U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001

72–982 PDF 2001

HUMAN CLONING

HEARING

BEFORE THE

SUBCOMMITTEE ON CRIME

OF THE

COMMITTEE ON THE JUDICIARY

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

ON

H.R. 1644 and H.R. 2172

JUNE 7 AND JUNE 19, 2001

Serial No. 40

Printed for the use of the Committee on the Judiciary

(

Available via the World Wide Web: http://www.house.gov/judiciary

(II)

COMMITTEE ON THE JUDICIARY

F. JAMES SENSENBRENNER, JR., WISCONSIN, Chairman

HENRY J. HYDE, Illinois

GEORGE W. GEKAS, Pennsylvania

HOWARD COBLE, North Carolina

LAMAR SMITH, Texas

ELTON GALLEGLY, California

BOB GOODLATTE, Virginia

STEVE CHABOT, Ohio

BOB BARR, Georgia

WILLIAM L. JENKINS, Tennessee

ASA HUTCHINSON, Arkansas

CHRIS CANNON, Utah

LINDSEY O. GRAHAM, South Carolina

SPENCER BACHUS, Alabama

JOE SCARBOROUGH, Florida

JOHN N. HOSTETTLER, Indiana

MARK GREEN, Wisconsin

RIC KELLER, Florida

DARRELL E. ISSA, California

MELISSA A. HART, Pennsylvania

JEFF FLAKE, Arizona

JOHN CONYERS, JR., Michigan

BARNEY FRANK, Massachusetts

HOWARD L. BERMAN, California

RICK BOUCHER, Virginia

JERROLD NADLER, New York

ROBERT C. SCOTT, Virginia

MELVIN L. WATT, North Carolina

ZOE LOFGREN, California

SHEILA JACKSON LEE, Texas

MAXINE WATERS, California

MARTIN T. MEEHAN, Massachusetts

WILLIAM D. DELAHUNT, Massachusetts

ROBERT WEXLER, Florida

TAMMY BALDWIN, Wisconsin

ANTHONY D. WEINER, New York

ADAM B. SCHIFF, California

PHILIP G. KIKO, Chief of Staff-General Counsel

JULIAN EPSTEIN, Minority Chief Counsel and Staff Director

SUBCOMMITTEE ON CRIME

LAMAR SMITH, Texas, Chairman

MARK GREEN, Wisconsin

HOWARD COBLE, North Carolina

BOB GOODLATTE, Virginia

STEVE CHABOT, Ohio

BOB BARR, Georgia

ASA HUTCHINSON, Arkansas,

Vice Chair

RIC KELLER, Florida

ROBERT C. SCOTT, Virginia

SHEILA JACKSON LEE, Texas

MARTIN T. MEEHAN, Massachusetts

WILLIAM D. DELAHUNT, Massachusetts

ADAM B. SCHIFF, California

JAY APPERSON, Chief Counsel

SEAN MCLAUGHLIN, Counsel

ELIZABETH SOKUL, Counsel

BOBBY VASSAR, Minority Counsel

(III)

C O N T E N T S

HEARING DATES

Page

June 7, 2001

HUMAN CLONING .................................................................................................. 1

June 19, 2001

HUMAN CLONING PROHIBITION ACT OF 2001 AND THE CLONING PROHIBITION

ACT OF 2001 ...................................................................................................... 41

June 7, 2001

OPENING STATEMENTS

The Honorable Lamar Smith, a Representative in Congress From the State

of Texas, and Chairman, Subcommittee on Crime ............................................ 1

The Honorable Ric Keller, a Representative in Congress From the State

of Florida ............................................................................................................... 2

WITNESSES

Mr. Leon Kass, Professor of Bioethics, The University of Chicago

Oral Testimony ..................................................................................................... 2

Prepared Statement ............................................................................................. 4

Mr. Daniel Callahan, Director of International Programs, Hasting Center,

Garrison, NY

Oral Testimony ..................................................................................................... 18

Prepared Statement ............................................................................................. 19

Mr. David A. Prentice, Ph.D., Professor of Life Sciences, Indiana State University

Oral Testimony ..................................................................................................... 22

Prepared Statement ............................................................................................. 23

Mr. Robyn S. Shapiro, Professor of Bioethics, Medical College of Wisconsin

Oral Testimony ..................................................................................................... 30

Prepared Statement ............................................................................................. 32

June 19, 2001

OPENING STATEMENTS

The Honorable Lamar Smith, a Representative in Congress From the State

of Texas, and Chairman, Subcommittee on Crime ............................................ 41

The Honorable Adam B. Schiff, a Representative in Congress From the State

of California .......................................................................................................... 42

WITNESSES

Mr. Alex Capron, Professor of Law and Medicine, University of Southern

California School of Law, Los Angeles, CA

Oral Testimony ..................................................................................................... 44

Prepared Statement ............................................................................................. 46

Ms. Jean Bethke Elshtain, Professor of Social and Political Ethics, The University of Chicago, Chicago, IL

Oral Testimony ..................................................................................................... 51

Prepared Statement ............................................................................................. 53

Page

IV

Mr. Gerard Bradley, Professor of Law, Notre Dame Law School, Notre Dame,

IN

Oral Testimony ..................................................................................................... 54

Prepared Statement ............................................................................................. 56

Dr. Thomas Okarma, President and CEO, Geron Corporation

Oral Testimony ..................................................................................................... 61

Prepared Statement ............................................................................................. 63

APPENDIX

STATEMENTS SUBMITTED FOR THE RECORD

June 7, 2001

The Honorable Bob Barr, a Representative in Congress From the State of

Georgia .................................................................................................................. 81

The Honorable Sheila Jackson Lee, a Representative in Congress From the

State of Texas ....................................................................................................... 82

June 19, 2001

The Honorable Lamar Smith, a Representative in Congress From the State

of Texas ................................................................................................................. 83

MATERIAL SUBMITTED FOR THE RECORD

June 7, 2001

Post Hearing Questions and Answers from the Honorable Sheila Jackson

Lee ......................................................................................................................... 84

George Will’s Article From The Washington Post on ‘‘Human Cloning a Major

Threat’’ dated, Monday, January 22, 2001 ........................................................ 88

June 19, 2001

Letter From American Society for Reproductive Medicine .................................. 89

Letter From the Federation of American Societies for Experimental Biology ... 91

Newsletter from the United States Catholic Conference ..................................... 92

Letter From National Bioethics Advisory Board ................................................... 94

REFERENCE MATERIAL

Cloning Human Beings, Volume I, Report and Recommendations of the National Bioethics Advisory Commission, Rockville, MD, June 1997 .................. 95

Ethical Issues in Human Stem Cell Research, Volume I, Report and Recommendations of the National Bioethics Advisory Commission, Rockville,

MD, September, 1999 .......................................................................................... 95

(1)

HUMAN CLONING

THURSDAY, JUNE 7, 2001

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON CRIME,

COMMITTEE ON THE JUDICIARY,

Washington, DC.

The Subcommittee met, pursuant to notice, at 11 a.m., in Room

2237, Rayburn House Office Building, Hon. Lamar Smith [Chairman of the Subcommittee] presiding.

Mr. SMITH. The Subcommittee on Crime will come to order. We

appreciate the great interest this hearing has attracted, and I want

to say by way of an announcement at the outset that we do not expect any votes for the next hour, so we should be able to proceed

uninterrupted. Also, I want to mention that the Ranking Member,

Bobby Scott of Virginia, is in another Subcommittee meeting and

will be late, otherwise we would be waiting for him before we started. We do appreciate the attendance of the gentleman from Florida,

Mr. Rick Keller, and we expect other Members to join us shortly,

as well. I am going to recognize myself for an opening statement

and other Members, if they have opening statements, and then I

will introduce the witnesses and we will proceed with our hearing.

Today the Subcommittee on Crime holds the first of two hearings

on the issue of human cloning. We all recognize that biotechnology

has enhanced our lives in many ways, and I am a strong supporter

of it, but there are some lines that we should not cross. Our efforts

to improve humanity should never devalue humanity. The theoretical ability to clone humans raises profound moral and ethical

issues. Since reports indicate that scientists and physicians are

soon planning to produce the first human clone, it is critical that

Congress examine whether or not this type of experimentation

should be allowed to proceed.

This hearing will focus on the ethical issues and the possible consequences of cloning human beings. The second hearing will examine the legal issues relating to Federal regulation of human

cloning. The issue of human cloning came to the public’s attention

first when scientists announced they had successfully cloned Dolly,

the sheep, in February 1997. A February, 2001 Time-CNN poll

found that 90 percent of all Americans oppose cloning humans. The

science of cloning has advanced rapidly since 1997. Scientists have

successfully cloned monkeys, cattle, pigs, mice and other animals.

Because of this, there are a growing number of groups who claim

they can and will clone a human being.

We should not rush to prove what can happen until we first consider whether it should happen. How does the scientific community

2

define a successful cloning experiment? Scientists often downplay

the fact that the cloning failure rate is extremely high. It took 277

stillborn, miscarried or dead sheep to make one Dolly. That failure

rate has remained steady since 1997. Even if human cloning were

ethically acceptable, it should not cost even one human life. The

most celebrated cloning experiment failed 277 times before succeeding. The National Bioethics Advisory Commission has stated

that such a failure rate is morally unacceptable.

What happens to those who survive? Attempts to clone human

beings could carry massive risks of producing unhealthy, abnormal

and malformed children. If scientists successfully create a Brave

New World, will we lose our humanity along the way? Proponents

of human cloning argue that the possible benefits for mankind outweigh the concerns. One of the issues that will be addressed today

is whether or not there are alternative means available to obtain

some of the medical benefits claimed for human cloning. Cloning

arguably is a product of manufacturer, not the result of

procreation.

The manufacture of human beings is a proposition that alarms

an overwhelming majority of Americans. Today, we will hear from

a panel of four witnesses who have extensive backgrounds in the

field of bioethics, and I thank the witnesses in advance who are

coming before the Subcommittee today and, certainly, we all look

forward to your testimony. I will now recognize any other Member

who has an opening statement. Does the gentleman from Florida

have an opening statement?

Mr. KELLER. Thank you, Mr. Chairman. I would just like to take

a few seconds to acknowledge and recognize and appreciate my colleague from Florida, Dr. Weldon, for his outstanding work in this

area, also to thank the witnesses on both sides of the issue for coming and educating folks like me on this cutting-edge issue. I yield

back, Mr. Chairman.

Mr. SMITH. Thank you, Mr. Keller. You were right to do so. I see

our colleague, Dave Weldon, in the second row, and we appreciate

his attendance here as well. Let me introduce the witnesses and we

will proceed: Dr. Leon Kass, Professor of Bioethics at the University of Chicago; Dr. Daniel Callahan, Director of International Programs, Hastings Center, Garrison, New York; Dr. David Prentice,

Professor of Life Scientists, Indiana State University; and Dr.

Robyn S. Shapiro, Professor of Bioethics, Medical College of Wisconsin.

We welcome you all and we will begin with Dr. Kass.

STATEMENT OF LEON KASS, PROFESSOR OF BIOETHICS, THE

UNIVERSITY OF CHICAGO

Dr. KASS. Thank you, Mr. Chairman and Members of the Committee. My name is Leon Kass and I have been, for over 30 years,

concerned with the ethical implications of biomedical advance.

Originally trained in medicine and biochemistry, I remain enthusiastic about biomedical research and its promise to cure disease and

relieve suffering, yet it has been obvious for some time that new

biotechnologies are providing powers to intervene in human bodies

and minds in ways that threaten fundamental changes in human

nature and in the meaning of our humanity.

3

These technologies have now brought us to a crucial fork in the

road, where we are compelled to decide whether we wish to travel

down the path that leads to the Brave New World, and that, and

nothing less, I submit, is what is at stake in your current deliberations about what whether we should tolerate the practice of human

cloning. I am here to testify in favor of a national ban on human

cloning and, in particular, in favor of H.R. 1664, the Human

Cloning Prohibition Act of 2001 for two reasons.

First, I believe that human cloning is unethical, both in itself

and in what it surely leads to; and secondly, I believe that this bill

offers us the best, indeed, the only reasonable chance of preventing

human cloning from happening. The vast majority of Americans object to human cloning, and on multiple grounds. In my written testimony, I have outlined these. This is just the summary. It constitutes unethical experiments on the child to be, it threatens identity and individuality, it represents a giant step toward turning

procreation into manufacture, especially when understood as the

harbinger of genetic manipulations to come, legitimizing in advance

the eugenic redesigning of our children according to our specifications. It is a radical form of parental despotism and of child abuse.

Permitting human cloning means saying yes to the dangerous principle that we are entitled to determine and design the genetic

makeup of our children.

If we do not wish to travel down this eugenic road, an effective

ban on cloning human beings is needed and needed now before we

are overtaken by events. The majority of Members in Congress, I

believe, are, like most Americans, opposed to human cloning, but

opposition is not enough. For if we do nothing about it, we shall

have human cloning and we shall have it soon. Our failure to try

to stop human cloning and by the most effective means will, in fact,

constitute our tacit approval. What, then, is the most effective way

to ban reproductive human cloning?

Two legislative bans competed with each other last time Congress considered this matter. One bill would have banned only socalled reproductive cloning by prohibiting the transfer of a cloned

embryo to a woman to initiate the pregnancy. The other bill would

have banned all cloning by prohibiting the creation even of the embryonic human clones. Both sides opposed reproductive cloning, but

because of the divide over the question of embryo research, we got

no ban at all. It would be tragic if we again failed to produce an

effective ban on cloning human beings, especially now that certain

people are going ahead with it and defying us to try to stop them.

A few years ago, I was looking for a middle way between the two

alternatives that failed us last time. But, I am now convinced that

we need an all-out ban on human cloning, including the creation

of the embryonic human clones. I submit that anyone who is truly

serious about preventing human reproductive cloning must seek to

stop the process from the beginning, and here is why.

Once cloned embryos are produced and available in laboratories

and assisted reproduction centers, it will be virtually impossible to

control what is done with them. Stockpiles of cloned human embryos could be produced and bought and sold in the private sector

without anybody knowing it. Efforts at clonal reproduction would

take place out of sight, within the privacy of the doctor-patient reVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
4

1Leon R. Kass, M.D., Ph.D. is the Addie Clark Harding Professor, The Committee on Social

Thought and the College, The University of Chicago, and co-author (with James Q. Wilson) of

lationship, making outside scrutiny extremely difficult. Moreover, a

ban on only reproductive cloning will turn out to be unenforceable.

Should the illegal practice be detected, governmental attempts to

enforce the reproductive ban would run into a swarm of practical

and legal challenges, both to any efforts aimed at preventing transfer to the woman, and even worse, to efforts seeking to prevent

birth after the transfer has occurred. Should an ‘‘illicit clonal pregnancy’’ be discovered, no Government agency is going to compel the

woman to abort the clone, and there would be an understandable

swarm of protest, should she be fined or jailed before she gives

birth.

For all these reasons and others that I elaborate on in the written testimony, the only practically effective and legally-sound approach is to block human cloning at the start, at the production of

the embryonic clone. Such a ban can be rightly characterized not

as interference with reproductive freedom, nor even as an interference with scientific inquiry, but as an attempt to prevent the

unhealthy, unsavory and unwelcome manufacture of and traffic in

human clones.

The bill introduced by Dr. Weldon and his nearly 100 co-sponsors

is, in my view, extremely carefully drafted, and its substantial

criminal and monetary penalties will shift the incentives for renegades who are tempted to proceed. The bill makes very clear that

there is to be no interference with the scientifically and medically

useful practices of animal cloning or the cloning of human DNA

fragments, somatic cells, or stem cells and tissue culture. Moreover,

if enacted, this bill would bring the United States into line with the

already, and soon to be enacted, practices of other nations. In collaboration with those efforts, it offers us the best and, I think, the

only realistic chance we have of keeping human cloning from happening or happening much.

The issue of cloning is most emphatically not an issue of pro-life

versus pro-choice. It is not mainly about death and destruction and

it is not about a woman’s right to choose. It is only and emphatically about baby design and manufacture, the opening skirmish of

what will be a long battle against eugenics and against the posthuman future. Once the embryonic clones are produced in laboratories, the eugenic revolution will have begun and we will have lost

our best chance to do anything about it and to assume responsible

control over where biotechnology is taking us. The present danger

posed by human cloning is, paradoxically, also a golden opportunity. The prospect of cloning, so repulsive to contemplate, is the

occasion for deciding whether we shall be slaves of unregulated innovation and ultimately its artifacts or whether we shall remain

free human beings who guide our medical powers toward the enhancement of human dignity. The humanity of our human future

is now in our hands. Thank you.

[The prepared statement of Dr. Kass follows:]

PREPARED STATEMENT OF LEON R. KASS, M.D., PH.D.1

Mr. Chairman and Members of the Committee. My name is Leon Kass, and I am

the Addie Clark Harding Professor in the Committee on Social Thought and the ColVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00008 Fmt 6633 Sfmt 6621 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
5

The Ethics of Human Cloning. Mailing Address: The University of Chicago, 1116 E. 59th Street,

Chicago, IL 60637. Telephone number: 773–702–8571. E-address: <lrk1@midway.uchicago.edu>.

lege at the University of Chicago. Originally trained both as a physician and a biochemist, I have for more than thirty years been professionally concerned with the

social and ethical implications of biomedical advance. In fact, my first writing in

this area, in 1967, was on the moral dangers of human cloning. I am therefore very

grateful for the opportunity to testify before this Committee on the ethics of human

cloning and in support of HR 1644, the ‘‘Human Cloning Prohibition Act of 2001.’’

And I am profoundly grateful to Rep. Weldon and the many co-sponsors of this bill

for their vision in recognizing the momentous choice now before us and for their

courage in stepping forward to protect us from what is surely a very great danger

to the future of our humanity.

My testimony takes the form of an essay written precisely to gain support for such

a bill. It has been published in the May 21, 2001 issue of The New Republic, under

the title, ‘‘Preventing a Brave New World: Why We Should Ban Human Cloning

Now.’’ I begin by calling attention to what is humanly at stake in the decision about

human cloning and also to the fact that we have here a golden opportunity to exercise deliberate human command over where biotechnology may be taking us. I argue

that we stand now at a major fork in the road, compelled to decide whether we wish

to travel down the path to the Brave New World, a path made possible by the genetic control of future generations. I next present four arguments against reproductive cloning of human beings: (1) it constitutes unethical experimentation on the

child-to-be; (2) it threatens identity and individuality; (3) it is a giant step toward

turning procreation into manufacture (especially when understood as the harbinger

of genetic manipulations to come); and (4) it means despotism over children and perversion of parenthood. I conclude by arguing, on multiple grounds, that the only effective way to prevent reproductive cloning is to stop the process at the start, at

the stage of creating the embryonic clones, just as is provided for in HR 1644, and

I show the weaknesses of the other widely discussed alternative. Once embryonic

clones are produced in laboratories, the eugenic revolution will have begun. And we

shall have lost our best chance to do anything about it and to assume responsible

control over where biotechnology is taking us. I heartily endorse HR 1644 not only

because it offers our only real hope of preventing the cloning of human beings, but

also because it will give us for the first time some control over those biotechnological

powers that threaten to bring about a ‘‘post-human’’ future.

Here is the essay, in full. (I also provide a one-page summary)

PREVENTING A BRAVE NEW WORLD: WHY WE SHOULD BAN HUMAN CLONING NOW

BY LEON R. KASS

I.

The urgency of the great political struggles of the twentieth century, successfully

waged against totalitarianisms first right and then left, seems to have blinded many

people to a deeper and ultimately darker truth about the present age: all contemporary societies are travelling briskly in the same utopian direction. All are wedded

to the modern technological project; all march eagerly to the drums of progress and

fly proudly the banner of modern science; all sing loudly the Baconian anthem,

‘‘Conquer nature, relieve man’s estate.’’ Leading the triumphal procession is modern

medicine, which is daily becoming ever more powerful in its battle against disease,

decay, and death, thanks especially to astonishing achievements in biomedical

science and technology—achievements for which we must surely be grateful.

Yet contemplating present and projected advances in genetic and reproductive

technologies, in neuroscience and psychopharmacology, and in the development of

artificial organs and computer-chip implants for human brains, we now clearly recognize new uses for biotechnical power that soar beyond the traditional medical

goals of healing disease and relieving suffering. Human nature itself lies on the operating table, ready for alteration, for eugenic and psychic ‘‘enhancement,’’ for

wholesale re-design. In leading laboratories, academic and industrial, new creators

are confidently amassing their powers and quietly honing their skills, while on the

street their evangelists are zealously prophesying a post-human future. For anyone

who cares about preserving our humanity, the time has come to pay attention.

Some transforming powers are already here. The Pill. In vitro fertilization. Bottled embryos. Surrogate wombs. Cloning. Genetic screening. Genetic manipulation.

Organ harvesting. Mechanical spare parts. Chimeras. Brain implants. Ritalin for

6

the young, Viagra for the old, Prozac for everyone. And, to leave this vale of tears,

a little extra morphine accompanied by Muzak.

Years ago Aldous Huxley saw it coming. In his charming but disturbing novel,

Brave New World (it appeared in 1932 and is more powerful on each re-reading),

he made its meaning strikingly visible for all to see. Unlike other frightening futuristic novels of the past century, such as Orwell’s already dated Nineteen EightyFour, Huxley shows us a dystopia that goes with, rather than against, the human

grain. Indeed, it is animated by our own most humane and progressive aspirations.

Following those aspirations to their ultimate realization, Huxley enables us to recognize those less obvious but often more pernicious evils that are inextricably linked

to the successful attainment of partial goods.

Huxley depicts human life seven centuries hence, living under the gentle hand of

humanitarianism rendered fully competent by genetic manipulation, psychoactive

drugs, hypnopaedia, and high-tech amusements. At long last, mankind has succeeded in eliminating disease, aggression, war, anxiety, suffering, guilt, envy, and

grief. But this victory comes at the heavy price of homogenization, mediocrity, trivial pursuits, shallow attachments, debased tastes, spurious contentment, and souls

without loves or longings. The Brave New World has achieved prosperity, community, stability, and nigh-universal contentment, only to be peopled by creatures of

human shape but stunted humanity. They consume, fornicate, take ‘‘soma,’’ enjoy ‘‘centrifugal bumble-puppy,’’ and operate the machinery that makes it all possible.

They do not read, write, think, love, or govern themselves. Art and science, virtue

and religion, family and friendship are all passe. What matters most is bodily health

and immediate gratification: ‘‘Never put off till tomorrow the fun you can have

today.’’ Brave New Man is so dehumanized that he does not even recognize what

has been lost.

Huxley’s novel, of course, is science fiction. Prozac is not yet Huxley’s ‘‘soma’’;

cloning by nuclear transfer or splitting embryos is not exactly ‘‘Bokanovskification’’;

MTV and virtual-reality parlors are not quite the ‘‘feelies’’; and our current safe and

consequenceless sexual practices are not universally as loveless or as empty as those

in the novel. But the kinships are disquieting, all the more so since our technologies

of bio-psycho-engineering are still in their infancy, and in ways that make all too

clear what they might look like in their full maturity. Moreover, the cultural

changes that technology has already wrought among us should make us even more

worried than Huxley would have us be.

In Huxley’s novel, everything proceeds under the direction of an omnipotent—albeit benevolent—world state. Yet the dehumanization that he portrays does not

really require despotism or external control. To the contrary, precisely because the

society of the future will deliver exactly what we most want—health, safety, comfort, plenty, pleasure, peace of mind and length of days—we can reach the same humanly debased condition solely on the basis of free human choice. No need for World

Controllers. Just give us the technological imperative, liberal democratic society,

compassionate humanitarianism, moral pluralism, and free markets, and we can

take ourselves to a Brave New World all by ourselves—and without even deliberately deciding to go. In case you had not noticed, the train has already left the

station and is gathering speed, but no one seems to be in charge.

Some among us are delighted, of course, by this state of affairs: some scientists

and biotechnologists, their entrepreneurial backers, and a cheering claque of sci-fi

enthusiasts, futurologists, and libertarians. There are dreams to be realized, powers

to be exercised, honors to be won, and money—big money—to be made. But many

of us are worried, and not, as the proponents of the revolution self-servingly claim,

because we are either ignorant of science or afraid of the unknown. To the contrary,

we can see all too clearly where the train is headed, and we do not like the destination. We can distinguish cleverness about means from wisdom about ends, and we

are loath to entrust the future of the race to those who cannot tell the difference.

No friend of humanity cheers for a post-human future.

Yet for all our disquiet, we have until now done nothing to prevent it. We hide

our heads in the sand because we enjoy the blessings that medicine keeps supplying, or we rationalize our inaction by declaring that human engineering is inevitable and we can do nothing about it. In either case, we are complicit in preparing

for our own degradation, in some respects more to blame than the bio-zealots who,

however misguided, are putting their money where their mouth is. Denial and despair, unattractive outlooks in any situation, become morally reprehensible when

circumstances summon us to keep the world safe for human flourishing. Our immediate ancestors, taking up the challenge of their time, rose to the occasion and rescued the human future from the cruel dehumanizations of Nazi and Soviet tyranny.

It is our more difficult task to find ways to preserve it from the soft dehumanizations of well-meaning but hubristic biotechnical ‘‘re-creationism’’—and to do it withVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6621 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
7

out undermining biomedical science or rejecting its genuine contributions to human

welfare.

Truth be told, it will not be easy for us to do so, and we know it. But rising to

the challenge requires recognizing the difficulties. For there are indeed many features of modern life that will conspire to frustrate efforts aimed at the human control of the biomedical project. First, we Americans believe in technological automatism: where we do not foolishly believe that all innovation is progress, we fatalistically believe that it is inevitable (‘‘If it can be done, it will be done, like it or not’’).

Second, we believe in freedom: the freedom of scientists to inquire, the freedom of

technologists to develop, the freedom of entrepreneurs to invest and to profit, the

freedom of private citizens to make use of existing technologies to satisfy any and

all personal desires, including the desire to reproduce by whatever means. Third,

the biomedical enterprise occupies the moral high ground of compassionate humanitarianism, upholding the supreme values of modern life—cure disease, prolong life,

relieve suffering—in competition with which other moral goods rarely stand a

chance. (‘‘What the public wants is not to be sick,’’ says James Watson, ‘‘and if we

help them not to be sick, they’ll be on our side.’’)

There are still other obstacles. Our cultural pluralism and easygoing relativism

make it difficult to reach consensus on what we should embrace and what we should

oppose; and moral objections to this or that biomedical practice are often facilely dismissed as religious or sectarian. Many people are unwilling to pronounce judgments

about what is good or bad, right and wrong, even in matters of great importance,

even for themselves—never mind for others or for society as a whole. It does not

help that the biomedical project is now deeply entangled with commerce: there are

increasingly powerful economic interests in favor of going full steam ahead, and no

economic interests in favor of going slow. Since we live in a democracy, moreover,

we face political difficulties in gaining a consensus to direct our future, and we have

almost no political experience in trying to curtail the development of any new biomedical technology. Finally, and perhaps most troubling, our views of the meaning

of our humanity have been so transformed by the scientific-technological approach

to the world that we are in danger of forgetting what we have to lose, humanly

speaking.

But though the difficulties are real, our situation is far from hopeless. Regarding

each of the aforementioned impediments, there is another side to the story. Though

we love our gadgets and believe in progress, we have lost our innocence regarding

technology. The environmental movement especially has alerted us to the unintended damage caused by unregulated technological advance, and has taught us

how certain dangerous practices can be curbed. Though we favor freedom of inquiry,

we recognize that experiments are deeds and not speeches, and we prohibit experimentation on human subjects without their consent, even when cures from disease

might be had by unfettered research; and we limit so-called reproductive freedom

by proscribing incest, polygamy, and the buying and selling of babies.

Although we esteem medical progress, biomedical institutions have ethics committees that judge research proposals on moral grounds, and, when necessary, uphold

the primacy of human freedom and human dignity even over scientific discovery.

Our moral pluralism notwithstanding, national commissions and review bodies have

sometimes reached moral consensus to recommend limits on permissible scientific

research and technological application. On the economic front, the patenting of

genes and life forms and the rapid rise of genomic commerce have elicited strong

concerns and criticisms, leading even former enthusiasts of the new biology to recoil

from the impending commodification of human life. Though we lack political institutions experienced in setting limits on biomedical innovation, federal agencies years

ago rejected the development of the plutonium-powered artificial heart, and we have

nationally prohibited commercial traffic in organs for transplantation, even though

a market would increase the needed supply. In recent years, several American

states and many foreign countries have successfully taken political action, making

certain practices illegal and placing others under moratoriums (the creation of

human embryos solely for research; human germ-line genetic alteration). Most importantly, the majority of Americans are not yet so degraded or so cynical as to fail

to be revolted by the society depicted in Huxley’s novel. Though the obstacles to effective action are significant, they offer no excuse for resignation. Besides, it would

be disgraceful to concede defeat even before we enter the fray.

Not the least of our difficulties in trying to exercise control over where biology

is taking us is the fact that we do not get to decide, once and for all, for or against

the destination of a post-human world. The scientific discoveries and the technical

powers that will take us there come to us piecemeal, one at a time and seemingly

independent from one another, each often attractively introduced as a measure that

will ‘‘help [us] not to be sick.’’ But sometimes we come to a clear fork in the road

8

where decision is possible, and where we know that our decision will make a world

of difference—indeed, it will make a permanently different world. Fortunately, we

stand now at the point of such a momentous decision. Events have conspired to provide us with a perfect opportunity to seize the initiative and to gain some control

of the biotechnical project. I refer to the prospect of human cloning, a practice absolutely central to Huxley’s fictional world. Indeed, creating and manipulating life in

the laboratory is the gateway to a Brave New World, not only in fiction but also

in fact.

‘‘To clone or not to clone a human being’’ is no longer a fanciful question. Success

in cloning sheep, and also cows, mice, pigs, and goats, makes it perfectly clear that

a fateful decision is now at hand: whether we should welcome or even tolerate the

cloning of human beings. If recent newspaper reports are to be believed, reputable

scientists and physicians have announced their intention to produce the first human

clone in the coming year. Their efforts may already be under way.

The media, gawking and titillating as is their wont, have been softening us up

for this possibility by turning the bizarre into the familiar. In the four years since

the birth of Dolly the cloned sheep, the tone of discussing the prospect of human

cloning has gone from ‘‘Yuck’’ to ‘‘Oh?’’ to ‘‘Gee whiz’’ to ‘‘Why not?’’ The

sentimentalizers, aided by leading bioethicists, have downplayed talk about

eugenically cloning the beautiful and the brawny or the best and the brightest. They

have taken instead to defending clonal reproduction for humanitarian or compassionate reasons: to treat infertility in people who are said to ‘‘have no other choice,’’

to avoid the risk of severe genetic disease, to ‘‘replace’’ a child who has died. For

the sake of these rare benefits, they would have us countenance the entire practice

of human cloning, the consequences be damned.

But we dare not be complacent about what is at issue, for the stakes are very

high. Human cloning, though partly continuous with previous reproductive technologies, is also something radically new in itself and in its easily foreseeable consequences—especially when coupled with powers for genetic ‘‘enhancement’’ and

germline genetic modification that may soon become available, owing to the recently

completed Human Genome Project. I exaggerate somewhat, but in the direction of

the truth: we are compelled to decide nothing less than whether human procreation

is going to remain human, whether children are going to be made to order rather

than begotten, and whether we wish to say yes in principle to the road that leads

to the dehumanized hell of Brave New World.

Four years ago I addressed this subject in these pages, trying to articulate the

moral grounds of our repugnance at the prospect of human cloning (‘‘The Wisdom

of Repugnance,’’ TNR, June 2, 1997). Subsequent events have only strengthened my

conviction that cloning is a bad idea whose time should not come; but my emphasis

this time is more practical. To be sure, I would still like to persuade undecided readers that cloning is a serious evil, but I am more interested in encouraging those who

oppose human cloning but who think that we are impotent to prevent it, and in mobilizing them to support new and solid legislative efforts to stop it. In addition, I

want readers who may worry less about cloning and more about the impending

prospects of germline genetic manipulation or other eugenic practices to realize the

unique practical opportunity that now presents itself to us.

For we have here a golden opportunity to exercise some control over where biology

is taking us. The technology of cloning is discrete and well defined, and it requires

considerable technical know-how and dexterity; we can therefore know by name

many of the likely practitioners. The public demand for cloning is extremely low,

and most people are decidedly against it. Nothing scientifically or medically important would be lost by banning clonal reproduction; alternative and non-objectionable

means are available to obtain some of the most important medical benefits claimed

for (non-reproductive) human cloning. The commercial interests in human cloning

are, for now, quite limited; and the nations of the world are actively seeking to prevent it. Now may be as good a chance as we will ever have to get our hands on

the wheel of the runaway train now headed for a post-human world and to steer

it toward a more dignified human future.

II.

What is cloning? Cloning, or asexual reproduction, is the production of individuals

who are genetically identical to an already existing individual. The procedure’s

name is fancy—‘‘somatic cell nuclear transfer’’—but its concept is simple. Take a

mature but unfertilized egg; remove or deactivate its nucleus; introduce a nucleus

obtained from a specialized (somatic) cell of an adult organism. Once the egg begins

to divide, transfer the little embryo to a woman’s uterus to initiate a pregnancy.

Since almost all the hereditary material of a cell is contained within its nucleus,

9

the re-nucleated egg and the individual into which it develops are genetically identical to the organism that was the source of the transferred nucleus.

An unlimited number of genetically identical individuals—the group, as well as

each of its members, is called ‘‘a clone’’—could be produced by nuclear transfer. In

principle, any person, male or female, newborn or adult, could be cloned, and in any

quantity; and because stored cells can outlive their sources, one may even clone the

dead. Since cloning requires no personal involvement on the part of the person

whose genetic material is used, it could easily be used to reproduce living or deceased persons without their consent—a threat to reproductive freedom that has received relatively little attention.

Some possible misconceptions need to be avoided. Cloning is not Xeroxing: the

clone of Bill Clinton, though his genetic double, would enter the world hairless,

toothless, and peeing in his diapers, like any other human infant. But neither is

cloning just like natural twinning: the cloned twin will be identical to an older, existing adult; and it will arise not by chance but by deliberate design; and its entire

genetic makeup will be pre-selected by its parents and/or scientists. Moreover, the

success rate of cloning, at least at first, will probably not be very high: the Scots

transferred two hundred seventy-seven adult nuclei into sheep eggs, implanted

twenty-nine clonal embryos, and achieved the birth of only one live lamb clone.

For this reason, among others, it is unlikely that, at least for now, the practice

would be very popular; and there is little immediate worry of mass-scale production

of multicopies. Still, for the tens of thousands of people who sustain more than three

hundred assisted-reproduction clinics in the United States and already avail themselves of in vitro fertilization and other techniques, cloning would be an option with

virtually no added fuss. Panos Zavos, the Kentucky reproduction specialist who has

announced his plans to clone a child, claims that he has already received thousands

of e-mailed requests from people eager to clone, despite the known risks of failure

and damaged offspring. Should commercial interests develop in ‘‘nucleus-banking,’’

as they have in sperm-banking and egg-harvesting; should famous athletes or other

celebrities decide to market their DNA the way they now market their autographs

and nearly everything else; should techniques of embryo and germline genetic testing and manipulation arrive as anticipated, increasing the use of laboratory assistance in order to obtain ‘‘better’’ babies—should all this come to pass, cloning, if it

is permitted, could become more than a marginal practice simply on the basis of free

reproductive choice.

What are we to think about this prospect? Nothing good. Indeed, most people are

repelled by nearly all aspects of human cloning: the possibility of mass production

of human beings, with large clones of look-alikes, compromised in their individuality; the idea of father-son or mother-daughter ‘‘twins’’; the bizarre prospect of a

woman bearing and rearing a genetic copy of herself, her spouse, or even her deceased father or mother; the grotesqueness of conceiving a child as an exact ‘‘replacement’’ for another who has died; the utilitarian creation of embryonic duplicates of oneself, to be frozen away or created when needed to provide homologous

tissues or organs for transplantation; the narcissism of those who would clone themselves, and the arrogance of others who think they know who deserves to be cloned;

the Frankensteinian hubris to create a human life and increasingly to control its

destiny; men playing at being God. Almost no one finds any of the suggested reasons for human cloning compelling, and almost everyone anticipates its possible

misuses and abuses. And the popular belief that human cloning cannot be prevented

makes the prospect all the more revolting.

Revulsion is not an argument; and some of yesterday’s repugnances are today

calmly accepted—not always for the better. In some crucial cases, however, repugnance is the emotional expression of deep wisdom, beyond reason’s power completely

to articulate it. Can anyone really give an argument fully adequate to the horror

that is father-daughter incest (even with consent), or bestiality, or the mutilation

of a corpse, or the eating of human flesh, or the rape or murder of another human

being? Would anybody’s failure to give full rational justification for his revulsion at

those practices make that revulsion ethically suspect?

I suggest that our repugnance at human cloning belongs in this category. We are

repelled by the prospect of cloning human beings not because of the strangeness or

the novelty of the undertaking, but because we intuit and we feel, immediately and

without argument, the violation of things that we rightfully hold dear. We sense

that cloning represents a profound defilement of our given nature as procreative

beings, and of the social relations built on this natural ground. We also sense that

cloning is a radical form of child abuse. In this age in which everything is held to

be permissible so long as it is freely done, and in which our bodies are regarded

as mere instruments of our autonomous rational will, repugnance may be the only

10

voice left that speaks up to defend the central core of our humanity. Shallow are

the souls that have forgotten how to shudder.

III.

Yet repugnance need not stand naked before the bar of reason. The wisdom of our

horror at human cloning can be at least partially articulated, even if this is finally

one of those instances about which the heart has its reasons that reason cannot entirely know. I offer four objections to human cloning: that it constitutes unethical

experimentation; that it threatens identity and individuality; that it turns

procreation into manufacture (especially when understood as the harbinger of manipulations to come); and that it means despotism over children and perversion of

parenthood. Please note: I speak only about so-called reproductive cloning, not about

the creation of cloned embryos for research. The objections that may be raised

against creating (or using) embryos for research are entirely independent of whether

the research embryos are produced by cloning. What is radically distinct and radically new is reproductive cloning.

Any attempt to clone a human being would constitute an unethical experiment

upon the resulting child-to-be. In all the animal experiments, fewer than two to

three percent of all cloning attempts succeeded. Not only are there fetal deaths and

stillborn infants, but many of the so-called ‘‘successes’’ are in fact failures. As has

only recently become clear, there is a very high incidence of major disabilities and

deformities in cloned animals that attain live birth. Cloned cows often have heart

and lung problems; cloned mice later develop pathological obesity; other live-born

cloned animals fail to reach normal developmental milestones.

The problem, scientists suggest, may lie in the fact that an egg with a new somatic nucleus must re-program itself in a matter of minutes or hours (whereas the

nucleus of an unaltered egg has been prepared over months and years). There is

thus a greatly increased likelihood of error in translating the genetic instructions,

leading to developmental defects some of which will show themselves only much

later. (Note also that these induced abnormalities may also affect the stem cells that

scientists hope to harvest from cloned embryos. Lousy embryos, lousy stem cells.)

Nearly all scientists now agree that attempts to clone human beings carry massive

risks of producing unhealthy, abnormal, and malformed children. What are we to

do with them? Shall we just discard the ones that fall short of expectations? Considered opinion is today nearly unanimous, even among scientists: attempts at human

cloning are irresponsible and unethical. We cannot ethically even get to know

whether or not human cloning is feasible.

If it were successful, cloning would create serious issues of identity and individuality. The clone may experience concerns about his distinctive identity not only because he will be, in genotype and in appearance, identical to another human being,

but because he may also be twin to the person who is his ‘‘father’’ or his ‘‘mother’’—

if one can still call them that. Unaccountably, people treat as innocent the homey

case of intra-familial cloning—the cloning of husband or wife (or single mother).

They forget about the unique dangers of mixing the twin relation with the parentchild relation. (For this situation, the relation of contemporaneous twins is no precedent; yet even this less problematic situation teaches us how difficult it is to wrest

independence from the being for whom one has the most powerful affinity.) Virtually

no parent is going to be able to treat a clone of himself or herself as one treats a

child generated by the lottery of sex. What will happen when the adolescent clone

of Mommy becomes the spitting image of the woman with whom Daddy once fell

in love? In case of divorce, will Mommy still love the clone of Daddy, even though

she can no longer stand the sight of Daddy himself?

Most people think about cloning from the point of view of adults choosing to clone.

Almost nobody thinks about what it would be like to be the cloned child. Surely his

or her new life would constantly be scrutinized in relation to that of the older version. Even in the absence of unusual parental expectations for the clone—say, to live

the same life, only without its errors—the child is likely to be ever a curiosity, ever

a potential source of de ́ja` vu. Unlike ‘‘normal’’ identical twins, a cloned individual—

copied from whomever—will be saddled with a genotype that has already lived. He

will not be fully a surprise to the world: people are likely always to compare his

doings in life with those of his alter ego, especially if he is a clone of someone gifted

or famous. True, his nurture and his circumstance will be different; genotype is not

exactly destiny. But one must also expect parental efforts to shape this new life

after the original—or at least to view the child with the original version always

firmly in mind. For why else did they clone from the star basketball player, the

mathematician, or the beauty queen—or even dear old Dad—in the first place?

11

Human cloning would also represent a giant step toward the transformation of

begetting into making, of procreation into manufacture (literally, ‘‘handmade’’), a

process that has already begun with in vitro fertilization and genetic testing of embryos. With cloning, not only is the process in hand, but the total genetic blueprint

of the cloned individual is selected and determined by the human artisans. To be

sure, subsequent development is still according to natural processes; and the resulting children will be recognizably human. But we would be taking a major step into

making man himself simply another one of the man-made things.

How does begetting differ from making? In natural procreation, human beings

come together to give existence to another being that is formed exactly as we were,

by what we are—living, hence perishable, hence aspiringly erotic, hence procreative

human beings. But in clonal reproduction, and in the more advanced forms of manufacture to which it will lead, we give existence to a being not by what we are but

by what we intend and design.

Let me be clear. The problem is not the mere intervention of technique, and the

point is not that ‘‘nature knows best.’’ The problem is that any child whose being,

character, and capacities exist owing to human design does not stand on the same

plane as its makers. As with any product of our making, no matter how excellent,

the artificer stands above it, not as an equal but as a superior, transcending it by

his will and creative prowess. In human cloning, scientists and prospective ‘‘parents’’ adopt a technocratic attitude toward human children: human children become

their artifacts. Such an arrangement is profoundly dehumanizing, no matter how

good the product.

Procreation dehumanized into manufacture is further degraded by

commodification, a virtually inescapable result of allowing baby-making to proceed

under the banner of commerce. Genetic and reproductive biotechnology companies

are already growth industries, but they will soon go into commercial orbit now that

the Human Genome Project has been completed. ‘‘Human eggs for sale’’ is already

a big business, masquerading under the pretense of ‘‘donation.’’ Newspaper advertisements on elite college campuses offer up to $50,000 for an egg ‘‘donor’’ tall

enough to play women’s basketball and with SAT scores high enough for admission

to Stanford; and to nobody’s surprise, at such prices there are many young coeds

eager to help shoppers obtain the finest babies money can buy. (The egg and wombrenting entrepreneurs shamelessly proceed on the ancient, disgusting, misogynist

premise that most women will give you access to their bodies, if the price is right.)

Even before the capacity for human cloning is perfected, established companies will

have invested in the harvesting of eggs from ovaries obtained at autopsy or through

ovarian surgery, practiced embryonic genetic alteration, and initiated the stockpiling

of prospective donor tissues. Through the rental of surrogate-womb services, and

through the buying and selling of tissues and embryos priced according to the merit

of the donor, the commodification of nascent human life will be unstoppable.

Finally, the practice of human cloning by nuclear transfer—like other anticipated

forms of genetically engineering the next generation—would enshrine and aggravate

a profound misunderstanding of the meaning of having children and of the parentchild relationship. When a couple normally chooses to procreate, the partners are

saying yes to the emergence of new life in its novelty—are saying yes not only to

having a child, but also to having whatever child this child turns out to be. In accepting our finitude, in opening ourselves to our replacement, we tacitly confess the

limits of our control.

Embracing the future by procreating means precisely that we are relinquishing

our grip in the very activity of taking up our own share in what we hope will be

the immortality of human life and the human species. This means that our children

are not our children: they are not our property, they are not our possessions. Neither are they supposed to live our lives for us, or to live anyone’s life but their own.

Their genetic distinctiveness and independence are the natural foreshadowing of the

deep truth that they have their own, never-before-enacted life to live. Though

sprung from a past, they take an uncharted course into the future.

Much mischief is already done by parents who try to live vicariously through their

children. Children are sometimes compelled to fulfill the broken dreams of unhappy

parents. But whereas most parents normally have hopes for their children, cloning

parents will have expectations. In cloning, such overbearing parents will have taken

at the start a decisive step that contradicts the entire meaning of the open and forward-looking nature of parent-child relations. The child is given a genotype that has

already lived, with full expectation that this blueprint of a past life ought to be controlling the life that is to come. A wanted child now means a child who exists precisely to fulfill parental wants. Like all the more precise eugenic manipulations that

will follow in its wake, cloning is thus inherently despotic, for it seeks to make one’s

12

children after one’s own image (or an image of one’s choosing) and their future according to one’s will.

Is this hyperbolic? Consider concretely the new realities of responsibility and guilt

in the households of the cloned. No longer only the sins of the parents, but also the

genetic choices of the parents, will be visited on the children—and beyond the third

and fourth generation; and everyone will know who is responsible. No parent will

be able to blame nature or the lottery of sex for an unhappy adolescent’s big nose,

dull wit, musical ineptitude, nervous disposition, or anything else that he hates

about himself. Fairly or not, children will hold their cloners responsible for everything, for nature as well as for nurture. And parents, especially the better ones, will

be limitlessly liable to guilt. Only the truly despotic souls will sleep the sleep of the

innocent.

IV.

The defenders of cloning are not wittingly friends of despotism. Quite the contrary. Deaf to most other considerations, they regard themselves mainly as friends

of freedom: the freedom of individuals to reproduce, the freedom of scientists and

inventors to discover and to devise and to foster ‘‘progress’’ in genetic knowledge and

technique, the freedom of entrepreneurs to profit in the market. They want largescale cloning only for animals, but they wish to preserve cloning as a human option

for exercising our ‘‘right to reproduce’’—our right to have children, and children with

‘‘desirable genes.’’ As some point out, under our ‘‘right to reproduce’’ we already

practice early forms of unnatural, artificial, and extra-marital reproduction, and we

already practice early forms of eugenic choice. For that reason, they argue, cloning

is no big deal.

We have here a perfect example of the logic of the slippery slope. The principle

of reproductive freedom currently enunciated by the proponents of cloning logically

embraces the ethical acceptability of sliding all the way down: to producing children

wholly in the laboratory from sperm to term (should it become feasible), and to producing children whose entire genetic makeup will be the product of parental eugenic

planning and choice. If reproductive freedom means the right to have a child of one’s

own choosing by whatever means, then reproductive freedom knows and accepts no

limits.

Proponents want us to believe that there are legitimate uses of cloning that can

be distinguished from illegitimate uses, but by their own principles no such limits

can be found. (Nor could any such limits be enforced in practice: once cloning is permitted, no one ever need discover whom one is cloning and why.) Reproductive freedom, as they understand it, is governed solely by the subjective wishes of the parents-to-be. The sentimentally appealing case of the childless married couple is, on

these grounds, indistinguishable from the case of an individual (married or not) who

would like to clone someone famous or talented, living or dead. And the principle

here endorsed justifies not only cloning but also all future artificial attempts to create (manufacture) ‘‘better’’ or ‘‘perfect’’ babies.

The ‘‘perfect baby,’’ of course, is the project not of the infertility doctors, but of

the eugenic scientists and their supporters, who, for the time being, are content to

hide behind the skirts of the partisans of reproductive freedom and compassion for

the infertile. For them, the paramount right is not the so-called right to reproduce,

it is what the biologist Bentley Glass called, a quarter of a century ago, ‘‘the right

of every child to be born with a sound physical and mental constitution, based on

a sound genotype . . . the inalienable right to a sound heritage.’’ But to secure this

right, and to achieve the requisite quality control over new human life, human conception and gestation will need to be brought fully into the bright light of the laboratory, beneath which the child-to-be can be fertilized, nourished, pruned, weeded,

watched, inspected, prodded, pinched, cajoled, injected, tested, rated, graded, approved, stamped, wrapped, sealed, and delivered. There is no other way to produce

the perfect baby.

If you think that such scenarios require outside coercion or governmental tyranny,

you are mistaken. Once it becomes possible, with the aid of human genomics, to

produce or to select for what some regard as ‘‘better babies’’—smarter, prettier,

healthier, more athletic—parents will leap at the opportunity to ‘‘improve’’ their offspring. Indeed, not to do so will be socially regarded as a form of child neglect.

Those who would ordinarily be opposed to such tinkering will be under enormous

pressure to compete on behalf of their as yet unborn children—just as some now

plan almost from their children’s birth how to get them into Harvard. Never mind

that, lacking a standard of ‘‘good’’ or ‘‘better,’’ no one can really know whether any

such changes will truly be improvements.

13

Proponents of cloning urge us to forget about the science-fiction scenarios of laboratory manufacture or multiple-copy clones, and to focus only on the sympathetic

cases of infertile couples exercising their reproductive rights. But why, if the single

cases are so innocent, should multiplying their performance be so off-putting? (Similarly, why do others object to people’s making money from that practice if the practice itself is perfectly acceptable?) The so-called science-fiction cases—say, Brave

New World—make vivid the meaning of what looks to us, mistakenly, to be benign.

They reveal that what looks like compassionate humanitarianism is, in the end,

crushing dehumanization.

V.

Whether or not they share my reasons, most people, I think, share my conclusion:

that human cloning is unethical in itself and dangerous in its likely consequences,

which include the precedent that it will establish for designing our children. Some

reach this conclusion for their own good reasons, different from my own: concerns

about distributive justice in access to eugenic cloning; worries about the genetic effects of asexual ‘‘inbreeding’’; aversion to the implicit premise of genetic determinism; objections to the embryonic and fetal wastage that must necessarily accompany the efforts; religious opposition to ‘‘man playing God.’’ But never mind why:

the overwhelming majority of our fellow Americans remain firmly opposed to cloning

human beings.

For us, then, the real questions are: What should we do about it? How can we

best succeed? These questions should concern everyone eager to secure deliberate

human control over the powers that could re-design our humanity, even if cloning

is not the issue over which they would choose to make their stand. And the answer

to the first question seems pretty plain. What we should do is work to prevent

human cloning by making it illegal.

We should aim for a global legal ban, if possible, and for a unilateral national ban

at a minimum—and soon, before the fact is upon us. To be sure, legal bans can be

violated; but we certainly curtail much mischief by outlawing incest, voluntary servitude, and the buying and selling of organs and babies. To be sure, renegade scientists may secretly undertake to violate such a law, but we can deter them by both

criminal sanctions and monetary penalties, as well as by removing any incentive

they have to proudly claim credit for their technological bravado.

Such a ban on clonal baby-making will not harm the progress of basic genetic

science and technology. On the contrary, it will reassure the public that scientists

are happy to proceed without violating the deep ethical norms and intuitions of the

human community. It will also protect honorable scientists from a public backlash

against the brazen misconduct of the rogues. As many scientists have publicly confessed, free and worthy science probably has much more to fear from a strong public

reaction to a cloning fiasco than it does from a cloning ban, provided that the ban

is judiciously crafted and vigorously enforced against those who would violate it.

Five states—Michigan, Louisiana, California, Rhode Island, and Virginia—have

already enacted a ban on human cloning, and several others are likely to follow suit

this year. Michigan, for example, has made it a felony, punishable by imprisonment

for not more than ten years or a fine of not more than $10 million, or both, to ‘‘intentionally engage in or attempt to engage in human cloning,’’ where human cloning

means ‘‘the use of human somatic cell nuclear transfer technology to produce a

human embryo.’’ Internationally, the movement to ban human cloning gains momentum. France and Germany have banned cloning (and germline genetic engineering), and the Council of Europe is working to have it banned in all of its forty-one

member countries, and Canada is expected to follow suit. The United Nations,

UNESCO, and the Group of Seven have called for a global ban on human cloning.

Given the decisive actions of the rest of the industrialized world, the United

States looks to some observers to be a rogue nation. A few years ago, soon after the

birth of Dolly, President Clinton called for legislation to outlaw human cloning, and

attempts were made to produce a national ban. Yet none was enacted, despite general agreement in Congress that it would be desirable to have such a ban. One

might have thought that it would be easy enough to find clear statutory language

for prohibiting attempts to clone a human being (and other nations have apparently

not found it difficult). But, alas, in the last national go-around, there was trouble

over the apparently vague term ‘‘human being,’’ and whether it includes the early

(pre-implantation) embryonic stages of human life. Learning from this past failure,

we can do better this time around. Besides, circumstances have changed greatly in

the intervening three years, making a ban both more urgent and less problematic.

Two major anti-cloning bills were introduced into the Senate in 1998. The Democratic bill (Kennedy-Feinstein) would have banned so-called reproductive cloning by

14

prohibiting transfer of cloned embryos into women to initiate pregnancy. The Republican bill (Frist-Bond) would have banned all cloning by prohibiting the creation

even of embryonic human clones. Both sides opposed ‘‘reproductive cloning,’’ the attempt to bring to birth a living human child who is the clone of someone now (or

previously) alive. But the Democratic bill sanctioned creating cloned embryos for research purposes, and the Republican bill did not. The pro-life movement could not

support the former, whereas the scientific community and the biotechnology industry opposed the latter; indeed, they successfully lobbied a dozen Republican senators

to oppose taking a vote on the Republican bill (which even its supporters now admit

was badly drafted). Owing to a deep and unbridgeable gulf over the question of embryo research, we did not get the congressional ban on reproductive cloning that

nearly everyone wanted. It would be tragic if we again failed to produce a ban on

human cloning because of its seemingly unavoidable entanglement with the more

divisive issue of embryo research.

To find a way around this impasse, several people (myself included) advocated a

legislative ‘‘third way,’’ one that firmly banned only reproductive cloning but did not

legitimate creating cloned embryos for research. This, it turns out, is hard to do.

It is easy enough to state the necessary negative disclaimer that would set aside

the embryo-research question: ‘‘Nothing in this act shall be taken to determine the

legality of creating cloned embryos for research; this act neither permits nor prohibits such activity.’’ It is much more difficult to state the positive prohibition in

terms that are unambiguous and acceptable to all sides. To indicate only one difficulty: indifference to the creation of embryonic clones coupled with a ban (only)

on their transfer would place the federal government in the position of demanding

the destruction of nascent life, a bitter pill to swallow even for pro-choice advocates.

Given both these difficulties, and given the imminence of attempts at human

cloning, I now believe that what we need is an all-out ban on human cloning, including the creation of embryonic clones. I am convinced that all halfway measures will

prove to be morally, legally, and strategically flawed, and—most important—that

they will not be effective in obtaining the desired result. Anyone truly serious about

preventing human reproductive cloning must seek to stop the process from the beginning. Our changed circumstances, and the now evident defects of the less restrictive alternatives, make an all-out ban by far the most attractive and effective option.

Here’s why. Creating cloned human children (‘‘reproductive cloning’’) necessarily

begins by producing cloned human embryos. Preventing the latter would prevent the

former, and prudence alone might counsel building such a ‘‘fence around the law.’’ Yet some scientists favor embryo cloning as a way of obtaining embryos for research

or as sources of cells and tissues for the possible benefit of others. (This practice

they misleadingly call ‘‘therapeutic cloning’’ rather than the more accurate ‘‘cloning

for research’’ or ‘‘experimental cloning,’’ so as to obscure the fact that the clone will

be ‘‘treated’’ only to exploitation and destruction, and that any potential future beneficiaries and any future ‘‘therapies’’ are at this point purely hypothetical.)

The prospect of creating new human life solely to be exploited in this way has

been condemned on moral grounds by many people—including The Washington Post,

President Clinton, and many other supporters of a woman’s right to abortion—as

displaying a profound disrespect for life. Even those who are willing to scavenge socalled ‘‘spare embryos’’—those products of in vitro fertilization made in excess of

people’s reproductive needs, and otherwise likely to be discarded—draw back from

creating human embryos explicitly and solely for research purposes. They reject outright what they regard as the exploitation and the instrumentalization of nascent

human life. In addition, others who are agnostic about the moral status of the embryo see the wisdom of not needlessly offending the sensibilities of their fellow citizens who are opposed to such practices.

But even setting aside these obvious moral first impressions, a few moments of

reflection show why an anti-cloning law that permitted the cloning of embryos but

criminalized their transfer to produce a child would be a moral blunder. This would

be a law that was not merely permissively ‘‘pro-choice’’ but emphatically and prescriptively ‘‘anti-life.’’ While permitting the creation of an embryonic life, it would

make it a federal offense to try to keep it alive and bring it to birth. Whatever one

thinks of the moral status or the ontological status of the human embryo, moral

sense and practical wisdom recoil from having the government of the United States

on record as requiring the destruction of nascent life and, what is worse, demanding

the punishment of those who would act to preserve it by (feloniously!) giving it

birth.

But the problem with the approach that targets only reproductive cloning (that

is, the transfer of the embryo to a woman’s uterus) is not only moral but also legal

and strategic. A ban only on reproductive cloning would turn out to be unenforceVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00018 Fmt 6633 Sfmt 6621 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
15

able. Once cloned embryos were produced and available in laboratories and assistedreproduction centers, it would be virtually impossible to control what was done with

them. Biotechnical experiments take place in laboratories, hidden from public view,

and, given the rise of high-stakes commerce in biotechnology, these experiments are

concealed from the competition. Huge stockpiles of cloned human embryos could

thus be produced and bought and sold without anyone knowing it. As we have seen

with in vitro embryos created to treat infertility, embryos produced for one reason

can be used for another reason: today ‘‘spare embryos’’ once created to begin a pregnancy are now used in research, and tomorrow clones created for research will be

used to begin a pregnancy.

Assisted reproduction takes place within the privacy of the doctor-patient relationship, making outside scrutiny extremely difficult. Many infertility experts probably

would obey the law, but others could and would defy it with impunity, their doings

covered by the veil of secrecy that is the principle of medical confidentiality. Moreover, the transfer of embryos to begin a pregnancy is a simple procedure (especially

compared with manufacturing the embryo in the first place), simple enough that its

final steps could be self-administered by the woman, who would thus absolve the

doctor of blame for having ‘‘caused’’ the illegal transfer. (I have in mind something

analogous to Kevorkian’s suicide machine, which was designed to enable the patient

to push the plunger and the good ‘‘doctor’’ to evade criminal liability.)

Even should the deed become known, governmental attempts to enforce the reproductive ban would run into a swarm of moral and legal challenges, both to efforts

aimed at preventing transfer to a woman and—even worse—to efforts seeking to

prevent birth after transfer has occurred. A woman who wished to receive the embryo clone would no doubt seek a judicial restraining order, suing to have the law

overturned in the name of a constitutionally protected interest in her own reproductive choice to clone. (The cloned child would be born before the legal proceedings

were complete.) And should an ‘‘illicit clonal pregnancy’’ be discovered, no governmental agency would compel a woman to abort the clone, and there would be an

understandable storm of protest should she be fined or jailed after she gives birth.

Once the baby is born, there would even be sentimental opposition to punishing the

doctor for violating the law—unless, of course, the clone turned out to be severely

abnormal.

For all these reasons, the only practically effective and legally sound approach is

to block human cloning at the start, at the production of the embryo clone. Such

a ban can be rightly characterized not as interference with reproductive freedom,

nor even as interference with scientific inquiry, but as an attempt to prevent the

unhealthy, unsavory, and unwelcome manufacture of and traffic in human clones.

VI.

Some scientists, pharmaceutical companies, and bio-entrepreneurs may balk at

such a comprehensive restriction. They want to get their hands on those embryos,

especially for their stem cells, those pluripotent cells that can in principle be turned

into any cells and any tissues in the body, potentially useful for transplantation to

repair somatic damage. Embryonic stem cells need not come from cloned embryos,

of course; but the scientists say that stem cells obtained from clones could be therapeutically injected into the embryo’s adult ‘‘twin’’ without any risk of immunological

rejection. It is the promise of rejection-free tissues for transplantation that so far

has been the most successful argument in favor of experimental cloning. Yet new

discoveries have shown that we can probably obtain the same benefits without embryo cloning. The facts are much different than they were three years ago, and the

weight in the debate about cloning for research should shift to reflect the facts.

Numerous recent studies have shown that it is possible to obtain highly potent

stem cells from the bodies of children and adults—from the blood, bone marrow,

brain, pancreas, and, most recently, fat. Beyond all expectations, these non-embryonic stem cells have been shown to have the capacity to turn into a wide variety

of specialized cells and tissues. (At the same time, early human therapeutic efforts

with stem cells derived from embryos have produced some horrible results, the cells

going wild in their new hosts and producing other tissues in addition to those in

need of replacement. If an in vitro embryo is undetectably abnormal—as so often

they are—the cells derived from it may also be abnormal.) Since cells derived from

our own bodies are more easily and cheaply available than cells harvested from specially manufactured clones, we will almost surely be able to obtain from ourselves

any needed homologous transplantable cells and tissues, without the need for egg

donors or cloned embryonic copies of ourselves. By pouring our resources into adult

stem cell research (or, more accurately, ‘‘non-embryonic’’ stem cell research), we can

also avoid the morally and legally vexing issues in embryo research. And more to

16

our present subject, by eschewing the cloning of embryos, we make the cloning of

human beings much less likely.

A few weeks ago an excellent federal anti-cloning bill was introduced in Congress,

sponsored by Senator Sam Brownback and Representative David Weldon. This carefully drafted legislation seeks to prevent the cloning of human beings at the very

first step, by prohibiting somatic cell nuclear transfer to produce embryonic clones,

and provides substantial criminal and monetary penalties for violating the law. The

bill makes very clear that there is to be no interference with the scientific and medically useful practices of cloning DNA fragments (molecular cloning), with the duplication of somatic cells (or stem cells) in tissue culture (cell cloning), or with wholeorganism or embryo cloning of non-human animals. If enacted, this law would bring

the United States into line with the current or soon-to-be-enacted practices of many

other nations. Most important, it offers us the best chance—the only realistic

chance—that we have to keep human cloning from happening, or from happening

much.

Getting this bill passed will not be easy. The pharmaceutical and biotech companies and some scientific and patient-advocacy associations may claim that the bill

is the work of bio-Luddites: anti-science, a threat to free inquiry, an obstacle to obtaining urgently needed therapies for disease. Some feminists and pro-choice groups

will claim that this legislation is really only a sneaky device for fighting Roe v. Wade, and they will resist anything that might be taken even to hint that a human

embryo has any moral worth. On the other side, some right-to-life purists, who care

not how babies are made as long as life will not be destroyed, will withhold their

support because the bill does not take a position against embryo twinning or embryo

research in general.

All of these arguments are wrong, and all of them must be resisted. This is not

an issue of pro-life versus pro-choice. It is not about death and destruction, or about

a woman’s right to choose. It is only and emphatically about baby design and manufacture: the opening skirmish of a long battle against eugenics and against a posthuman future. As such, it is an issue that should not divide ‘‘the left’’ and ‘‘the

right’’; and there are people across the political spectrum who are coalescing in the

efforts to stop human cloning. (The prime sponsor of Michigan’s comprehensive anticloning law is a pro-choice Democratic legislator.) Everyone needs to understand

that, whatever we may think about the moral status of embryos, once embryonic

clones are produced in the laboratories the eugenic revolution will have begun. And

we shall have lost our best chance to do anything about it.

As we argue in the coming weeks about this legislation, let us be clear about the

urgency of our situation and the meaning of our action or inaction. Scientists and

doctors whose names we know, and probably many others whose names we do not

know, are today working to clone human beings. They are aware of the immediate

hazards, but they are undeterred. They are prepared to screen and to destroy anything that looks abnormal. They do not care that they will not be able to detect most

of the possible defects. So confident are they in their rectitude that they are willing

to ignore all future consequences of the power to clone human beings. They are prepared to gamble with the well-being of any live-born clones, and, if I am right, with

a great deal more, all for the glory of being the first to replicate a human being.

They are, in short, daring the community to defy them. In these circumstances, our

silence can only mean acquiescence. To do nothing now is to accept the responsibility for the deed and for all that follows predictably in its wake.

I appreciate that a federal legislative ban on human cloning is without American

precedent, at least in matters technological. Perhaps such a ban will prove ineffective; perhaps it will eventually be shown to have been a mistake. (If so, it could

later be reversed.) If enacted, however, it will have achieved one overwhelmingly important result, in addition to its contribution to thwarting cloning: it will place the

burden of practical proof where it belongs. It will require the proponents to show

very clearly what great social or medical good can be had only by the cloning of

human beings. Surely it is only for such a compelling case, yet to be made or even

imagined, that we should wish to risk this major departure—or any other major departure—in human procreation.

Americans have lived by and prospered under a rosy optimism about scientific

and technological progress. The technological imperative has probably served us

well, though we should admit that there is no accurate method for weighing benefits

and harms. And even when we recognize the unwelcome outcomes of technological

advance, we remain confident in our ability to fix all the ‘‘bad’’ consequences—by

regulation or by means of still newer and better technologies. Yet there is very good

reason for shifting the American paradigm, at least regarding those technological

interventions into the human body and mind that would surely effect fundamental

(and likely irreversible) changes in human nature, basic human relationships, and

17

what it means to be a human being. Here we should not be willing to risk everything in the naive hope that, should things go wrong, we can later set them right

again.

Some have argued that cloning is almost certainly going to remain a marginal

practice, and that we should therefore permit people to practice it. Such a view is

shortsighted. Even if cloning is rarely undertaken, a society in which it is tolerated

is no longer the same society—any more than is a society that permits (even smallscale) incest or cannibalism or slavery. A society that allows cloning, whether it

knows it or not, has tacitly assented to the conversion of procreation into manufacture and to the treatment of children as purely the projects of our will. Willy-nilly,

it has acquiesced in the eugenic re-design of future generations. The humanitarian

superhighway to a Brave New World lies open before this society.

But the present danger posed by human cloning is, paradoxically, also a golden

opportunity. In a truly unprecedented way, we can strike a blow for the human control of the technological project, for wisdom, for prudence, for human dignity. The

prospect of human cloning, so repulsive to contemplate, is the occasion for deciding

whether we shall be slaves of unregulated innovation, and ultimately its artifacts,

or whether we shall remain free human beings who guide our powers toward the

enhancement of human dignity. The humanity of the human future is now in our

hands.

SUMMARY

New biomedical technologies are rapidly providing powers to intervene in human

bodies and minds in ways that threaten fundamental changes in human nature and

the meaning of our humanity. We now stand at a major fork at the road, compelled

to decide whether we wish to travel down the path to the Brave New World: we

must decide whether to tolerate the practice of human cloning, the asexual reproduction of human beings, made as genetic copies of already (or previously) existing

individuals. Reputable scientists have announced plans to clone human beings in

the coming year and are daring us to stop them. Our failure to try to do so constitutes our tacit acquiescence.

The vast majority of Americans object to human cloning, and on multiple moral

grounds. It constitutes unethical experimentation on the child-to-be. It threatens

identity and individuality. It represents a giant step toward turning procreation into

manufacture, legitimizing in advance the eugenic redesigning of our children. And

it is a radical form of parental despotism and child abuse. Permitting human

cloning means saying yes to the dangerous principle that we are entitled to determine the genetic make-up of our children. If we do not wish to travel down this eugenic road, an effective ban on cloning human beings is needed, and needed now

before we are overtaken by events.

Two legislative alternatives have been proposed: one would ban only so-called reproductive cloning by prohibiting the transfer of a cloned embryo to a woman to initiate a pregnancy; the other would ban all cloning by prohibiting the creation even

of the embryonic human clones. Arguments are given why the latter proposal is

much to be preferred. Once cloned embryos are produced and available in laboratories and assisted-reproduction centers, it will be virtually impossible to control

what is done with them. Stockpiles of cloned human embryos could be produced and

bought and sold without anyone knowing it. Efforts at clonal reproduction would

take place out of sight, within the privacy of the doctor-patient relationship. Moreover, a ban on only reproductive cloning will turn out to be unenforceable. Should

‘‘illicit cloning’’ be discovered, governmental attempts to enforce the reproductive

ban would run into a swarm of legal and practical challenges, and the practice will

prove impossible to police or regulate. Anyone truly serious about preventing human

reproductive cloning must seek to stop the process from the beginning.

This is not an issue of pro-life vs. pro-choice. It is not about death and destruction

or about a woman’s right to choose. It is only and emphatically an issue of babydesign and manufacture, the opening skirmish of a long battle against eugenics and

against a ‘‘post-human’’ future. Once embryonic clones are produced in laboratories,

the eugenic revolution will have begun. And we shall have lost our best chance to

do anything about it and to assume responsible control over where biotechnology is

taking us. The humanity of the human future is now in our hands.

Mr. SMITH. Thank you, Dr. Kass. Dr. Callahan.

18

STATEMENT OF DANIEL CALLAHAN, DIRECTOR OF INTERNATIONAL PROGRAMS, HASTING CENTER, GARRISON, NY

Mr. CALLAHAN. Thank you, Mr. Chairman. I want to talk about

two things today. First, I would like to say a little bit about my

opposition, ethically, to cloning, but then I would like to deal with

the question of whether it would be ethically appropriate to ban

scientific research on cloning. I want to argue that there are obvious legal issues involved in the scientific ban, but it seems to me

that there is a fundamental ethical question of whether that is a

way to go in the first place.

Let me very briefly sum up my general objection to cloning. I

come down to one point most decisively; that is, I see a profound

threat to the individuality of children so born. I think it is part of

our human nature, part of what we consider our fundamental individuality and identity, that we’re different from other people. Surely it is the case, as many have pointed out, that a cloned person

would not be genetically absolutely identical, and because of environmental forces, it is also the case at the person would not even

be psychologically identical, but as we know from twin studies, approximately 50 percent of personal traits are shared by identical

twins. More importantly, even if a clone is not going to be totally

identical, it would be identical enough that there would be a fundamental threat to what is distinctive about ourself, which is partly

our appearance, partly the fact that there is no one on earth quite

like us. I begin with that basic point.

On the question of the relationship of law and ethics, which is

obviously a major problem in American society, and always has

been, the question of what moral principles do we want to enact

into law, which ones do we want to leave free of the law, subject

to stigmatization, personal pressure, political forces and the like, is

an issue long debated. I believe in this case that a ban would be

appropriate and justifiable. The main justification needed for a ban

is that there is a fundamental threat to important social and public

values, and in this case I believe there is such a threat.

The question, though, is still, given the important precedent that

would be set by banning research at this fundamental level, whether the very powerful burden of argument in favor of it—against it— can be discharged. I think that the bias in our society, an appropriate bias, is that anyone who would want to ban scientific research has a very difficult burden to discharge. I believe in this

case that the burden can be discharged. First of all, the simple fact

that we would be changing the nature of procreation and parenthood in a radical way is, itself, a very strong argument, but I think

we can anticipate that scientists would feel this is a fundamental

threat to their liberty and to an important part of the American

and scientific tradition.

A fundamental response to this argument can be made. First of

all, we certainly have restricted science in many ways in our society. We have a requirement with human subject research that people give informed consent before being used as subjects, and we

simply do not allow practical or utilitarian considerations to overturn that very firm ban. We have certainly regulated science in

many ways, and, it seems to me, by enacting a ban here, we will

not be doing something fundamentally different, but granted we

19

are taking one further step. I think the fundamental reason for a

ban, part of which has been really developed by Dr. Kass, is that

if we do not have a ban at the very fundamental research level

with the techniques for human cloning, the ability to really control

in the long run will not be possible.

I am struck by the fact that too much of our current interest in

biomedical research is, seems to me, fueled by a kind of singleminded passion to eliminate disease, often likened to a war, in fact,

we use the language of a war against disease very often. I think

the worst possible analogy of biomedical research is that of warfare. Illness, death and suffering are terrible human threats, but

to approach them as if nothing less than all out battle with no

holds barred will demonstrate our moral seriousness is a profound

mistake. Health is a great and vital human good, but not the only

such good.

The point of a ban on research for human cloning is to make certain that some time-tested critical means of human procreation and

human individuality are protected. They are an as important part

of our Western American heritage as freedom of scientific inquiry,

the freedom that has well co-existed for some years with ethical

limitations and has managed to flourish is the face of and sometimes because of those limitations. In short, I do not think that a

ban would in any way fundamentally be a threat to the future of

scientific research here. I believe there are alternatives to the proposed lines of research which ought to be explored, and in any case,

it seems to me, that the very basic necessity to protect our children

and children in the future and to protect our very fundamental

commitment to a procreation that generates individual, unique people is something that ought not to be in anyway overcome. Thank

you.

[The prepared statement of Mr. Callahan follows:]

PREPARED STATEMENT OF DANIEL CALLAHAN

I am Daniel Callahan, Director of the International Program of The Hastings Center, Garrison, N.Y., a research center devoted to biomedical and environmental ethics. I pleased to take part in this hearing. It focuses on a topic of great important

for the human future and the proper use of scientific research as it moves toward

that future. Research on human cloning would chart not only a new direction for

biomedical research but also, in its implications, a new direction for the procreation

of human life.

I oppose such research, for reasons I will shortly present, but the main purpose

of my testimony will be to discuss proposals to ban such research, at both the federal and the private levels. I want to combine the topics of the ethics of human

cloning and the ethics of controlling the research for one simple reason: if research

on human cloning is a bad direction in which to go, what can be done about that?

What is the appropriate connection, with the issue of human cloning, between ethics

and the law? The connection is particularly important in this instance because, so

far as I can determine, the federal government has never before tried to use the

police power of the state to ban a particular line of biomedical research.

While there have been a variety of moral objections voiced against human cloning,

the one that has most persuaded me is the two-fold argument that: (a) children have

a right to their own genetic identity, an identify which, if not interfered with, will

be unlike any other person’s identify; and that (b) parents ought not to manufacture

children to their specifications or to serve their needs, even understandable needs.

Our moral and political tradition has always understood each of us to be individuals in our own right, to be accorded respect precisely because of our unique individuality. Human cloning would jeopardize that identity. It is true, as many scientists

have noted, that a cloned human being would not, even genetically, be exactly like

the person from whom he or she was cloned. It is also true that the different enviVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00023 Fmt 6633 Sfmt 6621 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
20

ronmental and social context of the clone would lead to a person with many different traits and even personality. But twin studies have suggested that at least

50% of their personal traits are similar; and the simple fact that we would have

the same appearance as the source of the clone is not something to be lightly dismissed. Common sense, moreover, suggests that there would be no point in cloning

a person unless that person shared many of the traits of the genetic originator. The

fact that genetically identical twins occur in nature does not, by itself, prove that

it is acceptable to manufacture them.

The very first question to be asked about human cloning is whether it would benefit the clone. That question is, surprisingly, hardly addressed at all by those favorable to cloning. The best that can be said is that some cloned children might not

be alive at all but for the fact that its parents would or could only procreate in a

way that would produce a clone. By far the greater emphasis of proponents has been

a claim that the idea of reproductive rights can extend to cloning a child, and that

once such a right is recognized—satisfying the desires of the parent—then there is

little more of moral interest to be said.

There is, in short, little apparent concern for what was not long ago called ‘‘re- sponsible parenthood.’’ That important concept has been pushed aside by the seemingly unlimited notion of reproductive rights, not only the right to have or not have

a child, but to have a child with the traits, any traits, of one’s own choosing and

procreated in any manner. Yet responsible parenthood is still an important concept,

one that needs to be reinvigorated. To be sure, people have always had children to

satisfy their own needs and interests: to carry on family lines, to care for them in

old age, to provide helpers on the farm, to provide parents with the pleasure of having and raising children. But there has always been a powerful, and parallel, tradition that children are demeaned in their meaning and personhood if they are not

loved and respected and reared for their own good and not that of the parents.

There is surely something of a paradox here in observing why people have children—for their own sake and that of the child at one and the same time—but the

final desired outcome had been less mixed in its ideals. That outcome is simply that

the child must grow into an adult who is his or her own person, shaped by, educated

by, cherished by his or her parents, but not made in the image of, or according to

the plan of, the parents. Jokes are often made about pushy parents, and sometimes

children thank parents for moving them in one direction rather than another; but

for children who have been forced to live up to some predetermined parental notion

of what the child must be or do there can be, and often has been, great tragedy.

To say each of us ought, in the end, to be our own person is to say it all. That

cloning does not deprive someone entirely of his identity is beside the point. It badly

compromises it, and that is grounds enough for condemnation.

There is, however, a long-standing and important difference between ethics and

law. The former is meant to shape our individual virtues and principles, and to provide a foundation for making distinctions between right and wrong, good and bad.

The latter may and often does embody our ethical values, but its purpose is primarily to establish those rules and prohibitions necessary for a society to function

well, in reasonable peace and harmony. Not every ethical principle or belief is appropriate for law, and not every law embodies moral principles (though law should

never be incompatible with them).

So, even if we can come to some agreement that research on human cloning is

wrong-headed, and morally wrong, does that mean that we should ban it? We could,

after all, leave matters as they now stand, with a prohibition against federal grants

to support such research, with most professional and public opinion hostile to it, and

with little apparent interest in the private sector, which apparently sees no great

profit in it. Would not that be enough to stop it from ever happening?

Probably not. Not only is there a minority body of scientific and lay opinion that

human cloning is worth pursuit, but also some well-publicized instances of individuals and groups who have told us they will do the research necessary to produce

a clone. They should be taken seriously. If they succeed, or others who come later

do, then those of us—and our children and our children’s children—will have to live

with the result: a radical change in the procreation of children, a change that offers

a minor promise of some therapeutic benefit and a major promise of social harm.

But, even so, is that a good enough reason to enact a federal ban? A ban would

be a most drastic response, unprecedented at the level of the combined basic and

applied research that would be needed to create a human clone. That should be

enough to give pause to anyone who appreciates the great contribution that a free

science can make to our health and welfare. It is easy to imagine many scientists,

legislators, and lay people agreeing that research on cloning to be morally wrong,

like with most harmful consequences—and yet fearing the precedent for research restrictions that could be even worse in its consequences. Moreover, is not the diVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00024 Fmt 6633 Sfmt 6621 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
21

lemma made all the worse when it is proposed, as is the case with one bill before

the House of Representatives, to ban not just direct research into human cloning—

called ‘‘reproductive cloning’’—but also a ban on embryo cloning as well for research

purposes, which might best be called ‘‘cloning for research.’’

Such a proposed ban lays a heavy burden of proof on its proponents: to show that

the harms to be averted are serious threats to the public interest; that dangerous

precedents for the future of science would not be established; and that the loss to

scientific research, of opportunities for knowledge foregone, would not be unacceptably high.

I believe that burden can be discharged. First, human cloning would change the

nature of procreation and parenthood in a radical way and, in the process, change

its social as well as individual meaning. There is good reason to believe such a

change would be harmful and no good reason to believe such a change would

produce any important benefit for procreation or, as often alleged, for the relief of

infertility. As for the precedents that might be set, there has always been a recognition that scientific freedom is not an absolute value. The international covenants requiring informed consent for clinical research, for instance, draw a sharp line

against the use of human being as research subjects against their will—however

great might be the research or medical benefits of doing so. Few seem to reject the

idea that it would be wrong to put children at risk to make human cloning work.

The physical safety of child-to-be who is part of human cloning research is taken

to be a value overriding that of scientific knowledge or benefits to parental infertility.

Scientists with no particular interest in human cloning might, however, worry

about the research opportunities that would be lost if legislation banned cloning for

research as firmly as it banned cloning for reproduction. A strong reason for doing

such research is to assist in stem cell investigations, which would be particularly

helped if immunological incompatibility and tissue rejection problems can be overcome. Cloning could help solve that problem.

Two points can be made in response. One of them is that it would be almost pointless to ban research on human cloning without banning research—cloning as well;

the former would provide the necessary knowledge to do the latter, and would make

it all the harder to have any kind of oversight over what would be done with the

knowledge.

The second point is that, as with much of genetic and biomedical research, there

is rarely anything such as a one-and-only way to gain knowledge, and this is as true

of stem cell research and its potential clinical applications as it is of most other research. There is no reason in principle to say that, much less any way to show, that

other approaches to stem cell research will and must fail—just as there is no reason

in principle to assume that research-oriented human cloning is the only way to deal

with the immunological compatibility problem. This is not to deny there could be

some scientific loss. Progress might come more slowly and with more difficulty with

a ban in place; but even there the best one can say is ‘‘might’’ because there is no

necessary correlation between methods that will at any historical moment appeal

to scientists and those that will, in the long run, prove most successful.

If there are no exact precedents for a ban on research of this kind, it is worth

noting that the National Bioethics Advisory Commission called for such a ban on

reproductive cloning research ( though it also asked for a sunset-clause and Congressional Review after 3–5 years). France and Germany have enacted a ban on that

kind of research as well. A ban on cloning for research purposes goes a step further,

but it is the only logical way to help insure that research on reproductive cloning

does not have other research off of which too easily to feed. It should be self-evident,

finally, that a ban can be revoked, that science can change, that what seems methodologically valid at the moment can give way to methods even better in the future.

Too much of the current research drive is fueled by a singleminded passion to

eradicate disease, often likened to a war. The worst possible analogy for biomedical

research is that of warfare. Illness, death, and suffering are terrible human threats,

but to approach them as if nothing less than all-out battle, with no holds barred,

will demonstrate our moral seriousness is a profound mistake. Health is a great and

vital human good, but not the only such good. The point of a ban on research for

human cloning is to make certain that some time-tested, critical means of human

procreation and human individuality are protected. They are as important part of

our American and Western heritage as freedom of scientific inquiry—a freedom that

has well coexisted for some years with ethical limitations and has managed to flourish in the face of (and sometimes because of) those limitations.

Mr. SMITH. Thank you, Dr. Callahan. Dr. Prentice?

22

STATEMENT OF DAVID A. PRENTICE, Ph.D., PROFESSOR OF

LIFE SCIENCES, INDIANA STATE UNIVERSITY

Mr. PRENTICE. Mr. Chairman and distinguished Members of the

Subcommittee, thank you for the opportunity to testify today at

this important hearing regarding human cloning. There is almost

uniform agreement against what has been termed reproductive

cloning, creating a cloned human being and allowing that clone to

develop to a live birth, but some scientists proposed therapeutic

cloning, the production of human embryos by cloning for the purpose of harvesting embryonic stem cells from the early embryo.

But, is cloning really necessary for production of embryo stem

cells? No. If necessary, those cells can be derived from so-called excess human embryos from in vitro fertilization. Proposals already

exist to design methods to prevent transplant rejection.

Of course, the debate will continue as to whether such excess

human embryos should be donated to research or perhaps instead

adopted through programs such as the Snowflakes Embryo Adoption Program. The real crux of the debate rests on the necessity for

embryonic stem cells for regenerative medicine; are they really necessary? Is there the potential for these cells to provide actual clinical treatments for disease versus other, less ethically contentious

alternatives? There is no dispute that embryonic stem cells, the

inner cells of the very early embryo, have the potential to produce

all human tissues under normal developmental circumstances, but

despite the initial enthusiasm for the use of these cells, they have

been disappointing.

Considerable technical problems remain to be surmounted, including the difficulty in growth and maintenance of the cells, slow

growth rate of the cells, potential chromosomal instability, difficulty in directing the production of specific desired tissues and potential tumor formation. The National Bioethics Advisory Commission in September 1999 expressed it this way, ‘‘In our judgment,

the derivation of stem cells from embryos remaining following infertility treatments is justifiable, only if no less morally problematic alternatives are suitable for advancing the research.’’ Such an

alternative does exist, adult stem cells.

Since that first statement in 1999, there has been an avalanche

of research reports describing success after success with adult stem

cells. The published scientific research voids all the arguments that

have been made against adults stem cells. Sufficient numbers of

adults stem cells can be easily generated and cultured for clinical

applications. A recent study showed that only one transplanted

adult stem cell from bone marrow in a mouse could regenerate tissue in several parts of the body. That single, transplant in cell expanded in number sufficiently and in enough time to rescue the

host mouse, into which it was transplanted from lethal irradiation.

Since the original stem cell came from another mouse, you might

term that technique mouse-to-mouse resuscitation.

However, there have been various studies that now show adult

stem cells from many tissues are pluri-potent. They have the ability to form many different tissues, in fact, the indications are

adults stem cells can regenerate all human tissues. Examples include transformation of brain stem cells in the blood, umbilical cord

blood into nerve, and bone marrow stem cells into an array of tisVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00026 Fmt 6633 Sfmt 6601 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
23

sues such as cartilage, bone, muscle, liver, nerve endocardiac tissue. Even fat has been recently found to contain stem cells. Placenta is a rich source of stem cells. Adult stem cells have also

shown that they can form functional tissues when injected into animal models. Bone marrow stem cells have been shown to transform

into functional liver, muscle and even into heart tissue, repairing

cardiac damage. Bone marrow and umbilical cord blood stem cells

have been shown to provide therapeutic benefit after stroke in a

mouse model.

Adult pancreatic stem cells have reversed diabetes in mice and

bone marrow stem cells have regenerated muscle in a mouse model

of muscular dystrophy. In addition, adult stem cells are already

being used successfully for therapeutic benefit in humans, treatments associated with cancer, relieving lupus, multiple sclerosis,

arthritis, immunodeficiencies, restoration of sight by regeneration

of corneas. Initial clinical trials have begun to repair heart damage

using the patient’s own adult stem cells. The weight of published

scientific evidence seems to clearly indicate an acceptable, less morally problematic alternative to embryonic stem cells does exist.

Adult stem cells are making good on what are only promises of

embryonic stem cells. Now, if the purpose of human cloning is as

a source of donor cells and tissues for others, there is no justification for such a practice. Therapeutic cloning takes a utilitarian

view of human embryos, useful for a purpose, not valued in and of

themselves. They are not viewed as people, but as property, a commodity. Dr. Irwin Chargaff, renowned biochemist, characterized

this attitude as a kind of capitalist cannibalism. A complete ban on

human cloning, as proposed in the Brownback-Weldon bill, is the

only sufficient answer. Thank you, sir.

[The prepared statement of Mr. Prentice follows:]

PREPARED STATEMENT OF DR. DAVID A. PRENTICE, PH.D.

Mr. Chairman, distinguished Members of the Subcommittee, thank you for the opportunity to testify today at this important hearing regarding human cloning.

There is almost uniform agreement against what has been termed ‘‘reproductive

cloning’’—creating a cloned human being and allowing that clone to develop to a live

birth. And there are good scientific reasons for opposition to reproductive cloning.

Of the half-dozen or so mammals which have been cloned thus far, almost all (95– 99%) do not survive, either dying during embryological development or soon after

birth. It has even been said that there are no normal clones, in that even the few

that survive after birth have various physiological problems, possibly genetic problems as well. This seems due to problems with the necessary re-programming of the

genetic material in the transplanted nucleus to allow normal development. Cloning

is thus a wasteful, inefficient, and even dangerous process for the clones themselves.

In addition, the surrogate mothers of the clones experience physiological problems.

In short, this whole notion is fraught with peril and should be banned.

But some scientists propose ‘‘therapeutic cloning’’, or euphemistically ‘‘cellular replacement through nuclear transfer’’. This involves production of human embryos by

cloning for the purpose of harvesting embryonic stem (ES) cells from the early embryo. On the surface the goal seems noble—to produce genetically-matched tissues

for clinical use. However, there are significant scientific problems with therapeutic

cloning as well, revolving primarily around both the claim of the necessity for production of embryonic stem cells in this manner and the claim that embryonic stem

cells are the only or the most promising route to clinical success in regenerative

medicine.

First in terms of the need for production of embryonic stem cells via cloning. The

proposals for use of this technique cite the very real probability that ES cells from

‘‘excess’’ human embryos frozen for in vitro fertilization (IVF) will not be an

immunological match for patients, leading to rejection of transplanted tissues created from such ES cells, as with organ transplant rejection. While this is a real posVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00027 Fmt 6633 Sfmt 6621 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
24

sibility, there are research proposals to design methods to mask the incompatibilities of stem cells from any source, allowing the transplanted cells to be accepted

in a transplant host. This would obviate the need to clone the patient in order to

produce genetically-matched cells and tissues and ES cells, if necessary, could be derived from frozen IVF embryos. Of course, the debate continues as to whether such

‘‘excess’’ human embryos should be donated to research, or rather adopted through

programs such as the Snowflakes embryo adoption program. Nonetheless, a telling

point regarding the production of cloned human embryos for derivation of ES cells

is that the Stem Cell Research Act of 2001 (S.723) introduced by Senators Specter

and Harkin, which supports human embryonic stem cell research, still requires that

the research involved shall not result in the creation of human embryos.

The crux of the debate regarding human cloning actually rests then on the necessity for production of embryonic stem cells for clinical use. Further, the question of

the necessity of embryonic stem cells for ‘‘regenerative medicine’’ has to do with the

potential of such human embryonic stem cells to provide actual clinical treatments

for disease versus other, less ethically contentious alternatives. There is no dispute

that embryonic stem cells, the inner cells of the very early embryo (approximately

5–9 days old), have the potential to produce all human tissues, under normal developmental circumstances. However, despite the initial enthusiasm for use of embryonic stem cells and the media hype, in laboratory cultures as well as in animal

transplant experiments, embryonic stem cells have been disappointing. Considerable

technical problems remain to be surmounted regarding both laboratory and potential clinical work with these cells, including the difficulty in growth and maintenance of the cells in culture, the relatively slow growth rate of ES cells, potential

chromosomal instability of some ES lines, difficulty in directing specific desired differentiation of the cells, and potential tumor formation.

The National Bioethics Advisory Commission (NBAC) expressed it this way in its

report in September of 1999:

‘‘In our judgment, the derivation of stem cells from embryos remaining following

infertility treatments is justifiable only if no less morally problematic alternatives are available for advancing the research . . . The claim that there are

alternatives to using stem cells derived from embryos is not, at the present

time, supported scientifically. We recognize, however, that this is a matter that

must be revisited continually as science advances.’’

Ethical Issues in Human Stem Cell Research, Volume I, (Rockville, MD; September 1999; p. 53

The question is thus whether a less morally problematic, and scientifically acceptable, alternative exists at this time. Such an alternative does exist: adult stem cells.

The name is somewhat of a misnomer, since these same stem cells can be found

in newborns as well as adults, and can also come from umbilical cords and placentas

after delivery of an infant. A better term might be ‘‘tissue stem cells’’ or ‘‘post-natal

stem cells’’, but since the term adult stem cells is widely known I will continue to

use it here.

Since the NBAC statement in 1999, there has been an avalanche of research reports describing success after success with adult stem cells. Early detractors of adult

stem cells raised several questions regarding these cells and their abilities. For example, it has been said that stem cells in adults are often present in only minute

quantities, are difficult to isolate and purify, and their numbers may decrease with

age, and further that any attempt to use stem cells from a patient’s own body for

treatment would require that stem cells would first have to be isolated from the patient and then grown in culture in sufficient numbers to obtain adequate quantities

for treatment. Numerous research papers have voided these arguments. Studies

have shown that previously reported human stem cell frequencies and their self-renewal activity have been markedly underestimated, and that sufficient numbers of

adult stem cells can be easily generated in culture for clinical applications. In fact,

a recent study showed that only one transplanted adult stem cell from bone marrow

could possibly regenerate tissue in several parts of the body. The single transplanted bone marrow stem cell actually expanded its numbers sufficiently and in

short enough time to rescue the host mouse in which it was transplanted from lethal irradiation, allowing the transplant recipient to survive. Since that single original stem cell came from another mouse, the technique could have been termed

‘‘mouse-to-mouse resuscitation’’.

As far as difficulty in isolation of adult stem cells, this might be true were we

to target extraction of neural stem cells from the brain. However, various studies

now show that adult stem cells from many tissues are ‘‘pluripotent’’, that is, they

have the ability to form many different tissues in the body, not just regenerate the

one tissue from which they were taken. In fact, the indications are that adult stem

25

cells can regenerate all human tissues. This potential answers another criticism,

that an individual stem cell has not yet been found for each of the 210 tissues of

the human body. The proven potential of adult stem cells to transform from one tissue type to another negates the necessity to find 210 different adult stem cells, since

one or a small set can suffice. Examples include transformation of neural stem cells

into blood,, umbilical cord blood stem cells into nerve, and bone marrow stem cells

into an array of tissues as diverse as cartilage, fat, bone, muscle, liver, nerve, lung,

gastrointestinal tissue, and cardiac tissue. Even fat was recently found to contain

stem cells which show indications of the ability to transform into other tissue types.

For our nation, this source might truly provide an unlimited quantity of stem cells.

Another recent report suggests that the placenta is rich in stem cells which might

be transformed into other tissues. And the Scottish company involved in the original

cloning of Dolly the sheep, PPL Therapeutics, recently reported that they have developed a technique to reprogram normal adult somatic cells into pluripotent stem

cells which can be induced to form almost any tissue; their original experiment involved turning a skin cell from a cow into a heart cell.

If the only thing that could be accomplished were to turn adult stem cells from

one tissue type into another in a lab dish, then this would be simply a cute scientific

trick. However, adult stem cells have shown that they can form functional tissues

when injected into the body. Bone marrow stem cells have been shown to transform

into functional liver and muscle; these adult stem cells could potentially ‘‘mend broken hearts’’—the cells can transform into functional heart tissue, repairing cardiac

damage. Bone marrow and umbilical cord blood stem cells have also been shown to

migrate to the brain, and in published reports have provided therapeutic benefit

after stroke in animal models. Adult pancreatic stem cells have reversed diabetes

in mice and regenerated muscle in an animal model of muscular dystrophy.

Adult stem cells are already being used successfully for therapeutic benefit in humans. This includes treatments associated with various types of cancer, to relieve

systemic lupus, multiple sclerosis, rheumatoid arthritis, anemias, and immunodeficiency diseases, and restoration of sight through regeneration of corneas. And

initial clinical trials have begun to repair heart damage using the patient’s own

adult stem cells. Per the NBAC statement, if we now revisit the science of stem

cells, the weight of published scientific evidence would seem to clearly indicate that

an acceptable, less morally problematic alternative to embryonic stem cells does

exist. Adult stem cells are making good on what are only promises of embryonic

stem cells.

On balance then, is it necessary to destroy some human beings to save other

human beings? Is it ethical when viable alternatives exist? The evidence would indicate that it is neither necessary nor ethical. If the purpose of human cloning would

be as a source of donor cells and tissues for others, there is no justification for such

a practice. Therapeutic cloning takes a utilitarian view of human embryos, useful

for a purpose and not valued in and of themselves. They are not viewed as people,

but as property, a commodity. Dr. Erwin Chargaff, renowned biochemist, characterizes this attitude as ‘‘a kind of capitalist cannibalism’’.

To artificially try to separate types of human cloning based on the end purpose

of the embryo is absurd. What is to prevent embryos which have been manufactured

for destruction and harvesting of embryonic stem cells from being implanted into

the uterus? If production in the laboratory of cloned humans for the purpose of embryonic stem cell harvesting results in excess embryos beyond that of clinical need,

will these excess embryos simply be discarded? Will they be frozen for storage? How

would stored embryos created by cloning be distinguished from stored embryos created by in vitro fertilization? The techniques used for reproductive cloning and

therapeutic cloning are identical, only the intent for use of the cloned human being

is different. And how are we to judge intent? How shall we provide oversight of intent?

A complete ban on human cloning as proposed in the Brownback-Weldon bill is

the only sufficient answer.

Mr. Chairman, distinguished Members, I thank you for the opportunity to provide

testimony on this important issue, and I would be pleased to answer any questions.

REFERENCES

PLURIPOTENT NATURE OF ADULT STEM CELLS

Showed the ability of a single adult bone marrow stem cell to repopulate the bone

marrow of mice, forming functional marrow and blood cells, and also differentiate

into functional cells of liver, lung, gastrointestinal tract (esophagus, stomach, intestine, colon), and skin. Indications that it could also form functional cells in heart

and skeletal muscle. Evidence that the stem cells ‘‘home’’ to sites of tissue damage.

26

Reference: Krause DS et al.; ‘‘Multi-Organ, Multi-Lineage Engraftment by a Single

Bone Marrow-Derived Stem Cell’’; Cell 105, 369–377; May 4, 2001

Research with mice indicates that adult stem cells from brain can grow into a

wide variety of organs—heart, lung, intestine, kidney, liver, nervous system, muscle,

and other tissues. The study by Swedish scientists, reported in the June 2, 2000

issue of Science, confirms that adult stem cells are in fact much more adept at redefining themselves than previously thought. The study involved growing adult stem

cells from brain with embryonic cells and within an embryo. Even lone neural adult

stem cells had the ability to differentiate into various cell types. The authors observe that the ‘‘most striking indication’’ of this complete cellular redefinition was

the finding of apparently normal and beating embryonic mouse hearts that contained very large amounts of the stem cells.

According to Dr. Ihor Lemischka, professor of developmental biology at Princeton

University, ‘‘This is a very exciting and interesting result,’’ and if the research can

be confirmed in human cells it would ‘‘nip in the bud’’ the moral and ethical concerns that now block federal funding of human embryonic stem cell research. The

authors of the study state that ‘‘This demonstrates that an adult neural stem cell

has a very broad developmental capacity and may potentially be used to generate

a variety of cell types for transplantation in different diseases.’’ They also note that

‘‘. . . these studies suggest that stem cells in different adult tissues may be more

similar than previously thought and perhaps in some cases have a developmental

repertoire close to that of ES cells.’’

Reference: Clarke et al.; ‘‘Generalized potential of adult neural stem cells’’; Science

288, 1660–1663, June 2, 2000.

STEM CELLS FROM FAT

Isolated adult stem cells from HUMAN fat. Cells could be expanded and maintained in culture for extended periods, and could be differentiated into fat, cartilage,

muscle, and bone. Characteristics similar to bone marrow stem cells.

Reference: Zuk PA et al.; ‘‘Multilineage cells from human adipose tissue: Implications for cell-based therapies’’; Tissue Engineering 7, 211–228; 2001

STEM CELLS FROM PLACENTA

Anthrogen, Inc. in a press release reports that they can isolate stem cells from

placenta after delivery, and that these stem cells so far have been induced to form

bone, nerve, cartilage, bone

REPAIRING CARDIAC DAMAGE

Used bone marrow stem cells from mice expressing green fluorescent protein to

track the cells. Injected the stem cells into area of heart where damage had been

induced. Newly formed myocardium occupied 68% of the infarcted portion of the

ventricle 9 days after transplanting the bone marrow cells. The developing tissue

comprised proliferating myocytes and vascular structures. The studies indicate that

locally delivered bone marrow cells can generate de novo myocardium, ameliorating

the outcome of coronary artery disease.

Reference: Orlic D et al.; ‘‘Bone marrow cells regenerate infarcted myocardium’’;

Nature 410, 701–705; April 5, 2001

Human bone-marrow-derived stem cells were implanted into rats with cardiac

damage. The cells participated in formation of new cardiac blood vessels and stimulated existing vessels. The authors note that ‘‘The use of cytokine-mobilized

autologous human bone marrow—derived angioblasts for revascularization of

infarcted myocardium (alone or in conjunction with currently used therapies) has

the potential to significantly reduce morbidity and mortality associated with left

ventricular remodeling.’’

Reference: Kocher AA et al.; ‘‘Neovascularization of ischemic myocardium by

human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces

remodeling and improves cardiac function’’; Nature Medicine 7, 430–436; April 2001.

Cell transplantation is a potential therapeutic approach for patients with chronic

myocardial failure. Experimental transplantation of neonatal and fetal cardiac

myocytes showed that the grafted cells can functionally integrate with and augment

the function of the recipient heart. Clinical application of this approach will be limited by shortage of donors, chronic rejection, and because it is ethically contentious.

By contrast skeletal myoblasts (satellite cells) are abundant and can be grafted successfully into the animal’s own heart even after genetic manipulation in vitro.

Reference: El Oakley RM et al.; ‘‘Myocyte transplantation for cardiac repair: A few

good cells can mend a broken heart’’; Ann Thorac Surg 71, 1724–1733; 2001

27

TREATING STROKE

Marrow Stromal Cells delivered to ischemic brain tissue through an intravenous

route in rats provide therapeutic benefit after stroke. MSCs may provide a powerful

autoplastic therapy for stroke.

Reference: Chen J et al.; ‘‘Therapeutic benefit of intravenous administration of

bone marrow stromal cells after cerebral ischemia in rats’’; Stroke 32, 1005–1011;

April 2001

These data suggest that intracerebral transplantation of bone marrow could potentially be used to induce plasticity in ischemic brain.

Reference: Li Y et al.; ‘‘Adult bone marrow transplantation after stroke in adult

rats’’; Cell Transplant 10(1), 31–40; Jan-Feb 2001

Researchers at the University of South Florida have reported at the meeting of

the American Association for the Advancement of Science (Jan 2001) and the American Academy of Neurology meeting (May 2001) that human cord blood stem cells

can be induced to form neurons. When injected into the bloodstream of rats which

had suffered stroke, the adult stem cells found their way to the brain and repaired

much of the damage. Rats which were previously paralyzed showed 80% recovery.

TREATING MUSCULAR DYSTROPHY

Multipotent stem cells were isolated from mouse muscle, capable of differentiating

into muscle and multiple blood cell types. The adult stem cells were injected into

bloodstream of mdx mice, a model of Duchenne muscular dystrophy. The stem cells

migrated to muscle, participated in formation of muscle fibers, and helped in regeneration of muscle and restoration of production of dystrophin protein, which is deficient in muscular dystrophy.

Reference: Torrente Y et al.; ‘‘Intraarterial injection of muscle-derived CD34+Sca1+ stem cells restores dystrophin in mdx mice’’; Journal of Cell Biology 152, 335–

348; January 22, 2001

REVERSING DIABETES

Were able to reverse diabetes in mice using the animals’ own adult stem cells;

after treatment, the mice no longer needed insulin shots to survive.

Reference: Ramiya VK et al.; ‘‘Reversal of insulin-dependent diabetes using islets

generated in vitro from pancreatic stem cells’’; Nature Medicine 6, 278–282; March

2000

TRANSFORMING BONE MARROW TO BRAIN

Adult stem cells from mouse bone marrow injected into mouse blood stream, could

be found developing neuron characteristics in brain. Generation of brain cells from

adult bone marrow ‘‘demonstrates a remarkable plasticity of adult tissues with potential clinical applications.’’

Reference: Brazelton TR et al.; ‘‘From marrow to brain: expression of neuronal

phenotypes in adult mice’’; Science 290, 1775–1779; Dec 1 2000

Showed in mice that intraperitoneally transplanted adult bone marrow stem cells

can migrate into brain and differentiate into neuronal cells. ‘‘These findings raise

the possibility that bone marrow-derived cells may provide an alternative source of

neurons in patients with neurodegenerative diseases or central nervous system injury’’;

Reference: Mezey E et al.; ‘‘Turning blood into brain: Cells bearing neuronal antigens generated in vivo from bone marrow’’; Science 290, 1779–1782; Dec 1 2000

ADULT STEM CELLS CAN MIGRATE WITHIN BRAIN TO SITES OF DAMAGE

Implanted neural stem cells infiltrate brain tumors. The neural stem cells show

the ability to migrate extensively throughout the brain to reach sites of damage. The

results ‘‘suggest that NSC migration can be extensive, even in the adult brain and

along nonstereotypical routes.’’

Reference: Aboody KS et al., ‘‘Neural stem cells display extensive tropism for pathology in adult brain: evidence from intracranial gliomas’’; Proc Natl Acad Sci U

S A 97, 12846–12851; Nov 7 2000

GENERATION OF NERVES STARTING WITH A SINGLE ADULT STEM CELL

Cultures of adult stem cells from spinal cord can be grown from single cells, and

can differentiate into neural cells when injected into the spinal cord or brain of rats.

The adult stem cells generate region-specific neurons in the body, including neurons,

astrocytes, oligodendrocytes, and glial cells.

Reference: Shihabuddin S et al.; ‘‘Adult spinal cord stem cells generate neurons

after transplantation in the adult dentate gyrus’’; J Neuroscience 20, 8727–8735;

December 2000

28

LARGE-SCALE GROWTH OF ADULT STEM CELLS

Human and animal adult stem cells shown to be able of extensive proliferation

in culture, providing potentially unlimited supplies of adult stem cells for clinical

treatments.

References:

Bhardwaj G et al. ‘‘Sonic hedgehog induces the proliferation of primitive human

hematopoietic cells via BMP regulation’’, Nature Immun. 2, 172–180; 2001

Cashman JD and Eaves CJ; ‘‘High marrow seeding efficiency of human

lymphomyeloid repopulating cells in irradiated NOD/SCID mice’’; Blood 96, 3979–

3981; Dec. 1 2000

Gilmore GL et al.; ‘‘Ex vivo expansion of human umbilical cord blood and peripheral blood CD34(+) hematopoietic stem cells’’; Exp. Hematol. 28, 1297–1305; Nov 1

2000

Woodbury D et al.; ‘‘Adult rat and human bone marrow stromal cells differentiate

into neurons’’; J. Neuroscience Research 61, 364–370; August 15, 2000

SOME CURRENT CLINICAL APPLICATIONS OF ADULT STEM CELLS

CANCER TREATMENTS

Brain Tumors

Dunkel, IJ; ‘‘High-dose chemotherapy with autologous stem cell rescue for malignant

brain tumors’’; Cancer Invest. 18, 492–493; 2000.

Kawa, K et al.; ‘‘Long-Term Survivors of Advanced Neuroblastoma With MYCN Amplification: A Report of 19 Patients Surviving Disease-Free for More Than 66

Months’’; J Clin Oncol 17:3216–3220; October 1999

Abrey, LE et al.; ‘‘High dose chemotherapy with autologous stem cell rescue in

adults with malignant primary brain tumors’’; J. Neurooncol. 44, 147–153;

Sept., 1999

Ovarian Cancer

Schilder, RJ and Shea, TC; ‘‘Multiple cycles of high-dose chemotherapy for ovarian

cancer’’ Semin. Oncol. 25, 349–355; June 1998;used autologous, purified peripheral blood stem cells

Solid Tumors

Schilder, RJ et al.; ‘‘Phase I trial of multiple cycles of high-dose chemotherapy supported by autologous peripheral-blood stem cells’’; J. Clin. Oncol. 17, 2198–2207;

July 1999 used for malignant solid tumors. Overall response rate 96%, complete

clinical response rate 67%.

Multiple Myeloma

Vesole, DH et al.; ‘‘High-Dose Melphalan With Autotransplantation for Refractory

Multiple Myeloma: Results of a Southwest Oncology Group Phase II Trial’’; J

Clin Oncol 17, 2173–2179; July 1999.

Breast Cancer

Stiff P et al.; ‘‘Autologous transplantation of ex vivo expanded bone marrow cells

grown from small aliquots after high-dose chemotherapy for breast cancer’’;

Blood 95, 2169–2174; March 15, 2000

Koc, ON et al.; ‘‘Rapid Hematopoietic Recovery After Coinfusion of Autologous-Blood

Stem Cells and Culture-Expanded Marrow Mesenchymal Stem Cells in Advanced Breast Cancer Patients Receiving High-Dose Chemotherapy’’; J Clin

Oncol 18, 307–316; January 2000

Non-Hodgkin’s Lymphoma

Josting, A; ‘‘Treatment of Primary Progressive Hodgkin’s and Aggressive Non-Hodgkin’s Lymphoma: Is There a Chance for Cure?’’; J Clin Oncol 18, 332–339; 2000

AUTOIMMUNE DISEASES

(multiple sclerosis, systemic lupus, juvenile rheumatoid arthritis, rheumatoid arthritis)

Traynor AE et al.; ‘‘Treatment of severe systemic lupus erythematosus with highdose chemotherapy and haemopoietic stem-cell transplantation: a phase I

study’’; Lancet 356, 701–707; August 26, 2000

Burt, RK and Traynor, AE; ‘‘Hematopoietic Stem Cell Transplantation: A New Therapy for Autoimmune Disease’’; Stem Cells 17, 366–372; 1999

29

Burt RK et al.; ‘‘Hematopoietic stem cell transplantation of multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus’’; Cancer Treat. Res. 101,

157–184; 1999

Martini A et al.; ‘‘Marked and sustained improvement 2 years after autologous stem

cell transplant in a girl with system sclerosis’’; Rheumatology 38, 773; August

1999

Anemia

Gonzalez MI et al.; ‘‘Allogeneic peripheral stem cell transplantation in a case of hereditary sideroblastic anaemia’’; British Journal of Haematology 109, 658–660;

2000

Kook H et al.; ‘‘Rubella-associated aplastic anemia treated by syngeneic stem cell

transplantations’’; Am. J. Hematol. 64, 303–305; August 2000

Stroke

Kondziolka D et al.; ‘‘Transplantation of cultured human neuronal cells for patients

with stroke’’; Neurology 55, 565–569; August 2000

Corneal scarring

Schwab IR et al.; ‘‘Successful transplantation of bioengineered tissue replacements

in patients with ocular surface disease’’; Cornea 19, 421–426; July 2000.

Tsai et al.; ‘‘Reconstruction of damaged corneas by transplantation of autologous

limbal epithelial cells.’’; New England Journal of Medicine 343, 86–93, 2000.

Tsubota K et al.; ‘‘Treatment of severe ocular-surface disorders with corneal

epithelial stem-cell transplantation’’; New England Journal of Medicine 340,

1697–1703; June 3, 1999

Osteogenesis imperfecta (leads to bone and cartilage deformities)

Horwitz, EM et al.; ‘‘Transplantability and therapeutic effects of bone marrow-derived mesenchymal cells in children with osteogenesis imperfecta’’; Nat. Med. 5,

309–313; March 1999.

Gene Therapy

Cavazzana-Calvo M et al.; ‘‘Gene therapy of human severe combined immunodeficiency (SCID)-X1 disease’’; Science 288, 669–672; April 28, 2000

*First successful trial of human therapy, re-injecting the infants’ own bone marrow stem cells containing a normal copy of the gene that they lacked.

Disclosure of federal grants, contracts, or subcontracts received in the current

and preceding two fiscal years

National Institutes of Health

Indiana University School of Medicine, Indiana University-Purdue University at Indianapolis (collaborative research sub-contract with Dr. David A. Williams); 1 January 2000–31 July 2000; $11,000; ‘‘Molecular and Functional Characterization of a

Novel Mutation in Murine Stem Cell Factor’’

National Institutes of Health

Indiana University School of Medicine, Indiana University-Purdue University at Indianapolis (collaborative research sub-contract with Dr. David A. Williams); 1 August 2000–30 June 2001; $16,000; ‘‘Molecular and Functional Characterization of a

Novel Mutation in Murine Stem Cell Factor’’ (renewal)

SUMMARY

There is almost uniform agreement against ‘‘reproductive cloning’’—creating a

cloned human being and allowing that clone to develop to a live birth. But some

scientist propose ‘‘therapeutic cloning’’, production of human embryos by cloning for

the purpose of harvesting embryonic stem (ES) cells.

If necessary, ES cells can be derived from ‘‘excess’’ human embryos frozen for in

vitro fertilization. But are ES cells really necessary for regenerative medicine? Despite the initial enthusiasm, ES cells to date have been disappointing. A less morally problematic and scientifically viable alternative exists—adult stem cells. Studies have shown that sufficient numbers of adult stem cells can be generated in culture for clinical applications. Even one transplanted adult stem cell from bone marrow could possibly regenerate tissue in several parts of the body. Various studies

now show that adult stem cells from many tissues are ‘‘pluripotent’’, with the ability

to form many different tissues. The indications are that adult stem cells can regenerate all human tissues. Examples include transformation of neural stem cells into

blood, umbilical cord blood stem cells into nerve, and bone marrow stem cells into

an array of tissues as diverse as cartilage, fat, bone, muscle, liver, nerve, lung, gasVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00033 Fmt 6633 Sfmt 6621 G:\WORK\CRIME\060701\72982.000 HJUD2 PsN: HJUD2
30

trointestinal tissue, and cardiac tissue. Even fat was recently found to contain stem

cells. Another report suggests that placenta is rich in stem cells. And the Scottish

company involved in the original cloning of Dolly the sheep, PPL Therapeutics, has

reported that they have developed a technique to reprogram normal adult somatic

cells into pluripotent stem cells which can be induced to form almost any tissue.

Adult stem cells have shown that they can form functional tissues when injected

into the body. Bone marrow stem cells have been shown to transform into functional

liver and muscle, as well as functional heart tissue, repairing cardiac damage. Bone

marrow and umbilical cord blood stem cells have also been shown to migrate to the

brain and provide therapeutic benefit after stroke in animal models. Adult pancreatic stem cells have reversed diabetes in mice and regenerated muscle in an animal model of muscular dystrophy.

Adult stem cells are already being used successfully for therapeutic benefit in humans. This includes treatments associated with various types of cancer, to relieve

systemic lupus, multiple sclerosis, rheumatoid arthritis, anemias, and immunodeficiency diseases, and restoration of sight through regeneration of corneas. And

initial clinical trials have begun to repair heart damage using the patient’s own

adult stem cells. An acceptable, ethical alternative to embryonic stem cells does

exist. Adult stem cells are making good on what are only promises of embryonic

stem cells.

Therapeutic cloning is therefore unnecessary and unjustifiable. It takes a utilitarian view of human embryos, viewing them not as people, but as property, a commodity; this is ‘‘a kind of capitalist cannibalism′′′′. It will be virtually impossible to

provide oversight of the intent for cloning a human embryo, or distinguishing stored

IVF embryos from stored cloned embryos. A complete ban on human cloning as proposed in the Brownback-Weldon bill is the only sufficient answer.

Mr. SMITH. Thank you, Dr. Prentice. Ms. Shapiro, we have you

down as both doctor and Ms. Which would you prefer?

Ms. SHAPIRO. Attorney.

Mr. SMITH. We can say Counselor Shapiro then.

STATEMENT OF ROBYN S. SHAPIRO, PROFESSOR OF

BIOETHICS, MEDICAL COLLEGE OF WISCONSIN

Ms. SHAPIRO. Perfect, thank you. It is a pleasure to be here. I

am not here, though, to stand by Richard Seed’s side and advocate

that we immediately clone a human being. What I am here to do

today is to point out my concerns about any prospective notion of

criminalizing cloning. Unfortunately, Dolly the sheep set off a frenzy of horrific and hypothetical human cloning scenarios, which

were picked up by the press in large measure as evildoers or rich

people cloning themselves time and time again, middleman deciding that they were going to hire women to bear the clones of Michael Jordan or Michael Jackson or somebody like that. This tended to overlook the potential benefits of cloning, which are enormous.

With cloning animal cells and tissues with particular traits and

a high degree of DNA similarity can be produced much more easily,

and for that reason, there is tremendous interest on the part of so

many for progressing with these advances. Veterinary geneticists,

agricultural biotechnology experts firmly support cloning animals

to do things like replicating transgenic cows or sheep that have

been genetically engineered to produce in their milk therapeutic

proteins that are valuable to humans. When we get to the human

side, facilitating the integration of DNA synthesis and new reproductive technologies through cloning allows us to greatly advance

cellular and tissue transplants by allowing us to clone genetically

matched cells and tissues for transplantation into patients who suffer from disorders that result from tissue loss or tissue dysfunction.

31

Beyond that, we have the capability through cloning of being

able to turn human cells into specific tissue types, to regenerate

nerve cells in individuals with Parkinson’s or Alzheimer’s or heart

muscle cells in those with heart disease; and additional positive

spinoffs of cloning in the field of genetic engineering include producing human proteins, like blood clotting factors that can help us

heal wounds. We also, down the line, perhaps would see important

benefits from cloning in human reproduction. If both a male and

a female in a couple had a recessive—carried a recessive gene for

a serious disorder, cloning might allow them, down the road, to

avoid conceiving an embryo with that disorder and thereby avoid

the prospect of having to choose abortion.

The regulation that we have today applicable to human cloning

seems appropriate to me. In 1997, the White House issued a directive on cloning, applicable both to research and to clinical application—that bans all Federal funding for human cloning. We have

Federal regulations applicable to all federally funded human subjects research and under these where safety concerns about human

cloning certainly would preclude IRB approval of any advance

along those lines. The Food and Drug Administration has claimed

that clinical research using cloning technology to create a human

being is subject to its jurisdiction, under the Public Health Service

Act and also the Food, Drug and Cosmetic Act. There is some controversy about whether they are right, but they claim that to be

true and they intend to exercise that jurisdiction.

So, if we were to move beyond that to any thought of criminalizing cloning, we would encounter some ill-advised effects, I believe.

First and probably foremost, there are real dangers in mixing medical and scientific work with criminalization. If a statute were to

create criminal penalties, for example, for the performance of any

somatic cell nuclear transfer in order to create a human being (and

that is what many proposals have suggested) enforcement really

would require monitoring the intent of scientists engaged in what

may very well be very beneficial research, and that certainly would

create a huge and disturbing, chilling effect on scientific inquiry.

Added to this problem of trying to come up with a criminal prohibition that would be appropriately circumscribed and that could be

easily enforced are problems of obsolescence. It is likely that any

statute that we could conceive of that would criminalize human

cloning would be outpaced by technological advances—and we have

already seen that. In California, they have a statute that prohibits

cloning and that uses a definition of cloning that uses the term

‘‘human’’ when talking about enucleated eggs. In other words, it

prohibits putting the DNA from another cell into a human

enucleated egg. That could be evaded, for example, by using a cow’s

enucleated egg to incubate the nucleic DNA of a human, which certainly appears feasible in light of our very own University of Wisconsin researcher’s success in using enucleated cow eggs to serve

as incubators for other mammalian species’ nucleic DNA.

Finally, with all due respect, any Congressional act that would

create criminal penalties for human cloning would open important

aspects of scientific development to political tug-of-war, and we

have seen this with debates about fetal tissue and embryonic research. The risk is that we will end up with laws that cover too

32

much for reasons that do not have to do with human cloning, and

that, unfortunately, make it impossible to attain the promises of

the technology. So, given all these hazards, the three main hazards

that I pointed out, criminalizing cloning because human cloning, at

the moment, is unsafe and/or because certain applications of the

technology would be unethical, threatens, unnecessarily, given the

regulation we currently have, to stifle scientific progress.

To balance the dangers that I have talked about against the

promise of the research, which is significant, informed regulation,

to me, seems the better approach and this has worked in the past.

We have to recall, in the 1970’s, that there were heated discussions

about how to prevent abuses of recombinant DNA technology. Some

called for criminalization. We did not get that. We got standards;

we got guidelines and we certainly have seen the benefits, the huge

benefits in medicine, of those advances. We need to ensure that our

approach today to cloning similarly allows research in the field to

progress.

Thank you.

[The prepared statement of Ms. Shapiro follows:]

PREPARED STATEMENT OF ROBYN S. SHAPIRO, J.D.

The debate about human cloning raises a number of important ethical, legal, and

social issues. While the emotionally-charged nature of the issues now has led some

to insist that human cloning should be criminalized, a more appropriate approach

is to assure, through regulation or guidelines, that cloning technology is used to enhance, rather than limit, individual freedom and welfare.

Dolly the sheep—the first mammal to be cloned from a single adult cell—set off

a frenzy of horrific hypothetical human cloning scenarios, including evil-doers or

rich or powerful persons cloning themselves time and again, or commercial entrepreneurs hiring women to bear clones of movie stars or sports heroes to sell to others. But the potential benefits of cloning are enormous. For example, animals, cells

and tissues with particular traits and a high degree of DNA similarity can be produced much more easily. For this reason, veterinary geneticists and agricultural biotechnology experts firmly support cloning in animals in order to advance animal research (for example, replicating transgenic cows or sheep that have been genetically

engineered to produce in their milk therapeutic proteins valuable to humans—such

as clotting factors or hormones). Perhaps more importantly, by facilitating the integration of DNA synthesis and new reproductive technologies, cloning will greatly advance cellular and tissue transplants by allowing us to clone genetically matched

cells and tissues for transplantation into patients suffering from a variety of disorders that result from tissue loss or dysfunction. Beyond that, therapeutic cloning

has the capability of turning human cells into specific tissue types—to regenerate

nerve cells in patients suffering with Parkinson’s or Alzheimer’s, or heart muscle

cells in those with heart disease. Additional positive spin-offs of cloning in the field

of genetic engineering include the production of human proteins such as blood clotting factors that aid in healing wounds. Research on somatic-cell nuclear transfer

will also yield important information on stem cell differentiation, which could provide valuable information about the mechanism of aging and the causes of cancer.

Cloning also may offer important potential benefit in human reproduction. For example, if both the male and female in a couple carried a recessive gene for a serious

disorder, cloning would allow them to avoid conceiving an embryo with the disorder

and thereby avoid the prospect of selective abortion.

The regulation currently applicable to human cloning seems appropriate—for now.

A 1997 White House Directive on Cloning, applicable to both research and clinical

application, bans all federal funds for human cloning; under regulations applicable

to federally-funded human subjects research, safety concerns would preclude approval of human cloning research; and the Food and Drug Administration has

claimed that clinical research using cloning technology to create a human being is

subject to FDA regulation under the Public Health Service Act and the Food, Drug

and Cosmetic Act.

Moving beyond that regulation to criminalization of cloning would be ill-advised.

First, there are significant dangers in criminalizing medical and scientific work. If

33

1Some have argued that the First Amendment right to free speech encompasses the right of

scientific inquiry. In Branzburg v. Hayes, 408 U.S. 665, 705 (1972), the United States Supreme

Court specifically analogized the information function performed by academic researchers to

that performed by the press; and in Meyer v. Nebraska, 262 U.S. 390 (1923), the Supreme Court

stated that 14th Amendment liberty rights encompass freedom to ‘‘acquire useful knowledge— and generally to enjoy those privileges long recognized at common law as essential to the orderly

pursuit of happiness by free men.’’ 2 Cal. Bus. & Prof. Code § 2260.5

a statute were to create criminal penalties, for example, for the performance of any

somatic cell nuclear transfer in order to create a human being, enforcement would

require monitoring the intent of scientists engaged in beneficial research—thereby

creating a disturbing chilling effect on scientific inquiry.1

Added to problems of crafting a criminal prohibition that would be appropriately

circumscribed and capable of being reasonably enforced are problems of obsolescence. It is likely that any statute criminalizing human cloning would be outpaced

by technological advances. California’s statute prohibiting cloning, for example, uses

a definition of cloning that uses the term ‘‘human’’ when referencing enucleated

eggs.2 That statutory prohibition could be evaded by using a cow’s enucleated egg

to incubate the nucleic DNA of a human—a procedure that appears entirely feasible

in light of University of Wisconsin researchers’ success in using enucleated cow eggs

as incubators for other mammalian species’ nucleic DNA.

Moreover, any Congressional act creating criminal penalties for human cloning

would open important aspects of scientific development to a political tug-of-war— as has been the case with debates about fetal tissue and embryo research. The risk

is the creation of laws that cover too much for reasons that have nothing to do with

human cloning, and that make it impossible to attain the promises of the technology.

Given these hazards, criminalizing cloning because human cloning currently is

unsafe and/or because some applications of the technology would be unethical

threatens unnecessarily to stifle scientific progress. To balance these dangers

against the promise of research, informed regulation seems the better approach.

This approach has worked in the past. In the 1970’s, there were heated discussions

about how to prevent abuses of recombinant DNA technology. While guidelines and

standards were adopted, criminal legislation was not passed, and this technology

certainly has yielded tremendous benefits in medicine. We need to assure that our

approach to regulating cloning similarly allows research in the field to progress.

Mr. SMITH. Thank you, Ms. Shapiro. Let me thank you all for

your testimony, as well, and we will now go to our question period.

Let me begin, Dr. Kass, with a question for you—and by the way,

I noticed in your more extensive written testimony, and all your

testimonies will be made a part of the record without objection— that you have been writing on human cloning since 1967. I’m

tempted to ask you what gave you the idea in 1967 the we would

be wrestling with human cloning?

Dr. KASS. The first cloning of frogs—there was an article in the

Washington Post by Joshua Letterburg saying that if we could develop this for human beings we could end the unpredictable variety

that comes as a result of sex.

Mr. SMITH. I was just curious. That was not a legitimate first

question, but it does seem to me that we are wrestling with trying

to establish a balance, as described by Dr. Callahan, and that is

a balance between the need for free scientific inquiry and the need

to establish ethical standards. You really do have to have some restraint on what we do. Dr. Kass and Dr. Callahan, my first question is really why do you believe that we do need to have criminal

penalties and ban human cloning; and why do you not think that

current regulations are sufficient, as Ms. Shapiro does?

Dr. KASS. Well, the first point is that I treat the danger as much

greater than Ms. Shapiro does. I think we stand on the threshold

of something terribly important and that merely withholding Federal funds, and having Federal regulations of research done with

34

Federal funds, does not touch what goes on in the private sector

where this research is proceeding pell-mell, and under great secrecy, partly conditioned by the competition in the field.

Second, in vitro fertilization, which we have lived with and has

brought great benefits to many infertile couples, is a completely unregulated and unstudied practice. If this goes on, not covered by

the FDA, and were the clonal embryos available created commercially, they could be bought and sold and used in reproductive clinics and no one would know. So, I think that if we regard this as

a serious and important matter and that we see this as an opportunity to place the burden of proof on the other side to say we absolutely have to have human cloning for these and these reasons— and I do not think they can meet that burden—this is the time to

do it and to put down this marker.

Mr. SMITH. Dr. Callahan, do you agree with that?

Mr. CALLAHAN. I very much agree. I would simply add that I

think it would be extraordinarily difficult to regulate the private

sector. This would require a great deal of snooping around laboratories, of trying to find out what is going on, breaking through proprietary restraints. We find it very difficult now to know what’s

going on in the private sector. This would be very difficult particularly if the scientist and whoever was doing it knew that it was

likely to be controversial research, they would do everything possible, it seems to me, to make it difficult to find out what they were

doing. It seems to me that this is one of those horrible situations.

Regulation seems the moderate, reasonable, middle way to go, but

I simply don’t think it would effectively work and, hence, we have

to go a more Draconian route.

Mr. SMITH. Dr. Callahan, one more question—a lot of people are

concerned, I think, that we, in our scientific discoveries, might gain

the world, but sell our soul at the same time. You mentioned in

your written testimony that scientific freedom is not an absolute

value. Aren’t there other instances where we have banned or prohibited scientific experiments as unethical or criminal, and this is

not unprecedented, were we to go in this direction?

Mr. CALLAHAN. Well, certainly, a number of European countries

have already banned cloning. I guess what is different here is that

this research is at what might be called the basic—somewhere between basic and applied research—and there I think it is probably

difficult to find very good legal precedents for efforts to ban research at that level, but other countries have indeed done it, for

many of the reasons Dr. Kass has presented. It seems to me that

when one is faced with what seems to be a very difficult decision,

you really have to ask the question what is going to be good for

us in the long run?

Science is doing terrific these days. The National Institute of

Health has lots of money. The private sector has money. The public

sector has money. Research will go forward. Some research may be

slowed down. Some may be slightly harmed, but it seems to me,

in general, we are going to find it very much in the whole biological

realm in years to come, and this is not going to make a great deal

of difference if it is stopped.

Mr. SMITH. Thank you, Dr. Callahan. Dr. Prentice, you made the

point that there are alternatives to the medical benefits that we

35

might enjoy from cloning and you mentioned adult stem cells as an

example. What if it were shown or proved that we really could not

achieve everything that we wanted to in the way of medical advances by using adult stem cells? Would you still be opposed to

human cloning and if so, why?

Mr. PRENTICE. Yes, Mr. Chairman, I would, and I think it relates

back more to the idea what some people have termed human dignity. I think the vast weight of scientific evidence says that it is

probably the other way around, that the embryonic stem cells are

not going to be able to make good on those sorts of promises and

the adult cells are already doing that. But, I think it comes back

to the idea of a human being and the way we view humanity or

how we view ourselves as a society, and science tells us that even

at one cell we are a human being. This is not some other species,

not fish nor fowl. It is a question now of how we view other members of our species. I think this is a particular route down which

we just do not need to go.

Mr. SMITH. Thank you, Dr. Prentice. I’m going to say Dr. Shapiro. I think all attorneys should be called doctor because of J.D.s.

Mr. SMITH. My time this up, but let me squeeze in one brief

question and that is, I understand your point about relying on current regulation rather than criminalize human cloning. A couple of

your objections, though, to me, seem to be technical in the sense

that they could be overcome. You mentioned enforcement problems.

You mentioned definitional problems. It seems to me if you write

the laws well or if you update the legislation, you can address

those kinds of concerns. Therefore, we could justify going beyond

just the regulations. Do you want to comment on that?

Ms. SHAPIRO. Two responses. One is I hope that is true, but problems in doing that could happen on account of the third factor that

I mentioned, and that is the political tug-of-war aspect of all of

this. Probably the most important response I would have to that

is the chilling effect that a statute like that would have regardless.

That is, even if we could try to craft it very specifically, we have

seen physicians and scientists could read it in a different way, and

if the threat of going to jail for life is hanging over them, they are

very likely to be conservative about what might be permissible.

Mr. SMITH. Thank you, Dr. Shapiro. The gentleman from Virginia, the Ranking Member, Mr. Scott, is recognized for his questions.

Mr. SCOTT. No questions.

Mr. SMITH. The gentlewoman is recognized.

Mr. JACKSON LEE. Let me thank the witnesses very much, and

please accept my apologies—I was detained on the floor of the

House—for not hearing the testimony of earlier witnesses, but I

have had the opportunity and will have the opportunity further to

review your testimony. Let me applaud the legislation’s intent. I

am going to remain open—that is what hearings are for, as we

move toward trying to find the best solution. I do want to commend

Dr. Weldon for the intent and his reaching out to Members of this

Committee and others to further explain this particular legislation.

The first, if you will, response to human cloning is for those of

us who grew up on Frankenstein, is extremely negative. Frankly,

as we watched that creation, we didn’t want to add to it. It may

36

not have been cloning. It may have been just be piecing things together, but we are in a new century and I think we have to be open

minded on what helps us to solve today’s problems, particularly

medical research. Might I, Dr. Shapiro, since we are going to adhere to the new title, probe you a little bit and then I have some

questions for the other individuals? I want to pursue your line of

reasoning on the chilling effect, which, I think, has great merit. I

would offer and ask you how this might reach out into stem cell

research, which is so important for people suffering from Parkinson’s disease and other aspects, and tell me where that would

reach if you are talking about in vitro fertilization? I am interested

in the concept of banning implantation for scientific research, but

possibly the work you do in the lab can be distinguished, because

hopefully you are there in the lab to do good, as opposed to do ill.

Would you comment on those two concepts, please?

Ms. SHAPIRO. Sure. I think part of your question actually is your

answer, and that is, in my mind, the threat, the chilling effect

threat, could very well reach to reluctance or refusal on the part

of scientists and medical personnel to explore stem cell research

and/or even in in vitro fertilization, and we certainly have seen the

promise and the reality of the benefits of those procedures. In

terms of prohibiting implantation, we heard remarks earlier about

what European countries are doing, and actually Britain is allowing for embryonic cloning as long as there is no implantation, on

account of just what you’re suggesting; that is, that the research

is potentially very beneficial, but we want to avoid creating a

cloned human being.

Mr. JACKSON LEE. You are from the medical school in Wisconsin,

as I understand.

Ms. SHAPIRO. Yes.

Mr. JACKSON LEE. Research is done at the school, to your knowledge?

Ms. SHAPIRO. Well, actually, there are two medical schools. I am

from the Medical College of Wisconsin and a mere hour-an-a-half

away is the University of Wisconsin where Dr. Jamie Thompson

has led great efforts in stem cell research.

Mr. JACKSON LEE. You might include them in your answer. My

question really goes to the point, the broader point, that I come

from a community where the Texas Medical Center is and several

medical schools; would you view legislation like this permeating

the research that is done in those institutions, in light of the sensitivity that I imagine physicians have who are not lawyers, in not

wanting to have their lab criminalized?

Ms. SHAPIRO. Absolutely. Without any legislation, and I can

speak about the experience we are going through at the moment

at the Medical College of Wisconsin, there is tremendous caution

in going into this sort of research simply because of the important

ethical issues involved. But, with any sort of a criminal statute, I

can tell you that they would run the other way as far as they could.

Mr. JACKSON LEE. Let me raise this question for all of you, and

I’m going to refer you to—if you have in front of you—but if the

Chairman would indulge me, it is the definition section of the legislation that I think we are presently looking at, H.R. 1644, human

cloning. Let me just quickly go over it. Human cloning means

37

human asexual reproduction, accomplished by introducing the nuclear material of a human somatic cell into a fertilized or

unfertilized oocyte whose nucleus has been removed or inactivated

to produce a living organism in any stage of development with a

human or predominately human constitution. I’m not sure if this

has been amended. I know we have not marked it up and forgive

me for reading so quickly, but I would appreciate Dr. Kass, Dr.

Callahan, Dr. Prentice and Dr. Shapiro—as I read it as a lawyer,

engaged only in this ethically, and not from the perspective of

being in a lab, this is enormously broad.

Mr. SMITH. Ms. Jackson Lee, let me interrupt you just for a

minute. I would like you to get a brief response from one individual, but actually our second hearing is going to be on the legislation itself. So, there will be more opportunity to question the legislation.

Mr. JACKSON LEE. I’ll take a first answer. Would you mind if Dr.

Kass and Dr. Shapiro, and I will not have the other——

Mr. SMITH. If you all would briefly reply.

Mr. JACKSON LEE. Thank you, Mr. Chairman.

Dr. KASS. I think this is very narrow, especially when read with

the other section, which indicates what is does not cover. This is

very, very precise. I think everybody would understand what this

means.

Mr. JACKSON LEE. You think it’s narrow.

Dr. Shapiro?

Ms. SHAPIRO. I don’t think so. I have to tell you, I have not yet

read this, so, I don’t know where the definition or how the definition is being used in the bill, but it seems broad to me.

Mr. JACKSON LEE. Thank you very much, Mr. Chairman.

Mr. SMITH. Thank you, Ms. Jackson Lee. The gentleman from

Florida, Mr. Keller, is recognized for his questions.

Mr. KELLER. Thank you, Mr. Chairman. Let me just say, Dr.

Shapiro, like you and many others here, I also am a lawyer by

trade and, unfortunately, there are some folks that say we are a

good example of why human cloning is a bad idea.

Let me begin by asking you, Dr. Kass, a question. Some people

will argue or say that cloning is really not morally different from

in vitro fertilization, and I suspect you have a different view. What

is your thought on that?

Dr. KASS. No, I do have a different view. I think cloning is in

some respects continuous, but in the decisive respect something

radically different. In in vitro fertilization, the egg and sperm come

together by the usual sexual activity of chance. There’s a chance

meeting of and egg and a sperm and the individual that is produced is the product of that chance union. In the case of cloning,

deliberate efforts are made to produce an individual who is genetically identical or virtually identical, not just to some contemporary,

but to an individual who already exists and, in fact, who could

have existed and is now deceased. In this respect, cloning is the

first of a foreseeable group of technologies that will enable us to

control, not just whether a child is born, but precisely what the genetic constitution of that child is.

38

Mr. KELLER. Okay. Dr. Prentice, what is the gist again and the

difference between reproductive cloning and what they call therapeutic cloning?

Mr. PRENTICE. Congressman, essentially the idea behind reproductive cloning would be to clone the individual and actually bring

them to a live birth. Therapeutic cloning, frankly, the intent is not

to bring them to a live birth, but at a very early embryonic stage,

approximately five to 9 days—at that point we look like a hollow

ball with some cells inside—is to harvest those cells from the inside, the embryonic stem cells, and in doing so you do have to destroy the embryo to put those cells in the culture.

Mr. KELLER. Okay. It is my understanding from some of your

previous writings that of the mammals cloned so far, approximately

95 to 99 percent do not survive. Would you anticipate a similar failure rate on attempts to clone humans?

Mr. PRENTICE. Definitely so. Now, obviously, techniques can improve, but there’s so much unknown at this point in terms of the

whole cloning procedure. It sounds very simple on paper or drawn

on the board, but we do not know too much about what actually

goes on in terms of reprogramming that nucleus which is inserted

into that oocyte, and that appears to be, at least to a large extent,

what gives us the problems with many of the clones not even making it to term, and virtually all of them not surviving even after

term. The possibility could be genetic problems that develop in

terms of this technique.

Mr. KELLER. Thank you, Dr. Prentice. Mr. Chairman, I’ll yield

back the balance of my time.

Mr. SMITH. Thank you, Mr. Keller. What was the last question

you had, Mr. Keller?

Mr. KELLER. The last question—I asked him the difference between therapeutic cloning and reproductive cloning.

Mr. SMITH. Thank you. The gentleman from Virginia, Mr. Scott,

is recognized for his questions.

Mr. SCOTT. Thank you. On this morning’s radio, I heard a piece

on the cell research to help hemophiliacs. They would take a piece

of skin, do something with it in the lab, and it would produce Factor VIII. That is about all I remember about it, and that would

help blood-clotting for hemophiliacs. Would any of the legislation in

this area affect that kind of research?

Mr. PRENTICE. No, sir, it actually would not. The bill which I

have seen, I think is very carefully crafted, very tight. The type of

research you are discussing is covered under this section, which

talks about no prohibition for the use of nuclear transfer or other

cloning techniques to produce molecules, including the Factor VIII

clotting factor, DNA, cells other than human embryos, tissues, organs, plants or animals other than humans. In my reading of this,

this has no chilling effect on medically necessary research. It only

prohibits the actual production by this cloning technique of a

human individual.

Mr. SCOTT. Would the violations start with the implantation or

would it start earlier?

Mr. PRENTICE. I guess I will take that one, too. My assumption

in reading this is that the violation would start at the point where

the nucleus was inserted into that enucleated oocyte. At that point,

39

you have the clone. The problem, again, in terms of distinguishing

between reproductive and therapeutic cloning is, if you were to

take an embryo produced by reproductive cloning, therapeutic

cloning, in vitro fertilization and put them under a microscope, you

could not distinguish how that embryo was produced. So, as my colleague referred to earlier, there is no way we can judge intent. It

could be that we might clone an individual, clone an embryo, and

the original intent could have been for therapeutic cloning, deriving

the embryonic stem cells, but, if we put some of those excess embryos in the freezer and take them out, how are we going to judge

whether that was an IVF embryo put in there, one that was going

to be used for reproductive cloning or one that might be used for

therapeutic cloning? There is no real way to tell the difference.

Mr. SCOTT. Therefore, your suggestion is not to have any therapeutic cloning?

Mr. PRENTICE. Yes, sir, that’s it. I think we should follow the

Brownback-Weldon bill and totally ban human cloning.

Mr. SCOTT. Did somebody else want to comment on whether that

would be a good thing or bad thing, to prohibit all therapeutic

cloning, Dr. Kass?

Dr. KASS. Yes, I would like to comment. Dr. Prentice and others

have indicated that, to our great amazement, the work with stem

cells derived from adults, from cord blood, is providing us with the

kinds of tissues we need to do exactly this kind of therapy. We

have a morally unproblematic alternative to the so-called therapeutic cloning. That would be the first point, so I do not think

there is a great deal we are losing if we give this up.

Second, if you’re serious, really serious about trying to prevent

so-called reproductive cloning, that is, the birth of cloned children,

I don’t think you can actually make that ban effective unless you

ban that process at the beginning. Once the embryos are there, you

are not going to be able to control what is done with them. We

have learned that with the so-called spare embryos to this point.

Mr. SCOTT. Let me ask you a practical question. If we create a

criminal statute prohibiting therapeutic cloning, all kinds of

cloning, that criminal statute would only have an effect within the

jurisdiction of the United States?

Dr. KASS. Actually, sir, we are behind the curve on this one.

Many, many nations—the Council of Europe has called for this.

The U.N. has called for a ban on this and on germ line modification, and it seems to me they look upon us as being something of

a rogue nation in this way. I would not call this a ban on therapeutic cloning. I think what one wants to say is this is a ban on

the cloning of human beings in the most effective way possible, and

I think the bill is carefully drawn and could be made effective and

would not chill the other necessary and desirable, medically beneficial and therapeutic research.

Mr. SCOTT. Is your testimony that if we passed a criminal statute, there would be nowhere that the research would move to totally unregulated, without any oversight at all, and whether that

would be better or worse than trying to regulate it the best we

could in the United States?

Dr. KASS. Well, for most things, I am not in favor of legal bans.

Bans are a blunt instrument, and you cannot prevent—you do not

40

prevent all cases of incest by laws against incest and we do not

prevent the buying and selling of organs for transportation in other

parts of the world, but we have made this a crime in the United

States and it has been enforced. So, I don’t say we are going to absolutely prevent this, but if we are serious about trying to do something, this is our best shot. In collaboration with other nations I

think we have a fighting chance to make sure that it doesn’t happen or doesn’t happen much. I don’t think you can do better with

law.

Mr. SCOTT. Ms. Shapiro, did you want to respond?

Ms. SHAPIRO. I’m not a doctor. However, what I read is that 1

day the literature may suggest that adult stem cells are going to

be equally as promising as embryonic stem cells and the next day

that is controverted. That is the point. If we snuff out the ability

to do this research, we may never know. I do not think that it is

as easy from what I read, and again, with all the disclaimers I put

on the table before, to simply say we will be losing nothing if we

prohibit this sort of research from going forward.

Mr. SMITH. Thank you, Mr. Scott, and also I would like to thank

all of the witnesses today for their expert testimony, even if they

are lawyers, and it is much appreciated and very helpful and useful. Also, I will let you know as well as the audience know that the

second hearing on human cloning is scheduled for June 19th. That

is a Tuesday, at 4 in the afternoon, and the subject of that hearing

will be more the Federal regulation of human cloning; and also we

will be talking about, certainly, Dr. Weldon of Florida’s bill that

has been introduced and perhaps Mr. Greenwood of Pennsylvania’s

bill if it has been introduced at that time. Thank you again for your

testimony. The gentlewoman from Texas has a comment.

Mr. JACKSON LEE. Mr. Chairman, may I submit a question for

the witnesses to respond to in writing?

Mr. SMITH. Absolutely. Without objection, anyone who has written questions can submit them and we will hope for answers within

2 weeks if you can accommodate us on that score, as well.

Mr. SCOTT. Mr. Chairman, I ask unanimous consent to include

this statement in the record.

Mr. SMITH. Without objection, Mr. Scott, we will make a part of

the record your opening statement.

Mr. JACKSON LEE. I’m sorry. Likewise, if I may.

Mr. SMITH. All Members are welcome and without objection, will

be allowed to make their full opening statements a part of the

record.

Mr. JACKSON LEE. Mr. Chairman, simply, I will not give the

question, but it regards the impact of this legislation on in vitro

fertilization and the embryo. Thank you.

Mr. SMITH. Thank you, Ms. Jackson Lee. Thank you again to all

of our witnesses. We appreciate your being here and the hearing

stands adjourned.

[Whereupon, at 12:03 p.m., the Subcommittee was adjourned.]

(41)

HUMAN CLONING PROHIBITION ACT OF 2001

AND THE CLONING PROHIBITION ACT OF

2001

TUESDAY, JUNE 19, 2001

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON CRIME,

COMMITTEE ON THE JUDICIARY,

Washington, DC.

The Subcommittee met, pursuant to notice, at 4:05 p.m., in Room

2141, Rayburn House Office Building, Hon. Lamar Smith [Chairman of the Subcommittee] presiding.

Mr. SMITH. The Subcommittee on Crime will come to order. We

welcome our witnesses.

I have an opening statement, then I will recognize other individuals who are here, who might have opening statements, and then

we will proceed to hear from our expert witnesses.

Today the Subcommittee on Crime holds the second of two hearings on the issue of human cloning. At our last hearing, the Subcommittee focused on the ethical issues and possible consequences

of cloning human beings.

Now we will examine the legal issues relating to the Federal regulation of human cloning and hear testimony regarding two bills on

the issue, H.R. 1644 and H.R. 2172.

Prior testimony revealed that there are a growing number of

groups who claim they can and will clone a human being. Currently, no clear regulations exist in the United States that would

prevent a private group from attempting to create a human clone.

In this sense, the United States lags behind most other industrialized nations.

Even though the Federal Food and Drug Administration has asserted that it has the authority to regulate this activity, legal scholars have expressed doubt as to whether this claimed authority

would stand a legal challenge. Furthermore, the consequences for

any scientist who ignores the FDA’s claimed authority are unclear.

Legal challenges to any Federal regulation of human cloning will

be swift. Opponents will argue against any ban on human cloning

because it allegedly interferes with the desire for scientific inquiry.

Yet an overwhelming majority of Americans oppose cloning.

Scientific advancement can enrich our lives, but not when it

erodes our most fundamental principles. While there is room to

roam, it is not an open range.

Although Congress may not prohibit research in an attempt to

prevent the development of new knowledge, it may restrict or proVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00045 Fmt 6601 Sfmt 6601 G:\WORK\CRIME\060701\72982.001 HJUD2 PsN: HJUD2
42

hibit the means used by researchers that threaten interest in

which the citizens of this country have a legitimate concern.

The two bills before us today would prohibit the cloning of

human beings. However, the scope of that prohibition is treated in

very different and important ways.

H.R. 2172, introduced by Congressman Greenwood of Pennsylvania, requires courts to determine a scientist’s intent. If the scientist clones a human to initiate a pregnancy, he is in the wrong.

If he clones without that intent, he is right.

H.R. 1644, introduced by Congressman Weldon of Florida, prohibits the use of human cloning technology to produce a living

human organism at any stage of development. The Weldon bill

would make it a criminal act to clone a human embryo for any reason, scientific or reproductive.

Neither of these bills places any restrictions on the use of cloning

technology to clone molecules, DNA, cells, tissues, organs, plants,

or animals. They would not interfere with the use of in vitro fertilization, fertility-enhancing drugs, or other medical procedures

that help women to become or remain pregnant.

Today we will hear from a panel of four witnesses who have extensive backgrounds in the field of law and bioethics. I would like

to thank the witnesses for appearing before the Subcommittee on

this important issue.

The Chair now recognizes the gentleman from California, Mr.

Schiff, for his opening statement.

Mr. SCHIFF. Thank you, Mr. Chairman.

The image of Dolly, a sheep cloned in Scotland in 1997, is a vivid

one in all of our recollections. All our impressions at the time, of

what that scientific achievement meant and the important ethical

issues it raised, have not been far from our thoughts ever since.

Although Dolly’s cloning was a scientific success, the process of

cloning remains a highly contentious issue. Most people have a

fairly narrow notion of what the term cloning means, particularly

in regard to humans. In fact, it encompasses a number of scientific

processes with widely diverse meanings, whether applied to animals or humans.

Today we’ll hear about two different types of cloning. One is

human reproductive cloning designed to create a human child. The

other is the cloning of human cell for the purpose of medical

achievement.

In 1997, the Clinton Administration asked the National Bioethics

Advisory Commission to study the ethical and legal implications of

cloning. A ban on the use of any Federal funding for cloning was

quickly put into place. Since then, researchers, ethicists, scientists,

religious leaders, and politicians have debated the issue.

With the possibilities offered by biomedical research, we have an

incredible opportunity to potentially clone our own cells to replace

diseased or defective cells with no chance for rejection, since it is

already a cell familiar to our body.

This research is playing a crucial role in the advancement of

modern science and may be the key to transforming the way diseases are treated in the United States and around the world.

Some cells can be used to generate specialized cells that are destroyed or damaged in various diseases and disabilities, which

43

could in turn lead to vastly improved treatments or cures for Alzheimer’s disease, AIDS, Parkinson’s, cancer, birth defects, and

countless other conditions.

Last year, the National Institutes of Health ensured that this scientific research would be conducted in accordance with the highest

scientific and ethical standards. Since then, the Bush Administration has put a hold on Federal funding for stem cell research while

it reviews the guidelines put forward by NIH.

In fact, the very first meeting scheduled for April of this year,

where an NIH committee was to review the first applications from

scientists seeking Federal funds for human embryo cell research,

was canceled after officials from the Department of Health and

Human Services requested they do so.

For the sake of everyone out there who has suffered from the

dreaded diseases that we now have a chance of attacking with new

methods, including my own mother-in-law who passed away with

Alzheimer’s disease earlier this year, I’m hopeful that we can

bridge our differences on the issue of research and advance the

cause and course of medical science.

Today we are faced with the issue of how to best prevent human

cloning with a bill drafted broadly enough to ban human cloning

itself but narrow enough so that it doesn’t prevent vital lifesaving

and highly desirable biomedical research.

The two bills before this Committee take a somewhat different

approach. One bill, H.R. 1644, introduced by Representatives

Weldon and Stupak, makes it a crime to participate in any type of

human cloning for any purpose. The other bill, H.R. 2172, introduced by Representative Greenwood, is focused on reproductive

cloning but is more narrowly crafted and perhaps more protective

of scientific study.

Both bills include an exception for the use of cloning techniques

to produce copies of DNA, tissues, organs, plants, or animals other

than humans. But the use of cloning to produce embryos is still forbidden.

We already have certain restrictions on the use of Federal funds

for human cloning. And the FDA has declared that cloning experiments cannot proceed without its approval. These restrictions prevent human cloning while allowing beneficial scientific research to

proceed, although questions have been raised as to whether the

FDA has the necessary power to deter improper cloning.

There was a broad consensus that we are not ready for the

cloning of a human being. Perhaps we never will be. Perhaps we

never should be.

How we prohibit cloning and protect vital research is the subject

of our inquiry. I look forward to the testimony of the witnesses and

the insight they provide to us on this complex issue.

Thank you, Mr. Chairman.

Mr. SMITH. Thank you, Mr. Schiff.

And let me mention that Mr. Schiff is an able stand-in for Bobby

Scott, the Ranking Member, who had a conflict this afternoon and

could not be with us.

Let me introduce all the witnesses and then we’ll begin.

Alex Capron, Professor of Law and Medicine, University of

Southern California School of Law, Los Angeles, California; Jean

44

Bethke Elshtain, Professor of Social and Political Ethics, the University of Chicago, Chicago, Illinois; Gerard Bradley, Professor of

Law, Notre Dame Law School, Notre Dame, Indiana; and Thomas

Okarma, President and CEO, Geron Corporation.

Thank you all again for being here.

And, Professor Capron, we will begin with you.

STATEMENT OF ALEX CAPRON, PROFESSOR OF LAW AND MEDICINE, UNIVERSITY OF SOUTHERN CALIFORNIA SCHOOL OF

LAW, LOS ANGELES, CA

Mr. CAPRON. Good afternoon.

Thank you, Mr. Chairman, for this opportunity to testify before

your Subcommittee. I will attempt to summarize the main points

of my written statement that has been submitted for the hearing

record.

Though I must be brief, I want to make clear that my remarks

are in two parts, as I have been invited to speak both as a member

of NBAC, the National Bioethics Advisory Commission, and as an

expert in legal issues and bioethics. I will first present relevant

NBAC conclusions and then state my personal views.

NBAC began its work in October 1996. Not long thereafter,

President Clinton, in response to the news reports that scientists

in Scotland had succeeded in cloning an adult mammal for the first

time, asked the commission to examine the ‘‘serious ethical issues’’

raised by ‘‘possible uses of this technology to clone human beings.’’

NBAC immediately undertook and intensive and open examination of the topic, hearing from experts in law, science, medicine,

ethics, religion, as well as members of the general public.

A little more than 3 months later, on June 9, 1997, we submitted

our report, ‘‘Cloning Human Beings,’’ to the President, and a copy

of that report has been submitted for the record as well.

In the light of the ‘‘unacceptable risks to the fetus and/or potential child,’’ we wrote, and of the many other serious ethical concerns,’’ which ‘‘require much more widespread and careful public

deliberation,’’ the commission concluded 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.’’

To this end, we recommended, among other things, that a Federal moratorium be imposed on human reproductive cloning for 3

to 5 years, at the end of which an appropriate oversight body would

evaluate the current state of the science and of the ethical and social debate.

We made no recommendations regarding research cloning, the

creation of embryos through somatic cell nuclear transfer that

would not be placed in a uterus to attempt to create a pregnancy.

Though sometimes labeled therapeutic cloning because of the

hope that someday such cells might be used to generate cells, tissues, or even whole organs for transplantation, a lot remains to be

learned before the label therapeutic would even possibly be appropriate or before, in the commission’s words, ‘‘it would be scientifically sound and therefore potentially morally acceptable to go forward with this approach.’’

45

The announcement in November 1998 that researchers at the

University of Wisconsin and Johns Hopkins University had for the

first time succeeded in creating human pluripotent stem cells from

IVF embryo and aborted fetuses resulted in NBAC being asked to

undertake another study.

The following September we recommended that changes be made

in the statutes and regulations to allow Federal funding of research

involving the derivation and use of human stem cells from aborted

fetuses and from embryos remaining after infertility treatments,

subject to appropriate ethical standards and procedures that include public oversight and review.

We also said that research involving stem cells from human embryos made using somatic cell nuclear transfer should not be eligible for Federal funding at this time. We did not address whether

this research should be allowed in the private sector.

I would now like to turn to the legislation before you, H.R. 1644,

the Human Cloning Prohibition Act of 2001. NBAC did not directly

address the question that is before this Committee, namely whether effective control of reproductive cloning requires controlling the

creation of cloned human embryos. Therefore, what I have to say

now reflects my personal views rather than those of the commission.

H.R. 1644 would ban both reproductive and research cloning. The

first is not controversial. Indeed, a ban on any attempt at cloning

a baby is favored by the majority of the American people for reasons that you have already heard from witnesses at the prior hearing.

The ban could be a moratorium for a term of years, as NBAC recommended, or it could be of unlimited term, which is the view that

I have come to favor as I’ve become more concerned with both the

physical and psychological risk to any child produced through

cloning, and more convinced that the reasons offered for its use are

slight compared with its potential harm to society, the family, and,

indeed, to the prospects of a decent future for humankind.

Why, then, hasn’t some form of prohibition been enacted? Largely, as far as I can tell, due to partisan politics and disagreements

over other topics, such as the permissibility of embryonic stem cell

research. I regard this as tragic, and I am here to plead with Members of this Committee and with your colleagues in both houses of

Congress to seek a way of halting reproductive cloning effectively

and without further delay.

As I think you can see, to be effective, a ban needs to encompass

the creation of cloned embryos in the lab, if you’re going to avoid

aiding reproductive cloning indirectly or perhaps directly.

As can be seen by looking at H.R. 2172, if cloned embryos exist

in labs, it will be very hard to stop people who want to use them

to create a pregnancy. The highly entrepreneurial fertility field is

characterized by a lack of effective professional or governmental

oversight, and a history of ethical scandals, including poor control

over embryos.

Thus, simply from a strategic viewpoint, if you want to halt reproductive cloning, you need, at this point, to control research

cloning as well.

46

The second strategic argument concerns getting a bill adopted. It

hasn’t happened in the past 4 years. People are going to have to

find common ground and to agree on a compromise result, albeit

for different reasons.

One way of reaching a compromise would be to apply the method

that NBAC recommended for reproductive cloning and change the

absolute ban on research cloning in H.R. 1644 to a moratorium.

You need to indicate to the research community not only that the

ban on the creation of embryos through somatic cell nuclear transfer is carefully limited to that one type of cloning, but also that it

is not necessarily permanent but will be reviewed in, say, 5 years.

Meanwhile, other lines of research can go forward on the cloning

of animals, on adult stem cells, on perfecting the means to differentiate stem cells into specific cell tissue and even organs that function normally if transplanted, and on the antigenicity of such cells,

tissues, and organs, creating from stem cells that are not clonally

matched with a recipient.

If researchers arrive at the point where the use of cloned embryos offers a means of achieving a lifesaving therapy that is otherwise unobtainable, they can then ask the public to weigh those no

longer merely hypothetical benefits against the risks of leakage to

reproductive cloning and against the well-being of the embryos that

would be destroyed.

Since they feel so confident of the eventual therapeutic outcome,

this is a burden that should not worry the biotechnologists.

Therefore, I urge you to change the ban to a time-limited moratorium as a compromise that should satisfy both sides and would

more effectively stop reproductive cloning without preventing scientists pursuing many other lines of research that are needed before the hypothesized therapeutic benefits of research cloning can

be realized.

When our descendants—and I do hope they are truly our descendants and not manufactured replicants—look back to this time,

let them find that we were equal to this unprecedented challenge.

The United States should take a lead in protecting our human

future by locking the barn door on reproductive cloning and by persuading other nations that, at this time, a ban on cloning of human

embryos represents the best way to ensure that the cows stay in

the barn.

Thank you.

[The prepared statement of Mr. Capron follows:]

PREPARED STATEMENT OF ALEXANDER MORGAN CAPRON

As Commissioner, National Bioethics Advisory Commission

Thank you, Mr. Chairman. I am Alexander Capron, and I have been invited to

testify before the Subcommittee in two capacities today: as a member of the National Bioethics Advisory Commission (NBAC) and as an expert on legal issues in

bioethics. In this statement, I summarize relevant conclusion of the Commission,

and in a separate statement I present my personal views.

NBAC was chartered by President Clinton in 1995 and began work on October

4, 1996. It studies ethical issues arising from biomedical and behavioral research

and makes recommendations to the President, the National Science and Technology

Council, and others. My fellow commissioners include physicians, theologians,

ethicists, scientists, and lawyers, psychologists, and members of the general public.

On February 24, 1997, the day that the American news media reported that scientists in Scotland had succeeded in cloning an adult mammal for the first time,

President Clinton asked NBAC to examine the ‘‘serious ethical questions’’ raised

47

by‘‘possible use of this technology to clone human beings.’’ NBAC immediately undertook an intensive and open examination of the topic, hearing from experts in law,

science, medicine, ethics, religion as well as from members of the general public. A

little more than three months later, we submitted our report, Cloning Human

Beings, to the President.

NBAC focused on a very specific aspect of cloning, namely where genetic material

would be transferred from the nucleus of a somatic cell of another human being,

living or dead, to an enucleated human egg with the intention of creating a child.

We did not revisit issues raised by human cloning by embryo-splitting in fertility

clinics: only cloning through the new somatic cell nuclear transfer (SCNT) technique. We examined only ‘‘reproductive cloning,’’ not ‘‘research cloning,’’ the creation

of embryos which would not be implanted in a uterus.

The Commission discovered that the potential ability to clone human beings

through SCNT raises a host of complex scientific, religious, legal, and ethical

issues—some new and some old. Especially noteworthy were the medical risks to

any child conceived in this manner, as well as the diversity of views that we heard

among religious scholars, indeed even among those within the same religious tradition.

The Commission concluded that no one—whether federally or privately supported—should be permitted to create babies through cloning at this time. To this

end, we recommended that a moratorium be imposed on such research. A moratorium gives society a safeguard not only against the extreme risks to any child created in this fashion but also against the possible harms that might accompany

crossing the line to controlled, asexual ‘‘reproduction.’’ A moratorium also provides

a period of time both for further knowledge to be accumulated about mammalian

cloning and for serious and sustained reflection about the sort of world that human

cloning could create. Then, say three to five years hence, Congress and the President would need to decide whether the results of the scientific research and of the

debate on the risks and potential benefits of human cloning had provided sufficiently strong reasons to lift the prohibition and permit human cloning under any

circumstances.

Because our Cloning report was prepared in a relatively short period of time, and

when the technology was still in its infancy, we made no attempt to write the final

word but instead provided a starting point for what we hoped would be the ‘‘profound and sustained reflection’’ our Nation needs on the subject of human cloning.

While the commission has not deliberated any further on this topic since submitting the Cloning report to President Clinton in June 1997, our main conclusions still

stand. Indeed, in a letter to President Bush on March 16, 2001, NBAC Chair, Harold T. Shapiro, stated:

While we did not resolve all of those [ethical] issues, we unanimously concluded

that given the current state of the science, any attempt to create a human being

through somatic cell nuclear transfer would be terribly premature and unacceptably dangerous. Besides being morally unacceptable on safety grounds, the

creation of human clones would involve risks to the children—and more broadly

to society—that are serious enough to merit further reflection and deliberation

before this line of research goes forward.

Issues relating to cloning emerged again with the announcement in November

1998 that researchers at the University of Wisconsin and Johns Hopkins University

had for the first time succeeded in creating human pluripotent stem cell lines from

embryos remaining after infertility treatments and aborted fetuses. President Clinton requested that NBAC also review the issues associated with that research.

Again, the commission heard testimony from a wide range of experts and commentators as well as the public. After many months of public deliberation we concluded in our report Ethical Issues in Human Stem Cell Research that changes

should be made in statutes and regulations to allow federal funding of research involving the derivation and use of human stem cells from aborted fetuses and from

embryos that would otherwise be discarded, subject to appropriate ethical standards

and procedures that include public oversight and review.

In that report, the commission recommended that research involving the derivation or use of stem cells from human embryos made using SCNT should not be eligible for federal funding at this time. However, NBAC noted that there was significant reason to believe that use of stem cells from such embryos may have therapeutic potential, due to the utility of matched tissue for autologous cell replacement

therapy, and stated that scientific progress and medical utility in this area of research should be monitored closely. NBAC did not address whether or not this research should occur in the private sector.

48

At the time it considered the question of cloning, NBAC had several courses of

action under consideration. One would have been no moratorium on any activities.

The second would have been a moratorium on both reproductive as well as research

cloning. The third, which is the one that the commission actually chose, was a temporary moratorium on reproductive cloning, but no moratorium on research cloning.

In so doing, NBAC recognized that while important moral considerations are at

stake, with respect to research and reproductive cloning, the nature of those moral

considerations are different in kind. With respect to research cloning, the issues are

those associated, in general, with the embryo research debate. With respect to reproductive cloning, however, the issues pertain to the safety of the fetus and mother

and the potential impact of reproductive cloning on the resultant children and our

institutions of parenting and child bearing. It was because of the difference between

these types of considerations that a moratorium was considered appropriate in one

case (reproductive cloning) but not the other (research cloning). At the time it considered stem cell research, the commission once again considered the question of research cloning. Here it concluded that the case had not yet been made for a need

for federal funding for this activity. It did not, however, propose a moratorium on

privately funded activity in this area.

Those are the recommendations of NBAC. While I suspect that the commissioners

hold a range of views on the consequences to society of the development and use

of SCNT to create children, all of us—like the overwhelming majority of Americans—agree that those consequences would be profound; and further, that the risks

have not yet been adequately explored, much less carefully balanced against competing interests, whatever they might be.

As Co-Director, Pacific Center for Health Policy and Ethics, University of Southern

California

I will now state my own understanding of NBAC’s reports, but my views are my

own, and I am aware that they do not reflect those of all my fellow commissioners.

One of the bills before you, H.R. 1644 ‘‘The Human Cloning Prohibition Act of

2001,’’ would permanently prohibit the use of SCNT to create human embryos for

any purpose, including reproductive cloning and the creation of embryos as a source

of embryonic stem cells. NBAC did not directly address one of the questions that

is before this Committee, namely, whether the control of reproductive cloning requires controlling the creation of embryos by SCNT for research purposes. It is my

opinion, however, that our Cloning report—when read in light of subsequent developments in that field and of the Stem Cell report—supports completely halting all

attempts to create human embryos through SCNT at this time.

Obviously, the most contentious issue in H.R. 1644 is the prohibition on the use

of SCNT to create cloned embryos from which stem cells of a predetermined genetic

background could be derived. Though often labeled ‘‘therapeutic cloning’’ because of

the hope that someday such cells could then be used to generate cells, tissues, or

even whole organs for transplantation, I believe the term ‘‘research cloning’’ is more

accurate. As NBAC recognized in Cloning Human Beings, an essential step before

the label ‘‘therapeutic’ would even possibly be appropriate would be for scientists to

understand how to direct cellular differentiation along a specific path to produce the

desired material for transplantation: ‘‘Given current uncertainties about the feasibility of this, however, much research would be needed in animal systems before it

would be scientifically sound, and therefore potentially morally acceptable, to go forward with this approach’’ (p. 30).

We reinforced and expanded on this conclusion in the Stem Cell report. Although

limited to the question of federal funding, I believe that report has wider implications, because we favored such funding not only to help ensure that the federal government would be in a position to set ethical standards to guide all researchers in

this field but also because we felt that serious public detriment would be arise from

leaving the development of science in this field entirely to private, and often commercial, researchers while excluding scientists at federal institutes (such as the

NIH) and those conducting studies with federal support.

Had a stronger justification been shown for using SCNT to create embryos for

stem cell research, I do not believe that we would have opposed federal funding. The

need for cloning human embryos was simply not established, given the rudimentary

state of the science on such matters as mammalian cloning in general or controlling

the differentiation and development of cells and organs from pluripotent stems cells.

In addition, NBAC recognized the availability of human embryos remaining after

fertility treatments to meet the needs of researchers. In my opinion, that picture

has not improved in the subsequent 21 months. If anything, the arguments for emphasizing basic research with nonhuman stem cells is even greater in light, for example, of the sad results involving unregulated cellular activity in the brains of

49

some Parkinson’s patients who received fetal tissue transplants in experiments in

New York and Colorado. Furthermore, the problems with development of the few

cloned animals that have survived to birth provide a warning signal that we cannot

simply assume that stem cells generated from cloned human embryos would themselves function normally.

Not only are we years away from having a good basis for using cloned embryos

for ‘‘therapeutic’’ research on human patient—subjects, but other avenues are being

pursued that might mean that cloned embryos will never be needed to achieve good

results in transplantation. First, scientists are investigating whether embryonic

stem cells are, as some believe, less likely to stimulate rejection following transplantation. If that proves to be the case, transplantation could be performed using tissues and organs derived from existing cell lines without having to produce cells that

are clonally identical to transplant patients. Second, promising laboratory work on

adult stem cells harvested from a number of tissues offers the prospect of achieving

autologous cellular therapy and transplantation without the need for cloned embryonic stem cells.

In light of the ethical and moral concerns raised by the use of human embryos

for research, NBAC concluded that ‘‘it would be far more desirable to explore the

direct use of human cells of adult origin to produce specialized cells or tissues for

transplantation into patients,’’ though we noted that the possible use of adult stem

cells ‘‘will be greatly aided by an understanding of how stem cells are established

during embryogenesis’’ (Cloning Human Beings, p. 31). Thus, while such research

with adult cells does not obviate the need for research with embryonic stem cells,

all these lines of research—including research in animals—have much further to go

before questions arise that can only be answered through the creation of human embryonic stem cells cloned through SCNT.

I have already mentioned the NBAC Cloning report recommended a prohibition

on human reproductive cloning, but only for a time period of three to five years,

after which time Congress and the President should revisit the issue and decide

whether the prohibition would stay in place. H.R. 1644 includes a permanent prohibition on all SCNT. For myself, I would be comfortable with the bill as written,

namely that the ban on reproductive cloning (but not research cloning) not be timelimited. Many reasons have been offered by those who favor cloning, from the wish

to create a copy of oneself or of another esteemed person to the desire to replicate

a deceased relative (particularly a child) to simply having an alternative means of

reproduction, whether as a means of overcoming infertility or otherwise. None of

these reasons seem compelling to me. Beyond the risk of physical harm to child and

perhaps to mother, cloning poses potential psychological and social harm to the children produced by this technology. More fundamentally, the use of cloning to produce

children would not merely be the ultimate form of eugenics but an alteration of the

basic relationship between generations. In the context of other means of genetic manipulation—indeed, the very means that Dolly’s makers had in mind in developing

SCNT in mammals, namely the creation of large numbers of animals whose genotype had been modified to produce a desired phenotype—allowing reproductive

cloning would be the decisive step toward the Brave New World. Since I do not

think that such a state of affairs would advance the ‘‘more perfect Union’’ enshrined

as the aspiration of the American people for more than 200 years, I would have no

problem with going further than NBAC went, enacting the prohibition now and

leaving to those who would so radically alter the manner in which human beings

are created the burden of showing that the benefits clearly outweigh the risks.

It does seem to me, however, that the idea of a moratorium—that is, a time-limited ban—can be usefully applied to the second activity addressed by H.R. 1644,

namely the creation of cloned embryos for research purposes. NBAC did not recommend the use of federal funds to support creation of cloned embryos for research

at this time. Although NBAC did not recommend a prohibition in the private sector,

I have already explained why I think our recommendations can (though need not)

be read more broadly to suggest that this area of research should not be pursued

by anyone at this time. Thus, it seems fair to me to read Recommendation 4 in our

Stem Cell report as consistent with prohibiting efforts to use SCNT to create human

embryos for research purposes at this time. I personally agree with the premise of

H.R. 1644 that the best (probably the only) way to stop what we all think should

be stopped—namely reproductive cloning—is to impose a moratorium on research

cloning as well. Producing normal human embryos through cloning is probably going

to be a challenge, but once such embryos are on hand (available in laboratories and

perhaps even as items of commerce) I believe it will prove impossible to prevent efforts to implant them and achieve a pregnancy behind the privacy veil of the physician-patient relationship. The slope here is slippery not just because the step may

be taken surreptitiously but because the slide downward will be accelerated by conVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00053 Fmt 6601 Sfmt 6621 G:\WORK\CRIME\060701\72982.001 HJUD2 PsN: HJUD2
50

tradictory ethical imperatives. On the one hand, once the cloned embryos have been

created, some who oppose reproductive cloning will feel so strongly that the embryos

have a right to life that they will insist that the embryos be used to attempt to

achieve a pregnancy. On the other hand, once a pregnancy has been established defenders of women’s right to control their own reproduction—including those who are

appalled by reproductive cloning—would be as loathe as any anti-abortionist to tell

a woman carrying a cloned fetus that she must abort it.

Thus, any serious effort to stop asexual reproduction needs in my opinion to encompass all efforts to create cloned embryos. I believe that placing research cloning

off-limits at this time is fully consistent with NBAC’s recommendation that such research not go forward now with federal funding because much more work needs to

be done in the basic science as well as with adult and noncloned embryonic stem

cells before we can possibly know whether the cloning of embryos offers the only

means of achieving a potentially life-saving therapy for certain patients.

A moratorium may not initially appeal to anyone who believes that it is always

wrong to create, much less to destroy, a human embryo for research or therapy

unconnected with that embryo’s own well-being. Yet to these people, I would say

that a moratorium achieves the very end that they seek, which is to forbid the creation of cloned embryos. Conversely, for those who do not take that view, a moratorium carries the promise that the issue of research with cloned embryos will be revisited. Just as NBAC favored a moratorium on reproductive cloning so that the

issue could be reconsidered, so too Section 4 of H.R. 1644 says that the National

Bioethics Advisory Commission or a successor group will study and report back

within five years on ‘‘the need (if any) for human cloning to produce medical advances’’ as well as the possible impact of permitting research cloning ‘‘upon efforts

to prevent human cloning for reproductive purposes.’’ Again, I want to stress that

the commissioners did not directly face or decide this particular question, but they

did agree with the objective of forestalling the cloning of human babies and that

grounds for cloning human embryos at this time are not so strong that federally

funded scientists need to conduct such research.

A moratorium was accepted by biomedical researchers 27 years ago, at the dawn

of the era of genetic engineering, when leading scientists recognized the unpredictable risks associated with some of the experiments and persuaded the community

to halt them until the risks could be better assessed and appropriate preventive

measures adopted. Last year, on the 25th anniversary of the famous Asilomar meeting that was held to decide whether and how the moratorium should be lifted, I

chaired a symposium back at Asilomar in which 50 scientists, social scientists,

ethicists, lawyers, government officials, and journalists examined that earlier moratorium and its continuing relevance today. In some ways, the decision to halt work

was more difficult a quarter of a century ago because some of what was stopped

was ‘‘the next logical step’’ in research and was being actively pursued by the leading scientists, which is not true of cloning human embryos today. Yet in other ways,

the gene splicing moratorium was easier to accomplish because the risks to be

avoided were immediate, physical harms, from injuries to laboratory personnel to

potential epidemics of novel pathogens, whereas the ethical and social issues that

really underlay the public’s concern (and that are the category of risks that arise

from human cloning) were not debated at Asilomar. Moreover, as we concluded at

the symposium in February 2000, the commercialization of biotechnology has

changed the pressures to pursue research as well as the freedom of scientists and

their credibility in calling for a halt to research. Thus, while a moratorium—putting

some research out of bounds while its risks can be assessed and possible safeguards

can be developed—is something that biomedical researchers have accepted in the

past, the impetus for a moratorium on human embryo cloning probably now must

come from the government.

Researchers must be assured that the moratorium will not prevent other lines of

research, either on stem cells not derived from cloned embryos or the cloning of molecules, cells, or the like that does not involve embryos. H.R. 1644 seems to me to

accomplish this objective. That leaves the question of whether the moratorium

should be framed as a sunset provision that lets the prohibition lapse if not renewed

or as ban that remains in place after the mandatory review unless reversed by a

majority. Reasonable people may differ on this point, but given both the importance

of the subject and the confidence with which biotechnologists predict that the creation of cells from cloned embryos will provide benefits not otherwise available, I

conclude that the burden of proof should be left with the proponents of the research

when the ban is reconsidered. If they have arrived at the point where the use of

cloned embryos offers a means of achieving a life-saving therapy that has been

found to be otherwise unobtainable, then I believe they will persuade a majority of

51

people that such steps should be allowed under the most stringent of ethical and

practical safeguards.

Agreeing on this course will require each side to compromise. It would seem to

me—if I may be so bold, and speaking as a citizen and a person concerned with the

ethical and policy implications of science and medicine rather than as a member of

NBAC—that this is one time that people on both sides of the aisle should do all

they can to avoid allowing their disagreements on other matters, such as abortion

and stem cell research, to stand in the way of a compromise that achieves the central aim that is overwhelmingly supported—and rightly so—by the American people,

and indeed, by most people around the world.

I hope that these hearings can help promote a genuine dialogue among people

holding a range of views on the subject and that a compromise, perhaps along the

lines I have urged here, can be forged. In recommending a moratorium on reproductive cloning, NBAC hoped that during the period of three to five years before the

issue was reconsidered in Congress, our Nation would engage in ‘‘profound and sustained reflection’’ on the issues. Regrettably, four years to the month after we submitted our report, this sort of serious, broadly based public discussion has yet to

occur. Partisan disputes have prevented Congress from acting even though it appears that there is overwhelming agreement here that reproductive cloning should

not be allowed at this time, And while a good deal of academic debate has occurred,

as time has passed the press seems to have found the topic too weighty for continued public scrutiny. Hence, the plans announced by various groups in recent months

to develop reproductive cloning are today more often the objects of comedians’

humor than commentators’ analysis. Indeed, from the tone of the inquiries I have

had lately from reporters and from some (though certainly not all) of the media coverage, I sense that the simple familiarity of the topic has served to trivialize it. The

initial reaction of many people to the technology and to the prospect of its being

applied to human beings—disbelief and repugnance—has been replaced by disinterest. As one reporter said to me recently, ‘‘Doesn’t cloning seem more acceptable

now? After all, despite the original objections, nothing bad has happened, has it?’’

Well, of course not, because as far as we know, no one (thankfully) has yet tried

to clone a human baby. Yet the risk of that happening is great if the serious problems with such a step are not brought before the public and if legislation is not

adopted to make clear that no one may take such a step at this time.

In conclusion, I want to return to Chairman Shapiro’s March 16 letter to President Bush, in which he stressed how seriously the present, announced efforts to engage in human cloning ought to be taken. He also stated that adopting a moratorium would bring the United States ‘‘into line with the position adopted by the

Council of Europe’’ and would ‘‘encourage other nations to do likewise.’’ As recommended by the G8 nations at the Denver Summit, and as emphasized in a number of the bills pending before Congress (including H.R. 1644), international cooperation is going to be essential for success. Humankind stands now at an historic

juncture. When our descendants—and I do hope they are truly our descendants, not

our manufactured replicants—look back to this time, let them find that we were

equal to what I think may fairly be labeled an unprecedented challenge. In my view,

the United States should take the lead in protecting our human future by locking

the barn door now on reproductive cloning and by persuading other nations that at

this time a ban on the cloning of human embryos represents the best way to ensure

that the cows stay in the barn.

Thank you for the opportunity to present my views on this subject, and I am

happy to answer any questions that you may have.

Mr. SMITH. Thank you, Professor Capron.

Professor Elshtain.

STATEMENT OF JEAN BETHKE ELSHTAIN, PROFESSOR OF SOCIAL AND POLITICAL ETHICS, THE UNIVERSITY OF CHICAGO, CHICAGO, IL

Ms. ELSHTAIN. Thank you, Mr. Chairman. Thank you for the opportunity to offer reflections on the political, ethical, and legislative

issues presented by the prospect of human cloning.

I teach social and political ethics at the University of Chicago,

where I am a member of the Divinity School and Department of

Political Science.

52

My work for nearly 30 years has been devoted to examining the

ethical implications of political and social policies and proposals. I

consider myself a realist, indeed, a hard-headed realist.

As such, it seems to me that the path down which we are headed, unless we intervene to stop human cloning, is one that will deliver harm in abundance. And that harm can be stated clearly and

decisively now, whereas any potential benefit is highly speculative

and likely to be achievable through less drastic and damaging

methods in any case.

The harms, in other words, are known, not a matter of speculation, whereas the benefits are a matter of conjecture, in some cases,

rather farfetched conjecture—this according to the bulk of current

scientific opinion.

Now, one of the basic rules of medicine is also a basic rule of politics: First, do no harm.

We are on the pathway to harm. That is why I support H.R.

1644.

Last August, I was in Berlin, Germany, for an international conference. On that occasion, the Lutheran bishop of Berlin presented

a talk in which he expressed alarm at the direction much of the

genetics ideology of the present is tending. That ideology identifies

the true essence of what is human with a particular genotype.

This ushers into a kind of genetic fundamentalism that reduces

our humanity to clusters of traits we phenotypically exhibit or fail

to—everything from a desirable height, hair and eye color, skin

color, I.Q., physical attractiveness, and so on. And I don’t think I

need to remind anyone of why they are particularly sensitive to

this issue in Germany.

The hope of genetic fundamentalists is that we can increasingly

control for that which is deemed desirable and eliminate that

which is not.

The aim in all this is not to prevent devastating illnesses but

precisely to reflect and to reinforce certain societal prejudices in

and through genetic selection. There is a word for this so-called genetic enhancement, and that word is ‘‘eugenics.’’

Human cloning belongs to this eugenics project. All the ethical,

political, scientific, and juridical arguments against eugenics apply

to the prospect of human cloning.

Hans Jonas, the distinguished philosopher and scientist, has already written that cloning is, and I quote, ‘‘both in method the

most despotic and in aim the most slavish form of genetic manipulation; its objective is not an arbitrary modification of the hereditary material but precisely its equally arbitrary fixation in contrast

to the dominant strategy of nature.’’ That’s the end of the quote.

Public policy reflects our understanding of who we are as a people. It indicates where we are going and our appreciation of where

we have been. I see this country and our people as strong, determined, energetic, creative, concerned, and realistic, rather than

careless and chaotic and sentimentalist.

Banning ill-considered, harmful ventures in human cloning will

show us at our best. It will demonstrate that the untrammeled

profit motive behind runaway and reckless—by contrast to responsible and controlled—developments in the area of genetics will not

53

be given full sway no matter how many powerful interests may be

involved.

It will show that the representatives of the American people are

not interested in pushing us into a post-human future dominated

by what President Vaclav Havel of the Czech Republic has called

the arrogant anthropocentrism that so ravaged the previous century.

It will say that we will not turn our children into objects and

products of manufacture and design.

It will say that we have said no to the threat of a damaging biogenetic uniformity of the sort that cloning portends.

It will say that we will not permit the emergence of unused products—failed clonees, poor, misbegotten children of distorted imaginations.

It will say that we are determined to protect and to sustain what

we know to be the best context for child nurture—a child who is

not a product but a precious and unique human being, a child who

has not been deprived a unique identity through the terms of its

production, but precisely given a unique identity through the terms

of its begetting.

I see, Mr. Chairman, that my time is up. And I hope that I will

be able to revisit this and a number of other issues during the

question and answer.

[The prepared statement of Ms. Elshtain follows:]

PREPARED STATEMENT OF JEAN BETHKE ELSHTAIN

Good afternoon. Thank you for the opportunity to offer reflections on the political

and ethical issues presented by the prospect of human cloning. I am Jean Bethke

Elshtain. I teach social and political ethics at the University of Chicago where I am

a member of the Divinity School and the Department of Political Science. My work

for nearly thirty years now has been devoted to examining the ethical implications

of political and social policies and proposals. I consider myself a hard-headed realist,

one obliged, therefore, to avoid utopian scenarios that assure us that paradise is just

around the corner if only we implement this ideology or enact this policy and, as

well, to challenge dark, nightmarish sketches of what the future will hold if a certain proposal is implemented or a technology developed. That said, it seems clear

to me that the path down which we are headed unless we intervene now to stop

human cloning is one that will deliver harm in abundance—and that harm can be

stated clearly and decisively now—whereas any potential benefits are highly speculative and likely to be achievable through less drastic and damaging methods, in

any case. The harms, in other words, are known—not a matter of speculation—

whereas the hypothesized benefits are a matter of conjecture, in some cases rather

far-fetched conjecture: this according to the bulk of current scientific opinion.

One of the basic rules of medicine is also a basic rule of politics: first, do no harm.

We are on the pathway to harm. That is why I support H.R. 1644, the ‘‘Human

Cloning Prohibition Act of 2001.’’ Last August, I was in Berlin, Germany, for an

international conference. On that occasion, the Lutheran Bishop of Berlin presented

a talk in which he expressed alarm at the direction much of the genetic ideology

of the present—not science, but an ideology that piggy-backs off scientific and technological developments and prospects—tends. That ideology increasingly identifies

the true essence of what is human with a particular genotype. This ushers into a

kind of genetic fundamentalism that reduces our humanity to the clusters of traits

we phenotypically exhibit, or fail to—everything from desirable height, hair and eye

color, skin color, I.Q., physical attractiveness, and so on. The hope of genetic fundamentalists is that we can increasingly control for that which is deemed desirable

and eliminate that which is not. The aim in all this is not to prevent devastating

illnesses but precisely to reflect and to reinforce certain societal prejudices in and

through genetic selection. There is a word for this so-called ‘genetic enhancement’.

That word is eugenics. Human cloning belongs to this eugenics project. All the ethical, political, scientific , and juridical arguments against eugenics apply to the prospect of human cloning. Hans Jonas, the distinguished philosopher and scientist, has

54

already written that cloning is ‘‘both in method the most despotic and in aim the

most slavish form of genetic manipulation; its objective is not an arbitrary modification of the hereditary material but precisely its equally arbitrary fixation in contrast

to the dominant strategy of nature.’’ Public policy reflects our understanding of who we are as a people. It indicates

where we are going and our appreciation of where we have been. Americans are a

strong, but not a reckless people when we are at our best. We are a determined but

not a willful people when we are at our best. We are an energetic but not a frenetic

people when we are at our best. We are a creative but not a chaotic people when

we are at our best. We are a concerned but not a sentimentalist people when we

are at our best. We are a realistic but not a narrow-minded people when we are

at our best. Banning ill-considered, harmful ventures in human cloning will show

us at our best. It will demonstrate that the untrammeled profit motive behind runaway and reckless, by contrast to responsible and controlled, developments in the

area of genetics will not be given full sway, no matter how many powerful interests

may be involved. It will show that the representatives of the American people are

not interested in pushing us into a post-human future dominated by what President

Vaclav Havel of the Czech Republic has called the ‘‘arrogant anthropocentrism’’ that

so ravaged the previous century. It will say that we will not turn our children into

objects and products of manufacture and design. It will say that we have said no

to the threat of a damaging biogenetic homogenization or uniformity of the sort that

cloning portends. It will say that we will not permit the emergence of unused ‘products’, failed clonees, poor misbegotten ‘children’ of our distorted imaginations. It will

say that we are determined to protect and to sustain what we know to be the best

contexts for child nurture—a child who is not a product but a precious and unique

human being, a child who has not been deprived of a unique identity through the

terms of its production but precisely given a unique identity through the terms of

its begetting.

There are those who tell us that banning this harmful procedure is an unacceptable diminution of human freedom. I do not understand the view of freedom they

promote. Responsible freedom has never been a notion that we should simply move

full steam ahead on whatever strikes our fancy or seems doable or promises profit

and glory and newspaper headlines. Freedom is always limited by my presence

among others. Rights are never absolute because we are not. Those who claim that

to prevent human cloning cuts into an unlimited right to ‘reproductive freedom’ ignore politics, ethics, and history. All decent societies restrict this freedom and set

boundaries to its operation. Banning human cloning would not, in this sense, be unprecedented but well within our established traditions. Authentic freedom and responsibility should never be reliquished in favor of an abstract, ideological claim

that feeds and fuels narcissitic imaginings of radical sameness, for one can see in

the arguments of those who express enthusiasm for cloning a real fear of the different and the unpredictable, a yearning for a world of guaranteed self-replication.

At base such a world flies in the face of everything we know about the importance

of bio-diversity and of social and political pluralism. I urge you to pass HR 1644,

a bill consistent with our traditions and our sense of who we are as a people when

we are at our very best.

Mr. SMITH. Thank you, Professor Elshtain.

Professor Bradley.

STATEMENT OF GERARD BRADLEY, PROFESSOR OF LAW,

NOTRE DAME LAW SCHOOL, NOTRE DAME, IN

Mr. BRADLEY. Mr. Chairman, Members of the Subcommittee,

thank you for this opportunity to evaluate the two anticloning bills

before you. I propose to evaluate them from both a constitutional

viewpoint and also from the viewpoint of criminal law and its enforcement.

My judgment is that bill 1644 is a lawful exercise of Congress’s

power over interstate commerce and that it is entirely consistent

with relevant constitutional doctrines, particularly those protecting

privacy and reproductive freedom.

The Greenwood bill is also, in my view, a lawful exercise of

Congress’s interstate commerce power, though the matter with

Greenwood is a little more difficult than with 1644. And the GreenVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00058 Fmt 6601 Sfmt 6601 G:\WORK\CRIME\060701\72982.001 HJUD2 PsN: HJUD2
55

wood bill does raise questions regarding the privacy cases which

1644 does not raise.

But most important, the Greenwood prohibition, in my opinion,

is unenforceable. Practically speaking, the bill will not attain its

stated objective of banning cloning intended to initiate pregnancy.

My judgment is this: The only effective way to prohibit human

reproductive cloning is to prohibit all human cloning, as 1644 does,

and it does so free of constitutional difficulty.

I should like to amplify, in these few minutes available to me,

two points I make in my prepared testimony.

One is the Commerce Clause question. It is true that since 1995,

starting with the Lopez case, the Supreme Court has engaged in

at least some modest pruning of congressional power under the

Commerce Clause. Nevertheless—and here I shall speak only of

1644—I am confident that that bill is free of constitutional difficulty and doubt on the Commerce Clause point.

It’s critical at the outset to exactly identify the activity whose relation to interstate commerce is in question. That activity is not

precisely somatic cell nuclear transfer. It is, rather, the whole prospective set of activities in connection with human reproductive

cloning and with cloning for scientific purposes which would arise

in due course absent the prohibition of 1644.

It seems to me that your judgment, if it is your judgment, that

this whole prospective market or web of activities in connection

with all types of human cloning does substantially affect interstate

commerce, if that is your opinion, I believe it is a reasonable view

and it is safe from constitutional doubt.

I turn to my second of two points. It’s the practical futility of the

Greenwood bill’s ban on reproductive cloning. I simply don’t think

it will work.

I have two points in connection with this of my second two main

arguments.

One is constitutional, and that is by prohibiting only cloning with

the intent to initiate pregnancy, Greenwood may well create a

plausible constitutional argument against itself. That is, once any

embryos are created, it is at least a plausible constitutional argument that some of them will be implanted or, to put it differently,

that some women will have a right to have those embryos implanted.

I say this especially with regard to a perspective female nucleus

donor asking, after a change of mind, perhaps, for her embryos

back from a scientific researcher in order to have them implanted

in her own womb.

She has a plausible constitutional argument in favor of controlling her reproductive freedom and controlling the terms and circumstances under which she becomes a parent.

And these cases, the cases that are most in point here, are the

few cases we have dealing with the resolution of the status of embryos frozen, which are left over in an IVF clinic and a question

arises about what to do with them after the couple, which gave the

rise to the embryo, was divorced.

I say this, there is at least a plausible constitutional argument

that once any embryo is created, parental rights with regard to

those embryos are created along with them. If you don’t want to

56

create parental rights in the embryos, however created and for

whatever purpose, don’t create the embryos in the first place.

My second of two points in this regard: I don’t think the Greenwood prohibition is practically going to be successful. Note that any

embryo created for research purposes is also suited for reproductive

purposes. Note also well that the Greenwood bill does not take any

position and certainly does not prohibit implantation of embryos.

Nor does it make unlawful the mere possession of embryos.

It attaches criminal liability to the point of creation with the intent to initiate a pregnancy.

In short, the opportunity arises—and this is conduct that would

be completely consistent with the Greenwood bill and, therefore,

lawful—for a researcher, having created embryos for research purposes, to have a change of mind and then to make them simply

available to someone else, who would then take possession of them,

with the intent to implant them and go ahead and implant them

in women willing to, if you want to say, rescue these embryos.

That scenario, it seems to me, is not a matter of evading the

strictures of the Greenwood bill; that is to say, a kind of

undetectable violation of the Greenwood bill. This scenario, it

seems to me, is lawful. It is not prohibited by the Greenwood bill.

[The prepared statement of Mr. Bradley follows:]

PREPARED STATEMENT OF GERARD V. BRADLEY

Mr. Chairman and members of the Subcommittee. I am grateful for this opportunity to evaluate the proposed anti-cloning bills, both from a constitutional viewpoint and from the viewpoint of criminal law and its enforcement. A copy of my entire C.V. is attached to the written testimony. I should like to note, however, that

I have taught, and published widely, in the areas of constitutional law and criminal

procedure throughout my eighteen years as a professor. Before that, I was a prosecutor in New York City, serving as an Assistant to Robert Morgenthau, District

Attorney of New York County.

I shall focus principally on H.R. 1644, and especially on its constitutionality. My

judgment is that this bill is a proper exercise of Congress’ power over interstate

commerce, and that it is entirely consistent with relevant constitutional doctrines,

particularly those protecting privacy and reproductive freedom. The Greenwood bill

is also a legitimate exercise of Congress’ interstate commerce power. But it raises

serious constitutional questions which H.R. 1644 does not. Moreover, the Greenwood

‘‘prohibition’’is unenforceable: practically speaking, the bill will not attain its stated

objective of banning cloning intended to initiate a pregnancy. My judgment is this:

the only effective way to prohibit human reproductive cloning is to prohibit all

human cloning, as H.R.1644 does. And H.R. 1644 provides the route to that end free

of constitutional difficulty.

The Constitutionality of H.R. 1644

The first question about H.R. 1644, as with every act of Congress, is whether a

specific constitutional authorization supports the proposed exercise of Congressional

power. This bill identifies the Commerce Clause as Congress’s lawmaking authority.

The controlling Commerce Clause precedents are summarized in U.S. v. Lopez, 514

U.S. 549 (1995). Lopez supplies the criteria for my analysis.

On one view of H.R. 1644, there cannot be any question concerning the Commerce

Clause. The bill states that it ‘‘shall be unlawful for any person or entity, public

or private, in or affecting interstate commerce’’ to engage in any of the prohibited

acts. It is possible to read the jurisdictional (i.e., interstate commerce) language here

as constituting an element of the offense. On this reading, a successful prosecution

under the act would require proof either that the particular defendant’s activities

(in general) affected interstate commerce, or that the charged act(s) of cloning did.

In other words, no one could be convicted under the proposed act without proof of

the requisite effect upon interstate commerce. Where that proof failed, the prohibition could not attach. On this view of the bill, no facial attack on commerce clause

grounds is possible.

I mention this reading not because I think it is the one intended by the bill’s

drafters. H.R. 1644 intends, it rather seems to me, a flat prohibition of human

57

cloning, as an exercise of Congressional power over interstate commerce. I turn to

the constitutionality of that momentarily. I mention this alternative reading to support the following caveat: if a court down the line, reviewing an enforcement action

under the enacted bill, doubts the constitutionality of a flat prohibition, that court

will not hold the bill unconstitutional. Instead, that doubting court will adopt the

narrower, and safer, reading I just described. Again: there is almost no chance that

this bill will be held unconstitutional on Commerce Clause grounds by any court.

There is, however, some chance that a court will adopt the safer reading of the jurisdictional language.

Let us henceforth treat H.R. 1644 as a flat prohibition of human cloning. My judgment is that, even with the modest pruning of Congressional commerce authority

in recent Supreme Court cases, the bill is constitutional.

First, there is no doubt that Congress may regulate interstate commerce for noncommercial purposes. Congress may go so far as to prohibit certain activities, in or

affecting interstate commerce, solely because they are deemed immoral, injurious to

human dignity, or violative of human rights. Many cases support this proposition.

The most compelling may be those upholding the Civil Rights Act of 1964, specifically, its ban on racial discrimination in motels and restaurants serving (in even

minuscule part) interstate travelers. See Katzenbach v. McClung, 379 U.S. 294

(1964); Heart of Atlanta Motel v. United States, 379 U.S. 241 (1964).

H.R. 1644 prohibits human cloning for a number of reasons, recited in the ‘‘Findings’’ section. That most, or even all, may be non-commercial therefore raises no interesting constitutional question.

Does a flat prohibition on human cloning have the requisite connection to interstate commerce? The prevailing Supreme Court tests, as found in the Lopez majority

opinion, recognize plenary Congressional power over the instrumentalities of interstate commerce, a protective power extending to intrastate activities which threaten

the instrumentalities of interstate commerce. Most of the activity prohibited by H.R.

1644—‘‘ship[ping]’’ or ‘‘receiv[ing]’’ products of human cloning, for example—could be

supported by these twin powers. Congress could, without constitutional question,

flatly prohibit all use of the mail and wires in furtherance of human cloning, prohibit all entities receiving any federal funds from human cloning, and even utilize

its special maritime and admiralty jurisdiction in aid of a total ban.

My judgment is, however, that these powers, either alone or in tandem, may not

be sufficient to support all that is banned by the bill. My opinion is that some portion of the flat ban on human cloning must rely upon the third type of Congressional commerce power, that over intrastate activity affecting interstate commerce.

The Lopez court emphasized, over against some prior authority, that the test was

whether the regulated activity ‘‘substantially’’ affects interstate commerce. H.R.

1644 does not use the modifier ‘‘substantial’’. But that alone does not affect the bill’s constitutionality, so long as it can be shown, in a later judicial test, that a ‘‘substantial’’ effect exists. Does Congress have a reasonable basis for asserting that ‘‘substantial’’ effect? I surely believe so.

Here is the argument that Congress does. It is important at the outset to exactly

identify the activity whose relation to interstate commerce is in question. That activity is not somatic cell nuclear transfer, the scientific act prohibited by H.R. 1644.

For that prohibition is merely the means chosen by Congress to forestall a different,

much more substantial economic activity: the whole prospective set of activities in

connection with human reproductive cloning, and with cloning for more limited scientific, medical, academic purposes—which would arise in due course absent H.R.

1644.

This projected web of activities would be high tech; it would be dependent upon

the interstate transportation of raw materials, lab equipment, and products; and it

would rely upon the national and international communication of needs, research

results, and opportunities. Though precisely speaking not a commodity for sale,

cloned human embryos could reasonably be projected to becomes articles of exchange, traded for ‘‘service’’ fees. In short, Congress could reasonably conclude that

H.R. 1644 is a pre-emptive strike against a potentially enormous interstate traffic

in connection with human cloning.

The central aim of H.R. 1644 is to forestall this projected commodification of the

results of human cloning. Nothing in the Constitution or the case law requires Congress to wait and see how things play out before acting. That Congress is poised

to act pre-emptively against an evil is neither unusual nor constitutionally troublesome. True, if the bill succeeds in its goals, we will never know in fine what the

unregulated market in human cloning would have looked like. But that fact weighs

in favor of constitutionality. For to strike down the bill as unconstitutional, a reviewing court would have to overrule, without any contrary facts in hand,

Congress’s informed judgment about the future.

58

In my professional opinion, there is little chance that a court, reviewing a factual

basis like the one just described, will upset, as an unwarranted exercise of the interstate commerce power, Congress’s judgment to prohibit human cloning,

THE PRIVACY CASES

According to the Supreme Court, its privacy cases have established constitutional

protection for the right: to marry; to have children; to direct the education and upbringing of one’s children; to marital privacy; to use contraception; to bodily integrity; and to abortion. See Washington v. Glucksberg, 117 S.Ct. 2258, 2267 (1997) (citations omitted). Only two of these rights are in the neighborhood of cloning. For

the proposition in favor of a right to ‘‘have children’’, the Court relied upon a 1942

decision against involuntary sterilization. For the right to ‘‘marital privacy’’ the

Court cited Griswold, its 1965 decision in favor a right of married couples to use

contraception. There is therefore no Supreme Court authority nearly in line against

a ban on human cloning.

There is, generally, Supreme Court precedent in favor of a woman’s right to decide, by herself, whether to ‘‘bear or beget’’ a child. But the cases giving rise to that

right make clear that ‘‘begotten’’ is surely not made—or cloned. And ‘‘bear’’ unequivocally refers to the abortion liberty. There is also authority for the proposition

that, in no exact sense, one has a right not to be a become a parent against one’s

wishes. But that right is limited to pregnant women; a man either deceived or the

victim of contraceptive failure has no constitutional traction whatsoever upon the

decision of the woman to abort their child, or to carry their child to term. Besides,

this woman’s right is surely asymmetrical. A right not to be a parent does not imply

or entail a right, simply, to be a parent.

No case, in any court, has ever held in favor of a constitutional right to reproduction by cloning. In fact, no case has ever held that anyone has a right to reproduce

by in vitro fertilization (IVF).

To generate a ‘‘privacy’’ argument against H.R. 1644 one would have to go beyond

all prior holdings of all the courts. The only way that I can think of to make that

argument would detach a commodious phrase, such as the ‘‘right to have children’’,

from its jurisprudential moorings, and then (somehow) maintain that the broad concept implies a right to reproduce by cloning. But no such argument could possibly

succeed, as I understand the Supreme Court’s stance towards all such novel claims

of constitutional rights.

The Court has repeatedly emphasized two fundamental requirements for any ‘‘privacy’’ argument in favor of an unrecognized liberty interest. First, the asserted liberty must be, objectively speaking, ‘‘deeply rooted in this nation’s history and tradition’’. See Glucksberg at 2268. Cloning clearly does not satisfy this requirement. Not

only is it an entirely new technology. By reducing reproduction to asexual replication, it is radically unlike all rights sounding in ‘‘reproductive liberty’’ heretofore

recognized. In other words, even argument by analogy will not work for cloning.

Second, the Supreme Court has cautioned, in very strong terms, against arguments relying upon spacious phrasing. The Court has insisted that the asserted liberty be described in specific, concrete terms. Vague, open-ended generalities will not

do. For example, the Court has rejected characterizations of its Cruzan holding as

favoring a ‘‘right to die’’. Instead, the Court, in its own description, held for a ‘‘constitutionally protected right to refuse lifesaving hydration and nutrition’’. Nor was

Glucksberg itself, according to the Court, about a ‘‘right to die’’ or a ‘‘right to commit

suicide’’. It was instead about ‘‘a right to commit suicide which itself includes a right

to assistance in doing so.’’ Id.

According to this second requirement, no general ‘‘right to reproduce’’, ‘‘to be a

parent’’, or ‘‘to have a child’’ will be credited, either as a conclusion or as a premise,

in any argument in the Supreme Court. The Court will insist that a claimant defend

a right specifically to cloning. Given the high burden of persuasion imposed by the

high Court upon such claimants, the chances of success in the are virtually nil.

The Supreme Court has said: ‘‘We must therefore ‘exercise the utmost care whenever we are asked to break new ground in this field’. . .lest the liberty protected

by the Due Process Clause be subtly transformed into the policy preferences of the

members of this Court’’. Id. This statement of judicial restraint implies that ‘‘policy’’

is the business of Congress, at least where the Court does not stake a claim to constitutional supervision. The Court has not and, in my judgment, will not, with regard to cloning.

Let me explain, in one more way, why members of Congress are constrained in

this matter by their sworn duty to uphold the Constitution and to legislate for the

common good, unconstrained by judicial doctrine. It is true that cloning has some

features in common with acts that are constitutionally protected. Cloning is, for exVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00062 Fmt 6601 Sfmt 6621 G:\WORK\CRIME\060701\72982.001 HJUD2 PsN: HJUD2
59

ample, a way to have a baby, and people (women especially) have a right to decide

whether to have a baby. Also, let us say for argument sake, that individuals have

a right to have babies outside of marriage. (They do, in the limited sense of being

immune to penalties for doing so. But individuals do not actually have a constitutional right to unwed parenthood.) Again, you do not have to be married to have

baby by cloning.

But, to observe that cloning is like protected acts in two respects is not saying

much. It is not saying much because cloning posses several additional features, and

it is precisely those additional features which are the grounds of the proposed ban— features included in the description of cloning as the asexual manufacture of genetic

replicas. We may presume that members of Congress voting for this bill do not do

so because they are opposed to people having babies, even outside of wedlock. So

far considered, then, members do not adopt as a reason for action any adverse moral

judgment upon any act (or feature of an act) declared by courts to be private, or

none of Congress’s business. Congress, in this thought experiment, regulates only

for reasons entirely left open to their policy judgment by the courts. There is no

good reason to anticipate authoritative judicial action which would block Congressional action upon those reasons. There is every good reason to conclude that none

will be forthcoming.

A comparison might help to make this point clearer. There is no doubt now that

movies are a constitutionally protected mode of speech. Individuals therefore may

be said to have a right to make movies. And, so long as amenities are preserved,

they have a right to make movies about children, using child actors. Francis Ford

Coppola, for example, may be said to have a right to do a remake of ‘‘Heidi’’, using

the Olson twins as stars. Should Congress attempt to suppress this project, so far

described, Congress would be acted unconstitutionally.

But, does anyone think that if a particular director wished to make a porno version of ‘‘Heidi’’, using child actresses, he has a right to do so? That Congress would

be acting unconstitutionally by prohibiting child pornography?

Of course not, even though porno ‘‘Heidi’’ possesses, we may suppose, every feature of Coppola’s ‘‘Heidi’’. And that is because porno ‘‘Heidi’’ possesses one additional

feature—sexual exploitation of children—which is not constitutionally protected.

Cloning possesses many unprotected features.

A NOTE ON IVF

As I noted above, no court in any American jurisdiction has held in favor of a federal constitutional right to have a child by in vitro fertilization. It is nevertheless

permitted in most, if not all, jurisdictions. At least one state court (Tennessee), construing its state constitution, may have implicitly recognized some right to use IVF.

Does approval of IVF imply or suggest approval of cloning? Is a ban on cloning

somehow inconsistent with approval of IVF? Would a projected court decision in

favor of a constitutional right to IVF implicitly undermine the constitutionality of

this bill?

The answer to all these questions is ‘‘No’’.

IVF and cloning are both methods of asexual human reproduction which rely upon

scientific technique to bring an embryo into being. Both techniques require the implantation of the embryo into a woman’s womb in order to bring forth a fully developed baby approximately nine months later. But, otherwise, cloning is radically discontinuous with IVF, and much more distant from human reproduction as traditionally morally approved, and as recognized in Due Process cases.

For: the principle of reproduction in IVF procedures is the human couple. The

child born is the issue of two parents, who become mother and father of that child.

That child is genetically unique, the unrepeatable combination (genetically speaking) of his/her mom and dad. None of the problems of individuality and identity created by cloning plague IVF. Though assisted by the lab technician, the embryo is

created in IVF as it is within the woman’s body in intercourse: by the spontaneous

fusion of gametes—egg and sperm. Most important, because of the unique and spontaneous genetic constitution of the IVF baby, there is scarcely a trace of the manufactured product status that would be characteristic of cloning.

By contrast, cloning is the impersonal, individualized undertaking to make a person to the specifications of a single (genetic) parent. It is replication, not true reproduction, and it is radically de-humanized. The way to think of IVF in relation to

cloning is an aggravated form of the relation between the two Heidi movies.

MAY CONGRESS BAN ALL HUMAN CLONING?

My opinion so far has noticed only H.R. 1644, and that insofar as it bans all

human reproductive cloning. But H.R. 1644 goes further, and that further step is

60

1This is probably the best place to note a shortcoming of draftsmanship in H.R. 1644. It omits

all explicit mention of mens rea. This omission appears to make its provisions binding in strict

liability. Since the ten-year sentence authorized strongly suggests that either knowing, or perhaps reckless, misconduct is the target of the bill, some mens rea should be made explicit.

what most distinguishes it from H.R.——(the Greenwood bill). H.R. 1644 would prohibit all human cloning, as the only practical way to make a ban on reproductive

cloning effective. The Greenwood bill would instead ban cloning ‘with the intent to

initiate a pregnancy’’. In my opinion, the comprehensive ban of H.R. 1644 raises no

new or interesting constitutional questions.1 Also, it is the only practical way to ban

reproductive cloning. The Greenwood bill, by contrast, raises difficult constitutional

questions, and would be wholly ineffective.

Let me explain.

The comprehensive ban will obviously curtail the activities of researchers who

may have no direct interest in or connection to reproductive cloning. But the judgement that their activities would imperil the ban on reproductive cloning is entirely

for Congress to make. Since research of the type involved here is a mixture of

speech and act, it is not protected as pure speech is by the Constitution. Congress

has the constitutional power to limit these speech acts in the public interest. H.R.

1644 does that.

What new constitutional questions does the Greenwood bill raise? First, by limiting the scope of its prohibition to some fraction of the comprehensive ban of H.R.

1644, Greenwood necessarily weakens the Commerce Clause argument in its favor.

Recall that the basis for concluding that H.R. 1644 was on safe interstate commerce

ground was the potentially huge interstate traffic in all types of cloning. By prohibiting one subset of cloning Greenwood may have to justify itself by reference to

imagined traffic in just that subset. Also,Greenwood does not have the fall-back interpretation available to H.R. 1644. Nothing in Greenwood suggests that ‘‘affecting

interstate commerce’’ may be an element of each prosecution under it.

By prohibiting only cloning ‘‘with the intent to initiate a pregnancy’’ Greenwood

creates a plausible constitutional argument against itself. It requires, as a matter

of federal law, the intentional destruction of human embryos, which many consider

to be incipient human life. The requirement thus creates a constituency who will

be both opposed to human cloning, and to the Greenwood bill (for its required destruction of embryos). This constituency will be motivated to locate plaintiffs with

standing to save from destruction at least some of those embryos. A nuclear donor,

especially a female nuclear donor asking for ‘her’’ embryos in order to have them

implanted in her own womb, has a plausible constitutional argument in favor of a

right to do so.

This female plaintiff will say that, notwithstanding any contractual agreement

with researchers, the fact is that her very tiny child now exists, and that the courts

have two choices. They may authorize the destruction of her tiny child, or they may

restore that tiny child to its mother. She will rely upon the few decided cases involving frozen embryos, derived from IVF, cases usually arising out of conflicts engendered by divorce. Those courts have recognized parental rights in embryos, frozen

and in possession of laboratories. Some of these courts were even willing to put

aside contractual agreements for the destruction of embryos, in light of parental

claims to he embryos. In other words, parents may have the right to change their

minds.

Simply put, allow the creation of embryos by anyone for any purpose, and you create parental rights. The only way to avoid creating parental rights is to avoid creating embryos.

The Greenwood ban is not only dubious as a matter of law. It is untenable and

unworkable in practice. Sections 8 (a) and (b) of H.R. 1644 provide sound reasons

for concluding that evasions of the Greenwood ban would be all but undetectable.

I should like to add a different set of observations, not about evading Greenwood,

but about the porous quality of its coverage. I shall speak about human reproductive

cloning which is not unlawful under the Greenwood bill.

Greenwood does not ban the implantation of embryos obtained by cloning. It does

not ban the possession of embryos created by cloning; only knowing ‘‘ship[ping]’’ and

‘‘transport[ing]’’ the ‘‘cellular product’’ of cloning are prohibited. Greenwood explicitly immunizes from its reach ‘‘other medical procedures to assist a woman in becoming or remaining pregnant’’. Simply getting pregnant with a cloned embryo is

entirely outside the scope of this self-styled ‘‘prohibition against human cloning’’. In

sum, the Greenwood ‘‘prohibition’’ would actually privilege the creation of an untold

number of embryos suitable for implantation, and does not make any act in connection with implantation itself unlawful. And a human embryo created for research

61

purposes is just as suitable for implantation as one created for that end, and viceversa. Now consider this very simple, eminently workable scenario.

The act’s main prohibition attaches at the moment of cloning. A researcher must

not clone ‘‘with the intent to initiate a pregnancy’’. A researcher who undergoes a

change of heart could therefore lawfully tell another person, whom we shall call the ‘‘mule’’, to deliver a vial of embryos (which the researcher had created days ago in

good faith) to an office across town. That deliverer would not be guilty of ‘‘knowingly’’ shipping or transporting cloning products. Across town, a doctor takes possession of the embryos, and implants them in a like number of women. Neither the

doctor or the women are guilty of anything. None created embryos with the intent

to cause pregnancy, and none shipped or transported them at all.

CONCLUSION

H.R. 1644 makes good moral sense, is free of constitutional infirmities, and it is

practically enforceable. The Greenwood alternative is morally dubious, constitutionally questionable, and practically unenforceable.

Mr. SMITH. And are you finished, Professor Bradley?

Mr. BRADLEY. Yes, I am, unless you have a question.

Mr. SMITH. Okay, thank you, Professor Bradley. Dr. Okarma.

STATEMENT OF DR. THOMAS OKARMA, PRESIDENT AND CEO,

GERON CORPORATION

Dr. OKARMA. Thank you. Good afternoon, I’m Tom Okarma,

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.

I’m testifying today on behalf of my company and the Biotechnology Industry Organization, BIO. BIO, as you know, represents over 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.

In my testimony today, I’d like to make three points. First, Geron

Corporation, BIO, and the overwhelming portion of scientists and

physicians oppose human reproductive cloning of human beings.

On this point, I think we are all in agreement.

However, my second point: In our shared zeal to prevent reproductive cloning, we must not prevent research on tissue cloning,

which is fundamental to enable the development of safe and effective cellular transplantation therapies that could revolutionize

medicine in our lifetimes.

My third point is that the objective of this research is to develop

a scalable process to enable the direct conversion of a somatic or

body cell into a pluripotent cell without consuming oocytes and

without generating blastocysts or embryos. Such a process would

allow the generation of transplantable replacement cells that would

not be rejected by the immune system.

First, ban reproductive cloning. It would be extremely dangerous

to attempt human reproductive cloning. As we know, it took over

270 attempts before Dolly was successfully cloned. In fact, in most

animals, reproductive cloning has no better than a 3 to 5 percent

success rate.

62

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.

It is simply unacceptable to subject humans to those risks.

To allow human reproductive cloning 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 will describe today, that could lead to cures and treatments for some of our most deadly and disabling diseases.

My second point: It is critical to distinguish use of cloning technology to create a new human being, so-called 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.

The full potential of this technology comes from its applications

in regenerative medicine. Many diseases result in the disruption of

cellular function or the disruption of tissue. Heart attacks, stroke,

diabetes are all example of common conditions in which critical

cells are lost to disease.

Today’s medicine is completely unable to 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 our 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, spinal cord injury, and many others.

For example, in our current work, we are learning how to turn

the undifferentiated human pluripotent stem cell into human neurons, human liver cells, and human heart muscle cells. So far these

cells function normally in vitro, raising the possibility of 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 step in the production

of sufficient quantities of vigorous replacement cells for the clinical

treatment of patients.

Somatic cell nuclear transfer is essential if we are to achieve our

goals in regenerative medicine. We must understand the biological

properties of the egg cell and the transferred nucleus that cause a

differentiated cell to turn into a pluripotent one. This process is

called reprogramming, and we’re still not sure how it works, which

is why we need to continue to perform the research.

At Geron, our aim is to harness and therapeutically apply this

biology. Once we fully understand reprogramming, we’ll be able to

develop specific cells for transplantation without immune rejection.

We’ll do that by taking a differentiated cell from a particular individual, reprogramming it back to form a pluripotent cell, from

which we can produce the differentiated cells we need for transVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00066 Fmt 6601 Sfmt 6601 G:\WORK\CRIME\060701\72982.001 HJUD2 PsN: HJUD2
63

plantation back into that individual. By using the patient’s own

cells as starting material, we avoid complications due to immune

rejection.

This, however, is precisely the research that would be banned by

the Weldon bill. Because the Weldon bill does not distinguish between reproductive cloning and use of cloning for research purposes, it will cut off this work and prevent its therapeutic applications from reaching patients.

In contrast, the bipartisan bill introduced by Representatives

Greenwood and Deutsch and others bans reproductive cloning but

allows the continuation of research. BIO supports GreenwoodDeutsch because it strikes the appropriate balance between prohibiting acts that unsafe and unethical while promoting vital medical

research.

Lastly, it is critical to emphasize that once we understand the

molecular biology of reprogramming, we will no longer need to use

egg cells or to create blastocysts. The commercial process would

transform a somatic cell, such as a skin cell, into a pluripotent cell

directly, without the use of oocytes and without the creation of

blastocysts.

Moreover, understanding the biology of reprogramming is a critical step to improve the usefulness of so-called adult stem cells.

Ironically, the Weldon bill will also be a setback for adult stem cell

research.

In conclusion, Mr. Chairman, human reproductive cloning remains unsafe and the ethical issues it raises have not been reasonably resolved. It should be prohibited.

However, as Congress seeks to outlaw reproductive cloning, it

must not write legislation that would stop research using cloning

technology. Unfortunately, the Weldon bill fails this test. Simply

put, enactment of the Weldon bill will stop critical therapeutic

work in its tracks. Only Greenwood-Deutsch strikes the right balance.

Thank you, and I would be happy to answer questions.

[The prepared statement of Dr. Okarma follows:]

PREPARED STATEMENT OF THOMAS OKARMA

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 earlier this year 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. It took

over 270 attempts before Dolly was successfully cloned. In fact, in most animals, reVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00067 Fmt 6601 Sfmt 6621 G:\WORK\CRIME\060701\72982.001 HJUD2 PsN: HJUD2
64

productive 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. Rogue and

grandstanding so-called scientists who claim they can—and will—clone humans for

reproductive purposes insult the hundreds of thousands of responsible, reputable

scientists who are working hard to find new therapies and cures for millions of individuals suffering from a wide range of genetic diseases and conditions.

The Food and Drug Administration (FDA) has publicly stated that it has jurisdiction over human reproductive cloning experiments and that it will not approve

them. BIO supports that view and hopes that the next FDA commissioner—whoever

that might be—will assert FDA’s current statutory authority forcefully.

There are also many ethical concerns raised by the specter of cloning. As noted

in BIO’s letter to the President, ‘‘Cloning humans challenges some of our most fundamental concepts about ourselves as social and spiritual beings. These concepts include what it means to be a parent, a brother, a sister and a family.

‘‘While in our daily lives we may know identical twins, we have never experienced

identical twins different in age or, indeed, different in generation. As parents, we

watch with wonder and awe as our children develop into unique adults. Cloning humans could create different expectations. Children undoubtedly would be evaluated

based on the life, health, character and accomplishments of the donor who provides

the genetic materials to be duplicated. Indeed, these factors may be the very reasons

for someone wanting to clone a human being.’’

As you can see, Mr. Chairman, 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 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 will describe today—that could lead to

cures and treatments for some of our most deadly and disabling diseases.

BENEFICIAL USES OF CLONING TECHNOLOGY

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 many

diseases. They 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.

Let me briefly explaining a cloning technology—somatic cell nuclear transfer—and

how it is used for research purposes. First, the nucleus of an egg cell is removed.

In its place, we insert the nucleus of an already differentiated cell (a cell that performs a specific function in the body). Chemicals are added to stimulate the egg to

start dividing. At about 3–5 days, a blastocyst is formed which contains an inner

cell mass comprised of undifferentiated, pluripotent cells. These cells are removed

and used for research. The research value of these cells is enormous. These stem

cells have the potential to form any cell in the body and can replicate indefinitely.

Studies in animals demonstrate that this could lead to cures and treatments for millions of Americans who suffer from diseases and disabilities such as diabetes,

stroke, Parkinson’s Disease, heart disease, and spinal cord injury.

As exciting as that is—it’s only a part of the story. The full potential of this technology comes from its use in regenerative medicine.

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

65

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.

Somatic cell nuclear transfer research is essential if we are to achieve our goals

in regenerative medicine. We must understand the biological properties of the egg

cell (and the transferred nucleus) that cause a differentiated cell to turn into a

pluripotent cell. This process is called ‘‘re-programming’’—and we’re still not sure

how it works. That’s why we need to continue to perform research.

At Geron, our aim is to harness and therapeutically apply the power of this biology. Once we fully understand re-programming we will be able to develop specific

cells for transplantation without immune rejection. We’ll do that by taking a differentiated cell from a particular individual and re-programming it to form a

pluripotent cell from which we can produce the differentiated cells we need for

transplantation back into that individual. By using the patient’s own cells as starting material, we will avoid complications due to immune response rejection.

However, this is precisely the research that would be banned by the Weldon bill.

Because the Weldon bill does not distinguish between reproductive cloning and use

of cloning for research purposes, it will cut off this work and prevent its therapeutic

applications from reaching patients. In contrast, the bi-partisan bill introduced by

Reps. Greenwood, Deutsch, and others bans reproductive cloning but allows the continuation of research. BIO supports Greenwood/Deutsch because it strikes the appropriate balance between prohibiting acts that are unsafe and unethical, while promoting vital medical research.

It is important to emphasize that once we understand the molecular biology of reprogramming, we will no longer need to use egg cells or create blastocysts. Therefore,

this technology is likely to be used only for a short, finite period of time. Moreover,

understanding the biology re-programming is a critical step to improve the usefulness of adult stem cells. Ironically, therefore, the Weldon bill will also be a setback

to adult stem cell research.

CONCLUSION

As the current Congress pursues legislative prohibitions on human reproductive

cloning, we urge caution and a distinction between reproductive and therapeutic

cloning. We all agree that given the current safety and social factors, human reproductive cloning is repugnant. However, it is critical that in our enthusiasm to prevent reproductive cloning, we not ban vital research, turning wholly legitimate biomedical researchers into outlaws, and thus squelching the hope of relief for millions

of suffering individuals.

Our nation is on the cusp of reaping the long dreamed of rewards from our significant investment in biomedical research. The U.S. biotech industry is the envy of

much of the world, especially our ability to turn basic research at NIH and universities into applied research at biotech companies and in turn, into new therapies

and cures for individual patients. Using somatic cell nuclear transfer and other

cloning technologies, biotech researchers will continue to learn about cell differentiation, re-programming, and other areas of cell and molecular biology. Armed with

this information, they can eventually crack the codes of diseases and conditions that

have plagued us for hundreds of years, indeed, for millennia.

In conclusion, Mr. Chairman, human reproductive cloning remains unsafe, and

the ethical issues it raises have not been reasonably resolved. It should be prohibited. However, as Congress seeks to outlaw reproductive cloning, it must not write

legislation that will stop research using cloning technology. Unfortunately, the

Weldon bill fails that test. Simply put, enactment of the Weldon bill will stop critical

66

therapeutic research in its tracks. Only Greenwood/Deutsch strikes the right balance.

Thank you for the opportunity to testify. I’ll be happy to answer any questions.

Mr. SMITH. Thank you, Dr. Okarma.

It seems to me that there is agreement at least among our witnesses today that reproductive cloning should not be allowed. We

have various suggestions, ranging from outright ban to a 3- to 5-

year moratorium.

The question, then, is whether we should have reproductive

cloning. Three of you all say we should not. Dr. Okarma feels that

we should.

What I would like to do, to start with, is, Dr. Okarma, read you

some of the statements by Professor Capron and Dr. Elshtain, and

ask you respond to what they said in their testimony.

And then I would like you all to respond to what Dr. Okarma

says.

Dr. OKARMA. Thank you. I’ll be responding extemporaneously. I

have not had the opportunity to review the written copy, so I’m responding from my hearing——

Mr. SMITH. I’ll read you the statement. I hope it won’t be out of

context and it will give you a feel for what the argument is, and

then you could respond, if you would.

Let’s see, Professor Capron, let me read from your statement.

The need for cloning human embryos was simply not established.

If anything, the arguments for emphasizing basic research with

nonhuman stem cells is even greater in light, for example, of the

sad results involving unregulated cellular activity in the brains of

some Parkinson’s patients who received fetal tissue transplants in

experiments in New York and Colorado.

And then in Professor Elshtain’s testimony, she said:

It seems clear to me that the path down which we are headed,

unless we intervene now to stop human cloning, is one that will deliver harm in abundance, whereas any potential benefits are highly

speculative. The harms are known; the benefits are a matter of

conjecture.

Dr. Okarma, I gather you feel that research cloning would be

beneficial, it might alleviate the suffering of many individuals who

have a number of diseases or might suffer those diseases in the future. But how do you respond to the arguments that it doesn’t look

like the research cloning is that effective or that helpful? And, in

fact, recently there has been some doubt cast on it.

Dr. OKARMA. I can respond to that, actually, quite clearly. In

point of fact, the demonstration of the ability to produce mouse embryonic stem cells through cloning has been reduced to practice and

has been published, so that we know in an animal model of nuclear

transfer that one can generate histocompatible cells through the

nuclear transfer process that will produce embryonic stem cells

that are pluripotent.

So the notion that this is hypothesis or fanciful thinking is not

in fact true. It has been reduced to practice in animals.

However, in fairness, we do not know whether this process is

even possible in humans.

67

To the point that there are other ways to prevent immune rejection, this is also possibly true. And we and others are pursuing

them in parallel.

They would, for example, involve genetically altering the embryonic stem cell to render it immunologically null, not recognizable

by the immune system. And the notion would be that all cells derived from that engineered cell would also be not recognized.

That requires, however, an enormous leap in the technology. We

are asking for a genetic change to be carried through many leaps

of production of cells, to breed true, so to speak.

They also could have the disastrous consequence of losing that

nullness after the cells were in fact transplanted, leading to a rejection.

So the facts of the matter, as we understand them and as they’ve

been published in peer-review literature, argue that the approach

of nuclear transfer would in fact be a final solution to the problem.

As for—— Mr. SMITH. Dr. Okarma, let me interrupt you, because I want to

hear from the two professors, as well.

Professor Capron, if you would respond first.

Mr. CAPRON. In the first place, I want to underline what, it

seems to me, is a slippery use of the word therapeutic cloning in

Dr. Okarma’s statement. He uses that to describe not only the creation of research embryos for an eventual therapeutic purpose but

cells and so forth. And both the bills before us, as you have heard,

are very clear that we are not talking about any prohibitions on the

duplication of DNA, the duplication of stem cells and so forth, other

kinds of cloning other than the creation of an embryo.

As to the question of whether we need research cloning now in

order to achieve results of a therapeutic nature, it seems to me

that we have not heard a refutation of the two lines of argument

that are presented in the statement.

On the one hand, there is the argument about other ways that

need to be explored: the use of adult stem cells and the use of

nonclonally derived human stem cells, embryonic stem cells, to see

if their antigenicity, and, therefore, their chance of causing a rejection phenomena, can be reduced. And these are both under active

research.

Obviously, if either of those pan out, there is no need to use

cloned stem cells to create cellular tissues.

The second——

Mr. SMITH. Let me, real quickly, get a response from Dr.

Okarma——

Mr. CAPRON. Okay.

Mr. SMITH [continuing]. As to that point.

If we get to that point, would you favor a ban, if we get to the

point where we didn’t need to have those cells?

Dr. OKARMA. Well, it’s hard to answer the hypothetical, sir. I

think the decision would really turn on its merits. We would really

need to know the viability and degree of immune-nullness that

cells produced by those alternative methods produced.

Mr. SMITH. Okay, thank you.

Professor Capron, I would like to go to Dr. Elshtain——

Mr. CAPRON. Okay.

68

Mr. SMITH [continuing]. And hear her response as well. Thank

you.

Ms. ELSHTAIN. Thank you, Mr. Chairman.

I ran out of time before I indicated the reasons, the specific reasons, for why I favored H.R. 1644 by contrast to H.R. 2172, and it’s

quite specifically because it would not create an effective, workable

ban on the cloning of human beings for a number of reason, including the fact that the bill permits the use, as we’ve already heard,

of human somatic cell nuclear transfer technology, the act that creates a human clone.

It says only that people are prohibited to do this if they intend

to begin a pregnancy. Well, it’s easy to see that people would have

a stake in saying they intend no such thing as they went ahead

with the process and then, through a variety of means, found ways

to sidestep the law, the law criminalizing, if you will, an intent.

And one of the things I learned as a graduate student in political

science was that legislation is usually not very effective in the business of trying to discern and to punish an intent, that it is in fact

acts, it’s deeds, over which legislation can be effective. Intent is

very difficult, it is very difficult to legislate.

So H.R. 1644 prohibits a specific deed or, in effect, a chain of

deeds at the end of which you have a cloned human being. So, in

other words, we have to prohibit the creation of embryonic human

clones in order to prevent the cloning of human beings.

And it seems to me that H.R. 1644 does that. H.R. 2172 does not,

because of the emphasis on intent by contrast to actual deeds or

webs. I think Professor Bradley called it webs of activities.

And the other point I would make is that, in fact, the scenario

sketched by Dr. Okarma, or the possible whole panoply of possible

therapeutic benefits, again, is highly hypothetical, as he himself indicated, in effect, in his response to you when he said that the scientists at this point didn’t even know if some of the techniques that

have now been worked, workable—are proven to be workable with

mice, if those are possible in human beings. And yet we’re promised the cure to a whole long list of diseases.

If there are alternative ways to begin to go after some of these

devastating conditions and illnesses that do not trail in their wake

the harm that human cloning does and the possibility of a technology that is unleashed that will lead inevitably to that result,

then that’s the direction we should go.

Mr. SMITH. Okay, thank you, Dr. Elshtain.

Professor Bradley, you mentioned in your testimony a few minutes ago the distinction between the two bills and how each bill

banned reproductive cloning. You said one was constitutional, one

was not constitutional, as I recall.

In any case, what I wanted to ask you was about two constitutional rights that sometimes come into play when we discuss this

subject. Do you feel that there is a constitutional right to procreate? And do you think there’s a constitutional right to scientific

inquiry?

Mr. BRADLEY. Well, first I should say that I think that the

Greenwood raises constitutional questions. I’m not sure that I want

to be heard to say that it is unconstitutional.

Mr. SMITH. Okay.

69

Mr. BRADLEY. But it’s not free of constitutional difficulty—— Mr. SMITH. Fair enough.

Mr. BRADLEY [continuing]. As I think 1644 is.

Although, as you’re suggesting, my conclusion about 1644 includes an opinion about a right to scientific inquiry. I think no such

right, you know, just as such exists. And there are rights to pursue

unimpeded by Government information and knowledge.

But scientific inquiry, at least in this context, is not a matter of

pure speech, because we’re talking about research and experimentation. It’s a speech act or even principally an act.

So, therefore, the acts that we’re talking about—let’s call them

scientific research and experiment—are not governed by traditional

free speech doctrines, which are themselves not absolutes. Government can regulate speech under certain circumstances. But we’re

not talking about pure free speech.

So I don’t think there is, at least in the relevant sense, a right

of free scientific inquiry involved.

Now, there is something—or a multifaceted—— Mr. SMITH. Professor Bradley, I better stop you there. I am way

over time.

Mr. BRADLEY. Okay.

Mr. SMITH. And if you need to return to that later, let me know.

But you’ve really answered my question. And it was a fine distinction you made, and I was glad to hear it. Thank you.

Let me say also that, without objection, all of your statements,

complete statements, will be made a part of the record.

The gentleman from California, Mr. Schiff, is recognized for his

questions.

Mr. SCHIFF. Thank you, Mr. Chairman.

I wanted to address a question to the three witnesses that testified in opposition to research cloning, as we’re describing it today.

And I understand that it can be used in different ways, but we’re

talking about, essentially, human somatic cell nuclear transfer, not

for the purpose of pregnancy or to create a child, but for research

purposes.

I’ve listened to the points you’ve made, and I have to say that

I don’t find them all that compelling, and I wonder if there’s a reason that we haven’t talked about that is more compelling to each

one of you.

Professor Capron, you make the point that we need to prevent

this because, in the lab, loosely regulated environment, it could be

going on for one purpose. It could be then taken and used for an

illicit purpose.

And while I suppose that’s true, that logic would lead us also to

preclude a whole lot of infertility treatments in Irvine, California.

And I come from California.

We had a huge problem with people’s eggs being sold, and enormous ethical lapses and criminality. Now, we wouldn’t preclude

those kinds of fertility treatments because of that prospect, and I

don’t think it would be compelling to do so here.

Dr. Elshtain, you make the point that intent is difficult to legislate, and yet our criminal laws—and this is a criminal law that

we’re contemplating—are replete with requirements of intent and,

in fact, very definite states of intent, depending on the crime.

70

It is very rare that we find crimes that require no requirement

of intent, that are per se violations merely because you conduct a

certain act. And I would submit, even as you’re proposing, there

would be a certain level of intent required.

I also don’t think the benefits are all that much a matter of conjecture. And I have to say I put this on the spectrum of things that

are not conjecture at all and then, perhaps, national missile defense being more on the speculative side.

And where this fits within that spectrum, I’m not sure, but I

would hate to see us prevent an important medical research opportunity merely because we haven’t seen the documented success of

it yet when there is so much progress being made.

I found the constitutional theory to be a very interesting one,

that the narrower bill has a greater constitutional problem than

the broader bill. I’m not sure that’s correct. I think it’s a very interesting idea.

To the degree any court is going to find that you have a constitutional right to procreate, using different scientific techniques, my

guess is, if they’re going to find you have that right, and I think

at the point we’re talking about, it’s probably not likely, but if they

were going to find you had that right, you probably have the right

to go through the cloning process. It wouldn’t simply be created

once you had undergone part of the process. But I think it’s interesting theory.

I think your other point, though, is very well-taken, that there

does need to be some tightening up of the bill in that there are certain things precluded, that if there were a mental change along the

way might not bar the cloning that we are all attempting to bar.

But I guess what I’m trying to say is that, or what I would like

to ask is, of the three of you, if we could see today the measurable

benefits—if they were not speculative, if the benefits we knew were

real right now in treating Alzheimer’s, cancer, a whole host of

things—if we could be certain that it wouldn’t be subject to any

greater likelihood of risk and that we had great oversight of our

laboratories, if there was no greater constitutional threat, would

the three of you still be opposed to this type of research cloning

simply because you believe that it is immoral and unethical without more?

Mr. CAPRON. No, I would not. And it seems to me that the issue

is, at the moment, what is the correct characterization?

In order to get to the point of therapeutic benefit, we need research that amounts to building blocks. We need research on the

differentiation of stem cells, not cloned stem cells, but other stem

cells, into tissues and even organs in a way which will reliably

function in the human body if transplanted. You don’t need cloned

research embryos to do that.

We need research on reprogramming. That can be done with animal cells. We don’t need cloned human cells to do that.

And as I said, there are other ways that are under research that

might offer a way, which I think everybody favors, the commission

certainly favored, of avoiding the use of cloned embryos entirely, if

we could the therapeutic benefits.

Mr. SCHIFF. Professor, if this was the only way, would you support it?

71

And I realize——

Mr. CAPRON. I said yes, in answer to your question. Yes.

Mr. SCHIFF. And one of the reasons I ask this question is, you

know, you’ve made the point, and the doctor makes it also, that

this may be a temporary problem, in that we may find other cells

we can use for these purposes 5 or 10 or 15 years down the road.

And that’s wonderful, but for someone who is afflicted now, and

you may have seen recently, I think there was a press conference

today about Geraldine Ferraro and her use of——

Ms. ELSHTAIN. Thalidomide.

Mr. SCHIFF [continuing]. Thalidomide. Exactly.

Very promising in her treatment today. Now, there may be other

remedies in 5 years for her. But had it not been for the discovery

of the productive use of thalidomide now, she may not live to see

those other therapies.

Yes?

Mr. CAPRON. You answered—I answered your question but I—if

I may put it in form of a question: If we do not now have the ability to use cloned research embryos for therapy, if that is, as everyone would say, is speculative—so we’re not asking patients to forego a treatment that we now have. If that is speculative, and if,

given the examples, like Irvine—we know that there is huge leakage in the whole fertility field.

It’s a very entrepreneurial, almost Wild West phenomenon, very

different than all the rest of experimental medicine, for reasons

that I won’t take your time with now.

In that circumstance, doesn’t it seem prudent to draw the perimeter around reproductive cloning to include for the moment work

which isn’t essential now?

If it gets to be the point of being essential, we could then do it

in a limited number of labs, which are specifically producing an

organ for a particular patient or a tissue for a particular patient.

Mr. SCHIFF. Professor——

Mr. SMITH. Mr. Schiff?

Mr. SCHIFF. Yes.

Mr. SMITH. Let me interrupt you for a minute and apologize to

you and to the other Members up here. The 5-minute clock that we

have at our desk is working. However, the 5-minute notification devise on the witness table is not. And, therefore, I’m having to keep

time as the Chairman.

And even though your 5 minutes has lapsed, I’d like for the witnesses to respond to your question. But I just wanted to let you

know that’s the reason for the red light that has been constant during all your questions.

Would the other witnesses please respond briefly to Mr. Schiff’s

question?

Ms. ELSHTAIN. I’ll respond to the question of intent, Mr. Schiff,

that you raised.

You indicated that, in fact, legislation deals with intent all the

time, and I think you mentioned criminal law and the fact that one

evaluates the seriousness in certain kinds of infractions with reference to intent.

72

But I don’t think that I need to remind that you that, in fact,

it is not the intent to murder that is against the law, but it is actually murdering someone.

And then, if there is the objective fact of a body, one goes on in

the criminal—in the phase, the penalty phase, to evaluate the role

of intent and so on.

But you’re dealing with an objective fact. You’re dealing with a

deed.

That was my reference point, that it’s concrete. It’s stopping concrete deeds.

If the intent to murder were a crime, we’d all be in prison——

Mr. SCHIFF. Well, the intent——

Ms. ELSHTAIN [continuing]. Because all of us, at one point or

another——

Mr. SCHIFF. The intent——

Ms. ELSHTAIN [continuing]. Have harbored——

Mr. SCHIFF. The intent to kill——

Ms. ELSHTAIN [continuing]. Murderous thoughts.

Mr. SCHIFF. The intent to kill is an element, and without the element, you never get to the——

Ms. ELSHTAIN. That’s right.

Mr. SCHIFF [continuing]. The judge and sentencing.

Ms. ELSHTAIN. But the law prohibits the deed.

Mr. SCHIFF. And the——

Ms. ELSHTAIN. And that’s—and that’s precisely what I’m——

Mr. SCHIFF. Prohibits the deed with the intent.

Ms. ELSHTAIN. It prohibits the—but by definition, the deed involves the intent because murder is wrongful killing, which already

involves an intent. But to an—the objective fact—I mean, this

could get us into a long discussion, obviously.

The objective fact of a body—so what I’m saying is that when you

say, ‘‘Well, the thing that we’re going to criminalize is the intent

to, if you will, do harm,’’ to lead down this slippery slope, someone

can, it seems to me, very effectively evade that by claiming there

was no such intent and things simply got out of control.

As Dr. Capron pointed to with the infertility business at the

present time, things often get out of control.

When you have the end result, one that everyone acknowledges

is harmful, why would you want to take steps that would, it seems

to me, inevitably lead to that harm? And I—it seems to me that,

in fact, 2172 would lead to that harm or it would do nothing to prohibit it, whereas 1644 would more effectively try to prohibit the

harm that everyone at this table, and I think everyone you’ve

heard, probably agrees is a harm.

Mr. BRADLEY. Representative Schiff, I’ll try to answer your question as straightforwardly as I can.

I do oppose, for moral reasons, the creation of embryos in order

to perform research experiments on them and then—with the idea

of discarding them. But that conviction of mine is not a premise of

anything I’ve said to this Committee today, nor is it a premise of

anything in my written remarks.

Mr. SCHIFF. Thank you.

Mr. SMITH. Okay, Thank you, Mr. Schiff.

73

The gentleman from North Carolina, Mr. Coble, is recognized for

his questions.

Mr. COBLE. Thank you, Mr. Chairman.

And thank you all for being with us.

I say to the panelists, Mr. Chairman, I missed about threefourths of the testimony. I had to go take a phone call regarding

a patent matter on which I am working, so I regret that I didn’t— was not privy to most of what was today.

I think you and the gentleman from California pretty thoroughly

covered it.

Mr. Okarma, I have been advised by third parties that your corporation has performed outstanding bio work and research, and I

will say that to you—— Dr. OKARMA. Thank you, sir.

Mr. COBLE [continuing]. Before I make my statement.

I’ll say this to the panel, all of whom are experts, it seems to me

that this issue conjures up many descriptive words defining the

process: contentious, controversial, exciting, explosive, polarizing,

complex.

It is indeed a complex subject matter. Cuts across all sorts of disciplines, some of which are represented here today: medicine, ethics, the law, science, political science.

I have no question, Mr. Chairman, specifically, but to say that

I am not a man of letters to the extent that I can delve into this

with the expertise that we’ve heard here, and the expertise that

you and the gentleman from California have expressed, for that

matter.

But I know that this Subcommittee and the Judiciary Committee

as a whole, I am confident, will continue to keep a close lookout,

and perhaps, I guess it’s fair to say, Mr. Chairman, this may be

the first of many steps to follow before the matter is resolved with

finality.

And I thank you again for having staged this hearing today and

again express my thanks to the panelists for being here.

Mr. SMITH. Thank you, Mr. Coble. And I might say that anyone

who serves as Chairman of the Intellectual Property Subcommittee

has a lot of intellectual understanding, so you don’t need to

worry——

Mr. COBLE. Thank you, sir.

Mr. SMITH. The gentleman from Virginia, Mr. Goodlatte, is recognized for his questions.

Mr. GOODLATTE. Thank you, Mr. Chairman, and thank you for

holding this hearing.

I agree with much of what my good friend from North Carolina

said. I’m not sure about whether we can be as deliberative as we’d

like to be.

And I’d like to ask the panel what they can tell us about how

imminent it may be that there’ll be actual efforts at human cloning

where an actual human being is cloned from the embryonic cells

that might be cloned.

Start with Professor Capron.

Mr. CAPRON. For a number of years——

Mr. GOODLATTE. I’ve read articles that said——

Mr. CAPRON. Right.

74

Mr. GOODLATTE [continuing]. This could happen, it could be happening right now, so on.

Mr. CAPRON. Yes. The—for a number of years, various parties

have said that they intended to go forward. The statements in the

last 6 months by two groups in particular and the funding that

they have and apparently, in the case of one of the groups, the willing volunteers, in terms of people to serve as the surrogate mothers, makes it more urgent.

It’s hard to evaluate the credibility. And it is certainly true that

on the scientific side, there are—most of the scientific opinion that

I have read is that it would not only be highly irresponsible as a

form of totally premature experimentation, but probably not successful and perhaps even extremely harmful to the women who

were serving in the role.

That does not mean, it seems to me, that we can sit back and

say, ‘‘Well, they’ll never make it happen,’’ or, ‘‘It’s a long way off.’’ There is every reason to think that—— Mr. GOODLATTE. Are there people so unethical that they would

be willing to try without the—I mean, as I understand it—— Mr. CAPRON. They have publicly announced—— Mr. GOODLATTE [continuing]. When there has been animal

cloning, there have been lots of misfit-type failures that, it would

seem to me, you’d be likely to encounter with human cloning as

well.

Mr. CAPRON. I think that is the scientific opinion, that it is very

likely to encounter exactly those, because of difficulties in the reprogramming of the genetic material when it goes from the somatic

cell back to its pluripotent state to begin the organogenisis.

And it is for these reasons, among others, that the National Bioethics Advisory Commission said that there should be a moratorium on any reproductive cloning.

What I believe, however, is that the groups that have announced

have the backing and have the intention to go forward. And I think

it would be a great mistake for Congress to rely on the scientific

improbability of their success as the protection that we need

against the steps that they propose to take.

Mr. GOODLATTE. Dr. Elshtain?

Ms. ELSHTAIN. Yes. Unfortunately, Mr. Goodlatte, as you know,

society always contains people who are unethical and people who

are driven to garner all kinds of sensationalistic headlines. And

this would certainly produce them.

There have been a number of very publicized intentions announced in the press, people who said that if human cloning were

banned in the United States that they would move offshore and set

up their laboratories and so on.

So I think that we have to take—I quite agree with Dr. Capron.

I think we must take these people seriously and I think that these

attempts are now under way. I don’t think that this is a fantastic,

futuristic scenario.

And I think that the prospect of a kind a traffic in cloned embryos with a possibility of trying to bring them to term as human

clonees, and the number of failures this would involve, and what

kinds of entities would one have, and what would their fates be,

I think that is something that one should——

75

Mr. GOODLATTE. Let me interrupt and ask—— Ms. ELSHTAIN [continuing]. Really shudder at.

Mr. GOODLATTE [continuing]. Another question.

Do any of you know, is there an active investigation ongoing by

any governmental entity, you know, a law enforcement agency or

a consumer protection agency or anybody, a State licensing board

for the practice of medicine? Anybody who is investigating these

statements made by people and attempting to stop this under any

current laws that they might be able to utilize?

Mr. BRADLEY. I’m not aware of any. There wouldn’t be any law

enforcement cause unless cloning is contrary to the criminal laws

of some State that we’re talking about. And to my knowledge, few

if any States have criminalized cloning.

Mr. GOODLATTE. Dr. Okarma, would you respond to my first

question?

Dr. OKARMA. Well, I actually agree with much of what was said

a moment ago, and would perhaps extend it in the realm I’m comfortable in, which is the technical end.

These proponents of reproductive cloning, the Raelians and such,

make the argument that we are much now like we were at the beginning of IVF, and, therefore, IVF has turned out to be a successful and safe alternative to reproduction, so there’s no reason why

the cloning nuclear transfer could not also do the same.

But that obfuscates the very fundamental difference in the biology. IVF is still, although in a test tube, the normal mechanism of

procreation of humans. They haploid genomes of egg and sperm

joining.

That is not, in fact, what happens somatic cell nuclear transfer.

We are asking an oocyte, which has had its own nucleus removed,

to completely reprogram an adult nucleus that is only expressing

the genes required for that particular tissue, to take that nucleus

all the way back to the beginning of development and to recapitulate Mother Nature’s tape of development.

That’s a huge biological burden for the egg. And, therefore, the

likelihood of equal success that is enjoyed by IVF is very low.

Mr. GOODLATTE. Now, as I understand it, the difference between

your perspective and the other three witnesses here relates to

where you draw the line in terms of what can be done. Is there a

clear, bright line that can be drawn?

I very much respect Dr. Elshtain’s concern about intent. I think

that is a very serious problem here, and I can see people with unethical motives attempting to cover up their intent somehow.

But would the type of research that you’re advocating involve the

placement of these cells in a woman to carry on the research at all?

I mean, is that a line you can draw there, that——

Dr. OKARMA. The research that we advocate absolutely would not

do that. We are, in fact, all in agreement to proscribe the transfer

of any cloned embryo into a human uterus.

Mr. GOODLATTE. Dr. Elshtain, how would—it seems to me the

law could very clearly say that that was the—I’m not advocating

this, because I’m inclined to your side of the perspective here, that

we shouldn’t get into this at all.

But given the arguments of Dr. Okarma and others, that there

are medical benefits to be derived from this, is it simply a way of

76

determining what the intent is, to say that if they go across that

line and place these into a uterus, that that is the dividing line

that would clearly show intent?

Ms. ELSHTAIN. Well, I think that, in fact, there isn’t a bright line

and there can’t be, that sometimes we really—there really is a slippery slope and this is one.

That is, it seems to me that once you start creating embryonic

human clones, that you can imagine a subterranean traffic, if you

will, in those—in those clones. And that those who were—the originators of them, so to speak, could deny the intent of creating actual

cloned human beings out if it.

But once you start doing that, and doing that en masse, it seems

to me that you would start to get this traffic in cloned human embryos.

Mr. GOODLATTE. It’s kind of like nuclear proliferation, is it?

Ms. ELSHTAIN. And it would simply—yeah. And it would be, yes,

some kind of genetic equivalent of an arms race. And you would

have a situation that really would be out of control.

And I think that’s really what must be forestalled at this stage

of the game.

Again, I think it’s important to emphasize, as my colleagues

have, that the Weldon bill does not stop animal cloning or the

cloning of human DNA fragments. It doesn’t stop duplication of somatic cells. It doesn’t stop stem cells and tissue culture research

and so on.

So the medical—— Mr. GOODLATTE. Let me interrupt you there.

Ms. ELSHTAIN [continuing]. Technology and medical benefits—— Mr. GOODLATTE. And, Dr. Okarma, that’s enough, all of those

other tools still being available?

Dr. OKARMA. Well, none of those tools speak to the essential

issue of trying to prevent immune rejection of the transplanted

cells.

And there are some technical subtleties here. It may seem to you

that since this is a form of transplantation, much like an organ,

why not simply rely on available immunosuppressive drugs, notwithstanding their toxicity and their expense? And the difference

is actually quite profound.

Our intent is to transplant small numbers of highly purified

cells, which may not survive the toxic side effects of currently

available immunosuppressive therapy. That’s why there is urgency

here in this research.

And one other point I would like to make. While I do really respect and sustain both Dr. Capron and Dr. Elshtain’s caveat about

over-promising and under-delivering in this technology, I appreciate that point, however neither of them have spent much time in

our laboratory, so I can tell you that we do in fact have the data

now on differentiation, that the three cell types that we have deliberately chosen to manufacture from the embryonic stem cell, each

represent one of the three germ layers of embryonic development,

thereby enabling the notion that we can in fact produce any cell

from these embryonic stem cells.

Mr. GOODLATTE. And where—what is the source of

embryonic——

77

Dr. OKARMA. The embryonic stem cell is derived from in vitro fertilized blastocysts that are no longer needed to achieve pregnancy

and are donated under informed consent for research.

These cells are infinitely self-renewing. That means they grow

forever in the undifferentiated state, which we have, in fact, documented. And they are pluripotent, meaning because of their derivation from early embryos, they literally grow into all the cells and

tissues in our body.

And I would add——

Mr. GOODLATTE. The source of this——

Dr. OKARMA. We——

Mr. GOODLATTE. If I might just interrupt for a second, and then

you can finish.

The source of the cells that you use for this purpose are not from

fetuses, then?

Dr. OKARMA. That’s correct. Although we do have a different

technology, the embryonic germ, that is derived from therapeutic

abortions. It is somewhat different and has properties that are

frankly inferior from a therapeutic perspective from ES cells.

I just would like to make one point in closing about the differentiation argument, about how near and present the technology is.

Because we can scalably make these cells, as opposed to the adult

stem cells—which are so rare and slow-growing that you cannot, at

this point, produce many of them—we can expose these manufactured cells to rigorous functional testing, just as if they were a

monoclonal antibody or a chemical made by a pharmaceutical firm.

And these cells withstand that scrutiny. They make—for example, the liver cells make all the drug metabolizing enzymes of our

livers. The nerve cells make all of the appropriate synaptic materials. We are currently in animal studies with these neurons in animal model of Parkinson’s disease and have in fact seen human neurons that we’ve implanted in this animal making synaptic connections in the damaged part of the brain.

So while I’m not saying that we are ready to initiate a human

clinical trial, the data on differentiation and functionality of cells

that we manufacture from the ES cells are very solid and are here

today.

Mr. GOODLATTE. Thank you, Mr. Chairman.

Mr. SMITH. Thank you, Mr. Goodlatte.

I would like to ask you all a quick question to end on, and it is

this: Do you feel that the Food and Drug Administration had the

power to regulate cloning or to ban cloning?

Mr. Okarma, I believe you think they do have the power?

Dr. OKARMA. Let me simply answer that question from the perspective of appropriateness in their statements. I’m not a legal

scholar, as you know, so I really——

Mr. SMITH. Okay.

Dr. OKARMA [continuing]. Cannot comment on the legal framework for their position. I do think, however, that the FDA is in an

informed and appropriately judicial position to do that regulation.

Mr. SMITH. Okay, thank you.

Professor Bradley?

78

Mr. BRADLEY. No, I would have to say I don’t know for sure. If

it pleases you, I would be happy to work up something as a response that I would have more confidence in giving to you.

Mr. SMITH. Okay, fair enough. Thank you.

Dr. Elshtain?

Ms. ELSHTAIN. I’m not sure about whether it has the legal power,

but I think the presupposition would be that the embryo is like an

ordinary drug, in a sense. And I think that it would be—there

would be a substantial problem in treating human embryos in the

way that one treats a drug.

Mr. SMITH. That’s what I’ve got as well.

Professor Capron?

Mr. CAPRON. Well, the FDA asserted, back in October 1998, to

the institutional review boards that it had that authority. And it

may well have that authority over the embryos as a biologic agent.

But the problem is that the authority they are asserting is something which they have never asserted in the fertility field before,

and it is odd—a lot of the challenges and the doubts that are raised

about that authority among legal scholars, who I think pretty uniformly doubt that the present statute has it.

And secondly, that what their authority would be limited to

would be entirely issues of safety. So that if researchers establish

that there was a wide enough, within the margin of safety, and

combined with the arguments that Professor Bradley gave you

about people asserting their reproductive rights and treating this

as just a fertility method, at that point, it would be very hard, it

seems to me, for the FDA to stand in the way.

One other issue about this whole treating this as the FDA, as the

Greenwood bill does, it throws a cloak of confidentiality over all the

proceedings and treats all the information as proprietary information.

In the cloning field itself, research results that came out early on

from the American—for the Advanced Cell technology in the use of

the cow oocyte as a vehicle for cloning of human nucleus never end

up being published. Those are, so far as I know, retained as proprietary information.

We know from the debacle around some of the dangers with gene

transfer that the open body, the recombinant DNA advisory committee, was not getting the information that the FDA was getting

about some of the research risks and was holding as a matter or

proprietary information.

If we put things in a kind of a registration, leave it to the FDA

mode, what we’re in effect saying is the public won’t know.

Mr. SMITH. Okay. Thank you, all, for those answers.

I want to recognize the gentleman from California, Mr. Schiff, for

a request to insert some materials into the record.

Mr. SCHIFF. Thank you, Mr. Chairman. Just to ask that we include a letter received by the Committee from American Society for

Reproductive Medicine, and a second letter from the Federation of

American Societies for Experimental Biology, and ask that be

added to the record.

Mr. SMITH. Without objection, those documents will be made a

part of the record.

79

Mr. SMITH. Thank you all again for your testimony today. This

was our second hearing, as I mentioned at the outset. It concludes

our series of hearings on the subject, and we will see which bill we

consider next.

But thank you a lot for being here.

We stand adjourned.

[Whereupon, at 5:19 p.m., the Subcommittee was adjourned.]

(81)

A P P E N D I X

STATEMENTS SUBMITTED FOR THE HEARING RECORD

82

PREPARED STATEMENT OF THE HONORABLE SHEILA JACKSON LEE, A REPRESENTATIVE

IN CONGRESS FROM THE STATE OF TEXAS

Thank you, Mr. Chairman.

I want to thank Chairman Smith and Ranking Member Scott for holding a hearing on this important public policy matter. With this topic we step into the vast unknown. Cloning is a fascinating, promising issue but one that remains to be more

fully explored. It is crucial that Congress carefully consider all options regarding

this issue before it proceeds. We must carefully balance society’s need for lifesaving

scientific research against the numerous moral, ethical, social and scientific issues

that this issue raises.

Just over four years ago, the world learned of the first successful cloning of a

sheep, ‘‘Dolly.’’ Recognizing the urgent dilemma that this momentous occasion

brought, President Clinton wisely instituted an immediate ban on federal funding

related to attempts to clone humans. Further, at his request, the National Bioethics

Advisory Commission recommended a voluntary moratorium on human cloning. It

appears that in this country, this moratorium has been observed, and that human

cloning has been discouraged in other nations as well.

It is generally accepted that Americans are not yet comfortable for the reproduction of a human clone. The legal, ethical, physical and psychological implications of

such an act are not yet fully understood. The existence of these unresolved questions

greatly overwhelms the need to create a cloned human being. We do not yet know

the long term health risks for a cloned human being, nor have we even determined

what the rights of a clone would be as against the person who is cloned or how either would develop emotionally. Mr. Chairman, we do not seem ready to start down

the road of cloning.

83

What we can accept as a useful and necessary practice, however, is the use of the

cloning technique to conduct embryonic stem cell research. This work shows promise

in the effort to treat and even cure many devastating diseases and injuries, such

as sickle cell anemia, spinal cord damage and Parkinson’s disease. This research

also brings great hope to those who now languish for years or die waiting for a

donor organ or tissue. Yet just as we are seeing the value of such research, there

are those among us who would seek not only to stop this research, but also to criminalize it. We must pause for a moment to consider what conduct should be definitely criminalized. There is an irresistable tendency to consider that science will

be utilized to bring about undesirable results—full human replications.

Those who support such drastic action will claim that we must do so merely because we do not fully understand it. I contend that quite the opposite action is necessary. We must study what we do not understand. We would not know progress if

we were to criminalize every step that yielded some possible negative results along

with the positive.

In addition to unknown scientific ramifications of human cloning, we face some

legal uncertainties. First, we face the argument that reproductive cloning may be

constitutionally protected by the right to privacy. We must also carefully consider

whether we take a large step towards overturning Roe v. Wade when we legislatively protect embryos. We do not recognize embryos as full-fledged human beings

with separate legal rights, and we should not seek to do so.

There may also be some who seek to impose criminal penalties on cloning in reaction to claims by individuals who are attempting to plunge into the unknown by

claiming to be planning to create clones abroad to help infertile couples. But we

must throw out the bunch of apples because one in the bunch is bad. The majority

who would engage in therapeutic cloning are ethical and would not attempt such

negative activity. In fact, research scientists do not have ready access to infertility

laboratories, which would be the link needed to complete the reproductive cloning

process. And crimininalizing cloning would not deter those who are intent on doing

it.

Hence, I am concerned at this time about any legislation that bans cloning, such

as H.R. 1644, the Human Cloning Prohibition Act of 2001. The more prudent approach may be that supported by Dr. Shapiro, who advises that Congress refrain

from regulating cloning and instead engage in informed regulation.

Mr. Chairman, I am looking forward to hearing the testimony of the panel of experts on this important topic of cloning and to the dialogue that will ensue as we

address this controversial and complex matter. Thank you.

PREPARED STATEMENT OF THE HONORABLE LAMAR SMITH

Today the Subcommittee on Crime holds the second of two hearings on the issue

of human cloning. In our last hearing, the Subcommittee focused on the ethical

issues and possible consequences of cloning human beings. Today, we will examine

the legal issues relating to the federal regulation of human cloning and hear testimony regarding two bills on the issue, H.R. 1644 and H.R. 2172.

Testimony from our last hearing revealed that there are a growing number of

groups who claim they can, and will, clone a human being. Currently, no clear regulations exist in the United States that would prevent a private group from attempting to create a human clone. Even though the Food and Drug Administration has

asserted that it has the authority to regulate this activity, legal scholars have expressed doubt as to whether this claimed authority would stand a legal challenge.

Furthermore, the consequences for any scientist who would ignore the FDA’s

claimed authority is unclear. For this reason, this Congress must act to protect the

health and safety of its citizens.

Legal challenges to any federal regulation of human cloning will be swift. Opponents will argue that any ban on human cloning will be unconstitutional because

it unduly interferes with a scientific right of inquiry and denies a person’s ‘‘fundamental right to reproductive freedom.’’ I believe that these arguments will fail. Although Congress may not prohibit research in an attempt to prevent the development of new knowledge, it may restrict or prohibit the means used by researchers

that threaten interests in which the citizens of this country have a legitimate concern. Furthermore, human cloning is not sexual reproduction, it is asexual replication for which there is no guaranteed ‘‘fundamental right.’’

The two bills before us today would prohibit the cloning of human beings, however, the scope of that prohibition is treated in very different and important ways.

H.R. 1251, introduced by Congressman Greenwood of Pennsylvania, would only prohibit the use of human cloning technology when the intent of the scientist is to iniVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00087 Fmt 6601 Sfmt 6621 G:\WORK\CRIME\060701\72982.001 HJUD2 PsN: HJUD2
84

tiate a pregnancy. The prohibition in this bill would still allow for the cloning of

human embryos for experimental purposes as long as the scientist creating that embryo does not intend to bring a fully mature human being into existence.

H.R. 1644, introduced by Congressman Weldon of Florida, goes beyond the Greenwood bill and prohibits the use of human cloning technology to produce a living

human organism at any stage of development. The Weldon bill would make it a

criminal act to clone a human embryo even if the scientist had no intention of trying

to initiate a pregnancy.

I should point out that neither of these bills place any restrictions on the use of

cloning technology to clone molecules, DNA, cells, tissues, organs, plants or animals.

They would not interfere with the use of in vitro fertilization, the administration

of fertility-enhancing drugs, or the use of other medical procedures to assist a

woman in becoming or remaining pregnant.

Today we will hear from a panel of four witnesses who have extensive backgrounds in the field of law and bioethics. I would like to thank the witnesses for

appearing before the Subcommittee on this important issue and I look forward to

hearing their testimony. The Chair now recognizes Bobby Scott, the ranking Member for an opening statement.

MATERIAL SUBMITTED FOR THE HEARING RECORD

POST HEARING QUESTIONS AND ANSWERS

FROM THE HONORABLE SHEILA JACKSON LEE

Witness Questions

1. Dr. Leon Kass, Professor of Bioethics, the University of Chicago:

Isn’t it likely that even if human cloning is banned, there are some who will

engage in it anyway, unregulated?

Doesn’t the prohibition of embryonic cloning have the secondary effect of defining an embryo as a life, and thereby outlawing abortion?

2. Dr. David Prentice, Professor of Life Sciences, Indiana State University:

Nobel laureate and Caltech President David Baltimore, along with Stanford

University researcher Irving Weissman have stated that a moratorium on the

use in research and transplantation of fetal or embryonic stem cells would be

‘‘devastating’’ as it is likely that only fetal or embryonic stem cells have the capacity generate a number of specific tissues. The National Bioethics Advisory

Commission has also described the use of adult stem cells as scientifically and

technically limited. How do you respond to these statements?

Have the adult stem cells been used successfully in treatment for sickle cell

anemia? If not, have embryonic stem cells?

3. Dr. Daniel Callahan, Director of International Programs, Hasting Center:

You have stated ‘‘too much of the current research drive is fueled by a single

minded passion to eradicate disease.’’ Eradication of disease and consequent improvement of the human condition are the primary purposes of health research.

4. Dr. Robyn S. Shapiro, Professor of Bioethics, Medical College of Wisconsin:

You have opposed criminalization of cloning and endorsed a voluntary moratorium on it.

Does the rapid pace at which technology changes render it difficult for legislators to criminalize cloning. Why?

What is your response to the debate over the success and progress of embryonic

stem cell research versus adult stem cell research?

To what extent do you support regulation of cloning? Would you be more likely

to support regulation through Congress or the Food and Drug Administration?

5. Question to all witnesses:

How would criminalizing both reproductive and research cloning affect treatment and prevention of infertility and research into new contraceptive technologies?

85

ANSWERS TO THE HONORABLE SHEILA JACKSON LEE FROM DR. DANIEL CALLAHAN

Question 1: You have stated ‘‘too much of the current research drive is fueled by

a single minded passion to eradicate disease.’’ Eradication of disease and consequent

improvement of the human condition are the primary purposes of health research.

Please explain your comments.

First, the passion to combat disease is often pressed at the expense of other values,

as if the conquest of disease is the highest of human obligations. It is not, but simply

one of many obligations. Too much of the talk, say, of therapeutic cloning or embryonic stem cell research treats the conquest of disease as trumping all moral values.

There seems to be almost a systematic effort to disabuse people of their ethical scruples in the name of medical research.That is wrong. Those scruples are just as important as research, and ought not to be put aside in the name of research.

Question 2: How would criminalizing both reproductive and research cloning affect

treatment and prevention of infertility and research into new contraceptive technologies.

Second, well before the idea of therapeutic cloning was even thought of, there were

many research possibilities for the relief of infertility being pursued—and there are

many still. It is a mistake to assume that, without therapuetic cloning, no further

medical progress is necessary. That is wrong. The NIH and the private sector have

all kinds of non-cloning research underway. Therapuetic cloning is one possible route

to the development of new contraceptives and the relief of infertility—but is only one

route; there are many others.

ANSWERS TO THE HONORABLE SHEILA JACKSON LEE FROM LEON R. KASS, M.D.

Question 1: Isn’t it likely that even if human cloning is banned, there are some who

will engage in it anyway, unregulated? Doesn’t the prohibition of embryonic cloning

have the secondary effect of defining an embryo as a life, and thereby outlawing

abortion?

A ban on cloning will not guarantee that it will never be done, any more than a ban

on murder or incest prevents all cases of these crimes. But the ban will surely curtail

all attempts by all reputable scientists and physicians, and will strongly deter even

the rogues from doing it, or at least standing up to claim the credit and notoriety

that they are seeking. It will also deter prospective clients from seeking to clone. We

must remember that the law also functions as a teacher in these matters, setting

forth the community’s deep values—just as it does in outlawing slavery, hate crimes,

and child abuse. It is also not true that if we ban cloning the practice will go offshore. Many other nations have already banned cloning and regard us as an outlaw

nation in this respect. American leadership now will help galvanize the international

community in developing a powerful deterrent to human cloning everywhere.

To the second part of the question, the answer is NO. The ban on creating the embryonic clones does not ban the use of existing embryos for research, nor does it even

ban the creation of such embryos by means other than somatic cell nuclear transfer.

The ban simply tries to stop the cloning activity at its start—at the most difficult

step and the one where we have the best chance of controlling this matter. The fact

that the NARAL is not opposed to this ban and that vigorous pro-choice advocates

have testified for the strict ban indicates that this is a far-fetched concern.

Question 2: How would criminalizing both reproductive and research cloning affect

treatment and prevention of infertility and research into new contraceptive technologies.

Such treatment and research will be unaffected. The proposed ban is very carefully

drafted so as not to affect IVF or any other (non-cloning) means of helping a woman

become pregnant. Research seeking new contraceptive techniques does not require

CLONED embryos, and the law is silent on research using embryos derived by IVF.

It simply bans the production of clones.

ANSWERS TO THE HONORABLE SHEILA JACKSON LEE FROM ROBYN S. SHAPIRO

Question 1: Does the rapid pace at which technology changes render it difficult for

legislators to criminalize cloning? Why?

It is likely that any statute that might be enacted to criminalize human cloning

would be quickly outpaced by technological advances. As an example, California’s

statute prohibiting cloning adopts a definition of cloning that uses the term ‘‘human’’

86

1 Cal. Bus. & Prof—Code § 2260.5

enucleated egg.1 This statutory cloning prohibition could be evaded by use of a cow’s

enucleated egg to incubate the nucleic DNA of a human—a procedure that appears

entirely feasible in light of University of Wisconsin researchers’ success in using

enucleated cow eggs as incubators for other mammalian species’ nucleic DNA.

Question 2: What is your response to the debate over the success and progress of

embryonic stem cell research versus adult stem cell research?

While studies have reported the successful use of adult stem cells, there are three important reasons to also advance embryonic stem cell research.

First, it is not clear that adult stem cells can give rise to the variety of tissue types

that embryonic stem cells can.

Second, on account of greater difficulties in harvesting and culturing sufficient

numbers of adult stem cells that are appropriate for transplantation, the utility of

embryonic stem cell therapy is likely to be much greater than that of adult stem cell

therapy. Any attempt to use stem cells for treatment of an adult’s own body would

require harvesting the stem cells from the patient (which is technically difficult and

can be painful and risky) and then growing them in culture in sufficient numbers

to obtain adequate quantities for treatment. For some rapidly progressing disorders,

there likely would not be sufficient time to grow enough cells to use for treatment.

In addition, with respect to disorders caused by a genetic defect, the genetic error

likely would be present in the patient’s stem cells, making them inappropriate for

transplantation. Also, adult stem cells may contain more DNA abnormalities caused

by exposure to daily living (e.g. sunlight, toxins, etc.) than are found in embryonic

stem cells.

Finally, even if adult stem cell research is seen in the most positive light, true scientific progress demands that we proceed with both. Unless all stem cell types are

studied, the differences between adult stem cells and embryonic stem cells simply will

not be known. As the NIH has said: ‘‘[G]iven the enormous potential of stem cells

to the development of new therapies for the most devastating diseases, it is important

to simultaneously pursue all lines of promising research. It is possible that no single

source of stem cells is best or even suitable or usable for all therapies. . . In order

to determine the very best source of many of the specialized cells and tissues of the

body for new treatments and even cures, it is vitally important to study the potential

of adult stem cells for comparison to that of stem cells derived from embryos and

fetuses. Unless all stem cell types are studied, the differences between adult stem cells

and embryo and fetal-derived stem cells will not be known.’’

Question 3: To what extent do you support regulation of cloning? Would you be more

likely to support regulation through Congress or the Food and Drug Administration?

Physical safety concerns as well as potential psychological and social harms from reproductive cloning indicate the need for regulation. Regulation through the Food and

Drug Administration is preferable because regulation through Congress would open

important aspects of scientific development to a political tug-of-war—as has been the

case with debates about fetal tissue and embryo research. The risk is the creation of

laws that cover too much for reasons that have nothing to do with human cloning,

and that make it impossible to attain the promises of the technology.

Question 4: How would criminalizing both reproductive and research cloning affect

treatment and prevention of infertility and research into new contraceptive technologies?

Scientists believe that the creation of research embryos may be the only way to conduct certain kinds of research, such as research into the process of human fertilization. Moreover, aside from this specific research use of cloned embryos, as a more

general matter, a ban on research cloning could greatly inhibit embryonic stem cell

research. While today there are an estimated 100,000 embryos in frozen storage (some

of which will be used for privately-funded stem cell research), as in vitro fertilization

techniques improve (e.g., as we acquire the ability to freeze oocyctes), it is possible

that the supply of embryos for stem cell research from this source will dwindle.

ANSWERS TO THE HONORABLE SHEILA JACKSON LEE FROM DR. DAVID PRENTICE

Question 1: Nobel laureate and Caltech President David Baltimore, along with Stanford University research Irving Weissman have stated that a moratorium on the use

in research and transplantation of fetal or embryonic stem cells would be ‘‘devastating’’ as it is likely that only fetal or embryonic stem cells have the capacity

to generate a number of specific tissues. The National Bioethics Advisory CommisVerDate 11-MAY-2000 12:32 Nov 20, 2001 Jkt 000000 PO 00000 Frm 00090 Fmt 6601 Sfmt 6621 G:\WORK\CRIME\060701\72982.001 HJUD2 PsN: HJUD2
87

sion has also described the use of adult stem cells as scientifically and technically

limited. How do you respond to these statements?

Despite the exaggerated claims, it is much more likely that adult stem cells (including cord blood and placental stem cells) will be the ones to provide all therapeutic

treatments for patients. In debates, several proponents of embryonic stem cell research have admitted that this will be the case, and that the desire for human embryonic stem cells will be for basic research purposes only. And in fact, very few specific tissues have actually been derived from embryonic stem cells, and even those are

not pure cultures but contain only a few percent of the desired cell type mixed with

many other types, as well as growing cells which are known to contribute to tumor

formation when injected into animals.

Indeed, the actual statement from the National Bioethics Advisory Commission in

September of 1999 was that ‘‘In our judgment, the derivation of stem cells from embryos remaining following infertility treatments is justifiable only if no less morally

problematic alternatives are available for advancing the research. . . . The claim

that there are alternatives to using stem cells derived from embryos is not, at the

present time, supported scientifically. We recognize, however, that this is a matter

that must be revisited continually as the demonstration of science advances.’’ Since

that time, the vast majority of advances have been made with adult stem cells, and

all clinical treatments have used adult stem cells. Even proponents of embryonic stem

cell research such as Dr. Douglas Melton of Harvard now admit, for example, that

‘‘bone marrow stem cells probably can form any cell type.’’

Question 2: Have adult stem cells been used successfully in treatment for sickle cell

anemia? If not, have embryonic stem cells?

Yes, adult stem cells have been used successfully for treatment of sickle cell anemia

(see sample references below). Embryonic stem cells have not yet been used to treat

ANY patients for ANY disease.

Steen, RG et al.; ‘‘Improved cerebrovascular patency following therapy in patients

with sickle cell disease: initial results in 4 patients who received HLA-identical

hematopoietic stem cell allografts’’; Annals of Neurology 49(2), 222–229; Feb.

2001.

Gore, L et al., ‘‘Successful cord blood transplantation for sickle cell anemia from

a sibling who is human leukocyte antigen-identical: implications for comprehensive care’’, Journal of Pediatric Hematology and Oncololgy 22(5), 437–440; SepOct, 2000

Question 3: How would criminalizing both reproductive and research cloning affect

treatment and prevention of infertility and research into new contraceptive technologies?

Criminalizing human cloning of any type would have no effect whatsoever on research or treatment of infertility or contraception. Cloning is totally unnecessary to

further such research.

88

89

90

91

92

93

94

95

[NOTE: Additional material submitted for the Hearing Record is

not reprinted here but is on file with the House Judiciary Committee. The material referred to is listed below.]

Cloning Human Beings, Volume I, Report and Recommendations of the National Bioethics Advisory Commission, Rockville, MD, June 1997

Ethical Issues in Human Stem Cell Research, Volume I, Report

and Recommendations of the National Bioethics Advisory

Commission, Rockville, MD, September, 1999

Æ