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EMBRYONIC STEM CELL RESEARCH: 

EXPLORING THE CONTROVERSY 

HEARING 

BEFORE THE

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, 

AND SPACE 

OF THE

COMMITTEE ON COMMERCE, 

SCIENCE, AND TRANSPORTATION 

UNITED STATES SENATE 

ONE HUNDRED EIGHTH CONGRESS 

SECOND SESSION 

SEPTEMBER 29, 2004 

Printed for the use of the Committee on Commerce, Science, and Transportation 

( 

(II) 

SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION 

ONE HUNDRED EIGHTH CONGRESS 

SECOND SESSION 

JOHN MCCAIN, Arizona, Chairman 

TED STEVENS, Alaska 

CONRAD BURNS, Montana 

TRENT LOTT, Mississippi 

KAY BAILEY HUTCHISON, Texas 

OLYMPIA J. SNOWE, Maine 

SAM BROWNBACK, Kansas 

GORDON H. SMITH, Oregon 

PETER G. FITZGERALD, Illinois 

JOHN ENSIGN, Nevada 

GEORGE ALLEN, Virginia 

JOHN E. SUNUNU, New Hampshire 

ERNEST F. HOLLINGS, South Carolina, 

Ranking 

DANIEL K. INOUYE, Hawaii 

JOHN D. ROCKEFELLER IV, West Virginia 

JOHN F. KERRY, Massachusetts 

JOHN B. BREAUX, Louisiana 

BYRON L. DORGAN, North Dakota 

RON WYDEN, Oregon 

BARBARA BOXER, California 

BILL NELSON, Florida 

MARIA CANTWELL, Washington 

FRANK R. LAUTENBERG, New Jersey 

JEANNE BUMPUS, Republican Staff Director and General Counsel 

ROBERT W. CHAMBERLIN, Republican Chief Counsel 

KEVIN D. KAYES, Democratic Staff Director and Chief Counsel 

GREGG ELIAS, Democratic General Counsel 

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE 

SAM BROWNBACK, Kansas, Chairman 

TED STEVENS, Alaska 

CONRAD BURNS, Montana 

TRENT LOTT, Mississippi 

KAY BAILEY HUTCHISON, Texas 

JOHN ENSIGN, Nevada 

GEORGE ALLEN, Virginia 

JOHN E. SUNUNU, New Hampshire 

JOHN B. BREAUX, Louisiana, Ranking 

JOHN D. ROCKEFELLER IV, West Virginia 

JOHN F. KERRY, Massachusetts 

BYRON L. DORGAN, North Dakota 

RON WYDEN, Oregon 

BILL NELSON, Florida 

FRANK R. LAUTENBERG, New Jersey 

(III) 

C O N T E N T S 

Page 

Hearing held on September 29, 2004 ..................................................................... 1 

Statement of Senator Brownback ........................................................................... 1 

Statement of Senator Dorgan ................................................................................. 28 

Statement of Senator Ensign .................................................................................. 31 

Statement of Senator Wyden .................................................................................. 2 

Article dated September 20, 2004 from The Washington Post entitled, 

‘‘Two Studies Bolster Stem Cells’ Use in Fighting Disease’’ by Rick 

Weiss .............................................................................................................. 3 

Article dated August 17, 2004 from USA Today entitled, ‘‘Nobel Laureate 

decrees limits on stem cell research’’ by Katharine Webster, Associated 

Press ............................................................................................................... 4 

WITNESSES

Daley, M.D., Ph.D., George Q., Representing the American Society for Cell 

Biology ................................................................................................................... 38 

Prepared statement .......................................................................................... 40 

Doerflinger, Richard M., Deputy Director, Secretariat for Pro-Life Activities, 

U.S. Conference of Catholic Bishops .................................................................. 10 

Prepared statement .......................................................................................... 13 

Hedrick, M.D., Marc, President, MacroPore .......................................................... 61 

Prepared statement .......................................................................................... 63 

Prentice, Ph.D., Dr. David A., Senior Fellow for Life Sciences, Family Research Council; Affiliated Scholar, Center for Clinical Bioethics, Georgetown 

University Medical Center .................................................................................. 42 

Prepared statement .......................................................................................... 45 

Zoloth, Ph.D, Laurie, Professor, Bioethics and Religion, Medical Humanities 

and Bioethics Program and Director of Bioethics, Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University .......................... 6 

Prepared statement .......................................................................................... 8 

APPENDIX

Article dated March 2004 entitled, ‘‘Voters’ Views on Stem Cell Research’’ 

prepared by Peter D. Hart Research Associates for the Civil Society Institute ........................................................................................................................ 78

Lautenberg, Hon. Frank R., U.S. Senator from New Jersey, prepared statement ...................................................................................................................... 77 

(1) 

EMBRYONIC STEM CELL RESEARCH: 

EXPLORING THE CONTROVERSY 

WEDNESDAY, SEPTEMBER 29, 2004 

U.S. SENATE, 

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE, 

COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION, 

Washington, DC. 

The Subcommittee met, pursuant to notice, at 2 p.m. in room 

SR–253, Russell Senate Office Building, Hon. Sam Brownback, 

Chairman of the Subcommittee, presiding. 

OPENING STATEMENT OF HON. SAM BROWNBACK, 

U.S. SENATOR FROM KANSAS 

Senator BROWNBACK. Call the hearing to order. Thank you all for 

joining us today. If we could have the first two witnesses please 

come up to the table, Senator Wyden and I have opening statements and then we’ll go with the witnesses. 

We have two votes, starting at 2:15. We’ll try to get as far along 

as we can before we take a break. I doubt if we can, two votes, 

back to back. But we want to move as far as we can. 

Calling this hearing, the Senate Subcommittee on Science, Technology, and Space, to order. We had a hearing a couple of months 

ago on adult stem cell advances, and I stated at that time that we’d 

be holding one on embryonic stem cell. And that’s what this hearing is about today. And I appreciate all of you being here. 

As Chair of the Science Subcommittee, I called this hearing to 

examine the ethics and scientific advances of 20 years of embryonic 

stem cell research. The first panel of witnesses will discuss the ethics of embryonic stem cell research, and the second panel will examine the scientific advances of embryonic stem cell research. 

It’s alleged that human embryonic stem cells are a veritable 

fount of cures for those afflicted with disease; however, to date, I 

am unaware of one person being cured from either private or federally funded human embryonic stem cell research. In July, this Subcommittee heard testimony from real Parkinson’s and spinal injury 

patients whose lives have been dramatically improved by adult 

stem cell treatments. To date, 45 diseases and medical conditions 

in humans have been treated with adult stem cells, such as those 

taken from umbilical cord blood and placenta tissue where there 

are no ethical or moral problems. We need to put finite Federal dollars where they will make the most difference and do no harm. 

We will discuss the issues of cures on the second panel. First, we 

will start with the basic science. 

2 

Science is very clear. Human embryos are living human beings 

at their earliest stages of development. A one cell zygote, whether 

created through fertilization or cloning, is human. We all agree it 

is alive and it is a human; the question seems to be, is it a life? 

Science is about the pursuit of truth in the service of mankind, 

and science tells us that the human embryo, whether created naturally or in a petri dish, is an organism of the species homo sapiens, 

a human being. To obtain human embryonic stem cells, human embryos must be destroyed. Is it right to destroy these human embryos, human beings, at the youngest stages of life, in order to collect their stem cells? 

I’ve called this hearing largely because I’m troubled that science 

is being distorted in the debate over human embryonic stem cells 

and that some are even casting doubt on the scientific fact that 

young human embryos are human lives. Make no mistake, this 

issue involves both biology and ethics. That’s why we have two separate expert panels to discuss each of these issues separately. 

Let us be clear, when it is said that human life begins at the embryonic stage, biology is being discussed—not ideology, belief, or 

ethics. When it is said that no human life, young or old, should be 

taken, we are discussing the traditional Western ethic that have 

made our nation great. 

A human embryo is, biologically speaking, a young human life. 

It is not a scientific statement to assert that it is not a life or that 

it is a potential life. In fact, to assert that a human embryo is not 

a human life is a belief unsupported by the facts. To assert that 

a human embryo is not a human life is inaccurate. 

The topic of human embryonic stem cell research is controversial 

because it touches on the beginnings of human life, the value of 

human life, and respect for human life. Human embryonic stem 

cells force us to consider the fundamental questions about the beginnings of human life. And for that, we can be thankful. Human 

adult and non-embryonic stem cells that are noncontroversial are 

yielding results at no cost to any living human beings. 

We hope to have a good discussion on this topic today. We look 

forward to the panel and the presentations. 

And I turn to my Ranking Member for an opening statement. 

STATEMENT OF HON. RON WYDEN, 

U.S. SENATOR FROM OREGON 

Senator WYDEN. Thank you very much, Mr. Chairman. As you 

know, you and I agree on so many issues in the area of science and 

technology and international affairs and others. And this is one 

where I think even a casual observer of what goes on in this Subcommittee is aware that this is one where we do have diametrically 

opposed views. And I want to say, as we go to today’s hearing, I 

want to commend you for your fairness, because we have always 

debated these issues in an open and straightforward kind of fashion, and you’ve always been eminently fair, and I thank you for it. 

And I know we’re going to have a good debate today. 

Just, if I might, Mr. Chairman, a few comments. First, I’d like 

to put into the record an article from the Washington Post on Sunday by Rick Weiss, a reporter who specializes in this area, and it 

discusses how human embryonic stem cells, through some new exVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 S:\GPO\DOCS\81636.TXT JACKIE
3 

periments that we have seen with the cells, are producing some 

very significant results. One of the reports discussed in the article 

discusses how stem cells, for the first time, are now a cell crucial 

to vision. They can become a cell that is crucial to this area that 

is of concern to so many patients. I would just ask that that be 

made a part of the record. 

Senator BROWNBACK. Without objection. 

[The information referred to follows:] 

The Washington Post—September 26, 2004 

TWO STUDIES BOLSTER STEM CELLS’ USE IN FIGHTING DISEASE

By Rick Weiss 

The prospect of using human embryonic stem cells to treat disease appears a 

small step closer as the result of two new experiments with the cells, which are 

mired in political controversy because they are derived from human embryos. 

In one report released yesterday, researchers showed that the versatile cells can 

serve as ‘‘biological pacemakers,’’ correcting faulty heart rhythms when injected into 

the failing hearts of pigs. 

In another report, scientists demonstrated for the first time that stem cells can 

become a cell crucial to vision. Many doctors believe that several vision-destroying 

diseases could be fought by transplanting these cells directly into the eyes. 

Human embryonic stem cells, derived from five-day-old embryos, have the biological potential to morph into virtually all of the 200 or so kinds of cells in the body. 

Researchers are racing to learn how to direct them to develop into specific types of 

cells that can be transplanted into failing organs. It is an approach that could 

launch a new era of regenerative medicine—but only if the cells prove capable of 

integrating into existing organs and functioning normally there. 

Izhak Kehat and Lior Gepstein of the Technion-Israel Institute of Technology in 

Haifa and their colleagues sought to test that capacity with stem cells that were 

growing into heart muscle cells. 

The team started with masses of stem cells growing in laboratory dishes, from 

which they isolated those few that were spontaneously developing into heart cells. 

They were easy to spot: They were the ones that were pulsing in unison, as heart 

cells are apt to do. 

In one experiment, the scientists isolated small balls of the human cells—each 

ball about the size of the head of a pin, or about 1 million cells—and placed that 

little mass into a lab dish with rat heart cells. 

The cells of each species, rat and human, beat at different rates at first. Within 

24 hours of living together, however, the combined masses of cells coordinated their 

pulsing into a single rhythm. 

‘‘At least in the dish, they integrated structurally, mechanically and electrically,’’ 

Gepstein said. 

But could stem-derived heart cells help set the pace of a heart in a live animal? 

To find out, the team threaded a probe into the hearts of 13 pigs and made a 

small burn in the area that regulates the heart beat, causing a permanent severe 

slowing of those animals’ heart rates. The injury mimicked a human heart rhythm 

disorder that could be caused by disease or a small heart attack. 

Then they injected about 100,000 of their human embryo-derived heart cells into 

the damaged pig hearts. Eleven of the 13 returned to faster heart rates, the team 

reported in yesterday’s advanced online edition of Nature Biotechnology. There was 

no improvement in control animals that did not receive the cells. 

‘‘It’s not like tomorrow people are going to be waiting in line for biological pacemakers,’’ Gepstein said. ‘‘But we were happy to see after a few days a new rhythm 

arose,’’ providing what he called ‘‘proof of principle.’’ 

A second report—appearing in the fall issue of the journal Cloning and Stem 

Cells—describes the first documented growth of retinal pigment epithelial cells, or 

RPE cells, from human embryonic stem cells. 

RPE cells, which are related to nerve cells, live inside the eye and provide essential ‘‘housekeeping’’ duties for the rods and cones—the light-sensitive cells in the retina. RPE cells scavenge the retinal area for cellular debris, sucking old material up 

like little vacuum cleaners. And they secrete substances that aid in tissue repair 

within the eye. 

The loss of RPE cells in middle and old age is a major cause of age-related vision 

loss, including macular degeneration. That disease is the leading cause of blindness 

4 

in people older than 60, affecting 30 million people worldwide. Doctors have begun 

to experiment with RPE cell transplants into people’s eyes, but the approach has 

been plagued by problems—including an inadequate supply of cells. 

In experiments led by Irina Klimanskaya and Robert Lanza of Advanced Cell 

Technology in Worcester, Mass., human embryonic stem cells grown in lab dishes 

under certain conditions spontaneously became RPE cells, offering a possible solution to the supply problem. 

Moreover, the ACT system involves no animal cells or products—a feature the 

Food and Drug Administration has said will be important as it considers granting 

permission to test stem cell-derived cells in people. 

Lanza said the company hopes to complete transplant studies in large animals 

during the next year, after which it will apply for permission to test the cells’ safety 

and therapeutic value in the eyes of people with RPE-related vision loss. 

Not all stem cell colonies worked equally well, Lanza noted, touching on a hot 

area of political debate. Six of the colonies—those developed by Harvard researcher 

Douglas Melton with private funds—‘‘worked like a charm,’’ Lanza said, as did two 

colonies developed by ACT. 

But the three colonies developed by a Wisconsin team—among the few approved 

by President Bush for study with Federal dollars—worked only ‘‘very reluctantly,’’ 

Lanza said. Bush has banned Federal funding for research on newly derived stem 

cell lines in order not to encourage the destruction of human embryos, but Lanza 

said his work shows that policy is short-sighted. 

‘‘It’s becoming clear that each colony is different and can do different tricks,’’ 

Lanza said. ‘‘To limit federally funded research to just a handful of lines is a mistake.’’ 

Senator WYDEN. Mr. Chairman, as we all know, the President, 

a number of years ago, limited Federal-funded research in this area 

to what amounts to literally just a few more than existing cell 

lines. Now only 21 of the initial 78 stem cell lines seem to be available to researchers, and it’s recently been reported—and I’d ask 

that this article be made a part of the record, as well—that more 

than a hundred new lines have been developed since the President’s cutoff date, and now we have many that are much better 

suited for research. And I’d like an article that addresses that point 

to be made a part of the record, as well. 

Senator BROWNBACK. Without objection. 

[The information referred to follows:] 

USA Today—August 17, 2004 

NOBEL LAUREATE DECRIES LIMITS ON STEM CELL RESEARCH

By Katharine Webster, Associated Press 

MANCHESTER, N.H.—A Nobel laureate in medicine says the Bush administration’s limits on funding for embryonic stem cell research effectively have stopped the 

clock on American scientists’ efforts to develop treatments for a host of chronic, debilitating diseases. 

‘‘This is a topic of science and medicine, but it’s a topic that’s become embroiled 

in politics,’’ H. Robert Horvitz, a Massachusetts Institute of Technology biologist, 

said Monday at an Elliot Hospital forum organized by Democratic presidential nominee John Kerry’s campaign. 

Embryonic stem cells are cultured from leftover, 5-day-old embryos created for infertility treatment. They would be discarded if not used for research, with the permission of the infertile couple, Horvitz said. Embryonic stem cell lines were first 

successfully cultured in 1998. 

Three years ago, President Bush—concerned that harvesting the cells required 

the destruction of human embryos—limited federally funded research to a few dozen 

existing cell lines. 

Only 21 of the initial 78 stem cell lines are available to researchers now. Scientists say more than 100 new lines have been developed since Bush’s cutoff date, 

some of which are much better suited for research. 

Horvitz also said researchers need access to diverse embryonic stem cell lines so 

they can develop treatments that are good genetic matches for patients of different 

races and ethnic backgrounds. 

5 

Horvitz, whose father died of Lou Gehrig’s disease, said research and treatments 

derived from embryonic stem cells have the potential to help future sufferers of 

brain diseases, diabetes, heart disease, multiple sclerosis and cancer. 

‘‘Some people who oppose embryonic stem cell research say the problem of curing 

these diseases is very far in the future,’’ he said. ‘‘My response is: Let’s get on with 

it.’’ 

Embryonic stem cell research will not yield quick results in some areas, but in 

others, treatments could be available within a decade, he said. 

‘‘In 10 years, a child with a spinal cord injury may be able to walk—if we start 

now,’’ the 2002 Nobel Prize winner said. 

Ann McLane Kuster, vice-chairwoman of New Hampshire Women for Kerry, made 

an emotional appeal for lifting the restrictions. Her mother, former Republican state 

Sen. Susan McLane, suffers from Alzheimer’s and no longer can stand or speak, she 

said. 

‘‘Advances in stem cell research are being held hostage by the extreme right,’’ she 

said. ‘‘This is emotional. This is about our future, our children, our parents, and we 

cannot let ideology determine our future.’’ 

She said it is a bipartisan issue, noting that U.S. Reps. Charles Bass and Jeb 

Bradley, both New Hampshire Republicans, support lifting the restrictions. 

Speaking for the Bush campaign at a muddy baseball field near the hospital, state 

Rep. Rogers Johnson, R-Stratham, accused the Kerry campaign of ‘‘using stem cell 

research for purely political gain.’’ 

‘‘There are people leading with their hearts on this issue, and I feel for them,’’ 

he said. But, ‘‘Alzheimer’s is not likely to be something you can cure using embryonic stem cells.’’ 

Because treatments are far in the future, there is no harm in proceeding cautiously with a debate on the ethical issues, he said. 

Johnson also noted that Bush was the first president to authorize any Federal 

spending on stem cell research. However, most of the money has gone to research 

on adult stem cells, not embryonic cells. 

Senator WYDEN. Perhaps my biggest single concern at this point, 

Mr. Chairman, is the fact that because all over the country our citizens are so frustrated with the restrictions on research at the Federal level, we now see states—California is the latest—essentially 

taking off on their own. They are simply saying, as the result of 

enormous grassroots pressure in various parts of the country, that 

they’re not going to abide by the Federal Government’s policy of inaction and stonewalling on this issue, and they’re, in effect, going 

to go to their constituents and start their own program. 

And what troubles me is, as a result of these Federal restrictions—in terms of funding, in particular—we are going to see 

states all over America essentially go off and do their own thing. 

And, at a minimum, I think we are going to end up with what 

amounts to a crazy quilt of rules and certainly ethical kinds of 

standards, at a minimum. We’ll see California take one approach, 

another area—New Jersey will perhaps take another approach; 

we’ll have a set of rules at the Federal level. 

And what the scientists have been telling us, what the NIH scientists who have been writing in on this have said, that it’s important that there be one ethical standard. We need to have one ethical standard so that it is clear that we can address some of the 

concerns that we’re going to hear about today. I know they’re 

heartfelt. Witnesses who have a different view of this issue than 

I do are going to raise legitimate ethical concerns. We do need one 

strong Federal ethical standard, rather than this mishmash, a kind 

of crazy quilt of rules that I think we’re going to end up with, and 

end up very quickly with, as a result of the frustration that we are 

seeing around this country. 

6 

So this is a timely hearing. It’s timely because of the new evidence reported about the potential for human embryonic stem cells 

just this week. It’s important because we are seeing that there are 

a lot of new stem cell lines that are available since the President’s 

cutoff date. And it is timely because, once again, with this California ballot measure, we are going to see the consequences where 

we have what amounts to, I think, sort of, scientific chaos as people 

try to figure out what the rules are in an area that really cries out 

for a responsible, thoughtful approach that ensures that the research can go forward that is of such promise for our citizens, 

while, at the same time, addressing the ethical concerns that you 

and a number of our witnesses appropriately highlight. 

So I look forward to working with you today, Mr. Chairman, and 

in the days ahead. I suspect that this will not be our last hearing 

on the subject, and know that you will, as you have been in the 

past, be very fair. 

Senator BROWNBACK. Thanks. And thank you for how you’ve always conducted yourself in these discussions, and I appreciate that 

greatly. 

And I hope today can be a good hearing and discussion of the 

issues, where there can be a candid discussion of the thoughts, 

both ethical and scientific, as we really try to take an in-depth look 

at the overall issue. And I know you share the desire to do that, 

as well. 

We’re going to go ahead with the presentations and start, even 

though we’re likely to have interruption with a vote taking place. 

The first panel is an ethics panel. We’ll have Dr. Laurie Zoloth. 

She’s the Director of Bioethics, Center for Genetic Medicine, Professor of Medical Ethics and Humanities, and a Professor of Religion at Northwestern University in Chicago. Delighted to have you 

here. And Mr. Richard Doerflinger, Deputy Director of the U.S. 

Conference of Catholic Bishops here in Washington, D.C. Mr. 

Doerflinger, delighted to have you here. 

Dr. Zoloth, please proceed with your presentation, and then we’ll 

go with Mr. Doerflinger, and we’ll have questions. 

STATEMENT OF LAURIE ZOLOTH, PH.D, PROFESSOR, 

BIOETHICS AND RELIGION, MEDICAL HUMANITIES AND 

BIOETHICS PROGRAM AND DIRECTOR OF BIOETHICS, 

CENTER FOR GENETIC MEDICINE, FEINBERG SCHOOL OF 

MEDICINE, NORTHWESTERN UNIVERSITY 

Dr. ZOLOTH. Mr. Chairman, Mr. Wyden, I want to thank the 

Committee for asking us to testify why my university supports 

human embryonic stem cell research. It’s part of our broad commitment to the translation of basic medical science into healing. Serving the public’s health is the core moral gesture of the medicine we 

teach. Basic research is free speech that must both be funded and 

regulated in full view of the public. 

As I wrote this testimony, my tenth grader was also writing a 

speech about stem cells. It’s a big topic in our democracy. And, like 

each of you, I worry about the sort of moral universe I will leave 

to my children. 

I’ve listened carefully to the scientific researchers, and I’m convinced by the growing body of evidence both that these cells can 

7 

be made into some useful tissue, and that research on them can explain the nature of how disease works at the cellular level, and this 

is stunningly important. If even some of what we are told to hope 

for is correct, then how we think about illness and injury will be 

transformed. 

So what ethical considerations are a barrier to the full funding 

of this science? There are three: how we get the cell, where we get 

the cell, and what we use them for. 

First is the moral status of the human blastocyst and our duties 

toward it. Second is the process that researchers need to get eggs 

and sperm donated fairly and safely, and our duties to donors. Finally, if researchers can find successful therapies, how will only 

good goals of medicine be pursued, and access to the cures be fair? 

I think we can agree about the duties of justice and science and 

how we must treat human research subjects, but we cannot come 

to an agreement on what most divides us here today: when human 

life begins. This is a profoundly religious question in a profoundly 

religious country profoundly dedicated to the proposition that our 

freedom to faithfully interpret our faith is the core of American life. 

For nearly all Jews, most Muslims, many Buddhists, many 

Protestants, it is not only permissible to use human blastocysts to 

create stem cell lines, it is morally imperative—it must be done if 

it can lead to saving lives. 

As an orthodox Jew, I understand the blastocysts made in the 

lab at the very first stages of division is, at that moment, a cluster 

of cells, and does not have the moral status of a human child. It 

lacks a mother’s womb, its existence is only theoretical without 

this, and it is far before our tradition considers it a human person. 

I respect that there is a difference in theology. And while I understand your passion and the conviction of those for whom the 

blastocyst is a person from the moment of fertilization, I do not believe that it is; and it is a matter of faith for me, as well. My passion and my conviction are toward the suffering of the one I see 

in need. For Jews, the commandant to attend to the suffering is 

core to my faith. Jewish organizations, from Hadassah to the Rabbinic boards of Jewish organizations, speak in one voice on this 

matter: stem cell research is an activity of pikuach nefesh, saving 

and healing broken lives, and of tikkun olam, repairing an unfinished natural world. 

What are you to do, as leaders, when we do not want to compromise our faith positions? I suggest we must learn to compromise 

our public policies. We do it for other deeply felt issues. We did not 

agree when life ended, but when heart transplants became a possibility, Harvard convened a committee to set criteria for brain 

death, an imperfect, but usable, compromise that allowed transplant research to develop. The U.S. now leads the world in successful transplant surgical techniques. We still do not agree, but we 

publicly fund this research, allowing each family and physician to 

make private choices. 

In the last 6 months, I have traveled to three countries to look 

at their stem cell research and meet with their scientists—in 

Israel, in England, and Korea. In each of these places, I also met 

with the bioethicists and philosophers, who demanded careful, national, and public oversight. What I saw was impressive. These 

8 

countries understood that turning their full attention to science is 

not only prudent in our global society, it is compassionate, it is the 

right thing to do to shape your country’s future toward healing. 

Ought we to tremble when we cross such a threshold of human 

knowledge? Of course. For we are being asked to understand things 

that were impossible to know a decade ago. Of course, we need to 

think soberly about the possibility that research may still fail utterly or lead us into dangerous places. That is the very nature of 

free research. Courage to face the problem will mean a compromise 

that can be regulated. 

I would urge a far broader policy than our American scientists 

face now, for it is too late to ban the basic science of human embryonic stem cells. Where that road may turn us to is unknown, but 

what is certainly known is that if we, as Americans, turn aside, we 

will watch others pass us by. Our challenge will be how to live 

bravely and decently in a complex world of difficult moral choices. 

I tell my son that he must write about the core question of ethics, ‘‘What must I do about the suffering of the other person?’’ Stem 

cell science reminds us that we are most human when we act as 

healers. We are the most free when we can explore what we don’t 

yet know. And we are bound by a duty to shape our work, always 

to care for the person in need. 

Thank you. 

[The prepared statement of Dr. Zoloth follows:] 

PREPARED STATEMENT OF LAURIE ZOLOTH, PH.D, PROFESSOR, BIOETHICS AND

RELIGION, MEDICAL HUMANITIES AND BIOETHICS PROGRAM AND DIRECTOR OF

BIOETHICS, CENTER FOR GENETIC MEDICINE, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY

The Ethical Issues in Human Embryonic Stem Cell Research 

Mr. Chairman, Senators: 

My name is Laurie Zoloth, and I am a professor of bioethics and religion in the 

Medical Humanities and Bioethics program, and director of bioethics at the Center 

for Genetic Medicine at the Feinberg School of Medicine, Northwestern University 

in Illinois. I want to thank the Committee for asking us to testify about the ethical 

issues in human embryonic cell research, and tell you why my University and many 

of the organizations in which I serve—the Howard Hughes Medical Institute, the 

International Society for Stem Cell Research, the AAAS, the NAS, support and encourage human embryonic stem cell research. First, for it is part of our broad commitment to the translation of basic medical research into the great moral enterprise 

of healing—serving the public’s health is the core moral gesture of the medicine we 

teach. Second, we support stem cell research as a free academic activity, like free 

speech, that must be protected and sustained in our University and that must be 

both funded and regulated in full view of the public. 

As I wrote this speech, my 10th grader was also writing a speech about stem 

cells—I note this not tangentially, nor merely to remind that I am a mother of five, 

and I, like each of you, worry about the sort of moral universe I will leave to my 

children, but to stress how central this debate has become in our American democracy—it is the subject of how we speak of healing and our duty to heal, and it is 

the subject when we speak of human dignity, and it is how we express our hope 

and our fear of the future. Stem cells are important in this way because of the serious rumor of hope they carry for millions of yearning patients and families. As an 

early watcher of the science of stem cells, I have listened carefully to the excitement 

of the researchers, and while ethicists urge caution and avoid hyperbolic claims, 

most ethicists are convinced that the sincerity and veracity of a growing body of evidence about how these cells can be coaxed into useful tissue, and how these cells 

can explain the very nature of how cells grow, change and divide and die—in short, 

how disease plays out at the cellular level—is stunningly important. If even some 

of what we are told to hope for is correct, then how we think about illness and injury will be transformed. 

9 

So why do ethical considerations stop full funding of this science? I would argue 

that there are three issues: where we get the cell, how we get the cell and what 

we use them for. First, is the issue of the origins of the cells, which means the moral 

status of the human blastocyst—can we destroy blastocysts, made in the lab, for any 

purpose? Can we do it for medical research and why or why not? Second is the process that researchers need to get eggs and sperm donated fairly and safely and responsibly, and handled with dignity. How are women’s special needs protected? How 

do we protect human subjects in the first stages of this research? Finally, if researchers can find successful therapies, how will good goals of medicine be protected, and access to the therapies be fair? Can we come to agreement on the proper 

ends of medicine? 

Stem cells are interesting to ethicists for precisely the same reason that they are 

intriguing to the market—they represent a therapeutic intervention that, unlike 

heart transplants, could be universally available, replicable and scaleable. If the 

daunting problems of histocompatibility can be overcome, embryonic stem cells could 

be made universally acceptable to anybody. Unlike adult stem cells, which would 

have to be created each time for each particular user, the premise of application is 

the wide use. Bioethicists defend high intensity interventions like organ transplant, 

which have saved, albeit at high cost, thousands of individuals. But organ transplants are terribly expensive, and always rationed, and the risks considerable. Stem 

cell research is aimed at a wider community of vulnerable patients, and at no one 

particular category, age, ethnicity, or class. The sort of injury and diseases that 

stem cells are indicated for are not boutique, or rare—cell death and cell growth is 

at the core of nearly all disorders. Research into these essential causes would be 

precisely the sort of research we ought to insist on. Further, understanding how embryonic cells are programmed and reprogrammed might allow us to understand how 

to de-program cells, allowing adult cells to regenerate, teaching the body to heal 

itself. The demand for justice and the scrutiny to which genetic medicine is given 

are indications that we understand the power of genetics to reconfigure the self, and 

the society—in this way, the very debate about stem cells forces precisely the justice 

considerations that I would argue must be a part of medicine. The principle of justice places a priority on the public aspects of research—on public funding and on 

public oversight review boards for protocols. 

I think we can come to some agreement—around the duties of just medicine, and 

just science, and we have in the past come to agree on the how we must treat 

human research subjects and regulate that process, but I think we cannot come to 

some sort of agreement on what most divides us today—when human life begins, 

for this is a profoundly religious question in a profoundly religious country, profoundly dedicated to the proposition the our freedom to faithfully interpret our faith 

is the core of American life. For nearly all Jews, most Muslims, many Buddhists, 

and many Protestants, it is not only permissible to use human blastocysts to create 

stem cell lines, it is morally imperative—it must be done if it can lead to saving 

lives or healing. As an orthodox Jew, I understand the blastocyst, made in the lab, 

at the very first stages of division, prior to the time it could even successfully be 

transferred to a women’s body as just what it is at that moment: a cluster of primitive cells. It does not have the moral status of a human child—it lacks a mother’s 

womb, it existence is only theoretical without this, and even in the course of a normal pregnancy a blastocyst at 3 days is far before our tradition considers it a 

human person. While I respect that this is a difference in theology, and while I understand the passion and the conviction of those for whom the blastocyst is a person 

from the moment of fertilization, I do not believe this, and it is matter of faith for 

me as well. My passion and my conviction are toward the suffering of the one I see 

in need, ill, or wounded—for Jews and Muslims, the commandment to attend to this 

suffering is core to our faiths. Jewish organizations from Hadassah to the rabbinic 

and lay boards of all national Jewish denominations speak in one voice on this matter: human embryonic stem cell research is an activity of pikuach nefesh, saving and 

healing broken lives, and of tikkun olam—repairing an unfinished natural world. 

What are you to do, as leaders of our polity when we will not compromise faith 

positions? I suggest we must learn to compromise our faith policies—we do for other 

deeply felt issues and we must in this case as well. For example: we did not agree 

when life ended, but when heart transplants became a possibility, Harvard convened a committee to set criteria for ‘‘brain death’’—an imperfect, biologically ragged, but useable compromise that allowed transplant research to develop. The U.S. 

leads the world in successful transplant surgical techniques—and yet some faiths 

do not agree on these criteria. We do not agree on prenatal diagnosis, yet this is 

widely done, as is IVF even if it means embryos are destroyed to get one successful 

pregnancy. We do not agree, but we publicly fund and publicly go forward with research about these polices and we allow each family and physician to make private 

10 

choices. We do this by a combination of courage and compromise—you shape our 

policy in different ways: Republicans in one way, Democrats in another, but both 

allow for research to go forward with limits, based in time, or geography. Now it 

is time to revisit these limits. 

In the last six month, I have traveled to three countries to look at their stem cell 

research and meet with their scientists: Israel, England and Korea. In each of these 

places, I also met with the bioethicists, philosophers, legal scholars and theologians 

who reflect on the research—who have demanded the same sort of careful, national, 

and public oversight I would think ethically important. What I saw was impressive—and for this committee in particular, critical. I saw that these countries understood that basic research in biology would be a core driver of their economy, that 

the knowledge, wisdom and energy that inspired that research would open the door 

to a world of new possibilities, some false starts, to be sure, but perhaps-just perhaps—some new starts. These countries understand that turning their full attention 

to science is not only prudent in our competitive global world, it is compassionate— 

it is the right thing to do to shape your country’s future toward healing the needs 

of the suffering. In South Korea’s labs, they meet at dawn to begin the work every 

single day, working with the same passion and government support we give to our 

Mars Rover programs, for example. 

Ought we to tremble when we cross such a threshold of human knowledge? Ought 

we to worry that we may be going too far or too fast? Of course, for we are being 

asked to understand the world differently, the self differently, what it means to be 

human and to be unique, differently—to know and to see things which were impossible to know or see a decade ago. Of course we need to think soberly about the possibility that the research may fail utterly, or that it may succeed but lead us into 

a place of great unpredictability—that is the very nature of research—that is why 

the future is what makes us free, this uncertainty. 

Courage to face the problem will mean a compromise that can be regulated, as 

we did with recombinant DNA, as we did in organ transplantation. I would urge 

a far broader and more open policy than our American scientist face now, for it is 

far too late to stop, ban, or have a moratorium on the basic science of human embryonic stem cells—it not only will proceed, it has proceeded, in Asia, Israel, Europe 

and England. Stem cell research will now clearly be a possible road. Where that 

road might turn us is unknown—but what is certain is that if we turn off the road, 

we will watch others pass us by. Our challenge-and this means each of us—scientist, 

citizen, congregant, critics and enthusiast—most of all Senator—will be how to live 

bravely and decently and fairly in a complex world of difficult moral choices. Can 

stem cell research yield therapies that could help millions who now suffer? Will it 

yield cures for diabetes, Parkinson’s, spinal cord injury? Who can yet know? If it 

were able to help even some, that might be light enough in the storm filled world. 

I tell my son that he must raise these questions, the core questions of ethics and 

of biology—How are we human? How will we be free? What must I do about the 

suffering of the other person? And that stem cell science can remind us that we are 

most human when we act as healers, we are the most free when we explore what 

we don’t yet know, and we are bound to a duty to shape our work to care always 

for the person in need. 

Thank you. 

Senator BROWNBACK. Thank you very much, Dr. Zoloth. 

Mr. Doerflinger? 

STATEMENT OF RICHARD M. DOERFLINGER, 

DEPUTY DIRECTOR, SECRETARIAT FOR PRO-LIFE ACTIVITIES, 

U.S. CONFERENCE OF CATHOLIC BISHOPS 

Mr. DOERFLINGER. Thank you, Mr. Chairman. 

Our longer written statement has been submitted for the record. 

I would like to review three points. 

First, the need for ethical safeguards in human research. The 

ethical issue raised by this research arises whenever proponents of 

unlimited research freedom complain that ethical restraints get in 

the way of ‘‘progress.’’ The Nuremberg Code and other declarations 

have affirmed that human life and dignity must not be trampled 

on in the pursuit of medical knowledge useful to others. Yet American scientists, and others dazzled by visions of technical progress, 

11 

are tempted to endorse a utilitarian ethic, and to treat helpless or 

unpopular members of the human race as mere means to their 

ends. When society has dropped its guard and failed to set clear 

limits, we ended up with the Tuskegee syphilis experiment, the infamous study at Willowbrook Children’s Home in New Jersey, our 

government’s Cold War radiation experiments, and other even 

more recent scandals. This same utilitarian approach drives those 

who pursue harmful experiments on human embryos today. 

Because scientists and the for-profit companies that increasingly 

support and use their research are tempted to mistreat helpless 

members of the human family, society, including government, must 

supply the urgently needed barrier against the inhuman use of 

human beings. 

Second, the moral status of the human embryo. Some with a 

vested interest in embryo research claim, and have testified before 

Senate committees, that the early human embryo is more like a 

goldfish than a human being, or at least has that moral status. But 

that’s based on scientific ignorance. The continuity of human development and the reality of the embryo as a living organism of the 

human species, has actually been underscored by recent biological 

discoveries. The embryo is also recognized and respected as a member of the human family in numerous areas of Federal law. 

Catholic moral teaching holds that human life has intrinsic dignity, not only a relative or instrumental value. Thus, every living 

member of the human species, including the embryo, must be treated with the respect due to a human person. To reject that position 

is to risk undermining the inherent and inalienable rights of 

human beings after birth as well, to turn these into mere privileges 

gained or lost depending on one’s mental and physical abilities. 

But even those who do not hold the human embryo to be a fullfledged human person can find embryonic stem cell research unethical. Setting aside debates on personhood, surely no one prefers 

funding research that requires destroying human life. 

Four major advisory groups recommending Federal policies on 

human embryo research over two decades, three of them under 

Democratic administrations, have agreed that this research destroys human lives that deserve our respect. It’s a simple biological 

fact. It is absurd to treat a human life solely as a source of spare 

parts for other people and claim that this demonstrates your respect for that life. The claim that the only embryos to be destroyed 

for research are those who ‘‘would have been discarded anyway’’ 

fails as a moral argument—all of us will die anyway. That gives 

no one the right to kill us. But that claim also misunderstands the 

consent process at fertility clinics. It would violate their professional code to take the embryos slated to be discarded and use 

them for research instead, or vice versa. They’re two mutually exclusive categories of embryos. 

In 1999, the National Bioethics Advisory Commission under 

President Clinton tried to explain what respect for the embryo 

might mean in the research context: ‘‘In our judgment, the derivation of stem cells from embryos remaining following infertility 

treatments is justifiable only if no less morally problematic alternatives are available for advancing the research.’’ 

12 

The burden of proof needed to justify destructive embryo research by NBAC’s ethical standard has never been met. Scientific 

and practical barriers to the medical use of embryonic stem cells 

now loom larger than many expected. Meanwhile, non-embryonic 

stem cells and other alternatives have moved quickly into promising clinical trials for a wide array of conditions, including spinal 

cord injury, Multiple Sclerosis, Parkinson’s disease, and heart damage, to name just a few. 

Proponents’ response to that evidence has been simply to abandon the Bioethics Commission’s standard. They are losing the 

game, and have decided to move the goal post. What is now heard 

is that research using both embryonic and non-embryonic stem 

cells must be equally funded now to determine which source is best 

for various functions. But that would be justifiable only if the embryo deserves no respect at all, if it really were a goldfish and not 

a human being. 

In short, Federal funding of embryonic stem cell research fails 

even the test offered by its proponents when they advised the Federal Government on this issue 5 years ago. 

Third, the ethical slippery slope. The campaign for expanded 

Federal support for embryonic stem cell research cannot achieve its 

medical goals without violating even more ethical norms. Some 

claim the stem cells now eligible for Federal funds are inadequate 

in number and contaminated by the mouse feeder cells in which 

they are cultured. They say new cell lines, like those recently created with private funds at Harvard, must now be used. 

But the cell lines already eligible for funding seem adequate for 

their intended task: conducting basic research on the advantages 

and disadvantages of these cells. Moreover, the new Harvard cell 

lines have the same deficiencies as those already eligible—they 

were grown on mouse feeder cells, as well—and have already developed serious genetic abnormalities typical of cancer cells, the researchers say, to be exact, typical of testicular cancer. 

The cell lines that could be obtained by killing all the frozen embryos now available for research nationwide would still be inadequate in sheer number and genetic diversity to treat any major 

disease. To solve this problem, some researchers propose creating 

a new genetically diverse bank of cell lines by creating and killing 

numerous embryos solely for research, including a disproportionate 

number of embryos conceived by members of racial minorities who 

are under-represented at fertility clinics. Others have declared that 

mass production of new embryos by cloning will be essential. 

Either way, the logical conclusion is this. Unless you are willing 

to commit yourself in the future to the mass production of human 

lives solely to exploit and destroy them, there is no point in funding 

research using so-called excess embryos now. 

And there is yet another moral line to cross, beyond this. For the 

effort to get so-called therapeutic cloning to work in animals has 

generally succeeded only when cloned embryos are implanted in a 

womb, developed to later fetal stages, then aborted for their tissues. The biotechnology industry has supported bills in many 

states to authorize such fetus farming in humans, has helped pass 

such a law already in New Jersey, and now supports a ballot initiaVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00016 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\81636.TXT JACKIE
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1 Claude Bernard, An Introduction to the Study of Experimental Medicine (1865), quoted in 

Stephen Post, Inquiries in Bioethics (Georgetown University Press 1993), at 145. 2See ‘‘The Nuremberg Code (1947)’’ (www.cirp.org/library/ethics/nuremberg/). The Code acknowledges one possible exception to this norm, which if taken absolutely would itself be problematic: ‘‘those experiments where the experimental physicians also serve as subjects.’’ Researchers have a moral responsibility to take due care of their own lives as well. 

tive in California that could end up requiring the use of state funds 

to promote it. 

In short, the promise of this approach is too speculative, and the 

cost too high. That cost includes the early human lives destroyed 

now and in the future, the exploitation of women for their eggs and 

perhaps in the future for their wombs, and the diversion of finite 

public resources away from research avenues that offer real reasons for hope for patients with terrible diseases. Let’s agree to support avenues to medical progress that we can all live with. 

Thank you. 

[The prepared statement of Mr. Doerflinger follows:] 

PREPARED STATEMENT OF RICHARD M. DOERFLINGER, DEPUTY DIRECTOR, 

SECRETARIAT FOR PRO-LIFE ACTIVITIES, U.S. CONFERENCE OF CATHOLIC BISHOPS

I am Richard M. Doerflinger, Deputy Director of the Secretariat for Pro-Life Activities at the U.S. Conference of Catholic Bishops. On behalf of the bishops’ conference I want to thank this Subcommittee for asking us to present our views on 

the ethics of human embryonic stem cell research. 

I. The Need for Ethical Safeguards in Human Research 

The central ethical issue raised by this research is raised whenever proponents 

of unlimited research freedom complain that ethical restraints get in the way of 

‘‘progress.’’ This tension between technical advance and respect for research subjects 

is at least as old as modern medicine itself. As soon as Western thinkers began to 

see medicine as a science that could advance and acquire new knowledge, the temptation arose of using human beings as mere means to this end. 

When Dr. Claude Bernard sounded an alarm against this temptation in the 19th 

century, the preferred victims were prisoners convicted of serious crimes. He insisted that the physician must not deliberately do harm to any human being simply 

to acquire knowledge that may help others: 

The principle of medical and surgical morality, therefore, consists in never performing on man an experiment that might be harmful to him to any extent, 

even though the result might be highly advantageous to science, i.e., to the 

health of others. But performing experiments and operations exclusively from 

the point of view of the patient’s own advantage does not prevent their turning 

out profitably to science.1

In 1865, Dr. Bernard was already making the important distinction between 

therapeutic and nontherapeutic experimentation. The fact that an experiment may 

benefit the research subject is only one moral requirement among others; but it is 

one thing to provide a human being with an experimental treatment whose outcome 

may also help in treating others in the future, and quite another thing simply to 

use him or her as a means, imposing significant risk of harm on him or her solely 

to benefit others. 

In the Nuremberg Code, the United States and its allies responded to the horrors 

of the Nazi war crimes by restating this principle, to ensure that human dignity 

would not again be trampled on in the pursuit of medical knowledge. Among other 

things, the Code declared: ‘‘No experiment should be conducted where there is an 

a priori reason to believe that death or disabling injury will occur . . .’’ 2

This Code inspired many later declarations, including the ‘‘Declaration of Helsinki’’ first approved by the World Medical Association in 1964. Here the key principle is: 

In medical research on human subjects, considerations related to the well-being 

of the human subject should take precedence over the interests of science and 

society. 

14 

3World Medical Association, ‘‘Declaration of Helsinki’’ (www.wma.net/e/policy/17-cle.html). 4World Medical Association, ‘‘Declaration of Geneva,’’ reprinted in Reiser, Dyck and Curran 

(eds.), Ethics in Medicine (The MIT Press 1977), at 37. In the Declaration’s 1994 revision, this 

phrase was amended to ‘‘human life from its beginning’’ (www.wma.net/e/policy/17-ale.html). 5 Eunice Rivers et al., ‘‘Twenty Years of Follow-Up Experience in a Long-Range Medical 

Study,’’ 68 Public Health Reports 391–5 (April 1953). 6See the source materials in J. Katz, Experimentation with Human Beings (New York: Russell 

Sage Foundation 1972) at 1007–8. 7See A. Skolnick, ‘‘Advisory Committee Report Recommends That U.S. Make Amends for 

Human Radiation Experiments,’’ 274 Journal of the American Medical Association 933 (Sept. 27, 

1995). 8 Ronald Green, in Transcript of the NIH Human Embryo Research Panel (National Institutes 

of Health: Rockville, MD 1994), Monday, April 11, 1994, at 92. 9 J. Fletcher, Situation Ethics: The New Morality (Philadelphia: Westminster Press 1966) at 

120–21. 

The Helsinki declaration noted that this principle must apply to all human 

beings, and that ‘‘some research populations,’’ including those who cannot give consent for themselves, ‘‘need special protection.’’ 3 It seems this principle was intended 

to encompass the unborn, as the same organization’s statement on the ethics of the 

practicing physician, the ‘‘Declaration of Geneva,’’ had the physician swear that ‘‘I 

will maintain the utmost respect for human life, from the time of conception.’’ 4

Despite these solemn declarations, American scientists and others dazzled by visions of technical progress have always been tempted to endorse a utilitarian approach to ethics, and to treat helpless or unpopular members of the human race as 

mere means to their ends. 

In the Tuskegee syphilis experiment, for example, hundreds of poor black sharecroppers were deliberately left with untreated syphilis for over twenty years to observe the course of their disease. This was no isolated aberration but a sustained, 

decades-long study conducted with U.S. Government support. A report filed by the 

Public Health Service at the end of the process, in 1953 (years after Nuremberg!), 

shows no trace of ethical concern—rather, the authors comment favorably on how 

subjects were encouraged to comply with the study by the offering of ‘‘incentives’’— 

including the offer of free burial assistance once they died from their untreated 

syphilis! The authors concluded: ‘‘As public health workers accumulate experience 

and skill in this type of study, not only should the number of such studies increase, 

but a maximum of information will be gained from the efforts expended.’’ 5

There were indeed more such studies. We need only think of the study at 

Willowbrook children’s home, where retarded children in the 1960s were deliberately injected with hepatitis virus to study ways of preventing spread of the disease. One justification offered by the researchers was that hepatitis was so common 

in the institution that these children probably would have been exposed to it anyway—an argument we now see in the embryo research debate, when researchers insist that the human embryos they destroy probably would have been discarded anyway.6 Or we can look to our government’s Cold War studies on the effects of radiation using unsuspecting military and civilian subjects, conducted from the 1940s 

to the 1970s—where the drive to pursue knowledge could claim additional support 

from the drive for national security.7

The same utilitarian approach drives those who seek to justify harmful experiments on human embryos today. When asked in 1994 whether the National Institutes of Health’s Human Embryo Research Panel should base its conclusions on the 

principle that ‘‘the end justifies the means,’’ the Panel’s chief ethicist quoted the 

man known as the father of situation ethics, Joseph Fletcher: ‘‘If the end doesn’t 

justify the means, what does?’’ 8 This ethicist later became the chief ethicist for Advanced Cell Technology, the Massachusetts biotechnology company most prominent 

in the effort to clone human embryos for research purposes. Interestingly, Fletcher 

himself claimed that the phrase originally came from Nikolai Lenin, who reportedly 

used it to justify the killing of countless men, women and children in the Russian 

revolution of 1917.9

History provides us with little reason to favor utilitarian thinking about human 

life—for even judged by its own terms, making moral judgments solely on the basis 

of consequences has so often had terrible consequences. Because scientists, and the 

for-profit companies that increasingly support and make use of their research, are 

always tempted to treat helpless members of the human family as mere means to 

their ends, the rest of society—including government—must supply the urgently 

needed barrier against unethical exploitation of human beings. 

II. The Moral Status of the Human Embryo 

Some will object that one-week-old human embryos, uniquely among all classes 

of living human organisms, deserve no such protection from destructive experiVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00018 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\81636.TXT JACKIE
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10Mary Tyler Moore, Testimony on behalf of the Juvenile Diabetes Foundation before the Senate Appropriations Subcommittee on Labor, Health and Human Services and Education, September 14, 2000. 11K. Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology, 7th 

edition (Saunders: Philadelphia 2003), at 2, 3. For similar statements from other textbooks see 

USCCB Secretariat for Pro-Life Activities, ‘‘What is an Embryo?’’, at www.usccb.org/prolife/ 

issues/bioethic/fact298.htm. 12 H. Pearson, ‘‘Your destiny, from day one,’’ 418 Nature 14–15 (4 July 2002) at 15. For an 

overview of the recent findings see the Appendix to our June 2003 testimony to the President’s 

Council on Bioethics, reprinted as R.M. Doerflinger, ‘‘Testimony on Embryo Research and Related Issues,’’ 3 National Catholic Bioethics Quarterly 767–86 (Winter 2003) at 783–6. 13This is even generally true in the context of abortion, wherever Supreme Court decisions 

have allowed the legislative branch to make policy choices (as with Federal funding of abortion). 

In any event, the Supreme Court has allowed legislatures to respect unborn human beings and 

recognize them as human persons, in contexts other than abortion. Webster v. Reproductive 

Health Services, 492 U.S. 490, 506–07 (1989). Because the human embryo in the laboratory is 

not encompassed by any reproductive liberty or ‘‘privacy’’ defined in the Court’s abortion decisions, there is no constitutional barrier to the laws passed by several states against destroying 

embryos in the laboratory. The research that some members of Congress want to subsidize with 

Federal funds would be a felony in their own home states. See USCCB Secretariat for Pro-Life 

Activities, ‘‘Current State Laws Against Human Embryo Research,’’ www.usccb.org/prolife/ 

issues/bioethic/states701.htm, and ‘‘Current State Laws on Human Cloning,’’ www.usccb.org/ 

prolife/issues/bioethic/statelaw.htm. 14Laci and Conner’s Law, signed into law April 1, 2004 (Pub. L. 108–212). 15Final Rule: State Children’s Health Insurance Program; Eligibility for Prenatal Care and 

Other Health Services for Unborn Children, 67 Fed. Reg. 61956–74 (Oct. 2, 2002) at 61974 (definition of ‘‘child’’ includes ‘‘the period from conception to birth’’). 16The version currently in effect is Section 510 of Division E of the Consolidated Appropriations Act of 2004 (Pub. L. 108–199). 17See Pope John Paul II, Evangelium vitae (The Gospel of Life) (1995), nos. 60–63. 18Thus human life must be respected as having intrinsic dignity before birth, or it will not 

have such dignity even after birth. This is recognized by many ethicists favoring human embryo 

research, most famously by Peter Singer of Princeton University. Ronald Green, cited above for 

his role in the embryo research debate, holds that there is nothing objective in any human being 

that demands our recognition of that human as a ‘‘person’’—rather, society may judge in given 

Continued 

ments. They hold that these embryos, ‘‘according to science, bear as much resemblance to a human being as a goldfish.’’ 10

But this is simply scientific ignorance. Modern embryology textbooks tell us that 

the initial one-celled zygote is ‘‘the beginning of a new human being,’’ and define 

the ‘‘embryo’’ as ‘‘the developing human during its early stages of development.’’ 11

The continuity of human development from the very beginning, and the reality 

of the early embryo as a living organism of the human species, has been underscored by recent biological discoveries. Commenting on these new findings, a major 

science journal concluded that ‘‘developmental biologists will no longer dismiss early 

mammalian embryos as featureless bundles of cells.’’ 12 Political groups may still attempt to do so, of course, but they cannot claim that science is on their side. 

While it makes no sense to say that any of us was once a body cell, or a sperm, 

or an egg, it makes all the sense in the world to say that each of us was once an 

embryo. For the embryo is the first stage of my life history, the beginning of my 

continuous development as a human organism. This claim makes the same kind of 

sense as the claim that I was once a newborn infant, although I do not have any 

recollection of cognitive or specifically human ‘‘experiences’’ during that stage of life. 

The principle that the embryo deserves recognition and respect as a member of 

the human family is also already reflected in numerous areas of Federal law.13 At 

every stage of development, the unborn child in the womb is protected by Federal 

homicide laws as a separate victim when there is a violent attack upon his or her 

mother.14 That same child is recognized in Federal health regulations as an eligible 

patient deserving prenatal care.15 And of course, for the last eight years that same 

embryo has been protected, in much the same way as other human subjects, from 

being harmed or killed in federally funded research.16

Catholic moral teaching on this issue is very clear. Every human life, from the 

first moment of existence until natural death, deserves our respect and protection. 

Human life has intrinsic dignity, not only a relative or instrumental value; thus 

every living member of the human species, including the human embryo, must be 

treated with the respect due to a human person.17 We hold further that attempts 

to make a principled argument as to why embryos need not be respected as persons 

end up excluding many other members of the human race from this status as well. 

Any mental or physical ability or characteristic (aside from simple membership in 

the human race) that one may propose as the deciding factor for ‘‘personhood’’ will 

be lacking in some people, or held more by some people than by others.18

16 

cases that born humans, as well, have qualities making them more valuable dead than alive. 

Ronald M. Green, ‘‘Toward a Copernican Revolution In Our Thinking About Life’s Beginning 

and Life’s End,’’ 66 Soundings 152 (1983) at 159–160. If one attempts to develop and apply objective criteria for personhood, based for example on cognitive abilities, says Green, then ‘‘it 

seems to be true that if the fetus is not a person, neither is the newborn or young infant.’’ Id. 

at 156. 19 ‘‘Report of the Ethics Advisory Board,’’ 44 Fed. Reg. 35033–58 (June 18, 1979) at 35056. 20 National Institutes of Health (NIH), Report of the Human Embryo Research Panel (September 1994), at 2. 21 National Bioethics Advisory Commission (NBAC), Ethical Issues in Human Stem Cell Research (Rockville, Maryland: September 1999), Vol. I at ii; cf. 2. 22 National Academy of Sciences (NAS), Scientific and Medical Aspects of Human Reproductive 

Cloning (National Academy Press 2002), 262. 23Says ethicist Glenn McGee, who supports embryo research: ‘‘Pretending that the scientists 

who do stem cell research are in no way complicit in the destruction of embryos is just wrong, 

a smoke and mirrors game on the part of the NIH. It would be much better to take the issue 

on directly by making the argument that destroying embryos in this way is morally justified— 

is, in effect, a just sacrifice to make.’’ Quoted in J. Spanogle, ‘‘Transforming Life,’’ The Baylor 

Line (Winter 2000) at 30. 

Thus Catholic morality regarding respect for human life, and any secular ethic in 

agreement with its basic premises, rejects all deliberate involvement with the direct 

killing of human embryos for research or any other purpose. Such killing is gravely 

and intrinsically wrong, and no promised beneficial consequences can lessen that 

wrong. This conviction is also held by many American taxpayers, who should not 

be forced by government to promote with their tax dollars what they recognize as 

a direct killing of innocent human persons. 

But even those who do not hold the human embryo to be a full-fledged human 

person can conclude that embryonic stem cell research is unethical. Many moral 

wrongs fall short of the full gravity of homicide but are nonetheless seriously wrong. 

Setting aside ‘‘personhood,’’ surely no one prefers funding research that requires destroying human life. 

Four major advisory groups recommending Federal policies on human embryo research over the past 23 years have agreed that the destruction of human life is exactly what is at stake in research that involves destroying human embryos. For example, the Ethics Advisory Board to the Department of Health, Education and Welfare concluded in 1979 that the early human embryo deserves ‘‘profound respect’’ 

as a form of developing human life (though not necessarily ‘‘the full legal and moral 

rights attributed to persons’’).19 The NIH Human Embryo Research Panel agreed in 

1994 that ‘‘the preimplantation human embryo warrants serious moral consideration 

as a developing form of human life.’’ 20 In 1999, the National Bioethics Advisory 

Commission (NBAC) cited broad agreement in our society that ‘‘human embryos deserve respect as a form of human life.’’ 21 And in 2002, the National Academy of 

Sciences acknowledged that ‘‘in medical terms,’’ the embryo is a ‘‘developing human 

from fertilization’’ onwards.22

What does this respect mean, if it does not mean full and active protection from 

harm of the kind we extend to human persons? At a minimum, doesn’t it mean that 

we will not use public funds to promote such harm? It is absurd to treat a human 

life solely as a source of spare parts for other people, and claim that this demonstrates your ‘‘respect’’ for that life. It is equally absurd to fund stem cell research 

that encourages researchers to destroy human embryos for their cells, and claim 

that one is not promoting disrespect for the lives of those embryos.23

It does not help this argument to claim that the only embryos to be destroyed for 

research are those who ‘‘would have been discarded anyway.’’ The mere fact that 

some parents discard ‘‘excess’’ embryos creates no argument that the Federal government should intervene to assist in their destruction—any more than the fact that 

many abortions are performed in the U.S. creates an argument that Congress must 

use its funding power to promote such killing. In fact, Congress has for many years 

rejected arguments that it can fund harmful experiments on unborn children slated 

for abortion because ‘‘they will die soon anyway.’’ See 42 U.S.C. § 289g. The claim 

that humans who may soon die automatically become fodder for lethal experiments 

also has ominous implications for condemned prisoners and terminally ill patients. 

In the final analysis, all of us will die anyway, but that gives no one a right to kill 

us. Even on its own amoral terms, that argument also misunderstands the informed 

consent process for ‘‘disposition’’ of frozen embryos in U.S. fertility clinics. When 

these clinics produce more embryos in a given cycle than parents need for their immediate reproductive goals, they do indeed freeze the ‘‘excess’’ embryos and ask the 

parents what should be done with them after a given time. Most clinics offer the 

options of continuing to preserve the embryos, using them for further reproductive 

17 

24 In its 1999 report, NBAC recommended that clinics first offer parents the option of having 

their embryonic children destroyed, and only then offer a choice between discarding and destructive research as the two ways of destroying them. NBAC, note 21 supra at 53. Such a policy 

might provide a factual basis for determining that embryos slated for research would have been 

destroyed anyway. But as far as anyone can determine, no fertility clinic has taken this approach. The number of frozen embryos in the United States now designated for research, that 

one can determine would only have been ‘‘discarded anyway,’’ is zero. 25Transcript, note 8 supra, April 11, 1994, at 40 (remarks by Dr. Bernard Lo). 26 NBAC, note 21 supra, at 53. 27 NIH, Stem Cells: Scientific Progress and Future Research Directions (Dept. of Health and 

Human Services, June 2001), at 17; also see 63 (any possible advantages of embryonic cells remain to be determined), 102 (not known whether these cells are better suited for gene therapy). 28See the sources cited in USCCB Secretariat for Pro-Life Activities, ‘‘Practical Problems with 

Embryonic Stem Cells,’’ www.usccb.org/prolife/issues/bioethic/stemcell/obstacles51004.htm. 29See: the sources cited in USCCB Secretariat for Pro-Life Activities, ‘‘Scientific Experts 

Agree: Embryonic Stem Cells are Unnecessary for Medical Progress,’’ www.usccb.org/prolife/ 

issues/bioethic/fact401.htm; Testimony of Susan Fajt, Laura Dominguez, and Dennis Turner before this Subcommittee, July 14, 2004, at www.stemcellresearch.org/testimony/index.html; and 

the constantly updated reports of therapeutic advances at www.stemcellresearch.org. 

efforts by the couple, donating them to another couple for reproduction, discarding 

them, or donating them for research. But these are mutually exclusive options. For 

example, it would violate the professional code of the fertility industry to take embryos ‘‘to be discarded’’ and use them for research instead. And among embryos donated for research, no researcher or government official can tell which embryos 

‘‘would have been discarded’’ if this option had not been offered.24

The problem with past Federal advisory panels is that they have generally failed 

to give any real content to the notion of ‘‘respect’’ or ‘‘serious moral consideration’’ 

for the embryonic human. The NIH Human Embryo Research Panel failed miserably in this task. Since the Panel approved a wide array of lethal experiments on 

human embryos—including some which required specially creating embryos solely 

to destroy them—even the Panel’s own members publicly observed that it had come 

to use the word ‘‘respect’’ merely as a ‘‘slogan’’ with no moral force.25

In the end, the Panel’s report was rejected in part by President Clinton (who denied funding for experiments involving the creation of embryos for research), and 

rejected in its entirety by Congress (which enacted the appropriations rider against 

funding harmful embryo research that remains in law to this day). 

Five years later, the National Bioethics Advisory Commission tried to give more 

definition to what ‘‘respect’’ for the embryo might mean in the research context: 

In our judgment, the derivation of stem cells from embryos remaining following 

infertility treatments is justifiable only if no less morally problematic alternatives are available for advancing the research.26

While this standard does not fully respect the embryo as a person with inviolable 

rights, it creates a presumption against research that requires killing embryos: Such 

research was to be a last resort, pursued only after it is found that research benefits 

cannot be pursued in any other way. However, the Commission then evaded the implications of this standard, by ignoring the emerging evidence about the promise of 

adult stem cells and other alternatives. But the Commission admitted that its factual claim on this point must be reevaluated as scientific knowledge advanced. 

As the National Institutes of Health acknowledged in 2001, the burden of proof 

needed to justify human embryo research by NBAC’s ethical standard has never 

been met. The NIH’s review of stem cell research concluded that any therapies 

based on embryonic stem cells were ‘‘hypothetical and highly experimental,’’ and 

that it could not be determined at that time whether these cells would have any 

advantages over the less morally problematic alternatives.27

Since that time, in fact, scientific and practical barriers to the medical use of embryonic stem cells have loomed larger than many scientists expected in 1999. Problems of tumor formation, uncontrollability, and genetic instability are now cited 

among the reasons why embryonic stem cells cannot safely be used in human trials 

any time in the foreseeable future.28 At the same time, non-embryonic stem cells 

have moved quickly into promising clinical trials for a wide array of conditions, including spinal cord injury, multiple sclerosis, Parkinson’s disease, heart damage and 

corneal damage.29

Many researchers and biotechnology companies have responded to this evidence 

by simply abandoning NBAC’s standard. In short, they are losing the game and 

have decided to move the goalpost. 

What is now often heard is that research using both embryonic and non-embryonic stem cells must be fully funded now, to determine which source is best for various functions. In other words, we must help researchers violate NBAC’s ethical 

18 

30See A. Robeznieks, ‘‘The politics of progress: How to continue stem cell research despite limitations,’’ American Medical News, August 9, 2004, www.ama-assn.org/amednews/2004/08/09/ 

prsa0809.htm#s1. 31The abnormal cells have a ‘‘proliferative advantage’’ over the remaining normal cells in the 

culture, suggesting that these cell lines may soon consist largely of abnormal cells. C. Cowan 

et al., ‘‘Derivation of Embryonic Stem Cell Lines from Human Blastocysts,’’ 350(13) New England Journal of Medicine 1353–6 (March 25, 2004) at 1355. 

standard now, to determine whether they will ever be able to meet the burden of 

proof that standard places on them. 

But this approach simply reduces ‘‘respect’’ for the embryo to nothing at all. For 

that is the approach one would take if there were no moral problem whatever—if 

the only factor determining our research priorities were relative efficiency at achieving certain goals. ‘‘Respect’’ must mean, at a minimum, that we are willing to give 

up some ease and efficiency in order to obey important moral norms instead of 

transgressing them. 

At this point, it is not even established that continued pursuit of embryonic stem 

cell research would increase the ease and efficiency of arriving at any treatments, 

for it may only divert attention and resources away from alternative approaches 

that could cure diseases more quickly. 

In short, using Federal funds to encourage the destruction of embryos for new 

stem cell lines not only fails the test of a principled ‘‘sanctity of life’’ ethic. Given 

the lack of clear evidence for any unique or irreplaceable role for embryonic stem 

cells in the treatment of devastating diseases, it even fails the test offered by proponents of human embryo research when they advised the Federal government on 

this issue five years ago. 

III. The Reality of an Ethical Slippery Slope 

The campaign for expanded Federal support for embryonic stem cell research also 

ignores the fact that its goal cannot be achieved without violating even more ethical 

norms. Any agenda that will inevitably require such further violations in order to 

produce any of its promised results must be held accountable now for justifying 

those violations. Otherwise our government could waste years of effort and millions 

of dollars on an approach that must be abandoned in midstream, before producing 

results—with devastating consequences for patients now awaiting treatments. 

At present, contrary to many misleading comments in the political debate, there 

are no set limits on the amount of Federal funding that may be allocated for embryonic stem cell research. However, current policy is to fund only research using the 

embryonic stem cells obtained by destroying human embryos prior to August 9, 

2001. These cell lines are intended to be adequate only for basic research, to determine whether embryonic stem cells offer uniquely promising benefits without encouraging the destruction of live embryos to obtain the cells for that project. 

Some claim the currently eligible cell lines are inadequate in number and ‘‘contaminated’’ by the mouse feeder cells used to culture them. They argue that new 

cell lines like those recently created with private funds by Harvard researchers, and 

the ‘‘more than 400,000 IVF embryos’’ now frozen that could be used for research, 

must not be allowed to go to waste. The implied argument is that if only these additional cell lines, and currently existing ‘‘excess’’ embryos, were offered up for federally funded research, researchers would have all they need to cure terrible diseases. 

But even if embryonic stem cells could ever be used to cure serious illnesses— 

which at this point is hypothetical—this argument makes no sense. It is important 

to understand why. 

First, it has not been shown that the cell lines already eligible for funding are 

inadequate for their intended task—conducting basic research in the advantages 

and disadvantages of these cells. Because some of the cells were frozen for later use 

immediately after being harvested from embryos, the number of actual cell lines 

continues to grow as the cells are thawed and cultured. For example, there were 

15 lines when House members wrote to President Bush urging an expanded policy 

this summer, and 19 by the time the Senate letter was circulated a few weeks later. 

According to the NIH, over 400 derivatives of these lines have been shipped to researchers as of February 2004. Some cells remain frozen at this point (and so could 

be cultured without the ‘‘contamination’’ of animal feeder cells if necessary), while 

over two dozen eligible cell lines are currently unavailable to federally funded researchers only because their owners have not yet agreed to share them with other 

researchers.30

Second, the new Harvard cell lines have the same deficiencies as the currently 

eligible cell lines. They are inadequate for any significant clinical use, they were cultured in mouse feeder cells, and—most interesting of all—they have already developed serious genetic ‘‘abnormalities’’ in culture.31 A recent study suggests that all 

19 

32 J. Draper et al., ‘‘Recurrent gain of chromosomes 17q and 12 in cultured human embryonic 

stem cells,’’ 22 Nature Biotechnology 53–4 (2003). 33D. Hoffman et al., ‘‘Cryopreserved embryos in the United States and their availability for 

research,’’ in 79 Fertility and Sterility 1063–9 (2003) at 1068. 34S. Hall, ‘‘Bush’s Political Science,’’ in The New York Times, June 12, 2003, A33. 35 R. Faden et al., ‘‘Public Stem Cell Banks: Considerations of Justice in Stem Cell Research 

and Therapy,’’ in Hastings Center Report, November–December 2003, 13–27. 36 R. Lanza and N. Rosenthal, ‘‘The Stem Cell Challenge,’’ Scientific American (May 2004), 93– 

99 at 94. Another study, while noting that other solutions to the immune rejection problem 

might be found, agrees that the creation of a sufficiently diverse bank of embryonic stem cell 

lines is ‘‘almost impossible.’’ M. Drukker and N. Benvenisty, ‘‘The immunogenicity of human embryonic stem-derived cells,’’ 22(3) TRENDS in Biotechnology 136–141 (March 2004) at 138. 37 ‘‘Optimistically, ∼100 human oocytes would be required to generate customized ntES cell 

[nuclear transfer embryonic stem cell] lines for a single individual . . . human oocytes must be 

harvested from superovulated volunteers, who are reimbursed for their participation. Add to this 

the complexity of the clinical procedure, and the cost of a human oocyte is ∼$1,000–2,000 in the 

U.S. Thus, to generate a set of customized ntES cell lines for an individual, the budget for the 

human oocyte material alone would be—$100,000–200,000. This is a prohibitively high sum that 

will impede the widespread application of this technology in its present form.’’ P. Mombaerts, 

‘‘Therapeutic cloning in the mouse,’’ 100 Proceedings of the National Academy of Sciences 11924– 

5 (September 30, 2003) at 11925. 38 ‘‘Somatic cell nuclear transfer research is essential if we are to achieve our goals in regenerative medicine.’’ Testimony of Thomas Okarma on behalf of BIO before the House Energy and 

Commerce Subcommittee on Health, June 20, 2001, http://energycommerce.house.gov/107/hearings/06202001Hearing291/Okarma450.htm. During the question session Dr. Okarma made it 

clear he meant the use of this technology to create genetically tailored human embryos for research, including stem cell research. 

human ESC lines may spontaneously accumulate extra chromosomes that are typical of human embryonal carcinoma cells from testicular cancer.32

Third, the Rand study which concluded that there may be as many as 400,000 

frozen embryos in the United States also found that only 11,000 (less than 3 percent 

of the total) are designated by parents for possible use in research. If all these 

11,000 frozen embryos were destroyed for their stem cells (seen by the authors as 

a ‘‘highly unlikely’’scenario), this may produce a grand total of 275 cell lines—surely 

inadequate for use in treating any major disease.33

Last year an opinion piece attacking President Bush’s policy cited two prominent 

researchers in support of the claim that merely determining the ‘‘best options for 

research’’ (to say nothing of clinical use) would require ‘‘perhaps 1,000’’ stem cell 

lines—about four times as many as those which could be obtained by destroying 

every available human embryo in frozen storage nationwide.34 Another group of researchers has concluded that in order to reflect the genetic and ethnic diversity of 

the American population, an embryonic stem cell bank geared toward treating any 

major disease would have to include cell lines from many embryos created solely in 

order to be destroyed for those cells—including a disproportionate number of specially created embryos conceived by black couples and other racial minorities, who 

are underrepresented among current fertility clinic clients.35 Yet another prominent 

stem cell researcher estimated that unless researchers resort to human cloning to 

produce genetically matched stem cells for each patient, ‘‘millions’’ of embryos from 

fertility clinics may be needed to create cell lines of sufficient genetic diversity for 

clinical use.36

Of course, trying to address this problem with cloning would require specially creating and then destroying many millions of embryos as well—an estimated hundred 

embryos per individual patient, potentially requiring the exploitation of many millions of women for their eggs to treat even one major disease.37 Undaunted, the national Biotechnology Industry Organization (BIO), in a statement echoed by many 

researchers, has testified that the use in humans of the cloning technique that created Dolly the sheep will be ‘‘essential’’ to realizing the promise of embryonic stem 

cell research.38

BIO’s testimony on this point should help to clarify our minds, for it may be rephrased as follows: Unless you are willing to commit yourself in the future to 

human cloning and the mass-production of human lives in order to exploit and destroy them, there is no point in promoting federally funded research using so-called 

‘‘excess’’ embryos now. 

And there is yet another moral line to cross beyond this. For the effort to use 

human embryo cloning for ‘‘therapeutic’’ purposes involves all the practical barriers 

inherent in embryonic stem cell research in general, plus some additional problems. 

For example, even cloned embryos with a normal genetic makeup generally suffer 

from chaotic gene expression, leading to many embryonic and fetal deaths and to 

increased risks in using any cells from these embryos for future therapies. There 

20 

39 J. Fulka et al., ‘‘Do cloned mammals skip a reprogramming step?’’, 22(1) Nature Biotechnology 25–6 (January 2004). 40 In the first study, mice derived from cloning had to be brought to live birth to harvest their 

adult bone marrow stem cells. W. Rideout III et al., ‘‘Correction of a Genetic Defect by Nuclear 

Transplantation and Combined Cell and Gene Therapy,’’ 109 Cell (April 5, 2002), 17–27. For 

a critique see Americans to Ban Cloning, ‘‘Why the ‘Successful’ Mouse ‘Therapeutic’ Cloning 

Really Didn’t Work,’’ www.cloninginformation.org/info/unsuccessfullmouseltherapy.htm. A 

second study required placing cloned cow embryos in wombs to develop them to the fetal stage, 

then aborting them for their kidney tissue. R. Lanza et al., ‘‘Generation of histocompatible tissues using nuclear transplantation,’’ 20(7) Nature Biotechnology 689–696 (July 2002). The authors wrote: ‘‘Because the cloned cells were derived from early-stage fetuses, this approach is 

not an example of therapeutic cloning and would not be undertaken in humans.’’ Id. at 689. 

But these same authors published a new study this year, in which cloned mouse embryos had 

to be developed to 11 to 13 days of gestation (the equivalent of the fifth to sixth month in humans) and then aborted to obtain usable cardiac cells. R. Lanza et al., ‘‘Regeneration of the 

Infarcted Heart With Stem Cells Derived by Nuclear Transplantation,’’ 94 Circulation Research 

820–7 (April 2, 2004). This time there were no disclaimers. Instead the lead author declared 

that this is ‘‘an important new paradigm’’ for human ‘‘therapeutic cloning.’’ See Advanced Cell 

Technology, ‘‘Cloned Stem Cells Regenerate Heart Muscle Following a Heart Attack,’’ 

February 10, 2004, http://salesandmarketingnetwork.com/newslrelease.php?ID=14109&key= 

Advanced%20Cell%20Technology. 41See Americans to Ban Cloning, ‘‘Report: State Bills on Human Cloning,’’ March 26, 2003, 

www.cloninginformation.org/info/ABC-State-Laws.htm. 42See: W. Smith, ‘‘Cloning in New Jersey,’’ in The Daily Standard (online service of The Weekly Standard), December 11, 2003, www.weeklystandard.com/Content/Public/Articles/000/000/ 

003/482iusla.asp; News Article, ‘‘A safe haven for human cloning?’’, The Monitor (Newspaper 

of the Diocese of Trenton, NJ), December 19, 2003, http://www.dioceseoftrenton.org/department/newsldetail.asp?newsid=850. 43See ‘‘California Stem Cell Research and Cures Act,’’ Website of the Attorney General of 

California, http://www.caag.state.ca.us/initiatives/pdf/sa2003rf0055amdt1lns.pdf. The ‘‘initial’’ time limit on the age of embryos to be destroyed for their stem cells (8 to 12 days) can 

be changed by the Oversight Committee (Id. at 11), whose chairperson must have a ‘‘documented history in successful stem cell research advocacy’’ (Id. at 6). The initiative places a ‘‘high 

priority’’ on stem cell research not eligible for Federal funding, ensuring that the funds will be 

used primarily for embryonic stem cell and human cloning research (Id. at 16). 

is evidence that there may be a later opportunity in fetal development to correct 

these gene expression problems, if the embryo can survive to that point.39

Perhaps due partly to this phenomenon, the major studies seeking to provide an 

animal model for ‘‘therapeutic’’ cloning have found it necessary to implant the cloned 

embryo in a womb and develop it past the embryonic stage to obtain usable cells and 

tissues.40 Thus the old alleged distinction between ‘‘reproductive’’ cloning (placing 

cloned embryos in a womb for gestation) and ‘‘therapeutic’’ cloning (destroying 

cloned embryos for research purposes) is breaking down, as the former increasingly 

becomes a necessary component of the latter. 

BIO has already acted to provide legislative authorization for this approach in humans—by supporting state laws to allow researchers to clone human embryos and 

develop them in wombs into the last stages of fetal development, as long as they 

do not allow a full-term live birth.41 One such law has already been enacted, in New 

Jersey.42 And the pending California ballot initiative known as Proposition 71, which would force the financially strapped state government to borrow $3 billion to 

fund embryonic stem cell and human cloning research, would ‘‘initially’’ forbid developing cloned human embryos past 12 days—but allow indefinite expansion of this 

limit, by vote of a new Oversight Committee dominated by stem cell advocates.43

In short, no new breakthroughs have shown that embryonic stem cells are ready 

or almost ready for clinical use. Use of new cell lines from frozen embryos has not 

been shown to be necessary for current basic research, and would still be completely 

inadequate for any large-scale clinical research—suggesting that proposals for expanding the current embryonic stem cell policy are themselves only a transitional 

step toward mass-producing embryos (by cloning or other means) solely for harmful 

experimentation. The for-profit biotechnology industry has known this for years, and 

has begun paving the legislative road toward large-scale human cloning and ‘‘fetus 

farming’’ in case these prove necessary for technical progress in this field. 

Conclusion 

Since human embryonic stem cells were isolated and cultured in 1998, initial 

hyped promises of miracle cures for devastating diseases have collided with reality. 

More than two decades of research using mouse embryonic stem cells have produced 

no treatments in mice that are safe or effective enough for anyone to propose in humans. These cells have not helped a single human being, and the practical barriers 

to their safe and effective use loom larger than ever. Meanwhile, alternative approaches that harm no human being have moved forward to offer realistic hope for 

21 

patients who many said could be helped only by research that destroys human embryos. Campaigns for increased public funding have grown in inverse proportion to 

the dwindling hopes of medical benefit, as private funding sources increasingly realize that embryonic stem cell research may not be a wise investment. 

We should not succumb to this latest campaign, but reflect on the ethical errors 

that brought us this far. Even proponents of the research have admitted that it 

poses an ethical problem, because it involves destroying human lives deserving our 

respect. Based in part on the actions and statements of proponents, we can see that 

still further ethical breaches will be required of Congress and society to realize the 

‘‘promise’’ of this approach. Already the policy debate has moved from ‘‘spare’’ embryos in fertility clinics, to specially creating embryos for destruction, to mass production of embryos through cloning, to the gestation of these embryos for ‘‘fetus 

farming’’ and the harvesting of body parts. 

Congress should take stock now and realize that the promise of this approach is 

too speculative, and the cost too high. That cost includes the early human lives destroyed now and in the future, the required exploitation of women for their eggs and 

perhaps for their wombs, and the diversion of finite public resources away from research avenues that offer real reasons for hope for patients with terrible diseases. 

Let’s agree to support avenues to medical progress that we can all live with. 

Senator BROWNBACK. Thank you very much. 

That was excellent testimony presented by both of you. We have 

a few minutes left in this vote. We’re going to go vote on this one. 

And there is supposed to be a second vote, and we will vote at the 

front end of that and then come back and consume—we’ll move forward with questions on this panel. 

So we will be in recess until we are able to return, hopefully in 

about 15 minutes. 

[Recess.] 

Senator BROWNBACK. I call the hearing back to order. I’m sorry 

it took us so long. I think we will have other Members that will 

be joining us. Let’s run the time clock at 7 minutes so we can 

bounce this back and forth. 

Thank you all for staying here and being with us. 

Dr. Zoloth, I read your testimony last night, and I appreciate it, 

I appreciate the thoughtfulness of it. And I don’t always get testimony read, so I wanted to make sure to look through it and to inquire of you about it. And you talk about the nature of, you know, 

the very ethical decision of, When does life begin? And you look at 

this and say, ‘‘Well, I don’t think this qualifies to it.’’ And, as I understand it, it’s the issue of not being in the womb. Is that the 

issue of how you determine that this is not human life? 

Dr. ZOLOTH. It’s two different things. It’s both the fact that the 

kind of blastocysts we’re talking about are always created artificially, never inside of a woman’s womb, and they’re taken and used 

for stem cell research before the time that they would, even if they 

were part of a normal pregnancy cycle, be considered a human life 

for the legal requirements of Judaism. Because, for Jews, human 

life begins—and it’s assessed developmentally—and the first 40 

days of a pregnancy are a time of a lesser moral status, and the 

pregnancy really begins when it takes shape and form at the 40th 

day. This tradition—— 

Senator BROWNBACK. So it’s after 40—I just want to get to—— 

Dr. ZOLOTH. Forty days. 

Senator BROWNBACK.—this—— 

Dr. ZOLOTH. It’s actually the tradition—— 

Senator BROWNBACK.—after 40 days. 

22 

Dr. ZOLOTH. After 40 days. Now, the interesting thing is, that’s 

true not only for Jews, but for Muslims and for a long Aristotelian 

tradition of an unformed fetus; in fact, as our colleagues in the 

Catholic Church could tell us, until 1859, for many in the Catholic 

Church, and many who interpreted Canon law, as well. So this uncertainty about when human life begins, it’s a very old, deeply understood as a religious consideration. 

Senator BROWNBACK. Let me take a point, then, on that. The 

Democrat Presidential nominee believes life begins at conception. 

That’s what he’s stated recently. And that is at the very heart of 

what we’re talking about here, is, when does that life begin? In 

your own existence, in your own case—you—when did your life 

begin? 

Dr. ZOLOTH. That’s a complicated question. My life begins in— 

obviously, there’s an event that takes place when I, myself, comes 

into existence in terms of my DNA. If you’re just looking at when 

my DNA begins to exist, obviously, at the moment of fertilization. 

But as a religious Jew, I believe that human life is a developmental 

process. You acquire moral status as you acquire more and more 

milestones on this developmental path. And as a religious Jew, my 

duties and obligations began, for me, in the classically, religiously 

understood terms, at the moment that I was born into the world 

and capable of being received as a person in my religious community. People have, then, duties to me, and I would grow in my duties to them. 

Senator BROWNBACK. Well, let me ask you, biologically, when did 

your life begin? 

Dr. ZOLOTH. Well, no one can really know that answer, because 

it’s not a fixed biological question. Maybe it’s when the first noggin 

gene turned on or when my cells began to organize or when the 

first neuron begins to assert itself. 

Senator BROWNBACK. When do you believe your life began, biologically? 

Dr. ZOLOTH. Biologically? I believe—I think about these things in 

terms of my faith’s tradition and my—— 

Senator BROWNBACK. Biologically—— 

Dr. ZOLOTH.—biologically, I think my life begins as a DNA’d organism. Right? When my DNA begins to assert itself. But it’s not 

an important—— 

Senator BROWNBACK. That would be the moment—— 

Dr. ZOLOTH.—point. 

Senator BROWNBACK.—of conception, is that correct? 

Dr. ZOLOTH. But that—but what moment is that, really? What 

moment is that? Maybe it’s when I’m organized. I think that’s an 

infinitely complex biological question, and I am—I’m not a biologist; I’m a religious Jew, so my life begins as an entity perhaps 

when I’m capable of living independent from my mother’s body. 

Now, I used to be a neonatal intensive-care nurse—— 

Senator BROWNBACK. Right. 

Dr. ZOLOTH.—so I’m aware of how differently—before I was a 

philosopher—I’m aware of how differently embryos come to change 

and grow, and the success by which they do or don’t live outside 

of a woman’s body. And that, too, is the developmental process. 

23 

Senator BROWNBACK. Let me ask you this, then. When did the 

life of your son begin? You were talking about the paper he’s writing. When did, biologically, his life begin? 

Dr. ZOLOTH. Well, we’re going to keep going back around and 

around that, and I think that’s the question that as I’m—— 

Senator BROWNBACK. That’s what we’re trying to get at. 

Dr. ZOLOTH. But I don’t think it’s a biological answer. For me— 

I don’t think it’s an—I don’t think it’s an—for me, it’s not the salient point, ‘‘When does it biologically begin?’’ I could be convinced 

that—by a number of different arguments, but the most important 

one is that it’s a biological process that doesn’t have a moment of 

divinity or a moment of conception that is of biological importance 

to me. Many—— 

Senator BROWNBACK. OK—— 

Dr. ZOLOTH.—many genes have to work as a system. The system 

has to be successful. There are a number of different milestones before I can truly say I’ve biologically begun a process that will be 

successful. 

Senator BROWNBACK. So then—but you advocate we should experiment on humans at these very early stages of development. Indeed, you would we are required to do this, justice requires this. 

But if we researched on me at 2 days of age, or you at 2 days biological age, or your son at 2 days biological age, would that have 

been appropriate? 

Dr. ZOLOTH. This isn’t about my son or myself, human persons 

at different stages within a woman’s body. We’re talking about 

blastocysts at the 3-day-age stage—— 

Senator BROWNBACK. OK, then—— 

Dr. ZOLOTH.—created outside of a womb. 

Senator BROWNBACK.—blastocysts—— 

Dr. ZOLOTH. And I think of that—blastocysts, I would—I do believe, religiously and morally, are warranted. And, in fact, we have 

an imperative to research on these clusters of cells if we believe— 

have come to believe that they can yield cures. 

Senator BROWNBACK. What would have happened had we experimented on you at the blastocyst stage? 

Dr. ZOLOTH. Well, that’s an obvious question. If I was—it’s an 

odd theoretical one—if I could somehow be—— 

Senator BROWNBACK. It’s not a theoretical. I’m just—— 

Dr. ZOLOTH. If I could have been taken out—— 

Senator BROWNBACK.—asking biologically. 

Dr. ZOLOTH.—if I could have been taken out of my mother’s 

womb, which is—which is different—— 

Senator BROWNBACK. What—— 

Dr. ZOLOTH.—from our situation, then I wouldn’t have—— 

Senator BROWNBACK. What would have happened to you? 

Dr. ZOLOTH. I wouldn’t have existed, obviously. But this same 

token is, I’m going to be, for instance—as our colleague pointed out, 

I’m going to be, inevitably, dead; but I’m not now treated as though 

I’m dead now. I’m treated as though I’m a living philosopher, not 

as a dead one. And so we take account of different moments in our 

biological process. 

Senator BROWNBACK. Do you support human cloning? 

24 

Dr. ZOLOTH. Under some limited circumstances, with a number 

of restraints, never for reproduction—never for reproduction—or 

implantation in the human womb. I do, for experimental purposes 

to do basic research, yes. 

Senator BROWNBACK. Mr. Doerflinger, when did your life begin, 

biologically? 

Mr. DOERFLINGER. Biologically? I think there are two different 

questions that we shouldn’t confuse. One is a biological question. 

And in the embryology textbooks—there are sources cited in my 

testimony—say that the first one-celled embryo is ‘‘the beginning of 

a new human being.’’ A simple biological fact. This is a new member, an individual member, of the species; therefore, a human 

being, in that sense. That’s when I started, that’s when everybody, 

as far as I know, started. 

Now, the moral question, it seems to me, is what moral value we 

attribute to different stages of that process. Now, it’s our conviction 

in the Catholic Church that unless you see every stage of that process as having inherent worth simply because this is a member of 

the human race, you end up with a theory in which nobody really 

has inherent rights; everybody has different moral value attributed 

to them based on the traits or the abilities, the mental and physical abilities, they have at any given time. You can acquire 

personhood, you can lose personhood when you’re near the end of 

your life and get into a coma or have Alzheimer’s, because you 

don’t have any cognitive processes, maybe, going on then either. 

And we feel that’s a very risky logical argument that would endanger a lot of helpless human beings. 

But the Catholic Church never held that, as a matter of religion, 

life begins at 40 days. What we’ve always said is that—here’s 

where we were doing a lot better than we did with astronomy in 

the Galileo case—— 

Dr. ZOLOTH. That’s not hard. 

Mr. DOERFLINGER.—we have to respect life whenever the biologists tell us it’s there. And the biologists, until the 19th century, 

were very confused about those early stages, because they didn’t 

know about the process of conception. They thought that the form 

for the new human being was entirely located in the male sperm, 

and they had to figure out some kind of intermediate stages for 

how that sperm can turn into someone who is specifically human 

and somehow even has traits from the mother. And in 1825, the 

ovum was discovered, the process of conception discovered, and, at 

that point, the church acknowledged that this, then, should be the 

beginning for moral respect, as well. 

Senator BROWNBACK. Senator Wyden, I’ll bet you never thought 

you’d get this sort of education, did you? 

Senator WYDEN. That’s for sure. And I’m going to ask a couple 

of questions to start with, for you, Dr. Doerflinger, that I’d really 

like just a yes or no answer to, because this is a complicated field, 

and it’s one where sometimes the more you learn, the less you 

know. 

And let me start by asking you about fertility clinics. I think you 

know that I wrote the only Federal law that’s on the books now 

with respect to fertility clinics. It at least provides some measure 

of oversight and consumer protection for the millions of couples 

25 

that look to them. And my question that I’d like a yes or no answer 

to is, Do you support the in vitro process that is used at fertility 

clinics around the country? 

Mr. DOERFLINGER. You mean morally? 

Senator WYDEN. No, I just want to know, yes or no, do you—— 

Mr. DOERFLINGER. No. 

Senator WYDEN.—support it. You do not. 

Mr. DOERFLINGER. Right. 

Senator WYDEN. If you had your way, then because of your answer millions of couples wouldn’t have the opportunity to have 

what they want more than anything else. And your—— 

Mr. DOERFLINGER. No. 

Senator WYDEN.—candor is appreciated on it, but—— 

Mr. DOERFLINGER. No, that’s—no, I think that’s a false statement. 

Senator WYDEN. Well, how would they? I mean, that’s the process that is used at fertility clinics, and you’ve said you don’t 

favor—— 

Mr. DOERFLINGER. Well—— 

Senator WYDEN.—using that process. 

Mr. DOERFLINGER.—that’s one process that actually has a success rate that’s far below a lot of other things that I have a lot less 

moral problem with. 

Senator WYDEN. Well, that—— 

Mr. DOERFLINGER. I thought it was a question, so I answered. 

Senator WYDEN. Well, but that—and I appreciate that. And 

that’s what my legislation does, of course, is make it possible for 

people to compare success rates. But you said you don’t favor a 

process that has provided incredible happiness to millions of couples, and you’ve answered my question clearly. 

The reason I asked is, I wanted to lay the foundation for the second question, and that is—as you know, at fertility clinics, there 

are often embryos that aren’t used. What do you favor being done 

with those embryos that are not used? 

Mr. DOERFLINGER. I think I’d have to be favoring the process in 

order to be in the position to—obviously, I don’t want them to be 

happening at all. 

Senator WYDEN. Yes. So you’re—— 

Mr. DOERFLINGER. I think you’d have to ask that question of 

someone who supports it. 

Senator WYDEN. Yes, I appreciate your answer. I mean, I 

thought that you would be supportive of the process, and I was 

going to ask you some questions about whether they ought to be 

donated or the like. But you’ve answered, and I appreciate the answer. 

My second question for you is, Do you think the country is better 

off funding embryonic stem cell research on the Federal level so 

that we could have one tough set of Federal ethical guidelines, 

rather than what I have described as this kind of crazy quilt of policy and state regulation? I think you were here when I gave my 

opening statement, and one of the concerns that I have is—because 

our citizens are so frustrated now about the inaction of the Federal 

Government—is, they’re just, kind of, going off and doing their own 

thing. And so New Jersey is going to do theirs, and Harvard’s going 

26 

to have a program, and California’s going to have a program. And 

what will happen—and Senator Brownback—because he and I have 

sat through hours of these hearings—makes a very good case that 

we need a good set of ethical guidelines. This is not something I 

want to see done without ethical guidelines, but I think we ought 

to have one clear, strong set of Federal guidelines, rather than 

what we’re going to have now, which is a sort of hodgepodge and 

crazy quilt. Do you think that we ought to have one set of guidelines? 

Mr. DOERFLINGER. I think we have one set of Federal guidelines 

now, Senator. 

Senator WYDEN. We do—— 

Mr. DOERFLINGER. Except that—— 

Senator WYDEN.—but that’s going to change once the California 

ballot measure passes. 

Mr. DOERFLINGER. Oh, no, I—— 

Senator WYDEN. It will. 

Mr. DOERFLINGER. Now I understand your question. 

Senator WYDEN. Yes. 

Mr. DOERFLINGER. No, no, the—you could expand the Federal 

guidelines all you want, and there would still be a crazy quilt on 

what’s funded by the states. Deciding that you’re going to set limits 

or expand the limits on federally funded research doesn’t change 

anything, one way or the other, as to privately or state-funded research. In fact, the California initiative says that it’s their top priority to fund only embryonic stem cell and cloning research that is 

not funded by the Federal Government. So, for example, if you put 

these tough Federal guidelines in, and you say, ‘‘But we’re only 

going to fund research on the spare embryos,’’ that means all $3 

billion of the California money might go into cloning. So it’s not a 

restraint—unless you were to say, ‘‘The Federal policy is going to 

reach out and cover all privately and state-funded research, at all,’’ 

which hasn’t been done on any research, including research on 

adults, since the beginning of Federal regulations. 

Senator WYDEN. Dr. Zoloth, do you want to answer that question, 

as well? Would we be better off with one standard? 

Dr. ZOLOTH. Like I said, I’ve traveled to other countries to see 

how they do it, because I think it’s an interesting question, and the 

most well-established principle is the one Britain. And, in fact, it 

does cover both public and private sorts of research. I believe very 

strongly in a Federal—reasonable Federal standard that would 

be—set a gold standard, as it were, for how research should be 

done in the Federal—in public—in publicly available labs, in privately funded labs, in pharmaceutical-company labs. I want private 

companies and all researchers, in fact, to have the same sort of ethical guidelines and standards so that we can publicly debate, publicly know what they’re doing, and have it be a shared decisionmaking process, like it is with so much of other research. 

Senator WYDEN. Well, I want to ask about one other area, but 

that’s very much a view that I share, is, I think you ought to have 

a debate, you ought to make sure that everybody’s heard. There are 

certainly a lot of stakeholders in this. For all practical purposes, 

hundreds of millions of Americans are stakeholders in this. But I 

think there’s a reason that the states are going off and doing their 

27 

own thing. And they are not, Dr. Doerflinger, you know, pursuing 

human cloning and—you know, in California, they are responding 

to the abysmal performance of the Federal Government, in terms 

of restricting the lines that are available. 

And I want to ask one last question on this first round, if I could, 

for Dr. Zoloth. 

Dr. Zoloth, I think I mentioned the reports indicating that something like 21 of the initial 78 stem cell lines are now available to 

researchers, scientists coming forward and saying a hundred new 

lines have been developed since the original cutoff by the President. I mean, it seems to me that these two facts, alone—these two 

facts alone—show the real consequences for researchers, in terms 

of this ‘‘turn back the clock’’ approach that is being chosen by this 

Administration in the field. Would you like to address those two 

facts, alone—the question of the reduction of the number of initial 

stem cell lines that’s actually been available, and then the new 

lines that have been available? Because that seems to me to be— 

those areas are really what’s taking the toll now on the prospects 

for research. 

Dr. ZOLOTH. I actually thought that President Bush’s compromise 

was a sensible one when he made it in August 2001 because it 

said, ‘‘We’ll allow this to go forward, and we will fund it federally, 

and we’ll have some oversight at the NIH.’’ The problem was that 

that—the lines didn’t pan out. And so it’s reasonable now to take 

another look at those limits and say, ‘‘Since we had already made 

the compromise of using leftover embryos, can we expand them so 

that the scientific basis of that original thoughtful compromise 

could now be expanded to be more scientifically valid, and open it 

to a far wider number of lines, including the new lines that have 

been developed, and are being developed, with better technologies?’’ 

The scientists—and I’m not a scientist—the scientists tell me 

that one of the things that happens, and happens because science 

is global all over the world, is they’re constantly developing new 

ways of growing these. It’s a tricky business to grow these stem cell 

lines, and we want our American researchers to have access to the 

best and the freshest stem cell lines possible. 

Good stuff can be done with the ones that were funded and created a number of years ago, and I want to applaud the NIH for 

continuing to do that work. But that’s just at the very, very early 

beginning, and we could expand that quite easily, even within the 

framework already established—— 

Senator WYDEN. My—— 

Dr. ZOLOTH.—by this Administration. 

Senator WYDEN.—my time is up. And that is a thoughtful response, because I think you’re absolutely right, when you’re in a 

controversial field, and people say, ‘‘All right, I’d like to start here,’’ 

then you start there, and you see what happens. But what has, in 

fact, happened—and you have pointed this out—is, we have gotten 

something like a third of the number of stem cell lines—— 

Dr. ZOLOTH. Yes. 

Senator WYDEN.—that people originally conceived of, plus another hundred are now, according to scientists, supposed to be out 

there. And I appreciate your answers. 

And thank you, Mr. Chairman. 

28 

Senator WYDEN. Thank you. 

Mr. Dorgan? We’ll go in order of appearance. 

STATEMENT OF HON. BYRON L. DORGAN, 

U.S. SENATOR FROM NORTH DAKOTA 

Senator DORGAN. Mr. Chairman, thank you very much. 

I did not hear the testimony of the witnesses because I was elsewhere, but I thank you for appearing. 

Let me follow up on Senator Wyden’s question to Mr. 

Doerflinger. In an in vitro fertilization clinic, there are fertilized 

eggs that are not used, and frozen, and then later discarded. Let 

me ask about the status of a fertilized egg that is now frozen at 

one of those clinics. Is that, ‘‘a member of the human race,’’ as you 

use the term? 

Mr. DOERFLINGER. Yes, Senator, it’s no longer a fertilized egg; 

it’s now an embryo that consists of, depending on when they froze 

it, four or eight or sixteen or maybe a hundred cells. 

Senator DORGAN. So you have great angst about those being discarded, I assume. 

Mr. DOERFLINGER. Well, I think it’s immoral to discard a human 

embryo. But the embryos that parents choose to discard are not the 

ones available for research, obviously. 

Senator DORGAN. Right. And there are now about one million 

children born as a result of the work at in vitro fertilization clinics. 

And that, it seems to me, is a process that is giving life, and it 

would seem to me to be pro life in its impact on our country and 

on the parents and on the children who are born. But your position, as I understand it, is that you do not support the in vitro fertilization. Is that correct? 

Mr. DOERFLINGER. That’s correct, Senator. We understand the 

desires of infertile couples and the good goal that’s intended. But 

a lot of the hard questions in morality have to do with whether the 

means to the end are worthy of the end. And here, we have a process that basically takes reproduction away from the parents. The 

act of conception is done by a laboratory technician in a laboratory 

dish and obviously exposes these embryos to a lot of dangers of 

dying in the laboratory, of being discarded, of being misused for research. 

Senator DORGAN. So your position is, there’s an equivalency between a fertilized egg that is now frozen at an in vitro fertilization 

clinic and a 40-year-old person suffering from Parkinson who 

might—Parkinson’s disease or some other disease—that might benefit from the research that comes from stem cell research. There’s 

an equivalency. Both are, ‘‘members of the human race,’’ and deserve equal status and equal protection. Is that fair? 

Mr. DOERFLINGER. Equal protection is probably the right word. 

Neither of these should be killed to help anybody else. 

Senator DORGAN. All right. And so your position is that those 

who—those fertilized eggs at an in vitro fertilization clinic are 

being discarded are being killed, that is the killing of a human? 

Mr. DOERFLINGER. They’re certainly being neglected. 

Senator DORGAN. Are they being killed? 

29 

Mr. DOERFLINGER. Well, I think there’s direct killing when you 

take the inner cells out and destroy them for research. It’s more 

negligent when you just leave them out to thaw and die. 

Senator DORGAN. I react—you know, I react strongly to those 

that use the term ‘‘kill’’ and ‘‘murder.’’ I’ve heard, until I’m about 

sick, of the term ‘‘clone and kill,’’ ‘‘murdering embryos,’’ and so on. 

And—— 

Mr. DOERFLINGER. Well, I don’t use the word ‘‘murder,’’ Senator. 

Senator DORGAN. I understand you didn’t. But I—it’s used all 

over the country in this debate, and I—— 

Mr. DOERFLINGER. How about the word ‘‘destroy’’? 

Senator DORGAN. Let me ask, also, about the issue of the cloning 

of a cell. My colleague Senator Brownback asked the question 

about, Do you favor human cloning? I’m not sure I understand 

what that question means. If it’s the cloning of a human being, I 

assume everyone here agrees that there ought to be criminal penalties against it. If the question is to elicit an answer with respect 

to the cloning of a cell to—somatic cell nuclear transfer—for the 

purpose of embryonic stem cell research, that’s a different set of 

issues. I don’t know what the intent of the question was. 

Senator BROWNBACK. Mine was to Dr. Zoloth to ask her if she 

supported human cloning. 

Senator DORGAN. Is that the somatic cell—would that be therapeutic? 

Senator BROWNBACK. That’s the creation of a human being by 

means of the cloning process that was used to create Dolly. 

Senator DORGAN. So—— 

Senator BROWNBACK. At the very earliest of stages. 

Senator DORGAN. Then I think—but I think all of us would—we’d 

reach agreement on that point. We don’t intend to try to create a 

Dolly or a human version of Dolly. So I think we all agree on that 

point. I think—let me just ask a couple of question of Dr. Zoloth 

on the question of somatic cell nuclear transfer. 

We, I think, 30 years ago, in addition to having a debate about 

the opening of in vitro fertilization clinics and having people talk 

about how awful that would be and so on, we had a debate about 

recombinant DNA cloning back then, and the same specter of discussions back then about the fear that science was going too far, 

too fast. They weren’t sure what would come from the Harvard laboratories, what would, ‘‘crawl out of the laboratory,’’ was the reason 

one city passed an ordnance against it, and so on. And I know that 

that’s a different type of cloning; but, nonetheless, it is a debate 

that we constantly have about scientific inquiry. 

And let me ask you the question, whether it is using your skin 

cell from your earlobe through the cloning of that cell and the development of embryonic stem cells or an embryonic stem cell that’s 

derived from a fertilized egg that’s to be discarded at a clinic, is 

there—and I don’t know that you’re the right person to ask this— 

but is there a dramatic difference in the experience with respect to 

embryonic stem cells and also the promise of adult stem cells with 

respect to this kind of research? 

Dr. ZOLOTH. These are complicated questions, and I want to try 

to answer them separately. 

30 

The first is, we did have a debate about recombinant DNA technology. It wasn’t really cloning, but it did raise the issue of the 

specter of genetic manipulation. And it was resolved, in large part, 

because scientists, themselves, agreed to set their own limits and 

they established the kind of Federal guidelines that Mr. Wyden 

talked about at the Recombinant DNA Technology Committee that 

oversees, and still does oversee, recombinant DNA technology experiments. 

Senator DORGAN. Can I just interrupt—— 

Dr. ZOLOTH. But the decline—— 

Senator DORGAN.—for one moment—— 

Dr. ZOLOTH. Yes. 

Senator DORGAN.—to ask this question? My understanding about 

the monoclonal antibodies issue is that the development of new 

cancer therapies is, the cloning of cells that produce special antibodies. So there is a cloning process—— 

Dr. ZOLOTH. Yes. 

Senator DORGAN.—in there, isn’t there? 

Dr. ZOLOTH. It means—cloning means doubling, means replicating. And so—— 

Senator DORGAN. Replicating, copying. 

Dr. ZOLOTH.—in essence, it makes copies. 

Senator DORGAN. Right. 

Dr. ZOLOTH. The International Society of Stem Cell Research just 

has decided that the word ‘‘cloning,’’ itself, can be confusing because it has so many scientific meanings—to use the words ‘‘somatic cell nuclear transfer’’ or ‘‘nuclear transfer’’ to define the thing 

that people are really worried about, which is taking an adult nucleus and putting into a human—in human egg and then starting 

the process of a new blastocyst creation at that moment. 

So then you asked a second question, which is, Is there a difference in that sort of blastocyst that’s created that way and in the 

blastocysts created through the normal gametes—two gametes mixing? And the answer is, scientifically, we don’t know yet. We can’t 

know such a thing yet. We know a few experiments in animals— 

obviously, not in humans, for very good reasons—and we can’t yet 

know. 

And that’s the interesting thing about this early technology. It’s 

very early. And that’s why I think it’s more like free speech, because the basic thing that we are thinking—or I’m—as I look over 

the shoulder of the scientists in the labs, as an ethicist—is, they’re 

learning how cells signal and change and grow and die. And so 

growth and death and change is the basis for all human disease. 

Basic research is very basic. We’re well before applications, but we 

won’t get to the applications if we don’t know how cells change and 

become from an undifferentiated cell, a pluripotent cell, into a committed cell. And that shift is a very unexplored one, and it’s that 

exploration that this research is aimed toward. 

Senator DORGAN. Just one comment, to say that I think that 

there are significant ethical, religious, moral issues around all of 

these discussions. I understand that. I think we should move carefully with regard to all of that. But, in the end, I also believe differently, for example, than Dr. Doerflinger, that things like the in 

vitro fertilization clinics, the advances in research, the capability to 

31 

save lives is very important, even as we think through all of these 

more difficult issues. 

I thank you for the time. 

Senator BROWNBACK. Thank you. 

Mr. Ensign? 

STATEMENT OF JOHN ENSIGN, 

U.S. SENATOR FROM NEVADA 

Senator ENSIGN. Thank you, Mr. Chairman. Thanks for having 

these incredibly important hearings. 

And I agree with you, Senator Dorgan, that the questions raised 

with these issues are difficult from a moral standpoint, regardless 

of your viewpoint, difficult from a scientific standpoint. And so I 

want to explore a little bit about how we make these moral decisions. 

Dr. Zoloth, you’ve talked about that you would be against human 

cloning for reproductive purposes, but then you said ‘‘but not for 

basic research.’’ Am I correct in that? 

Dr. ZOLOTH. That’s correct. 

Senator ENSIGN. How do you make the moral stand that one is 

OK and one isn’t? In other words, where do you get your morals 

to judge that one is OK and one isn’t? 

Dr. ZOLOTH. That’s a very interesting question. To what extent 

does my religious faith influence my moral position as a bioethicist, 

as an academic bioethicist? 

Senator ENSIGN. Well, I don’t even know if you have a religious 

faith. I just want to know how you make these moral decisions. 

Dr. ZOLOTH. To make the distinctions, all right. In two ways. The 

first really is that I am—I’m guided in these issues which—like 

when life begins—which I believe are deeply theological, religious 

issues, by my position as an orthodox Jew and by the process of 

examination of the science by religious leadership and by scholars, 

in light of the text and in light of the traditional of Judaism. And 

so that does inform my opinion and my passion. Just as Mr. 

Doerflinger’s position is deeply informed by his Catholic moral theology, mine is deeply informed by Judaism and the orthodox tradition from which I speak. So that’s one answer. 

The other answer is the years of study and research that my 

field, American bioethics and international bioethics, has done in 

taking a look at these complicated ethical and moral debates. I like 

good arguments from whatever religious tradition they emerge, 

from whatever philosophical tradition emerge. And that’s how I became convinced, by listening not only to my own sources, but to the 

wise counsel and the gravitas of the Catholics and of the Protestants, the Buddhists, the Hindus, who all have looked at this issue 

with great and exquisite care. And I’ve come to a position that I 

think that human reproductive cloning is wrong in the same way 

that slavery is wrong, in the same way that certain forms of servitude are wrong—— 

Senator ENSIGN. Well, why is it wrong? 

Dr. ZOLOTH. I think because of one thing that’s important to me. 

I think it gives us a very distorted idea about the—our ideas of 

death. That’s actually what I come down to about human cloning. 

I think—because our usual argument is, it’s completely unsafe. 

32 

And I can’t conceive of an experiment that we could prove it’s safe 

inside the woman’s body. I mean, I just can’t think of a way to— 

even if you had hundreds of animal studies that proved it’s safe, 

how would the first human experiments be done? As a bioethicist, 

it’s hard to imagine the phase-one clinical trial that one could design. 

But the moral issue for me is that I think it confuses us about 

the limits of human mortality and the limits of death itself if it’s 

ever used to try to replace an actual human person. 

Senator ENSIGN. OK. 

Dr. ZOLOTH. That’s the sort of confusion that I would pose. 

Senator ENSIGN. And the reason I’m asking this, and I don’t 

want to be combative—the reason I’m going down this line of questioning is because some who are in favor of embryonic stem cell research are looking at it from strictly a pragmatic point of view. 

You’re going to help other people with the research over here, you 

know, and that’s a greater good. That’s what their morality is telling them. And then there are others that are looking at it from 

their moral absolute point of view, you know, saying, ‘‘This is a 

human being, and we shouldn’t mess with it.’’ And because we 

don’t know these questions—you know, first rule of medicine is, 

‘‘Do no harm,’’ and if you’re, you know, somebody who is looking 

at our Creator, you know, our first rule in that regard would be 

‘‘Don’t violate whatever His law is set down to us.’’ 

So it is important to grapple with these as we’re going forward. 

And I think it’s important for the entire community, regardless of 

which side somebody comes down on, on this issue, for people to 

recognize that there is a lot of internal struggle on our personal 

moral standpoints from this. And people do disagree, depending on 

their background. 

But the bottom line is, this is a moral decision. 

Dr. ZOLOTH. Yes. 

Senator ENSIGN. It is a moral decision, and we have to figure out 

from where we are defining our morality. You know, I do this exercise with kids all the time in high school. You mentioned slavery 

is wrong. Well, why is slavery wrong? Kids will say, ‘‘Well, because, 

you know, it’s wrong to enslave, you know, one set of people over 

another.’’ And I say, ‘‘Well, why?’’ And they say, ‘‘Well, you know, 

we’ve, you know, decided as a, you know, society that that’s 

wrong.’’ And I’ll ask them, I’ll say, ‘‘Well, what if we decided as a 

society, like many societies did, that that was OK. Would it make 

it OK?’’ 

The bottom line is, I bring them to a point—you have to come 

with certain moral absolutes. There has to be rights and wrongs. 

Dr. ZOLOTH. Yes. 

Senator ENSIGN. There are no rights and wrongs, and moral relativism is the way of the world, then you can justify anything. You 

could justify human cloning. I mean, there’s no question, with 

moral relativism, what’s wrong with human cloning? If there is no 

higher power to answer to this, none of this is wrong. 

Dr. ZOLOTH. I completely agree with you. And what’s interesting 

and wonderful about living in America is that we’re allowed to hear 

the voice of that higher power in a very diverse number of ways— 

one hears the call of God’s law in a number of ways, and then you, 

33 

as the U.S. Senate, have to decide what to do with a country that 

hears God’s law in such complicated and divergent ways. 

Senator ENSIGN. Right. 

Dr. ZOLOTH. And that’s where science policy comes into play, to 

respect that voice, to honor it, and to care for each minority view 

that you hear, and then—— 

Senator ENSIGN. The difference is that when we—as policymakers, we have to make that moral choice. I mean, that’s—our 

laws are based on morals. 

Dr. ZOLOTH. Yes. 

Senator ENSIGN. So we have to—at a point, we have to say where 

we come down, and we have to make the call. There can be all the 

arguments in the world and all the discussion in the world, but, 

you know, the kind of—we have to then decide, based on our individual morals or the morals we represent in America, where those 

laws are going to come to effect. 

I don’t know, Mr.—I didn’t give you a chance to respond to any 

of this conversation. If you’d like jump in—as my time is very 

short—— 

Mr. DOERFLINGER. OK, thank you very much, Senator. 

Just to clarify something about cloning. The cloning—and we’re 

not talking about monoclonal antibodies. That’s just replicating 

cells in a culture and it doesn’t have anything to do with human 

embryos—but there’s one technique of cloning called somatic cell 

nuclear transfer. It makes a human embryo. There’s only one such 

procedure available right now that people are debating. And some 

people have said there’s a difference between reproductive cloning 

and therapeutic cloning. But that’s really not a difference in the 

procedure; it’s simply a difference in what you do with the embryo 

after you’ve cloned it. 

Senator ENSIGN. Correct. 

Mr. DOERFLINGER. Some people want to put it in a womb and get 

a baby. A very risky procedure, by the way. And some want to put 

it in a dish and destroy it for its stem cells. The distinction between the two is increasingly breaking down, for two reasons. 

One is that the fertility clinics realize—and the researchers realize—that any research that advances in refining somatic cell nuclear transfer for research purposes will equally serve the wild and 

crazy guys who want to do this for reproductive purposes, since the 

technique is exactly the same. 

The second way it’s breaking down is that in the laboratory of 

the states, the new laws that have been proposed by the biotechnology industry to allow cloning for research have increasingly 

started changing the definition of where the distinction lies. Increasingly—and this is already passed in New Jersey—you have 

bills introduced, and some passed, that say, ‘‘It’s not reproductive 

cloning unless you get a live birth.’’ You could put that embryo in 

a woman’s womb, you could gestate it into late fetal stages, and 

abort it for its tissue—which, at this point, has been done in animals—and call that ‘‘therapeutic cloning.’’ 

Cloning is allowed, and will be given state funds, under this California ballot initiative, Proposition 71. Because of their market research, they don’t call it cloning; they call it somatic cell nuclear 

transfer. But it’s exactly the same thing. 

34 

Senator DORGAN. Would the Senator yield on that point? 

Senator ENSIGN. Could we have Dr. Zoloth just comment on—I 

mean, from what I understand from, at least, my scientific background, they are the same process, up to a point, in what he is 

talking about. Do you disagree with what he said, as for—up to a 

process, they’re basically the same thing? 

Dr. ZOLOTH. You create a blastocyst. That is, in fact, true. It’s 

not a marketing campaign. It’s trying to be clear about the scientific language and to really describe the process, which is taking 

a human nucleus, an adult nucleus, and putting it in an egg—— 

Senator ENSIGN. I guess—here’s the simplest way to describe it. 

Is there any difference between—up to that point—— 

Dr. ZOLOTH. Yes. 

Senator ENSIGN.—where you go to then use it, is there any difference between how Dolly was cloned—how Dolly was created, up 

to that point, and somatic cell nuclear transfer? 

Dr. ZOLOTH. In humans, that question has not been fully answered, biologically. That’s what I’m told, that we don’t know yet. 

Because human biology is different from sheep biology, and we 

don’t know clearly—— 

Senator ENSIGN. I’m just talking about the—— 

Dr. ZOLOTH. We don’t know. 

Senator ENSIGN.—I’m talking about the study, though, or the 

technique—well, now, this is a fundamental question. The technique to get to that point is the same. That is the point of it. 

Dr. ZOLOTH. The technique is the same. There’s no question 

about that. 

Senator ENSIGN. OK, so—and that—yes. 

Senator BROWNBACK. We’ve got a second panel—— 

Senator DORGAN. Mr. Chairman? 

Senator BROWNBACK. Yes? 

Senator DORGAN. Let me just, if I might, just clear up one point. 

I had asked the Senator if he would yield. I understand he was out 

of time, but I don’t want the panel to leave, leaving in the air this 

notion of putting a cloned embryo in the uterus—— 

Dr. ZOLOTH. Right. 

Senator DORGAN.—for the purpose of harvesting body parts. That 

is the most preposterous nonsense I’ve ever heard. Are you aware 

of anybody in the country that’s proposing that sort of thing? 

Mr. DOERFLINGER. Footnote 40 in my testimony, Senator. Three 

different animal trials, in each of which the animal, the cloned animal embryo, could not produce usable tissues for the transplants 

until they had gestated and brought it to the fetal stage. In the 

most recent one, conducted by Robert Lanza et al., of Advanced 

Cell Technology, they had to develop the cloned mouse embryo to 

the equivalent of the fifth to sixth month in humans, and then 

abort it to obtain usable cells that were used to try to repair heart 

damage in a mouse. The researchers declared in their press release 

that ‘‘This is an important new paradigm,’’ for human therapeutic 

cloning. 

Senator DORGAN. Well, that’s not responsive to my question. 

We’ve also cloned a sheep and dairy cows, but I was asking whether you know of anybody that wants to implant a cloned embryo in 

35 

a uterus for the purpose of harvesting body parts. No one that I 

know of in this country has proposed that. It’s preposterous. 

Mr. DOERFLINGER. They are proposing it, Senator, I’m sorry. 

Senator DORGAN. Who’s proposing it? 

Mr. DOERFLINGER. To deny it is preposterous. 

Senator DORGAN. Dr. Zoloth? 

Mr. DOERFLINGER. That’s exactly how the New Jersey law is 

crafted. 

Senator DORGAN. Well, that is—that is nonsense. The fact is, no 

one in this country—— 

Mr. DOERFLINGER. I agree it’s nonsense, but I insist to you that 

it’s happening, and I’ll give you more documentation. 

Senator DORGAN. Well, Mr. Chairman, it is a specter of this debate that is the worst, in my judgment, of this debate. It is not 

thoughtful. 

Senator BROWNBACK. Well, this should—if—this should be able 

to track this, whether or not this is the case or not, and—— 

Mr. DOERFLINGER. I’ll be very happy to—— 

Senator BROWNBACK.—let us get—— 

Mr. DOERFLINGER.—give you the supplemental documentation. 

Senator BROWNBACK.—laws, and let’s get a copy of the New Jersey law and put it in. 

Dr. ZOLOTH. It’s—— 

Senator BROWNBACK. And, Dr. Zoloth, if you would care to respond—— 

Dr. ZOLOTH. I just—— 

Senator BROWNBACK. And I want to go to the next panel then. 

Dr. ZOLOTH. I think it’s real important. Mr. Dorgan has raised 

a very important point. We’re talking about very early basic science 

research. It’s important not to do science fiction or to instill fear 

in the American public. We’ve had quite enough of that, I think. 

No responsible researcher, no IRB, no bioethicist in this country 

would ever pass, support, or approve such a protocol. It is unthinkable. 

Senator BROWNBACK. Have you reviewed the New Jersey law? 

Dr. ZOLOTH. New Jersey law, I think, does not imply that at all. 

Senator WYDEN. Mr. Chairman, before—— 

Senator BROWNBACK. But does the New Jersey law allow that? 

Dr. ZOLOTH. No, I don’t think the New Jersey law would allow 

that. 

Senator WYDEN. Mr. Chairman? 

Senator BROWNBACK. OK. Well—— 

Dr. ZOLOTH. It’s about animal—— 

Senator WYDEN. That’s the—— 

Dr. ZOLOTH.—it’s about animal research. It’s really quite a different category. 

Senator WYDEN. Right. Before a riot breaks out—— 

[Laughter.] 

Senator WYDEN.—that is the key point. It has not been done 

with respect to humans. 

Dr. ZOLOTH. Right. It’s not about humans. 

Senator WYDEN. We are talking about animals. And I agree with 

the Chairman, we can have these debates in a thoughtful way. I 

36 

mean, this is—and I’ve been trying to make my way through footnote number 40—— 

[Laughter.] 

Senator WYDEN.—but I think my reading of footnote number 40 

that you cited, Doctor, is that it does not apply to humans. And 

that’s why I thought the point made by Senator Dorgan was important. 

Senator BROWNBACK. Let’s—and we’ll get a copy of the New Jersey law, and let’s put it in the record, so we’ll have it as part of 

this. 

[The information referred to follows:] 


929LAW1.eps
37 


929LAW2.eps

10 

SI909 [IR] 

2 

medical research, raises significant ethical and public policy concerns; 

and, although not unique, the ethical and policy concerns associated 

with stem cell research must be carefully considered; and 

h. The public policy of this State governing stem cell research 

must: balance ethi cal and medical considerations, based upon both an 

understanding of the science associated with stem cell research and a 

thorough consideration of the ethical concerns regarding this research; 

and be carefully crafted to ensure that researchers have the tools 

necessary to fulfill the promise o f this research. 

11 2. a. It is the public policy of this State that research involving the 

12 derivation and use of human embryonic stem cells, human embryonic 

13 germ cells and human adult stem cells 1 [ from any source ] 1 , including 

14 somatic cell nucl ear transplantation, shall· 

15 (1) be permitted in this State; 

16 (2) be conducted with full consideration for the ethical and medical 

17 implications of this research ; and 

18 (3) be reviewed, in each case, by an institutional review board 

19 operating in accordance with applicable federal regulations. 

20 b. (1) A physician or other health care provider who is treating a 

21 patient for infertility shall provide the patient with timely, relevant and 

22 appropriate information sufficient to allow that person to make an 

23 infonned and voluntary choice regarding the disposition of any human 

24 embryos remaining follov.ring the infertility treatment. 

25 (2) A person to whom infOimation is provided pursuant to 

26 paragraph (1) of this subsection shall be presented v.rith the option of 

27 storing any unused embryos, donating them to another person, 

28 donating the remaining embryos for research purposes, or other means 

29 of disposition. 

30 (3) A person who elects to donate, for research purposes, any 

31 embryos remaining after receiving infertility treatment shall provide 

32 written consent to that donation. 

33 c. (1) A person shall not knowingly, for valuable consideration, 

34 purchase or sell, or othelwise transfer or obtain, or promote the sale 

35 or transfer of, embryonic or cadaveric fetal tissue for research 

36 purposes pursuant to this act; however, embryonic or cadaveric fetal 

37 tissue may be donated for re search purposes in accordance with the 

38 provisions of subsection b. of this section 1 or other appljcabl e State or 

39 ' 

40 For the purposes of this subsection, "valuable consideration" means 

41 financial gain or advantage, but shall not include reasonable payment 

42 for the removal, processing, disposal, preseIV'ation, quality control, 

43 storage, transplantation, or implantation of embryonic or cadaveric 

44 fetal tissue. 

45 (2) A person or entity who violates the provisions of this 

46 subsection shall be 19l1i lty of a crime of the third degree and 
38 

Senator BROWNBACK. We’ll get the second panel up before we get 

further here. I thank both panelists very much. I think this is an 

excellent discussion, and one we should do more of. 

First will be Dr. George Daley, Associate Professor of Pediatrics 

and Biological Chemistry and Molecular Pharmacology, Children’s 

Hospital, Harvard School of Medicine out of Boston; next, Dr. 

David Prentice, Senior Fellow, Family Research Council in Washington, D.C.; and then Dr. Marc Hedrick, President, MacroPore 

Biosurgery out of San Diego, California. Delighted that all of you 

could join us. 

Dr. Daley, thank you for being here. I’d say to all the panelists 

your written testimony will be put into the record. If you’d like to 

summarize, that’s quite all right. And I think you should gather 

from us we like to have a good period of question and answer, if 

we could do that. 

Dr. Daley? 

STATEMENT OF GEORGE Q. DALEY, M.D., PH.D., 

REPRESENTING THE AMERICAN SOCIETY FOR CELL BIOLOGY 

Dr. DALEY. Yes, thank you. 

Senator Brownback, Members of the Committee, thank you for 

inviting me to testify. I am here today representing the American 

Society for Cell Biology, which represents over 8,000 basic biomedical researchers in the United States. 

I am a physician scientist. I am clinically active in the care of 

children and adults with malignant and genetic diseases of the 

blood. I run an NIH-supported laboratory and hold grants pertinent to both adult and embryonic stem cells. We study chronic myeloid leukemia, a cancer that arises from the adult blood stem cell, 


929LAW3.eps
39 

and we investigate how to coax embryonic stem cells to differentiate into blood. 

My laboratory can transplant mice with blood stem cells derived 

entirely in vitro from embryonic stem cells. Our goal is to replicate 

this success using human embryonic stem cells, with the hope of 

someday treating patients with leukemia, immune deficiency, 

aplastic anemia, and genetic diseases like sickle cell. 

At the core of the controversy we’re discussing today are principles that are informed more by religious and moral beliefs than 

by scientific issues. However, the scientific issues, indeed, play an 

important role in the debate. As with most controversies, much 

misinformation and spin exists. Today, I am here to offer scientific 

testimony to help clarify the facts and dispel the myths surrounding competing claims in adult and embryonic stem cell research. 

I will address two central scientific questions. First is research 

on human adult stem cells so promising that we need not pursue 

research with embryonic stem cells? And second is the current 

Presidential policy that restricts federally funded researchers to 

only a limited set of cell lines adequate to explore the potential of 

human ES cell research? 

The simple, but emphatic, answer to the first question is, no. Although research on adult stem cells is enormously valuable, adult 

stem cells are not the biological equivalents of embryonic stem 

cells, and adult stem cells will not satisfy all medical and scientific 

needs. 

Unequivocally, adult stem cells have been isolated from bone 

marrow, skin and mesenchyme, which would include fat, but adult 

stem cells do not appear to exist for all tissues of the body, especially all tissues that are ravaged by disease. Claims of stem cells 

for the heart, pancreas, and kidney remain controversial. 

You will also hear claims that adult stem cells are highly plastic, 

perhaps as versatile as embryonic stem cells, and that success with 

adult stem cells obviates the need to study ES cells. 

As an expert in both the biology of adult and embryonic stem 

cells, I disagree with these claims. It is the nature of adult stem 

cells to regenerate only a limited subset of the body’s tissues. As 

best we can tell under normal physiology, adult stem cells do not 

have a measurable capacity to replenish cells beyond their tissue 

of origin. Therefore, asking blood stem cells to regenerate heart or 

liver or brain is to ask adult stem cells to betray their intrinsic nature. Like cellular alchemy, attempts to engineer adult stem cell 

plasticity may never succeed in a clinically practical manner. 

While the differentiation spectrum of adult stem cells is restricted, it is an incontrovertible scientific fact that embryonic stem 

cells can form all cells in the body. Such is the natural destiny of 

the stem cells of the early embryo, and the reason they inspire 

such fascination among biologists. 

Claiming that the promise of adult stem cells trumps the need 

to study embryonic stem cells is an opinion at the fringe, not the 

forefront, of scientific thinking. The American Society of Cell Biology and every other major scientific society supports the study of 

both adult and embryonic stem cells. 

40 

To the second question, ‘‘Is the current Presidential policy adequate to explore the potential of ES cell research,’’ I also answer 

an emphatic no. Today, federally funded scientists operate under a 

restrictive policy that limits us to a modest number of cells generated over 3 years ago. We cannot use new lines, and, consequently, cannot take advantage of the latest tools to explore some 

of the most medically promising avenues. It runs contrary to the 

American spirit of innovation for our government to deny its scientists every advantage to push the frontiers. The President’s policy is slowing research, and it’s compromising the next generation 

of medical breakthroughs. 

I recently published an article in the New England Journal of 

Medicine entitled ‘‘Missed Opportunities in Human Embryonic 

Stem Cell Research.’’ In it, I point out that in the 3 years since the 

President announced his policy, over a hundred additional lines 

have been generated, some which model diseases like cystic fibrosis, muscular dystrophy, and genetic forms of mental retardation. 

What does the President say to families whose children are affected 

by these devastating diseases? How does the President justify his 

lack of support for this research? Where is the compassion in such 

a conservative policy? 

I am the father of two young boys, Nick and Jack, ages 3 and 

6. Currently, I’m taking great delight in teaching them baseball. I 

count my blessings for their health; more so every time I walk 

through the lobby of the Children’s Hospital and I see the many 

kids in wheelchairs who will never know the excitement of running 

the bases or smacking a home run. 

As a physician, I wholeheartedly support ES cell research, and 

I see it delivering the medical breakthroughs of tomorrow. 

As a scientist engaged in stem cell research, I have listened intently to the voices arguing against our work. I do not accept that 

the interests of microscopic embryos should trump the needs of patients. 

I firmly believe that our research mission, which is to advance 

human knowledge in the hopes of improving health and relieving 

human suffering, is compassionate, life-affirming, and dedicated to 

the highest ideals of medicine. This important work must continue, 

and it is in the best interest of our society for our government to 

support it. 

Thank you. 

[The prepared statement of Dr. Daley follows:] 

PREPARED STATEMENT OF GEORGE Q. DALEY, M.D., PH.D., REPRESENTING THE

AMERICAN SOCIETY FOR CELL BIOLOGY

Senator Brownback, members of the Committee, thank you for inviting me here 

today to testify before you. My name is George Daley. I am here representing The 

American Society for Cell Biology where I serve as a member of the Public Policy 

Committee. The ASCB represents over 11,000 basic biomedical researchers in the 

United States and in 45 other countries. 

[For the record, I am Associate Professor of Pediatrics and Biological Chemistry 

at the Boston Children’s Hospital and Harvard Medical School, Associate Director 

of the Children’s Hospital Stem Cell Program, a member of the Executive Committee of the Harvard Stem Cell Institute, a Board member of the International Society for Stem Cell Research, and chair of the Scientific Review Committee of the 

Stem Cell Research Foundation. I received one of the first grants issued by the NIH 

for the study of human embryonic stem cells.] 

41 

I am a physician-scientist, board certified in Internal Medicine and Hematology 

and clinically active in the care of children and adults with malignant and genetic 

diseases of the blood and bone marrow. I run an NIH-supported laboratory that 

studies both adult and embryonic stem cells. Part of my lab focuses on the human 

disease Chronic Myeloid Leukemia, a cancer that arises from the adult blood stem 

cell. Part of my lab is investigating how to coax embryonic stem cells to differentiate 

into blood stem cells. My laboratory has succeeded in transplanting mice with blood 

stem cells derived entirely in vitro from embryonic stem cells. Our goal is to replicate this success using human embryonic stem cells, with the hope of someday 

treating patients with leukemia, immune deficiency, aplastic anemia, and genetic 

diseases like sickle cell anemia. 

As the title of the hearing states, controversy surrounds the field of human embryonic stem cell research. At the core of the controversy is the fact that harvesting 

embryonic stem cells requires the destruction of a human embryo. If you ascribe full 

personhood to the earliest stages of human development, then you are vigorously 

opposed to embryonic stem cell research and opposed to fertility treatments that 

generate embryos that are the source of embryonic stem cells. In contrast, if you 

believe that the earliest human embryos, as microscopic balls of primitive cells, are 

not the moral equivalents of babies, then you are likely to be equally vigorous in 

supporting embryonic stem cell research because of its immense promise for understanding and treating disease. These dueling perspectives are informed more by religious and moral beliefs than by scientific principles. However, scientific issues indeed play an important role in the current debate. As with most controversies, much 

misinformation exists. Today, I am here to offer scientific testimony to clarify the 

facts and dispel the myths surrounding competing claims in adult and embryonic 

stem cell research. 

I will address two central scientific questions: First, is research on human adult 

stem cells so promising that we need not pursue research with embryonic stem 

cells? Second, is the current Presidential policy that restricts researchers to only a 

limited set of cell lines created before August 9, 2001 adequate to explore the potential of human embryonic stem cell research? 

The simple but emphatic answer to the first question is ‘‘no.’’ Although research 

on adult stem cells is enormously promising and has already yielded clinical success 

in the form of bone marrow transplantation, adult stem cells are not the biological 

equivalents of embryonic stem cells, and adult stem cells will not satisfy all scientific and medical needs. Moreover, a great many questions about adult stem cells 

remain unanswered. Adult stem cells have been unequivocally isolated from bone 

marrow, skin, and mesenchyme, but adult stem cells do not appear to exist for all 

tissues of the body. Claims of stem cells for the heart, pancreas, and kidney remain 

controversial. You will also hear claims that adult stem cells are plastic, perhaps 

as versatile as embryonic stem cells, and that success with adult stem cells obviates 

the need to study embryonic stem cells. As an expert in both adult and embryonic 

stem cell biology, I take issue with these claims. It is the nature of adult stem cells 

to regenerate only a limited subset of the body’s tissues. As best we can tell, under 

normal physiologic circumstances, adult stem cells do not have a measurable capacity to differentiate beyond their tissue of origin. Therefore, asking blood stem cells 

to regenerate heart or liver or brain is to ask adult stem cells to betray their intrinsic nature. Like cellular alchemy, attempts to engineer adult stem cell plasticity 

may never succeed in a clinically practical manner. I am not arguing we should not 

invest in some highly speculative realms of cellular engineering with adult stem 

cells. Indeed, we should. I am arguing however, that the promise of adult stem cells 

in no way obviates the need to investigate embryonic stem cells. Claiming that the 

study of adult stem cells should trump the study of embryonic stem cells is an opinion at the fringe and not the forefront of scientific thinking. 

While the differentiation spectrum of adult stem cells is restricted, it is an incontrovertible fact that embryonic stem cells have the ability to form all cells in the 

body. Such is the natural endowment of the stem cells of the early embryo, and the 

very reason they inspire such fascination among stem cell biologists. Scientists are 

seeking to discover the natural mechanisms that drive formation of specific cells and 

tissues, so that these principles can be faithfully reproduced with embryonic stem 

cells in the Petri dish. I would argue that coaxing embryonic stem cells to do what 

comes naturally to them is more likely to prove successful in the near term than 

reengineering adult stem cells towards unnatural ends. The American Society of 

Cell Biology and every other major scientific society supports the study of both adult 

and embryonic stem cells. 

To the second question, ‘‘Is the current Presidential policy adequate to explore the 

potential of human embryonic stem cell research?’’ I also answer an emphatic ‘‘no.’’ 

Today, federally-funded scientists operate under a restrictive policy that limits the 

42 

1Daley GQ. Missed opportunities in embryonic stem cell research. N Engl J Med 351:627– 

8, 2004. 

human embryonic stem cells that can be studied to a modest number of lines generated over three years ago. With the pre-2001 vintage cell lines we can address generic questions, but are prohibited from exploiting the latest tools being developed 

around the Globe. It runs contrary to the American spirit of innovation for our government to deny its scientists every advantage to push the frontiers. Ultimately this 

will slow the pace of medical research, and compromise the next generation of medical breakthroughs. I recently published an article in the New England Journal of 

Medicine entitled ‘‘Missed opportunities in human embryonic stem cell research’’ 1, in which I articulated the scientific avenues that are not being adequately investigated due to the current Presidential policy. In the three years since the President 

announced his policy, over a hundred additional lines have been generated, many 

with advantageous properties that make them highly valuable to medical scientists. 

Some of these new lines model diseases like cystic fibrosis, muscular dystrophy, and 

genetic forms of mental retardation. What does the President say to families whose 

children are affected by these devastating diseases? How does the President justify 

his lack of support for this research? Where is the compassion in such a policy? 

Thankfully, I am the father of two healthy boys, ages 3 and 6. I am taking great 

delight in teaching them baseball and watching them root for the Red Sox. (They 

have much to learn about heartache in the world). As a father, I count my blessings 

for these God-given gifts, more so every time I walk through the lobby of the Children’s Hospital, and see the many kids who will never run the bases or smack a 

home run. As a physician, I see the mission of ES cell research as providing the 

greatest hope to relieve the suffering I see in many of my patients. As a scientist, 

I am not impervious to the expressions of ethical concern for the sanctity of the 

human embryo. But in our religiously plural society, I fear we may never reach an 

ethical consensus given the competing entities in this debate: microscopic human 

embryos that represent incipient human life on the one hand, desperate patients 

suffering from debilitating diseases on the other. From my perspective as a father, 

physician, and scientist, I am moved by concern for my two boys, my patients, and 

for the life-affirming mission of hope and promise in embryonic stem cell research. 

Senator BROWNBACK. Thank you, Dr. Daley, for your presentation. 

Dr. Prentice? 

STATEMENT OF DR. DAVID A. PRENTICE, PH.D., SENIOR 

FELLOW FOR LIFE SCIENCES, FAMILY RESEARCH COUNCIL; 

AFFILIATED SCHOLAR, CENTER FOR CLINICAL BIOETHICS, 

GEORGETOWN UNIVERSITY MEDICAL CENTER 

Dr. PRENTICE. Thank you, Mr. Chairman. 

Mark Twain noted that, ‘‘There is something fascinating about 

science; one gets such wholesale returns of conjecture out of such 

a trifling investment of fact.’’ This is certainly true regarding the 

hype and emotion surrounding the stem cell issue. 

I’d like to start with some biological definitions, more of which 

are in my written testimony, to provide a common scientific frame 

of reference. This is from Patten’s ‘‘Foundations of Embryology, 

Sixth Edition.’’ ‘‘Almost all higher animals start their lives from a 

single cell, the fertilized ovum, or zygote.’’ The time of fertilization 

represents the starting point in the life history or ontogeny of the 

individual. Thus, within the body or in the laboratory via in vitro 

fertilization, the first stage of development of a new individual begins with fertilization. Because it has become an area of interest, 

it is useful to point out that, biologically, the process of cloning, 

also termed somatic cell nuclear transfer, or SCNT, also produces 

a zygote as a starting point for development. 

The President’s Council on Bioethics has noted, quote ‘‘The first 

product of SCNT is, on good biological grounds, quite properly reVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00046 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\81636.TXT JACKIE
43 

garded as the equivalent of a zygote and its subsequent stages as 

embryonic stages in development,’’ end quote. 

The National Academy of Sciences has also noted that embryonic 

stem cells can be isolated from blastocyst-stage embryos early in 

human development, whether produced by fertilization or by 

cloning, and has called those blastocysts by the same name, whether produced by either technique. 

The first question we might address, then, is, Why use stem 

cells? Well, the short answer is to treat degenerative diseases such 

as heart disease, stroke, chronic lung disease, Parkinson’s, and diabetes. The stem cell has two chief characteristics. It multiplies, 

maintaining a pool of stem cells; and, second, given the correct signal, it can differentiate into other specific cell types for use by the 

body. 

Embryonic stem cells were first isolated in mice in 1981, and in 

humans in 1998. Adult stem cells were first identified in bone marrow in the 1960s, and in recent years have been found in a wide 

range of tissues throughout the body. 

Embryonic stem cells are derived by removing the inner cell 

mass of the early human embryo, or blastocyst; and, in this process, the embryo is destroyed. The cells purportedly have the advantage that they can proliferate indefinitely and can form any tissue. 

Scientific publications document the claim that they can proliferate for long periods of time, but the experimental basis for 

their potential to form any tissue relies on the cells being within 

the normal developmental context of the embryo. 

The published literature, however, shows that claims for embryonic stem cell advantages over adult stem cells are, so far, unsubstantiated. The National Institutes of Health actually has noted, 

‘‘Thus, at this stage, any therapies based on the use of human embryonic stem cells are still hypothetical and highly experimental.’’ 

And also quotes, ‘‘Whether embryonic stem cells will provide advantages over stem cells derived from cord blood or adult bonemarrow hematopoietic stem cells remains to be determined.’’ There 

are no current clinical treatments based on embryonic stem cells; 

in fact, only few and modest published successes using animal models of disease. For embryonic stem cells, there is difficulty in obtaining pure cultures of specific cell types in the laboratory dish. 

There is a potential for tumor formation. The cells are actually difficult to establish and maintain in culture, and they face a significant risk of immune rejection. 

A recent publication from the Whitehead Institute reported that 

‘‘embryonic stem cells are actually genomically unstable,’’ meaning 

that the expression of their genes is unstable. And this may explain the problems in achieving true functional differentiation of 

embryonic stem cells. 

It has been particularly troubling in terms of diabetes. Some reports suggested a fraction of embryonic stem cells could be stimulated to produce insulin. But those reports were called into question by a Harvard study that indicated the embryonic stem cells 

were not making insulin themselves, but were imbibing it from the 

culture medium in which they were grown, and then releasing it. 

Another recent study found that supposedly differentiated insulin-expressing embryonic stem cells were not actually true insulinVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00047 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\81636.TXT JACKIE
44 

expressing cells, and, when injected into animals, caused tumors. 

Human embryonic stem cells, even the new lines, have been found 

to accumulate chromosomal abnormalities in culture, as well. 

Commentary in the New England Journal of Medicine noted significant problems still facing the potential utility of embryonic stem 

cells, quote, ‘‘There are still many hurdles to clear before embryonic 

stem cells can be used therapeutically. For example, because undifferentiated embryonic stem cells can form tumors after transplantation, it is important to determine an appropriate state of differentiation before transplantation. Differentiation protocols for many 

cell types have yet to be established. Targeting the differentiated 

cells to the appropriate organ and the appropriate part of the organ 

is also a challenge,’’ end quote. 

And the theory that cloning, or somatic cell nuclear transfer, will 

produce matching tissues for transplant that will not be rejected 

has already been shown to be incorrect. When tested in mice, the 

transplanted embryonic stem cells from the cloned mouse embryo 

were rejected by the genetically identical host. Even Dr. James 

Thompson, who was the first to isolate human embryonic stem 

cells, has stated that cloning is unlikely to be clinically significant. 

And other world leaders in the embryonic stem cell field, including 

Australia’s Alan Trounson, have echoed this. 

Cloning also will require a tremendous number of human eggs, 

or oocytes, to produce even one embryonic stem cell line. One estimate is a minimum of 100 eggs per patient. The recent South Korean cloning of a human embryo required 242 eggs to get just one 

embryonic stem cell line. 

There have actually been few positive published scientific reports 

regarding the claims put forth for embryonic stem cells. The relative lack of success should be compared with the real success of 

adult stem cells. A wealth of published scientific papers over the 

last few years document that adult stem cells are a much more 

promising source of cells for regenerative medicine, to actually 

treat patients. They do, for example, show pluripotent capacity, 

meaning the capacity to form most, potentially all, of the tissues 

of the adult body. And this capacity has been found in cells from 

diverse sources, including bone marrow, peripheral blood, the inner 

ear, and umbilical cord blood. I’ve attached a chart as Appendix A 

to my written testimony that outlines some, though not all, of the 

tissues from which adult stem cells have been isolated, and some 

of the derivatives. In fact, even liposuctioned fat has been found to 

contain stem cells, which Dr. Hedrick will address in a moment. 

Many published references show adult stem cells can multiply in 

culture, retaining their ability to differentiate, and provide a sufficient numbers of cells for clinical treatments. Moreover, they’ve 

been found effective in treating animal models of disease for diseases including diabetes, stroke, spinal cord injury, Parkinson’s disease, and retinal degeneration. 

Moreover, adult stem cells are already being used clinically for 

many diseases. When I say ‘‘clinically,’’ I mean ‘‘in patients.’’ These 

include treatments for cancers, autoimmune diseases, such as multiple sclerosis, lupus, and arthritis, anemias, such as sickle-cell 

anemia, immune deficiencies, making new cartilage, growing new 

corneas to restore sight to blind patients, clinical trials for stroke, 

45 

1 Carlson, Bruce M.; Patten’s Foundations of Embryology, 6th edition. New York: McGrawHill, 1996, p. 3 

and several groups using adult stem cells with patients to repair 

damage after heart attacks. In fact, Mr. Chairman, at your last 

hearing, you heard testimony from patients treated with adult 

stem cells and receiving benefit for spinal cord injury and Parkinson’s disease. The adult stem cells circumvent the problems of immune rejection, and do so without tumor formation. 

The mechanism is still unknown, and it’s a fascinating area, for 

this regeneration. In some cases, the cells do seem to interconvert 

into other tissues. In other cases, they fuse with the tissue, such 

as liver, and take on the characteristics to pursue the regeneration. 

And, in some cases, they simply stimulate the cells already present 

in the tissues so the adult stem cells are not, themselves, forming 

the new tissue. 

But as Robert Lanza, a proponent of embryonic stem cell research, has noted, quote, ‘‘There is ample scientific evidence that 

adult stem cells can be used to repair damaged heart or brain tissue. If it works, it works, regardless of the mechanism,’’ end quote. 

I’ve given you only a sampling of citations here. I have attached 

to my written testimony a paper prepared for the President’s Council documenting over 200 references of adult stem cell successes, as 

well as, in the Appendix B to this testimony, a list of approximately 54 human diseases currently being treated with adult stem 

cells. 

In summary, these adult stem cells, including umbilical-cord 

blood, have been shown by the published evidence to be a more 

promising alternative for patient treatment. Adult stem cells have 

proven success, not just in the dish or in the animal, but also in 

the patients in the early clinical trials, and they avoid the problems 

with tumor formation, transplant rejection, and provide realistic 

excitement for patient treatment. 

Thank you. 

[The prepared statement of Dr. Prentice follows:] 

PREPARED STATEMENT OF DR. DAVID A. PRENTICE, PH.D., SENIOR FELLOW FOR LIFE

SCIENCES, FAMILY RESEARCH COUNCIL; AFFILIATED SCHOLAR, CENTER FOR

CLINICAL BIOETHICS, GEORGETOWN UNIVERSITY MEDICAL CENTER

Mr. Chairman, Distinguished Members of the Committee, thank you for the opportunity to provide testimony on this important subject. 

Mark Twain noted that ‘‘There is something fascinating about science. One gets 

such wholesale returns of conjecture out of such a trifling investment of fact.’’ This 

is certainly true regarding the hype and emotion surrounding the stem cell issue. 

We should start with some biological definitions, to provide a common scientific 

frame of reference. 

‘‘Almost all higher animals start their lives from a single cell, the fertilized ovum 

(zygote). . . The time of fertilization represents the starting point in the life history, 

or ontogeny, of the individual.’’ 1

The quotes below are from internationally preeminent human embryologist Ronan 

O’Rahilly in his latest textbook. Dr. O’Rahilly originated the international Carnegie 

Stages of Human Embryological Development, used for many decades now by the 

International Nomina Embryologica (now the Terminologica Embryologica) Committee which determines the scientifically correct terms to be used in human embryology around the world. 

‘‘Although life is a continuous process, fertilization. . .is a critical landmark because, under ordinary circumstances, a new, genetically distinct human organism is formed when the chromosomes of the male and female pronuclei blend 

46 

2 Ronan O’Rahilly and Faiola Muller, ‘‘Human Embryology & Teratology’’, 3rd ed. New York: 

Wiley-Liss, 2001; p. 8 3 Ronan O’Rahilly and Faiola Muller, ‘‘Human Embryology & Teratology’’, 3rd ed. New York: 

Wiley-Liss, 2001; p. 87 4 ‘‘Human Cloning and Human Dignity: An Ethical Inquiry’’, Report of the President’s Council 

on Bioethics, July 2002; p. 50 5Scientific and Medical Aspects of Human Reproductive Cloning, Report of the National Academy of Sciences and the Institute of Medicine, National Academy Press, Washington, DC, Jan 

2002; Preface page xii. 

in the oocyte. This remains true even though the embryonic genome is not actually activated until 2–8 cells are present, at about 2–3 days. . . During the embryonic period proper, milestones include fertilization, activation of embryonic 

from extra-embryonic cells, implantation, and the appearance of the primitive 

streak and bilateral symmetry. Despite the various embryological milestones, 

however, development is a continuous rather than a saltatory process, and 

hence the selection of prenatal events would seem to be largely arbitrary.’’ 2

‘‘Prenatal life is conveniently divided into two phases: the embryonic and the 

fetal . . . [I]t is now accepted that the word embryo, as currently used in 

human embryology, means ‘an unborn human in the first 8 weeks’ from fertilization. Embryonic life begins with the formation of a new embryonic genome 

(slightly prior to its activation).’’ 3

Thus whether within the body or in the laboratory via in vitro fertilization or 

other assisted reproductive techniques, the first stage of development of a new individual begins with fertilization. Because it has become an area of interest, it is useful to point out that biologically the process of cloning (somatic cell nuclear transfer; 

SCNT) also produces a zygote as the starting point for development. As the President’s Council on Bioethics has noted, ‘‘The first product of SCNT is, on good biological grounds, quite properly regarded as the equivalent of a zygote, and its subsequent stages as embryonic stages in development.’’ 4 The National Academy of 

Sciences noted the following: 

‘‘The method used to initiate the reproductive cloning procedure is called nuclear transplantation, or somatic cell nuclear transfer (SCNT). It involves replacing the chromosomes of a human egg with the nucleus of a body (somatic) 

cell from a developed human. In reproductive cloning, the egg is then stimulated to undergo the first few divisions to become an aggregate of 64 to 200 cells 

called a blastocyst. The blastocyst is a preimplantation embryo that contains 

some cells with the potential to give rise to a fetus and other cells that help 

to make the placenta. If the blastocyst is placed in a uterus, it can implant and 

form a fetus. If the blastocyst is instead maintained in the laboratory, cells can 

be extracted from it and grown on their own.’’ 5

Embryonic stem cells can be isolated from a blastocyst-stage embryo early in 

human development, whether produced by fertilization or by cloning (SCNT): 


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47 

6 ‘‘Stem Cells: Scientific Progress and Future Research Directions’’, National Institutes of 

Health, June 2001; Pg. 5 

‘‘[A]n embryonic stem cell (ES cell) is defined by its origin. It is derived from 

the blastocyst stage of the embryo. The blastocyst is the stage of embryonic development prior to implantation in the uterine wall.’’ 6

A first question we might address is, ‘‘Why use stem cells?’’ The short answer is 

to treat degenerative diseases. In the past, infectious diseases were the scourge of 

mankind; antibiotics, vaccinations, and sanitation have dealt with these as killers. 

Today degenerative diseases, such as heart disease, stroke, chronic lung disease, 

Parkinson’s disease, and diabetes are our main concern. These leading causes of 

death in the U.S. are common to all developed nations and are becoming more prevalent in developing nations. In degenerative diseases, it is usually only part of the 

organ or tissue that is damaged, rather than the entire organ. Stem cells are proposed to treat these diseases by repairing and replacing the damaged tissue. 


929PREN2.eps
48 

7 National Institutes of Health, ‘‘Stem cells: Scientific progress and future directions’’, June 

2001; p. 17. 8 National Institutes of Health, ‘‘Stem cells: Scientific progress and future directions’’, June 

2001; p. 63. 9 Assady S et al., Insulin production by human embryonic stem cells, Diabetes 50, 1691–1697, 

Aug 2001. 

A stem cell has two chief characteristics: (1) it multiplies, maintaining a pool of 

stem cells, and (2) given the correct signal, it can differentiate into other specific 

cell types for use by the body. There are several sources of stem cells (see figure 

above). The two types which have generated the most interest are embryonic stem 

cells derived from the early embryo (5–7 days after conception), and so-called adult 

stem cells which reside in most, if not all, tissues of the body. Embryonic stem cells 

were first isolated in mice in 1981, and in humans in 1998; adult stem cells were 

first identified in bone marrow in the 1960s, and in recent years have been found 

in a wide range of tissues throughout the body. Adult stem cells are actually present 

in the tissues of the individual from the moment of birth, and could more properly 

be termed tissue stem cells, post-natal stem cells, or non-embryonic stem cells, and 

include umbilical cord blood stem cells and placental stem cells. 

Embryonic stem cells are derived by removing the inner cell mass of the early 

human embryo (the blastocyst); in this process, the embryo is destroyed. The cells 

are placed into culture, and their purported advantages are that they can proliferate 

indefinitely, and can form any tissue. Scientific publications support the claim that 

they can proliferate for long periods of time in culture. In theory they can form any 

tissue; however, the experimental basis of their potential to form any tissue relies 

on the cells being within the normal developmental context of the embryo, where 

they form the range of tissues and organs of the human body during normal development. 

While embryonic stem cells might seem to have a theoretical advantage over adult 

stem cells, the published literature shows that the claims for embryonic stem cell 

advantages over adult stem cells are thus far unsubstantiated. Indeed, the National 

Institutes of Health has noted that: ‘‘Thus, at this stage, any therapies based on the 

use of human ES cells are still hypothetical and highly experimental.’’ 7 And also 

‘‘Whether embryonic stem cells will provide advantages over stem cells derived from 

cord blood or adult bone marrow hematopoietic stem cells remains to be determined.’’ 8

There are no current clinical treatments based on embryonic stem cells, and there 

are in fact only few and modest published successes using animal models of disease. 

Those who work with embryonic stem cells even have difficulty obtaining pure cultures of specific cell types in the laboratory dish. For example, an Israeli group reported in 2001 that they had obtained insulin-secreting cells from human embryonic 

stem cells.9 While this report was seized on by the press as a potential treatment 

for diabetes, what was not reported, and what was revealed by the scientific paper, 

was that only 1 percent of the cells in the culture dish supposedly made insulin. 

The remaining 99 percent of the cells were a mixture of other cell types, including 

nerve, muscle, a few beating heart cells, and also cells which continued to proVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00052 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\81636.TXT JACKIE

929PREN3.eps
49 

10Wakitani S et al.; ‘‘Embryonic stem cells injected into the mouse knee joint form teratomas 

and subsequently destroy the joint’’; Rheumatology 42, 162–165; January 2003. 11 Humpherys S et al.; ‘‘Epigenetic instability in ES cells and cloned mice’’; Science 293, 95– 

97; 6 July 2001. 12 Rajagopal J et al.; ‘‘Insulin staining of ES cell progeny from insulin uptake’’; Science 299, 

363; 17 Jan 2003. 13Sipione S et al., ‘‘Insulin expressing cells from differentiated embryonic stem cells are not 

beta cells’’, Diabetologia 47, 499–508, 2004 (published online 14 Feb 2004). 14 Cowan CA et al., ‘‘Derivation of embryonic stem cell lines from human blastocysts’’, New 

England Journal of Medicine 350, 1353–1356, 25 March 2004; published online 3 March 2004. 15Draper JS et al., ‘‘Recurrent gain of chromosomes 17q and 12 in cultured human embryonic 

stem cells’’, Nature Biotechnology 22, 53–54; January 2004. 16Odorico JS, Kaufman DS, Thomson JA, ‘‘Multilineage differentiation from human embryonic 

stem cell lines,’’ Stem Cells 19, 193–204; 2001. 17Schuldiner M et al.; ‘‘Effects of eight growth factors on the differentiation of cells derived 

from human embryonic stem cells’’; Proc. Natl. Acad. Sci. USA 97, 11307–11312; Oct. 10, 2000. 18 Robert P. Lanza, Jose B. Cibelli, & Michael D. West; ‘‘Human therapeutic cloning’’; Nature 

Medicine 5, 975–977; September 1999 

liferate. In fact, those growing cells point out another problem with embryonic stem 

cells—the potential for tumor formation.10 Embryonic stem cells have a distinct 

tendency to run out of control. 

Embryonic stem cells are actually difficult to establish and maintain in culture. 

James Thompson, who originated the first human embryonic stem cells in 1998, required 36 human embryos to finally obtain just 5 stem cell lines. Each stem cell line 

derives from one embryo. The Jones Institute in Virginia, in the summer of 2001, 

used 110 human embryos to derive 3 stem cell lines. And in the spring of 2004, a 

Harvard group used 342 human embryos to obtain 17 stem cell lines. In addition, 

embryonic stem cells face a significant risk of immune rejection. Tissue formed from 

embryonic stem cells will thus be rejected like most organ transplants without a 

precise tissue match. Indeed, a group from the Whitehead Institute reported that 

embryonic stem cells are actually genomically unstable, meaning that the expression of their genes is unstable: ‘‘The epigenetic state of the embryonic stem cell genome was found to be extremely unstable.’’ 11 This might in fact explain why there 

is such difficulty in obtaining pure cultures and why they tend to form tumors. This 

may also explain the problems in achieving true functional differentiation of embryonic stem cells. This has been particularly troubling with regards to diabetes. While 

some reports have suggested that a fraction of embryonic stem cells could be stimulated to produce insulin, those reports were called into question by a Harvard study 

that indicated the embryonic stem cells were not making insulin themselves, but 

were imbibing it from the culture medium in which they were grown and then releasing it.12 Another recent study found that supposedly differentiated insulin-expressing embryonic stem cells were not actually true beta cells, and when injected 

into animals caused tumors.13 Human embryonic stem cells (even new lines) have 

been found to accumulate chromosomal abnormalities in culture as well.14 15

It is illustrative to examine some quotes from proponents of embryonic stem cell 

research. In a review paper co-authored by James Thompson,16 the following statements are noteworthy: 

‘‘Rarely have specific growth factors or culture conditions led to establishment 

of cultures containing a single cell type.’’ 

‘‘Furthermore, there is significant culture-to-culture variability in the development of a particular phenotype under identical growth factor conditions.’’ 

‘‘[T]he possibility arises that transplantation of differentiated human ES cell derivatives into human recipients may result in the formation of ES cell-derived 

tumors.’’ 

‘‘[T]he poor availability of human oocytes, the low efficiency of the nuclear 

transfer procedure, and the long population-doubling time of human ES cells 

make it difficult to envision this [generation of human embryos by nuclear reprogramming] becoming a routine clinical procedure . . .’’ 

Other researchers have noted similar problems with embryonic stem cells: 

‘‘The work presented here shows that none of the eight growth factors tested 

directs a completely uniform and singular differentiation of cells.’’ 17

‘‘Transplanted ES cells spontaneously differentiate into any of a variety of ectodermal, endodermal and mesodermal cell types—sometimes into a disorganized 

mass of neurons, cartilage and muscle; sometimes into teratomas containing an 

eye, hair or even teeth.’’ 18

50 

19 Vogel G, ‘‘Can Adult Stem Cells Suffice?’’, Science 292, 1820–1822, June 8, 2001 20Phimister EG and Drazen JM, ‘‘Two fillips for human embryonic stem cells,’’ New England 

Journal of Medicine 350, 1351–1352, 25 March 2004 (published online 3 March 2004). 21 Rideout WM et al., ‘‘Correction of a genetic defect by nuclear transplantation and combined 

cell and gene therapy,’’ Cell 109, 17–27; 5 April 2002 (published online 8 March 2002). 22Tsai RYL, Kittappa R, and McKay RDG; ‘‘Plasticity, niches, and the use of stem cells’’; Developmental Cell 2, 707–712; June 2002. 23Trounson AO, ‘‘The derivation and potential use of human embryonic stem cells’’, Reproduction, Fertility, and Development 13, 523–532; 2001 24Mombaerts P, ‘‘Therapeutic cloning in the mouse’’, Proceedings of the National Academy of 

Sciences USA 100, 11924–11925; 30 Sept. 2003 (published online 29 August 2003). 25 Hwang WS et al., ‘‘Evidence of a pluripotent human embryonic stem cell line derived from 

a cloned blastocyst’’, Science 303, 1669–1674; 12 March 2004 (published online 12 Feb. 2004). 26McDonald JW et al., ‘‘Transplanted embryonic stem cells survive, differentiate and promote 

recovery in injured rat spinal cord,’’ Nature Medicine 12, 1410–1412, Dec 1999; Liu S et al., ‘‘Embryonic stem cells differentiate into oligodendrocytes and myelinate in culture and after spinal 

cord transplantation,’’ Proc. Natl. Acad. Sci. USA 97, 6126–6131; 23 May 2000; Bru ̈ stle O et al., 

‘‘Embryonic Stem Cell-Derived Glial Precursers: A Source of Myelinating Transplants,’’ Science 

285, 754–756, 30 July 1999. 27 Nishimura F et al.; ‘‘Potential use of embryonic stem cells for the treatment of mouse 

Parkinsonian models: improved behavior by transplantation of in vitro differentiated 

dopaminergic neurons from embryonic stem cells’’; Stem Cells 21, 171–180; March 2003; 

Bjorklund LM et al.; ‘‘Embryonic stem cells develop into functional dopaminergic neurons after 

A commentary in the journal Science included the following:19

‘‘[M]urine ES cells have a disturbing ability to form tumors, and researchers 

aren’t yet sure how to counteract that. And so far reports of pure cell populations derived from either human or mouse ES cells are few and far between— 

fewer than those from adult cells.’’ ‘‘Bone marrow stem cells can probably form 

any cell type,’’ says Harvard’s [Douglas] Melton. 

And a commentary in the New England Journal of Medicine noted the significant 

problems still facing potential utility of embryonic stem cells:20

‘‘There are still many hurdles to clear before embryonic stem cells can be used 

therapeutically. For example, because undifferentiated embryonic stem cells can 

form tumors after transplantation in histocompatible animals, it is important 

to determine an appropriate state of differentiation before transplantation. Differentiation protocols for many cell types have yet to be established. Targeting 

the differentiated cells to the appropriate organ and the appropriate part of the 

organ is also a challenge.’’ 

Furthermore, the theory that cloning (SCNT) will produce matching tissues for 

transplant that will not be rejected has already been shown incorrect. When tested 

in mice,21 the ES cells from the cloned mouse embryo were rejected by the genetically-identical host: 

‘‘Jaenisch addressed the possibility that ES clones derived by nuclear transfer 

technique could be used to correct genetic defects . . . However, the donor cells, 

although derived from the animals with the same genetic background, are rejected by the hosts.’’ 22

As noted above, Dr. James Thomson has stated that cloning is unlikely to be clinically significant. Other leaders in the embryonic stem cell field have also published 

similar views, including Australia’s Alan Trounson:23

‘‘However, it is unlikely that large numbers of mature human oocytes would be 

available for the production of ES cells, particularly if hundreds are required 

to produce each ES line . . . In addition, epigenetic remnants of the somatic 

cell used as the nuclear donor can cause major functional problems in development, which must remain a concern for ES cells derived by nuclear transfer 

. . . it would appear unlikely that these strategies will be used extensively for 

producing ES cells compatible for transplantation.’’ 

The evidence from animal studies indicates that it will indeed require a tremendous number of human oocytes to produce even one ES line from cloned embryos. 

Dr. Peter Mombaerts, who was one of the first mouse cloners, estimates that it will 

require a minimum of 100 eggs.24 The reported first cloning of a human embryo in 

South Korea this year actually required 242 eggs to obtain just one ES cell line.25

There are in truth few actual positive published scientific reports regarding the 

claims put forth for embryonic stem cells, and a significant number of negative characteristics. At present embryonic stem cells have shown modest success in repairing 

spinal cord damage 26 and Parkinson’s disease,27 though the latter experiments 

51 

transplantation in a Parkinson rat model,’’ Proc. Natl. Acad. Sci.USA 99, 2344–2349; 19 Feb 

2002. 28Krause DS et al.; ‘‘Multi-Organ, Multi-Lineage Engraftment by a Single Bone Marrow-Derived Stem Cell’’; Cell 105, 369–377; 4 May 2001. 29 Jiang Y et al.; ‘‘Pluripotency of mesenchymal stem cells derived from adult marrow’’; Nature 

418, 41–49; 4 July 2002. 30D’Ippolito G et al., ‘‘Marrow-isolated adult multilineage inducible (MIAMI) cells, a unique 

population of postnatal young and old human cells with extensive expansion and differentiation 

potential’’, J. Cell Science 117, 2971–2981, 15 July 2004 (published online 1 June 2004). 31Zhao Y et al.; ‘‘A human peripheral blood monocyte-derived subset acts as pluripotent stem 

cells’’; Proceedings of the National Academy of Sciences USA 100, 2426–2431; 4 March 2003. 32Li H et al., ‘‘Pluripotent stem cells from the adult mouse inner ear’’, Nature Medicine 9, 

1293–1299, October 2003. 33Ko ̈gler G et al., ‘‘A new human somatic stem cell from placental cord blood with intrinsic 

pluripotent differentiation potential’’, J. Experimental Medicine 200, 123–135, 19 July 2004. 34Oh S-H et al., ‘‘Adult bone marrow-derived cells transdifferentiating into insulin-producing 

cells for the treatment of type I diabetes,’’ Laboratory Investigation published online 22 March 

2004; Kodama S et al., ‘‘Islet regeneration during the reversal of autoimmune diabetes in NOD 

mice’’, Science 302, 1223–1227; 14 Nov 2003; Hess D et al., ‘‘Bone marrow-derived stem cells 

initiate pancreatic regeneration’’, Nature Biotechnology 21, 763–770; July 2003. 35Willing AE et al., ‘‘Mobilized peripheral blood stem cells administered intravenously produce 

functional recovery in stroke’’, Cell Transplantation 12, 449–454; 2003; Arvidsson A et al.; 

‘‘Neuronal replacement from endogenous precursors in the adult brain after stroke’’; Nature 

Medicine 8, 963–970; Sept 2002; Riess P et al.; ‘‘Transplanted neural stem cells survive, differentiate, and improve neurological motor function after experimental traumatic brain injury’’; Neurosurgery 51, 1043–1052; Oct 2002. 36 Hofstetter CP et al., ‘‘Marrow stromal cells form guiding strands in the injured spinal cord 

and promote recovery’’, Proc Natl Acad Sci USA 99, 2199–2204; 19 February 2002; Sasaki M 

et al., ‘‘Transplantation of an acutely isolated bone marrow fraction repairs demyelinated adult 

rat spinal cord axons,’’ Glia 35, 26–34; July 2001; Ramo ́n-Cueto A et al., ‘‘Functional recovery 

of paraplegic rats and motor axon regeneration in their spinal cords by olfactory ensheathing 

glia,’’ Neuron 25, 425–435; February 2000. 37Liker MA et al.; ‘‘Human neural stem cell transplantation in the MPTP-lesioned mouse’’; 

Brain Research 971, 168–177; May 2003; A ̊ kerud P et al.; ‘‘Persephin-overexpressing neural stem 

cells regulate the function of nigral dopaminergic neurons and prevent their degeneration in a 

model of Parkinson’s disease’’; Molecular and Cellular Neuroscience 21, 205–222; Nov. 2002; 

Ourednik J et al.; ‘‘Neural stem cells display an inherent mechanism for rescuing dysfunctional 

neurons’’; Nature Biotechnology 20, 1103–1110; Nov. 2002. 38Otani A et al., ‘‘Rescue of retinal degeneration by intravitreally injected adult bone marrowderived lineage-negative hematopoietic stem cells’’, J. Clinical Investigation 114, 765–774, September 2004; Otani A et al., ‘‘Bone marrow derived stem cells target retinal astrocytes and can 

promotes or inhibit retinal angiogenesis’’; Nature Medicine 8, 1004–1010; Sept. 2002; Tomita M 

et al., ‘‘Bone marrow derived stem cells can differentiate into retinal cells in injured rat retina’’; 

Stem Cells 20, 279–283; 2002. 

showed significant tumor formation in the animals. The theoretical potential of embryonic stem cells to treat diseases, and the theoretical ability to control their differentiation without tumor formation, is wishful thinking. 

The relative lack of success of embryonic stem cells should be compared with the 

real success of adult stem cells. A wealth of scientific papers published over the last 

few years document that adult stem cells are a much more promising source of stem 

cells for regenerative medicine. Adult stem cells actually do show pluripotent capacity in generation of tissues, meaning that they can generate most, if not all, tissues 

of the body. In a paper published in May 2001, the researchers found that one adult 

bone marrow stem cell could regenerate not only marrow and blood, but also form 

liver, lung, digestive tract, skin, heart, muscle.28 Other researchers have found 

pluripotent ability of adult stem cells various sources including from bone marrow,29

30 peripheral blood,31 inner ear,32 and umbilical cord blood.33

The chart attached as Appendix A shows examples (not all-inclusive) of tissues 

from which adult stem cells have been isolated, as well as some of the derivatives 

from those stem cells. Bone marrow stem cells seem particularly ‘‘plastic’’, potentially with the ability to form all adult tissues. Even liposuctioned fat has been 

found to contain stem cells which can be transformed into other tissues. In point 

of fact, any time someone has looked in a tissue for stem cells, they have found 

them. 

Many published references also show that adult stem cells can multiply in culture 

for extensive periods of time, retaining their ability to differentiate, and providing 

sufficient numbers of cells for clinical treatments. More importantly, adult stem 

cells have been shown to be effective in treating animal models of disease, including 

such diseases as diabetes,34 stroke,35 spinal cord injury,36 Parkinson’s disease,37 and 

retinal degeneration.38

Moreover, adult stem cells are already being used clinically for many diseases. 

These include as reparative treatments with various cancers, autoimmune diseases 

52 

39Steve Mitchell, ‘‘Study casts doubt on adult stem cells’’, UPI; 12 October 2003. 

such as multiple sclerosis, lupus, and arthritis, anemias including sickle cell anemia, and immunodeficiencies. Adult stem cells are also being used to treat patients 

by formation of cartilage, growing new corneas to restore sight to blind patients, 

treatments for stroke, and several groups are using adult stem cells with patients 

to repair damage after heart attacks. Early clinical trials have shown initial success 

in patient treatments for Parkinson’s disease and spinal cord injury. An advantage 

of using adult stem cells is that in most cases the patient’s own stem cells can be 

used for the treatment, circumventing the problems of immune rejection, and without tumor formation. 

The mechanism for these amazing regenerative treatments is still unclear. Adult 

stem cells in some cases appear capable of interconversion between different tissue 

types, known as transdifferentiation. In some tissues, adult stem cells appear to 

fuse with the host tissue and take on that tissue’s characteristics, facilitating regeneration. And in some studies, the adult stem cells do not directly contribute to the 

regenerating tissue, but instead appear to stimulate the endogenous cells of the tissue to begin repair. Whatever the mechanism, the adult cells are successful at regenerating damaged tissue. As Robert Lanza, a proponent of embryonic stem cells 

and cloning has noted, ‘‘there is ample scientific evidence that adult stem cells can 

be used to repair damaged heart or brain tissue . . . if it works, it works, regardless 

of the mechanism.’’ 39 The citations given above for adult stem cells are only a sampling, including some more recent references. A representative list of diseases currently in patient clinical trials with adult stem cells is given as Appendix B. A more 

complete review of the recent adult stem cell literature is appended at the end, as 

a paper prepared for the President’s Council on Bioethics in 2003 (see: http://bioethics.georgetown.edu/pcbe/reports/stemcell/appendixlk.html). 

In summary, adult stem cells have been shown by the published evidence to be 

a more promising alternative for patient treatments, with a vast biomedical potential. Adult stem cells have proven success in the laboratory dish, in animal models 

of disease, and in current clinical treatments. Adult stem cells also avoid problems 

with tumor formation, transplant rejection, and provide realistic excitement for patient treatments. 

Mr. Chairman, Distinguished Members, thank you once again for allowing me to 

present testimony on this issue. 

53 

APPENDIX A 

Post-Natal (non-embryonic) Stem Cells and their Known or Possible Derivatives 

(not an all-inclusive list) 

(From the peer-reviewed scientific literature; for placenta by company press releases) 


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54 

APPENDIX B 

CURRENT CLINICAL APPLICATIONS OF ADULT STEM CELLS 

(NOT A COMPLETE LISTING) 

ADULT STEM CELLS—HEMATOPOIETIC REPLACEMENT 

CANCERS 

BRAIN TUMORS—medulloblastoma and glioma 

Dunkel, IJ; ‘‘High-dose chemotherapy with autologous stem cell rescue for malignant 

brain tumors’’; Cancer Invest. 18, 492–493; 2000. 

Abrey, LE et al.; ‘‘High dose chemotherapy with autologous stem cell rescue in 

adults with malignant primary brain tumors’’; J. Neurooncol. 44, 147–153; 

Sept., 1999 

Finlay, JL; ‘‘The role of high-dose chemotherapy and stem cell rescue in the treatment of malignant brain tumors: a reappraisal’’; Pediatr. Transplant 3 Suppl. 

1, 87–95; 1999 

RETINOBLASTOMA 

Hertzberg H et al.; ‘‘Recurrent disseminated retinoblastoma in a 7-year-old girl 

treated successfully by high-dose chemotherapy and CD34-selected autologous 

peripheral blood stem cell transplantation’’; Bone Marrow Transplant 27(6), 

653–655; March 2001 

Dunkel IJ et al.; ‘‘Successful treatment of metastatic retinoblastoma’’; Cancer 89, 

2117–2121; Nov 15 2000 

OVARIAN CANCER 

Stiff PJ et al.; ‘‘High-dose chemotherapy and autologous stem cell transplantation 

for ovarian cancer: An autologous blood and marrow transplant registry report’’; Ann. Intern. Med. 133, 504–515; Oct. 3, 2000 

Schilder, RJ and Shea, TC; ‘‘Multiple cycles of high-dose chemotherapy for ovarian 

cancer’’; Semin. Oncol. 25, 349–355; June 1998 

MERKEL CELL CARCINOMA 

Waldmann V et al.; ‘‘Transient complete remission of metastasized merkel cell carcinoma by high-dose polychemotherapy and autologous peripheral blood stem 

cell transplantation’’; Br. J. Dermatol. 143, 837–839; Oct 2000 

TESTICULAR CANCER 

Bhatia S et al.; ‘‘High-dose chemotherapy as initial salvage chemotherapy in patients with relapsed testicular cancer’’; J. Clin. Oncol. 18, 3346–3351; Oct. 19, 

2000 

Hanazawa, K et al.; ‘‘Collection of peripheral blood stem cells with granulocyte-colony-stimulating factor alone in testicular cancer patients’’; Int. J. Urol. 7, 77– 

82; March 2000. 

LYMPHOMA 

Tabata M et al.; ‘‘Peripheral blood stem cell transplantation in patients over 65 

years old with malignant lymphoma—possibility of early completion of chemotherapy and improvement of performance status’’; Intern Med 40, 471–474; 

June 2001 

Josting, A; ‘‘Treatment of Primary Progressive Hodgkin’s and Aggressive Non-Hodgkin’s Lymphoma: Is There a Chance for Cure?’’; J Clin Oncol 18, 332–339; 

2000 

Koizumi M et al.; ‘‘Successful treatment of intravascular malignant lymphomatosis 

with high-dose chemotherapy and autologous peripheral blood stem cell transplantation’’; Bone Marrow Transplant 27, 1101–1103; May 2001 

ACUTE LYMPHOBLASTIC LEUKEMIA 

Ohnuma K et al.; ‘‘Cord blood transplantation from HLA-mismatched unrelated donors as a treatment for children with haematological malignancies’’; Br J 

Haematol 112(4), 981–987; March 2001 

Marco F et al.; ‘‘High Survival Rate in Infant Acute Leukemia Treated With Early 

High-Dose Chemotherapy and Stem Cell Support’’; J Clin Oncol 18, 3256– 

3261; Sept. 15 2000 

ACUTE MYELOGENOUS LEUKEMIA 

Ohnuma K et al.; ‘‘Cord blood transplantation from HLA-mismatched unrelated donors as a treatment for children with haematological malignancies’’; Br J 

Haematol 112(4), 981–987; March 2001 

55 

Gorin NC et al.; ‘‘Feasibility and recent improvement of autologous stem cell transplantation for acute myelocytic leukaemia in patients over 60 years of age: 

importance of the source of stem cells’’; Br. J. Haematol. 110, 887–893; Sept 

2000 

Bruserud O et al.; ‘‘New strategies in the treatment of acute myelogenous leukemia: 

mobilization and transplantation of autologous peripheral blood stem cells in 

adult patients’’; Stem Cells 18, 343–351; 2000 

CHRONIC MYELOGENOUS LEUKEMIA 

Ohnuma K et al.; ‘‘Cord blood transplantation from HLA-mismatched unrelated donors as a treatment for children with haematological malignancies’’; Br J 

Haematol 112(4), 981–987; March 2001 

JUVENILE MYELOMONOCYTIC LEUKEMIA 

Ohnuma K et al.; ‘‘Cord blood transplantation from HLA-mismatched unrelated donors as a treatment for children with haematological malignancies’’; Br J 

Haematol 112(4), 981–987; March 2001 

ANGIOIMMUNOBLASTIC LYMPHADENOPATHY with DYSPROTEINEMIA 

Lindahl J et al.; ‘‘High-dose chemotherapy and APSCT as a potential cure for relapsing hemolysing AILD’’; Leuk Res 25(3), 267–270; March 2001 

MULTIPLE MYELOMA 

Laughlin MJ et al.; ‘‘Hematopoietic engraftment and survival in adult recipients of 

umbilical-cord blood from unrelated donors’’, New England Journal of Medicine 344, 1815–1822; June 14, 2001 

Vesole, DH et al.; ‘‘High-Dose Melphalan With Autotransplantation for Refractory 

Multiple Myeloma: Results of a Southwest Oncology Group Phase II Trial’’; 

J Clin Oncol 17, 2173–2179; July 1999. 

MYELODYSPLASIA 

Ohnuma K et al.; ‘‘Cord blood transplantation from HLA-mismatched unrelated donors as a treatment for children with haematological malignancies’’; Br J 

Haematol 112(4), 981–987; March 2001 

Bensinger WI et al.; ‘‘Transplantation of bone marrow as compared with peripheralblood cells from HLA-identical relatives in patients with hematologic cancers’’; 

New England Journal of Medicine 344, 175–181; Jan 18 2001 

BREAST CANCER 

Damon LE et al.; ‘‘High-dose chemotherapy and hematopoietic stem cell rescue for 

breast cancer: experience in California’’; Biol. Blood Marrow Transplant 6, 

496–505; 2000 

Paquette, RL et al., ‘‘Ex vivo expanded unselected peripheral blood: progenitor cells 

reduce posttransplantation neutropenia, thrombocytopenia, and anemia in patients with breast cancer’’, Blood 96, 2385–2390; October, 2000. 

Stiff P et al.; ‘‘Autologous transplantation of ex vivo expanded bone marrow cells 

grown from small aliquots after high-dose chemotherapy for breast cancer’’; 

Blood 95, 2169–2174; March 15, 2000 

Koc, ON et al.; ‘‘Rapid Hematopoietic Recovery After Coinfusion of Autologous-Blood 

Stem Cells and Culture-Expanded Marrow Mesenchymal Stem Cells in Advanced Breast Cancer Patients Receiving High-Dose Chemotherapy’’; J Clin 

Oncol 18, 307–316; January 2000 

NEUROBLASTOMA 

Kawa, K et al.; ‘‘Long-Term Survivors of Advanced Neuroblastoma With MYCN Amplification: A Report of 19 Patients Surviving Disease-Free for More Than 66 

Months’’; J Clin Oncol 17:3216–3220; October 1999 

NON–HODGKIN’S LYMPHOMA 

Tabata M et al.; ‘‘Peripheral blood stem cell transplantation in patients over 65 

years old with malignant lymphoma—possibility of early completion of chemotherapy and improvement of performance status’’; Intern Med 40, 471–474; 

June 2001 

Josting, A; ‘‘Treatment of Primary Progressive Hodgkin’s and Aggressive Non-Hodgkin’s Lymphoma: Is There a Chance for Cure?’’; J Clin Oncol 18, 332–339; 

2000 

Kirita T et al.; ‘‘Primary non-Hodgkin’s lymphoma of the mandible treated with radiotherapy, chemotherapy, and autologous peripheral blood stem cell transplantation’’; Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 90, 450–455; 

Oct. 2000 

Yao M et al.; ‘‘Ex vivo expansion of CD34-positive peripheral blood progenitor cells 

from patients with non-Hodgkin’s lymphoma: no evidence of concomitant exVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00059 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\81636.TXT JACKIE
56 

pansion of contaminating bcl2/JH-positive lymphoma cells’’; Bone Marrow 

Transplant 26, 497–503; Sept. 2000 

HODGKIN’S LYMPHOMA 

Josting, A; ‘‘Treatment of Primary Progressive Hodgkin’s and Aggressive Non-Hodgkin’s Lymphoma: Is There a Chance for Cure?’’; J Clin Oncol 18, 332–339; 

2000 

RENAL CELL CARCINOMA 

Childs R et al., ‘‘Regression of Metastatic Renal-Cell Carcinoma after 

Nonmyeloablative Allogeneic Peripheral-Blood Stem Cell Transplantation’’, 

New England Journal of Medicine 343, 750–758; Sept. 14, 2000 

Childs, RW; ‘‘Successful Treatment of Metastatic Renal Cell Carcinoma With a 

Nonmyeloablative Allogeneic Peripheral-Blood Progenitor-Cell Transplant: 

Evidence for a Graft-Versus-Tumor Effect:; J Clin Oncol 17, 2044–2049; July 

1999 

VARIOUS SOLID TUMORS 

Nieboer P et al.; ‘‘Long-term haematological recovery following high-dose chemotherapy with autologous bone marrow transplantation or peripheral stem cell 

transplantation in patients with solid tumours’’; Bone Marrow Transplant 27, 

959–966; May 2001 

Lafay-Cousin L et al.; ‘‘High-dose thiotepa and hematopoietic stem cell transplantation in pediatric malignant mesenchymal tumors: a phase II study’’; Bone 

Marrow Transplant 26, 627–632; Sept. 2000 

Michon, J and Schleiermacher, G. ‘‘Autologous haematopoietic stem cell transplantation for paediatric solid tumors’’, Baillieres Best Practice Research in Clinical Haematology 12, 247–259, March-June, 1999. 

Schilder, RJ et al.; ‘‘Phase I trial of multiple cycles of high-dose chemotherapy supported by autologous peripheral-blood stem cells’’; J. Clin. Oncol. 17, 2198– 

2207; July 1999 

SOFT TISSUE SARCOMA 

Blay JY et al.; ‘‘High-dose chemotherapy with autologous hematopoietic stem cell 

transplantation for advanced soft tissue sarcoma in adults’’; J. Clin. Oncol. 18, 

3643–3650; Nov 1 2000 

ADULT STEM CELLS—IMMUNE SYSTEM REPLACEMENT 

AUTOIMMUNE DISEASES 

SCLEROMYXEDEMA 

Feasel et al., ‘‘Complete remission of scleromyxedema following autologous stem cell 

transplantation,’’ Archives of Dermatology 137, 1071–1072; Aug. 2001. 

MULTIPLE SCLEROSIS 

Mancardi GL et al.; ‘‘Autologous hematopoietic stem cell transplantation suppresses 

Gd-enhanced MRI activity in MS’’; Neurology 57, 62–68; July 10, 2001 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

Burt, RK and Traynor, AE; ‘‘Hematopoietic Stem Cell Transplantation: A New Therapy for Autoimmune Disease’’; Stem Cells17, 366–372; 1999 

Burt RK et al.; ‘‘Hematopoietic stem cell transplantation of multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus’’; Cancer Treat. Res. 101, 

157–184; 1999 

CROHN’S DISEASE 

Burt RK et al., ‘‘High-dose immune suppression and autologous hematopoietic stem 

cell transplantation in refractory Crohn disease’’, Blood 101, 2064–2066, 

March 2003 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

Hawkey CJ et al.; ‘‘Stem cell transplantation for inflammatory bowel disease: practical and ethical issues’’; Gut 46, 869–872; June 2000 

RHEUMATOID ARTHRITIS 

Burt RK et al., ‘‘Induction of remission of severe and refractory rheumatoid arthritis 

by allogeneic mixed chimerism’’, Arthritis & Rheumatism 50, 2466–2470, August 2004 

57 

Verburg RJ et al.; ‘‘High-dose chemotherapy and autologous hematopoietic stem cell 

transplantation in patients with rheumatoid arthritis: results of an open 

study to assess feasibility, safety, and efficacy’’; Arthritis Rheum 44(4), 754– 

760; April 2001 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

Burt, RK and Traynor, AE; ‘‘Hematopoietic Stem Cell Transplantation: A New Therapy for Autoimmune Disease’’; Stem Cells17, 366–372; 1999 

Burt RK et al.; ‘‘Hematopoietic stem cell transplantation of multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus’’; Cancer Treat. Res. 101, 

157–184; 1999 

Burt, RK et al., ‘‘Autologous hematopoietic stem cell transplantation in refractory 

rheumatoid arthritis: sustained response in two of four patients’’, Arthritis & 

Rheumatology 42, 2281–2285, November, 1999. 

JUVENILE ARTHRITIS 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

Burt, RK and Traynor, AE; ‘‘Hematopoietic Stem Cell Transplantation: A New Therapy for Autoimmune Disease’’; Stem Cells17, 366–372; 1999 

SYSTEMIC LUPUS 

Wulffraat NM et al.; ‘‘Prolonged remission without treatment after autologous stem 

cell transplantation for refractory childhood systemic lupus erythematosus’’; 

Arthritis Rheum 44(3), 728–731; March 2001 

Rosen O et al.; ‘‘Autologous stem cell transplantation in refractory autoimmune diseases after in vivo immunoablation and ex vivo depletion of mononuclear 

cells’’; Arthritis res. 2, 327–336; 2000 

Traynor AE et al.; ‘‘Treatment of severe systemic lupus erythematosus with highdose chemotherapy and haemopoietic stem cell transplantation: a phase I 

study’’; Lancet 356, 701–707; August 26, 2000 

Burt, RK and Traynor, AE; ‘‘Hematopoietic Stem Cell Transplantation: A New Therapy for Autoimmune Disease’’; Stem Cells17, 366–372; 1999 

Burt RK et al.; ‘‘Hematopoietic stem cell transplantation of multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus’’; Cancer Treat. Res. 101, 

157–184; 1999 

Traynor A and Burt RK; ‘‘Haematopoietic stem cell transplantation for active systemic lupus erythematosus’’; Rheumatology 38, 767–772; August 1999 

Martini A et al.; ‘‘Marked and sustained improvement 2 years after autologous stem 

cell transplant in a girl with system sclerosis’’; Rheumatology 38, 773; August 

1999 

POLYCHONDRITIS 

Rosen O et al.; ‘‘Autologous stem cell transplantation in refractory autoimmune diseases after in vivo immunoablation and ex vivo depletion of mononuclear 

cells’’; Arthritis res. 2, 327–336; 2000 

SYSTEMIC VASCULITIS 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

SJOGREN’S SYNDROME 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

BEHCET’S DISEASE 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

MYASTHENIA 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

RED CELL APLASIA 

58 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

AUTOIMMUNE CYTOPENIA 

Rabusin M et al.; ‘‘Immunoablation followed by autologous hematopoietic stem cell 

infusion for the treatment of severe autoimmune disease’’; Haematologica 

85(11 Suppl), 81–85; Nov. 2000 

Papadaki HA et al.; ‘‘Assessment of bone marrow stem cell reserve and function and 

stromal cell function in patients with autoimmune cytopenias’’; Blood 96, 

3272–3275; Nov 1 2000 

IMMUNODEFICIENCIES 

Banked unrelated umbilical cord blood was used to reconstitute the immune system 

in 2 brothers with X-linked lymphoproliferative syndrome and 1 boy with Xlinked hyperimmunoglobulin-M syndrome. Two years after transplantation, 

all 3 patients have normal immune systems. These reports support the wider 

use of banked partially matched cord blood for transplantation in primary 

immunodeficiencies. 

Reference: 

Ziegner UH et al.; ‘‘Unrelated umbilical cord stem cell transplantation for X-linked 

immunodeficiencies’’; J Pediatr 138(4), 570–573; April 2001 

Eight children with severe immunodeficiencies treated by adult bone marrow stem 

cell transplants. Six of 8 showed relatively normal immune systems after 1 

year. 

Reference 

Amrolia, P. et al., ‘‘Nonmyeloablative stem cell transplantation for congenital 

immunodeficiencies’’, Blood 96, 1239–1246, Aug. 15, 2000. 

SEVERE COMBINED IMMUNODEFICIENCY SYNDROME–X1 (ASC gene therapy) 

Cavazzana-Calvo M et al.; ‘‘Gene therapy of human severe combined immunodeficiency (SCID)-X1 disease’’; Science 288, 669–672; April 28, 2000 

ANEMIAS 

SICKLE CELL ANEMIA 

Gore L. et al.; ‘‘Successful cord blood transplantation for sickle cell anemia from a 

sibling who is human leukocyte antigen-identical: implications for comprehensive care’’, J Pediatr Hematol Oncol 22(5):437–440; Sep-Oct 2000 

Steen RG et al.; ‘‘Improved cerebrovascular patency following therapy in patients 

with sickle cell disease: initial results in 4 patients who received HLA-identical hematopoietic stem cell allografts’’; Ann Neurol 49(2), 222–229; Feb. 

2001 

Wethers DL; ‘‘Sickle cell disease in childhood: Part II. Diagnosis and treatment of 

major complications and recent advances in treatment’’; Am. Fam. Physician 

62, 1309–1314; Sept. 15, 2000 

SIDEROBLASTIC ANEMIA 

Ayas M et al.; ‘‘Congenital sideroblastic anaemia successfully treated using 

allogeneic stem cell transplantation’’; Br J Haematol 113, 938–939; June 2001 

Gonzalez MI et al.; ‘‘Allogeneic peripheral stem cell transplantation in a case of hereditary sideroblastic anaemia’’; British Journal of Haematology 109, 658– 

660; 2000 

WALDENSTROM’S MACROGLOBULINEMIA 

Anagnostopoulos A et al.; ‘‘High-dose chemotherapy followed by stem cell transplantation in patients with resistant Waldenstrom’s macroglobulinemia’’; Bone 

Marrow Transplant 27, 1027–1029; May 2001 

APLASTIC ANEMIA 

Gurman G et al.; ‘‘Allogeneic peripheral blood stem cell transplantation for severe 

aplastic anemia’’; Ther Apher 5(1), 54–57; Feb. 2001 

Kook H et al.; ‘‘Rubella-associated aplastic anemia treated by syngeneic stem cell 

transplantations’’; Am. J. Hematol. 64, 303–305; August 2000 

AMEGAKARYOCYTIC THROMBOCYTOPENIA 

Yesilipek et al.; ‘‘Peripheral stem cell transplantation in a child with 

amegakaryocytic thrombocytopenia’’; Bone Marrow Transplant 26, 571–572; 

Sept. 2000 

59 

CHRONIC EPSTEIN–BARR INFECTION 

Fujii N et al.; ‘‘Allogeneic peripheral blood stem cell transplantation for the treatment of chronic active epstein-barr virus infection’’; Bone Marrow Transplant 

26, 805–808; Oct. 2000 

Okamura T et al.; ‘‘Blood stem cell transplantation for chronic active Epstein-Barr 

virus with lymphoproliferation’’; Lancet 356, 223–224; July 2000 

FANCONI’S ANEMIA 

Kohli-Kumar M et al., ‘‘Haemopoietic stem/progenitor cell transplant in Fanconi 

anaemia using HLA-matched sibling umbilical cord blood cells’’, British Journal of Haematology 85, 419–422, October 1993 

DIAMOND BLACKFAN ANEMIA 

Ostronoff M et al., ‘‘Successful nonmyeloablative bone marrow transplantation in a 

corticosteroid-resistant infant with Diamond-Blackfan anemia’’, Bone Marrow 

Transplant. 34, 371–372, August 2004 

THALASSEMIA 

Tan PH et al., ‘‘Unrelated peripheral blood and cord blood hematopoietic stem cell 

transplants for thalassemia major’’, Am J Hematol 75, 209–212, April 2004 

STROKE 

Meltzer CC et al.; ‘‘Serial [18F]Fluorodeoxyglucose Positron Emission Tomography 

after Human Neuronal Implantation for Stroke’’; Neurosurgery 49, 586–592; 

2001. 

Kondziolka D et al.; ‘‘Transplantation of cultured human neuronal cells for patients 

with stroke’’; Neurology 55, 565–569; August 2000 

Cartilage and Bone Diseases 

OSTEOGENESIS IMPERFECTA 

Horwitz EM et al., ‘‘Isolated allogeneic bone marrow-derived mesenchymal cells 

engraft and stimulate growth in children with osteogenesis imperfecta: Implications for cell therapy of bone’’, Proceedings of the National Academy of 

Sciences USA 99, 8932–8937; 25 June 2002. 

Horwitz EM et al., ‘‘Clinical responses to bone marrow transplantation in children 

with severe osteogenesis imperfecta’’, Blood 97, 1227–1231; 1 March 2001. 

Horwitz, EM et al.; ‘‘Transplantability and therapeutic effects of bone marrow-derived mesenchymal cells in children with osteogenesis imperfecta’’; Nat. Med. 

5, 309–313; March 1999. 

SANDHOFF DISEASE 

CORNEAL REGENERATION 

Anderson DF et al.; ‘‘Amniotic Membrane Transplantation After the Primary Surgical Management of Band Keratopathy’’; Cornea 20(4), 354–361; May 2001 

Anderson DF et al.; ‘‘Amniotic membrane transplantation for partial limbal stem 

cell deficiency’’; Br J Ophthalmol 85(5), 567–575; May 2001 

Henderson TR et al.; ‘‘The long term outcome of limbal allografts: the search for surviving cells’’; Br J Ophthalmol 85(5), 604–609; May 2001 

Daya SM, Ilari FA; ‘‘Living related conjuctival limbal allograft for the treatment of 

stem cell deficiency’’; Opthalmology 180, 126–133; January 2001 

Schwab IR et al.; ‘‘Successful transplantation of bioengineered tissue replacements 

in patients with ocular surface disease’’; Cornea 19, 421–426; July 2000. 

Tsai et al.; ‘‘Reconstruction of damaged corneas by transplantation of autologous 

limbal epithelial cells.’’; New England Journal of Medicine 343, 86–93, 2000. 

Tsubota K et al.; ‘‘Treatment of severe ocular-surface disorders with corneal 

epithelial stem cell transplantation’’; New England Journal of Medicine 340, 

1697–1703; June 3, 1999 

Ocular corneal regeneration 

HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS 

Matthes-Martin S et al.; ‘‘Successful stem cell transplantation following orthotopic 

liver transplantation from the same haploidentical family donor in a girl with 

hemophagocytic lymphohistiocytosis’’; Blood 96, 3997–3999; Dec 1, 2000 

PRIMARY AMYLOIDOSIS 

Sezer O et al.; ‘‘Novel approaches to the treatment of primary amyloidosis’’; Exper 

Opin. Investig. Drugs 9, 2343–2350; Oct 2000 

60 

LIMB GANGRENE 

Tateishi-Yuyama E et al.; ‘‘Therapeutic angiogenesis for patients with limb 

ischaemia by autologous transplantation of bone-marrow cells: a pilot study 

and a randomised controlled trial’’; Lancet 360, 427–435; 10 August 2002. 

SURFACE WOUND HEALING 

Badiavas EV, ‘‘Participation of Bone Marrow Derived Cells in Cutaneous Wound 

Healing’’, Journal Of Cellular Physiology 196, 245–250; 2003. 

HEART DAMAGE 

Wollert KC et al., ‘‘Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial’’, Lancet 364, 

141–148, 10 July 2004 

Britten MB et al., ‘‘Infarct remodeling after intracoronary progenitor cell treatment 

in patients with acute myocardial infarction’’; Circulation 108, 2212–2218; 

Nov 2003 

Perin EC et al.; ‘‘Transendocardial, autologous bone marrow cell transplantation for 

severe, chronic ischemic heart failure’’; Circulation 107, r75–r83; published 

online May 2003 

Stamm C et al.; ‘‘Autologous bone-marrow stem cell transplantation for myocardial 

regeneration’’; The Lancet 361, 45–46; 4 January 2003 

Tse H-F et al.; ‘‘Angiogenesis in ischaemic myocardium by intramyocardial 

autologous bone marrow mononuclear cell implantation’’; The Lancet 361, 47– 

49; 4 January 2003 

Strauer BE et al.; ‘‘Repair of infarcted myocardium by autologous intracoronary 

mononuclear bone marrow cell transplantation in humans’’; Circulation 106, 

1913–1918; 8 October 2002 

Strauer BE et al.; ‘‘Myocardial regeneration after intracoronary transplantation of 

human autologous stem cells following acute myocardial infarction’’; Dtsch 

Med Wochenschr 126, 932–938; Aug 24, 2001 

Menasche ́ P et al. ‘‘Myoblast transplantation for heart failure.’’ Lancet 357, 279–280; 

Jan 27, 2001 

Menasche ́ P et al. [‘‘Autologous skeletal myoblast transplantation for cardiac insufficiency. First clinical case.’’] [article in French] Arch Mal Coeur Vaiss 94(3), 

180–182; March 2001 

PARKINSON’S DISEASE 

Le ́vesque M and Neuman T, ‘‘Autologous transplantation of adult human neural 

stem cells and differentiated dopaminergic neurons for Parkinson disease: 1- 

year postoperative clinical and functional metabolic result’’, American Association of Neurological Surgeons annual meeting, Abstract #702; 8 April 2002 

Gill SS et al.; ‘‘Direct brain infusion of glial cell line-derived neurotrophic factor in 

Parkinson disease’’; Nature Medicine 9, 589–595; May 2003 (published online 

31 March 2003) 

See also July 14, 2004 Senate testimony by Dr. Michel Le ́vesque: 

http://commerce.senate.gov/hearings/testimony.cfm?id=1268&witlid=3670 

and Mr. Dennis Turner: 

http://commerce.senate.gov/hearings/testimony.cfm?id=1268&witlid=3676 

SPINAL CORD INJURY 

See July 14, 2004 Senate testimony by Dr. Jean Peduzzi-Nelson: 

http://commerce.senate.gov/hearings/testimony.cfm?id=1268&witlid=3671 

and a more extensive testimony at: 

http://www.stemcellresearch.org/testimony/peduzzi-nelson.htm 

and Ms. Laura Dominguez: 

http://commerce.senate.gov/hearings/testimony.cfm?id=1268&witlid=3673 

and Ms. Susan Fajt: 

http://commerce.senate.gov/hearings/testimony.cfm?id=1268&witlid=3674 

For appended review paper on adult stem cells, see 

http://bioethics.georgetown.edu/pcbe/reports/stemcell/appendixl.html 

Senator BROWNBACK. Thank you, Dr. Prentice. 

Dr. Hedrick, thank you for joining us today. 

61 

STATEMENT OF MARC HEDRICK, M.D., PRESIDENT, 

MACROPORE

Dr. HEDRICK. Mr. Chairman, Mr. Wyden, thank you for allowing 

me to be here today. 

I’ve been fortunate to be have been involved on the front lines 

of the stem cell debate for some time. As a surgeon at UCLA, I 

saw, firsthand, the need for stem cell treatments in my patients. 

As a researcher, I received NIH funding while doing stem cell research at UCLA in our laboratory. And now I serve as President 

of MacroPore Biosurgery, a San Diego-based biotechnology company that’s dedicated to developing adult stem cell therapies to 

help as many patients as we can. 

Based on this experience, I feel like I can say to you, in the 

strongest possible terms, we truly are on the edge of a new frontier 

in medicine. Over the past 2 years, our company has made a strategic decision to try to take a leadership role in developing adult 

stem cell therapies. This decision was based both on our excitement 

for the technology, but also our vision for what we think it can do 

for patients. 

If I may, permit me to quote from the NIH, ‘‘Given the enormous 

promise of stem cells to develop new therapies for the most devastating diseases when a readily available source of stem cells is 

identified, it is not too unrealistic to say that this research will revolutionize the practice of medicine and improve the quality and the 

length of life.’’ And that’s absolutely our goal. We agree with the 

NIH that cell availability has been a significant challenge, not only 

for the clinical, but for the commercial application of stem cells. 

Stem cells have been thought to be rare, difficult to obtain, and 

requiring long periods of cell culture or multiplication. But today 

we have found a potential solution to some of the significant challenges particularly related to cell availability. We believe the solution is the use of fat or adipose tissue as the source of stem cells. 

It’s a low-cost, high volume alternative to other stem cell sources. 

This technology enables us to rethink how patients might be treated using their own stem cells. It’s an important breakthrough in 

stem cell technology. 

From adipose, we can obtain at least two of the key types of 

adult stem cells that could potentially treat many diseases. Heart 

disease, stroke, injured bones and joints, vascular disease, degenerative spinal disease are all diseases that are in our target area. 

The first adult stem cells, though, were identified 40 years ago. 

Since then, bone-marrow transplants have been very common for 

treating things like blood diseases and for cancers. 

And only until recently, bone marrow was thought to be the only 

significant clinical reservoir of stem cells in the adult. But even 

this source yields a relatively few number of stem cells. 

So how does adipose or fat tissue measure up as a stem cell 

source? Well, about a cup of adipose tissue translates into about a 

million stem cells. That’s about a hundred times more stem cells 

found in the same amount of bone marrow. 

And let me use myself as an example to, sort of, illustrate this. 

Senator BROWNBACK. A cup has a hundred million—did you say 

a hundred million stem cells, a cup of fat? 

Dr. HEDRICK. About a million stem cells. 

62 

Senator BROWNBACK. A million. Wow. No wonder it grows so 

easy. I’m sorry, go ahead. 

[Laughter.] 

Dr. HEDRICK. We haven’t solved that problem yet. 

Senator BROWNBACK. Yes. 

[Laughter.] 

Dr. HEDRICK. But I’m six feet one inch tall, weigh about 180 

pounds, and about 15 percent of my body weight is fat tissue. That 

translates to about 27 pounds of fat, which equals about six billion 

stem cells. 

What does this mean? I think it means opportunities, many opportunities, potentially, to use your own body to heal different 

problems and diseases that you have, but not stem cells have been 

obtained in weeks or months, but stem cells that can be obtained 

in about an hour. 

And so what we’re talking about with adipose-derived stem cells 

is using stem cells in real time without cell culture. This realtime 

approach is not just conceptual. At this meeting—this week at a 

cardiology meeting in Washington, D.C., our company, along with 

our collaborators at UCLA and Cedar Sinai, reported the use of 

adipose-derived stem cells, and noted that they are safe and improved heart function after heart attacks. We used pigs in this 

study, because they’re predictive of future success in the treatment 

of heart attacks. 

Heart disease is fast becoming the most promising area for the 

use of stem cell therapy. In 15 years, cardiovascular disease is 

going to be the principal cause of death worldwide, not just in the 

U.S. Over a million Americans each year have a heart attack, and 

another six million Americans right now have heart failure. Sadly, 

this means that one out of three people in this room are going to 

die from heart disease. It’s a staggering thought. 

And MacroPore is addressing this clinical need by developing a 

unique system that enables doctors to take the patient’s stem cells 

and then treat them in real time. If successful, the system will fundamentally be state-of-the-art for heart attack treatment. It will 

enable us to move from supportive care, which is really all we have 

to offer patients now, to regenerative therapy. 

Both our research and the research of our collaborators and others have found out that adult stem cells can do three important 

things for the failing heart. It can make new heart cells, it can 

make new blood vessels, and it can rescue dying heart muscle. 

While the science is obviously complex and there’s still a lot to 

learn, for the doctor and the patient the procedure represents a relatively simple way to help heal the heart. 

Seven clinical studies, most of them clinician-initiated studies, 

are now in progress around the world to study adult stem cells for 

cardiovascular disease, and the early results are promising. For example, follow up data just presented from the Joint Texas Heart 

Institute and Brazilian Heart Failure Stem Cell Human Trial 

noted that four out of five patients being studied were no longer 

in need of a heart transplant. Those patients were treated with 

adult bone-marrow stem cells. 

But despite all the clinical successes of adult stem cells, misconceptions are still commonplace. For example, in a recent study 

63 

of Americans who claim to be knowledgeable about adult stem 

cells, 68 percent thought that adult stem cells come from embryos. 

But there are other misconceptions that perhaps are more subtle. 

Some think that adult stem cells are too rare, don’t multiply well 

enough, or are too limited in their potency to ever be useful. 

But all of these misconceptions are just that, they’re misconceptions. The truth is that bone-marrow and adipose tissue are clinically promising sources of adult stem cells, they grow well in the 

petri dish, and they have the ability to make and repair many 

types of tissues throughout the body. 

So I think we often make the mistake of referring to ‘‘the promise of stem cells,’’ like it’s some future event. And, in fact, this 

promise has already become a reality. The list of successful therapies that are being treated with adult stem cells grows every year, 

as does the list of patients’ health. 

While there’s still a tremendous amount of work to be done—and 

I don’t want to belittle this—I would humbly remind you that, in 

many cases, the promise of adult stem cells is already being realized. 

Thank you. 

[The prepared statement of Dr. Hedrick follows:] 

PREPARED STATEMENT OF MARC HEDRICK, M.D., PRESIDENT, MACROPORE

Mr. Chairman, Distinguished Members of Committee, I would like to thank you 

for the opportunity to be here today. 

I have been fortunate to have been on the front lines of the stem cell issue. As 

a surgeon at UCLA, it was easy to recognize the need for stem cell treatments in 

my patients, as a researcher, I received NIH funding to study adult stem cells 

through our program at UCLA and now as President of MacroPore, a public company located in San Diego, California our group is focused on developing adult stem 

cell therapies for as many people as possible. Based on this diverse experience, I 

feel I can say to you in the strongest possible terms, we truly are on the edge of 

a new frontier in medicine. 

Over the past 2 years, our company, has made a strategic decision to take a leadership role in developing adult stem cell therapies. In large part this decision is 

based our excitement and vision for what our technology will be able to do for patients whom may benefit from stem cell therapies. 

According to an official statement of the NIH in May 2000: 

‘‘. . . given the enormous promise of stem cells to the development of new 

therapies for the most devastating diseases, when a readily available source of 

stem cells is identified, it is not too unrealistic to say that this research will 

revolutionize the practice of medicine and improve the quality and length of 

life.’’ 

That certainly is our goal. 

We recognize that cell availability has been the most significant unsolved problem 

for the clinical application of stem cells. Stem cells have been thought to be rare, 

difficult to obtain, often requiring long periods of cell culture. 

Today, we have found a potential solution to the significant challenge of cell availability. The solution is the use of fat tissue as a source of stem cells. I know we 

are all familiar with having a little too much fat tissue. With this low cost, high 

volume alternative to other stem cell sources, we are able to rethink how patients 

can be treated using their own stem cells. We view this as an important new breakthrough in adult stem cell research. 

From this tissue source, we can obtain large numbers of at least 2 of the key varieties of adult stem cells: mesenchymal stem cells and endothelial progenitor cells. 

The resulting implication is that fat tissue is a plentiful source of stem cells that 

potentially can treat many diseases such as heart disease, stroke, injured bones and 

joints, degenerative spinal disease and vascular diseases, to name a few of the disorders researchers are currently studying. 

64 

As you know, stem cells are unique cells that have 2 well established properties: 

they have the ability to make more stem cells through cell multiplication, and they 

can mature into differentiated cells or tissues. The first adult stem cells were identified approximately 40 years ago and have been extensively studied and used to treat 

many diseases, particularly blood diseases or cancer, through bone marrow transplants. Later, in the 1990s, adult stem cells were then identified broadly in many 

organs and tissues, but in small numbers. They had to be multiplied in Petri dishes 

to collect large enough batches of cells to be useful, which could take many weeks. 

Until today, bone marrow was thought to be the only significant clinical reservoir 

of adult stem cells. But it too yields only a limited number of cells. 

Believe it or not, a few ounces of fat, or less than a cup, can yield approximately 

1 million stem cells. This is about 100x more stem cells found in the same amount 

of bone marrow. 

There is no shortage of fat either. According to scientific calculations, Americans 

carry 30 pounds of fat tissue around with them. Conceptually, it is important to understand that dosing stem cells for patients will be like giving aspirin to patients 

with headaches. 

If you do not give them aspirin, their headache will not get better. 

It is the same with stem cells, if they don’t get enough stem cells, they won’t get 

better. 

In fact, this week at a meeting of cardiologists here in Washington, our Company 

in conjunction with UCLA and Cedar& Sinai Medical Center reported that fat derived stem cells are safe and improve heart function after heart attacks in pigswhich is animal model that is most predictive of future success in the treatment of 

human heart attacks. 

And here’s what that really means for all of us. Heart attack patients can be 

treated with their own stem cells soon after they arrive in the emergency room. 

Time is critical in the treatment of heart attack. The longer the delay in treatment, 

the more complex and difficult the stem cell treatment becomes. 

However, with fat as a stem cell source, we can retrieve a therapeutic dose of 

cells, all in about an hour, not the weeks that cell culturing can take. We can treat 

patients in ‘‘real time’’. 

Heart disease is becoming the most promising emerging area for the use of stem 

cell therapy. The timing is fortunate, because in 15 years, cardiovascular disease 

will supplant infectious disease as the principle cause of death worldwide. Sadly, 

one in 3 of us in this room will die of cardiovascular disease. A rather staggering 

thought. Over 1 million Americans each year have a heart attack and another 6 million have significant heart failure. Compounding the need is the fact that the efficacy of heart failure drugs seems to be at a plateau. Despite the prevalence, only 

8 percent of drug discovery investment is going to cardiovascular disease. 

The stem cell system that MacroPore is developing for treating heart patients is 

unique in its ability to treat the patient with their own stem cells immediately without waiting for someone else’s cells to grow in a Petri dish. 

Here’s what it means in a real life situation. 

If someone was unfortunate enough to have a heart attack today, that person 

would develop severe pain below the breast bone and be brought immediately by 

ambulance to the hospital. If the examination and lab tests confirm the heart attack, the cardiologist will immediately move the patient into a cardiac catheterization suite, where through a small catheter, dye will be injected into the heart so 

areas of blood vessel blockage can be seen and treated with a balloon or stent. This 

is called the angiogram procedure. Except for the addition of some standard heart 

medications, this is essentially the state-of-the-art for heart attack treatment. 

However, with the availability stem cells derived from fat tissue, the cardiologist 

will soon be able to take the patient’s own stem cells and reinject them directly 

through the angiogram catheter into the heart in about an hour. While the science 

is complex, for the doctor and patient the procedure represents a truly simple way 

to help heal the heart. 

This ’global epidemic’ of cardiovascular disease corresponds to a significant opportunity for stem cell therapies. Many groups worldwide are leveraging the safety and 

efficacy profile of adult stem cells for this epidemic. 

Seven clinical studies, mostly clinician initiated, are now in progress globally to 

study adult stem cells in cardiovascular disease, and an estimated 150+ patients 

have been treated thus far. Phase II efficacy trials are underway and early results 

are promising. If the improvements in cardiac function now being seen hold true, 

previous data suggests this may result in lower hospital utilization rates, decreased 

hospital readmission rates and possibly removal of patients from the transplant list. 

Therefore, while most importantly having the potential to prolong life, adult stem 

cells may soon save some of the $18B spent each year on heart failure. 

65 

In fact, last week, in follow up data to the Texas Heart Institute/Pro-Cardiac Hospital stem cell trial, Dr. Hans Fernando Dohmann, coordinator of the research noted 

four out of five patients being studied no longer needed transplants after being 

treated with stem cells. He said, ‘‘It was the first time we saw that stem cells actually generate new arterioles’’ he went on to say that, ‘‘[stem cells] eliminated the 

need for transplants in four patients who had had indisputable transplant indications.’’ 

The success we are seeing in the treatment of cardiovascular disease should come 

as no surprise. Adult stem cells treatments have been commonplace in medicine for 

decades. Furthermore, it is the daily job of adult stem cells to sustain, renew, heal 

and in some circumstances regenerate human organs and tissues over one’s entire 

life. 

For decades, doctors have, sometimes intuitively, taken adult stem cells from one 

part of the body and transplanted them to another area to help patients. We have 

given these operations names like skin grafting, bone marrow transplantation, and 

bone grafting, but make no mistake-these operations achieve durable results in part 

by virtue of transplanting adult stem cell populations. 

But despite the daily clinical successes of adult stem cells, misconceptions are 

commonplace. For example, in a recent study of Americans who claim to be knowledgeable about stem cells, 68 percent claim adult stem cells are from embryos. More 

subtle misconceptions include the idea that stem cells are too rare, don’t multiply 

well or are too limited in their potency to be useful. All of these misconceptions are 

just that, they are not factually correct. The truth is that both bone marrow and 

fat tissue are plentiful and clinically promising sources of adult stem cells. They 

both multiply well, and increasingly more and more research shows that adult stem 

cells have the ability to make many cell and tissue types throughout the body. 

We often make the mistake of referring to the promise of stem cells as if it is 

a future event. In fact, this ’promise’ has become a reality. The list of successful 

therapies using adult stem cell grows yearly as does the list of patients cured. While 

there is still much work to be done, I would humbly remind you that in many cases 

the ’promise’ has already been realized. 

Senator BROWNBACK. Thank you. 

Let me—I want to probe in this some more. So you’re saying use 

the fat tissue stem cells in a broad array of places in the body. And 

I take it what you’re suggesting is that this is going to be the new 

source of bone marrow; I mean, that what we’ve been doing in bone 

marrow, you can do with fat tissue stem cells. Is that correct? Kind 

of in layman’s terms, is that—— 

Dr. HEDRICK. It is possible that, with further research, we could 

show that fat tissue is equal to bone marrow as a source of adult 

stem cells. But bone marrow’s been around for about 40 years, and 

there’s a lot of very good research for that. And we’ve only been 

around for about 5 years, and we’re, sort of, catching up. So I think 

the jury is still out on just how significant adipose is as a source 

of stem cells. 

Senator BROWNBACK. Now, the heart trials you were talking 

about, the seven or eight clinical trials going on around the world, 

where damaged heart tissue, dead heart tissue, is being regenerated with stem cells, that’s all being done through bone marrow 

stem cells. Is that correct? 

Dr. HEDRICK. Yes, sir. All that study’s being—all the studies are 

being done with either bone marrow stem cells or stem cells that 

have been tricked out of the bone marrow by giving the patient a 

drug and then removing the blood from the patient several days 

later. 

Senator BROWNBACK. But it’s showing great promise, great success, a number of these people are getting off the transplant lists, 

their heart is—what, the fracture rate? What do they call that, the 

pumping rate of the—— 

66 

Dr. HEDRICK. Ejection fraction. 

Senator BROWNBACK. I’m not a scientist, but I’ve listened to 

enough of this that I’m getting closer. That that’s really growing, 

doing well. 

You were saying that you have an animal trial, though, that 

shows that you can do this with fat stem cells. Is that correct? 

Dr. HEDRICK. Yes, sir. There actually have been one reported, 

and now our trial, that show that stem cells from adipose tissue 

make the heart function better. You talk about pumping ability; 

that’s called ejection fraction. And the early results—again, these 

are in pigs, not in humans, and we have to make sure they translate—that we’re seeing somewhere in the neighborhood of a 20 to 

30 percent improvement in the pumping ability of the heart. 

Senator BROWNBACK. What about the—one of the beefs on adult 

stem cells for some period of time has been the plasticity. And, Dr. 

Daley, you may want to jump on this. But it’s saying these just 

aren’t—— 

Dr. DALEY. Yes. 

Senator BROWNBACK.—we don’t think you can do this. But, Dr. 

Hedrick—let me get him first, and then I’ll bounce over to you, 

happily—you’re saying that with the fat tissue, you believe the 

plasticity is there for these to be able to treat a whole host of different types of needs within the body. 

Dr. HEDRICK. Well, I—— 

Senator BROWNBACK. What do you base that upon? 

Dr. HEDRICK. I can only speak to the science. And we, our group, 

and many others around the world have published the fact that 

there are nine or ten different kinds of cell types that can come 

from adipose tissue or fat tissue. 

Senator BROWNBACK. Nine of ten. 

Dr. HEDRICK. Nine or ten different types of cells. 

Senator BROWNBACK. OK. 

Dr. HEDRICK. Effectively everything we’ve looked for in a meaningful way, we’ve been able to show. 

The research in heart, though, is interesting. And this is really 

a new area, not only for us, but others. And we really haven’t 

shown that—in humans or in animals—that we can get heart differentiation, but we’ve shown it in the petri dish, and we’ve shown 

it in rodents, and other people have shown the same thing. 

Senator BROWNBACK. So that you believe that the plasticity is 

not an issue on this type of stem cell, the fat tissue stem cells. Is 

that correct? 

Dr. HEDRICK. Well, I believe that of the things that we’ve done 

so far, there’s a high likelihood that these cells could be clinically 

useful. But I can’t speak to the other 180 different tissue types, the 

cell types in the body. But what I’m saying is, these cells are on 

par, in terms of their plasticity, seemingly, with bone marrow. 

Senator BROWNBACK. Dr. Daley? 

Dr. DALEY. Yes, I—the science behind cardiovascular regeneration is a perfect case in point where the claims are getting way 

ahead of the actual scientific reality. It’s a very seductive possibility that bone-marrow cells or fat cells injected into the heart is 

going to regenerate the failing heart muscle. 

67 

In fact, where it has been looked at very carefully, no heart-muscle cells are actually regenerated at all. The data that suggests 

there’s an effect on the function of the heart is fairly reliable and 

reproducible in many centers around the world. But it’s becoming, 

I think, increasingly clear—and in data that was presented at this 

same that Dr. Hedrick referred to—it may not be the cells themselves, but rather factors that are liberated from the cells— 

cytoprotective or cytokine or growth factors—that actually save the 

dying heart muscle in the various animal models. Whether or not 

this will translate into effective human therapies, I think, is really 

still an open question. 

So it may be that the stem cells aren’t there as—for plasticity at 

all; but, rather, to produce these other proteins, and I—— 

Senator BROWNBACK. But, for whatever reason—— 

Dr. DALEY.—think that where we’re going to move is identifying 

those factors and to deliver them with other means not involving 

stem cells. 

Senator BROWNBACK. But, for whatever reason, it’s working. You 

believe, in these trials, it appears to be something that’s happening 

positive in the pump rates of these people is working. 

Dr. DALEY. Something is happening. But whether or not it’s a fat 

stem cell or a bone-marrow stem cell becoming a heart muscle, I 

think is highly unlikely. 

Senator BROWNBACK. But the heart is improving. They’re taking 

them off—— 

Dr. DALEY. That’s right. 

Senator BROWNBACK.—transplant—— 

Dr. DALEY. So the way the science should go is to be very careful 

about how you design the experiments, to determine whether it’s 

the cells or the things the cells are making which are actually having the beneficial effect on the heart. 

Senator BROWNBACK. I understand. I also understand, if I’m a 

heart patient, what I care about is that this is working. And I understand you, from the scientist—your point of view. 

The tumor issue, Dr. Daley, I want to address that, because that 

has come up previously in other work, other policy issues that have 

come up. In 1993—and you maybe familiar with this—we started 

down the road of funding fetal tissue use—aborted fetuses, use the 

fetal tissue. A lot of the claims being made then are being made 

now in embryonic stem cell. And I think that’s—so that’s always 

part of the cynicism and the debate. 

And I’ve got a series of quotes from people in 1993 that this is 

going to cure Parkinson’s and Alzheimer’s and all sorts of things 

with fetal tissue research—or fetal tissue transfer. And the issue 

then—and it seemed as if what happened at that point in time— 

they did a series of clinical trials, series of applications, and these 

were just not—they were not stable cells. I believe, in the New 

York Times, they had a series of articles on this, that once implanted in the brain, they were forming some—forming some brain 

tissue, but some were forming hair, some were forming—were developing fingernails, some were developing tumors. 

This—here’s a question that I’ve wrestled with, is, that’s a further-down-the-line development than what you’re working on right 

now. You’re at the embryonic—so you’re even earlier—you’re at an 

68 

earlier growth stage. You’re at a—it seems to me, as a layman, a 

less stable stage of this cell’s development. It’ll rapidly grow, but 

it’ll make everything, and that’s the real problem. It didn’t work 

there, and what makes you think it will not form tumors now, 

when you’ve backed up to even an earlier stage? 

Dr. DALEY. Well, we would all have to be very careful and look 

for that very risk. There’s no doubt that undifferentiated embryonic 

stem cells, when put into an animal, will form a form of benign encapsulated tumor, called the teratoma. And I think everybody who 

is involved in embryonic stem cell transplantation strategies is 

going to be prepared to look for that and hope it doesn’t happen. 

Now, the goal in ES research is to pre-differentiate the cells to 

a stage where they could be, then, characterized and isolated and 

purified free of these tumor-forming cells. 

I should point out that this issue of genomic and epigenetic instability that Dr. Prentice referred to, and that is often referred to in 

the ES cells, is a characteristic of all cells that are kept for long 

periods in culture. In fact, I think it’s rather remarkable that embryonic stem cells are as stable as they are in their immortal state, 

because, for most cells, getting things to grow in a petri dish actually involves significant chromosomal or genetic changes. 

So we’re all aware of this issue. We do not think it’s going to be 

a deal-breaker for bringing these types of cells into clinical therapies. 

Senator BROWNBACK. Senator Wyden? 

Senator WYDEN. Thank you, Mr. Chairman. 

Dr. Prentice, several hours ago, when we began, I noted that 

there was an important article in the Washington Post a couple of 

days ago—— 

Dr. PRENTICE. Yes, sir. 

Senator WYDEN.—outlining these new studies that show that 

human embryonic stem cells are showing great promise in some 

key areas, particularly vision. I want to be clear, are you saying 

that the published peer-reviewed results, like those that are cited 

in the article that I have mentioned with respect to embryonic stem 

cells, are you saying that these articles are off-base, that they’re invalid? 

Dr. PRENTICE. I’m not saying they’re off-base, Senator. What I’m 

saying is, if you look at the articles carefully, in terms of how much 

success have they achieved, especially if our goal is regenerating 

tissue for disease damage, if you read, for example, the article 

about the vision regeneration, what Dr. Lanza and his team at Advanced Cell Technology did was achieve—for the first time, I might 

note—differentiation of the specific cell type from human embryonic stem cells. He calls it an RPE, retinal pigmented epithelial 

cell. Now, this was all done in the dish. He actually got some of 

them to coalesce together. I think he notes, perhaps, in the article, 

they looked like little eyes coalescing together. Probably not. But 

it’s interesting that they showed that characteristic. He did not, at 

least in terms of the peer-reviewed report, test the ability of these 

cells to treat any kind of retinal degeneration. 

I’d note that Mr. Weiss failed to report, in the Post, a paper that 

came out just 2 weeks ago in which a group at UCLA School of 

Medicine reported that they had actually rescued or repaired retVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00072 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\81636.TXT JACKIE
69 

inal degeneration by injecting adult bone marrow stem cells into 

the eyes of mice suffering from a similar type of condition as Dr. 

Lanza has proposed to treat. There actually have been two other 

previous adult stem cell studies where they were doing the same 

thing for models of macular degeneration. As we age, our retinas 

tend to break down, retinitis pigmentosa, which is another similar 

condition. 

So what I’m saying, Senator, is—— 

Senator WYDEN. You’re saying that there’s no problem with the 

validity of this study. I just want to move on. You—— 

Dr. PRENTICE. No, the—— 

Senator WYDEN.—you’d like—— 

Dr. PRENTICE. No, the scientific evidence—— 

Senator WYDEN.—you’d like some—— 

Dr. PRENTICE.—is there. 

Senator WYDEN.—you’d like some other—— 

Dr. PRENTICE. It’s just about 3 years behind. 

Senator WYDEN.—and you’d like some other studies to be made 

a part of the record, as well. Is that—— 

Dr. PRENTICE. I would hope that Dr. Lanza would now show us 

that those cells could achieve the same type of success in animals, 

safely, as the adult stem cells. 

Senator WYDEN. Another question for you, Dr. Prentice. Are you 

opposed to in vitro fertilization at fertility clinics in America? 

Dr.—— 

Dr. PRENTICE. I’ve been troubled by it, Senator—— 

Senator WYDEN. I’d like a yes—— 

Dr. PRENTICE.—because of the manipulation—— 

Senator WYDEN.—I’d like a yes or no answer, because I was really pretty floored by the answer I got, you know, earlier, because I 

had not, you know, heard that from Dr. Doerflinger. I had thought 

that he would not be opposed, that there would be some questions 

with respect to what would be done with the embryos. And that’s 

something that I’m interested in. But just a yes or no answer. I 

mean, this is important, because millions of couples have found 

happiness through a specific procedure, IVF. Millions of couples. 

And I like to think that I played an itty-bitty part in it because 

I wrote the one law that makes it possible for couples to have some 

real protections, in terms of how they use it. Do you, or do you not, 

favor IVF as a procedure? 

Dr. PRENTICE. As you’ve expressed it, yes, I favor IVF. But I 

would like, Senator, to see you write some more laws so that 

they’re not making so many embryos that end up in the freezer. In 

Germany, there are 40, total. 

Senator WYDEN. Well, the Chairman and I have talked about, 

Dr. Kass and others, have talked talk about ways in which we 

might update the law, but I appreciate your answer and appreciate 

your candor. 

Dr. Daley, a couple of questions for you, if I could. There are a 

wide range of funds, including Federal funding for adult stem cell 

research. And it’s been the view of Dr. Prentice and others having, 

you know, reservations about the value of embryonic stem cell research. Now, embryonic stem cell research, of course, faces restrictions on Federal funding, as opposed to adult stem cell research. 

70 

Do you think, therefore, that it is fair to compare the two—adult 

stem cell research and embryonic stem cell research, in terms of 

the progress, given the fact that there are restrictions with respect 

to embryonic stem cell research that there aren’t with adult stem 

cells? 

Dr. DALEY. Even without regard to the restriction, I think it’s unfair to say that adult stem cells are doing so much better than embryonic stem cells that it justifies putting more emphasis behind 

adult stem cells. 

Really, adult stem cells—and we’re talking primarily about bonemarrow stem cells—have been studied, really, more like 50 or 60 

years; whereas, human embryonic stem cells were first published 

6 years ago. You’re talking about a tenfold difference in time. You 

know, I mean, I think if you gave me a 50 year head-start in a bicycle race, I’d probably beat Lance Armstrong, too. 

The fact is that human ES cell research is a fledgling field just 

getting off the ground. It has enormous promise, not solely for its 

therapeutic potential, the ability to actually move cells into patients, but these are enormously valuable tools for research. So you 

have to give us time to let the field mature. 

Senator WYDEN. One other question for you, Dr. Daley, with respect to the practice of scientists. And I think you heard me earlier 

express—you know, my concern is that I think we’re just, sort of, 

headed for a kind of crazy quilt of standards with respect to ethical 

practices, at a minimum. And I think it stems from the restrictions 

on Federal funding. And Dr. Doerflinger and others have different 

views on that, and I respect it. 

My question to you would be, If there were Federal guidelines 

coupled with the availability of Federal funds for embryonic stem 

cell research for the new lines, the new areas that are so promising, wouldn’t those guidelines essentially become an industrywide standard at this point? 

Dr. DALEY. I would hope so. I can’t answer the specific legal aspects of how the Federal guidelines would ultimately compete with 

a patchwork quilt of guidelines on the level of the states. But I 

think we, as scientists, are very much looking to the Federal Government for leadership on this issue. It would make it a lot easier. 

The cloud—— 

Senator WYDEN. Wouldn’t it be—on that point, wouldn’t it be in 

the interest of scientists and industry and all concerned if we tried 

to get to the point where we’re sensitive to these ethical, you know, 

concerns? I want to emphasize, I want to do that, but we want to 

do it I in a clear kind of fashion. And wouldn’t the kind of straightforward Federal role facilitate that kind of sensitivity throughout 

the field? 

Dr. DALEY. There’s no doubt that, since the NIH is really the lifeblood of funding for most of American science, that something done 

at the Federal level, under the auspices of the NIH, would certainly 

clarify the goals and mission of this field. 

Senator WYDEN. My time is up. Just on this one point, Mr. 

Chairman. 

See, what I’m concerned about is, almost everybody that I talk 

to in this field, regardless of their, you know, point of view, will 

usually say, ‘‘I want a win-win. I want the research done, I want 

71 

to help people who are suffering, and I want to be sensitive to ethics.’’ Now, nobody wants to just go out and say, ‘‘There are no ethical concerns here,’’ because there very obviously are. 

My concern is that what’s going to happen in this country, in 

terms of the direction we’re going, instead of getting the win-win, 

we’re going to have a lose-lose, we’re not going to tap all the opportunities for research. And I think I documented what’s happening 

in that regard. We’re not using the available stem cell lines, even 

from the earlier plan of the President, nor are we using the new 

lines. And we’re going to cause a significant amount of confusion 

with respect to what the ethical strictures are that we all want to 

have. 

So instead of the win-win that, I think, virtually everybody, regardless of their point of view on this issue wants to have, I think 

if we don’t get a clearly defined Federal role and have necessary 

Federal funding, instead of the win-win and the kind of opportunities for our country to provide the leadership role that we have the 

potential to play, we’re going to have more of what I would characterize as a lose-lose. And I think that’s regrettable, and I think Dr. 

Daley essentially agrees, and I suspect your two colleagues at the 

table would see that differently. 

But, Mr. Chairman, I’m going to have to take off. But I think it’s 

been a good hearing, and I thank you again for your fairness, in 

terms of how you approach all of this. 

Senator BROWNBACK. Well, thank you for participating in it. 

I do want to note, though, where you would see a lose-lose in this 

situation, we have patients who are being treated now with stem 

cell therapies, that are being cured. I’ve had them in here testifying—sickle cell anemia, something you’d be familiar with, Dr. 

Daley, umbilical cord blood transfusion, two ladies, Susan Fite— 

and other spinal cord injuries that are walking now—using canes, 

full body feeling, but walking—with adult stem cell therapy. We 

give heart transplant patients—I mean, I’d hardly say—call that a 

lose-lose in this situation. I respect how you’re looking at it, but 

this thing is really moving forward. 

And, Dr. Daley, as well, in your work, you are receiving NIH 

money to do stem cell research, umbilical—or, I mean, excuse me, 

embryonic and adult. So, I mean, you are receiving Federal dollars 

to do embryonic stem cell research. That’s happening. And I understand your desire to expand the lines, but there is no private limitation at all, there is no limitation on any funding, there’s no limitation on, for that matter, human cloning in this country. So the 

notion that—you know, that we’ve got this big clamp down at the 

Federal Government, I don’t think is accurate. I think you really 

have to look at what is being limited is, you can use the Federal 

dollars on a set of lines that are developed. That’s the limitation. 

And I would put into the record a Wall Street Journal article of 

August 12, 2004, on the politics—the political science, they say, of 

stem cells. They document FY 2002, $521.1 million being spent on 

all forms of stem cell research. I can’t think there’s any country in 

the world with anywhere close to that spending level, and that includes embryonic, human non-embryonic, nonhuman embryonic, 

and nonhuman non-embryonic. So you’ve got both adult and embryVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00075 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\81636.TXT JACKIE
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onic in the whole field, but over a half billion dollars on an annual 

basis. 

[The information referred to follows:] 

The Wall Street Journal (on-line edition)—REVIEW & OUTLOOK—August 12, 2004 

THE (POLITICAL) SCIENCE OF STEMS

You might not know about it from listening to the news lately, [but] the 

President also looks forward to medical breakthroughs that may arise from 

stem cell research. Few people know that George W. Bush is the only President to ever authorize Federal funding for embryonic stem cell research.— 

Laura Bush 

The First Lady was way too polite: The way stem cells have been reported, you’d 

think we were in a new Dark Ages, with government-backed religious inquisitors 

threatening scientists on the cusp of life-saving treatments. 

Reinforcing this misimpression are the headlines and commentators talking up a 

‘‘ban’’ on research. ‘‘First lady Laura Bush defends ban on stem cell research’’ is how 

the Philadelphia Inquirer spun Mrs. Bush’s talk. A sampling of other headlines 

shows the Inquirer is far from alone: ‘‘Rethink the stem cell ban’’ (Des Moines Register); ‘‘Stem cell ban stays, despite Reagan pleas’’ (Newark Star-Ledger); ‘‘Kerry 

says he’d reverse stem cell ban’’ (The Grand Rapids Press); ‘‘Kerry ‘would lift stem 

cell ban’ ’’ (BBC), and on and on. You get the drift. 

The problem is that the drift is wrong. As Mrs. Bush gently reminded her audience in Pennsylvania this week, far from banning embryonic stem cell research, 

George W. Bush is the first President to expand Federal funding for it. The nearby 

table shows that, as a result of his decision, Federal funding went from zero in 2000 

to nearly $25 million today—and this doesn’t include the many tens of millions more 

being spent by the private sector. As Health and Human Services Secretary Tommy 

Thompson points out, the supply of embryonic stem cell shipments available is 

today greater than the demand. 

In other words, this is not, as Ron Reagan characterized it during his prime time 

slot at the Democratic convention, a battle between ‘‘reason and ignorance.’’ It’s an 

argument about taxpayer money and how to draw the lines around it. 

On the whole this would be a healthy debate for America to have. But the Kerry 

campaign seems more interested in politicizing the issue by continuing to advance 

claims for a ban that simply does not exist. Typical was the press release by the 


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73 

campaign Website this week entitled ‘‘Edwards Calls for an End to Stem Cell Ban 

and a Return to Scientific Excellence in America.’’ This is no slip: It’s the same language Mr. Kerry used in his radio address when he declared he intends to ‘‘lift the 

ban on stem cell research.’’ And it’s the same language Hillary Clinton used during 

her own convention speech, drawing cheers when she invoked the ‘‘need to lift the 

ban on stem cell research.’’ 

All these people know better. The issue is Federal subsidies. The need for a Presidential decision arose from an appropriations rider passed by Congress in the mid1990s forbidding Federal funding for any research that creates, injures or destroys 

human embryos. 

The President’s answer was that there ought to be no restrictions on the private 

sector but that Federal subsidies should be limited to lines that had already been 

harvested and should not be used to encourage the destruction of embryos. In short, 

it was a reasonable middle ground. It’s worth noting that other countries, such as 

Germany, Ireland and Austria, ban even the private sector from creating embryos 

for stem cell research. 

The potential for embryonic stem cells is that they are malleable and can differentiate themselves into needed cells. That gives them tremendous potential, but it also 

presents a liability because we can’t yet control what these cells will turn into. In 

one animal study, a fifth of the mice injected with embryonic stem cells developed 

brain tumors. 

Which helps explain why we still have not had a single human trial for embryonic 

stem cells. And it means that political claims that cures for diabetes or Parkinson’s 

are just around the corner are cruelly raising false hopes. 

Meanwhile there is another alternative we don’t hear much about in the headlines: adult stem cells. Unlike embryonic research, adult stem cells do not get us 

into questions about the destruction of human life. In addition, a report in the journal Nature this summer suggests that adult stem cells may have a broader differentiation potential than previously thought. 

Plainly this is one of those subjects that involves clashes of goods, in this case 

the sanctity of human life versus the needs of scientific research. The best way to 

resolve the issue of taxpayer funding is to let the American people make that decision themselves, through their elected representatives. And dealing, we hope, with 

the science—not just the Kerry campaign sound bites. 

Senator BROWNBACK. So we’re investing heavily in this field, and 

finding some beautiful science out. I understand you don’t have— 

share quite the ethical concern I do for the—— 

Dr. DALEY. We always need more resources. There’s—there 

are—— 

Senator WYDEN. Mr. Chairman? 

Dr. DALEY.—this is among the most exciting new areas of biology. I can tell you that there’s an interesting dynamic. On the one 

hand, you have the students who are so enormously excited, and 

they want to jump in; on the other, you have a lot of investigators 

who, because of the current cloud, the controversy, are staying on 

the sidelines. There’s a very interesting dynamic going on. 

Senator WYDEN. Mr. Chairman, can I—— 

Senator BROWNBACK. Let me—— 

Senator WYDEN.—can I just make a unanimous consent request, 

in terms of the battle between newspaper articles? 

[Laughter.] 

Senator BROWNBACK. You can, but I want to finish with my battle on this, and then I’ll be happy to take that one from you. 

There’s no country in the world that’s investing heavier in stem 

cell research than the United States, is there, Dr. Daley? 

Dr. DALEY. Actually, I don’t know, but I don’t imagine there’s 

any country in the world that enjoys the level of support that the 

United States does for basic biomedical research, and I am thankful for that, and I think it’s one of the greatest gifts of our Federal 

Government to our society. 

74 

Senator BROWNBACK. Well, and we’ve doubled, under a Republican Congress—and Senator Wyden supported it—NIH funding 

over the past 5 years, 6 years. I think most of us view that as an 

excellent investment in research. Stem cell funding has benefited 

from that. 

So I just—I want to get this honed down a little bit. When we 

talk about all these restrictions on it, at the end of the day it’s bout 

the level of the lines, and the funding has been far and away above 

what any other country in the world is doing in this area. 

So now if you want to put your—I want to ask unanimous consent mine be put in the record, and yours will be accepted, as well. 

[The articles referred to are reprinted on pp. 3–4 of this hearing 

record.] 

Senator WYDEN. I thank you, Mr. Chairman. I just think it’s important. I would just ask unanimous consent that the two articles 

that have been discussed be placed side by side, because the one 

that my friend, the Chairman, is talking about essentially offers an 

opinion piece, but the—because I have read that, and I respect the 

Wall Street editorial writers on this point—but the facts are, as 

documented in this article that I’ve asked to be put in the record, 

that only 21 of the initial 78 stem cell lines are available to researchers today, number one; and scientists say that more than a 

hundred new lines have been developed since the cutoff date of the 

President, and that some of those are better suited for research. 

That is essentially a direct quote out of the article that will be in 

the record in the battle of the newspaper articles. 

And just, since the Chairman’s being very kind to me, I only say 

that I acknowledge—and, Dr. Prentice, I think you might have 

been here when we talked earlier about adult stem cells—there’s 

no question that people have been helped with adult stem cells. 

And more power to it. I am for it. What I am concerned about is 

the potential for the field, and that’s what I have characterized is, 

unfortunately, headed toward instead of the, kind of, win-win that 

everybody at this table, you know, appropriately and sincerely 

wants—but in terms of the potential, we don’t get what we ought 

to have, in terms of the ethical standards, nor do we get what’s— 

in terms of the potential for the research. 

But this debate will continue with the usual level of thoughtfulness that Senator Brownback brings to this Committee, and I look 

forward to it. 

Senator BROWNBACK. Thank you very much. 

Dr. Daley, in the scientific community, you’ve got a—amongst 

your colleagues when you’re meeting, you’ve got to talk about this 

issue a fair amount. And I’m sure there’s a great deal of frustration, because I get it in the testimony, people coming up and testifying. But you have to—I presume you must be debating, as well, 

When is there moral significance to the youngest of humans? And 

you would agree, biologically, you became your person—you became 

your life when that union and fertilization occurred, biologically. 

You can just debate the theological position, but, biologically, you 

became genetically you at the moment of fertilization, biologically. 

That would be accurate, wouldn’t it? 

Dr. DALEY. I mean, yes, of course. 

75 

Senator BROWNBACK. So when scientific—when you—just in talking with your colleagues, or talking about, ‘‘Well, OK, yes, obviously I was biologically me at the moment of conception,’’ but I 

don’t want to—I’m so—there’s so much promise here, I want to set 

the date at this point in time, before we really attach moral significance to—what is this date that you would then attach, when you 

talk with your colleagues, moral significance to the youngest of humans? 

Dr. DALEY. Honestly, I don’t think any scientist can draw a line 

for you at when moral significance is endowed in the period of 

human development. It is not a line. But I think that we are all 

comfortable with the idea of using the earliest microscopic ball of 

cells in our research. 

From a biologist’s perspective, life is, indeed, a continuum. We 

are all, in some way, shape, or form, descended from our original 

ancestors—Adam, Eve. Cells are immortal in the sense that 

through our line, we pass on life to our kids. I am mortal as a 

being, but, in seeing my children, I realize that we, as a species, 

are immortal. Life is in every cell. Every cell has the potential to 

give forth life. So these arguments about trying to get us to say, 

‘‘When does life begin,’’ I think, is really defined in the realm of 

theology and the realm of things beyond biology. 

Senator BROWNBACK. Well, you make it difficult for us, then, because, at some point in time, you gained moral significance. And 

you talked about teaching your boys baseball, which is such a 

pleasurable thing. And, at some point in time, they gained moral 

significance to you. Have you thought about when that line was? 

Dr. DALEY. I’m really challenged by it. Yes. I’ll tell you when I 

think about it. I think about it when I’m called to consult in our 

neonatal intensive-care unit—that’s when I’m thinking about it— 

and you’re seeing these tiny little premature babies, and it really 

calls into question, When is it that that life can exist independent 

of all of our technology? And when is it that you can actually hug 

that child and feel that it has significance? 

You know, I—when I—I can’t hug an embryo. I just can’t see it 

as morally equivalent to my kids and my patients. And my mission 

in stem cell research is aimed more at serving their needs. 

Senator BROWNBACK. But you would agree, if your children were 

researched on at the blastocyst stage, they wouldn’t be here. 

Dr. DALEY. Yes. 

Senator BROWNBACK. Nor would you, nor would I, at that point 

in time. And you’re not willing to set for me, ‘‘OK, at this point in 

time, moral significance begins to the’’—and you and your colleagues don’t particularly, I guess, discuss when this line is. You 

see the promise of the research, and you’re looking—and I applaud 

your heart of, ‘‘I want to cure people,’’ because I want to cure people, too, and I’m glad you’ve got that heart. But you don’t discuss 

about, ‘‘OK, we would really put moral significance at this point in 

time, or that.’’ 

Dr. DALEY. I think that there would be consensus among biologists that it would be impossible to define that time. There are 

definitions that, say, the British have assigned, through the 

Human Fertilization and Embryo Authority, which are convenient 

biological timelines, and the definition would be 14 days, for inVerDate Nov 24 2008 08:32 Jun 27, 2013 Jkt 075679 PO 00000 Frm 00079 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\81636.TXT JACKIE
76 

stance, with a human embryo, which is about the time that the 

primitive streak forms, the earliest specialization of the embryo 

into the different tissue types. That’s a matter of convenience. I 

don’t think one is defining 14 days as the point of moral significance; it just does allow us to say—certainly before that time, very 

few people would argue; after that time, I think it’s impossible. 

Senator BROWNBACK. All right, that’s fair enough. I just—I would 

hope that your colleagues, as you discuss in your cell biology organization and others, would, you know, discuss about—this is a 

major issue. You obviously wouldn’t want to research on somebody 

that’s a full blown human being. You wouldn’t want research on 

your children or yourself. You wouldn’t want it on me, on my children. OK, we accept that. Then where can we, then, start researching on you without your permission? At what age? 

Dr. DALEY. Right. I invite your opinion, as well as everyone else, 

to engage in that discussion. I don’t think it’s at the age of the 

blastocyst, however. 

Senator BROWNBACK. But you’re not willing to establish when I 

think this would or should—— 

Dr. DALEY. No. No. Sorry. 

Senator BROWNBACK. All right, fair enough. 

Gentlemen, thank you very much. It’s very illuminating. I’m delighted to hear about the potential for the use of fat. We have plenty of it in America. We have this huge obesity problem, and I’m 

hopeful for the day when we can use it to solve many of our maladies. The hearing’s been excellent. 

The hearing’s adjourned. 

[Whereupon, at 4:30 p.m., the hearing was adjourned.] 

(77) 

A P P E N D I X 

PREPARED STATEMENT OF FRANK R. LAUTENBERG, U.S. SENATOR FROM NEW JERSEY

Mr. Chairman: 

This hearing is entitled ‘‘Embryonic Stem Cell Research: Exploring the Controversy.’’ Frankly, if you ask me, there is no controversy here. Embryonic stem cell 

research is critical to our mission to fight and cure disease in this country. 

The debate over whether we should pursue adult stem cell research or embryonic 

stem cell research sets up a false choice. 

Both types of stem cell research should be pursued simultaneously. Each type of 

research offers the potential for cures; neither is a substitute for the other. No 

promising stem cell research should be stopped. The National Academy of Sciences 

has said as much. 

Stem cell research, particularly the burgeoning field of embryonic stem cell research, has tremendous potential to help up better understand, treat, and even cure 

deadly and disabling diseases like diabetes, cancer, Parkinson’s Alzheimer’s and 

multiple sclerosis. Stem cell research could help us cut the incidence of heart disease, the Nation’s leading killer. 

Most American support embryonic stem cell research. Significantly, by a margin 

of 54 percent to 29 percent, Catholics support such research, according to a recent 

survey by Peter D. Hart Research Associates. The survey also indicated that the 

more people learn about the issue, the more they are inclined to support the research. I ask unanimous consent that the survey results appear in the hearing 

record following my statement. 

Members of Congress from both sides of the political aisle support the research, 

including our ‘‘pro-life’’ colleague, Senator Hatch, who stated that ‘‘life begins in the 

womb, not in a petri dish.’’ 

Forty Nobel Laureates also support the research, as does former First Lady Nancy 

Reagan who spent ten years watching her husband suffer from Alzheimer’s disease. 

Virtually every major medical, scientific, and patients’ advocacy group supports 

embryonic stem cell research. I’m talking about the American Medical Association, 

the Federation of American Societies for Experimental Biology, the Juvenile Diabetes Research Foundation, and the Parkinson’s Action Network. 

In my view, President Bush’s stem cell research policy sacrifices sound science in 

favor of policy expediency. His policy is, in effect, denying tens of millions of people 

suffering from physically and mentally debilitating diseases, illnesses, and injuries 

from being cured. 

First Lady Laura Bush recently said, ‘‘We don’t even know that stem cell research 

will provide cures for anything—much less that it’s very close’’ to yielding major advances. 

What the First Lady is saying, in effect, is that because we don’t know what the 

research will yield—and because it will take a long time—we shouldn’t bother starting it. With all due respect, scientists disagree and that’s not the sort of attitude 

that leads to scientific breakthroughs that improve life. 

I appreciate the sincerity of the views of those who oppose embryonic stem cell 

research, but I have met with too many diabetic children and their families. I have 

seen how they suffer and I simply cannot tell these children or their parents that 

in the hierarchy of rights, a week-old undifferentiated cell is more important than 

they are and cannot be used in research, treating, or possibly curing their terrible 

disease. 

The millions of men, women, and children who are suffering from diabetes and 

other life threatening diseases, illnesses, and injuries are engaged in a race against 

time. It is our responsibility to make sure that they and future generations benefit 

as quickly as possible from the wonders of modern science, medicine, and technology 

have to offer. 

Thank you, Mr. Chairman. 

78 

1 Virginia Commonwealth University survey, conducted 8/29–9/2/01; surveyed 1,122 adults nationwide; margin of error ±3 percent (release, 10/4/01). 

VOTERS’ VIEWS ON STEM CELL RESEARCH

Prepared by Peter D. Hart Research Associates for the Civil Society Institute—March 2004 

Introduction 

From March 24 to 29, 2004, Peter D. Hart Research Associates conducted a telephone survey on behalf of the Civil Society Institute. This survey was conducted 

among registered voters in 18 states and was designed to explore public opinion on 

Federal funding for stem cell research. The states included were Ohio, Michigan, 

Pennsylvania, Maine, New Hampshire, Wisconsin, Minnesota, Iowa, Washington, 

Oregon, New Mexico, Nevada, Arizona, Florida, Louisiana, Arkansas, Missouri, and 

West Virginia. With 802 interviews, the margin of error for this survey is ±3.5 percent, with larger margins of error for subgroups. 

Knowledge and Impact of Stem Cell Issue 

Public knowledge of stem cell research has increased over the past few years. 

Three in four (76 percent) voters say that they have heard a lot or a little about 

medical research involving embryonic stem cells, up from 69 percent of voters nationally in August 2001. 1 Nearly one-third (31 percent) of voters affirm hearing a 

lot, an increase from August 2001 when 25 percent claimed the same level of knowledge about stem cell research. 

Nearly all have a personal connection to the issue. Nearly every (86 percent) voter 

reports having a family member or close friend who potentially could benefit from 

stem cell research. More than two-thirds (68 percent) have some experience with 

cancer, and more than half (58 percent) have been affected by heart disease. Aside 

from these two more widespread diseases, 49 percent of voters report having a close 

personal friend or family member who has suffered from Alzheimer’s disease, Parkinson’s disease, juvenile diabetes, or spinal cord injury—and thus could be affected 

by medical research on stem cells. 

Voters strongly support Federal funding for medical research. Even when compared with other items such as national defense, transportation, or education, 59 

percent of voters say that Federal funding for medical research should be a high 

priority, including 31 percent who say that it should be a very high priority. Another 

35 percent say that funding for medical research should be a moderate priority. Just 

6 percent do not see medical research funding as a priority for the Federal government. Support is higher among Democrats (64 percent) than among Republicans (46 

percent), and is highest among the politically important independents (67 percent). 

A majority of voters in these states support embryonic stem cell research.—Overall, 

voters favor stem cell research by 53 percent to 30 percent. This is an increase in 

support from the August 2001 survey, when voters nationwide expressed support for 

embryonic stem cell research by only 48 percent to 43 percent. 

Democrats and Republicans offer different views on embryonic stem cell research 

(in the demographics portion of the survey, voters were asked whether they would 

describe their overall point of view in terms of the political parties as Democratic, 

Republican, or completely independent). Democrats favor stem cell research by a 46- 

point margin (65 percent to 19 percent), whereas Republicans oppose stem cell research by a nine-point margin (47 percent to 38 percent). However, independents 

have a view that is much closer to Democrats’ than Republicans’, as independent 

voters favor stem cell research by a 32-point margin (55 percent to 23 percent). In 

political terms, the center of the electorate clearly embraces the importance of stem 

cell research. 

79 

Support increases with education level, as 63 percent of college graduates favor 

stem cell research compared with 48 percent of non-college voters who say the same. 

Support is even higher among those with a postgraduate degree: nearly three in 

four (74 percent) say that they strongly or somewhat support embryonic stem cell 

research. Along gender lines, support is equal among men (53 percent) and women 

(53 percent). College men (61 percent) are much more likely than are non-college 

men (49 percent) to favor stem cell research, and the education gap is even greater 

among women, with 65 percent of college women and just 47 percent of non-college 

women favoring stem cell research. 

Dividing the states into regions shows that a majority of voters in the West (60 

percent), rural Midwest (54 percent), Northeast (52 percent), and South (52 percent) 

support stem cell research, along with a large plurality in the industrial Midwest 

(49 percent). Religion is another strong predictor of voters’ views on stem cell research. As expected, support is low among Evangelical Protestants (34 percent) but 

much stronger among mainline Protestants (59 percent). Significantly, Catholics (54 

percent) support stem cell research nearly as strongly as the mainline Protestants. 

Analysis also reveals that the more people have heard about the issue, the more 

they support stem cell research. Voters who say that they know a lot about the issue 

support stem cell research by 68 percent to 26 percent, whereas voters who say that 

they know little about the issue support it by a much smaller 36 percent to 30 percent. 

Support grows with more information. Support for embryonic stem cell research 

increases 13 percentage points to 66 percent when people are informed that couples 

are donating unwanted embryos that otherwise would be discarded. After hearing 

a more detailed description of embryonic stem cell research and the diseases it can 

help cure, support grows even more. Overall, three in four (76 percent) voters support stem cell research after hearing the following description: 

Embryonic stem cells are special cells that can develop into every type of cell 

in the human body. The stem cells are extracted from frozen embryos in fertility 

clinics, donated by couples who no longer want or need the embryo. This process 

destroys the embryo. These stem cells can then reproduce on their own, creating 

what is called a ‘‘line’’ of stem cells that many researchers can work with. Scientists believe that there is a good chance that stem cells can be developed into 


929SRVY1.eps
80 

cures or treatments for diseases such as cancer, Parkinson’s, Alzheimer’s, juvenile diabetes, and spinal cord injuries. 

Clearly, the potential of stem cell research to produce treatments for a wide range 

of diseases and conditions is a very powerful consideration for voters. Even subgroups originally resistant to the idea, such as Evangelicals and Republicans, support stem cell research after hearing a description of the process and potential of 

the research, despite the explicit recognition of the embryo destruction required. 

A large majority of voters in these states would change the Bush Administration’s 

August 2001 policy restricting embryonic stem cell research.—More than two-thirds 

(68 percent) of voters support the three longstanding criteria for Federal government funding of stem cell research: (1) the cells must come from an embryo that 

was created for reproductive purposes and is no longer needed, (2) researchers must 

obtain the consent of the couple donating the embryo, and (3) the donors cannot be 

paid for use of the embryo. 

In August 2001, the Bush Administration established a new restriction on Federal 

funding for embryonic stem cell research. This restriction says that research on 

stem cell lines created before August 2001 can receive funding, but funding is prohibited for research on stem cell lines developed after that date. However, the survey results reveal that voters overwhelmingly oppose this restriction and favor funding for research using newer stem cell lines. Fully 65 percent support expanding 

Federal government funding for stem cell lines created after August 2001, including 

50 percent who feel strongly, compared with only 17 percent who support maintaining the Bush Administration’s August 2001 restrictions. 

Key political groups, such as independents and persuadable voters, strongly support a policy allowing Federal funding for research on newer stem cell lines. As the 

accompanying table shows, the August 2001 restrictions garner relatively little support even among groups not favorable to stem cell research initially, such as Republicans, Evangelicals, and conservatives. 


929SRVY2.eps
81 

It is important to note that strong majorities of voters disagree with the two primary justifications for the August 2001 restriction: 1) that there are enough stem 

cell lines that were created before August 2001 to support research needs, and 2) 

that the government should not create an incentive to destroy more embryos by 

funding research on them. 

On the topic of the number of viable stem cell lines available for research, voters 

were read statements from both supporters and opponents of the Bush Administration’s August 2001 policy and were asked which statement they agree with more. 

Statement A: People who support the Bush Administration’s policy say that there 

already are sufficient embryonic stem cell lines to meet the needs of researchers. 

The Bush Administration’s policy will allow stem cell research to move forward 

and help cure diseases, without violating our ethical standards by supporting the 

destruction of additional embryos. 

Statement B: People who support funding for research using newer stem cell 

lines point out that when the Bush Administration’s policy was created, people 

thought there were at least seventy stem cell lines available for research. But it 

turns out there are only fifteen lines available, and almost all researchers agree 

that many more are needed for stem cell research to fulfill its promise. Given 

these new facts, we need a new policy that allows life-saving research to proceed. 

Again, after hearing statements from both sides of the debate, a large majority 

(65 percent) agree with those who favor expanded funding for newer stem cell lines, 

with 49 percent who feel strongly. Fewer than one in four voters (23 percent) agree 

that funding should be limited to the old stem cell lines, including 16 percent who 

feel strongly. 

On the topic of destruction of embryos, voters again were presented with statements from opponents and supporters of expanding Federal funding for use in research on newer stem cell lines, and were asked which statement they agree with 

more. 


929SRVY3.eps
82 

Statement A: People who support the Bush Administration’s policy say that 

funding for the old stem cell lines is right because those embryos already had 

been destroyed, but if funding is made available for research on newer stem cell 

lines it will create an incentive for the destruction of additional embryos. They 

say it is wrong for the government to support or encourage the destruction of 

human embryos. 

Statement B: People who support Federal funding for research using newer stem 

cell lines say these newer stem cells will come from embryos in fertility clinics 

that are voluntarily donated by couples who no longer need or want them and 

they likely will be discarded. They say there are already tens of thousands of 

such frozen embryos that will be discarded by their donors if they are not used 

for research. It only makes sense to use these embryos to cure diseases and save 

lives. 

Again, by a more than two to one, voters solidly agree with supporters of Federal 

funding on newer stem cell lines, as 66 percent of voters say that they agree with 

the supporters of expanded Federal funding, including 51 percent who strongly 

agree. On the other side of the coin, just 24 percent agree that funding should be 

limited to the old stem cell lines, including 18 percent who feel strongly. 

Voters in these states are more persuaded by arguments in favor of allowing research than by arguments in favor of the August 2001 restriction.—The survey presented voters with the strongest arguments made by both sides of the stem cell debate. The most persuasive argument tested in favor of the Bush Administration’s 

policy of limited funding for stem cell research is that there should be more comprehensive research on stem cell lines from adults, umbilical cords, and animals to 

gauge their usefulness before more embryos are destroyed. Half (50 percent) of voters find this argument very or fairly convincing, and a nearly equal proportion (47 

percent) say that it is just somewhat or not at all convincing. Other arguments in 

favor of the administration’s policy—that embryonic stem cell research is immoral, 

that it is possibly unethical, that it is exploitative of a human life—generally prove 

less persuasive to voters. 

Reasons to Support the Bush Administration’s Policy 

(Proportion saying each is a very/fairly convincing reason) 

50% In addition to embryonic stem cell lines, there are many stem cell lines available to 

researchers that come from adult humans, umbilical cords that are discarded 

after birth, and animals. We should first see whether these stem cells can provide 

the cures and treatments we need, before destroying more human embryos. 

43% Under the current policy, there already are sufficient stem cell lines available for researchers to begin exploring the potential of stem cell research. We do not know 

yet whether additional stem cell lines are needed, and until we do, we should 

maintain the strongest protections possible against exploitation of human life. 

35% For the sake of moral principle and human dignity, it is time that we draw the line. 

Banning Federal government funding for research on newer stem cell lines is a 

good way to make sure that embryos are not created and destroyed for research 

purposes. 

32% Pro-life organizations believe that it is immoral to destroy living human embryos, 

even for medical research. 

32% Research on embryonic stem cells raises profound ethical questions, because extracting the stem cell destroys the embryo, and thus destroys its potential for life. It is 

wrong to provide taxpayer funding to research that sanctions and encourages the 

future destruction of human embryos. 

30% There is no such thing as an excess life, and the fact that a living embryo is going to 

be discarded does not justify experimenting on it or exploiting it as a natural resource. 

Voters agree more with arguments for allowing research on newer stem cell lines. 

The most convincing argument is that embryonic stem cell research is similar to 

organ donation in that neither organ donors nor frozen embryos will live and that 

there is a great medical need for both (69 percent very/fairly convincing). Two-thirds 

(65 percent) of voters agree that our government should support rather than stand 

in the way of research that will help ease the suffering of more than 100 million 

Americans who are suffering from diabetes, Alzheimer’s, Parkinson’s, and other diseases and conditions. 

83 

Reasons to Fund Research on Newer Cell Lines 

(Proportion saying each is a very/fairly convincing reason) 

69% This issue is very similar to organ donation. Neither frozen embryos nor organ donors are going to live, and in both cases there is an urgent medical need that can 

be filled by the donation of needed tissue. Just like organ donation, stem cell research can save millions of lives. 

65% Stem cell research offers the best hope we have today for curing such diseases as 

Alzheimer’s, diabetes, heart disease, and cancer, which today cause pain and suffering to more than 100 million Americans. Our government should be fully supporting this research, not standing in the way. 

63% Currently fertilization clinics in the United States have tens of thousands of embryos that have been donated by couples who no longer need or want them. If 

these embryos cannot be used in stem cell research, they will simply be discarded 

by the donors, and no benefits at all will be derived from them. 

63% Highly respected organizations such as the AMA, National Academy of Sciences, 

National Institutes of Health, Juvenile Diabetes Research Foundation, and Alzheimer’s Association strongly support allowing research on newer stem cell lines. 

58% Nancy Reagan, Michael J. Fox, and Christopher Reeve all support funding for research on newer stem cell lines, because they know it represents the best chance 

we have to prevent suffering from Alzheimer’s, Parkinson’s disease, spinal cord 

injuries, and other afflictions. 

56% When the Bush Administration’s policy was established, it was believed that there 

were 78 stem cell lines available for research. But it turns out there are only 15 

lines that meet the Bush Administration’s conditions, and researchers agree that 

many more are needed to move forward with meaningful stem cell research. 

Sixty-three percent of voters are convinced by the argument that if embryos that 

donors no longer need are not used for research, fertility clinics will simply discard 

them with no benefit to medical research. An equal proportion find the support of 

the American Medical Association, the National Academy of Science, National Institutes of Health, the Juvenile Diabetes Research Foundation, and the Alzheimer’s 

Association of research on new stem cell lines a convincing reason to lift the August 

2001 restrictions on Federal funding. 

Many supporters of changing the August 2001 restriction are seen as highly trustworthy sources of information on the issue of stem cell research.—Two-thirds or more 

of voters say that they trust the information provided by a number of stem cell research supporters, including 87 percent who say they trust information from health 

organizations such as the American Medical Association and the Alzheimer’s Association. Additionally, the opinions of celebrities who favor funding for newer cell 

lines, such as Mary Tyler Moore (75 percent), chairwoman of the Juvenile Diabetes 

Research Foundation; Christopher Reeve (73 percent), founder of the Christopher 

Reeve Paralysis Foundation; Michael J. Fox (67 percent), founder of the Michael J. 

Fox Parkinson’s Research Foundation; and Nancy Reagan (65 percent) are considered trustworthy. These findings indicate that not only do the arguments in favor 

of expanded stem cell research resonate strongly with voters, they also consider the 

individuals and organizations making these arguments to be highly credible. 

After hearing arguments from both sides, support for research on new cell lines remains high.—Total support climbs four percentage points to 69 percent, and strong 

support increases eight points to 58 percent, whereas support for the 2001 Bush Administration’s policy is just 20 percent. Clearly, voters broadly favor dropping the 

August 2001 Bush Administration restrictions and allowing research funding to include using newer stem cell lines. Further debate is likely to strengthen, not weaken, that consensus. 

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