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29–580 PDF 2006

HUMAN CLONING AND EMBRYONIC STEM CELL

RESEARCH AFTER SEOUL; EXAMINATION EXPLOITATION, FRAUD AND ETHICAL PROBLEMS

IN THE RESEARCH

HEARING

BEFORE THE

SUBCOMMITTEE ON CRIMINAL JUSTICE,

DRUG POLICY, AND HUMAN RESOURCES

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

SECOND SESSION

MARCH 7, 2006

Serial No. 109–169

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

GINNY BROWN-WAITE, Florida

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(Independent)

DAVID MARIN, Staff Director

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY, AND HUMAN RESOURCES

MARK E. SOUDER, Indiana, Chairman

PATRICK T. MCHENRY, North Carolina

DAN BURTON, Indiana

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

STEVEN C. LATOURETTE, Ohio

CHRIS CANNON, Utah

CANDICE S. MILLER, Michigan

GINNY BROWN-WAITE, Florida

VIRGINIA FOXX, North Carolina

ELIJAH E. CUMMINGS, Maryland

BERNARD SANDERS, Vermont

DANNY K. DAVIS, Illinois

DIANE E. WATSON, California

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

MAJOR R. OWENS, New York

ELEANOR HOLMES NORTON, District of

Columbia

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

MARC WHEAT, Staff Director

MICHELLE GRESS, Counsel

MALIA HOLST, Clerk

TONY HAYWOOD, Minority Counsel

(III)

C O N T E N T S

Page

Hearing held on March 7, 2006 .............................................................................. 1

Statement of:

Battey, James F., Jr., M.D., Ph.D., Chair, NIH Stem Cell Task Force,

Director, National Institute on Deafness and Other Communication

Disorders, National Institutes of Health, U.S. Department of Health

and Human Services; Bernard Schwetz, D.V.M, Ph.D., Director, Office

for Human Research Protections, U.S. Department of Health and

Human Services; and Chris B. Pascal, Director, Office of Research

Integrity, U.S. Department of Health and Human Services ..................... 30

Battey, James F., Jr. ................................................................................. 30

Pascal, Chris B. ......................................................................................... 44

Schwetz, Bernard ...................................................................................... 36

Chole, Richard A., M.D., Ph.D., Lindberg professor and chairman, Department of Otolaryngology, Washington University School of Medicine,

St. Louis; Judy Norsigian, executive director, Our Bodies Ourselves,

co-author of ‘‘Our Bodies, Ourselves’’; Joe Brown, Parkinson’s Action

Network State coordinator, Texas; Diane Beeson, M.A., Ph.D., professor

emerita, Department of Sociology and Social Services, California State

University, East Bay; Richard Doerflinger, deputy director, secretariat

for pro-life activities, U.S. Conference of Catholic Bishops; and Debra

J.H. Mathews, M.A., Ph.D., assistant director for science programs,

the Phoebe R. Berman Bioethics Institute, Johns Hopkins University ... 66

Beeson, Diane ............................................................................................ 87

Brown, Joe ................................................................................................. 83

Chole, Richard A. ...................................................................................... 66

Doerflinger, Richard .................................................................................. 112

Mathews, Debra J.H. ................................................................................ 126

Norsigian, Judy ......................................................................................... 76

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

Battey, James F., Jr., M.D., Ph.D., Chair, NIH Stem Cell Task Force,

Director, National Institute on Deafness and Other Communication

Disorders, National Institutes of Health, U.S. Department of Health

and Human Services, prepared statement of ............................................. 33

Beeson, Diane, M.A., Ph.D., professor emerita, Department of Sociology

and Social Services, California State University, East Bay, prepared

statement of ................................................................................................... 89

Brown, Joe, Parkinson’s Action Network State coordinator, Texas, prepared statement of ........................................................................................ 85

Chole, Richard A., M.D., Ph.D., Lindberg professor and chairman, Department of Otolaryngology, Washington University School of Medicine,

St. Louis, prepared statement of ................................................................. 70

Cummings, Hon. Elijah E., a Representative in Congress from the State

of Maryland, prepared statement of ............................................................ 18

Doerflinger, Richard, deputy director, secretariat for pro-life activities,

U.S. Conference of Catholic Bishops, prepared statement of .................... 115

Mathews, Debra J.H., M.A., Ph.D., assistant director for science programs, the Phoebe R. Berman Bioethics Institute, Johns Hopkins University, prepared statement of ..................................................................... 128

McHenry, Hon. Patrick T., a Representative in Congress from the State

of North Carolina, prepared statement of ................................................... 22

Norsigian, Judy, executive director, Our Bodies Ourselves, co-author of

‘‘Our Bodies, Ourselves’’, prepared statement of ........................................ 79

Pascal, Chris B., Director, Office of Research Integrity, U.S. Department

of Health and Human Services, prepared statement of ............................ 47

Page

IV

Letters, statements, etc., submitted for the record by—Continued

Schwetz, Bernard, D.V.M, Ph.D., Director, Office for Human Research

Protections, U.S. Department of Health and Human Services, prepared

statement of ................................................................................................... 39

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

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

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, prepared statement of ........................................................... 25

(1)

HUMAN CLONING AND EMBRYONIC STEM

CELL RESEARCH AFTER SEOUL; EXAMINATION EXPLOITATION, FRAUD AND ETHICAL

PROBLEMS IN THE RESEARCH

TUESDAY, MARCH 7, 2006

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY,

AND HUMAN RESOURCES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 2:05 p.m., in room

2247, Rayburn House Office Building, Hon. Mark E. Souder (chairman of the subcommittee) presiding.

Present: Representatives Souder, McHenry, Foxx, Schmidt, Waxman, Cummings, Watson, Ruppersberger, and Norton.

Staff present: Marc Wheat, staff director and chief counsel;

Michelle Gress, counsel; Malia Holst, clerk; Sarah Despres, Tony

Haywood, and Naomi Seiler, minority counsels; Earley Green, minority chief clerk; and Teresa Coufal, minority assistant clerk.

Mr. SOUDER. The committee will come to order.

Good afternoon, and I thank you all for being here. We are here

to examine the controversial research areas of human cloning and

embryonic stem cell research in light of the massive scientific scandal in Seoul, South Korea. The scandal revealed that cloning research widely acclaimed by proponents of human cloning and embryonic stem cell research was a fraud. The scandal also brought

to light the disturbing fact that women were paid large sums of

money, and female assistants were coerced to donate, if that is the

word, their eggs for stem cell and cloning research in violation of

the Helsinki agreement.

Embryonic stem cell research and human cloning have been intense political and societal issues for several years now. Embryonic

stem cell research requires the destruction of living human embryos to harvest their stem cells, and research cloning involves the

deliberate creation of cloned human embryos for sole purpose of destroying them to obtain their stem cells.

Proponents of these research areas promise they will result in

therapies and cures for a range of maladies and diseases, although

there has been little hard, empirical evidence to support these

claims. In fact, there are currently ho human clinical trials or

therapeutic applications using human embryonic stem cells.

And here I will quote British stem cell expert Professor Lord

Winston. ‘‘One of the problems is that in order to persuade the pubVerDate 11-MAY-2000 11:15 Dec 14, 2006 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 D:\DOCS\29580.TXT HGOVREF1 PsN: HGOVREF1
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lic that we must do this work, we often go rather too far in promising what we might achieve. I am not entirely convinced that embryonic stem cells will, in my lifetime, and possibly anybody’s lifetime, for that matter, be holding quite the promise that we desperately hope they will.’’

In contrast to the lack of any therapeutic applications using embryonic stem cells, adult stem cells have provided therapeutic benefits to human patients for at least 67 diseases and conditions.

Nonetheless, even in the absence of therapeutic applications for

embryonic stem cells, scientists have been very clear that they seek

to use stem cells from cloned human embryos as research tools.

Various critics of research cloning and embryonic stem cell research have raised a myriad of objections to the research: The research necessarily requires the destruction of living human embryos, and in the case of cloning, the special creation of embryos

to be destroyed for their stem cells. The research necessarily requires a large number of eggs, likely leading to the exploitation of

women in order to obtain their eggs for research. Advocates of research cloning/embryonic stem cell research have created unjustified hype of the research that is not supported by current science,

but plays on the hopes of suffering patients.

These criticisms were borne out through the cloning research

conducted by Dr. Hwang, whose two groundbreaking papers were

retracted in January by the peer review journal that initially published them. In addition to admitting that he deliberately fabricated data, Hwang has also admitted the had lied about the circumstances under which he obtained eggs for his research, and

that in fact he had used eggs from junior scientists in his laboratory, a violation of the Helsinki declaration, as well as from paid

donors.

Skeptics of cloning and embryonic stem cell research consistently

warned that the sheer volume of eggs needed to pursue this line

of research would make it untenable, and virtually invite ethical

lapses by feeling the temptation to exploit women for their eggs.

Hwang’s research proves these fears. He initially claimed that he

had used only 185 eggs from female donors, which the scientific

community agreed was astonishingly low. But investigators now

believe that more than 2,200 eggs were obtained from 199 women.

Some donors who have since reported they were in desperate

need of money when they were offered and paid more than $1,400

for their eggs. And according to the South Korean National Bioethics Committee, the women had not been properly informed about

the risks to their health; 15 to 20 percent of those women developed ovarian hyperstimulation syndrome.

This scientific scandal is not an isolated incident of fabrication,

without real application to U.S. research efforts. Rather, it highlights the serious inherent political problems with research cloning

and embryonic stem cell research, including but not limited to exploitation, fraud, and coercion. The incident is a siren warning

against proceeding in these research areas without most cautiously

examining the societal costs necessarily associated with it. It would

be quite disingenuous to say otherwise.

Dr. Hwang was not a rogue scientist operating on the fringes of

his field with no oversight. He operated in an environment that

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proponents of cloning and embryonic stem cell research would like

to see adopted in the United States.

Dr. Hwang enjoyed the full support of his Government, which

vigorously promoted his research and funded it with tens of millions of dollars. Dr. Hwang also enjoyed enormous popular support

and had agreed to conduct his research under accepted ethical protocols. Dr. Hwang suspended his research until ethics laws were

enacted by the South Korean Government to demonstrate his willing compliance with ethical standards. Dr. Hwang’s research was

conducted with the approval of two separate Institutional Review

Boards.

Nonetheless, Dr. Hwang’s actions represent the fulfillment of

every warning dismissed by proponents of research cloning and embryonic stem cell research. Thousands of eggs were obtained

through payments and coercion. Many women suffered terrible side

effects after they were not properly informed of the risks. Not a

single embryonic stem cell line was obtained for the tens of millions of dollars in Government funds that were invested in research. Anxious patients were misled about the research potential.

As stem cell researcher Ron McKay said about the hype involved

with embryonic stem cell research and distortions that are not aggressively corrected by scientists, ‘‘To start with, people need a

fairy tale. Maybe that’s unfair, but they need a story line that’s relatively simple to understand.’’

Our examination today will include an overview of current Federal policies related to these research areas. In particular, we will

hear what if any extra protections exist in the United States that

would prevent the type of widespread fraud or exploitation apparent in the Hwang research. Also of special interest to the subcommittee are the huge Federal grants that have been awarded to

the University of Pittsburgh researcher Gerald Schatten, who was

initially a co-author on one of Hwang’s fraudulent papers.

We will also hear from scientists, ethicists, women’s advocates,

and a patient advocate discuss these research areas and the known

problems associated with them.

On our first panel today, we have James Battey, Chair of the National Institutes of Health Stem Cell Task force, and Director of

the National Institute on Deafness and Other Communication Disorders; Bernard Schwetz, Director of the Office for Human Research Protections; and Chris Pascal, Director of the Office of Research Integrity.

The second panel consists of Dr. Richard Chole, Lindberg professor and chairman, Department of Otolaryngology, Washington University School of Medicine, St. Louis; Judy Norsigian, executive director, Our Bodies Ourselves, co-author of the book, ‘‘Our Bodies,

Ourselves’’; Ms. Diane Beeson, professor emerita, Department of

Sociology and Social Services, California State University, East

Bay; Mr. Richard Doerflinger, deputy director of secretariat for prolife activities of the U.S. Conference of Catholic Bishops; Ms. Debra

Mathews, assistant director for Science Programs, the Phoebe R.

Berman Bioethics Institute; and Mr. Joe Brown, Parkinson’s Action

Network State coordinator of Texas.

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

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Mr. SOUDER. I will now yield to the ranking member, Mr. Elijah

Cummings, for his opening statement.

Mr. CUMMINGS. Thank you very much, Mr. Chairman.

Just yesterday a disgraced researcher, Dr. Hwang Woo Suk, admitted to prosecutors in South Korea that he had directed a subordinate at the World Stem Cell Hub to fabricate research results.

This was the first admission by Dr. Hwang of his personal involvement in fabricating claims made by his research team in two landmark papers on embryonic stem cell research published in the journal Science.

An investigative team at Seoul National University already had

determined that Hwang’s claims that he had developed 11 patientspecific stem cell lines were in fact false. Dr. Hwang also acknowledged that donated eggs used in the research were coerced from

junior members of his research team, and that some donors had

been paid large sums of money.

Throughout the investigation, however, Dr. Hwang acknowledged

no personal involvement in the scientific fraud. The fraud, exploitation, and coercion for which Dr. Hwang has now admitted personal responsibility have earned him a resounding international rebuke, including from Seoul National University where he was employed.

We can only hope that Dr. Hwang’s humiliation will serve to

deter other scientists who might contemplate seeking glory through

reporting fraudulent research, exploiting employees, and coercing

women to donate their eggs without informed consent.

In a sense, this case offers a measure of vindication to the broader scientific community, demonstrating that it is difficult at best to

fool one’s peers for very long. Ultimately, the very nature of scientific research tends to ensure that the truth about claims of

major scientific advances will surface.

In this very high profile case, questions have been raised as to

whether the claims of Dr. Hwang’s teams should have been verified

in advance by the publishing journal. In any case, it was mere

months before questions about Dr. Hwang’s methods and results

began to be called into question publicly. In fact, it is almost startling how quickly many of Dr. Hwang’s claims have been thoroughly debunked, including yesterday through his own admission

of scientific fraud.

But the case of Dr. Hwang is no cause for celebration, even if opponents of embryonic stem cell research seem to have difficulty

containing their glee. Opponents of the research have been eager

to portray the Korean scandal as proof that not only is this field

a research uniquely prone to ethical pitfalls, but that the research

itself is inherently bogus, offering nothing more than false hope to

patients.

Mr. Chairman, I join the mainstream of the United States and

the international scientific community in drawing a different lesson

and conclusion. This research, which will go forward with or without the U.S. funding and oversight, needs the oversight that the

broader U.S. oversight would bring. Our own National Institutes of

Health is, without question, the entity best equipped to ensure that

embryonic stem cell research proceedings with scientific integrity

and in a way that ensures that women who donate their eggs are

17

protected from coercion, exploitation, and undisclosed risk of adverse health effects.

In the absence of strong Federal leadership, several States, including California and Maryland, have taken steps toward adopting guidelines for conducting embryonic stem cell research. The

National Academy of Sciences has adopted guidelines as well.

But accountability for U.S. research will come with substantial

support for this research, and that support will also help to ensure

that important lines of research that offer relatively less profit potential are pursued.

In closing, Mr. Chairman, it is important that we recognize that

fraud and ethical misconduct are hardly unique to science, and that

scientific fraud is not unique to embryonic stem cell research. Our

goal therefore should not be to use this controversy as a justification to impede the search for important new knowledge that could

yield therapies and cures for many major diseases. Rather, our objective should be to ensure that as research in this important field

inevitably proceeds in and beyond the United States, it does so

with the benefit of strict Federal guidelines and a rigorous oversight.

With that, Mr. Chairman, I thank our witnesses for appearing

today, and I yield back.

[The prepared statement of Hon. Elijah E. Cummings follows:]

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Mr. SOUDER. I would like to yield to the vice chairman of the

committee, Mr. McHenry.

Mr. MCHENRY. Thank you, Mr. Chairman. Thank you so much

for holding this hearing today.

Recent events in South Korea have brought to light and global

attention has been brought to the issue of human cloning and embryonic stem cell research. A number of concerns have been raised

surrounding this subject here and abroad, including the ethical dilemma of destroying life; fraudulent scientific procedures, as has

been mentioned by Ranking Member Cummings, as well as exploitation of women. All these are very serious subject matters that we

must address here today in this hearing.

As a part of this discussion, it is important to make the distinction between human embryonic stem cell research and adult stem

cell research. Adult stem cells and the research derived from adult

stem cells do not destroy human life, and do not take the essence

of life from the host being; whereas in embryonic stem cell research, that is the case. Life is taken from that fertilized egg, and

that life is destroyed.

Embryonic stem cell research is the purposeful creation of

human embryos destined to be destroyed for scientific research, in

this case, in the name of stem cell research. Adult stem cells have

provided therapeutic benefits and cures to 67 diseases and conditions such as diabetes, damaged heart tissue, strokes, cancers, Parkinson’s, and spinal cord injuries, among others. We need to focus

in the successes of adult stem cell research, an ethical approach

that provides cures and therapies, instead of focusing on this alltoo-political, it seems, issue of embryonic stem cell research.

Beyond the fact that there are currently no clinical trials or

therapeutic applications using embryonic stem cells, there are a

number of complications due to this approach, such as immune rejections and the inability to obtain pure cultures. The fact that this

process is so inefficient means an outrageous number of eggs will

be required for this approach.

And I would like to hear from our panel today as to their estimates on how many eggs would be required to actually move forward with major cures and major therapies. Some have said that

even for a disease that touches 17 million people or 20 million people, you would have to have roughly 850 million eggs harvested,

which means if you had 10 women willing to donate their eggs, you

would have to have about 85 million women in this country donate

their eggs.

It is a staggering sum. And this also goes back to the other issue

that is of major substance, and that is the exploitation of women,

which has been brought to light with the controversy and the fraud

perpetrated out of South Korea.

I would like to welcome our witnesses today. I thank you for taking the time to be here. And this issue today is not simply about

South Korean research fraud. It is about the larger issue of stem

cell research and what is an ethical, realistic, and moral approach

that moves science forward while keeping to ethics in medicine and

science.

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Thank you all again for being here today. And again, Mr. Chairman, thank you so much for your hosting this meeting today.

[The prepared statement of Hon. Patrick T. McHenry follows:]

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Mr. SOUDER. Thank you. I will now yield to the distinguished

ranking member of the full Committee.

Would you yield to Ms. Norton?

Ms. NORTON. I yield to the ranking member.

Mr. WAXMAN. Well, I thank you both very much for this chance

to make an opening statement.

We are going to hear testimony today about the ethical issues

around embryonic stem cell research and therapeutic cloning. In

particular, we will focus on the scandal in South Korea regarding

fraudulent research and abuses of research subjects.

Many opponents of stem cell research would like to use the

South Korean experience as a basis for banning embryonic stem

cell research. The story of Dr. Hwang’s fraudulent research in

South Korea is shocking because we rely on scientists to discover

the truth, not subvert it. We need to condemn the fraud, figure out

what happened, and learn how we can keep it from happening

again. And we need to make sure that this research is well-regulated and thoroughly scrutinized.

But banning future stem cell research would be a gross overreaction. Unfortunately, though the vast majority of researchers

are honest, fraud sometimes occurs in scientific and medical research. In fact, among Members of Congress, while most are honest, there are some who are not.

In 1983, a cardiology researcher at Harvard was found to have

fabricated much of his data. In 1996, it was revealed that reports

of a re-implanted ectopic pregnancy by British physicians were

fraudulent. And in 2002, it was discovered that a rising star physicist working on carbon-based semiconductors had fabricated most

of the data.

The answer to these instances of fraudulent research was not to

ban or deny funding for research on heart disease, ectopic pregnancy, and semiconductors. The right answer is to create and uphold high standards of oversight. When doubts emerge, disclosure,

investigation, and corrections must happen swiftly and openly.

That is the right response whether the fraud involves heart disease

or stem cell research.

We are also going to hear questions raised today about the potential benefits to be gained from various types of stem cell research.

Those who oppose embryonic stem cell research often claim that because we do not yet know what therapies it will yield, we should

not allow it to proceed.

That is a flawed line of reasoning. If we followed this to its logical conclusion, it would mean that the Federal Government should

only fund research into cures and therapies that we already know

about. The argument also understates that we do know about embryonic stem cells.

Decades of research have established the potential that these

cells hold for addressing serious illnesses such as Alzheimer’s, Parkinson’s, and even cancer. I say potential, not promise, because

there are no promises in any form of research. But what scientists

have already learned about stem cells indicates great potential,

which is an argument for moving ahead.

Opponents of embryonic stem cell research claim that there is

still much to learn from adult stem cells and therefore we should

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focus our efforts there. It is true that adult stem cells may hold potential, and I fully support researching the possibilities of adult

stem cells. But evidence tells us that the potential of adult stem

cells may be limited because they are already more specialized

than other types of stem cells. We should indeed move forward

with research on adult stem cell lines, but this is no argument

against pursuing study of other types of stem cells with even more

potential.

The third issue we will discuss today is the safety of women who

donate oocytes or eggs for stem cell research. Egg donation relates

to a specific type of research called somatic cell nucleic transfer

[SCNT]. This technique involves removing the nucleus of an

unfertilized egg and replacing it with the nucleus of an adult cell.

SCNT has two benefits compared to stem cell research on embryos from a fertility clinic. First, the possible outcome of this research is the production of tissues that are genetic match to the patient, reducing the risk of rejection such as that we have often seen

with organ recipients.

Second, the technique holds great potential for studying genetic

and other diseases because scientists could potentially develop cells

using nuclei from people who have the disease. This would not generally be possible using embryos donated from fertility clinics because researchers cannot select the genes for such cells.

Witnesses today will discuss their concerns about the safety of

the women who donate eggs for this research. Some of these concerns are legitimate. The drugs and techniques used are identical

to those used by women undergoing fertility treatments, but they

are not without risk. And I believe that we need to carefully examine research and monitor safety.

I also agree that we need to think carefully about how egg donors

for research should be compensated. We must respect the contribution that these women make, and we must ensure that they participate voluntarily. As with any new field of research, the safety and

ethics of human participants are paramount.

What we must not do, however, is become paralyzed into inaction. Stem cell research, including research using embryonic cells,

may help cure diseases that cause untold suffering to millions of

Americans and hundreds of millions more around the world. With

strict scientific and ethical oversight, embryonic stem cell research,

including SCNT, should be supported with Federal funds.

Thank you, Mr. Chairman.

[the prepared statement of Hon. Henry A. Waxman follows:]

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Mr. SOUDER. Congresswoman Schmidt.

Ms. SCHMIDT. Thank you. Thank you, Chairman Souder, for

holding this important hearing on the abuse in human cloning and

embryonic stem cell research.

As a strong supporter of reasonable science, true women’s health,

and the culture of life, this topic is very dear to my heart. I commend you, Chairman Souder, for bringing these panels of experts

together to shed light on the dangerous practices that some researchers are willing to use to advance their agenda. They, with

the help of the media, have unfairly raised the hopes of many

Americans, who have been led to falsely believe that embryonic

stem cell cures are possible in the near future.

While scientists were touting Hwang’s research as

groundbreaking and necessary for the medical miracles around the

corner, Hwang was actually falsifying data and possibly exploiting

women for their eggs. How many of these promises were ill-founded?

While it now appears that no scientist has effectively created

stem cell lines using cloned embryos, adult stem cell treatments

march ahead showing great promise for numerous diseases. The

facts have shown that cord blood stem cells and adult stem cells

are making great advances in curing diseases today, while clinical

trials in embryonic stem cells are still years away.

In the light of this fraud and abuse, and the fact that embryonic

stem cell research is just not producing the results that were promised, I am proud to have co-sponsored H.R. 596, the Stem Cell

Therapeutic and Research Act of 2005, or the cord blood bill, and

H.R. 1359, the Cloning Prohibition Act.

Again, Mr. Chairman, I applaud your leadership on these issues,

and I look forward to learning more about them to working with

you for a rightful resolution.

Mr. SOUDER. Thank you.

Ms. Norton.

Ms. NORTON. Thank you very much, Mr. Chairman. I want to

thank you for focusing the subcommittee on an unusually thorough-going example of the worst kind of scientific fraud because

what we have in the Hwang—I hesitate to call it South Korean example because I would hate to think that is characteristic of the

science of our friends in South Korea, but it is certainly an example

the likes of which I don’t think anyone has ever seen before, a massive scientific fraud at every level, fraud that was so good, as it

were, if you would forgive the use of the phrase, that even other

scientific researchers around the world were fooled by it.

It is a kind of case study in what can happen when nobody is

watching very closely, and when scientific research at the cutting

edge goes totally and absolutely unregulated. It was very troublesome to see and to count the violations and to see that they ranged

from what scientists were doing to violations of individual human

rights acknowledged to be important and necessary to the world.

So I welcome laying this matter out in detail, although I must

say I was fascinated with what my good friends on the other side

focused on. I mean, you would have thought this was not the Congress of the United States that could do something about the issue

that we are describing today.

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I mean, we are not a television program. Any reasonably literate

person or anybody who looks at television has been scandalized by

what happened in South Korea. I am pleased we are focusing on

this matter not because of any evidence I know of that anything

close to it is happening here, but because I have no reason to believe that what happened in South Korea could not or would not

happen here, at least to some degree. And I believe it is urgent to

move this Congress and this subcommittee from what we cannot do

anything about to what we can and must do something about.

This is a national issue, my friends. On a national scientific issue

of this kind, the burden is on the Federal Government, first and

foremost, to offer leadership and guidance. So if you are really concerned about South Korea, this is the time to focus on remedy, if

ever there was.

This much is clear: We cannot legislate against science any more

than we can legislate against the weather. But we can ourselves

enact reasonable measures in order to make sure that Congress

does not—that science does not march ahead in violation of every

ethical measure that both science universally has accepted and

that are a matter of documented international human rights.

Instead, very frankly, I must say that time after time, I see the

Congress trying to stop science. I am embarrassed by the congressional approach to the march of science. It is as if we were still in

the 19th century. Science is marching ahead, and it requires deeply

analytical, very deep thinking about how to harness science when

we know good and well it is marching.

And how do we know it is marching ahead? Well, next door you

have heard my good colleague from Maryland talk about what is

happening in that State. A Republican Governor, Governor Robert

Ehrlich, has proposed spending $20 million on stem cell research

in the coming year. That is happening all over the United States.

The States are joining the advanced countries of the world, marching ahead to make use of embryonic cell research.

I can only hope that in the countries of our allies, the national

legislatures have been more enlightened than to sit by and describe

the problem, while parts of their countries march ahead and do

whatever they want to do. We could affect how Maryland, how

California, and how every other State in the United States goes

about this work because we are the Federal Government.

I have every confidence that Mr. Cummings’ colleagues in Maryland are going to take up the slack and do the appropriate guidance. I don’t think there is a State in the Union that would allow

this work to go forward without redoubling their efforts in every

way to make sure that what happened in South Korea cannot happen here.

So I don’t need to add to the disagreement on the ban on embryonic research. You are not going to change peoples’ minds on that.

You haven’t done it in the States, some of which are governed by

Republicans.

But I want to ask this question: Unbelievably, Mr. Chairman, no

bill has passed this Congress outlawing, banning, even human

cloning. Can we agree on that? Can we get everybody to raise their

hands on that? Isn’t there any part of this issue where we would

be prepared to meet our obligations, instead of going over and over

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again the polarizing issue of shall we ban what we can’t ban and

what our States are telling us we can’t ban because we are going

ahead and doing it.

So I believe that this hearing is important because perhaps it

could lead to more than beating our chests against the obvious.

There is no disagreement in the United States of America or

among anybody in this Congress that what happened in South

Korea should not happen here.

Hearings are for remedies. I will be interested in whether any of

the witnesses today are prepared to help this Congress move forward on urgently needed remedies. And I Tim Howard, Mr. Chairman.

Mr. SOUDER. Ms. Foxx.

Ms. FOXX. Thank you, Mr. Chairman. I want to tell you how

pleased I am that you are having the hearing today.

I might get the reputation around here for being the person who

always brings up the issue of language and how important it is to

us. But I hear a lot of very inflammatory terms being used about

banning future stem cell research, and legislating against science,

and that we are not doing the kinds of things that we should be

doing.

We have not at all banned—talked about banning stem cell research in the Congress. We have encouraged stem cell research,

adult stem cell research. I am really curious about the word ‘‘therapeutic cloning’’ being used. I don’t know how the destruction of

human life could ever be called therapeutic.

I think that what you are doing here today is calling attention

to what I think is a microcosm of the fraud that has been perpetrated in relation to embryonic stem cell research itself. I think

focusing on what has happened in Korea and the fraud that happened there can, I think, enlighten people about this issue of embryonic stem cell research and the negative things about that. So

I think we can change peoples’ minds. I think we can enlighten

people. And I think we can do it in a way that is respectful of

human life and not destructive of human life.

So I applaud you for holding the hearing, and look forward to our

shedding some light on this issue that is the truth, rather than letting something like this continue to be a fraud. We have allowed—

unfortunately, people in very sad circumstances think that by the

use of embryonic stem cell research, we are going to have a cure

right around the corner. And we know that it has brought no cures,

whereas adult stem cell research has.

So thank you for doing this, and thank you for calling attention

to the issue.

Mr. SOUDER. Thank you. I ask unanimous consent that all Members have 5 legislative days to submit written statements and questions for the hearing record, and that any answers to written questions provided by the witnesses also be included in the record.

Without objection, it is so ordered.

I also ask unanimous consent that all exhibits, documents, and

other materials referred to by the Members and the witnesses may

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

Without objection, it is so ordered.

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Before swearing in our first panel, I feel compelled to tell all of

our witnesses to remember: This is an oversight committee, not a

legislative committee. We only have legislative jurisdiction over

narcotics. We do oversight and legislation on narcotics.

On the Department of Health and Human Services, we do not

write the bills. We are here to talk about the past. What the question is in front of us is what happened there and whether in fact

they are inherent to the process, or whether in fact controls can be

made to regulate this.

It is a legitimate debate, but it is not about where we are headed

legislatively. First, we are here to analyze the past, analyze what

has happened, analyze what the different agencies are doing and

what the potentials are, that then Energy & Commerce and the

Health Committee and others would look at legislatively. I think

there was some confusion on the panel as to the role of our hearing

and what our committee does. And I think it is important to clarify

that.

Now, as you know, it is the practice of this committee to swear

in their witnesses. Our first panel is Dr. James Battey, Chair of

the NIH Stem Cell Task Force and Director of the National Institute for Deafness and Other Communication Disorders; Mr. Bernard Schwetz, Director of the Office for Human Research Protections; and Chris Pascal, Director of the Office of Research Integrity.

Would you each stand and raise your right hand?

[Witnesses sworn.]

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

We appreciate that you have joined us, and we will start with

Dr. Battey.

STATEMENTS OF JAMES F. BATTEY, JR., M.D., Ph.D., CHAIR,

NIH STEM CELL TASK FORCE, DIRECTOR, NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; BERNARD

SCHWETZ, D.V.M, Ph.D., DIRECTOR, OFFICE FOR HUMAN RESEARCH PROTECTIONS, U.S. DEPARTMENT OF HEALTH AND

HUMAN SERVICES; AND CHRIS B. PASCAL, DIRECTOR, OFFICE OF RESEARCH INTEGRITY, U.S. DEPARTMENT OF

HEALTH AND HUMAN SERVICES

STATEMENT OF JAMES F. BATTEY, JR.

Dr. BATTEY. Good afternoon, Chairman Souder and distinguished

members of the subcommittee. I am pleased to be joined here by

my two other colleagues from the Department of Health and

Human Services. And I appear before you today in my joint roles

as a scientist and Chair of the NIH Stem Cell Task Force to discuss the recent events concerning stem cell research fraud that is

reported to have occurred in South Korea.

As you know, a review and analysis by the Seoul National University Investigation Committee concluded that human embryonic

stem cell lines were not derived from embryos created by somatic

cell nuclear transfer, as claimed, that fabricated data was used in

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publications, and that there had been ethical violations in the donation of human oocytes used in these experiments.

In 2004, Dr. Woo Suk Hwang and collaborators published an article in the journal Science claiming that they had derived a stable

human embryonic stem cell line, which they referred to as NIGHT–

1, from an embryo generated by somatic cell nuclear transfer. That

is a process, as Mr. Waxman described, where the nucleus is removed from a human oocyte and replaced by the nucleus from a

somatic cell.

Subsequent investigation by the Seoul National University investigation committee revealed that this claim was not supported by

rigorous DNA testing. In addition, the investigation revealed that

the photographs allegedly taken of the NT–1 cell line were in fact

photographs of an existing stem cell line not derived from an embryo created by SCNT, but instead derived from an embryo produced by in vitro fertilization.

In 2005, Dr. Hwang and collaborators published a second article

in Science, where they claimed to have made the process or deriving human embryonic stem cell lines from embryos created by

SCNT much more effort than was reported in the 2004 publication,

where several hundred oocytes were reported to be needed to create

a single stem cell line, which we now know was not created in the

way they described.

In this paper, the authors claimed to have developed an improved protocol for deriving patient-specific embryonic stem cells

from embryos created through SCNT. They reported the creation of

11 human embryonic stem cell lines from 185 embryos created by

SCNT, many of which involved nuclei from cells derived from individuals with debilitating diseases such as spinal cord injury, juvenile diabetes, or congenital inherited deficiencies of the immune

system.

Subsequent review by Seoul National University led the investigation committee to conclude that the data presented in this 2005

paper was based on only two human embryonic stem cell lines, neither of which was derived from an embryo created by SCNT. They

concluded that no disease-specific human embryonic stem cell lines

derived from SCNT embryos are represented in this publication,

nor is there any factual basis for believing the Koreans ever successfully created any such lines.

While the events in South Korea are deeply troubling to all of us

here and everyone in the scientific community, I think it is important to point out that scientific fraud of this type is not common

at all, and is certainly not restricted to the area of stem cell research. As one of your colleagues pointed out earlier, John Darcy

fabricated data in hundreds of publications in the area of cardiology over a decade ago. That doesn’t mean that it was inappropriate to continue doing work in the area of cardiology.

The scientific community must remain as vigilant as we can be

to ensure that the risk of scientific fraud is minimized. It is also

important to note that such fraud is sometimes revealed, often revealed, when other reputable scientists cannot reproduce results

that are subsequently revealed to be fabricated, and the great majority of scientists around the world are deeply committed to rigorous standards of proof and verification. The Rosetta Stone of

32

science is reproducibility in another independent laboratory. And

this is where scientific fraud is typically uncovered.

The scientific enterprise absolutely depends on such standards.

And while the stem cell research fraud in South Korea is completely unacceptable, it does not reflect on the potential of human

embryonic stem cell research one way or the other. The vast majority of my scientific colleagues are honest and hardworking in pursuing their research, which they deeply hope will ultimately benefit

the human condition.

I thank you very much for your time, and I will do the very best

I can to answer any questions that the subcommittee may have for

me.

[The prepared statement of Dr. Battey follows:]

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Mr. SOUDER. Thank you.

Dr. Schwetz.

STATEMENT OF BERNARD SCHWETZ

Dr. SCHWETZ. Mr. Chairman and distinguished members of the

subcommittee, I am Bernard Schwetz, the Director of the Office for

Human Research Protection. Thank you for inviting me here today

to discuss the Department of Health and Human Services [HHS],

Protection of Human Subjects regulations, particularly as they relate to human cloning and embryonic stem cell research.

These HHS regulations are designed to protect the rights and

welfare of all who participate in research studies that are conducted or supported by HHS. They are based in large part on the

ethical principles for human subjects research identified in the Belmont Report that was written by the congressionally mandated National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978.

The protection of human subjects in research studies is a priority

for HHS, and it is the mission of the Office for Human Research

Protections [OHRP], to support, strengthen, and provide leadership

to the Nation’s system for protecting volunteers in research that is

conducted or supported by HHS.

By signing an assurance of compliance with OHRP, an institution pledges to conduct its HHS-funded or supported research in

accordance with these regulations. In addition to assurances of

compliance, the HHS regulations also stipulate a number of other

requirements for which the institution and its institutional review

board [IRB], are responsible.

Primary among these is the need to determine if the risks to subjects are reasonable in relation to anticipated benefits, if any, to

the subjects, and the importance of the knowledge that may reasonably be expected to result. Some research studies offer individual studies the prospect of direct benefit, and others do not.

When research studies offer no prospect of direct benefit to research subjects, IRBs must consider whether the potential benefits

to society justify the risks to the individual subjects. For these

studies, including some research involving human embryonic stem

cells, the expected benefits would occur often in the future, and

would only be of help to others.

Informed consent: At the heart of the human subject protection

system is the requirement relating to informed consent. The investigator must seek a potential subject’s informed consent according

to the requirements laid out in the regulations. The investigator’s

method for obtaining this consent must be approved by the IRB before it can be used.

In seeking informed consent, HHS regulations require that investigators do so only under circumstances that provide the prospective subject with sufficient opportunity to consider whether or not

to participate, and that minimizes the possibility of coercion or

undue influence.

As part of the consent process, the prospective research subject

must be given sufficient information about a research study to

make an informed decision about whether or not to participate in

the research. If the study does not offer the subjects the possibility

37

of direct benefit, this must be clearly stated in the informed consent process.

For example, if a research study that involves identifiable human

cell lines is not intended to offer donors with the prospect of direct

benefit, then prospective donor subjects would need to be informed

of this unless the requirement for the informed consent has been

waived by the IRB.

OHRP guidance on research involving stem cells: OHRP has provided guidance to help insure that investigators and IRBs understood how the HHS regulations apply to research involving human

embryonic stem cells, germ cells, and the stem cell-derived test articles. A copy of this guidance is included in my written statement

for your consideration.

In essence, this guidance indicates when such research does and

does not generally meet the HHS definition of human subjects research. Under the HHS regulations, ‘‘human subject’’ means a living individual about whom an investigator conducting research obtains either data through intervention or interaction with an individual, or identifiable private information.

OHRP considers that neither of these definitions is met with research involving embryonic stem cells as long as the investigator

has not obtained data about an individual through a research

intervention or interaction, and cannot readily ascertain the identity of the individual from whom the human material was obtained.

In such cases, the study would not be considered human subject research and the institution’s IRB would not be required to review

this type of research.

However, some research may use established human cell lines

where the donor or donors may be readily identified by investigators, or may involve the obtaining of data through research interventions or interactions with individuals. In these cases, the research is considered to have involved human subjects, it would be

governed by the HHS regulations, and IRB review and approval

would be required for the research to proceed.

Finally, I would like to emphasize that the stem cell research

conducted at Seoul National University by Dr. Hwang which provided the impetus for this hearing was neither conducted nor supported by HHS. Quite apart from the issues of fraud and abuse,

such research could not have been conducted or supported by HHS

under Federal law in the United States.

Dr. Hwang’s research involved attempts to create new human

embryonic stem cell lines solely for research purposes through the

process of somatic cell nuclear transfer, sometimes called human

cloning. HHS is specifically prohibited by law from supporting research in which a human embryo or embryos are destroyed, as well

as from supporting the creation of a human embryo or embryos for

research purposes. And that law defines ‘‘human embryo’’ to specifically include embryos created by cloning.

As it was not conducted or supported by HHS, and does not appear to have been conducted at an institution that voluntarily

agreed to comply with the HHS regulations for all human subjects

research conducted at the institution, Dr. Hwang’s research was

therefore not subject to any of the regulatory protections that I

have discussed throughout this statement.

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Thank you for your attention, and I would also be happy to answer any of the questions you may have.

[The prepared statement of Dr. Schwetz follows:]

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Mr. SOUDER. Thank you.

Director Pascal. Did I say that correctly? Or Pascal? Thank you.

STATEMENT OF CHRIS B. PASCAL

Mr. PASCAL. Chairman Souder and distinguished members of the

subcommittee, I appreciate the opportunity to talk to you today

about research misconduct and the work of the Office of Research

Integrity in the Department of Health and Human Services.

ORI is charged with overseeing allegations of research misconduct in biomedical and behavioral research supported by the

U.S. Public Health Service. ORI has over 10 years of experience in

reviewing misconduct allegations and making findings of research

misconduct.

PHS-supported research institutions and ORI make findings of

research misconduct when evidence demonstrates that fabrication,

falsification, or plagiarism has occurred in PHS-funded research.

ORI has made more than 160 findings of misconduct since 1992,

and has reviewed hundreds of additional allegations of misconduct

that did not result in misconduct findings.

In May 2005, HHS published a new, more comprehensive regulation governing research misconduct investigations entitled, ‘‘Public

Health Service Policies on Research Misconduct,’’ codified at 42

CFR part 93, which can be found on the ORI Web site. This new

regulation replaces the previous regulation from 1989 for dealing

and reporting research misconduct.

ORI is aware of the controversy regarding Dr. Hwang’s human

stem cell research project at Seoul National University and the

findings of fraud by the Seoul National University investigation

committee. However, based on current information available to

ORI, ORI has no jurisdiction in this matter since the research was

not supported by PHS funds, and ORI does not have jurisdiction

over non-PHS-supported research.

Had the actions been under the purview of HHS, ORI has a staff

of scientists and additional consultants who have developed extensive knowledge and exploits in overseeing and assessing allegations

of research misconduct, primarily through evaluating investigations conducted by the PHS-funded research institution.

By law, direct investigations are usually initiated by the research

institutions that receive allegations of research misconduct. These

allegations are generally made by members of the grantee institution who are part of the particular laboratory or department conducting the research. And I might add that ORI considers these individuals to be heroes in coming forward with allegations of research fraud because without them, it would continue and grow.

And those individuals take great risk to come forward.

One or more members of the team may suspect misconduct and

then report it to the grantee institution directly. Sometimes the investigator suspecting fraud will report to ORI, and then ORI will

refer the matter to the appropriate grantee institution for review.

Grantee institutions are required by the HHS regulations to report

allegations to ORI when they reach the formal stage of investigation of the process, and when admissions of misconduct are made

by the accused scientist.

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In conducting the investigation, the institution must promptly secure the research records—without access to the research records

and to the original data, it is very difficult to solve these cases—

and other relevant documents in order to have a sound basis to

identify and evaluate any evidence of research misconduct.

When an institution has completed its investigation, it must submit a written report to ORI. ORI will then engage in a thorough

oversight review of the report and, depending on the quality and

thoroughness of the investigation, may accept the institutions report and find either misconduct or no misconduct based on the institution’s findings.

If ORI believes further investigation is required, we may request

and review the grantee institution’s entire investigation record, including the research data, copies of interviews or tapes of interviews, and other relevant documents. When the analysis is completed, ORI may find no misconduct and close the case, or propose

findings, PHS findings of research misconduct.

ORI findings of no misconduct, as well as open cases that are

under review, are considered confidential, both by the ORI regulation and other Federal law, and ORI does not discuss these cases

publicly. When HHS makes a finding of misconduct, however, it

formally announces the finding, which is then published in the

Federal Register, summarized on the ORI Web site and in our

newsletter, and the finding is listed in the NIH Guide for Grants

and Contracts. In ORI’s view, it is important to make these findings public. Otherwise, scientists can move around to other institutions and commit fraud again if it is not public information.

HHS takes findings of research misconduct seriously and takes

appropriate action. Findings of research misconduct typically result

in remedial HHS administrative actions that may include debarment or suspension from PHS-funded research, which means they

cannot come back to the Public Health Service and get new funding

for a period of time. And in very serious cases, they could be precluded from doing so for life.

ORI also strives to correct the research record that may have

been corrupted by fraudulent studies. As you heard earlier today,

Science withdrew two articles that were published because of the

fraud, and we think that is very important to making sure that the

scientific record is accurate and honest for other scientists and the

public to rely upon.

In those research misconduct cases that result in criminal fraud

charges, which has happened a couple of times, and civil proceedings of false claims, ORI works collaboratively with the Department of Justice and other Federal law enforcement agencies, including the HHS Office of the Inspector General. Accused scientists

who wish to contest findings of research misconduct are offered a

due process administrative hearing to defend themselves.

In order to promote research integrity and responsible research

practices, ORI has an active education program. We collaborate

with the scientific community, and we provide resources to institutions to develop their own educational products.

ORI believes that its educational programs and collaborations

with the research community can help prevent research misVerDate 11-MAY-2000 11:15 Dec 14, 2006 Jkt 000000 PO 00000 Frm 00049 Fmt 6633 Sfmt 6633 D:\DOCS\29580.TXT HGOVREF1 PsN: HGOVREF1
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conduct. It will not ever eliminate it just because of the nature of

the human condition.

For example, ORI has a collaboration with the Association of

American Medical Colleges to fund scientific and academic societies

to hold workshops and conferences on research integrity issues, or

develop guidelines or educational programs describing appropriate

normative standards for conducting and reporting research.

ORI has a collaboration with the Council of Graduate Schools to

fund pilot projects at 10 institutions to provide formal training to

graduate students in the responsible conduct of research. ORI has

published a booklet on responsible conduct of research that has

been translated into Chinese and Japanese, as well as in English.

Finally, ORI has an active program of evaluation and research

studies, partly in collaboration with the National Institutes of

Health within HHS, to determine what scientific practices are

working well and to learn what practices can be improved. It is important to study the science of science itself in order to improve

how you conduct research.

Although any individual case of research misconduct can have serious consequences for biomedical research, it is ORI’s experience

that the great majority of scientists are dedicated to conducting research in a responsible and professional manner, and are committed to producing research results that will benefit all Americans

and healthcare consumers around the world.

Thank you for the opportunity to discuss ORI’s work, and I

would be pleased to answer any questions you have.

[The prepared statement of Mr. Pascal follows:]

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Mr. SOUDER. Let me start with the questioning. And first, if we

are going to have any kind of reasonable discussion, let’s cut out

this cardiologist stuff and so on. There is a major difference between the exceptions in fraud that we see in the scientific community in fields of research where we have had research for decades

and decades, and fraud in the sole big case touted in journals and

touted by all sorts of researchers in a field that has no history of

such research, and the question of whether the fraud involved was

endemic to the process. Don’t treat us like little children and try

to BS us. It is not going to work.

Now, one of the things that Mr. Waxman, Mr. Cummings, and

I have had a question about baseball and steroids is whether or not

you can trust an institution to patrol itself when they have a financial stake in the matter that is being investigated.

And Mr. Pascal, you went through this detail, but you said the

first, basic, where you get your information whether there is fraud

is whether the grantee discovers there is fraud, who clearly has a

conflict of interest. Could you elaborate on this and how you

would—how we find out, if the institution chooses to cover up? Because South Korea had tougher laws than we have in the United

States, and they weren’t followed.

Mr. PASCAL. Well, it is true that an institution can have a natural preference for not finding research misconduct. It can lead to

embarrassment, it may lose—loss of funds from NIH or whoever

the funding source is, or whatever.

But based on ORI’s many years of experiences with institutions,

we think most of them want to do a good job in finding out what

actually happened, and make findings when it is appropriate. In

fact, some institutions make findings of research misconduct that

ORI does not pursue because we don’t think the evidence is substantial enough to support a finding that we could uphold in an administrative hearing.

Also, part of this is in the structure of the regulatory process.

Our new regulation has followed the policy established by the Office of Science and Technology Policy which was adopted in 2000,

which states that research institutions bear primary responsibility

for prevention and detection of research misconduct, and for the inquiry and investigation and adjudication of research misconduct alleged to have occurred in association with the institution.

There are also a number of checks and balances in the ORI regulation. ORI has oversight review over the institution’s findings. The

institution sometimes will make minimal findings or weak findings,

and ORI will come in and do additional analysis and investigation

with its scientists, and we make additional findings.

There is a regulatory requirement that the institution must utilize experts in the relative scientific field, and must ensure objectivity in the investigation. That is a regulatory——

Mr. SOUDER. Let me ask a followup question and we will submit

your full answer for the record.

Mr. PASCAL. OK.

Mr. SOUDER. Because that is basically the procedure that Korea

had.

In ORI, you have given a major grant to University of Pittsburgh

researcher Gerald Schatten, who is the co-author of these studies,

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who withdrew after the fraud became public, but who was co-author. And I am going to have some detailed questions that we submitted before and we are trying to get the answers to.

But given that he cited this Korean research multiple times in

his grant application, are you in the process of reviewing that

grant? And do you have a process—because in effect, what you

were just giving me is a whole process that, if the review was

weak, if you had questions about it, then you could step in. Are you

reviewing this grant?

Mr. PASCAL. Due to ORI confidentiality constraints, we cannot

admit nor deny any specific——

Mr. SOUDER. OK. Let me re-ask. Do you have the authority to

review this grant based on the information that came out that he

had been a co-author of the fraudulent study in Korea?

Mr. PASCAL. If there is a matter that involves PHS funds and alleged research misconduct, yes. ORI would have authority to review the results of the investigation by the institution.

Mr. SOUDER. And Dr. Battey, I am going to read a number of

questions here. You have been—we sent these over 2 years ago.

Your response to some of the questions was—not these particular

questions, but you responded slowly to some of the others. But we

are trying to make a policy. And I am going to read a couple of

these. If you can kind of give a general feeling, and then submit

back in the record regarding Pittsburgh researcher Schatten’s question.

One is, how much money was spent on human embryonic stem

cell research in 2005, and how much of that went to University of

Pittsburgh researcher Gerald Schatten?

Also, is his research on the Bush-approved stem lines as well as

on primate embryos, and could you separate that funding for us? Also, of his $16.1 million, how does this compare to other people

who have embryonic stem cell grants? If you could give us his rank

in terms of grants for the research on monkeys and approved stem

lines, and how many grants he has been awarded. And is he your

top single grantee? Because his grant makes reference several

times to this Korean research, which he was co-author of till he

withdrew after the fraud became public.

And also, will you give us the 2005 figures for ESCR grant

awards? How many grants, total dollar amount, smallest grant

award, and largest grant award? Because quite frankly, and your

agency is doing oversight, this is just basic data, and it shouldn’t

take 2 years to get to this oversight committee to get basic data.

Now, if you don’t have it today, although we did submit these in

advance.

Dr. BATTEY. Let me do the best I can to answer your questions

immediately.

In fiscal year 2005, NIH supported about $40 million in research

involving human embryonic stem cells. In fiscal year 2005, Dr.

Schatten’s NIH-supported research involving human embryonic

stem cells was approximately $1.1 million.

Getting to your issue about size of grants, Dr. Schatten is not the

champion in terms of garnering NIH support for human embryonic

stem cell research. Larger awards have been made, and in fact, an

award of a little over $4 million was made to WiCell, which is a

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biotechnology firm associated with the University of Wisconsin, to

form the National Stem Cell Bank, which is an effort to make the

stem cell lines that are eligible for Federal funding more readily

available to the research community.

In fiscal year 2005, NIH supported 154 individual research

projects involving human embryonic stem cells at the total amount

of about $40 million. Of these, the smallest grant was $2,000

awarded to NGRI Intramural Scientists to conduct genome instability in cancer development research. The largest human embryonic stem cell project was the $4.2 million that I mentioned earlier

awarded to the WiCell Research Institute.

Mr. SOUDER. Thank you very much. That was helpful. Can you

submit a full list of the grants for the record?

Dr. BATTEY. The full list of the 154 individual research projects?

Yes.

Mr. SOUDER. In 2005?

Dr. BATTEY. Yes.

Mr. SOUDER. OK. Thank you very much.

Yield to Mr. Cummings.

Mr. CUMMINGS. Thank you very much.

Dr. Battey, I think it was you that said that one of the best ways

to discover fraud in these instances is when you have to duplicate

the research in another lab. Is that correct?

Dr. BATTEY. Yes. If I can elaborate on that for just a moment.

Mr. CUMMINGS. Please do.

Dr. BATTEY. When a major scientific breakthrough takes place,

it generally has implications for research going on in a number of

other independent laboratories. And one of the first things they will

try to do to take the next step and build on that research is to take

the protocol that was reported in the published literature to have

given a specific result and reproduce that result.

Now, when multiple laboratories around the world or in the

United States cannot reproduce a major scientific finding, it rapidly

falls into disrepute.

Mr. CUMMINGS. Now, you stated in your testimony that while the

stem cell research fraud in South Korea is unacceptable, it doesn’t

reflect on the potential of human embryonic stem cell research one

way or the other. Is that what you said?

Dr. BATTEY. I am saying that the arguments for or against doing

human embryonic stem cell research are not directly implicated by

the—or directly influenced by the fraud that everybody agrees was

inappropriate that took place in South Korea.

Mr. CUMMINGS. You know, the thing that has—I think you listened to the opening statements, and you heard Ms. Norton. And

I think one of the major concerns here is, do you—I mean, are you

a scientist?

Dr. BATTEY. I am reported to be a scientist, yes.

Mr. CUMMINGS. OK. Well, I will take your word for it.

Dr. BATTEY. My mother thinks I am a scientist.

Mr. CUMMINGS. I am sorry. Say that again?

Dr. BATTEY. My mother thinks I am a scientist.

Mr. CUMMINGS. Your mother?

Dr. BATTEY. Yeah.

Mr. CUMMINGS. OK. That is good. [Laughter.]

53

Dr. BATTEY. She also thinks I am a doctor.

Mr. CUMMINGS. I guess the question becomes—I think at least

two of you, and I know Mr. Waxman, referred to it, and others—

this whole thing of fraud and whether the fraud in an area like

this should then cause us not to go into that area. And then the

chairman got very upset when we talked about—you all talked

about the cardiology piece.

But I guess the point is that you can have these problems. You

are going to have problems as long as you have human beings

doing things. The question becomes, do you stop going in the direction because of that research. Is that what you all are saying?

Dr. BATTEY. My comment was that there is an enormous potential to improve the human condition through research that involves

all types of stem cells. And it is my belief, and the belief of the National Institutes of Health, that we need to move forward and explore all avenues that are reasonable and ethically sound that have

the potential to alleviate human suffering.

Mr. CUMMINGS. And when you see instances like California and

Maryland moving toward funding this research, how does that affect the people in you all’s shops? In other words, if you see States

now moving toward that and you are, I guess, kind of standing on

the sideline and watching, does that create concern for you all at

all?

Dr. BATTEY. My job as the Chair of the NIH Stem Cell Task

Force, which is a role that I was asked to assume by the NIH Director, Dr. Zerhouni, in the summer of 2002, is to try to find areas

within the President’s policy where we can accelerate the pace of

research using stem cells.

And I think it is fair to say that there has been very significant

progress made by support provided by the National Institutes of

Health. As I mentioned, in the last fiscal year we have 154 research projects. We invested $40 million. And much has been

learned about the fundamental events that drive cells to become

specialized adult cell types.

This is the information that will ultimately allow us to potentially generate cells for cell replacement third party in the laboratory; to potential mobilize endogenous populations of stem cells

within patients to become these interesting cell types; or, ultimately, to understand the molecular mechanisms that determine

this magical process of nuclear reprogramming whereby an adult

nucleus in a specialized cell can turn back the clock and become

a pluripotent cell nucleus, and in so doing, allow us the opportunity

to generate pluripotent cells without the destruction of human embryos.

Mr. CUMMINGS. We have a tough time situation, but I have to

ask you this one last question. You know, so you—based upon what

you just said and your testimony, you don’t see this area of research as some pie in the sky. And it has been implied that some

of this research is just giving people false hope. You don’t see that

based upon your knowledge and expertise? Do you understand the

question?

Dr. BATTEY. I understand the question very well, I believe. I will

say freely that the comments that have been made about therapies

using adult stem cells and the therapies using embryonic stem cells

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at this time are 100 percent true. There are no therapies using

human embryonic stem cell lines at the current point in time.

Adult stem cells, in particular hematopoietic stem cells, stem

cells of the blood-forming organ, the bone marrow, have been part

of the research landscape for nearly 31⁄2 decades. Human embryonic stem cells first became available to the research community in

1998, when James Thompson published his landscape paper.

I think it is premature at this point in time to evaluate exactly

what type of stem cell and in what way knowledge gleaned from

studying that type of stem cell in 10, 20, or 30 years is going to

inform the medicine of the future and empower the next generation

of physicians.

Mr. CUMMINGS. And I imagine if we had taken that position in

a lot of our science, we wouldn’t be where we are today in various

areas of science.

Dr. BATTEY. It is unfortunate, but the progress of science is usually incremental. And we make slow steps forward, and it takes

many, many of those slow steps over a long period of time, before

we have even done the safety and efficacy testing in animal models

that poise us to do the first experiments that involve human patients.

And I am delighted to be joined here by my colleagues from Office of Human Research Protection, who see to it that we do these

studies in people in a responsible fashion. You know, we are absolutely bound to do that, as human beings and as physicians.

Mr. CUMMINGS. Thank you very much.

Mr. SOUDER. I really need to hold to the 5-minute rule because

we have a lot of Members, and we are trying to reach a 5 p.m.

deadline, and we have six witnesses on the second panel.

Ms. Foxx.

Ms. FOXX. Thank you very much.

I want to ask Dr. Battey: Did SCNT create Dolly the sheep?

Dr. BATTEY. Dolly the sheep was created by somatic cell nuclear

transfer. That was in fact the time that we learned that an adult

cell nucleus could be reprogrammed. That was the first demonstration that I am aware of in a mammal that was possible, although

such experiments had been done in amphibians for decades.

Ms. FOXX. Then what is the difference between somatic cell nuclear transfer and cloning?

Dr. BATTEY. Somatic cell nuclear transfer is the process whereby

the nucleus is removed from an oocyte and replaced by the nucleus

from a somatic cell, a body cell. That is why it is called somatic cell

nuclear transfer.

When this procedure is done with the goal of creating an embryonic stem cell line that is genetically matched to an individual or

has a specific genetic background, that term that is used for that

is therapeutic cloning. When it is done with the intent of creating

a new life through—all the way through gestation and having, in

this case, a baby sheep born, in the case of Dolly, that is reproductive cloning.

And, you know, the nomenclature—you mentioned that language

can be very tricky. And the whole word ‘‘cloning’’ is a word that is

a tricky word because it is used in many different ways. In my laboratory, we talk about cloning a cell line, which means basically

55

taking a culture of cells and growing up a new culture from a single cell.

We talk about cloning a recombinant DNA molecule, where we

take a single recombinant DNA molecule and make 10 to the 8 copies of that molecule. And then here we talk about therapeutic

cloning and reproductive cloning. And while they employ similar

technologies at the beginning, they have different end points.

Ms. FOXX. Well, I am curious about the phrase that you use,

‘‘ethically sound.’’ I wonder whose definition of ethically sound it is.

And I will tell you what went through my mind when you said

that, and I want to be very careful how I say this.

I heard a presentation a couple of weeks ago by a physician, and

he raised the issue of the Tuskegee experiments that were done.

If there is anybody here who doesn’t know those, those were experiments done on African American men in Alabama, I believe, or—

I am not sure what State it was in, 40 years ago, 40 or 50 years

ago, where they were injected with syphilis, I believe, and then

studied for it.

I wonder if those people said those studies were ethically sound.

And would you feel that those were ethically sound studies?

Dr. BATTEY. No. I would not feel they are ethically sound. And

they led, in fact, to the creation of human subjects protection rules

as we know them today.

Ms. FOXX. OK. Then how would you define ethically sound if, in

the process of doing embryonic stem cell research, you are destroying human life? How do you define ethically sound?

Dr. BATTEY. That is the subject of a national debate at this time.

And there are many different opinions on that subject that cut to

the very heart of when people believe that life begins. That is a

subject where the major religions of the world are divided. And it

will be a subject that I predict will be a contentious subject that

will need to be debated for the foreseeable future.

Ms. FOXX. Mr. Chairman, that is the last question I had. But I

would really like to go back to some of the testimony that might

have been given around the Tuskegee experiments, and I will have

a feeling that a lot of the scientists who were engaged in those

used the very same language that you use.

Mr. SOUDER. Mr. Waxman.

Mr. WAXMAN. The Tuskegee experiments were reprehensible.

They involved human subjects who were not informed of the nature

of the experiments. As I understand it, they never were reviewed

by any outside agency. And you indicated, Dr. Battey, that is why

the whole protections for human subjects has been created, so that

an institutional review board has to approve any kind of experiment to be sure that it is ethical and meets ethical standards. Is

that correct?

Dr. BATTEY. That is correct.

Mr. WAXMAN. Now, a lot of people worry that embryonic stem

cell research is going to be conducted. It is going to be conducted

by private companies.

If embryonic stem cell research is conducted by the Government,

is there a greater chance that ethical standards will be met, that

there are going to be—there will be greater scrutiny of all the procedures that go into that research?

56

Dr. BATTEY. I think it is fair to say that there will be the same

scrutiny that we have applied to other areas of biomedical research, with doubling scrutiny because of the respect that one has

to have for the sensitive area of research where there is an enormous divide in our country.

Mr. WAXMAN. Well, the American Society for Cell Biology emphasized the importance of public funding. And they at one point said

that without Federal funding, the Nation’s top academic researchers at universities, medical schools, and teaching hospitals cannot

join in the search for cures, which means slower progress, and that

the Government oversight will ensure that research complies with

ethical guidelines.

Do you agree with that statement, that last point, and how does

it guarantee or ensure that research complies with ethical guidelines?

Dr. BATTEY. We can insist that before Federal funds are expended, that proper oversight has taken place. And that in fact is

done with all the research that involves human subjects, where the

experiment must be reviewed by an institutional review board in

the institution in question before such an experiment goes forward.

Mr. WAXMAN. In your view, does the Korean scandal establish or

suggest that the field of embryonic stem cell research is unique in

being susceptible to scientific fraud and/or patient exploitation?

Dr. BATTEY. Unfortunately, I am afraid that scientific fraud has

been found in many areas of science, as I mentioned earlier. It is

rare, but it happens in many different areas. And scientists need

to be vigilant to try to prevent it.

But I would emphasize that it is my sincere belief in my 23 years

of experience as a scientist has taught me that the overwhelming

majority of individuals engaged in biomedical research are sincere,

hardworking, and would like nothing better than to see what they

do in their laboratories lead to better cures and better health of the

Nation.

Mr. WAXMAN. Should women be allowed to donate eggs for purely

research purposes under any condition? And if so, what should

those conditions be? Maybe you want to——

Dr. BATTEY. I think that might be a better question for Mr.

Schwetz to try to answer, if he would like to, or I will answer to

the best of my ability if he would prefer.

Mr. SCHWETZ. All we can say is that if in fact there is going to

be research that involved eggs from donors, and this is research

that is funded by HHS and doesn’t involve the cell lines—it doesn’t

get outside of the cell lines that are acceptable for HHS-funded research, then all we can say is that we have a network in place

through the institutional review board system that determines that

these protocols must be reviewed, and they need to meet the standards that are set in our regulation.

Mr. WAXMAN. Well, what if we changed the ban on this research

through NIH and broadened it to further investigations using embryonic stem cells, does a—exploitation of women is a major and

disturbing theme in the story of the Korean scandal. Would this be

something that we could make sure is done appropriately, if a

woman wishes to participate in donating an egg for research beyond stem cells that are available now?

57

Mr. SCHWETZ. It is hard to know what is going to come up in the

future. But based on what we know today, these—we are faced—

this is an enterprise that is faced with a number of risks in research, and the possibility that there would be a problem with harvesting eggs from females is one of a number of risks that would

be handled by the institutional review board system on a regular

basis.

So I don’t think there are limitations in the regulations that

would suggest we shouldn’t go into this kind of research because

we don’t know how to handle it.

Mr. WAXMAN. We don’t know how to handle it until it is reviewed? Until some proposal is reviewed?

Mr. SCHWETZ. That is correct.

Mr. WAXMAN. OK. Thank you. Thank you, Mr. Chairman.

Mr. SOUDER. I have a feeling that though Mr. Waxman and I

may disagree fundamentally on where life begins and in embryonic

research, if this were to go forward with congressional standards,

I have a feeling that we would want more than an institutional review because that is partly what happened here. In other words,

just trusting the university isn’t going to cut it in something this

controversial ethically. Is that——

Mr. WAXMAN. Well, I don’t think an institutional review board is

trusting the university, and maybe we can have the experts inform

us on the subject. But I think an institutional review board is to

oversee the work of the universities and their proposals when they

evaluate the ethics of any experiment.

Mr. SOUDER. This is important to clarify because we had it in the

testimony in response to several questions. My understanding is

that unless you feel there has been abuse, the research on whether

there has been fraud, and the guidelines are standard, they submit.

Then they do an internal review, and unless you feel something is

wrong, you don’t review it. Is that correct?

Mr. WAXMAN. I think they have to review it in advance to prevent an abuse, not wait till——

Mr. SOUDER. They set the guidelines, but to make sure that the

guidelines are being followed, it is self-reported unless somebody

blows a whistle or you suspect something. Is that correct, Mr. Pascal?

Mr. PASCAL. Is your question to me?

Mr. SOUDER. Yes.

Mr. PASCAL. I am sorry. Yes. We normally get complaints of allegations from individual scientists. Also, the institution is required

to report to us when they get to the investigation stage.

Mr. SOUDER. Thank you. Is that clarified?

Mr. WAXMAN. Well, I think it is an answer, and I appreciate the

answer. Thank you.

Mr. SOUDER. OK. Ms. Schmidt.

Ms. SCHMIDT. Thank you. I have a question. But before I ask my

question, Ms. Foxx said that language is important. And Dr.

Battey, this goes to you as well as the question. Language is important, and I don’t think we should discuss the term ‘‘religion’’ when

we are discussing when life begins because I have a very dear

friend that is an atheist, and he believes the same as I do as to

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when life begins. And he doesn’t believe in any God or in any religion.

But having said that, I have been concerned about the issue of

appropriate stem cell research for some time. In my days when I

was in the Ohio Legislature, I actually went to the University of

Cincinnati to find out exactly how they were handling this. And so

I know that extrapolating information is important. And when I got

here, I did some research, and I found out that this committee in

its past has had a difficult time getting information from you.

As you know, and as I found out, this subcommittee requested

information from you in October 2002 seeking a detailed report

providing comprehensive information on the medical applications of

adult and embryonic stem cells, as well as cells from cloned embryos and aborted fetuses. The subcommittee received a response

from you in June 2004, 20 months after its initial request, during

which time the subcommittee staff continuously inquired about the

status of this report, and subsequent chairmen’s letters were sent

seeking this material. And I have copies of them.

Your reply to this oversight request, 20 months in the making,

was completely insufficient and unresponsive to the plain meaning

of the committee’s request. Ultimately, you acknowledged this and

apologized for the inadequacy of the response.

But throughout this entire period, when Congress was seeking

critical information about these very issues we are discussing today

in 2006, information that would have been useful for complex policy decisions being faced by the Congress and our President, members and their staffs were unable to obtain the kind of accurate,

timely, and up-to-date information from NIH necessary to do, quite

frankly, the people’s work.

This happened on your watch. It seems only appropriate that

while we are examining the problems in this research area, that

you explain to this body why such critical information was withheld from Congress for so long. And the second part of that is: Will

you be forthcoming when we ask for additional information in a

timely manner and a comprehensive format in the future? Because

I believe the public has a right to know.

Dr. BATTEY. It is a fair question. I am very sorry that response

was delayed the length of time that it was. But I must inform the

committee that the NIH had developed its response within a few

weeks of when the request was initially received. Once we develop

a response, it is then subject to a clearance process in the Department of Health and Human Services over which I have no control.

So yes, it was done on my watch, and I take responsibility for

it. But aspects of that delay were beyond my control. And what I

will tell you is that I will do what I can to get information to this

subcommittee or any other subcommittee, factual scientific information, in as timely and accurate a fashion as the resources I have

at my disposal allow me to do.

But again, I say I am sorry you were without that information

for a 2-year period.

Ms. SCHMIDT. Well, I have a followup, sir. And again, I am new

to this process. But information is key——

Mr. SOUDER. Mr. Schmidt, will the gentlelady yield a second?

Ms. SCHMIDT. I would be honored, yes.

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Mr. SOUDER. And I will put your time back on. And if Ms. Norton

and Ms. Watson will let me make a brief comment, that I appreciate your apology. Ms. Schmidt will have a followup question.

But in the role of oversight in the U.S. Congress—and this is not

directed at you—I am getting increasingly frustrated with this administration coming up with multiple excuses as to why they can’t

give us documents on this, on HHS, on the State Department, on

the Office of Faith-Based, and other departments. We constantly

hear, well, it has to be reviewed.

We represent the American people. Two-year review is not acceptable. And I am not sure who we have to call in, whether we

have to do this at the full committee level. But other subcommittees are having the same problem, in that exactly what takes 2

years of review to figure out, when we ask data and the data is

coming over to us, what kind of review has to happen for elected

officials to see the fundamental data.

Then second, then we are told that the process of why it took 2

years is pre-decisional, as though there was some sort of a political

discussion over what they were going to get us. And quite frankly,

both at Department of HHS under this Secretary and at the State

Department under multiple Secretaries, if it wasn’t for individuals

leaking us documents, we wouldn’t know that when we get the documents, often, what has been taken out.

And different agencies are saying—because we will make a document request. Then we will be told that this is all the documents.

Then we will show the department—this happened three times in

one State Department request. This, I think, dealt with Afghanistan. And it is getting increasingly exasperating. Then you are sent

up here having to defend that.

But the bottom line is: We need timely responses. The type of requests we made were basically factual requests. They shouldn’t

have had such a political screen. Even though we know this is a

difficult subject, we are the same party. We know how difficult the

subject is, but elected officials have a right to know what this data

is.

And the extra-exasperating part of this is that by the time we

get the data, then we don’t have the trust in the data. And then

we—in the example of the State Department—had to request

10,000 documents. And then they came back and said the great

cost.

Well, we lost confidence in the trust of the Department. And

HHS is headed this direction, too. If you can take this back. We

will try to target our document requests if we get them in a timely

fashion and get the documents that we requested. But if we don’t

get the documents requested in a timely fashion, we have to keep

broadening the search because we are an oversight committee.

And quite frankly, this happened under the last administration

until the last stretch, and then they started sending over like

truckloads of documents and taking forever to go through. But at

least they were more forthcoming. And I appreciate your willingness to cooperate, and that this administration, hopefully at higher

levels than yourself, will start to respond. But the frustration is

building, and it is going to boil over if we can’t figure out how to

do it.

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So thank you for having the other data earlier. I yield to Ms.

Schmidt. But sorry, I wanted to go on the record that this is far

greater, even, than just his Department. We are having a tremendous problem in doing oversight right now for this very reason, getting 2 years and then not getting the—getting an incomplete

amount, and not knowing what we are missing. That is because we

don’t know what has been taken out.

Do you have any insight as to what took 2 years to review?

Dr. BATTEY. No.

Ms. SCHMIDT. Thank you, Mr. Chairman. As a followup, since

you had to put this through a review process, who are the people

we have to call to stop the delay in the review? Who—give me the

name, please, of the person that is accountable for the holdup in

this document request because as the chairman said, it is not just

Congress that has the right to know. It is the people that have the

right to know.

We represent the people of the United States. And we have the

right to know information in a timely fashion, sensitive information

on this issue, and this is a very controversial issue. If we don’t

have that information, we can’t make the appropriate policy decisions that the people expect us to make.

So who at your Department held this up for 2 years, so we can

bring him in and ask why?

Dr. BATTEY. I don’t know.

Ms. SCHMIDT. Can you find that out for us?

Dr. BATTEY. I can try to find it out for you.

Ms. SCHMIDT. Thank you, Mr. Chairman.

Mr. SOUDER. Thank you. Ms. Norton.

Ms. NORTON. Mr. Chairman, I have a couple of questions, but I

want to just say a word because both gentleladies have mentioned

the word—the care we must take in language. And I want to second what they said.

I want to say I appreciate that the gentlelady from North Carolina said she wanted to be careful about her language when she

made analogies to the Tuskegee experiments involving living,

Black men who were treated in a way that was emblematic of the

way Black people were treated in the Southern States.

And I just want to say for the record, for those of you who want

to use those analogies into the African American experience, you

are right. You had best be careful. Because I believe I speak for African Americans when I say we do not want anybody comparing

Black people to human embryos.

Mr. Chairman, I just want to say, because you have always been

very remedy-oriented and I was a little surprised at what you said

to the ranking member about BS’ing about analogies, we just heard

some analogies that, frankly, I resented.

But I really don’t think you meant that we are only interested

in the past. I have never seen you approach an issue that way. And

I know you don’t—you are not holding the hearing for political reasons or to keep any information we get from these witnesses to ourselves.

And Mr. Chairman, if I can remind you, our own Chair, Mr.

Davis, has said repeatedly that the Government Reform Committee, by the way, has the largest staff in the Congress of the United

61

States because its writ is to investigate anything involving the

Government.

And I suppose the best indication of that, Mr. Chairman, for

something that some would argue is totally outside our jurisdiction,

is not only the hearings, not only the investigation, but the bill we

passed on baseball. I mean, there is another committee that has

primary jurisdiction over that matter, but the chairman brought

forward his own bill on it.

And I think when we are talking about this matter, we would

want to be remedy-oriented. And in light of my work with you on

this committee and my respect for your work on this committee, I

know that you would want us, if we could uncover some remedies

for adult stem abuses or embryonic stem abuses, to let everybody

know about it.

Let me have—let me ask a question to Mr.—Dr.—I think it is

Battey. Am I pronouncing that Right?

Dr. BATTEY. Yes, ma’am.

Ms. NORTON. And your role is the chair, of course, of this important task force on stem cell research. And Mr. Pascal, who is a lawyer, who speaks from another angle.

First of all, I was relieved that both of you appear to have testified that we don’t yet have this problem in this country, Dr. Battey,

that the vast majority are honest, do not reflect on even the potential on the human embryonic cell research one way or another.

You refuse to draw conclusions in advance. By the way, everybody, that is how the scientific—how the scientific method works.

You come in with a hypothesis and you say, prove it one way or

the other. Prevent it if you can. Mr. Pascal says virtually the same

thing. Serious consequences if you had any particular case of—

great majority of scientists here are dedicated.

My question, and as far as you know have not been involved in

anything like this kind of fraud and human rights violation. Let me

ask you this. We talked about how fraud gets uncovered. Again,

going back to scientists, who first uncovered this fraud?

Dr. BATTEY. The initial——

Ms. NORTON. In Korea?

Dr. BATTEY. The initial allegations of fraud involved members of

the research team in Korea.

Ms. NORTON. Very important point to put on the record, that it

is a primary obligation of scientists themselves, as any ethical scientist moves forward, to replicate, to investigate, and moves forward in the spirit of great skepticism and that. But very important,

as we seek guidance—at least people like me seek guidance—from

the Federal Government, I don’t know what form it should take to

indicate how most fraud is uncovered, how most matters of this

kind are uncovered.

Are most of them brought forward by scientists, or was that unusual?

Dr. BATTEY. I will yield to my colleague, Mr. Pascal, who probably knows better than I do, but would comment that in my experience generally, they are brought forward by individuals familiar

with the research in question.

Mr. PASCAL. I would agree with that, that it is usually somebody

who is in the laboratory or the department and is familiar with the

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research being done so they have enough knowledge to know that

something is wrong.

Ms. NORTON. Whereas whistleblowers are uncommon in the Federal Government, that is the job of a scientist. And I am just

pleased to hear that for the most part, it seems to be working in

this country.

I have a question that bothers me very much, though, and this

involves the testimony of Mr. Schwetz—yes, of Mr. Schwetz, who

said that—in page 4 of your testimony that the guidance, the stem

cell guidance, does not generally meet the—your definition, HHS

definition, of human subjects research, and that is where you have

offered guidance. Is that correct?

Mr. SCHWETZ. Let me clarify because there are circumstances

where research involving stem cells would be human research that

would have to be reviewed and approved by an institutional review

board, and you would have to have——

Ms. NORTON. No. I am trying to establish—I am not trying to understand that. What I am trying to establish is that you have no

guidance involving stem cell research.

Mr. SCHWETZ. Yes. We do have guidance to the IRB and investigator community on their responsibilities if they are doing research involving stem cells. We do have guidance on that.

Ms. NORTON. So the guidance you have—the guidance you have

offered would keep—in your judgment, would alert the scientific

community that the kind of abuses we find in South Korea are

not—or violate, I guess, your regulations and U.S. law?

Mr. SCHWETZ. I am not sure I really understand your question.

But there are some circumstances where fraud would represent

risk to subjects. But there are other—to research subjects. There

are other cases where fraud would not necessarily represent risk

to subjects of research, but would have other implications for the

quality of the data that are coming out of a laboratory.

Guidance that we have put out regarding research involving

human subjects and stem cell research is meant to be taken in the

context of our broader regulations that tell investigators and the

IRB community how to ethically review the research.

Ms. NORTON. Dr. Battey, one last question. Are you aware of the

research—they have been very careful in how they have described

it. I have read it. I have seen some of it on television involving

rats, where rats have been injected with human embryonic cells.

These rats were totally paralyzed before, and you see that the rats

now move, awkwardly but amazingly and astoundingly.

Without commenting on where this would lead because I don’t

think anybody knows where it would lead, and those who have

been involved in this astounding, this startling, this amazing research are careful to say that these are rats only, but they were

injected, were they not, with embryonic human stem cells?

Dr. BATTEY. I believe that is correct.

Ms. NORTON. Very important to note since we had all kinds of

opinion from non-scientists on the other side that there is no

progress whatsoever. And Congress, however, knows best.

Thank you very much, Mr. Chairman.

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Dr. BATTEY. I am. Could I add just one comment, though? It is

not clear in what way the embryonic stem cells are enabling the

rats to move their hind legs again.

Ms. NORTON. That is precisely why this work is going on, Dr.

Battey. And in fact, you know, I mention it only because of the implication on the other side that there is no evidence of any results

from embryonic—not because——

Mr. SOUDER. He just said there was no evidence.

Ms. NORTON [continuing]. And to their credit—to their credit, I

have to say not because even those who are responsible for this——

Mr. SOUDER. Ms. Norton.

Ms. NORTON [continuing]. Scientific feat have said, hey, right

around the corner, guess what? Everybody who is paralyzed is

going to walk. All they have said is, we have a moral obligation——

Mr. SOUDER. He said——

Ms. NORTON [continuing]. To proceed with this——

Mr. SOUDER. Ms. Norton, your time is well past.

Ms. NORTON [continuing]. With this kind of scientific research.

And I agree they do.

Mr. SOUDER. There is no evidence. What he said is there is hope

in that research. His opinion gives hope, among other potential research. But there is no evidence.

Ms. Watson.

Ms. WATSON. Thank you, Mr. Chairman. And thank you for this

oversight hearing on the issue.

In listening to the questions my colleagues have asked, there was

a mention of the challenges of when life begins and so on. And in

reading through the materials that were prepared for this hearing,

it comes to light that the Korean government had approved of Dr.

Hwang’s research.

Now, my question is: Do we have a bioethic commission similar

within your Department, NIH or HHS? And do we run papers

through it? When they have come up with a new piece of research,

what do we do in response? Because in other countries, the ethics

and morals and principles upon which they might do research can

differ with the country, the culture, and tradition.

And what do we do when we receive something called research

and, you know, the controversy is over the fact that he misrepresented how he got the ova. So our concern should be: How do we

protect our research and not allow this to happen? So can you respond?

Dr. BATTEY. I will respond to the best of my ability. You are correct in pointing out that there are different national standards for

providing Government funding or private funding for research in

the area of human embryonic stem cells and human somatic cell

nuclear transfer.

Right now, the Department of Health and Human Services is operating under the President’s policy as well as legislative language

that is on the DHHS appropriation. The legislative language prohibits the use of DHHS funds for human embryo research. This is

often called the Dickey language.

The President’s policy allows Federal funds to be used for human

embryonic stem cell research so long as the embryo was created for

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formed consent was obtained from the donors; and no fiduciary incentive was provided for the donation of the embryo, with the condition that the inner cell mass be removed from the 5-day-old blastocyst on or before 9 p.m. Eastern Daylight time, August 9, 2001.

So the policy under which DHHS currently operates is a policy

that oversees the use of Federal funds for research. There is no national policy governing this research when the funds being used

come from sources other than the Federal Government. And there

is a patchwork of regulations in various States that provide different sets of guidelines for the legality or the provision of funds

for this area of research.

Ms. WATSON. I think you make my point. And if we are resultsoriented and remedy-oriented, and I too must agree with my colleague that our Chair seems to try to get to that point, and I appreciate that because that is the function of our committee, to have

that kind of oversight.

I would hope that you and maybe HHS could come together and

talk about what the standard would be for Federal funding. We

cannot control what other countries do. We look at their results

and we look at the 50 States, and I know I chaired a committee

where we dealt with this issue.

We look at—as you say, they are a patchwork. But maybe we

could develop some standards that would be guidelines. And when

we read a piece of research that comes from another country, it has

to go through a screening process before we make a big deal over

it. You know, that is the way the Koreans dealt with this. The professor resigned. The doctor resigned, but he is going to go on with

his research. So there is a cloud over whatever he produces.

But I think we ought to set some standards where anything that

comes from abroad flows through. And we ought to have a bioethics

unit through which they go so we can discuss, you know, all these

different theories and all these different ethics, and separating

church from State, and, you know, what I believe in my religion

versus what you believe. You are the scientist, and all.

So I would like you to respond to that. I think I heard you mention that we needed something like that. Can you respond, please?

Dr. BATTEY. You raise a very interesting issue. My response is

that the fraud that was perpetrated in South Korea is reprehensible to everybody in the scientific community, every physician that

I know in this country, and in fact, every responsible citizen that

I know.

It was wrong. It should never have happened. It was revealed because responsible individuals, subordinates within the laboratory,

brought forward allegations. And in a very short amount of time,

the problem was explored and revealed, and the fraud revealed to

the entire world, and Dr. Hwang discredited.

Had this individual not come forward, when it became apparent

that no one else could reproduce his results, his results would have

fallen into discredit. So we have a process that sorts out the truth

from fabrication. And the linchpin of that process is reproducibility

in another laboratory. And it isn’t science if it can’t be reproduced

in another laboratory.

Ms. WATSON. Did you want to mention my suggestion that we

look at the bioethics and try to work that piece out so that when

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you come forth with your empirical evidence that this can be duplicated, we have run it through these tests, including our discussion?

Because I think there is a future for this research, and particularly

here in this country. But we want to be sure that we can avoid the

fraudulent practices up front.

Dr. BATTEY. I think that is an interesting suggestion that should

be considered by those who are higher ranking than I am in the

administration.

Ms. WATSON. Well, I throw that out for whoever is listening.

Maybe it will get into the press and somebody will start considering it.

Thank you so very much, panel.

Mr. SOUDER. I want to also thank this panel. We will most likely

have some written questions. Hopefully we can get a timely response. We will leave the record open longer than 3 days. But if

we can’t, my inclination will be to write that we could not get clearance of the Secretary of HHS, OMB, and the White House for the

answers because we will try to keep the questions narrow enough.

When this hearing book comes out, it should include a fair amount

of data with that.

I also want to clarify two things that Ms. Norton said. She is correct that we do—in this committee, what I said is we look back on

the past. We look in the past, at Katrina, at steroids, at whatever

the issue is, to try to then develop and highlight what can be solutions that would then move to legislative committees. And so we

have a future orientation by looking back on the past, and I didn’t

mean to imply we didn’t have a future orientation.

The second thing, but I do think the record needs to reflect this:

This committee does have jurisdiction over both the oversight on

baseball, but also the legislation. There was a difference of opinion,

which we have worked out, that if the steroid was overseen by the

Office of National Drug Control Policy, it would be our legislative

as well as oversight. If it is DEA, it is Judiciary. If it is FDA, it

is Energy and Commerce.

The only question of where jurisdiction fell was on oversight, and

that is really what we are battling over because we did have—in

narcotics, we do have legislative as well as oversight. So I wanted

the record to show that.

I once again thank this panel. Thank you for your time, and I

look forward to continuing to work with you.

If the second panel could come forward.

Dr. BATTEY. Thank you, Mr. Chairman.

Mr. SOUDER. Thank you.

Our second panel is Dr. Richard Chole, Lindberg professor and

chairman of the Department of Otolaryngology—the subcommittee

stands in brief recess.

[Recess.]

Mr. SOUDER. The subcommittee will come to order.

Our second panel is Dr. Richard Chole, Lindberg professor and

chairman, Department of Otolaryngology, Washington University

School of Medicine, St. Louis; Judy Norsigian, executive director,

Our Bodies Ourselves, co-author of ‘‘Our Bodies, Ourselves’’; Dr.

Diane Beeson, professor emerita, Department of Sociology and Social Services, California State University, East Bay; Mr. Richard

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Doerflinger, deputy director of secretariat for pro-life activities, the

U.S. Conference of Catholic Bishops; Dr. Debra J.H. Mathews, assistant director for science programs, the Phoebe R. Berman Bioethics Institute; and Joe Barden—Brown, excuse me, Parkinson’s

Action Network State coordinator of Texas.

If you will each stand—well, why don’t I swear the four of you

in, and then I will catch the other two, maybe, by the time we do

the third one.

[Witnesses sworn.]

Mr. SOUDER. Let the record show that Dr. Chole, Judy Norsigian,

Richard Doerflinger, and Joe Brown all responded in the affirmative. We will swear in the other two witnesses before their testimony.

We will start Dr. Chole. Thank you for coming.

STATEMENTS OF RICHARD A. CHOLE, M.D., Ph.D., LINDBERG

PROFESSOR AND CHAIRMAN, DEPARTMENT OF OTOLARYNGOLOGY, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE,

ST. LOUIS; JUDY NORSIGIAN, EXECUTIVE DIRECTOR, OUR

BODIES OURSELVES, CO-AUTHOR OF ‘‘OUR BODIES, OURSELVES’’; JOE BROWN, PARKINSON’S ACTION NETWORK

STATE COORDINATOR, TEXAS; DIANE BEESON, M.A., Ph.D.,

PROFESSOR EMERITA, DEPARTMENT OF SOCIOLOGY AND

SOCIAL SERVICES, CALIFORNIA STATE UNIVERSITY, EAST

BAY; RICHARD DOERFLINGER, DEPUTY DIRECTOR, SECRETARIAT FOR PRO-LIFE ACTIVITIES, U.S. CONFERENCE OF

CATHOLIC BISHOPS; AND DEBRA J.H. MATHEWS, M.A., Ph.D.,

ASSISTANT DIRECTOR FOR SCIENCE PROGRAMS, THE PHOEBE R. BERMAN BIOETHICS INSTITUTE, JOHNS HOPKINS UNIVERSITY

STATEMENT OF RICHARD A. CHOLE

Dr. CHOLE. Thank you, Mr. Chairman. I am Richard Chole. I am

a professor at Washington University, but I am not representing

Washington University but rather myself as a private citizen.

I am a physician and a scientist. I have been funded for about

25 years by the institute, actually, that Dr. Battey directs. I am

going to restrict my comments because of a lot of territory that has

been covered already.

Biomedical sciences are on a brink of a real revolution in the development of our science. This is the era of regenerative medicine.

This is an exciting area. It is not necessarily a new area, but it is

the result of incremental change over several decades. These incremental changes continue to occur. This might in the future allow

us to not only ameliorate and manage disease, but actually cure

some diseases. Organ transplants are an example of the beginning

part of that.

While the potential to help mankind is great, this new era poses

some ethical and moral issues that we have never really encountered before that must be addressed not only by the scientists and

physicians doing the research, but the public, probably more importantly by the public.

The source of these regenerative cells for regenerative medicine

will come from a variety of sources, and I would like to briefly discuss a couple—make a couple of comments about these sources.

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They might be embryonic, at the very earliest part of development. They might be fetal, at later parts of development. Or they

may be adult, so-called adult, from the time of birth on. All of these

sources of regenerative cells are called stem cells in that they can

differentiate into any particular type of tissue. Some are more restricted than others.

Embryonic stem cells, as we have been referring to them, come

from the very earliest human embryos, those from the stage of fertilization, the zygote, through the blastocyst, about 5 to 9 days. In

order to get the embryonic stem cells from these early embryos, the

early human embryo must be destroyed. And this is a human being

at the earliest stage of developmental life.

Those inner cells, that inner cell mass, are the stem cells. They

then are the ones that have been studied to lead to differentiation

into different types of tissues. And indeed, scientists have been able

to coax these cells to develop into a variety of types of tissues with

potential uses for medical therapeutics.

Research into these cells has been incremental, and unlike the

hype in the popular press, these have not been major breakthroughs but incremental, very small breakthroughs, showing some

difference between experimental and control animals. The pitfalls

of this type of research are that by definition, it requires the destruction of a living human being at the embryonic stage.

There are others as well. An embryonic stem cell is a different

person. If you take the cells from that person and then put them

into a different individual, there is a rejection process that goes on.

That rejection would lead to the destruction of those cells unless

the person was immunosuppressed by very powerful drugs.

These cells by nature are vigorous growers. They don’t know

when to stop growing in many cases, and most of this research has

resulted in implantation of these cells where they will grow rather

uncontrollably into tumors called teratomas. This particular question has not been answered.

These cells, once transplanted into an individual, may not—although they may function like a particular type of cell, may not be

controllable. And in that environment, they may make too much of

a hormone or not enough of the hormone. And there is no reason

to—no evidence that these can really be controlled.

So those are some potential problems with embryonic stem cells.

One of those problems, that they may be rejected, may be surmounted, scientists say, by cloning them. Cloning, as we have

heard, is the placement of a nucleus from the body into an empty

egg from an egg donor. This develops into a zygote and then a blastocyst.

If it were done in a human being, and it has never been done

in a human being, this would recreate a living human being at the

embryonic stage. The same ethical issues are faced by destroying

this human being, albeit a cloned human being, if that were indeed

possible. The advantage of this, theoretically, would be there would

be no problem with cell compatibility. And I think that is why the

excitement about this.

The difficulties are many. These cloned embryos are not normal

embryos. Dolly was not a normal sheep. It took 250-plus times to

get a cloned embryo from a sheep to become Dolly the lamb. These

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cells have many, many different problems. They are defective embryos, and they are defective cells.

These stem cells in cloned embryos are defective stem cells. So

they are not normal at all. They are defective. And the idea of

using a defective embryonic stem cell that really can’t be controlled

for medical therapeutics is pretty conjectural thinking and far, far

off from current scientific knowledge.

On the other hand, adult stem cells have their advantages and

disadvantages as well. Adult stem cells, which are cells in our

body—the most notable ones are in bone marrow, bone generation

cells—have been shown to have more and more potential in development into specific tissue types. We have found recently that

these cells can be caused to de-differentiate and become more like

elementary stem cells, and can then be guided to develop into other

types of tissue.

This line of research has great promise because it is taken

from—the cells are taken from the individual, and there are no

compatibility or rejection problems when the cells are given back.

It also has great potential because of the variety of diseases that

can be treated with it, and in fact, we treat many diseases with it

in common clinical practice, and clinical trials in humans for lupus

and heart problems and other problems have showed very promising results.

So the opportunities for adult stem cells are tremendous. There

are disadvantages of adult stem cells, of course, in that they don’t

have all of the potential of an embryonic cell. But the problems can

be overcome by further research into how these are developed.

I would like to just make a comment about this question of when

life begins. It is my contention that life begins at the fertilization

of the egg and the development of the zygote. Every, single person

in this room was once a zygote, a unique zygote. From the time of

the fertilization of the egg until this moment, it has been a process

of your development. The genes were set. You are a human being

at that point.

Medical science really has had little question about that, and I

will read to you from a couple of textbooks that I took off the shelf

at Washington University.

The first one: ‘‘The development of a human being begins with

fertilization, a process by which the spermatozoon from the male

and the oocyte from the female unite.’’

Another textbook: ‘‘Union of these gametes’’—that is, the sperm

and the egg—‘‘during fertilization produce the zygote or fertilized

ovum, which is the beginning of a new human being.’’

Another one: ‘‘Although life is a continuous process, fertilization

is the critical landmark because under ordinary circumstances, a

new, genetically distinct human organism is formed.’’

So, really, there has never been any question in the teaching in

embryology and the textbooks, maybe until the current era—these

may be changed—that life begins at that point.

Finally, I would like to make a comment about scientific hype

and hype in the press about this.

Mr. SOUDER. You need to summarize. We let you go over 2 minutes.

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Dr. CHOLE. OK. In the popular press, one might get the impression that paralyzed rats can walk again. This is incorrect. The

studies have shown that when the experimental animals are compared to the control animals, both recover quite well in the experiments that she was citing, but the embryonic stem cell animals recover a little bit better. It is not the contrast that has been depicted

in the popular press.

This drama to this field has led some scientists to assume the

position of celebrity. Scientists are not prepared to be celebrities.

The scientist’s role is to use cold, dispassionate analysis for his or

her data, and then present it in an honest way. This element of celebrity has led to some distortion, maybe the distortion that led to

the big scandal in Seoul.

Thank you very much.

[The prepared statement of Dr. Chole follows:]

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Mr. SOUDER. Thank you very much.

Our next witness is Judy Norsigian.

STATEMENT OF JUDY NORSIGIAN

Ms. NORSIGIAN. Thank you, Chairman Souder, Mr. Cummings,

and members of the committee for the opportunity to speak. Judy

Norsigian, executive director of Our Bodies Ourselves, a women’s

health education and advocacy organization, best known for our

landmark book about women’s health and sexuality, ‘‘Our Bodies,

Ourselves.’’

At the outset, let me make clear, as I did at similar hearings 4

and 5 years ago, that my organization supports most embryonic

stem cell research. We fully support ESC research that utilizes otherwise discarded embryos from IVF clinics. Thus, we do not agree

with President Bush, for example.

At the same time, we have serious concerns about a small subset

of ESC research known as somatic cell nuclear transfer, more commonly referred to as research cloning, therapeutic cloning, or embryo cloning, as we have discussed today. My organization believes

that our country should follow the prudent example already adopted by Canada and place a moratorium on all SCNT research until

better safety data are available for some of the drugs used during

multiple egg extraction procedures.

There are several reasons for this position, but I will focus my

remarks primarily upon our concerns regarding the risks of multiple egg extraction. And although women who undergo these procedures experience similar risks whether doing this for reproductive purposes, as is the case in an IVF clinic, or for research purposes, there is a critical difference.

In the former instance, there is a 10 to 40 percent chance that

someone, either the woman herself or another woman who is seeking to become pregnant at an IVF clinic, will be able to have a

baby. That is a clear benefit. In the latter instance, when a woman

undergoes these procedures solely for research purposes, the benefits to her or someone else are far more dubious at this time.

Although some stem cell researchers have discussed this matter

and even share our concerns, few have been willing to write about

these issues. It may be that one positive outcome of the scandal in

South Korea will be greater recognition of just how risky multiple

egg extraction can be, as well as how easily frenetic competition

and unjustified hype can lead to a more ready dismissal of these

risks.

In a recent issue of the American Journal of Bioethics, Stanford

faculty David Magnus and Mildred Cho write the following: ‘‘In a

previous paper, we argued that there were risks associated with

being an oocyte donor that were not given adequate attention in

the informed consent process. This claim was based upon the informed consent documents by the South Korean researchers, an accompanying written description of the consent process, and their

responses to questions posed.’’

‘‘We argued that it would be easy to give short shrift to the small

but serious risks that typically arise in a clinical setting precisely

because these risks are not associated with the research aspects of

oocyte donation.’’

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They go on to say that: ‘‘The language used to describe scientific

experiments also makes a great deal of difference in how accurately

we convey the nature of stem cell research.’’

Finally, they say, ‘‘There is an important distinction between oocyte donation for research and live organ donation for transplantation. Live organ donation has a clearly established clinical value.

Stem cell research does not. If that should change, we would agree

that allowing women to donate oocytes for stem cell-based treatments would be permissible, if conducted properly. But allowing research donation to take place under these circumstances is an invitation for a new kind of therapeutic misconception, and should be

avoided at this early stage of scientific development.’’

The risks of multiple egg extraction are not well-enough studied,

especially the risks associated with the drugs most often used to

suppress a woman’s ovaries. Lupron, generally referred to as

leuprolide acetate, the generic term, is the drug I would like to

focus on now.

I have listed many of the adverse reactions in my testimony.

These include: pituitary and liver function abnormalities; chronic

joint, muscle, and bone pain; headaches and migraines; dizziness

and blackouts; and serious memory disturbances and brain fog that

persist well after the drug is discontinued.

And we have had this from numerous reports. The FDA has received numerous adverse drug reports, and one of the things we

are hoping we will see in the near future is a data mining analysis

by scientists at the FDA to give us better direction on what kind

of research we need to conduct.

Lupron’s use in the IVF setting is off-label use, and as former

Chief Medical Officer Suzanne Parisian pointed out in her memorandum of February 2005, there are serious safety concerns yet to

be resolved. Only well-designed research will answer critical questions that would then allow true informed consent for women undergoing multiple egg extraction procedures for any purpose.

The drugs used to hyperstimulate the ovaries after ovarian suppression also have negative effects, most notably Ovarian

Hyperstimulation Syndrome, a condition in which the ovaries continue to enlarge even after the eggs have been collected. Serious

cases of this syndrome involve the development of many cysts and

massive fluid buildup in the body. Rarely, death has resulted. The

most recent one documented was in England in December.

And it is not only the women undergoing the procedures who

may be at risk from ovarian hyperstimulation. A very important

article published in the past month by a Dutch team including

medical and basic scientists suggests that infants may also suffer

adverse consequences.

This group has shown that female mice subjected to ovarian

hyperstimulation had offspring with reduced birth weight as well

as a high incident of congenital anomalies, including delayed formation of bones and an eightfold increase over background levels

of cervical ribs, a condition which, when present in human infants,

is associated with stillbirth and cancer.

Should SCNT research go forward despite the concerns mentioned here, it will be left to women’s health advocated to emphasize the inadvisability of women undergoing these procedures, espeVerDate 11-MAY-2000 11:15 Dec 14, 2006 Jkt 000000 PO 00000 Frm 00081 Fmt 6633 Sfmt 6633 D:\DOCS\29580.TXT HGOVREF1 PsN: HGOVREF1
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cially younger women, whose risk of Ovarian Hyperstimulation

Syndrome is actually greater than that for older women.

Also, if such research does go forward, certain regulations and

oversight of the research with respect to egg procurement are essential. I have listed seven here: that eggs should be obtained without any hormonal stimulation, since there is still insufficient information to get true informed consent. No relatives or coworkers of

those doing research on eggs should be allowed to provide eggs for

research.

All medical expenses resulting from egg extraction for research

should be covered; in cases where would be hormonally manipulated, longer-term healthcare coverage may be necessary to provide

medical care for certain delayed health problems.

Those performing egg extraction for research purposes should

function totally separate from IVF services. And no research should

be allowed on eggs or stem cell lines developed from eggs procured

by means other than those just mentioned. This would avoid use

of stem cell lines created in other countries or regions where safeguards to women’s health might not be in place.

We also believe that no patents should be allowed for products

that might result from research on these eggs. Without such a policy, many therapies will likely never be accessible to the wider public. I can give you other such examples already. In addition, it

would be extraordinarily difficult to avoid a problematic commercial market in women’s eggs.

And, of course, no payment to egg providers beyond direct expenses. We think both the researchers and the women who provide

eggs in this case may be going to be making a sacrifice.

So in conclusion, many scientists now acknowledge that individualized disease third parties will not research from embryo cloning

research anyway, in part because of the need for massive numbers

of eggs. The main benefit of embryo cloning would be the ab light

to develop research models for studying particular diseases and

conditions, but some of this type of work can be done already with

otherwise discarded embryos that result from PGD, pre-implantation genetic diagnosis, testing.

At this point in time, given both the known and unknown risks

involved in multiple egg extraction procedures, these procedures

should not be done solely for SCNT research. At the same time, we

do support most embryo stem cell research.

Thank you.

[The prepared statement of Ms. Norsigian follows:]

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Mr. SOUDER. Thank you.

I am going to move to Mr. Brown next because he has an airplane to catch.

STATEMENT OF JOE BROWN

Mr. BROWN. Thank you, sir. Thank you, Mr. Chairman and members of the subcommittee, for inviting me today. My name is Joe

Brown. I am a State coordinator for the Parkinson’s Action Network, a founding member and vice president of Texans for Advancement of Medical Research, and a founding member of the Alliance for Medical Research. I have been an advocate for 20 years.

As someone living with chronic disease, as a patient and an active caregiver, I was dismayed when I read the memorandum published by the committee that appeared to reach pertinent conclusions before this hearing was convened. It mistakenly concluded

that somatic cell nuclear transfer [SCNT], is not supported by current science, and those who support this research have created an

unjustified hype that plays on the hopes of suffering patients.

I am not going to talk about theory and intellectual concepts. I

am going to talk about life—my life, my wife’s life, and the lives

of you and your families.

Having watched a genetic form of Parkinson’s slowly steal the

quality of life from my beautiful wife, I am concerned for my children and grandchildren. I have lived 70 years with a genetic heart

condition that has sudden death as its most significant side effect.

I have been fortunate enough to survive three heart attacks, bypass surgery, cardiac arrest, and cancer.

I have reason to hope, especially since I have benefited from research that was thought to be wrong and unethical. I was the ninth

person in the United States to receive a procedure that took me

from being unable to walk from one room to another and days filled

with countless hours of angina, to being able to carry my grandchild up a flight of stairs.

This procedure, which actually gives the patient a heart attack

to reduce obstructive heart muscle, was originated by a Swiss cardiologist. Switzerland didn’t believe that giving heart attacks was

ethical and wouldn’t allow the procedure. The quality of my life

was improved because Dr. Sigwart was forced to leave his country,

just as American scientists are doing today in order to pursue stem

cell research.

So yes, as a patient, I do have hope that SCNT will succeed. But

it is not unjustified hope. The breakthroughs have been exciting

and amazing, but I recognize that sound research takes time. It

took 52 years for the polio vaccine to get to market. I don’t expect

the scientific community to have these treatments or cures available in my lifetime, but if we don’t start now and start solving the

problems that we have with communication with each other, the

cures won’t be there for our children and grandchildren.

When I visited the University of Texas Medical Branch in Galveston, scientists working with adult stem cells told me the most

significant advances in adult stem cell research have occurred since

embryonic stem cells were first isolated in 1998. The reason these

scientists gave me is the embryonic stem cells are teaching them

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how to work with adult stem cells. To promote one form of stem

cell research to the exclusion of another is counterproductive.

I am astounded that there are those who don’t recognize, while

there may be fraudulent researchers, by definition, it is impossible

for research in and of itself to be fraudulent. We don’t stop basketball games when a player is called on a foul, nor do we stop having

congressional sessions due to a Representative’s misconduct.

In the future, as the past, scientific fraud will be detected when

peers are unable to replicate the results. And unfortunately, this

self-policing mechanism has been disengaged in our country because the Federal Government isn’t supporting the research.

The fact that one scientist apparently procured egg donations

without appropriate attention to the welfare of the patients doesn’t

mean that everyone else will do the same. Women have a right to

donate eggs for the benefit of others when properly informed and

with informed consent.

It is incumbent on the United States, where both the quality of

science and dignity of life are of uppermost concern in all of our

minds, to take the lead in creating an appropriate framework for

stem cell research while promoting and protecting its progress.

On behalf of my family and the more than 1 million Americans

with Parkinson’s disease who would benefit from this research

moving forward, I appreciate the opportunity to provide testimony

to the subcommittee today.

[The prepared statement of Mr. Brown follows:]

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Mr. SOUDER. Thank you, and whenever you feel you need to head

to the airport——

Mr. BROWN. It is going to be a little while.

Mr. SOUDER. Now, I did the full introductions. But Dr. Beeson

and Dr. Mathews, I need to swear you in yet. So if you will both

stand and raise your right hands.

[Witnesses sworn.]

Mr. SOUDER. Let the record show that both Dr. Beeson and Dr.

Mathews responded in the affirmative. And I will go to Dr. Beeson.

STATEMENT OF DIANE BEESON

Ms. BEESON. Thank you, Chairman Souder, Representative

Cummings, and committee members. I appreciate being invited to

testify today.

My name is Diane Beeson. I am medical sociologist and professor

at California State University, East Bay. For over 30 years, I have

conducted research on social issues related to genetics and new reproductive technologies. I am a lifelong supporter of women’s abortion rights, and I support embryonic stem cell research using embryos left over from IVR treatments.

Like many social scientists, I have broad concerns related to the

wisdom of developing cloning technologies. However, today I will

focus on the most immediate social and ethical problems created by

the demand for human eggs needed in experimental cloning, or

SCNT, and that is the threat to women’s health.

Dr. Hwang and his colleagues used over 2,000 eggs without producing even one clonal embryo. This means we still do not know

how many thousands or tens of thousands of eggs this research

may require before achieving even preliminary success. Furthermore, it has become clear that payment, coercion, and lying were

used to acquire the eggs that the media reported many women

were eager to donate.

Because egg extraction has come into expanded use since the

birth of the Nation’s first test tube baby in 1981, it is often assumed to be safe. Unfortunately, this is not the case. The fact is

that egg extraction as currently practiced poses inadequately understood but clearly significant risks to the health of women.

As you have heard from Ms. Norsigian, extraction of eggs involves introducing powerful hormones into a woman’s body to manipulate it into producing many eggs at a time rather than the normal one or two. It often uses drugs not approved for this process,

off-label, or drugs for which no long-term safety data are available.

The FDA currently has on file over 6,000 complaints regarding

Lupron alone, including 25 reported deaths. These complaints must

be investigated and analyzed before more women are exposed to

such potential dangers.

We know that a coalition of Korean women’s organizations is

suing their Government for damage to the health of Korean egg

providers. Scientific replication will not help these women.

We should understand that the problems related to egg extraction are not unique to Korea. I have included with my testimony

a letter from the mother of a young woman who died an agonizing

death from Ovarian Hyperstimulation Syndrome in Dublin in 2003.

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Last April in London, another young woman dropped dead from a

massive heart attack at a bus stop, linked directly to OHSS.

While such events appear to be rare, it is possible that many

deaths and other longer-term side effects have simply not been

linked officially to the egg extraction procedures that preceded

them. And if we look at the history of the use of hormones in this

country, with DES particularly, we find that it often takes 30 years

and hundreds of thousands of women being hurt by these things

before they are taken off the market.

A former Chief Medical Officer of the FDA, in a letter I have attached to my written testimony, reminds us that, ‘‘Studies to date

have not ruled out a possible link between stimulation drugs and

increased risk of ovarian cancer.’’

Another destructive consequence of ovarian hyperstimulation for

women may be serious abnormalities in their children. Just this

month, a new study reports that ovarian hyperstimulation treatment in mice results in several significant abnormalities in their

later offspring. One in particular is associated, in humans, with an

increased incidence of deformities and cancer.

These concerns must be investigated before involving thousands

of women in egg extraction purely for research purposes. Informed

consent to participate in egg extraction is not possible without first

following up on these serious warnings, particularly in the context

of research.

Informed consent is also made difficult by the fact that scientists

and other proponents of SCNT have been reluctant to confront

forthrightly the dangers related to egg extraction. Certainly in

California this has been the case.

This reluctance is a function of conflicts of interest resulting from

recent legal changes affirming the right to patent genetically engineered life forms, and also allowing universities and their researchers to patent even those research products funded by the Federal

Government. As a result, the field of embryonic stem cell research

has become a virtual biotech gold rush.

Under these conditions, it is highly unlikely that any regulation

can adequately manage the ethical quagmire created by moving

forward with SCNT. As a society, we are at a turning point in our

relationship to science. We are being asked to make women the

servants of biotechnology rather than insisting on a biotechnology

that promotes the well-being of all people.

For these reasons, until we understand more fully its human

costs, I strongly urge your support for a moratorium on somatic cell

nuclear transfer in both publicly and privately funded contexts.

Thank you.

[The prepared statement of Ms. Beeson follows:]

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Mr. SOUDER. Thank you very much for your testimony.

We will now go to Mr. Doerflinger. Thank you very much for joining us.

STATEMENT OF RICHARD DOERFLINGER

Mr. DOERFLINGER. Thank you, Mr. Chairman.

As we know, Korean researchers led by Dr. Woo Suk Hwang are

now seen as having perpetrated a massive fraud, details of which

have been ably described here by others. I think there are scientific, political, and moral lessons to be learned from this. Each

point here is documented in my longer written statement I have

submitted for the record.

First, the scientific lesson: Cloning researchers must go back to

the drawing board. After 8 years of effort to clone human embryos,

no one has achieved even the first step in using this procedure for

human treatment, so-called therapeutic cloning.

Usually, fraud by one researcher does not discredit an entire

field, but Dr. Hwang’s studies were the field of allegedly successful

human cloning for research purposes. If his research is a fraud,

there is at present nothing left of that field. As the New York

Times says, ‘‘Cloning researchers are back to square one.’’

This is, by the way, the third time in 8 years we have heard announcements of success in cloning human embryos for their stem

cells, only to find the claim had little basis in fact. The other false

starts, in 1999 and 2001, were by Americans. South Korea has no

monopoly on misleading hype in this field.

And let me just say, the word ‘‘fraud’’ is used, and it is perfectly

appropriate. But Dr. Hwang did not start as a fraud. He started

as someone trying to make this work. And after years of attempt,

endangering the health of 100 women, thousands of eggs, creating

hundreds of embryos in the lab, with those tens of millions of dollars and the full Government support of South Korea, just like everyone else, he failed.

And that is why he was tempted, in his desperation, to commit

fraud. He is the biggest fraud in this field, but the key word that

is common to all the cloning researchers, is failure, failure, failure.

And I heard some subcommittee members say, therefore, this is the

very sort of thing the Federal Government has to get into funding.

Attempts at therapeutic cloning in animals have also been discouraging. In several studies, researchers achieved any therapeutic

goal only by implanting the cloned embryos in an animal’s uterus

and growing it to the fetal stage, then killing it for more developed

fetal stem cells.

Such fetus farming is now seen by some researchers as what

they call the new paradigm for therapeutic cloning, and some State

laws on cloning have even been crafted to allow such grotesque

practices in humans. This would compound cloning’s exploitation of

women as egg factories by exploiting them as incubators for cloned

humans as well.

What are the implications of embryonic stem cell research in

general? There is a distinction. It depends on whether cloning is essential for progress in embryonic stem cells. Cloning supporters

used to say it is essential. Now that judgment is being reversed.

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Evan Snyder, in the New England Journal of Medicine, said

cloning plays only a minor role. One recent overview called it a

boutique science, at the fringe of stem cell biology. But if it is at

the fringe, why not ban cloning now and have debates about the

other issues in embryonic stem cells later?

It remains possible that someone will solve these programs someday. But the prospect of making the cloning procedure efficient,

separating it from the exploitation of women, and deriving cost-effective therapies from it in your lifetime seems remote.

Second, the political lesson is that while there has been some

misrepresentation in the scientific field, that has been magnified 10

times in the political field, in which in order to get public support

in Government funding, supporters have acted more like snake oil

salesmen than scientists at times, marketing the dream of miracle

cures around the corner.

Researchers are now issuing disclaimers to reduce people’s unrealistic expectations about cures and looking for other people to

blame. Some have even blamed the Bush administration for the

failure and fraud in South Korea, as though by opposing cloning,

you are some how making somebody else elsewhere do it wrongly.

But no one has ever done it rightly. To blame unethical cloning in

Korea on those who warned against doing it at all takes blameshifting to new depths.

The political lesson is that we need to be aware of the human

cost of this agenda here and now, not only its alleged promise down

the road. And we need to demand evidence for these grandiose

claims.

Third, and most importantly, a moral lesson: Utilitarianism is

not useful. The ethic of the end justifies the means, and particularly the creation and destruction of life in the laboratory in order

to achieve the miracle cures, has unfortunately become almost the

official ethic of those seeking to justify this research.

Government advisory panels have been forced to concede the

early embryo is a developing form of human life, but used a cost/

benefit analysis to argue that cures for born persons is worth more.

As the chief ethicist at the NIH Human Embryo Research Panel

said in 1994, ‘‘If the end doesn’t justify the means, what does?’’

The problem is that the utilitarian ethic relativizes truth just as

quickly as it relativizes lives. If human embryos are lives in a biological sense but lack the value of persons, could be sacrificed to

help born patients who really matter, then the merely factual truth

can sometimes be sacrificed by the same ethic for the higher truth

of progress. Dr. Hwang did not violate the new ethic of his allies.

He took it to its logical and inevitable conclusion.

By demeaning life, we learn to demean truth, rendering science

itself meaningless. If some researchers have not learned that important lesson, a sound ethical response must come from society

and its policymakers. That response should begin with a complete

ban on human cloning, and with legislation to prevent the mistreatment of women as egg factories for research, or as surrogate

incubators for unborn children grown for their body parts.

Only by respecting fellow human beings of every age and condition, and by refusing to treat them as mere instruments for achievVerDate 11-MAY-2000 11:15 Dec 14, 2006 Jkt 000000 PO 00000 Frm 00117 Fmt 6633 Sfmt 6633 D:\DOCS\29580.TXT HGOVREF1 PsN: HGOVREF1
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ing our research goals, will we promote a human progress worthy

of the name. Thank you.

[The prepared statement of Mr. Doerflinger follows:]

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Ms. FOXX [presiding]. Thank you.

Dr. Mathews.

STATEMENT OF DEBRA J.H. MATHEWS

Ms. MATHEWS. Hello. Thank you very much for having me here

today to share with you some of my thoughts. My name is Debra

Mathews. I am a human geneticist by training. I also have training

in bioethics and science policy.

The first thing I want to say is that nothing—again, reiterate

something that has been said here before today—nothing that Woo

Suk Hwang and his collaborators did or didn’t do has disproved

any of the basic tenets of human embryonic stem cell research, or

taken away any of the potential of the research.

When Woo Suk Hwang and his collaborators were doing this research, parallel research in the United States and other places did

not stop. And the field did not crash and burn with the unfortunate

and reprehensible activities that occurred with Woo Suk Hwang

and his collaborator.

Everyone in the embryonic stem cell research field knew that

this would take a long time, and were surprised when Hwang came

out with the results in 2004 and 2005. And their estimate turned

out to be right. It is going to take time. This research did only

begin in 1998, and that is not when scientists began attempting to

do SCNT. That is when the first human embryonic stem cells were

first derived.

I am going to focus most of my comments on the question of

fraud and the question of egg donation for research. My primary

message here is that oversight is happening, and scientists care

about developing oversight for this research.

SCNT does raise the issue of egg donation for research purposes.

Last summer the National Academy of Sciences issued guidelines,

not only guidelines to govern the research, but also including

guidelines relevant to tissue donors and egg donors.

These guidelines have been broadly adopted by research institutions in the United States. And in addition to the national guidelines, the California Institute for Regenerative Medicine has recently issued interim guidelines that go above and beyond the protections provided by the National Academy’s in their protection of

egg donors.

The California Institute for Regenerative Medicine has also

partnered with the Society for Gynecologic Investigation on a scientific conference this May to focus on the risks of egg donation.

I think that the message from the scientific community on this

issue is very clear. They understand and are prepared to address

the ethical issues raised by stem cell research, including egg donation for research purposes.

With respect to the question of fraud, again, scientists do not embrace fraud. Scientists are slaves to their data, and they want the

data to be as pristine as possible. And fraudulent data is of no use

to the scientific community.

The process of oversight associated with Federal funding provides some protection against breaches of scientific and ethical integrity. And the National Academy’s guidelines add additional—

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which, as I mentioned, have been broadly adopted by research institutions in this country—provide additional oversight.

The National Academy has also announced just recently that

they will be setting up a committee for oversight of stem cell research. Given the lack of Federal funding and therefore the lack of

oversight over this research, the National Academy has taken it

upon themselves to set up an oversight committee specifically for

stem cell research.

The International Society for Stem Cell Research has also set up

a task force to develop internal standards and ethical guidelines for

embryonic stem cell research. And they will be presenting their

findings at the annual meeting in the end of June/beginning of

July.

Finally, recently a group of approximately 60 scientists, ethicists,

lawyers, and policymakers got together and developed a consensus

statement providing recommendations for fostering the ethical and

scientific integrity of embryonic stem cell research in a global context. And I can make those—all of these guidelines available to

you.

Scientists in the United States and around the world recognize

both the promise and the controversy of stem cell research, and

they are willing to step up to the plate and provide and accept ethical guidance to make sure that this science has the scientific and

ethical integrity that is necessary.

Thank you very much, and I would be happy to answer any questions.

[The prepared statement of Ms. Mathews follows:]

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Ms. FOXX. Thank you.

Dr. Mathews, I want to ask you one question. And we are nearly

out of time, so we will try to make the questions short and the answers short, too. Has anyone ever created stem cells from cloned

human embryos?

Ms. MATHEWS. Not that I’m aware of.

Ms. FOXX. OK. Has it been done even in monkeys?

Ms. MATHEWS. Monkeys have been very difficult to clone, it is

true.

Ms. FOXX. OK. Is there anyone on the panel who disagrees with

that answer?

Dr. CHOLE. Monkey embryos have been cloned by Gerry Schatten

in Pittsburgh. I don’t—I am not sure if their stem cells have been

extracted and cultured, but the embryos have been made. He is

doing that for reproductive purposes for one way to protect endangered species.

Ms. FOXX. Is he the person who was collaborating with Dr.

Hwang in Korea?

Dr. CHOLE. That is correct.

Ms. MATHEWS. Is it the case that his embryos were basically in

vitro embryos, or were they SCNT embryos?

Dr. CHOLE. They are SCNT embryos. He has had some success

with that. But they have not developed. They have implanted but

not developed.

Ms. FOXX. Dr. Chole, is there any biological difference between

the entity that is created through so-called therapeutic cloning and

reproductive cloning?

Dr. CHOLE. No.

Ms. FOXX. Thank you. OK.

Ms. Norsigian, what have other countries done in the area on

SCNT and egg donation, and what role did a concern for women’s

rights have in the passage of these laws? Do you think the conservative movement, as we are typically used to thinking about in the

United States, was very active in getting these laws passed? And

what reaction would you have to that?

Ms. NORSIGIAN. Well, I have to say I think it is unfortunate that

the abortion debate and debates about the moral status of the embryo have clouded the discussion of cloning for research purposes

that I focused on in my remarks.

In Canada, interestingly enough, advocates, researchers, people

with differing religious views, sat down and they actually came up

with something that was acceptable to everyone, including the scientists.

And they are putting a moratorium on SCNT. They are not saying never. They are saying, right now we have so much to learn

with other embryo stem cell research. Some of the problems were

just raised: the inability to control differentiation so you get the

kind of tissue type you want, the inability to control tumorigenicity.

I believe that only John Gearhardt and Johns Hopkins has avoided that by growing the mice embryos to the fetal stage so that

germ line cells were harvested. These are not embryo stem cells.

And in that instance, he was then able to eliminate the issue of

tumorigenicity.

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There are many problems that I think may be able to be overcome. And those problems can be possibly solved, and you can use

embryo stem cells that would be created from otherwise discarded

embryos from IVF clinics. Though there are reasons, and I mention

them, that make SCNT advantageous, I don’t think they yet justify

the known and unknown risks that we are asking women to undergo.

There have been similar concerns expressed in England. And it

is interesting. They are allowing this to go forward. The HFEA

there has fairly strict regulations. But there is quite a controversy

about this, particularly as we see some of the harms that women

experience.

Ms. FOXX. We don’t have something—I am.

Ms. Watson.

Ms. WATSON. Are you doing an overhead presentation? Is someone doing an overhead?

Ms. FOXX. No. I don’t think it is going to work.

Ms. WATSON. OK. I just want to thank the panelists, and of

course the Chair. I think this has been very enlightening because

it opens up a whole new, I would say, panoply of thought. And I

think these are some of the issues that have been brought up today

that we are going to have to deal with.

I would definitely hate to see conclusions because of some of the

fraud that has been perpetrated stop the serious research that can

save lives, limbs, and improve physical conditions. I would hope

that we could think through and work through the ethical issues,

moral issues, and reach for a higher goal, and that is research that

can improve the quality of life.

So I would look forward—not a question, just a statement—to

further discussions of this type and to the panelists getting back

to us with messages from your research as to the direction the Federal Government should take.

With that, I want to thank you, Madam Chair, and I will have

to leave. And thank you very much.

Ms. FOXX. Well, Mr. Doerflinger, I want to share some information and then ask you a question.

In the district that I represent, there is some absolutely fabulous

and earth-shaking research going on, Baptist Medical Center, with

the use of adult stem cells. The key researcher there said in front

of me and another Member of Congress who was visiting there recently that—in response to a question about why he was not

using—or why he did not advocate the use of embryonic stem cells,

said that—voiced many of the issues that have been voiced here

today, aside from—even aside from religious and ethical issues,

that these lines of stem cells simply created more problems than

they resulted in benefits from.

He and his researchers are able to grow organs that are helping

make massive changes in peoples’ lives. And they are helping our

military people by regeneration of limbs.

Is it your experience, again, that many of the scientists are not

using the embryonic stem cells not for religious purposes but because of scientific reasons, so that they do not have to ‘‘cloud the

issue’’ by bringing that issue—by bringing the issue of religion into

it?

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Mr. DOERFLINGER. Well, the ethical issue, which I agree with

what was said here earlier about the ethical issue being far broader than any religious issue, is certainly a factor. But I also know

of many researchers who do all of their work on non-embryonic

stem cells simply because they are easier to work with, easier to

control.

In many cases, they do not require lengthy FDA approval because they are the patients’ own cells. They are not rejected as foreign tissue. They are in plentiful supply and can be—the research

is showing they can be multiplied for clinical use more effectively

than used to be the case. And they are working.

Last night, ABC had a premier of its—I guess a new series called

‘‘Miracle Workers’’ featuring a man whose blindness was cured by

his sister’s adult corneal stem cells. And researchers at the University of South Florida, I think, up at St. Elizabeth’s Medical Center

in Massachusetts, have all said, it is not that we object to the ethics of the embryonic cells, it is that these are working and we think

they are going to work better.

And I think it is important to put this in a context that even in

the Clinton administration, the National Bioethics Advisory Commission said that they did realize there is an ethical problem here.

They were willing to override the ethical problem because they

thought that was the only way to go.

But they said that the pursuit of embryonic stem cell research,

even using embryos, spare embryos, from fertility clinics, would not

be justifiable if there were less morally problematic alternatives

available for pursuing the research.

And I think researchers have shown over and over again that

those alternatives are real. They are very promising. And in many

cases, they may well make it unnecessary for us to face these terrible ethical dilemmas.

Ms. FOXX. Thank you very much. I believe that—Mr. Brown.

Mr. BROWN. I would just like to make a comment as a patient

and as a patient advocate. I heard earlier that there are 60 adult

cell cures that have been put in place, some of which I am aware

of. One of them that was mentioned was Parkinson’s.

First, I question if the acid test has actually been made of replication. I know on some of it, it has—leukemia, for instance. The

first time I heard about the Parkinson’s was 2003. I know of no

Parkinson’s patient who is waiting for embryonic stem cells. If

adult stem cells in truth were doing the job, I would be one of the

happiest people in the world because I would see my wife of 44

years being able to walk 24 hours a day again.

So I think that there is—and I believe that there is a tendency

to overstate a great deal of what this science has and has not accomplished from both sides of the issue. I believe there is a great

deal of misstatement, a great deal of miseducation—which I think

it is very important that we educate. And what I would like to see

is a more civil building of consensus and compromise to allow all

of this research to go forward; that we close no doors, and see

where science can take us.

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Ms. FOXX. Thank you all very much for being with us today. The

hearing is adjourned.

[Whereupon, at 5 p.m., the subcommittee was adjourned.]

[Additional information submitted for the hearing record follows:]

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