cow cloning and learn and refine the technique with 
those. It will not help for human cloning because this is 
completely different cells. Again, they are different species 
with different reproduction techniques involved in there. The 
techniques that have been described right for the mice is not 
the one that has been used that are proven interesting for the 
cows and so on. So they could refine that and finally do the 
right imprinting of the DNA to get a viable embryo and have 
something completely reproducible. It will not help for human 
clone because it's different media, different way to generate 
the embryo.
    What I'm saying is that through this in vitro fertilization 
experiences that have been accumulated for 23, 24 years now, 
they learn how to really start an embryo, how to screen an 
embryo, how to see how an embryo is viable one or not just 
looking sometimes just at the microscope, it can tell well this 
one is not right. They had this kind of experience I'm talking 
about the experts in this technique and they will detect 
whether an embryo is not viable or not, which is not true for 
cow which is not true for mice, because they don't have the 
same length of experience. So I'd like really for you to come 
to hear that.
    Mr. Zavos. I'd like to make a comment just in reference to 
the comments that were made so far. The other day I was on 
Swiss TV debating a scientist from the home country and he 
obviously told me that here I am trying to clone mice of this 
particular subspecies and I'm having almost 99 percent failure. 
And he says to me what is your reaction about cloning humans 
with that kind of failure? And my reaction to those kinds of 
statements is that I cannot really justify for some of those 
people's incompetency in cloning animals, just because they 
simply enter the field and they've done a few animals and 
they've done a few observations with absolutely no controls and 
when you design an experiment you have controls and 
experimental procedures as well as experimental control and 
experimental groups of animals in order to study various 
aspects. Some of the studies that are done out there are very 
isolated. Let's just take Dolly, for instance, 277 enucleated 
oozytes.
    Twenty-nine embryos were produced. All transferred in 13 
recipient use, that's female sheet. One took and yielded Dolly. 
No other abnormalities from any of the other embryos that were 
or were not implanted. One Dolly was born and now we question 
Dolly's IQ. Now Dolly has since reproduced and obviously we may 
have to take him to Harvard or something in order to have an IQ 
and that is really somewhat of an insult to people's 
intelligence talking about that. That sheep only needs enough 
brain to graze and thank God, we know that much. I mean where 
do we go from here?
    So you know, the questions that are appearing in this panel 
are beginning to deviate from the main theme here is that we 
are, we have a technology here that inevitably will be 
developed. Mr. Chairman, everybody has to understand and I 
think that 60 Minutes footage indicated very clearly today that 
the genie is out of the bottle.
    What we need to be debating here is that how do we put this 
genie back in a bottle and disseminate securely and safely? 
We're not talking about America. We are not talking about 
Turkey or Greece of Israel or Italy. We're talking about the 
world. And the world needs to address this issue very, very 
seriously.
    Mr. Greenwood. The gentleman's time has expired. We're 
going to turn to Mr. Whitfield. I would ask that perhaps in 
response to a question from Mr. Whitfield, if you have 
additional comments you want to make, the Chair has been way 
overboard in terms of the little red light here and really in 
respect for the other members needs to move forward.
    Mr. Whitfield for 5 minutes.
    Mr. Whitfield. Thank you, Mr. Chairman. Mr. Westhusin, I 
would like to give you a minute to respond.
    Mr. Westhusin. I just wanted to make a brief comment about 
that. If the criticism is that we're incompetent and people 
that are cloning animals have not done controlled experiments 
to do that, is Dr. Zavos proposing that we jump in and not do 
more controlled experiments with animals, but just jump 
straight to humans to do those controlled experiments?
    Mr. Zavos. I have never indicated that.
    Mr. Westhusin. What else would it be besides 
experimentation?
    Mr. Zavos. I do have a plan and I'm not going to reveal it 
before this committee today.
    Mr. Whitfield. Dr. Zavos, you were talking about these 
controls and so forth. Do you have the technology to screen for 
the 30,000 genes? Yes or no?
    Mr. Zavos. Not for the 30,000, no.
    Mr. Whitfield. So you don't have the technology. Are you 
currently a professor at the University of Kentucky?
    Mr. Zavos. I'm sorry, what?
    Mr. Whitfield. Are you currently a professor at the----
    Mr. Zavos. I'm professor emeritus, up to 22 years of 
service at the University of Kentucky. .
    Mr. Whitfield. And you made a comment and unless I misheard 
you that at your clinic, I thought you said that you maybe had 
a 50 percent success rate?
    Mr. Zavos. That's correct, sir.
    Mr. Whitfield. Because it's my understanding that generally 
the success rate at most IVF clinics is like 20 to only 25 
percent.
    Mr. Zavos. The CDC data from 1998 it's 30.8 percent.
    Mr. Whitfield. So you're around----
    Mr. Zavos. Above average, yes, way above average, yes, 
correct.
    Mr. Whitfield. Let me ask you, why did you not participate 
in the national voluntary program through which IVF clinics 
report their success rates?
    Mr. Zavos. Our clinic is only less than 2 years old and we 
have a certain gray period. First of all, I need for this panel 
to understand that we do not need by law or any other standards 
to report to SART, that's the Society of Assisted Reproductive 
Technologies. We chose not to do that for the first 2 years. 
We're in the process of becoming candidates for SART and we 
will be reporting, but for a young program like ours, we wanted 
to establish a track record before we begin that effort.
    Mr. Whitfield. Have you ever cloned an animal yourself?
    Mr. Zavos. No sir, I have not.
    Mr. Whitfield. And have you been part of any group that has 
cloned an animal?
    Mr. Zavos. No, I have not. I represent a consortium of 
experts from all over the world that obviously, this is not a 
man's show here. I'm not the one that is going to be doing 
this. We have scientists, we have a scientific group that will 
be going to work to do this and therefore we feel like this is 
a team effort and that's why I spoke about the various aspects 
of putting a lot of brains together in order to get there on 
that 60 Minutes footage.
    Mr. Whitfield. You've indicated that you would not do this 
in the United States, is that correct?
    Mr. Zavos. That's correct, sir.
    Mr. Whitfield. Where would you do it?
    Mr. Zavos. Well, we cannot disclose that. It's obviously 
for security purposes and other purposes, we do not wish to 
disclose that.
    Mr. Whitfield. Dr. Boisselier? Now you have a doctorate 
degree in what?
    Ms. Boisselier. In chemistry.
    Mr. Whitfield. From which university?
    Ms. Boisselier. University of Houston.
    Mr. Whitfield. Houston.
    Ms. Boisselier. And I had one in University of Dijon in 
France before.
    Mr. Whitfield. Okay, now recent press reports have 
indicated that work is underway at one of your labs or at your 
lab that was started last October, is that correct?
    Ms. Boisselier. Well, we got the funding in September. We 
tried to assemble all the equipment. We had about everything by 
the end of December and so the scientists have been working and 
refining the protocols since then.
    Mr. Whitfield. And you claim that you have four scientific 
staffers, two biologists, one geneticist and one M.D., is that 
correct?
    Ms. Boisselier. It is correct.
    Mr. Whitfield. And they're there now, working now?
    Ms. Boisselier. Yes. The M.D. is not full-time because we 
are not working on human cells.
    Mr. Whitfield. And you claim that almost 200 people are 
willing to pay up to $200,000 in order to participate, is that 
correct?
    Ms. Boisselier. Actually, there are thousands of people who 
are willing to be called and I mentioned those because they are 
the ones who are really willing to be, even the first.
    Mr. Whitfield. So is $200,000 a realistic figure?
    Ms. Boisselier. I don't know exactly the amount that will 
be asked because we decided, I know that this is put on the 
website, but I didn't correct that for a long time. We will set 
the price once we have a successful birth because we'll know 
then how much we had to invest and also how many customers we 
have and we will go through the usual thing of a financial of a 
company.
    Mr. Whitfield. Now you've stated that this lab is in the 
United States, but you've also publicly stated that it's 
outside the United States. Where is it?
    Ms. Boisselier. Well, I don't think I have said that it is 
outside of the United States. I think I started to say it was 
in the United States in September or late September, before I 
was saying I am not disclosing where it is. That was my answer.
    Mr. Whitfield. So you're not disclosing where it is?
    Ms. Boisselier. So today, I am saying it is in the United 
States. Before I was saying I'm not disclosing where it is, so 
I was saying no for every----
    Mr. Whitfield. And it is your intention to proceed to clone 
a human being?
    Ms. Boisselier. Yes, it is. And will do that if it is 
allowed in this country. Of course, if there are laws against 
it, because from what I know today, I'm not against the law or 
I'm not breaching any law in doing it here in the United States 
in certain states. I know that we have some states where there 
are laws against it. I'm not based in one of those.
    Mr. Whitfield. I see my time has expired, Mr. Chairman.
    Mr. Greenwood. The time of the gentleman has expired. The 
Chair recognizes the gentle lady from Colorado, Ms. DeGette for 
5 minutes.
    Ms. DeGette. Thank you, Mr. Chairman. Now Ms. Boisselier, 
I'm sorry, Dr. Boisselier, I got your resume off of the 
internet and it looks to me that you are a biochemist with an 
emphasis on metals research. Would that be an accurate summary 
of your resume?
    Ms. Boisselier. Yes.
    Ms. DeGette. So you yourself are not conducting this cell 
research I would assume?
    Ms. Boisselier. You are right.
    Ms. DeGette. Thank you. Instead, as I heard you tell 
Congressman Whitfield, you have some scientists working for 
you. Is that correct?
    Ms. Boisselier. This is correct.
    Ms. DeGette. Now are those folks biologists?
    Ms. Boisselier. And they are biologists, geneticists and an 
M.D.
    Ms. DeGette. Now many biologists do you have?
    Ms. Boisselier. Two.
    Ms. DeGette. Now many geneticists?
    Ms. Boisselier. One.
    Ms. DeGette. And how many M.D.s?
    Ms. Boisselier. One.
    Ms. DeGette. So you have four of those folks working for 
you?
    Ms. Boisselier. Right.
    Ms. DeGette. Can you please let me know who those folks 
are?
    Ms. Boisselier. Now, I'm not able to disclose that.
    Ms. DeGette. And why is that?
    Ms. Boisselier. Because they don't want to go public now.
    Ms. DeGette. And can you get, can you submit at least their 
qualifications to this committee in writing, are you willing to 
do that without disclosing their actual names? Obviously, we're 
quite concerned that people conducting this kind of genetic 
research might be qualified to do it.
    Ms. Boisselier. Okay, I will certainly disclose that to 
you, but not in public here.
    Ms. DeGette. Thank you. We can take it in writing in the 
committee.
    Now let me ask you what exactly is the research that is 
being conducted by your organization?
    Ms. Boisselier. The first main step that has to be very 
well done is the enucleation of the egg.
    Ms. DeGette. And are you, in fact, enucleating the eggs 
now?
    Ms. Boisselier. So they are enucleation of eggs that are 
performed.
    Ms. DeGette. Is that happening now?
    Ms. Boisselier. It's the training of these----
    Ms. DeGette. Yes or no. Is that happening now?
    Ms. Boisselier. Let me finish. It's actually done on cow 
eggs.
    Ms. DeGette. Okay, so you're doing that with cow eggs now.
    Ms. Boisselier. Right.
    Ms. DeGette. What's the second step?
    Ms. Boisselier. Sorry?
    Ms. DeGette. What's the second step?
    Ms. Boisselier. The second step is to do the enucleation of 
human eggs.
    Ms. DeGette. And have you done that yet?
    Ms. Boisselier. No.
    Ms. DeGette. When do you expect to do that?
    Ms. Boisselier. Soon.
    Ms. DeGette. How soon?
    Ms. Boisselier. When the answers that I have been asking to 
my scientists are clear with the enucleation of cow eggs.
    Ms. DeGette. And what are those questions you're asking 
your scientists?
    Ms. Boisselier. To show me that there is indeed absolutely 
a very good reproductive activity in the enucleation of the 
cow.
    Ms. DeGette. Great. Now you had just said a few minutes ago 
that a cow is a different type of mammal than a human.
    Ms. Boisselier. Yes.
    Ms. DeGette. So how is it that you're doing the 
enucleations of the cows and you somehow think that this 
research will be positively affect your research on human 
cloning?
    Ms. Boisselier. Because we know perfectly the difference 
between the enucleation of the cow eggs and the enucleation of 
the human eggs. These have been very well described.
    Ms. DeGette. Why are you doing the cow eggs if you know 
they're different from the human eggs?
    Ms. Boisselier. It's easy to answer. It's difficult and I 
will not sacrifice any human eggs in the practicing of this 
technology so what they are doing today is doing the practicing 
on cow eggs.
    Ms. DeGette. Now you don't know that once you do the cow 
eggs that the human eggs will be the same because they're a 
different species?
    Ms. Boisselier. Yes, I know. This is described. What I'm 
telling you----
    Ms. DeGette. So what's going----
    Ms. Boisselier. --When we're training them it's not on how 
to do it, it's on what is the protocol to do it because it's 
well described.
    Ms. DeGette. Right, okay. I have a short time and I 
apologize. You don't know that when you begin enucleating human 
cells that there won't be terrible anomalies as we've seen with 
cows, sheeps and in fact every other mammal that has been 
cloned, do you?
    You don't know that, do you?
    Ms. Boisselier. Yes, it's not a problem of enucleation. You 
are associating enucleation with defect. It's not that.
    Ms. DeGette. Once you start cloning human cells, you do not 
know that there will--that you will be safe from abnormalities, 
do you?
    Ms. Boisselier. I have great confidence that there will not 
be any----
    Ms. DeGette. None?
    Ms. Boisselier. Because of what we know about that. There 
will be miscarriages----
    Ms. DeGette. No, no. But what----
    Ms. Boisselier. I'm saying that these are defects.
    Ms. DeGette. These gentlemen over here have testified that 
it's not an issue of the in vitro fertilization being 
successful or not. But actually, and I'm not a doctor, but it's 
actually the genetic channels in the cells which are going to 
change after the cloning. And I don't see how, if there's never 
been and certainly if you folks have never cloned a cell, I 
don't see how you can be certain from that. So let me ask you 
just one more question----
    Ms. Boisselier. Could I answer that question?
    Ms. DeGette. Who's going to bear the financial 
responsibility for wrongful anomalies, abnormalities and 
births?
    Ms. Boisselier. I will answer the previous question. You 
said that we don't know about the rate of success. You should 
know that when we do implantation of embryo in in vitro 
fertilization clinics, they have a lot of miscarriages.
    Ms. DeGette. I'm not talking about miscarriages.
    Ms. Boisselier. There will be the same----
    Ms. DeGette. I'm talking about the cellular makeup.
    Ms. Boisselier. That's defect. That's defect. When there is 
a miscarriage, there is a defect in the embryo.
    Ms. DeGette. Right. But as we've seen with the other 
experiments, you can have a fetus carried to term and they 
still have genetic abnormalities.
    Let me ask you one more question. When are you going to 
apply--I assume your researchers are planning to apply to the 
FDA for an IND for this human research, correct?
    Ms. Boisselier. I've received a letter telling me to do 
that recently, yes.
    Ms. DeGette. So are they going to apply?
    Ms. Boisselier. I will check with my counsel.
    Ms. DeGette. You don't know if they are?
    Ms. Boisselier. I just don't know.
    Ms. DeGette. Who did you get the letter from, the FDA?
    Ms. Boisselier. The FDA.
    Ms. DeGette. So you don't know whether you'll apply or not 
for doing this human cloning research?
    Ms. Boisselier. I have to review the letters, of course.
    Ms. DeGette. Do you think you do need to apply?
    Ms. Boisselier. I will review the letter.
    Ms. DeGette. When did you get the letter?
    Ms. Boisselier. Yesterday, so I am sorry, I do not have the 
time to review that.
    Ms. DeGette. Well, now here's what the FDA says and I'm 
quoting. ``Clinical researchers in cloning technology to clone 
a human being 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. FDA 
believes that there are major unresolved safety questions on 
the use of cloning technology to clone a human being and 
therefore would not permit any investigation to proceed at this 
time.'' So do you plan to follow that and apply or not?
    Ms. Boisselier. I will ask my counsel.
    Ms. DeGette. I just have a couple of quick questions for 
you, Dr. Zavos.
    First of all, I'd like to ask you the same question that I 
asked the previous witness is let's say that you have genetic 
abnormalities resulting from the cloning. Who's going to bear 
the financial responsibility for those----
    Mr. Zavos. Obviously, that's a hypothetical question and--
--
    Ms. DeGette. So you don't feel there will be any genetic 
abnormalities either?
    Mr. Zavos. No, no. We believe that there will be, but every 
precautionary measurement will be taken.
    Ms. DeGette. Well, now you've heard the researchers to your 
right testify that in every mammal that we've done this 
research on, there have been significant genetic abnormalities 
as a result of the cloning technique.
    Mr. Zavos. That's correct.
    Ms. DeGette. Do you agree when we start cloning humans that 
there will be similar genetic abnormalities?
    Mr. Zavos. The Consortium's effort will be to transfer only 
viable embryos into recipient mothers in order to achieve a 
healthy pregnancy.
    Ms. DeGette. Well, I sure understand that's your hope, 
Doctor, but the problem that I've got is as these researchers 
have testified, in animal research the way the genetic 
development happens is even if the embryo seems to be 
genetically complete, there are mutations and that, in fact, 
there will be abnormalities. We haven't had any research in 
other mammals without abnormalities.
    Mr. Zavos. That is correct. That's a new area of expertise 
and we need to learn, as we go along as to what the 
ramifications will be and therefore it is very important that 
as we obtain those embryos, human embryos we will scrutinize 
them appropriately----
    Ms. DeGette. One last question and we've got to vote. Do 
you believe that those human cloning research experiments need 
FDA approval and do you believe they need FDA approval?
    Mr. Zavos. Absolutely, I do.
    Ms. DeGette. Thank you.
    Mr. Greenwood. We do have a vote. We will recess the 
hearing until 3.
    [Brief recess.]
    Mr. Greenwood. We will come to order. Guests will please 
take their seats. The Chair recognizes the gentleman from 
Florida, Mr. Stearns for 5 minutes for inquiry.
    Mr. Stearns. Thank you, Mr. Chairman. I just wanted to go 
back I think to some earlier testimony in opening statements. 
As I understand it, an egg cell donated for cloning has its own 
mitochondria DNA which is different from the mitochondria DNA 
of the cell that provided the nucleus and therefore the clone 
will therefore not be truly identical. I'd like you just 
explain that. Give me a little bit understanding of what the 
implications of that are, Dr. Westhusin?
    Mr. Westhusin. We really don't know what the implications 
of it are. And there have only been about three studies that 
have actually been able to be controlled in such a way that you 
could track mitochondria that came from the cell that was 
donating the nucleus with mitochondria that came from the egg, 
the donor that donated the egg. So if you think about this 
process, normally a human being or any animal is going to get 
their mitochondria from their mother because the mitochondria 
comes from the egg, so if you think about that you collect an 
egg from an individual, for instance, in our case if we collect 
an egg from one species of cow, that may have a different 
mitochondrial genotype in that egg actually than the 
mitochondria from the cow maybe that we're interested in 
cloning and so you can actually set up experiments to try and 
track the contribution of each one of those mitochondria, but 
in general, the egg takes that over. We don't really know the 
implications of that because you can end up with a 
heteroplasmic situation where you have some populations of 
mitochondria from both and then also you know we really don't 
know. I mean that's a whole area of research that needs to be 
explored.
    Mr. Zavos. May I follow up on that?
    Mr. Stearns. Sure. Just for the sake of the members and the 
folks in the audience, mitochondria is defined as any of 
various round or long cellular organelles that are found 
outside the nucleus, produce energy for the cell through 
cellular respiration and are rich in fats, proteins and 
enzymes.
    Mr. Westhusin. It coats about 21 genes, 16.5 KB of DNA, 
compared to 30 what billion base peers, Rudy?
    I'm trying to compare. It's a very small, in terms of its 
genetic component, it's very, very small.
    Mr. Stearns. Okay, but could I say because of that 
phenomena that when you clone an individual--if you tried to 
clone an individual--you would never get an identical clone 
because of those cells?
    Mr. Westhusin. As defined, right. It would not be the same 
as two genetically identical twins because genetically 
identical twins arose from the same egg where two clones might 
come from two completely different eggs with two different 
mitochondrial genotypes.
    Mr. Stearns. And without the research to understand the 
implication of that, that you have these different 
mitochondrial cells, we don't know what effect that has in the 
development for that DNA and therefore we don't know whether 
it's good or bad.
    Mr. Westhusin. And there are studies that suggest, there 
are studies that have been done in mice using the nuclear 
transfer procedure that, in fact, show there are--that can, in 
fact, have a significant effect.
    So if you take nuclei--how shall I explain it--if you take 
pronuclei, it's not a cloning procedure. You're just swapping 
nuclei between embryos early on in development. What you find 
is there are going to be compatibilities between cytoplasm and 
the nucleus, there are mice studies that have shown that. And 
they don't develop.
    Mr. Stearns. Dr. Zavos, does that concern you at all that 
there's been no research on this and that the fact that these 
particular cells might provide the energy, they might provide 
the needed sustenance for this DNA which would make it survive?
    Mr. Zavos. I am not sure that I really understand your 
question. Would you just please repeat it for me?
    Mr. Stearns. Yes, I'll take it through. An egg cell donated 
for cloning has its own mitochondrial DNA.
    Mr. Zavos. Yes.
    Mr. Stearns. Which is different from the mitochondrial DNA 
of the cell that produced the nucleus. Are you with me to that 
point?
    Mr. Zavos. Yes.
    Mr. Stearns. The clone therefore will never be truly 
identical. It appears to be no research on this to see the 
harmful effects when you make this attempt of cloning, the 
implications of that is on the cloning process. And without 
that, I don't quite understand how you feel confident you can 
go ahead when there seems to be a lot of concern about it.
    Mr. Zavos. Well, there's a lot of concern about other 
things as well, not just only that.
    Mr. Stearns. I know.
    Mr. Zavos. There are two--there's data out there that--a 
variation between the two clones, it does exist because of 
simply of different variations in the environment that could 
bring about expression of DNA differently. In two identical 
clones, and George Seidel from Colorado State University back 
almost 10, 15 years ago when he was splitting embryos, he was 
able to show that in cows that that diversity could come about 
because of that.
    Now as you may know, may not know, we do ooplasmic transfer 
today in the humans to treat deficiencies of eggs of patients 
that do not have adequate documentation of mitochondria. We can 
transfer mitochondria ooplasm from a fertile individual, 
fertile egg to a subfertile group of eggs in the human today 
and we are assuming that the DNA that is bound or associated 
with the mitochondria has no really any implications at all and 
that's why we're doing it.
    It is done today in the human in IVF programs today, we do 
ooplasmic transfer.
    Mr. Stearns. Mr. Chairman, can I have just 30 additional 
seconds?
    Mr. Greenwood. Without objection.
    Mr. Stearns. Dr. Zavos, would you transfer human nucleus 
into a non-human egg, do you think there's anything wrong with 
doing that?
    Mr. Zavos. No.
    Mr. Stearns. There's nothing wrong with it?
    Mr. Zavos. No, no, no. I wouldn't do that.
    Mr. Stearns. And why wouldn't you do that?
    Mr. Zavos. Because that's obviously, I don't think there's 
a competency between the two that can--I think various 
scientists that done that already, where they transfer mice 
into cow eggs and what have you.
    Mr. Stearns. No, no, I mean a human nucleus.
    Mr. Zavos. No, no. I wouldn't do that because that would be 
silly, mad science.
    Mr. Stearns. Dr. Boisselier, would that be acceptable to 
you, to transfer a human nucleus into a nonhuman egg?
    Ms. Boisselier. No, I wouldn't do that.
    Mr. Stearns. Okay, thank you, Mr. Chairman.
    Mr. Greenwood. The gentleman's time has expired. The Chair 
recognizes the gentleman from Illinois, Mr. Rush, for 5 
minutes.
    Mr. Rush. I think that it's clear that we all appreciate 
many of the advances of the biotech industry has brought us and 
my question is how do we ensure that human cloning, that a 
human cloning ban does not interfere with the safe use of 
biotechnology by your company and others?
    Mr. Okarma. Thank you for that question. It is a very 
important issue to our company and to the field as a whole, so 
I think one needs to focus the language in such a ban to 
include very precisely transfers to uteri, to a uterus of these 
kinds of recombined embryos with the intent of forming a live 
birth. That, for us, is the bright line that should not be 
crossed.
    Mr. Zavos. Can I make a comment, Mr. Rush? I was very 
impressed, obviously, of your background and your ethical 
issues that you addressed here and I want to bring to this 
panel a discussion, some sort of a dimension here that 
everybody needs to understand.
    What would be the ethical reaction of somebody if we would 
say that a 14-day embryo, a 14-day embryo that is used in stem 
cell research can be dismembered and be killed literally to 
harvest those stem cells and do research on those stem cells 
that's dismembered as a child. That 14-day embryo is a child by 
definition.
    Okay, how can we afford to dismember that embryo and take 
it apart and take all those cells out of it and clone them or 
proliferate them and transfer them to treat somebody else's 
disease and it's morally or ethically incorrect to take a 
cloned embryo and implant it in a woman to give birth to a live 
child. If we're going to start discussing ethical issue, that 
ethical issue here really needs to be addressed as such.
    Mr. Rush. Dr. Jaenisch, would you care to comment?
    Mr. Jaenisch. I think Dr. Zavos is mixing up things again. 
With the embryo stem cell work, it's clear that it never goes 
in the uterus. It's a blastocyst which develops into an 
embryonic stem cells and this is very different than an 
implanted embryo which is disrupted and used for other 
research. So I think this is very clear.
    I would like to really raise the question, are those people 
ready to produce abnormal children and I think what I appear to 
hear from them, they are. They are ready to do this because 
there's just no way to pre-screen embryos and I really 
reemphasize this, to prescreen embryos for those defects. 
There's a misunderstanding also in the committee. I'd like to 
try to clarify this. Clones don't have genetic defects. They 
have reprogramming problems. And I would like to really 
reemphasize this important point because it's an analogy which 
I think is familiar to anyone in this room. If you write a 
text, this text, the words has spaces between them, there is 
punctuation, there are paragraphs, italics, it makes it easy to 
read. Now if you just follow my experiment, if you know totally 
the format of this text, taking all the spaces out between the 
words, taking all punctuation away, you will have a lot of 
problems reading the text. You cannot read it. This is exactly 
what I mean with reprogramming. The genes which are not 
expressed are in this reprogrammed format. They're not readable 
by the cell. The sequence has not changed. Information is 
exactly the same. So these genes which are expressed in the 
skin cell, the example I brought, the embryonic genes and the 
brain genes are not readable. Like the text, your informed of 
the text. These nucleus goes to the oocyte into the egg and now 
all the 30,000 genes in principle have to make readable this 
normally occurring string, egg maturation, sperm maturation 
which is short-cut in cloning. I think this is the really very 
important point, so when they say, on my left, they can 
prescreen the blastocysts on early embryo for false gene 
expression, this is again incorrect. Many of the genes that 
will be expressed in the genes normally in the brain. I've 
never expressed the blastocysts in the embryo. There's just no 
basis even to do this. You have to look at the structure of 
those genes. You have to look, in principle, at all 30,000. So 
it's just utter--it's not correct what they're saying. They're 
misleading in a major way to the public that they say they 
could do this. So I think if they do this, they must be ready 
to produce abnormal children. I think this is rather 
distressing to me.
    So then I would like to get one comment that Dr. Zavos made 
earlier that these colleagues on his right don't have 
experience with cloning. Is this correct? I have experience 
with reprogramming. I've been working on this for 20 years. 
That's what is fascinating to me because reprogramming is 
something which is important for normal development.
    When the mice were cloned from this group in Honolulu, I 
right away arranged a collaboration with this Honolulu group.
    Mr. Rush. Dr. Jaenisch, my time is running out and I have a 
couple of questions I want to ask the others. I know you are 
very, very informed about this matter.
    Ms. Boisselier, are you familiar with a magazine called 
Wired Magazine?
    Ms. Boisselier. Yes.
    Mr. Rush. Do you recall doing an interview with Wired 
Magazine?
    Ms. Boisselier. I'm sorry?
    Mr. Rush. Do you recall giving an interview to Wired 
Magazine or being quoted in a Wired Magazine?
    Ms. Boisselier. Yes.
    Mr. Rush. I'm going to read from page 133. It says, ``From 
Montreal, it takes about an hour by highway and country roads 
to reach a huge white barn painted with the word UFO Land. This 
is the home base for the Raelians. Clonaid's founders and 
religious believers who teach that advanced extraterrestrial 
beings called Elhouin landed in France in 1973 to meet aspiring 
race car driving Claude Varillion. They changed Varillion's 
name to Rael and told him that humans are clones of Elhouin and 
revealed that some day he will lead mankind into a blissful, 
techno-utopian future. Rael was to be the last prophet, the end 
of the line that includes Moses and Jesus, Mohammed and 
Buddha.'' Are those accurate comments?
    Ms. Boisselier. Well, that's the comments of that Brian 
Alexander and I mean there is a religion that is called the 
Raelian religion and you have Rael here in this room and----
    Mr. Rush. Rael is in this room?
    Ms. Boisselier. Yes, and I understand that he's a witness, 
so he will explain all of this to you. I am a Raelian and I 
hope that you will not discuss my religion because this is not 
the purpose of this hearing. I believe that we're talking about 
human cloning.
    Mr. Rush. I was just discussing something that was printed, 
published in a publication. I'm not in any way trying to----
    Ms. Boisselier. But again, I guess----
    Mr. Rush. [continuing] lessen the impact of your religion.
    Ms. Boisselier. Did you ask Dr. Zavos his religion?
    Mr. Rush. No.
    Ms. Boisselier. It's true my religion----
    Mr. Rush. I didn't know this was your religion.
    Ms. Boisselier. I don't know either.
    Mr. Rush. I'm asking about a comment that you mae and 
that's my only purpose.
    Ms. Boisselier. It's not a comment. It's a comment of Brian 
Alexander. This is where he met me.
    Mr. Rush. You made the comment in the Wired Magazine and 
it's accurate, is that correct?
    Ms. Boisselier. I don't recall what he wrote about that, 
but what you read is a comment of Brian Alexander's----
    Mr. Rush. Let me ask you another question. Earlier, you 
indicated, I think, that there will not be any cloning done in 
the continental United States, is that right?
    Ms. Boisselier. I don't understand your question. You mean 
am I doing this in United States? Is that what your question 
is?
    Mr. Rush. No, the question is in your earlier testimony----
    Ms. Boisselier. Oh yes, with Brian Alexander, you mean. 
Yes, it's true we met end of August, beginning of September and 
at that time I didn't want to reveal where it was because we 
were talking with my partner at that time and I told him this 
is not--I said no to any State he mentioned, okay? I didn't 
want to reveal that. It's true that in November I started to 
say yes, it's in the United States.
    Mr. Rush. My question, Mr Chairman, my question is earlier 
in your testimony you indicated that there would not be any 
cloning by yourself or your organization conducted within the 
continental United States, is that right?
    Ms. Boisselier. I'm sorry, I said it will be here in the 
United States.
    Mr. Rush. It will be here in the United States.
    Ms. Boisselier. It will be if it's legal to do it here. So 
far it is legal as far as my counsel told me and I think I'm 
not breaching any law in doing it here.
    Mr. Greenwood. Time of the gentlemen has expired.
    Ms. Boisselier. There is something different--I'm sorry.
    Mr. Greenwood. The time of the gentleman has expired. The 
Chair recognizes the gentleman from Oklahoma, Mr. Largent for 5 
minutes.
    Mr. Largent. Thank you. Dr. Boisselier, are you doing human 
cloning in the United States at this time?
    Ms. Boisselier. We are in the process of doing it in the 
United States.
    Mr. Largent. And are you seeking FDA approval to do that?
    Ms. Boisselier. I received a letter from the FDA that came 
to the college I am teaching in yesterday or the day before. I 
don't remember. They gave me a letter that I will review with 
my counsel.
    Mr. Largent. Okay. Dr. Zavos, is it your belief that it is 
possible to determine which embryos are destined to develop 
abnormally? Can you determine that today?
    Mr. Zavos. Our team is working toward the development of 
very strict criteria that are currently available and we will 
be developing additional criteria in order to be able to screen 
what a viable embryo is which the definition of a viable embryo 
is something, an embryo that can be transferred in utero with 
the idea of implanting properly and giving birth to a healthy 
child.
    Mr. Largent. So the answer is no, you cannot?
    Mr. Zavos. Of course not, we haven't even done a clone 
embryo human clone embryo yet.
    Mr. Largent. So if, in fact, you cannot do it, are you 
saying then that you will not do any human cloning until you 
can accurately determine abnormal embryos?
    Mr. Zavos. Mr. Congressman, I think I stated at the very 
end of my statement that this Consortium will not step on dead 
bodies or deformed babies to get this accomplished and 
therefore I think that that statement defines exactly the 
answer that you're looking for.
    Mr. Largent. So let me ask you this question, if you went 
forward believing that you had a method to screen abnormal 
embryos which Dr. Jaenisch says you cannot do----
    Mr. Zavos. Well, that's his opinion.
    Mr. Largent. I understand that. MIT carries a little weight 
up here.
    Mr. Zavos. Yes, I know.
    Mr. Largent. If, in fact, you went forward and created a 
child that was abnormal, would that stop your efforts?
    Mr. Zavos. That's obviously not for me to make that 
decision, but for the Consortium. Bear in mind that I'm just a 
spokesman for a larger group of----
    Mr. Largent. I understand. Would you advocate that for your 
Consortium?
    Mr. Zavos. I would.
    Mr. Largent. To say we need to stop?
    Mr. Zavos. Yes, I would advocate for that. And the 
statement at the end of my presentation today just defines 
that. We don't intend to step on dead bodies or deformed babies 
to get there. And that pretty much really determines and 
defines that.
    Mr. Largent. In January, Dr. Zavos, you and Dr. Severino 
stated in your intent to lead a project to clone a human being 
within the next 2 years.
    Mr. Zavos. Eighteen to 24 months is to yield viable embryos 
for the purpose of transferring in utero to establish a 
pregnancy.
    Mr. Largent. Where exactly will this project take place?
    Mr. Zavos. I cannot disclose that. I think I have already 
stated to the committee that this is obviously, it's outside 
the continental USA, but I cannot tel you where that would be.
    Mr. Largent. Okay, and----
    Mr. Zavos. Can I just take one--about 10 seconds of your 
time, if I would. The people here are talking about the left 
and the right and we're not Republicans and Democrats, 
obviously. They could be on the right here, but on the left 
here, Dr. Boisselier and myself were not associated in any way, 
shape or form. Therefore, she represents a different group of 
people that she works with and I represent a Consortium for 
human therapeutic cloning and I just wanted for the record to 
be established as such and be very clear and vivid.
    Mr. Largent. Dr. Zavos, let me ask you another question. 
When my colleague, Cliff Stearns asked you would you ever do a 
combination of a nonhuman egg with a human DNA or whatever, you 
said absolutely not, mad science.
    Mr. Zavos. That's correct.
    Mr. Largent. Why?
    Mr. Zavos. Because by scientific standards it doesn't make 
sense.
    Mr. Largent. Okay, but you agree that to a lot of people 
what you're proposing doesn't make sense either, so in other 
words, there could be more people that would be encouraged to 
do exactly what you said would be mad science because of the 
work you're doing. In other words, we kind of get on that 
proverbial slippery slope so that people would go there, maybe 
not you, but somebody would because you've taken the ball down 
the field a little bit. Somebody else might say why not? Why 
can't we do this?
    Mr. Zavos. Mr. Largent, I think that we need to talk about 
this a bit because I think it is your responsibility of the 
government of the good old U.S.A. to take some precautionary 
measurements. I just finished coming back from Israel where I 
met with many, many figures including the President of Israel. 
Three weeks ago I was in Greece talking to the Greek 
government. I spoke to the Cypriot government where I have 
instructed the Cypriot government to establish guidelines and a 
committee to study for the employment of this type of 
technology and put the adequate restrictions that are necessary 
to employ this technology safely.
    Mr. Largent. Right, okay. Dr. Zavos, let me just finish by 
saying I see my time is about to expire, is that you've been 
quoted as saying ``ethics is a wonderful word.''
    Mr. Zavos. Yes.
    Mr. Largent. ``But we need to look beyond ethical issues 
here. It's not an ethical issue. It's a medical issue. We have 
a duty here.''
    And I would just say that it is the responsibility of 
Congress to look at this medical issue, but that we don't put 
the ethical issues antecedent or behind the ethical issues that 
we're facing and confronting here and we do have a 
responsibility to look at that and so anyway, I want to thank 
all of you for your testimony, it's been an enlightening panel 
and I yield back my time, Chairman.
    Mr. Greenwood. The time of the gentleman has expired and 
all time for questioning this panel has expired, so we----
    Mr. Rush. Mr. Chairman, can I indulge the committee and ask 
just one burning question that I absolutely have?
    Mr. Greenwood. The gentleman from Illinois asks unanimous 
consent for 40 seconds, without objection.
    Mr. Rush. Dr. Zavos, is the practice of human cloning, is 
that a medical practice, is that considered in the practice of 
medicine?
    Mr. Zavos. If it becomes safe and reproducible, I think 
that it will become just like IVF was not in 1978, it was 
banned in the U.S.A. for 3 years until it became legal and it 
was employed properly in the U.S.A. Therefore, the future will 
tell. And of course, people like you have to make those kinds 
of decisions as we go along.
    Mr. Rush. So if it's not safe, considered safe, then it 
would not be a medical practice?
    Mr. Zavos. Absolutely.
    Mr. Greenwood. The time of the gentleman has expired.
    Mr. Rush. Thank you, Mr. Chairman.
    Mr. Greenwood. The Chair wishes to thank our witnesses in 
this panel. You have spent 3\1/2\ hours with us and we 
appreciate that very much and you are excused. You are welcome 
to stay and listen to the other witnesses.
    For the benefit of everyone, particularly those who have 
travel arrangements, our intention now is to take the second 
panel in sequence, the FDA and Bioethics panel beginning at 4. 
We expect to have them come up, testify, respond to questions 
by 4 o'clock and we'll bring the third and final panel up at 4 
o'clock.
    Gentlemen and lady, you are excused.
    I would then call Dr. Kathryn C. Zoon, a Ph.D., Director of 
the Center for Biologics Evaluation and Research at the Food 
and Drug Administration and Dr. Thomas Murray, a Ph.D., 
National Bioethics Advisory Commission. Would you please come 
forward?
    Dr. Zoon and Dr. Murray, thank you very much for your 
patience and thank you for joining us today. You are aware that 
the committee is holding an investigative hearing and when 
doing so has had the practice of taking testimony under oath. 
Do either of you have any objection to testifying under oath?
    The Chair then advises you that under the rules of the 
House and the rules of the committee you are entitled to be 
advised by counsel. Do you desire to be advised by counsel 
during your testimony? Neither of you do.
    In that case, would you please rise and raise your right 
hands? Do you swear that the testimony you are about to give is 
the truth, the whole truth and nothing but the truth? Thank you 
very much.
    [Witnesses sworn.]
    You are welcome to begin and I believe that we will ask Dr. 
Zoon to start out and you are recognized, ma'am, for 5 minutes.

 STATEMENTS OF KATHRYN C. ZOON, DIRECTOR, CENTER FOR BIOLOGICS 
  EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION; AND 
    THOMAS H. MURRAY, NATIONAL BIOETHICS ADVISORY COMMISSION

    Ms. Zoon. Thank you, Mr. Chairman. Mr. Chairman and members 
of the committee, I am Dr. Kathryn Zoon, Director of the Center 
for Biologics Evaluation and Research at the Food and Drug 
Administration. I can assure the members of this committee and 
the American public that FDA views the use of cloning 
technology to clone a human being as a cause for public health 
concern.
    I appreciate the opportunity to discuss FDA's role with 
respect to this issue. I want you to know that because of the 
unresolved safety questions on the use of cloning technology to 
clone a human being, FDA would not permit it at this time.
    Very recently, there have been numerous press articles on 
individuals and groups expressing interest in cloning a human 
being by the use of cloning technology. We have heard that 
people have incorrectly stated that there are no legal controls 
in place in the United States governing the use of cloning 
technology to clone a human being. My hope today is to clarify 
FDA's role in regulating the use of cloning technology to clone 
a human being and to discuss the significant scientific 
concerns regarding safety that would lead us to disallow any 
such activities at this time.
    It is important to note that FDA's role in assessing the 
use of cloning technology to clone a human being is a 
scientific one. As recognized by the National Bioethics 
Advisory Commission, there are additional unresolved issues 
including the broader, social and ethical implications of the 
use of cloning technology to clone a human being.
    We have heard much today regarding the cloning of the sheep 
named Dolly and several other animal species, including cattle, 
pigs and mice. I will not repeat the science behind that 
because we have heard it today.
    Again, though, I would like to remind the committee that it 
took 276 failed attempts before Dolly was born. The failure 
rate remains extremely high for the cloning of sheep and other 
mammals. Moreover, when live births occurred, there have been 
deaths and major abnormalities such as defective hearts, lungs 
and immune systems in the newborns and older animals. In 
addition, significant maternal safety risks including deaths 
have been observed. These facts raise serious concerns 
regarding the use of cloning technology to clone a human being.
    With regard to FDA jurisdiction, the use of cloning 
technology, to clone a human being would be subject to both the 
biologics provision of the Public Health Service Act and the 
drug and device provisions of the Federal Food, Drug and 
Cosmetic Act. Before clinical research could begin, the sponsor 
must submit an investigational new drug application to the FDA 
which we would review to determine if such research could 
proceed. Again, I want to reemphasize that FDA believes that 
there are major unresolved safety questions on the use of 
cloning technology to clone a human being and therefore would 
not permit any such investigation to proceed at this time.
    As part of our compliance strategy, in 1998, professional 
organizations, institutional review boards and several 
individuals professing an interest in using somatic cell 
nuclear transfer to clone a human being were notified of FDA's 
position.
    FDA continues to communicate its jurisdiction with those 
that have expressed an intention to pursue the use of cloning 
technology to clone a human being. FDA continues to monitor 
information as it becomes available.
    We can assure you that the Agency will continue to inform 
such individuals and entities of the laws and regulations 
governing such research and take appropriate enforcement action 
as warranted to protect the health and safety of the public.
    Thank you.
    [The prepared statement of Kathryn C. Zoon follows:]

 PREPARED STATEMENT OF KATHRYN C. ZOON, DIRECTOR, CENTER FOR BIOLOGICS 
 EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
                       HEALTH AND HUMAN SERVICES

                              INTRODUCTION

    Mr. Chairman and Members of the Committee, I am Kathryn C. Zoon, 
Ph.D., Director of the Center for Biologics Evaluation and Research 
(CBER) at the Food and Drug Administration (FDA or the Agency). I can 
assure the members of this Committee and the American public that FDA 
views the use of cloning technology to clone a human being as a cause 
for public health concern. I appreciate the opportunity to discuss 
FDA's role with respect to this issue. Because of unresolved safety 
questions on the use of cloning technology to clone a human being, FDA 
would not permit the use of cloning technology to clone a human being 
at this time.
    Very recently, there have been numerous press articles on 
individuals and groups expressing interest in cloning a human being by 
cloning technology. We have heard that people have incorrectly stated 
that there are no legal controls in place in the United States 
governing the use of cloning technology to clone a human being. My hope 
today is to clarify FDA's role in regulating the use of cloning 
technology to clone a human being and to discuss the significant 
scientific concerns regarding safety that would lead us at this time to 
disallow any such activities. It is important to note that FDA's role 
in assessing the use of cloning technology to clone a human being is a 
scientific one. As recognized by the National Bioethics Advisory 
Commission, there are additional unresolved issues including the 
broader social and ethical implications of the use of cloning 
technology to clone a human being. Because of the profound moral, 
ethical, and scientific issues, the Administration is unequivocally 
opposed to the cloning of human beings.

                               BACKGROUND

    To give you a better understanding of cloning technology, the 
Statement for the Record submitted by Dr. Harold Varmus, then Director 
of the National Institutes of Health, to the House Committee on 
Commerce, Subcommittee on Health and Environment, (February 12, 1998 
hearing, ``Oversight Hearing Regarding Cloning: Legal, Medical, 
Ethical, and Social Issues'') is helpful:
          In order to understand this technology, it is necessary to 
        briefly review normal sexual reproduction in mammals . . . 
        Normally, an egg and sperm join to create a fertilized egg, 
        which develops into an embryo and ultimately a newborn animal. 
        In this situation, the progeny receives genetic material from 
        both the mother and father.
          In the Dolly experiment, a lamb was produced using the 
        technology of somatic cell nuclear transfer. Unlike the normal 
        process of sexual reproduction in which an egg and a sperm each 
        contribute genetic material, somatic cell nuclear transfer is 
        asexual. A somatic cell is any cell except the egg cells or 
        sperm cells. Somatic cells contain the full complement of 
        chromosomes. In contrast, an egg or a sperm contains half that 
        number.
          Somatic cell nuclear transfer is done in the following way . 
        . . using sheep as an example. First a normal sheep egg cell is 
        taken from a ewe and the nucleus (the cell structure containing 
        the chromosomes) is removed, yielding an egg cell containing 
        the nutrients and other energy producing materials that are 
        essential for embryo development, but not the chromosomes. 
        Next, a somatic cell is isolated--in the case of Dolly, a cell 
        grown in cell culture from the mammary tissue of an adult 
        sheep. Under certain conditions, the somatic cell (in this 
        example, the mammary cell) is placed next to the egg from which 
        the nucleus had been removed, an electrical stimulus is 
        applied, and the two cells fuse. The result is a cell that 
        contains the nutrient environment of an egg cell and genetic 
        material only from the donated somatic cell. This is not sexual 
        reproduction, since genetic material is derived from only one, 
        not two, individuals. There is no sperm involved. The egg 
        provides only the environment for growth. After a number of 
        cell divisions, these cells are placed into the uterus of a 
        sheep. In the case of Dolly, a lamb was born--an identical twin 
        of the original donor, only born later.
    This technology did not readily result in the birth of a lamb 
cloned from an adult sheep. It took 276 failed attempts before Dolly 
was born. Since the time of Dolly, additional animals have been cloned. 
However, the success rate remains low and numerous abnormalities in the 
offspring and safety risks to the mother have been observed. These 
facts raise serious concerns regarding the use of cloning technology to 
clone a human being.

                            FDA JURISDICTION

    FDA has the authority to regulate medical products, including 
biological products, drugs, and devices. The use of cloning technology 
to clone a human being 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 response to questions about cellular products, 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.
    Clinical research using cloning technology to clone a human being 
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. FDA believes that there are major unresolved safety questions 
on the use of cloning technology to clone a human being and therefore 
would not permit any such investigation to proceed at this time.
    The following briefly describes the established FDA process in 
overseeing clinical research. 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 Sec. 312.42.)
    Following the reports about the cloning of Dolly, the sheep, there 
were reports in the media that scientists were contemplating using 
cloning technology to clone human beings. FDA notified professional 
organizations, Institutional Review Boards, and several individuals 
professing an interest in using somatic cell nuclear transfer to clone 
a human being. This ``Dear Colleague'' letter, which is available on 
FDA's website: www.fda.gov/oc/oha/irbletr.html reiterated FDA 
jurisdiction over the use of cloning technology to clone a human being. 
The letter notified researchers that clinical research could proceed 
only when an IND is in effect. The letter stated that until significant 
safety issues are appropriately addressed, FDA would not permit any 
such investigation to proceed. Since the 1998 ``Dear Colleague'' letter 
was issued, circumstances have not changed to warrant a change in FDA's 
position.
    FDA has further communicated regarding its jurisdiction with 
individuals or entities that expressed an intention to pursue the use 
of cloning technology to clone a human being. FDA continues to monitor 
information, as it becomes available, with regard to individuals or 
entities that express an intention to use cloning technology to clone a 
human being. We can assure you that the Agency will continue to inform 
such individuals and entities of the laws and regulations governing 
such research and take appropriate enforcement action as warranted to 
protect the health and safety of the public.

                               CONCLUSION

    The Agency's regulatory approach encourages research and 
innovation, while at the same time helping to ensure that safeguards 
are in place to protect the public from unreasonable risks that may be 
associated with clinical trials. Because of the unresolved safety 
questions pertaining to the use of cloning technology to clone a human 
being, FDA would not permit any such investigation to proceed at this 
time.

    Mr. Greenwood. Thank you very much, Dr. Zoon.
    Dr. Murray, please offer your testimony.

                 STATEMENT OF THOMAS H. MURRAY

    Mr. Murray. Thank you very much, Mr. Chairman. I'm told 
that I should request that my statement be entered into the 
record.
    Mr. Greenwood. And without objection, it will.
    Mr. Murray. Thank you. I do that so that I don't have to 
bore you by reading it, or at least not much of it and then 
instead try to give some comments inspired by what's gone on 
already this afternoon.
    My name is Dr. Thomas Murray. I'm a member of the 
National----
    Mr. Greenwood. Dr. Murray, I forgot to tell you that your 
Congresswoman Connie Morella asked me to say hello.
    Mr. Murray. Thank you very much. And she's actually in a 
different district, but she's a lovely person.
    National Bioethics Advisory Commission, I'm a member of the 
Commission, but that's more or less a voluntary job in that all 
of us also have day jobs. The Commission was established by 
then President Clinton in 1995 to advise and to make 
recommendations to the President through the National Science 
and Technology Council on bioethics issues and their policy 
implications.
    My fellow Commissioners on NBAC, as it's known, come from a 
variety of disciplines and backgrounds to include research 
scientists, religious scholars, physicians, lawyers, members of 
the public and others.
    My day job is President of a place called the Hastings 
Center, a nonprofit, independent, nonpartisan research 
institute in Garrison, New York that addresses fundamental 
ethical issues in health and medicine, the biomedical sciences 
and the environment. I should note that at least I believe 
three of the people quoted in the members' own statements this 
morning on cloning including Leon Kass, Dr. Author Caplan right 
behind me at this time and Laurie Andrews are all fellows of 
the Hastings Center and I'm proud to see them represented on 
both sides of the debate.
    I also serve on the Committee on Ethics of the American 
College of Obstetricians and Gynecologists and in my own work I 
do a lot of writing and thinking about parents and children and 
the ethical implications of reproductive technology, genetics 
and the like.
    When Dolly's cloning was announced in February 1997, then 
President Clinton asked NBAC to review the legal and ethical 
issues associated with cloning technology and asked us to 
report in 90 days. I'll try to describe briefly what we said at 
that time and the process we followed. Since then, I should 
note that the Commission has issued three other reports with 
two more to be completed soon, one on research internationally, 
particularly in a developing world and another on the general 
oversight and protection of research on human subjects.
    Now there's a saying in the field of bioethics, my field, 
that good ethics begins with good facts and I was pleased to 
see that this subcommittee apparently operates on the same 
presumption and that you started with a scientific panel. NBAC 
did too. It might be of interest to note that of the first 
eight witnesses, the first was a scientist and the following 
seven theologians representing four important religious 
traditions, traditions important both in the United States and 
around the world. We also invited ethicists, legal scholars and 
the general public. We commissioned a paper on issues related 
to cloning.
    NBAC focused on a very specific issue. It seems precisely 
the one before this subcommittee, namely, where you would use 
genetic material, so called somatic cell nuclear transfer 
cloning, put it in another person's egg and try to create a 
child by cloning. We didn't look at other procedures like 
embryo splitting, nor did we look at the broader areas of 
embryo research. We were focused on trying to create a child by 
cloning. That's what struck us as new and important for our 
deliberations.
    Not surprisingly we found that this potential ability to 
clone human beings through this technique raised a host of 
complex scientific, religious, legal and ethical issues, some 
new, some old. It was noteworthy that we found a great 
diversity of views among religious scholars and indeed, even 
within the same religious traditions. We would find a range of 
views about cloning.
    Although we didn't agree on all the ethical issues, after 
all, we were 18 individuals with different perspectives. We 
nonetheless concluded unanimously that given the state of the 
science any attempt to create a child using somatic cell 
nuclear cell technique we've been talking about today, whether 
in the public or private sector is uncertain in its outcome, 
unacceptably dangerous to the fetus and therefore morally 
unacceptable.
    We've had no reason to retract that conclusion. Now we 
suggested a number of things, a moratorium, a voluntary 
moratorium to be bolstered and followed up with Federal 
legislation that would prohibit trying to create a child by 
cloning. We asked that if there would be legislation, it would 
be advisable to have a sunset period on it so that it could be 
revisited if and when the science changed. We also cautioned 
that any legislation written should be careful not to prohibit 
things that you don't want to prohibit it because scientists 
use the term cloning to refer to all kinds of things, including 
making copies of little snippets of DNA or copies of regular 
cells. All that in a lab is called cloning, so if you could 
prohibit all human cloning, you're going to criminalize a lot 
of what goes in laboratories today that's totally morally 
acceptable, no one would object to.
    We urge international cooperation. In fact, as has already 
been mentioned a number of other nations have made statements 
as have some international groups.
    I want to turn to some of my personal views now and I want 
to make it clear I do not at this point speak for the 
Commission, but for Tom Murray. As I think was made clear in 
the previous panel, the scientific literature, evidence that's 
accumulated since 1997 describing the cloning of non-human 
animals has only further illustrated the risks posed to any 
children that might be born as a result of this procedure as 
well as to any woman who would be asked to try to carry such a 
pregnancy. Researchers are only beginning to understand the 
causes of the abnormalities in cloned animals born in recent 
years.
    Now imagine for a minute a new drug that caused 
abnormalities or neonatal deaths in half of the babies born to 
the woman treated with this new drug. Imagine further that the 
women itself, many of them suffered serious harm and then last 
imagine that the women who are given this drug were otherwise 
totally healthy. Would we be having a debate about the ethical 
acceptability of whether this drug should be distributed? Or 
would we condemn it resoundingly as unethical experimentation 
on human beings?
    I think and I hope we would express moral outrage, but 
those are the very risks we're talking about today using 
cloning.
    To create a human child by cloning at this time is a clear 
and unambiguous assault on worldwide ethical principles to 
protect human subjects against irresponsible and morally 
outrageous conduct in the name of progress. Neil Armstrong's 
name was evoked. Neil Armstrong was an exhaustively trained 
adult volunteer. I wish he were here to give his own opinion 
about the use of his name in this cause, and the astonishingly 
arrogant claims, I believe, made in his name and to ask him 
whether he would have agreed to made his voyage, however 
historically important, over the damaged bodies of women and 
the broken bodies of children.
    I also believe we need a vigorous public conversation about 
broader ethical issues raised by cloning, its impact on 
children and parents and the relationship between the two. The 
probably illusory control, people believe it and they offer 
over the traits of their offspring. I have fantasized that the 
best antidote to the enthusiastic support of cloning that 
exists out there, at least among some people would be if 
somebody actually did clone Michael Jordan and Michael II was 
totally uninterested in basketball and really wanted to be a 
good accountant. What makes Michael Jordan is in part his 
genes, but so much more than that, it is his drive, his fierce 
determination, his unexcelled competitiveness, not even just 
his physical gifts.
    What is accomplished, I find myself asking, today by 
proclamation such as those made by Dr. Richard Seid, Dr. Zavos 
and the Raelians. Well, it seems to me two things are clearly 
accomplished. No. 1, you get enormous heaps of free publicity. 
This is good for business, if that's what you're after. No. 2, 
you provide false hope and possible exploitation of parents 
desperate in their grief over having lost a child. One more 
thing, if people are permitted to go ahead at this time is that 
we will have many dead fetuses, probably some damaged women and 
maybe, but maybe not a live born child or two who will almost 
certainly be born with severe abnormalities.
    NBAC's recommendations are as relevant to the current 
discussion as they were when offered 4 years ago. I asked you 
take them under consideration and thank you for inviting me.
    [The prepared statement of Thomas H. Murray follows:]

    PREPARED STATEMENT OF THOMAS H. MURRAY, COMMISSIONER, NATIONAL 
                     BIOETHICS ADVISORY COMMISSION

    I want to begin by thanking Representative Greenwood for the 
invitation to speak to you today. My name is Dr. Thomas Murray, and I 
am a member of the National Bioethics Advisory Commission (NBAC). NBAC 
was established by President Clinton in 1995 to advise and make 
recommendations to the President through the National Science and 
Technology Council and to others on bioethics issues and their policy 
implications. My fellow commissioners on NBAC come from a variety of 
disciplines and backgrounds, and include research scientists, religious 
scholars, physicians, lawyers, and members of the public. My day job is 
as President of The Hastings Center in Garrison, New York, an 
independent non-partisan research institute that addresses fundamental 
ethical issues in the areas of health and medicine, the biomedical 
sciences, and the environment. I serve on the Committee on Ethics of 
the American College of Obstetricians and Gynecologists, and am the 
author of The Worth of a Child.
    Upon the announcement of the cloning of Dolly the sheep in February 
of 1997, former President Clinton asked NBAC to review the legal and 
ethical issues associated with cloning technology and report back to 
him in ninety days. Today I will briefly describe NBAC's report and its 
recommendations. This report represents NBAC's assessment of these 
issues as we saw them in 1997. The Commission has since issued three 
other reports, with two more to be completed soon, on issues related to 
research with human subjects.
    There is a saying in my field that ``good ethics begins with good 
facts.'' To that end, NBAC held three meetings, with testimony from 
scientists, theologians, ethicists, legal scholars, and the general 
public, and commissioned eight papers on different issues relating to 
cloning. NBAC focused on a very specific aspect of cloning, namely 
where genetic material would be transferred from the nucleus of a 
somatic cell of an existing human being to an enucleated human egg with 
the intention of creating a child. We did not revisit questions of 
human cloning by embryo-splitting or issues surrounding embryo 
research.
    The Commission discovered that the potential ability to clone human 
beings through somatic cell nuclear transfer techniques raises a host 
of complex scientific, religious, legal, and ethical issues--some new, 
and some old. Especially noteworthy was the diversity of views that we 
heard among religious scholars, indeed even among those within the same 
religious tradition. Although we did not agree on all of the ethical 
issues surrounding the cloning of human beings, we nonetheless 
unanimously concluded that given the state of science, any attempt to 
create a child using somatic cell nuclear transfer, whether in the 
public or private sector, is uncertain in its outcome, is unacceptably 
dangerous to the fetus, and therefore, morally unacceptable.
    In addition, NBAC made the following recommendations:

 The moratorium on the use of federal funding in support of any 
        attempt to create a child by somatic cell nuclear transfer 
        should be continued. Non-federally funded entities should be 
        asked to comply voluntarily with the intent of the federal 
        moratorium. Professional and scientific societies should make 
        it clear that such an act would be irresponsible, unethical, 
        and unprofessional at this time.
 Federal legislation should be enacted to prohibit any attempt 
        to create a child by somatic cell nuclear transfer. Such 
        legislation should include a sunset clause to ensure that 
        Congress reviews the issue after a specified time period, such 
        as three to five years. Any state legislation should have a 
        similar sunset clause. At some point prior to the expiration of 
        the sunset period, an appropriate oversight body should 
        evaluate and report on the current status of the technology and 
        the ethical and social issues that cloning would raise.
 Any legislative or regulatory actions should be carefully 
        written so as not to interfere with other important areas of 
        research, such as cloning of human DNA and cell lines.
 If a legislative ban is not enacted or is lifted, clinical use 
        of somatic cell nuclear transfer to create a child should be 
        preceded by research subject to independent review and informed 
        consent.
 The United States should cooperate with other nations and 
        international organizations to enforce common aspects of their 
        policies.
 The federal government and others should encourage continuing 
        deliberation on these issues, in part to enable society to 
        develop appropriate policies regarding cloning should the time 
        come when present safety concerns have been addressed.
    We hoped that the report would form a useful initial basis for 
ongoing deliberations and educational dialogues that we believe are 
essential. We also recommended that the federal government actively 
encourage public education in this area of science so that public 
deliberation is as informed as possible.
    NBAC has not continued to debate human cloning issues, but we have 
been well aware of the continuing scientific developments and the 
ethical and policy discussions that have ensued in this country and 
abroad.
    For example,

 In 1997, the G8 nations agreed at the Denver Summit on the 
        ``need for appropriate domestic measures and close 
        international cooperation to prohibit the use of somatic cell 
        nuclear transfer to create a child.''
 With regard to our recommendation on federal legislation, it 
        is worth noting that at least 14 countries, including the 
        United Kingdom, Australia, and Israel, have existing 
        legislation prohibiting cloning. Earlier this month, a Council 
        of Europe protocol prohibiting cloning human beings went into 
        effect.
 In this country, several states have proceeded to pass their 
        own legislation regulating cloning. The NBAC staff surveyed 
        state laws in 1999, at which time five states had enacted 
        legislation to directly prohibit human cloning, and ten states 
        had laws regulating research on embryos and fetuses that could 
        also restrict cloning activities. Some of these laws are 
        broader in scope than others, and I would recommend that 
        Congress follow NBAC's recommendation to craft a law that does 
        not interfere with other areas of research.
    In my personal view, the scientific literature since 1997 
describing the cloning of non-human animals has only further 
illustrated the risks posed to the children that might be born as a 
result of this technique as well as to the women who would carry these 
pregnancies to term. Researchers are only beginning to understand the 
causes of the abnormalities in cloned animals that have been born in 
recent years. Imagine a new drug that caused abnormalities or neonatal 
deaths in half of the babies born to women treated with it, and risks 
to the women as well. Imagine further that this drug was given to women 
who were otherwise healthy. Would there be any debate over the ethical 
acceptability of using this drug? Or would we condemn it resoundingly 
as unethical experimentation on human beings? I believe that we would 
express moral outrage. Yet these are the very risks encountered when we 
try to create a human child by cloning today.
    I also believe that we need urgently a vigorous public conversation 
about the broader ethical issues raised by cloning: its impact on 
children and the parent-child relationship, the perhaps illusory 
control people may believe it offers over the traits of their 
offspring. I have wondered if the best antidote to the enthusiasm 
behind human cloning would be if someone were successful at cloning 
Michael Jordan--and Michael II, although he would begin to lose his 
hair at roughly the same age as his progenitor, had absolutely no 
interest in playing basketball but wanted desperately to become an 
accountant. What made Michael the First great was his fierce 
determination and unexcelled competitiveness, not merely his physical 
gifts.
    NBAC's recommendations are as relevant to the current discussion on 
human cloning as they were when first offered four years ago. I would 
ask you to take them into consideration.
    Thank you for the opportunity to speak to you, and I am happy to 
answer any questions that you may have.

    Mr. Greenwood. Thank you, Dr. Murray.
    The Chair recognizes himself for 5 minutes for inquiry.
    Dr. Zoon, you were here, I believe, when Dr. Boisselier 
testified that she only received a letter from the FDA within 
the last day or two. Are you aware of that letter and when it 
was sent?
    Ms. Zoon. Yes sir.
    Mr. Greenwood. What can you tell us about that?
    Ms. Zoon. I am aware that she had received the letter on 
Monday.
    Mr. Greenwood. It would seem to this member that given the 
fact that FDA has asserted its jurisdiction, a claimed 
jurisdiction for the last 2 or 3 years--and given the notoriety 
of the Raelians in the American press--that such a letter would 
have been sent certainly long before the eve of this hearing.
    Can you explain why that was not the case?
    Ms. Zoon. Yes, the information regarding the Raelians first 
came to our attention at the end of last year when looking at a 
website and as a result of that, the Agency did start a process 
in which to find the various individuals associated with that 
website. As you know, as we have seen today, the 60 Minutes 
program raised additional information which FDA pursued. We 
were able to contact Dr. Boisselier and provide her with a 
letter giving her the instructions on what FDA's position was 
with regard to using cloning technology to clone a human being.
    Mr. Greenwood. Dr. Boisselier said that when asked by a 
number of members of this panel whether she intended, her 
organization intended to clone a human being in the United 
States and whether they would comply with the dictates of that 
letter, she deferred responding until she spoke with her 
counsel. If the FDA were aware that her organization was 
embarking on human cloning somewhere in the United States, what 
would be the response of the FDA?
    Ms. Zoon. FDA would look at this process with regard to our 
compliance strategies when dealing with such a claim and 
investigate it and do what we would normally do in a compliance 
action. We cannot reveal what we would do here today in public, 
but we would pursue this vigorously and take appropriate steps.
    Mr. Greenwood. The strategy that you're not revealing here, 
one of the things that would, of course, be important to 
members of this committee is that such a strategy provides for 
a rapid enough response from the moment you became aware of 
where and when such cloning might take place or was about to 
take place, that we wouldn't be faced with a situation in which 
you have a cloned egg implanted in the uterus because my sense 
is that that would pose a fairly difficult enforcement 
situation.
    Ms. Zoon. Yes. We would not wait until such action took 
place in order to----
    Mr. Greenwood. So I would assume you would seek some sort 
of enforceable injunction?
    Ms. Zoon. There are many mechanisms we would use for 
pursuing this. One would be to investigate this as a whole and 
get the appropriate information and find out as much as we can.
    Mr. Greenwood. Suppose that you raided a clinic and found 
out that in fact, the cloning had taken place--whether that egg 
was or was not yet implanted in a uterus. Would you walk us 
through what you would anticipate might happen in terms of 
arrests, charges and penalties? What would be the most severe 
penalties under the current statute that such a person might 
confront?
    Ms. Zoon. Clearly, it would depend on the circumstances of 
what FDA found. FDA has a number of actions it could take, 
depending on the nature of the violation. They would include 
for such a violation under the Public Health Service Act or 
such a misdemeanor under the Federal Food Drug and Cosmetic Act 
a penalty of I believe $100,000 and up to 1 year in jail----
    Mr. Greenwood. Are you aware whether anyone has ever been 
imprisoned under that section?
    Ms. Zoon. I am not personally aware of anyone imprisoned--
--
    Mr. Greenwood. Will you please get us the answer and 
respond in writing to the committee with that information?
    Ms. Zoon. Yes sir.
    [The following was received for the record:]

          Department of Health & Human Services    
                                  Public Health Service    
                               Food and Drug Administration
                                                       May 18, 2001
The Honorable James C. Greenwood
Chairman, Subcommittee on Oversight and Investigations
Committee on Energy and Commerce House of Representatives
Washington, D.C. 20515-6115
    Dear Mr. Chairman:
    Thank you for your interest in issues associated with human 
cloning. This is a follow-up to the March 28, 2001, hearing on ``Issues 
Raised by Human Cloning Research.'' Dr. Kathryn Zoon appeared as a 
witness at that hearing for the Food and Drug Administration (FDA or 
the Agency).
    At that hearing, you asked Dr. Zoon whether the government has 
prosecuted persons for criminal violations of the Public Health Service 
Act (PHSA).
    The answer to your question is yes.
    In general, after discovering evidence of a criminal violation 
related to a biological product, FDA may refer a matter to the 
Department of Justice (DOJ). On the basis of that evidence, it may be 
possible to charge a person with violating the PHSA, the Federal Food, 
Drug, and Cosmetic (FD&C) Act, and provisions of Title 18. However, it 
is not unusual for the government to decide to concentrate on only a 
few of those charges, and to decide not to bring charges under the 
PHSA.
    A prosecutor makes such decisions for a variety of reasons, 
including the potential penalties associated with a criminal charge. 
For example, the maximum penalty that could be imposed on an individual 
for violating the PHSA is one year imprisonment and/or fine of up to 
$100,000 (for a misdemeanor not resulting in death) or an alternative 
fine of twice the amount of gross pecuniary gain or loss. When the 
evidence supports it, government prosecutors frequently choose instead 
to bring felony charges under the FD&C Act and Title 18. The maximum 
penalty that could be imposed on an individual for a felony violation 
of the FD&C Act ``with the intent to defraud and mislead'' is three 
years imprisonment and/or a fine of up to $250,000, or the alternative 
fine described above. The maximum penalty that could be imposed on an 
individual for violating Title 18 provisions, often charged in FDA 
cases such as obstruction of an agency proceeding, false statements, 
and mail and wire fraud, is five years imprisonment and/or a fine of up 
to $250,000, or the alternative fine described above.
    Because of these factors, in recent years few cases have resulted 
in convictions for violations of the PHSA. Older cases, in which the 
government successfully prosecuted violations of the PHSA, include the 
following:

1. United States v. Southwestern Plasma Center, Inc., et al. (M.D.Fla. 
        1976) (individual defendants sentenced to one year in prison on 
        PHSA violations, to run concurrently with other charges);
2. United States v. Westchester Blood Service, et al. (S.D.N.Y. 1962) 
        (individual defendants sentenced on PHSA violations to terms 
        ranging from 60 to 90 days imprisonment, or to suspended 
        sentences);
3. United States v. Calise (S.D.N.Y. 1962) (individual defendant 
        received suspended sentence);
4. United States v. Paterson Blood Bank, et al. (D.N.J. 1963) 
        (individual defendant sentenced on PHSA violations to nine 
        months imprisonment).
    FDA continues to refer cases concerning biological products to the 
Department of Justice, and the Department of Justice continues to 
prosecute those cases, generally under the FD&C Act felony provisions 
and Title 18. For example, on April 30, 2001, a defendant was sentenced 
to five-year probation with a five-year fine, after pleading guilty to 
making a false statement regarding the disposition of units of blood. 
United States v. Petrik (C.D.Ca. 2001). In connection with crimes 
committed by employees of the New York Blood Center viral testing 
laboratory, one defendant, convicted of misbranding and adulteration in 
violation of the FD&C Act, conspiracy, and false statements, was 
sentenced to 12 months and one day imprisonment. His co-defendant, 
convicted of conspiracy and false statements, was sentenced to six-
months imprisonment. United States v. Maniago and Gonzales (S.D.N.Y. 
1997).
    Thank you again for your interest in this issue. If you have 
further questions, please let us know.
            Sincerely,
                                        Melinda K. Plaisier
                             Associate Commissioner for Legislation
cc: The Honorable Peter Deutsch
   Ranking Minority Member
   Subcommittee on Oversight and Investigations
   Committee on Energy and Commerce
   House of Representatives

    Mr. Greenwood. Do you believe that it would be helpful to 
the FDA if the Congress made clearer its intent with regard to 
the law, and for instance, banned the creation of a human clone 
and increased the penalties?
    Ms. Zoon. We would be happy to work with Congress and 
provide any technical advice that would be of assistance.
    Mr. Greenwood. I thought that's what you might say.
    The Chair recognizes the gentleman, Mr. Deutsch, for 5 
minutes.
    Mr. Deutsch. Thank you, Mr. Chairman, thank you both very 
much for being here and I guess listening through the last 
panel as well.
    You heard testimony to the effect that there are people who 
are stating and people whose intentions seems to be to, in 
fact, do human cloning, that they legally--there are no legal 
prohibitions to them doing that. You've obviously presented 
testimony directly contrary to that effect.
    At this point in time what else are you doing to prevent 
it? What else, as a practical matter, what else are you doing?
    Ms. Zoon. One of the things that--we've done several things 
since FDA established it had jurisdiction over this area since 
1998 and one avenue we have chosen is to get letters out to 
numerous professional associations alerting them of FDA's 
jurisdiction in this area. We have also sent out letters to the 
institutional review boards alerting them if these activities 
go on that this is FDA's position and that we would have 
jurisdiction in this area. As I stated, any information that we 
get, or see in the press, or that comes to our attention from 
other sources--we actively follow-up on those issues.
    Mr. Deutsch. Now again, I guess it's not so much from an 
FDA perspective that human cloning is illegal, but going on 
with the experimentation without going through your procedure 
is what the illegal aspect is, is that correct? It's not saying 
that human cloning in and of itself is described as illegal, 
but going through that experimentation without going through 
the FDA process is, in fact, what's illegal?
    Ms. Zoon. The process is that if someone were to undertake 
experiments in which they were going to use cloning technology 
to clone a human being, even before they took their first 
steps, they would need to submit an IND, an investigational new 
drug----
    Mr. Deutsch. I understand. And I guess what I say is that--
I think that's a distinction which is worth really nothing 
because I think there's a consensus that I hear on this panel 
today, a total consensus, at least on this panel, if not the 
panel of the witnesses, that we should absolutely completely 
ban human cloning in the United States of America, period. And 
what you're saying, the only legal impediment that we're aware 
of right now is the impediment that they're not going through 
the FDA for experiments, not that human cloning is unacceptable 
in the United States of America, but if you want to go to human 
cloning, you have to go through this procedure and 
theoretically, if they were able to meet your standards, then, 
in fact, they could do it.
    Again, I'm very serious, if they can meet the standards 
which clearly I think by any objective analysis it would be 
impossible that they can meet today, but if they were able to 
meet those standards next year, 2 years from now, you would be, 
in fact, compelled to allow them to do human cloning, is that 
not correct?
    Ms. Zoon. The answer to your question is yes. Even though 
we don't believe that the scientific data supporting the safety 
would allow this to proceed, and I don't think even in the 
timeframe that you gave, I think there are issues not only----
    Mr. Deutsch. I understand. But I just obviously presented a 
hypothetical to you.
    Ms. Zoon. Right.
    Mr. Deutsch. I think that's important for members to 
understand.
    Ms. Zoon. Right.
    Mr. Deutsch. Because there really is a debate going on 
which I think you sense from a member level about how to 
proceed with this and I think we've let the genie out of the 
bag in a sense that there really is a debate because I think 
there's a debate which both the chairman of the committee and 
myself would not want this hearing to be about stem cell 
research, but the reality is there is a debate about stem cell 
research and we don't want this hearing or human cloning to be 
about that. But I think if we're going to make sure that this 
doesn't occur in the United States of America, it would seem as 
if by definition we're going to have legislation. I would seem 
as if the FDA legally today can prevent it, in this sort of 
round about way, but maybe in a year or 2 years or 5 years will 
not be able to prevent human cloning from taking place in the 
United States of America if the research advances, if in fact, 
the types of things that clearly are not--there's no question 
today that the risks are unacceptable, I think by any objective 
scientific analysis. The percentage of embryos lost, the 
percentage of stillbirths, deaths, premature deaths, almost 
immediate deaths. There's no way you would ever prove human 
research in this type of statistic evidence. Impossible under 
any--I mean not even close. To give--I have some sense of your 
approval process, not even close.
    But if scientific progress occurs that we can, in fact, do 
some of this embryo prescreening for 30,000 different genes, 
you would, in fact--and again, we're dialoguing, you would in 
fact be compelled to approve it.
    Ms. Zoon. But if there were no safety issues identified and 
based on the scientific information, the FDA would then allow 
that IND to proceed.
    Mr. Deutsch. Thank you very much. I see my time has 
expired.
    Mr. Greenwood. The Chair recognizes the gentleman from 
Louisiana, the chairman of the committee, Mr. Tauzin.
    Chairman Tauzin. Thank you very much. Dr. Zoon, that is 
indeed a good place to start with your statement that absent 
safety concerns the FDA might allow this to proceed, right?
    Ms. Zoon. Yes, based on our jurisdiction and our laws.
    Chairman Tauzin. Let's talk about your jurisdiction for a 
second. First of all, you've not gone through any rulemaking. 
The ordinary process in this kind of a matter might require 
well-established procedures to publish a proposed regulation in 
the Federal Register, to provide notice and opportunities for 
the public to comment. You've chosen to exercise jurisdiction 
through a letter to Dr. Seed in 1998, is that right?
    Ms. Zoon. The FDA has had a history in the regulation of 
cellular products and it starts as far back as our regulation 
of blood and blood components and more recently in its rules 
with regard to the regulation of tissue which----
    Chairman Tauzin. Let's talk about the connection to this 
issue with those regulations. The Food, Drug and Cosmetic Act 
uses the term ``drug'' to define articles for the use and 
diagnosis, cure, mitigation, treatment or prevention of disease 
and articles other than food intended to affect the structure 
of any function of the body. These definitions are limited to 
articles. The ordinary meaning of an article is a piece of 
good. How is a cloned embryo a piece of goods under the FDA's 
jurisdiction?
    Ms. Zoon. The product that the FDA is looking at here, what 
the FDA is regulating actually is the cells and the cellular 
components that would be used for the cloning technology----
    Chairman Tauzin. I would suggest that's a stretch. You did 
not exercise a similar jurisdiction in in vitro fertilization, 
did you not?
    Ms. Zoon. What I would say is, sir, that we had 
jurisdiction over in vitro fertilization at the time when that 
went on. We did not exercise our regulation of that. And in 
fact, the FDA in 1997 proposed a tissue framework strategy 
which was a tiered approach based on risk.
    Chairman Tauzin. Here's my problem. My problem is that even 
if you've defined this tissue that's really a human being as an 
article under the Food and Drug and Cosmetic Act, it has to be 
an article that's intended, as I read the act, for the use and 
the diagnosis, cure, mitigation and treatment and prevention of 
disease and intended to affect the structure and function of 
the body.
    Now the intended use of cloning materials is not to do any 
of those things, it's to produce a human being.
    Ms. Zoon. There are several aspects of this and I can talk 
to several because we're talking about two acts----
    Chairman Tauzin. I'll ask you about the second act in a 
minute, but be brief because I have but limited time.
    Ms. Zoon. Okay. The treatment here would be presumably 
infertility, in that case, and with the intention of producing 
a human baby. So that we believe that the cells and the 
cellular therapies and the components are the integral part----
    Chairman Tauzin. Now staff tells me and my reading of the 
act tells me this is a very tenuous hold on it and I'm deeply 
concerned about whether or not that would hold up in court. 
Under the PHS Act that section that you claim to have 
jurisdiction over, 351, applies to any virus, therapeutic 
serum, toxin, blood component or analogous product which would 
be applicable to the prevention, treatment or cure of diseases 
or injuries.
    The FDA apparently claims that a cloned human embryo is an 
analogous product. How do you do that?
    Ms. Zoon. Because many of the products we regulate are 
cellular therapies and in fact, in 1997, Congress changed the 
Act to----
    Chairman Tauzin. But a child is not a cellular----
    Ms. Zoon. [continuing] include not only a disease, but also 
condition. I think that's important to point out.
    Chairman Tauzin. But you keep tying the jurisdiction, the 
jurisdiction over cellular products and I must tell you I have 
a grave concern as to whether or not the law would recognize 
jurisdiction over a whole human being because you have 
jurisdiction over bloods and toxins and cellular products. I'm 
concerned about that. I'm concerned enough to wonder why when 
Dr. Seed announces in the press that he's going to do this, you 
react immediately and send him a letter saying you need an IND, 
and yet when the Raelians in October announced that they're 
well-funded and prepared and 50 women have volunteered to carry 
these cloned embryos, they don't get a letter until Monday when 
this hearing is announced?
    Why shouldn't that give us real cause to be concerned about 
how seriously the FDA is taking this issue?
    Ms. Zoon. When we found out about the website, we started 
our investigations and----
    Chairman Tauzin. You sent Dr. Seed a letter within 2 
months.
    Ms. Zoon. Yes, because----
    Chairman Tauzin. The Raelian group says they have the 
money, the volunteers, they're going forward, no letter until 
Monday. Tell me, what was the delay all about?
    Ms. Zoon. There are multiple parties involved with Clonaid 
which is the group and the agency was trying to identify----
    Chairman Tauzin. Did you have problems finding addresses?
    Ms. Zoon. [continuing] where they were.
    Chairman Tauzin. We contacted them within an afternoon. 
When we decided we wanted them here, we simply used the phone 
directory and contacted them, got names, addresses and notified 
them we'd like them to be here. Why did the FDA have so much 
trouble finding addresses?
    Ms. Zoon. Well, sir, we were investigating. I think the 
information and the increased visibility of these activities 
since the 60 Minutes show did, in fact, reveal different 
additional information that helped our investigators locate 
these folks.
    Chairman Tauzin. I just want you to know that when our 
staff using a phone directory can locate him in an afternoon 
and since October you can't send him a letter until this 
Monday, that it raises the level of our concern about the FDA's 
attention and serious regard for this issue.
    I must tell you, Mr. Chairman, I'm deeply concerned about 
the tenuous nature of the FDA's assertion of jurisdiction here 
and I, like you, wonder what would happen if somebody started a 
project here in America challenging the FDA's jurisdiction and 
implanted cloned embryos in a whole group of volunteers as to 
what on earth you could or would do about it. And if anything, 
your testimony has raised our level of interest in legislating 
to a much higher degree.
    Thank you, Mr. Chairman.
    Mr. Greenwood. The gentleman's time has expired. The Chair 
recognizes the gentleman from Illinois, Mr. Rush, for 5 
minutes.
    Mr. Rush. Thank you, Mr. Chairman and Mr. Chairman, I think 
the chairman of the full committee had some very, very 
insightful points and I want to just kind of piggyback on some 
of his questioning.
    Dr. Zoon, do you believe that the FDA's authority in this 
area needs to be strengthened through a more explicit statement 
of its jurisdiction, i.e., through legislation?
    Ms. Zoon. Sir, I believe FDA does have jurisdiction over 
the scientific areas regarding using cloning technology for the 
purposes of creating a human being. If Congress would like to 
strengthen that, we'd be happy to work with you.
    Mr. Rush. Well, the chairman of the full committee 
mentioned situations before where your jurisdiction was 
question, for example, it brings to mind tobacco, the tobacco 
industry.
    Do you think it is clear that the FDA has jurisdiction and 
authority over the regulation of human cloning and why and do 
you think that it would be defined well enough to withstand in 
an abbreviated time period court challenges? And I'm concerned 
because in the tobacco industry FDA was hauled into court for 
multiple years and we certainly want to avoid the same type of 
situation if we are brought into court over the issue of 
cloning.
    Do you feel as though you have jurisdiction, adequate 
jurisdiction and why and whether or not do you feel this 
jurisdiction is proper enough and strong enough and legal 
enough to withstand immediate challenges in court, in the 
courts?
    Ms. Zoon. Based on FDA's analysis, we believe we do have 
jurisdiction. The issue you raise is would it stand up in 
court, if challenged. We believe we could make our position 
very strong. Would it guarantee we would prevail? I don't think 
I could give you that guarantee. I think the FDA could make a 
very good case.
    Mr. Rush. Well, in a statement, in a document rather 
attached to Mr. Wicker's statement and I think he's going to 
testify on the third panel, he remarks that FDA's regulation 
and I quote ``are just fluff and have no real weight. They 
would not withstand any legal challenge. Ask any knowledgeable 
lawyer about that. Cloning is not a food, nor is it a drug.''
    In Mr. Eibert's testimony he remarks that ``virtually every 
lawyer on both sides of this debate agrees that FDA has no such 
authority over cloning under current law.''
    Now you have disagreement already about the nature of your 
authority and whether or not your authority is strong enough. 
Can you respond to those comments?
    Ms. Zoon. I would just say there's always disagreement. If 
the Chair would wish and if the Congressman would wish, Ms. 
Kate Cook, who is knowledgeable in the specifics of this, could 
come up to speak more. I'd be happy to have her come up here.
    Mr. Rush. Mr. Chairman?
    Mr. Greenwood. I'm sorry, yes. I'm the new chairman. I'm 
not used to responding to that.
    Mr. Rush. I see. Mr. Chairman, she indicated that there's 
another witness that could be brought to answer some of these 
specific questions about----
    Ms. Zoon. Jurisdiction and I'm asking permission if it's 
okay.
    Mr. Greenwood. That person would have to be sworn in. The 
other option in the interest of time since there's a vote is 
perhaps the questions could be submitted in writing and 
responded to in writing.
    Mr. Rush. That would be good. I have one final question. 
If, in fact, cloning is not conducted, doesn't take place 
within the continental United States and it takes place on 
foreign territory, on foreign land, is there anything that the 
Congress could do to ensure that American services and/or 
products would not be--could not be utilized or that anyone 
would be prohibited from utilizing services and/or products, 
pharmaceuticals, anything that's manufactured here in the 
United States to promote cloning in other places?
    Ms. Zoon. I think as far as FDA's jurisdiction in this area 
goes, we do have regulatory jurisdiction over various equipment 
and drugs that could be used in this procedure, but whether or 
not the agency could take action with regard to their export 
would very much depend on the situation, the type of equipment 
and drugs that are being exported and how they're labeled. So I 
think the answer to your question is right now, FDA would have 
some jurisdiction, but it would really depend very much on a 
number of factors.
    Mr. Greenwood. The time of the gentleman has expired. The 
Chair recognizes the gentleman from Oklahoma for 5 minutes.
    Mr. Largent. Thank you, Mr. Chairman. It was Benjamin 
Franklin, I believe, who plagiarized actually a phrase, a Latin 
phrase, e pluribus unum that we've adopted in this country 
which means out of many, one. I don't think this was what he 
was referring to when he adopted that phrase. Sometimes, but 
rarely, we are asked to address issues that can kind of shake 
the core of who you are as we catch glimpses of where this all 
may be leading us to and I think this is one of those areas. I 
think that this holy ground, frankly, that what we're talking 
about is not cellular products. What we're talking about is the 
creation of an eternal soul and I think it's best that we tread 
lightly on this and reverently.
    My question is very simple and I'd like to ask you, Dr. 
Zoon and Dr. Murray, take off your FDA hat, take off your 
Federal Government hats and represent just you, as doctors, 
given your experience, your education, your families. Should 
Congress ban human cloning reproductive activity in this 
country, yes or no.
    Dr. Zoon?
    Ms. Zoon. I believe that Congress----
    Mr. Largent. It's just a yes or no. Yes, we should or no, 
we shouldn't? This is your--you're not speaking for FDA now. 
I'm asking you to take that hat off and speak for yourself 
personally. Should we ban the topic of this hearing this 
morning in this country?
    Ms. Zoon. My opinion on this is I do not think human 
cloning should proceed in this country at this time.
    Mr. Largent. So that would be a no. Thank you. Dr. Murray?
    Mr. Murray. I think it's a yes.
    Mr. Largent. You're right. It is a yes. I got confused. 
Yes, we should ban it.
    Mr. Murray. And Ben Franklin would be turned on his head, 
it would be many out of one. I think that's what cloning 
purports to do.
    Speaking as a parent and husband and child and thinking 
about what we value in those relationships, I think human 
reproductive cloning at this time, it ought to be prohibited 
and I agree with the recommendation the President's Commission 
made in 1997, that there ought to be legislation to prohibit it 
and that the legislation ought to have a sunset clause so that 
we should come back and revisit this once there's been a wider 
public consideration of the larger moral issues.
    Mr. Largent. Thank you, Dr. Murray. Thank you, Dr. Zoon.
    Mr. Greenwood. I thank the gentleman for yielding. I thank 
the panel for testifying. I would suggest that Michael Jordan 
is probably a pretty good accountant as it is. And I call the 
next panel: Dr. Caplan, Director of the Center of Bioethics, 
University of Pennsylvania; Dr. Gregory Pence, Ph.D., Professor 
of Philosophy, School of Medicine and Humanities; Dr. Nigel M. 
De S. Cameron, Ph.D., Principal, Strategic Futures Group; Dr. 
Mark Donald Eibert, Esq., the law offices of Mark Eibert; 
Sharon Terry, M.A., Genetics Alliance, Inc.; Mr. Randolfe 
Wicker, Founder, Clone Rights United Front, Spokesman for the 
Human Cloning Foundation; Dr. Michael Soules, President of the 
American Society of Reproductive Medicine; Mr. J.D. Hanson, 
Assistant General Secretary, General Board of Church and 
Society, the United Methodist Church; and Rael, leader of the 
Raelian Movement, United States Raelian Movement. Please come 
and for everyone's benefit, what we're going to do is swear in 
the witnesses. I'm going to ask Dr. Caplan to testify first, 
since he has to catch a train and then we're going to recess 
briefly so the last of us can vote.
    I am going to ask all of the members, as the members are 
being seated, I address this question to you. You are aware 
that the committee is holding an investigative hearing and when 
doing so has had the practice of taking testimony under oath. 
Do any of you have objection to testifying under oath? Seeing 
no affirmative responses, I then advise you that under the 
rules of the House and the rules of committee you are entitled 
to be advised by counsel. Do any of you desire to be advised by 
counsel during your testimony? Again, seeing no affirmative 
responses, I would ask that you please rise, raise your right 
hand and I'll swear you in.
    Do you swear that the testimony you are about to give is 
the truth, the whole truth and nothing but the truth?
    Thank you very much, you may be seated.
    [Witnesses sworn.]
    The Chair recognizes Dr. Caplan for 5 minutes for his 
testimony.

STATEMENTS OF ARTHUR L. CAPLAN, DIRECTOR, CENTER OF BIOETHICS, 
    UNIVERSITY OF PENNSYLVANIA; GREGORY PENCE, PROFESSOR OF 
 PHILOSOPHY, SCHOOL OF MEDICINE AND HUMANITIES, UNIVERSITY OF 
   ALABAMA AT BIRMINGHAM; NIGEL M. DE S. CAMERON, PRINCIPAL, 
  STRATEGIC FUTURES GROUP; MARK D. EIBERT, THE LAW OFFICES OF 
MARK EIBERT; SHARON F. TERRY, GENETICS ALLIANCE, INC.; MICHAEL 
    R. SOULES, PRESIDENT, AMERICAN SOCIETY OF REPRODUCTIVE 
  MEDICINE; RANDOLFE H. WICKER, FOUNDER, CLONE RIGHTS UNITED 
   FRONT, SPOKESMAN FOR THE HUMAN CLONING FOUNDATION; JAYDE 
 HANSON, ASSISTANT GENERAL SECRETARY, GENERAL BOARD OF CHURCH 
  AND SOCIETY, THE UNITED METHODIST CHURCH; AND RAEL, LEADER, 
                        RAELIAN MOVEMENT

    Mr. Caplan. Thank you, Mr. Chairman. I apologize for having 
to run out of here quickly and I'm going to penalize myself. 
I've submitted written testimony to the committee, tried to 
acknowledge the importance of this hearing and I know that the 
Chair has a personal interest in families and children that's 
longstanding and I think it's simply appropriate that this 
hearing be held now.
    I wold like to make four points, basically, if I can, about 
where we're at with respect to human cloning. It seems to me 
the evidence on safety ends the discussion. There should not be 
human cloning. It's not safe. The data from animals ends that 
discussion. No reputable person other than cults, cranks, kooks 
and capitalists seems to believe that the science is there to 
undertake human cloning. Whether it ever will be possible to 
clone a human being remains in some doubt. It may be that 
biology doesn't let us do what science fiction writers and 
Hollywood sometimes dreams about.
    Be that as it may I think there are then some questions to 
be asked about cloning and the ethics of cloning that we 
haven't heard much about and I'll just introduce two points. I 
think No. 1, from where I come at this issue at, there are 
ethical issues separate from safety and I just want to 
introduce the two that I think are the most important. Some 
would argue that we should not outlaw, ban or restrict human 
cloning because it is a restriction on reproductive rights, on 
the ability of people to have children and that's not 
appropriate to do.
    However, I would argue that that view is wrong, that 
reproductive rights do extend to being left alone, not 
interfered with, having a zone of privacy about one's behavior, 
but they don't extend to the entitlement to have a child or the 
entitlement to the means to have a child. There are many people 
in this world, I was once one of them who have no mate, who 
have no spouse, who would possibly want to reproduce and the 
government does not supply them, last time I looked with a 
wife, a mate, a concubine or some means to reproduce.
    We all know that there are innovative ways to reproduce as 
well, sometimes you build families by adoption. The government 
deems in its wisdom appropriate that when a child is created 
and brought into this earth in a new type of environment that 
it will have some jurisdiction over who can do that, the means 
they must have, the abilities they must demonstrate.
    In other words, it is not an inappropriate role for this 
Congress to legislate with respect to human reproduction if 
we're going to try and look out for the interest of children. 
The interest of children is the driving question that takes us 
outside of safety. If we're going to make children in new ways, 
using technology, if we're going to put them into situations 
that they've been in before, looking like others, if not being 
the same as others, if we're going to have them made asexually 
and be the products of single parents, it seems to me that 
government appropriately should be able to regulate this area.
    Second point about the ethics of cloning. I said the 
driving interest should be in my opinion, is it good for the 
child and I believe that the jury is out on that. If you are 
made in the image of someone else, if you know things about how 
you will look and appear and what genetic risks you will carry 
with respect to health and disease, I would suggest your future 
may, it doesn't have to be, but it could be limited, restricted 
and your life made more miserable than it otherwise would have 
been had you been born by ordinary means and have your future 
open before you.
    To put it simply, whether or not you are the same as the 
person who cloned you, many will treat you that way, whether or 
not you are the same as the person who clones you, you will 
look and age and succumb to certain genetic problems that have 
afflicted your parent and you may be able to have less of a 
life, less freedom, less opportunity to be who you want to be 
than we would normally say is appropriate for human beings. 
Those two reasons, I think, give us some reason to move toward 
perhaps saying that human cloning not only should not happen 
now, because it's not safe, that it should never happen because 
it's not good for the child.
    I believe that there's another area of concern that people 
raised that I would just like to mention and that is well, why 
bother to regulate or legislate, how do we know that someone 
won't go on an island or in a distant land or somewhere and do 
this anyway?
    I think, Mr. Chairman, that this committee despite the 
interest of the FDA in exercising its authority can send a 
clear message to the world by putting penalties in place that 
are severe and clear about what is wrong with human cloning 
that will be heard around the world in every nook and cranny, 
the premier scientific and technological Nation on the globe, 
if it says that human cloning is wrong, leave the decision to 
revisit that statement or not some time down the road will be 
heard everywhere.
    Does it mean that no one will break the law? No. No more 
than having laws about speeding or killing or anything else 
mean that people won't do them, but it is very clear that the 
reception that will greet someone who tries to do this will be 
one of disapprobation and penalty. It seems to me that is 
exactly why this nation, since it is the world's science and 
technology leader, should make a clear national statement that 
human cloning is to be banned.
    Last, I would like to conclude these remarks with a 
thought, if you will, about why it is that human cloning 
policy, I think, should be made here and not at the FDA or 
anywhere else. At the end of the day we are talking about human 
reproduction and I listened to the previous panel and some of 
the questions put to the FDA representative and I do believe 
that FDA has a role to play in regulating experimentation and 
the use of new biological materials. As the Chair knows I have 
another hat that I wear as the chairman of the advisory 
committee on Blood Safety and Availability. I deal with the FDA 
on those blood products and many of those substances trying to 
keep the blood supply safe. That's not what making people is 
about.
    Congress should exercise its authority and say we 
understand the special nature, the respect, the special moral 
status that attends to human reproduction an we are going to 
put that under our ambit, not a bureaucracy, not a regulatory 
agency, but we representing the people of the United States are 
going to say clearly that certainly for now and I believe for 
the foreseeable future, human cloning is not only unsafe and 
ought not be pursued on scientific grounds, it is morally 
undesirable to do it, until we have a lot more clear evidence 
that it will be good for those made in that way.
    Thank you.
    [The prepared statement of Arthur L. Caplan follows:]

PREPARED STATEMENT OF ARTHUR L. CAPLAN, TRUSTEE PROFESSOR AND DIRECTOR, 
            CENTER FOR BIOETHICS, UNIVERSITY OF PENNSYLVANIA

    Mr. Chairman it is an honor to have the opportunity to testify to 
this committee. I have long hoped that the Congress would hold hearings 
on the subject of human cloning and I am very pleased that Congressman 
Greenwood, who has long been a leader in protecting the interests of 
children and families, has deemed it important to do so.
Will Human Cloning Happen Any Time Soon?
    This Committee has deemed it important to meet to discuss human 
cloning because there is a strong perception current in our society 
that human cloning will soon take place. This perception is fueled by 
four factors.
    There has been progress in the cloning of animals with a number of 
species now having been cloned. This makes it seem as if we are moving 
rapidly and inexorably up the evolutionary ladder toward the cloning of 
human beings.
    A number of groups and individuals have announced that they intend 
to try to create human clones. These announcements lend some urgency to 
the need to decide what the government should do about human cloning.
    The media has contributed to the perception that human cloning will 
soon occur with a flurry of reports and stories, many feeding directly 
off one another and reinforcing one another about these pronouncements. 
The New York Times Magazine, Wired magazine and many other journals and 
television programs have stated that human cloning will happen in the 
very near future.
    And, lastly, there is a very strong belief in our society that 
science and technology cannot be controlled. Senators, opinion leaders 
and editorialists have all been hard at work assuring the public that 
once the genie is out of the proverbial bottle there is no way to reign 
it back in. Cloning is the genie and Dolly was the bottle. Human 
cloning must be right behind.
    I do believe that it is important to examine the need for 
regulations concerning human cloning. My view is that the Federal 
government should pass legislation declaring a complete moratorium on 
all cloning intended to create human beings. I think that this ban 
should be imposed until such time as the Food and Drug Administration 
is convinced that animal studies on many species including primates 
shows that human cloning is reasonably safe with a high degree of 
probability. I should add that I do not believe there is any reason for 
the government to take any action with respect to the cloning of cells, 
tissues or organs for medical and therapeutic purposes. But, my reasons 
for these opinions have nothing to do with the prospect of imminent 
human cloning. I do not believe the cloning of human beings is 
imminent.
    While it is true that some animal species have been cloned the 
ability to successfully clone animals is severely limited. The failure 
rate among cloning attempts can best be described as embryonic and 
fetal carnage. Of the embryos that make it to birth many are born dead, 
many others are deformed and others still severely disabled. The only 
thing that work to date on animals convincingly shows is that the 
cloning of human beings at any time in the next few years would be 
completely immoral, unethical and barbaric human experimentation 
undertaken for no purpose other than publicity or to be the first to 
win a race that there is no need to hold--who can make the first human 
clone.
    Not only does animal work not support the idea that human cloning 
is just around the corner neither do the pronouncements of any current 
group or individual. To date a collection of kooks, cranks, cultists 
and con-men have been the sole members of the club announcing that 
cloning will soon be used to make a human. No one and I mean no one who 
has any real expertise in cloning has made any such statement. No one 
and I mean no one with any real expertise in cloning believes that 
human cloning is imminent. The media has simply got the story wrong. 
Human cloning has been irresponsibly hyped using the pronouncements of 
persons who have no skills or abilities or track record with respect to 
cloning to fuel that hype.
    In fact, it is just as likely that the successful cloning of a 
health human being will never occur as that it will. The biological 
problems inherent in using ``old'' DNA to make new organisms may not 
permit the creation of healthy human beings.
The Time For a Moratorium Is Now.
    The fact that cloning will not be used any time soon to make human 
beings does not mean that this committee should not recommend that 
Congress enact legislation to insure that the inept and the 
irresponsible do not try. On the contrary the primitive nature of 
cloning technology is precisely why Congress must act. Congress should 
act to place a moratorium on cloning until the FDA is satisfied that 
animal work provides a reasonable basis for undertaking human trials. 
This will clearly send the simple message that until those who know 
what they are doing can show that they can clone animals with a 
reasonable success rate and which are healthy and vigorous attempts at 
human cloning will result in severe fines and time in prison.
    There are those who will say that any effort at legislation is 
pointless since the bad guys will not obey the law and since you cannot 
reign in technology once it has emerged. Both arguments are simply poor 
arguments.
    Of course bad people will break the law. But if we adopt the view 
that we will only pass laws that everyone will follow at all times then 
we will have no laws about anything. In one sense laws are made 
precisely because there are those who may seek to do immoral things. A 
tough law banning human cloning until the FDA states that the technique 
is safe makes it clear that there is a price to be paid and a severe 
for breaking that law. By acting quickly to issue simple and clear 
regulations Congress also sends the message to the world that the 
world's premier scientific and technological society believes no one 
anywhere should undertake human cloning without much more research on 
animal and cell cloning. This message will ring loud and clear across 
the globe--even on the proverbial off-shore islands and remote jungle 
locations where so many seem convinced that cloning companies are or 
will soon begin operation.
    Can the law really regulate technology? Of course it can. It 
already does. In human experimentation there is a complex set of laws 
that have worked to limit and restrict various kinds of inquiries for 
decades. In the United States embryo research and fetal tissue research 
have proceeded at a snail's pace. Work on xenografting has stalled due 
to regulatory and legal concerns about safety. The point being that 
science is no less amenable to control by society than any other human 
activity. What is needed is the will to steer and control science and 
technology--a will that has been all too often lacking in our society 
when it comes to genetics and reproductive technologies.
What Happens If Cloning Is Shown to Be Safe?
    Not only will human cloning not occur soon if at all, it will 
never, even if it is shown to be safe3, become an important method for 
creating human beings. There are a number of reasons for my making this 
claim. The most important is that when it comes to reproduction human 
beings will prefer sex with another to spending a few hours and tens of 
thousands of dollars at a fertility clinic. If the choice is sex or a 
Petri dish bet on sex.
    Those who favor allowing human cloning or who want to promote it 
argue that cloning may still help some people. Human cloning can be 
used to bring back deceased loved ones, to allow some of us to achieve 
immortality or to solve the chronic shortage of vital organs that 
results in so many otherwise preventable deaths.
    Cloning can do none of these things. Cloning can no more bring back 
the dead than can owning a videotape of a deceased person. Genes do not 
control our minds and our thoughts. Clones are people made in an 
unusual manner. But they will have their own feelings, thoughts, free 
will and if you like--spirits or souls. Replicating a person's genes 
does not replicate the environment and the developmental that make the 
person who they are. It is simply impossible to step in the gene pool 
twice.
    Evidence that having the same genes does not make us the same 
person is all around us. Human clones already exist. They are Even 
identical twins who have all their genes in common. Twins also are 
usually raised in a relatively common environment by the same parents. 
Yet they are not identical copies of one another. They do not have the 
same thoughts and feelings and do not make the same life-choices and 
plans.
    Specially created human clones will have free will. Clones are 
simply people made in a never before seen way. But they are still 
people who will grow and develop. Bet on this--teenage human clones 
will not want to do or be what their parents wish they would any more 
than any other teenager born by more conventional means is or does 
exactly what their parents want them to do. So you cannot replace a 
lost child or loved one by cloning. Nor can you be immortal by cloning 
yourself any more than you can be literally immortal by having a child.
    And making human clones will not solve the organ shortage. The 
clones will have every right to consent to having their organs removed, 
just as you and I do now despite the fact that someone may well need 
our kidney or a piece of our liver.
    The most poignant claim made on behalf of cloning is that it will 
help the infertile have children. But the infertile can already have 
children through adoption, artificial insemination, and in vitro 
fertilization. Sterile men and women, gay men and single mothers have 
all had children using current techniques. Cloning would add another 
type of treatment for infertility but for nearly all of the infertile 
it would do nothing more then add a new option. It is not a 
breakthrough in the treatment of infertility.
Two Fundamental Problems with Human Cloning
    Presume that cloning is safe. Presume too that very few people will 
want to clone themselves. Are there still any fundamental moral reasons 
why cloning a human being would be wrong?
    One problem with cloning someone is that they will be made in the 
biological image of another person who has lived before them. They will 
know much about their appearance. This will lead others to have very 
strong expectations and reactions to them especially in an appearance 
conscious culture such as ours. The clone may find that it is a 
terrible emotional burden to be a lookalike of someone who is twenty, 
thirty, fifty or eighty years older.
    And others will have a hard time reacting to the commonality of 
appearance that clones will have with their parents. Some will see 
their former wife or husband reappear as they were in their youth. Some 
will find themselves puzzled over how to relate to a family member who 
looks like their mother but is actually a sister or a granddaughter.
    In addition to these psychosocial issues cloning threatens to rob a 
person of their future. Because biology does dictate much about our 
health and many of our general capacities and abilities a clone will 
know much about what lies in store for them. A clone is the 
unconsenting subject of the most comprehensive genetic testing 
possible. While some may be able to adapt to this many other may find 
it more than they can bear. Even today many people when given the 
choice of knowing the results of a single genetic test prefer not to 
know for fear that the knowledge would make their lives hell. What 
would the impact be of not knowing one genetic test result but 
thousands of them on a child or young adult?
    Cloning may be something that some persons choose to do. But 
government may still find that while it respects the rights of people 
to reproduce without interference it does not grant the right to people 
to use technologies that stand a high risk of creating people who are 
miserable or psychologically harmed. Cloning may simply not be good for 
humans, psychologically, emotionally or in terms of their own self-
esteem and peace of mind.
    So the day may come when Congress decides to convert a moratorium 
on human cloning into a ban on human cloning. Just as we severely 
restrict who it is that can serve as a foster parent or adoptive 
parent, just as we do not permit parents to do things to their children 
that traumatize them, Congress may decide that cloning is simply too 
risky a technology for making people.
    But that day is far off. Today Congress should simply put cloning 
off-limits. The kooks and the cultists and the cranks and the con men 
can find otherways to prey on our fears. The media can strive to 
restore some balance to the public's anxiety about human cloning. 
Scientists can continue their efforts to use cloning to engineer cells 
and tissues and animals, which is where the real value of cloning lies 
and will always lie. And the ethicists and theologians and thought-
leaders can strive to insure that our schools and religious 
institutions, and state legislatures and civic organizations are filled 
with spirited dialogue and debate about where we want human cloning to 
go if anywhere when and if it proves safe to try as a way to create a 
new member of our species.

    Mr. Greenwood. Thank you, Mr. Caplan for your testimony and 
you are dismissed sir, for your transportation needs.
    I have about 30 seconds to vote. This hearing will be 
recessed for 15 minutes.
    [Brief recess.]
    Mr. Greenwood. Again, with apologies to all concerned, the 
committee will reconvene and Dr. Pence, thank you for your 
patience throughout the afternoon. You are recognized to 
present your testimony, sir.

                   STATEMENT OF GREGORY PENCE

    Mr. Pence. Thank you, Mr. Chairman, for inviting me to 
testify today. I've been a proponent, philosophically, of human 
cloning when safe for about 3 years now and I have just a few 
points to make today.
    One, I think the language is real important. I think to 
talk about the clone or the human clone, these are slightly 
negative phrases, almost question begging and kind of like 
referring to women as chicks. I would prefer talking about a 
delay twin or even better, a person originated by cloning, just 
so the language doesn't throw us.
    I've taught and written about medical ethics for 25 years 
in the Medical School in Birmingham and so some of the 
philosophical issues here have a sense of deja-vu to me. In the 
early 1970's many people opposed test tube babies because of 
fear of harm to the family, to children and to society. And 
some of the same critics on philosophical grounds, oppose human 
cloning today.
    Today, we have over 100,000 American babies created through 
test tube technology or assisted reproduction and I'm glad that 
the philosophical objections weren't listened to 25 years ago, 
else those babies wouldn't exist today.
    I also want to point out that 25 years ago 80 percent of 
Americans were against test tube babies and now the figure have 
reversed.
    What can we learn from this experience? First, it was 
predicted that test tube babies would be regarded as products 
or as commodities by their parents. That, in fact, did not turn 
out to be true. Because of the effort and the costs that the 
parents went through, those babies today are probably some of 
the most loved babies around.
    To me, there are two essential questions here. One, is it 
safe? And two, the more philosophical question, is it 
intrinsically wrong?
    As for whether cloning is intrinsically wrong I believe 
that if 1 day it becomes safe, there will be nothing 
intrinsically wrong about this process. I believe it will be 
just another way of creating a family, just like in vitro 
fertilization and indeed it might be a way of creating a family 
and avoiding hereditary genetic disease.
    Now to the question of safety. There's really two questions 
of safety. One is psychological harm and one physical harm. As 
far as psychological harm here, I think most of the criticisms 
that have been given are fairly speculative and stem from 
science fiction and pop psychology. It was also predicted that 
test tube babies would be harmed and there would be prejudice 
against them or they would be traumatized by being born in a 
test tube, all that, of course, turned out to be wrong. The 
only real requirement was the happiness of--the happiness of 
children is loving parents.
    Now for the physical danger. I've always argued that 
children should not be originated by cloning until this process 
is as safe as sexual reproduction. Sexual reproduction has a 
rate of abnormalities of about 1 to 2 percent. Until about a 
year ago, the evidence was still, I think, up in the air that 
human cloning could be as safe as that. However, recently, the 
latest data and especially those unpublished data of Dr. 
Jaenisch was really one of the leaders in the field about 
molecular biology and the reprogramming and expression and Mark 
Westhusin is also a very recognized expert in animal cloning. 
These are fairly devastating, I think, about safety. So I think 
it is premature to proceed at attempts to originate humans by 
cloning now, but I would add this caveat. Four years ago, we 
thought it was a law of nature that once cells became 
differentiated they couldn't become undifferentiated. At first 
we thought Dolly was too old and then we learned that maybe 
she's too young. We thought we could only do a sheep, but 
couldn't do a frog or a cat, so the science is moving very 
rapidly and it might change a couple of years down the pike.
    So the really interesting question is should we make this a 
Federal crime at this point? Having some experience in this 
field I remember that 20 years ago, Congress banned Federal 
funds from being used for embryonic research when it was 
concerned about test tube babies and other things. Over 
subsequent decades, scientists tried to get this ban 
overturned, but it was very, very difficult to do so. I believe 
that if human cloning were similarly made into a Federal crime 
and the scientific evidence changed, it would be very, very 
difficult to undo.
    To make an analogy here, we now know that bone marrow 
transplantation for breast cancer, many women went through this 
procedure. It was fairly horrible. Part of the data was based 
on fraudulent studies. Most of the data, I would say 96 percent 
of the data now says doing a bone marrow transplantation for 
breast cancer is not effective and shouldn't be done. But some 
physician might choose to go ahead and do that. Do we want to 
make that a Federal crime? Does every person who goes against 
the evidence in medicine, does that have to be a Federal crime?
    Finally, philosophically, if government bans attempts at 
human cloning because of worries about developmental defects, I 
worry about the intrusion of the Federal Government in the 
private life. I'm not a legal scholar, but I'm not sure there's 
anything in the U.S. Constitution that gives the Federal 
Government as opposed to the State government the right to tell 
people how to originate children and why. Also, as a result of 
the human genome project, more and more fetuses are going to be 
tested for genetic diseases, more parents will learn their 
fetuses carry genetic defects. These are certain defects, not 
probable like in cloning. And it's important if some people 
decide to carry such fetuses to term. If the worthy aim is to 
prevent defects to children and the mighty power of the Federal 
Government is going to come in here, won't logical consistency 
force us to encourage or even require abortions of fetuses with 
such defects? Do we really want to open this door?
    If the best interest of children is the moral criterion 
here for bringing in the Federal Government, then maybe we 
should make it a Federal crime to drink and smoke during 
pregnancy. You open a fairly big door here.
    One final point. The reverse of this is also interesting. 
Let's suppose the scientific data really does change. Let's 
suppose that 1 day cloning is safer than sexual reproduction. 
Does that mean that we would ban sexual reproduction for the 
good of children?
    Thank you.
    [The prepared statement of Gregory Pence follows:]

 PREPARED STATEMENT OF GREGORY PENCE, PROFESSOR OF PHILOSOPHY, SCHOOLS 
    OF MEDICINE AND HUMANITIES, UNIVERSITY OF ALABAMA AT BIRMINGHAM

    Thank you, Mr. Chairman, for inviting me to testify today. I 
believe that phrases such as ``the clone'' or ``the human clone'' are 
prejudicial, like ``chick'' or ``queer'' and should be avoided. I 
believe that the phrase ``delayed twin'' is much less question-begging.
    Mr. Chairman, I have taught and written about medical ethics for 
nearly 25 years in the medical school in Birmingham. In the early 
1970's, all bioethicists except Joseph Fletcher opposed ``test tube 
babies'' for fear of monsters, harm to families, and harm to the 
identity of the children created. Many of these same critics today 
oppose human cloning. Now over 100,000 American babies exist--200,000 
worldwide--who would not have existed had these critics won. Back then, 
over 80% of Americans opposed test-tube babies; now the same percent of 
Americans support such efforts.
    What can we learn from this experience? First, such babies were not 
viewed by their parents as the critics predicted, that is, as 
``commodities'' or as ``products.'' Instead, and because of the effort 
and cost that the parents endure, these children are very, very loved.
    To me, the essential moral question is whether human cloning is 
intrinsically wrong. But how can a new way of creating a family be 
intrinsically wrong? How can a way of avoiding hereditary genetic 
disease be intrinsically wrong?
    If it is not intrinsically wrong, then we must ask whether it I 
wrong for some other, associated reason, mainly, whether a child 
created by cloning would be harmed, psychologically or physically.
    I believe that questions of psychological harm here are entirely 
speculative and stem from science fiction and pop psychology. I believe 
that how children are originated has little to do with their future 
mental health. The real requirement for the happiness of children is 
loving parents.
    As for physical danger, I believe that children should not be 
originated by cloning until this process is as safe as sexual 
reproduction, which now has a roughly 1-2% rate of abnormalities. At 
the moment, Mr. Chairman, I believe it is premature to proceed with 
attempts to originate humans by cloning, but continuing research and 
advanced screening techniques for embryos may one day achieve safe 
results. Until then, I believe that families and physicians should be 
allowed to handle such matters without being subject to criminal 
penalties.
    Over twenty years ago and partly in response to worries about 
assisted reproduction, Congress banned federal funds from being used 
for embryonic research. Over subsequent decades, many scientists tried 
to get this ban overturned, but it was very difficult to do so. If 
cloning were similarly banned or criminalized, it would be very 
difficult to ever undo such prohibitions--no matter what science later 
learned. Let us learn from the past and not repeat its mistakes. Let us 
leave such matters to physicians, scientists, and families, not to the 
federal government.
    Finally, if government bans attempts at human cloning because of 
worries about developmental defects, will such a ban be the first step 
toward greater federal intrusions? As a result of the Human Genome 
Project, more fetuses will be tested for genetic diseases and more 
parents will learn that their fetuses carry genetic defects. Only 
instead of probable or likely genetic defects, these babies will have 
certain defects. Here it is important that some couples decide not to 
abort such fetuses and decide to carry them to term.
    In this situation, and for the worthy aim of preventing such 
defects, will the same government be forced to encourage or even 
require abortions of such fetuses with genetic diseases? Doesn't the 
same goal and the same expansion of federal power justify both 
intrusions into reproductive freedom? If our moral criterion is the 
best interest of future children, how can government ban reproduction 
for likely defects but not for certain defects?
    The reverse of this point is also interesting. If preventing 
defective children justifies federal intervention in the bedroom, and 
if cloning one day becomes safer than sexual reproduction, will cloning 
then be the only required way to have children--based on the good of 
future children?
    Thank you, Mr. Chairman, for allowing me to testify today.

                              References:

    Gregory E. Pence, Re-Creating Medicine: Ethical Issues at the 
Frontiers of Medicine (Rowman & Littlefield, Lanham, Md. 2001) (on the 
effects of the ban on federal funding of embryo research).
    Gregory E. Pence, Who's Afraid of Human Cloning? Rowman & 
Littlefield, Lanham, Md. 1998) (on irrationalities about cloning 
humans).
    Gregory Pence, Classic Cases in Medical Ethics: Accounts of the 
Cases that Shaped Medical Ethics, 3rd edition, McGraw-Hill, 2000 (on 
the history of assisted reproduction and past controversy).

    Mr. Greenwood. Probably not.
    Dr. Cameron.

              STATEMENT OF NIGEL M. DE S. CAMERON

    Mr. Cameron. Thank you. I'm Nigel Cameron. I'm a consultant 
in bioethics. I serve as Executive Chair of the Center for 
Bioethics and Public Policy in London and also as Dean of the 
Wilbeforce Forum in Reston, Virginia.
    In human cloning we confront the quintessential question 
faced in bioethics as we address so many issues in which the 
promise for good and the promise for harm needs to be weighed 
by the human community. The means of human procreation itself, 
all of a sudden lies in our hands. And we face a watershed as 
we address this question in the contest of public policy.
    Now the field of bioethics, of course, is a meeting point 
for various disciplines of technology and science and medicine 
and policy and ethics and within the framework of the 
Hippocratic medical tradition, which is still widely 
acknowledged within our Judeo-Christian culture, the challenge 
is to make policy which will frame the values of the community 
as the values for bioscience.
    It's been said that if it isn't possible for us to do this 
in the case of human cloning, it is very hard to say what issue 
we will be able to address effectively within the policy 
context.
    Now I've been asked to talk about the international 
approaches to this question and then I shall offer one or two 
brief comments of my own.
    Several nations, as has been noted, has enacted bans on 
human cloning, statutory bans, since the Dolly experiment and 
yet, it was in Germany in 1990 anticipating all of these 
developments that the most significant legislative move was 
made in that a statutory ban on human cloning was enacted in 
advance with a 5-year penalty of imprisonment in that one 
nation, of course, which has as we were reminded briefly in the 
movie, in 60 Minutes, which we were reminded, has had its own 
national experience of bioscience gone wrong.
    Other nations have been noted. There's a bunch of nations 
around the world now, Ireland, Israel, Italy, France, 
Argentina, Colombia, Spain with legislative process in other 
nations including Canada.
    But second, I want to draw attention to the one 
international treaty on bioethics, the European Convention on 
Biomedicine and Human Rights. I'm interested that this document 
has not been referred to yet. I was pleased that my thunder 
wouldn't be entirely stolen and there is a copy of the European 
Convention attached to my testimony.
    The Convention adopted in 1997 appropriately 1 year after 
the announcement of Dolly, in the year of Dolly's announcement, 
open for signature then, seeks to bring together the issues in 
biomedicine and the European human rights tradition and 
international law. And sets them together in the title of the 
treaty which is one of the Council of Europe Treaty series. The 
Convention adopts the European principle of subsidiary in 
allowing a lot of freedom to the nations to interpret it and 
apply it, but the convention does ban human cloning. 
Specifically, intervention seeking to create a human being 
genetically identical to another human being, whether living or 
dead is prohibited. That is the primary language of the treaty. 
As of today, 29 European states have signed the protocol and it 
actually came into force on March 1 of this year after 
ratification by the first five nations.
    I have one or two brief closing comments. One, there's a 
fundamental need for development of public policy in our 
address to the issue of biosciences and this a question which 
has been referred to and we are way behind the curve and we 
need to address these questions urgently as a whole because, of 
course, this is one of the simpler questions being raised as 
the biosciences develop.
    Second, one of the reasons for doing that, one reason why 
the biotech industry itself has an interest in policy is the 
need to develop public confidence in these technologies and so 
to avoid, for example, repetition of the European experience, 
with genetically modified food, where something akin to a 
peasants' revolt has led to handwritten signs in restaurants 
and shops all over Europe saying we don't stock GM food.
    Third, the overriding significance of a single principle in 
this discussion, that of the dignity of the individual. It is 
this question which lies at the heart of every one of these 
questions and this question which makes this a priority 
question for public policy and not a matter simply for private 
commercial or other decisionmaking.
    And then fourthly and finally, the significance of the need 
for international agreement. This has been referred to by 
various contributors and it's the one point at which I find 
myself in agreement with Dr. Zavos, that human dignity, like 
the world of bioscience, is indivisible and that if we cannot 
address these questions as a world community finally using the 
European Convention, using a current UNESCO process which 
parallels that Convention, then we shall finally be unable to 
address them as one human community.
    Thank you, sir.
    [The prepared statement of Nigel M. de S. Cameron follows:]

 PREPARED STATEMENT OF NIGEL M. DE S. CAMERON, CONSULTANT IN BIOETHICS 
                           AND PUBLIC POLICY

    In human cloning we confront the quintessential question of the new 
bioethics. The challenge it poses is emblematic of the new bioscience 
and its agenda, which offers both such promise for good, and such 
threat of harm, to the human community. The means of human procreation 
itself now suddenly lies in our own hands: nowhere is it clearer that 
we face a watershed for the human race.
    The field of bioethics lies at the meeting-point of ethics with 
several disciplines, including science, technology, medicine, and 
policy. The challenge to policy is to maintain the priority of what is 
ethical, and therefore to assert the fundamental values of the human 
community as the context for these extraordinary new developments. It 
has been said that if it does not prove possible for us to do this in 
the case of human cloning, it is hard to have confidence in our 
capacity to address the thousand issues that are standing in line for 
attention, in the unfolding agenda of biotechnology. The distaste of 
the human community for cloning is almost universal. And the stakes 
could hardly be higher, since we are discussing experimentation on and 
the manufacture of human subjects.
    I shall briefly outline some international policy approaches to 
human cloning, and then offer some observations.
National jurisdictions
    In the four years since it was announced that Dolly the sheep had 
been cloned, many nations have taken steps to prevent the application 
of the somatic cell nuclear transfer technique, and in some cases other 
cloning techniques, to human beings. But they were anticipated in that 
one nation to which we should be most attentive in this debate, since 
its experience in the twentieth century offers the world a laboratory 
for misdirected science. In 1990 Germany enacted a statutory ban on 
cloning, with a penalty of five years imprisonment. German prescience 
stands in marked contrast to the reactive approaches of other 
jurisdictions, in which at every point science and technology have 
outstripped the policy process, in a pattern we may expect to see 
indefinitely repeated.
    Several major nations have now enacted statutory cloning bans, or 
such enactment is in process. One of the most recent is Japan, which 
takes effect in June of this year, and carries a 10-year sentence for 
infringement, though no penalty for Japanese who travel abroad for the 
process--since a Japanese couple is said to be among those on Zavos and 
Antinori's list of clients, the responsible Japanese government 
minister is reported to be seeking an amendment to cover 
extraterritorial cloning involving Japanese nationals. Other nations 
that have banned cloning include Ireland, Israel, Italy, France, 
Argentina, Colombia, and Spain. Nations with current legislative 
process include Korea, Canada, New Zealand, and Russia.
The European Convention on Biomedicine and Human Rights
    In 1997, appropriately the year of the Dolly announcement, the one 
international treaty on bioethics was opened to signature. The European 
Convention on Biomedicine and Human Rights seeks as its title suggests 
to set the questions being raised in biotechnology firmly in the 
context of the human rights tradition in European law, recognizing that 
the dignity of the individual is the prime question at issue. The 
Convention was the result of a lengthy consultative process--I myself 
attended one consultation in the late 1980s--and a product of the 
treaty process of the Council of Europe through the work of its 
bioethics advisory committee.
    The Convention, while adopting the European principle of 
subsidiarity in recognizing diversity within its jurisdictions, adopts 
a series of key positions, including a ban on any profit from trade in 
body parts; a ban on germline gene therapy (therapy that affects 
subsequent generations); and a ban on the creation of human embryos for 
the purposes of research (while requiring protections for other, 
``spare,'' embryos that are used for research purposes; in fact, the 
advisory committee originally recommended to the Council of Ministers a 
ban on all deleterious embryo research).
    The Convention provides for the addition of subsequent protocols on 
fresh questions, and the first such protocol to be drafted bans human 
cloning. That protocol went into effect on March 1, after ratification 
by the requisite five signatories. It reads, in pertinent part,
        Considering that the cloning of human beings may become a 
        technical possibility . . . Considering . . . that the 
        instrumentalisation of human beings through the deliberate 
        creation of genetically identical human beings is contrary to 
        human dignity and thus constitutes a misuse of biology and 
        medicine . . . Considering also the serious difficulties of a 
        medical, psychological and social nature that such a deliberate 
        biomedical practice might imply for the individuals involved . 
        . .
        Article 1
    1. Any intervention seeking to create a human being genetically 
            identical to another human being, whether living or dead, 
            is prohibited.
    2. For the purpose of this article, the term human being 
            ``genetically identical'' to another human being means a 
            human being sharing with another the same nuclear gene set.
    As of today, 29 European states have signed the protocol, and it 
came into force on March 1 after ratification by the first five 
signatories. The full text of the treaty and the protocol are included 
as an attachment to this testimony.
Observations
    Let me add four brief observations to be considered as we move to 
develop policy:

1. The need for policy in bioethics and the biosciences
2. The need to build public confidence
3. The overriding significance of the dignity of the individual
4. The importance of international agreement
5. The need for policy in bioethics and the biosciences. It is curious, 
        and disturbing, that the development of policy--particularly 
        here in the United States--has lagged far behind the 
        development of technique and the growth of the commercial 
        sector. In light of the detailed regulatory regimes--that have 
        wide and bipartisan approval--operating through bodies such as 
        the FDA, the USDA, and indeed the SEC, there is a powerful 
        argument that the stakes here are the highest of all.
6. The need to build public confidence. This offers a powerful support 
        to the development of policy, and is illustrated by a recent 
        statement quoted from Carl Feldbaum, president of the 
        Biotechnology Industry Organization (BIO), to the effect that 
        ``from the industry's standpoint, attempting to clone humans is 
        a lose-lose proposition,'' since whether it succeeds or fails 
        ``it is likely to result in a backlash against mainstream 
        biomedical research.'' (The Record, Bergen Co., NJ, 2/18/01). 
        This concern reflects the remarkable story of the popular 
        European response to genetically modified (GM) foods, widely 
        dubbed ``Frankenfoods'' in the European media, and largely 
        rejected by European consumers. While the industry has not been 
        in the forefront of demands for regulation, a strong argument 
        can be made that its long-term interest vitally requires public 
        confidence, and that such confidence needs expression and 
        confirmation through the policy process. This offers a contrast 
        to anti-science Luddism on the one hand, and unrestrained 
        exploitation on the other, and suggests a sound regulatory 
        context for the biotechnology industry.
7. The overriding significance of the dignity of the individual. From 
        one perspective this is such a statement of the obvious. Yet it 
        actually states the central challenge confronting bioscience 
        policy, since these unfolding developments will offer a stream 
        of benefits to some individuals at potential cost to others. 
        That is of course the central role for policy in a free 
        society: to defend the individual against the encroachment of 
        others, including the state itself. Questions such as access to 
        genetic information (for insurance, employment, and other 
        external purposes), germline gene therapy (in which we change 
        the genetic inheritance of the next generation, a procedure 
        summarily outlawed in the European Convention), and so-called 
        ``therapeutic'' embryo experimentation (in which putative 
        benefits to some are balanced against the destruction of 
        individual embryos), offer samples of the decisions that await 
        us.
8. The importance of international agreement. Plainly, there is value 
        in setting policy within individual jurisdictions, and those 
        states such as California, Louisiana, Michigan, and Rhode 
        Island that have banned human cloning are to be commended for 
        their initiative in asserting the common values of their 
        citizens. The same is true of nations. But both human dignity, 
        and the worlds of bioscience and the biotechnology industry, 
        are indivisible, and there is urgency in the task of 
        international agreement. This was well illustrated by the 
        statement of Drs Zavos and Antinori that they intend to press 
        ahead with the birth of a cloned human baby, and locate in an 
        unnamed European country in which, one presumes, it is not 
        illegal. The European Convention on Biomedicine and Human 
        Rights offers a model; the present UNESCO process that has 
        begun with a statement on the human genome offers a process.

    Mr. Greenwood. Thank you.
    Mr. Eibert?

                   STATEMENT OF MARK D. EIBERT

    Mr. Eibert. Thank you, Mr. Chairman. Sir, I am a patient 
advocate. I'm going to talk about the needs and the rights of 
infertility patients. Infertility affects about 12 million 
adult Americans. Medically, infertility is classified as a 
disease and legally, the Supreme Court and the EEOC have 
declared it a disability within the meaning of the Americans 
With Disabilities Act. Psychologically, infertility is a 
devastating condition. It interferes with one of the most 
powerful biological drives that every human being has. Being 
diagnosed as being incurably infertile is like having all of 
your children die and all of your grandchildren too.
    Unfortunately, current reproductive medicine can only help 
less than half of infertility patients to have biologically 
related children. Among the millions that they cannot help are 
the many patients who cannot produce viable eggs or viable 
sperm. For many such Americans, cloning will soon provide the 
only way possible to have their own biologically related 
children and families.
    Many people want to outlaw cloning as a treatment for 
infertility. The Constitution does not allow that. The Supreme 
Court has ruled many times that every American has a 
constitutional right to have biological children and to make 
all kinds of reproductive decisions without government 
interference. As the Supreme Court has said, ``if the 
constitutional right of privacy means anything, it is the right 
of the individual to be free from unwarranted governmental 
intrusion into matters so fundamentally affecting a person as 
the decision of whether to bear or beget a child.''
    Some people like Mr. Caplan argue, oh, that only applies to 
sex. Disabled people who need medical help to have children 
don't have the same reproductive freedom that healthy people 
do, but that isn't true. Federal courts have struck down State 
laws to try to restrict IVF and similar high-tech reproductive 
technologies as violations of the constitutional right to have 
children.
    It's not any particular means of reproduction that is 
constitutionally protected, it is the end, the right to have 
biological children and families and that is what the opponents 
of cloning are trying to deny to disabled Americans.
    Other cases prohibit discriminatory laws that deny 
reproductive freedom to some people, but not others. For 
example, Oklahoma once had a law that required the 
sterilization of convicted criminals as part of a broader 
eugenics program designed to prevent the birth of seriously 
defective children, but the Supreme Court struck that law down, 
declaring that the right to have offspring was a fundamental 
constitutional right.
    This case means that anyone who attempts to ban cloning 
will have to explain to the courts under a strict scrutiny 
standard why infertile people should have less of a right to 
have children and families than convicted criminals do. For 
infertile people who cannot have biological children any other 
way, anti-cloning laws are the practical equivalent of forced 
sterilization.
    In short, the Federal Government simply does not have the 
constitutional authority to decide which Americans can and 
cannot have children or which children are likely to be perfect 
enough to be allowed to be born.
    Today, the FDA claims to have statutory authority to 
regulate reproductive cloning. It's a pretty radical claim 
since America has never before had a Federal reproductive 
police. However, virtually every lawyer on both sides of this 
debate agrees that the FDA has no such authority under current 
law. I would be happy to tell you why during the question 
period.
    Should Congress pass a new law giving the FDA control over 
reproductive cloning? If you do, what message would you be 
sending, that reproductive cloning is perfectly acceptable once 
it is safe or that chopping up human embryos for stem cell 
research, what many Members of Congress call cloned then 
killed, is acceptable while cloned then loved is not. Either 
way, Congress cannot delegate to the FDA powers that Congress 
does not have, like the power to control the reproduction of 
American citizens.
    Finally, there is nobody in the world who cares more about 
having normal, healthy children than infertile patients and 
their doctors. Safety is what everyone wants above everything 
else and that is precisely why infertile people are 
overwhelmingly pro-choice on cloning. Cloning will happen very 
soon. It will either be done legally in fertility clinics that 
are already licensed and regulated by the states or it will be 
done in illegal underground clinics, similar to the old back 
alley abortion clinics of the 1960's. If the Federal Government 
denies infertility patients, all options except underground 
clinics, the most likely result will be thousands of dead and 
deformed children.
    Mr. Chairman, the infertile population does not want the 
government to protect them from their own doctors. They want to 
be left alone to make their own private, reproductive, medical 
and family decisions free from government interference, just 
like healthy people do.
    Thank you. I would ask that the article that I attached to 
my testimony which is much more detailed outlining what I just 
said be included in the record.
    Mr. Greenwood. Without objection, it will be.
    [The prepared statement of Mark D. Eibert follows:]

                  PREPARED STATEMENT OF MARK D. EIBERT

    Mr. Chairman, I am a patient advocate. I speak for a group that is 
otherwise not represented at this hearing--the infertile population.
    Infertility affects about 12 million adult Americans. Medically, 
infertility is classified as a disease. Legally, the Supreme Court has 
declared it a disability under the Americans with Disabilities Act.
    And psychologically, infertility is a devastating condition. It 
interferes with one of the most powerful biological drives every human 
has. Being diagnosed as incurably infertile is like having all your 
children die, and all your grandchildren too.
    Unfortunately, current reproductive medicine can only help less 
than half of infertility patients to have biologically related 
children. Among the millions they cannot help are the many patients who 
cannot produce viable eggs or viable sperm. For many such Americans, 
cloning will soon provide the only way possible to have their own 
biological children.
    Many people want to outlaw cloning as a treatment for infertility. 
But the Constitution won't allow that. The Supreme Court has ruled many 
times that every American has a constitutional right to have biological 
children, and to make all kinds of reproductive decisions without 
government interference. As the Supreme Court has said, ``if the 
[constitutional] right of privacy means anything, it is the right of 
the individual . . . to be free from unwarranted governmental intrusion 
into matters so fundamentally affecting a person as the decision 
whether to bear or beget a child.'' 1
---------------------------------------------------------------------------
    \1\ Eisenstadt v. Baird, 405 U.S. 438 (1971).
---------------------------------------------------------------------------
    Some people argue, ``oh, that only applies to sex. Disabled people 
who need medical help to have children don't have the same right to 
reproductive freedom as healthy people.'' But that's not true. Federal 
courts have struck down state laws that tried to restrict IVF and 
similar reproductive technologies as violations of the constitutional 
right to have children.2 It is not the means of reproduction 
that is constitutionally protected, it is the end--the right to have 
children and families. That's what the opponents of cloning are trying 
to deny to disabled Americans.
---------------------------------------------------------------------------
    \2\ As one federal court put it, ``within the cluster of 
constitutionally protected choices that includes the right to . . . 
contraceptives, there must be included . . . the right to submit to a 
medical procedure that may bring about, rather than prevent, 
pregnancy.'' Lifchez v. Hartigan, 735 F.Supp. 1361 (N.D. Ill.), 
affirmed, 914 F.2D 260 (7TH Cir. 1990), cert. denied, 111 S.Ct. 787 
(1991).
---------------------------------------------------------------------------
    Other cases prohibit discriminatory laws that deny reproductive 
freedom to some people but not others. For example, Oklahoma once had a 
law that required the sterilization of convicted criminals, as part of 
a broader eugenics program designed to prevent the birth of seriously 
defective children. But the Supreme Court struck that law down, 
declaring that the right to ``have offspring'' was a fundamental 
constitutional right.3 This case means that anyone who 
attempts to ban cloning will have to explain to the courts why 
infertile people should have less of a right to have children and 
families than convicted criminals do. For infertile people who can't 
have biological children any other way, anti-cloning laws are the 
practical equivalent of forced sterilization.
---------------------------------------------------------------------------
    \3\ Skinner v. Oklahoma, 316 U.S. 535 (1942).
---------------------------------------------------------------------------
    In short, the federal government simply does not have the 
constitutional authority to decide which Americans can and cannot have 
children, or which children are likely to be ``perfect'' enough to be 
born.
    Today the FDA claims to have statutory authority to regulate 
reproductive cloning--a pretty radical claim, since America has never 
before had a Federal Reproductive Police. However, virtually every 
lawyer on both sides of this debate agrees that the FDA has no such 
authority under current law. I would be happy to tell you why during 
the question period.
    Should Congress pass a new law giving the FDA control over 
reproductive cloning? If you do, what message would you be sending? 
That reproductive cloning is perfectly acceptable once it is safe? Or 
that chopping up human embryos for stem cell research--what many 
members of Congress call ``clone then kill''--is acceptable, while 
``clone then love'' is not? But either way, Congress cannot delegate to 
the FDA powers that Congress itself does not have--like the power to 
control reproduction.
    Finally, there is nobody in the world who cares more about having 
normal, healthy children than infertile patients and their doctors. 
Safety is what everyone wants above everything else. That is why 
infertile people are pro-choice on cloning. Cloning will happen very 
soon. It will either be done legally in fertility clinics that are 
already licensed and regulated by the states, or it will be done in 
illegal underground clinics, like the old back alley abortion clinics. 
If the federal government denies patients all options except 
underground clinics, the result will be thousands of dead and deformed 
children.
    Mr. Chairman, the infertile population does not want the government 
to ``protect'' them from their own doctors. They want to be left alone 
to make their own private reproductive, medical and family decisions 
free from government interference, just like healthy people do.
    Thank you. I would be happy to take your questions.
    Human Cloning: Myths, Medical Benefits and Constitutional Rights
    This article is adapted from a speech and multimedia presentation 
on cloning given by Mark D. Eibert, Esq., at the annual joint meeting 
of the San Bernardino County Medical Society, the Riverside County 
Medical Society, and the San Bernardino County Bar Association, on 
September 23, 1999. It is being reprinted by the permission of the 
author, who retains all right in it. Copyright 1999 by Mark D. Eibert.
    Tonight I'm going to discuss three topics. The first is what 
cloning is, how it's done, what is going on in cloning today, and most 
importantly, what cloning is not. The second is the potential medical 
benefits of cloning, especially in the treatment of infertility and the 
prevention of genetic diseases and defects. My third topic is the 
current state of the law on cloning, and what constitutional questions 
those laws raise, especially with respect to reproductive and 
scientific freedom.
    What Cloning Is And How It Is Done.
    Cloning is a method of producing a baby--whether animal or human--
that has almost the same genetic makeup as its parent. In very simple 
terms, it works like this.
    You take an egg, and remove the nucleus, thereby removing nearly 
all of the egg's DNA or genes. You throw that nucleus away, because you 
don't need it any more.
    Then, you take a nucleus from a cell belonging to the adult parent. 
(Ian Wilmut used a mammary cell--that's why he named his sheep 
``Dolly'' after Dolly Parton.)
    You insert this cell nucleus into the egg, either by fusing the 
adult cell with the enucleated egg, or by a more sophisticated nuclear 
transfer.
    You then stimulate the reconstructed egg, either electrically or 
chemically, to trick it into behaving like a fertilized egg--into 
dividing and becoming an embryo. The embryo is then cultured, and when 
it reaches the appropriate stage, you transfer it to the uterus of a 
surrogate mother. There it follows the usual course of any embryo. It 
becomes a fetus, gestates for the usual time, and is then born in the 
usual way, looking and acting just like any other newborn of its 
species. That's how Dolly the sheep was created.
    Today Dolly is a normal, healthy sheep, who has had four lambs of 
her own, one single lamb followed by a set of triplets, all the result 
of ordinary sexual reproduction.
    Now you may have heard that Dolly was born already the age of the 
sheep that she was cloned from--which is six years old. This assertion 
is based on an experiment that attempted to measure Dolly's 
``telomeres''--structures within cells that become shorter with each 
cell division. But that experiment has been widely criticized for 
technical reasons (it seems that the telomere measurements were within 
both the margin of error of the study and the normal variation for 
sheep), and also because on the same day that Ian Wilmut announced the 
``telomere problem,'' the company he works for announced that it had 
found the solution to the problem--a substance called telomerase.
    There is a more fundamental reason not to worry about Dolly's 
telomeres. If Dolly were really born 6 years old, then she was 9 years 
old when she had her triplets. Since virtually all Poll Dorset sheep 
are dead by the age of 9, that would make her the ``fertile 
octogenarian'' of sheep. I don't think so. Not only does Dolly show no 
signs of premature aging, she is doing things--like having triplets--
that would be impossible if she were prematurely aged. The truth is 
that Dolly is a healthy young sheep.
    Now, I hate to start with badly outdated science, but before I tell 
you where cloning is today I need to dispel one of the great cloning 
myths. People seem to almost universally believe that because it took 
``277 tries'' to make Dolly, that means there were 276 miscarriages or 
deformed or dead lambs along the road to Dolly. The Washington Post 
reported exactly that shortly after Dolly was born, and we've been 
reading it in the newspapers ever since. But that's not true. What 
really happened is this:
    Dr. Wilmut started with 277 reconstructed eggs--eggs that had their 
nucleus removed and were then fused with an adult cell. That's what the 
number 277 refers to.
    The eggs were then cultured in sheep oviducts, and of the 277, only 
29 divided and became embryos. All 29 embryos were transferred to the 
uteruses of 13 sheep--some got one, some got two, and some got three.
    When Wilmut later performed an ultrasound, he learned that only one 
of the 13 sheep had become pregnant. That pregnancy proceeded normally 
and produced Dolly. There were no dead or deformed lambs, no 
miscarriages, and no discarded embryos in this particular experiment.
    More importantly, let's put this in perspective--the perspective of 
fertility treatments involving in vitro fertilization (IVF).
    IVF doctors and the federal government measure the sucess rate of 
IVF clinics by the ratio of live births to uterine transfers. IVF with 
humans began in 1978, but it wasn't until 1990, after 12 years of 
worldwide human clinical practice, that the average success rate for 
IVF in humans got to be as good as one live birth out of 13 uterine 
transfers the Dolly success rate. (Today the average IVF success rate 
is about one out of four, but it took 20 years of human clinical 
practice and research to get it there).
    And in the year Dolly was conceived, 1995, the largest IVF clinic 
in my area, the San Francisco Bay Area, was creating thirty human 
embryos for every one that made it to the delivery room, compared with 
29 for the Dolly experiment.
    The only part of the Dolly experiment that was out of line with IVF 
success rates of either today or the recent past was the large number 
of eggs it took. It was very inefficient.
Where Cloning Technology Is Today (September 1999).
    But the second cloning experiment to be reported in a peer review 
journal, the cloning of 50 mice in Hawaii, had an efficiency rate 
(measured by number of eggs per live birth) that was ten times higher 
than the Dolly experiment.
    The third published adult cell cloning experiment, using cows in 
Japan, was seventeen times more efficient than the Dolly experiment in 
terms of the number of eggs needed to get each live birth. Furthermore, 
if you go back to the measurement of success that IVF clinics use--live 
births per uterine transfer--the Japanese transferred two embryos into 
each of 5 cows and ended up with 8 calves--all five cows gave birth to 
at least one calf, which is better than any IVF clinic in the world can 
do today.
    And cloning has continued with a variety of other species, like 
goats and pigs. There are now literally hundreds of animals in the 
world who were conceived through adult cell cloning.
    Most importantly, scientists are already using cloning technology 
to create cloned human embryos. The first cloned human embryo was 
created by a pair of IVF doctors at a fertility clinic in South Korea. 
They used the egg and body cells of an infertile woman patient. 
Unfortunately, they only allowed the embryo to reach the two-cell stage 
before stopping the experiment.
    In addition, a biotechnology company on the East Coast is currently 
mass producing cloned human embryos for medical research on stem cells. 
According to BBC-TV, they are producing them in batches of 600 at a 
time. They use cow eggs to hold the human DNA, but the cloned embryos 
they produce are quite human.
    I'm not saying that cloning is sufficiently developed and safe 
enough for human clinical use right now. It probably isn't--not just 
yet. Nor do I advocate trying it before there is evidence of reasonable 
safety from animal studies.
    What I am saying is that cloning is not nearly as dangerous as the 
press makes it out to be--in fact, when compared with early IVF success 
rates, the current success rates with cloning look very promising 
indeed. I'm also saying that the process is improving very rapidly. And 
most of the scientists involved in cloning research that I talk to 
report that their success rates are steadily increasing, and that 
they're optimistic that improvements in efficiency and safety will 
continue with more research, just as you would expect with any new 
treatment--just as occurred with IVF and heart transplants, for 
example.
    In other words, if ``safety'' is your main argument against 
cloning, you'd better have a backup, because if the current trend of 
research continues, that may not be an issue for very much longer.
What Cloning Is Not--The ``Xerox Copy'' Myth.
    If you've been watching television and movies and reading popular 
fiction for the last 30 years, you've learned a lot about cloning. 
Unfortunately, almost everything you learned about cloning was 
scientifically false.
    For example, in ``The Boys From Brazil,'' starring Gregory Peck as 
the evil cloning expert Dr. Joseph Mengele, you learned--or thought you 
learned--that cloning could be used to ``replicate'' Adolph Hitler, and 
the Third Reich along with him--unless the good guys could stop him in 
time. They did stop him, but it was a real cliffhanger.
    In less serious movies like ``Multiplicity'' with Michael Keaton, 
you learned--or thought you learned--that ``clones'' would be ``xerox 
copies'' of the original person, born fully grown and with all the 
memories and feelings of the original--but if you copied one too many 
times, it was like making a xerox of a xerox of a xerox, and you might 
end up with a fuzzy copy, like Michael Keaton number four, the 
gibbering idiot.
    But the problem with these and other cloning fiction is that the 
whole idea of cloning as copying or replicating people is just plain 
false. Even the National Bioethics Advisory Commission, which is no 
friend of cloning, admits that the vision of cloning portrayed by 
popular fiction is ``based on gross misunderstandings of human biology 
and psychology.'' Let me explain some of the reasons why.
    Yes, children conceived with the aid of cloning technology will be 
genetic twins--or almost genetic twins--of the person who is the cell 
donor. But we already have 1.5 million genetic twins walking around the 
United States. We call them ``identical twins'' but it would be just as 
accurate to call them naturally occuring clones.
    We know a lot about these natural clones. An entire branch of 
academia is devoted to the study of identical twins. There is a ``Twin 
Studies'' department at Cal State Fullerton, another at the University 
of Minnesota. Physicians, psychologists, sociologists, people who study 
family relationships, all just love to study twins. And the one thing 
we know for sure after decades of research is that so-called identical 
twins are not identical.
    Physically, twins have different fingerprints and different organic 
brain structures, among many other examples.
    Intellectually, twins have different IQ's--a recent analysis of 212 
separate studies of twins concluded that genes are only responsible for 
about 48% of a person's IQ.
    And of course, twins have different personalities. If you have ever 
known ``identical'' twins you that each member of the pair is a 
separate and different person. That's why the law and society and 
everyone who knows twins treat them as unique individuals.
    And children conceived with the aid of cloning technology will be 
even more different from their genetic parents than natural twins are.
    Most of their genes will come from the adult cell donor. However, a 
small percentage of the child's genes will come from the mitochondria 
of the egg donated for the procedure. This mitochondrial DNA primarily 
affects how cells process energy. Thus, the child will have almost--but 
not quite--the same genes as the adult cell donor.
    The child will grow in a different uterus. Uterine environment has 
an enormous impact on many different aspects of fetal development. 
That's why doctors tell you not to smoke and drink during pregnancy, 
for example.
    Most importantly, these children will be born into different 
families, have different parents and siblings, go to different schools, 
have different friends, have different experiences from the day they 
are born, be raised in a diffferent culture--surfing the web rather 
than watching ``Leave it to Beaver'' after school, for example. The 
nurture part of the nature versus nurture equation will be completely 
different.
    But even that's not all.
    I have a beautiful calico cat named Tribble. What if I used cloning 
technology to give Tribble kittens--what would they look like?
    Interestingly, they would not look like Tribble. Like all calicos, 
Tribble has patches and splotches of different colored fur--black, 
orange and white. If I cloned Tribble, the kitten would also have 
patches of different colored fur--but they wouldn't be the same size or 
shape or location as they are on Tribble. Where Tribble has a mostly 
black back with a few patches of orange fur, her cloned kitten might 
have a mostly orange back with patches of black. Instead of a face that 
was half black and half orange, like Tribble, the cloned kitten's face 
might be all one color. And so on.
    The reason for that is a phenomenon known as ``random inactivation 
of the X chromosome.''
    Chromosomes are structures that carry genes. The X chromosome of a 
cat, for example, has about 5,000 genes on it. Male mammals--humans and 
tomcats--have one X chromosome and one Y chromosome. Female humans and 
cats have two X chromosomes--they inherited one from their mother and 
the other from their father, so the genes on the two X chromosomes are 
all different.
    What happens when you have two sets of blueprints for the same 
5,000 genetic traits in the same mammal? Which one gets used? Well, 
nature decides in a very fair way. Randomly. In every cell in Tribble's 
body, one of the two X chromosomes is switched off. And which of the 
two is switched off--the one from mom or the one from dad--is 
completely random.
    What genes are on the X chromosome? Well in cats, the genes that 
determine fur color are among those located on the X chromosome. The 
reason that the patches and splotches of color on a calico's coat look 
random is because they are random, thanks to random inactivation of the 
X chromosome. In other words, you can make a million clones of Tribble, 
and not one of them will look exactly like Tribble, or exactly like any 
of the other Tribble clones. Although it wouldn't be as visual and 
dramatic, the same principle would apply to humans.
    A related concept, called gene expression, would also apply equally 
to male and female ``clones.'' Basically, two identical twins could 
have the same gene, but they might express that genetic trait 
differently--or one might not express it at all. That's because whether 
and how a specific genetic trait or characteristic is expressed depends 
on very complex interactions both among genes and between genes and the 
environment. People who have all the same genes can and do turn out 
differently, even with respect to genetic traits.
    In other words, every ``clone'' is different.
    My final example is Chang and Eng Bunker. They were the original 
``Siamese Twins,'' what we now call conjoined twins. They were joined 
at the chest, and they shared one liver between them.
    Chang and Eng were identical twins, with identical nuclear and 
mitochondrial DNA. They grew in the same uterine environment. They were 
born at the same moment. They had the same parents and family. And from 
the moment they were born, they had as close to the same experiences--
as close to the same nurture in the nature versus nurture sense--as any 
two humans could possibly have. When they got married, they even 
married sisters.
    In spite of all that, Chang and Eng turned out to have radically 
different personalities.
    Chang was an alcoholic, a moody introvert who hated people and was 
verbally and physically abusive.
    Eng was a lifelong teetotaler, an extrovert who loved parties and 
children and was generally liked by everyone who knew him--everyone who 
could stand being around Chang long enough to get to know him.
    But enough examples. The point I'm trying to make is this: anybody 
who thinks their child conceived through cloning technology is going to 
be a little copy of himself is going to be hugely disappointed. You 
can't copy or replicate a human. That is scientifically impossible, 
even with cloning.
    The truth is this: children conceived with the aid of cloning 
technology will be ordinary children who will grow up to be unique 
individuals, just like everyone else.
    Once you understand that scientific fact, over 90 percent of the 
arguments--including most of the ``ethical'' arguments--against human 
cloning evaporate like fog when the sun comes up.
    Of course you can't replicate Hitler, or an army of Arnold 
Schwartzeneger soldiers, or a factory full of compliant zombie workers. 
Cloning by itself has no more potential to do those things than IVF 
does.
    Nor are the children going to be burdened or restricted by how they 
were conceived. These children will not be freaks leading second-hand 
lives; they will be unique individuals who have as much of an open 
future as anyone does. And there is no scientifically valid reason for 
these children to think of themselves as mere copies, or to be treated 
like copies by anyone else, or to be psychologically harmed by such an 
absurd thought.
Medical Uses Of Cloning.
    Now we're ready to answer the next question: who in their right 
mind would want to be ``cloned''?
    Now that you understand that cloning has nothing to do with copying 
people, you can eliminate dictators, narcissists, megalomaniacs, 
ruthless employers, people who want to bring Hitler or Christ or Elvis 
back to life, and so on. There's nothing in cloning for them. People 
like that will find cloning totally useless.
    The only thing cloning is really good for is building families, 
families composed of genetically related but unique individuals--a lot 
like the families we have now.
    And the largest group of people who would be interested in that, 
once the technology is reasonably safe, is infertile people. About 10 
to 15 percent of the population is infertile--physically unable to have 
children.
    Medically, infertility is classified as a disease, according to the 
American Society for Reproductive Medicine and the American College of 
Obstetricians and Gynecologists.
    Legally, infertility is a disability--the kind that entitles people 
to protection from discrimination under the Americans with Disabilities 
Act. That's based on both a recent U.S. Supreme Court case called 
Bragdon v. Abbott and on a recent decision of the EEOC in New York.
    Psychologically, infertility is a devastating condition. It 
frustrates a basic and very powerful biological drive, one that is an 
intimate part of the will to survive. One analogy that you hear over 
and over again from infertile people is that learning that you are 
incurably infertile is not like having your child die. It's like having 
all your children die, and all your grandchildren as well. Infertile 
people are so motivated to find a cure that many of them spend year 
after year undergoing painful and expensive treatments that are not 
covered by health insurance and that, for many of them, have a very low 
chance of success.
    Now everybody knows that in vitro fertilization (IVF) is one way 
that infertility is treated. The first so-called ``test tube baby,'' 
Louise Brown, was born in 1978. She's a college student now.
    But IVF doesn't work for everyone. For a 21 year old woman who's 
infertile because of blocked fallopian tubes, IVF will probably be a 
miracle cure. But for a woman who can't produce viable eggs or a man 
who can't produce viable sperm, IVF isn't much help. To get a good 
embryo out of the dish, you have to put good ingredients into the dish. 
There are literally millions of women who can't produce viable eggs no 
matter how big a dose of fertility drugs you give them--that's why 
they're infertile.
    What makes cloning so revolutionary as an infertility treatment is 
that it does not require the patient to produce viable eggs or viable 
sperm. If they can spare a few cells scraped from the inside of their 
cheek, they can have genetically related children.
    Now for a little historical footnote: twenty years ago, when the 
idea of IVF was first being discussed, most people had a strong 
visceral reaction against the idea of ``manufacturing babies in test 
tubes.'' At first they thought it was weird and disgusting and it 
reminded them of ``Frankenstein.'' And there was a debate about whether 
so-called ``test-tube babies'' should be outlawed.
    All the same arguments now used against cloning were used against 
IVF. IVF would be ``unsafe,'' the babies would be born deformed or with 
birth defects, they would be psychologically harmed when they found out 
that they were only ``test-tube babies'' rather than ``real'' babies, 
family structures and relationships would be radically altered, and so 
on. Part of the reason the arguments were the same is that the people 
making them were the same--some of the current leaders of the anti-
cloning movement were also leaders of the movement to outlaw IVF 20 
years ago. And before Louise Brown was born, 85 percent of the American 
public agreed with them and thought that IVF should be outlawed, which 
is about the same percentage that think cloning should be outlawed 
today. If you know your history, this cloning debate is just what Yogi 
Berra called ``deja vu all over again.''
    But then along came Louise Brown, the world's first ``test-tube 
baby,'' whose face graced the front pages of almost every newspaper in 
the world for awhile. People looked at those pictures and said ``that 
just looks like an ordinary baby, ten fingers, ten toes, mom is 
grinning from ear to ear--what's so terrible about that?'' And the 
movement to outlaw IVF faded away.
    Today it's 21 years later. The public has forgotten its horror and 
now accepts IVF, which so far has brought children, families and 
happiness to over 150,000 disabled couples. And we now know that all 
the arguments against IVF were wrong. The same thing will happen with 
cloning. And it will happen a lot sooner than most people expect.
    The second biggest group of people who will be interested in the 
use of cloning to create children is people who know, from family 
history or genetic testing or counseling, that they have a high risk of 
producing children with serious genetic diseases or defects.
    As explained by Dr. Lee Silver in his excellent book ``Remaking 
Eden: Cloning and Beyond in a Brave New World'', the vast majority of 
genetic diseases and defects are caused one of two ways. The first is 
errors that occur during meiosis, which is part of the process of 
sexual reproduction. These types of errors cause problems like Down 
Syndrome.
    The second major way to get a serious genetic disease is by 
inheriting it from a parent who is a carrier. That's how children get 
born with such serious and often lethal conditions as Tay Sachs 
disease, sickle cell anemia, cystic fibrosis, hemophilia, and so on--
there's a long list of horribles.
    Cloning should make all of these kinds of diseases and defects 
extremely rare, if not impossible. There is no reduction of genetic 
material in cloning, so there is no opportunity for the kinds of errors 
that cause Down Syndrome to occur.
    And a child conceived with the aid of cloning technology shouldn't 
get a genetic disease that his genetic parent didn't have--if the 
parent is a carrier the child will be a carrier too, but he typically 
won't actually get the disease.
    For a lot of people who are at risk of having seriously ill or 
defective children, cloning technology may soon be a safer way to have 
children, and a more certain way of having normal, healthy children, 
than sex is.
    So-called ``reproductive cloning'' isn't the only medical use of 
the technology. There are also some exciting and important medical uses 
that don't require the production of whole human beings.
    For example, cloning could be used to create embryonic stem cells, 
which could be used to make tissues, and perhaps even organs, for 
transplant. Not only would this relieve the serious shortage of tissues 
and organs for transplant, but if you use cells from the patient who 
needs the tissue or organ, you could virtually eliminate the danger 
that the patient's body would reject it. Examples would include 
creating bone marrow for transplants for leukemia victims, islet cells 
to return to the pancreas of a diabetic, heart or liver tissue to 
repair the damage caused by heart attacks or hepatitis, healthy skin 
for grafts to burn victims, and so on.
    Cloning can also be used to create animals that excrete therapeutic 
human proteins, like insulin, in their milk. You do this by inserting 
selected human genes into animal embryos during the process of cloning, 
thereby turning cows into walking drug factories providing an endless 
supply of cheap and plentiful human medicines. This is already being 
done.
    Cloning may even help to find a cure for cancer by teaching us how 
to reprogram cells. Cancer cells grow uncontrollably; perhaps they 
could be reprogrammed.
    These are just a few examples of the many exciting medical 
breakthroughs that should be possible with cloning technology.
Cloning and the Constitution--The State of the Law.
    Now let's talk about law. What is the current state of the law 
about human cloning?
    First of all, by Executive Order signed by President Clinton, you 
can't use federal funds for human cloning research. But since there's 
already a ban on the use of federal funds for embryo research, that 
doesn't add very much--it was a purely political gesture.
    Beyond that, human cloning is currently illegal in three--and only 
three--states.
    California is one of the three, with a moratorium on using cloning 
to create a child that automatically expires after five years (about 3 
years from now). In the meantime, the penalty for using cloning to 
create a child in California is a fine of up to $1 million for an 
organization and $250,000 for an individual--it's not at all clear that 
the fine wouldn't apply to the patient as well as the doctors 
involved--and the doctor could lose his medical license. Rhode island 
has a similar law, also with a five year sunset clause. Michigan has an 
even more radical law, which permanently outlaws not just the 
conception of children, but also the creation of cloned embryos for 
laboratory research on, say, curing diseases. The penalty is up to 10 
years in prison, and that applies whether you are a laboratory 
researcher trying to cure cancer, a doctor helping an infertile 
patient, or an infertile woman who uses cloning to have children.
    Human cloning is legal in the other 47 states. It's also legal in 
most countries, Western Europe being the major exception.
    And there is no federal law on cloning. Last year, Congress debated 
various anti-cloning bills, but they got bogged down in a debate over 
abortion and couldn't agree on a law. The Republicans wanted a 
Michigan-style law forbidding the creation of all cloned human embryos. 
The Democrats filibustered that because it would end almost all cloning 
research and prevent the technology from being used for all the 
important non-reproductive medical purposes I mentioned. They proposed 
a law more like California's, but the Republicans wouldn't go along 
with it because they thought it was the moral equivalent of abortion--
``clone then kill'' they called it. Of course, both sides wanted to 
outlaw ``clone then love,'' but because they couldn't agree on the 
``clone then kill'' issue they fought themselves to a standstill and no 
law got passed. And now it seems very unlikely that they will be able 
to agree on a federal law anytime in the forseeable future.
    The last piece to the legal puzzle is kind of confusing. When it 
became clear that Congress couldn't agree on a law, the Food and Drug 
Administration announced that it had authority to regulate cloning. Not 
to ban it exactly, but to make researchers go through a lot of hoops to 
prove to the FDA that cloning is safe and effective before they use it 
on patients.
    What's confusing is that nothing in the Food, Drug and Cosmetics 
Act or any other piece of relevant legislation gives the FDA 
jurisdiction over cloning or anything that could even arguably include 
cloning. As most doctors know, the FDA has no authority to regulate the 
practice of medicine, and as one of the most vehemently anti-cloning 
members of Congress (Rep. Ron Ehlers) put it, ``it's hard to argue that 
a cloning procedure is a drug.'' Moreover, the FDA has for years 
totally ignored reproductive medicine, including procedures like ICSI 
and cytoplasm transfer that have a lot in common with cloning.
    So far, I have yet to find a lawyer on either side of this debate 
who thinks the FDA really has statutory authority to regulate cloning, 
and when I called the FDA myself to find out what statute they were 
relying on, even they couldn't tell me.
    So that's the state of the law. Human cloning is legal in 47 out of 
50 states, and in about 175 of 200 countries, and the FDA may or may 
not be able to enforce safety and efficacy standards. The courts will 
have to decide that.
Constitutional Rights: Reproductive Freedom.
    What I personally find most interesting about this topic is the 
profound questions raised by anti-cloning laws.
    Can the state really ban cloning? I'm going to suggest that under 
current constitutional principles, it probably cannot.
    Let's start with a few highlights of the legal arguments of 
infertile people for whom cloning technology, once it's reasonably 
safe, will be the only way possible to have biologically related 
children and families.
    Reproductive freedom means a lot more than just the right to an 
abortion. The Supreme Court has said many times that every American has 
a constitutional right to have children, and to make all sorts of 
reproductive decisions without government interference. That right 
stems from the constitutional right to privacy, because reproductive 
decisions are some of the most private and personal and life-changing 
decisions an individual can make.
    The statement that is quoted over and over again in cases 
discussing reproductive freedom comes originally from a Supreme Court 
case about the right to contraception, Eisenstadt v. Baird. There the 
Supreme Court said 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.''
    Now, some people argue, ``that only applies to sex. People who need 
high-tech medical help to have children don't have the same right to 
reproductive freedom that healthy people do.'' Well there isn't a lot 
of case law on that yet, but what there is says just the opposite.
    In 1990, for example, the state of Illinois tried to outlaw a 
variety of reproductive technologies and tests, some of which were 
related to IVF and could be used to treat infertility. In a decision 
that was later affirmed on appeal, a federal district court struck down 
that law, explaining that ``[i]t take no great leap of logic to see 
that within the cluster of constitutionally protected choices that 
includes the right to have access to contraceptives, there must be 
included within that cluster the right to submit to a medical procedure 
that may bring about, rather than prevent, pregnancy.''
    So it looks like you have a constitutional right to high-tech baby-
making too, at least if you're infertile. And notice the progression. 
In 1978, 85 percent of the American people thought ``test-tube babies'' 
were terrible and ought to be outlawed. Just 12 years later, in 1990, 
courts were starting to rule that IVF was a constitutional right. But 
the right to privacy isn't the only constitutional principle that 
protects people from government interference with their reproductive 
decisions. There's also equal protection--the principle that you can't 
deny basic rights to some people and not to others without a very good 
reason.
    In 1942, for example, the state of Oklahoma had a law requiring the 
sterilization of convicted criminals. It was a eugenics law, based on 
the idea that criminal tendencies could be passed down genetically to 
children.
    The Supreme Court analyzed the case under the equal protection 
clause of the Fourteenth Amendment, and unanimously ruled that 
``procreation involves one of the fundamental rights of man'' and that 
even a convicted criminal who is sterilized ``is forever deprived of a 
basic liberty.''
    Because the Oklahoma law affected a fundamental constitutional 
right--which the Supreme Court described as the ``right to have 
offspring''--the court applied what is known as ``strict scrutiny.'' 
That means that the Supreme Court placed the burden of proof on 
Oklahoma to justify its discriminatory law. And strict scrutiny is the 
highest and toughest burden of proof there is. The state couldn't carry 
that burden, so the Supreme Court struck the law down. There are a 
number of other more recent cases that reaffirm that having children is 
a fundamental right and that laws that interfere with that right are 
subject to strict scrutiny.
    This is my favorite reproductive freedom case because it means that 
sometime soon--certainly before the current anti-cloning law sunsets--
lawyers for the state of California will have to explain to a court, 
under a strict scrutiny standard, why legally disabled citizens should 
have less of a right to have children and families than convicted 
rapists and child molesters do.
    Now it's time for a second historical footnote, a legal one this 
time.
    The case I just told you about struck down a state ``eugenics 
law.'' Oklahoma was just one of 36 American states that passed eugenics 
laws in the early part of this century. Those laws required the 
sterilization of people who were thought likely to produce seriously 
defective children. People with leprosy and other dread diseases, 
mentally retarded people, mentally ill people, habitual criminals and 
others were sterilized, mostly because the best science of their day 
said that such people would probably produce children with the same 
defects.
    Supporters of eugenics laws argued that they were necessary to 
protect the safety and welfare of children. It was said to be in the 
best interests of children who might be born with defects that they 
never be born at all. It wasn't until the Vietnam war that our military 
came up with an accurate characterization of this brand of logic--it's 
called ``destroying the village in order to save it.''
    The most successful--if you want to call it that--state eugenics 
law was California's. During the early part of this century, our state 
government rendered more than 30,000 of its sick and disabled citizens 
unable to have children. So when the Nazis were drafting their own 
eugenics law, they modeled it in part on the eugenics law that came out 
of Sacramento.
    But during World War II, Americans got a graphic demonstration of 
what politicians could do when given the power to decide who was and 
was not ``perfect'' enough to be born, and attitudes about eugenics 
began to change. By the 1960s almost all of our state eugenics laws had 
either been repealed, struck down as unconstitutional, or fallen into 
disuse, and states got out of the business of regulating their 
citizens' reproduction.
    Until now. Two years ago, California passed the first anti-cloning 
law in the nation. Once again, the state of California has singled out 
a class of disabled Californians and forbidden them by law to have 
children. Once again, the state has defined a class of children that it 
says are so likely to be born ``imperfect'' that the state won't allow 
them to be born or to live at all. Once again, California has a 
reproductive police charged with stopping unauthorized breeding by 
California citizens. Once again, the politicians in Sacramento have a 
chance to play God. And once again California has a eugenics law.
    What our legislature has done is radical all right, but it's not 
unprecedented. We've been here before.
Scientific Freedom and the First Amendment.
    Reproductive freedom isn't the only constitutional value that anti-
cloning laws infringe on.
    For instance, there's a lot of Supreme Court dictum to suggest that 
scientific freedom might have some constitutional protection, and some 
lower courts and about a million legal scholars have said that 
scientific freedom does or should have constitutional protection. That 
protection is based on the First Amendment right to free speech. In 
science, it's not enough to argue for your theory, or to publish your 
theory. You and others--including those who disagree with you--have to 
be able to test your theory through experimentation. That's how science 
works and how it finds the truth.
    Now the Supreme Court hasn't directly addressed that question yet. 
But cloning may not be such a bad case to try to determine the extent 
of constitutional protection for science. After all, as one member of 
the National Bioethics Advisory Commission observed, anti-cloning laws 
like California's moratorium are the first time in American history 
that an entire field of medical research has been outlawed. That's a 
very radical thing to do. And in Michigan today, a scientist who clones 
cells in a dish to try to find a cure for cancer can get up to 10 years 
in prison--that's even more radical. In Michigan, the ACLU is 
considering challenging their anti-cloning law on both scientific 
freedom and reproductive freedom grounds, and perhaps we will get some 
new case law on scientific freedom as well.
The REAL Question.
    Now I want to conclude by telling you that I think there is only 
one question of lasting social significance that cloning presents to 
us. That question is this: Who Decides?
    Who should decide whether and how a particular individual can have 
children--the individual, or the government?
    Who should decide which classes of children are likely to be 
perfect enough, or happy enough, or socially desirable enough, or 
politically popular enough, to be born--the prospective parents or the 
politicians?
    Who should decide which treatment is medically best for a 
particular patient, the physician acting with the informed consent of 
his patient, or the bureaucrat? Aren't doctors regulated enough 
already? Do they really need to have the reproductive police looking 
over their shoulder along with everyone else?
    Who should decide how much risk is acceptable for a prospective 
mother and her unborn child, the mother, with the advice of her 
physician, or the legislature, making one risk-benefit calculation for 
all patients at all times, no matter what their personal medical 
condition is, no matter what their personal religious and moral beliefs 
may be, and no matter how the technology may have changed during the 
three or five years since the politicians last debated appropriate 
treatment protocols? You know, for 200 years American women have been 
free to make decisions that pose much greater risks to their unborn 
children than cloning possibly could.
    And who should decide what subjects scientists can investigate, or 
what truths the general public is ready for them to uncover--the 
scientist or the platform committees at political conventions?
    If the word ``copy'' is the scientific fallacy of the anti-cloning 
argument, the word ``we'' is the legal fallacy. The opponents of 
cloning are always wringing their hands and asking what should ``we'' 
do about cloning, and whether ``we'' should allow it. But ``we'' don't 
decide whether John and Mary Smith can have children, they do. That's a 
private decision, not a political one. And I don't think there is 
anything so horrible or horrifying about twins that would justify 
changing that.
    This question--``who decides''--is the real heart of the cloning 
debate. And the Constitution, supported by over 200 years of American 
tradition and culture, permits only one answer.

    Mr. Greenwood. Ms. Terry, you are recognized for 5 minutes.

                  STATEMENT OF SHARON F. TERRY

    Ms. Terry. Thank you, Mr. Chairman. I'm speaking on behalf 
of the Board of Directors of the Genetic Alliance and I've 
submitted written comment and I'll make a few comments here.
    The Genetic Alliance is the largest coalition, 
internationally, of lay advocacy groups and professional and 
genetics organizations worldwide. We work together to promote 
healthy lives for millions of individuals affected by common 
and rare genetic disorders. We work to establish safeguards to 
ensure the benefits of genetic technologies and to encourage 
debate and informed public policies and we're committed to the 
highest standards in this regard.
    I'll give you a little background about my involvement with 
the Genetic Alliance. My children with diagnosed with a genetic 
disorder about 5 years ago and my husband and I were devastated 
and went through all the things that parents typically do with 
such an incredible situation. They were diagnosed with 
something called pseudoxanthoma elasticum which is a disease 
which causes blindness and some gastrointestinal and 
cardiovascular difficulties. With no biological background at 
all, my husband and I were at a loss as what to do. I'm a 
former Roman Catholic nun and a teacher. We went to the Genetic 
Alliance to ask for help in setting up an advocacy organization 
and they helped mentor us to the point we are today.
    As a result of my work with them, they connected me with 
networks, they gave me lots of resources. I decided to join the 
Genetic Alliance and am now on the Board of Directors as Vice 
President for Consumers.
    The Genetic Alliance would like to request that all cloning 
of human beings be halted at this time and we have a couple of 
reasons for that. As we've eloquently today by scientists, 
medical, safety and efficacy issues are not resolved around 
human cloning and we really need to be sure of those issues 
before we look further at this issue.
    Right now we think that those outweigh any current 
potential benefits. These things do not come close to meeting 
the rigors of minimum human protection, safety and efficacy 
standards.
    In addition to just considering a ban, we would also 
recommend that we consider a large societal informed debate 
that would occur across many sectors of the population. We need 
to identify and understand these risks as a population and we 
have not had this debate as a society yet. We need to engage 
all stakeholders and as a society, we must discuss and debate 
the full range of the ethical, legal and social issues.
    The issue of cloning a human being touches upon the essence 
of what it means to be human and so it deserves serious 
consideration. Families and communities must be involved in the 
debate within the context of culture and faith.
    We must look at whether we are just propelled by 
justifiable societal needs or simply by new biomedical 
opportunities. Regardless of funding source, whether it's 
government or private, the spotlight should be on human 
subjects' protections.
    Science and technologies are outpacing the development of 
appropriate policies for decisionmaking. Genetic testing, 
medical privacy, genetic discrimination and others are some of 
the issues we face without having the right policies in place. 
So we call for an immediate halt to all effort to clone human 
beings and we look forward to being an active partner and a 
resource in the broad societal debate that we hope will ensue.
    Thank you.
    [The prepared statement of Sharon F. Terry follows:]

 PREPARED STATEMENT OF SHARON F. TERRY, VICE PRESIDENT FOR CONSUMERS, 
                            GENETIC ALLIANCE

    The Genetic Alliance, the largest coalition of genetics consumer 
and professional organizations worldwide, calls for an immediate halt 
to all efforts to clone human beings and recommends open and informed 
societal dialogue on this crucial issue.
    The Genetic Alliance provides a unified voice for millions of 
people living with common genetic disorders such as diabetes and breast 
cancer, as well as rare conditions such as cystic fibrosis and sickle 
cell anemia. Our families and communities look forward to the 
tremendous potential of biomedical research and technologies to improve 
health and well being. We know that cellular, tissue andorgan cloning 
holds significant promise for generating treatments and cures for 
common and rare diseases. We also underscore the fact that creating a 
living human being through cloning is very distinct to working with 
cells in culture to achieve new medical benefits. The Board of 
Directors of the Genetic Alliance maintains that efforts to clone human 
beings--in contrast to cellular, tissue and organ cloning--pose 
significant safety, medical, ethical, legal and social risks, far 
outweighing any current potential benefits.
    The Genetic Alliance expresses grave concerns about recently 
announced plans by several individuals to attempt to clone human 
beings. Based on recent scientific reports about the current status of 
mammalian cloning, we know that there are tremendous potential human 
safety risks for mother and child. The track record for mammalian 
cloning indicates that these medical risks are formidable and extreme, 
even dire. The fact is that current cloning techniques to produce a 
genetically identical human being do not come close to meeting the 
rigors of minimum human protection, safety, efficacy and medical 
standards.
    Moreover, societal dialogue is urgently needed to identify and 
understand the social, legal and ethical risks posed by the application 
of this technology. Rapidly emerging scientific research and 
technologies--such as human cloning--force us to examine the very 
essence of what it means to be human. The immensity of these issues 
demands that we halt all current efforts to clone human beings and 
engage all stakeholders in open and informed debate about the 
implications and impact of this technology.
    At every step in advancing technology, we must ask ourselves 
whether we are propelled by justifiable societal needs or simply by new 
biomedical opportunities. As a society, we must discuss and debate the 
full range of ethical, legal and social issues surrounding the cloning 
of human beings. It is critical that this broad-based dialogue engages 
families and communities within the context of culture and faith.
    Central to this dialogue is consideration of the role and 
responsibility of society in preventing harm to individuals and 
families. Debate about the cloning of human beings highlights a 
fundamental necessity that all research and clinical projects, 
regardless of funding source, come under the spotlight of human 
subjects regulatory protections. This is the only way to ensure, in a 
landscape of escalating biomedical technologies, the well being and 
safety of families and communities. In addition, protections must 
extend beyond current levels to encompass all research and clinical 
projects, regardless of whether the funding comes from the government 
or private sector. The discovery of a new technology should not 
automatically translate into availability of that technology without 
regard for public safety and well being.
    The Genetic Alliance recognizes that biomedical technologies are 
quickly outpacing the development of appropriate policies to inform the 
decision-making of researchers and the general public on many issues, 
including genetic testing, medical privacy, genetic discrimination and 
others. Grounded in the personal experiences of people already at the 
frontlines of technologies, the Genetic Alliance works to ensure the 
potential benefits of biomedical research, while promoting meaningful 
and informed public policies about the implications, impact and promise 
of these technologies. Our stance in calling for a halt to the cloning 
of human beings reflects the Genetic Alliance commitment to 
establishing the highest levels of medical, social, legal and ethical 
protections.
    In summary, the Board of Directors of the Genetic Alliance 
recommends that Congress take immediate action to halt all cloning of 
human beings. However, we must take care not to obstruct current 
cellular, tissue and organ cloning that may result in significant 
health improvements for our families and communities. Moreover, the 
Genetic Alliance urges Congress to call for immediate and broad-based 
societal dialogue about the implications and impact of cloning human 
beings.
    The Genetic Alliance looks forward to being an active partner and 
resource in the open, informed and broad-based debate that must guide 
public policy deliberations about the translation of biomedical 
technologies into mainstream medicine.

    Mr. Greenwood. Thank you very much for that testimony.
    Dr. Soules.

                 STATEMENT OF MICHAEL R. SOULES

    Mr. Soules. Mr. Chairman, thank you for the invitation to 
attend this committee hearing and to participate.
    Before I start, I'd like to request that my written 
testimony that I've submitted already, plus our society had an 
ethics committee report in November 2000 to be made part of the 
record.
    Mr. Greenwood. Without objection, they will be made part of 
the record.
    Mr. Soules. Thank you. My name is Dr. Michael Soules. I'm a 
physician. I think maybe among all the people testifying today, 
I'm the only practicing physician. I'm a Professor in the 
Department of Obstetrics and Gynecology at the University of 
Washington in Seattle and I'm also Reproductive Endocrinologist 
and Director of the Division of Reproductive Endocrinology in 
our Department.
    I'm here today because I'm President of the American 
Society for Reproductive Medicine. Our society is somewhat 
unique among professional medical societies in that we have a 
diverse membership. It's not only physicians and a number of 
different physicians, but it's also biologists who do the 
laboratory work like with IVF, there's nurses, there's mental 
health professionals, there's clinic managers and so on, so 
we're quite a strong organization and all the members are 
dedicated toward improving the practice of reproductive 
medicine.
    I have three basic points I wish to make in my testimony 
today. First, ASRM finds unacceptable any attempt at 
reproductive cloning of an existing or preexisting human being. 
At this time, we feel there is no clinical, scientific, 
therapeutic or moral justification for it. Put simply, this is 
a technology that's not ready for prime time.
    Second, we are satisfied that the Food and Drug 
Administration already has the legal authority to stop any such 
attempts and the FDA has made that clear to the reproductive 
medicine community. I realize that was a point of discussion a 
little while ago, but about 18 months ago I got a letter at the 
University of Washington from the FDA making it clear that I 
would need an IND to proceed. So therefore, we don't think 
there's need for new legislation on this matter at this time.
    My third point, I want to provide some information to help 
the committee understand the differences between reproductive 
cloning and sexual reproduction. I won't be redundant than 
what's been talked about, but where the differences seem at one 
level to be obvious, but the media reports and some of the 
testimony today, I suspect would confuse some people that were 
listening.
    The American Society of Reproductive Medicine has been on 
record as opposing attempts at human reproductive cloning since 
the announcement of the successful cloning of a sheet in 1997. 
We reiterated this stance in 1998 by leading the effort for a 
moratorium on human cloning by scientific groups. That 
moratorium has now been joined by nearly every reputable and 
relevant scientific organization of which we are aware.
    We have learned how to use cloning with microscopic 
organisms and any of us who do gardening or any work with 
plants would realize that not all cloning is bad, for instance, 
I come from Washington State and apple is the fruit of a cloned 
tree. But it appears that in larger more complicated animals, 
cloning can be made to work, but it is not yet reliable, 
efficient nor safe.
    As we've heard, cows and sheep have been cloned, but there 
have been many problems that while that's unfortunate in 
animals, it would be a disaster in humans. Until there are 
better results in animals, we have no business even considering 
it in human beings.
    Parenthetically, talking about different means to screen 
embryos and screen pregnancies, Dr. Zavos mentioned a number of 
methods that could be used to make it safe. Well, when I submit 
a grant to the NIH or a proposal to my IRB and I have a bunch 
of ideas like that, that's nice. But the first thing that a 
responsible committee at NIH would do would look at my 
preliminary data to see can I back it up, basically. And I 
would encourage Dr. Zavos, in fact, the ASRM of which Dr. Zavos 
is a member, we would encourage him to do this research and if 
he has background in animals, do the research in animals. There 
seemed to be a problem in the discussion sort of leaping from 
cows to humans. Well, there's an obvious animal model to use 
and that would be the nonhuman primate and so we would strongly 
encourage Dr. Zavos and we would be very disappointed at our 
society, our medical society would be very disappointed if Dr. 
Zavos would proceed with his work.
    I realize there have been calls for additional or more 
explicit legislative prohibitions on human cloning. We feel 
these would be unnecessary and potential harmful. We have seen 
in other countries and in some of the United States and even in 
Congress, proposed legislation which, if enacted, would 
endanger research, deny therapies and even hinder drug 
production in areas that have nothing whatsoever to do with 
cloning.
    The very first tenet of medicine, that's what I take and 
physicians take, the Hippocratic Oath when we graduate is 
first, do no harm. The Hippocratic Oath appears to apply in 
this legislative context as well. Additional legislation will 
not deter a rogue scientist from making ill-advised attempts at 
cloning outside of the United States jurisdiction. Therefore, 
ASRM supports current FDA policy and sees no need for new 
legislation. But I would go on to say if the committee and 
Congress felt that they needed to or it was wise in your 
opinion to proceed with legislation, to keep it narrow. The 
biotechnology representative that was here earlier, we would 
totally agree with his statement that if cloning research was 
allowed to continue, and if the law basically said that no 
embryos would be implanted and you can't grow an embryo beyond 
14 days basically even in the best labs and so if that embryo 
is not transferred, it's not going to become a life. And so I 
think that would be sort of a gatekeeper or an area to 
concentrate on it and our society would very--if Congress feels 
compelled to proceed with legislation, we would like to work 
with you in that regard.
    Mr. Greenwood. Dr. Soules, excuse me. We're going to have 
recess. This will be the last recess of the day, the last vote 
of the day and we'll reconvene in 10 minutes.
    [Brief recess.]
    Mr. Greenwood. The hearing will come to order. Dr. Soules, 
your time had expired, but you seemed to be in mid-sentence, I 
think, when I interrupted you. Did you have a final thought 
that you wanted to make?
    Mr. Soules. One paragraph?
    Mr. Greenwood. At most.
    Mr. Soules. I've got to find the best paragraph. I'd just 
like to make the point that, as I mentioned earlier, I take 
care of infertile patients every day. In fact, I have clinic 
tomorrow. But I employ a range of medical therapies, many of 
them quite complicated to help people to have children they 
desperately want. My colleagues and I are interested in helping 
our patients have children and start their families, but the 
main point infertile patients are desperate and they don't 
always make good decisions. That's what IRBs are for and that's 
what ethics committees are for. And I think anyone who 
justifies cloning based on they have a list of patients who 
want the procedure, have basically pandered to a vulnerable 
audience.
    Thank you.
    [The prepared statement of Michael R. Soules follows:]

 PREPARED STATEMENT OF MICHAEL R. SOULES, PRESIDENT, AMERICAN SOCIETY 
                       FOR REPRODUCTIVE MEDICINE

    Good afternoon Mr. Chairman and members of the committee. Thank you 
for holding this important hearing and for inviting us to participate.
    I am Dr. Michael R. Soules, Professor of Obstetrics and Gynecology, 
and Director of the Division of Reproductive Endocrinology and 
Infertility at the University of Washington in Seattle, Washington. 
Currently I am President of the American Society for Reproductive 
Medicine (ASRM). ASRM is a national professional organization whose 
nearly 9,000 members are dedicated to advancing knowledge and expertise 
in reproductive medicine and biology and treating infertility. Our 
membership is made up of physicians; (ob/gyns, reproductive 
endocrinologists, and urologists), reproductive biologists, laboratory 
directors, nurses and mental health professionals, all of who are 
dedicated to advancing the cause of reproductive medicine.
    I have 3 simple points I wish to make in my testimony today:
    First, that ASRM finds unacceptable any attempt at reproductive 
cloning of an existing human being. At this time, there is no clinical, 
scientific, therapeutic or moral justification for it. Put simply, this 
a technology that is not ready for prime time.
    Second, that we are satisfied that the Food and Drug Administration 
already has the legal authority to stop any such attempts, the FDA has 
made that clear to the reproductive medicine community. Therefore we do 
not think there is a need for new legislation, or new activity at the 
FDA, on this matter.
    Third, I want to provide some information to help the committee 
understand the differences between reproductive cloning and sexual 
reproduction. These differences are at one level obvious, but if one 
follows recent media reports, often misunderstood.

                            THE ASRM STANCE

    ASRM has been on record as opposing attempts at human cloning since 
the announcement of the successful cloning of a sheep in 1997. We 
reiterated this stance in 1998 by leading the effort for a moratorium 
on human cloning by scientific groups. That moratorium has now been 
joined by nearly every reputable and relevant scientific organization 
of which we are aware. We have also assisted policy makers in 
determining the best way to protect the public on this issue. We have 
participated in earlier Congressional hearings and worked on cloning 
legislation. In November of last year our ethics committee released a 
very thoughtful report on somatic cell nuclear transfer (cloning), 
again concluding that because the safety and efficacy of the procedure 
had not been established, it would be unethical at this time to attempt 
human cloning. This year, in response to media reports and other non-
scientific events, we again stated our view that attempts at cloning 
are unethical.
    Please note we are not making a judgment on the ultimate ethical 
validity of human cloning. It is possible that some form of cloning 
might, under some circumstances, be warranted. We simply have not yet 
made that determination within our professional society nor has the 
general public. More information and indeed more discussion are needed. 
We welcome those discussions, but at present we need not come to any 
conclusion. Until more is understood about cloning in animals, there is 
no ethical justification for attempting it in humans.
    We have learned how to use cloning with microscopic organisms and 
any of us who gardens know cloning works with many plants (e.g., 
apple). Some species of animals, such as frogs and mice can be cloned 
quite successfully. It appears that in larger, more complicated 
animals, cloning can be made to work, but it is not yet reliable. Cows 
and sheep have been cloned, but there have been many problems that, 
while unfortunate in animals, are completely unacceptable in human 
beings. Until there are better results in animals, we have no business 
even considering it in human beings.

                              FDA CONTROL

    Fortunately, the very lack of scientific evidence that the 
procedure is safe or effective (that leads us to conclude it is 
unethical to attempt human cloning), would allow the FDA to stop any 
attempt at human cloning. The FDA has said quite clearly that any 
attempt at human cloning would require a New Drug Application (NDA), 
and I feel certain that such an application would not be approved given 
the current scientific realities.
    I realize there have been calls for additional or more explicit 
legislative prohibitions on human cloning. We feel these would be 
unnecessary and potentially harmful.
    We have seen in other countries, in some of the states, and even in 
Congress proposed legislation which, if enacted, would endanger 
research, deny therapies and even hinder drug production in areas that 
have nothing whatsoever to do with cloning.
    The very first tenant of medicine in the Hippocratic oath is 
``First, do no harm.'' The Hippocratic oath appears to apply in this 
legislative context as well. Existing law gives FDA the authority to 
stop human cloning. Additional legislation will not deter rogue 
scientists from making an ill-advised attempt at cloning outside U.S. 
jurisdiction. Therefore ASRM supports current FDA policy and sees no 
need for new legislation.

                  ASSISTED REPRODUCTION IS NOT CLONING

    I also want to provide the committee some assurance in regards to 
advanced therapies for infertility. Despite what you might see in the 
news media, human cloning is not easy, nor imminent. It presents many 
more scientific challenges than have been generally portrayed. People 
have said that anyone could take current technology used for assisted 
reproduction and apply it to human cloning. This is simply not true.
    First, while we are constantly improving our ability to treat 
patients suffering from the disease of infertility, it is still far 
from easy. The education, training, and equipment required are 
extensive. Frankly, we resent the media reports that make it appear 
that anyone could set up an IVF clinic in their garage. The asexual 
replication in cloning is nothing like the Assisted Reproduction that 
has helped provide families with more than 100,000 new children in the 
U.S. alone.
    More significant however, there are huge fundamental differences 
between Cloning and sexual reproduction, even if that reproduction 
occurs in a laboratory in both instances. In an IVF procedure we help a 
sperm and an egg ``get together.'' Just as with natural conception, 
half the genetic material comes from the mother and half from the 
father. These gametes mix and mingle and align themselves in new ways 
to form a new and unique genetic combination. Cloning is the 
replication of an existing genome, and it's simply a copy. This is 
very, very different from the new being created through sexual 
reproduction.
    For some primitive species, cloning is the main method of 
reproduction. However, it is sexual reproduction that has given us the 
magnificent diversity of species we have on our planet today. Many of 
the problems seen in recent attempts to clone animals stem from the 
fact that these clones are replications and not new combinations.
    I take care of infertile patients every day. I employ a range of 
medical therapies, many of them quite complicated to help people have 
the children they so desperately want. My colleagues and I are 
interested in helping our patients have children and start families. 
Infertility is an emotional devastating disease. Infertile patients are 
desperate. Anyone who justifies cloning based on requests from 
infertile patients is pandering to a vulnerable audience.
    However, we have seen first hand in the U.S., how fear and unwise 
policy decisions can make it extremely difficult for us to improve the 
treatments we have available to offer our patients. The decision to 
deny federal funds for research involving human IVF has harmed the 
millions of Americans suffering from infertility. I am fearful that a 
negative decision may be made on stem cell research that will cause 
needless suffering for patients with heart disease, diabetes or 
Parkinson's disease. Please do not make these situations worse by 
enacting new and unneeded prohibition on human cloning.
    I thank you for your time and will be happy to answer any 
questions.

    Mr. Greenwood. Thank you very much.
    Mr. Wicker, thank you for your patience and you are 
recognized to testify for 5 minutes.

                 STATEMENT OF RANDOLFE H. WICKER

    Mr. Wicker. Thank you. My name is Randolfe Wicker. I'm the 
Director of the Human Cloning Foundation and the founder of the 
Clone Rights United Front. I would request that my full 
testimony and the four attachments be included in the official 
record. I'm going to read briefly from some highlighted 
sections of that testimony.
    Mr. Greenwood. Mr. Wicker, could you pull your microphone 
in a little closer and make sure it's turned on. Is the light 
on?
    Mr. Wicker. The light is on.
    Mr. Greenwood. Okay, very well.
    Mr. Wicker. Can I begin again, without losing time? Anyway, 
I would like to make quickly the points and summary that I made 
of rehighlighted points of my testimony. I ask that my full 
testimony and four attachments be included in the record.
    Mr. Greenwood. It will.
    Mr. Wicker. The points made are cloning is a part of every 
citizen's reproductive right. Stem cell research is based on 
human cloning technology. The FDA has no authority over the 
fertility industry. Cloning is a part of every American's right 
to religious liberty. The Raelian Movement is a legitimate, 
religious movement. The Raelian Movement and its Clonaid have 
behaved fraudulently. There is no need for new laws in this 
area. The dangers of animal cloning are not applicable to human 
cloning. And finally, the international consortium which 
includes Dr. Zavos is a cautious, professional, experienced 
team. The regulation of medicine should be left to physicians. 
Medicine and science are not areas in which unknowledgeable 
politicians should meddle.
    Thank you for inviting me to testify today. This hearing is 
being held because everyone knows that human cloning is going 
to happen. As Dr. Zavos points out, the genie is out of the 
bottle. As a human cloning activist during the last 4 years, 
I've viewed with alarm the growing public hysteria surrounding 
this issue. The general public is both highly opinionated and 
totally misinformed regarding human cloning.
    The first and most central issue raised by human cloning 
involves each individual citizen's reproductive rights, the 
decision by individual citizens about having children and their 
manner of conception has always been the decision made by a 
patient in consultation with her or his doctor. Politicians in 
Washington and politicians in State capitals have no business 
deciding for American citizens how and when they can have 
children.
    The second critical issue raised by human cloning involves 
each individual citizen's right to religious belief and 
practice. I testified to the House of Representatives' 
Committee on Commerce in 1998. I'd like to quote a short part 
of that before tackling the difficult situation currently 
facing us. I would also like to note that on this issue, I'm 
speaking for myself and not as an official representative of 
the Human Cloning Foundation.
    This is from my previous testimony, ``Religious-based 
decisions have no place in the law. They violate religious 
freedom. Those who believe cloning offers a partial temporary 
immortality have the right to secure an extended life for their 
genotype. Human cloning does change, at least slightly, the 
traditional clear line between life and death. If even after 
death, a later born identical twin can be born carrying the 
originator's genotype into another life, doesn't that somehow 
deny death as traditional totality? An appropriate phrase might 
be right to life equals right to clone. As a Montreal-based 
group, the Raelians with which''--and this is from 1998--``from 
which I have no association whatsoever, I might say, are 
virtually preaching an extended life through cloning. They 
offer to clone you for $200,000 at their Bahamian facilities 
which we have found don't really exist.'' That was on page 11, 
February 12, 1998.
    I'm submitting to this committee a copy of a press release 
and an invitation to me, sent on October 8, 2000 by Nadine 
Gerry on behalf of Clonaid entitled ``The First Human Cloning 
Company'' entitled ``Human cloning will allow gay couples to 
have children that--enables gay couples to have children.'' I 
ask that it be included in the official printed record. That's 
Attachment 1.
    Virtually all media, with the exception of Wired Magazine 
which had an excellent article, really factual, not 
opinionated. Exceptional cover story about Brian Alexander 
having ignored the outrageous hype and attempted fraud 
perpetuated by the Raelian Movement. Apparently, you can get 
away with almost anything in the United States if you just do 
it in the name of religion and call yourself a faith-based 
enterprise.
    I would like to just quote the Raelians, they claim to have 
cloning facilities no one has ever seen. They prey on parents 
with dying children as if through cloning you can bring back a 
lost, loved one. This is morally reprehensible. In my opinion, 
the press release, Attachment 1 proves this group has attempted 
to defraud the gay community by creating, saying they can 
create children with the combined genes of two members of the 
same sex and that has at this time been scientifically 
impossible.
    It is mind boggling that the most major media equate 
declarations by a group of space cadet wackos about their 
secret lab where they are claiming they are actually cloning 
human beings, that they compare that to the professional 
responsible cautious attempt to perfect cloning technology by 
two of the world's most renown and experienced fertility 
doctors, Dr. Zavos and Dr. Antinori. During a personal meeting, 
less than a week ago, Dr. Zavos pointed out to me that he was 
not selling anything, compared to the Raelians who tell the 
media that he who pays the most, gets cloned first. Dr. Zavos' 
services are not for sale. I believe he is as he appears to be, 
a dedicated, warm human being seeking to perfect a narrowly 
focused therapy for disabled, infertile couples so that they 
may have children genetically related to themselves. For 
instance, I would not qualify for Dr. Zavos' and Dr. Antinori's 
criteria. They have set narrow limits and strict guidelines.
    The soundbyte for today is cloning is dangerous because 
animal experiments have shown it to be so. I would suggest that 
journalists read carefully the detailed screening procedures 
that will be undertaken before human cloning is even attempted 
by this professional international consortium. That is in his 
Exhibit 1, very excellent presentation. Please read that 
collaborative effort.
    Now we face the great issue of animal deformities that 
resulted from animal experiments. This is the big issue this 
week. Well, to begin with, let us say 2 year old cloning 
technology and/or studies are equivalent to 10 year old 
computer technologies. I would ask any thinking person to 
consider the facts, the international consortium is working to 
perfect human cloning technology. Indeed, because it has taken 
a cautious, professional approach, it might well be faced with 
the disastrous results from those crazies seeing money, fame 
and glory for their profit.
    I respectfully submit this testimony to the committee and 
hope that the information contained in it helps it shape 
constructive, political and social policy for the new 
millennium.
    I remain cloningly yours, Randolfe H. Wicker.
    [The prepared statement of Randolfe H. Wicker follows:]

 PREPARED STATEMENT OF RANDOLFE H.WICKER, FOUNDER, CLONE RIGHTS UNITED 
               FRONT, DIRECTOR, HUMAN CLONING FOUNDATION

    Thank you for inviting me to testify today. This hearing is being 
held because everyone knows that human cloning is going to happen. As 
Dr. Zavos points out: ``The Genie is out of the bottle''.
    As a human cloning activist during the past four years, I have 
viewed with alarm the growing public hysteria surrounding this issue. 
The general public is both highly opinionated and totally misinformed 
regarding human cloning.
    Cloning technology is a scientific achievement as significant as 
the conquering of smallpox, although less important than the discovery 
of the printing press. Cloning technology has achieved monumental 
importance due to its central role in stem cell research.
    Despite all the hand-wringing and declarations against the cloning 
of human beings by biotech companies, stem cell research cannot be 
separated from human cloning. The same technology, inserting a cell 
into an enucleated egg, is central to both.
    The only difference between the two is that, in stem cell research, 
a tiny embryo no larger than the dot at the end of this sentence is 
killed through transforming it into a stem cell culture. In human 
cloning, the same embryo would be implanted into a woman's womb and 
allowed to develop into a wanted and loved child.
    The general public supports stem cell research because it promises 
to revolutionize medicine. The same public opposes human cloning, which 
itself is simply a medical cure for the human disability called 
infertility.
    The FDA has issued invalid legally unenforceable politically 
popular feel-good regulations forbidding human cloning in American 
fertility clinics. Mark Eibert will elaborate on this later.
    The Government that governs best governs least.
    The first and most central issue raised by human cloning involves 
each individual citizen's reproductive rights.
    The decision by individual citizens about having children and their 
manner of conception has always been a decision made by a patient in 
consultation with her or his doctor.
    Politicians in Washington and politicians in state capitols have no 
business deciding for American citizens who can bear children and how 
they can have them.
    The second critical issue raised by human cloning involves each 
individual citizen's right to religious belief and practice.
    I testified to the U S House of Representatives Committee on 
Commerce, Subcommittee on Health and Environment, on Thursday, February 
12, 1998. I would like to quote a short part of that testimony before 
tackling the difficult situation currently facing us.
    I would also like to note that, on this issue, I am speaking for 
myself and not as an official representative of The Human Cloning 
Foundation.
    ``. . . Religiously based restrictions . . . have no place in the 
law. They violate religious freedom. Those who believe cloning offers a 
partial temporary immortality have the right to secure an extended life 
for their genotype . . . human cloning does change, at least slightly, 
the traditionally clear line between life and death.``If, even after 
death, a later born identical twin can be born carrying the 
originator's genotype into another life, doesn't that somehow deny 
death its traditional totality?
    [An appropriate phrase might be, `` Right To Life equals Right to 
Clone.'']
    ``Already, a Montreal-based group, the Raelians--with which I have 
no association whatsoever, I might say--are virtually preaching eternal 
or extended life through cloning. They offer to clone you for $200,000 
at their Bahamanian facility, which we have found out doesn't really 
exist.'' (See page 111 of February 12, 1998, Testimony to the 
Subcommittee.)
    I am submitting to this committee a copy of a press release and 
invitation sent to me on October 8, 2000 by Nadine Gary on behalf of 
CLONAID, ``The First Human Cloning Company,'' entitled ``HUMAN CLONING 
WILL ALLOW GAY COUPLES TO HAVE CHILDREN,'' I ask that it be included in 
the official printed record. (See Attachment 1)
    I am also submitting the opening few paragraphs of an article I 
wrote and which was published in GayToday, www.gaytoday.badpuppy.com 
that gives context and perspective to the CLONAID press release with 
the same name. (See Attachment 2)
    I am also submitting two other articles filled with valuable 
information. The first is an editorial from www.clonerights.com 
entitled ``Religious Group Hijacks Human Cloning Movement,'' January 8, 
2001. (See attachment 3)
    The second is one of many items sent to me to be shared with the 
press. It is titled ``A Christian's Letter to CLONAID.'' (See 
Attachment 4)
    Virtually all media, with the exception of Wired Magazine's 
exceptional cover story by Brian Alexander (February 2001), have 
ignored the outrageous hype and attempted fraud perpetuated by the 
Raelian Movement. Apparently, you can get away with almost anything in 
the United States if you just do it in the name of religion and called 
yourself a faith-based enterprise.
    Freedom of speech does not give anyone the right to falsely scream 
``Fire!'' in a crowded theater. Freedom of religion does not give 
anyone the right to commit fraud.
    There is no need for new legislation or regulation on either 
reproductive freedom or religious belief. There is only a need to 
prosecute ``fraud'' whenever it occurs regardless of the person or 
group perpetrating it.
    Finally, the last critical question raised by human cloning 
technology revolves around ``who'' should control and regulate it or 
whether control and regulation are even possible. It is nearly 
impossible to draft legislation to outlaw reproductive cloning without 
harming medical and scientific research in the process.
    It is mind-boggling that most major media equate declarations by a 
group of space-cadet wackos about their ``secret lab'' where they are 
claiming that they are actually cloning a human being to the 
professional, responsible, cautious attempt to perfect cloning 
technology by two of the world's most renowned and experienced 
fertility doctors.
    This is like comparing ``moon rocks'' to polished Earthly diamonds. 
Drs. Zavos and Antinori speak in terms of ``perfecting techniques,'' 
which will make human cloning safe and viable.
    During a personal meeting less than a week ago, Dr. Zavos pointed 
out to me that he was ``not selling anything''--compared to the 
Raelains who tell the media that ``he who pays the most gets cloned 
first.''
    Dr. Zavos' services are not for sale. I believe that he is as he 
appears to be--a dedicated warm human being seeking to perfect a 
narrowly-focused therapy for disabled infertile couples so that they 
might have children genetically related to themselves.
    For instance, I would not qualify under Dr. Zavos' and Dr. 
Antinori's criteria. They have set ``narrow limits'' and ``strict 
guidelines'' regarding their goals. I would suggest that those 
interested read a leaflet about the 62-year-old woman who had a healthy 
child with Dr. Antinori's help, which I will not submit as testimony 
unless requested by the Committee.
    The ``sound bite'' for today is ``Cloning is Dangerous Because 
Animal Experiments Have Shown It to be So.'' I would suggest that 
journalists read carefully the detailed screening procedures that will 
be undertaken before human cloning is even attempted by this 
professional international consortium.
    I see a line-up of witnesses ready to testify to this committee. We 
have Arthur Caplan, whose voice has so crowded out other voices within 
bioethics that he is recognized as an American secular Pope. In Time 
Magazine, he said, ``The short answer to the cloning question is that 
anybody who clones somebody today should be arrested.''
    Dr. Zavos and I have decided to ``depose'' this self-anointed 
secular Pope by refusing to debate him. See our leaflet ``Let Other 
Bioethicists Be Heard,'' which this Committee may include in its 
publication if it so chooses. How does one engage in civilized 
discourse with a man who begins the debate declaring that you should 
``be arrested''?
    This ``moral authority'' who would have us arrested was the first 
ethicist sued because of his involvement in the unnecessary death of 
Tucson teenager Jesse Gelsinger. I would suggest that HE should be the 
one ``arrested.'' This is a man who has contributed to the death of a 
healthy young American citizen. I object to his being allowed to 
testify to this committee. His ``morality'' has been the subject of 
legal action.
    I also see that you have another anti-cloning witness, Rudolf 
Jaenisch, from MIT. I listened carefully to this man's arguments on 
``The Charlie Rose Show.'' Basically, he argued that Dolly, the sheep 
conceived through cloning, might be ``mentally retarded and/or 
schizophrenic.''
    I would appreciate Rudolf Jaenisch supplying me with an 
``intelligence test'' or a psychological screening test to see if an 
apparently normal sheep is or is not schizophrenic.
    You can't win with these people. When I testified in 1998, the 
skeptics were asking if ``we could be sure `Dolly' wasn't a fraud?'' 
After that, the naysayers said ``Dolly'' was seven years old when she 
was born. Well, we now have five successive generations of cloned mice, 
and their telomeres seem to indicate that ``cloning'' actually 
increases life expectancy. Dolly, if she was six or seven years of age 
at birth, must be the oldest living sheep in memory to have had 
offspring just recently.
    I am not an ``expert'' in sheep menopause. I refer you to Rudolf 
Jaenisch on that issue. And please, get me that ``intelligence test'' 
and that ``personality evaluation'' test for sheep so we can evaluate 
his allegations.
    Now, we face the great issue of animal deformities that resulted 
from animal experiments. This is the ``big issue'' this week.
    Well, to begin, let us say ``two year old cloning technology and/or 
studies are equivalent to ten year old computer technology.'' Adults 
come to this issue (and I might well be one of them) with emotionally-
based biases around which they construct intellectual defenses.
    I would ask any thinking person to consider the facts: the 
international consortium is working to ``perfect'' human cloning 
technology. Indeed, because it is taking a cautious professional 
approach, it might well be faced with disastrous results from those 
``crazies'' seeking money, fame and glory for their ``prophet.''
    I would point to an extraordinary situation in Brazil (Economist, 
July 22, 2000) in which science funding is insulated from the whims of 
politicians and the general public's hysteria. Shouldn't this be the 
model for the United States of America?
    I respectfully submit this testimony to this committee and hope 
that the information contained in it helps shape constructive political 
and social policy for the new Millennium.
    [All attachments submitted are retained in subcommittee files.]

    Mr. Greenwood. Thank you, Mr. Wicker, I'm sure your 
testimony will help us in just that way.
    Mr. Hanson.

                   STATEMENT OF JAYDEE HANSON

    Mr. Hanson. We have a flood a little smaller than Noah's 
here, but I'm Jaydee Hanson speaking on behalf of the United 
Methodist General Board of Church and Society. The General 
Conference of the United Methodist Church is the only body 
empowered to speak for the entire church. The United Methodist 
has some 8.4 million members in the United States. This past 
May, the General Conference called for, and I quote, ``a ban on 
all human cloning including the cloning of human embryos. This 
would include all projects, privately or governmentally funded, 
that are intended to advance human cloning.''
    The General Conference based its position on the work of 
the United Methodist Genetic Science Task Force which began its 
work in 1989, some 8 years before the Scottish laboratory 
succeeded in cloning Dolly. The task force includes scientists, 
social scientists, theologians, ethicists, doctors and a 
lawyer.
    Since the cloning of Dolly this issue of cloning has 
sparked enormous and sustained concern in the general public 
including the church. Many other denominations, other than the 
United Methodist Church have also issued statements opposing 
human cloning. The United Methodist Church's opposition to 
cloning comes from our understanding of a theology of God's 
creation and how humans are to be stewards of God's creation.
    The new biological technologies, including cloning, force 
us to examine as never before the meaning of life and our 
understanding of ourselves as humans in our proper role in 
God's creation. Our ``General Conference cautions that the 
prevalent principle in research that what can be done should be 
done is insufficient rationale and should not be the prevalent 
principle guiding the development of new technologies. 
Technologies need moral and ethical guidance.
    As United Methodists, our reflections on these issues 
emerge from our faith. We remember that creation has its 
origin, value and destiny in God and that humans are stewards 
of creation, that technology has brought both great benefit and 
great harm to creation. As people of faith, we believe that our 
identity is more than our genetic inheritance, our social 
environment or the sum of the two. We are created by God and 
have been redeemed by Jesus Christ. In light of these 
theological questions, fears and expectations we recognize that 
our present human knowledge on this issue is incomplete and 
finite. We do not know all of the consequences of cloning, but 
it is important that the limits of human knowledge be 
considered as policy is made.'' That ends of the quote of the 
General Conference.
    Rebekah Miles, a professor of ethics at Southern Methodist 
University is a member of our Genetic Science task force and I 
think has summarized well the questions we all should consider, 
at least those of us that are part of the church. ``Will human 
cloning compromise our God-given uniqueness or distinctiveness? 
How might human cloning be misused by sinful humans to further 
their selfish ends and objectify other people? Is a desire to 
replicate one's genetic inheritance in a human clone an attempt 
to deny our inevitable finitude as human beings? Will human 
cloning further social justice? When does human alteration of 
creation so go far as to become a violation of God's creation? 
What is the difference between our human capacities for 
creation and God's?''
    Our Genetic Science Task Force concluded that cloning would 
compromise human distinctiveness, that it would be used as a 
way to further social injustice, and that it was a violation of 
their understanding of God's creation.
    The General Conference statement on cloning notes a number 
of ways that human cloning could have social and theological 
implications and they list the use and abuse of people, 
exploitation of women, tearing the fabric of the family, 
compromising human distinctiveness, lessening of genetic 
diversity, the direction of research and developing on cloning 
would like be controlled by profit. The General Conference 
further noted that given the profound theological and moral 
implications, the imperfection of human knowledge that there be 
a moratorium on cloning-related research.
    One of the most basic Christian stories in the Bible 
concerns the temptations of Jesus in the wilderness. In none of 
these temptations was Jesus tempted to do bad things. Turn 
stones into bread, show the glory of God, become an earthly 
ruler, none of those were in and of themselves bad things. But 
Jesus resisted the temptation to do the wrong thing at the 
wrong time.
    We face a similar temptation in our shared desire to have 
healthy children. But cloning is the wrong way to address 
infertility and other reproductive problems. Cloning proponents 
will argue that cloning will soon become a normal way of 
producing humans and that initial opposition will fade away 
when the safety concerns are addressed. The cloning of humans 
should never be allowed to become normal.
    The U.S. Congress has the opportunity to join with many 
other countries and ban cloning. The rest of the world is 
looking to the United States for leadership on this issue. As 
the ethicist, leon Kass notes, ``This is not business as usual 
to be fretted about for a while but to finally be given our 
approval. We must rise to the occasion and make our judgments 
as if the future of our humanity hangs in the balance. For so 
it does.''
    Thank you for hearing me. I would request permission of the 
committee to expand my remarks for the record.
    Mr. Greenwood. Any other material that you'd like to submit 
to the committee will be included in the record, sir.
    Mr. Hanson. Thank you very much.
    [The prepared statement of Jaydee Hanson follows:]

 PREPARED STATEMENT OF JAYDEE HANSON, ASSISTANT GENERAL SECRETARY FOR 
 PUBLIC WITNESS AND ADVOCACY, GENERAL BOARD OF CHURCH AND SOCIETY, THE 
                        UNITED METHODIST CHURCH

    The General Conference of The United Methodist Church, is the only 
church body that speaks for the entire 8.4 million member United 
Methodist Church. This past May, the General Conference called ``for a 
ban on all human cloning, including the cloning of human embryos. This 
would include all projects, privately or governmentally funded, that 
are intended to advance human cloning.'' (The Book of Resolutions of 
The United Methodist Church, 2000, p. 254)
    The General Conference based its position on the work of the United 
Methodist Genetic Science Task Force which began its work in 1989, some 
8 years before a Scottish laboratory succeeded in cloning ``Dolly.''
    Since the cloning of Dolly, this issue of cloning has sparked 
enormous and sustained concern in the general public, including the 
church. Many other denominations other than the United Methodist Church 
have also issued statements opposing human cloning. The United 
Methodist Church opposition to cloning comes from our understanding of 
a theology of God's creation and how humans are to be stewards of God's 
creation. The new biological technologies, including cloning, force us 
to examine as never before, the meaning of life, our understanding of 
ourselves as humans, and our proper role in God's creation. The General 
Conference ``caution(s) that the prevalent principle in research that 
what can be done should be done is insufficient rationale . . . and 
should not be the prevalent principle guiding the development of new 
technologies . . . technologies need moral and ethical guidance.'' 
(Book of Resolutions, p. 248)
    As United Methodists, our reflections on these issues emerge from 
our faith. We remember that creation has its origin, value, and destiny 
in God, that humans are stewards of creation, and that technology has 
brought both great benefit and harm to creation. As people of faith, we 
believe that our identity as humans is more than our genetic 
inheritance, our social environment, or the sum of the two. We are 
created by God and have been redeemed by Jesus Christ. In light of 
these theological claims and other questions, fears and expectations, 
we recognize that our present human knowledge on this issue is 
incomplete and finite. We do not know all of the consequences of 
cloning . . . It is important that the limits of human knowledge be 
considered as policy is made. (Book of Resolutions, p.254)
    Dr. Rebekah Miles, associate professor of ethics, at Perkins School 
of Theology, Southern Methodist University and a member of the United 
Methodist Task Force on Genetic Science summarized the questions asked 
by our taskforce.
    Will human cloning compromise our God-given uniqueness or 
distinctiveness?
    How might human cloning be misused by sinful humans to further 
their selfish ends and objectify other people?
    Is a desire to replicate one's genetic inheritance in a human clone 
an attempt to deny our inevitable finitude as human beings?
    Will human cloning further social injustice . . .?
    When does human alteration of creation go so far as to become a 
violation of God's creation?
    What is the difference between our human capacities for creation 
and God's?
    Our Genetic Science Task Force concluded that cloning would 
compromise human distinctiveness, that it would be used as a way to 
further social injustice, and was a violation of their understanding of 
God's Creation and as such should be banned.
    The General Conference statement on human cloning notes a number of 
ways that human cloning would have social and theological 
ramifications: (the) use and abuse of people, exploitation of women, 
(the) tearing of the fabric of the family, the compromising of human 
distinctiveness, the lessening of genetic diversity, the direction of 
research and development (on cloning would likely be) . . . controlled 
by corporate profit . . . (Book of Resolutions, p. 254) The General 
Conference further noted that Given the profound theological and moral 
implications, the imperfection of human knowledge that there be a 
moratorium on cloning-related research.
    Cloning proponents will argue that cloning will soon be come a 
normal way of reproducing humans and that initial opposition will fade 
away when safety concerns are addressed. The cloning of human humans 
should never be allowed to become ``normal''. The US Congress has the 
opportunity to join with many other countries where the United 
Methodist Church has members and ban human cloning. The rest of the 
world is looking to the United States for leadership on this issue. As 
the ethicist, Leon Kass notes, This is not business as usual to be 
fretted about for a while but to finally be given our approval. We must 
rise to the occasion and make our judgements as if the future of our 
humanity hangs in the balance. For so it does. (Leon Kass, ``The Wisdom 
of Repugnance: Why We Should Ban the Cloning of Humans.'')

    Mr. Greenwood. Rael, you are recognized to testify for 5 
minutes.

                        STATEMENT OF RAEL

    Mr. Rael. Thank you, Mr. Chairman, for inviting me. I have 
a request to include to my text, manifesto signed by 36 
scientists and philosophers of the world from New Humanist 
Association including Frances Crick, co-discoverer of DNA and 
numerous Nobel prize laureates who support the freedom for 
human cloning as part of freedom of science be attached to my 
testimony.
    Mr. Greenwood. Without objection, it will be included in 
the record.
    Mr. Rael. Thank you, Mr. Chairman. I wish to dedicate my 
testimony to Giordanno Bruno who was burned alive four 
centuries ago, sentenced to death penalty by the Catholic 
Church for saying that there was life on other planets.
    Why did I ask Brigitte Boisselier to create the first human 
company in America? Because as the country of freedom you have 
a Constitution which would be a model for the world and the 
most wonderful jewel of your system, the Supreme Court, which 
guarantees a respect of your Constitution and the freedom of 
your citizens, events against your own government and law 
makers.
    I am quite confident that even if human cloning was done, 
Supreme Court of America would consider this law as 
unconstitutional as they did for IVF. Two hundred thousand 
children alive today thanks to IVF in the world. If the laws 
against IVF had been kept, the 200,000 children will not exist. 
The life being denied under the pressure of the religious 
power. Before IVF was legalized, proponents were also 
predicting that this procedure would give birth to monsters and 
disformity. If 100 years ago religious powers could have passed 
law against the freedom of science we today would have no 
antibiotic, no surgery, no blood transfusion, no organ 
transplant, no vaccine, no cars, no electricity, no computers 
and no airplane. Stopping science is a crime against humanity. 
If these discoveries were forbidden 100 years ago, 2 billion 
people would never have enjoyed life, dying at very early stage 
of their existence and they may have included your own parents 
and yourself.
    We can see that at least 90 percent of the people in this 
room are still alive today thanks to science. Three billion 
people, this is more than any other criminal against humanity 
ever killed, including Hitler or Napoleon. Today, you have in 
your hands alive of billions of people, alive now or future 
generations. You have the choice to be remembered as heroes for 
saving billion of life or as criminal against humanity for 
denying them a possible cure, a new life or even eternal life 
by retarding scientific progress, retarding because it will be 
done anyway, somewhere, some day as thankfully nothing can stop 
science.
    But law can slow down research and it is the people who 
will suffer from it and you will be responsible for the delay 
and the death and the suffering it will create. The deaths and 
suffering can be yours as well as lawmakers are not immune to 
sudden disease or your own beloved children or beloved 
grandchildren. Religious people were against human cloning 
should be free to refuse it for themselves or their own 
children as they are free today to refuse abortion, blood 
transfusion or surgery.
    Human cloning will make it possible for us to reach eternal 
life. It is the right of the people who want to enjoy the fruit 
of scientific progress, including human cloning and eternal 
life, to benefit from it. If religion and superstition which 
are the same have power over science, we would still be living 
in the Dark Age. Your great Constitution includes the freedom 
of religion and that means also the freedom to be atheist, 
freedom to believe there is no god and benefit from science 
without any moral restriction.
    We at Raelian believe that science should be our religion. 
Science saves lives, while religion and superstition kill. 
Science destroys superstition and supernatural belief. That's 
why religion was always an enemy of science and progress and is 
again trying to stop science at its best.
    It should be the freedom of the people to decide if they 
want to benefit or not from human cloning. Legalizing human 
cloning is protecting the right of the unreborn as cloning 
makes it possible a second chance to live for infant, like the 
one Clonaid planned to clone now, a 10 month old baby killed by 
medical malpractice. It could be your own beloved child or 
grandchild, think about them personally. Lawmakers should not 
be accomplice of Dark Age power and superstition as they will 
be judged by history.
    Human cloning is the first step to what is a great 
discovery, the creation of totally artificial form of life, 
like that was done by our creator, Zealohim, when he created us 
on earth. Not is human cloning is not against the wish of what 
people called God, but it is our creator's plan to discover and 
use it as many other religious leaders claim becoming as it is 
written in the Bible, equal to our work creator's.
    [The prepared statement of Rael follows:]

                       PREPARED STATEMENT OF RAEL

    The conservative, orthodox, fanatic traditional religions have 
always tried to keep humanity in a primitive stage of darkness. It is 
easy to see that in countries like Afghanistan which are back to the 
middle ages due to a fanatic Moslem government.
    But this was also true in occidental powers. The first medical 
doctors who tried to study the human by opening cadavers were 
excommunicated by the Catholic Church. It was considered a sin to try 
to unveil the mystery of the creation of god . . . So were the first 
antibiotics, blood transfusions, vaccines, surgeries, contraception, 
organ transplants . . . religious fanatics were always saying that 
``it's a sin to go against the will of god . . . If somebody is sick, 
let him die, his life is in god's hands.''
    If our civilization would have respected these primitive ideas from 
dark ages, we would all die around 35, and 9 out of 10 babies born 
would die in their first 2 years.
    Traditional religions have always been against scientific progress. 
They were against the steam engine, electricity, airplanes, cars, 
radio, television, etc . . .
    If we had listened to them we would still have horses and carts and 
candles . . .
    Twenty-two years ago they were against IVF, talking about monsters, 
Frankenstein and playing god, and now IVF is well accepted, performed 
every day by thousands and helping happy families with fertility 
problems to have babies.
    Today human cloning will help other families to have children, and 
again they are against it. It will also help to cure numerous diseases, 
will help us live a lot longer, and finally will help us reach, in the 
future, eternal life.
    Nothing should stop science, which should be 100% free.
    Ethical committees are unnecessary and dangerous as they give power 
to conservative, obscurantist forces, which are guided only by 
traditional religious powers.
    As well as there should be a complete separation of state and 
religion, there should also be a complete separation of science and 
state, or science and religion.
    If there was an ethical committee when antibiotics, blood 
transfusions and vaccines were discovered it would have certainly been 
possible that these technologies would have been forbidden. You can 
imagine the poor health the world would be in today . . .
    Ethical committees should be necessary when a deadly technology is 
making the production of weapons of mass destruction possible . . . And 
to my knowledge there are no ethical committees concerning nuclear, 
chemical or biological weapons. These things are created to kill 
millions of people and possibly destroy all life on earth. Cloning is a 
pro-life technology, a technology made to give birth to babies!
    The first benefit of human cloning is to make it possible for 
couples who cannot have children using other existing techniques to 
have babies inheriting genetic traits from one of their parents. They 
can be unfertile heterosexual couples or gay couples.
    The second benefit is for families who lose a child due to crime, 
accident or disease to have the same child brought back to life.
    All conservative ``pro life'' groups always talk about ``the right 
of the unborn'', but in this case we must talk about protecting the 
rights of the ``unreborn''. As cloning technology makes this possible, 
why should we accept the accidental death of a beloved child, when we 
can bring this very child back to life?
    People who are opposed to it are always influenced by a terrible 
Judeo-Christian education . . . the same as those who could have made 
antibiotics, vaccines, transfusions, surgery and organ transplants 
forbidden. Their main objections are:

1. ``It is an unsafe technology, which is not advanced enough: the best 
        way to develop this technology like all other technologies is 
        by doing it. The first surgeries, organ transplants, and IVF 
        were unsuccessful. But by doing it, scientists were able to 
        develop their expertise.
2. ``It will create monsters'': a percentage of ``normally'' (sexually) 
        conceived babies are born ``monsters'' or with genetic faults . 
        . . Would you make a law against making babies sexually through 
        the ``natural'' way because of these problems? Of course not 
        and the percentage amongst cloned babies will be lower as they 
        will be more precisely scrutinized from the first days after 
        conception.
3. ``The children made by cloning will have a terrible life being 
        looked at as abnormal people'': not more than IVF conceived 
        children, or twins, or physically handicapped children or gay 
        or colored people. It is not the problem of the children 
        themselves, but the responsibility of the society to educate 
        the public to respect the differences, all the differences, 
        between human beings.
4. ``It is against biodiversity to create cloned children, creating 
        identical people'': we have already on earth millions of twins 
        and this is not a problem. The conception through cloning will 
        always be used by a limited number of people and that will not 
        affect biodiversity. But even if you imagine 6 billion human 
        beings being cloned, the biodiversity is still the same as we 
        still would be 6 billion different people!
5. ``Cloned children will not be exactly the same'': so what is the 
        problem? As long as the families are informed about this, (and 
        they are) there is absolutely no problem with that. People 
        against cloning keep saying ``it is terrible they will be the 
        same'' and then suddenly they argue ``they will not be exactly 
        the same'' . . . So what is the problem?
6. ``Cloned children will have terrible psychological problems being 
        created to replace dead babies, but they will never be exactly 
        the same'': loving families who lose a child and want to have 
        him back through cloning have so much love for this child, a 
        child they hope so much to have back, that I cannot imagine a 
        child being loved more. More than other families, those who 
        lose a child due to disease or accident or crime have learned 
        so much about how life is fragile, that they will protect and 
        care for these children much more than ``normal'' families. And 
        a good education is to accept that your children are not 
        exactly what you would want them to be. ``Normal'' families 
        experience that every day when a father who is a medical doctor 
        sees his child only interested by music or painting, as the 
        father was dreaming to have his son become a doctor like he is 
        . . . Real love is accepting the differences, and that includes 
        the differences between the image you have of your child and 
        who he really is.
7. ``Human cloning is unnatural'': we already answered to this 
        objection. Nor are blood transfusions, antibiotics, organ 
        transplants, vaccinations, surgery, etc . . . If we let 
        ``mother nature'' work we would be all dead around 45 and 9 out 
        of ten babies would die as infants . . .
8. ``Only God can create life'': this is pure belief, and religious 
        people who are against human cloning have the right and the 
        freedom not to do it, as they can refuse blood transfusion, 
        organ transplant, surgeries, antibiotics, contraception, 
        abortion, etc., but those who decide to do it should be 
        respected as well.
    These are the most frequent objections to human cloning, but we 
should also consider the advantages in the middle and long term aspects 
of human cloning for a non-fanatically religious society.
    Human cloning will help cure numerous if not all diseases. It will 
also make possible to create a genetic bank where you will be able, if 
you need an organ transplant, to have it. Not by creating babies to 
take replacement organs from them . . . but by preserving stem cells of 
your body in very early stage embryos of yourself and develop in vitro 
only the organs you need in case of disease or accident.
    One more time those opposed for religious reasons to this just 
should be free not to use it.
    Finally, in the more long term, human cloning will make possible--
when Accelerated Growth Process will be discovered to clone an adult 
copy of ourself directly just before we die and when Brain Data 
Transfer will be discovered, to transfer, or download (or upload) our 
memory and personality in this new young body for a new long life. The 
progress of humanity will be exponential at this level. Presently, when 
a scientist is at the top of his art, he starts to age and dies. We can 
imagine Einstein, Newton and Leonardo Da Vinci still alive and working 
together . . . the discoveries they could do would be unlimited. And 
the same for artists like Mozart, Beethoven and Bach being still alive.
    Not only should human cloning be allowed for the good of today's 
people, but even more for future generations who will remember your 
historical decision forever.
    That's why I chose America to create the first Human Cloning 
company, because it is the country of individual freedom and science on 
earth. Thanks to the U.S. system, which should be a model for the whole 
world, and special thanks to the Supreme Court, I am confident that the 
right to clone yourself as an individual, freedom, guaranteed by the 
great U.S. constitution, will be protected.

    Mr. Greenwood. Thank you, sir, for your testimony.
    The Chair recognizes himself for 5 minutes and I'm going to 
indulge myself with an editorial comment or two before I ask 
questions.
    First, Mr. Rael, what strikes me is that what I've 
experienced today in this hearing is not religious voices 
overcoming scientific voices, but in fact, the respected 
scientists perhaps in opposition to your religious group. With 
regard to the law and science, our responsibility is to make 
sure that we use the best science in order to set policy.
    I recall when I was a young boy, some very good scientists 
developed a medicine called thalidomide and that medicine was 
used to prevent morning sickness. And it was the scientists who 
ultimately we relied upon, the country relied upon to 
understand, to teach us, that this thalidomide was causing 
terrible deformities in children. So we utilized good science 
to direct the scientists that were involved in thalidomide so 
as not to harm children.
    Which causes me to turn my attention to the comments of Mr. 
Wicker and Mr. Eibert about what the responsibility of the law 
is and the politicians is with regard to having children. 
Before I was a politician, I was a social worker and I worked 
with abused and neglected children. Part of my responsibility 
was to see who it was and when it was that parents could safely 
rear children and to remove and deny the rights of parents who 
could not safely rear their children. So I think the real 
question for us here is not to assume that there's some 
ultimate and absolute right of anyone to have children. There's 
a lot of reasons why that's not the case, but as Mr. Pence 
suggested, to find out whether that we quote, ``we must ask 
whether it was wrong for some other associated reason, mainly 
whether a child created by cloning would be harmed 
psychologically or physically.'' And that's the question we 
have to determine: whether cloning is such a threat to the 
physical well-being or the psychological well-being of a child 
so that we would pre-empt the right of someone to pursue their 
desire to be a parent when we think that the interest of the 
child or the prospective child come foremost and would be 
affected by that.
    So let me address my question then to you, Dr. Pence, 
because what seemed to be circular about your testimony to me 
was that what you said I think is that we should permit cloning 
if we can determine that it can be done safely.
    Mr. Pence. Yes.
    Mr. Greenwood. The question is how can we determine that 
cloning is safe for children if we don't clone children as an 
experiment and take the risk that it will be harmful? It seems 
to me the very difficult question here is that I don't know how 
to permit cloning experiments to go on when we could have 
deformed children born who would have to live their lives with 
those deformities, if they're fortunate enough to live their 
lives, who might have apparently been born physically well, and 
as others, some of the scientists have testified, could be 
walking, ticking biological time bombs because we don't know 
what the long-term effects of cloning might be. So they may 
have conditions that don't materialize for years and then 
materialize into something that is completely unpredictable and 
completely horrible. Certainly there is no way, it seems to me, 
to know what the psychological consequences are of being not a 
unique individual produced by the merging of the cells of a 
mother and father, but rather to be the replica of a pre-
existing person. I don't know how we could ever determine 
beforehand that that was safe.
    So my question is how could we possibly determine that it 
is safe enough to do this, without having taken the risk of 
doing it in the first place?
    Mr. Pence. I'm not so worried myself about the 
psychological harm, although I could speak to that, but I think 
the physical harm is really the devastating objection right 
now. I think if the science changed and we did get a handle on 
the reprogramming, especially in animal studies, primates would 
be the appropriate place to study that and to actually study 
them over the term of their life. At some point, if that--if we 
thought we understood that, the primate studies, we probably 
would have to take a risk for the first child. I should point 
out that we did this with ICSI, intercytoplastic sperm 
injection, a technique where we just use one sperm to 
impregnate the egg and create an embryo. This was really not 
tested before it was tried and 3 days after it was used, 
announced in Holland, it was being used across the country. But 
there was pretty good evidence that it would work. So I think 
primate studies would be the way to go.
    Mr. Greenwood. And since I heard you say that we would need 
to do primate studies, plural, and since I heard you say that 
we probably need to study those primates over the course of 
their lifetime----
    Mr. Pence. What Dr. Jaenisch says is that the defects may 
not show up.
    Mr. Greenwood. I do know that the closest primate 
genetically to the human is the chimpanzee and I know that 
chimpanzees live for a very long time.
    Mr. Pence. Yes.
    Mr. Greenwood. So I would assume that we're probably 
talking decades under that theory, decades before you could 
actually clone enough chimpanzees or other relatively close 
genetic relatives to humans and observe them over their 
lifetimes, looking for the unknown before one would dare 
perform such an experiment on humans. Do you concur with that?
    Mr. Pence. Right, in this country. I mean what other people 
do in other countries, we can't control and we may get some bad 
data from that, but in this country, yes.
    Mr. Greenwood. Thank you. The Chair recognizes the gentle 
lady from Colorado for 5 minutes.
    Ms. DeGette. Thank you, Mr. Chairman. I've been thinking 
about something here and you know, maybe Mr. Wicker you can 
tell me. Is cloning something you yourself would be interested 
for yourself? Would you be interested in being cloned?
    Mr. Wicker. Yes, I would.
    Ms. DeGette. You can answer with the mike.
    Mr. Wicker. Yes, I would because I believe it's my 
reproductive right and my----
    Ms. DeGette. Yeah, I got you.
    Mr. Wicker. [continuing] to live on to another lifetime.
    Ms. DeGette. Mr. Rael, would you personally be interested 
in being cloned?
    Mr. Rael. Not actually, because I have already two 
children, but----
    Ms. DeGette. No, no, my question is would you yourself be 
interested in being cloned?
    Mr. Rael. Not at the actual level because I have already 
two children. The problem is for people who have no children.
    Ms. DeGette. Thank you. So you only want this for people 
with no children, so as a reproductive issue.
    But here's the question I have and Dr. Pence, you're Dr. 
Pence, right? I'm sorry, I wasn't here for the beginning of the 
testimony.
    Maybe some of you can answer this, because with cloning 
technology, see, you're not talking about traditional 
infertility treatments in that you have two people who want to 
donate sperm and egg and so on. What you're talking about is 
taking cells from really one person and it seems to me there 
are some yet unresolved ethical issues about say issues like 
Mr. Wicker who would like to be cloned or maybe for someone who 
had a baby who tragically died at 10 months and they might want 
to clone that, versus someone who did not want to be cloned, 
like let's say I tragically died and my family decided they 
wanted to clone me. Doesn't that present a fairly serious 
bioethical issue that we're going to need to deal with in this 
debate? What about cloning of people who don't want to be 
cloned and how do we deal with that?
    Mr. Pence. I take it that's for me?
    Ms. DeGette. Yes. You seem to be our remaining ethicist.
    Mr. Pence. I don't know what happened to the other one. I'm 
sorry, I can't read your name, what is your name?
    Ms. DeGette. DeGette.
    Mr. Pence. DeGette. You seem to be asking the right 
questions today. I think if it became safe that you would have 
a right to control what happens to your genotype, an absolute 
right. I mean I don't think we want people going around 
stealing Brad Pitt's hair.
    Ms. DeGette. How do we control that? I mean that's exactly 
right.
    Mr. Pence. I suppose legally. You can't--we have a decision 
in the Moore case where a man's cell line was used to create a 
very valuable product and he sued to try to have a piece of 
that. There are some existing precedents for people having 
control.
    Ms. DeGette. Dr. Cameron, did you want to comment?
    Mr. Cameron. Indeed, I mean I think this whole question of 
the accessibility of genetic material is a very serious 
practical problem.
    Ms. DeGette. That's right.
    Mr. Cameron. And even if we were to take the view that 
cloning were some kind of human right, as some of our 
colleagues have suggested, this practical issue really is a 
roadblock here because unless you go around with a plastic bag 
over your head all the time, I mean you are shedding genetic 
material and the notion that this can somehow be kept private, 
this is a practical issue, aside all together from the other 
ethical issues involved here.
    Ms. DeGette. And I would assume an issue that we really are 
going to need to investigate in depth before cloning becomes 
widespread at all.
    In other words, as everyone is saying, the genie is out of 
the bottle, before it gets much farther out of the bottle, I 
think we really need to look at these ethical issues, wouldn't 
you agree?
    Mr. Cameron. I certainly agree and it does seem to me that 
we are just being so slow, this discussion, of course, is--this 
particular discussion is now 3 and 4 years old, in addressing 
issues when the curve is going up so sharply, that if we are 
going to be able to cope with this genie climbing out of the 
bottle, cloning is one of the simpler issues involved here.
    Ms. DeGette. Yes. Dr. Soules, you can speak to that and 
then I have another question for you.
    Mr. Soules. I have an analogy for you. We have a 
reproductive technology ethics committee at the University of 
Washington and the analogy is this posthumous use of sperm.
    Ms. DeGette. Right, exactly.
    Mr. Soules. If a man dies, within 24 hours or so the sperm 
is still viable and we can create an embryo and we went through 
some requests on that and our local university ethics committee 
decided without the man's written explicit, written consent, in 
other words, he had cancer and knew he was going to die, but 
these accidental deaths, they did not allow us to do 
posthumous----
    Ms. DeGette. And what if someone picks up one of my hairs 
and tries to clone me.
    Mr. Soules. In other words, it's an analogy. Cloning is the 
bigger issue, I think, but the analogy was a conservative 
stance in terms of if the person did not explicitly state they 
wanted to have reproduction occur after their death, that it 
was not allowed.
    Ms. DeGette. And just one final question for you, why 
haven't we done primate studies? People have been referring in 
this panel to primate studies. Why haven't they been conducted 
yet?
    Mr. Soules. I think people have tried. They're more 
expensive and complex, but NIH does have a series of regional 
primate centers and the studies--if you look at progression of 
studies, it's usually from mouse to higher animals and so on, 
and it's just getting to monkeys now and to jump to humans now 
would be premature.
    Ms. DeGette. Dr. Pence, did you want to comment on that?
    Mr. Pence. I think people, especially in Oregon have tried, 
but they haven't gotten good results, so we aren't hearing 
anything.
    Ms. DeGette. So you would agree also that it's far too 
premature to start cloning?
    Mr. Pence. Absolutely.
    Ms. DeGette. Thank you. Thank you, Mr. Chairman.
    Mr. Greenwood. The Chair recognizes the gentleman from 
Florida, Mr. Deutsch for 5 minutes.
    Mr. Deutsch. Thank you, Mr. Chairman. At some level I think 
most of you who have sat here all day, as most of us have sat 
here all day as well, and I almost feel at least initially to 
give you the opportunity to ask each other questions in which I 
will do. Does anyone feel compelled while you are sitting there 
as a panel who would like to ask any of the other panel members 
a question? You can ask us questions too, if you want.
    Mr. Wicker. I found it somewhat stumpuous for the woman 
representative to say cloning me would be one cell, one parent. 
My native born twin would have two parents. They were my 
parents. I think when the chairman talked about how do we have 
to have it perfectly sure that this is going to be the perfect 
child, you're almost talking about perfect human beings and 
we'd have to watch them forever. My mother is 85 years old and 
has Alzheimer's. She's been in perfect health until that time. 
So I mean I think there comes a time where there's no such 
thing as surety. No such thing as a perfect person. And finally 
these questions about psychological consequences of being a 
second somebody else is utter nonsense because every human 
being, including identical twins are their own unique first 
self. And I don't understand why you gentlemen seem to sit and 
rather than deal with reality, think up problems, it's almost 
like what issues can we raise to delay cloning 3 years, 30 
years or 300 years? The bottom line is I get the impression 
that many of you would like to ban cloning for all time 
regardless of how safe and how promising it would be.
    Mr. Deutsch. I think that's accurate.
    Mr. Wicker. Thank you for an honest answer.
    Mr. Deutsch. And again, I will tell you, we have a role 
more than just I think pure science as elected Members of the 
U.S. Congress. I think what I've gained from today and also 
from reading before this hearing is I don't think there's 
really a debate that at this point in time human cloning is 
medically totally unsafe. The last answer to the question on 
primates, I mean we're not even able, willing to do this on 
primates as much sort of--when we had testimony that you can't 
rely upon cows and mice for people, well, maybe primates are 
better, but we have no primate data. So there's no question. I 
mean so that's one level and I guess we had testimony from 
ethicists earlier about the health-related issues.
    I do think though that there are very legitimate other 
issues that Congress legislates, we legislate morality in a 
sense and we have the ability to and I think as a society, we 
have the obligation to. Not all science is good science. I mean 
the worse example I'm aware of in human history goes to Nazi 
scientists who all felt they were doing good things. They all 
felt they were doing good work, who could document and 
articulate very rational, significant reasons for things that 
they were doing which I think all of us would have--or I would 
hope, all of us would have a consensus were despicable, immoral 
acts. I guess to some level the concept--and again, maybe I'm 
limited in terms of putting that on the table at this point in 
time, but I think there is positive research, there's positive 
things that we can get out of research related to this, but the 
concept of what we're talking about, I have a real problem with 
and I guess, Rael, I take it seriously everything you said. If 
you could respond to that, I mean just in terms of saying 
science by definition is positive, then how do you respond to 
uses of science which I think by any definition would be evil.
    Mr. Rael. I am surprised that everybody is in a hurry to 
create ethical committees and ruling for cloning because it's 
giving birth, it's not killing. And there is no ethical 
committees against nuclear weapons who killed hundreds of 
thousands of people in Hiroshima and Nagasaki and chemical 
warfare and biological warfare. There should be ethical 
committee for this science who are now under government 
manipulation in the world and who are mass killing. But giving 
birth to a child I do not see any reason.
    Mr. Deutsch. I just want you to have at least the 
opportunity to respond as well. Would you question what I said 
earlier in terms of just the medical science status today? 
Would you question that assessment of where science is today in 
terms of cloning?
    Maybe putting the question another way, how, in your 
assessment as a lay person, not as a scientist, but obviously 
someone very involved in this, if the Federal Government 
doesn't get involved, when will the first human clone be born?
    Mr. Rael. It will happen anyway as nothing can stop 
science.
    Mr. Deutsch. I guess I don't want to pin you down too much, 
but two things, one is is it safe to do it now, now, and No. 2 
is, when will it happen?
    Mr. Rael. As one of the scientists explained earlier, when 
IVF started there was only 2 percent of success. How did they 
improve to reach almost 100 percent today? By doing it. If they 
stopped doing it, science has to do it to progress. The first 
heart transplants were deadly. The first airplanes were deadly. 
But we didn't stop it because of that. Because by doing it, 
scientists can improve the technology and finally be 
successful.
    Mr. Deutsch. I don't feel you answered it, but that's okay. 
Let me just respond because I think it's worthy of response, 
specifically, with in vitro fertilization. When it wasn't 
successful, you didn't create a live birth or a miscarriage 
that is tragic consequences. I think that the problem that we 
have here is the lack of success in each in vitro situation, 
the downside risk was minimal. The downside risk of the 
unsuccessful cloning process based on everything that we've 
seen at this point is dramatic. I mean very, very serious, for 
the person involved, for the mother involved, for the child 
involved, for society as a whole. So I think the comparison is 
a totally unfair comparison.
    Mr. Rael. May I answer?
    Mr. Deutsch. It's up to the chairman at this point.
    Mr. Greenwood. We've broken all the rules today, so you go 
right ahead, Rael and respond.
    Dr. Soules, did you wish to respond as well?
    We will allow both of you to respond.
    Mr. Soules. We've been hearing that it's relatively easy if 
you have an IVF clinic to do cloning and that's simply not 
true. If somebody gave the University of Washington about $5 
million and we recruited a couple hundred donors, donor eggs 
that is, and I had about 20 Ph.D.s working on it, we could pull 
it off, probably in a couple of years. So I think there's 55 
IVF clinics in New York City so they could do at any time. I'm 
in an IVF lab almost every day talking to our basic scientists 
and it's just not that easy. I'm not saying it can't be done. 
our society, ASRM, says it shouldn't be done, but yet on the 
other hand it's not easy and it's not efficient.
    Mr. Greenwood. Rael, did you wish to make a comment?
    Mr. Rael. Yes, I just wanted to say that every day 
thousands of children in the world are born with problems as 
what some people call monsters, retarded people, handicapped 
people, made, conceived by sexual intercourse. Because of that 
should we make sexual reproduction forbidden? Of course not, 
nothing is perfect as has already been said, but we cannot have 
double standard, I mean.
    Mr. Greenwood. We've already addressed the issue and we 
decided not to make sexual intercourse illegal.
    Let me quickly respond. First off, it is not the case that 
this committee is rushing to judgment on cloning per se. I 
think, speaking for myself, that there are a myriad of 
extraordinarily good uses for cloning, therapeutic uses to cure 
diseases, to create organs for transplant and so forth. And I 
should also tell you that there's a lot of work that gets done 
in this town to try to ban weapons of mass destruction, be they 
nuclear, biological and chemical and so forth, so there is a 
lot of work on that.
    I would just like to make one comment to Mr. Wicker in 
response to his, some of his comments. The issue, it seems to 
me isn't just about your right to pass your genetic material on 
into the future. To me, there's a question which is some day a 
little boy, were you to succeed at that, some day a little boy 
would say to his mother and father, whoever was raising him. 
Where did I come from, mom and dad? We all did that when we 
were little boys and girls. And most of us heard a response 
well, mommy and daddy got married and then, you know. In this 
case somebody would say well, there was this fellow Mr. Wicker 
and Mr. Wicker wanted to pass his genetic material on to the 
future and so he made a genetic copy of himself and that's who 
you are. That's the philosophical question that we're wrestling 
with.
    Mr. Wicker. No, no. This boy would know that he was so 
wanted and loved that I dedicated all my money to see that he 
received the gift of life and I want to make one other point, 
you set standards of safety and a good example was recently on 
the Charlie Rose show. Dolly, when I was here in 1998, they 
said how do we know Dolly isn't a fraud. Then Dolly was 
supposed to be 6 or 7 years old at birth and about ready to 
drop dead. Well, now she's 5 or 6 years and she's still having 
lambs. I think she's past sheep menopause, but Dr. Rudolf 
Jaenisch said on the Charlie Rose Show, she seems normal, but 
how do we know that Dolly is not mentally retarded or 
schizophrenic. You can't win an argument. If Dr. Jaenisch would 
just give me a test so I can test the intelligence of sheet or 
test their personality adjustment, I mean the point I'm making 
is that even if you seem absolutely perfectly normal and 
whatever, people that are opposed to it will demand 
unreasonable and reasonable perfection.
    Mr. Greenwood. The Chair recognizes from gentleman from 
Illinois, Mr. Rush, for 5 minutes to inquire.
    Mr. Rush. Thank you, Mr. Chairman. First of all, I want to 
tell all the witnesses that I really respect and appreciate the 
fact that you've spent most of your day here and you've done 
quite well and I certainly apologize for the length of time 
that you've been here, but it's been very, very interesting, 
your testimony and this hearing has been very, very 
interesting.
    I'd like to ask Mr. Hanson, Mr. Hanson, there's clearly 
issues of separation of church and State that abounds in this 
particular issue. However, what do you feel faith has to bring 
to this discussion, to this issue of cloning? Where should we--
we've heard the scientists and the ethicists and others, but 
enlighten us a little bit in terms of what role faith has in 
this, your perspective.
    Mr. Hanson. First off, let me say that our denomination 
would be among those that would be first in supporting the 
rights of other religious bodies to hold their beliefs, so 
nothing that I say really should be interpreted as infringing 
on other religious bodies to hold beliefs. I think one of the 
uniqueness of this U.S. system is that the government is not to 
legislate a required religion. That being said, I think that 
one of the things about this country is we are one of the most 
religious countries in the world, that our citizenry does take 
seriously their religious practices, all of them. The faith 
community is very often the first place someone dealing with 
these difficult issues of reproduction turn to. People go to 
their priests and rabbis and ministers, seeking help to decide 
difficult questions. We have, because of that, a wealth of very 
practical experience as well as our theological reflections.
    The United Methodist Church has not entered this discussion 
quickly. We have--some of the issues taken here, we do not have 
a policy against IVF. We are a denomination that supports the 
legal right that a woman has to an abortion. We have lots of 
caveats about how that should happen.
    I think what's interesting about this issue is that you 
have the United Methodist Church, the U.S. Conference of 
Catholic Bishops, the Southern Baptists, the United Church of 
Christ, all saying very similar things. When you have such a 
broad spectrum of religious voices, I would suggest that it is 
something that the faith community has something to say about.
    Mr. Rush. Okay.
    Mr. Greenwood. Ms. Terry, did you wish to respond?
    Ms. Terry. Yes. I would just add, in our testimony from the 
Genetic Alliance we called for faith communities dialoguing 
about this issue because we believe that many people form 
decisionmaking and their values based in a faith community in 
America and so that should be part of the dialog. And in 
addition, I think technologies like this and other genetic 
technologies can create great disparities between 
disenfranchised communities and marginalized communities and 
faith communities are often a way for them to access the dialog 
and they should be included in the dialog.
    Mr. Rush. Thank you. Mr. Eibert, earlier in my questioning 
I quoted a question from you and I want to get back to that, 
give you a chance to respond to it. Your testimony says today, 
the FDA claims to have statutory authority to regulate 
reproductive cloning. A pretty radical claim since America has 
never had a Federal reproductive police. However, virtually 
every lawyer on both sides of the debate agrees that the FDA 
has no such authority under current law. And you say you will 
be happy to tell us why during the question period. Why don't 
you take a shot at that?
    Mr. Eibert. Thank you, I would have loved to tell you 
during my time, but I only had 5 minutes. I'm not sure I can 
expand too much on what Chairman Tauzin has said because I 
agree with him completely. There is nothing in the Food Drug 
and Cosmetics Act or the Public Health Service Act or any 
relevant piece of legislation that gives the FDA authority over 
cloning or anything that even arguably could be defined as 
cloning. Nor does the FDA have the authority to regulate the 
practice of medicine, that's typically done by the states or to 
regulate the reproduction of American citizens.
    What it does have authority to do is to regulate certain 
statutorily identified and listed things. And as even 
Congressman Ellers who, as you know, is one of the main leaders 
of anti-cloning sentiment in Congress has said, ``it's hard to 
argue that a cloning procedure is a drug.'' Given the complete 
absence of any support in legislative history, case law, 
statutory language or in the legislative, the regulatory 
history of the FDA itself, it's even harder to argue that human 
embryos are a drug or that human embryos are biological 
products such as a toxin which is my understanding of what 
their current position is.
    I don't believe that the Congress that passed the Food, 
Drug and Cosmetics Act in 1902, had any intention of making the 
FDA the reproductive police or giving them control over human 
embryos.
    As Chairman Tauzin said, 1 year ago the Supreme Court 
struck down the FDA's unilateral effort to seize control or 
gain control over tobacco, citing the fact that like cloning, 
tobacco was not listed among the enumerated items that the FDA 
can regulate in the Food, Drug and Cosmetics Act or the Public 
Health Service Act and they also pointed out that as with 
reproductive medicine, the FDA had a history of ignoring that 
area including things which are extremely similar to cloning, 
both in technique, ICSI, cytoplasm transfer, things like that.
    I would anticipate that the FDA's authority will be 
challenged. I think it's more likely to be challenged by 
patients than by doctors and I think it's going to come out the 
same way as the tobacco thing happened.
    My last point is that what I heard the FDA representative 
saying was well, okay, maybe it's true it's not in there, but 
we recently, as of January 2001 have finalized regulations 
where we say we have authority over not embryos, exactly, but 
something else. Well, I would say number that's a bootstrapping 
argument as the Supreme Court pointed out. Just because they 
say they have authority over something doesn't mean that they 
and second, that's a pretty new regulation and I think we 
should wait to see what the courts have to say about that 
before we assume that you can regulate one thing, you can then 
regulate whole human beings which is what we're talking about 
here.
    Mr. Rush. Dr. Cameron, you wanted to chime in here?
    Mr. Cameron. Thank you, if I might briefly. Of course, much 
of our effort this afternoon has been focused on the safety 
question and this FDA context is exclusive of a safety question 
as has been pointed out and on the assumption that safety 
issues were removed, then it would be hard for the FDA to 
contain the cloning situation. And I simply want to make sure 
we don't leave our discussion underlining the fundamental moral 
question here is not the safety question. That is a fundamental 
moral question of itself, but back of that lies the question of 
cloning in itself. And I made some reference to the European 
Convention on Biomedicine and Human Rights which wants an 
international treaty on bioethics which has been as a protocol 
to ban cloning and I just want to read the two lines in the 
convention which specifically give the fundamental ground for 
this ban on cloning. There's a reference to psychological, 
social, medical problems which may be expected. But the basic 
phrase is this one, because of the instrumentalization of human 
beings, through the deliberate creation of genetic and 
identical human beings is contrary to human dignity and thus 
constitutes a misuse of biology and medicine, that to have this 
discussion is not about the safety issues. That is one reason 
why some of us think the FDA is inadequate. By the same token, 
it's why the moratorium approach is not adequate. The question 
at the heart is whether ever human beings, even if it's 
perfectly safe should be created as photocopies of other human 
beings. And whereas we've had various people say that they 
would quite to be cloned, I think we've yet to have somebody 
say they wish that they had been born a clone. And the bottom 
line for me in this issue is that every child has a right not 
to have been born a clone because the instrumentalization of 
the child which is a central moral question at stake.
    Thank you.
    Mr. Rush. Yes, Dr. Soules?
    Mr. Soules. I could just comment a little bit on the FDA. 
In terms of their ability to stop a clinic from cloning I can't 
comment, but we've been working with the FDA for the last 2 
years in the sense of this cell and tissue based products and 
it has more to do with the efficiency and safety of the 
embryology laboratories that do IVF today. And so it's been a 
good relationship with the FDA and we're in agreement on how to 
make these laboratories function better, so in that sense it is 
working with the FDA, but in terms of stopping a cloning 
clinic, I'm not sure how that would work.
    Mr. Rush. Thank you, Mr. Chairman. I yield back.
    Mr. Greenwood. I thank the gentleman. I thank the 
witnesses. You have done yeoman service today, both in your 
forbearance and in your testimony. As a matter of record 
keeping, I'd like to enter into the record my letter of March 
15 to Ruth Kirschstein, M.D., Acting Director of National 
Institutes of Health and her response to me of March 26.
    This issue is probably the most complex and profound issue 
that this Congress will wrestle with in this new millennium. 
These are unchartered waters and the question for us, I think, 
is difficult because we don't know what lies beneath these 
waters. What makes it even more agonizing is that we're asked 
not to place ourselves or our witnesses on these waters, but 
little babies to float out on these very unchartered waters. It 
is my view that risk is so grave and it appears to be that 
grave for the foreseeable future, for decades, that we will 
have to act and I suspect that, in fact, I am certain that in 
the near future Chairman Tauzin, the chairman of this 
committee, myself and Mr. Deutsch, the ranking member, will 
introduce legislation to ban the cloning of a human being in 
this country and perhaps we'll have you back to testify about 
that legislation at some point in the future.
    Thank you again. This hearing is adjourned.
    [Whereupon, at 6:20 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]

 PREPARED STATEMENT OF ROBERT A. BEST, PRESIDENT, THE CULTURE OF LIFE 
                               INSTITUTE

    Mister Chairman, Representative Deutsch, members of the 
Subcommittee, I applaud your determination to keep abreast of the facts 
about human cloning and I appreciate the opportunity to submit 
testimony. As our elected representatives, you have an essential role 
to play in framing laws regarding human cloning. There are many reasons 
why human cloning in all forms should be prohibited, but one that 
relates closely to your Constitutional role is that human cloning 
attacks the understanding of equality, which is the organizing 
principle of our Republic. The equality clause of the Declaration of 
Independence and the concept of ``one person, one vote'' lose their 
meaning when human persons become manufactured products. In other 
words, a democracy that permits human cloning will not remain one for 
very long.
    I know the subcommittee will look carefully at the question of 
cloning for therapeutic purposes, in other words the creation by 
cloning of human embryos which are used for research in the embryonic 
stage (resulting in their destruction) or are developed into a fetal 
stage, used for research, and then killed prior to birth. Even if such 
a practice were not lethal to the embryo or fetus, it would still be 
objectionable in terms of the moral and ethical tradition of this 
country. Research on cloned embryos and fetuses, like research on any 
other human embryos and fetuses, would constitute medical 
experimentation on human persons without their individual voluntary 
consent, and would violate the Nuremberg Code. This Code, enunciated 
following the trials of Nazi leaders at the close of World War II, is 
not a law or a treaty obligation. But the Code is a fair summary of the 
civilized ethical standard of experimentation on living human beings.
    Mister Chairman, the embryo may not look it, but it is a human 
being. Whether by cloning or by the fertilization of an egg by sperm, 
the resulting embryo is a new and unique human being with its complete 
genetic code in place and the capability, properly protected and 
nurtured, to become as apparently independent as you or I. Some say the 
need for protection and nurturing invalidates the embryo's claim to 
humanity, but which of us, at any stage of life, does not require 
protection and nurturing? The only difference is of degree, and if we 
accord human rights only to those who are substantially free of the 
need for protection and nurturing by others, than many people in 
hospitals and nursing homes and supersonic airliners and space stations 
and at this moment in the Metro tunnel under the Potomac between Foggy 
Bottom and Roslyn are not human beings, either.
    Mr. Chairman, there is nothing ``therapeutic'' about killing a 
human being, even in the earliest stages of life. ``Therapeutic'', 
according to my Webster, means ``to serve, take care of, treat 
medically . . . of or pertaining to healing''. The proponents of human 
cloning have masked their mission of killing one human being or group 
of human embryos to ``create'' another human being. Whatever their 
motives, there is no moral justification for killing an innocent human 
being. Once we go down that road, life becomes cheap, culture become 
coarse, killing becomes thrilling or ``therapeutic''.
    Mr. Chairman, we as a nation dare not go down that road. The 
precedents for using human beings as fodder for creating the 
``perfect'' human being resulted in disaster for more than one nation 
in the twentieth century. German scientists and the medical profession 
of that nation created a climate in which they determined which life 
was ``worth living'', the ultimate arrogance. By the time Hitler came 
to power, the medical profession in Germany had already engaged in 
massive killing of innocents for the sake of a ``pure race''. The 
culture of death started in German long before Hitler came to power; he 
turned a culture of death against the Jews and others who he deemed 
unworthy of living.
    At the dawn of a new millennium, we must see in every human being 
someone precious and worthy of our love. The Pope, who lived under both 
the Nazi's and the Communists, has called out for a culture of life. To 
foster a culture that loves life is not a partisan or even a 
``religious'' cause; it is a human cause that Democrats, Republicans, 
Independents and all people of good will should aspire to and champion.
    Those who want to conduct experiments that involve the killing of 
human embryos understand the issue, and therefore seek to call embryos 
by some other name, at least for the duration of the experiment. Thus 
some maintain that no human embryos should be termed as such during 
their first two weeks of existence. Terms like ``totipotent cell'', 
``clump of embryonic cells'', and ``unfertilised oocyte'' are used to 
evade the issue. However, the scientific data are clear: a successful 
somatic cell nucleus transfer to a de-nucleated egg creates an embryo.
    Experimentation on embryos and fetuses turns human beings into 
spare parts sources and test beds for other human beings. Such 
experimentation not only kills individuals, and is therefore cruel, but 
it also denigrates the dignity of being human by bringing a person into 
existence and then manipulating him or her for one's own purpose. The 
advocates of such use of human embryos and fetuses describe the 
suffering caused by defects and diseases which might be cured by their 
experiments, but adult stem cells, which are freely available without 
killing or manipulating anyone, have shown more promise thus far than 
have either embryonic stem cells or fetal tissue.
    Let me be clear: good cannot come from a bad action. Even the most 
dire human suffering would not justify the involuntary death of another 
human being, embryonic, fetal, or ambulatory. But the promise of adult 
stem cells may obviate even this insufficient but emotionally strong 
argument for lethal experimentation on human embryos and fetuses.
    There are many other reasons why all human cloning should be 
banned, and I stress that these reasons are practical, not theoretical, 
and are based on universal truths. First, cloning changes the nature 
and meaning of human sexuality. If a new person can be produced by 
taking the nucleus of a somatic cell from a man and injecting it into 
the de-nucleated oocyte of a woman, then human sexuality becomes 
superfluous. From its age-old purpose of transforming human love into 
new life, sexuality in an age of cloning would become, even more than 
it has unfortunately already become, simply an itch to scratch. We have 
seen in the past half-century, as the connection between sexuality and 
reproduction has weakened in the ``sexual revolution'', a rise in 
negative social indicators such as a divorces, abortions, an explosion 
of sexually transmitted diseases including one that is 100% fatal, and 
greatly increased exploitation of women in prostitution and 
pornography. By further weakening sexuality's reproductive purpose, 
cloning would therefore further weaken families and communities.
    Second, human cloning would weaken or even pervert basic human 
relationships such as family, fatherhood and motherhood, consanguinity, 
and kinship. For example, if a clone resulted from the nucleus of a 
somatic cell taken from his ``father'', his biological tie to his 
``mother'' would be vastly different than that of a natural child. 
Apart from mitochondria DNA, which is outside the nucleus and is always 
passed on the maternal side, the clone would inherit no 
characteristics, no other DNA, no genetic material, from his mother. 
This very different biological tie could contribute to a different 
emotional mother-son tie as well. Further, as the clone would likely be 
``the spitten image'' of his father, the mother's already different 
relationship with her child would become truly bizarre. Human cloning 
therefore perverts the relationships that are fundamental to our mental 
health and to the health of society.
    Third, human cloning would compromise the dignity of the cloned 
person because she would forever know she was biologically identical to 
another person. Richard Seed, a scientist who wants to set up a cloning 
clinic in the U.S., has reportedly said that he wished he could have 
obtained a blood sample from Mother Teresa from which to clone a saint. 
Of course, the resulting little girl would only be biologically 
identical to Mother Teresa. Her own environment and experiences would 
make her a unique person. But the expectations that others would put on 
that child, and the expectations she would place on herself, would make 
for a miserable life. She would have lost the essential human freedom 
to be oneself. The children of the famous and notorious sometimes carry 
a heavy burden, but at least they retain the freedom of their own 
individuality. The cloned person would have lost that basic freedom 
because of the decision of another person.
    The threat of power over others is a fourth reason to oppose human 
cloning. Most parents consciously choose to have children, and some try 
to influence the development of their child in utero. All responsible 
parents exercise authority over the children after birth and use their 
authority to educate and develop their children. This use of parental 
authority is natural. But human cloning gives a person absolute 
dominion over the existence of another. Whether the person comes into 
existence at all, when the person comes into existence, what the 
person's genetic material will be, what the person's intelligence and 
appearance and special skills will be--all this would be determined by 
another person. As I noted earlier, if people can have this kind of 
power over others, than the equality clause is just empty words from a 
quaint past. Those who would clone people seek a dominion over others 
which can only be termed ``Godlike''. Like the bypassing of human 
sexuality to achieve reproduction, the calling into existence of a 
precisely specified new person is an exercise in apparent human 
omnipotence.
    A fifth reason to oppose human cloning is that it will increase a 
trend which we need to reverse, if we want to retain our freedom: the 
trend toward evaluating other people on the basis of their qualities 
instead of on their existence. Human cloning will always be the outcome 
of a choice about the specific traits and qualities of a child. As we 
have seen, cloning turns human reproduction into a manufacturing 
process. In time, given our national genius at capitalism, particular 
qualities and the raw material needed to obtain them will be available 
in exchange for money. Health insurers, for example, have a financial 
incentive to favor healthier children. Wealthy parents will use cloning 
to get ever-higher ``quality'' children (``quality'' meaning whatever 
the fashion of the time dictates) while poor people, reproducing in the 
traditional way, would lag ever farther behind. Again, the strain 
imposed on our concept of equality will be too much, and self-
government will end.
    I said earlier that human cloning would be an exercise in apparent 
human omnipotence. I say ``apparent'' because, unlike the natural 
reproductive system which has brought us to this point, cloning is 
fraught with physical risks. Many of those risks have already been 
displayed in the cloning of mammals. For example, Dolly the cloned 
sheep was the one live birth derived from 277 sheep embryos which were 
created in the experiment. Cloned embryos appear to develop into 
larger-than-normal foetuses, resulting in a high incidence of 
stillbirths and Caesarean section deliveries. Developmental problems 
associated with abnormal size of human clones would include a high 
incidence of death in the first few weeks from heart and circulatory 
problems, diabetes, underdeveloped lungs, or immune system problems. 
The January death from a common infection of a cloned wild gaur (an 
endangered South Asian species) at Trans-Ova Genetics in Sioux Center, 
Iowa, may indicate that cloned animals have a lower resistance to 
disease. Another problem is the potential for clones to have aging DNA 
and thus an accelerated aging process. Lord Robert Winston, one of the 
developers of in vitro fertilization, has stated that because of the 
faster aging process, he would not want a child of his to be cloned.
    The current low rate of cloning success with mammals (two clones 
born per 100 implantations, according to one source, up to 17 per 100 
according to another) suggests a similarly low success rate for human 
cloning. And even if a seemingly normal and healthy animal is born, a 
defect that was not apparent can suddenly cause death, as was the case 
with a cloned sheep born last December at the same centre which 
produced Dolly. The March 25, 2001 New York Times, reporting on the 
cloning of animals, described a high rate of spontaneous abortion and 
post-natal developmental delays, heart defects, lung problems, and 
malfunctioning immune systems among cloned animals who had initially 
seemed normal. But let us stipulate that human ingenuity will gradually 
increase the success rate: who could live with having caused the pain 
of the many human clones who suffered and died along the way?
    Mister Chairman, for these many reasons the Culture of Life 
Institute urges you to protect the lives of an untold number of 
individuals and to protect the principle of equality which is the basis 
of our legal and governmental system by drafting and passing a bill 
which would prohibit the cloning of human beings, at any stage of 
development, for any purpose. Thank you.
                                 ______
                                 
        Prepared Statement of C. Ben Mitchell, Ph.D.1
---------------------------------------------------------------------------
    \1\ Consultant on biomedical and life issues for the Ethics & 
Religious Liberty Commission (ERLC) of the Southern Baptist Convention, 
associate professor of bioethics and contemporary culture, Trinity 
International University, senior fellow of the Center for Bioethics and 
Human Dignity, and editor of the journal, Ethics & Medicine: An 
International Perspective on Bioethics.
    The Ethics & Religious Liberty Commission is the moral concerns, 
public policy, and religious liberty agency of the Southern Baptist 
Convention, the nation's largest non-Catholic religious denomination 
with over 15.8 million members in over 40,000 congregations nationwide. 
The ERLC has offices in Nashville, Tennessee and Washington, DC.
---------------------------------------------------------------------------
    ``I was convinced that there was still plenty of time.'' 
2 With those haunting words, Aldous Huxley looked back to 
the 1931 publication of his prescient book, Brave New World. Huxley's 
vision of an oppressive culture of authoritarian control and social 
engineering was among the more shocking literary events of the 
twentieth century. But a mere 27 years after the publication of his 
novel, Huxley was already aware that he had underestimated the threat 
of modern technocratic society.
---------------------------------------------------------------------------
    \2\ Aldous Huxley, Brave New World Revisited (New York: Harper and 
Row, 1958), p. 3.
---------------------------------------------------------------------------
                  EXPLAINING OUR DIS-EASE WITH CLONING

    When Wilmut, et. al, announced the first successful cloning of an 
adult mammal, there was a public gasp, as it were. That which could 
only be imaged as science fiction had become science fact. If one 
mammalian species could be cloned, surely the cloning of Homo sapiens 
could not be far off. As we now know, the cloning of a human being is a 
present reality. Not have maverick scientists Severino Antinori and 
Panos Zavos begun their quest to clone a human being, but Australian 
researchers have disclosed that they have already clone human embryos. 
The clone age is here.
    Nevertheless, the public is decidedly against cloning human beings. 
In nearly every poll, the overwhelming majority of those surveyed find 
the idea of cloning a human being repugnant. In a poll released by 
ABC's NIGHTLINE program the day after the Dolly announcement, 87 
percent of those polled said the cloning of a human being should be 
banned. Eighty-two percent said cloning human beings would be morally 
wrong, and 93 percent said they personally would not choose to be 
cloned.
    In an often cited article in The New Republic, Leon Kass of the 
University of Chicago argued compellingly that cloning is not ``to be 
fretted about for a while, but finally to be given our seal of approval 
. . . the future of our humanity hangs in the balance.'' 3 
Human cloning, he maintained, ought to be prohibited immediately. We 
were forewarned.
---------------------------------------------------------------------------
    \3\ Leon R. Kass, ``The Wisdom of Repugnance: Why We Should Ban the 
Cloning of Humans,'' The New Republic (2 June 1997), p. 18.
---------------------------------------------------------------------------
    Some scientists and a few ethicists have asked us to lower our 
defenses and give human cloning a shot. In an editorial in the same 
issue of Nature which premiered Dolly the cloned sheep, we were told 
that ``Ethical constraints aside, there are even some rare genetic and 
medical disorders for which [cloning] would be a desirable way for a 
couple to produce offspring.'' 4 President Clinton's 
temporary moratorium on human cloning was castigated in the same 
article: ``At a time when the science policy world is replete with 
technology foresight exercises, for a US president and other 
politicians only now to be requesting guidance about what appears in 
today's Nature is shaming.'' 5 At the same time, the 
International Academy of Humanism, a group which includes such 
luminaries as Francis Crick, Richard Dawkins, Anthony Flew, W. V. 
Quince, Kurt Conneaut, and E. O. Wilson, ``call[ed] for continued, 
responsible development of cloning technologies, and for a broad-based 
commitment to ensure that traditionalist and obscurantist views do not 
irrelevantly obstruct beneficial scientific developments,'' which 
include human cloning.6
---------------------------------------------------------------------------
    \4\ Editorial, ``Caught Napping By Clones,'' Nature 385 (27 
February 1997).
    \5\ Ibid.
    \6\ Press Release, International Academy of Humanism, ``Statement 
in Defense of Cloning'' (16 May 1997).
---------------------------------------------------------------------------
    We anticipated such reactions. Boston University professor of 
health law George Annas pointed out a long time ago that ``ethics is 
generally taken seriously by physicians and scientists only when it 
either fosters their agenda or does not interfere with it. If it 
cautions a slower pace or a more deliberate consideration of science's 
darker side, it is dismissed as `fearful of the future,' anti-
intellectual, or simply uninformed.'' 7 Taking a strong 
stance against cloning a human being is hardly being a fear-monger.
---------------------------------------------------------------------------
    \7\ George J. Annas, ``Whose Afraid of the Human Genome?'' Hastings 
Center Report (1989), p. 21.
---------------------------------------------------------------------------

                       WHY HUMAN CLONING IS WRONG

    In my view, it will take something much stronger than moral 
intuition to prevent the cloning of a human being. The technological 
imperative (``if we can do it, we should do it'') 8 and the 
commodification inherent in contemporary biotechnology are powerful 
forces. The technopolists are many.9
---------------------------------------------------------------------------
    \8\ Neil Postman reminds us that ``technology is not a neutral 
element in the practice of medicine: doctors do not merely use 
technologies but are used by them.'' Neil Postman, Technopoly: The 
Surrender of Culture to Technology (New York: Alfred A. Knopf, 1992), 
p. 105.
    \9\ For a very engaging discussion of the commercial interests at 
stake in the burgeoning biotechnology industry, see Lori Andrews and 
Dorothy Nelkin, Body Bazaar: The Market for Human Tissue in the 
Biotechnology Age (New York: Crown Publishers, 2001).
---------------------------------------------------------------------------
    Probably the first question most persons find challenging with 
respect to cloning is: ``Is a cloned human being a human person?'' For 
sake of space, I will have to make short work of this question. Not 
only do I think we have to agree that a human clone is a human person, 
but I think it would be dangerous not to think this would be the case. 
Joseph Fletcher, the father of so-called Situation Ethics, teased us 
with this question back in the 1960s. He invited us to imagine cloning 
chimeras or sub-humans who could do the menial and repetitive tasks 
which were either too dangerous or too demeaning to full human 
existence.
    There is no good reason to assume that a human clone would be any 
less human than a person conceived through normal reproduction. A 
cloned human being would have the full complement of genomic 
information in her DNA. If Dolly is the prototypical clone, a cloned 
human being would possess all the qualities and faculties of any other 
human being.
    From a Christian perspective, a cloned human being would be as much 
a person as any other human being. She would be an embodied soul and 
would be an imager of God (Cf. Genesis 1:27; 9:6ff). Humans are, 
according to both Jewish and Christian theology, the only beings made 
in the image of God (imago Dei). As an imager of God, human clones 
would possess the same dignity and divinely-bestowed moral worth as any 
other member of our species.
    The dignity of individual human lives both prescribes and 
proscribes how human beings are to be treated. Human beings may not be 
used as means to our own ends. They may not be the subjects of 
experiments without their knowledge and permission. We may not demean 
human beings by imposing upon them conditions they might not have 
consented to, if allowed to make the decision for themselves.
    These principles would make immoral most of the reasons that have 
been suggested as reasons to clone human beings. Thus, human clones 
would not be suitable ``organ farms'' for those needing transplantable 
organs. Human clones would not be acceptable ``substitutes'' for 
children who died leaving their parents grief-stricken. Human clones 
likewise, would be ethically unacceptable candidates as ``icons'' in 
some kind of narcissistic cult of self-worship.
    Furthermore, research on human embryos for cloning is wrong on the 
face of it. Note that it took some 277 attempts to clone one little 
lamb. That means that 276 little lamb embryos were sacrificed on the 
altar of biotechnology. While this might be an acceptable practice when 
cloning sheep (providing the sheep were not abused in the lab), such 
experimentation would be unconscionable when applied to human embryos.
    TIME magazine's pictorial, ``How to Clone a Human,'' 10 
is absolutely chilling. The authors estimate that it might take 400 
human ova which would be coaxed into dividing through somatic cell 
nuclear transfer. ``According to experts,'' the caption says, 
``producing a single viable clone will require scores of volunteers to 
donate eggs and carry embryos--most of which will have major 
abnormalities and never come to term. The clones that do survive could 
suffer more subtle problems that might show up well after birth.'' 
11 Toward the end of the chart there is an image of a ``baby 
clone.'' Next to that image are images of two human babies surrounded 
by dotted lines (similar to the lines used to mark homicide victims on 
pavement) with the caption: ``some babies do not survive.'' Even if the 
end were justifiable (and it is not), the means would not justify the 
end.
---------------------------------------------------------------------------
    \10\ TIME, 19 February 2001, pp. 52-53.
    \11\ Ibid.
---------------------------------------------------------------------------
    More recently, research on animal clones has demonstrated that 
cloning humans would result in untold loss of life and grotesque 
consequences in the lives of those who survived. University of Hawaii 
researcher Ryuzo Yanagimachi has observed that ``Cloned embryos have 
serious developmental and genetic problems.'' 12 Dr. Brigid 
Hogan, professor of cell biology at Vanderbilt University calls human 
cloning ``morally indefensible'' 13 and Dr. Rudolph Jaenisch 
of Massachusetts Institute of Technology calls human cloning ``reckless 
and irresponsible.'' 14 Jaenisch points out that if cloned 
embryos are created ``most of those will die in utero. Those are the 
lucky ones. Many of those that survive will have . . . abnormalities.'' 
15 Cloning a human embryo is morally unconscionable and 
scientifically repugnant.
---------------------------------------------------------------------------
    \12\ Reuters News Service, ``Report Says Scientists See Cloning 
Problems,'' 24 March 2001.
    \13\ Ibid.
    \14\ Ibid.
    \15\ Jeremy Manier, ``Potential Perils Born in Cloning,'' Chicago 
Tribune, 4 March 2001.
---------------------------------------------------------------------------
    I am troubled, therefore, by the decision of the National Bioethics 
Advisory Commission (NBAC) to support the cloning of human embryos, as 
long as those embryos are not allowed to develop into 
babies.16 According to the Executive Summary of the NBAC 
report on human cloning, ``The commission concludes that at this time 
it is morally unacceptable for anyone in the public or private sector, 
whether in a research or clinical setting, to attempt to create a child 
using somatic cell nuclear transfer cloning.'' 17 Yet, the 
commission nowhere condemned experimentation on preborn children. In 
fact, the commission's recommendations would permit the cloning of 
human embryos.18 It is too early, of course, to know the 
precise language of forthcoming legislation, but at this point it seems 
clear that NBAC and President Clinton left the gate wide open for 
privately-funded embryo research, including embryo 
cloning.19 We are now paying for their moral negligence.
---------------------------------------------------------------------------
    \16\ Rick Weiss, ``Panel Backs Some Human Clone Work,'' The 
Washington Post (4 June 1997), A1, 29.
    \17\ Executive Summary, Cloning Human Beings: Report and 
Recommendations of the National Bioethics Advisory Commission (June 
1997), p. iii. Emphasis added.
    \18\ Patricia Wilson, ``U.S. Ethics Panel Urges Ban on Human 
Cloning,'' Reuter's News Service (8 June 1997). President Clinton 
announced in 1994 a ban on tax-funded research which involves producing 
human embryos solely for research which would result in their 
destruction. This leaves open, however, the private-funding of human 
embryo research.
    \19\ George Annas, Art Caplan, and Sherman Elias have opined, ``To 
create human embryos solely for research--or to sell them, or to use 
them in toxicity testing--seems morally wrong because it seems to 
cheapen the act of procreation and turn embryos into commodities. 
Creating embryos specifically for research also puts women at risk as 
sources of ova for projects that provide them no benefit. The moral 
problem with making embryos for research is that as a society we do not 
want to see embryos treated as products or mere objects, for fear that 
we will cheapen the value of parenting, risk commercializing 
procreation, and trivialize the act of procreation.'' George Annas, 
Arthur Caplan, and Sherman Elias, Sounding Board, New England Journal 
of Medicine (16 May 1996).
---------------------------------------------------------------------------
    There is no relevant moral distinction between an embryo and a 
postnatal baby. Because both are imagers of God, both possess the same 
dignity and deserve the same protection. Philosopher-ethicist and 
former bench scientist Dianne Irving has argued convincingly that the 
terms ``preembryo'' and ``preimplantation human embryo'' reflect a 
politicization of science rather than biological facts.20 
``Embryo,'' ``baby,'' and ``adult'' are merely three terms we use to 
discriminate between stages of biological development. They are not 
terms that ought to carry moral baggage. With respect to the 
ontological status of Homo sapiens, these terms represent a distinction 
without a moral difference.
---------------------------------------------------------------------------
    \20\ Dianne N. Irving, in Diane M. Gianelli, ``Embryo Research 
Division Set to Spark Controversy,'' American Medical News (20 June 
1994).
---------------------------------------------------------------------------
    In 1997, my own denomination, the Southern Baptist Convention, 
passed a resolution on genetic technology and cloning which made just 
this point. Messengers at the convention affirmed, ``WHEREAS, Southern 
Baptists are on record for their consistent and vigorous opposition to 
the devaluation of human life and the encroachment of the culture of 
death . . . BE IT FURTHER RESOLVED, That we call on Congress to enact 
federal legislation against producing human embryos for the purpose of 
experimentation, whether by tax-funded or privately-funded 
researchers.'' 21
---------------------------------------------------------------------------
    \21\ ``Resolution on Genetic Technology and Cloning,'' adopted by 
messengers to the 140th annual Southern Baptist Convention, meeting in 
Dallas, Texas, June 17-19, 1997.
---------------------------------------------------------------------------
    Interestingly, the United Methodist Church's General Board of 
Church and Society concurs with this view. Their Genetic Science Task 
Force issued a statement on May 9, 1997, stating:

1. At this time, we call for a ban on human cloning. This would include 
        all intended projects, privately or governmentally funded, to 
        advance human cloning. (For purposes of this document, human 
        cloning means the intentional production of genetically 
        identical humans and human embryos.)
2. We call for a ban on therapeutic, medical, and research procedures 
        that generate waste embryos.
3. As Christians, we affirm that all human beings, regardless of the 
        method of reproduction are children of God and bear the Image 
        of God. If humans were ever cloned, they along with all other 
        human beings, would have inherent value, dignity, and moral 
        status and should have the same civil rights . . .22
---------------------------------------------------------------------------
    \22\ Statement from the United Methodist Genetic Science Task 
Force, General Board of Church and Society of the United Methodist 
Church, Washington, DC (9 May 1997).
---------------------------------------------------------------------------
    Since neither I nor, presumably, the United Methodists, wish to be 
viewed as reductionists, it must be said that human cells, genes, 
tissues, etc., are not human beings. We are more than the sum of our or 
genetic parts. That is to say, even though I think cloning human 
embryos is wrong, that does not mean cloning human genes for research 
purposes or cloning individual human organs for transplant or cloning 
human nerve cells to treat spinal cord injuries would be wrong. In 
fact, I would support such uses of cloning, as long as the means of 
getting there does not treat humans sub-humanly.

           THE NEWEST REPRODUCTIVE TECHNOLOGY AND THE FAMILY

    Another of the major foci in the cloning debate is the way human 
cloning would impact the family. Family is, obviously, a very important 
institution in Jewish and Christian theology. It is clear to observers 
that human cloning would upset traditional family patterns.
    Mark Sauer, M.D., an infertility specialist at Columbia 
Presbyterian Medical Center in New York sees cloning as offering a 
potentially powerful new reproductive technology for helping infertile 
couples.23 At the same time, Randolfe Wicker, one of the 
founders of the Mattachine Society, an early homosexual rights advocacy 
group, sees cloning as a desirable means of asexual reproduction. Jack 
Nichols, author of The Gay Agenda: Talking Back to the Fundamentalists, 
says, ``Let's not rush to judgment and forget the way in which the 
technology might help gay people create their own families, free from 
the coercion of the state.'' 24
---------------------------------------------------------------------------
    \23\ Gina Kolata, ``For Some Infertility Experts, Human Cloning Is 
a Dream,'' The New York Times (7 June 1997), A6.
    \24\ Chris Bull, ``Send in the Clones,'' The Advocate (15 April 
1997), p. 37.
---------------------------------------------------------------------------
    Quite apart from the debate over homosexuality, cloning raises the 
important question, ``Why have children? Why reproduce?'' In his 
article, ``Why Have Children?'' Marshall Missner suggests that persons 
choose to have children for either social or personal goals. He 
includes:
    Social goals

1. The survival of humanity.
2. The survival of one's culture or community.
3. Biological drive.
    Personal goals

1. A simple desire to have children.
2. Viewed as part of a ``full'' human life and young adulthood.
3. Financial benefit and/or improved social status.
4. Religious conviction.
5. As a kind of personal immortality.
6. Enhancement of personal happiness.
7. Altruism.25
---------------------------------------------------------------------------
    \25\ Marshall Missner, ``Why Have Children?'' The International 
Journal of Applied Philosophy 3 (Fall 1987). Of course all of these 
questions were thrust into the American conversation in the Ayala case, 
where a California woman chose to give birth to a child for the purpose 
of producing a bone marrow donor for her 16 year-old daughter. See 
``Conceiving a Child for ``Ulterior Motive'' Creates Ethics Furor,'' 
Medical Ethics Advisor (April 1990), p. 41-43.
---------------------------------------------------------------------------
    John A. Robertson, University of Texas law professor (and one who 
testified at the NBAC hearings on cloning), has argued that ``in almost 
all instances an individual or couple's choice to use technology to 
achieve reproductive goals should be respected as a central aspect of 
people's freedom to define themselves through reproduction.'' 
26 Is that what is going on in reproduction? Are we having 
children in order to ``define ourselves''?
---------------------------------------------------------------------------
    \26\ John A. Robertson, Children of Choice: Freedom and the New 
Reproductive Technologies (Princeton: Princeton University Press, 
1994), p. 18.
---------------------------------------------------------------------------
    Before I proceed, I suppose I should confess that I am half of an 
infertile couple. My wife and I have been married for 26 years and have 
been unable to have children. I mention this to explain that I 
understand something of the psychology of infertility. I also have 
written on the ethics of the new reproductive technologies. If anyone 
has a personal stake in cloning, I do.
    Nevertheless, I find that moral and theological reasons against 
cloning as a reproductive (or should I say, replicative?) assistance 
technology always trump the psychosocial reasons for the technology.
    From a biblical perspective, then, sexual differentiation (male and 
female) and the place of childbearing within the matrix of a monogamous 
heterosexual marriage is normative. From the beginning God said, ``. . 
. in the image of God he created them: male and female he created 
them'' (Genesis 1:27) and ``Therefore shall a man leave his father and 
mother, and shall cleave unto his wife: and they shall be one flesh'' 
(Genesis 2:24). From this one-flesh relationship children proceed. They 
are ``a heritage from the Lord,'' as the psalmist says. They are a gift 
from God. Procreation should not be viewed as a form of self-
definition. Rather, bearing children is a covenant responsibility 
granted sovereignly by the God who made us.
    Now, assuredly, in the biblical witness there is a presumption in 
favor of procreation. We are told to ``Be fruitful, and multiply, and 
replenish the earth . . .'' (Genesis 1:28). As Anglican theologian 
Oliver O'Donovan points out, ``Some understanding like this is needed 
if the sexual relation of a man and woman is to be more than simply a 
profound form of play.'' 27
---------------------------------------------------------------------------
    \27\ Cited by Gilbert Meilaendar in his testimony before the 
National Bioethics Advisory Commission, 13 March 1997.
---------------------------------------------------------------------------
    Nevertheless, children are to be viewed as a divine gift, not a 
narcissistic means of self-definition. The gift of children comes with 
an enormous bundle of moral and spiritual obligations. They are to be 
reared ``in the training and instruction of the Lord'' (Ephesians 6:4 
NIV). Parents, fathers in particular, are not to provoke to wrath or 
exasperate their offspring (Ibid).
    My point is that the time is long overdue for us to re-examine and 
recommit ourselves as a culture to fulfill our obligations to our 
children as treasured members of the familial covenant--not commodities 
to be used for our desired ends. If Barbara Defoe Whitehead's volume, 
The Divorce Culture, teaches us anything, it teaches us that, removed 
from the context of a nurturing, two-parent family, children are 
tragically sacrificed on the altar of modernity's selfishness.
    Contrary to what some feminists believe, ``the conjugal bond is not 
a biological trap from which we should seek escape. The marital 
relationship is the only divinely sanctioned locus of human sexuality, 
and the bearing of children. The blessing of children is the intended 
result of the marital bond and the conjugal act.'' 28
---------------------------------------------------------------------------
    \28\ R. Albert Mohler, Jr., ``The Brave New World of Cloning: A 
Christian Worldview Prespective,'' forthcoming in Ronald Cole-Turner 
(ed), Religious Perspectives on Cloning (Louisville:Westminster/John 
Knox Press, 1997).
---------------------------------------------------------------------------
    Some forms of reproductive technology have separated fertility and 
child bearing from the conjugal act, and in many cases from the marital 
relationship. This separation is of great moral consequence. As Gilbert 
Meilaender has said, ``In our world there are countless ways to `have' 
a child, but the fact that the end `product' is the same does not mean 
that we have done the same thing.'' 29
---------------------------------------------------------------------------
    \29\ Gilbert Meilaender, Bioethics, pg. 15.
---------------------------------------------------------------------------
    In a post-Enlightenment culture which celebrates atomistic 
individualism as its crowning achievement, the use of cloning as a 
reproductive technology would be like sending divers down to repair the 
screws as the Titanic slowly sinks into the darkness.
    There are many additional concerns raised by human cloning, such 
as,

1. To what extent children have a right to expect to have a mother and 
        father?
2. How do we combat the inherent eugenics motivations behind human 
        cloning?
3. Would persons with disease genes be cloned? Would the near-sighted, 
        far-sighted, or deaf be cloned? Would the obese or frail be 
        cloned?
    In fact, Leon Kass my not be far off when he says of the cloning 
debate: ``We must rise to the occasion and make our judgments as if the 
future of humanity hangs in the balance. For so it does.'' 
30
---------------------------------------------------------------------------
    \30\ Leon R. Kass, ``The Wisdom of Repugnance.''
---------------------------------------------------------------------------

                               CONCLUSION

    Human cloning, including the cloning of human embryos, ought to be 
banned immediately. The January decision of the British House of Lords 
to allow human embryonic cloning coincided nicely with the publication 
of WIRED magazine's lead article predicting that someone will clone a 
human in the next twelve months.31 The decision by the House 
of Lords is troublesome in many ways. First, the Peers had the 
opportunity to postpone their decision in favor of establishing a 
select committee to assist in doing the ethical analysis warranted by 
such a momentous step. After all, some of the most respected voices in 
England, including Lady Warnock's, called for such a commission. 
Instead, the Lords rushed in where angels fear to tread. Even worse, 
the policy proposed by the House of Lords requires that any cloned 
human embryo would have to be destroyed within 14 days after the 
procedure. Mandatory destruction hardly seems a fitting end for a human 
being who entered this world at the will of human somatic cell nuclear 
manipulators.
---------------------------------------------------------------------------
    \31\ Brian Alexander, ``(You)\2\,'' WIRED 9.02, February 2001, pp. 
120-135.
---------------------------------------------------------------------------
    The temptation to manipulate another human life is almost 
irresistible to some. University of Kentucky reproductive physiologist, 
Panos Zavos, and an his Italian colleague, Severino Antinori, doubtless 
believe they are more like Lewis and Clark than Butch Cassidy and the 
Sundance Kid. They are nevertheless scientific mavericks with egos the 
size of the Grand Canyon.
    It hardly takes prognosticatory gifts to know that someone has 
already successfully cloned a human being or that a human will be 
cloned soon. The near inevitability of cloning does not, however, make 
its imminence more welcome. We are exquisitely ill-equipped morally to 
deal with the reality of a human clone in our midst.
    He or she would first have to suffer the notoriety of being born 
through human somatic cell nuclear transfer. Next, his or her future 
would be shaped by someone else's past. That is to say, those who 
reared the clone would, no doubt, want to duplicate the environment of 
the donor as much as possible. Otherwise the experiment would be less 
likely to produce an identical replica of the original, since 
environment is as important as inheritance. So much for that celebrated 
quality called human freedom. Furthermore, proprietary interests would 
be at stake. Who owns a clone--the cloned, the clone, or the cloner? In 
the commodified world of biotechnology, the one with the most 
investment money is likely to win. So, obviously, the cloner would own 
the clone. Prospective parents might be able to purchase a clone, but 
the market would determine the selling price. Will the price be set in 
pounds, dollars, Euros, or yen?
    If there were ever an appropriate time to clone a human being (and 
there is not), this is not that time. At the beginning of the 21st 
century, we are experiencing a period of unequaled technological 
prowess combined with unparalleled moral vacuity, especially when it 
comes to judging who counts in the moral equation. Do clones count as 
persons? On what moral ground could one deny the personhood of a cloned 
human? When does protectable personhood obtain? How does one avoid 
being arbitrary in determining personhood? Until these questions are 
answered thoroughly and satisfactorily, cloning a human being ought to 
be forthrightly banned or effectively postponed in order to engage in a 
global debate about the morality of human cloning. Critics of such a 
proposal say that the debate would prove intractable. Perhaps that fact 
alone is a necessary and sufficient reason to prohibit cloning a human 
being in the next twelve months, twenty-four months, or forever.