[Senate Hearing 106-413]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 106-413
 
                       STEM CELL RESEARCH, PART 2

=======================================================================

                                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


                                 ______

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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
                                 ------                                

 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

                              ----------                              
                                                                   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

                              ----------                              


                       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.
---------------------------------------------------------------------------
    \1\ Splicing Life: The Social and Ethical Issues of Genetic 
Engineering of Human Beings. November 1982, Library of Congress card 
number 83-600500.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \2\ Stephen J. Gould, Rocks of Ages: Science and Religion in the 
Fullness of Life, Ballintine Publishing Group 1999.
---------------------------------------------------------------------------
    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.]

                                 
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