[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
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
http://www.house.gov/reform
U.S. GOVERNMENT PRINTING OFFICE
29-580 PDF WASHINGTON : 2006
------------------------------------------------------------------
For sale by Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800;
DC area (202) 512-1800 Fax: (202) 512-2250. Mail: Stop SSOP,
Washington, DC 20402-0001
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:]
[GRAPHIC] [TIFF OMITTED] 29580.001
[GRAPHIC] [TIFF OMITTED] 29580.002
[GRAPHIC] [TIFF OMITTED] 29580.003
[GRAPHIC] [TIFF OMITTED] 29580.004
[GRAPHIC] [TIFF OMITTED] 29580.005
[GRAPHIC] [TIFF OMITTED] 29580.006
[GRAPHIC] [TIFF OMITTED] 29580.007
[GRAPHIC] [TIFF OMITTED] 29580.008
[GRAPHIC] [TIFF OMITTED] 29580.009
[GRAPHIC] [TIFF OMITTED] 29580.010
[GRAPHIC] [TIFF OMITTED] 29580.011
[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:]
[GRAPHIC] [TIFF OMITTED] 29580.018
[GRAPHIC] [TIFF OMITTED] 29580.019
[GRAPHIC] [TIFF OMITTED] 29580.020
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:]
[GRAPHIC] [TIFF OMITTED] 29580.021
[GRAPHIC] [TIFF OMITTED] 29580.022
[GRAPHIC] [TIFF OMITTED] 29580.023
[GRAPHIC] [TIFF OMITTED] 29580.024
[GRAPHIC] [TIFF OMITTED] 29580.025
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:]
[GRAPHIC] [TIFF OMITTED] 29580.026
[GRAPHIC] [TIFF OMITTED] 29580.027
[GRAPHIC] [TIFF OMITTED] 29580.028
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:]
[GRAPHIC] [TIFF OMITTED] 29580.029
[GRAPHIC] [TIFF OMITTED] 29580.030
[GRAPHIC] [TIFF OMITTED] 29580.031
[GRAPHIC] [TIFF OMITTED] 29580.032
[GRAPHIC] [TIFF OMITTED] 29580.033
[GRAPHIC] [TIFF OMITTED] 29580.034
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:]
[GRAPHIC] [TIFF OMITTED] 29580.035
[GRAPHIC] [TIFF OMITTED] 29580.036
[GRAPHIC] [TIFF OMITTED] 29580.037
[GRAPHIC] [TIFF OMITTED] 29580.038
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:]
[GRAPHIC] [TIFF OMITTED] 29580.039
[GRAPHIC] [TIFF OMITTED] 29580.040
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:]
[GRAPHIC] [TIFF OMITTED] 29580.041
[GRAPHIC] [TIFF OMITTED] 29580.042
[GRAPHIC] [TIFF OMITTED] 29580.043
[GRAPHIC] [TIFF OMITTED] 29580.044
[GRAPHIC] [TIFF OMITTED] 29580.045
[GRAPHIC] [TIFF OMITTED] 29580.046
[GRAPHIC] [TIFF OMITTED] 29580.047
[GRAPHIC] [TIFF OMITTED] 29580.048
[GRAPHIC] [TIFF OMITTED] 29580.049
[GRAPHIC] [TIFF OMITTED] 29580.050
[GRAPHIC] [TIFF OMITTED] 29580.051
[GRAPHIC] [TIFF OMITTED] 29580.052
[GRAPHIC] [TIFF OMITTED] 29580.053
[GRAPHIC] [TIFF OMITTED] 29580.054
[GRAPHIC] [TIFF OMITTED] 29580.055
[GRAPHIC] [TIFF OMITTED] 29580.056
[GRAPHIC] [TIFF OMITTED] 29580.057
[GRAPHIC] [TIFF OMITTED] 29580.058
[GRAPHIC] [TIFF OMITTED] 29580.059
[GRAPHIC] [TIFF OMITTED] 29580.060
[GRAPHIC] [TIFF OMITTED] 29580.061
[GRAPHIC] [TIFF OMITTED] 29580.062
[GRAPHIC] [TIFF OMITTED] 29580.063
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:]
[GRAPHIC] [TIFF OMITTED] 29580.064
[GRAPHIC] [TIFF OMITTED] 29580.065
[GRAPHIC] [TIFF OMITTED] 29580.066
[GRAPHIC] [TIFF OMITTED] 29580.067
[GRAPHIC] [TIFF OMITTED] 29580.068
[GRAPHIC] [TIFF OMITTED] 29580.069
[GRAPHIC] [TIFF OMITTED] 29580.070
[GRAPHIC] [TIFF OMITTED] 29580.071
[GRAPHIC] [TIFF OMITTED] 29580.072
[GRAPHIC] [TIFF OMITTED] 29580.073
[GRAPHIC] [TIFF OMITTED] 29580.074
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:]
[GRAPHIC] [TIFF OMITTED] 29580.075
[GRAPHIC] [TIFF OMITTED] 29580.076
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:]
[GRAPHIC] [TIFF OMITTED] 29580.077
[GRAPHIC] [TIFF OMITTED] 29580.078
[GRAPHIC] [TIFF OMITTED] 29580.079
[GRAPHIC] [TIFF OMITTED] 29580.080
[GRAPHIC] [TIFF OMITTED] 29580.081
[GRAPHIC] [TIFF OMITTED] 29580.082
[GRAPHIC] [TIFF OMITTED] 29580.083
[GRAPHIC] [TIFF OMITTED] 29580.084
[GRAPHIC] [TIFF OMITTED] 29580.085
[GRAPHIC] [TIFF OMITTED] 29580.086
[GRAPHIC] [TIFF OMITTED] 29580.087
[GRAPHIC] [TIFF OMITTED] 29580.088
[GRAPHIC] [TIFF OMITTED] 29580.098
[GRAPHIC] [TIFF OMITTED] 29580.099
[GRAPHIC] [TIFF OMITTED] 29580.100
[GRAPHIC] [TIFF OMITTED] 29580.101
[GRAPHIC] [TIFF OMITTED] 29580.102
[GRAPHIC] [TIFF OMITTED] 29580.103
[GRAPHIC] [TIFF OMITTED] 29580.104
[GRAPHIC] [TIFF OMITTED] 29580.105
[GRAPHIC] [TIFF OMITTED] 29580.106
[GRAPHIC] [TIFF OMITTED] 29580.107
[GRAPHIC] [TIFF OMITTED] 29580.108
[GRAPHIC] [TIFF OMITTED] 29580.109
[GRAPHIC] [TIFF OMITTED] 29580.110
[GRAPHIC] [TIFF OMITTED] 29580.111
[GRAPHIC] [TIFF OMITTED] 29580.112
[GRAPHIC] [TIFF OMITTED] 29580.113
[GRAPHIC] [TIFF OMITTED] 29580.114
[GRAPHIC] [TIFF OMITTED] 29580.115
[GRAPHIC] [TIFF OMITTED] 29580.116
[GRAPHIC] [TIFF OMITTED] 29580.117
[GRAPHIC] [TIFF OMITTED] 29580.118
[GRAPHIC] [TIFF OMITTED] 29580.119
[GRAPHIC] [TIFF OMITTED] 29580.120
[GRAPHIC] [TIFF OMITTED] 29580.121
[GRAPHIC] [TIFF OMITTED] 29580.122
[GRAPHIC] [TIFF OMITTED] 29580.123
[GRAPHIC] [TIFF OMITTED] 29580.124
[GRAPHIC] [TIFF OMITTED] 29580.125
[GRAPHIC] [TIFF OMITTED] 29580.126
[GRAPHIC] [TIFF OMITTED] 29580.127
[GRAPHIC] [TIFF OMITTED] 29580.128
[GRAPHIC] [TIFF OMITTED] 29580.129
[GRAPHIC] [TIFF OMITTED] 29580.130
[GRAPHIC] [TIFF OMITTED] 29580.131
[GRAPHIC] [TIFF OMITTED] 29580.132
[GRAPHIC] [TIFF OMITTED] 29580.133
[GRAPHIC] [TIFF OMITTED] 29580.134
[GRAPHIC] [TIFF OMITTED] 29580.135
[GRAPHIC] [TIFF OMITTED] 29580.136
[GRAPHIC] [TIFF OMITTED] 29580.137
[GRAPHIC] [TIFF OMITTED] 29580.138
[GRAPHIC] [TIFF OMITTED] 29580.139
[GRAPHIC] [TIFF OMITTED] 29580.140
[GRAPHIC] [TIFF OMITTED] 29580.141
[GRAPHIC] [TIFF OMITTED] 29580.142
[GRAPHIC] [TIFF OMITTED] 29580.143
[GRAPHIC] [TIFF OMITTED] 29580.144
[GRAPHIC] [TIFF OMITTED] 29580.145
[GRAPHIC] [TIFF OMITTED] 29580.146
[GRAPHIC] [TIFF OMITTED] 29580.147
[GRAPHIC] [TIFF OMITTED] 29580.148
[GRAPHIC] [TIFF OMITTED] 29580.149
[GRAPHIC] [TIFF OMITTED] 29580.150
[GRAPHIC] [TIFF OMITTED] 29580.151
[GRAPHIC] [TIFF OMITTED] 29580.152
[GRAPHIC] [TIFF OMITTED] 29580.153
[GRAPHIC] [TIFF OMITTED] 29580.154
[GRAPHIC] [TIFF OMITTED] 29580.155
[GRAPHIC] [TIFF OMITTED] 29580.156
[GRAPHIC] [TIFF OMITTED] 29580.157
[GRAPHIC] [TIFF OMITTED] 29580.158
[GRAPHIC] [TIFF OMITTED] 29580.159
[GRAPHIC] [TIFF OMITTED] 29580.160
[GRAPHIC] [TIFF OMITTED] 29580.161
[GRAPHIC] [TIFF OMITTED] 29580.162
[GRAPHIC] [TIFF OMITTED] 29580.163
[GRAPHIC] [TIFF OMITTED] 29580.164
[GRAPHIC] [TIFF OMITTED] 29580.165
[GRAPHIC] [TIFF OMITTED] 29580.166
[GRAPHIC] [TIFF OMITTED] 29580.167
[GRAPHIC] [TIFF OMITTED] 29580.168
[GRAPHIC] [TIFF OMITTED] 29580.169
[GRAPHIC] [TIFF OMITTED] 29580.170
[GRAPHIC] [TIFF OMITTED] 29580.171
[GRAPHIC] [TIFF OMITTED] 29580.172
[GRAPHIC] [TIFF OMITTED] 29580.173
[GRAPHIC] [TIFF OMITTED] 29580.174
[GRAPHIC] [TIFF OMITTED] 29580.175
[GRAPHIC] [TIFF OMITTED] 29580.176
[GRAPHIC] [TIFF OMITTED] 29580.177
[GRAPHIC] [TIFF OMITTED] 29580.178
[GRAPHIC] [TIFF OMITTED] 29580.179
[GRAPHIC] [TIFF OMITTED] 29580.180
[GRAPHIC] [TIFF OMITTED] 29580.181
[GRAPHIC] [TIFF OMITTED] 29580.182
[GRAPHIC] [TIFF OMITTED] 29580.183
[GRAPHIC] [TIFF OMITTED] 29580.184
[GRAPHIC] [TIFF OMITTED] 29580.185
[GRAPHIC] [TIFF OMITTED] 29580.186
[GRAPHIC] [TIFF OMITTED] 29580.187
[GRAPHIC] [TIFF OMITTED] 29580.188
[GRAPHIC] [TIFF OMITTED] 29580.189
[GRAPHIC] [TIFF OMITTED] 29580.190
[GRAPHIC] [TIFF OMITTED] 29580.191
[GRAPHIC] [TIFF OMITTED] 29580.192
[GRAPHIC] [TIFF OMITTED] 29580.193
[GRAPHIC] [TIFF OMITTED] 29580.194
[GRAPHIC] [TIFF OMITTED] 29580.195
[GRAPHIC] [TIFF OMITTED] 29580.196
[GRAPHIC] [TIFF OMITTED] 29580.197