MEDICAL SCIENCE AND BIOETHICS: ATTACK OF

THE CLONES?

HEARING

BEFORE THE

SUBCOMMITTEE ON CRIMINAL JUSTICE,

DRUG POLICY AND HUMAN RESOURCES

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

MAY 15, 2002

Serial No. 107–194

Printed for the use of the Committee on Government Reform

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MEDICAL SCIENCE AND BIOETHICS: ATTACK OF THE CLONES?

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MEDICAL SCIENCE AND BIOETHICS: ATTACK OF

THE CLONES?

HEARING

BEFORE THE

SUBCOMMITTEE ON CRIMINAL JUSTICE,

DRUG POLICY AND HUMAN RESOURCES

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

MAY 15, 2002

Serial No. 107–194

Printed for the use of the Committee on Government Reform

(

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

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

BOB BARR, Georgia

DAN MILLER, Florida

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

JAMES C. WILSON, Chief Counsel

ROBERT A. BRIGGS, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY AND HUMAN RESOURCES

MARK E. SOUDER, Indiana, Chairman

BENJAMIN A. GILMAN, New York

ILEANA ROS-LEHTINEN, Florida

JOHN L. MICA, Florida,

BOB BARR, Georgia

DAN MILLER, Florida

DOUG OSE, California

JO ANN DAVIS, Virginia

DAVE WELDON, Florida

ELIJAH E. CUMMINGS, Maryland

ROD R. BLAGOJEVICH, Illinois

BERNARD SANDERS, Vermont

DANNY K. DAVIS, Illinois

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

JANICE D. SCHAKOWKY, Illinois

EX OFFICIO

DAN BURTON, Indiana HENRY A. WAXMAN, California

CHRISTOPHER DONESA, Staff Director

ROLAND FOSTER, Professional Staff Member

CONN CARROLL, Clerk

JULIAN A. HAYWOOD, Minority Counsel

(III)

C O N T E N T S

Page

Hearing held on May 15, 2002 ............................................................................... 1

Statement of:

Kelly, James, patient advocate; Elizabeth Howard, patient advocate; and

Judy Norsigian, Boston Women’s Health Book Collective ........................ 55

Usala, Anton-Lewis, M.D., Brody School of Medicine, East Carolina University; Bryan Cowan, M.D., department of OB/GYN, University of

Mississippi Medical Center; and Panayiotis Zavos, the Andrology Institute of America .............................................................................................. 10

Letters, statements, etc., submitted for the record by:

Cowan, Bryan, M.D., department of OB/GYN, University of Mississippi

Medical Center, prepared statement of ....................................................... 19

Howard, Elizabeth, patient advocate, prepared statement of ....................... 69

Kelly, James, patient advocate, prepared statement of ................................ 59

Norsigian, Judy, Boston Women’s Health Book Collective, prepared statement of ........................................................................................................... 78

Souder, Hon. Mark E., a Representative in Congress from the State

of Indiana, prepared statement of ............................................................... 4

Usala, Anton-Lewis, M.D., Brody School of Medicine, East Carolina University, prepared statement of ..................................................................... 13

Zavos, Panayiotis, the Andrology Institute of America, prepared statement of ........................................................................................................... 39

(1)

MEDICAL SCIENCE AND BIOETHICS: ATTACK

OF THE CLONES?

WEDNESDAY, MAY 15, 2002

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY AND

HUMAN RESOURCES, COMMITTEE ON GOVERNMENT REFORM, Washington, DC.

The subcommittee met, pursuant to notice, at 1:05 p.m., in room

2154, Rayburn House Office Building, Hon. Mark E. Souder (chairman of the subcommittee) presiding.

Present: Representatives Souder, JoAnn Davis of Virginia,

Weldon, and Cummings.

Staff present: Chris Donesa, staff director and chief counsel; Roland Foster, professional staff member; Conn Carroll, clerk; Julian

A. Haywood, minority counsel; and Earley Green, minority assistant clerk.

Mr. SOUDER. The subcommittee will now come to order.

We will start with my opening statement. Good afternoon and

thank you all for being here today. Today’s hearing will examine

the scientific, medical, and ethical issues related to human cloning,

and examine the need for Federal law in this area.

Scientists stunned the world 5 years ago when they announced

the creation of the world’s first clone, a sheep named Dolly. In the

short time since, cattle, goats, mice, rabbits, and a cat have also

been cloned. Efforts are now underway in the United States and

elsewhere to create a cloned human being.

The President, the public, religious leaders, and many scientists

have all expressed their disapproval of efforts to conduct human

cloning for any reason, and the House of Representatives overwhelmingly approved legislation last year, authored by Dr. David

Weldon, a member of this subcommittee, to prohibit all human

cloning.

Opposition to human cloning is based upon both ethical and scientific considerations. All clones so far have been found to suffer

from severe abnormalities, premature aging, and early death. In

addition to these problems, cloning also poses significant health

risks to the mother of a clone and to the women from whom the

eggs necessary for cloning are harvested.

These dangers have not, however, deterred some from attempting

to produce cloned humans. We know scientists, such as Dr. Panos

Zavos, who is with us today, are pursuing cloning as a means of

producing live human offspring, while others seek to create cloned

human embryos in order to destroy them for scientific research,

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with the hopes that such research may potentially yield treatments

or cures.

Regardless of the goals of those who are attempting to manufacture human clones, the fact is that cloning, for whatever purpose,

creates human life.

There is no difference between a cloned human embryo created

for procreation or for research purposes. Whether or not the newly

created embryo is implanted with the intent of reproduction or destroyed for the purpose of research is irrelevant to the fact that a

cloned human being has been created. Therefore, a prohibition on

cloning that is limited only to preventing the implantation of a

cloned embryo, as some have suggested, in effect legalizes human

cloning, and raises additional ethical dilemmas.

A ban that permits embryonic clones to be created but forbids

them to be implanted in utero legally requires the destruction of

human life and criminalizes efforts to preserve and protect such

life, once created.

Under a partial ban that permits the creation of cloned embryos

for research, human embryos would be manufactured in numerous

laboratories around the country. Once cloned embryos are available, it would be virtually impossible to monitor or control what is

done with them.

Stockpiles of embryonic human clones could be produced, bought,

and sold. Implantation of cloned embryos, an easy procedure, could

take place out of sight, and not even the most elaborate and intrusive regulations and policing could detect or prevent the initiation

of a clonal pregnancy.

Scientists agree that once begun, a clonal pregnancy would be almost impossible to detect or differentiate from a routine pregnancy,

and if detected, what could the government do? Would a woman

with a clonal pregnancy be forced or coerced with severe penalties

to abort the child? Allowing human cloning for research brings us

further down the slippery slope that devalues the sanctity of

human life.

Not even a year ago, this subcommittee held a hearing on research involving the destruction of human embryos. At that time,

supporters of embryonic stem cell research, which requires the destruction of a human embryo, found ‘‘extremely troubling’’ the announcement that embryos were being created in order to conduct

stem cell research. There was a consensus among opponents and

supporters of embryonic stem cell research that embryos should

never be created solely and specifically for research. But now that

is exactly what the proponents of research cloning are demanding.

If we now permit the manufacturing of human embryos for research, where do we draw the line? Do we allow cloned embryos

to grow for 5 days before they are destroyed in the process of extracting their stem cells? What about removing tissues from 5-

week-old embryos? Should we consider harvesting the organs from

5-month-old fetuses? What will those who support destructive research next claim is necessary in the name of research?

We must finally draw the line that stops the exploitation of any

form of human life. Cloning, regardless of intent, reduces human

life to a commodity that is created and destroyed for convenience.

And despite the claims to the contrary, there is no evidence that

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cloning can or ever will cure diseases. Such statements are purely

speculative, and pursuing cloning merely diverts limited resources

away from more promising research that is already producing

promising results.

It is clear that a ban that applies only to reproductive cloning is

a false ban, which merely creates an illusion that human cloning

has been prohibited. The fact is that all cloning is reproductive

cloning, and therefore human cloning for any reason should be

banned.

Thank you all for being here today. We look forward to hearing

the testimony of each of our witnesses.

[The prepared statement of Hon. Mark E. Souder follows:]

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Mr. SOUDER. I yield to Dr. Weldon for an opening statement.

Dr. WELDON. Thank you, Mr. Chairman, and thank you for calling this very important hearing.

As a physician who still sees patients on a regular basis, I have

a keen interest in developing cures for diseases that plague so

many of my patients. We all have family members who suffer from

diseases, and we all hope for cures for these conditions.

I have been and remain a supporter of the NIH, and I have been

pleased to take an active role in doubling the funding for NIH so

we can pursue the necessary cures.

Scientists have announced they are working to clone human

beings. Today we will hear testimony from one such researcher.

The complete ban on human cloning passed the House on last July

and was supported by a wide bipartisan margin, 265 to 162. It was

supported by liberals, progressives, conservatives, pro-life, prochoice Members, and many supporters, I will note, of embryo stem

cell research.

Clearly, the support for a complete ban on human cloning is very

broad-based support. Why is that so? Because human cloning is a

threat to society. Human cloning moved from science fiction to reality when researchers in 1997 cloned Dolly the sheep. For the first

time, we had the power to redesign human beings at a basic level.

Human cloning is not about procreation, it is about baby manufacture. It does not produce a child with two parents, it creates a

duplicate of an existing human being. Human cloning is not a reproductive right, it is about eugenics and depriving children of

their genetic individuality.

No one has the right to alter the human species in such a fundamental way. No one has the right to turn human procreation

into baby manufacture, and no one has the right to create children

to their own specifications.

This is why it is very important that the other body pass a complete ban like the ban that passed the House. This is why the Senate needs to stop delaying and act on this very, very important

issue.

I just want to underscore a very, very important point that I

think we need to make. I was hoping that we would have a Justice

Department witness at this hearing today. As I understand it, they

were unable on the short notice to provide someone, but they have

provided us a statement. I think this is a very, very important

point, Mr. Chairman.

There are several proposals in the other body that are similar to

some of the ideas that were floated here in the House of Representatives last year that entailed various bans on just so-called reproductive cloning, banning the implantation of a cloned embryo into

a woman, but allowing unfettered embryo cloning for either scientific purposes or other purposes.

The concern that I have had—and I have a statement from the

Justice Department validating this—is that these proposals, such

as proposal S. 2439 introduced by Senators Specter, Feinstein and

Kennedy, along with others, are essentially unenforceable.

Specifically, what the Justice Department talks about in their

statement is that what they attempt to make illegal, the implantation of a cloned embryo into a woman for reproductive purposes, is

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actually a procedure that is occurring daily all over the country on

a regular basis in fertility clinics, where these fertility clinics are

taking sexually fertilized embryos and implanting them in women.

Let me just quote from the statement from the Justice Department. ‘‘hence, there is no visible difference between the prohibited

activity and the permitted activity, both of which would presumably be conducted within the privacy of a hospital or medical office.

Entrusted with enforcing such a limited ban, law enforcement

would be in the unenviable position of having to impose new and

unprecedented scrutiny over doctors and fertility clinics and/or research facilities to ensure that only fertilized embryos were being

transferred to would-be mothers.’’

This is a very, very critical point, and a point I made in argument and debate in the House, and it is an important point that

the supporters of the Kennedy-Feinstein approach have not really

successfully addressed: How on Earth would law enforcement enforce such a ban as they are proposing?

Mr. Chairman, I would just like to ask that we strongly consider

the possibility of having a second hearing next month and bringing

the Justice Department in here to elaborate on this. As I understand it, the vote in the Senate has been put off again, so this issue

I think is still very, very timely and very much worth discussion.

Mr. SOUDER. I thank the gentleman from Florida. We will certainly work hard on the calendar to see if we can accommodate

both the Justice Department and possibly HHS in an enforcement

hearing.

Dr. WELDON. I thank the chairman. Might I also ask unanimous

consent to insert this statement in the record.

Mr. SOUDER. Hearing no objection, so ordered.

Before proceeding, I would like to take care of a couple of procedural matters.

First, I ask unanimous consent that all Members have 5 legislative days to submit written statements and questions for the hearing record, and that any answers to written questions provided by

the witnesses also be included in the record.

Without objection, it is so ordered.

Second, I ask unanimous consent that all exhibits, documents,

and other materials referred to by Members and the witnesses may

be included in the hearing record, and that all Members be permitted to revise and extend their remarks.

Without objection, it is so ordered.

If each of the witnesses on the first panel could stand and raise

your right hand, I will administer an oath. This is an oversight

committee, so it is standard practice that everyone has to take the

oath.

[Witnesses sworn.]

Mr. SOUDER. Let the record show the witnesses have each answered in the affirmative.

Witnesses will each be asked to now summarize your opening

statements. You have 5 minutes for testimony. Your full statement

will be included in the record as well as any other materials that

you wish to submit.

At this time, we will start with Dr. Usala.

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STATEMENTS OF ANTON-LEWIS USALA, M.D., BRODY SCHOOL

OF MEDICINE, EAST CAROLINA UNIVERSITY; BRYAN COWAN,

M.D., DEPARTMENT OF OB/GYN, UNIVERSITY OF MISSISSIPPI

MEDICAL CENTER; AND PANAYIOTIS ZAVOS, THE

ANDROLOGY INSTITUTE OF AMERICA

Dr. USALA. Chronic disease states, such as Type 1 diabetes, Parkinson’s Disease, and spinal cord injury result from the destruction

of specific cells. Replacement of these tissues may provide immense

relief, and possibly cure of the disease. One approach to replace

these tissues is to find acceptable transplantation sources and implant donor cells into a patient. If these cells are derived from a

source other than the patient, there will be problems with rejecting

the foreign transplant material. Cloned patient cells, that is, cells

that are induced to replicate with the same DNA template as the

patient’s, do not have foreign markers and theoretically would not

be rejected. However, cloned cells, as well as other cells, still must

overcome the problem of appropriate integration into the transplant site in order to replace the function of the destroyed tissues.

Shortly after conception, the human being has a unique DNA

template from which all other cells are generated. A differentiated

heart cell has the same DNA template as a differentiated skin cell,

and they both have the same DNA template as the undifferentiated

cells currently in embryogenesis.

Different areas of the DNA template are promoted and repressed,

resulting in different cell functions. Which area of the DNA template is promoted and repressed is largely determined by environmental factors outside the cell. Thus, it is hypothetically possible

to induce any cell to become any other kind of cell if the right environment were provided.

The mass of cells that begins this replication and differentiation,

either shortly after conception or induction through nuclear transfer, defines the beginning of any mammal’s life. The continuum of

human life thus starts at the beginning of the complex, explosive

process of cellular DNA differentiation during embryogenesis and

continues throughout a person’s life until death. One cannot stop

the continuum at any one point and say it is not human life simply

because it lacks the ability to do certain functions.

When the mass of cells has feelings or reason is subject to debate. When it begins as human life is a biologic fact. The developing embryo is surrounded by different proteins and factors than

later in development, but the DNA template remains the same

throughout the person’s life.

My hypothesis was that if the correct embryonic environment

could be duplicated, a patient’s cells may be able to be induced to

regenerate within a given site, as they rapidly did earlier in the patient’s life, during embryogenesis. This would result in totally compatible, integrated replacement tissue for the disease being treated.

I tested this concept in an FDA-monitored feasibility study.

Human patients with diabetic foot ulcers were injected with an artificially made copolymer I designed that resembled early embryonic proteins. It needs to be emphasized that no cells were transplanted into the patients. Their ulcers were injected only with the

copolymer protein structure.

If I could have the first slide.

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Shown here is the first large animal which I injected the copolymer into. This was a spontaneously diabetic dog that was brought

to a veterinarian for euthanasia. After 2 months of IV antibiotic

therapy and efforts at surgical closure, the dog’s diabetic ulcers

persisted. This is very similar to what we see in human patients

with diabetic foot ulcers. After many years of diabetes, the circulation is damaged and healing can no longer take place effectively.

Up on the left panel we see the ulcer. That was there for 2

months. You can see part of the elbow bone poking through. That

was before the injection, which we injected around the periphery

and through the center. Two days later, as you can see, the ulcer

became very, very erythematous but not swollen. This was not inflammation. We knew from earlier studies that we induced rapid,

explosive growth of new blood vessels with new red blood cells in

them.

By 6 days, the animal’s chronic ulcer was completely closed, and

you can see the new hair follicles growing. Again, no cells were injected. This was just induction of what each one of our cells contains: the power to regenerate if put in the proper environment.

Next slide, please.

After review, the FDA allowed us to try a feasibility trial. We

took six patients with chronic diabetic foot ulcers at the University

of North Carolina at Chapel Hill to their chronic wound care center.

This is a photo of an ulcer that was 4 years in duration. This patient was treated every 2 weeks for 4 years in an attempt to get

this ulcer to close.

Next slide, please.

This is the ulcer 15 minutes after the initial injection of the copolymer matrix. You can see it looks a little different. You can see

the spots where the needle was placed to inject one time this scaffolding.

Next slide, please.

Here you have 7 days. You can see what happened, the explosive

regeneration that has filled the ulcer that was there for 4 years.

This is very delicate tissue, and it is highly vascularized. How do

we know? The surgeon poked it and you can see the blood exuding

out.

Next slide, please.

This was day 14. It continued to grow with the keratinization occurring.

Next slide.

This was at 1 month.

Next slide.

The same patient at 2 months.

There he was at 3 months.

Four weeks later, this man was able to dance at his daughter’s

wedding. He was not able to walk for the previous 4 years.

Transplantation strategies, whether derived from foreign donors

or cloned cells from the patients themselves, are clearly not the

only approach to replace damaged tissue. Other avenues are much

further along in clinical trials and should be considered as a first

approach for study.

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Claims that only human embryonic stem cells or cloned tissues

can overcome problems of rejection are false. Indeed, the patient’s

existing cells provide the most rational source for fully integrating

replacement tissue, as occurs during embryogenesis.

Thank you.

Mr. SOUDER. Thank you very much.

[The prepared statement of Dr. Usala follows:]

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Dr. Cowan.

Dr. COWAN. Good afternoon, Mr. Chairman and members of the

committee. Thank you for holding this important hearing and for

inviting us to participate.

I am Dr. Bryan Cowan, professor of obstetrics and gynecology at

the University of Mississippi Medical Center in Jackson, Mississippi. I am here today representing the American Society of Reproductive Medicine, ASRM. ASRM is a national professional organization whose nearly 9,000 members are dedicated to advancing

knowledge and expertise in reproductive medicine and biology and

treating infertility. Our membership is made up of physicians, reproductive biologists, laboratory directors, nurses, and mental

health professionals, all of whom are dedicated to advancing the

cause of reproductive medicine.

ASRM supports a ban on reproductive cloning at this time but

endorses somatic cell nuclear transfer for research. And let me tell

you why. ASRM is on record as opposing attempts at human reproductive cloning since the announcement of the successful cloning of

a sheep in 1997. In November 2000, our ethics committee released

a very thoughtful report on somatic cell nuclear transfer, both

therapeutic and reproductive cloning, and concluded that human

reproductive cloning was not safe and efficacy of the procedure had

not been established.

We have learned how to use cloning with microscopic organisms,

and any of us who gardens knows how cloning works. Some species

of animals, such as frogs and mice, can be cloned quite successfully.

It appears that in larger, more complicated animals, cloning can be

made to work but is not yet reliable. Cows and sheep have been

cloned, but there have been many problems that, while unfortunate

in animals, are completely unacceptable in human beings.

Until there are better results in animals, we have no business

even considering reproductive cloning in human beings. Thus, we

feel it would be entirely appropriate for the Congress to make

human reproductive cloning illegal. We are concerned, however,

that much of the proposed legislation, including the bill passed by

this body last summer, simply goes too far.

Research using somatic cell nuclear transfer holds tremendous

promise. If we take an egg, remove its nucleus and thus the genetic

material, replace that nucleus with the DNA from the donated somatic cell, spark that cell to artificially begin cell division and use

the resultant stem cell, we may unlock the cures for diabetes, Parkinson’s Disease, cardiovascular disease and spinal cord injury, just

to name a few conditions. This science is in its infancy. To slam

the door shut before we understand it would be unconscionable.

This view, to prohibit reproductive cloning but to allow research

into somatic cell nuclear transfer, is not just my view and not just

the view of the ASRM. Rather, it is without question the view of

nearly every serious scientific and medical group that has examined the issue.

The ASRM is a founding member of the Coalition for the Advancement of Medical Research, a coalition that supports this view.

Members include the American Society for Cell Biology, the American Association of Neurological Surgeons, the Congress of

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Neurologic Surgeons, the American Society of Hematology, and the

American Medical Association, just to name a few.

In addition, the National Academy of Sciences, a Blue Ribbon

Commission in California, and a letter signed by 40 Nobel Laureates, concluded that the scientific and medical communities are

clear: reproductive cloning should be banned, but research utilizing

related techniques must be allowed to go forward.

Yes, there are individual scientists who would defend reproductive cloning, as well as individuals who would support a prohibition

even on related research, but there is a clear consensus in the

mainstream scientific community that the potential advantages of

somatic cell nuclear transfer are so great that the ethical concerns

of a minority must not be used to prohibit it. Instead, we should

develop wise policy decisions that can solve these ethical concerns.

We have seen firsthand in the United States how fear and unwise policy decisions can make it extremely difficult for us to improve the treatments we have available to offer our patients. The

decision to deny Federal funds for research involving human IVF

has harmed the millions of Americans suffering from infertility.

History is replete with examples of government attempts to block

scientific and medical advancement, almost always with negative

results.

In the 17th century, Galileo was arrested for arguing that the

planets revolved around the sun. In the 19th century, the Church

of England argued that providing anesthesia during childbirth violated Biblical tenets, and attempted to outlaw it. Today, organ

transplantation and IVF were hugely controversial upon their introduction, and we were greeted with the same objections raised

here against cloning. Thankfully, this knowledge was not made illegal, and today we can successfully use these advances to help patients every single day.

There have also been concerns raised about the use of donated

eggs for therapeutic cloning. We have been using egg donation to

assist reproduction for more than 10 years. To date in the United

States, more than 15,000 children have been born into loving families using this important therapy.

Over the years, the ASRM has developed a strict set of guidelines on how to go about egg donation and how to protect egg donors. There is no reason these standards cannot be applied to all

eggs used for somatic cell nuclear transfer research and guarantee

patient privacy and protection.

The real goal of most of this research would be to develop a better understanding of how an egg works. Once we know how an egg

deregulates the DNA after somatic transfer, this knowledge would

obviate or even eliminate the need for more eggs to be used to develop stem cells. Any claims as to the number of eggs that would

be needed are, frankly, speculation.

I am fearful that a negative decision may be made on somatic

cell nuclear transfer that will cause needless suffering for patients

with heart disease, diabetes, Parkinson’s, or others. Please do not

make their situations worse by enacting a new and unneeded prohibition on research just because those techniques might allow reproductive cloning to occur. As a physician, I must tell you how important hope is to our patients. By outlawing this very promising

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research, you would be denying hope to millions of Americans and

their loved ones.

I thank you for your time, and would be happy to answer any

questions. Thank you.

Mr. SOUDER. Thank you.

[The prepared statement of Dr. Cowan follows:]

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Mr. SOUDER. Dr. Zavos.

Mr. ZAVOS. Good afternoon, everyone. Thank you, Mr. Chairman,

for inviting me for this very interesting session.

I am a reproductive specialist and scientist that has dedicated

the last 24 years of my life in helping infertile couples have children and complete their biological cycle. I care about couples suffering from infertility. Do you care about infertility?

Infertility affects approximately 10 to 15 percent of the couples

of reproductive age throughout the developing world. There are 10

to 12 million infertile couples in the United States alone. Assisted

reproductive technologies have played a major role in treating various causes of infertility. In fact, about 65 percent of the couples

who seek medical help will eventually succeed in having a child.

However, in cases where there are no sperm or eggs present, possibly due to loss of testicular or ovarian function, for those couples,

they must go to other options such as sperm donation, oocyte donation, or adoption.

If you care about these unfortunate infertile couples, why are you

considering legislation that would make both them and the people

that are trying to help them criminals? Criminalizing human reproductive cloning in the United States will only make it less safe

and more costly for these infertile couples. They will be forced to

travel outside the United States to pursue their dream of creating

a family.

After all, according to the Americans with Disabilities Act, infertility is a disability, and reproduction is major life activity for purposes of the ADA. In light of this, it is the right of each and every

American citizen to bear a child.

Cloning cannot be curbed. Mr. Chairman, experts state repeatedly, and history proves the point very clearly, that scientists will

clone, even if President Bush and the Congress will ban it. The

House of Representatives may vote against human cloning, but

that will not stop scientists from doing it and people from wanting

it.

In the words of an infertility patient who wants her own genetic

baby so badly that she would go wherever she had to in order to

clone either herself or her husband, ‘‘If they called me right now

and said, ‘We are paying for everything and giving you the chance

to have your own genetic child,’ I would be on the plane so fast it

is not even funny.’’

In the words of a bioethicist, ‘‘The best way to control this research is to fund it by the Federal Government, because then you

create rules and regulate it.’’

In my words, Mr. Chairman, the genie is out of the bottle and

it keeps getting bigger every day. There is no way this genie is

going back into the bottle. Let us find ways to develop it properly

and disseminate it safely.

If you are concerned about the risks of human cloning, the proper

approach is to fund it and then institute regulations that will ensure that human cloning is done properly, with a minimum of risks

to the baby, just as is done in other medical and drug innovations.

This is what our team is working on, and we will not go forward

with human cloning until the risks are comparable with other IVF

procedures.

36

We have no intentions of doing this in the U.S.A., whether any

legislation is passed for or against this technology. Furthermore,

Mr. Chairman, we have no intentions of breaking the laws of this

country or any other country to accomplish this. We are law-abiding citizens of this great Nation of ours, but we are a compassionate group of people that wish to help our fellow men and

women to have the gift of life, the gift of life that most of us have

been so fortunate to have to enjoy and take for granted. Let us not

be so uncompassionate and so insensitive to tell those people that

we are not willing to listen to them and are unwilling to help them.

This is not what our country’s Constitution and principles are all

about. We believe in creating families, not preventing them. In God

we trust.

Reproductive Regeneration as a Means of Infertility Treatment.

It is quite evident to us, along with other competent human reproductive specialists, that with further elucidation of the mechanisms

involved during the process of embryogenesis, careful tailoring of

subsequently developed culture conditions and manipulation strategies, and appropriate screening methods, will eventually allow infertile couples to safely have healthy, genetically related children

through somatic cell nuclear transfer methods.

The Opponents of Human Cloning or Reproductive Regeneration.

The most prominent opponents to human reproductive regeneration

and spokesmen for animal cloning are Drs. Ian Wilmut from the

Roslin Institute and Rudolph Jaenisch from the Massachusetts Institute of Technology, MIT, who have misled and have misdirected

the public and its leadership for their very own gains, whatever

those gains might be.

If one reviews the animal cloning literature, which is so eloquently alluded to as being totally destructive in your opening

statements today, Mr. Chairman, I must tell you that one can deduce that the poor cloning success rates noted by ‘‘the animal

cloners’’ are mainly due to experiments that are poorly designed,

poorly executed, approached, understood, and interpreted, and

these experiments were mostly done under nonsterile and uncontrolled conditions and environments and having a hit-and-miss

type of an outcome.

According to a recent article in Time Magazine, Wilmut and

Jaenisch stated that animal cloning is inefficient and is likely to

remain so for the foreseeable future. On the contrary, a number of

studies have already demonstrated far higher rates of success, and

in some cases, matching or exceeding success noted in human IVF

today.

Interestingly enough, and this is especially for the Congressman

from Florida to listen, the Roslin Institute scientists who cloned

Dolly the sheep and had so many problems with the sheep that

they have cloned that they have changed their agenda today on the

cloning subject and have stated recently that they plan to seek permission to experiment on cloned human embryos for medical purposes. What are their true motives? What are they?

Animal Cloning vs Human Reproductive Regeneration. It has

been very clearly shown that animal cloning and its difficulties appear to be species-specific. The data cannot be extrapolated with a

great degree of accuracy to the human species. In a recent study

37

by scientists from Duke University, it was demonstrated that it

may be technically easier and safer to reproduce somatic cell nuclear transfers in humans than in sheep, cows, pigs, and mice because humans possess a genetic benefit that prevents fetal overgrowth, one of the major obstacles in cloning animals.

The Political Status on Cloning. The political situation with

cloning in general remains very fluid, Mr. Chairman, today mainly

because of the inability of the politicians to understand, comprehend, and act decisively on the issues that cloning presents to

society. After all, their inability to act decisively may have a great

deal to do with their resistance to debate and face the facts that

humans will be cloned.

Recent statements by the President of the U.S.A., Mr. George

Bush, in his speech to the American public President Bush made

an appeal for a global ban on cloning, whether it may be for therapeutic or reproductive cloning, on the basis that we should not use

people for spare parts and we should not manufacture people.

Reproductive cloning, Mr. Chairman, does neither. Quoting

President Bush, ‘‘Life is a creation, not a commodity. Our children

are gifts to be loved and protected, not products to be designed and

manufactured. Allowing cloning would be taking a significant step

toward a society in which human beings are grown for spare body

parts and children are engineered to custom specifications, and

that’s not acceptable.’’

And that is not acceptable to us either, Mr. Chairman. We agree

with President Bush on the sanctity of human life. Reproductive

cloning does not involved a destruction of human embryos, nor does

it modify or engineer the genetic code to custom modifications. Reproductive cloning is nothing more than another modality for the

treatment of human infertility and giving the gift of life to childless

couples that have exhausted all other choices for having a child.

What is so wrong about that?

History tends to repeat itself. This is not the first time that the

scientific community has had to deal with controversial issues regarding new technologies. Exactly the same thing happened with

IVF in the Kennedy Institute in Washington in 1978, when Professor Robert Edwards and Dr. Patrick Steptoe were faced with such

criticism; 24 years later, the exact opposite of everything the experts predicted happened: IVF today is synonymous to sliced bread.

In conclusion, Mr. Chairman, I would like to say the following.

As Professor Robert Edwards, the great English scientist, who I

have great respect for and who helped create the world’s first test

tube baby, Louise Brown, in 1978, so eloquently prophesied recently, saying the following, ‘‘Cloning, too, will probably come to be

accepted as a reproductive tool if it is carefully controlled.’’

It is your responsibility, Mr. Chairman, to control this, with the

guidelines via which this can be developed, but it will be developed.

Mr. Chairman, science has been very good to us, and we should not

abandon it now. Consider why America has the best medical care

in the world. It is because we have the freedom to investigate, research, and market the latest medical techniques, all within proper

procedures and safeguards.

This is not the time to panic and try to turn back the clock. The

genie is already out of the bottle. Let us make sure it works for

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us, not against us. Let us do it right, and let us do it here. By banning cloning, America will be showing the world that she is hesitant and/or reluctant to take the lead in this new arena of technological advancement. The world today is looking at the most powerful Nation on Earth for leadership on this issue. And walking away

from it, banning it, is not a sign of leadership but cowardice.

Do not let the future of this technology slip away from our fingers because we are too afraid to embrace it. I believe that it is the

right of the American people to choose whether or not they want

to have this technology available to them. Let us educate ourselves

and debate the issues, and not make irrational decisions based

upon fear of a new technology.

Banning this technology would not only give our enemies license

to use it to their advantage, and that is really pretty much one of

the important aspects of it, but let us learn from history, Mr.

Chairman and forge ahead in this brave new world as leaders, not

spectators. That is the American way. Thank you very much.

Mr. SOUDER. Thank you.

[The prepared statement of Mr. Zavos follows:]

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40

41

42

43

44

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Mr. SOUDER. I want to thank each of you for your testimony. Nobody can accuse us of not hearing all sides of debate in the first

panel.

I am next going to yield to the ranking member, Mr. Cummings,

for his opening statement, and then we will move to questions.

Mr. CUMMINGS. Thank you, Mr. Chairman.

Back in 1995, Congress passed legislation banning the use of

Federal funds for human cloning research. Two years later, the

birth of Dolly the sheep gave immediacy to the unsettling prospect

of thinking, feeling, human clones also walking the Earth.

In recent years, a vigorous debate has ensued over the medical

and ethical implications of all aspects of human cloning research.

Last July, that debate reached the floor of the House of Representatives. When all was said and done, the House had passed legislation that would render all human cloning research efforts a criminal enterprise, including those aimed not at reproduction but exploring the potential for new medical therapies and cures to human

diseases and ailments.

During the House debate, a substantial minority of Members, including myself, questioned whether closing the door to therapeutic

or research cloning activity in the United States was timely or prudent. These concerns were expressed through support of a substitute amendment by Representative James Greenwood of Pennsylvania. That substitute amendment failed.

The U.S. Senate is now about to embark on a similar debate in

which the same central issue will be aired: should a ban on human

cloning extend to therapeutic or reproductive cloning research?

Dr. Zavos, we, too, take it very, very seriously. As a matter of

fact, I think it is one of the most wrenching issues that we deal

with in this Congress, because we have a debate, and on the one

hand—and a lot of it is based upon religion—a lot of people feel you

should not interfere with life. There are others who feel that we

should try to address the issue and provide, I think as you are talking about, possible cures to diseases and trying to open up the door

for research that might very well do a lot of good.

It is a wrenching issue. In this very hearing room not very long

ago, we had a couple who testified they had two young children

who actually needed certain—or could have benefited possibly from

certain research of this nature. And it was clear that they had very

little likelihood of surviving without it. They, by the way, were testifying against cloning, and it was very interesting.

On the other hand, we had some folks who felt very strongly that

there was—they wanted to allow research to help other people. So

this is a tough, tough issue. I do not want anyone here to go for

1 second thinking that we do not consider this matter to be a very,

very serious matter.

Those who support a ban on therapeutic cloning raise a variety

of objections to this research, ranging from the morality of creating

embryos for research purposes to the practicality of the research to

whether a partial ban can effectively be enforced.

There are, of course, counterarguments to each of these objections. Today we will hear from witnesses whose views cover the

spectrum, as we have already heard, from support for reproductive

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cloning at one end to a categorical opposition to all human cloning

research at the other.

We will also hear testimony proposing some intermediate approaches not embodied in the current legislative proposals. I hope

that the members of the subcommittee and Members of the Senate

who may be paying attention will listen with an open mind.

Ultimately, this debate is about whether Congress will close off

an avenue of scientific research that some reputable scientists believe may offer immense benefits to millions of people in and beyond this country, ladies and gentlemen, people who are suffering

and people who will suffer in the future from a range of life-threatening and severely debilitating diseases and ailments, including diabetes, Parkinson’s Disease, and spinal cord injury, to name just a

few. This we should not do rashly. I think the House did act rashly

last July, and I hope therefore that today’s hearing will serve the

constructive purpose of establishing a more thorough record that

will provide for a more informed and thoughtful debate in the Senate.

To all our witnesses, we thank you. I have often said it is so

pleasing to see so many young people in the room, because I have

often said that our children are the living messages we send to a

future we will never see. This is an issue that they will have to

grapple with. We are grappling with it today, but they will grapple

with it in future generations, so we have a duty to give it our very,

very best thought, our very, very best research, and come to our

very, very best conclusions. With that, I thank all of you for being

here. Good day.

Mr. SOUDER. Thank you.

Just so you understand, this is being carried over our Government Reform channel, so that Members and their staff can see it

in their offices, in addition to later on on C-Span and others. The

House is in session, so it is not on regular C-Span right now.

I would like to start the questioning with Dr. Zavos.

Have you as yet produced a cloned human embryo?

Mr. ZAVOS. I’m sorry?

Mr. SOUDER. Have you as yet produced a cloned human embryo?

Mr. ZAVOS. No, sir.

Mr. SOUDER. Do you expect to be capable of impregnating a

woman with a cloned human embryo in the future, the near future?

Mr. ZAVOS. The answer to that is yes.

Mr. SOUDER. The near future?

Mr. ZAVOS. There is obviously very high speculation, as you may

have read in the news recently, that there may be three women

pregnant already with a cloned embryo. Therefore, there might be

some children born soon via reproductive cloning, as my former associate, Severino Antinori from Rome, has stated recently.

Mr. SOUDER. Are you saying you have women who are currently

impregnated, or just your former colleague from Rome?

Mr. ZAVOS. I have no cloned pregnancies to announce, and I have

never produced a cloned embryo as yet.

Mr. SOUDER. Do you expect to be able to do so in the near future?

Mr. ZAVOS. Yes. Our team is ready to carry on the process, and

we feel like we are quite confident that we can carry this successfully.

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Mr. SOUDER. Do you believe the reports from Rome are true?

Mr. ZAVOS. I’m sorry, with those cameras here——

Mr. SOUDER. Do you believe the reports from Rome are true?

Mr. ZAVOS. I don’t believe those reports from Rome, no. Obviously, I have my reasons for that, and you know, obviously, I may

have been born elsewhere, outside the United States, but I am still

from Missouri.

Mr. SOUDER. The ‘‘show me’’ State, for those who may be too

young to know that.

Mr. ZAVOS. Yes.

Mr. SOUDER. Would it be possible to distinguish between natural

pregnancy and a clonal pregnancy, in your mind? In other words,

how would the government be able to tell the difference?

Mr. ZAVOS. No. To my knowledge, no. The only way, obviously,

is to DNA-test the offspring and the DNA donor, if they concede

to that, of course.

Mr. SOUDER. So you believe if the bill passed that authorized reproductive cloning, there really would not be a functional way to

tell the difference?

Mr. ZAVOS. No, not really. After we create an embryo, after that

embryo is cloned or sexually produced via IVF or whatever, they

cannot be told apart. Therefore, you know, all this speculation that

goes around that we are going to be able to supervise it and do this

and do that reminds me of the 1940’s, of the Germans, somewhere.

I hope that America does not come to that.

Mr. SOUDER. Dr. Usala, do you think the money spent on human

cloning takes away research on more realistic and promising avenues for cures that could actually treat a large number of people?

We have been having this debate in the halls of Congress and literally meeting in the hall. We have had this debate among a number of Members on the zero sum game. How do you think this plays

out?

Dr. USALA. I feel very strongly that it would detract. I feel very

strongly that if cloning were allowed, there would be a landslide of

funding from the NIH and other sources to only go that route. The

reason is that my colleague, Dr. Cowan, was saying, talking about

Galileo. Galileo was the odd man out. He was viewed as an extremist.

The way funding really works in this country, those with original

ideas do not participate in the funding from government sources.

I was part of a private company that developed this technology.

I didn’t ask for NIH funding until I didn’t need it anymore, and the

reason for that is that researchers will go where the review committees will approve grants. If cloning, if human embryonic stem

cell research is viewed as a promising area, whether or not it really

is, academic scientists will be drawn to it.

As an example, before 1992, the NIH and the American Diabetes

Association said that there is no real evidence that type blood

sugar control prevents complications in Type one diabetes. Well, we

now know that wasn’t true.

I have had diabetes since I was 1 year of age, and I am currently

43. The children I grew up with with diabetes are all dead because

the scientists that were very respected at the NIH and the American Diabetes Association said that no control doesn’t make any difVerDate 11-MAY-2000 12:48 Jun 04, 2003 Jkt 000000 PO 00000 Frm 00055 Fmt 6633 Sfmt 6633 D:\DOCS\86435.TXT HGOVREF1 PsN: HGOVREF1
48

ference, and as a result of that, research wasn’t geared for developing therapies that could help keep blood sugars in the normal

range.

Now, again, I was viewed as an extremist for taking insulin

shots before 10 years of age, but I am alive to tell you about this.

But my point is that if we decide as a society that a therapy may

be useful, and particularly if the Federal Government allows funding for it, all efforts seem to go in that direction. And it is only,

‘‘the extremists,’’ that take others.

I have shown you preliminary data that was reviewed by the

FDA, and I can assure you that FDA standards are far more stringent than just the peer review process of article publication. I was

only interested in finding a cure of medical therapy for my patients; and as a result, I obtained funding from other sources.

In summation, Mr. Chairman, I think that if we do allow cloning

to occur, we will be going down a path that will require years of

research on only speculation.

Mr. SOUDER. Thank you.

Mr. Cummings.

Mr. CUMMINGS. Doctor, as I listen to you, I just couldn’t help but

think that you were the one who fought sort of out of the box; is

that right?

Dr. USALA. Correct, sir.

Mr. CUMMINGS. And you would have been viewed as somebody

who may have been a little radical; am I right?

Dr. USALA. That’s correct.

Mr. CUMMINGS. At 43, you are still here to tell us about it. And

I’m just thinking, when I look at Dr. Zavos I think he would be

looked at perhaps today as being a little radical. And as I listen

to you, you almost make the argument for making sure that we do

try to look at things outside the box. And help me with that.

Dr. USALA. Well, I think that the Federal Government might

not—it might not be the correct place for it to go down a path that

seems to favor one form of therapy or another. Certainly we can’t

discuss the scientific validity of any of our approaches here. That

would take days, weeks, months, years, and we still wouldn’t come

to a conclusion. But I think what we have to always remember is,

is this consistent with our society?

The problem I have with using cloning for research purposes is

that a human life is destroyed, and it is as simple as that. And the

paradox of creating life and then mandating by law that you have

to destroy it to prevent what Dr. Zavos would like to do seems to

me total contradictory to the fabric of American society.

So that is my largest objection against the therapeutic cloning

issue.

Mr. CUMMINGS. Thank you.

Dr. Zavos, has the existing regulatory framework, namely the

FDA, been the reason why you are pursuing cloning outside the

United States; and will your plans change if a ban on cloning is

made into law?

Dr. ZAVOS. We don’t have any intentions of changing our plans

at this moment. I think we are not in the business of pitching tents

anywhere that people sort of show us to do that. It is the responsible way, I think, for us as a team. We already have two places

49

that we could be executing this particular type of research and this

project. And, therefore, we are not interested, and we have decided

that.

And I testified before the Congress last year that we had decided

from the beginning that America is not the best place to do this,

the reason being that I think our society is the best society in the

world to live in. But when it comes to subjects like that, we cannot

get the Americans to agree on too many things. Therefore—there

is a great deal of diversity in this country, and I don’t think that

we can unite the Americans on this issue. And I respect that. And

we cannot afford to be disrupted by the politics and the so-called

‘‘ethical’’ and other rules and variables that are thrown at us.

Obviously, we remain focused on this subject and that is to clone

a human for reproductive purposes, because I think it is time for

that to happen. And there is no way of turning back. There are five

teams in this world that I know of that are doing this right now;

and I think that we—and I happen to believe that, because I know

the depth of our team, we’re the best ones to do this.

Mr. CUMMINGS. Dr. Cowan, we seem to have some difference of

opinion among the scientists here. It gets a little hard for us to sort

out these things. You are all the experts and we have to rely on

you, and you all are kind of saying different things.

Should we give all of these perspectives equal weight?

Dr. COWAN. In my opinion, the differences that you hear are

based on both the extremes and the main frame of research work

in the United States. And I think that you have to bring all of this

information together to form the opinion, but in fact, pick the

straightforward pathway of what the main contingency in the

United States brings forward.

The debate that emerges from the outside—no research, no

cloning, all the way to cloning and research—allow us to fold this

information together. And these debates are very important. It is

certainly very important to hear this information, but I think that

the main thrust of the information will come from the medical scientific community, yes, sir.

Mr. CUMMINGS. I know you don’t have a crystal ball, but if you

could, based upon what you hear and see today and the research

you have done, what do you see in 20 years?

Dr. COWAN. On this subject, we will be done with embryo

cloning. That process will have brought us new technology, so we

don’t need to take an embryo and try to clone it. We will have developed substantial treatments for our patients. If this research is

allowed to go forward, we’ll have developed substantial treatments

for our patients.

Mr. CUMMINGS. Thank you all very much.

Mr. SOUDER. Dr. Weldon?

Dr. WELDON. Thank you, Mr. Chairman.

Dr. Cowan, you said in your testimony on page 2, human reproductive cloning would be wrong at this time—I am quoting you

there—at this time.

Dr. COWAN. That’s correct.

Dr. WELDON. On page 3 you said, ‘‘Until there are better results

in animals, we have no business even considering it in humans.’’

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The gentleman to your left has no problem with trying with humans right now. Am I reading and understanding your testimony

correctly to say that the society you represent feels that once the

proper research is done and that this could be developed safely in

humans, that your professional association would support reproductive cloning?

Dr. COWAN. I do not know what the professional society will ultimately recommend. At the present time, however, we know only a

small part of cloning from animal work, and that work tells us that

it is not safe. We have no controls in place, and we do not recommend it for clinical care.

Dr. WELDON. You are the president; is that right?

Dr. COWAN. I am sorry?

Dr. WELDON. You are the Director of the American Society of Reproductive Medicine.

Dr. COWAN. No, sir, I am not. I am on the board of directors.

Dr. WELDON. But you kind of leave the door open. That’s the impression I get. You say, at this time, until there are better results

in animals; I can’t help but conclude that at least in your opinion

and the position of many members of your professional association

that you may come out ultimately in support of Dr. Zavos’ position

that we should allow reproductive cloning.

Dr. COWAN. Yes, sir. It is a difficult position. Certainly, at this

time though, we don’t recommend it; but times can change. Times

have changed for all of us, and we may very well see the position

for reproductive cloning in the future. Rather than close this door,

we would prefer to say, leave it open until we know more about it.

Dr. WELDON. Would you not agree that this would raise some

very serious ethical issues that extend far beyond the original debate associated with IVF, issues of paternity, who’s the mother,

who’s the father, inheritance, legal issues, whole hosts of moral and

ethical issues.

Dr. COWAN. Yes, Dr. Weldon, I would.

Dr. WELDON. You further made statements about tremendous potential for cures. You know, I am a physician, and I’m sure you’re

aware of that. I treat persons with diabetes and Parkinson’s disease.

I remember the great debate we had in this country back in the

early 1990’s about the so-called tremendous potential of fetal tissue

research and all of the attempts at transplanting neuronal tissues

to treat Parkinson’s disease were a dismal failure. Why are you

coming as a physician before this committee contending that there

is great promise in this arena?

I read the New England Journal of Medicine every month—it

comes out every week; I read the JAMA every week. I haven’t seen

any articles that suggest that there is the great potential that you

claim in your testimony.

Where are you coming from on this? Are you doing research that

we don’t know about?

Dr. COWAN. No, sir, I am not doing any stem cell research or somatic transfer research at all. But I do believe that this research

is a very important tool for us to investigate and learn the answers

to the questions that you’re asking—will it help us treat these patients?

51

If we fail, we fail, but it offers hope to our patients for the treatments of the diseases.

Dr. WELDON. I want to interrupt you on that. You say it offers

hope. In my opinion, it offers false hope because there are millions

of people who listen to these debates and hear what people like you

are saying, and they think this is around the corner.

But I met with the—I think he is the president of the Research

Division of the Juvenile Diabetes Foundation, a Dr. Goldstein, I

think his name was. They have over $100 million budget. They’re

spending zero on cloning.

You get the impression out there that there’s all these great

breakthroughs that are on the horizon when you say, we have to

do this research. And, you know, what I’m saying to you is you

could just as easily make the argument that you’re creating blatant

false hopes.

And, you know—I was so intrigued by your testimony, Dr. Usala.

I can’t tell you how many diabetic ulcers I have treated. And the

outcome of your kind of research is really fantastic. It is cutting

edge, it’s on the horizon. I assume you can use this product in

other tissues; it is not limited to diabetic ulcers. You can do research in heart tissue and neuronal tissue to stimulate growth; is

that correct?

Dr. USALA. This particular product, Dr. Weldon, induces regeneration of mesenchymally derived tissues, deep skin, bone, cartilage

and blood vessels. Again, I am just looking to how nature does it.

Nature spent several hundred million years coming up with the

template for how this works. I have currently formed another company, ECTOcell, trying to find a similar scaffolding that will induce

ectodermally derived tissues.

But the concept, I believe, is a valid one because we all know as

scientists the chaperone proteins really modulate the expression of

the DNA template. And those chaperone proteins are modulated by

cytoplasma factors which are modulated by the external environment. During embryogenesis there are particular proteins that

come into play naturally, and what I am trying to do is find artificial analogues of those to induce the same effect.

In answer to your question, this, I believe—and we have—the

company that I left has data to support that tissues derived from

the mesodermal layer can be induced to regenerate with this material.

Dr. WELDON. I know my time has expired with you, but could

you explain to the people on this committee what you’re talking

about, ‘‘mesoderm’’ and ‘‘ectoderm,’’ because I know what you’re

talking about, but——

Mr. SOUDER. I have no idea.

Dr. WELDON. I yield back after he answers that question.

Dr. USALA. There are three basic germ layers that evolve during

embryogenesis, mesoderm which gives rise to kind of connective

tissue structures, like blood vessels, bone, cartilage, deep skin, ectoderm, which gives rise to all of your neural tissue and the outer

layer of skin; and endoderm, which gives rise primarily to the internal organs.

And basically all these cells from the different germ layers, have

the same DNA. Well, why is it that they differentiate into different

52

things? And so what I try to do is to mimic what I thought was

the structure that surrounded the different tissue layers, to tell

those cells to become blood vessels, to tell those cells to become

nerves.

I think I hit it right with the mesodermal layer; at least in the

feasibility trial, when I left, it—you could call Dr. Bill Morriston at

the University of North Carolina. It was pretty spectacular stuff.

And we don’t have to go through the mental ‘‘what if’’ or we don’t

have to go through the—perhaps with enough funding, on a very

limited budget, we were able to bring this to human clinical trials

and achieve good results.

Mr. SOUDER. Next we go to Congresswoman Davis of Virginia.

Mrs. JO ANN DAVIS OF VIRGINIA. Thank you, Mr. Chairman.

And, gentlemen, I apologize. I wasn’t here to hear your testimony, but I was chairing another committee.

Dr. Zavos, I did come in in time to hear that I think you said:

You haven’t already impregnated a woman with a cloned embryo,

but you would expect to in the future. Can you tell me when?

Dr. ZAVOS. No. I can’t answer that, obviously. We are doing this,

but it’s our plan and we obviously are not ready to release that.

And when? Sometime in the future.

Mrs. JO ANN DAVIS OF VIRGINIA. I have had people in my office

telling me that China has already cloned humans. Have you heard

anything to that effect?

Dr. ZAVOS. I am familiar with what the Chinese are doing, the

Russians are doing, the Europeans are doing. I know of several

teams that are making a great deal of progress on this issue, and

their goal is to clone a human being; so there’s obviously no shortcut on this one. And the Chinese will obviously be successful in

probably—by passing us very significantly.

And I wanted to refer to Congressman Weldon’s comment in reference to, why are we keeping the doors open? There is a reason

why we keep doors open, until we can see quite vividly that this

technology is a total disaster or it holds a great deal of promise.

My question is why are the British legislating in favor of therapeutic cloning? Why did the Australians just pass a law allowing

that? And that is a very big issue.

Mrs. JO ANN DAVIS OF VIRGINIA. I don’t mean to cut you off, but

I have limited time, and I would like to ask some more questions.

I am not sure who this would be for, but how many eggs have

to be harvested to clone a human embryo?

Dr. ZAVOS. We don’t know that except to say that our experience

with our team doing cloning in mice and cows have yielded a very

high success in creating embryos via somatic cell nuclear transfer.

The recent events at ACT, Advanced Cell Technology, they have attempted to—out of six anucleated embryo host sites they were able

to do two human embryos, which is a 33 percent success rate in

creating embryos.

So this technology is developing very fast and it’s developing by

the day, not by——

Mrs. JO ANN DAVIS OF VIRGINIA. Thank you, Dr. Zavos. I want

to go to Dr. Usala now.

Why do you think the adult stem cell research has not gotten the

attention that the embryo stem cells have? I mean, it seems to me

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that if we are going to set up a bank that you know someone could

deposit the stem cells in, why does that not work or why are we

not getting the attention there?

Dr. USALA. I am not sure, Congresswoman Davis. It is speculation at best, and I would not be able to speculate for you.

I think that those who have brought the human embryonic stem

cell debate to our attention, even the people that really did the initial work on it, do not believe you can grow parts from it. What

has happened is, I think this has been taken up by others who are

more peripherally involved; and it seems just intuitively that if you

take something at an earlier stage of development, you should be

able to get it to do what you want. And I think that it’s more complex than that, as we found out—the same issues as Dr. Weldon

brought up.

In the early 1990’s they said, we can cure diabetes if we take

fetal islets because they are less developed. They should be easier

to take. And we don’t hear about it anymore; it is a dismal failure.

I believe the human—in the case of adult stem cells, it is not

quite as intuitive that they would work, but in fact, they do. And

in fact, the adult stem cells probably will work better because they

are in the environment of the actual patient that they are trying

to get to induce some tissue replacement with.

So I think it’s basically—and I think this is unfortunate to say,

but I think it just has to do with the way it has been marketed.

And, again, that is speculation.

Mrs. JO ANN DAVIS OF VIRGINIA. And, again, I am just still trying to learn about this, so if I am hearing you right then, adult

stem cell has worked and embryonic stem cell has not worked?

Dr. USALA. Human embryonic stem cells, to date, have not

worked well. And in animal models they haven’t worked—or some

of them have worked in small animals; in large animals they really

haven’t. And there have been some very profound complications, including uncontrolled growth, cancer.

With the adult stem cells we don’t seem to see that.

Mrs. JO ANN DAVIS OF VIRGINIA. Thank you, Mr. Chairman.

Thank you, gentlemen.

Mr. SOUDER. Thank you.

We have been joined by the distinguished gentleman from New

York, Mr. Gilman.

Mr. GILMAN. Thank you very much. I regret I was delayed at another hearing.

Let me ask the panelists, what is the benefit in scientific research of cloning? Do any of the panelists care to answer that?

Dr. COWAN. I guess I’ll take that one.

And the question is, what is the benefit of therapeutic cloning?

Mr. GILMAN. For medical research.

Dr. COWAN. Well, I can’t specifically identify any particular disease. We have had some diseases discussed; spinal cord injury, Parkinson’s disease, diabetes, these are diseases that are discussed.

The issue for research to me, however, is the ability to probe the

cells, probe the therapeutic modalities and develop understanding

about the cell process, as well as therapeutic options for our patients. We all dream that we’re going to do a therapeutic investigation, but most of these dreams actually do not come forward for us

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conducting medical research. Instead we learn just a small piece of

that helps us go further and further down the road.

I don’t know if that is the answer to your question, but it’s what

we seem to understand today.

Mr. GILMAN. Do any of the other panelists wish to comment on

that?

Dr. USALA. I think that what cloning will do is provide perhaps

hundreds of millions of dollars for NIH grants, for career development.

I am not sure I agree with my colleague that oftentimes this does not relate in any therapy. On $6 million, I brought from animal

trials into human clinical trials, FDA-monitored, done under the

very strict FDA regulations of both product production, clinical protocol.

I think that—well, it is like the movie, Animal House, knowledge

is good. And I think sometimes the funding isn’t really given for

medical therapy, but rather as an end in and of itself. In my view,

there really isn’t any goal on the horizon of medical therapy. It

really would just be interesting knowledge.

Mr. GILMAN. Does any other panelist care to comment?

Dr. ZAVOS. There is no doubt that there is a great deal of potential, and we haven’t really sort of touched this topic yet. I think we

have a long way to go.

And I think the evidence I can provide, Mr. Congressman, is the

fact that governments such as England, Australia and others have

already passed legislation regulating the exploitation of this technology, of this science. And there’s obviously—are they smaller

than we are? I don’t think so. They are more opportunistic than we

are.

I think we are walking a very tight rope here calling ourselves

ethically and morally better than they are, and we are going to pay

a hefty price to buy that technology 10, 20 years down the road.

And we’re making a big mistake.

Mr. GILMAN. Thank you very much.

Thank you, Mr. Chairman.

Mr. SOUDER. Before we move to the second panel, first let me

thank each of you for taking the time to come here today. We will

have additional written questions from some of us and some followup. This has been our second hearing. We’re clearly intending to

have a third as this issue continues to work. We have oversight of

both the Department of Health and Human Services and the Justice Department.

Dr. Zavos, we have asked you a couple of times, and I understand that this isn’t the time or place where you want to release

any particular announcement, do you have a rough timeframe?

When I first asked you the question of when there might be a clonal pregnancy, you suggested that it would be sooner rather than

later. Do you have a rough timeframe? Is that 3 months, 1 month?

Dr. ZAVOS. My notion is that it will happen. A pregnancy can

take place this year, 2002. A birth will be 2003. So all indication

is that 2002 could be the year of the clones.

Mr. SOUDER. Do you think that will be outside the United

States?

Dr. ZAVOS. Oh, definitely it will be outside the United States.

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Mr. SOUDER. I thank you for coming today and look forward to

talking to you.

If the second panel could now come forward.

Each raise your right hands.

[Witnesses sworn.]

Mr. SOUDER. Let the record show that each of the witnesses responded in the affirmative.

As you heard, we ask you to try to summarize your testimony

within 5 minutes, and your full statement will be inserted into the

record, as well as any other materials.

Dr. James Kelly is a patient advocate, and activist probably, and

we would appreciate you starting with your testimony.

STATEMENTS OF JAMES KELLY, PATIENT ADVOCATE; ELIZABETH HOWARD, PATIENT ADVOCATE; AND JUDY NORSIGIAN,

BOSTON WOMEN’S HEALTH BOOK COLLECTIVE

Mr. KELLY. Mr. Chairman, I just want to say for the record, I

am not a doctor.

Mr. SOUDER. We made you an honorary doctor today. Can you

pull the mic a little closer? You are recognized for 5 minutes.

Mr. KELLY. Five years ago——

Mr. SOUDER. Your promotion got you so excited you got distracted there.

Mr. KELLY. Five years ago, I had an auto accident and I became

paralyzed with a spinal cord injury.

And right off the bat, because I was a troubleshooter for 19 years

for the railroad industry and eventually a train dispatcher, I took

Dr. Zavos’ advice and I educated myself concerning what it was

going to take to get me out of my condition to return my body. And

I did this by spending literally thousands of hours a year reading

PubMed and MEDLINE, medical journals, in speaking with the

leading researchers in the country in neuroscience, to find out just

exactly what it was going to take to cure spinal cord injury, because I wanted to support the researchers that were doing the kind

of research that was going to lead to the cure that I needed.

I didn’t want to just support research, blank research or a blank

check on research, because the way that you fix anything, whether

it’s the way Dr. Usala fixes people with diabetic foot ulcers or the

way you fix a diesel locomotive, you do it by finding out what needs

to be done and you take care of what has to be done.

With that said, every year 26 million Americans are diagnosed

with conditions that stem cells are expected to some day cure.

Many more millions already suffer from these life threatening conditions or crippling conditions. Therefore, it is not farfetched to say,

even a year’s delay in the availability of cures for these conditions

will result in millions of Americans needlessly suffering catastrophic impairment or enduring needless misery. Their loved ones

will know profound sadness and grief.

Americans are being told that cloning has the potential to play

a large part in curing disease. Americans are believing what they

are being told, and therefore they are speaking out in defense of

their cures.

But in my opinion, the question we should be asking ourselves

is not, does cloning have therapeutic potential, but rather, will

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cloning—giving cloning research the green light speed the availability of medical cures, or will it slow or block their progress?

After many months of investigation into the—sorry; I am jumping around and I’m losing my place—into the safety, performance

and marketing potentials of embryonic stem cells, adult stem cells

and cloned embryonic stem cells, I’ve arrived at a definite conclusion regarding the question that I think we should be asking; and

I would like to present what I learned.

I hope each of you will draw your own conclusions from this information and will speak up for your future where you have a

chance; but please do so while considering the following points because this issues outcome will soon be a matter of life and death

for millions. I want to emphasize that my only intention, or my

only priority in getting involved in this investigation was that people with things like cancer, heart disease, spinal cord injury, Parkinson’s, Alzheimer’s, Rett disease will not have to suffer and die

needlessly.

I want the cures that everybody else wants. I want out of this

wheelchair. I want Dr. Usala to be cured of Type 1 diabetes. I want

Dr. Usala’s two children to be cured of Type 1 diabetes. I want you

to know what my priorities are.

This is the information I learned about cloning. Embryonic stem

cells taken from cloned embryos have safety and performance obstacles that need to be overcome before they can be medically tested in humans, including short- and long-term, genetically patience

and reliability, a tendency to form tumors when injected into the

host animals, and unexpectedly foreign tissue rejection. In other

words, stem cells taken from cloned embryos, even though they

have the patient’s DNA, can still be rejected.

The whole point is, it’s supposed to not be rejected, but it will

be rejected as a recent study in cell pointed out, and I will get to

that later here if I have time.

Another thing that is a problem with cloned embryonic stem cells

is, they may offer questionable benefits regarding the potential to

medical conditions with a genetic basis. In his March 5th testimony

to the Senate, Dr. Stuart Newman of New York Medical College

noted genetically matched cells from cloning may well be useless in

treating conditions with a genetic basis, such as juvenile diabetes,

for these cells will have the same genetic defect to cause the problem in the first place.

Unfortunately, ma’am, I am sorry to say the same thing is true

with Retts disease, because I want the same thing you want. I

want your daughter cured. And I hope you understand the points

I just said there. Do you?

Cloned embryonic stem cells have yet to play a necessary part in

treating any condition that improves a live animal or a human’s

medical condition. Cloned embryonic stem cells would require 15

million women’s eggs to cure all diabetic Americans if attempting—

if every attempt to clone was successful. However, most sources

now claim that 100 attempts are needed to create a single cloned

embryo able to yield usable stem cells, with each attempt needing

another egg. Therefore 1.5 billion eggs would be required to use

cloning for diabetic uses alone. Heart disease would require five to

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seven times more with 21 million new cases of heart disease a

year.

There are a couple of quotes here I would like to quote of leading

scientists who—where I got this information. Thomas Okarma is

the chief executive of Geron Corp., a self-therapy company. He says

he has no interest in using cloned embryos to produce customized

treatments for disease. The odds favoring success ‘‘are vanishingly

small,’’ he says. The costs are daunting. Okarma explains that it

would take thousands of eggs on an assembly line to produce a custom therapy for a single person. ‘‘the process is a nonstarter commercially,’’ he says. In the previously—and that came out of an

L.A. Times article.

In the same article, Lutz Giebel, CEO of CyThera, a cell therapy

company in San Diego, points out, ‘‘Quality control presents another hurdle...the FDA can’t regulate it’’ and ‘‘no one could afford

the treatment.’’ Giebel calls therapeutic cloning a research tool

only.

Also the embryonic stem cells are not expected by scientific supporters to have the potential for leading the medically available

cures for a very long time. Scientist Janet Rowley is a pro-cloning

member of the President’s Council on Bioethics. In speaking of the

therapeutic potential of cloned embryonic stem cells, she recently

cautioned, ‘‘I think it’s not fair to say that the promise will not be

realized, but I think it is fair to say that the promise may take a

very long time.’’ And I want to point out that we began our war

on cancer with the notion it was going to be over in 10 to 20 years,

and we are far from it.

Mr. SOUDER. Mr. Kelly, we have let you go over some. We will

insert into the record your information on adult stem cells, and if

you would like to do a conclusion, then we’ll draw more out.

Mr. KELLY. What would you like me to do?

Mr. SOUDER. If you want to just make a few concluding comments, then we’ll ask you further questions, and we’ll put into the

record the adult stem cell material.

Mr. KELLY. It was my fault. I am very sorry.

My closing statement, what I would like to say is, I did not look

at the ethical or the moral sides of this because my primary and

my only concern was what was going to lead to cures faster, OK?

After I came to the conclusion that banning cloning of humans

was going to actually keep funds from being diverted from more

promising avenues, I was then able to look at the moral and ethical

issues involved, and I came to the conclusion that it actually is

wrong to use human life at any stage for any purpose, especially

if you are using that human life with the idea that you are going

to destroy it.

And what I would like to say finally is, most of us are instinctively horrified—what I want to say is, this is a very important—

very, very important. This issue is going to determine the life and

the quality of life and even the life and death of many millions of

Americans. It is actually probably one of the most important issues

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that our Senate and our Congress has faced for very many years,

and we need to get it right.

We need to understand what is going on and we need to get it

right.

[The prepared statement of Mr. Kelly follows:]

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Mr. SOUDER. We appreciate your passion, and it is personal and

it is an addition for people you work with; and we appreciate that

passion. Because often we can look at these things in a detached

way, and it is important for us to see how you feel it and to see

the impact on individuals, as well as for us to theoretically understand it. So I appreciate the emotion that you have brought to it

in addition to the personal research that you have done.

Thank you for your testimony.

Ms. Howard.

Ms. HOWARD. Good afternoon, chairman and members of the

committee. It is good to see someone from my home State of Virginia here. Thank you for the opportunity to testify on the importance of somatic cell nuclear transfer, also known as therapeutic

cloning or regenerative medicine.

My name is Elizabeth Howard, and I am here on behalf of the

Coalition for the Advancement of Medical Research. The Coalition

consists of over 70 universities, scientific and academic societies,

patient organizations and other groups that are dedicated to supporting and advancing stem cell research.

Today, I know I am speaking for millions of Americans living

with MS, spinal cord injuries, ALS, Parkinson’s disease and many

other less known illnesses that are equally as tragic, who may benefit from therapeutic cloning. I entered this debate from the patients’ perspective. I do not profess to have a scientific or medical

background, but I do have a background in watching suffering

without the ability to help.

Almost 3 years ago, I gave birth to a beautiful, healthy girl

named Allison, and Allison is with me here today. My pregnancy

and delivery were textbook perfect. Everything about Allison

checked out fine and there was great joy in my family about this

new life and its promise.

Back then, in June 1999, I was oblivious that all expectant mothers are at risk of having a Rett syndrome daughter, that I might

be one of those moms who had watched in horror as her happy,

healthy baby girl did not develop properly and would lose a few acquired skills from which she derived joy and contact with the outside world.

Rett syndrome strikes girls very early in their development, anywhere between the first 6 to 18 months of life. In 1999, it was discovered that Rett syndrome arises from a noninherited mutation in

the MeCP2 gene on the X chromosome. MeCP2 plays an important

role in brain growth and function. Because Allison’s Rett syndrome

onset was particularly early, she has never crawled, walked or

talked.

After undergoing numerous tests for over 2 years, involving

many big needles, she began continuous compulsive hand-wringing,

which is the hallmark of this syndrome. We finally had a diagnosis,

but with this, learned that Allison might be trapped at the 6-month

developmental level forever at best.

Sadly, it is easier to point out the short list of abilities Allison

does have than enumerate the long list of skills that she should

have attained by now, but hasn’t. She still manages to chew food

with assistance. She can no longer use her hands. She can sit up

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very slouched, but still falls over. She has a contagious laugh and

beams a wonderful smile.

Finally, she makes excellent eye contact. It is with her penetrating blue eyes that Allison speaks to me, urging me to do everything

I can to make her life less traumatic and more whole. She compels

me to push me for advances in science, like SCNT, that hold promise to protect her from the many, many dreadful manifestations of

Rett syndrome. These include seizures that can significantly set

back development; breathing abnormalities that can be so intense

the girls pass out; GI problems, which typically lead to feeding

tubes; curvature of the spine, frequently resulting in complicated

scoliosis surgery and/or dying suddenly while sleeping for no obvious or immediate reason.

Despite all the important and vast advances in medical research

over the last 20 to 30 years, there is still no cure or treatment for

Rett syndrome.

Let me state for the record that the Coalition for the Advancement of Medical Research supports efforts to prohibit human reproductive cloning. However, it is imperative that advancements in

SCNT not be stifled or outlawed, since this may be one of the best

avenues for ensuring that girls like Allison and the millions of

Americans suffering from other disorders might some day live a

more meaningful life and future generations of people afflicted by

these disorders, perhaps our very own children and their children,

might never have to endure what this current generation has suffered through.

It is not my intent to exaggerate the promise or timing of SCNT

research, but how can I look into my daughter’s sparkling blue eyes

and not assure her that scientists and lawmakers are embarking

upon an area of research supported by 40 scientific Nobel Laureates that might allow her to have a happier ending.

During the first panel, the American Society for Reproductive

Medicine spoke to the science involved in the SCNT process. So in

the interest of time, I won’t explain it again. But let me just reiterate there is a critical distinction between the use of cloning technology to create a baby, which is reproductive cloning, and therapeutic cloning techniques central to the production of breakthrough

medicines, diagnostics and potential vaccines to treat various diseases.

Due to its promise to enhance the quality of life of both the

young and the old suffering from various devastating, often lifethreatening, disorders, how can we not allow this research to advance? The present momentum in biomedical research and the profound implications of what we are learning will inevitably raise

public concerns. Yet an across-the-board ban on all types of human

cloning would significantly set back advances in research that offer

hope for Rett syndrome girls and the numerous Americans struggling on a daily basis just to make it past another uncontrollable

seizure or tremor, to breathe without pain, to use their eyes as the

onset of blindness occurs, and to continue walking before the amputation of their legs is required.

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On behalf of the Coalition for the Advancement of Medical Research and the countless Americans who stand to benefit from

therapeutic cloning and the family members and friends who love

them, I again thank the committee for its deliberations and for the

opportunity to speak on this issue.

Mr. SOUDER. We thank you for your testimony.

[The prepared statement of Ms. Howard follows:]

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Mr. SOUDER. Ms. Norsigian.

Ms. NORSIGIAN. Thank you, Mr. Chairman, and others on the

committee. I am Judy Norsigian, the Executive Director of the Boston Women’s Health Book Collective, and coauthor of ‘‘Our Bodies,

Ourselves,’’ now in its 7 edition. There are now 4.5 million copies

in print in over 20 editions around the world with seven more on

the way. It is the book that is the mainstay of the global women’s

health movement.

First, I want to note that we do support embryo stem cell research that utilizes not only existing cell lines, but also embryos

originally produced for use in IVF clinics. At the same time, along

with other women’s health and reproductive rights advocates, we

have raised serious concerns about the wisdom of allowing embryo

cloning, even for research purposes, at this point in time.

We also believe, after a number of conversations with knowledgeable scientists, that today’s most pressing challenges in the field of

embryo stem cell research do not require access to embryo cloning.

Despite much media hype to the contrary, there really have not

been compelling arguments to allow embryo cloning now, especially

in light of the serious and profound consequences of developing this

particular technology.

I have attached earlier Senate testimony that addresses a number of our concerns.

But today I would like to underscore just two of the reasons that

warrant a far more cautious approach than that adopted by the

Sector/Kennedy/Feinstein/Hatch bill, permitting embryo cloning for

research purposes, and the Dorgan/Johnson bill which does not

even totally ban implantation of a clonal embryo. Most importantly,

neither bill would adequately protect the women who would be donating eggs for somatic cell nuclear transfer.

First, embryo cloning is a key element in the development of

germline genetic modifications including modifications that go far

beyond the realm of curing diseases into the world of so-called ‘‘designer babies.’’ The matter of germline modification, selecting for

traits that would be passed on to future generations, is a separate

discussion from human reproductive cloning and must take place

before embryo cloning is allowed to go forward, and be refined in

an environment with completely inadequate regulation of human

germline genetic modification.

Second, there are substantial risks to women’s health posed by

Lupron, the most common drug used to hyperstimulate the ovaries

in the process of gathering eggs for somatic cell nuclear transfer.

And unlike situations where individual women might benefit directly from using this drug, as could be the case when undergoing

IVF or in treating endometriosis or in treating anemia-associated

fibroids, women who take this drug solely for the purpose of providing eggs for research do not benefit personally.

At this point, it is not clear they would be benefiting relatives or

loved ones either.

As of the spring of 1999, the FDA, the Food and Drug Administration, had received 4,228 reports of adverse drug effects from

women using Lupron. Interestingly, they also received 2,943 such

reports from men who used the drug in prostate cancer treatment;

and despite the differences in age, sex and indication for use, the

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complaints were remarkably similar. 325 adverse events reported

for women resulted in hospitalization, and additionally, 25 deaths

were reported. Whether these deaths are directly attributable to

Lupron remains to be determined, and I have recently asked FDA

staff to look into this more carefully.

Although the FDA cannot now provide more detailed data on adverse reports for women over the past 3 years—and there have

been thousands—nor data on how many of these problems were

long-lasting, rather than transient, FDA staff have indicated they

will be reviewing these data in the near future. Our office, meanwhile, has received numerous complaints over the past decade from

women who have had persistent joint pain, headaches and other serious problems many months and even years after their last

Lupron shot. I am attaching a list of problems that have been reported to the FDA and in the medical literature.

By the way, given our current problems with under-resourced

and inadequate IRBs, we cannot now expect most IRBs to protect

the women who would be providing eggs for research purposes.

Once the FDA has completed its analysis of the many additional

adverse reports on this drug, we will certainly have a more complete picture of the risks than we do now. But until such a time

when more reassuring data might become available, or different

drugs developed with a better safety profile have a longer track

record, it is unethical to move forward with somatic cell nuclear

transfer.

Parenthetically, I do want to note that scientists in Italy and possibly elsewhere claim to have already perfected techniques for

freezing eggs, something I have been told has not yet been done

with success in this country. If unused, frozen eggs harvested initially for the purposes of IVF were to become available for subsequent somatic cell nuclear transfer, then of course you would not

be exposing those same women to risks for the purpose of research

only.

Just at the practical level, it makes little sense to pursue clone

cures for the diseases most often mentioned in media reports. Parkinson’s and Alzheimer’s diseases alone affect 5 million American

and would require, minimally, 250 million eggs to produce individualized therapy that would match the patient’s own genome. This

figure of 250 million assumes that at least 50 eggs would be needed

per patient. And since, on average, about 10 viable eggs are likely

to be collected from each individual woman who is a donor, 25 million women would be needed as donors, about half of all women of

reproductive age, and that is just for these two diseases.

The specter of such massive use of ovarian hyperstimulation,

coupled with laparoscopic surgery, makes no sense, especially when

other fruitful and less problematic approaches to developing therapies are already under way.

In closing, I would like to note recent articles by Professor

George Annas of the Boston University School of Public Health in

both the Boston Globe April 21 and the New England Journal of

Medicine last week. Professor Annas is not opposed to research

cloning, but he does recommend that three features are essential

to any bill that would effectively prevent human reproductive

cloning: first, a prohibition on the stockpiling of embryos by outlawVerDate 11-MAY-2000 12:48 Jun 04, 2003 Jkt 000000 PO 00000 Frm 00084 Fmt 6633 Sfmt 6633 D:\DOCS\86435.TXT HGOVREF1 PsN: HGOVREF1
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ing the freezing and storage of research embryos; two, a prohibition

on the purchase and sale of human eggs or embryos; and three, disqualifying of, ‘‘anyone who is involved in activities related to in

vitro fertilization or other infertility treatments’’ from doing research with cloned embryos.

These three elements are absent from all bills I mentioned earlier that permit embryo cloning for research purposes, and it would

seem that their inclusion would have been an obvious thing to do

to minimize the likelihood of human reproductive cloning.

Professor Annas also notes that a compromise position which

calls for a moratorium on embryo research cloning could also make

it possible to pass legislation that would ban human reproductive

cloning. Last June, a statement on cloning, signed by over 100 individuals and organizations and posted at our Web site, has called

for such a moratorium on the use of cloning to create human embryos for research purposes.

We recognize that no current legislative proposals embody this

position, but we do believe that it still remains the best public policy. And during such a moratorium the FDA could more completely

analyze the problems with drugs used for ovarian

hyperstimulation, and the public could have a more thorough discussion of the scientific, regulatory and ethical issues at stake. This

moratorium would be prudent and reasonable policy when faced

with a technology of such profound consequence.

Thank you very much.

[The prepared statement of Ms. Norsegian follows:]

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Mr. SOUDER. I want to thank each of you.

And once again we have a very diverse panel with different approaches to this same concern, which is how best to help people in

this country.

Let me ask Ms. Norsigian, would it be—without the last three

restrictions you have, in other words, one of the things that is likely to happen if, in fact, that many women were needed, much like

other things, even blood donation, wouldn’t this likely also skew to

those who are low income as far as donors and often younger people who are needing money?

Ms. NORSIGIAN. Absolutely. There is actually quite a bit of literature on this issue of excessive incentives and in situations of

poverty. We have got worldwide examples where women have been

exposed to unacceptable research risks or treatment risks because

of the incentives that were offered.

There would be an incentive. Mostly low-income women, women

of color, would probably be candidates. But I think when you are

looking at creating public policy of this sort, I think the safety

issues are the paramount issues. And the other ethical issues, this

would be a problem.

But there are other examples where we have passed legislation,

where we have public policy that lends itself to this. Already, when

we look at the situation where women provide eggs for women who

are undergoing IVF procedures, young women, coeds across the

country are being paid $5,000 on up for providing eggs for IVF clinics.

Some argue those are inappropriate incentives. Others say they

are not inappropriate. But in those situations, you can definitely

say there is a potential for benefiting somebody.

In the case of research cloning, the individual women who are

going to provide the eggs do not have any conceivable chance right

now of benefiting someone. It is a very distant prospect of cures

given the state of research we have right now.

Mr. SOUDER. What is the potential scale?

Ms. NORSIGIAN. The scale would be enormous, that is true. Of

course, there are scientists who are saying ultimately we would do

away with cloning. We, of course, would develop better approaches.

From a business point of view it doesn’t make sense.

But I do not think we justify a path from here to there that is

littered with the bodies of women who have been damaged, whose

health has been seriously damaged because we think there may be

an end point that we cannot guarantee, especially when we have

other avenues that, as people today have pointed out, seem to be

much more promising.

Mr. SOUDER. Thank you.

Mr. Kelly, we have asked this a couple of different times, and it

was suggested in the first panel, as well as our last hearing; and

certainly in debate of when we spend the money on human cloning,

does that take money from research from more realistic and promising avenues for cures that actually help people with different disabilities such as your own, or different diseases.

Could you elaborate on what you’ve learned from some of your

research?

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Mr. KELLY. Thank you for asking me that. I can definitely elaborate on that.

I want to say something right off the bat, OK, if any money—

if any money at all is spent on cloning, it will definitely take away

money from avenues that could lead to cures for my condition. I

can say that without a doubt. And the reason why I can say that

is because cloning doesn’t offer anything for my condition, all right?

People with spinal cord injury—Christopher Reeve, for example,

they are being led to believe that cloning is going to cure them.

Cloning is not going to cure a spinal cord injury, because they don’t

know what it takes to cure a spinal cord injury.

What cloning offers is specialized cell replacement, neurons and

oligodendrocytes. Oligodendrocytes are the cells in the central nervous system that remyelinate the central nervous system axons or

the nerves in the central nervous system.

Christopher Reeve testified to the Senate that he needs

remyelination in order to be cured. He told the Senate that embryonic stem cells are the only way you can do that.

That is not true. There are four adult cell types that remyelinate

the central nervous system. Two of them are in clinical trial. One

is in a clinical trial at Yale; and the other is going to clinical trial

at the NIH, and it’s called bone marrow stem cells.

But remyelination is not the main obstacle to curing spinal cord

injury. The main obstacle is getting nerves to grow across the injury site. That has nothing to do with specialized cell replacement.

Neurons won’t grow across the injury site. Oligodendrocytes won’t

grow across it.

There are dozens of avenues that are being developed to try to

get nerves to grow across that lesion. It is called a lesion, and is

what’s called a gleal scar, and the gleal scar is very inhibitory to

nerve regeneration. And cloning in any way cannot help get nerves

to go across that lesion. And any money that goes to cloning will

definitely impede the progress of research for spinal cord cures.

Now, just to finalize this, the leading researcher in the United

States has, per Time Magazine—his name is Wise Young; he is the

neuroscience director of Rutgers University, and by the way, he is

in favor of anything the NIH is in favor of. He is in favor of cloning

because he is in favor of research for the sake of research, I believe—in my opinion.

But he did say on his on-line forum to the SCI community—when

asked, what are the prime motivations of researchers, what motivates scientists and researchers, he said, Most scientists that I

know of work for recognition by other scientists; we have been

trained this way.

Funding is, of course, important to scientists. Many scientists

will go to great lengths to get funding from the NIH and other organizations, including changing their experiments and even changing their fields to get funding. The NIH has great influence over

science in the United States for this reason.

What many people do not understand is, the NIH runs mostly

through peer review, i.e., scientists who decide which applications

have sufficient scientific merit to be funded. Only 20 percent of the

grants are funded. Therefore, the competition is fierce and publications are important to decide funding. Therefore, if scientists

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around the United States and researchers around the United

States decide the best way to get funded by the NIH is to fund

what they think the NIH wants to fund, they will change their research to do it.

You could have somebody that works on adult stem cells, which

are right now very close to clinical trials for many conditions; and

if they think—if they turn in a couple grant applications and they

get turned down for whatever reason, they think they might be

able to get it approved by submitting grant applications for cloning,

Dr. Young is saying that they will do it.

And I know that they will do it. I know it because Dr. Young,

in 1985, wrote a letter to the FDA—and I have it here also. And

in this letter to the FDA, he told the FDA that he was working on

an avenue for my condition, spinal cord injury, that resulted in 78

percent of the treated animals being able to walk independently 4

months after having their spinal cords severely crushed. And he

pointed out in his letter to the FDA that this was better than anything he had ever seen in his lab, including methylprednisolone

and maxillim, which he pointed out was in a multicenter clinical

trial by the NIH.

Two months after submitting this letter to the FDA, he abandoned this line of research, which he had been working on for 7

years, because the NIH would not fund it. And he took over the

methylprednisolone national clinical trial that the NIH was conducting. And he conducted that clinical trial for 12 years, all right?

The NIH looked into methylprednisolone and that is what they

backed for 12 years. And Dr. Young admits that he had a more

promising research avenue that was not funded by the NIH and

was abandoned because it was not funded by the NIH.

And now in the year 2000, here we are in the year 2000, these

scientists publish and they say that the national acute spinal cord

injury studies, 2 and 3, which were the NIH clinical trials, often

cite as evidence that high dose methylprednisolone is an efficacious

intervention in the management of acute spinal cord injury.

Neither of these studies convincingly demonstrates the benefits

of steroid. There are concerns about the statistical analysis randomization and clinical end points. Even if the punitive gains are

statistically valid, the clinical benefits are questionable. Furthermore, the benefits of this innovation may not warrant the possible

risk.

The point is, there are other studies that back this up, and I

cited them in my presented paper. The point is, the NIH turned its

back on promising research in the past that scientists had compelling evidence was better than what the NIH was backing. And

what they did in doing that was they spent 12 years on this other

avenue methylprednisolone that scientists now say not only does

not improve the condition of people with spinal cord injury, but it

causes more damage.

Now what is going to happen—I am telling you this with total

certainty of everything that I have put in my paper—I am sorry I

am such a poor speaker. What’s going to happen is what happened

in 1985 that probably led to as many as half of the people paralyzed today being unnecessarily paralyzed. And now what is going

to happen in cloning, history is going to repeat itself, but it’s not

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going to be 300,000 Americans that are going to be affected, it is

going to be 100 million Americans.

Mr. SOUDER. Well, thank you for that. I am going to yield to Dr.

Weldon in just a minute, but let me reinforce from our end what

you have shown in your studies. I know from being in the legislative end—first as a staffer, now as a Member of Congress—and

also with friends in different agencies that we get what we ask for.

We get what we ask for. I work not in the health field so much

but in the education area; and when we say we want this kind of

research and we put that in legislation or when somebody in the

department does it or, as in one case in one bill where a Member

had gone to a conference and thought this education idea sounded

good so it got written in a bill and then the research dollars were

diverted to that form of education based on one Member having

gone to a conference, that is how the research dollars get driven,

from our end.

What you have done is put it in the reverse. In other words, you

said here you saw it, that the researchers will respond to where the

money flows and that the policies that seem to be asked for out of

Congress or are media-driven may not be based on science.

There has been this false dichotomy today that implies that this

is a scientific decision that is being made, and I don’t believe it is.

This is our second hearing, and we have yet to hear, after 20-some

years of research in embryonic stem cell research and other things,

of anyone seeing any information where we have other promising

results. In fact, in talking with a number of my colleagues who

favor this type of research, they admit they do not have it.

We are trying to look for a less politically charged way, because

they are acknowledging the potential diversion of huge amounts of

dollars from things that in fact are working.

This is not science versus nonscience. It is ridiculous to compare

it to Galileo about the flat earth, for crying out loud. This is science

versus science and where do we put the dollars to most effectively

help people like yourself and your daughter and that we are getting caught up in, roughly, name-calling about how best to do this.

I believe ethics are a key variable to this, but particularly when

the ethics is debatable, the science is screaming out that there is

research on one side, it is baffling to me why we continue to debate

this when there is no hope but a false hope. I have not heard anything specific other than that.

Mr. KELLY. Sir, unbelievably, what I am finding, without a

doubt, is it is not science versus science, it is science versus cures,

OK? There is definitely science out there that offers hope for cures.

There definitely is. But cloning is not that science.

It does not offer it for several reasons. Not only does it have huge

technical obstacles that are going to take decades to overcome, and

the scientists I have quoted in my paper—I am not just pulling

these numbers off the top of my head, but it is going to take decades to overcome them, if they can be overcome. And they even say

that, that they are not even sure they can be.

But, on top of that, the cost of overcoming these obstacles and

the cost of the treatment itself is going to be so astronomically

high.

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James Thomson—that’s where I got that number—is the father

of embryonic stem cells. He admits that the cost of many types of

therapies that could come from cloning could be astronomically

high. Nobody could afford it. And if you cannot afford it, where are

people getting the word therapeutic for cloning if there is not going

to be any therapy? If I cannot afford it, the government cannot afford it and the insurance companies cannot afford it, who is going

to afford it? It is not going to happen.

We are being used. We are being misled. We are—and when I

say ‘‘we,’’ I mean the disabled communities—we are slitting our

own throats by trying to back cloning, and we are doing it out of

desperation.

Mr. SOUDER. Thank you very much.

Dr. Weldon.

Dr. WELDON. Thank you, Mr. Chairman.

I want to thank all of our witnesses and Ms. Norsigian in particular. Your testimony was excellent and to the point.

I got the impression that you would like to see a moratorium, but

there are no moratoriums currently being debated in the Senate.

As you know, we passed a ban in the House. Understanding that,

the political reality, of the two bills to come out of the Senate,

which one would you prefer, the Brownback-Landrieu version or

the Kennedy-Feinstein version of the bill? Which would be better

for women’s rights, would you say?

Ms. NORSIGIAN. If I had to choose, I would choose the

Brownback-Landrieu, because I know if the evidence were to

emerge that would convince me that this was a promising line of

research, we could revisit the issue.

I know the bill asks for a revisitation of the issue, and new scientific progress or discoveries could be considered, and the ban

could be overturned. In the meantime, women would be protected.

I want to caution everybody who might go to an IVF clinic and

be told that Lupron is perfectly safe or that it is fine and we do

not have problems, it is a bit of a sleeping giant here. I want to

use an analogy.

Some of you remember what happened with genetically engineered insulin. You know that it finally caused the animal-based

insulin to be taken off the market, and those who were forced to

use the genetically engineered insulin had some serious problems.

There is a Canadian woman named Colleen Fuller who went into

a coma several times. She is not the only one. Many, many people

did.

It took a long time before physicians and the government recognized that there really was a problem associated with genetically

engineered insulin, and it took the people who suffered quite a long

time to have this recognized. In the end, animal-based insulin came

back on the market, so those people who could not use the genetically engineered insulin had another choice.

This is not dissimilar in that we have many women—they have

formed the Lupron Victims Network. Many of them have been

sharing information on the Internet. I have talked to several people

who work at IVF clinics who have seen these problems. But, in

some cases, the women do not go back to the clinics because they

have had such a bad experience with Lupron they do not trust the

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physician who gave it to them to begin with, so physicians do not

see those women again.

Dr. WELDON. Let me make sure I understand you clearly,

though.

Ms. NORSIGIAN. What I am saying is there is a need to protect

women from what I think right now are fairly substantial risks,

and the FDA has yet to do the job we want it to do. That is such

a great need that we need to take the legislative route that will not

allow somatic cell nuclear transfer now for research purposes.

Dr. WELDON. Your position, though, is you support the use of

Lupron in the setting where a woman wants to become pregnant,

wants to go through the IVF process and has been properly counseled on the potential side effects of Lupron? You are opposed to

the potential wide-scale large numbers of women who would be exposed to this drug in the setting of somatic cell nuclear transfer?

Ms. NORSIGIAN. ‘‘Support’’ is maybe too strong a term. I wish we

had better safety data on this particular drug before it became in

widespread use. It is in widespread use. The cat is out of the bag.

I do not agree with Dr. Zavos that cloning human beings is absolutely inevitable, it is just going to come, and we should just learn

to accept it. This is a case where there might be better drugs. We

might develop them.

I am not so sure that I am happy about the way Lupron has been

used for off-label use. It has never been approved for this purpose

in IVF clinics. I am not happy about this, but I am happy for the

many women, some of whom are my good friends, were able to use

IVF to become mothers. So for those women, and they are a minority, but for those women who were successful, even knowing there

were more risks than they were told, they would have taken those

risks to have a baby.

It is a very different risk-benefit ratio from a research setting

where providing eggs for research cloning would have nothing to do

with the opportunity of becoming a mother or treating a disease.

Dr. WELDON. Just for the record, and I know we have discussed

this privately, you do come at this cloning issue from a pro-choice

perspective? You support abortion rights, is that correct?

Ms. NORSIGIAN. Absolutely. I did not even think I had to say that

because Our Bodies, Ourselves is so well-known. We have been

strong reproductive rights advocates for many, many years. But we

also believe in having a strong FDA and having a strong system

of regulation. We are very concerned about the inability of IRBs to

monitor research protocols adequately.

I also serve on the board of directors of Public Responsibility in

Medicine and Research, which is doing a fair amount if not most

of the training of IRB members in the country. So I am deeply concerned with research issues.

I support research, and I want to say that I come from that position, but that it is not to be construed as accepting any and all research simply because it can be done.

Dr. WELDON. I thank the gentlewoman.

If the chairman could just indulge me for a little longer, Ms.

Howard—and by the way, I am very sympathetic to the problem

that you are facing with your daughter. I have had the opportunity

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to take care of some patients with Rett’s disease, and I understand

fully the challenge that you face.

Have you been led specifically to believe that there are researchers who have clinical applications of cloning technology specifically

designed for the use in Rett syndrome, or are you just taking the

position that you want to see all kinds of research go forward that

might have a potential?

I am just curious. As a physician, I have never seen anything

across my desk on a clinical application of cloning methods in

Rett’s, specifically.

Ms. HOWARD. Thanks for the question.

Let me say this, that after about a 20-year search, the Rett gene

was finally found only 2 years ago, so there is a lot still unknown

about Rett syndrome. Cystic fibrosis is a gene that I understand is

a gene that was discovered in 1989, and therefore people in that

field have had a much longer period to investigate how that gene

works, unlike Rett syndrome, which actually was discovered after

my daughter was born, in fact.

So my role as I see it in this debate is, since there is still so little

known about how that gene works, what the remedies for Rett syndrome could ultimately be, I believe strongly that this avenue

should be kept open. Because at the end of the day, it might

best——

Dr. WELDON. But you have not seen any evidence——

Ms. HOWARD. I have not. I have not seen any evidence that any

other pharmaceutical products could ultimately help, that any

other—even knowing we are in the 21st century and medical

science has advanced significantly, there is really nothing that can

help Rett syndrome.

So I want this avenue kept open, since this may be ultimately

the best avenue. I do not know that for certain.

Dr. WELDON. Just from a clinical perspective, I would argue that

cloning is extremely unlikely to ever be beneficial to your daughter,

but gene therapy would have the potential to help the victims of

Rett syndrome. I don’t want to burden the committee hearing with

a lengthy scientific discussion of that.

Now, you are representing the Coalition for the Advancement of

Medical Research, correct?

Ms. HOWARD. Yes.

Dr. WELDON. Their basic position is that they want to see this

move forward just because it might have some potential, but they

do not have any knowledge that it has any specific applications in

any of the conditions they are concerned about, correct?

Ms. HOWARD. Correct. Let me speak to that.

First off, let me just say generally that I recognize that we are

at a very new juncture in terms of science and that this is inevitably going to raise a lot of questions, all of which are good ones.

But, yes, indeed, the true application of therapeutic cloning has

not fully been realized. But 40 Nobel Laureates believe it holds a

lot of promise.

Let me also mention this point, that I know there is discussion

in the Senate about potentially just putting a temporary ban on

therapeutic cloning while we investigate further what its real

promise is. But what you do then is take a significant amount of

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momentum out of the focus on therapeutic cloning now, and even

a 1-year ban or a 2-year ban could sap resources out of biomedical

research companies, could make scientists go overseas.

So if one does want to realize the ultimate potential of therapeutic cloning, stopping it even for a year or two would set back

significantly ever finding out the potential of therapeutic cloning.

I will not ever profess to have been or I do not think this is ultimately the cure. I am just looking for some potential to help my

daughter and other people that are suffering.

Dr. WELDON. I could go on and on, but I see my time has well

expired.

I just want to mention for the record, Mr. Chairman, the 40

Nobel Laureates who signed the letter, 31 of them signed a letter

1 year ago stating that they would oppose or they would only support embryo stem cell on excess embryos from fertility clinics, 31

of the 40, and that they would oppose creating embryos for this

type of research, and 31 of these 40 in 12 months have changed

their position and now support the creation of embryos for this

kind of research, I think just essentially making the case that this

is a tremendous slippery slope.

I yield back. Thank you, Mr. Chairman.

Mr. SOUDER. Mr. Cummings.

Mr. CUMMINGS. Thank you very much. I apologize for being out

of the room. We have another hearing going on at the same time.

I apologize.

Ms. Howard, what do you say to those who argue that cloning

embryos is immoral?

Ms. HOWARD. First off, it is important to look at the difference

between reproductive and therapeutic cloning. I think the differences between the two have been lost in the debate.

Also, as I understand it, some of this original debate arose out

of knowing that there were embryos at fertility clinics that were

not being used and, instead of just throwing them away in the

trash bin, actually using them because they held some promise—

again, promise. I understand that I am not saying that there is a

solution, that therapeutic cloning is going to cure my daughter a

year from now. I don’t ever want to make that statement falsely.

Mr. CUMMINGS. But there is a possibility. You are looking at the

possibility, I take it.

We have had extensive testimony on what you just talked about,

the embryos that would normally be discarded. But go ahead.

Ms. HOWARD. OK. And then the idea, again, is to use an

unfertilized egg and take the nucleus out and mix it with the person who has troubles, including my daughter—with their own

DNA, mixing them together. I do think it is important to emphasize again that it is an unfertilized egg we are discussing.

Mr. CUMMINGS. Do you think there is a moral problem?

Let us deal with the therapeutic. You know, you have this group

of people who are very, very emphatic about the fact that you

should not mess with life. They do not care whether it is therapeutic or otherwise—or reproductive.

I was just wondering, before your daughter—or before you knew

about your daughter’s illness, did you have a position and has your

position changed as a result of that?

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Ms. HOWARD. My position has not changed at all. Even before Allison was born—and I think sometimes the point on pro-life is lost

on people. I am pro quality of life for those who actually are alive

now, and that is the extent to which I would extend my so-called

pro-life position, is enhancing the quality of life of those who are

suffering.

My daughter has the potential in the next year to 5 years of

dying suddenly, and that is why I take this moral position to work

with her and hope that there are treatments for her, including potentially this one, that could extend her life.

I don’t think that fact should be lost on people, that this is not

only about the life of the embryo, ultimately, but also the life of

those who have made it through the gestation period and now have

serious problems, as my daughter does.

Mr. CUMMINGS. Since we are seeing that you make the same argument that I have made, I can appreciate that. I mean, when we

see people who stand the possibility of suffering for the rest of their

lives or dying and if there is a possibility, I guess as a parent, I

share with you, I guess I would try to go to the ends of the Earth

to try to save my child. So I can understand that.

How do you respond to the notion that what is therapeutic

cloning is basically offering some type of false hope? We have had

some testimony about that today. There are some people who claim

it is false hope. How do you feel about that?

Ms. HOWARD. In my testimony, I pointed out that there are lots

of false hopes I could be chasing, not only therapeutic cloning, but

there could be false hope that a pharmaceutical product is going to

help my daughter.

After this juncture, after 20 or 30 years of miraculous advances

in science in this country and overseas, there still is no cure for my

daughter. So I am not walking around hopeful that there may be

a cure next week or within 2 or 3 years.

Actually, even if it takes 20 or 30 years for this science to ultimately bloom and come to fruition, I, as a mom, would hope that

the next generations of mothers who have Rett syndrome daughters could have a cure that I do not actually have for my daughter.

So if I am not here in this generation in the beginning of the 21st

century able to help my daughter, I am hoping that science at least

advances or I am pushing science along for the next 20 or 30 years

so future generations do not have to cope with what I am coping

with.

Mr. CUMMINGS. Dr. Kelly, if therapeutic cloning research produced, directly or indirectly, a cure for spinal cord injury, would

you avail yourself of it?

Mr. KELLY. That is a really good question. That is a really good

question. I appreciate your asking that.

As a matter of fact, I definitely would avail myself of it. At least

I would—I thought I would several months ago, because I refused

to look at the moral science of the question. I thought to myself,

you know, let us not look at the moral science of it, because what

happens if it turns out you need this to get cured? That is what

led me to not look at the moral aspects of it.

Now I have come to the conclusion that, No. 1, it is not going to

lead to a cure for spinal cord injuries, for reasons I have already

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told the panel. No. 2, I have come to the conclusion that it is morally wrong, OK?

I have also looked at myself. I said, now, Jim, would you have

the guts to stand up for your convictions, your moral convictions?

If something came out next week for—and I don’t believe it is going

to happen, I don’t think it is even possible it could happen, I don’t

think it is possible it could happen in 10 or 20 years—but if there

was a miracle and somebody came out next week and the cure was

with cloning, if that is what you are asking me, right——

Mr. CUMMINGS. Yes, sir.

Mr. KELLY [continuing]. I will tell you the truth, I don’t think I

would have my guts to turn my back on it, all right?

Now, having said that, having said that, you have to understand

that I must really believe that it is not going to happen or else I

would not be coming in front of you today and trying to talk whoever is listening to this panel, this testimony, talk you into backing

Senator Brownback’s bill and fully banning human cloning.

I would not be doing that, because I am fully admitting that I

would avail myself of the cure if it was here. And I know it is im

immoral. I am admitting it is immoral, and I am a weak person.

I have a wife who would hate me, I know she would, because she

does not have my moral views on this matter, and she would hate

me if I told her, honey, you would have to stay with me the way

I am, because I am not going to take the cure. I know that, if that

is what it was. I will tell you, sir, I don’t think I have the moral

courage. But it is not going to happen.

Mr. CUMMINGS. Well, let me just leave you with this, then, with

the Chair’s indulgence. I think, when I look at science, when I look

at something as simple as the computer, and the idea that maybe

20 or 30 years ago, 40 years ago, somebody could have easily said,

one day we are going to be able to fax things across the wire and

we are going to be able to have computers that talk to each other,

I think or I am sure there were people who were naysayers and

saying, it will never happen. Yet, it is happening, and things that

I never imagined, never imagined, are happening.

I will never forget the first time I saw a fax coming over a fax

machine, I could not believe it.

So I think that I often say it is the people who are the misfits

that make a difference in our society, the ones that step out of the

box. We are enjoying a lot of the benefits that come from people

who have been misfits.

Mr. KELLY. Sir, can I say something about that?

Mr. CUMMINGS. Yes.

Mr. KELLY. You made the same comment as Dr. Usala, if I am

not mistaken, about out-of-the-box thinking and misfits, right?

Supposedly, what is supposed to be so revolutionary about

cloning, what it might be able to do, is offer embryo stem cells that

have the patient’s own DNA, right? OK. And what you are saying,

if I understand correctly, is if you can use out-of-the box thinking,

then maybe that might lead to a cure that nobody thinks is even

possible. Maybe I don’t think it is possible. My research is telling

me it is not possible. Maybe I am wrong, OK?

I am glad you used the word ‘‘out-of-the-box.’’ The reason why is

what Dr. Usala does is he started out in his research 10 years ago

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with the theory that he proved later on in clinical trials, you saw

that, that the cells respond to the environment that is around it.

But not only do the cells do that, but now they are finding out in

cloning that the nucleus of the cells respond to the cytoplasm,

which is the yoke of an egg, OK, or the yoke of a cell. They are

finding that the nucleus responds to that.

So now they have come to the point, Dr. Wise Young, I mentioned, the Director of the Rutgers University Neuroscience Department, he wrote to me and he said that there is ‘‘a growing consensus in the field that the most desirable cells for transplantation are

cells that are far enough along the way to differentiating into desirable cells, such as neurons, insulin-secreting cells, radial glial or olfactory ensheathing glial cells, that they have a high likelihood of

producing such cells.’’

OK, that is not really what I wanted to say, here. What that is

saying is that embryo stem cells—early stage embryonic stem cells

which cloning can lead to are not even considered the most attractive cells for implantation anymore.

But that is not what I want to say. He wrote to me, and he said,

‘‘The other recent finding that has really turned a lot of heads in

the regenerative field is the study showing that skin cells can be

turned into lymphocytes by using a chemical to permeabilitize the

skin cells and soak them in lymphocyte cytoplasm.’’

OK, now I know this is very confusing. What this is saying here

is that they found out that if you take the yoke of an egg, what

they are calling the cytoplasm, and if you inject that into a skin

cell, what that does is it bathes the nucleus of that cell.

Instead of taking the nucleus out and putting in an embryo to

make a clone in order to get stem cells, now they have found out

that they can take the cytoplasm out of the embryo, the yoke out

of it, or even the yoke out of another stem cell and put it into your

skin cells, and that will bathe that nucleus in the skin cell, and

that skin cell will turn into a stem cell or an embryo or whatever

cytoplasm you put in it.

Now that is completely out of the box. Because, if you want to

call an egg a box, you are taking the yoke out of the box and you

are putting it in there. So what you are doing now is making—basically, what they are after with cloning, they are after embryonic

stem cells with a patient’s DNA. What he is telling us here is that

you can make embryonic stem cells with the patient’s DNA, and

you don’t have to make an embryo to do it. Now that is out-of-thebox thinking.

He also says that it is cheaper, it is safer, and it is more effective

than going with the cloning process, and this man is in favor of

cloning.

Mr. CUMMINGS. Thank you very much.

Mr. SOUDER. Thank you.

I appreciate your patience, Mrs. Davis, for letting us each go over

on our time here.

I yield to Congresswoman Davis.

Mrs. JO ANN DAVIS OF VIRGINIA. Thank you, Mr. Chairman.

Ms. Howard, you said a moment ago, I believe, and you stressed

it several times, that the cloned human embryo would be not fertilized. Is that correct?

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Ms. HOWARD. Yes.

Mrs. JO ANN DAVIS OF VIRGINIA. President Clinton’s National

Bioethics Advisory Commission, in its 1997 Report on Cloning

Human Beings, stated that the Commission began its discussions

fully recognizing that any effort in humans to transfer a somatic

cell nucleus into an enucleated egg involves the creation of an embryo with the apparent potential to be implanted in utero and developed to term.

If it is a nonfertilized egg, why would it be planted in utero and

then come to full term?

Ms. HOWARD. I am not going to—I am not here to talk about eggs

that would be implanted in utero. I am here to talk about growing

cells in a petri dish for 3 or 4 days that could——

Mrs. JO ANN DAVIS OF VIRGINIA. I understand that, but you stated, and you emphasized it more than once, that it was a nonfertilized egg. I am trying to find out why you think that a cloned

human embryo was a nonfertilized egg.

Ms. HOWARD. Go ahead.

Ms. NORSIGIAN. I was just mentioning to her that we were talking about asexual reproduction, but it is still potential reproduction. So you are right, it has the potential of being implanted and

becoming maybe a malformed human being, but a human being.

So I think most people who look at this accept that somatic cell

nuclear transfer introduces the possibility of having human reproductive cloning, and that is why we are having this discussion and

why the Justice Department is looking at the question of enforcement.

I think it is also very important to get back to what you were

saying, Mr. Cummings, about the question of, you know, research

and the potential and do you say no.

There is a researcher at Johns Hopkins, Dr. Gerhart, who has

demonstrated that he has been able to solve one of the problems

with embryo stem cells. Two of the major problems are the

tumorogenicity and the inability to control differentiation, and if he

in an animal model lets the embryo grow to a fetus and it is at the

8- or 9-week-old stage and he harvests germ line cells—these are

no longer embryo stem cells, but they are still stem cells—he harvests germ cells, he has been able to inject that into tissue and

avoid the problem of creating tumors.

So that creates an example of the type of slippery slope we would

be facing. If we knew we could have cures or we might potentially

develop cures, do we then say, OK, we are not going to say 7 or

14 days is the limit, we are going to let ourselves grow embryos in

an artificial setting to a later stage of development because we

think we could have an effective cure?

It does create huge moral and ethical issues to simply say, because we can do it, maybe we should.

Ms. HOWARD. Let me speak——

Mrs. JO ANN DAVIS OF VIRGINIA. I would like to reclaim my time

so I can ask all the questions I need to ask.

Ms. HOWARD. OK, but you did ask a question. Can I explain

briefly how to——

Mrs. JO ANN DAVIS OF VIRGINIA. If the chairman will indulge me

and let me go over my time, sure.

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Ms. HOWARD. In SCNT, somatic cell nuclear transfer, i.e., therapeutic cloning, the nucleus of the donor’s unfertilized egg is removed and replaced with the nucleus of a patient’s own cells, like

skin, heart, or nerve cells. These types of cells are called somatic

cells. No sperm is used in this procedure. The cells are not transplanted into the womb. The unfertilized egg cells are stored in a

petri dish to become a source of stem cells that can be used to treat

life-threatening medical conditions.

What I think would be important to get you more background

about——

Mrs. JO ANN DAVIS OF VIRGINIA. Is that a human cloned embryo?

Ms. HOWARD. This is an unfertilized egg. I am not sure—let me

say this. I know that in both bills people have raised questions

about the definition of what an embryo even is. I am not going to

be here to tell you—to get into that. I will not have a definitional

debate with you, but I think it is important for you to see the material that the coalition has put out about how they hope SCNT

would be used.

Mrs. JO ANN DAVIS OF VIRGINIA. I am short on my time here.

As I understand it, the only difference in therapeutic cloning and

reproductive cloning is simply the purpose, what they are used for.

So I guess that is why I am having the confusion if it is nonfertilized.

I guess, Ms. Norsigian, I would ask you, do you think that approving and permitting therapeutic cloning would then lead to reproductive cloning when there is effectually no difference except for

the purpose for which they are used?

Ms. NORSIGIAN. I think people who have—especially the statement that we heard read earlier, or parts of it that were read by

the Chair, are very good comments about how it would be almost

impossible to enforce a ban on human reproductive cloning if we

allowed clonal embryos to be produced en masse, ostensibly for research purposes, but you would never be able to know that they

would not be, and they could be fairly easily used in other ways,

especially given the other bills that have absolutely no protections

of the sort that might even reduce that likelihood.

So you are absolutely right, it is really the intent that matters

here. But when you create a clonal embryo, it is an embryo that

is capable of becoming a human being. We just would rely on people’s good will not to do so, if there was a ban against human reproductive cloning.

Mrs. JO ANN DAVIS OF VIRGINIA. If you just stated that if you

clone an embryo it has the potential to become a human being,

then you disagree with the nonfertilized——

Ms. NORSIGIAN. Of course I disagree. If you have asexual reproduction, it is still reproduction. The fact that you are not using

sperm is really not that relevant in terms of the issue of whether

you can create a human being or not. It is very unusual, and there

are people wondering, you know, this talk about the post-human

future and all of that. But it is still the potential reproduction,

even though it is not your classic fertilization the way we have always known it.

Mrs. JO ANN DAVIS OF VIRGINIA. Thank you, Mr. Chairman. I

would yield to you, Doctor, but I don’t have any time left.

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Dr. WELDON. From a biological perspective, when you put a nucleus from a somatic cell into an egg and it begins to divide and

form an embryo, you have a human embryo. It has the full potential, if it were introduced into a woman, to grow into a human

baby. Just like Dolly the sheep was created, the same way, that is

what they are talking about, in using humans.

What I think the gentlelady was trying to somehow imply is that

it is somehow not human because you did not use a sperm to create

it, that it is not an embryo somehow. The quote you have from the

Bioethics Advisory Committee, President Clinton’s Bioethics Advisory Committee, states very categorically that it is an embryo. That

is because any biologist with his head screwed on right knows it

is a human embryo. Despite some of the linguistic gymnastics that

some people are trying to engage in on this issue, it is a human

embryo.

Mrs. JO ANN DAVIS OF VIRGINIA. Thank you, Doctor, because it

was very confusing to me.

Thank you, Mr. Chairman.

Mr. SOUDER. I want to thank this panel, as well as the first

panel, for taking the time to come here to Washington. We may

have additional written questions. I want to do a couple of things

in summing up.

One is that I thought Mr. Kelly did a good job of pointing out

the ‘‘box’’ question. In fact, cloning is inside the box. It is the currently PC term. It is the term that is the trendy thing to do. What

we need are the creative proposals that we have heard at all the

hearings that actually have produced results, and that research

has basically been outside the box and shorter in duration than the

types of research that have not been productive.

The question we need to be asking is, why is so much being driven toward nonproductive research and away from dollars that could

be productive research? ‘‘outside of the box’’ is reversed on its head.

There is a difference between a promise which is based on something and a possibility based on a hope that does not have any scientific evidence.

I think as we move forward in these hearings we continue to look

for—and as we can see from today’s hearing, we had—wide diversity. This was not an ethics of the debate hearing.

The second point, in one of these hearings we are going to get

into the ethics more. I found Dr. Zavos’ statement extremely troubling. That was what he said, we cannot be distracted by ethics.

We are entering an era in the world where we had better be distracted by ethics, because these are very difficult questions. Individuals may disagree about when precisely life begins, how to define that life, how we should relate to each other, but just like here

in the origins of life, we have to be concerned about ethics, and we

are going to get into this in bioterrorism and when is a terrorist

attack justified and not justified.

We need to have ethics as part of the public debate. It is scary

to think it would not be part of the public debate.

Last, because I am sure anybody watching today is going to be

very confused, because terminology in Washington changes based

on kind of who wants to spin something for what time period, we

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have seen a dramatic change in the argument toward research

cloning from human cloning.

But somatic cell nuclear transfer, as has been stated here, is still

a human embryo. It is a human embryo that is not necessarily

being implanted. It is human cloning for research purposes, as opposed to human cloning for growing a future human being, but it

is still human cloning, and it is just a different form. Changing a

name to somatic cell nuclear transfer does not mean it is not

human cloning, but it has a different purpose to the human

cloning.

We are debating today about the different types of human

cloning. We crossed two different types of human cloning, but we

were still debating human cloning and not human cloning; and inside human cloning, two types, one just for research purposes, and

one Dr. Zavos was arguing was for actually creating future, living

human beings.

I want to once again thank all of the panelists who came forward

today. If you have additional comments you want to insert for the

record, or additional materials, you may.

I want to thank all the Members who participated and look forward to working with you in the future.

With that, our hearing stands adjourned.

[Whereupon, at 3:35 p.m., the subcommittee was adjourned.]

[Additional information submitted for the hearing record follows:]

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