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78383 PDF 2002

S. HRG. 107–444

CLONING, 2001

HEARING

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON APPROPRIATIONS

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

SPECIAL HEARING

DECEMBER 4, 2001—WASHINGTON, DC

Printed for the use of the Committee on Appropriations

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/senate
(II)

COMMITTEE ON APPROPRIATIONS

ROBERT C. BYRD, West Virginia, Chairman

DANIEL K. INOUYE, Hawaii

ERNEST F. HOLLINGS, South Carolina

PATRICK J. LEAHY, Vermont

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

BYRON L. DORGAN, North Dakota

DIANNE FEINSTEIN, California

RICHARD J. DURBIN, Illinois

TIM JOHNSON, South Dakota

MARY L. LANDRIEU, Louisiana

JACK REED, Rhode Island

TED STEVENS, Alaska

THAD COCHRAN, Mississippi

ARLEN SPECTER, Pennsylvania

PETE V. DOMENICI, New Mexico

CHRISTOPHER S. BOND, Missouri

MITCH MCCONNELL, Kentucky

CONRAD BURNS, Montana

RICHARD C. SHELBY, Alabama

JUDD GREGG, New Hampshire

ROBERT F. BENNETT, Utah

BEN NIGHTHORSE CAMPBELL, Colorado

LARRY CRAIG, Idaho

KAY BAILEY HUTCHISON, Texas

MIKE DEWINE, Ohio

TERRENCE E. SAUVAIN, Staff Director

CHARLES KIEFFER, Deputy Staff Director

STEVEN J. CORTESE, Minority Staff Director

LISA SUTHERLAND, Minority Deputy Staff Director

SUBCOMMITTEE ON DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND

EDUCATION, AND RELATED AGENCIES

TOM HARKIN, Iowa, Chairman

ERNEST F. HOLLINGS, South Carolina

DANIEL K. INOUYE, Hawaii

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

MARY L. LANDRIEU, Louisiana

ROBERT C. BYRD, West Virginia

ARLEN SPECTER, Pennsylvania

THAD COCHRAN, Mississippi

JUDD GREGG, New Hampshire

LARRY CRAIG, Idaho

KAY BAILEY HUTCHISON, Texas

TED STEVENS, Alaska

MIKE DEWINE, Ohio

Professional Staff

ELLEN MURRAY

JIM SOURWINE

MARK LAISCH

ADRIENNE HALLETT

ERIK FATEMI

ADAM GLUCK

BETTILOU TAYLOR (Minority)

MARY DIETRICH (Minority)

SUDIP SHRIKANT PARIKH (Minority)

Administrative Support

CAROLE GEAGLEY

EMMA ASHBURN (Minority)
(III)

CONTENTS

Page

Opening statement of Senator Tom Harkin .......................................................... 1

Opening statement of Senator Arlen Specter ........................................................ 2

Opening statement of Senator Mike DeWine ........................................................ 4

Statement of Hon. Sam Brownback, U.S. Senator from Kansas ......................... 4

Statement of Dr. Michael D. West, president and CEO, Advanced Cell Technology, Worcester, MA ......................................................................................... 14

Prepared statement .......................................................................................... 16

Statement of Dr. Ronald M. Green, professor, Dartmouth College ..................... 20

Prepared statement .......................................................................................... 21

Statement of Dr. Bert Vogelstein, professor of Oncology and Pathology, Johns

Hopkins University, Baltimore, MD ................................................................... 23

Prepared statement .......................................................................................... 25

Statement of Phyllis E. Greenberger, president and CEO, the Society for

Women’s Health Research, Washington, DC ..................................................... 26

Prepared statement .......................................................................................... 28

(1)

CLONING, 2001

TUESDAY, DECEMBER 4, 2001

U.S. SENATE,

SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN

SERVICES, AND EDUCATION, AND RELATED AGENCIES,

COMMITTEE ON APPROPRIATIONS,

Washington, DC.

The subcommittee met at 9 a.m., in room SD–192, Dirksen Senate Office Building, Hon. Tom Harkin (chairman) presiding.

Present: Senators Harkin, Specter, and DeWine.

OPENING STATEMENT OF SENATOR TOM HARKIN

Senator HARKIN. This hearing of the Senate Labor, Health and

Human Services, and Education Appropriations Subcommittee will

now come to order. Three years ago, Dr. Michael West of Advanced

Cell Technology testified before this committee about a new plan

to transplant a patient’s DNA into a human egg, grow some stem

cells, and then use those cells to cure devastating diseases. It was

a plan that brought hope to millions of Americans suffering from

Alzheimer’s, Parkinson’s, spinal cord injuries, diabetes, and many

other diseases and debilitating conditions. Late last month Dr.

West announced that he had taken the first step toward reaching

that goal. Dr. West’s announcement received a great deal of media

attention, but it has also started an avalanche of disinformation

about what this advance means and whether or not it will lead to

human cloning. I think it’s time to spend more time on the facts

and less on the fiction. That’s why Senator Specter and I decided

to invite Dr. West to join us once again today.

One thing has become very clear in this debate: as long as the

opponents of stem cell research can wave the flag of human

cloning, science will be inhibited. The proposition of human cloning

worries most Americans, as it should. Some choose to feed these

worries. That’s why I think it’s important forever to separate the

issue of human cloning from the science of stem cell research.

Soon I will be introducing legislation that will ban human

cloning, and impose strict criminal and civil penalties on any misguided person who would conduct this type of procedure. This legislation would draw what I call an ‘‘iron curtain’’ between responsible

research and misguided attempts to pursue human cloning. At the

same time that this ‘‘iron curtain’’ shields us from a reckless few,

it protects responsible scientists, allows them to continue their

search for cures to many devastating diseases, and I think it is

very important that we make that distinction. The chart that I

have here illustrates my point. The research we’re discussing today
2

involves taking the DNA out of a donated egg and replacing it with

the DNA from someone who may have a disease like Alzheimer’s

or Parkinson’s. That’s called somatic cell nuclear transfer. Now my

bill prohibits this process from ever leading to a human clone. But

it does allow the creation of stem cells that could result in a cure;

in other words, once you get the somatic cell nuclear transfer, you

can go two ways: you can go to implantation in a woman’s womb

to try to get a cloned human, or you go in the other direction to

get the stem cells that can go to cure someone who has an illness.

What my proposed legislation would do would be to ban that one

avenue, and to impose very strict criminal and civil penalties on

anyone who would engage in that, thus leaving open the avenue

that would go from somatic cell nuclear transfer down to stem cells

and to possible cures.

This technology and science has enormous potential to ease

human suffering, and I believe it would be a very serious mistake

to ban it. My legislation would protect our values by banning

human cloning, but protect our health by fostering research into

stem cells.

We’re very fortunate to have a distinguished panel of witnesses

to testify about these issues this morning. Before we hear from

them, I would turn now to my distinguished ranking member, Senator Specter, to make his opening remarks.

OPENING STATEMENT OF SENATOR ARLEN SPECTER

Senator SPECTER. Well, thank you very much, Mr. Chairman,

and thank you for promptly scheduling this hearing within just 10

days of the widely publicized disclosures regarding the cloning

issue, which reached the covers of the national magazines. I think

it is very unfortunate that the name ‘‘cloning’’ has been attached

to what is called ‘‘therapeutic cloning,’’ because it confuses the

issue with reproductive cloning, and the appropriate scientific

name, as you have already noted, Mr. Chairman, is somatic cell nuclear transfer. And there is no doubt about the abhorrence of reproductive cloning to create another human being. But simply stated,

that is not what is involved here. What we have, essentially, is a

technique which involves the taking of genetic material out of an

unfertilized egg and inserting in its place the DNA of an adult cell,

for example if somebody is suffering from Parkinson’s or Alzheimer’s or amyotrophic lateral sclerosis, so that when the stem

cells are derived and injected into that individual, there is not a

rejection. We have had some very heated debate on the floor of the

U.S. Senate with all of the evils and all of the dangers of human

cloning, which we all agree to. But I do believe it is plain at this

juncture that we can have legislation which will ban human reproductive cloning without prohibiting so-called ‘‘therapeutic cloning.’’

But I believe that it is indispensable that the scientific community

come forward and take an aggressive role in educating the American people as to just what is involved here. The House of Representatives has passed legislation which prohibits somatic cell nuclear transfers, so-called ‘‘therapeutic cloning,’’ and it is entirely

possible that the Senate could take similar action. And we had the

matter come to the floor of the Senate with our appropriations bill

for the Department of Health and Human Services where this sub-
3

committee and the full committee inserted language which would

codify the decision of President Bush to permit Federal funding on

existing stem cell lines.

Now there is little doubt that President Bush does not intend to

permit Federal funding on stem cell lines beyond the approximately 70 which he identified as of August 9. But the subcommittee wanted to codify that, and the full committee agreed,

but concerns were raised on the Senate floor about that provision

on the grounds that another president might permit further funding. Then amendments were offered which would raise a whole

range of prohibitions against reproductive cloning and therapeutic

cloning, and in order to avoid a lengthy debate we deferred the

matter until February or March when the Senate majority leader

has agreed to take this issue up as a free-standing bill. Then the

publicity occurred 10 days ago when the matter was back on the

Senate floor yesterday in a complex procedural issue where an effort was made to bring the matter back up, notwithstanding our

agreement to defer it until February or March, and it came up on

a so-called ‘‘cloture vote’’ and was defeated. That is interpreted in

this morning’s news media as saying that the Senate has rejected

the effort on banning somatic cell nuclear transfers or therapeutic

cloning. Well, that’s not exactly right, but I don’t think it’s going

to come back up this session.

This hearing has been called so that the scientific community can

come forward. My own view is that the limiting of the Federal

funding on stem cell research to the approximately 70 lines in existence as of August 9 is tying the hands of scientists. There hasn’t

been a groundswell on that issue because there has been insufficient time to find that those lines will not support all the research

which is necessary. But prior to the President’s announcement, we

had some 64 senators who had signed on urging Federal funding

on stem cell research, and another dozen had orally committed to

me that they would support Federal funding, but didn’t want to put

it in writing.

So what we have are a group of issues where there is enormous

potential for curing Parkinson’s and Alzheimer’s and heart disease

and cancer and to have these matters inhibited on ideological

grounds is, in my view, just unthinkable in the 21st century. There

are people who feel very passionately on the other side, and in accordance with the way our democracy works, let’s shed light on it.

Let’s bring it all out into the open. But to do that, the scientific

community is going to have to be activated. Too often the scientific

community is inert. And Senator Harkin and I have taken the lead

in adding some $11 billion to the $12 billion in NIH funding, including our current appropriations bill, thereby providing the funding resource for enormous advances to cure many, many maladies.

So that’s the challenge we have. So I hope the scientific community—I know quite a few will watch this on C-Span—understands

that the time has come to move forward. Thank you very much,

Mr. Chairman.

Senator HARKIN. Thank you, Senator Specter. Senator DeWine.
4

OPENING STATEMENT OF SENATOR MIKE DE WINE

Senator DEWINE. Mr. Chairman, I just thank you for this hearing. I’m a co-sponsor of Senator Brownback’s bill. I’m looking forward to hearing his testimony and also hearing the other witnesses

as well. Thank you.

Senator HARKIN. Thank you, Senator DeWine. I’ll leave the

record open for any other statements that any other members of

the subcommittee might have. Now we’ll turn to our first witness,

our colleague Senator Brownback, who was elected to the Senate

in 1996 and serves on the Commerce, Science and Transportation

Committee, the Judiciary Committee, and the Foreign Relations

Committee. He received his law degree from the University of Kansas and his BA from Kansas State University. Senator Brownback

has testified before this subcommittee two times on the issue of

stem cell research, and it is a pleasure to welcome him back again

to discuss this important issue. Senator Brownback, welcome back.

STATEMENT OF HON. SAM BROWNBACK, U.S. SENATOR FROM KANSAS

Senator BROWNBACK. Thank you very much, Mr. Chairman,

members of the committee and thank you for allowing me the opportunity to be here to testify in front of you today. My testimony

will be more in the form of questions than in comments, as I really

think that’s the stage that we’re at with the issue of human

cloning, and that’s why I’ve advocated on the floor a moratorium

at this point in time before we go forward with further human

cloning, under whoever’s definition you want to put it, of human

cloning, but that we just call a timeout now, while we really contemplate some deep questions.

I’ve supported and continue to support you and Senator Specter’s

efforts to increase funding at NIH for incredible breakthroughs

that I think are potentially there as well in other areas, and in

adult stem cell work, which I’m a strong advocate of us funding.

And I continue to support that funding increases that you put forward at NIH and I think that’s a wonderful place for us to invest.

So we can find cures, so we can give hope. So we can give a better

life to people that certainly deserve it. But at this point in time I

have a lot of questions about human cloning and I think that’s

really where the public is, and that that’s why the public in such

an overwhelming fashion is opposed to human cloning. In any poll

that you see it gets nearly 90 percent opposition to human cloning.

And I want to pose some of those questions to you if I could this

morning.

The issue of human cloning is an issue of vast historical significance, and one that should give us all considerable pause. It is, as

I have stated before, a debate with a moral status of the young

human. Succinctly put, is the cloned human a ‘‘who’’ or a ‘‘what?’’

A person or a thing? Does a cloned human embryo have any moral

significance? Is there a difference between a human embryo created

by man and one created by God? These are historical questions

that the world is grappling with right now, as we hold hearings

here, hearings are being held in the European Union, in capitals

throughout the world some 28 countries have already wrestled with

and passed laws to some degree or another dealing with the issue

of human cloning. Yet it is occurring in our country, and I really,
5

Mr. Chairman, with all deference to my colleagues, think that this

is a moment in history, the history of humanity, that we should

pause. Just pause for a period of time and really hold a series of

hearings over a period of months, while we hold up and say, now

wait a minute, before we unleash this issue, and this question, let’s

pause, and let’s really think this through and debate. Is this a person or not? Does this have any moral significance or not? And let’s

bring in a broad cross-section of people over a lengthy period of

months, and then let’s take this issue forward, rather than saying

‘‘We will let private companies decide this issue in the absence of

any speaking of this by the congress and the president of the

United States,’’ which is currently the situation of what’s taking

place.

That’s why I really think that this issue deserves considerable

debate, and a moratorium at this period of time, for a period of 6

months, while we really sort through these historic questions about

humanity.

Let me read to you some comments from other people that I

want to share the broad-based nature of the concern over the issue

of human cloning at this point in time. Because there’s an interesting coalition of groups that are forming opposed to all human

cloning, by all definitions, all human cloning. In fact, pro-choice

feminist Judy Norsega, and biologist Stuart Norman recently commented in a Boston Globe column the following: Because embryo

cloning will compromise women’s health, turn their eggs and

wombs into commodities, compromise the reproductive autonomy,

and with virtual certainty lead to the production of experimental

human beings, we are convinced that the line must be drawn here.

Now despite some similarities, this debate is not about abortion,

and I don’t think it should be confused with that debate. And perhaps this is why we have such a broad coalition forming of groups

who are strongly opposed to abortion, groups also that are strongly

supportive of abortion, environmentalists and others. The reason

for the broad range of interests is that there is truly something

about this issue that should concern us all, and should cause us to

pause.

I’d like to read another statement, this from an environmentalist

group. Dr. Brent Blackwelder, president of Friends of the Earth,

stated at a recent news conference this:

‘‘Environmentalists embrace an ethic of respect for nature and strive to demonstrate the interdependence of humans and our natural world. Proponents of

cloning and inheritable modification, on the other hand, extol the virtues of ‘remaking Eden,’ of improving what nature has given us. For example: designer babies, or

the cloning of pets that don’t cause allergies, will lead us down a slippery slope toward the redesign of the rest of life. Indeed, if society allows the cloning of human

beings today, inheritable genetic manipulation of humans and all other species cannot be far behind.’’

Now Mr. Chairman, I don’t necessarily agree with what both of

those individuals are saying. But what I want to demonstrate for

you is the depth of conviction that some people have of the real historical questions that we’re entering into right now, and that we’re

not even speaking on it. The Senate has not issued its rules that

it is saying on this. There are no regulatory guidelines. These

things are taking place basically at the review of ethical boards put
6

forward by private companies. At a monumental time. At a monumental time.

Therefore, Mr. Chairman, I would submit that the technology is

now moving faster than expected, and our ability to consider a full

and permanent ban on human cloning is moving slower than it

should, and that it is time for us to pause and contemplate. I urge

my colleagues, and in particular the Majority Leader, to call up

H.R. 2505, that’s the House-passed bill on a permanent ban on

human cloning, or at a minimum—at a minimum—a 6-month moratorium so that we can restore the status quo in our country, until

such time as the Senate can debate and really hear the issue.

The President has asked for us to pass the 2505 bill that the

House has passed by a bi-partisan majority, a hundred vote margin

passed that House bill overall. And I really think that—I do know

how this debate—I do not know how this debate will be resolved,

Mr. Chairman, but I do know that history is watching what we do

today, and it will record our actions for the benefit of our ancestors.

And I hope it’s a history that we can be proud of at this point in

time.

Mr. Chairman, I don’t want to disparage anybody’s work in the

research community that they’ve done. I think all operate from a

laudable set of objectives. But this is one that shouldn’t be decided

by private companies. The public bodies should speak, and should

speak clearly on this issue, and we should have a moratorium at

the present time, while we consider the full ramifications of what

we’re doing. Thank you, Mr. Chairman.

Senator HARKIN. Thank you, Senator Brownback, for, as always,

a very thoughtful and lucid presentation.

You were asking for a 6 month moratorium, is that correct?

Senator BROWNBACK. At this point in time, what I was bringing

up on the floor yesterday was a moratorium for a period of 6

months, while we could fully contemplate, consider the issue, before really the technology gets out way in front of the contemplation.

Senator HARKIN. I just want to be clear. Since this is a private

company that’s doing this, I’m not certain if they’re using any Federal monies at all—I don’t know that. The answer to that question

I’ll find out soon, I guess. But how do you stop a private company?

Senator BROWNBACK. We put a moratorium on human cloning of

all types for a period of 6 months.

Senator HARKIN. But how is it enforced against a private company?

Senator BROWNBACK. You could do the 2505 bill and sunset it in

6 months.

Senator HARKIN. No, but I’m saying——

Senator BROWNBACK. And that is a total ban.

Senator HARKIN. I mean, do you have criminal penalties or civil

penalties in place?

Senator BROWNBACK. Criminal and civil penalties that would be

in place for 6 months—period of 6 months and you would sunset

it after that period of time so that they would have to act.

Senator HARKIN. What happened to my chart? You’ve taken an

egg and removed the DNA, and you’ve taken the DNA out from

this individual that may have Alzheimer’s and you’ve placed this
7

DNA in this egg. What I’m saying is, you could put an iron curtain

right here [motioning to chart], and say you can’t go that path, but

you could go this path. You still want to put a moratorium on that?

Senator BROWNBACK. If I could answer your question with the

recommendations of the National Bioethics Advisory Commission—

this is 1997—they stated this about the creation of that middle are,

the somatic cell nuclear transfer. ‘‘The Commission began its discussions fully recognizing that any efforts 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.’’ In other words, that creation of the entity

right there is a creation of the embryo by definition of the—President Clinton’s National Bioethics Board, with the potential of implantation. I don’t see how you stop the implantation from then

taking place.

Senator HARKIN. Well, you pass a law that says if you do this,

this has criminal and civil penalties attached to it.

Senator BROWNBACK. But what effect are—let’s say you do implant at that point in time. Are you going to require that she abort

the child in the law? I wouldn’t anticipate we would do that. There

might be some penalty that you put on a person, but you will have

a cloned human born at that point in time.

Senator HARKIN. All right, I’ll ask you the question. You say that

you want to put the ban right here [motioning to chart]——

Senator BROWNBACK. From the creation of the somatic cell——

Senator HARKIN. Stop it right here [motioning to chart]——

Senator BROWNBACK. That’s where an embryo is created by the

definition of the National Bioethics Board.

Senator HARKIN. Let’s say that someone went ahead and did it,

and implanted it, then what would you do? Would you say that

that woman would have to abort it or not?

Senator BROWNBACK. No.

Senator HARKIN. What would you do?

Senator BROWNBACK. I think you’re going to—you’re going to see

the civil penalties put in place, but the child is going to be born.

Senator HARKIN. Well then, the penalties that my bill would put

in place would be the same as yours if this happens. Right? If——

Senator BROWNBACK. I don’t know what penalties you’d put—

what would there be penalties——

Senator HARKIN. Well, let’s say I have civil and criminal penalties, you would put these starting here [motioning to chart.] It

would cover both of these.

Senator BROWNBACK. From the creation of the embryo, yes.

Senator HARKIN. What my legislation would do is say, okay, you

would stop it here, you put the criminal and civil penalties here.

Your question to me was, well what if someone went ahead and did

this, what are you going to do? I mean, you’re not going to abort

it or anything but I asked you the same question. What if you draw

the iron curtain here [motioning to chart] and someone goes ahead

in a private company, does this, then implants it, you face the

same problem with your legislation.

Senator BROWNBACK. You have that problem, but I also—as I

posed at the outset the question of is there any moral significance

at all to the creation of an embryo? Is there any? And what I’m
8

submitting to you at this point in time is that we should err on the

side of caution and say there is some moral significance here, and

that we shouldn’t be allowing that to take place. I think you try

to do the best you can to keep that from occurring.

Senator HARKIN. I just want to be clear on that, where you’d

draw it here [motioning to chart,] some of us would draw it here

and permit this. Now——

Senator BROWNBACK. The House drew it there as well.

Senator HARKIN. Pardon?

Senator BROWNBACK. The House, in their passed bill, drew it

there, and that is what the President is seeking as well.

Senator HARKIN. You mentioned in your comments, Sam, that

these ethical guidelines were put forward by private companies. In

fact you pointed out that there was a national bioethics commission

set up—at NIH it has just gone out of commission in October of

this year, by the way, it sunsetted. They came up with a number

of recommendations and ethical guidelines for stem cell research.

And quite frankly, if you match their guidelines with the guidelines

proposed by President Bush on August 9 of this year, they are exactly the same, except for one thing, one thing. I’ve got the list, I

compared them side by side, they’re exactly the same but for the

fact that the President said you could only utilize stem cell lines

that were derived prior to 9 p.m. on August 9. The bioethics commission did not draw that kind of arbitrary line. But the other

thing—you know, you can’t buy them, there cannot be any monetary consideration, they cannot be used for reproductive cloning—

all those were in that bioethics commission. So this was not a private company. This was a separate bioethics commission you just

quoted from.

Senator BROWNBACK. Yes, but—we know about the issue of stem

cells, but I think that issue’s been resolved pretty much by the

President’s order. What we’re talking about here is the creation of

a human clone, and I consider this a different set of issues that

you’re talking about on creating an actual—into which—as I recall

in front of this entity before, this body before—most of the Members were advocating then we shouldn’t be creating embryos for research purposes. I think the Members here have stated that to me

previously. We’re talking about, these are leftover embryos at in

vitro fertilization clinics, going to be thrown away, so why not?

Which, I have some questions about that, but that’s not the stage

we’re at now. Now we’re talking about the actual creation of embryos for research purposes, which Members of this body had

talked previously we should not be doing that, and we should not

be going there.

Senator HARKIN. That will be coming up here later about the definition really of an embryo and if something reaches just the blastocyst stage, it is—I’m not a scientist, but from what I have been

told by scientists is that, at that stage of the blastocyst, where you

have the requisite number of cells that you could extract for stem

cell purposes, that at that stage the embryo really cannot be implanted in the womb. So it’s still something prior to, or pre-embryonic at that point. It becomes embryonic at some point after that.

Now I will ask the scientists to further elaborate on that. But you
9

are saying that as soon as you take DNA of any nature and put

it in an egg, you have an embryo. That’s what you’re saying.

Senator BROWNBACK. I’m quoting from the National Bioethics

Commission, that they’re saying that’s the creation of an embryo

at that point in time. And the DNA structure of that embryo is the

same DNA structure that, if you let it fully grow through to term,

to full physical status, its DNA structure will not be any different.

It will be—that will be its DNA.

Senator HARKIN. Let me ask you this question, Senator. Are you

in favor or opposed to in vitro fertilization?

Senator BROWNBACK. I have no opposition to in vitro fertilization.

And the issue here is about the creation of clones. I’ve had a number of friends and family members—not family members—friends

who’ve gone through that procedure and they have children—beautiful children.

Senator HARKIN. So in vitro fertilization is fine?

Senator BROWNBACK. It is fine by me.

Senator HARKIN. But as you know, when you have in vitro fertilization you have leftover embryos.

Senator BROWNBACK. As it’s practiced here in the United States,

we do, yes.

Senator HARKIN. So what do you do with them?

Senator BROWNBACK. Well, we’ve been through this discussion

before as well, there are adoption procedures that people can go

through—what I’m discussing here today is the creation of an embryo just for that research purposes, which is the issue that we’re

on on human cloning. And that’s the one I think we should pause

on.

Senator HARKIN. I’m not so certain that—and I will ask scientists

further to elaborate on this, and I’m not certain the bioethics commission was correct in that I haven’t read that exactly. But I’ve

been told, and I will ask further scientists to give me the exact

reading on this is, if you implant DNA in an egg in which other

DNA’s been extracted, and that develops only to the blastocyst

stage, is it really embryonic or is it not embryonic at that point?

Again, I don’t know, I’m not a scientist. But I’ve heard that it may

not be, and I want to find that out. I don’t know if that bioethics

commission was correct in that, I just don’t know.

Well, I appreciate the give-and-take with you, Senator, thank you

very much. Senator Specter.

Senator SPECTER. Thank you, Mr. Chairman. Senator

Brownback, what we have here so far is research not to have

human cloning, not to make babies, so to speak, but to develop tissues for treating disease. You raise a question about the moral significance of creating an embryo, and I can certainly understand

that, where you raise a concern about having a man-made creation

of an embryo result in reproductive cloning or the creation of another person. But it is quite another matter where this is done for

therapy. For example if someone has Parkinson’s you can have the

curative stem cells derived from an embryo that has been created

in part with the DNA of the potential recipient, someone illustratively who has Parkinson’s, so that they will not reject the stem

cells, but can, in fact, be cured. So taking away the possibility of

creating another human being, and having as a sole purpose ther-
10

apy to cure someone with Parkinson’s or amyotrophic lateral sclerosis, Lou Gehrig’s Disease or many other ailments, what’s wrong

with that? The embryo has significance morally if it leads to the

creation of a person. But if it’s sole purpose is for therapy, and it

works, why not?

Senator BROWNBACK. I would submit there’s another route we

can go, that we are going presently that’s being quite successful,

as we’ve discussed many times in the area of the adult stem cell

work, where the genetic match-up is identical, where the donating

person is also the person that needs the help. And that research

is moving beautifully, it’s being well-funded by the Federal Government and I support that. And I think we should be doing that as

rapidly and as aggressively as possible.

The issue that you raise is about, well, why not just go ahead

and create this human embryo, is the very question I put in front

of you, and one I think we need to contemplate and that is, is there

any moral significance at all to that human embryo that’s being

created? There is no difference physically between it and one created naturally by God.

Senator SPECTER. Well, Senator Brownback, that’s by no means

certain. There is considerable scientific speculation. At the time

you have this entity, there’s no person involved. There is only a

procedure for curing a disease. If you strike out the possibility of

creating a person, how does that differ from any other scientific research?

Senator BROWNBACK. What have you created then? I mean, have

we created a human embryo or not? I guess there’s dispute as to

whether we’ve created a human embryo or not, and you’ll hear

from other testimony. I’m just reading from our own National Bioethics Advisory Board which says that we’ve created a human embryo. If that is the case, then this is a human egg that’s fertilized

that in other species we protect. We protect bald eagle eggs because

we look at them, we say, well, if we don’t protect them we’re not

going to get any bald eagles. So these or other endangered species

we say we’re going to protect these because they lead ultimately to

a full grown bald eagle. DNA-wise, they are identical to what this

bald eagle will be. We have contemplated that as a body, and we’ve

enacted that in laws. What I’m saying here is that we should really

contemplate as a body, is does what we’re creating here have any

moral significance? If it doesn’t, if it’s a piece of property, we move

on forward with it. If it does have some moral significance, then

we should grant it whatever protections that we deem appropriate,

and that this is the point for us to stop and really chew through

those, for a moratorium for 6 months, is why I asked for that.

Senator SPECTER. Senator Brownback, when you talk about adult

stem cells, I’m for doing the research there. This is our 12th hearing on this subject. In the 3 years since stem cells came forward,

we’ve invited you to testify on a number of occasions. But there’s

been a lot of scientific evidence at that table that the adult stem

cells don’t have the potential which embryonic stem cells do. But

in any event, why should these decisions be made in room 192 of

the Dirksen Senate Office Building as opposed to a laboratory?

What business do we have, as long as we don’t allow reproductive

human cloning, to tell the scientists what to do?
11

Senator BROWNBACK. Because this body has generally considered

issues regarding protection of rights and life, if that is a life. And

that’s what this body has generally considered. And we don’t let

just anybody take somebody’s else’s life or, for that matter, property without consequences in this society. We put boundaries. And

what I’m simply asking here is let’s contemplate that question first,

before that’s taking place in private laboratories in this country.

This is the appropriate place for it to occur. This is where the people’s business is discussed. The House has passed it and contemplated it. The President’s asking for it. This is the appropriate

place, Senator Specter.

Senator SPECTER. Senator Brownback, when we propose that we

could ban reproductive cloning at implantation, and you say, how

do you know that that’s going to be carried out. Whenever you have

a criminal law, you don’t know that it’s going to be carried out. We

may pass your legislation, and someone may totally disregard it

and move right through to reproductive cloning. Now they may run

the risk of not being detected or run the risk of penalty. So if you

prohibit part of it, if you prohibit only the second phase of implantation, you have precisely the same chance of having an effective

criminal deterrent.

Where we have generalized agreement is on no reproductive

cloning. Why not end it there and allow science to have free rein

to try to cure Parkinson’s, Alzheimer’s, etc?

Senator BROWNBACK. I am for curing Parkinson’s and Alzheimer’s. I want that to be clear. I think that there is a way that

we can go about this, and I think you’ll look at the adult stem cell

work today, because we’ve been in this debate now for a year, it

has improved marvelously—that that has grown and that that has

moved forward. But we have to contemplate, and a number of people in this country hold very significant, moral significance to the

embryo. There’s a large cross-section of Americans that do hold

that there is moral significance to what you are laboring here, somatic cell nuclear transfer, what our bioethics board is calling the

creation of an embryo. So I just think that the really sensible approach here is just to pause for a while. Just pause.

Senator SPECTER. Senator Brownback, is there any realistic likelihood that something’s going to happen between now and February, March, when you and I have agreed to set in motion the

mechanism where the bill will come up as a free-standing bill?

These embryos didn’t even succeed by the company which made

them. Do you think there’s any chance at all that something’s going

to happen between December 3 and March?

Senator BROWNBACK. Absolutely. Absolutely. I didn’t know this

was being contemplated—this work was being—was going on by

this Massachusetts-based company. And I think that now that

they’ve started and gotten this far, I think it’s very clear that the

road map has been made and that we’re going to, going to see this

moving on forward quite easily, quite quickly. Even though it may

take, I think in Dolly there was 257 attempts before you finally got

to Dolly, that was there, 257 aberrations or changes, you’re going

to see a lot taking place here as well. But I think that’s a very high

probability.
12

Senator SPECTER. Well, that is another area for disagreement. I

think the chances in the few months are just nonexistent. Final

question: when President Bush agreed to use Federal funding on

stem cells, it drew a lot of opposition—I think opposition from you,

among others—and the President has pretty much held the line.

There was an overwhelming sentiment, as I said earlier, in the

Senate to have Federal funding on stem cells. Don’t you think that,

in a sense, President Bush’s recognition of the propriety of useing

Federal funds on stem cell research has moved beyond some of the

moral issues which had been raised earlier about the propriety of

using these embryos and extracting the stem cells and working for

the cure of diseases.

Senator BROWNBACK. Absolutely not, Senator, and I want to say

as well, I generally was overall supportive, and I stated that at the

time, supportive of what President Bush put forward. I had some

questions and some concerns about certain key areas of it, but

overall—and I stated that at the time—I thought he generally

found a route where we weren’t incentivizing further destruction of

what a number of people believe is the starts of life. But now you

have the President last week himself saying: ‘‘We shouldn’t create

life to destroy it.’’ It’s a quote from the President. We haven’t resolved the moral issues here about the creation of life or its destruction. Indeed the President’s saying we shouldn’t do that. The

House is saying we shouldn’t do that. Should we have embryo

farms, as being contemplated by a company in the state of Virginia? Where we get naturally created embryos, but that are more

vigorous and vital, is what this company is saying, taking place.

That’s another issue that we really should wrestle with. But no, I

think you’re just—we’re wading into—and then what about the

issue when you start bringing genetic material from outside the

human species into the human species, as some companies are contemplating? You know, clearly we ought to be taking that up, before that’s actually a reality.

Senator SPECTER. Well, I quite agree with you about outside the

human species and inside the human species, but your legislation

doesn’t do that. And I agree with President Bush’s statement that

we shouldn’t create life to destroy life. But I hardly think that

we’re talking about the creation of life here. Well, Senator

Brownback, I have deep respect for your convictions, and you and

I have crossed swords on this here and in others forums, and I suspect we may well again even before March or—when we debate it

on the Senate floor. So thank you.

Senator BROWNBACK. Thank you.

Senator SPECTER. Thank you, Mr. Chairman.

Senator BROWNBACK. Thank you, Mr. Chairman.

Senator HARKIN. Senator Brownback, we’ve talked about birth

purposes versus therapeutic purposes. I wonder if, in your opinion,

does the ultimate purpose for which a particular act takes place affect its morality or affect its propriety? In other words, does the intent of the person who is starting this act or doing these things ultimately affect how we as a society should view this particular act?

It seems to me that distinction is being made here, and we’re going

to hear in a moment from further witnesses who are going to try
13

to shed some light on that. But I just wondered, in your opinion

does that, does the intent matter?

Senator BROWNBACK. I don’t know how you effectively draw clear

differences if you’re basing it upon intent. Is there an intent to implant or not? And yet you’ve still created the same entity. I don’t

think you can draw effective differences based upon the intent of

the creator of the entity. So I—no, I don’t think that’s an effective

line to draw, and indeed, basically that’s what’s taking place—here

you’re saying there’s no intent to implant, therefore it’s not a clone.

Well, then you’re making your distinction based upon what’s in

somebody’s thinking process, and I don’t think you can effectively

do that and I don’t think that’s the right way for us to consider it.

Thank you, Mr. Chairman.

Senator HARKIN. Thank you. Sam, before you leave, I pulled off

the Scientific American web site an article that was by Ron

Green—Mr. Green will be testifying later—and he said: ‘‘What is

the moral status of the organisms created by cloning?’’ And basically—I’ll let him read it when he comes up, but I ask—you ought

to take a look at it and read it, it’s from the November 24 issue,

2001 of Scientific American.

Senator BROWNBACK. I’m glad those issues are being

contemplated——

Senator HARKIN. And Ron Green, who wrote it, is going to come

up and testify, and I’m going to ask him—because he has a different view of it. He said:

‘‘We pointed out that, unlike an embryo, a cloned organism is not the result of

fertilization of an egg by a sperm. It is a new type of biological entity never before

seen in nature. Although it possesses some potential for developing into a full

human being, this capacity is very limited. At the blastocyst stage, when the organism is typically disaggregated to create an embryonic stem cell line, it is a ball of

cells no bigger than the period at the end of this sentence. Embryos normally do

not attach to the wall of the uterus and begin development until after the blastocyst

stage. It has no organs, it cannot possibly think or feel, and it has none of the attributes thought of as human. Although Board members understood that some people would liken this organism to an embryo, we prefer the term ‘activated egg,’ and

we concluded that its characteristics did not preclude its use in work that might

save the lives of children and adults.’’

So there’s a difference of opinion about what the bioethics advisory commission had termed an embryo. I think these are the

things we’ve got to be thinking about and looking at and getting

the scientists and others to talk about and the ethicists and others

to talk about.

Senator BROWNBACK. Well, as I stated at the outset, I have far

more questions than I have comments at this point, but that’s exactly why we should hold up here. Plus I would point out a number

of people are saying the embryo is an embryo if it’s implanted. Well

that’s a distinction based upon location. And do we make that distinction anywhere else—that it’s an embryo if it’s implanted, but

it’s not if it’s not. I think you’ve got to really question if you draw

lines based upon intent, which I don’t think you effectively can do,

or location as well. And I’m pleased that you’re, and others, are

considering these very historic type of questions and comments.

Mr. Chairman, thank you very much for allowing me to come and

discuss the issue and I have a great deal of respect for the charge

that you have here.

Senator HARKIN. Thank you very much, Senator Brownback——
14

Senator BROWNBACK. Thank you.

Senator HARKIN [continuing]. I appreciate it.

Next we’d like to ask our panel to come up—that would be Dr.

West, Michael West, Dr. Ronald Green, Dr. Bert Vogelstein and

Ms. Phyllis Greenberger. All of your statements will be made a

part of the record in their entirety. I’d like to ask if you could sort

of summarize them in a short span of time. We’ll put the clock on

for 5 minutes. But we’ll be very lenient there and—maybe 7 minutes or something like that—but if you could summarize it so we

could get into a discussion I would appreciate that.

Dr. Michael West, we’ll start with you, then we’ll just go down

the line. Dr. West is the president and CEO of Advanced Cell Technology in Worcester, Massachusetts. He received his bachelor’s degree in psychology from Rensselaer Polytechnic Institute, his master’s in biology from Andrews University and a Ph.D. in cell biology

from Baylor College of Medicine. This is Dr. West’s fourth appearance before this subcommittee. So we welcome you back, Dr. West.

As I said your statement will be made a part of the record, so

please proceed.

STATEMENT OF DR. MICHAEL D. WEST, PRESIDENT AND CEO, ADVANCED CELL TECHNOLOGY, WORCESTER, MA

Dr. WEST. Mr. Chairman and members of the committee, thank

you very much for inviting me today. I would like to speak to you

both about the opportunities and the challenges we have this year

and moving into the coming years. I think we’ve been seeing three

major developments in the history of biology and medicine that will

impact our lives and the lives of our children and subsequent generations in, I think, a significant way. The first of course, which is,

I think well known now, is the sequencing of the human genome.

We have a fundamental new understanding of the blueprint of life,

DNA, which will have a profound impact on all of our lives.

I would argue a second major development is the discovery or the

isolation of the human embryonic stem cell. These cells are, to use

an analogy, the building materials of life. If you imagine the building being constructed, and a truck driving up full of lumber, these

cells are completely undifferentiated cells that can branch out and

make any cell in the body. And of course their importance in medicine is exemplified by the recent report by the National Institute

of Health. There’s much discussion about their relative merit compared to the adult stem cell, but just as one simple example of

their relative benefit: the embryonic stem cell can self-assemble

into a complex tissue given the right circumstances. It can actually

form intestine and other kidney tissue, and other important tissues—we’ve never seen this before in the history of medicine. So

these cells are unique and have, I think, an important role in medicine in the future.

A third area where I think we’ve seen a dramatic advancement

that could be used for the benefit of humanity is the discovery of

nuclear transfer. What attracted cell biologists and medical researchers such as myself to the discovery of what we call cloning

is not, I think, what’s popularly perceived. It’s not that we could

clone our favorite race horse or hunting dog. What excites us about

nuclear transfer is that it is a means of taking a person’s cell back
15

in developmental time, to make embryonic stem cells identical to

the patient. And of course, what this could mean is—you know, the

dream of research scientists—is that we might finally solve this

age-old problem of transplantation.

Our automobile, if the carburetor breaks, we can go to the store

and get a new one. But, as amazing as it sounds, for our loved ones

when we have a heart attack and our heart muscle dies, until now

we’ve never had a means of giving people back all the cells and tissues of their own DNA type so they would not be rejected. And this

is one of the greatest promises of the medical uses of nuclear transfer. Of course we’re not talking about cloning of humans, as has

been pointed out. We’re talking about the cloning of cells.

Now it’s been—the concept has been introduced, and the concern

has been introduced, what is it that we’re talking about making

here? We’re talking about cloned embryos. What are these, and

what should be their moral significance? I think this is—and I

share with Senator Brownback the concern over—this is a very serious issue. I personally hold a deep respect for the sanctity of

human life. And let me say, if the proposition was that we would

clone a developing human being, I would argue, with Senator

Brownback, we shouldn’t cross that line. We have a line here. It’s

the primitive streak. Early in development—what we call pre-implantation embryos—prior to forming a pregnancy—we’re talking

about a little clump of cells that has no body cells of any kind, and

no cells on their way to becoming yet a body cell of any kind. Purely the raw material of cellular life.

The bright line, I would argue, would be a wise one for us to

draw, is primitive streak. At about the time of implantation, this

pre-implantation embryo begins the first steps toward becoming

human being, or indeed it may form two human beings, identical

twins. Primitive streak, I think, is an effective line to draw and say

that is the beginning of a human being. And prior to primitive

streak we should use some other terminology, a pre-implantation

embryo or some other such terminology, because this is not an individualized human being.

I would like to summarize by saying and sharing the sense of

gravity on this issue. Millions of human lives hang in the balance

on these important decisions. One of the reasons I would not recommend a moratorium is, as I calculate, in 6 months, a 6 month

delay in medical research we would estimate would cost potentially

541,800 lives that could potentially be treated someday with these

technologies.

PREPARED STATEMENT

And so I would argue rather than slowing medical research, that

we take the time to carefully understand these issues, as we did

IVF. We had the same, I think, knee-jerk reaction to IVF. Isn’t this

Brave New World? Isn’t this the kind of world we don’t want to

make? But with time we came to realize that the proposition of

making in vitro fertilized embryos and making pregnancies was a

gift to mankind. It built families, and it had in it positive benefit.

So what I would ask is, let’s take the time and get this right.

Thank you very much.

[The statement follows:]
16

PREPARED STATEMENT OF DR. MICHAEL D. WEST

Mr. Chairman and members of the Subcommittee, my name is Michael D. West

and I am the President and Chief Executive Officer of Advanced Cell Technology,

Inc., a biotechnology company based in Worcester, Massachusetts. A copy of my curriculum vitae is presented in Appendix A.

INTRODUCTION

I am pleased to testify today regarding human embryonic stem cell and nuclear

transfer technology and their applications in medicine. I would like to first speak

to the potential benefits of this emerging science, and then speak to some of the

questions and concerns that have been voiced.

THE POTENTIAL BENEFITS OF ES AND NT TECHNOLOGY

Human Embryonic Stem (ES) cells are unique in the history of medical research

for at least two reasons. First, they alone are totipotent stem cells. By stem cells,

we mean cells that can branch out like the stems of a tree, becoming other cell

types. By ‘‘totipotent’’ we mean to say that they stand near the base or ‘‘trunk’’ of

the developmental tree and so are capable of forming any cell or tissue type needed

in medicine. In addition to forming any cell type, they are unique in their ability

to self-assemble into complex multicellular tissues such as intestine, full thickness

skin, kidney tissue, and so on. They differ in this respect from adult stem cells that

are ‘‘pluripotent’’—that is, capable of forming several, but only a limited number,

of cell types. One can think of adult stem cells as limbs further out on the branches

of a tree. While able to branch out in several different directions, only the trunk

of the tree branches out into every leaf and limb. An example of adult pluripotent

adult stem cells are the bone marrow stem cells now widely used in the treatment

of cancer and other life-threatening diseases.

The second distinguishing feature of ES cells is the ease with which they can be

purposefully modified in a precise manner. This precise genetic modification is designated ‘‘gene targeting’’. The enhanced ability of ES cells to be modified with precision likely opens the door to many hundreds of clinical applications making human

cells of any kind, genetically modified in any way to ‘‘heal’’ mutations in genes,

something never before possible in medicine.

These two unique characteristics of human ES cells open the door to manifold

novel therapeutic strategies. It may not be an exaggeration to state that the combination of the ability to precisely genetically modify these cells by targeted modifications and the ability to make any cell type may have as profound an application

in medicine as the ability to arrange electrical components has made in the electronics industry.

To attempt to name every disease that potentially could be treated using this

technology would require a larger report. Here are just a few examples. Neurons

could be manufactured to treat degenerative diseases such as Parkinson’s and spinal

cord injury. Gene targeting to find and ‘‘heal’’ mutations could be used to manufacture neuronal stem cells for childhood retardation from diseases like Rett syndrome.

Heart and skeletal muscle cells could be used for heart failure and age-related skeletal muscle wasting, and targeted genetic modification could be useful in muscular

dystrophy. Blood forming cells would be useful in bone marrow grafting after cancer

treatments, and anemias. Precision genetic modification could lead to better therapies for inherited blood cell disorders such as sickle cell anemia and infectious diseases such as AIDS.

I would argue that the debate over the number of human ES stem cell lines approved for Federal funding largely misses the point. Human ES cells obtained from

IVF preimplantation embryos are not identical to the patient, that is they are

‘‘allogeneic’’. We should expect that such cells derived from the 20–60 approved lines

would be rejected by the patient’s immune system. The primary purpose in funding

human ES cell research is not just the pure pursuit of human knowledge, but rather

to accelerate the delivery of novel therapeutics to afflicted people. We must address

from the beginning how we are going to make these cells useful in transplantation.

THE USE OF NUCLEAR TRANSFER IN MEDICINE

The recent success in the cloning of animals from body cells demonstrates that

the transfer of a body cell into the environment of an egg cell can ‘‘reprogram’’ it

back to an embryonic developmental state. We have recently demonstrated that

such technology actually rebuilds the replicative lifespan as well, suggesting that

‘‘young’’ cells can be derived from ‘‘old’’ cells. This is a profound development and

perhaps the ideal solution for making real the longstanding dream of transplan-
17

tation medicine; namely, to be able to offer any patient, even an aged patient, young

healthy embryonic stem cells of from which any kind of cell could be make all of

which would be their own cells, not expected to be rejected by their immune system.

Nuclear transfer offers an important solution of the problem of tissue rejection.

Every year many thousands of people die for the inability to liver, kidney, or other

tissue with the right constellation of markers to allow it to accepted by the body

as self. It is estimated that three thousand people a day die from degenerative disease potential addressed by therapeutic cloning. This new procedure would begin

with the patient donating living cells to a physician, who would then reprogram

them back to a totipotent state using the cloning procedure. This is called therapeutic cloning, to distinguish it from reproductive cloning which is designed to clone

an entire human being. Therapeutic cloning does not involve the cloning of a human

being, it involves the medical use of cloning to make living cells. The cells and tissues made from these cloned stem cells would be expected to be grafted stably for

the life of the patient without immunosuppression.

RESPONSES TO CONCERNS AND OBJECTIONS

(1) The preimplantation embryo is a human life and to use therapeutic cloning

is to ‘‘clone and kill’’.

Answer. In the first few days following the fertilization of an egg cell by a sperm

cell, there develops a microscopic ball of cells called a preimplatation embryo. This

embryo is destined to die unless it implants in the uterus to form a pregnancy. Indeed, it is estimated that 50–80 percent of these preimplantation embryos naturally

formed in a woman’s body never implant and therefore die, naturally. Prior to day

14, the preimplantation embryo has no body cells of any kind, and, in fact, has no

cells even committed to somatic cell lineages. Indeed, the embryo has not individualized. Once this ball of cells attaches to a uterus, one or even two or more individuals

can form from it. It is therefore proper to say that it is not yet an individual. At

ACT, we neither allow cell development beyond day 14, nor do we implant the cells

in a uterus.

(2) Therapeutic cloning is merely theoretical; there is no reason to suggest it will

work.

Answer. There are published reports of success of therapeutic cloning research in

at least two mammalian species; namely mice (1–2). While never performed in a

human, the animal data suggests that therapeutic cloning has great promise. The

National Academy of Sciences has formally recommended in a report titled ‘‘Stem

Cells and the Future of Regenerative Medicine’’ as follows:

‘‘Recommendation: In conjunction with research on stem cell biology and the development of potential stem cell therapies, research on approaches that prevent immune rejection of stem cells and stem cell-derived tissues should be actively pursued. These scientific efforts include the use of a number of techniques to manipulate the genetic makeup of stem cells, including somatic cell nuclear transfer.’’

(3) Allowing therapeutic cloning would cause a ‘‘slippery slope’’ effect, whereby

regulating human reproductive cloning would not be possible.

Answer. In reality the procedures to clone a human being are well known in the

scientific literature. The widespread use of therapeutic cloning would not significantly increase the likelihood of the success of an effort to clone a human being.

In addition, laws can easily be written to allow one and prohibit the other as reproductive cloning requires the transfer of a cloned preimplantation embryo into a uterus.

(4) Therapeutic Cloning will lead to ‘‘embryo farms’’.

Answer. Therapeutic cloning guidelines could easily be constructed to limit development to less than 14 days as is the current practice with in vitro fertilization.

SUMMARY

In conclusion, nuclear transfer and human embryonic stem cell technology offer

novel pathways to develop lifesaving therapies that will impact the lives of millions

suffering from such diseases as Parkinson’s disease, diabetes, arthritis, heart disease, kidney failure, spinal cord injury, liver failure, skin burns, blood cell cancers,

to name only a few. The gravity of this issue calls for a compassionate, reasoned,

and dispassionate debate. History will judge us harshly if we as a society fail to recognize and deliberate carefully upon a medical technology that could so powerfully

alleviate the suffering of our fellow human being.
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SOMATIC CELL NUCLEAR TRANSFER TECHNOLOGY IS JUSTIFIED AND ESSENTIAL FOR

PRODUCING EMBRYONIC STEM CELLS FOR BASIC RESEARCH AND THERAPEUTIC APPLICATIONS

Since 1997 The American Society for Cell Biology has stated and stood by its

strong opposition to the reproductive cloning of human beings. Media claims notwithstanding, current scientific information suggests that the technology now available will not be able to lead to the creation of a cloned human being or to an embryo

capable of being born as a cloned normal human. Equally important, no responsible

scientist favors reproductive cloning.

It is unlikely that current biomedical technology can be used to clone adult human

beings. But there is substantial justification to believe that somatic cell nuclear

transfer (SCNT), or what many have referred to as therapeutic cloning, will energize

scientific progress in the fight against the most debilitating illnesses known to man.

New embryonic stem cell lines, potentially capable of avoiding the rejection complications of stem cell therapies for cancer, diabetes, spinal cord injury, kidney disease, and Parkinson’s disease, may be produced by using the genetic material of the

prospective transplant recipient to generate recipient-matched stem cells. These procedures could be vital in solving the persistent problem of a lack of genetically

matched, qualified donors of organs and tissues that we face today. Stem cell research is an essential first step if we are ever to be able to achieve the promise of

regenerative medicine, a wholly new approach for repairing cells and tissues in the

treatment of currently intractable human diseases. Beside the therapeutic promise,

the SCNT procedure permits entirely new approaches to the study of the earliest

phases of human development, of how a single cell is transformed into the trillions

of different cells and tissues with myriad fates and capabilities during embryonic

development. By deriving embryonic stem cells with defined mutations scientists

gain a new approach to understanding how such inherited predispositions lead to

serious disease in adulthood.

Unfortunately, an onerous cloud has been cast on the term cloning because it has

been used in the public discourse both to refer to attempts to create genetically

identical adult humans and to describe other procedures that are less controversial.

However, cloning is a scientific term that describes the preparation of an ‘‘infinite’’

number of copies of, for example a single molecule, cell, virus or bacterium. For example, cloning DNA molecules was essential for solving the human genome sequence. Similarly, cloning DNA is critical to fight against bioterrorism and has already been used in the determination of the entire genome sequences of several organisms identified as bioweapons. Furthermore, cloning is integral to modern forensic procedures, medical diagnostics, vaccine development, and the discovery and production of many of the most promising drugs. Cloning is also used to make genetically identical plants and livestock enabling continued agricultural breakthroughs

necessary to feed a rapidly growing and undernourished world population.

Conflating the term cloning as it is used for the creation of genetically identical

humans with the valuable and appropriate uses of cloning embryonic stem cell lines

for basic research and therapeutic purposes is inappropriate. The two issues need

to be considered separately; otherwise we run the serious risk of sacrificing certain

great benefits to prevent a perceived undesirable practice.

Senator HARKIN. Thank you, Dr. West. Senator Specter has to go

to another committee, but wanted to ask a question or two before

he left. Normally I’d go through the whole panel, but I’m going to

interrupt right here and let Senator Specter——

Senator SPECTER. Well, thank you very much, Mr. Chairman.

The Judiciary Committee is meeting on the military tribunals and

I’m going to have to excuse myself for a few minutes and I’ll come

back as soon as I can. But I wanted to question you a bit here, Dr.

West. Picking up on the number of lives which you said could be

saved in the intervening 6 months, what is the basis for you conclusion on that?

Dr. WEST. That’s based on the number that approximately 3,000

people die a day, every day, from degenerative diseases that could

potentially be treated with these technologies.

Senator SPECTER. So you think you could save a total of how

many lives? And it will be—the delay would cost how many lives?
19

Dr. WEST. It’s a large number, because——

Senator SPECTER. What figure had you just said?

Dr. WEST. 3,000 a day.

Senator SPECTER. So you made a calculation of 541,000, more

than a half million lives would be lost by a 6 month delay?

Dr. WEST. Obviously we’re not talking about therapies that

would be available next week, next month, next year, but a delay

would have that impact someday on——

Senator SPECTER. On the results that you reported, the embryos

did not live. Is there any chance at all of human reproductive

cloning in a 6 month period? Any chance at all?

Dr. WEST. Reproductive cloning? I don’t think so.

Senator SPECTER. Creation of a human being.

Dr. WEST. Well, I mean, there’s always some measurable chance.

But the cloning of a human being, in my own professional opinion,

I don’t believe that that’s at all a likely outcome.

Senator SPECTER. Dr. West, where the example has been used

about taking the genetic material out of an unfertilized egg and illustratively taking some skin tissue from somebody who has Parkinson’s, and placing that in the egg and then implanting it—could

that result in having a human being created? If so, what if the

donor of the DNA is a woman, is that possible, scientifically?

Dr. WEST. If the donor of the DNA is a woman?

Senator SPECTER. Yes.

Dr. WEST. Could a woman clone herself, you mean, or

through——

Senator SPECTER. Well, the donated egg comes from woman, obviously. Then you have a woman who has Parkinson’s, and you get

a DNA specimen from that woman who has Parkinson’s, and you

put that in the donated egg—can that then be implanted in a

woman and create a baby?

Dr. WEST. I think your diagram is very accurate. As far as we

know today, both branches of that diagram are possible. So we believe, indeed, it would be—as best as we know today, possible.

Senator SPECTER. Even if the DNA from the Parkinson’s patient

comes from a woman?

Dr. WEST. If I understand your example correctly, once you’ve

made a pre-implantation embryo by nuclear transfer, if that embryo was transferred into a uterus in an attempt to establish a

pregnancy, which obviously it is not at that point, pregnancy would

be possible.

Senator SPECTER. Even though you have a woman who has donated the egg, and you have a woman whose DNA is transplanted

to the donated egg, you can create a baby?

Dr. WEST. As I understand your question, yes.

Senator SPECTER. The answer then is yes?

Dr. WEST. If the cell, the DNA from the sick patient is, you

know, healthy DNA, then you would expect that you could create

a healthy baby by transferring——

Senator SPECTER. And it doesn’t matter that the DNA comes

from a woman?

Dr. WEST. No. No, indeed Dolly the sheep was cloned from a female.
20

Senator SPECTER. Thank you very much. I’ll come back as soon

as I can.

Senator HARKIN. Okay, thank you very much, Senator Specter.

Now we turn to Dr. Ronald Green. Dr. Green’s been a member of

Dartmouth University Faculty for 20 years. He is now the director

of the Ethics Institute and Chair of the Religion Department. Dr.

Green graduated from Brown University and received his Ph.D. in

religious ethics from Harvard University. Now Dr. Green, I didn’t

mean to quote you earlier, but I had read that article in Scientific

American, so I decided to go ahead and quote it, but—again, welcome, and please proceed.

STATEMENT OF DR. RONALD M. GREEN, PROFESSOR, DARTMOUTH

COLLEGE

Dr. GREEN. Thank you for doing so, Senator Harkin. Good morning to Senator Harkin and the other members of the committee. As

has been indicated, I am a professor of religion at Dartmouth College, where I also chair the Ethics Institute. As a matter of public

service, I serve as head of the Ethics Advisory Board, or EAB as

we call it, of Advanced Cell Technology in Worcester, Massachusetts. ACT’s scientists recently announced that they had successfully produced the first cloned human organism. I want to report

to you on some of the ethical reflections that led the members of

ACT’s EAB to endorse this research. Above all, I want to signal a

crucial difference between what has been called reproductive

cloning and the kind of so-called therapeutic cloning research in

which ACT is engaged.

Reproductive cloning, as has been said today, aims at the birth

of a child. ACT has never pursued this goal. All the members of

ACT’s EAB believe that at this time reproductive cloning in human

beings is too risky to be responsibly pursued. In addition, most

EAB members believe that many other difficult ethical questions

would have to be answered before reproductive cloning could ever

be justified. Therapeutic cloning is an entirely different matter.

This is the kind of research ACT is conducting. Therapeutic cloning

involves the use of nuclear transfer or cloning technology to

produce immunologically compatible human stem cell lines. If

therapeutic cloning research is successful it will mark the beginning of a new era in medical science.

You have all heard about the promise of human stem cells, the

basic building blocks from which almost any tissue in the human

body could be fashioned. This summer, President Bush authorized

Federal funding for research using a limited number of human

stem cell lines. However, the problem with these and any other

stem cells is that the patient’s body would see them as foreign tissue. The result could be rejection. Therapeutic cloning offers a way

around this problem. In the future, the mother of a child suffering

from juvenile diabetes could donate an egg from one of her ovaries.

A cell could be scraped from the inside of the child’s cheek. Using

a cloning procedure it might then be possible to produce a stem cell

line that could be coaxed to differentiate into new insulin-producing

cells. These could be injected back into the child’s body, where they

would not likely be rejected. The child would be spared a lifethreatening disease.
21

The members of ACT’s EAB came to the conclusion that this research direction is important and ethically sound. On the one hand,

we believe that the life-saving promise of this research constitutes

an important ethical consideration in its favor. On the other hand,

as we reviewed the biological qualities of these cloned organisms,

we concluded that they could not be equated morally with the children or adults whose lives could be saved by therapeutic cloning research. We noted that these clusters of cells lack most of the qualities we normally equate with a human life. They are not the result

of the union of sperm and egg. They represent an entirely new kind

of biological organism, never before seen in nature. They have no

differentiated cells, and cannot think or feel. Because spontaneous

twinning is still a possibility at this very early stage of development, they are not yet human individuals.

We acknowledge that others may come to different conclusions

about the moral status of this very early form of human life. We

doubt, however, that there is a moral consensus in our society

about this matter or likely to be one soon. In view of this, we concluded that privately funded researchers and scientists should be

free to continue with this research on the basis of their own conscientious beliefs.

The primary message I have tried to communicate today is that

therapeutic cloning and reproductive cloning are two different

things. Some will object, however, that there is a slippery slope

here, that therapeutic cloning could lead to reproductive cloning.

For two reasons, the members of the ACT EAB did not share this

fear. First, we believe that open and publicly discussed research

like this may actually reduce the chances that unscrupulous researchers will pursue reproductive cloning. It could do so by highlighting the physiological dangers of reproductive cloning. ACT’s research shows that cloned human organisms are extraordinarily

fragile. Second, we do not agree that shutting down therapeutic

cloning research is an effective way of blocking reproductive

cloning. The best way to do that now is by imposing and enforcing

a strict ban on reproductive cloning. Adding therapeutic cloning to

the prohibition will only result in the loss of the medical benefits

that therapeutic cloning research can bring. If I may use an analogy, banning therapeutic cloning in order to stop reproductive

cloning is a little bit like halting all air travel in order to prevent

hijacking.

PREPARED STATEMENT

The members of ACT’s EAB stand ready to share our ethical debates and conclusions with you and the members of the public.

Thank you very much for inviting me here today.

[The statement follows:]

PREPARED STATEMENT OF DR. RONALD M. GREEN

Good morning. I am Ronald M. Green, a professor at Dartmouth College in Hanover, New Hampshire, where I head the Department of Religion and direct the Ethics Institute. As a matter of public service, I also serve as chair of the Ethics Advisory Board (or EAB) of Advanced Cell Technology in Worcester, Massachusetts. The

EAB is an independent body of ethicists and health care professionals brought together by ACT to provide guidance and oversight for the company’s research.
22

ACT’s scientists recently announced that they had successfully produced the first

cloned human embryo. This accomplishment is the first step in the company’s effort

to use nuclear transfer (cloning) technology to produce replacement cells or tissues

that would not be subject to rejection by a patient’s body. The ACT EAB provided

oversight for this research. I am here to report briefly to you on some of the ethical

reflections that led us to endorse, with careful consideration, the research in question.

Above all, I want to signal a crucial difference between what is called ‘‘reproductive cloning’’ and the kind of ‘‘therapeutic cloning’’ research in which ACT is engaged.

Reproductive cloning aims at the birth of a child. ACT has never pursued this

goal. All the members of ACT’s EAB agree that at this time reproductive cloning

in human beings is too risky to be responsibly pursued. Cloned animals in many

species have evidenced problems during gestation or following birth. Until further

research establishes the likely safety of cloning in human beings it would be irresponsible to try to bring a human child into the world in this way. In addition, most

EAB members believe that many other difficult ethical questions would have to be

answered before reproductive cloning could ever be justified.

Therapeutic cloning is an entirely different matter. It involves the use of nuclear

transfer (cloning) technology to produce human stem cell lines. To accomplish this,

a cloning procedure is used to produce a small cluster of early dividing cells similar

to but not the same as a normal human embryo. Because these cells are produced

by nuclear transfer, they are not the product of fertilization. They represent an entirely new kind of biological organism never before seen in nature. Following international guidelines, ACT’s EAB laid down strict rules for the handling of these organisms, including the requirement that none be allowed to develop beyond fourteen

days. We also insisted upon intensive security and monitoring procedures to insure

that no cloned organisms could be diverted to reproductive purposes.

If ACT’s research on therapeutic cloning proves successful, it will mark the beginning of a new era in medical science. You have all heard about the promise of stem

cells, the basic building block cells from which almost any tissue in the human body

can be fashioned. This summer, President Bush authorized Federal funding for research using a limited number of stem cell lines already in existence. However, the

problem with these and any other stem cells is that the patient’s body would see

them as foreign tissue. The result would be rejection, or, worse, a very serious toxic

crisis. To minimize these problems, patients could be given immunosuppressive

drugs. But these drugs carry their own risks because they expose the patient to infections or the risk of developing cancer.

Therapeutic cloning promises a dramatic way to avoid all of these problems. In

the not-too-distant future, the mother of a child suffering from severe Type I juvenile diabetes could donate an egg from her own ovaries. A cell could be scraped from

the inside of the child’s cheek. Using the kind of nuclear transfer procedure being

researched now by ACT, it might then be possible to produce a stem cell line that

could be coaxed to differentiate into new insulin-producing cells. These cells could

be injected back into the child’s body, where they would provide an entirely new

pancreatic system. Because these cells are made from the child’s own genetic material, they would not be rejected. The child would be spared a life-threatening disease

often accompanied by amputations or blindness.

I should note that therapeutic cloning is only a transitional technology toward the

long-term goal is direct cell reprogramming. We know that in the nuclear transfer

procedure something almost magical happens when a differentiated cell nucleus is

placed inside an egg. Substances in that egg return the nuclear DNA to its embryonic state and prepare it to become any cell type in the body. If cloning research

helps scientists to understand these processes, the cloning step might be skipped.

A cell could be taken from any of our bodies and directly induced to become primordial nerve, blood, muscle or skin tissue. By means of both therapeutic cloning

and eventually direct cell reprogramming, we might realize the Biblical vision of the

lame walking and the blind seeing.

ACT’s EAB came to the conclusion that this research direction is important and

ethically sound. On the one hand, we believe that the lifesaving promise of this research constitutes an important ethical consideration in its favor. On the other

hand, as we reviewed the biological qualities of these cloned organisms, we concluded that they could not be equated morally with the children or adults whose

lives could be saved or health restored by therapeutic cloning research.We noted

that these clusters of cells, while arguably worthy of some respect, lack most of the

qualities we normally equate with a human life. They are not the result of the union

of sperm and egg. They lack differentiated cells and cannot think or feel. Since spontaneous twinning is still a possibility at this very early stage of development, they
23

even lack individuality. It is true that they could potentially go on to full development if placed in a womb. But in an era of cloning technology, this statement is

true of every cell in our body. Surely we would not want to declare every human

cell or tissue off limits to research.

We acknowledge that others may come to different conclusions about the moral

status of this very early and novel form of human life. We doubt, however, that a

consensus now exists in our society about this matter. In view of this dissension,

we concluded that privately funded researchers and scientists should be free to proceed with this research on the basis of their own conscientious beliefs. We hope that

the Senate will agree.

The primary message I have tried to communicate today is that therapeutic

cloning and reproductive cloning are two different endeavors. Some will object, however, that there is a slippery slope here, that therapeutic cloning will lead inevitably

to reproductive cloning and the birth of a human clone. Again, after considering this

matter carefully, the members of the ACT EAB did not agree. Two considerations

moved us.

First, we believe that open and publicly discussed research like this may actually

reduce the chances that unscrupulous researchers will pursue reproductive cloning.

It could do so by highlighting the physiological dangers of reproductive cloning.

Most of the cloned human embryos produced at ACT died within hours of the nuclear transfer procedure. They are extraordinarily fragile and vulnerable organisms.

Even if it is possible eventually to produce a stem cell line from these entities, as

ACT researchers hope to do, it will be years before we understand all the genetic

factors that are necessary for a healthy pregnancy and birth. Irresponsible researchers will certainly try to beguile women or couples into cooperating with reproductive

cloning research by promising them a healthy child. ACT’s published research on

therapeutic cloning can help to better inform such couples of the gravity of the risks.

Second, we do not agree that shutting down therapeutic cloning research is an

effective way of blocking reproductive cloning. The best way to do that now is by

imposing and enforcing a strict ban on reproductive cloning. Adding therapeutic

cloning to the prohibition will add little force to it and will additionally result in

the loss of the medical benefits that therapeutic cloning research can bring. If I may

use a readily understandable analogy, I believe that trying to stop reproductive

cloning by banning therapeutic cloning is a little bit like trying to prevent hijacking

by halting all air travel. The members of ACT’s EAB stand ready to share our extensive ethical debates and conclusions with you and other members of the public.

Thank you very much for inviting me here today.

Senator HARKIN. Thank you very much, Dr. Green. Now we’ll

turn to Dr. Bert Vogelstein. Dr. Bert Vogelstein is a professor of

oncology and pathology at Johns Hopkins University, a leader and

international expert and pioneer in the field of molecular genetics.

He received his medical degree in 1974 from Johns Hopkins, where

he’s also completed his internship and residency. He joined the

Johns Hopkins faculty in 1978. Dr. Vogelstein.

STATEMENT OF DR. BERT VOGELSTEIN, PROFESSOR OF ONCOLOGY

AND PATHOLOGY, JOHNS HOPKINS UNIVERSITY, BALTIMORE,

MD

Dr. VOGELSTEIN. Thank you, Mr. Chairman, all the members of

the committee. I take to heart Senator Specter’s directive to scientists to help clarify the issues in this debate. I think it is our responsibility to do so. In particular, my goal today is to try and clarify the differences between these very different procedures: onecloning and second, regenerative medicine. And towards that goal

I’d like to today propose a different name for the second procedure,

the name nuclear transplantation. I think that has significant advantages over other names that have been used to describe parts

of this procedure, such as therapeutic cloning, which is really not

accurate, is a misnomer, or somatic cell nuclear transfer, although

scientifically accurate, it’s a mouthful.

In contrast, nuclear transplantation is both perfectly accurate

and, in addition, has the connotation of transplantation. That’s
24

what this scientific procedure is used for, much like bone marrow

transplantation, heart transplantation, liver transplantation. The

sole purpose of this procedure is to produce cells for transplantation.

Now I’d like to explain some of the scientific differences between

these two procedures. What is a clone? A clone is an exact copy of

an organism. The organism could be a fruit fly, it could be a mouse,

it could even, perhaps, be a human. In the movie ‘‘Multiplicity’’

clones were created. Those were real clones, at least on the movie

screen. There’s a difference between clones and cells. Let me illustrate those differences by comparing what we could do with cells

taken from me. I could take a—skin cells from a little biopsy or

cheek cells, or I could even take a hair. Now, is that hair a clone

of me? It’s not such a trivial question, because each cell in the hair

is genetically identical to me, to every other cell in my body, and

moreover, the cells in that hair have the potential to be me. It used

to be, just a few years ago, thought that there was a strict line between the potential to form human life and human life, and that

potential was only in embryos. But we now know that every living

cell in an animal’s body could at least potentially be used to create

human life. And it’s very important to discriminate the potential

for human life from real human life.

Let me give you some more examples that will emphasize these

distinctions. This hair—is it a clone of me? Well, it can’t walk, it

can’t talk, it can’t be educated, it can’t marry my wife, it can’t father my children—it can do none of the things that we equate with

human beings, and it would be clearly wrong to look or consider

the cells in this hair as a clone—they are not.

Now, what else could we do with the cells from this hair? I could

put them in a culture dish. I could grow millions of cells that were

genetically identical to that hair or the cells from the hair. And, interestingly enough, I could use nuclear transplantation to create a

variety of other cell types different from the hair that I could do

even more interesting things with. Why would I do that? If I had

Alzheimer’s Disease or Parkinson’s Disease or a variety of other degenerative diseases for which there was no other cure I might want

to make such cells from that hair cell in a test tube. But these

other cells are no more a clone of me than were the cells in the

hair. There’s a huge difference between the cells derived from me

and a clone of me.

And furthermore, it’s important to point out that one of the reasons I might wish to do this is that other forms of stem cells, such

as those approved by President Bush on August 9th, could not do

the same thing. Any of those other 64 lines, if I used them for

transplantation purposes to try to correct a degenerative disease

would not do the trick, they would be rejected, because they are not

derived from me, they are not genetically identical to me.

PREPARED STATEMENT

I urge you then to deeply consider the differences between nuclear transplantation and human cloning, and to consider the enormous impact on research and, indeed, patients’ lives if a ban on nuclear transplantation were to be enacted. President Bush’s announcement on August 9th to allow Federal funding for research
25

on existing stem cell lines was a giant step in the direction toward

realizing the promise of stem cells in regenerative medicine. To ban

nuclear transplantation would be a giant step backwards in this effort. Thank you, and I’d be glad to try to answer any questions.

[The statement follows:]

PREPARED STATEMENT OF DR. BERT VOGELSTEIN

Good morning, Mr. Chairman, and members of the Committee. My name is Bert

Vogelstein, and I am a Professor of Oncology and Pathology at the John Hopkins

Oncology Center and a Howard Hughes Medical Institute Investigator. I am here

today as the chairman of a National Research Council and Institute of Medicine

Committee on the Biological and Biomedical Applications of Stem Cell Research

that recently released the report: ‘‘Stem Cells and the Future of Regenerative Medicine.’’

My goal today is to clarify some of the confusion surrounding two very different

medical endeavors; the first is regenerative medicine, and the second is the cloning

of a human being. Regenerative medicine, which as a field is in its infancy, involves

growing cells and tissues for implantation in people with diseases or injuries to their

organs, for example diabetes, Parkinson’s disease, heart disease, and spinal chord

injury. The most promising avenue of regenerative medicine is the use of embryonic

stem cells for eveloping tissues of many different types for transplantation into patients with these diseases or injuries.

A substantial obstacle to the success of transplantation of any cells, including

stem cells and their derivatives, is the immune reaction of a patient’s body to cells

that it perceives as foreign. Our report recommended that multiple approaches to

reducing this problem be explored, including ways to manipulate the genetic makeup of the stem cell tissue to make it less likely to provoke an immune reaction, the

creation of a large bank of diverse stem cell lines, and the development of embryonic

stem cells using a technique known as somatic cell nuclear transfer. This involves

taking the DNA from a cell of a patient in need of a transplant, inserting it into

an egg cell that has had its nucleus removed, and triggering cell division. The resulting stem cells and tissue that can be obtained from this procedure would be genetically identical to the patient’s cells, and would in theory not be rejected by the

patient’s immune system when transplanted into him or her.

This procedure for producing embryonic stem cells that are genetically identical

to the donor’s tissue should not be confused with human cloning, which has the goal

of creating a human being. In that endeavor, the DNA from the cell of an individual

would be inserted into an egg cell that has had its nucleus removed, and that embryo would be implanted into a woman’s uterus so that it would grow into a child

who is genetically identical to the individual whose DNA was inserted into the egg.

Unfortunately, the notion that genetically identical stem cells are the same as a

genetically identical human being has obfuscated the important potential of developing transplant therapies with lower probabilities for rejection, and greater chance

of helping improve the health of many sorts of patients.

There has been much confusion surrounding the terminology common to the

causes of both regenerative medicine and those who wish to clone human beings.

Because the term ‘‘therapeutic cloning’’ has been used by different sources to mean

both the cloning of human beings and the production of embryonic stem cells genetically identical to their donor, it has become effectively useless. And because the

term ‘‘somatic cell nuclear transfer’’ smells of scientific jargon, I propose the use of

the term ‘‘nuclear transplantation’’ be entered into the debate over cloning legislation.

I urge lawmakers to deeply consider the differences between nuclear transplantation and human cloning, and to consider the enormous impact on clinical research,

and indeed patients’ lives, if a ban on nuclear transplantation were to be enacted.

President Bush’s announcement last August to allow Federal funding for research

on existing embryonic stem cell lines was a great step in the direction toward realizing the promise of stem cells in regenerative medicine. To ban nuclear transplantation would be a step backwards in this effort.

Our committee is respectful of the wide array of social, political, legal, ethical, and

economic issues that must be considered in policy-making in a democracy, and we

have been impressed by the commitment of all parties in this debate to life and

health, regardless of the different conclusions they draw. It should be recognized

that a large number of citizens oppose human cloning at the same time they support

embryonic stem cell research and regenerative medicine. We hope our report, by
26

clarifying what is known about stem cells and how best to realize their potential,

will be a useful contribution to the discussion of this important issue.

Thank you for this opportunity to testify. I would like my statement to be put into

the record, and I will be happy to answer any questions the Committee might have.

Senator HARKIN. Dr. Vogelstein, thank you very much for a very,

I think, fairly presented concept. Now we turn to Ms. Phyllis

Greenberger. Greenberger is the first president and CEO of the Society for Women’s Health Research, a Washington, D.C.-based advocacy organization formed in 1990 to utilize medical research to

improve the health of women. Ms. Greenberger received her bachelor’s degree from Syracuse University and a master’s from Catholic University here in Washington, D.C. Ms. Greenberger, welcome

and please proceed.

STATEMENT OF PHYLLIS E. GREENBERGER, PRESIDENT AND CEO,

THE SOCIETY FOR WOMEN’S HEALTH RESEARCH, WASHINGTON,

DC

Ms. GREENBERGER. Good morning Mr. Chairman and members of

the subcommittee. As you said, I’m Phyllis Greenberger, president

of the Society for Women’s Health Research, and I appreciate the

opportunity to present this morning. And also, as you said, our

mission is to improve the health of women through research.

For the last 10 years the Society has spoken out on important

scientific issues that advance research on women’s health, and

have the potential to alleviate suffering and improve the quality

and longevity of life. Today’s discussion about therapeutic cloning

is no exception. The Society is deeply concerned about any impediments that would slow research in regenerative medicine. This

area of research has the potential to treat a range of confounding

human diseases and health disorders, many of which are prevalent

in or disproportionately affect women.

The specter of human reproductive cloning clouds the potentially

enormous benefits of this new area of research. The future benefits

are being overshadowed by a new cycle of ethical and political debate. We must carefully distinguish between creating an entire

human being and therapeutic cloning, which, used in conjunction

with new stem cell research, has the potential to produce new

diagnostics, medicines and vaccines.

Research on human stem cells derived from both adults and embryos provides the most efficient and responsible means to fulfilling

the promise of regenerative medical research for achieving medical

breakthroughs. The Society for Women’s Health Research believes

that the potential of therapeutic cloning for treating and perhaps

curing a variety of debilitating diseases demands that the scientific

community be allowed to continue this promising work. Unfortunately, if the Senate were to pass the cloning prohibition act, HR

2505, this research would be prohibited.

Many of these research advances are critically important to

women. We are on the cusp of putting into everyday medical practice many promising techniques. Investigators are evaluating the

use of embryonic stem cells to treat incontinence. Stem cell tissue

engineering has been used to restore urethral sphincter muscles in

animal models. This lays the foundation for further investigative

methods to use stem cells to treat urinary incontinence. Urinary incontinence affects 35 percent of American women over the age of
27

50. This kind of stem cell research is also being used to transplant

or replace damaged cells in Parkinson’s Disease. Studies in animal

models have shown that embryonic stem cells derived from neural

cells can be used successfully to treat nervous system disorders.

Mouse embryonic stem cells which were stimulated to differentiate

into neural cells, when transplanted into mice with neurological

disorders helped to restore normal function. Heart muscle cells

known as cardiomyocytes do not regenerate after being damaged by

a heart attack and are replaced with non-functioning scar tissue.

Each year more than 1 million Americans, more than half of them

women, will have a heart attack, which is the primary cause of

heart muscle damage. Therapeutically treated cardiomyocytes in

animal tests have been shown to replace heart tissue and successfully reintegrate into the animal’s heart.

We should also not overlook the fact that this field of research

may also improve the way we develop and test new drugs. These

drugs could be tested on liver cells or skin cells, and only those

drugs that are safe and effective would be advanced for testing in

humans.

Embryonic stem cell research is in its infancy and holds tremendous promise. An enormous amount of research must be done before it can be translated into medical treatments, but we should

carefully weigh the implications of any roadblocks that might derail it. Any impediments would have serious implications for medical research. Pharmaceutical and biotechnology companies that

have the resources to translate these breakthroughs into medical

treatments would be reluctant to invest in this research if serious

roadblocks were created.

We recognize that this research is controversial. But therapeutic

cloning should not be confused with reproductive cloning. Never is

there any intention of implanting the resulting embryo to produce

a child. In therapeutic cloning the nucleus of an egg cell is removed

and genetic materials are inserted from the transplant recipient,

triggering cell division. This new technique goes a long way to

overcoming tissue rejection, an important breakthrough in organ

and tissue transplantation.

I believe it is important to point out that both the National Institutes of Health and the National Academy of Sciences recently

noted that the use of this technique will lead to promising new

techniques for patients. We understand the fundamental ethical dilemmas and scientific uncertainties raised by therapeutic cloning.

The Society concurs with the National Academy of Sciences, which

in late November created a national advisory committee made up

of leading scientists, ethicists and other stakeholders to be established at the National Institutes of Health. This group is charged

with ensuring that proposals for Federal funding to work on embryonic stem cells are justified on scientific grounds, and meet current and future federally mandated ethical guidelines.

The NIH in the past has set up similar watchdog panels including a recombinant DNA admonitory committee which oversees the

once-controversial genetic engineering research. The Society agrees

with a recent Washington Post editorial which said that barring all

therapeutic cloning would likely drive research underground, and
28

guarantee that only the most unscrupulous would advance these

technologies.

PREPARED STATEMENT

We urge you to take time and carefully weigh appropriate options for promoting public policy that best serves the nation. A

rush to judgment would be premature, and has the potential for

impeding much-needed and potentially beneficial research. Thank

you very much, Senator.

[The statement follows:]

PREPARED STATEMENT OF PHYLLIS E. GREENBERGER

Good morning, Mr. Chairman and members of the subcommittee. I am Phyllis

Greenberger, president of the Society of Women’s Health Research. For over 10

years the Society has spoken out on important scientific issues that advance research on women’s health and have the potential to alleviate suffering and improve

the quality and longevity of life.

Today’s discussion about therapeutic cloning is no exception. The Society is deeply

concerned about any impediments that would slow research in regenerative medicine. This area of research has the potential to treat a range of confounding human

diseases and health disorders, many of which are prevalent in or disproportionately

affect women.

The specter of human reproductive cloning clouds the potentially enormous benefits of this new area of research. The future benefits of regenerative medicine are

being overshadowed by a new cycle of ethical and political debate. We must carefully distinguish between creating an entire human being and therapeutic cloning,

which used in conjunction with new stem cell research, has the potential to produce

new diagnostics, medicines and vaccines.

Research on human stem cells derived from both adults and embryos provides the

most efficient and responsible means to fulfilling the promise of regenerative medical research for achieving medical breakthroughs.

The Society for Women’s Health Research believes that the potential of therapeutic cloning for treating and perhaps curing a variety of debilitating disease demands that the scientific community be allowed to continue this promising work.

Unfortunately, if the Senate were to pass the Cloning Prohibition Act, H.R. 2505,

this research would be prohibited.

Many of these research advances are critically important to women. We are on

the cusp of putting into everyday medical practice many promising techniques.

Investigators are evaluating the use of embryonic stem cells to treat incontinence.

Stem cell tissue engineering has been used to restore urethral sphincter muscles in

animal models. This lays the foundation for further investigative methods to use

stem cells to treat stress urinary incontinence. Urinary incontinence afflicts 35 percent of American women over the age of 50. Approximately 60 percent of women

with incontinence will have stress incontinence.

Embryonic stem cell research is also being used to transplant or replace cells

damaged in Parkinson’s disease. Studies in animal models have shown that embryonic stem cells derived from neural cells can be used successfully to treat nervous

system disorders. Mouse embryonic stems cells were stimulated to differentiate into

neural cells which, when transplanted into mice with a neurological disorder, helped

to restore normal function.

Heart muscle cells, known as cardiomyocytes, do not regenerate after being damaged by a heart attack and are replaced with nonfunctioning scar tissue. Each year

more than one million Americans-more than half of them women—will have a heart

attack which is the primary cause of heart muscle damage. Therapeutically treated

cardiomyocytes in animal tests have been shown to replace heart tissue and successfully reintegrate into the animal’s heart.

We should also not overlook the fact that this field of research may also improve

the way we develop and test new drugs. These drugs could be tested in liver cells

or skin cells and only those drugs that are safe and effective would be advanced for

testing in humans.

Embryonic stem cells research is in its infancy and holds tremendous promise. An

enormous amount of research must be done before it can be translated into medical

treatments. But we should carefully weigh the implications of any roadblocks that

might derail this research.
29

Any impediments would have serious implications for medical research. Pharmaceutical and biotechnology companies that have the resources to translate these

breakthroughs into medical treatments would be reluctant to invest in this research

if serious roadblocks were created.

We recognize that this research is controversial. But therapeutic cloning should

not be confused with reproductive cloning. Never is there any intention of implanting the resulting embryo to produce a child. In therapeutic cloning the nucleus of

an egg cell is removed and genetic materials are inserted from the transplant recipient triggering cell division. This new technique goes a long way to overcoming tissue

rejection, an important breakthrough in organ and tissue transplantation.

I believe it is important to point out that both the National Institutes of Health

and the National Academy of Sciences recently noted that the use of this technique

will lead to promising new treatments for patients.

We understand the fundamental ethnical dilemmas and scientific uncertainties

raised by therapeutic cloning. The Society concurs with the National Academy of

Sciences, which in late November created a national advisory committee made up

of leading scientists, ethicists and other stakeholders to be established at the National Institutes of Health.

This group is charged with ensuring that proposals for federal funding to work

on embryonic stem cells are justified on scientific grounds and meet current and future federal mandated ethical guidelines. The NIH in the past has set up similar

watch dog panels including the Recombinant DNA Admonitory Committee which

oversees the once controversial genetic engineering research.

The Society agrees with a recent Washington Post editorial which said that barring all therapeutic cloning would likely drive research underground and guarantee

that only the most unscrupulous would advance these technologies. We urge you to

take time and carefully weigh appropriate options for promoting public policy that

best serves the nation. A rush to judgment would be premature and has the potential for impeding much needed and potentially beneficial research.

Senator HARKIN. Thank you, Ms. Greenberger. Thank you all

again for being here and for your statements. I’ll start with my

time of 5 minutes, then I’ll recognize the senator, Senator DeWine.

Dr. West, let’s start with you. Just a few weeks ago your company, ACT, indicated that you were able to take out the DNA from

the donated egg, you took DNA from another donor—I don’t know

from what, where you derived that DNA—and you replaced it in

the egg, but that it only developed into four or five cells. Could you

elaborate on that? Now, the reason I’m asking is that—some have

said that what you did was not all that significant, that this is not

a big breakthrough, that the breakthrough will come when you actually are able to develop that into the blastocyst stage. Could you

respond to that, please?

Dr. WEST. Right. What we reported on were the first steps towards demonstrating that this technique will work in humans. It’s

previously—us and others have demonstrated that this technique

appears to work in mouse—where mouse skin cells were taken

back to an embryonic state by nuclear transfer, making Parkinson’s

neurons and other types of cells. And we demonstrated this in a

cow, as well—that you could reprogram a cell back in time using

nuclear transfer.

On a human, we just reported that the first evidence is that we

believe this will work. What were those evidences? One, what happens to the DNA of a body cell when you put it into an egg cell

is, it is reprogrammed, like when you put a disk into a computer

and you say ‘‘initialize,’’ it takes it back to its blank state, this embryonic state. And when a somatic cell, body cell nucleus is put into

an egg cell and reprogrammed, it takes on a certain kind of shape

and appearance, called the pro-nucleus. And we reported——

Senator HARKIN. A pro or cro——
30

Dr. WEST. Pro-nucleus it’s called. And we reported that, as evidence that—again, preliminary evidence, very preliminary, but—

first steps that this is—the DNA is being reprogrammed, we reported that we saw pro-nuclear development.

No. two, we reported that we got the beginnings of cell divisions.

Now obviously we would need to get these cells to divide to some

one hundred cells, we think, to effectively take the step of making

stem cells and then making medically useful cell types. We also reported on some related observations, what we call parthenogenesis,

which is a whole separate discussion and a separate way of making

stem cells directly from an egg cell.

The reason we reported on this without having taken the technology all the way through to showing that we could make stem

cells and medically important stem cells, is in the spirit of transparency. We felt that it was important for us to publish often,

every step, so we disclosed early on that we had arranged for egg

cell donors to provide us with egg cells, and we decided that we

would report each step of the way. Similar to the way in IVF, back

some twenty years ago, Bob Edwards in publishing on the production of human embryo as an idea, first reported a paper that the

sperm cell has penetrated the egg, and then another paper on -he’d

gotten the embryo to divide once, and then another paper when he

divided to make an embryo, and of course, finally, the production

of the baby.

Senator HARKIN. Now let’s get something secure and on the

record. What you did is right now not against the law—there’s no

law against what you did.

Dr. WEST. That’s correct.

Senator HARKIN. As I understand it there is no law against taking it the next step. In other words, if you were to take the DNA

and put it into an egg from which the donor egg’s DNA had been

removed, and you were able to grow that into the blastocyst stage

and to remove stem cells, there is no legal ban on that now, either?

Dr. WEST. As far as I understand.

Senator HARKIN. That’s my understanding, I’m just wondering if

any of you have any different understanding of that, Dr. Green, is

that correct?

Dr. GREEN. I believe that is correct, there is no law that——

Senator HARKIN. Yes, I believe that’s also correct, there’s no Federal funding for it, but there’s no law against it, for private entities

to continue on down that course.

You told us two or three years ago you were doing this. I mean,

it was not anything you didn’t tell us, that ACT was going to be

working on. I assume that you are proceeding to perfect the technique for the extraction of stem cells. My question is, what kind of

timeline do you see for that, when you would actually have that

kind of breakthrough where you could actually reach the blastocyst

stage, remove the stem cells, and then regenerate them?

Dr. WEST. It’s a difficult question to answer. We just reported

yesterday in a meeting at the Society for Regenerative Medicine

some now rather old research on nuclear transfer in non-human

primates. When we move from one species to another like the recent effort to try to clone pigs, we saw obstacles in making this

technology work, and then suddenly by altering the laboratory—
31

you know, the recipe, the media that these cells are grown in, so

on, suddenly we get successful results. It’s difficult to predict. And

I would hesitate to——

Senator HARKIN. Could you do it in the next month or two?

Dr. WEST. You know, I would—let me say it this way: I would

be disappointed if we could not publish another paper, scientific

paper showing that we had successfully made heart muscle cells,

neurons for Parkinson’s and so on, using this technology, sometime

in the next 6 months or so. I’d be disappointed if we couldn’t do

that in that timeframe.

Senator HARKIN. That’s quite promising. Senator DeWine.

Senator DEWINE. Thank you, Mr. Chairman. Dr. Green you—let

me quote from your written statement, and then I’ll want to ask

you a question if I could.

‘‘We concluded that they could not be equated morally with the children or adults

whose lives could be saved or health restored by therapeutic cloning research. We

noted that these clusters of cells, while arguably worthy of some respect, lack most

of the qualities we normally equate with a human life. They are not the result of

the union of sperm and egg. They lack differentiated cells and cannot think or feel.

Since spontaneous twinning is still a possibility at this very early stage of development, they even lack individuality.’’

And that’s the end of the quote. During that period of time, are—

this cluster that you refer to, is it distinguishable in any way from

a cluster that would have been formed as a result of the conventional union of the sperm and egg? From a scientific point of view,

not knowing how it started, is it distinguishable in any way? Or

could that statement have been true about a cluster that was

formed in the traditional way.

Dr. GREEN. Well, I think apart from the fact that the DNA is

wholly from one individual, and there may be subtle differences at

the DNA level, probably not. It might look like the result of fertilization.

Senator DEWINE. So my question, my point is, when you say,

‘‘they lack differentiated cells’’ that would be true.

Dr. GREEN. That’s correct.

Senator DEWINE. They can’t think. Or feel. And spontaneous

twinning is still a possibility. So from a—however you come down

on this issue—and obviously this is—I think we’ve had a very good

discussion and debate here. There is no real distinction between

what you have described and what we would see from the normal

union of sperm and egg other than what you just said about the

DNA. I just want to make sure I understand from a scientific point

of view——

Dr. GREEN. I think that is correct, Senator——

Senator DEWINE. That’s all, if anyone disagrees they can jump

in, but just, from a scientific point of view I wanted to make sure

I understood what we were——

Senator HARKIN. Will the Senator yield on that point, then? I do

have a question.

Senator DEWINE. Well sure, Mr. Chairman, certainly.

Senator HARKIN. No, I was just wondering because I had to get

cleared up in my head, too, then, because the Senator’s asked a

very pertinent question, very important question.

As I understand it, if you have an egg from a woman, it has her

DNA in it, in the nucleus. If that is fertilized in the normal sexual
32

manner, by the sperm from the man, that has the DNA of the man,

and those two combine.

Dr. GREEN. That’s correct.

Senator HARKIN. If, however, you remove the DNA of the woman,

and you replace only the DNA of a man or a woman, just one, then

it is something different.

Senator DEWINE. Well, it’s genetically different, right? Its DNA

is different.

Dr. GREEN. The DNA is not the immediate result of the union

of sperm and egg, it is the DNA from the individual who is the cell

donor initially. And furthermore, I think, right down to the genetic

level there may be subtle differences that we’re not aware of, given

the origin of that nuclear DNA. So I’m unprepared to say it is exactly identical, but my point in making this observation is that,

traditionally we have thought of an embryo—if I were to ask you

five years ago or two years ago ‘‘what is a human embryo?’’ you’d

say, well, it is the product of human fertilization and it has these

other qualities and characteristics. These cloned entities, these organisms, are not the product of fertilization. Their inception, their

origin, is completely different. They are novel in nature in that regard.

Now they have some of the qualities that we liken to an embryo,

although there are subtle differences as well. All of this, it seems

to me, challenges the use of the term embryo in this case—I’m not

clear that the term is an appropriate one. Beyond that I would say

this, that the question of how embryos are to be treated, even embryos, is a very disputed one in our society, there is no

consensus——

Senator DEWINE. Absolutely, Dr. Green, and I totally—I totally

acknowledge that. My only point was, this debate is a debate that

we have had before, and I suspect people that felt that there was

great moral implication to be given to that cluster, as you referred

to, before, will still feel, as I do, that there is great moral implication for this same cluster. I don’t know that we have changed the—

the debate’s a little different, but I suspect that we have not

changed the moral arguments, nor have we changed the ethical arguments that are involved here. What I was trying to do is, frankly, get beyond a label and get to a question of what, from a scientific point of view, are we dealing with. And what I take away

from, Mr. Chairman, from your testimony, Dr. Green, is that we’re

dealing with a different origin of this cluster, but at least so far we

can’t see much difference in what we are looking at from a scientific point of view at that point. The DNA source is different, but

your testimony as I hear it is that there is not really a fundamental difference.

Dr. GREEN. Well——

Senator DEWINE. So it doesn’t seem to me—the conclusion I

make—and everyone is going to have their different opinion—is

that we’re back—we’re into the same moral dilemma and moral debate, where honest people can certainly disagree, about what moral

weight to assign to that.

Dr. GREEN. But Senator——

Senator DEWINE. I’m afraid we have not escaped that debate.
33

Dr. GREEN. But if I may say so, the origin, I don’t think, is morally insignificant. As Dr. Vogelstein has remarked, in era of cloning

technology, every single cell in our body has the potential to be

equated with these clusters of cells. Yes, it would, in that case be

one cell, but it has a similar potentiality to go on to further development and so on.

So the problem here is that all of our terms, all of our ways of

thinking, have been scrambled, really, by technological and scientific advances.

Senator DEWINE. They are changed—and I’m just trying to get

the facts. And in fact, Dr. West, in a transcript from a recent NBC

interview, actually—I’ll quote him. You use the term embryo ‘‘talking about a cluster of cells far smaller than the head of a pin with

no body cells of any kind, the embryo hasn’t even decided if it’s

going to become one person or two.’’ So it’s understandable that we

get into a question of labeling, and my questioning to you all was

simply trying, Mr. Chairman, to get beyond that. And I see my red

light’s been on for a couple minutes, so I’ll——

Senator HARKIN. I interrupted you, so——

Senator DEWINE. No, no that’s fine. Thank you very much.

Senator HARKIN. This is an interesting pathway that Senator

DeWine has opened up. Back to the question of, you know, when

does life begin. It seems to me that the egg has life. Sperm has life.

I mean, they’re alive, they’re not dead. I mean, if you look at them

under a microscope they’re very much alive.

Dr. WEST. May I speak to that? I think that’s a very important

point. We need to make a distinction between human cellular life

and the beginnings of a human being. So a sperm cell is alive, and

an egg cell is alive. The union of the egg and the sperm cell is

alive, but the important point which we’re trying to, I think, focus

on is pre-implantation embryos, some—estimates are 50 to 80 percent of them may naturally, through sexual means, never find a

home in a uterus, never attach, and therefore never begin to develop. So they begin to develop upon implantation, in the formation

of a pregnancy. And if they never find a home in the uterus—in

fact, the majority of such embryos never attach—they never begin

to develop, and they stay in this, it’s like a blank, you know, a

blank sheet of paper.

And our point is, there is such a convenient line, a bright line

that we could draw, which is drawn for us by nature itself. It’s

called primitive streak. So once this cluster of cells attaches and

finds a home in the woman’s uterus, to begin pregnancy, nature begins by drawing a line on those cells. It’s called primitive streak,

it’s the first—it’s sort of the spade in the ground, you know, the

ceremonial spade to start the construction of a building. It’s the

first step toward the production, the beginnings of a human life. A

human life, as opposed to what was cellular life.

And indeed, of course, our point is two lines can be drawn on

that same cluster of cells making identical twins. I think this tells

us something very significant. There is a line, it’s a bright line that

nature’s given us for the beginnings of a human being, from what

was just cellular life—the hairs that Dr. Vogelstein spoke of, the

hair cells, living cells. And this line has been useful——

Senator HARKIN. Say again, what is that line?
34

Dr. WEST. Primitive streak. And it occurs at about fourteen days.

It’s about the time when the embryo implants. We don’t say that

that’s an important line because of implantation, per se. It’s just

that, about the time of implantation this also occurs. So when the

pre-implantation embryo finds a home and begins the pregnancy,

then it starts to develop into a human, or two humans.

And so that’s been an important distinction for IVF. It’s been debated widely in medical ethics. And so the concept is, when we create pre-implantation embryos by IVF, the understanding is we

would never take those embryos in culture beyond 14 days. Because that’s when we would expect the beginning of the development of a human being out of what is just merely cellular life.

Senator HARKIN. Dr. Vogelstein.

Dr. VOGELSTEIN. Yes, I think you’re right about two things. First

of all, there’s no clear line between cells that have the potential for

life and those that don’t any longer—any live cell has the potential

for full human life at least in theory.

I think the most important line is the one you drew there. It’s

the legislative line. And the reason that’s important is because it’s

easy—it legislatively, as apart from scientifically, to draw that line,

and say ‘‘No implantation.’’ That will totally preclude human

cloning. You could say ‘‘No development of blastocysts past the 64

or 128 cell stage.’’ You could say that every blastocyst should be destroyed after the inner cell mass has been removed to create stem

cells. Any of those legislative mandates or dictates would totally

preclude human cloning and still, as you said, help for patients.

Senator HARKIN. Is there a better one than just saying that it

would be prohibited from being implanted? You mentioned a couple

of others which I don’t know that I understand——

Dr. VOGELSTEIN. I think yours is the best, because that’s the

easiest to monitor. In order for implantation you obviously need all

kinds of people involved, including a woman. Not just a laboratory

worker. So I think yours is excellent and the best.

Senator HARKIN. I just didn’t know if there was maybe another

approach on this. Now, Dr. Vogelstein, I just wanted to ask you,

and perhaps others, too. You made a very good case when you took

your hair out and you said this hair is a clone of me, it has all the

cells in it that basically, that you have. And theoretically I assume

you could take the cells from that hair and implant it into an egg

and make a clone of you. It’s theoretically possible, I guess.

Dr. VOGELSTEIN. Yes, and what I meant—I tried to ask the question, are those cells from the hair or from my skin really a clone

of me. And the point I wanted to make is, even though they are

genetically identical, and even though they have the theoretical potential to form me, with a lot of procedures, they are not a clone

of me. As Dr. Green said, they have none of the characteristics of

a human being.

It’s essential to distinguish a human being from human cells.

They are two very different beasts.

Senator HARKIN. My second 5 minutes is up.

Senator DEWINE. I have nothing further.

Senator HARKIN. Well, if you have anything, just interrupt me at

any time. I have a couple more things I wanted to—one area I

want to cover, Ms. Greenberger, with you is—in his testimony Sen-
35

ator Brownback quoted one woman as saying that this research

would compromise women’s health. That’s one part. The other part

was just that in a meeting I had last week with some individuals,

we talked about how to get these eggs you have to pay women.

How does that enter into the whole process here? Now again, the

guidelines have been that you can’t make money off of this, but obviously you still can pay for a woman to donate her eggs, I guess?

I assume that’s how ACT did it——

Dr. WEST. That’s correct. That’s right.

Senator HARKIN. I just wonder, from your standpoint—how do

you see this in terms of affecting women’s health, and sort of the

status of women as it pertains to the donors of these eggs.

Ms. GREENBERGER. Well, first of all, obviously I disagree with the

quote from Senator Brownback about it compromising women’s

health, it—my testimony’s been clear that we see great potential

for many of the diseases that disproportionately affect women, that

this would be a great stride forward. So I don’t know, obviously,

what was behind that quote, but we certainly disagree with that.

In terms of paying for embryos, I think, as you know, and have

said, that women can do that. There are certain restrictions on you

not—you can’t donate for yourself, you have to know—you can’t

use—there are certain Federal regulations that protect a woman

and protect the embryo. And I think that, you know, along with

legislation that’s going to be passed, if it is, concerning this, that

those stipulations would be included also. And I think women can

make their own decisions. They don’t need to be told what to do

and how to do it. That they’re capable of making their own decisions, and if they feel that they want to donate their eggs to research, then they should be able to do that. And if they want to

help their own child or someone in their family or themselves, that

they should be able to do that.

So I think—and we know, certainly, in terms of IVF and surrogate mothers, I mean, there are a lot of things that we accept now

that, when we first discussed them years ago, people found sort of

abhorrent and strange to imagine. But now it’s accepted, and we

seem to have been able to work with it.

Senator HARKIN. All of you have mentioned in vitro fertilization

and I asked Senator Brownback whether or not he was in favor of

in vitro fertilization, and I think his answer was he saw nothing

wrong with in vitro fertilization.

I came across this article, it was in the paper here on November

30. It’s an op-ed piece, so it’s an editorial about this, in which the

writer, Michael Kinsley, quoted the President saying: ‘‘We should

not as a society grow life to destroy it. It is morally wrong, in my

opinion.’’ End quote. And yet, the President also earlier, in August

supported in vitro fertilization, on his August 9 television address.

The President praised IVF as ‘‘a process which helps so many couples conceive children.’’

And the article went on to say that there’s a web called

Healthfinder.gov. Didn’t know it existed. But it’s under the Department of Health and Human Services. And evidently, according to

this article, that the first item on Healthfinder’s list of references

about IVF is a brisk discussion, published in the New England

Journal of Medicine, of how many eggs should be fertilized to
36

produce an embryo. How many should be implanted in order to

maximize the chance of producing one baby and no more? Or put

it another way, how many embryos should you create and kill outside the many embryos—how many should you implant and hope

all but one die? Seems to me if you’re in favor of in vitro fertilization, then you’re going to create more embryos than obviously can

be implanted in the woman. There’s going to be some left over.

What do you do with those? I think I asked the Senator about that,

he said something about adoption and things, but I have a feeling

that most of those will be destroyed, I think a lot of them are frozen now, but are they going to be frozen for 50,000 years or 5,000

years or what?

Seems to me here a decision is made that the benefits to humankind, that is, the happiness and wellbeing of a couple to have a

child far outweigh any of the other perceived, real, moral obligations or moral dilemmas regarding the destruction of the embryos

that are left over.

And so, when we get to nuclear transplantation, then it seems

that that same argument might just carry over, I would think. I

mean, you’re developing it into stem cells to help save lives and

make peoples’ lives better. And in the process destroying—whether

it’s even an embryo or a pre-embryo, I’m still not clear on that in

my own mind, exactly what it is. But it seems like you almost have

the same kind of balancing act there as you do with in vitro fertilization. I don’t know, I just say that, and open it for any kind

of discussion that you might want to——

Mr. VOGELSTEIN. The problem perhaps lies in the phrase—it

sounds like a catchy phrase, create life to destroy it, which no one

would be in favor of. But the real purpose of nuclear transplantation is to create life to save lives. It’s to save the lives of sick people. That to me is a much more accurate and reasonable way to

look at it.

Senator HARKIN. It’s an interesting twist to put on it, yes. Dr.

Green?

Dr. GREEN. Senator, I think your observation is a correct one.

Apparently many thousands and thousands of couples routinely

create what they know are spare embryos that will not be transferred to a womb, and they freeze them, and eventually they discard them—thousands have been discarded. They make the decision that the opportunity to have a child for their family outweighs

those claims of those very early entities. Others may not agree with

that, and not engage in that. Others may feel that contributing an

embryo, a frozen embryo for example—ACT has received inquiries

from individuals who have frozen embryos who—which they wish

to donate for human stem cell research, and they say that the saving of a life of a child suffering from diabetes or whatever actually

weighs far more in their thinking than simply having a child.

So I think there is a range of views about this. That’s the reality.

I don’t think we’re going to change anybody’s opinion on that in 3

months, 6 months. Our society permits individuals to make those

decisions right now. Whether to make more embryos than they

need to have a pregnancy, whether to make an embryo for the purpose of assisting research—and we had many egg donors, inciden-
37

tally, this is one of the more interesting findings of the work of the

Ethics Advisory Board.

We found that there were many women out there who were perfectly willing to donate an egg for lifesaving research, because they

had family members who suffered from these diseases, but who

would never donate an egg for reproductive purposes, because they

didn’t want to create a child with that egg, they wanted primarily

to help save lives.

Those differences exist, they are not going to change, and I think

that we can permit that kind of research going forward on the

basis of what we all—the differences we all share now, without

going the other route toward reproductive cloning. We can stop

that and draw that line.

Senator HARKIN. Dr. Vogelstein, one last question, I’ll recognize

Senator Specter. Go ahead.

Senator SPECTER. Thank you. George Annas, who is a very wellknown bioethicist who participated in our workshop addressed exactly the point you raise, and he gave what I thought was a very

interesting example. He said, suppose you were in a room that on

one side of the room had a dish of stem cells derived from a human

blastocyst, say from in vitro fertilization, clearly have the potential

for life. And on the other side of the room, there was a 30-yearold individual in a wheelchair, a policeman who was injured on the

job and had a spinal cord injury. And suppose there was a fire in

the room, and you could save one. Which would you save? I thought

that was an interesting question.

Senator HARKIN. I think that kind of puts it really in perspective.

I’m going to pursue that, that’s a good thought.

I just want to say before I close down my questions, I know Senator Specter wants to engage in some dialogue with you.

Dr. West, I just want to make sure I heard correctly earlier, that

you would be disappointed if there were not some derivations of

cell lines that already had been differentiated into different types,

differentiated into different types of cells, muscle cells, neuron

cells—you would be disappointed if that had not been done within

the next 6 months.

Dr. WEST. That’s correct.

Senator HARKIN. Is that correct?

Dr. WEST. Yes——

Senator HARKIN. I would have thought you’d have said that you’d

have been disappointed if within the next 6 months you were not

able to reach the blastocyst stage——

Dr. WEST. Yeah, well——

Senator HARKIN. Now I find that you said 6 months not only to

reach that, but the extraction of stem cells and the differentiation

of those cells.

Dr. WEST. Yes. The——

Senator HARKIN. I just wanted to make sure I heard it correctly.

Dr. WEST. You heard it absolutely correctly.

Senator HARKIN. Well, I don’t know about the press here, but I

think that’s about the most important thing that I’ve heard this

morning. I mean, that really does push the envelope.

Dr. WEST. You’re asking a question that scientists always hesitate to answer, you know, it’s so hard to predict the future of
38

science and how fast things will develop, because they aren’t all

within our control. So the only way I’ve found that I can effectively

answer that is to tell you my own anticipation as measured by—

I would be disappointed, and that’s based on, you know, the work

that was done on both the mouse system and the cow, is to related

mammals where we—based on those kinds of timeframes, we could

generate successful results. That’s my hope, and anticipation, but

science moves at an unpredictable rate.

Senator HARKIN. Sometimes you have these serendipitous-type

happenings that things happen and moves everything ahead light

years——

Dr. WEST. That’s right.

Senator HARKIN. And other times you go along for a long time.

I understand that. But I find that exhilarating, quite frankly, that

it’s moving that rapidly. That gives even more hope to people who

are suffering from Parkinson’s Disease and spinal cord injuries

that, in fact, this is not too far beyond the horizon.

Dr. WEST. Its been said that, you know, we should remember

that many ideas fail. So going from the blackboard into the hospital—we can’t take every step and successfully deliver a therapy.

But given the breadth of this technology, I think it would be unwise for us not to recognize that there are likely going to be some

applications that will prove lifesaving.

Senator HARKIN. Well, just for my own part, I just, I would just

say that, rather than a moratorium, I feel very strongly what we

ought to do is to speak very clearly and simply, as Dr. Vogelstein

said, to absolutely ban the implantation, put severe restrictions,

penalties on that. But I think we ought to promote and support as

much as we can the nuclear transplantation, the somatic cell nuclear transfer, to derive those stem cells. To me that would be the

proper course for us to take, and to move ahead aggressively in

that manner.

Senator Specter welcome back.

Senator SPECTER. Well, thank you, Mr. Chairman, I regret the

necessity to leave as this hearing is in process. As I said earlier,

we’re hearing testimony on military tribunals, and on the floor, I

had an issue of importance to Pennsylvania on the Transportation

appropriations bill. The Department of Defense is also being

marked up on subcommittee, so although this is a matter of great

importance, we have to balance it with a lot of other concerns.

I want to come back to the issue about how many people are likely to die as a result of a 6 month delay. I have not heard a quantification of what the stem cell research means and the benefits of

nuclear transfers. Dr. West, I had asked you about that very briefly

before I had to leave. Could you amplify your thinking on the calculation of three thousand people die a day? How did you come to

that figure?

Dr. WEST. The estimates are that 3,000 people die a day of degenerative diseases that could be potentially treated by cell or tissue transplantation.

Senator SPECTER. When you say degenerative diseases, does that

include heart disease?

Dr. WEST. Yes, heart attacks, myocardial infarction, congestive

heart failure——
39

Senator SPECTER. Include cancer?

Dr. WEST. Renal failure, liver failure——

Senator SPECTER. Includes cancer?

Dr. WEST. That’s a good question. I frankly don’t know. I

wouldn’t think so, but I couldn’t speak to that for sure. I don’t

know. Dr. Vogelstein knows.

Senator SPECTER. Dr. Vogelstein, what do you think about that

estimate?

Dr. GREEN. I think that—without being able to say that this

500,000 identifiable people’s lives will be saved—I think that would

be mistaken. I think it would be wrong to say that there are people

out there now whose lives certainly will be saved—say that we

could point to. But I think the understanding that every day of

delay puts off for young children, for example, a cure to diabetes,

so that in the period of, say, 3 or 4 years a child may die who

might have reached the point that that therapy was available.

And therefore I think it’s not unreasonable to say that every day

here is a lifesaving day if it can be gained. Even if it was one person.

Senator SPECTER. Ms. Greenberger, do you concur that each day

has very substantial risks of many, many people dying?

Ms. GREENBERGER. Well, obviously I don’t know as much about

this as the other testifiers do, but certainly every day that’s a delay

in terms of finding the cures or the treatments for people suffering

from these diseases, obviously makes a difference. I think for young

children it’s certainly, especially for them, but also—and I have a

good friend that has Parkinson’s, my mother has Parkinson’s, I

think the sooner we can find a cure or successful treatments—you

know, every day, every day, every day that it takes is another day

of agony for these people.

Senator SPECTER. Dr. Vogelstein I appreciated the comment in

your statement that the term somatic cell nuclear transfer is excessive scientific jargon. Actually you said it smells of scientific jargon.

And you suggest the term nuclear transplantation, maybe even

simpler nuclear transfer. To eliminate the word cloning in therapeutic cloning might be enormously helpful in having the people

understand that.

You also made a comment about the advances where the President had authorized the use of Federal funding on stem cell research. Do you have an opinion as to the adequacy of the so-called

64 lines? We’ve had a good bit of information which we had a hearing on here, but in the popular media, in the news media, about

some of those cells being insufficient. Do you think that stopping

as of 9 p.m. on August 9 of this year will be sufficient to provide

the stem cell lines for all the productive research?

Dr. VOGELSTEIN. Yes, in our report we made a strong statement

about that. The statement was that the President’s remarks certainly opened the way to do research, which was an excellent first

step. But there were many reasons to feel that other types of research to produce new stem cell lines would be needed to take this

area from strictly the research arena to a clinical arena. And one

of those areas in particular involved nuclear transplantation.

Perhaps a good way to put this is, our job as scientific advisors

was simply to try and predict what would be the best way to win
40

this war against these diseases. And if military advisors were to

say that one couldn’t use jet planes against an adversary, or

couldn’t develop the technology to manufacture jet planes against

the adversary, they wouldn’t be very good military advisors. And

we looked at our job in the same way. As scientific advisors we felt

that the best way to make this research practicable in the clinic

would be to approach several avenues including nuclear transplantation.

Senator SPECTER. And that would require additional stem cell

lines beyond the so-called 64 available——

Dr. VOGELSTEIN. Yes. Yes, it would require lines derived from

nuclear transplantation as well as perhaps other lines derived by

more conventional techniques for a variety of reasons.

Senator SPECTER. Well, quantification would be enormously helpful in our public deliberation, in our Senate debates, so until Dr.

West had advanced the figure of 541,800 lives lost over a 6 month

delay or moratorium on nuclear transfer, I hadn’t heard a quantification. I think it would be very helpful if we could have some

judgment as to what is being lost by the failure to use Federal

funding on stem cell research. Senator Harkin and I have taken

the lead for many years on increasing the NIH budget, as you all

know. And concluding this year’s appropriation we’ll have $11 billion dollars added to $12 billion. And if we could have some idea

as to quantifying what that means in saving human lives, and

what it means in the therapeutic process, it could be a very powerful tool in our debate. Because that really boils it down. I would

very much appreciate it if you would give thought to that. I’m not

going to ask you for judgment at all here today, but that would be

enormously helpful, if these additional funds were put to use on

stem cell research and therapy. Dr. West, you have your hand up?

Dr. WEST. Yeah, I was just going to say, this is one example of

why it might be wise for us to consider using other lines and having Federal funding apply to them. We now know that it’s possible

to make embryonic stem cells or embryonic stem-like cells from egg

cells that are activated, as we say, parthenogenetically, where the

egg cell, without removing its DNA, is turned into a pre-implantation embryo, making embryonic stem cells that come from just an

egg cell on its own. It’s a new technique that we’re working on. And

those cells, because they are derived entirely from a female source,

whereas you and I are made from DNA from a male and female

source, they have a unique difference, a change in what’s called

‘‘imprinting,’’ which is sort of like when you highlight text in a book

with a magic marker. The genes are marked as being whether

they’re coming from male or female sources. Those cells would be

important for medical research, and would not—under the current

guidelines you could not have Federal monies apply.

Also there are congenital or inherited genetic disorders that are

now—we’re beginning to be able to take a cell from a pre-implantation embryo and determine that that embryo has the gene for muscular dystrophy, you know, both bad genes. So that embryo then

is not implanted into the uterus to prevent a pregnancy with that

particular problem. Well, those could be used to generate embryonic stem cell lines. And then those neurons and other cells made
41

from that source would display, before the laboratory researcher,

that particular genetic problem in the laboratory dish.

And so all these could be very important tools for medical research in the future. And unfortunately, because they would be

made from future embryos, no Federal funding could apply.

Senator SPECTER. Dr. West, there’s an article which appears by

Dr. Harold Varmus in today’s New York Times captioned ‘‘The

Weakness of Science for Profit.’’ Have you had a chance to see that?

Dr. WEST. No, I have not.

Senator SPECTER. Well, the article by Dr. Varmus, who used to

be head of NIH, raises a number of points. I’d like to ask you about

two of them.

Dr. WEST. Sure.

Senator SPECTER. He raises a question about the public disclosures which your firm made, suggesting that, while entirely appropriate within our free enterprise system, that the disclosures were

early in terms—or premature in terms of where you were, and that

he understands that that kind of publication, or that kind of attention is very helpful in getting additional investors so you can pursue your work, but—what would your comment be as to the consideration that you jumped the gun a little, with all that publicity—

why the number of counter-attacks and whether it was really right

for public disclosure.

Dr. WEST. Well, what we decided is that the application of nuclear transplantation or nuclear transfer in medicine—we knew

that there’s a considerable amount of public concern as to where

these technologies go. And so we went back and took a lesson from

history in the development of in vitro fertilization. There were the

same concerns. Brave New World concerns, you know, where are

we going with this technology. And the researchers who developed

in vitro fertilization decided to publish in a very transparent manner, and to publish frequently. And indeed were criticized for similar reasons.

So when the first egg cell was successfully combined with a

sperm cell and the sperm cell entered the egg cell, they published

that data. They hadn’t created an embryo, they hadn’t created a

pregnancy, but they wanted to frequently show what work was

being done in their laboratory, and that’s the policy we’ve decided

to take. We recognize that our fellow scientists who like to see data

published in a more complete form after certain milestones are met

may find fault with us and the way we did this. But we felt it was

important to be transparent and publish our data as frequently as

we possibly could. And so that’s why we published.

Senator SPECTER. And Dr. Varmus makes one more point, that

understanding what you did, that it is not desirable to have the

private sector solely conduct the research, and notes that in vitro

fertilization has not been financed by any Federal funding. Dr.

Varmus emphasizes the point that there really at least ought to be

public financing. And with the tremendous sums which NIH now

has as a result of the increase in funding, that rings loud and clear.

Anybody disagree with the conclusion of the Federal Government

ought to use the resources which the congress has appropriated to

try to move ahead with stem cell research. May the record show
42

that people are just nodding in the negative. Thank you very much,

Mr. Chairman.

Senator HARKIN. Thank you very much, Senator Specter. Senator

DeWine.

Senator DEWINE. Nothing further, Mr. Chairman.

Senator HARKIN. Well again, thank you all very much for your

attention to this matter. It’s one of the most important issues I

think confronting the American people—all humankind, I believe,

in the broadest context. And I just hope that we can find our way

clear through this, and to continue to try to develop those cures

and therapies that will help so many people that suffer from these

diseases. So I compliment you for the work you’re doing. I encourage you and I urge you on, and I hope that we can perhaps at least

approach it from this standpoint so that we can continue to develop

the nuclear transplantation stem cell derivations that hold so much

promise for people, at the same time preventing the implantation

and the cloning of a human being. Thank you.

CONCLUSION OF HEARING

The subcommittee will stand in recess until the call of the Chair.

[Whereupon, at 11:15 a.m., Tuesday, December 4, the hearing

was concluded, and the subcommittee was recessed, to reconvene

subject to the call of the Chair.]

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