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89–327 DTP 2003

S. HRG. 108–160

PROMOTING ETHICAL REGENERATIVE MEDICINE

RESEARCH AND PROHIBITING IMMORAL

HUMAN REPRODUCTIVE CLONING

HEARING

BEFORE THE

COMMITTEE ON THE JUDICIARY 

UNITED STATES SENATE

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

MARCH 19, 2003

Serial No. J–108–7

Printed for the use of the Committee on the Judiciary

(

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COMMITTEE ON THE JUDICIARY 

ORRIN G. HATCH, Utah, Chairman 

CHARLES E. GRASSLEY, Iowa 

ARLEN SPECTER, Pennsylvania 

JON KYL, Arizona 

MIKE DEWINE, Ohio 

JEFF SESSIONS, Alabama 

LINDSEY O. GRAHAM, South Carolina 

LARRY E. CRAIG, Idaho 

SAXBY CHAMBLISS, Georgia 

JOHN CORNYN, Texas 

PATRICK J. LEAHY, Vermont 

EDWARD M. KENNEDY, Massachusetts 

JOSEPH R. BIDEN, JR., Delaware 

HERBERT KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

RUSSELL D. FEINGOLD, Wisconsin 

CHARLES E. SCHUMER, New York 

RICHARD J. DURBIN, Illinois 

JOHN EDWARDS, North Carolina 

MAKAN DELRAHIM, Chief Counsel and Staff Director 

BRUCE A. COHEN, Democratic Chief Counsel and Staff Director 

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C O N T E N T S 

STATEMENTS OF COMMITTEE MEMBERS 

Page

Craig, Hon. Larry E., a U.S. Senator from the State of Idaho ............................ 6

prepared statement .......................................................................................... 72

Feinstein, Hon. Dianne, a U.S. Senator from the State of California ................. 4

prepared statement .......................................................................................... 76

Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah ............................ 1

prepared statement .......................................................................................... 80

Kennedy, Hon. Edward M., a U.S. Senator from the State of Massachusetts, 

prepared statement .............................................................................................. 101

Kyl, Hon. Jon, a U.S. Senator from the State of Arizona, prepared statement . 102

Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont, prepared 

statement .............................................................................................................. 107

WITNESSES 

Berg, Paul, Cahill Professor Emeritus of Cancer Research and Biochemistry, 

Stanford University Medical Center and Chair, Public Policy Committee, 

American Society for Cell Biology, Palo Alto, California .................................. 37

Brownback, Hon. Sam, a U.S. Senator from the State of Kansas ....................... 8

Kass, Leon, M.D., Hertog Fellow in Social Thought, American Enterprise 

Institute, Washington, D.C. ................................................................................ 23

Kelly, James, Patient Advocate, Granbury, Texas ............................................... 15

Langevin, Hon. Jim R., a Representative in Congress from the State of 

Rhode Island ......................................................................................................... 11

Mathews-Roth, Micheline M., M.D., Associate Professor of Medicine, Harvard 

Medical School, Boston, Massachusetts ............................................................. 33

Murray, Thomas, President, Hastings Center, Garrison, New York .................. 25

Usala, Anton Lewis, M.D., Clinical Professor and Medical/Administrative Director, Office for Regulatory Review of Clinical Trials, East Carolina University, Greenville, North Carolina .................................................................... 31

Varmus, Harold, M.D., President Memorial Sloan-Kettering Cancer Center, 

New York, New York ........................................................................................... 28

Wasson, Greg, Cotati, California ............................................................................ 17

SUBMISSIONS FOR THE RECORD 

Alliance for Aging Research, Daniel Perry, Executive Director, Washington, 

D.C., letter ............................................................................................................ 54

Alpha-1 Foundation, John W. Walsh, President and CEO, Miami, Florida 

and Alpha-1 Association, John P. Morton, Chair, Board of Directors, Washington, D.C., joint letter and attachments ......................................................... 55

American Association for Cancer Research, Margaret Foti, Chief Executive 

Officer, Philadelphia, Pennsylvania, letter ........................................................ 58

American Society of Hematology, Ronald Hoffman, M.D., President, Washington, D.C., letter ............................................................................................... 59

Association of American Medical Colleges, Jordan J. Cohen, M.D., President, 

Washington, D.C., letter ...................................................................................... 60

Association of Reproductive Health Professionals, Felicia H. Stewart, M.D., 

Chair, Board of Directors and Wayne C. Shields, President and CEO, Washington, D.C., letter ............................................................................................... 61

Page

IV

Berg, Paul, Cahill Professor Emeritus of Cancer Research and Biochemistry, 

Stanford University Medical Center and Chair, Public Policy Committee, 

American Society for Cell Biology, Palo Alto, California, prepared statement ...................................................................................................................... 62

Bledsoe, Rev. Michael, Pastor, Riverside Baptist Church, Washington, D.C., 

statement .............................................................................................................. 69

Californians for Cure, Don C. Reed, Chair, Fremont, California, letter ............. 70

Children’s Neurobiological Solutions Foundation, Fia Richmond, President, 

Santa Barbara, California, letter ........................................................................ 71

Christopher Reeve Paralysis Foundation, Michael Manganiello, Senior Vice 

President, Springfield, New Jersey, letter ......................................................... 74

Coalition for the Advancement of Medical Research, Michael Manganiello, 

President, Washington, D.C., letter .................................................................... 75

Hadassah, Bonnie Lipton, National President, New York, New York, letter ..... 79

International Myeloma Foundation, Susie Novis, President, North Hollywood, 

California, letter ................................................................................................... 84

Kass, Leon, M.D., Hertog Fellow in Social Thought, American Enterprise 

Institute, Washington, D.C., prepared statement ............................................. 85

Kelly, James, Patient Advocate, Granbury, Texas, prepared statement ............ 93

Mathews-Roth, Micheline M., M.D., Associate Professor of Medicine, Harvard 

Medical School, Boston, Massachusetts, prepared statement .......................... 108

Members of the religious community, February 5, 2003, joint letter .................. 111

Murray, Thomas, Hastings Center, Garrison, New York, prepared statement . 112

National Venture Capital Association, Mark G. Heesen, President, Arlington, 

Virginia, letter ...................................................................................................... 116

Rett Syndrome Research Foundation, Monica Coenraads, VP of Research, 

Cincinnati, Ohio, letter ........................................................................................ 117

Society for Women’s Health Research, Roberta Biegel, Director of Government 

Relations, Washington, D.C., letter .................................................................... 118

Steven and Michele Kirsch Foundation, Susan E. Frank, Director, Public 

Policy, San Jose, California, letter ...................................................................... 119

Union of Orthodox Jewish Congregations of America and Rabbinical Council 

of America, joint statement ................................................................................. 120

United Church of Christ, Justice and Witness Ministries, Pat Conover, Legislative Director, Washington, D.C., letter ............................................................ 122

University of California, Richard C. Atkinson, President, Oakland, California, 

letter ...................................................................................................................... 125

Usala, Anton-Lewis, M.D., Clinical Professor and Medical/Administrative Director, Office for Regulatory Review of Clinical Trials, East Carolina University, Greenville, North Carolina, prepared statement ................................. 127

Varmus, Harold, M.D., President, Memorial Sloan-Kettering Cancer Center, 

New York, New York, prepared statement ........................................................ 131

Wasson, Greg, Cotati, California, prepared statement ......................................... 139

Wiley, John D., Chancellor, University of Wisconsin-Madison, Madison, Wisconsin, letter ......................................................................................................... 146 

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PROMOTING ETHICAL REGENERATIVE MEDICINE RESEARCH AND PROHIBITING IMMORAL HUMAN REPRODUCTIVE CLONING 

WEDNESDAY, MARCH 19, 2003

UNITED STATES SENATE, 

COMMITTEE ON THE JUDICIARY, 

Washington, D.C. 

The Committee met, Pursuant to notice, at 10:34 a.m., in room 

SD–226, Dirksen Senate Office Building, Hon. Orrin G. Hatch, 

Chairman of the Committee, presiding. 

Present: Senators Hatch, Craig, Cornyn, Feinstein, and Durbin. 

OPENING STATEMENT OF HON. ORRIN G. HATCH, A U.S. 

SENATOR FROM THE STATE OF UTAH 

Chairman HATCH. Good morning. Today, the Judiciary Committee will explore whether and how it might be possible to draw 

a line between promoting ethical stem cell research and prohibiting 

immoral human reproductive cloning. 

I am a cosponsor, along with Senators Feinstein, Specter, Kennedy, Harkin, Durbin and others, of bipartisan legislation, S. 303, 

the Human Cloning Ban and Stem Cell Research Protection Act of 

2003. 

Our bill has two goals: first, to stop any attempts to facilitate the 

birth of a cloned baby. Virtually everyone in Congress and among 

the American public agrees that reproductive cloning should be 

criminalized so this practice can be stopped before it even begins. 

At a minimum, the 108th Congress should pass legislation that 

bans reproductive cloning. That is the very least we should do. 

Second, our legislation allows a promising form of stem cell research to go forward under strict ethical and moral guidelines. This 

research utilizes a cloning technique, and keep in mind that in biomedical science the term ‘‘cloning’’ merely means to make an exact 

copy of cells, proteins, molecules, viruses, DNA sequences, and 

other such entities. 

In the cloning technique of somatic cell nuclear transfer, also 

called nuclear transplantation, an egg’s normal component of 23 

chromosomes is removed and replaced with a full set of 46 chromosomes from a somatic or body cell, such as the skin. This process 

does not involve a fertilized egg or any sperm cells. 

There are two potential pathways for such engineered non-fertilized embryonic cells. If introduced into a womb, it is possible 

that a cloned human being could be born. Let me repeat my opposiVerDate 0ct 09 2002 14:43 Oct 21, 2003 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\89327.TXT SJUD4 PsN: CMORC
2

tion to reproductive cloning and stress that our bill would impose 

severe criminal penalties on anyone participating in that activity. 

It is the other pathway, using nuclear transplantation as a 

source to derive stem cells, that has generated so much excitement 

in the scientific community and has spawned so much discussion 

of the ethical dimensions of this type of research. 

I am proud to hold a right-to-life philosophy. I believe that 

human life begins in the womb, not in a petri dish. While I recognize that not everyone agrees with me, I am heartened that so 

many of the people that I meet in Utah and throughout the country, including many fellow right-to-lifers, have supported me in my 

views. I believe that as the public studies and reflects upon these 

issues, support for the legislation we have drafted will grow. 

Deciding where one stands on this matter is not easy. Among the 

difficult questions that must be carefully considered are: what does 

it mean to be human, when does life begin, and in our quest to improve the quality of human life, how can we best establish ethical 

safeguards to protect against doing harm to mankind? 

These are not easy questions. Although some are calling for a 

moratorium on somatic cell nuclear transfer, I fail to see how a 

moratorium will help our society fully consider, debate, and attempt to resolve the ethical issues. 

The cost of delay is real. Some 100 million Americans might 1 

day benefit from embryonic stem cell research. We must not forget 

them. There is no way to impose a moratorium on their pain and 

their suffering. We must also understand that this avenue of inquiry is still in the very early stages, and we must conduct basic 

research before any new tests or treatments can be developed. 

Some argue, including some of those you will hear today, that 

adult stem cell research is actually superior to embryonic stem cell 

research. I support a vigorous program of adult stem cell research. 

I just hope that my colleagues will listen carefully to our scientific 

witnesses today, because it appears that the consensus among most 

scientists is that embryonic stem cell research, including stem cells 

derived through nuclear transplantation, offers unique and perhaps 

revolutionary opportunities. 

From my discussions with experts, including Dr. Irv Weissman, 

of Stanford, and University of Utah faculty Dr. Mario Capecchi, a 

leading mouse stem cell researcher, and Dr. Stephen Prescott, the 

Director of the Huntsman Cancer Institute, I conclude that this 

line of research merits further investigation and it merits our support. 

At the least, we should all acknowledge that the progress that 

there has been with adult stem cells has been largely attributable 

to a 20-year head start in Federal funding of this research. I plan 

to work with Senators Specter and Harkin as they develop legislation to expand the number of stem cell lines derived from embryos 

no longer needed in the in vitro fertilization process beyond those 

lines deemed eligible by the administration for Federal funding. 

The issues we face today are difficult, but not totally unprecedented. For example, our society successfully addressed the issues 

attendant to recombinant DNA research and in vitro fertilization. 

Our bill, along with criminalizing reproductive cloning, contains 

a number of strict ethical protections. These include making this 

3

private sector research comply with the Federal Protection of 

Human Subjects regulations; separating the egg collection site from 

the nuclear transplantation research laboratory; a prohibition on 

exporting cloned embryos to any foreign country that does not ban 

human reproductive cloning; a prohibition on conducting nuclear 

transplantation research on fertilized eggs for a requirement that 

each egg donation be made voluntarily and that there be no profiteering on donated eggs; and a prohibition similar to the English 

rule on research conducted more than 14 days after the nuclear 

transplantation has occurred. 

These are sound rules. If we adopt these ethical requirements, it 

is likely that other countries will follow our lead. Unless we act to 

build an environment that encourages the United States to remain 

the leader in stem cell research, we will have lost much. 

Failure to enact legislation patterned after S. 303 can only undermine our Nation’s leadership in biomedical research. Investors 

and firms will be reluctant to commit the necessary resources to 

succeed in this costly, new arena if there is not a measure of certainty in the legal environment for this activity. 

Andy Grove, CEO of Intel, recently sent me an article that details how China is attempting to take the lead in this field of research. If this research is stifled, some of our best young scientists 

may feel compelled to move offshore and away from American patients. Such an outcome will not be good for the citizens of Utah 

and our neighbors across the country. 

Let me close by sharing with you a letter I recently received from 

Nancy Reagan that I think frames the issue in a helpful way. That 

letters says, ‘‘Dear Orrin, as you may know, Ronnie will observe his 

ninety-second birthday soon. In earlier times, we would have been 

able to celebrate that day with great joy and wonderful memories 

of our life together. Now, while I can draw strength from these 

memories, I do it alone, as Ronnie struggles in a world unknown 

to me or the scientists who devote their lives to Alzheimer’s research. Because of this, I am determined to do what I can to save 

other families from this pain. I’m writing, therefore, to offer my 

support to offer my support for stem cell research and to tell you 

I am in favor of new legislation to allow the ethical use of therapeutic cloning. Like you, I support a complete ban on reproductive 

cloning. However, I believe that embryonic stem cell research, 

under appropriate guidelines, may provide our scientists with 

many answers that are now beyond our grasp. Orrin, there are so 

many diseases that can be cured, or at least helped, that we can’t 

turn our back on this. We’ve lost so much time already. I can’t bear 

to lose anymore. Sincerely, Nancy.’’

Well, she is very dear to me, as is her husband. We have always 

been very good friends. Nancy Reagan is just one of thousands and 

thousands, and millions of people who are hoping that we might be 

able to find some breakthroughs that would help the living to be 

able to have lives that are more worthwhile, more healthy, and 

more resolving of the problems that they face everyday. 

With that, I am going to turn to Senator Feinstein for her remarks, and then if anybody on our side would care to remark, we 

will be glad to have that. 

Senator Feinstein? 

4

STATEMENT OF HON. DIANNE FEINSTEIN, A U.S. SENATOR 

FROM THE STATE OF CALIFORNIA 

Senator FEINSTEIN. Thank you very much, Mr. Chairman, and I 

am very proud of your leadership on this issue. I know how hard 

you have worked. I know the prayer and soul-searching that you 

have gone through to come to the position which you hold today, 

and that is a position which I share. I am very proud to cosponsor 

with you certain legislation which I will discuss in a moment. Also, 

we are joined by Senators Specter, Kennedy, Harkin, Corzine, 

Boxer, Lautenberg, and Durbin. 

If I may, Mr. Chairman, I would like to introduce a statement 

for the record from the ranking member, Senator Leahy. 

Chairman HATCH. Without objection. 

Senator FEINSTEIN. Thank you very much. 

Mr. Chairman, I hope that this hearing will help convince people 

that it is possible to draw a line between human cloning and valuable nuclear transplantation; that is, so-called stem cell research or 

therapeutic cloning. 

Many of us were disappointed with the House vote on this issue 

last month, and we know that a majority of Senators appear to disagree with the House’s position. I am hopeful that the Senate will 

pass our legislation that we introduced to ban human reproductive 

cloning, while ensuring that important medical research can go forward under strict oversight from the Federal Government. 

Simply put, this research offers hope to millions of Americans 

suffering from paralysis and debilitating diseases, including juvenile diabetes, Parkinson’s and Alzheimer’s. But let’s be very clear: 

human reproductive cloning is immoral and unethical. It must not 

be allowed under any circumstances. But at the same time, we 

must not, and we should not, I believe, prohibit nuclear transplantation research. It holds too much promise for millions of Americans. 

Just this past December, we were told that the Raelians had 

cloned a human being. This is almost certainly a hoax. However, 

it underscores the point: we must ban human reproductive cloning 

now before some unethical scientist is successful in creating a 

human clone. 

I believe this is a point on which we all agree. Human reproductive cloning is wrong. It should be banned forever, and our legislation which we have introduced does just that. But our legislation 

also allows medical researchers to continue to use what appears to 

be the most promising technique to cure debilitative diseases—somatic cell nuclear transplantation, a process used to produce embryonic stem cells. Under our legislation, though, these researchers 

will not have a free hand. They must conduct this research ethically, under strict guidelines, and with close oversight by the Federal Government. 

Now, I also believe that our bill is in the mainstream of American thinking on this subject. Just this morning, at nine o’clock, a 

poll was released that was done by Opinion Research for the Coalition for the Advancement of Medical Research. It was conducted on 

March 6 of this year, and what it shows is that 67 percent of those 

surveyed said they favored Congress allowing therapeutic cloning 

5

research to continue, while 30 percent polled wanted to outlaw the 

research. This was a poll of 1,012 adult Americans. 

So if I may, Mr. Chairman, I would like to place that in the 

record, as well. 

Chairman HATCH. Without objection. 

Senator FEINSTEIN. Mr. Chairman, our legislation will place 

tough regulations on scientists conducting nuclear transplantation 

research. It would impose a sentence of up to 10 years in Federal 

prison for anyone attempting to clone a human being, and establish 

a minimum civil penalty of $1 million, or three times the gross 

profits resulting from the violation, whichever is greater. 

It would mandate that eggs used in this research be unfertilized. 

We do so so there is no question that it is not a fertilized egg. We 

would prohibit the purchase or sale of unfertilized eggs, including 

eggs that have undergone nuclear transplantation. This would prevent so-called embryo farms or the possible exploitation of women. 

We would impose strong ethics rules on scientists, mandating informed consent by egg donors. We would have any nuclear transplantation research reviewed by an ethics board, and we would provide safety and privacy protections. We would also prohibit any research on an egg cell after 14 days, when that cell begins to divide 

and when cell differentiation takes place. So that egg would have 

to be disposed of before any of those things take place. These provisions establish a clear divide between nuclear transplantation research used only to produce embryonic stem cells and human reproductive cloning. 

I deeply believe that embryonic stem cell research has the potential to save literally millions of lives and to improve the quality of 

life for millions more. The promise of embryonic stem cells is that 

they are easily replicated, undifferentiated cells that can be induced into changing into any cell in the body—a heart cell, a liver 

cell, a spinal cord cell, or a kidney cell. 

Talented scientists across the country, and indeed the world, are 

conducting research using embryonic stem cells in the search for 

new cures and treatments. My point here is that this research is 

going to go on and it is going to go in other countries, and certain 

countries are establishing headquarters for this kind of research. 

So if we don’t move, we also risk the likelihood that we will lose 

some of our best scientists to other countries where they can conduct this somatic cell nuclear transfer research. 

In a preliminary study at Washington University, embryonic 

cells inserted into rats have led to regeneration of a rat’s spinal 

cord. The once crippled animals have been able to walk and bear 

their own weight. Imagine what this could mean for the 250,000 

Americans paralyzed by spinal cord injuries. 

Similarly, preliminary findings at the University of Wisconsin 

have shown that human embryonic stem cells can differentiate and 

actually express the insulin gene. Imagine what this could mean to 

17 million Americans suffering from diabetes. Much more research 

and testing needs to be done, but clearly these findings offer hope 

to those Americans who suffer from chronic, debilitating disease. 

Now, some have suggested that this research can be done without nuclear transplantation. They point to research being done, for 

example, with adult stem cells. I strongly support adult stem cell 

6

research and other research not involving stem cells, but I agree 

with leading scientists who argue that embryonic stem cell research offers much more promise than adult stem cell research. 

Why? Because the fact remains that adult stem cells are less 

versatile than embryonic stem cells. They don’t have the ability to 

be potentially grown into any organ or any tissue. They can be 

grown into certain organs or certain tissues, but not any. 

In addition, I support using nuclear transplantation to generate 

embryonic stem cells. Embryonic stem cells generated through 

means other than nuclear transplantation are much less useful. 

Any new organs or tissues created would not have the same DNA 

as the patient, and this is critical, forcing him or her to take dangerous immunosuppressant drugs and increasing the chances of rejection. 

In America today, there are more than 128 million Americans 

who could benefit from embryonic stem cell research. One of these 

is Emma Arvedon. Only a few years old, she suffers from juvenile 

diabetes. Her father wrote to us and this is what he said: ‘‘Our 

family is enormously hopeful that nuclear transplantation research 

may play a vital role in finding a cure for juvenile diabetes. There 

already exists empirical evidence that quite possibly this research 

could yield the insulin-producing pancreatic cells that my daughter’s body lacks. If research into this process were to be 

criminalized, how would I explain to Emma that our Government 

cares more about a cloned cell, smaller than a grain of sand, than 

they do about her?’’

So we today are introducing this legislation for Emma and the 

millions like her with the resounding support of the medical and 

scientific community. To deprive Emma and her family of a possible cure, to close the door on nuclear transplantation research, 

would be nothing short of tragic. 

We can, and should, ban human reproductive cloning, without 

hurting Emma and her family and the 127 million families like 

her. That is why we are here today, to offer hope to millions of 

Americans, and to help turn that hope into reality. 

So I am very proud, Mr. Chairman, to join you and to join Senators Specter, Kennedy, Harkin, Corzine, Boxer and Lautenberg, 

and as of yesterday, I believe, Senator Durbin, in sponsoring this 

legislation. 

Chairman HATCH. Thank you, Senator. We are happy to have 

Senator Durbin as a cosponsor. 

Senator Craig would like to make a short statement. 

STATEMENT OF HON. LARRY E. CRAIG, A U.S. SENATOR FROM 

THE STATE OF IDAHO 

Senator CRAIG. Well, thank you very much, Mr. Chairman. I am 

anxious to hear the testimony, and I will read most of it because 

I am going to have to leave. I will be brief. 

Let me ask unanimous consent that my full statement be a part 

of the record. 

Chairman HATCH. Without objection. 

Senator CRAIG. Let me say that I, like I think most who have 

spoken already, you and Senator Feinstein, am opposed to human 

7

cloning. I think morally and ethically I feel that the use of experimental science in the creation of human life is unacceptable. 

However, I understand that biological research could provide assistance to burn victims, heart attacks, diabetes, Parkinson’s, leukemia, and the list could go on and on, the crippling and fatal diseases that many of our citizens face and experience. 

But we must also accept that there is a need for limits when research goes beyond the boundaries of what is considered to be ethical, and that is the responsibility of this Committee and that is the 

responsibility of this Congress to draw that line and that is what 

we are attempting to do here. 

I am a cosponsor of S. 245. I am glad to see Senator Brownback 

here this morning. He has been an outspoken leader in this area. 

I also appreciate the work you are doing, Mr. Chairman and Senator Feinstein, and others, as we sort this out. And it really is that 

business that we are into at this moment because this is an issue 

that will be addressed legally and within the law, I do believe, in 

a reasonably short period of time, and it should be. 

Again, I do want to stress the importance of advancing medical 

research. There are countless people living with devastating diseases who live with the hope that medical research will help save 

their lives. I look forward to learning more about how we can make 

those advances in the area without treading on the sanctity of 

human life. We have that responsibility. 

Thank you. 

[The prepared statement of Senator Craig appears as a submission for the record.] 

Chairman HATCH. Thank you, Senator. 

We will begin with two distinguished Members of Congress. We 

are honored to have both of you here. Both hold the right-to-life 

philosophy. While they agree on the need to ban reproductive 

cloning, they have reached opposite conclusions on the matter of 

nuclear transplantation for research purposes. At least that is my 

understanding. 

Senator Brownback is no stranger to this Committee. We miss 

you. We wish you were still on the Committee, and on this issue 

I am sure you wish you still were on the Committee. 

Senator BROWNBACK. Yes, I do. 

Chairman HATCH. We welcome you back, Sam. We are grateful 

to have you here. 

Senator Brownback is the lead sponsor of legislation that would 

ban somatic cell nuclear transfer for both reproduction and research purposes. 

We also want to welcome to the Committee Representative Jim 

Langevin. Congressman Langevin is from Rhode Island and is in 

his second term in the House. We want to thank you for appearing 

with us today. It means a lot to us. I know that you have a commitment on the House side that will require you to leave as soon as 

you testify, and we will understand that. 

Before we start with Senator Brownback, I want to mention that 

due to scheduling conflicts with some of our members, the Committee will recess this hearing at about 11:30 and then reconvene 

at 1:30. We may only be able to get through this first panel this 

morning. Maybe if we have enough time, I will call the fourth 

8

panel so that we can do that. We will see how it goes and maybe 

we can reach that fourth panel, and then we will do the others as 

soon as we get back at 1:30. 

So let’s start with my friend, Sam Brownback. 

Senator BROWNBACK. Mr. Chairman, thank you very for allowing 

me to be here. I would be happy to let Congressman Langevin go 

first if he has a scheduling conflict. 

Chairman HATCH. That is very gracious of you. 

Congressman would that help you if you go first? 

Representative LANGEVIN. I am fine with waiting for the Senator. 

I don’t mind waiting. It is up to you, Senator. 

Chairman HATCH. Senator Brownback? 

STATEMENT OF HON. SAM BROWNBACK, A U.S. SENATOR 

FROM THE STATE OF KANSAS 

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

Chairman, and I would like to be back on the Committee to do a 

great deal of very important work. I hope you can clear some 

judges on through. I think the Federal bench could sure use it, and 

the appellate court bench in particular. 

Chairman HATCH. We are doing our best. 

Senator BROWNBACK. I know it is a difficult task. I also have appreciated my association with the Chairman over many years on 

many different topics. We have worked closely and carefully together, and I have always appreciated his great leadership, his 

thoughtfulness and his legislative ability. He is an excellent legislator. 

Chairman HATCH. Thank you. We are dear friends, there is no 

question about it. We do have our differences on this, but we can 

still be dear friends. 

Senator BROWNBACK. I hope to persuade you of the reasonableness of my position. 

Chairman HATCH. The error of ways? 

Senator BROWNBACK. Yes. 

Let me start with the good news, if I could. Senator Feinstein 

was talking about the hope and the promise of cloning and embryonic stem cell research. Let me produce for you a newspaper articles on cures from adult stem cells. This was in the Wall Street 

Journal March 6 of this year. Some of you may recall this story. 

This was about the 16-year-old boy who was shot through the 

heart with a nail gun, the other gentleman being charged with the 

crime. About a third of his heart was destroyed in this. The next 

day after the nail gun was shot through his heart, he had a heart 

attack, destroying further areas around it. 

They took stem cells from his bone marrow, so these are not 

heart stem cells; these are bone marrow stem cells. The first time 

in this country—this has been done overseas, but the first time in 

this country. They collected them, concentrated them and injected 

them back into his heart. He is now walking, talking, getting bored 

having to lie around. This has been an amazing repair procedure 

that has taken place with adult stem cells in humans. This isn’t 

about a promise that is taking place that we might have this taking place with cloning. This is in humans and it is occurring today, 

and I would ask that this full article be submitted into the record. 

9

Chairman HATCH. Without objection, we will put that in the 

record. 

Senator BROWNBACK. It also shows the malleability, the pliability 

of adult stem cells, that were thought previously, as we haven’t 

really understood these for very long, to be not particularly pliable, 

they weren’t malleable. But it turns out that particularly bone 

marrow stem cells are. 

We also learning from the scientific community that we have 

these stem cells throughout our bodies, adult stem cells. They are 

kind of like repairmen. They go around the building; they go 

around the Dirksen Office Building repairing different things. But 

if there is a massive attack somewhere, there are not enough of 

them to be able to fix the problem that might blow up, if we have 

a furnace that blows up, if we have some other problem. So they 

have to bring in more, and that is the idea of concentrating, sending them into a particular spot, and it is working. 

Now, some in the scientific community when adult stem cells 

first came out said this is not an answer, this doesn’t work; junk 

science, some referred to. I would say that this young man in Ohio 

would not refer to this as junk science at all. This is something 

that is saving his life. 

We are seeing this taking place in a broad cross-section of areas 

in adult stem cells. I remember when we started this debate on 

cloning a couple of years ago, people were saying adult stem cells 

really don’t work; well, sure, I support it, but it doesn’t really work; 

they don’t have the plasticity to be able to do it. 

Here is a book of the research articles now in adult stem cells. 

These are human trials and animal trials that are taking place in 

a variety of different areas—brain damage, cancer, cerebral palsy, 

diabetes, heart damage, eye diseases, multiple sclerosis, muscular 

dystrophy, Parkinson’s, spinal cord injuries, sickle cell anemia, 

transplants, overall versatility—and then sources at the end of it. 

Chairman HATCH. Senator, would you submit that for the record? 

Senator BROWNBACK. I would be happy to submit these to the 

record. We try to get these updated every 2 weeks. There is so 

much coming out in the area. 

Chairman HATCH. Well, let’s keep the record open so that you 

can submit whatever comes in, and then we will certainly look at 

every bit of that. We are all for what you are talking about. 

Senator BROWNBACK. My point in saying this is as I have started 

this debate several years ago, the research and how you treat the 

young human and the need to clone is immoral, illegal and unnecessary, were the three points that we started this debate with 

about 3 years ago, maybe a few more. 

I wanted to point to the last point on this about the unnecessary 

side of this. We have huge findings that are taking place in humans and in animal trials that these are occurring. We don’t need 

to go the cloning route because you have to cross the fundamental 

issue which we are all struggling with, which is when does human 

life begin, and is that youngest of human life something that is 

owned by somebody or is its own life? Is it a person or is it property, which is a point I have posed to the Chairman numerous 

times? How are we going to treat this youngest of human life? Are 

10

we going to treat it as a person or are we going to treat it as a 

piece of property? 

This is a philosophical issue, an issue perfectly suited for the Judiciary Committee to discuss, but one which we as a society have 

been, to date, unwilling to decide. We have been unwilling to say 

it is property and therefore it can be disposed of as its owner chooses, or it is a person and therefore it has legal rights. We have been 

unwilling to decide. 

Here, I would quote Ronald Reagan, when he said—and I am 

paraphrasing here—if you didn’t know if a person was dead yet, 

you wouldn’t bury him. I would put it in reverse, saying if you are 

not sure if it is a life or not, you wouldn’t kill it. We are at one 

of those similar sorts of questions. 

Are we sure or convinced that this is life, or isn’t it human life? 

Some would say it is clearly human life, it is genetically defined 

as human life, it has a full set of chromosomes, it is human life; 

all it needs is care and nurturing and it can become a full human 

life under anybody’s definition. 

There are others who will say, well, without care and nurturing, 

without it being in the womb, it cannot be human life, it cannot 

grow to a full life expectancy, and therefore it must be property. 

We could treat it as such. We could patent it. We will need to patent these young embryos, we will need to patent these clones. 

We haven’t been willing to deal with that, and that is why I submit to you that we have a procedure and it is working and it is 

working brilliantly. It is working wonderfully and it is producing 

results today. Why would we kill it if we are not sure it is alive? 

I also want to go into the issue about definition because this is 

a debate that is replete with questions about definition. First, I 

would submit, and I think this is very clear from the scientific evidence, that there is only one type of human cloning and it always 

results in the creation of a new human being. 

Many of the proponents of human cloning would have society believe there are two different types, the so-called reproductive and 

the so-called therapeutic. Well, these are not two types of cloning. 

There is only one and it always results in the creation of a new 

human embryo. 

There are others who would say we want to do nuclear somatic 

cell transfer. That is fine, but that is the name of a procedure that 

produces a clone. That is the name of a procedure and that procedure results in a human clone. Attempts to put a different label on 

it or change the intentions of the researcher by suggesting that are, 

I think, unhelpful to the debate. 

At the end of the process of somatic cell nuclear transfer, you end 

up with a clone, and that is the question about how are we going 

to treat clones. Are we going to treat them as a person or are we 

going to threat them as property? I would submit that we should 

not create this human life just to destroy it for the research on it. 

Recently, in what appears to be attempts to avoid negative opinion, a new term has been used to describe human cloning, the term 

of ‘‘unfertilized egg.’’ It is a euphemism that is being used by people 

who are proponents of therapeutic cloning. This term, which is as 

confusing as can be, I think, needs closer examination. 

11

Any biology textbook will define a human ovum or egg as a single cell. Moreover, it is a very unusual cell, a gamete cell, which 

means it has only 23 active chromosomes, half the number. Gender 

has not yet been determined. An ovum cannot grow stem cells or 

otherwise develop because it is just an egg. 

However, once an egg contains a complete nucleus, the full set 

of chromosomes from any species that is activated and developing, 

whether that has occurred by sexual fertilization or by asexual somatic cell nuclear transfer, then one has a developing embryo of 

that species, whether it is a sheep in the case of Dolly, which was 

asexual reproduction, or whether it is a cow or whether it is a 

homo sapiens. 

There is no such thing in biology or in any dictionary as a human 

egg or egg cell that has 46 chromosomes, has been determined to 

be either male or female and is 5 days old, consisting of several 

hundred cells, or 14 days old consisting of several thousand cells. 

Calling a 5-day-old or a 2-week-old human embryo an egg is an attempt really to hide the fact that this is an embryo and it is the 

true nature of a human clone, just as Dolly was at that stage a 

clone of a sheep. 

The phrase ‘‘unfertilized blastocyst’’ is likewise being used in this 

debate. Now, the term ‘‘blastocyst,’’ of course, refers to a stage of 

embryonic development, and an egg would never be a blastocyst. 

You are at an embryo stage. Human cloning is human cloning. All 

human cloning, I would submit to you, is wrong, no matter what 

one wants to call it or by what procedure you get to that clone. 

I think these definitions are important because what we need to 

deal with is the issue of human clones and what we intend to do 

with them as a society. The House has passed a bill by a large 

margin saying we should not be researching on humans and we 

should not create human clones. 

The cloning field is a very less-developed field to date. We saw 

Dolly was just put down, put to death, because of premature problems that she had. I think it is a very dangerous thing to submit 

human beings to. I think it is immoral to research on young humans. I don’t think it is right for us to create life to research on 

it, and we don’t need to; we have other routes to go. For all those 

reasons, I am here in opposition to human cloning either for therapeutic research purposes or for full reproductive purposes. 

I would be happy to take your questions. 

Chairman HATCH. Thank you, Senator Brownback. 

Congressman Langevin? 

STATEMENT OF HON. JIM R. LANGEVIN, A REPRESENTATIVE 

IN CONGRESS FROM THE STATE OF RHODE ISLAND 

Representative LANGEVIN. Thank you, Senator Hatch. I am honored to be here today and to be seated with Senator Brownback. 

I appreciated listening to his thought-provoking views, and I know 

they are well-thought-out, though we disagree on the issue. I enjoyed hearing his perspective. 

Senator Hatch, I would like to thank you and Senator 

Brownback, Senator Kennedy, Senator Feinstein, and the entire 

Judiciary Committee for convening today’s hearing on the topic of 

cloning. 

12

I feel strongly that it is time to pass a law that will put this matter to rest. Patient advocacy groups, leading scientists, lawmakers, 

and a majority of the American people agree that human reproductive cloning should not be allowed. It is clearly the obligation of 

Congress to pass a law prohibiting and criminalizing this practice, 

and to encourage other nations to follow suit. 

In the course of the debate on cloning, we have heard much discussion about somatic cell nuclear transfer, the procedure commonly referred to as therapeutic cloning. In the year-and-a-half 

since Congress first addressed this matter, I have studied the principles of nuclear transfer and analyzed the issue from the perspective of a policymaker, a pro-life Democrat and Member of Congress, 

and a devoted advocate of improving the lives of those with disabilities and diseases. 

I particularly want to thank you, Senator Hatch, and Christopher Reeve and many others on both sides of this issue for your 

advice and counsel in helping to arrive at my position. 

After a great deal of thought and discussion and personal struggle, it is my carefully considered position that we can and should 

ban the cloning of human beings without impeding ground-breaking and promising biomedical research in the area of somatic cell 

nuclear transfer. Like Senator Hatch, my pro-life beliefs include a 

commitment to defend, extend and improve the lives of those who 

are living among us. 

As many of you know, in the 107th Congress I became the first 

quadriplegic ever elected to the United States House of Representatives. While my physical condition does not define me, it does affect 

me on a daily basis, providing me with a unique perspective, shaping my pro-life position and my understanding of the value of the 

type of research that we are here to discuss. 

At the age of 16, I was in my fourth year of participating in the 

Warwick Police Cadet Explorer Scout program. I thought I was 

well on my way to realizing my dream of being a police officer or 

an FBI agent. But on August 22, 1980, my dream was shattered 

and my life was changed forever. 

I stood in a locker room with a fellow cadet watching two members of the SWAT team examining a new handgun. It accidentally 

discharged, launching a bullet that ricocheted off a metal locker 

and through my neck, severing my spinal cord and leaving me paralyzed for life. 

But perhaps now there is new hope for me and millions of others. 

Having come so close to losing my own life, I am reminded everyday of how precious a gift life truly is, and that is what has led 

me to be pro-life. I see my position in supporting therapeutic 

cloning as consistent with my pro-life views. 

In somatic cell nuclear transfer, the nucleus of a donor’s 

unfertilized egg cell is removed and replaced with the nucleus of 

a patient’s own cell; for example, a skin cell. Doctors are then able 

to develop stem cells that will not be rejected by the patient’s own 

immune system. The cells are never transplanted into a womb, and 

to me that is the difference between ethical regenerative medicine 

and immoral human cloning. 

Nuclear transfer is the cloning of one’s own cells, not the cloning 

of any viable form of life. A legal prohibition against implantation, 

13

as provided by the bill offered by Senator Hatch, provides sufficient 

assurances that nuclear transfer is ethical and should be allowed 

to proceed. 

Scientists believe that the knowledge they can gain from somatic 

cell nuclear transfer can lead to cures and treatments for conditions including Alzheimer’s, Parkinson’s, cystic fibrosis, diabetes, 

and even spinal cord injuries. The research done with cloned cells 

produces stem cells which have the potential to yield life-saving 

and life-enhancing treatments for millions of people living with diseases and disabilities. With appropriate safeguards, we can remove 

the risk of misuse of this technology and encourage scientific research that is likely to yield undeniably life-affirming results. 

Please understand that I am here to speak today not just for myself as a lawmaker and as someone living with a disability, but on 

behalf of the millions of people who struggle daily with the pain, 

suffering and debilitating effects of disease and disability. 

Many lives could be saved, lengthened and dramatically improved by this research. Large numbers of Americans could benefit 

from therapeutic cloning, including 1 million children with juvenile 

diabetes, 4 million Alzheimer’s sufferers, 230,000 people living with 

spinal cord injuries, 30,000 children and adults affected by cystic 

fibrosis, and 30,000 Lou Gehrig’s Disease patients. 

Every family in America has been touched by these diseases and 

conditions, and through the medical advances such as those being 

explored in somatic cell nuclear transfer and stem cell research, we 

have the opportunity to offer them real hope. 

I must also acknowledge the progress being made on these issues 

through other aspects of stem cell research. We do not yet know 

which research project might yield the treatment for Alzheimer’s or 

a cure for diabetes or the many other conditions and diseases that 

I have mentioned. We must explore all avenues of treatment for 

people living with disease and disability. 

In my research that led me to support embryonic stem cell research, I spoke with one of the foremost experts in adult stem cell 

research, Dr. Peter Quisenberry, from my home State of Rhode Island. He has devoted his career to adult stem cell research and he 

believes so strongly in the hope that that particular research offers. 

Yet, he acknowledges to me that we don’t yet know where the 

greatest potential for treatment of individuals with disabilities and 

diseases truly lies, whether it is adult stem cell research or embryonic stem cell research. 

Therefore, he believes that we should proceed on both tracks. In 

the quest to find new treatments and cures, we must leave no 

stone unturned, and it is essential that we continue to explore both 

adult and embryonic stem cell research, as well as somatic cell nuclear transfer. 

As legislators, we have a responsibility to protect society against 

abuses of technology. We also have an obligation to maximize its 

benefits in a responsible and ethical way. Clearly, human cloning 

is such an abuse and Congress must take the necessary measures 

to protect society from this exploitation. 

The bill offered by Senator Hatch provides these measures to 

offer the opportunity to ban human cloning without concurrently 

halting critical research in the area of area somatic cell nuclear 

14

transfer which promises a significant increase in quality of life, and 

in many cases the promise of extending and improving life itself for 

millions of Americans, and indeed for millions of people around the 

world. 

When we addressed this issue last month in the House of Representatives, an amendment was offered by Representative Greenwood containing the provisions protecting somatic cell nuclear 

transfer that you see in the Hatch bill. It generated 174 votes, indicating a significant amount of support for therapeutic cloning. 

However, it failed to pass the House. 

Subsequently, it may now be up to the Senate to make sure that 

the door is not closed on promising medical research. It is my hope 

that the Senate will pass a bill banning reproductive cloning, yet 

encouraging somatic cell nuclear transfer research, and setting the 

criteria for it to move forward in a responsible fashion under the 

direction and oversight of credible, trusted entities like the NIH. 

To that end, I urge my colleagues in the Senate to support S. 

303, in recognition that it provides appropriate safeguards against 

the ethically questionable practice of reproductive cloning, while 

maintaining the promise of the best in medical technology for all 

Americans. 

Mr. Chairman, I thank you for your time here today. 

Chairman HATCH. Well, thank you. I want to thank both of you 

for your testimonies. They are divergent in some ways, but both 

very sincere and dedicated testimonies. So I commend both of you. 

Congressman we will let you go. We know you have got to get 

back over to the other side of the Hill, but we are honored to have 

you here and we are very appreciative of your testimony. 

Representative LANGEVIN. Thank you, Senator. 

Chairman HATCH. Thank you so much. 

Sam, only one question from me, and that is it may be that neither bill will pass. But if that is not the case, we ought to join 

hands and at least pass a ban on reproductive cloning. I hope that 

is the minimum that we do this year. Hopefully, we can do that. 

That is all I wanted to say. 

Does anybody else have any questions? 

[No response.] 

Chairman HATCH. We are grateful to have you here. 

Senator BROWNBACK. Thank you very much. We will be having 

a hearing on the impact of therapeutic cloning on women next 

week because, as noted, if we move forward with this, there would 

be millions of eggs needed. We are going to look at that procedure 

in the Commerce Committee next week because there will be markets being created. 

Chairman HATCH. We will look forward to seeing what your panels say at that time. 

Senator BROWNBACK. Thank you. 

Chairman HATCH. We are very close to where we have to get 

over to that top-secret meeting. 

Senator FEINSTEIN. I beg your pardon? 

Chairman HATCH. We are very close to where we need to get 

over to that top-secret meeting. Should we try and do the fourth 

panel? 

15

Senator FEINSTEIN. If they are here. My understanding was—I 

know the signals have changed about this meeting—that there 

were going to be these opening comments and then we were going 

to recess until 1:30 today. Perhaps that has changed. 

Chairman HATCH. Well, I wonder if Jim Kelly and Greg Wasson 

are here. 

You are Mr. Wasson. Is Jim Kelly here? 

Mr. KELLY. Yes. 

Chairman HATCH. Well, I wonder if we could take both of your 

testimonies at this time. We will try and do it. If you can limit your 

testimony to 5 minutes, we can still make our appointment over in 

the Capitol. We will start with you so that you don’t have to stick 

around all day if you don’t want to. 

This next panel consists of two patient advocates. We want to 

thank Jim Kelly and Greg Wasson for traveling here today. While 

you both have reached different conclusions with respect to the 

best course for public policy with respect to stem cell research, no 

one can doubt that you share the ability to passionately convey 

your views. So we are pleased to have both of you before the Committee today. If you can summarize your remarks within 5 minutes, we will put your full statements in the record as thought fully 

delivered. 

Mr. Kelly, we will start with you first. 

STATEMENT OF JAMES KELLY, GRANBURY, TEXAS 

Mr. KELLY. Thank you, Mr. Chairman. 

Two years ago while closely researching my own condition, I 

blindly accepted media reports claiming embryonic stem cells were 

our best hope to cure other conditions. When I realized the push 

for cloning was supported by companies that claimed they had no 

interest in pursuing the field, I wondered why. 

When I read media reports that sharply contrasted with information I had gathered from medical journals, I became concerned. 

When I read of my own condition being used to justify cloning, I 

began studying the issue in earnest. This is what I found. 

In embryonic stem cells derived from cloning, chromosomes 

transferred in the cloning process retain physical changes that accrue with age. These age-related changes are known to contribute 

to age-related disease. Investors are unwilling to invest in cloning, 

since its potential for leading to clinical treatments, if any, is considered decades away, or as a recent New York Times articled concluded, ‘‘in the distant future.’’ Biotechnology corporate leaders believe its chances of success are ‘‘vanishingly small.’’

The public is being told that therapeutic cloning does not require 

the creation and killing of human embryos, when, in fact, that is 

exactly what it does. We have been led to believe that cloning’s 

widespread and variable genetic defects pose no therapeutic risk. 

The truth is that researchers don’t know how many genes are affected by cloning, or cloning’s potential for mutation or aberrant 

imprinting during adult cell mitotic division, or the long-term consequences of introducing such cells into adult organs. 

Dr. Robert Marcus, Director of the East Anglia Bone Marrow 

Transplant Unit, explains the risks: ‘‘Any time you transfer genes 

within the cloning process, or change the genetic material within 

16

a cell, there may be defects introduced into a natural organ or species development. I think I would be quite cautious there.’’

Embryonic stem cells derived from cloning are not expected to 

perfectly match the donor. They may face rejection and require immune suppression. Dr. John Gearhart told the President’s Council 

on Bioethics there is ‘‘no question’’ in his mind that embryonic stem 

cells derived from cloning ‘‘could be rejected.’’ ‘‘Absolutely,’’ Dr. 

Gearhart says. 

Dr. Irving Weissman explains: ‘‘I should say when you put the 

nucleus in from a somatic cell, the mitochondria still come from the 

host’’—that would be the egg—‘‘and in mouse studies it is clear 

that those genetic differences can lead to a mild but certainly effective transplant rejection and so immune suppression, mild though 

it is, will be required for that.’’

If custom treatments from cloning could someday exist, they are 

expected by leading scientists to be astronomically expensive. Australia’s leading embryonic stem cell expert, Professor Alan 

Trounsen, says the pace of stem cell technology has been so rapid 

that therapeutic cloning is now unnecessary. ‘‘My view,’’ he said, ‘‘is 

there are at least three or four other alternatives that are more attractive already.’’

In citing the clinical results using adult stem cells to repair 

human hearts, the director of a prestigious German medical journal 

presents a truth that Americans are not being told: ‘‘The promises 

of unscrupulous embryo researchers that clone without clear clinical goals and experiments are unsupportable. This remarkable 

proof has now given us a clear sign that the Americans with their 

prohibitions are exactly right. The biotechnological revolution can 

take place without embryonic stem cells if the alternatives are developed.’’

Embryonic stem cells from any source are not considered by most 

scientists to be the optimal transplantation cell of choice. This is 

another truth America is not being told which further explains 

why, in New Jersey, science and biotech are pushing for access to 

cloned late-term fetuses and newborn babies. 

To summarize, embryonic stem cells derived from cloning do not 

perfectly match the patient; contain known and unknown genetic 

defects, as well as defective imprinting; are expected to require immune suppression for immune-sensitive conditions; retain the genetic age of the donor; are not considered desirable for transplantation; and may be too expensive for patients to afford. 

Regarding the likelihood that science will overcome just one of 

these defects, Dolly’s creator predicted in Nature: ‘‘It should keep 

a lot of us in business for a long time.’’

Moreover, these flaws are in addition to critical defects already 

inherent in embryonic stem cells from any source. Regarding this 

point, the Institute of Science in Society, an international organization of 462 scientists from 57 countries, issued a statement: ‘‘The 

risks of cancer, uncontrollable growth, genome instability and other 

hurdles make ES cells a bad investment in terms of finance as well 

as public health benefits.’’ The Institute adds that adult stem cells 

‘‘are more likely to generate affordable therapies that can benefit 

everyone.’’

17

In other words, even if cloning’s very real practical concerns 

could be overcome, including its need for female eggs and its expected exorbitant costs, and even if rejection issues and genetic 

flaws could be addressed, it would still do nothing more than provide cells known to be genetically unstable, grow uncontrollably, 

and cause cancer. 

Why then are millions of dollars which could have been used to 

develop cures instead being spent on a national campaign to convince Americans that therapeutic cloning offers the brightest hope 

for cures? 

The ISIS offers an explanation: ‘‘Commercial imperatives are the 

major impetus for ES cell research, much more so than for adult 

stem cells. There are more opportunities for patenting cells and cell 

lines as well as isolation procedures.’’

The Institute concludes: ‘‘Scientists should stop manipulating 

public opinion to promote research that is both morally and scientifically indefensible. At the same time, governments need to invest our tax money in scientific research that can genuinely benefit 

the health of the nation, and not be misled by false promises of the 

next economic boom.’’

The exaggerated promise of therapeutic cloning is not a path to 

cures in our lifetime, but a dangerous diversion away from cures. 

It is in the interest of cures that I urge you to support S. 245, the 

Brownback-Landrieu ban on all human cloning. 

Thank you. 

[The prepared statement of Mr. Kelly appears as a submission 

for the record.] 

Chairman HATCH. Thank you, Mr. Kelly. 

We will turn to you, Mr. Wasson. 

STATEMENT OF GREG WASSON, COTATI, CALIFORNIA 

Mr. WASSON. Chairman Hatch, Senator Feinstein, and members 

of the Committee, thank you for giving me the opportunity to testify before you today. 

The potential of regenerative medicine is of great importance to 

my life. My name is Greg Wasson and I am here on behalf of the 

Coalition for the Advancement of Medical Research, CAMR. CAMR 

is comprised of universities, scientific and academic societies, patients’ organizations, and other entities that are devoted to supporting stem cell research. 

I, along with CAMR, support every effort to criminalize and ban 

human reproductive cloning. It is unsafe and it is unethical. However, it is imperative that we protect stem cell research using 

therapeutic cloning to provide better treatments and hopefully 

cures for a number of debilitating and presently incurable conditions. 

Eight years ago, I was diagnosed with Parkinson’s disease. My 

fiancee, Ann Campbell, who is here with me today, was given the 

same diagnosis that year. I was a lawyer. Ann was an editor and 

a children’s book author. Within 5 years of our diagnosis, we were 

both forced to retire on disability. I was later diagnosed with diabetes, a problem which runs in my family. 

An estimated 1 million Americans have Parkinson’s, a progressive, degenerative brain disorder that is presently incurable, whose 

18

cause is unknown, and which slowly robs its victims of the ability 

to move properly and eventually to move at all. 

We live with the knowledge that 30 percent of all Parkinson’s patients develop dementia and that we are three times as likely as 

the general population to develop Alzheimer’s. We have lesser cognitive problems which plague us as well. 

Eight years after my diagnosis, I take 25 pills per day. Yet, I 

have increasing difficulty controlling my symptoms. These medications do nothing to slow the progress of my disease. For both Ann 

and myself, the time will come when our medications will fail us 

permanently and we will be totally functionally disabled. We will 

leave this world and enter a twilight world of immobility, encased 

in our bodies as if entombed, able to think but not speak, understand but not communicate. Death will inevitably follow, and by 

then it may be welcome. 

Parkinson’s is just one of the many chronic diseases and conditions that are fatal, at worst, and leave their victims permanently 

disabled at best. These diseases and conditions affect more than 

100 million Americans. Each of us here today has a loved one or 

a friend who has a disease such as Alzheimer’s, ALS, diabetes, or 

Parkinson’s. 

Time is of the essence in pursuing promising research. Two years 

ago, I worked with a number of persons suffering from ALS. They 

became my friends. Now, 2 years later, most of them are dead. 

John Davis, an Alabama ALS victim and fellow advocate, fortunately still living, once said of embryonic stem cell using SCNT, 

‘‘this dog will hunt.’’ He meant that such research had the potential 

for saving countless lives, and he was right. But this research will 

hunt only if it is not leashed and muzzled. 

We are not without hope. Regenerative medicine, including responsibly regulated therapeutic cloning, may lead to a cure or 

treatment for Parkinson’s disease, ALS, and a host of other diseases and conditions. As you will hear today from the scientific 

panel, human reproductive cloning and cloning for therapeutic 

medical purposes are not the same. An unfertilized ball of perhaps 

100 cells the size of a pinhead is not a human being or anything 

near to one. The use of SCNT does not destroy human life; it is an 

attempt to restore human life. 

Ann Campbell and I, along with millions of other Americans, are 

human beings, human beings living with terrible diseases that will 

kill us unless cures are found. The willingness of some people to 

sacrifice our lives, to place less value on our lives than on a chemically-produced unfertilized mass of cells, perhaps grown from one 

of our own hair follicles, is to me the real shame and the real 

crime. 

Compassion and common sense must prevail. Ignoring the potential of therapeutic cloning would be a national tragedy and a huge 

mistake. But as with other scientific advances, a vocal and well-organized minority is trying to stop this research. Galileo, Columbus, 

and a South African physician named Christian Barnard all held 

scientific beliefs that frightened their contemporaries. But the 

earth does revolve around the sun, the earth is not flat, and today 

heart transplants are commonplace. 

19

Today, the target of scientific fear is therapeutic cloning. Opponents argue that legalizing therapeutic cloning will open the flood 

gates to a black market industry in reproductive cloning. But similar claims were once made that organ transplantations would lead 

to a huge black market in harvested organs. This fear was unfounded, and today donation and transplantation of organs is 

strictly and effectively regulated. 

Senators we believe that you understand and appreciate the 

enormity of the potential for saving human beings from fates such 

as Parkinson’s, ALS, diabetes and spinal cord injuries. We believe 

that, individually and collectively, you will make the choice to protect and to restore life. What greater legacy could any government 

leave its citizens? 

So because we have hope and faith that this country will recognize the value of research into regenerative medicine, Ann and I 

will be married this fall. On our wedding day, we will raise a glass 

to the promise of a new day when diseases like Parkinson’s are 

simply a terrible memory. In this Committee, in the Senate and in 

Congress, we place our highest hopes and most sacred trust. 

Thank you very much. 

[The prepared statement of Mr. Wasson appears as a submission 

for the record.] 

Chairman HATCH. Well, thank you. We thank both of you for 

being here. 

Questions, Senator Feinstein? 

Senator FEINSTEIN. No, Mr. Chairman, but I did want to read 

into the record—I should have done this when Senator Brownback 

was here—I would like to read something from Dr. Berg’s statement. For those who don’t know, Dr. Berg is the Chair of the Public Policy Committee of the American Society for Cell Biology. He 

is also a Nobel laureate in chemistry and he is known as, I think, 

a world expert on this subject. 

On page 5 of the testimony he is going to give—and I want to 

draw everybody’s attention to it—he says, ‘‘Both Congressman 

Weldon and Senator Brownback have accepted the assurances of 

their advisors that adult-derived tissue-specific stem cells, that is 

specialized stem cells that already exist in many of our tissues, are 

sufficient for meeting the clinical needs of repairing damaged or 

diseased tissue.’’

He goes on to say, ‘‘Those assurances contradict the evidence. 

The claims on which those assurances rest are largely anecdotal’’—

for example, the heart incident that Senator Brownback mentioned—‘‘relying on experiments that most often have not been replicated by others and, in some cases, are now known to be flawed.’’ 

For example, this heart incident had no science behind it. It was 

something that was tried, and so far it has worked and that is just 

great. 

‘‘Indeed, recent experiments have documented that claims that 

bone marrow can reconstitute tissues of other organs have been 

shown to be artifacts. Moreover, multipotent adult-derived stem 

cells have, with few exceptions, not been maintained in culture for 

any significant period.’’

‘‘It is certainly true that bone marrow harbors rare stem cells, 

the so-called hematopoietic stem cells that can reconstitute the enVerDate 0ct 09 2002 14:43 Oct 21, 2003 Jkt 000000 PO 00000 Frm 00023 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\89327.TXT SJUD4 PsN: CMORC
20

tire blood-forming system. Similar evidence exists that neural stem 

cells obtained from embryos can give rise to different neural cell 

types. But neural cells obtained by differentiation of cultured embryonic stem cells’’—and this is the key—‘‘can populate the brain 

and deliver sufficient dopamine to alleviate the symptoms of Parkinson’s disease in the mouse.’’

So the point I wanted to establish is this is what our legislation 

is really going to help develop, this new line of embryonic stem 

cells, where these cells can replicate themselves to be used with 

minimal rejection in virtually any part of the body. So I think that 

that point has to be made and we have to keep making it. 

For somebody like Mr. Wasson who has a problem and needs 

help, this is really the one area where he can get that help, and 

that is why it is so important. I just want to thank you for being 

here today. We are very grateful. 

Chairman HATCH. Yes? 

Mr. KELLY. Mr. Chairman, I would like to make a request of you, 

sir. 

Chairman HATCH. Yes, sir. 

Mr. KELLY. I would like to address you and Senator Feinstein on 

a couple of things. 

Senator Feinstein, you made some comments about spinal cord 

injury. Before I left last night from Dallas-Forth Worth, I 

downloaded the Rutgers University—Dr. Wise Young keeps a 

website where he keeps the spinal cord community up to date on 

the most promising developments in spinal cord research. 

He has a very comprehensive list here of the seven different 

areas of spinal cord research, and then he breaks each area down 

into whether it is neuro-protective, regenerative or reparative. It is 

very comprehensive and it is very clear and distinct. I would appreciate, sir, if you would accept this for the Senate record. 

Chairman HATCH. We will make that part of the record. 

Mr. KELLY. I am sorry. Senator Feinstein, I have to tell you that 

what you were told by Dr. Berg is not correct. The truth of the 

matter is the heart studies that you were saying have not been duplicated have been duplicated, Senator. They were duplicated in 

Australia, in Germany, in France, and now this is the first time it 

has been used in the United States, and they have been duplicated 

in humans in all those countries. 

The truth of the matter, Senator, is that adult stem cells are 

definitely the most promising area of research we have. As a matter of fact, Senator, I personally am not going to stay in the United 

States and wait for biotech to decide that they are going to try to 

bring treatments to the American people. This summer, I am going 

to Portugal and be treated with olfactory mucosa from my own 

nose that has adult neural stem cells that are already getting people on their feet who have been chronically paralyzed with spinal 

cord injury. 

I sincerely suggest, Senator Feinstein, that you question what 

you are being told because you are not being told the truth. 

Chairman HATCH. Well, I hope you have success in what you are 

doing. 

Mr. KELLY. Thank you, sir. 

21

Chairman HATCH. Let me just ask one question to both of you, 

though. Let’s assume that the Brownback bill passes. I don’t think 

that is going to be the case, but let’s assume that it does. If a therapy that could help you with your respective difficulties and disabilities were invented overseas with stem cells derived from a 

cloned embryo—if that therapy could actually be developed, would 

you avail yourselves of your treatment? 

Mr. WASSON. Answering personally, if the Brownback bill were 

passed, it is my understanding that I would, upon entry into this 

country, be imprisoned for using that therapy. 

Chairman HATCH. Well, let’s assume that they changed part of 

the original bill, which I think they are doing, that would not make 

that a crime for you to come back into this country with a cure or 

treatment that occurred from embryonic stem cell research overseas. Would you avail yourself of that treatment? 

Mr. WASSON. Certainly. 

Chairman HATCH. How about you, Mr. Kelly? 

Mr. KELLY. If I understand correctly, you are asking me would 

I avail myself of an embryonic stem cell cure using cloning, if it 

was possible? 

Chairman HATCH. That literally was developed overseas, if it 

worked. 

Mr. KELLY. If it was possible? 

Chairman HATCH. Yes. 

Mr. KELLY. I will tell you the truth, sir. A year ago, I told a Congressman when he asked me the same question that, yes, I would, 

because my No. 1 reason for taking the view that I am taking is 

I am trying to promote research that can genuinely lead to cures. 

But now, sir, I have to tell you that in the last year I have come 

to change my mind on that. The reason why I have changed my 

mind is my background is in blue-collar heavy industry, railroading, and I see things in very clear, black-and-white simplicity. 

And when I went to New Jersey to present what I believe is the 

pro-cures perspective on this issue and I saw that in New Jersey 

they are trying to promote cloning of not only fetuses for therapeutic cloning, but also newborn babies, I realized that I myself 

will not allow a baby to be killed to get out of this wheelchair. And 

I swear to you, sir, nobody wants to be cured more than me, but 

I draw the line at killing babies. 

Chairman HATCH. Well, that is a principled position. I don’t 

agree with you, but it is a principled position. I agree with Mr. 

Wasson. 

You are both excellent people. We appreciate having you here. 

We appreciate the testimonies that you have given. We will let Dr. 

Berg speak for himself on this issue, because he will be one of the 

panelists as we resume this afternoon at 1:30. So we are going to 

recess until 1:30 because we both——

Senator FEINSTEIN. Mr. Chairman, may I put a number of letters 

in the record? 

Chairman HATCH. We will, of course, do that, without objection, 

and keep the record open. 

We just want to thank all the witnesses so far. I am sorry we 

have to recess, but this is a very important meeting both of us have 

to go to. 

22

Mr. WASSON. Thank you. 

Chairman HATCH. Thank you. We will recess until 1:30. 

[Whereupon, at 11:44 a.m. the Committee was adjourned, to reconvene at 1:36 p.m. this same day.] 

Chairman HATCH. I am going to ask the two panels to come together all at once. We were going to have four panels, but we will 

put panels two and three together now. I think we had a good session this morning, and I understand that both Dr. Kass and Dr. 

Varmus have travel plans for later this afternoon, so I think it is 

best that we consolidate the two panels. 

We have two distinguished ethicists with us. Dr. Leon Kass is on 

leave from the University of Chicago, where he serves as Addie 

Clark Harding Professor in The College and the Committee on Social Thought. He is also a Fellow of the American Enterprise Institute. In his spare time, Dr. Kass chairs the President’s Council on 

Bioethics. I understand that he appears before us today in his individual capacity and not on behalf of the Council or the administration. So we welcome you, Dr. Kass. We are honored to have you 

here. 

We are also fortunate to have with us today Dr. Tom Murray, 

who serves as President of the Hastings Center, a non-profit, nonpartisan institution that focuses on ethical issues raised by health 

and the environment. Among Dr. Murray’s many accomplishments 

was his service on the National Bioethics Advisory Committee that 

studied the ethical issues attendant to stem cell research during 

the previous administration. 

We also have with us some respected scientists. Dr. Harold 

Varmus is President and CEO of the Memorial Sloan-Kettering 

Cancer Center, in New York. He also chairs the Joint Steering 

Committee for Public Policy, a coalition that represents 50,000 biomedical research scientists. 

Previously, Dr. Varmus served as the Director of the National Institutes of Health, one of the most important and prestigious positions in the world. Prior to his 6 years leading the NIH, he was 

on the faculty of the University of California in San Francisco. He 

was awarded the Nobel Prize in Medicine in 1989 for his groundbreaking work in discovering cancer genes called oncogenes. 

Next, we will hear from Dr. Anton-Lewis Usala. Dr. Usala wears 

two hats. He is Clinical Professor and Medical Director at the Office of Clinical Trials at East Carolina University. Dr. Usala is also 

CEO of Ectocelle, a start-up biotechnology company that is attempting to develop mechanisms whereby a body can regenerate its 

own cells. 

Next, we will hear from Dr. Micheline Mathews-Roth. She is an 

Associate Professor of Medicine at Harvard Medical School and a 

physician at the Brigham and Women’s Hospital in Boston. Much 

of Dr. Mathews-Roth research has centered on a rare genetic disease known as EPP. I will let Dr. Mathews-Roth explain what this 

acronym means and how she developed an approved treatment for 

this disease. 

Finally, we will receive the testimony of Dr. Paul Berg, who won 

a Nobel Prize in Chemistry for his ground-breaking work in developing recombinant DNA technology. Dr. Berg is Cahill Professor of 

Cancer Research and Biochemistry, and Director Emeritus of the 

23

Beckman Center for Molecular and Genetic Medicine at Stanford 

University. In addition, Dr. Berg serves as the Chairman of the 

Public Policy Committee of the American Society for Cell Biology. 

Before we begin this panel, I want to urge all of you to confine 

your oral presentation to 5 minutes, if you can, so that we will 

have time for questions. Of course, we will put your full, extended 

comments into the record so that we can have them. 

So we will proceed in the following order: Dr. Kass, Dr. Murray, 

Dr. Varmus, Dr. Usala, Dr. Mathews-Roth, and we will wind up 

with you, Dr. Berg, in the end. 

Dr. Kass, we turn the time over to you, and thank you so much 

for giving me your book this afternoon. I really appreciate it. 

STATEMENT OF LEON KASS, M.D., HERTOG FELLOW IN SOCIAL 

THOUGHT, AMERICAN ENTERPRISE INSTITUTE, WASHINGTON, D.C. 

Dr. KASS. Thank you very much, Mr. Chairman and Senator 

Feinstein. I am very grateful to you for this invitation to present 

some of my thoughts on human cloning, a topic about which I have 

been thinking and writing for 35 years. 

Mr. Chairman, I share your views that human cloning is immoral, as I also share your wish to advance ethical approaches to 

regenerative medicine. Human cloning constitutes unethical experimentation on the cloned child-to-be, confounds his genetic and social identity, represents a giant step toward turning procreation 

into manufacture, and would be a despotic attempt of parents to 

select and control the genetic makeup of their children. 

I conclude that human cloning threatens the dignity of human 

procreation and that it should be banned. The question is how best 

to do it effectively and ethically, with as little interference as possible to potentially beneficial biomedical research. 

With all due respect, I regret to say that the approach proposed 

in Senate bill 303 will not, in my opinion, do the job that we want 

to have done. It offers an ineffective and even counterproductive 

means of preventing the cloning of children. It is ethically problematic. It offers inadequate regulatory safeguards. And, in truth, I 

think it is unnecessary for advancing the mainstream of stem cell 

research, both embryonic and adult, about which the bill is, in fact, 

largely silent. 

Before trying to back up some of these claims, I want to speak 

first about the matter of terminology because the ethical discussion 

we need to have is obscured by some confusing language in the bill. 

Whether undertaken for the ultimate purpose of producing children or for the purpose of extracting stem cells for research, the 

deed of nuclear transplantation itself is an act of cloning. This is 

the deed that produces the genetic replica and its product is in 

both cases identical. The product is a cloned human embryo. This 

is the view of the earlier NBAC, and also of the current President’s 

Council on Bioethics, including all of the members who actually 

support the kind of cloning for research that this bill would endorse. 

When identical cloned embryos are grown to the blastocyst stage, 

their different fates depend solely on the purposes of the human 

users—baby-making or research. The language of the bill 

24

‘‘unfertilized blastocyst’’ is confusing and has no scientific currency 

or basis. And its definition as, quote, ‘‘intact cellular structure’’ 

hides the fact that this structure is a self-developing embryonic 

human organism. 

We should, of course, then have arguments, scientific and ethical, 

about why it would be important or permissible to create such 

cloned human blastocysts solely for research. But if we are to have 

that argument forthrightly, we should not hide from ourselves or 

others what we are doing and we should not try to win this moral 

argument by definitional sleight of hand. 

Here, then, would be a summary of my reasons for believing that 

a ban that tried to block cloning to produce children, while permitting cloning for biomedical research, is a bad idea and why I support a comprehensive ban on all human cloning. I have four arguments. I will summarize the large points. The details are in the 

written testimony. 

First, I regard this approach as ineffective and counterproductive. If wants to prevent the development of anthrax bombs, 

we do best to block the production of anthrax spores, not just their 

transfers to a weapon delivery system. 

Similarly, if we mean to be fully serious about stopping the 

cloning of human children, we should try to stop the process before 

it starts, at the creation of the embryonic human clones, not merely 

rely on efforts to prevent their transfer to women for delivery. 

A law such as S. 303 that tried to prevent cloning babies by banning only implantation of cloned embryos would be ineffective and 

unenforceable. It would be difficult to know when the law had been 

broken; it would be impossible to enforce it once it had. Further, 

by endorsing cloning for research, such a law would, in fact, increase the likelihood of cloning to produce children because it 

would allow the technique that was required to be perfected in the 

process. 

Second, I regard this approach to be ethically problematic. Allowing cloned embryos to be produced for biomedical research and 

stem cell extraction is highly problematic. It crosses several important moral boundaries, accelerating our slide down a slippery slope 

into a dehumanizing world of genetic control of offspring and the 

routine use of nascent human life as a mere natural resource. 

I would single out only one of the subordinate points for your attention. The use of cloned embryos in research, once allowed, will 

be impossible to limit. The arguments that are now used to justify 

creating cloned embryos to produce stem cells will also justify 

growing these embryos beyond the blastocyst stage. Experiments 

already done with cloned cow embryos have shown the possibly 

greater therapeutic value of fetal tissue derived from later stages. 

Any boundary you now try to set up here will be overridden by scientific events. 

Third, I believe that the regulation that is proposed in this bill 

is inadequate, given the unique status and dangers related to the 

creation of cloned embryos. They fall far short of the regulatory recommendations even of those members of the President’s Council on 

Bioethics who are in favor of doing cloning for research. 

Last, and this would be a long discussion, I think that cloning 

for biomedical research is unnecessary for promoting the mainVerDate 0ct 09 2002 14:43 Oct 21, 2003 Jkt 000000 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\89327.TXT SJUD4 PsN: CMORC
25

stream of regenerative medical research. The benefits of embryonic 

stem cell research in both knowledge and potential therapy do not 

require the creation of cloned embryos or stem cells from cloned 

embryos. 

The putative benefits of cloning research are at best speculative 

at present and it is unlikely to be the solution for the immune rejection problem. In contrast, a narrowly constructed yet complete 

ban on all human cloning would not interfere with stem cell research, adult or embryonic, using the cells derived from non-cloned 

embryos. 

In sum, even if no single argument above is by itself decisive, 

their cumulative weight leads me to support a comprehensive an 

on all human cloning, including the cloning of embryos for research. Such a ban would be prudent, moral and virtually cost-free, 

and it is the only real ban on human cloning. 

In contrast, a ban only on implanting cloned embryos would be 

imprudent and morally dubious and would likely yield little benefit 

that cannot be obtained by other morally unproblematic means. 

Purporting to be a ban on reproductive cloning, it would, in fact, 

increase the chances that cloned human beings would be born, and 

sooner rather than later. 

If I might take 30 seconds to conclude, Mr. Chairman, a more 

general point on the current deliberations. 

Chairman HATCH. Go ahead. 

Dr. KASS. Opposition to human cloning to produce children in 

America is overwhelming. The vast majority of our fellow citizens, 

including most scientists, would like to see it banned. Nearly every 

Member of Congress has condemned it. 

Yet, despite this near unanimity and despite the fact that bans 

on all human cloning are being enacted in many nations around 

the world, we have so far failed to give national public force to the 

people’s strong ethical verdict. The failure of the last Congress to 

enact a ban on human cloning casts grave doubt on our ability to 

govern the unethical uses of biotechnology, even when it threatens 

things we hold dear. 

If Congress fails again to act this time around, human cloning 

will happen here and we will have acquiesced in its arrival. It is 

my profound hope, Mr. Chairman and Senator Feinstein, that Congress will rise to the occasion and strike a blow in defense of 

human dignity. 

Thank you for your attention. 

[The prepared statement of Dr. Kass appears as a submission for 

the record.] 

Chairman HATCH. Thank you, Dr. Kass. We appreciate your testimony. 

Dr. Murray, we will turn to you. 

STATEMENT OF THOMAS MURRAY, PRESIDENT, THE 

HASTINGS CENTER, GARRISON, NEW YORK 

Mr. MURRAY. Senators Hatch and Feinstein, it is a great honor 

to be asked to speak before you today. What I say I will say with 

gratitude and respect. 

First, briefly, I will address reproductive cloning. In the 6-years 

since the birth of Dolly the cloned sheep was announced, the ethVerDate 0ct 09 2002 14:43 Oct 21, 2003 Jkt 000000 PO 00000 Frm 00029 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\89327.TXT SJUD4 PsN: CMORC
26

ical case against reproductive cloning has grown ever stronger. For 

one thing, the scientific evidence on the dangers of reproductive 

cloning has progressed from informed speculation to hard evidence. 

Scientists are beginning to understand the specific and powerful 

obstacles against reproductive cloning in primates. Indeed, one 

soon to be published study will indicate that using all the most advanced techniques in more than twice as many attempts as were 

used to make Dolly, there has been no success in cloning in monkeys. Trying to create a human child by cloning would be grossly 

unethical human experimentation. I think no one on the panel will 

disagree with that. 

Furthermore, the reasons why anyone would want to try to do 

reproductive cloning are themselves dubious. The most sympathetic 

case for cloning to make a child is to try to bring back someone, 

perhaps a child who died. The sad truth is that this is an illusion. 

For one thing, reproductive cloning works poorly when it works at 

all. Most cloned mammals die before or shortly after birth. Those 

that survive are almost certainly abnormal because of failures to 

reverse and redo epigenetic programming or other problems. 

If, despite the odds, a healthy child were born, it would be the 

same child only genetically. There is little reason to believe that 

this child would have the same personality, temperament, enthusiasms or interests as its progenitor. That child would live under 

a suffocating shroud of expectations that it would be just like the 

fantasy, really, of the child who was lost. And the parents would 

learn that there are no technical fixes for grief. Grief is a lifelong 

affliction that lies beyond the reach of science. 

A law to ban human reproductive cloning, such as bill 303, would 

be useful not to deal with the plague of human clones. There is no 

such plague, and despite the claims of would-be cloners, we can be 

virtually certain that there are no human clones alive or likely 

soon to be born, no healthy ones at least. 

We need the law to deny all legitimacy to that handful of entrepreneurs who are growing famous and wealthy with their ludicrous 

boasts to protect gullible, desperate, or hopelessly narcissistic people from exploitation, and most of all to prevent the almost certain 

harm befalling any child born through cloning. Such a law, I think, 

would be welcome by almost all Americans. 

The ethics of nuclear transplantation in research with human 

stem cells presents a very different picture. The commission of 

which I was a member, which has now sunsetted, did a report that 

was issued in September 1999 on ‘‘Ethical Issues in Human Stem 

Cell Research.’’ That report recommended funding for research on 

human embryonic stem cells derived from embryos left over after 

IVF, those embryos destined to be discarded and explicitly donated 

for research by the couple. That commission also proposed very 

stringent safeguards against commercialization and coercion largely consistent with, I believe, the language of 303. 

An important point: The National Bioethics Advisory Commission in its deliberations consulted not merely philosophers, lawyers, 

doctors and scientists, but quite a number of theologians, including 

from four great religious traditions—Roman Catholicism, Protestantism, Judaism and Islam. We found a great range of moral 

views within some of those traditions and across them all. So to 

27

equate having a religious view with a particular stance on human 

cloning or embryonic stem cell cloning is, I think, a mistake. 

The ethical arguments in favor of not criminalizing nuclear 

transfer in human stem cells is straightforward. The most compelling reason is that this research may contribute, in time, to the relief of suffering and the postponement of untimely death. 

Success is, of course, not certain. It is also possible that the 

greatest contributions to human health from research cloning will 

come from the basic research it makes possible as scientists create 

stem cell lines for an enormous variety of diseases, cell lines that 

may allow us to understand and ultimately treat or prevent those 

diseases. So nuclear transfer in human embryonic stem cells is not 

merely about transplantation, but a potentially incredibly powerful 

basic science model for the study of an enormous range of diseases. 

What is sometimes overlooked is the deep human truth that suffering and death afflicts families, not merely individuals. Our lives 

are entwined with the lives of others whom we love. Their suffering 

and their death profoundly affects our own lives. When we minister 

to suffering, we minister not only to the individual, but also to all 

of those who love and care for her or him. Any one of us who has 

loved someone who has suffered or died knows the truth of this. 

A second argument in favor of not criminalizing nuclear transfer 

in human stem cells appeals to our moral, legal and political traditions of freedom of speech and freedom of inquiry. Americans value 

the quest for new frontiers. Today’s explorers are more likely to 

wear white coats and inhabit laboratories than to paddle canoes. 

But scientific inquiry is also obliged to respect moral limits. That 

principle was resoundingly affirmed in the trials of Nuremburg and 

in our own Nation’s apology to the subjects of the Tuskegee syphilis 

study. But when we have no consensus that a particular form of 

research is ethically improper, the wiser course is to allow people 

to follow their individual consciences. This respects the value of 

freedom of inquiry without forcing people to violate their own beliefs. 

What reasons do people give for criminalizing nuclear transfer to 

create stem cells? Well, it is one thing to decide not to fund an activity because some Americans have moral objections to it. If we 

applied that principle broadly, there would be no funding of research on blood transfusion, or for that matter on transfusions 

themselves on the grounds that Jehovah’s Witnesses object to 

transfusions, which they do. The same would be true of all research 

using animals because many Americans object to any scientific use 

of animals. 

So it is one thing to object to funding and it is quite another to 

create a new Federal crime for doing what the majority of Americans do not find inherently wrong. We must acknowledge that morally thoughtful Americans are not of one mind on the moral status 

of 4- or 6-day-old blastocysts. 

In my book, The Worth of a Child, I posed a challenge. Imagine 

some entirely new ethical argument or scientific fact that was introduced into the debate over the moral status of the embryo that 

persuaded almost everyone on the other side that they were wrong; 

they dropped their objection and they agreed with you. 

28

Now, notice I didn’t say which side of the argument this came 

down on because I cannot imagine such a new argument or new 

fact. This is, I believe, not because people are impervious to logic, 

but because our beliefs about embryos are woven into a complex 

tapestry of other beliefs, about what it means to be a woman, a 

man, a child, about the value of families, about the importance of 

being a nurturing parent. This tapestry of beliefs and commitments 

affects everything, from our attitudes toward sex discrimination in 

employment, to the importance of family leave, to education opportunities for women, and to the moral status of embryos. 

Respecting the diversity of sincere and thoughtful beliefs about 

families, about women, men, children and embryos honors our most 

noble traditions. Where there is a clear and ringing consensus, as 

there is against cloning to create a child, let us act on it. Where 

there is a profound and principled disagreement, let our laws respect that. 

Declining to fund research can be an honorable choice and a wise 

public policy, depending on the circumstances. But sending scientists to prison for 10 years and subjecting them to fines of $1 

million or more devalues and dismisses the ethical views of the 

very many Americans for whom the possibility of alleviating suffering justifies research cloning. 

Just yesterday, I was with Rabbi Elliot Dorff, who is the chief 

rabbi at the University of Judaism in Los Angeles. Rabbi Dorff informed me that the three major strands of American Judaism—the 

Reform, Conservative and Orthodox traditions—have jointly issued 

a teaching that research on human stem cells is not merely permitted, but obligatory, if it has any hope of dealing with human 

suffering, disease and death. We would be in a very curious position indeed if we passed a law that sent someone who was following what they believe their religious tradition requires them to 

do to prison for 10 years for doing so. 

Thank you very much. 

[The prepared statement of Mr. Murray appears as a submission 

for the record.] 

Chairman HATCH. Thank you, Dr. Murray. 

We will turn to Dr. Varmus now. We welcome you back to the 

Committee and look forward very much to hearing your testimony. 

STATEMENT OF HAROLD VARMUS, M.D., PRESIDENT, MEMORIAL SLOAN-KETTERING CANCER CENTER, NEW YORK, NEW 

YORK 

Dr. VARMUS. Thank you very much, Mr. Chairman and Mrs. 

Feinstein. Thank you for a chance to discuss the contentious issues 

that have been raised by the possibilities of human cloning. 

Two bills are now before the Senate which seek to ensure ethical 

behavior in this new research arena. Both bills would ban efforts 

to create cloned human beings, an appropriate prohibition given 

the unsafe nature of the procedure you have heard detailed by Dr. 

Murray. 

However, the bill by Senator Brownback and his colleagues 

would set an unfortunate precedent. It would criminalized scientists, doctors and patients who pursue the benefits of some parts 

of cloning technology, even if those steps were taken without any 

29

intention of making a cloned human being. Your bill, Mr. Chairman, would allow those benefits to be pursued under the kinds of 

regulatory guidelines that have worked well for medical science in 

the past. 

Now, before returning to the legislation, let me briefly outline, at 

your staff’s request—I hope this will allow me to have an extra 

minute or two—the science involved, beginning usefully with the 

widely practiced procedure of in vitro fertilization, shown on the 

first chart. 

In IVF, as in normal human reproduction, a single sperm fuses 

with or fertilizes an egg in a dish, forming a cell that divides several times to produce an early embryo called a blastocyst. At this 

point, the cells are disordered; they lack any characteristics of specific organs or tissues. 

Now, if the blastocyst is transferred into the uterus, a pregnancy 

may result, and after a complex process of development a child 

might ultimately be born. If, instead of implanting the blastocyst, 

its immature cells are grown in a culture dish, as shown on the far 

right, they can divide and under appropriate circumstances can develop into various kinds of cells and tissues. 

Now, these so-called embryonic stem cells are a valuable by-product of IVF and have enormous potential, as you have heard, for discovery and therapy. Fortunately, for the hundreds of thousands of 

families with children born as a result of IVF, this procedure was 

not banned and it was not criminalized when introduced in the 

1970’s, even though it was obvious even then and known in practice now that many blastocysts would remain unused and might 

eventually be discarded, as indeed they are today. 

Likewise, it is permissible to derive embryonic stem cells from 

blastocysts without imposition of criminal penalties as long as Federal funds are not used. In fact, some existing stem cell lines can 

even be studied with Federal funds, with regulatory oversight. 

Now, unlike IVF which begins with the union of sperm and egg, 

cloning begins with the transfer of an intact nucleus from a mature 

cell to an egg from which the nucleus has been removed. That is 

shown on your left. 

As experiments with animals have shown, this procedure can, 

surprisingly to all, generate a blastocyst that is similar or identical 

to the one produced by fertilization. And if this unfertilized blastocyst were transferred to a uterus, development into an infant could 

conceivably occur, although judging from animal experiments, as 

you have heard, inefficiently and imperfectly. 

Embryonic stem cells can also be generated from these 

blastocysts for study and therapeutic use, as they would be after 

IVF, but with the important advantage that they could usually be 

transplanted without rejection to the individual who donated the 

nucleus. 

So, Mr. Chairman, let me return to the question of why I am unhappy with the bill proposed by Senator Brownback and happy 

with yours. Most importantly, his bill would ban all of the steps 

shown in that second chart. Your bill would selectively and judiciously ban only the transfer of an unfertilized blastocyst into the 

uterus, preserving the benefits and forbidding the abuses of these 

methods. 

30

But there are also four other issues I would like to mention briefly. First, I am troubled by the precedent of imposing criminal penalties on scientists, doctors and patients, even on patients who 

might return after treatment abroad. 

In the past, we have had ethically-sensitive science regulated in 

a variety of means, by Federal guidelines, for example, for work on 

recombinant DNA where Dr. Berg had a major role, and on gene 

therapy; regulated by prohibitions on the use of Federal funds, for 

example, as we have today with embryo research; or by classification, as for military research. 

Criminalizing the science I have described is unnecessary, unjustified and unprecedented. Further, by threatening to impose 

fines and imprisonment on well-meaning scientists, it sends a signal that could undermine the confidence of our remarkable research enterprise in this country. 

Second, legislative solutions tend to be inflexible, so rapidly 

changing science is a poor target for legislative remedy or control. 

The NIH and other Government agencies have shown repeatedly 

that they are well-equipped to oversee ethical conduct in research. 

Third, advocates for the Brownback bill, for the complete ban on 

all steps in nuclear transfer, have obscured the profound differences between studying immature human cells in a culture dish 

and making a cloned human being. Unlike the allegations made by 

Dr. Kass, there is no slippery slope here. The boundary between 

the two activities is broad and unambiguous. Federal rules and 

medical guidelines can easily delineate them. 

Under your bill, Mr. Chairman, crossing that clear boundary by 

trying to introduce cells into a uterus could lead to prosecution. 

The regulatory guidelines under your bill would require responsible 

Government oversight by the NIH or others, informed consent by 

cell donors, a 14-day limit on the growth of early embryos, physical 

separation of this activity from IVF clinics, and other things. 

Finally, the draconian legislation proposed by Senator 

Brownback and others shows inadequate appreciation for the pace 

and difficulty and for the long-range promise of science. Let’s face 

it, we are just beginning to understand how a fertilized egg develops into a mature organism. Embryonic stem cells derived from fertilized and unfertilized blastocysts have incredible potential to tell 

us how the instructions for making an organism are laid down, how 

they can be reversed, how they might be reconstituted, for example, 

to convert liver cells to nerve cells. 

Now, if we pursue such studies, we will discover great truths, 

and later use those truths in ways that are now difficult to predict 

to benefit patients who suffer from disease and disability. But if we 

don’t, somebody else somewhere else surely will. 

This year’s 50th anniversary of the discovery of the DNA double 

helix provides a vantage point for thinking about these problems. 

In 1953, it was evident that DNA embodied genes and that its 

structure was profoundly significant, but it was very difficult to 

know what we would learn by studying it. 

Fortunately, no one proposed that studies of human DNA ought 

to be banned. But if there had been prohibitions on the study of 

DNA, we might not now, 50 years later, have, for example, a vaccine for hepatitis B virus, drugs to protect the bone marrow of paVerDate 0ct 09 2002 14:43 Oct 21, 2003 Jkt 000000 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\89327.TXT SJUD4 PsN: CMORC
31

tients undergoing cancer therapies, tests to alert people to their 

risks of certain diseases, or a powerful new way, Mr. Chairman of 

the Judiciary Committee, to exonerate people who have been falsely imprisoned. 

With recent advances in the study of cells and the human genome, we have now, in fact, arrived at the starting line in a race 

to understand biology and to help the disabled with that knowledge. It is too early to know how to get to the finishing line, whether it is through embryonic stem cells derived from fertilized or 

unfertilized blastocysts or from adult stem cells. 

So I must finally ask why should any Member of Congress wish 

to punish those who wish to learn and to treat when we have so 

much more to learn, and who has such moral authority that they 

would impose on our pluralistic society an ethical standard that 

only a portion would endorse? 

Thank you, Mr. Chairman, for my chance to express these views 

and I will be pleased to answer any questions you might have. 

[The prepared statement of Dr. Varmus appears as a submission 

for the record.] 

Chairman HATCH. Thank you so much, Dr. Varmus. We appreciate having you here. 

Dr. Usala, we will turn to you. 

STATEMENT OF ANTON-LEWIS USALA, M.D., CLINICAL PROFESSOR AND MEDICAL/ADMINISTRATIVE DIRECTOR, OFFICE 

FOR REGULATORY REVIEW OF CLINICAL TRIALS, EAST 

CAROLINA UNIVERSITY, GREENVILLE, NORTH CAROLINA 

Dr. USALA. Thank you, Senator. 

In order to replace the function of destroyed patient tissues in 

human disease, cellular transplant material obtained from developing cloned embryos must first overcome the problem of appropriate integration into the transplant site. Without such integration, recovery of clinical function is not possible. 

Scientifically, it may make more sense to induce the patient’s 

own tissues to replicate at the injury site. If the patient’s own tissue could be induced to regenerate the site of injury, the communication and integration networks are already in place. 

I would like to share with the Committee the preliminary results 

of a product I developed while with my first biotech company which 

I left 18 months ago and currently have less than a 1-percent equity interest in. 

My hypothesis was that exposing cells to an environmental structure similar to that present during natural embryogenesis would 

induce the same explosive generation in tissue even in already mature cells, as the DNA template remains the same from the point 

of conception until death. 

This injectable material was made from modified naturally-occurring cow pounds synthetically polymerized to give the desired 

structure. The product contained no cells, only structures that patient cells would bind to upon injection at the damaged tissue site. 

The results I am about to show have been presented at several scientific meetings and have been recently submitted by the principal 

investigator from the University of North Carolina at Chapel Hill 

to a peer-reviewed journal. 

32

Shown is an example of the rapid wound healing induced in a 

dog that had naturally-occurring diabetes and had developed multiple full-thickness skin ulcers, similar to foot ulcers seen in diabetic human patients. The ulcers would not heal because of the 

chronic destruction of blood vessels commonly seen with longstanding diabetes. 

After a one-time injection of the artificial embryonic scaffolding, 

the wounds healed with regenerated tissue. And as you can see on 

the left side of the screen, we injected around the periphery of the 

lesion on that particular ulcer which was full thickness down to the 

bone. Within 6 days, it had generated skin and hair follicles. I was 

excited about the hair follicles. The new tissue resulting from exposure to the embryonic-like matrix was determined to be structurally identical to non-wounded areas. 

This photo micro graph shows the result of injecting this synthetic biopolymer into an adult dog’s liver. After 3 weeks, the section of liver was removed and brought to Dr. Ron Dudek, a medical 

embryologist, for interpretation. Shown are cells that have the appearance of undifferentiated mesenchymal cells morphologically 

similar in appearance to stem cells apparently associated with differentiating fibroblasts and more mature endothelial cells. Endothelial cells are the cells that make up blood vessel walls. 

Nucleated red blood cells found in large quantities only during 

fetogenesis are found in the newly formed blood vessels, apparently 

differentiating from the lining of the endothelial vessel wall. This 

process occurs only during fetogenesis as red blood cells, without 

nuclei, are made in the bone marrow later in development which 

does not exist early in fetal development. 

Further large and small animal studies confirmed our finding, 

and a six-page feasibility study was reviewed by the Food and Drug 

Administration to examine the effect of a one-time injection in patients with chronic diabetes foot ulcers refractory to conventional 

therapy. 

What we are looking here is the foot ulcer from our first patient 

who had diabetes for 20 years, and this ulcer was present for 4 

years. The ulcer is down to the lining of the bone in the heal. Just 

to orient the audience, what we are looking at is the heal down to 

the middle of the slide and the toes would be off to the north side 

of the slide. 

This is the appearance of the ulcer 15 minutes after the one-time 

injection. And, again, we injected the embryonic-like scaffolding 

around the perimeter and then through the center to try to get the 

damaged cells exposure to the embryonic matrix. Within 7 days, we 

had what we termed explosive generation of tissue. This has the 

morphology of fetal-type tissue, with the soft, glassy appearance. 

Over the course of two or 3 months, the tissue continued to mature. This is at 2 weeks, 4 weeks, 2 months, and 3 months. Again, 

this was a man who couldn’t really walk for 4 years because of the 

ulcer and he had gone every other week for that time to the University of North Carolina wound treatment center. Two months 

after this photo was taken, he was able to dance at his daughter’s 

wedding. 

Within days of a one-time injection, all the patients experienced 

rapid diminution of ulcer size, with apparent regeneration of skin, 

33

blood vessels and surrounding structures. Because these are 

human patients, it was unethical for us to take biopsies, as these 

ulcers were unhealing before we injected our matrix. However, in 

large-animal studies we did confirm that we had new tissue that 

was morphologically correct for that area. 

Since the new tissue derived from the patient’s own tissue, there 

was seamless integration with no evidence of rejection. It is important to remember, however, that further study is required to determine if this particular product is safe and effective, but clearly the 

large-animal and human patient studies suggest cellular transplantation is not necessarily required to replace damaged tissue. 

Shortly after conception, an individual is created with a new 

DNA template that begins the process of differentiation that continues until death. Transplantation strategies, whether derived 

from foreign donors or cloned cells from the patients themselves, 

are clearly not the only approach to replace damaged tissues. Such 

transplantation strategies require destruction of the newly formed 

individual DNA template. 

Other avenues are further along in clinical trials in human 

beings and should be considered as a first approach for study that 

do not require destruction of a new human embryo. Indeed, the patient’s existing cells provide the most rational source for fully integrating replacement tissues, as occurred during natural 

embryogenesis. 

Thank you, Senators. 

[The prepared statement of Dr. Usala appears as a submission 

for the record.] 

Chairman HATCH. Thank you, Doctor. We appreciate it. 

We will now turn to Dr. Mathews-Roth. 

STATEMENT OF MICHELINE M. MATHEWS-ROTH, M.D., ASSOCIATE PROFESSOR OF MEDICINE, HARVARD MEDICAL 

SCHOOL, BOSTON, MASSACHUSETTS 

Dr. MATHEWS-ROTH. As you were saying, I do work on a genetic 

disease called erythropoietic protoporphyria, but since nobody 

wants to say erythropoietic protoporphyria, that is why we call it 

EPP. I did develop what is the FDA-approved treatment for EPP, 

and my collaborators and I have cured the mouse model of EEP 

with gene therapy aimed at the bone marrow stem cells. 

I also want to say that I want to make it clear that I am not 

speaking as a representative of either Harvard Medical School or 

the Brigham, but as an individual physician and medical researcher. My testimony wants to give you some scientific facts you 

should know about therapeutic cloning. 

The science of embryology tells us that all human beings start 

their lives as one cell which we call the zygote, and I am sure the 

gentlemen here know that because they took embryology. The zygote of a cloned embryo, whether it is made for reproductive 

cloning or for therapeutic cloning, is the egg donor’s oocyte whose 

nucleus was removed and to which the nucleus of the person to be 

cloned was added. 

So it is scientifically incorrect to say that a human life begins in 

the mother’s womb. By the time the growing embryo, cloned or othVerDate 0ct 09 2002 14:43 Oct 21, 2003 Jkt 000000 PO 00000 Frm 00037 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\89327.TXT SJUD4 PsN: CMORC
34

erwise, implants in its mother’s womb, it is already about 5 days 

old and at the blastocyst stage of development. 

Embryos growing in a mother or made by IVF or made by reproductive or therapeutic cloning go through the identical stages of development. In fact, the publication called ‘‘Scientific and Medical 

Aspects of Human Reproductive Cloning,’’ put out by the National 

Academy of Sciences, shows in a diagram—and I have that as part 

of the hand-out that I gave you, and it shows that the development 

up to the blastocyst stage of an embryo which is made for reproductive cloning and an embryo made for therapeutic cloning is exactly 

the same. This is science, not philosophy. 

At the blastocyst stage, all contain the inner cell mass which is 

the group of embryonic stem cells. There is some differentiation between the inner cell mass and the layer around the inner cell mass, 

in that there are some antigens that are present in the outer layer 

that are not present in the inner cell mass. The outer layer of the 

blastocyst which is broken open is what is going to become the placenta. So there is a difference. There is already differentiation between the inner cell mass cells and the cells around the outside of 

it. 

Now, the important thing for everybody to realize is that presently the only way that embryonic stem cells can be obtained from 

any embryo is to break open the embryo of usually 5 to 7 days of 

life and remove them. This obviously kills what we know from 

science is a growing human being, a very young human, but nevertheless an individual member of our species. 

I want to point out an error in the S. 303 bill which I think was 

alluded to by Dr. Kass. There is no such thing as an unfertilized 

blastocyst. The somatic cell nucleus of the person to be cloned 

which was put into the oocyte was formed by fertilization. That nucleus has its full component of 46 chromosomes, as does the nucleus of every cell which will form when the cloned zygote starts 

to divide. 

So a cloned baby or cloned cells for therapeutic cloning has two 

genetic parents, the mother and the father of the nucleus donor. 

The clone is essentially an identical twin of the nucleus donor. 

There is no such thing, as I say, as an unfertilized blastocyst or an 

unfertilized egg. If there is an unfertilized egg, it is got half the 

number of chromosomes that you and I have. 

Cells and tissues derived from cloned embryonic stem cells can 

still cause problems in the recipient of the cloned material, and this 

again was pointed out in the National Academy of Sciences’ report. 

They can cause immunologic rejection problems, and this is caused 

by the mitochondria in the cloned tissue which comes from the egg 

donor’s cell. So they are foreign to the recipient. 

Mutations and imprinting and programming errors occurring in 

the early cloned embryo—and they will occur in any early embryo 

and these would be transmitted to the cloned cells and the cloned 

tissues. 

In addition, everybody knows that teratoma formation, these odd 

tumors, are very common to embryonic stem cells when you transplant them into animals, and these still exist with cloned embryonic stem cells. In fact, there is a recent paper—I think it is just 

with embryonic stem cells, though—that they transplanted some 

35

embryonic stem cells into knee joints of a rat, I believe, and ended 

up getting whopping teratomas which made the poor little rat lose 

its legs. 

Physicians are obliged to give complete and accurate information 

about treatment options to their patients. So patients receiving IVF 

embryo-derived or therapeutic cloning-derived stem cells will need 

to be clearly informed that a very young human, and in the case 

of therapeutic cloning their very young identical twin, will need to 

be killed to obtain the stem cells needed for this treatment. 

I notice that this was not mentioned—informed consent to the recipients was not mentioned in this bill. Now, interestingly enough, 

the society that is concerned with IVF, the American Society for 

Reproductive Medicine, has a statement that says, ‘‘Couples should 

also know that ES cells research typically involves deriving cells 

from the inner cell mass of an embryo at the blastocyst stage which 

leads to the embryo’s destruction.’’

I will repeat that: ‘‘that ES cells research typically involves deriving cells from the inner cell mass of an embryo at the blastocyst 

stage which leads to the embryo’s destruction.’’ So they are saying 

parents who donate their embryos should be informed that embryo 

research kills what we all know from embryology is a little growing 

human. 

The people who receive cloned tissues should also be informed of 

this. If these facts are withheld from the patients, then the physicians are being intellectually dishonest and the scientists are being 

intellectually dishonest if they don’t inform people about the fact 

that they are getting products that are being made unfortunately 

by the killing of a member of our species. They will have failed in 

their obligation to the patients to provide enough information so 

that patients can give truly informed consent to their treatment. 

As a physician doing research and dealing with patients like this, 

I know, and I am sure Dr. Varmus knows because he is—you are 

practicing, aren’t you? 

Dr. VARMUS. No. 

Dr. MATHEWS-ROTH. You are not, okay; you are in research. 

But those of us who deal with patients know how important it 

is to give our patients all the information they need to make truly 

informed consent. We can get into trouble if we don’t. In fact, some 

patients may choose not to undergo stem cell treatment if they 

learn that killing a young human is involved. And if they find out 

after the fact, if the scientists weren’t honest enough to tell them 

that, they may be angry enough to sue their doctors. And if you 

think we have got problems with malpractice now, this is going to 

add to it. So I think this is a very serious thing. 

It is to everyone’s advantage that potential patients be informed 

that to obtain stem cells, a young growing human being has to be 

killed. So are we denying treatment to our patients if we deny 

them the use of embryonic stem cells? I don’t think so. 

Certain kinds of adult stem cells can be transformed into many 

kinds of cells needed to treat serious diseases, not just stem cells 

that are characteristically found in one organ. There are some bone 

marrow-based stem cells that have indeed been shown to be able 

to be transformed into many different kinds of organs, and this is 

not fusion and it is not some little laboratory’s strange finding. 

36

For example, Dr. Catherine Verfaillie has discovered what she 

calls multipotent adult progenitor cells in human and mouse bone 

marrow which can be made to differentiate into cells from all three 

embryonic layers. I heard her not too long ago at Harvard and she 

really thinks that these have great possibilities to make a lot of different organs. They don’t form teratomas. They can multiply extensively. 

In fact, this was one of her points that they can multiply, and 

she showed a comparison slide between them and embryonic stem 

cells and they can do, as far as expansion and things are concerned, just about what embryonic stem cells can do. So they have 

this great potential and they multiply a lot, and they do this without losing their potential to differentiate into different tissues. 

This is one of the problems I have with hematopoietic stem cells 

right now, that if I try to expand them, they end up differentiating 

to red cells or white cells and I really don’t have enough time to 

put my gene therapy stuff in. I have a small window and I can only 

just transform so many. But with her MAPCs, you can grow them 

and make lots and lots of the undifferentiated cells. So you would 

have a greater opportunity to transform them with the gene therapy that you want to do, with the genes that you want to add. So 

these are cells that have a lot of promise to them. 

Dr. Eliezer Huberman, for another example, has found a cell 

from peripheral blood which can also multiply easily and can be 

differentiated into endothelial cells, nerve cells and liver cells. So 

here is another example of another kind, and there are many in the 

literature. Papers come out everyday. I mean, it is hard to keep up 

with the literature. Reviews are being written, new papers are 

coming up. It is hard to make definite statements, oh, 

embryological stem cells are better than adult stem cells. Time will 

tell. But the unbending embryological fact is if you take an early 

embryo, you are destroying a human life. And this is not going to 

change; this is not philosophy, it is embryology. 

To summarize, do we as a country, and especially people with 

diseases who might be helped by stem cell therapy, really want to 

sanction the practice of deliberately starting the lives of members 

of our own human species for the sole purpose of killing them to 

harvest their useful parts, especially when there exists the alternative of using adult stem cells? 

If you check the literature on adult stem cells, you will find that, 

at least in animals and starting in humans, one can make with 

them the different kinds of cells that people really want to use in 

therapy, like heart cells. There are some examples of pancreas 

being made; also, blood cells and different kinds of cells. There are 

other examples of other kinds of adult stem cells that you could 

harvest that will differentiate. So, again, this is a tough ethical 

question. Do we want to justify this? 

So I will close with say you, our legislative leaders, had better 

think long and hard about this because if you allow, by law, the 

production of embryonic stem cells from either extra IVF embryos 

or from embryos made by therapeutic cloning, you are going to be 

sanctioning this killing of early humans. 

Now, it is hard to say at this point whether embryonic stem cells 

or adult stem cells are going to be better, but I would say work 

37

with animals, work with primates, see what you can do in primates, see what you can do in mice, and work like heck with adult 

stem cells. But remember that if you do this in humans, you are 

killing members of our species. 

I know a lot of the scientists who are working with adult stem 

cells will just say, oh, but I still think we ought to keep on working 

with embryonic stem cells. It is still killing humans. Do we really 

want to get into that? 

Thank you. 

[The prepared statement of Dr. Mathews-Roth appears as a submission for the record.] 

Chairman HATCH. Thank you, Doctor. 

Dr. Berg, you have your work cut out for you here, and I want 

to know if you differ with Dr. Mathews-Roth. 

STATEMENT OF PAUL BERG, CAHILL PROFESSOR EMERITUS 

OF CANCER RESEARCH AND BIOCHEMISTRY, STANFORD 

UNIVERSITY MEDICAL CENTER, PALO ALTO, CALIFORNIA, 

AND CHAIR, PUBLIC POLICY COMMITTEE, AMERICAN SOCIETY FOR CELL BIOLOGY 

Mr. BERG. Well, one of the disadvantages of being last on a panel 

of six is that everybody has said some of the things that I wanted 

to say. I will be brief, but I do want to specifically address Dr. Mathews-Roth’s comments. 

First of all, let me just say that the congressional and public debate about cloning people is, I believe, a non-issue. Very few, if any, 

reputable biomedical scientists condone attempts to produce a 

cloned human being. A distinguished National Academy of Sciences 

panel that considered this issue concluded that it is dangerous and 

likely to fail, as we heard from Dr. Murray. 

In short, the risks to the mother and any fetus that would result 

from the procedure are unacceptable. If for no other reason than 

this, your bill, S. 303, and Senator Brownback’s bill, S. 245, are in 

agreement in mandating a legally enforceable ban on reproductive 

cloning. 

Dr. Kass raised the issue of this impasse and allowing us to continue in a situation where there is no prohibition on that, and his 

concern, which is many people’s concern, that this will move ahead 

if there is no such prohibition. So in one sense, we have the opportunity to agree on this one issue: We are all opposed to the cloning 

of human people and we ought to then produce legislation that will 

enforce that claim. 

But in contrast to Senator Brownback’s proposed legislation, your 

bill takes, I believe, a more enlightened position in permitting the 

somatic cell nuclear transplant procedure for research and therapeutic purposes. This research is supported by overwhelming scientific opinion because the technology may enable us to develop 

new forms of therapies for some of the most debilitating diseases 

and crippling disabilities. 

Presently, there are only proofs of principle behind this optimism, but these strongly suggest that if scientists are permitted to 

explore these opportunities, their benefits can be achieved. I believe 

we are ethically and morally obligated to pursue them for the benefit of those who suffer. 

38

Now, a particularly promising opportunity that is also foreclosed 

by the Brownback bill is the preparation of stem cells using cell 

nuclei from individuals with inherited mutations, particularly ones 

that pre-dispose them to an increased probability for developing a 

variety of life-threatening and debilitating illnesses in late life. 

Examples include breast, colon, prostate and other cancers, as 

well as heart, neurological and autoimmune diseases. Such currently unavailable stem cell lines would provide a new way to explore how these life-threatening, late-onset diseases develop, and 

they could possibly generate clues to their prevention or cure. Such 

studies might help reveal the interrelations between inherited and 

environmental contributions that govern much of the balance between health and disease. 

So in the end, I think, as was said earlier, we need safeguards, 

not a ban, and I think your bill includes safeguards as the predominate way to regulate this type of scientific research. 

Both Congressman Weldon and Senator Brownback, and we have 

just heard Dr. Mathews-Roth, have accepted the assurances of 

their advisers that adult-derived tissue-specific stem cells—that is, 

specialized stem cells that already exist in many of our tissues—

are sufficient for meeting the needs for therapeutic repair of damaged or diseased tissue. Many of these claims are contentious, for 

they rely on experiments that often have not been replicated and 

in some cases are known to result from artifacts. 

But I believe here is not the place nor the time to debate the relative therapeutic prospects of adult-derived versus embryonic stem 

cells. There are scientific issues, there are deep issues, there are 

huge disagreements. Just as in the law profession, conjecture and 

hearsay are not considered evidence. Much of what we have 

learned and heard about adult-derived stem cells doing the magic 

wonders of curing everything are, in my view, still hearsay and 

conjecture. And unless they are replicated on multiple occasions 

and verified, I would not accept that adult stem cells can do the 

entire job. 

Having said that, it is quite clear that the people who support—

and I consider myself one of them—going ahead with embryonic 

stem cells are not opposed to work on human adult stem cells. The 

President, in his address on August 9, 2001, encouraged research 

along both lines. It is the people who are working with adult stem 

cells who want to prohibit work with embryonic stem cells. 

I believe that most scientists working in this field recommend 

strongly, as do I, that research with both adult and embryonic stem 

cells should proceed vigorously, so as not to delay or forgo the benefits for patients. Just such a recommendation was actually made in 

a letter to Senator Specter last year by Dr. Catherine Verfaillie, 

whom Dr. Mathews-Roth cited as providing us with cells that are 

going to obviate the need for embryonic stem cells. 

She writes, ‘‘It is far too early to say whether the adult stem cells 

will stack up when compared to embryonic stem cells in longevity 

and function. There are still too many unknowns for researchers or 

policymakers to begin closing doors to opportunities of learning.’’

Given the present state of our knowledge, I believe it is premature to choose one line of investigation over the other. Doing so 

could prove to be as great a historical embarrassment as when the 

39

Soviets bet on Lysenko’s prejudices against genetics and lost out on 

improving their own agricultural productivity and on an entire generation of genetic science and geneticists and scientists. 

One justification for the criminalization of the nuclear transplant 

procedure is to guard against rogue attempts, or the slippery slope 

argument, to implant the product into a woman’s uterus for the 

purposes of creating a cloned child. 

But like any socially deviant behavior, we can discourage this 

with appropriate punishment. We punish murder under criminal 

statutes, but we fail to criminalized possession of the weapons used 

for the crimes. Prohibit what we all agree is presently an objectionable practice, but protect the means for producing life-saving therapies. And we should not be threatening to put people in prison for 

seeking cures for themselves or their children, even if those therapies were developed elsewhere. 

Now, we take considerable pride in being a pluralistic society, so 

there must be ample room for differences concerning the moral and 

ethical interpretations of early and intermediate stages of human 

development. We have heard some of that debate from Dr. Murray 

and from Dr. Kass. I think we have to be very careful in not foreclosing or acknowledging these alternative and legitimate views because they can mean the difference between life and death for 

many of our citizens. 

I want to point out that even on the President’s Bioethics Commission which studied this issue for at least half a year, they still 

were split in their decision or conclusions. Forty percent of the 

members of that commission came down in support of somatic cell 

nuclear transplantation being permissible. That reflects in large 

part, I think, the kind of diverse views that exist in society. 

I think Harold made an important point that, given that kind of 

split, dare we then foreclose for those people who are in dire need 

the opportunity to develop the cures? And I hold out that adult 

stem cells and embryonic stem cells don’t at the present time tell 

us which is the better, but we should certainly not ignore or make 

a premature bet today on choosing one and then allowing 5 years 

to pass before we decide we have made the wrong bet. 

Thank you. 

[The prepared statement of Mr. Berg appears as a submission for 

the record.] 

Chairman HATCH. Well, thank you so much. 

Let me ask a question of the two Nobel laureates, Dr. Varmus 

and Dr. Berg. Some, including Senator Brownback and Representative Weldon and Mr. Jim Kelly this morning, suggest and sometimes assert, as you have said, that the scientific evidence to date 

suggests that adult stem cell research is sufficient or even appears 

to hold more promise than embryonic stem cell research. 

I would like to know what the prevailing view is among scientists 

today—and both of you have as good a handle on that as anybody—

and what, if any, are the unique advantages of embryonic stem 

cells, including stem cells that might 1 day be derived from nuclear 

transplantation research. 

Can we go to you first, Dr. Varmus? 

Dr. VARMUS. Thank you, Senator. Let me make a few points 

about this debate. Fundamentally, I think you have heard from a 

40

few of us already that it is very difficult to say in this very short 

time that we have had to work on embryonic stem cells what will 

prove to be the most effective as a source of therapy in the long 

run. But let me just reflect on a couple of things. 

First, it is important to point out that we, as physicians, have 

been using adult stem cells in therapy for some time for treatment, 

for example, of loss of bone marrow capacity. So we have known 

that you can take a cell that has the capacity to regenerate itself 

and to make a multiplicity of cell types—for example, different 

blood cell types—and use that in therapy. 

We know that the adult has cells that regenerate and can make 

different kinds of cells, not all kinds of cells and not appropriate 

for treating most kinds of diseases, but for some. So there is a long 

head start here. There is no doubt that the study of adult stem 

cells ought to continue, and in a very vigorous way. 

But let me make the more important point, which is that in my 

estimation one of the most remarkable things that has happened 

in modern science is the discovery that you can take a nucleus from 

an adult cell, put it into the environment of an egg and basically 

reprogram it so that it losses its ability to regulate expression of 

its genes in a way that was appropriate for the cell from which it 

came, wipes the slate clean and has the capacity to make cells of 

virtually any type. That is a fundamentally thrilling point of view 

that should inspire us to think about how it happens. 

The reason I tried to emphasize the long view here, the fact that 

it has taken us 50 years to go from an understanding of the doublehelical nature of DNA to have all these remarkable accomplishments that followed the study of DNA, is to point out that we have 

a long road ahead of us. 

My dream is that we learn over the course of the next decade or 

two the way in which a cell nucleus can become reprogrammed, 

and that we develop very simply tools so that ultimately we can 

take a cell from an adult with a disease and reprogram that cell 

appropriately. We are not going to learn how best to do that if we 

follow only limited leads, restrict ourselves in our approach to the 

science and don’t give ourselves adequate time to understand what 

it takes to make the kinds of contributions to science and to medicine that are never accomplished in less than decades. 

Chairman HATCH. Thank you. 

Dr. Berg? 

Mr. BERG. Yes. I would like to just reiterate what Dr. Varmus 

just said particularly about the use of the hematopoietic stem cell. 

What has been shown is that you can isolate from bone marrow a 

specific type of cell which by itself, injected into animal whose bone 

marrow has been destroyed, repopulate the bone marrow and 

produce all of the blood cells. So we know the hematopoietic stem 

cell, which is an adult-derived stem cell, does, in fact, have the 

property of being able to differentiate into all of the blood cells. 

But in experiments that have been done now several times, that 

cell is incapable of populating any other tissue in the body. The experiments have been done by introducing just a single cell into an 

irradiated animal, repopulating or reconstituting the bone marrow, 

and then searching every tissue in the body for any trace of derivatives of that cell. And the answer is none have been found. 

41

What has been found is that there are artifacts which can explain a lot of the data that is out there because sometimes these 

derivative cells confuse with existing cells in the tissue. So when 

you looked at the fused cell, the occasional one that occurs, you 

think it is derived from the original input cell. But it is, in fact, 

not derived; it is a product of fusion. This has now been documented in a number of laboratories. 

So many of the people who work in this field are now concerned 

that many of the claims that are out there are, in fact, artifactual. 

I think that has to be sorted out just like any other scientific issue 

on which there are opposing views or appears to be opposing evidence. But in the end, the way science proceeds is verification by 

duplication and continued repetition to establish that as a scientific 

fact. 

We can’t live with just conjecture and people giving lectures and 

claiming this or not, saying there is a paper in press, or it appears 

in a newspaper, or my uncle called me and told me that this is a 

possible cure. That is not science, and if we are going to make law 

on that kind of conjecture, then I think we would be making a terrible mistake. 

Dr. MATHEWS-ROTH. Can I just add to that? I agree that there 

have been some papers that have shown cell fusion, but there have 

also been recent papers to show that there hasn’t been cell fusion. 

And you can take indeed one—and it is not a hematopoietic stem 

cell; I think it is further back in the stem cell’s evolution, more 

primitive—that can indeed not only form hematopoietic tissues, but 

have been found in other tissues in the body. 

And again going back to our mutual friend, Catherine Verfaillie, 

she has shown that her MAPCs, without fusion, can form cells that 

are characteristic of tissues of all of three embryonic layers, what 

they call endoderm, ectoderm and mesoderm. And these studies—

some of them have been confirmed, some of them have not. This 

is true. 

Dr. Berg is right. There are some specialized stem cells in almost 

each tissue that will only make that tissue, but we have as adults 

also non-specialized stem cells which have a repertoire of being 

able to make a couple of different tissues. And it is not fusion; it 

is just a characteristic of these a little bit more primitive cells. 

And I want to assure Dr. Berg that people who are interested in 

stem cells aren’t afraid of competition from embryonic stem cells. 

I think what should happen is the ideal situation would be at this 

time ban embryonic stem cell work on people; work with the lines 

that are already available, don’t make new ones. Don’t make embryos to kill them, but work with animals, do the same experiments that you would want to do in primates, especially primates, 

because we are primates. Let’s face it, monkeys are our closest relatives. If it is going to work in a monkey, it will probably work in 

man. 

With all due respect to the animal rights people, I think it would 

be better to sacrifice animals than growing little humans. No matter what you want to do, you have to remember the basic principle 

of embryology: you are still killing a growing human if you are 

going to work with a blastocysts, with these early cells. 

42

Chairman HATCH. Dr. Berg, you seem to indicate that you disagree with some of——

Mr. BERG. I am sorry. I didn’t hear that. 

Chairman HATCH. Were you in agreement with what Dr. Mathews-Roth said? 

Mr. BERG. She said a lot of things that I am not in agreement 

with, but are you saying——

Chairman HATCH. I saw you shaking your head and I thought 

you were in disagreement. 

Mr. BERG. One of the things which I neglected to mention, unfortunately, is hematopoietic stem cells which can do this wondrous 

thing of repopulating bone marrow cannot be grown at the present 

time. 

Dr. MATHEWS-ROTH. That is right, they can’t. 

Mr. BERG. There is no way to propagate them. 

Dr. MATHEWS-ROTH. Yes. 

Mr. BERG. Most of the so-called adult-derived stem cells have not 

been grown. There is no way to amplify them to be able to even 

use them for therapeutic purposes. There is good evidence that 

some of the cells which reside in the various tissues are circulating 

most of the time. So when people take bone marrow and then use 

the words ‘‘stem cells,’’ they are using the words to describe a complex mixture which we really don’t have well characterized. I almost likened it one time to studying sewage and calling it E. coli. 

But, in fact, the bone marrow probably contains a variety of cells 

that are there transiently. And these may be the ones that give 

these very low repopulation results that have been found, but they 

can’t be propagated. So as a therapy, one would have to solve the 

problem of how could you propagate these adult stem cells so that 

they could, in fact, be used therapeutically. 

Dr. MATHEWS-ROTH. Well, Catherine Verfaillie has solved that. 

Mr. BERG. Hold on for a moment, please. 

Dr. MATHEWS-ROTH. Yes. 

Mr. BERG. The virtue of the embryonic stem cells is you can 

propagate them virtually indefinitely. You can freeze them away, 

you can recover them, and you can invariably differentiate them, 

providing the appropriate cues, so they differentiate into different 

kinds of tissues. 

There are a number of papers that are clearly published which 

show that one can, in fact, generate beta islet cells which can, in 

fact, treat animals that are diabetic. You can regenerate a severed 

spinal cord with embryonic stem cell-derived neural cells, and you 

can do the same thing with curing Parkinson’s disease by appropriate neural cells derived from stem cells. So you can grow stem 

cells and learn how to differentiate them into different populations. 

Chairman HATCH. Let me interrupt for a minute. I can’t imagine 

anybody not being willing to go ahead and proceed with adult stem 

cell research. Naturally, we all want to do that. I mean, that is a 

given. 

I asked Senator Brownback to submit for the record his whole 

notebook of studies which he relies upon in concluding that adult 

stem cell research is the only way to go. I wonder if all of you 

would work on helping to coordinate an analysis of these particular 

43

studies by recognized and fair experts, and compare them to the 

opportunities for embryonic stem cell research. 

I understand that NIH and NAS have issued similar assessments 

in the last few years, but could you help us to be more certain that 

we are up to date by looking at and evaluating the particular information that Dr. Weldon and Senator Brownback rely upon so that 

we can be certain that we have the best knowledge we possibly 

can? 

Mr. BERG. We are in science, Senator. We are not in certainty. 

Chairman HATCH. But to the extent that you can help us——

Mr. BERG. I mean, to ask for certainty today is asking for something that is not available. They are both promising and we should 

be pursuing both. We needn’t make a bet today. 

Dr. VARMUS. Senator, I think it would be appropriate for people 

to make an evaluation of that kind, and if we were given the notebook I am sure we would be able to put together——

Chairman HATCH. We will get that to you. 

Dr. VARMUS. But I would point out to you that we are not going 

to give you an answer that will be ironclad, and that is the case 

because these problems are incredibly difficult. The idea of trying 

to make a hematopoietic stem cell that can grow is a big problem. 

The difficulty of learning how to differentiate an embryonic stem 

cell so it becomes all the tissues we would like it to become has 

been plaguing science for the last several years, and indeed being 

pursued not just with human stem cells, but also with animal stem 

cells. 

So I think the plea that you are hearing from the scientific community is we don’t know where the best answers are going to reside and we would encourage you to keep as many doors open as 

possible. 

Dr. MATHEWS-ROTH. But then again we still have the issue with 

the killing and, as I say, do the animal work. 

Chairman HATCH. I have that point. 

Dr. Kass? 

Dr. KASS. Senator, if I might, a lot of this discussion over the last 

10, 15 minutes has been about stem cells, embryonic versus adult. 

I wouldn’t want you to understand anything that I said to be 

taken——

Chairman HATCH. Let me interrupt you just for 1 second. 

Dr. KASS. Please. 

Chairman HATCH. Where I have always had some problem here 

is, first of all, although I agree that the blastocyst is a living cell, 

a human cell, I have a real difficult time believing that it is a 

human being until it is implanted in the mother’s womb. Now, it 

has the potential of becoming one. We all know that, but it doesn’t 

have a chance of becoming a human being without being implanted 

in a womb. 

I accept that, and I accept Dr. Mathews-Roth’s feeling that she 

is right on this and you are wrong. I agree with you, however. I 

just don’t think that we should foreclose what scientists have told 

me is the most promising avenue of research in their lifetimes that 

might help hundreds of millions of people in our country, or over 

100 million people in our country, and perhaps billions around the 

44

world to alleviate pain, suffering and difficulties. That is also prolife, in my view. 

I thought, Dr. Kass, you made some very interesting ethical remarks in your discussion here today. We have discussed ways to 

find common ground on this issue. You and I spoke in my office 

about a hypothetical development that, as I recall, you did find at 

first blush at least morally troublesome. 

One way to maybe test the hypothesis is to just ask you this 

question. Of course, you say whatever you were going to say. I just 

had to interrupt for this reason and the question would be this: If 

an egg could be rendered incapable of implantation or of implanting in a mother’s womb by a chemical or genetic manipulation of 

a haploid egg cell, could you personally view the process of somatic 

cell nuclear transfer in another light? 

In short, if the cell produced for nuclear transplantation could 

not implant due to manipulations made before the somatic cell nucleus was introduced into the non-implantable egg, are the ethical 

concerns bridged under those circumstances? 

Dr. KASS. I missed the verb. Are the ethical concerns——

Chairman HATCH. Are the ethical concerns bridged in that regard? Given the recent reports in the scientific literature about 

new insights into how blastocysts affix to the uterine wall, I think 

one could imagine the day when scientists would reverse-engineer—am I on the right track here—and render an egg incapable 

of implanting? Now, if that were so, would that be as ethically 

troublesome to you, or would that be as ethically concerning to 

you? 

Dr. KASS. Certainly, some of my concerns having to do with this 

matter would be alleviated. I mean, after all——

Chairman HATCH. That is my understanding. 

Dr. KASS. Some. Others, I think, might——

Chairman HATCH. But you are still worried about renegades 

doing full cloning? 

Dr. KASS. Well, what I want to say is that we seem in the discussion to have gotten the cloning question mixed up with the stem 

cell question. The bill, as I see it, is primarily about cloning for reproduction and what I would prefer to call cloning for biomedical 

research. Nothing that I——

Chairman HATCH. One of the problems I have—I keep interrupting you and I apologize, but this is a matter of great concern 

to me. One of the problems I have is if we don’t have NIH involved 

and we don’t set the moral and ethical standards for this research, 

then others are going to do it all over the world. This is going on 

now, and I would rather have our country lead the way and set the 

standards and the parameters pursuant to which this kind of research can be done. If we don’t do that, then I guarantee you you 

are going to have the results that you are talking about that we 

all would deplore. 

Dr. KASS. Senator, we agree on the principle that the United 

States has to be not only the leader in biotechnology, but the leader 

in the ethical uses of biotechnology. This has been a big division. 

Many nations around the world are, in fact, passing a ban on all 

cloning even in those countries where they are encouraging and 

permitting and funding embryonic stem cell research. I think it is 

45

a mistake to get the embryonic stem cell research mixed up with 

cloning. 

Chairman HATCH. But how do we get all these other countries 

to conform to our point of view without setting the moral and ethical standards ourselves through the most recognized and most important research agency in the world, the National Institutes of 

Health? The very thing that you are concerned about ethically is 

going to happen if we don’t do the basic, necessary things that 

should be done here. 

Dr. KASS. We are in agreement. I am not one of these people who 

thinks you have to choose between adult and embryonic stem cell 

research. I am in favor of allowing both of these things to go forward. It is too early to tell which of these lines will prove most 

promising. 

Chairman HATCH. But, again, on these lines—well, I am sorry. 

Go ahead. 

Dr. KASS. But I want to distinguish between embryonic stem cell 

research from in vitro fertilized embryos and the creation of cloned 

embryos for research. They are different. 

Chairman HATCH. Okay, they are different and let me tell you 

why I find that. It is true that when I got into this, my major argument was that since these fertilized eggs are going to be discarded 

anyway, why wouldn’t we utilize them for the benefit of mankind? 

Dr. KASS. Right. 

Chairman HATCH. And I think we would have gone a long way 

had the President allowed that type of research to go forward with 

fertilized eggs that were going to be discarded anyway. But as I understand it, he limited it to 70 stem cell lines worldwide, or at least 

in this country. In practicality, those are basically Caucasian stem 

cell lines. They are not diverse stem cell lines. 

I have been led to believe that there may be as few as nine that 

are functional because of intellectual property concerns, patent concerns, and a whole variety of other high-technology and informational technology concerns. I have also been led to believe that if 

we take—and I would like you all to help me understand this better, but if we take even the somatic cell nuclear transfer-changed 

eggs, we actually could reach a point where you would never have 

to use a mother’s egg again. But that would take 3, 4 or 5 years 

of very intensive work to be able to reach that point. 

Dr. KASS. That could be done first in animals, Senators. 

Chairman HATCH. What? 

Dr. KASS. Proof of that should be done in animals. It hasn’t been 

shown. 

Chairman HATCH. That may be, except for one thing, that the 

rest of the world is going ahead with this research and we could 

be left behind, with our greatest scientists in this area leaving this 

country to go where the research can be done. I am concerned 

about that. 

Dr. KASS. That is technically not so. I mean, there are a few 

countries—Britain, China, Singapore, Sweden, Israel, I think, 

are——

Dr. VARMUS. Australia. 

Dr. KASS. I am sorry? 

Dr. VARMUS. Australia. 

46

Dr. KASS. Not on cloning. Sorry. The Australians have imposed 

a ban, I think, on all cloning, including cloning for research, so has 

Norway, so has South Korea, so has France, so has Germany, so 

has Spain, so has Italy. The French and the Germans will probably 

come back to the UN to try to promote an international convention 

trying to stop all cloning, whether for research or for reproduction. 

It is true that the world is not of one opinion here. 

See, if you start where I start that we should do whatever we 

can to prevent cloning for baby-making, the most secure way would 

be to stop that process before it starts. This is not just creating an 

embryo; this is creating a genetically-engineered embryo, the first 

one. And until somebody does the research which shows me that 

it is not just a promise of something but that there is a real likelihood, either in animal studies—that there is something for which 

this is absolutely necessary, because the matter is so grave I don’t 

want to open Pandora’s box, especially when the technique to practice cloning for research is going to make cloning for baby-making 

much more likely. They are going to perfect this. 

Chairman HATCH. Doctor, I have tremendous respect for you. 

You know that. It is already opened. I mean, I read an article 

called ‘‘The First Cloning Superpower: Inside China’s Race to Become the Clone Capital of the World.’’ The Chinese pay an awful 

lot of attention to what we do, and so does everybody else in the 

world. 

There are those, as you have mentioned—France, Germany—I 

would have preferred maybe a couple of other countries besides 

them. 

Dr. KASS. I did. 

Chairman HATCH. I know. I am just kidding. 

Dr. KASS. South Korea, Australia, Canada. 

Chairman HATCH. I would prefer not to use France and Germany 

at this time. I am only trying to be humorous. 

The fact is that I am concerned that there are countries that are 

going ahead with all forms of cloning. And I agree with you and 

I agree with everybody on this panel that there should be no 

human cloning. That is the least we should do this year, but because we are involved in a fist-fight here over this, we may not 

even get that done. 

Go ahead. I have interrupted you so much and I apologize. 

Dr. KASS. No. I am enjoying this, Senator, if you don’t mind. I 

mean, this is dear to me. 

Chairman HATCH. You are saying you are enjoying it or you 

are——

Dr. KASS. I am enjoying the exchange and I am grateful for your 

generosity. 

Chairman HATCH. Well, I am, too. I am just sorry I am interrupting you so much, but I want to go to Dr. Murray. 

Dr. KASS. This is a momentous time in lots of ways, but it is a 

real question, Senator, whether we have the will and the capacity 

to give some direction to where biotechnology is taking us. 

I have the greatest regard for our research. My reputation isn’t 

that, but that is a mistake. I esteem biomedical research both in 

terms of its discoveries and its cures. I think it is a very bad thing 

47

for the most part to have legislative interference with scientific research, a very bad thing. 

Chairman HATCH. I agree with you, but we are pushed into doing 

this. 

Dr. KASS. But there come occasions where the things which are 

at issue and which are being threatened suggest that if we leave 

it to business as usual, we might regret it. I would submit this is 

one of those cases where we shouldn’t simply hope that if you let 

this genie out of the bottle, you are going to be able to control it. 

Sure, rogues in China might do this, but they also buy and sell 

organs in other parts of the world and we don’t follow suit even 

though it would save lives. We have the capacity to set an ethical 

standard without restricting very much of the research and allowing the embryonic stem cell research to go forward. 

Chairman HATCH. But how do you do that, Doctor? First of all, 

the Brownback bill won’t pass the Senate. There is no way that it 

has enough votes to pass the Senate. We have close to the 60 votes 

to pass this bill which would do away with reproductive cloning, 

but would permit the scientific research to go forward and would 

set moral and ethical standards for the NIH. And you would have 

the Federal Government involved. 

Dr. KASS. It doesn’t govern the private sector, Senator. 

Chairman HATCH. It would have us involved all over the world, 

in the World Health Organization and everywhere else, to make 

sure that your fears would at least have a chance of being alleviated. 

What we are going to wind up doing here probably is nothing, 

which means that the rogue countries where they are going to do 

this will be able to get away with it. 

Mr. BERG. England is not a rogue country and they have opted 

for a regulatory process that oversees the legitimacy of the 

work——

Chairman HATCH. Well, I agree with that. 

Mr. BERG [continuing]. Which is exactly what I think you are 

saying. 

Chairman HATCH. Yes. 

Mr. BERG. So it is being done and it can be done, and it can be 

done ethically and legitimately. 

Chairman HATCH. Well, let me go to Dr. Varmus, and then I 

have got to get to Dr. Murray. I have been trying to get to him. 

He had his hand up here a while ago. 

Go ahead, Doctor. 

Dr. VARMUS. I think that one misconception that Dr. Kass is portraying here is the idea that if there were no legislation banning 

cloning, suddenly there would be a tremendous waterfall of human 

reproductive cloning. That is not going to happen. Even without 

legislation, it is not going to happen. 

We all endorse the idea of having legislation, but the fact is it 

would be malpractice. You would have your pants sued off if you 

tried to do this because the great likelihood is it would be almost 

impossible to do it and if you succeeded, you would have a child 

deformed and you would be subject to tort law. 

So the idea that there is going to be a dramatic increase in 

human reproductive cloning without a law is frankly in my mind 

48

silly. If there are renegades who want to try this for publicity sake 

or something else, they will always be able to find a place to do 

this. What worries me about the argument is it is driving into an 

illegal state research that could lead to very important benefits. 

I am trying to make the reverse argument, Dr. Kass, that you 

are setting up a straw man here that we are going to be inundated 

with human cloning exercises, and that that is the motivation behind a bill such as the Brownback bill that would cut off important 

avenues for productive research to help human beings. 

Chairman HATCH. If the bill that we are talking about, the 

Hatch-Feinstein-Specter, et al, bill, passes, that bill would set 

criminal penalties for reproductive cloning. 

Dr. VARMUS. Absolutely. 

Chairman HATCH. It would set the rule in our country, at least. 

It would then designate NIH to set the standards that are moral 

and ethically proper in this. 

Dr. KASS. It doesn’t touch the private sector, Senator. 

Chairman HATCH. What? 

Dr. KASS. It does not touch the private sector. 

Chairman HATCH. No, but nothing touches them now. It does 

apply the common rule to the private sector, sure, and we also 

touch it from a criminal law standpoint. 

Dr. KASS. On the implantation, yes. 

Chairman HATCH. Well, yes. 

Dr. KASS. But on the research——

Chairman HATCH. We also apply the common rule. Frankly, if 

NIH is involved, the private sector can’t afford to not work with 

NIH. I think your very moral arguments really can be fulfilled by 

having a bill that sets parameters, which is what we have tried to 

do with this bill and I think we have accomplished that. 

I would like you to read it carefully. I know that you have studied this as much as anybody. 

Dr. KASS. I will do so. 

Chairman HATCH. And you have every right to your opinion, and 

I happen to respect you so much that the fact that we differ on this 

affects our relationship not in the least. But I can’t imagine going 

another year without having some way of setting the standards 

that have to be set here. I can’t imagine the right-to-life community 

not wanting that done. I can’t imagine anybody who believes that 

human suffering ought to be alleviated not wanting to do something here that would benefit the living. 

Dr. Murray, I said I would come to you next. I don’t mean to be 

preaching to you, but I am just saying it is flabbergasting to me 

that this is—go ahead. 

Mr. MURRAY. It is flabbergasting to others as well, Senator, myself included. It is always dangerous to do philosophy after 3 p.m. 

because people fall asleep. I will try to do it very quickly. 

There are really two kinds of arguments being put here against 

nuclear transfer and embryonic stem cells. The first is the argument that Dr. Mathews-Roth has repeated several times in her testimony, namely that the creation of stem cells—and this is about 

all stem cells—is killing them to harvest their useful parts. That 

is against all forms of human stem cell research. 

I think I need to grant Dr. Mathews-Roth the sincerity——

49

Dr. MATHEWS-ROTH. Not adult stem cells. 

Mr. MURRAY. Please don’t interrupt me. 

I think we need to grant the sincerity of her belief. On the other 

hand, you, Senator Hatch, and many others, equally morally 

thoughtful people, think that an in vitro blastocyst at the 4- to 6-

day stage is not the same thing, and that the creation of stem cells 

from that is not the same thing. So let’s put that argument aside. 

We have addressed that. I think criminalizing those who would feel 

as you do or others would be disrespectful of the diversity of moral 

beliefs in the United States. That is what I tried to say in my testimony. 

The other set of arguments were really the ones that Dr. Kass 

offered, and he offered four arguments. The fourth one has really 

been dealt with, and that was the claim that the claims that nuclear transfer in embryonic cells that they would be useful therapeutically or scientifically are putative and speculative. Well, that 

is true of all scientific research. 

Until we actually do the research and find out whether it can deliver, all claims of usefulness are putative and speculative. Scientists make judgments all the time about what lines of research 

are more likely to be fruitful than others, and most knowledgeable 

scientists about this are very excited about the possibilities here. 

His third argument—I am going to go backwards quickly—was 

really about complaints that your current bill may not adequately 

regulate all aspects of it. And since that is in details, I won’t go 

into that one. 

Chairman HATCH. We, by reference, pull into the legislation all 

of the NIH moral and ethical standards. So I think it is adequate, 

as I read it. 

Mr. MURRAY. Yes. 

Chairman HATCH. Now, if anybody has suggestions on how we 

might make it better, that is one reason we are holding this hearing. We would be very happy to see what we could do. 

Mr. MURRAY. Yes, and I think clarifying things such as whether, 

as Dr. Kass has asked, private research is covered, which I believe 

it is, or whether patenting is permitted, and permitted on the stem 

cell lines, say, rather than the actual cloned entity itself—those 

would be helpful clarifications, but I don’t think they go to the 

heart of the bill. 

The second complaint is that we will be on a slippery slope if we 

permit nuclear transfer in human embryonic stem cells, and that 

we will end up down at the bottom of a very nasty hill. Nearly 25 

years of working in bioethics has convinced me that all of life is 

lived on slippery slopes and the point is to try to carve out good, 

firm footing. I believe your bill is exactly an effort to carve out 

good, firm footing so that we can establish ourselves and live a 

morally decent life at that point on the hill. 

His first argument was that conditions for culturing blastocysts 

for stem cells—well, the first argument was that what we learn 

from doing nuclear transfer in embryonic stem cells for research 

will be immediately and perfectly transferable to trying to make a 

human baby by cloning. That is an empirical claim. 

The scientists I speak to who work with human embryonic stem 

cells indicate that what they are finding actually is if you want to 

50

develop stem cells of a certain type, say neural stem cells, it pays 

from the very beginning to use a culture medium and a culture 

procedure that drives them toward becoming such stem cells. 

So, actually, there may be a real divergence between efforts to 

create a human baby by cloning, the conditions you would have to 

try to do that, versus the conditions you would have to try to create 

stem cell populations. So that is an empirical claim, and the scientists here are better qualified than I am to say whether it is correct or not. But it may, in fact, be incorrect, and if the empirical 

premise is incorrect, then the conclusion is incorrect. 

Chairman HATCH. Well, Dr. Murray, your written testimony 

states that you would be pleased to comment on President Bush’s 

Commission on Bioethics’ call for a moratorium on the so-called 

cloning for biomedical research. I will bite. Why don’t you make a 

comment on that? 

Mr. MURRAY. Well, it was a close vote, but a majority did vote 

in favor of a moratorium. I disagree. It would be less interesting 

to hear that I disagree than it is to hear the details of the arguments. In fact, what I just did was basically respond to some of the 

principal arguments in the report, but thank you for asking, Senator. 

Mr. BERG. Senator Hatch, may I just make a comment? 

Chairman HATCH. Yes, Dr. Berg. 

Mr. BERG. My one experience with Government regulation of research goes back 25 years on recombinant DNA. 

Chairman HATCH. Right. 

Mr. BERG. At that time, one of the interesting arguments was 

raised that the best we could was to have the NIH supervise this 

regulatory process and it would not apply to the private sector. As 

it turned out, the private sector was delighted to follow the same 

guidelines that were elicited for the rest of the scientific community 

because, in fact, they needed that guidance themselves. 

Rather than go off and do their own thing and go against what 

was generally conceded to be a sensible way to approach this problem of the potential risks of the research, they all followed it. 

Chairman HATCH. And had 4 or 5,000 different directions and 

they actually followed what the NIH came up with. 

Mr. BERG. Absolutely. I mean, that was an interesting and unexpected outcome. We were worried about what private industry 

would do, but it turned out that they were, as Harold pointed out, 

much more concerned about the threats to their integrity, being 

picketed outside their research establishment because they were 

violating or found to be violating reasonable regulations. So they 

all adopted them. They set up internal review panels and followed 

exactly the same procedures that were mandated for the universities or for federally-funded scientists. 

So again, although I think the legislation, as I understand it, is, 

in fact, intended to cover all research in this country, I would not 

be so fearful whether the private sector is out looking for some way 

to get out of it. 

Chairman HATCH. Well, let me ask this last question because we 

have a vote. I know that a couple of you really have to go, too, but 

I am really enjoying this discussion. To have this quality of science 

discussion is really uplifting to me. Even though you disagree, you 

51

are all excellent people and I don’t think we could have had a better panel. 

Let me just ask the panel this question, and we will start with 

you, Dr. Kass. It is a question that Dr. Berg asked Senator Frist 

last year at a Health, Education, Labor and Pensions Committee 

hearing. Suppose that the United States bans both reproductive 

and therapeutic cloning, as has been suggested by those in opposition to this bill, and a therapy was developed overseas in a nation 

that allows such research that would be very beneficial to a great 

number of our folks here in this country. 

Now, if you were a treating physician—and I would like each of 

you to think this through—if you were a treating physician, would 

you have a moral obligation to prescribe such treatment to your patient, even though such treatment could not be directly developed 

or originated in the United States? 

If you gave the same answer that Dr. Frist gave, I will be interested if you would, but wouldn’t you be morally obligated if they 

came up with a cure or came up with a treatment that was beneficial to your patients to use that treatment, even though it was developed through a regenerative medicine approach? 

Dr. Kass? 

Dr. KASS. Yes, I would, Senator, and I find the part of the Housepassed bill, if I may say so publicly, that bans the importation of 

products regrettable. 

Chairman HATCH. I do, too. 

Dr. Murray, what would you do? 

Mr. MURRAY. I agree with Dr. Kass. 

Chairman HATCH. You would use that therapy? 

Mr. MURRAY. I would recommend it. I would inform my patient 

that this was a therapy that was proving itself to be safe and effective, if that was the evidence. If I felt there was any chance that 

my patient might have a moral objection to receiving embryonic 

stem cells, I would tell them that is what it came from. And it 

would be up to them whether they would overcome their personal 

moral qualms about it, but I would do as Dr. Kass did and tell 

them. 

Chairman HATCH. Dr. Varmus? 

Dr. VARMUS. Of course, I would do that, but it would be heartbreaking to have to say that when you return to this country, you 

might be subject to possible imprisonment or fines. 

Chairman HATCH. Which is what the Brownback-Weldon bill 

calls for. 

Dr. Mathews-Roth? 

Dr. MATHEWS-ROTH. Well, I would explain the therapy to them. 

I would tell them that this does involve killing a very young human 

being, if we are using cloned material. I would tell them that I am 

personally objecting to it; that I, because of my personal objection 

to killing and the Hippocratic Oath I took when I became a doctor, 

would not be involved with the implementation of this therapy; 

that it is up to them to choose to do it if they want to and they 

should go to someone else to do it. 

Chairman HATCH. Thank you. 

Dr. Berg? 

52

Mr. BERG. I asked that question of Dr. Frist because he was a 

physician. 

Chairman HATCH. That is right. 

Mr. BERG. And I wanted to see how he would respond to the 

issue of having to inform a patient that he had voted against the 

implementation of that kind of therapy. 

Chairman HATCH. He said basically that he would have to give 

his patient the best available treatment. 

Mr. BERG. He did say that, and yet at the same time subsequently he backed the Brownback bill fully even though it still contained that particular provision. 

Chairman HATCH. I was hopeful they would take that provision 

out, but even if they took that provision out, there would still be 

the feelings of Dr. Mathews-Roth. 

Mr. BERG. I think Dr. Mathews-Roth has suggested that the 

therapy would be available. It would just be the doctor’s choice. 

But, in fact, if the bill passes, that therapy is not available in this 

country. So the issue comes, as I think was implied by Dr. Varmus, 

somebody going to England to have the therapy having implanted 

in them cells derived from nuclear transfer-derived stem cells and 

coming back. 

The question was, in the interpretation of the bill, whether that 

person is liable to criminal penalties for bringing back derivatives 

of somatic cell nuclear transfer material. That is probably an arguable question, but the point was it is saying that we are prepared 

to prohibit 280 million from access to therapies that might save 

their lives because somebody is offended by the technology that 

was used to develop that therapy. 

Chairman HATCH. I have to say that Senator Brownback, I think, 

did modify his bill to alleviate that provision, in his defense, but 

I think the House bill has it in there. 

Dr. Usala, I am sorry I have been ignoring you here today, and 

yet I found your testimony very interesting. 

Dr. USALA. Senator, you are probably the most patient man I 

have ever had the pleasure of sitting with for listening to all of us. 

Actually, if I could just make a comment——

Chairman HATCH. I am starting to like you a lot. 

[Laughter.] 

Dr. USALA. I actually think that scientifically most of us agree 

with things, and I will answer your question directly in a second. 

Dr. Varmus is excited about the possibility of taking a DNA template, putting it in another environment and having it reproduce. 

It is horribly exciting and I agree with it, and I think that as physician-scientists or scientists, we do see the potential for making a 

DNA template replicate and to use it in therapeutic ways. 

But we can’t minimize, as has been done, I believe, the concept 

that the human being does start shortly after conception, scientifically speaking, because that is when that differentiation process—

the DNA joins, the template is formed with all the machinery of 

the chaperon proteins. 

You can’t arbitrarily say, well, at this point of differentiation it 

is human, and at this point it isn’t. It can’t be done. 

Chairman HATCH. I acknowledge it is a human cell. The egg is 

a living human cell, no question about it. The question is whether 

53

we will utilize that to help the living or we won’t. It is just that 

simple. 

Dr. USALA. And that is where, as a physician, a pediatrician, I 

would have to agree with Dr. Mathews-Roth. I took the Hippocratic 

Oath. Now, you know, if somebody goes to China and they execute 

a prisoner and they get his heart and transplant it, do we prosecute them here in the United States? I don’t believe so. So that 

is what it comes down to. 

As a physician, I took one of those old Hippocratic oaths. You 

know, we don’t believe in killing, and there are physicians in States 

where assisted suicide is legal in some circumstances that they do 

it. In their view, they are doing the best for their patients. I could 

not do that because of the oath I took and because of my understanding as a scientist. 

Chairman HATCH. Well, I think this has been one of the most interesting panels I have ever listened to, and I certainly want to 

compliment each of you. I respect each of you very much, in spite 

of the fact that I may differ on some matters. 

All I can say is that my goal here is to do the very best I can 

for mankind, and I think we should help the living as much as we 

help anybody. I have to say that I have learned so much here today 

and I don’t know when we have had a better panel on any subject. 

Even though you differ with each other, it has meant a lot to me 

that you would take the time to come and try and enlighten us. 

Hopefully, we can resolve this problem in a way that will bring 

most of us together. If not, we should resolve it in a true scientific 

way, it seems to me. You noticed I used the word ‘‘true.’’ I think 

that is a very important word in what we are trying to do with this 

bill. 

So I just want to thank each of you for being here. I have got 

to go and vote, and rather than have you wait for me to come back, 

I think we have had a good discussion and I will keep the record 

open so that if you care to offer any further written comments 

about these issues that might help us, I would be very grateful. 

That goes for each and every one of you. I want to thank each of 

you for being here today. 

With that, we will recess until further notice. 

[Whereupon, at 3:22 p.m., the Committee was adjourned.] 

[Submissions for the record follow.] 

[Additional material is being retained in the Committee files.]

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