[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]



 
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


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                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut       HENRY A. WAXMAN, California
DAN BURTON, Indiana                  TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota             CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio           DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania    DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee       DIANE E. WATSON, California
CANDICE S. MILLER, Michigan          STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California          LINDA T. SANCHEZ, California
GINNY BROWN-WAITE, Florida           C.A. DUTCH RUPPERSBERGER, Maryland
JON C. PORTER, Nevada                BRIAN HIGGINS, New York
KENNY MARCHANT, Texas                ELEANOR HOLMES NORTON, District of 
LYNN A. WESTMORELAND, Georgia            Columbia
PATRICK T. McHENRY, North Carolina               ------
CHARLES W. DENT, Pennsylvania        BERNARD SANDERS, Vermont 
VIRGINIA FOXX, North Carolina            (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   ELIJAH E. CUMMINGS, Maryland
DAN BURTON, Indiana                  BERNARD SANDERS, Vermont
JOHN L. MICA, Florida                DANNY K. DAVIS, Illinois
GIL GUTKNECHT, Minnesota             DIANE E. WATSON, California
STEVEN C. LaTOURETTE, Ohio           LINDA T. SANCHEZ, California
CHRIS CANNON, Utah                   C.A. DUTCH RUPPERSBERGER, Maryland
CANDICE S. MILLER, Michigan          MAJOR R. OWENS, New York
GINNY BROWN-WAITE, Florida           ELEANOR HOLMES NORTON, District of 
VIRGINIA FOXX, North Carolina            Columbia

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
                       Marc Wheat, Staff Director
                        Michelle Gress, Counsel
                           Malia Holst, Clerk
                     Tony Haywood, Minority Counsel


                            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
    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


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 public 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 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 pro-life 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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    [GRAPHIC] [TIFF OMITTED] 29580.012
    
    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 
patient-specific 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 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:]
[GRAPHIC] [TIFF OMITTED] 29580.013

[GRAPHIC] [TIFF OMITTED] 29580.014

    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 all-too-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.
    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:]
[GRAPHIC] [TIFF OMITTED] 29580.015

    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 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:]
    [GRAPHIC] [TIFF OMITTED] 29580.016
    
    [GRAPHIC] [TIFF OMITTED] 29580.017
    
    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.
    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 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.
    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 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 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 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.
    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.
    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 misconduct. 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, 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 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.]
    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 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 3\1/2\ 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 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?
    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?
    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 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.
    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.
    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 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 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.
    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 reproductive purposes; was no longer needed for 
those purposes; informed 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 
results-oriented 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 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 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.
    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 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.
    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.''
    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, especially 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 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. 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.
    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 blame-shifting 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 achieving 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--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.
    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?
    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.
    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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