[Senate Hearing 106-413]
[From the U.S. Government Publishing Office]
S. Hrg. 106-413
STEM CELL RESEARCH, PART 2
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARING
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/senate
______
U.S. GOVERNMENT PRINTING OFFICE
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_______________________________________________________________________
For sale by the U.S. Government Printing Office
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington FRANK R. LAUTENBERG, New Jersey
MITCH McCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
JON KYL, Arizona
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
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Subcommittee on Labor, Health and Human Services, and Education, and
Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
JON KYL, Arizona DIANNE FEINSTEIN, California
ROBERT C. BYRD, West Virginia
(Ex officio)
Professional Staff
Bettilou Taylor
Mary Dietrich
Jim Sourwine
Aura Dunn
Ellen Murray (Minority)
Administrative Support
Kevin Johnson
Carole Geagley (Minority)
C O N T E N T S
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Page
Statement of Dr. Frank Young, Former Commissioner, Food and Drug
Administration, Department of Health and Human Services........ 1
Opening statement of Senator Arlen Specter....................... 1
Summary statement of Dr. Frank Young............................. 2
Prepared statement of Dr. Frank Young............................ 4
Analysis of postulated benefits and inherent liabilities of
research on embryonic pluripotent stem cells................... 5
Conclusions and recommendations.................................. 6
Statement of Hon. Jay Dickey, U.S. Representative from Arkansas.. 7
Prepared statement of Hon. Jay Dickey............................ 9
Fetal tissue..................................................... 10
Statement of Dr. James Childress, Commissioner, National
Bioethics Advisory Commission; Kyle Professor of Religious
Studies and Professor of Medical Education, University of
Virginia....................................................... 12
Prepared statement of Dr. James Childress........................ 14
Background and process........................................... 14
NBAC's recommendations........................................... 15
New commission................................................... 17
Statement of Hon. Strom Thurmond, U.S. Senator from South
Carolina....................................................... 18
Prepared statement of Senator Strom Thurmond..................... 20
Would use of fetal tissue encourage abortions?................... 20
Prepared statement of Senator Dianne Feinstein................... 23
STEM CELL RESEARCH, PART 2
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THURSDAY, NOVEMBER 4, 1999
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 12:07 p.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senator Specter.
STATEMENT OF DR. FRANK YOUNG, FORMER COMMISSIONER, FOOD
AND DRUG ADMINISTRATION, DEPARTMENT OF
HEALTH AND HUMAN SERVICES
opening statement of senator arlen specter
Senator Specter. Ladies and gentlemen, we have been
awaiting the arrival of some of our witnesses. We had the
swearing in of Senator Chafee, Senator Lincoln Chafee, which
has delayed some. I think we will proceed with the testimony of
Dr. Young and Dr. Childress at this time, and when Senator
Thurmond and Congressman Dickey arrive, we will proceed to
interrupt the hearing to take them as soon as they do arrive.
This is the fourth hearing which this subcommittee is
holding on the stem cell issue. Last November, the issue of
stem cells burst upon the scene with disclosures that research
at Johns Hopkins and the University of Wisconsin demonstrated
the ability to grow stem cells taken from an embryo and modify
them so that they could become different body parts, promising
sensational breakthroughs in medical science.
There is a prohibition against Federal funding on embryos.
The Department of Health and Human Services has a legal opinion
saying that there may be research on stem cells which are
extracted from embryos privately funded, and the subcommittee
had inserted in the markup an elimination of that prohibition.
Not unexpectedly there was very strenuous opposition in the
full committee and opposition likely on the floor. How it would
have turned out is problematical, but in consultation with
Senator Lott, the Majority Leader, and Senator Stevens,
chairman of the full committee, the subcommittee decided to
delete it in the full committee report so that we could proceed
and get the appropriation bill passed. There would have been
perhaps a filibuster and a lengthy proceeding on the Senate
floor.
As a result of deleting that provision, we have not exactly
moved expeditiously to get the bill anyway, a matter of ongoing
struggle. But Senator Lott did say that once removed from the
appropriations bill, the issue would come up as a freestanding
bill in February. We intended to have hearings on it to give
people on both sides of the issue an opportunity to express
themselves.
summary statement of dr. frank young
So, at this time let us proceed with two of our witnesses
who are here. Dr. Frank Young, former Commissioner of the Food
and Drug Administration, 5 years, 1984 to 1989; previously
served as Deputy Assistant Secretary for Health in the Bush
administration, and as Director of HHS, Office of Emergency
Preparedness. He was Dean of the University of Rochester
Medical School, a microbiologist by training with an M.D. from
NYU and Ph.D. from Case Western. He now serves as pastor of the
Adult Ministries at the Fourth Presbyterian Church in Bethesda.
Thank you for joining us, Dr. Young, and we look forward to
your testimony.
In accordance with our practice, we have a 5-minute rule to
allow maximum time for questions and answers. The floor is
yours, Doctor.
Dr. Young. Thank you, Mr. Chairman. It is a pleasure to see
you again and to testify before you. I want to thank you for
your steadfast work also in the field of weapons of mass
destruction, which is the opportunity that I had to be with you
at the last time as we were planning the medical response.
I also want to thank you for the work that you have done
over the years in your support and this committee's support in
the Department of Health and Human Services.
I find myself in a very different position today, having
been an individual who was present at the Asilomar meeting.
Then on every one of the bioethics panels, with the exception
of up until the very last one, I have had a chance from the
recombinant DNA advisory committee forward to look at this
work, and as the Commissioner of the U.S. Food and Drug
Administration, had the privilege of bringing on line the
biotechnology industry that we have today. I am an advocate of
and a devotee of molecular genetics.
So, therefore, at this present time I find myself in a
rather unusual position because instead of being a complete
advocate of pushing forward with stem cell research at this
time, I raise a large caution. The very greatest concern that I
had as Commissioner was to be sure that the public was fully
supportive of the procedures, the processes, and the policies
that we were bringing forward. Otherwise, the fruits of
biotechnology were liable to rot on the laboratory bench.
In this particular case, though I compliment your hearing
process and the many hearings that you have had, I believe that
there are some serious concerns with the way the issue has been
addressed before the public. It is imperative that any
commission or group that we have is not only broadly
representative, but strives for a consensus. As you said, sir,
in your opening remarks, this is a controversial issue.
So, I bring forward to you today, if I may have my entire
statement introduced for the record----
Senator Specter. It will be in the record, without
objection.
Dr. Young [continuing]. Some recommendations and a way, I
think, out of this dilemma.
The first thing that I would say is that there is a need to
develop an ethical framework.
Second, a need to gather the full and carefully analyzed
results of the research, both on adult and embryonic stem
cells. I have not had the privilege of seeing the final report
of the committee, but I do know that the executive summary had
raised some important issues. But I did not see a summary there
of the research and the pros and cons. While it side-stepped
the ethical issues, the compelling scientific reasons for
choosing one versus the other was not apparent to me in the
executive summary.
Therefore, I believe that this committee should support a
very substantial focus on the alternatives, as well as the
other recommendations.
One quote that I would like to give you at this time for
perspective came from Professor Leff, a lawyer at Duke, in the
Duke Journal, and he said something that I think you almost
said in your opening remark. He said:
I want to believe, and so do you, in a complete
transcendent and imminent set of propositions set of
propositions about right and wrong, findable rules that
authoritatively and unambiguously direct us how to live
righteously. I also want to believe, and so do you, in no such
thing, but rather that we are wholly free, not only to choose
for ourselves what we ought to do, but to decide for ourselves,
individually and as a species, what we ought to be. What we
want, heaven help us, is simultaneously to be perfectly ruled
and perfectly free, that is, at the same time to discover the
right and good and to create it.
I have listed some recommendations, which is for the
establishment of a commission. I have given you some membership
that I would propose for this, a commission built by both
Congress, the House, Senate, and administration, that it have
representatives from the public sector, people from science,
theology, medicine, and law.
That in this time, we would have a moratorium for 3 years
for this commission to work.
That it be funded in the way that would be appropriate for
it to get its job done.
That the Food and Drug Administration be charged to examine
whether or not the regulations and the resources are adequate
because the commission aptly pointed out some regulatory
conundrums, and I believe that the Congress has the
responsibility to meet that.
prepared statement
Finally, I would hope there would be a way to communicate
with the public to try to bring together the various diverse
views. I have lived both as a scientist, a physician, and now
as pastor, and just this morning I met with a woman who is
having surgery at 6:45 in the morning. Her question was the
meaning of life and how she would survive. Therefore, science
speaks in one category, religion and theology in another. We
need to bring both of these together to talk, to work, and to
get a consensus.
Mr. Chairman, again I congratulate you for having this
hearing, and I thank you for the privilege of appearing before
you again.
Senator Specter. Well, thank you very much, Dr. Young.
[The statement follows:]
Prepared Statement of Dr. Frank Young
Mr. Chairman and Members of the Appropriations Subcommittee: Thank
you for the opportunity of participating in this hearing concerning the
controversial ethical issue of research on human embryos to optimize
the procedures for harvesting embryonic stem cells and the federal
funding of research on stem cells derived from human embryos. Allow me
to state the question clearly: should we destroy living human embryos
in order to experiment with their cells for the potential benefit of
the living? The Executive Summary of the Report of the National
Bioethics Advisory Committee (September 1999) aptly summarized the
Congressional intent. ``The current ban on embryo research is in the
form of a rider to the appropriations bill for the Department of Health
and Human Services (DHHS), of which the National Institutes of Health
(NIH) is a part. The rider prohibits use of the appropriated funds to
support any research `in which the embryo [is] destroyed, discarded, or
knowingly subjected to risk of injury greater than that allowed for
research on fetuses in utero' ''. This is not an unexpected
controversy. As early as 1982, the President's Commission for the Study
of Ethical Problems in Medicine and Biomedical and Behavioral Research
issued a report entitled ``Splicing Life: A Report on the Social and
Ethical Issues of Genetic Engineering with Human Beings.\1\ Yet there
has been little sustained development of consensus policies regarding
the ethics of the new genetics and cell biology on the National level
with the notable exception of recombinant DNA (rDNA) technology.
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\1\ Splicing Life: The Social and Ethical Issues of Genetic
Engineering of Human Beings. November 1982, Library of Congress card
number 83-600500.
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In 1999, the level of the intellectual and societal playing fields
were changed by recent advances in the cloning of animals and
manipulation of embryonic cells and by a decision of DHHS. On January
26, 1999, Dr. Varmis, in testimony before the Appropriations
Subcommittee stated that the General Counsel of DHHS concluded that
DHHS funds can be used to support research using human pluripotent cell
derived from human embryos because the statutory ban does not apply. It
was posited that ``the statutory prohibition does not apply to research
utilizing human pluripotent stem cells because pluripotent stem cells
are not embryos.'' In response to this decision, early in 1999, 70
members of the Congress signed a letter that called upon DHHS to
reverse the NIH Director's decision to allow funding for research on
pluripotent stem cells. In a letter in Science, a group of 73
scientists offered support for the Director Varmus' decision to fund
this research (Science 283:1849-1850, 1999) It is important to
emphasize that this research on embryos one of the most controversial
societal concerns today. It will be a proxy for our view of the essence
of the meaning of life in the 21st century.
To understand the issues fully, we must clearly realize that while
science measures and explores the known world, religion embodies a
devotion to God and the meaning of life. Thus, there will be different
worldviews within our society, and each one must be heard respectfully
and considered carefully. As noted by Professor Gould, science and
religion are two ``Non-Overlapping Magisteria.'' \2\ Both make major
contributions to society. But these contributions are different.
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\2\ Stephen J. Gould, Rocks of Ages: Science and Religion in the
Fullness of Life, Ballintine Publishing Group 1999.
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In this testimony, I shall present an analysis of this dilemma and
offer a recommendation to resolve it.
Throughout my scientific career as a molecular geneticist, I have
been involved in the ethical issues confronting biotechnology and
cellular biology as well as medical advances. I was present at the
Asilomar Conference where 150 scientists from 18 nations first met to
debate the safety of rDNA technology and also consider the ethics of
the research. Careful attention to both safety and scientific inquiry
was incorporated into the NIH Guidelines that resulted from the
Asilomar meeting. A deliberately careful approach was taken to this
research and the guidelines were relaxed as scientific and social
concerns permitted. As a member of the first Recombinant DNA Advisory
Committee, I participated in deliberation on the development of this
technology and was keenly aware that public confidence in this new
field of biotechnology was imperative. This rDNA research using
microbes and animal cells to produce medicines led to the establishment
of the biotechnology industry as we know it today. For many years, I
participated in recombinant DNA research and in policy deliberations on
implementation of guidelines for conducting rDNA research. As the
Commissioner of the Food and Drug Administration, I led in the
development of regulations nationally and internationally that ushered
in the current era of biotechnology. However, I must emphasize that
this research and industrial development did not involve the
disintegration of human embryos. Instead it used or ``enslaved''
bacterial yeast and animal cells to produce large amounts of desired
products. As Commissioner, I was conscious that the ethical
considerations as well as safety and effectiveness must be considered
carefully in order to ensure public support.
Today, we are considering embarking on an equally significant
revolution in cellular biology. The use of stem cells to produce
tissues such as blood vessels, brain cells and heart cells could result
in the partial regeneration of organs. Unlike the development of
biotechnology, which uses bacteria, yeast and adult tissue culture
cells to produce products, the research on embryonic stem cells is
dependent on disintegration of human embryos. Ethical problems abound.
I contend that killing embryos by disintegration to harvest stem cells
is illegal, immoral, and unnecessary.
analysis of postulated benefits and inherent liabilities of research on
embryonic pluripotent stem cells
(1) The potential benefits are clearly enunciated in the March 19,
1999 letter in Science. These hypothetical benefits range from research
to clinical medicine. It must be emphasized that these abundant
research promises have yet to be realized even in experimental animals
on a broad scale. Furthermore, history is replete with over promises as
evidenced by the ``War on Cancer'' and the rapid development of a
vaccine for AIDS. The risks, however, are real. An embryo, which could
have a chance to live, is destroyed.
(2) The Executive Summary of the Report of the National Bioethics
Advisory Committee (September 1999), recommends that Embryonic Stem
(ES) Cells be harvested from ``excess or spare'' embryos remaining
after infertility treatments. Recommendation 2 states, ``research
involving the derivation and use of human ES cells from embryos
remaining after infertility treatments should be eligible for federal
funding. An exception should be made to the present statutory ban on
federal funding of embryo research to permit federal agencies to fund
research involving the derivation of human ES cells from this source
under appropriate regulations that include public oversight and
review.'' At first glance this looks to be an attractive option. Why
not use an unwanted embryo to benefit the living? However, there are a
number of objections. First, there are no existing regulations on In
Vitro Fertilization procedures. Congress might wish to promulgate a law
to regulate this industry including production of spare embryos,
standards for preservation, record keeping and options for adoption.
Second, serious consideration should be given to developing procedures
for adoption of embryos. Third, there is enormous peer pressure in
science to ``support the current ethos or risk loss of funding or
intellectual denigration.'' Therefore, objectors could be cautious in
expressing contrary opinions.
(3) The NBAC proposed voluntary guidelines and possible regulations
to cover this research. However, the safeguards recommenced by the NBAC
are neither sufficient nor enforceable. The problem is clearly seen in
a report in The Washington Post on November 3, 1999. In an article
entitled ``Gene Research Moves Toward Secrecy,'' Deborah Nelson and
Rick Weiss reported that there were 8 deaths in gene therapy that were
neither reported to patients nor properly communicated to the
regulatory and scientific community. A loss of public confidence could
drastically curtail research and development. In the early days of the
recombinant research, there were reports of individuals leaving the
country to find a location where research not approved in the United
States could be conducted. Steps were rapidly taken to prevent these
ethical infractions.
(4) The DHHS proposal and the NBAC recommendations enable the
research to go forward expeditiously. However, there is an inherent
conflict of interest when academicians comprise the vast majority of
the membership. A special interest group that stands to ``profit''
through grants, industrial contracts, or research on the ethical
concerns, thereby engendering notoriety, should not propose the
recommendations. Any Commission that represents public interest should
have broad participation including people with opposing views. Did the
scientists learn from the rDNA regulations that public participation is
cumbersome and should be avoided? Finally, once the research is
initiated there is no turning back. An ethical position should be
established first. While not challenging the credentials of any
committee member, I contend that the NBAC was not sufficiently
independent and sufficiently broad to fulfill this mandate.
(5) Recommendation 2 in the NBAC report implies that the extra
embryos described have no legal status nor affords them any. This legal
issue raises many questions that demand further analysis. For example,
can the donors of the sperm and egg that were used to produce an embryo
legally give it away? Our Declaration of Independence states that ``we
hold these truths to be self-evident, that all men are created equal,
that they are endowed by their Creator with certain unalienable Rights,
that among these are Life, Liberty and the pursuit of Happiness.'' I
contend that the embryo should receive such protection no matter how it
is conceived. It is important to note that the embryo is accorded legal
protection in many states. Finally, the harvesting of an embryo and the
subsequent use of its cells for research might violate the 14th
Amendment. Throughout American history, our Nation has striven to
protect the vulnerable. The Americans with Disabilities Act, our
efforts in Kosovo, and the recent Clinton Administration's Conference
on Mental Health are contemporary examples of our National commitment
in this regard.
(6) The NBAC report focuses primarily on ES and Embryonic Germ (EG)
cells. In science there is an ethos of the imperative, ``if it can be
done, try to do it,'' or, stated differently, ``research is a 1st
Amendment right.'' However, we live in a society where the cardinal
principle is do no harm, whether in medicine or to the environment.
Therefore, the use of adult stem cells should be fully explored and
investigated prior to reversing the moratorium on human embryo
research. Recent studies have demonstrated that these cells might be a
suitable substitute for ES and EG cells.
We are at a critical junction in society and faced with a serious
dilemma. The problem of conflicting human desires was stated clearly by
Arthur A. Leff in the Duke Law Journal December 1979, pg. 1229. ``I
want to believe, and so do you, in a complete transcendent and immanent
set of propositions about right and wrong, findable rules that
authoritatively and unambiguously direct us how to live righteously. I
also want to believe, and so do you, in no such thing, but rather that
we are wholly free, not only to choose for ourselves what we ought to
do, but to decide for ourselves, individually and as a species, what we
ought to be. What we want, heaven help us, is simultaneously to be
perfectly ruled and perfectly free, that is, at the same time to
discover the right and good and to create it.''
conclusions and recommendations
The issues are contentious and difficult. Our population is divided
on the ethical appropriateness of the use of ES cells. The scientific
imperative impels us ever forward. But there are major costs. These are
the same considerations that we had at FDA as we embarked on the
approval of biotechnology products and developed regulatory policies.
We need to have the confidence of the people and to be concerned for
the social, religious, medical, environmental and scientific interests
of our citizens. Once we lose credibility, all chance for acceptance of
the adequacy of the public health system is eroded. Under such
conditions, the fruits of biotechnology would have rotted in the
laboratory. However, we succeeded admirably! Following the pattern of
the successful development of the biotechnology industry, I contend
that the rush to engage in embryonic pluripotent stem cell research is
foolhardy. We need to settle the ethical concerns first.
Since I have moved from medicine into pastoral ministry, I have
become more aware than ever of the need to ensure the dignity of each
person. As a scientist, I am fascinated with the complexity of life and
the capacity to develop medicines that can alleviate the suffering of
mankind. As a physician, I an committed to promoting health and
providing care to the living. Now as a pastor, I know that we are made
in the image of God (Genesis 1: 26-27) and as image bearers we must
respect the sanctity of life. Because each of us will die, it is
imperative that we must know the meaning of life and live accordingly.
Maintaining the endowment by the Creator ``with certain unalienable
rights, that among these are life, liberty and the pursuit of
happiness'' is as important for the embryo as for the adult. The
utilitarian ethical stance of promoting the greatest good could lead to
a new eugenics and the sacrifice of the vulnerable to relieve the pain
and suffering and extend the life of the living.
Recommendations
(1) To ensure a broad representation of the citizens of the
country, I recommend that Congress and the Administration appoint a
Commission to review the current progress in ES, EG and Adult Stem
cells. This Commission should be charged to hold public meetings and to
report annually to Congress and the President. Additionally the
Commission should develop an ethical framework for research with stem
cells and propose a well-designed way to communicate with the public.
The Commission should also recommend policy questions for analysis by
the Administration and Congress. To ensure representation of all points
of view, five members should be appointed by the President, five by the
Senate and five by the House of Representatives. The membership should
consist of at least two of each of the following: public
representatives, scientists, physicians, ethicists and theologians. The
term of service should be limited to three years.
(2) A moratorium for three years to enable the Commission to report
to the Administration and Congress.
(3) The Commission should be adequately funded through an
independent budget to accomplish its tasks.
(4) In the interim, as an added layer of safety, the FDA should
examine whether additional guidelines and regulations are required for
in vitro fertilization. FDA should report to Congress on the adequacy
of regulations to meet the new responsibilities and the adequacy of the
staff resources to accomplish the expectations of the public.
(5) In the meantime, there should be sufficient funding for
research on human adult stem cells and animal embryonic and germinal
stem cells to enable this technology to continue to be developed during
the moratorium on human pluripotent stem cells.
I will be pleased to answer any questions you have regarding my
testimony. If you wish, I shall provide more in depth recommendations
about the proposed Commission and additional insights into the
commercialization of biotechnology that occurred on my watch as
Commissioner of FDA. Thank you for your attention and concern.
STATEMENT OF HON. JAY DICKEY, U.S. REPRESENTATIVE FROM
ARKANSAS
Senator Specter. If Congressman Dickey would come forward.
We have started the hearing in the absence of--you had to go to
vote, as we understand, and Senator Thurmond I believe has been
detained with the swearing in of our new colleague. In order to
economize your time, Congressman Dickey, we will take you right
now.
Mr. Dickey. Oh, great, thank you.
Senator Specter. We do know that there are a few items on
your agenda. You have to finish up the appropriations bills.
Thank you for joining us, Congressman Dickey.
Jay Dickey represents the Fourth Congressional District in
Arkansas, previously a practicing lawyer in Pine Bluff and
served as City's Attorney, former State Chairman of the
Christian Legal Society, currently in his fourth term, serves
on the Appropriations Subcommittee of Labor, Health and Human
Services, and Education where we have had a great many
contacts, always cordial, not always in agreement, but always
cordial. He had expressed opposition to removal of the
restrictions in a discussion we had informally some time ago.
So, we thought we would invite him to present his views here
today. Welcome and the floor is yours.
Mr. Dickey. Thank you, Mr. Specter, and thank you for
having me here and for always listening to my views in
particular, and I notice that other people who differ with you
you will listen to them. I want to say this for the record that
each time we have had a confrontation, if we want to call it
friendly or otherwise, I always lose.
But maybe I will just keep trying and somehow my ideas will
prevail.
I think we have got a serious----
Senator Specter. That drew a chuckle, as expected,
Congressman Dickey, even though it is not exactly correct. The
record will be burdened with a very long list of your victories
when this hearing is over.
Mr. Dickey. Thank you, sir. But I do appreciate your
willingness to listen and consider all aspects of issues.
This particular one I think is unusual in that it has a
broad umbrella of concern across the Nation, and the question
comes down does science serve human beings or do human beings
serve science. A little bit of look into history shows us that
when governments or civilizations or whatever you might want to
call it get this in reverse where human beings serve science,
we have problems. Nazi Germany comes to mind where they
considered those that were infirm in whatever way, youth,
elderly, race, they were dispensable and science was put at
center stage and human beings were, in fact, treated
indifferently when compared to science.
In our own country, we had the experiment at Tuskegee. I
think officially it is called the Tuskegee Study of Untreated
Syphilis in the Negro Male where we did virtually the same
thing, where we considered certain people proper subjects for
scientific experiments without their knowing that they were
being used as such. I think the outrage is sort of the basis
for our opinion here, the outrage that came from that.
I am concerned personally that we are making a business out
of terminating life in this particular case, that we are not
treating life with the proper dignity. We are going to
eventually get to where we are going to have a storehouse with
prices on body parts. Science may be able to justify it. They
may say, well, we will be able to save a life here, but in the
process we are terminating lives.
But the big thing that we are going to have happen to us is
that our conscience is going to be numbed. We are not going to
understand the basis that our country was founded upon, and
that is the consideration of life and the human dignity that it
deserves.
Some people are drawn in the decision to support science
from the standpoint that how can we go wrong if we are trying
to improve our conditions. Everybody wants to be a part of
that, particularly a legislator and particularly someone on the
Appropriations Committee. I am the same way. I am no different
than anybody else. If we get a breakthrough and I happen to be
a part of voting for that, that is something that goes years
and years and years down the road. It is certainly something
that I would like to do, and I look closely in this committee
work to doing that.
But I feel for myself I am stopped cold, just dead cold,
when I find out that reaching for science has blinded me to the
fact that we are trashing human life, that we are throwing
human life aside and saying it does not matter. I think that is
what has concerned me here.
We have Federal funds that we have prevented from being
used in several different areas because our Nation just says it
is all right if you want to do it privately. We may disagree,
but we do not want to take tax receipts from people and then
use them against their consciences. We have done that in the
form of no Federal funds are used to destroy human embryos.
That law was enacted in 1996. No Federal funds for abortions or
even in some instances to subsidize programs that provide
abortions, prohibiting the NIH for harmful research on human
babies in the womb, even if the mother is going to get an
abortion. That has sort of been our standard, our standard of
conscience in our country.
Here we come with the stem cell research and all of this
scientific language that sounds good, saying yes, this is
different than destroying a human embryo, when in fact the
human embryo is a source of stem cells. There is no question we
are sort of in the same argument that we had back in 1995, when
we first started in this.
I want to say this. I want to point to a Terrence poll
where 75 percent of those people polled opposed use of Federal
funds for human embryo experimentation, or termination, as I
like to say it.
I just think we have got to bring ourselves up and say,
just what are we doing?
Are we stopping science? No. Adult stem cells can, in fact,
be used. That is one source. We can take the stem cells from
the person that is affected and we can bring that into some
kind of useful scientific application.
We can also use fetal tissue. The law is already there.
Fetal tissue is another way we can do it.
prepared statement
We could also let, as we have in the past, private industry
do this, even though we would object to it. There is no
question that I would be objecting to that, but that is their
business and that is private funds. Here we are dealing with a
trust of Federal funds, money that has been worked for and paid
into the Government, and somehow we are saying, look, we know
better than you do. The mind is going to overcome the heart in
all instances, and we are going to replace your conclusions
with ours and we are going to use your money to fund it.
[The statement follows:]
Prepared Statement of Hon. Jay Dickey
Thank you, Mr. Chairman, and Members of the Subcommittee, for
having me here today to testify regarding my moral and ethical concerns
with embryonic stem cell research. I feel very strongly about this
issue. Recently, there has been much discussion concerning federal
funding of research in which human embryos are destroyed. In 1995, and
every year since, Congress has passed an amendment to prohibit funding
of ``research in which'' human embryos are destroyed or discarded.
However, in January of this year, the General Counsel at the
Department of Health and Human Services (HHS) issued a memorandum to
the director of the National Institutes of Health (NIH), Harold Varmus,
claiming that taxpayer funds may be used for research on stem cells
taken from living human embryos. (Stem cells are unspecialized cells
with the capacity to develop into various body parts such as bone,
skin, nerves, organs, and they exist in all human beings, whether
embryos or adults.)
Shortly after this HHS determination, the NIH director Varmus
announced that he would reverse current federal policy and begin
funding research which relies on the mutilation and destruction of
human embryos.
As the author of the law restricting taxpayer funding of
experiments which harm living human embryos, I believe this decision is
wrong and undermines the spirit and letter of the law. The General
Counsel unilaterally narrowed the meaning of ``research in which a
human embryo or embryos are destroyed'' and stated that it prohibits
only direct federal funding of the specific act of destroying the
embryo. While the act of destroying or injuring a human embryo would
certainly be ineligible for Federal funding, the law has much broader
application. It also bans the use of tax dollars to fund research which
follows or depends upon the destruction of or injury to a human embryo.
In the embryonic stem cell experiments which NIH proposes to fund, the
timing, method and procedures for destroying the embryonic child would
be determined solely by the federally funded researchers need for
usable stem cells.
The HHS General Counsel also presumes to redefine what we mean by
``human embryo,'' calling an entity an ``embryo'' only if one can show
that it is capable, if implanted in the womb, of becoming a born
``human being.'' This narrow definition has no support whatsoever in
federal law, and it very clearly violates the foundation on which the
present law is based--respect for the lives of human beings from the
very beginning. This new definition of human embryo, fabricated by HHS,
would weaken even that part of the law supported by President Clinton
which bars the use of federal funds to create human embryos for
research purposes. Federally funded researchers might simply begin
creating embryos with lethal defects.
Science can sometimes be used to hide other agendas and must have
limits. So far, there is not any clear evidence that human embryo
research is the best route to relieve human suffering. The private
embryonic stem cell research which is presently being practiced and
which is not prohibited by this law has yet to provide any definitive
results that could justify using federal funds to accelerate such
activities. Moreover, numerous reports over just the last few months
have shown remarkable discoveries about the versatility and possible
uses of stem cells found in adults.
For more than 20 years, Federal laws and regulations have protected
the human embryo and fetus from harmful experimentation at the hands of
the Federal government--regardless of whether the embryo is ``perfect''
or damaged, wanted or unwanted, intended for abortion or intended for
live birth. This area of law has provided a barrier against
government's misuse or exploitation of human beings in the name of
medical progress. It would be a travesty for this Administration to
attempt to unravel this accepted ethical standard.
fetal tissue
Senator Specter. Congressman Dickey, when you raised the
issue of fetal tissue, that was very contentious a few years
back with some saying that the use of fetal tissue would
promote abortions, others saying that fetal tissue would only
be used where abortions were conducted otherwise. It was very
contentious in the Senate until Senator Thurmond took a
position in favor of use of fetal tissue, and he did so because
his daughter suffered from diabetes. Senator Thurmond is going
to be a witness here today. The votes were changed in the
Senate from about 40 to about twice that number, 80, when
Senator Thurmond testified in that way.
So, I am interested in your articulating fetal tissue as an
alternative, and I would like to have you amplify, if you
would, your feeling. I think you said you were still opposed to
it, but how do you make a judgment as to the use of fetal
tissue considering your sense of opposition?
Mr. Dickey. I think that is a point well taken. Again, I am
going to be countering your thoughts on this.
I want to say this. I voted against the fetal tissue. I
thought it was going to encourage abortions, it would give an
economic reason for abortions, for pregnancies to even occur,
and then for abortions to take place. I am not aware of whether
that has increased abortions or not, but I do not think it has.
At least the increase has not been an issue that has been
brought to my attention. It is the law. It is there and this
source can be used even though I do not agree.
What happens with me, Senator Specter, is if I have to err,
I am going to err on the side of life. I may err a lot because
I do not know science or I am not up on it as much as I should.
But that is what happened on the fetal tissue issue and that is
what is happening here. I feel stronger about the stem cell
because we have got the human embryo law in place and it has
been there since 1996. We are now trying to marginalize the
provisions of that law that were fought for both in the
committee level of the House and the committee level in the
Senate and the Senate.
Senator Specter. You do, though, as you have just
testified, leave latitude for private research.
Mr. Dickey. That is correct, even though I disagree with
that. We need to start doing that. What I see is that private
investment is a laboratory for us on this issue. If we are
getting into this dangerous area where we are going to
traumatize our Nation's conscience, we ought make sure, for
certain, that scientifically it can happen, that it can bring
some kind of benefit.
Senator Specter. Well, the General Counsel for the
Department of Health and Human Services, as you know, has come
down with an opinion that as long as the private funds are used
to extract stem cells from the embryos, then public funds may
be used for the research on the stem cells since it is not
research on the embryos. What is your thinking on that
interpretation?
Mr. Dickey. It still terminates the human embryo.
Senator Specter. Well, I think the embryo has been
terminated by the private research which extracts the stem
cells. So, when it comes into the public expenditure, you have
the stem cells without the embryo.
Mr. Dickey. I understand. It is one of those this equals
this equals this, but we are still terminating the embryo and
we are being a part of it. It is like being an accomplice to a
crime. You cannot just sit there and watch something happen and
then encourage it by receiving the goods from it and then say I
am innocent. I do not think we are innocent. I know I cannot do
that in my own conscience and my own commitment to what I think
is right and wrong.
But you have got an argument. Let me say this in all due
respect. That is an argument of the mind. What I am talking
about is a response from the heart, and I am just concerned
about what we are going to do on the sidelines while we watch
these things happen.
Senator, in graphic terms, I just do not want us to create
a situation where we have a storeroom full of body parts that
have price tags on them. That is an awfully tough thing for me
to say because you are a gentleman. This is a discussion among
friends, but I am just saying to you that that is what I am
concerned about.
On the other side, I want to encourage people to fight for
life, for the dignity of life, and I want to show them that the
Federal Government is not going to use their funds to do that.
I am not trying to convince anybody to believe like I am
believing. I am not trying to say that I want my will or my
conclusions to be yours. All I am saying to you is that I
believe the beginning of life is at conception. Our Nation is a
godly Nation, and we are not going to win by forcing people to
pay their money into the Federal Government and then disregard
that conclusion that a great number of people in this country
have, that life begins at conception.
Senator Specter. Well, Congressman Dickey, I very much
appreciate your coming today and your views. I know that they
are very sincerely held. When you make the distinction,
speaking from the mind as opposed to the heart, I respect that.
You and I have had quite a number of discussions formally on
the record and we have had conferences between the House and
the Senate on our subcommittee and informally as we have met
and talked on many occasions. This is an important subject to
be discussed and to be advanced. We very much appreciate your
coming over.
Mr. Dickey. Thank you for having me.
Senator Specter. May the record show that you had paused,
that I did interrupt you on your last statement. I want to be
clear that you can have as much time as you like to say
anything further.
Mr. Dickey. No, I have concluded. Probably talked too long
as it is.
Senator Specter. I think you have been very succinct and
very direct and very illuminating.
Mr. Dickey. Thank you, Senator.
Senator Specter. Thank you very much, Congressman.
Mr. Dickey. Good to see you.
STATEMENT OF DR. JAMES CHILDRESS, COMMISSIONER,
NATIONAL BIOETHICS ADVISORY COMMISSION;
KYLE PROFESSOR OF RELIGIOUS STUDIES AND
PROFESSOR OF MEDICAL EDUCATION, UNIVERSITY
OF VIRGINIA
Senator Specter. Let us proceed now with the testimony of
Dr. James Childress. Dr. Childress is Commissioner at the
National Bioethics Advisory Commission, who directly
participated in the commission's stem cell report. He is also
the Kyle Professor of Religious Studies and Professor of
Medical Education at the University of Virginia and the Co-
director of the Virginia Health Policy Center. He earned his
Ph.D. from Yale University.
Thank you for joining us, Dr. Childress, and the floor is
yours. We are going to go back to our 5-minute rule.
Dr. Childress. Thank you very much, Mr. Chairman. My name
is James Childress and I am a member, as you mentioned, of the
National Bioethics Advisory Commission, NBAC, and I teach at
the University of Virginia in religious ethics and biomedical
ethics.
I am pleased to testify before you this morning on behalf
of NBAC on the subject of its recent report, Ethical Issues in
Human Stem Cell Research. Your subcommittee has previously
received testimony that updated the status of this report.
Today I will briefly describe the process we used to arrive at
our 13 recommendations and summarize a few main points.
I would respectfully ask that the full text of my statement
be included in the record.
Senator Specter. Without objection, it will be made a part
of the record.
Dr. Childress. Copies of the executive summary of the
report have been distributed to the committee and are also on
NBAC's web site.
On November the 14, 1998, President Clinton asked NBAC to
undertake a thorough review of the issues associated with human
stem cell research balancing all ethical and medical
considerations. From that point until we submitted the report
in September of this year, we examined the full range of issues
associated with this research in order to reach the best
judgment we could about the appropriate balance of ethical and
medical considerations and about the appropriate ethical and
policy guidelines for such research in light of this great
medical promise, but also in light of its morally controversial
derivation and use of stem cells from fetal tissue following
deliberate abortions or embryos remaining after in vitro
fertilization.
In exploring these issues, we benefitted from broad and
diverse testimony by experts and the public. All of NBAC's
meetings are held in public and provide ample opportunity for
public input. Our deliberations were informed throughout by
perspectives provided by members of the public, as well as by
interpreters of major religious traditions, philosophers,
bioethicists, lawyers, scientists, physicians, and others.
For example, on May 7 of this year, NBAC convened a meeting
at Georgetown University to hear presentations on religious
perspectives relating to this research. Altogether 11 scholars
in Roman Catholic, Jewish, Eastern Orthodox, Islamic, and
Protestant traditions presented formal testimony that day, and
two others made statements in the public comment period. The
diversity of views, both across these traditions and within
them, demonstrated that there are different perspectives from
longstanding religious traditions, as well as other moral and
ethical traditions, about the ethical acceptability of research
on cadaveric fetal tissue and on the human embryo.
Over time we found widespread agreement that human embryos
deserve respect as a form of human life, but we also found
disagreements regarding both what form such respect should take
and what level of protection is required at different stages of
embryonic development. At the very least, this respect means
that these sources should not be used unless they are necessary
for important research, that alternative sources should be
simultaneously pursued, and that cadaveric fetal tissue and
embryos remaining after in vitro fertilization should not be
bought or sold.
We concluded that it would be appropriate for the Federal
Government to provide funds for the derivation and use of stem
cells from cadaveric fetal tissue and from embryos remaining
after infertility treatments if certain guidelines and
safeguards are in place and if there is an appropriate and open
system of national oversight and review.
First, we recommend that research involving the derivation
and use of stem cells from cadaveric fetal tissue continue to
be eligible for Federal funding and that the relevant statutes
and regulations be amended to make clear that the ethical
safeguards currently in place for fetal tissue transplantation
also apply to this new research.
Second, we proposed that research involving the derivation
and use of embryonic stem cells from embryos remaining after
infertility treatments be eligible for Federal funding. Thus,
we recommend on ethical grounds a limited exception to the
current statutory ban on Federal funding of embryo research in
part because, based on expert testimony, we came to the
conclusion that it is a mistake to suppose that derivation and
use can be neatly separated without damaging the development of
scientific knowledge. For example, the methods for deriving
stem cells may affect the properties of those cells.
We also recommended ethical guidelines to try to separate
the decision to dispose of embryos from the decision to donate
embryos for research.
We considered two other possible sources of stem cells.
Again after balancing the ethical and medical considerations,
we recommended against the deliberate creation of embryos for
research at this time whether by IVF or by somatic cell nuclear
transfer cloning.
prepared statement
We trust that this report will further stimulate and
contribute to our society's important ongoing debate about the
profound ethical issues regarding this potentially beneficial
research.
Thank you, Mr. Chairman. I will gladly try to answer any
questions that you or other members of the subcommittee may
have.
Senator Specter. Well, thank you very much, Dr. Childress.
[The statement follows:]
Prepared Statement of Dr. James Childress
Good morning, Mr. Chairman and members of the subcommittee. I am
James Childress, a member of the National Bioethics Advisory Commission
(NBAC) and the Kyle Professor of Religious Studies at the University of
Virginia. I am pleased to testify before you this morning on behalf of
NBAC on the subject of its recent report, Ethical Issues in Human Stem
Cell Research. I know you are aware that on two previous occasions NBAC
has testified before your subcommittee, providing updates on the status
of this report. Today I will briefly describe the background and
process we used to arrive at our recommendations, and summarize some of
our major recommendations. Copies of the Executive Summary of the
report have been distributed to the Committee and are also available on
NBAC's website, at www.bioethics.gov.
background and process
On November 14, 1998, President Clinton wrote to NBAC, requesting
that we ``undertake a thorough review of the issues associated with . .
. human stem cell research, balancing all ethical and medical
considerations.'' From then, until September 1999, when the commission
submitted its report, we spent most of our time examining the full
range of issues associated with human stem cell research in order to
reach the best judgment we could about the appropriate balance of
``ethical and medical considerations'' and about the appropriate
ethical and policy guidelines for such research.
We believed that it was necessary to get as clear a picture as
possible about the science involved and about the possible medical
benefits of research on human stem cells, in light of the reports about
a year ago that researchers had isolated and cultured human embryonic
stem cells (or ES cells) and embryonic germ cells (or EG cells). Our
initial meetings included testimony from Dr. Harold Varmus, Dr. John
Gearhart of Johns Hopkins University, Dr. Jamie Thomson of the
University of Wisconsin, and others. It became clear to us that the
published reports of isolating ES and EG cells generated considerable
scientific and clinical interest because of the prospect that human
stem cells could be used to produce more specialized cells or tissue to
treat injuries or diseases such as Alzheimer's disease, Parkinson's
disease, and heart disease. The research also could further the
development of life-saving drugs and other therapies and increase our
understanding of the earliest stages of human development.
While creating great excitement, particularly because of its
medical promise, this research also raised serious ethical concerns,
mainly because the major current sources of stem cells are cadaveric
fetal tissue obtained from elective abortions, and embryonic tissue
derived from embryos remaining after in vitro fertilization (IVF).
In exploring the scientific, medical, and ethical issues, NBAC
benefited from broad and diverse testimony, in both oral and written
form, by experts and the public. All of NBAC's meetings are held in
public and provide ample opportunity for public input. Indeed, NBAC's
deliberations about how to balance ethical and medical issues were
informed throughout by perspectives provided by members of the public,
as well as by interpreters of major religious traditions, philosophers,
bioethicists, lawyers, scientists, physicians, and others. Of the many
experts who provided valuable testimony to the Commission, one group
offered particularly helpful perspectives. On May 7, 1999 NBAC convened
a meeting at Georgetown University to hear presentations on religious
perspectives relating to human stem cell research. Altogether eleven
scholars in Roman Catholic, Jewish, Eastern Orthodox, Islamic and
Protestant traditions presented formal testimony that day, and two
others made statements in the public comment period. The diversity of
views, both across these traditions and within them, suggested to us
that there are different perspectives, from longstanding religious
traditions, about the ethical acceptability of research on cadaveric
fetal tissue and on the human embryo.
With specific attention to the ethical issues, NBAC found
widespread agreement that ``human embryos deserve respect as a form of
human life'' (p. 90) but, at the same time, disagreements ``regarding
both what form such respect should take and what level of protection is
required at different stages of embryonic development.'' At the very
least this ``respect'' means that these sources should not be used
unless they are necessary for research, that cadaveric fetal tissue and
embryos remaining following IVF should not be bought or sold, and that
alternative sources should simultaneously be explored. In addition,
NBAC sought to show respect for the range of serious ethical concerns
represented in various positions on stem cell research in our society.
NBAC's deliberations reflected the ``tension'' that many experience
between the ethically grounded desire to realize the promise of
therapeutic benefits of this research and the ethically grounded desire
to treat the different sources of stem cells with appropriate respect.
Because of these important ethical concerns, NBAC ``wrestled'' with the
strong arguments presented for and against the derivation and use of
stem cells from different sources in its efforts to formulate an
acceptable public policy regarding federal funding of and guidelines
for such research.
nbac's recommendations
Our report made 13 recommendations in several areas.
We concluded that it would be appropriate for the federal
government to provide funds for the derivation and use of EG and ES
cells from cadaveric fetal tissue and from embryos remaining after
infertility treatments. Building on current policies and practices
relating to fetal tissue transplantation, NBAC recommends that research
involving the derivation and use of human EG cells from cadaveric fetal
tissue, following deliberate abortions, ``should continue to be
eligible for federal funding,'' and that the ``relevant statutes and
regulations should be amended to make clear that the ethical safeguards
that exist for fetal tissue transplantation also apply to the
derivation and use of human EG cells for research purposes''
(Recommendation #1). These ``ethical safeguards'' were erected to
prevent the use of fetal tissue in transplantation research from
encouraging abortions. For example, they separate the consent process
for abortion from the consent process for the donation of fetal tissue
for research and prohibit the donor of fetal tissue from designating
the recipient of the transplant. These guidelines appear to be
sufficient in human fetal tissue transplantation research and should be
extended to stem cell research as well.
A second source of stem cells--ES cells from embryos remaining
after infertility treatments--is more controversial because the
derivation of ES cells destroys the embryo. NBAC proposes that
``research involving the derivation and use of human ES cells from
embryos remaining after infertility treatments should be eligible for
federal funding'' (Recommendation #2). To this end, NBAC recommends a
limited ``exception'' to the current statutory ban on federal funding
of embryo research to permit research that involves the derivation of
human ES cells from embryos remaining after IVF. Rather than attempting
to resolve the debate about the interpretation of the statutory ban on
embryo research, NBAC chose to focus on the ethical concerns involved.
Our conclusion that ``it is ethically acceptable for the federal
government to finance research that both derives cell lines from
embryos remaining after infertility treatments and that uses those cell
lines'' reflects our judgment, based on expert testimony, that it is a
mistake to suppose that derivation and use can be ``neatly separated
without affecting the expansion of scientific knowledge''--instead,
there is a ``close connection in practical terms.'' For instance, the
methods for deriving stem cells may affect the properties of the ES
cells, and increased understanding of the nature of ES cells may come
in part from the process of derivation.
Several ethical concerns arise in the derivation and use of ES
cells from embryos remaining after IVF, and some are similar to those
that arise in the derivation and use of EG cells from cadaveric fetal
tissue. NBAC proposes ways to separate, to the extent possible, donors'
decisions to dispose of their embryos from their decisions to donate
them for research, in order to reduce the possibility that ``potential
donors could be pressured or coerced into donating their embryos for
stem cell research.'' We stress that ``potential donors should be asked
to provide embryos for research only if they have decided to have those
embryos discarded instead of donating them to another couple or storing
them. If the decision to discard the embryos precedes the decision to
donate them for research purposes, then the research determines only
how the destruction occurs, not whether it occurs.''
We also recommend (Recommendation #5) the disclosure of certain,
specific information to those considering whether to donate their
embryos for research. The informational components include: the ES cell
research ``is not intended to provide medical benefit to embryo
donors''; a decision to donate or not to donate the embryos for
research will not affect future care provided to the prospective
donors; ``the research will involve the destruction of the embryos'';
and the ``embryos used in research will not be transferred to a woman's
uterus.'' In addition, we recommend (Recommendation #6) that, in
federally funded research, researchers ``may not promise donors that ES
cells derived from their embryos will be used to treat patient-subjects
specified by the donors.''
NBAC identified another ethical constraint that needs to be in
place for the derivation and use of stem cells from embryos remaining
after IVF as well as for research involving cadaveric fetal tissue:
``Embryos and cadaveric fetal tissue should not be bought or sold''
(Recommendation #7). Federal statutes and regulations and state
statutes should be examined to make sure that they or subsequent
modifications achieve this end.
I should note that we considered two other possible sources of
human ES cells, again balancing the relevant ethical and medical
considerations. We recommend against the deliberate creation of embryos
for research at this time, whether by IVF (Recommendation #3) or by
somatic cell nuclear transfer cloning (Recommendation #4). In NBAC's
judgment, the creation of research embryos could not be justified at
this time either on the grounds that the supply is inadequate or on the
grounds that matched tissue is needed for autologous cell replacement.
However, the report notes that it may be appropriate to reconsider
these issues in the future (p. 93).
Most of the remaining recommendations (#8-13) focus on the creation
and functions of a National Stem Cell Oversight and Review Panel, a
broad, multidisciplinary panel with public members, which NBAC
recommends that the Department of Health and Human Services (DHHS)
establish in order ``to ensure that all federally funded research
involving the derivation and/or use of human ES or EG cells is
conducted in conformance with the ethical principles and
recommendations contained in this report.'' (Recommendation #8).
conclusion
In summary, NBAC concluded that it would be acceptable for the
federal government to fund research that both derives and uses stem
cells from cadaveric fetal tissue and from embryos remaining from
fertility treatment, if certain guidelines and safeguards are in place
and if there is an appropriate and open system of national oversight
and review. However, at this time it recommends against federal funding
for the creation of embryos for research by either IVF or somatic cell
nuclear transfer cloning.
In part because of the evolving science and on-going societal
conversation about ethical issues, NBAC did not suppose that it could
offer the final word on the ethics of human stem cell research, on the
best possible balance of ethical and medical considerations, or on how
to resolve the tension between proper respect for cadaveric fetal
tissue and embryos remaining after IVF, on the one hand, and promoting
research that could relieve much human suffering, on the other hand.
However, our recommendations reflect our considered judgment, based on
an extensive, open, and public process of obtaining information and
engaging various ethical, legal, and policy perspectives, about an
``acceptable public policy'' that reflects ``widely shared views''
about not foregoing the potential benefits of stem cell research and
about respecting cadaveric fetal tissue and embryos remaining after IVF
as well as avoiding undue pressure, coercion, and exploitation of
potential donors. Throughout its deliberations, NBAC attempted to
propose policies ``that demonstrate respect for all reasonable
alternative points of view and that focus, where possible, on the
shared fundamental values that these divergent opinions, in their own
ways, seek to affirm.''
We hope that our report will further stimulate the important public
debate about the profound ethical issues regarding this potentially
beneficial research.
Thank you, Mr. Chairman. I would be glad to answer any questions
you or the members of the Subcommittee may have.
new commission
Senator Specter. Dr. Young, beginning with a question to
you, you have suggested a new commission be formed and that
there be a moratorium of 3 years. What would you see the new
commission doing, if anything, which the National Bioethics
Advisory Commission has not already done?
Dr. Young. Without any prejudice or concern about any
individual on the commission, I would say these few things that
I think are very important.
I practiced science for over a quarter of a century. I know
the peer pressure that exists on straying outside of existing
dogma. The penalties can be loss of research grants,
professorships, and appearances at national meetings. When we
set up the AIDS Commission, Admiral Watkins was chosen as
chair, a Navy officer who did not have an affiliation with
science. At the time that we did one of the early appointments
at RAC, we moved to Representative Thornton who was again not
involved or vested in this. Any university president,
academician, scientist, physician that is engaged in this I
believe has an inherent conflict of interest.
Second, I think that it is very important that it be
balanced between just the Congress, Senate, House that is, and
administration. If one has it as a handmaiden of any branch of
government, I do not believe it is as broadly representative.
Third, we tried in the Recombinant DNA Advisory Committee
to have on the committee representatives of the public that
were very different in views. We deliberately selected those
and also difference in background. That is why I suggested a
richness of individuals of various persuasions and at least two
from the public which had no vested concern.
I would urge that this group would also report to Congress,
the administration, would raise policy concerns, and above all,
try to reach some sort of a consensus. I do not believe that,
as the Congressman said, there is enough consensus in the land
about this research at this time.
Most importantly, I would like to see a very thorough
catalog of the type of studies that could be used with adult
versus the embryonic stem cells. The most recent literature, if
I could include a few press clippings on the monkey studies for
the record, show that adult stem cells might be able to be
isolated from the carotid body in the brain of monkeys and
utilized for treatment of Parkinson's disease.
Senator Specter. Dr. Young, when you look for consensus, it
is going to be very difficult or more likely impossible to
obtain because of the very deep-seated differences which are
present here. It brings up the dichotomy, for want of better
terms, of categorized pro life and pro choice. So, that is
going to be very hard, as I say, perhaps really impossible, to
do.
How would you compare this issue with the fetal tissue
issue where the same considerations were present on both sides,
and finally fetal tissue was approved because of the judgment
that it did not encourage abortions, but would be used only
after the abortions were completed, similar to the argument
that stem cells are derived from embryos which are not going to
be utilized for life?
Dr. Young. If I could answer that question with an
introductory answer.
At the time we first formed the Recombinant DNA Advisory
Committee, there were just as grave concerns of whether we
would be playing God, and we had to address by deliberately
being more conservative and then gradually roll back.
But to answer your question immediately, one of the major
concerns in the production of research on fetal tissue, or
termed cadaveric tissue, was that it would be highly successful
in the treatment of Parkinson's disease. Those aims that were
touted widely in the use of cadaveric tissue have not proven to
be highly successful at all. In fact, some of the work with
adult stem cells is more efficacious by factors of 30 or 40 or
so than actually the work that was done with cadaveric tissue.
I was in the Bush administration----
Senator Specter. Dr. Childress, let me ask you about the
adult stem cells as an alternative, which has been suggested
here today and by others. What is your view of that as a
realistic alternative?
Dr. Childress. I am not a scientist, but the evidence that
NBAC received and information that has appeared in the
literature would suggest to us that it is important to pursue
adult stem cells as a possibility, but there are limitations
given what we currently know. Those limitations have to do with
our inability so far, scientists' inability so far, to identify
adult cardiac stem cells, for instance, or adult pancreatic
eyelet stem cells. But in addition, often the stem cells that
can be derived this way appear to be available only in small
amounts and are hard to isolate and purify. Then there are
other questions about whether, if it is a genetic error that is
creating the problem, that would also be present in the stem
cells. So, those are reasons at least for some caution while
also supporting this particular avenue of research.
I think from NBAC's standpoint it was important not to view
these as alternatives, but rather as avenues to be pursued
simultaneously so that comparisons can be made about the
effectiveness of tissue or cell therapies that might be
developed accordingly.
Senator Specter. The commission came to the conclusion that
Federal agencies should not fund research involving the
derivation or use of human stem cells from embryos made solely
for research purposes. Is that essentially a cloning
conclusion?
Dr. Childress. In part, but also there would be two sources
that we considered. One would be from in vitro fertilization,
and the other would be from somatic cell nuclear transfer
cloning. So, we considered both of those and argued against the
creation of an embryo for research purposes by either means.
STATEMENT OF HON. STROM THURMOND, U.S. SENATOR FROM
SOUTH CAROLINA
Senator Specter. We have been joined, as you see, by our
distinguished President Pro Tempore of the U.S. Senate, the
senior Senator from South Carolina, in the Senate since 1953 or
1954?
Senator Thurmond. 1954.
Senator Specter. Candidate for the presidency, chairman of
the Judiciary Committee, chairman of the Armed Services
Committee, my good friend. Senator Thurmond, we very much
appreciate your appearing here. Senator Thurmond had testified
some time ago on a number of issues relating to diabetes. I saw
Strom earlier today at the Judiciary Committee meeting. We
welcome you here. We will interrupt our questioning of Dr.
Childress and Dr. Young to turn to you.
Senator Thurmond. Thank you very much.
Mr. Chairman and members of the committee, it is a pleasure
to be here today supporting Federal funding for stem cell
research. I am hopeful that we are on the verge of discovering
a whole new way of treating and curing diseases which for too
long have led to pain and suffering in the lives of too many
Americans.
Late last year, privately funded scientists made major
breakthroughs in stem cell research. As you may know, stem
cells are the body's basic cells from which all of a person's
tissues and organs develop.
While a number of scientific challenges must be overcome
before specific medical benefits might be realized, there is
great potential in this research. Scientists believe that stem
cells could be used to produce a supply of healthy cells and
tissues that can be used for transplantation. By replacing
existing damaged cells, new treatments and even cures for
numerous diseases might be developed.
There is great optimism that lifesaving therapies might be
produced. Cells and tissue capable for transplantation could
include insulin producing cells to cure diabetes, heart cells
to rebuild damaged hearts, or new brain cells for victims of
Parkinson's disease or other neurological disorders.
As a father of a daughter with juvenile diabetes, I know
firsthand the devastating nature of this disease. In addition,
during my service in the Senate, I have heard the personal
pleas of thousands of constituents who are affected by various
diseases and disorders. Therefore, I have been a longtime
supporter of medical research.
I recognize that many modern biotechnology developments are
complex issues and are frequently controversial. A number of
experts in medicine, religion, bioethics, and other disciplines
have reviewed and continue to comment on these issues. I
believe these discussions are beneficial as we seek to advance
medical progress and the well-being of patients without
demeaning the value of human life.
The National Institutes of Health have led the way in
medical research and must be actively involved in stem cell
research. NIH financial support of this basic research will
allow us to move toward clinical applications.
prepared statement
I commend you, Mr. Chairman, for your leadership on this
issue. I note this subcommittee has held a number of hearings
on this topic. These hearings have provided an important forum
for a broad discussion of the scientific, medical, and ethical
matters related to this important breakthrough. I look forward
to working with you and other colleagues to ensure adequate
funding and appropriate Government support is available to our
national medical research community.
Thank you very much.
Senator Specter. Thank you very much, Senator Thurmond, for
coming and testifying.
[The statement follows:]
Prepared Statement of Senator Strom Thurmond
Mr. Chairman and Members of the Committee: It is a pleasure to be
here today supporting Federal funding for stem cell research. I am
hopeful that we are on the verge of discovering a whole new way of
treating and curing diseases which for too long have led to pain and
suffering in the lives of too many Americans.
Late last year, privately-funded scientists made major
breakthroughs in stem-cell research. As you may know, stem-cells are
the body's basic cells from which all of a person's tissues and organs
develop.
While a number of scientific challenges must be overcome before
specific medical benefits might be realized, there is great potential
in this research. Scientists believe that stem cells could be used to
produce a supply of healthy cells and tissues that can be used for
transplantation. By replacing existing damaged cells, new treatments--
and even cures--for numerous diseases might be developed.
There is great optimism that lifesaving therapies might be
produced. Cells and tissue capable for transplantation could include
insulin-producing cells to cure diabetes, heart cells to rebuild
damaged hearts, or new brain cells for victims of Parkinson's disease
or other neurological disorders.
As a father of a daughter with juvenile diabetes, I know first-hand
the devastating nature of this disease. In addition, during my service
in the Senate, I have heard the personal pleas of thousands of
constituents who are affected by various diseases and disorders.
Therefore, I have been a long-time supporter of medical research.
I recognize that many modern biotechnology developments are complex
issues and are frequently controversial. A number of experts in
medicine, religion, bioethics, and other disciplines have reviewed and
continue to comment on these issues. I believe these discussions are
beneficial as we seek to advance medical progress and the well-being of
patients without demeaning the value of human life.
The National Institutes of Health have led the way in medical
research, and must be actively involved in stem cell research. NIH
financial support of this basic research will allow us to move toward
clinical applications.
I commend you, Mr. Chairman, for your leadership on this issue. I
note this Subcommittee has held a number of hearings on this topic.
These hearings have provided an important forum for a broad discussion
of the scientific, medical, and ethical matters related to this
important breakthrough. I look forward to working with you and other
colleagues to ensure adequate funding and appropriate Government
support is available to our national medical research community.
would use of fetal tissue encourage abortions?
Senator Specter. I had commented earlier when Congressman
Dickey was here and the subject of fetal tissue had come up
that when you had supported the use of fetal tissue, that it
was very influential with many of our colleagues in the Senate.
The disagreement had arisen whether use of fetal tissue would
encourage abortions or whether it would not encourage
abortions, with use of fetal tissue for abortions already
completed. Congressman Dickey commented that while he had not
seen statistics on the subject, he did not think that fetal
tissue had increased the number of abortions although, as I
say, he commented that he had not seen statistics.
But I think, given your stature and your general approach
to issues in the Senate, that your testimony will be very
influential with our colleagues, as was your testimony and your
vote some time ago on fetal tissue. So, thank you very much for
coming, Senator Thurmond.
Senator Thurmond. Thank you, Mr. Chairman, for the fine
work you are doing.
Senator Specter. Dr. Childress, you were in the middle of
responding to the question about the commission concluding that
the derivation or use of human stem cells from embryos should
not be financed where they are made solely for research
purposes.
Dr. Childress. Yes. I commented that we intended this to
cover, in two separate recommendations, the creation of
research embryos either by IVF, created specifically by IVF for
research, or from somatic cell nuclear transfer cloning.
Senator Specter. When you say created specifically for----
Dr. Childress. Instead of using----
Senator Specter. Created specifically for?
Dr. Childress. For research.
Senator Specter. Embryos can be created scientifically by
cloning?
Dr. Childress. If somatic cell nuclear transfer cloning
could be used to create embryos in this way----
Senator Specter. If it could be.
Dr. Childress. I cannot speak to the scientific part of
that at this point as to how soon this would be possible, but
the intention NBAC had was to cover the creation of research
embryos, embryos created solely for research purposes by either
in vitro fertilization or somatic cell nuclear transfer
cloning.
Senator Specter. Your commission further found that Federal
agencies should not fund research involving the derivation or
use of human stem cells from embryos made by the transfer of
DNA from a regular body cell into a human egg. Is that correct?
Dr. Childress. Yes.
Senator Specter. What does all that mean?
Dr. Childress. Which recommendation are you referring to
specifically? OK. That is a restatement of the somatic cell
nuclear transfer point.
Senator Specter. The same thing?
Dr. Childress. Yes, same. OK. Sorry. I thought there might
have been something there that I did not catch from the
previous one.
Senator Specter. OK.
Dr. Young, you have had a fascinating career in Government,
as I had noted, Commissioner of the Food and Drug
Administration, in the Bush administration, HHS. You are both
an M.D. and a Ph.D., and you now serve as Pastor of Adult
Ministries at the Fourth Presbyterian Church in Bethesda,
Maryland. If you do not mind my inquiring, that is quite an
interesting career change. Why did you move in that direction?
You do not have to answer that question or any other question,
if you do not want to.
Dr. Young. I would be happy to. I have felt over my life
that the struggles that I was trying to deal with was to see
the interrelationship between science and medicine and a belief
in God. To me that was a dominant question. As I looked into
this, one of the best answers that was given to this was when a
group of individuals went to Jesus--it is described in
Matthew--and asked him whether it is lawful to give taxes, to
pay taxes. The question was then answered by asking for a coin
and he said, render unto Caesar what is Caesar's and what is
God's God. Through my life I tried to figure out what I should
do and how I should live it.
In fact, those teachings were very helpful as I was
Commissioner of the Food and Drug Administration and tried to
represent all of the Nation in the development of a response to
the HIV crisis.
Senator Specter. So, now you have turned, essentially, to
the ministry.
Dr. Young. Now I have found that as I look into the 21st
century, the very struggle is what is the meaning of life. I
have seen this play out in the question of violence, the
question of treating people as parts and objects rather than as
real individuals. Now the search for God and the meaning of
life is most important.
Senator Specter. Well, you said that you were asked that
question this morning at 6:45 when a woman was on her way to
the operating room?
Dr. Young. Yes.
Senator Specter. Well, that was a private conversation, but
would you care to tell us what the answer was or, if not that
answer, your answer?
Dr. Young. No. The answer was actually from a psalm, and
the psalm that I read to her was Psalm 146.
Senator Specter. Justice William O. Douglas always reached
into his pocket and pulled out the Constitution, but you
reached into your pocket, may the record show, and pulled out a
psalm, or a Book of Psalms.
Dr. Young. There were two. The one was: ``Praise the Lord,
O my soul. While I live I will praise the Lord: I will sing
praises to my God while I have being.''
The other one that I read to her was Psalm 27. ``The Lord
is my light, my life, and my salvation. Of whom then shall I
fear?'' The psalm goes on to say there is one thing that I ask
that ``I may dwell in the House of the Lord forever.''
I think that people have both, as we look at this box
called life, the need through science and medicine to
understand life as we can see and measure it. Religion is
different. Religion is a private, personal relationship with
God. Now my responsibility is to help people understand ways to
reach God and to be reached by God because it is that calling.
I would finally say that the most sacred time in an
individual's life and in a minister's life is to help a person
at the hour of death because that is the time when all of life
comes into focus.
Therefore, I used to ask the medical students when I would
interview them at Rochester, after first asking them what do
they dislike, in the middle of the interview, I would say,
would you please tell me what is so important for you that you
would be willing to die for it? I asked that question to try to
find out what was the inside conviction of a person, not for a
selection or nonselection, but I submit that for each of us to
live, for you serve, for me to serve in whatever the careers
are, we must know what the very essence of life is.
I have found this to be the greatest challenge and greatest
change in my life. I must admit I was very scared, more scared
than an internship, to study for my ordination exams. They were
very difficult.
Senator Specter. Dr. Childress, I note you too have a
combination of approaches, a professor of medical education and
professor of religious studies. What was your Ph.D. from Yale
in, Dr. Childress?
Dr. Childress. It was in religious ethics, specifically
Christian ethics.
Senator Specter. What is your qualification or background
for being a professor of medical education?
Dr. Childress. The work I do in biomedical ethics, looking
at the relation between philosophical and religious
perspectives on the one hand and what happens in the biological
sciences, medicine, and health care on the other.
Senator Specter. But it is an ethical basis as opposed to
telling you how to carve up cadavers, et cetera.
Dr. Childress. Yes, indeed.
Senator Specter. Well, thank you very much, gentlemen.
Thank you very much.
At this point in the record we will insert Senator
Feinstein's prepared statement.
[The statement follows:]
Prepared Statement of Senator Dianne Feinstein
I want to thank Senators Specter and Harkin for scheduling today's
hearing on stem cell research.
I believe Congressional attention like this is critical to
supporting the research community's efforts to innovate and find new
cures and treatments for many of the diseases and disabilities that
plague humankind.
One of my constituents, Lawrence S. B. Goldstein at the University
of California San Diego School of Medicine wrote on May 25, 1999:
``Why should we use federal funds for human pluripotent stem cell
research? Ask Walter Payton and 12,000 other Americans who are waiting
for liver transplants. If they are fortunate, new livers will be found
and they may live; if not, they will die.''
This week saw that sad prediction come true. We lost Walter Payton.
As NIH Director Dr. Harold Varmus testified before this
subcommittee on December 2, 1998, by better understanding cell
development, ``research on stem cells could help us understand the
complex events that occur during human development.'' He also explained
quite eloquently how many diseases and disorders are the result of
disruption of cellular function or destruction of tissues of the body
and that some day in the future, stem cells could be a renewable source
of replacement cells to treat a broad range of diseases. He said, for
example that the transplant of healthy heart muscle cells could provide
new hope for heart attack victims.
Similarly, the Biotechnology Industry Association has written that
stem cell therapies could provide blood cells to treat anemia; skin
cells for burn victims; nerve cells for treating Alzheimer's Disease;
spinal cord cells for spinal cord trauma and paralysis; pancreas cells
to treat diabetes; bone cells for treating osteoporosis. The National
Coalition for Cancer Research has hailed the promise of this work. As
my constituent, Dr. Thomas Okarma of Geron Corporation, Menlo Park,
also testified before this subcommittee, ``The human pluripotent stem
cell has the potential to dramatically impact clinical medicine by
introducing fundamentally new therapeutic technologies.''
One important potential stem cells is that they may not be rejected
by the human body the way donated organs and other tissues often are.
Dr. Goldstein wrote: ``Pluripotent human stem cells, unlike all other
cells in the human body seem to `remember' how to become almost any
type of cell or organ.''
Because stem cell research inevitably raises ethical concerns, I am
pleased that the President asked the National Bioethics Advisory
Commission for guidance and I look forward to their testimony this
morning. We must demand the highest ethical standards, but we also must
continue to advance medical research to find cures and treatments for
the thousands of diseases that may affect us.
I look forward to a thoughtful public discussion on these important
issues and to the witnesses testimony.
Again, I thank you for holding this hearing and I look forward to
hearing the testimony this morning.
conclusion of hearing
Senator Specter. Thank you all very much for being here.
That concludes our hearing. The subcommittee will stand in
recess subject to the call of the Chair.
[Whereupon, at 12:58 p.m., Thurday, November 4, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]