[House Hearing, 107 Congress]
[From the U.S. Government Publishing 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
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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.
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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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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
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\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
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\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
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\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.
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\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
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\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
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\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).
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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.
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\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
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\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.
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\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.
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\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).
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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?'').
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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.
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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
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\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.
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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.
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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.
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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).
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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).
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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
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\160\ James Watson, Moving Toward the Clonal Man, 227 The Atlantic
50, 53 (May, 1971).
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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:
Baguisi A, Behboodi E, Melican DT, Pollock JS, Destrempes MM,
Cammuso C, Williams JL, Nims SD, Porter CA, Midura P, Palacios MJ,
Ayres SL, Denniston RS, Hayes ML, Ziomek CA, Meade HM, Godke RA, Gavin
WG, Overstrom EW, Echelard Y, 1999. Production of goats by somatic cell
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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.
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``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.
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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.
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\10\ TIME, 19 February 2001, pp. 52-53.
\11\ Ibid.
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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.
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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).
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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).
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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).
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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.
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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
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\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.
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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.''
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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.