SECRETARY
TOMMY THOMPSON, HEALTH AND HUMAN SERVICES;
PANEL
III
DOUGLAS MELTON, PH.D., THOMAS DUDLEY CABOT
PROFESSOR IN THE NATURAL SCIENCES, CHAIR, DEPARTMENT OF MOLECULAR AND CELLULAR
BIOLOGY, HARVARD UNIVERSITY;
KAREN HERSEY, SENIOR
COUNSEL FOR INTELLECTUAL PROPERTY, MASSACHUSETTS INSTITUTE OF TECHNOLOGY;
JAMES CHILDRESS, PH.D., EDWIN B. KYLE PROFESSOR OF
RELIGIOUS ETHICS, UNIVERSITY OF VIRGINIA;
FRIAR
KEVIN FITZGERALD, SJ, PH.D., DOCTOR LAULER PROFESSOR FOR CATHOLIC HEALTH CARE
ETHICS, ASSOCIATE PROFESSOR, DEPARTMENT OF ONCOLOGY, GEORGETOWN UNIVERSITY;
JOHN P. CHUTE, M.D., HEAD, HEMATOPOIETIC STEM CELL
STUDIES SECTION, NIDDK/NAVY TRANSPLANTATION AND AUTOIMMUNITY BRANCH, NAVAL
MEDICAL RESEARCH CENTER
BODY: SEN. EDWARD M. KENNEDY (D-MA): Good
morning.
We'll ask if our guests would kindly be seated
so that we can move along with the hearing. We have enormously important
hearings today and some really extraordinary witnesses. We're here to listen and
to learn and we're grateful to all of those who have come to share their
experience and their knowledge with us in this committee here this morning.
It's a privilege to convene this hearing on the important
issue of stem cell research. One of our greatest fears as human beings is that
one day we'll learn that we or a loved one has cancer, Alzheimer's, diabetes,
Parkinson's, heart disease or any of a number of dreaded and deadly illnesses.
But every day thousands of Americans are stunned by that bad news. The phone
rings, the doctor's on the line, and lives are changed forever by the awful
news.
Stem cell research holds the greatest promise of
hope for millions of Americans who face these diseases. Research on these tiny
cells may mean that the next time a doctor gives the bad news of a horrible
disease, the doctor can also say that these diseases are now curable. So there
is probably no more important work before this Congress than to support stem
cell research to provide life and hope to millions of Americans, who would
otherwise face lives of struggle, disability and even death.
President Bush has opened the door to government funding for this
important area of health research. And we look forward to hearing from Secretary
Thompson about his plans and those of the administration in moving forward on
stem cell research. The question before the Congress is whether the door is
opened wide enough, whether the stem cell lines identified by the administration
are adequate and available for the research that is needed now to save lives.
Today our committee will hear from an outstanding group of
leaders in national policy and science and ethics and the law. Their testimony
will be a useful guide to the committee and to Congress as we consider action in
this important area. We must make certain that stem cell research can fulfill
its vast potential to improve the health and relieve the suffering of millions
of Americans. President Bush has recognized the great value of this research
with this recent decision, allowing the federal funds for the work.
But many in the scientific community are concerned that
the president's decision established restrictive condition on this critical
research, and will delay development of cures for dread diseases for many years,
at the cost of countless lives and immeasurable suffering. Failure to seize this
unprecedented medical opportunity would be a tragic betrayal of the hopes and
dreams of millions of patients who expect us to do all we can to develop these
new cures. The president said that his policy which limits federally funded
research to cells in existence before August 9, will make more than 60 cell
lines available to researchers, and that these cells will be adequate to conduct
all needed research. But this conclusion is hardly clear; scientists question
whether many of these stem cell lines will actually be usable and available.
The president's limitation gives monopoly power to only 10
organizations, that will now control the supply of stem cells. Most of the
existing stem cell lines would not need federal guidelines for safety if they
were to be used in actual clinical work with human patients. These lines may
deteriorate, become unusable in just a few years. New and more effective
techniques at deriving stem cells may be developed but could not be used in
federally funded research, under the president's guidelines.
The questions about the president's policy are serious questions, and
they deserve serious answers because of the life and health of millions of
patients and their families are at stake. It would be unacceptable to offer
these patients and families the promise of effective stem cell research but deny
them the reality of it.
Our committee today begins its
oversight of stem cell research as it evaluates the need for legislation which
will ensure vigorous, ethical stem cell research. I hope our hearing will
contribute to the understanding of these important scientific and ethical
issues, and I look forward to the testimony of our witnesses and the comments of
our colleagues. Senator Gregg.
SEN. JUDD GREGG (R-NH):
Thank you, Senator Kennedy, and thank you for holding this important hearing
which goes to a subject which has captured the nation's attention, because the
potential for it is so immense. The potential is to address diseases which have
plagued many citizens of our nation and the world for generations and which now
have a potential source of relief.
Clearly, stem cell
research creates the opportunity to provide treatments for thousands of
Americans suffering from a variety of diseases including cancer, diabetes,
Alzheimer's, Parkinson's, leukemia, spinal cord injuries, and various other
areas of care.
The therapeutic advances that have
already been made by nearly 50 years of research on adult stem cells is very
encouraging and deserves our continued enthusiastic support also. These
therapies, unlike the unproven and untested potential application of embryonic
stem cell therapies, which are at a minimum five and potentially 10 years away
from clinical application, are actually being used today, and are being used
very successfully, and we should not forget that. We will hear today from Dr.
Chute, who will talk about some of the applications of adult stem cell research
and the therapies which are derived from adult stem cells.
So as we embark on the road of addressing the issue of embryonic stem
cell use, we certainly should not ignore the use of adult stem cells and should
make that a priority and focus of this committee also. Clearly, embryonic stem
cells and the policies which the president outlined, however, have become the
issue which we are addressing as a priority in this hearing. I certainly
congratulate the president for bringing forward this issue in the manner in
which he has. He has presented a thoughtful and I think comprehensive approach
to how we should proceed.
The questions before this
committee which we are to address are, one, how does this policy of the
president which has been enumerated -- how is it going to work and how is it
going to be applied?
And, secondly, we need to examine
how we as a federal government should continue to support or should support the
further research in the area of stem cells.
Senator
Kennedy has noted that the president has identified 64 lines of potential stem
cells which have been derived from embryonic cells. The issue of course, is
whether or not that is an adequate number and whether or not that number
correctly addresses the issues that are involved, the questions of principles of
life. This is not an easy issue for us to address as a political body, but it is
clearly one which we must address.
I believe the
president has made a comprehensive and aggressive attempt to try to bring this
issue forward, in a way which will allow science to pursue the opportunities
that are there. It is my belief that we should not act precipitously to expand
or to set out on another course; but rather see and determine what the effects
of the initial proposals of the president are. We do not really yet know whether
or not the 64 lines which have been identified are going to be adequate and
whether the science which will be developed from those lines will effectively
address the needs of people who are suffering from diseases which may be
relieved as a result of the use of those stem cells. We don't even know whether
or not those stem cells are going to be available for application to humans,
because of the manner in which they have been derived and been maintained.
These subsequent questions have to be addressed as a
threshold issue, I believe, before we start second guessing the issue whether or
not the 64 lines is the appropriate number. So there is a lot for us to talk
about, a lot for us to look at. I believe this hearing is really an entry level
discussion of the topic, but hopefully the results of this hearing will be that
we will set ourselves on a path of reaching conclusions which will move forward
the great opportunities that lie with this new area of stem cell therapy. Thank
you, Mr. Chairman.
SEN. KENNEDY: Thank you very much.
Senator Dodd.
SEN. CHRISTOPHER DODD (D-CT): Mr.
Chairman, I'm going to ask for unanimous consent that an opening statement be
included in the record and I want to yield to my colleague from Iowa who is an
author of one of the major bills, along with Senator Specter, and so we can get
to the witnesses if we can, if that's all right.
SEN.
KENNEDY: Fine. I thank Senator Dodd. Senator Harkin, I welcome your comments.
SEN. TOM HARKIN (D-IA): Thank you, Mr. Chairman, and thank
you, Senator Dodd, for giving me this time. I won't take long. I just ask that
my statement be made available for the record too, Mr. Chairman, and
congratulate --
SEN. KENNEDY: We know that you and
Senator Specter have conducted extensive hearings in your committee and so we're
looking forward to your comments and working with you.
SEN. HARKIN: Thank you, Mr. Chairman. I applaud you for having this
hearing. It's very timely. It's something, as have both you and Senator Gregg
have said, has captured the public's attention and imagination all over this
country. I think we have to pay very strong attention as to whether or not we
are having the door, as you said, open far enough to really move aggressively in
this research area.
Certainly, we are all concerned
about the ethical implications of this new science. But we have wrestled with
this over the last few years, we had an ethics committee at the NIH that came up
with, I thought, very strong ethical guidelines that are now in existence at
this point in time. But if there are others who have other views on this,
certainly we welcome that also. But I become more and more convinced that we
have to move forward on this basic research.
Every week
new findings come out, and just yesterday the potential of using stem cells to
make blood cells at the University of Wisconsin. We have seen that happen and
the potential that that holds alone for our country. And so the concern that I
think we have is whether or not within the strictures of ethical guidelines, we
can conduct good sound science, and we can use the massive resources of what my
colleague and friend, Senator Specter, has often said the crown jewel of our
federal government and that is the NIH. Can we use that power and that structure
of the NIH and all of the money that we provide to the NIH to involve
researchers all over this country to move this science forward as rapidly as
possible; as I said again, within ethical guidelines?
And that's really what -- I think what we are about and those are the
questions we have to answer. And whether or not -- I think that the essential
question is whether or not there are 64 cell lines; whether they are viable, and
whether they can actually lead in the future to therapies. I think these are the
essential questions that we have to wrestle with. Thank you, Mr. Chairman, for
having this hearing and thank you, Senator Dodd, for yielding your time.
SEN. KENNEDY: Thank you very much.
Senator Frist.
SEN. BILL FRIST (R-TN): Thank
you, Mr. Chairman. Mr. Chairman and Senator Gregg, thank you for jumping right
in with this hearing so that we can work closely and more clearly examine the
important issues of embryonic stem cell research.
On
July 18, a little over a month ago, I announced my strong support for federal
funding of both embryonic and adult stem cell research, and as we all know, and
have heard again and again through the press and through the various hearings
that have been held, embryonic stem cell research holds huge promise and great
potential for advancing the treatments for a broad range of diseases, illnesses
and injuries and conditions. Yet I think we need to be very, very careful at
this juncture, early in our discussions, and yes indeed it is early in the
evolution of this relatively new science, not to oversell the promise of this
research to the American people.
We must recognize that
the field of embryonic stem cell research is young. It is early. It is
pioneering. It is not yet tested. The benefits of this research, although we all
attach huge hope to this particular field, have not yet been realized, and they
are just possibilities. I think we also need to recognize that there are
millions of Americans, including myself, who hold very deeply felt moral and
religious concerns about research using stem cells derived from embryos.
The whole topic is important for us to address, and
address in a straightforward way, because we as a government have not yet come
to grips with what is the appropriate ethical and moral construct. How much
oversight? What should the guidelines be as we enter into a field maybe for the
first time? The one exception might be genetics, but for the first time, entered
into a field that will so profoundly affect the course of human life and
disease, by manipulation by human beings, in altering those fundamental, basic
building blocks of life, what make life; what is living, and indeed what makes
us human.
And, we just haven't had to address that in
the past in much of science, or medical science. This is the first time. We have
the possibility of producing powerful treatments. We talk about cures, but
treatments, as we address this in a step-wise fashion. But also there is the
possibility of unintended outcomes; of outcomes that were unanticipated, and
yes, you could even throw harm, or potential harm into those unintended
outcomes. We're just beginning to understand the capacities of this science; the
potential for this science, and therefore it is critical that we as public
servants respond in a way that we give respect to the pioneering research, with
awe, and moral respect, and great care.
The one thing
we've realized over the last several weeks is how little we know about the state
of the art today, and although people can be critical of the way public policy
is being developed we know a lot more today than we did four weeks ago; than we
did eight weeks ago. The press has participated through the hearings that have
been held previously through this hearing today. All of this to me has made
clear the lack of knowledge that we have as we address this issue of stem cells.
Therefore, I think that for the welfare of mankind it is, or there is a moral
imperative that we proceed with embryonic stem cell research, but that we do so
with caution, that we do so with restraint, remembering it's untested, untried
pioneering.
I've argued in the past that we need to
proceed within a fully transparent, carefully regulated framework that gives
respect for the potential of this science, but at the same time respect for that
moral significance of the human embryo. Earlier this year I set out ten
principles which I felt established this larger ethical framework of oversight
and regulation. I'm very excited about the hearing today, the hearings that are
planned among the various committees of the United States Senate and the United
States Congress, as we address the issues. I am 100 per cent in support of what
the president has put forward for the first time.
For
the first time, under President Bush's carefully balanced policy, NIH and
NIH-funded scientists will be able to access embryonic stem cell lines that do
hold the potential that we all understand is there. The issues are difficult
because they involve life; human life. This intersection of science and religion
that we just simply haven't had to address to this degree in the past. The
President of the United States, I believe, has put forward a balanced approach
that will allow stem cell research to begin immediately, right now, quickly, but
to do so in a very careful way. We'll also talk a little bit over the hearing
about the stem cell registry, which I am delighted that the president has put
forward, as well as the Bioethics Advisory Commission, which I think is critical
as we go forward.
Mr. Chairman and Senator Gray, thank
you for calling this hearing as we address these important issues.
SEN. KENNEDY: Thank you very much, and if other members
wanted to have a statement included in the record it will be so included. We'll
hear now from two members of Congress. First from Senator Specter, who with
Senator Harkin have been conducting very extensive hearings with their
Appropriations Committee and the NIH, and has taken a very serious interest in
this issue, and we will look forward to hearing from him. And after that, a good
friend from my neighboring state of Rhode Island, Congressman Langevin, someone
who has thought about this over a very considerable period of time, and is one
of the new, very bright lights in the Congress of the United States, who can
help us all understand this issue better as well, and we look forward to hearing
from him after Senator Specter.
Senator Specter.
SEN. ARLEN SPECTER (R-PA): Thank you very much, Mr.
Chairman, members of this distinguished committee, for an opportunity to present
some of the findings which the Appropriations Sub-committee on Labor, Health,
Human Services and Education has noted during the course of some nine hearings,
which began two weeks after stem cells were first broached on the American scene
in November of 1998. The president made a profound statement on August 9, and
has made an important opening of the door, but there is a real question as to
whether the door is open sufficiently, and there is a real question about the
accuracy of the facts which were presented to the president by the Department of
Health and Human Services.
A key statement by the
president related to 60 stem cell lines, now expanded to 64. But in the
intervening several weeks it has become apparent that many of the lines cited
are not really viable, or robust, or useable. For example, Goteborg (ph)
University in Sweden was reputed to have 19 lines, and they have at most three.
In India the researchers were supposed to have seven lines. None is ready for
research. The San Diego Consortium was reputed to have nine. Again, none is ripe
for utilization. It is up to the congressional hearings to make a detailed
examination, as to the accuracy of the representations by HHS, of robust, viable
and diverse lines.
Then there are the questions
relating to property rights; as to the patents, and our sub-committee has held
detailed hearings, and I ask unanimous consent, Mr. Chairman, that my lengthy
statement be included in the record, which summarizes those hearings. And I am
just giving a capsule in the time allotted to me this morning.
SEN. KENNEDY: It will be so included.
SEN.
SPECTER: Thank you. Then there are the intricate questions of informed consent.
And then, perhaps most fundamentally is the issue of therapy. Now, it was not
addressed in the president's statement, but it has come to light in the
intervening weeks that all of the stem cell lines have had nutrients from mice,
and have had bovine serum, and under the FDA regulations there cannot be a
mixing of the species. Now, it's a complex matter and there have been some
exceptions, but I think it is going to be up to Congress in these hearings to
make the determination as to what the facts are.
I
think it is very important to focus on the need for an independent review of all
of these facts. The information given to the president has not been complete,
and HHS has insisted, for example, that there are 19 lines from Sweden, when Dr.
Lars Hamberger (ph) has said that he personally advised the Secretary to the
contrary. So that these are facts which we must determine for ourselves. I agree
totally with what Senator Gregg has said, that we should not be precipitous. The
issue as to the hope has been documented in a detailed manner by responses to
letters which Senator Harkin and I sent to all of the directors of the 25
national institutes of health, which wrote back on the enormous potential for
stem cell research in so many lines.
And I regret, but
think it's necessary, to inform this committee that, when those letters were
transmitted to the subcommittee, we found they had been censured and that many
of the very, very positive statements which had been made by the directors of
the institutes, illustrative of which is Dr. James Bailey (ph) were omitted from
letters we got, it would be unfortunate if the ban on the NIH support for human
stem cell research results in a missed opportunity to restore hope and quality.
And some of the statements were made by Dr. Klausner (ph) to cancer and many of
the institute directors.
When the issue of research was
omitted, that is something which I believe has to proceed apace at the present
time. There is some conversation that let's do the basic research, if the lines
are sufficient. The hearings in our subcommittee suggested that you need 200
lines. And bear in mind that the Congress has been enormously generous with NIH.
That appropriations process started again with our subcommittee and so far we
have added more than $8 billion and by the end of this year, on our anticipated
doubling, we will have added $12 billion to NIH funding. So there is ample
funding to proceed. And let there be no mistake, we believe that there ought to
be funding on adult stem cell lines, on cords, on placenta, on every line so
that science should have the full range of opportunity.
Before the president's announcement, there was considerable sentiment
in the Congress and a considerable head of steam that the existing prohibition
on use of NIH funds on stem cells had to be changed. Some 64 senators signed a
variety of letters, saying they favored stem cell research and more than a dozen
others made commitments to stem cell research but didn't want to put it in
writing. And it is up to the Congress to take a look at these hard facts, and I
suggest, with a sense of urgency.
Karl Rove (ph) has
been quoted as saying: "The president equates the enormity, gravity and
magnitude of this decision to an issue of war and peace and whether to commit
American troops". That's a pretty strong statement, obviously. My own statement
has been that I believe that this issue of stem cell research with its potential
to touch virtually every family in America, all of whom are afflicted either
with Parkinson's or Alzheimer's or heart disease or cancer, that there is no
more important issue facing Congress except the issue of weapons of mass
destruction.
I have a friend and constituent in
Pittsburgh named Jim Cording (ph) who suffers from Parkinson's. Whenever I see
Jim Cording, he carries an hourglass with him to remind me that the sands of
time are passing, and that the days of his life are slipping away. And that's a
pretty emphatic message from the hourglass. So that it seems to me that this is
the kind of the sense of urgency which ought to motivate this very distinguished
committee and what we will be doing on two hearings later this month in our
appropriations subcommittee. Thank you, Mr. Chairman.
SEN. KENNEDY: Thank you very much, Senator Specter.
Congressman, I'm glad to hear from you.
REP.
JAMES LANGEVIN (D-RI): Thank you, Mr. Chairman and members of the committee. I'd
like to thank you, Chairman Kennedy and Senator Gregg, and of course my senior
senator from Rhode Island, Senator Reed, and the entire health committee for
convening today's hearing on stem cell research. I am honored to be joining
Senator Specter and Secretary Thompson, who I know will be testifying later, as
well as several eminent cellular biologists shedding light on the ramifications
of President Bush's August 9 decision.
Ladies and
gentlemen, the issue that we face today is not whether to move forward with
embryonic stem cell research but how. How do we ensure that all unnecessary
barriers to the research in development of lifesaving cures are removed? How do
we establish parameters that provide ethical oversight of this most delicate
issue? And how do we help as many as possible, as expediently as possible?
Well, fortunately today these questions are being answered
in the context of a policy that impedes the potential of this nation's leading
scientists. As many of you know, on November 7 last year, I became the first
quadriplegic elected to the United States Congress. While my physical condition
does not define me, it does affect me on a daily basis, providing me with a
unique perspective on stem cell research.
At the age of
16, I spent my summer vacation participating in the Warwick Police Cadet
Explorer Program. I'd dreamed of becoming a police officer or an FBI agent for
most of my young life. But on August 22, 1980, my dream was shattered. I stood
in a locker room with a fellow cadet, watching two members of the SWAT team
examining a new weapon which they thought was unloaded. That weapon accidentally
discharged, launching a bullet which ricocheted off a locker and entering my
neck, severing my spinal cord and leaving me paralyzed for life, perhaps, until
now.
Well, embryonic stem cell research could give me
the chance to walk again. Please understand that I am here today not just for
myself, or with others with spinal cord injuries, but also to help alleviate the
pain and suffering of millions of people whose lives could be saved, lengthened,
and dramatically improved by this research. Nearly half of all Americans could
benefit from embryonic stem cell research, including the one million children
with juvenile diabetes, the 8.2 million people with cancer, the 60 million
people who are struggling with heart disease, the four million Alzheimer's
sufferers, the 10 million people fighting osteoporosis, 43 million arthritis
sufferers, the quarter of a million people with spinal cord injuries, and 30,000
people suffering from Lou Gehrig's disease.
Every
family in America, ladies and gentlemen, has been touched by these diseases and
conditions, and now, we have the opportunity to offer them real hope. That's why
I support using stem cells derived from excess frozen embryos, that would
otherwise be discarded, and which will allow us to save, extend and improve
lives. Every year, thousands of couples experience the joy of childbirth through
in-vitro fertilization, a process which unfortunately creates more embryos than
can be used. To relegate these potentially lifesaving cells to the trash heap,
after the arbitrary deadline of August 9, is simply wrong.
While I applaud the door President Bush has opened with the new
embryonic stem cell policy, I am frustrated with the discovery of just how
little room it leaves for medical advancement. Despite NIH's recent disclosure
of the recent 64 cell lines that existed before August 9, we are learning now
that they are not all robust as one's kind. And some of these cells are still in
development and cannot yet be classified as lines.
Questions about the safety of using the cells in human trials are also
surfacing, because many researchers have mixed human cell lines with mouse
cells, which poses the risk of infecting people with the animal viruses.
Finally, we must recognize that, irrespective of the president's guidelines, the
existing embryonic stem cell lines, the private sector in the United States, as
well as the public and private sectors abroad will continue to conduct research
on stem cells that fall outside the parameters established by the Bush
administration.
I would like to conclude with this:
What will we do when embryonic stem cell derived from in vitro fertilization
process after August 9th, leads to a cure for heart disease, the number one
cause of death in this country. Will we deny 60 million Americans this life
saving cure? And worse, what if such a cure is found through the morally
offensive procedure of creating embryos purely for harvesting stem cells? We
must fund research on other cell lines besides the 64 cell lines identified by
NIH and we must provide strong oversight of this research to ensure that it is
conducted by ethical means that do not force us to wrestle with several immoral
quandaries in the future.
The administration's policy
impedes unprecedented life saving research and raises critical ethical dilemmas
that we must not ignore. Because embryonic stem cell research cannot deliver on
its promise of therapeutic benefit to millions of people under this policy, I am
forced and compelled to oppose it. I understand the struggle very well to
balance a pro-life position with embryonic stem cell research. This is, perhaps,
one of the most difficult decisions that I have had to make. Having come so
close to losing my own life, I am reminded every day of how precious the gift of
life truly is and that's why I am pro-life. However, nothing is more life
affirming than using what otherwise would be disposed of to save, extend and
improve quality of life. I urge my colleagues to open the door to research on
all excess embryonic stem cells derived in the in vitro fertilization process
and to do so with government oversight that ensures ethical research
procedures.
Mr. Chairman, I believe that as a
determined nation, we have an obligation to get behind this research and to see
it move forward and offer the hope of easing so much pain and suffering to so
many million Americans.
Thank you, Mr. Chairman.
SEN. KENNEDY: Thank you, congressman, for a very moving
presentation and statement and one that obviously includes a great deal of
thought and examination on this issue from a personal perspective and I thank
Senator Specter, who's given important leadership on this issue. I think unless
there is some differing opinion, I would excuse our two guests. Their excellent
comments and statements and ask that any questions to them be submitted in
writing.
MR. : Can I simply say how proud we are of our
congressmen --
SEN. KENNEDY: You certainly can.
MR. : And how distinguished and effective he is with his
principal discussion of these issues. He is an extraordinary public leader in
our state in terms of his management as the secretary of state before he came
here. We're all very proud of Jim and a wonderful statement. Thanks, Jim.
SEN. KENNEDY: Thank you, thank you very, very much.
It's a pleasure to welcome the secretary, Tommy Thompson
to speak to our committee on the stem cell research. His sense of timing is
impeccable. The secretary has a long-standing interest in this important issue
since much of the groundbreaking research in this area was done at the
University of Wisconsin. Look forward to hearing from him how the Department of
Health Human Services plan to implement the president's proposal for funding
stem cell research. I can tell, just personally, the good secretary spends a
great deal of time thinking about this issue.
I know he
has talked to most of the members of our committee and I know, as well, that he
has spent a good deal of time during the president's consideration and attending
so many of the briefings and expressing his views on this matter so we know
you've given a great deal of thought to this, Mr. Secretary, as you do to other
issues. We welcome you to our committee and we look forward to your testimony.
Thank you very much for joining with us here today.
SEC. TOMMY THOMPSON: Good morning, Mr. Chairman and Senator Kennedy and
Senator Gregg and all the other members. Let me start out by first thanking you
for holding the hearing. I thank you all for being so interested in the subject
that is very, very important to the American citizens and to the world, and I
certainly appreciate this opportunity to appear before this committee to talk
about a subject that I am very personally deeply involved in and have been ever
since Jamie Thompson discovered the embryonic stem cell procedure at university
in Madison three years ago in 1998.
I am accompanied by
Lana Skirboll (ph), director of the office of science policy at the NIH; Mark
Robar (ph) deputy director of the office of technology transfer; Maria Freire
(ph), the director of the office of technology transfer. This happens to be her
last day as a federal employee and is here to support this procedure. And also
Cathy Zoon, director of the center for biologics evaluation and research at the
FDA.
Let me just begin by thanking all of you for your
tremendous support for the Department of Health and Human Services, and more
specifically NIH, and I want to thank you, Chairman Kennedy, and Senator Gregg
for your support of research and all of you that they have worked so hard to
assist us in getting the dollars necessary to do the medical research at NIH;
your support for the great potential of stem cell research, both adult and
embryonic.
I submitted my written testimony for the
record, Senator, but there are some additional points that I would like to make
and take this opportunity to make them this morning.
All of us stand today at the precipice of a new era, where science
holds the promise of sharing the most devastating diseases. And most
importantly, President Bush is ushering America into this new era by opening the
door to the federal funding of human embryonic stem cell research in an ethical
and sound manner. The president came to a thoughtful, deliberate decision that
our administration will support policies that preserve and promote the sanctity
of life by allowing important medical research to proceed. There is nothing easy
about human embryonic stem cell research. It is a complex issue with great
ethical and moral implications. It is an issue that not only to our greatest
hopes and passions as a society, but also to who we are as a society. The moral
considerations cannot and must not be lost in this debate.
President Bush sent us on a wise and deliberate course with his
decision to allow federal funding of research on existing embryonic stem cell
lines. His decision balanced our nation's deepest respect for life with our
highest hopes for alleviating human suffering. These existing stem cell lines no
longer hold the potential for life but they do hold the potential to save life,
and it is that potential to save life that we must tap and bring to fruition Mr.
Chairman and members. Our challenge now is to move beyond the halls of debate
and into the laboratories of science where we can do the basic research that
will one day lead us to the therapies and the treatments for the most horrible
maladies that plague humanity.
This is an emotional
debate. It is a debate that spawns a great deal of speculation and feeds many
misunderstandings. My hope is that we can clear up the misunderstandings and
recognize that the only way that we are going to resolve the speculation is to
do the research and to find the answers. The first thing we must all understand
is the underlying need to conduct the basic research in the embryonic stem
cells. I cannot stress this point enough. We need to create a fundamental base
of knowledge about how these cells function and how they can be manipulated as
well as get the questions and answers to many other scientific questions.
Some people want to make the grand leap from the onset to
federally funded research to the cures for Parkinson's, Alzheimer's and other
diseases. If only it was that easy. It is easy to make such a leap in the
emotion of this debate, but it is also inaccurate and unfair to do so. The cures
for these diseases are not just around the corner, I wish they were. Before we
can even get to the stage of credibly talking about therapies for diseases, we
must complete the basic research. This will take years, possibly three, five,
and maybe even eight. No one knows for sure.
The
Senator first probably knows more than any of us about the time it took for
transplants and heart surgeries and how long it took to perfect that. But we now
have the ability to do the basic research with the stimulus of the federal
dollars. The role of Federal Government should be, and will be, to make sure
that that basic research takes place. With the support of Congress, this is
where our investments will be going. And as we're investing in the basic
research of embryonic stem cells, we will continue to fund research into the
other types of stem cells, including adult, core blood and placentas. There is
great value in all the research and we have so much to learn yet about how much
each can contribute to treating these diseases.
The
private sector is going to continue to pursue stem cell research as well. And
the logic of the American free enterprise system suggests that President Bush's
decision is going to provide the incentive for the private sector to get more
involved. And once the basic research is completed, the private sector likely
will have great incentive to step in and transform the basic research into
therapies for disease. It is in that context, of basic research, that we must
then address the underlying question of whether or not we have enough embryonic
stem cell lines to meet the eligibility criteria. We believe that the answer is
yes.
Let me explain by first addressing how we arrived
at this number and then why we believe the number is sufficient. So far, the
National Institute of Health has identified 64 stem cell derivations that meet
the president's eligibility criteria. The president never spoke about or drew
any limits on these lines based on where they were in their development.
Furthermore, we have consistently said that these lines are at various stages of
development. I have spoken to that fact, the NIH has spoken to that fact and the
NIH white paper identifying these derivations makes that fact crystal clear. But
unfortunately, and I believe unfairly, some are choosing to engage in word games
or hear only parts of the story. What's most unfair is that some are trying to
create conflict between myself, the NIH and the Swedish scientists from the
University of Guttenberg over the number of lines that they have that qualify
for federal funding. They have 19 lines that qualify for federal funding. That's
what we said, that's what they have.
Let me be
perfectly clear, that there is no misunderstanding and there is no conflict
between us, we're on the same page. In fact, I talked to Dr. Hamberger yesterday
at 5:00 in the afternoon. I'd like to point out for the committee, this is the
blastocyst for this five to eight days. Inner cell mass takes three days
depending upon what procedure you use to take from the blastocyst to develop the
cells -- (off mike) -- and the proliferation stage in the petri dish. This is
the characterization and this is what you have to do to characterize if you're
going to have a viable embryonic stem cell line. This is the cell line
established. This period here takes six to eight months. From here, after it is
removed, before it is perfected and before they freezing the cells and are able
to use them in the vials for further research.
The
scientists in Sweden, they have three cell lines at this stage that are
completed. They have four in the characterization process right now and they
have 12 in the proliferation stage. That's 19. All 19 of those lines qualify
under the president's remarks for funding. That means that they have been taken
from the blastocysts and are able, before August 9 at 9:00 p.m. to qualify for
federal funding. That's the 19. And all 64 meet those criteria. All 64 are at
different stages of development.
The Guttenberg
scientists have 19 derivations that meet the eligibility criteria. And we have
always acknowledged that most of these are in the earliest stages of
development. We agree with their scientists, that they only have three fully
developed lines. But they also agree with us that they have 19 in various stages
that meet the eligibility criteria for funding. In fact, they had enquired, the
scientists from Guttenberg, if 50 other blastocysts that they own would qualify
for federal funding as well. But they did not because the embryo had not yet
been destroyed.
I spoke yesterday with Dr. Lars
Hamberger to once again make sure that we had the same understanding.
And there is absolutely no disagreement or
misunderstanding between us. Now, let me explain why we believe the stem cell
derivations that we've identified are adequate and ample for basic research,
even though some are at various stages of development. First off, we will not be
taking applications for funding until after October 1. And to go through the
procedure at NIH will probably take eight to nine months to get the dollars out,
unless there's an amendment to an existing grant which could be sooner. And
during that eight to nine months, a lot of those 12 lines from Guttenberg will
have been fully characterized and fully developed, making those available, but
at different stages.
I begin by putting into
perspective how much work can be done with the use of a small number of lines,
and keep in mind that embryonic stem cells reproduce. And to the best of our
knowledge right now, they do so endlessly. For the past two decades there's been
research done on embryonic stem cells from mice. In 90 per cent -- 20 years of
research on mice. Ninety per cent of that research has taken place with just
five mice lines.
But a more impressive example is the
work being done at the University of Wisconsin in Madison. U.W. scientist, James
Thompson, was the first to isolate human embryonic stem cells and probably, I
believe, has more experience and knowledge working with them then any scientist
in the world. He has done nearly all of his research using just two of his five
stem cell lines. Now, the Wisconsin Alumni Research Foundation, which owns the
five stem cell lines, and licensed them through Y cell, says it has enough to
supply every researcher with a federal grant. That's not my words; that's Y
Cell, that's WARF, and that's what Jamie Thompson has indicated to them.
So that's one owner with just five lines who indicates
that they can feed all the scientists in the world at the present time, wishing
to engage in this research with federal funds. That's a powerful statement. Yet
one that many are choosing to ignore. What cannot be ignored is the remarkable
amount of work already being done on these few lines. As you know, yesterday the
University of Wisconsin, the Medical School reported Monday that its
researchers, under the direction of Jamie Thompson, have turned human embryonic
stem cells into blood cells called hematopoietic blood cells. They did so using
the WARF lines.
This break through is a profound
contribution to the research in understanding of stem cells. And I asked Jamie
last night, "How soon could you put that into therapy?" He said, "If everything
broke (ph), probably be four years; more likely five years or six years." Now,
this is the hematopoietic blood cells means that they have differentiated after
they have been frozen -- differentiated the embryonic stem cells into a blood
cell line, which makes it different than after it's differentiated from an
embryonic stem cell line.
And even while a handful of
lines can supply scores of researchers, the good news is that we have far more
than just the five lines from the University of Wisconsin. We have identified
dozens of already developed lines: 64 lines that meet the president's criteria
for federal funding, but dozens of lines that have already been fully
characterized and ready to be sent out to the researchers. We have identified
dozens of developed lines with the potential for many more to become fully
developed and useful. And as I indicated, it takes six to eight months to fully
perfect and develop an embryonic stem cell line from derivation.
These lines come from five different countries: India, Sweden, United
States, Australia and Singapore. Certainly we wish each of the derivations were
fully developed. But we must appreciate and we must not underestimate the basic
research value of those stem cells in developing stages, for we can benefit from
research into their development. So the 12 stem cell lines from Gotenborg
University at this stage -- at the proliferation stage, or even at the
characterization stage, can offer tremendous research and what stage they are in
and how they may be further developed. So just because they haven't been fully
established as a cell line does not mean that the research cannot go forward on
different aspects of embryonic stem cells.
Certainly,
we wish that each of the derivations were fully developed. But we must
appreciate and we must not underestimate the basic research value of those stem
cells in developing stages. For we can even benefit from research in those
developments. Now, there are some who still wish and will argue we don't have
enough. Well, we disagree for the reasons outlined. The only way that you and I
are going to fully be able to answer that question correctly is to do the
research. Get the scientists in and do the research. We need to move beyond the
back and forth over the numbers and get to actual work in doing the basic
research on this science.
The president has singled out
the embryonic stem cells that are most immediately available for research, and
he's done so in an ethically sound manner. We must seize the moment, Senators,
and take advantage of the opportunities for research that these cells present.
Before I wrap up, let me just quickly touch on a few of the other hurdles we are
clearing at NIH and the department so that this research can go forward.
First, the NIH is in the process of developing a stem cell
registry and making it available so scientists know exactly what lines are
eligible and who and how they can approach those lines for access. We're working
to make the registry available on NIH's website very soon and I would be able to
tell you today that we will be able to have that website up some time within the
next 10 days to two weeks.
Second, the FDA is making it
clear that the use of mouse feeder lines, or layers, in the development of lines
is not an insurmountable impediment to research including clinical trials. And I
have a letter here, Senator Kennedy, and one for you, Senator Gregg, for the
committee to outline FDA's policy on a xeno-transplantation. And I would like to
point out that the FDA has assured me that the issue is not unique to embryonic
stem cells. In fact, at the present time we have 13 INDs dealing with
xeno-transplantation currently. Not embryonic stem cells, but 13 currently under
development new drugs used xeno-transplantation.
They
have several investigations for new drugs beyond that for xeno-transplantation;
products currently in clinical trial. So scientists should not let this issue
deter them from research. I am submitting this letter for the record from the
FDA that outlines their stance on this issue.
And,
third, we're aggressively tackling many of the proprietary issues regarding the
stem cells lines and their availability. We're encouraged that the owners of the
lines want to make them available for basic research and are working very
closely with all of them. And I would like to point out parenthetically that
every one of the entities have been in to see NIH and I have personally talked
to them, and every one of them wants to cooperate and wants to contribute and
wants this basic research to continue and get started.
In fact, I'm very pleased today, Senator Kennedy, to announce that we
have negotiated as of yesterday afternoon a memorandum of understanding that
includes an MTA, material transfer agreement, that will accelerate research on
stem cells within the scientific community. The National Institutes of Health
and WARF, the White Cell Research Institute signed an MOU last might that will
allow for the research use of its five existing stem cell lines that meet the
eligibility criteria. And the NIH scientists will have these lines available to
them and will not be limited in the amount of research they do and will not be
limited to the publications.
This agreement allows
scientists to access these cell lines for their own research; permits scientists
to freely publish the results of that research and allows the NIH to retain its
ownership, its ownership, of any intellectual property that might arise from its
research using those lines. And, furthermore, the MOU provides for a simple
letter of agreement to govern the transfer of cell lines with minimal
administrative burden. This is a ground breaking agreement that we are happy to
be able to report to this committee this morning. That hopefully will serve as
the model for making the other lines available. But it also gives an indication
on how serious the owners of these lines are about making their products
available for basic research. We will continue to work with all stem cell owners
to address proprietary issues.
Carl Gulbrandsen (ph) of
the Wisconsin Alumni Research Foundation is here today and I would like to
publicly thank Carl and take this opportunity to do so. The folks at White Cell
and the dedicated team from the NIH Office of Technology Transfer, headed up by
Maria Freire for the hard work they put into reaching this agreement so quickly.
This agreement gives us even more momentum and incentive to get to work.
In closing, thank you again for giving me the time and the
opportunity to outline some important and fundamental issues regarding the
president's decision to allow embryonic stem cell research to go forward.
Yes, I'm passionate about this. I'm excited and
enthusiastic, as you are, about the president's decision. We all should be.
There's great potential for good from stem cell research, but there's also much
work to be done. So let's come together and move forward. The only place that
we're truly going to find the answers to all of our questions is in the
laboratories of America and the world. President Bush has opened the laboratory
door. Now let's get our best and our brightest scientists into the lab so that
they can do the work. Thank you.
SEN. KENNEDY: Thank
you very much, Mr. Secretary, for your presentation and for obviously the
thought and commitment that you reflected in the presentation, and your
knowledge about this issue. That's going to be a great help to all of us and to
the country in terms of developing policy. We'll try and have seven-minute
rounds on this, because I think it takes at least that amount of time to try and
-- do you have some questions? First of all, and I want to get through very
quickly, you have been talking about in the presentation this morning 64
derivations on the stem cells. The president talks about as a result of the
private research more than 60 genetically diverse stem cells already in
existence. So maybe it's semantics, I don't think it is, but there are -- was a
difference in terms of those two concepts.
But let me
get to my first question: that if the current stock of stem cells prove
inadequate for effective research, or if there are no new breakthroughs in ways
to extract stem cells, or if the existing cell colonies aren't available due to
patent restrictions, would you then consider revising the administration's
policy to ensure that doctors will have access to the stem cells that they need
to develop cures in the future?
SEC. THOMPSON: Senator,
we feel very strongly that the cells are available. We feel that we have already
knocked down the proprietary concerns with the first MOU, and we think there's
many available. There also is another procedure called subclonal that allows for
the subcloning of these existing stem cell lines for further research being
done. So we think there's adequate and we do not believe that we would be
advising the president to change his policy.
SEN.
KENNEDY: Well, as you know, there are many scientists which disagree with you
about the adequacy and the availability of the current stem cell lines,
including some of the scientists who developed the lines in the first place. As
you pointed out, we only discovered human stem cells approximately two and a
half to 3 years ago and no one can know what new advances are just around the
corner. We've seen repeated examples of the progress scientists can make in a
few short years. For example, it took five years after the start of human genome
project just to determine the DNA sequence. Only five years after that they
sequenced the entire genome genetic code. Wouldn't it be a tragic mistake to
freeze this field in its progress to August 9, and we don't know what
improvements are going to come down the pike?
SEC.
THOMPSON: Senator, the only real answer to that is that we have to do the
research. We have to do that basic research. There has not even been the
comparative research done between embryonic, adult, placenta and cord blood stem
cell lines and this research has got to be done. I don't know if you or I or any
scientist will be able to say at this point in time that the breakthroughs are
going to be that quick or whether or not these stem cell lines are going to be
enough. I think that they are; I really believe that, and I think that there's
adequacy to do it, but the only way we're going to get these answers is to get
our researchers and our scientists into the laboratory and start doing that
basic research.
SEN. KENNEDY: I agree with you and I
think we all want them in the laboratory doing as well as they can, but as you
well know, the stem cells receive their nutrients from mice tissue at the
present time.
SEC. THOMPSON: Mice layers, right.
SEN. KENNEDY: That's right. I'll come back to this. There
may be a development of a technology that can remove those once the
determination is going to be made about what those nutrients are. We'd be denied
under the August 9th restriction -- or the researchers would be -- from taking
advantage of breakthroughs in terms of new technologies, in terms of deriving
the stem cells, would we not?
SEC. THOMPSON: Some
scientists are already working on that particular question as we speak, sir.
SEN. KENNEDY: But they'd be precluded from taking
advantage of that new technology under the August 9th restriction, would they
not?
SEC. THOMPSON: We do not believe so. We think that
the --
SEN. KENNEDY: Since all of the current cells now
derive their nutrition from mice cells, all of them now --
SEC. THOMPSON: That is correct.
SEN. KENNEDY:
All of them now, correct?
SEC. THOMPSON: That is
correct.
SEN. KENNEDY: And I'll get to the question
about that issue --
SEC. THOMPSON: I might --
SEN. KENNEDY: Just let me finish.
SEC. THOMPSON: Okay.
SEN. KENNEDY: Now, there
may very well be the ability to derive those products of stem cells without
using the mice, and under the August 9th, that kind of possibility would not be
possible, as I understand it.
SEC. THOMPSON: All I can
do to answer that is that one of the scientists did tell us that they think they
have developed a system using pre-August 9th embryo derivations without mice
lines. I am not at liberty and I don't know for sure -- it was something in
passing that was said in one of the discussions.
SEN.
KENNEDY: Well, it's an example of what might -- now, here in this book is the
CDC guidelines for transplanting animal tissues into human beings. All cells --
and it says in these guidelines, and that was published August 24th, "All cells
that come in contact with human cells designed to be transplanted should come
from animals that are from a colony that is continually monitored for infectious
diseases or from a colony that was not allowed to interbreed with animals
outside of the colony, are routinely tested for infectious diseases or
quarantined for three weeks prior to procurement of the cells." Now, virtually
all of the stem cells approved under the president's plan were grown in the
presence of mouse cells. These mouse cells were almost certainly not procured
from animals treated consistent with the guidelines described above.
SEC. THOMPSON: All I can tell you, Senator, is that these
are the questions that I raised to FDA and they have indicated to me that they
have many current clinical trials and INDs going on using xeno- transplantation,
and they have indicated to me -- they are the experts. They have indicated to me
that they do not see this is as really an impediment. They will be questioning
it, they will be supervising it and doing the investigation, but as this letter
points out that I am submitting for the record, Senator, it indicates that they
do not believe that this is a real impediment.
SEN.
KENNEDY: This is again an area where research takes strong exception with the
nature of the kind of research that's being done on this. Let me come to another
area, and this is really the final area that I'll have a chance given the time.
Under your policy there are 10 organizations allowed to provide the stem cells
to federally funded researchers. People complain about OPEC being a monopoly,
but even they have 11 members. And I know you're working hard to get adequate
agreements and I commend you.
SEC. THOMPSON: Thank
you.
SEN. KENNEDY: Commend you for the agreements that
you've announced here. You ought to be commended on that. The concern will be
what -- how many other agreements will be able to be signed, and that's what
basically we want to do because without signed agreements from the suppliers,
it's hard for me to share the confidence that the problems are going to be
satisfactorily resolved. You've got 10 organizations, you've been able to sign
up one or two as I understand it -- one, whatever it is. You have these
organizations that we are basically have the control on these items.
How can you give us the assurances, given that kind of
restriction, that there's going to be the availability and accessibility for
researchers to do the job that's out there to be done?
SEC. THOMPSON: We have talked to all of the entities, all 10 of them.
All of them have indicated they would like to see the basic research go on. All
of them have cooperated. WiCell (ph) is the one that has the patent in the
United States at the present time. They're the one that has signed the MOU, plus
the material transfer agreement letter as of yesterday. And they have also
indicated, Senator, that they have five cell lines available right now and
they've also indicated that there will be no limitation on the scientists that
want to apply to use those lines and that those lines will then be able to be
used in research and it will not be a limitation to the 10 entities. Any
scientist -- and they have already reached an agreement with the scientists at
NIH to make them available for the NIH scientists as of today.
SEN. KENNEDY: Senator Gregg?
SEN. GREGG: Thank
you, Mr. Secretary. Just as a threshold issue here, I want to clarify the
situation of adult stem cell funding. Is it your intention and can you assure us
that funds won't be diverted from adult stem cell funding research into fetal
activity -- fetal and embryo stem cell?
SEC. THOMPSON:
Absolutely not, and that's what the beauty of the president's policy is, Senator
Gregg, is that the basic research on the comparison of adult stem cells,
embryonic stem cells, placenta flat in core blood has never been done, and the
best thing we can do is do that basic research and get it started in the
laboratories. And, no, there's not going to be any reduction on adult stem
cells. We used $250 million last year on stem cell research and I can assure
there's going to be more available for all forms of stem cells including, and
most importantly, adult stem cells and embryonic stem cells.
SEN. GREGG: I think that's very important. We have doubled, as was
mentioned the funding for NIH as a result of the efforts of Senator Hark and
Senator Specter and a lot of it was really started by Senator Mack when he was
serving in the Senate, and there's certainly a lot of money at NIH these days
and it seems to me, with this exciting new area of therapy, we should be able to
fully fund, especially the adult area which is already producing results. We
actually have physical therapies that benefit from adult stem cells right now
today.
SEC. THOMPSON: We will not limit that at all. In
fact I talked to the NIH scientists as of last night and yesterday, and they've
indicated they have enough money available for all good research projects. And
we're also, because of this hearing, because of the president's decision and all
of the publicity around embryonic stem cells, there's a tremendous amount of
interest from scientists and researchers and investigators around the country
and the world that want to apply.
SEN. GREGG: Let me go
through a couple of elementary questions, because I think there's some initial
policy issues we have to get clear her before we go into the substance of some
of the issues that Senator Kennedy was talking about. As I understand it,
without federal dollars, research on stem cells can proceed carte blanche.
SEC. THOMPSON: That is correct.
SEN. GREGG: So explain to us, if you could, why it's important to have
federal funds involved in this type of research.
SEC.
THOMPSON: Because the private dollars will want to go as quickly as possible
toward therapy, and it's more important to do the basic research at the
beginning. The kind of research that Jamie Thompson (ph) and other scientists
who are the forerunners in this research field are doing. That comparison that I
talked about previously to a previous question you asked, Senator, needs to be
done. And that kind of basic research of comparing adult, embryonic and all the
other stem cell lines will not be done just by the private sector. The federal
dollars allow that. That's point number one.
The second
point is the federal research dollars when they do base research, it encourages
other scientists to get involved in it. And once the basic research is done, the
privates come in and do more of the therapy research. And so it's sort of a
building block and that's why it's so important to get these federal research
dollars out quickly and into the laboratories as soon as possible.
SEN. GREGG: That's an important point to make. Secondly,
what's the role of patents in this exercise? This company Generon (ph) which I'm
not familiar with -- Geron (ph), I guess its name is. Geron has the patents from
the Wisconsin projects to the extent that there's commercialization. What do you
see as the role of patents in this exercise?
SEC.
THOMPSON: Well, first off, Geron does not have a patent, Senator Gregg. WiCell
is a --
SEN. GREGG: License.
SEC. THOMPSON: They have the license. Geron has the license of three of
the five lines and they've already reached an agreement with WiCell to make
those lines available. And that's part of the agreement, that's part of the MOU.
Really WARF and WiCell are directing this and they made the arrangements with
NIH yesterday by signing the MOU and the material transfer agreement letter to
make these available to any scientist in the world that wants to apply through
NIH.
SEN. GREGG: I'm talking more philosophically.
What's the role of patents in this --
SEC. THOMPSON:
Patents will come into play much more importantly when the therapies are
developed and they go into commercial products, hopefully, as soon as
possible.
SEN. GREGG: So in the basic research area,
you don't see that as being much of an issue.
SEC.
THOMPSON: I don't see that as much of a restriction, no.
SEN. GREGG: Can you explain to us --
SEC.
THOMPSON: Based upon the agreement signed yesterday.
SEN. GREGG: Can you explain to us why you picked the date August 9 at 9
p.m.?
SEC. THOMPSON: Because that's the time the
president made a speech. And it was not my decision, it was the president's
decision.
SEN. GREGG: And what's the implications of
that date, in your opinion?
SEC. THOMPSON: The
implication is that there is embryonic stem cell lines available for basic
research, there is money available for that basic research and allows us now to
open the door to the laboratories to get the money out and to get that
comparative and basic research done, which is so important in this whole
embryonic field of stem cells.
SEN. GREGG: The key to
that decision was, I believe, that you believe that the embryonic stem cell
lines that are out there can be used in a manner which, because they replicate
themselves limitlessly, I think was the term you used.
SEC. THOMPSON: Endlessly.
SEN. GREGG:
Endlessly. Because of that, there is no need to go past that date in order to
find at this time adequate stem cells for the research that's going on. Is that
correct?
SEC. THOMPSON: That is correct. They are
pluripotent (ph), which means that they replicate and, as long as they don't
differentiate, those cell lines are able to be used for basic research. And
Jamie Thompson has got five cell lines and he is sort of the creator, the father
of the embryonic stem cell lines and he, personally, uses about two of his stem
cell lines for his research. And as far as embryonic stem cell research has been
done for 20 years on mice, and 90 percent of that research has been done on five
cell lines.
SEN. GREGG: And it's also, as I understand
it, the position of FDA, as presented to us in this letter -- I haven't read it
yet -- but as you are characterizing it, that the fetal transportation issues
are not a problem when you move from basic research to therapy and they are not
going to be a problem for the FDA, as to how this --
SEC. THOMPSON: The FDA will certainly be looking at every facet of the
procedures as they go along. But they also have got currently 13 INDs going on
with different aspects of xeno-transplantation (ph); and they said that that
should not act as the impediment or reluctance to proceed on the research. But
they will continue to supervise, they will continue to make sure that it meets
all of the safety rules and regulations that CDC and FDA has put up.
SEN. GREGG: Let me ask you a -- that's on one line of
questioning. Let me ask you another question here, which I think raises the
issues that get to the issue of when -- well, my time is up, so I am not going
to get into that.
SEN. KENNEDY: How prompt. Senator
Dodd.
SEN. DODD: Thank you very much, Mr. Chairman.
Secretary, welcome.
SEC.
THOMPSON: Thank you, sir.
SEN. DODD: Good to have you
with us today and I appreciate your deep interest in this and your obvious
knowledge of it and that's tremendously helpful and I'm pleased as well that you
have some wonderful folks from NIH with you here. This is a tremendously
important issue, as you've pointed out and others have. Just a couple of
observations. I have asked unanimous consent that the opening statement be
included in the record.
But obviously, we are not going
to resolve this issue specifically with a piece of legislation or even a speech
on August 9. This is going to be an ongoing effort and my hope would be that,
whatever policies are developed, whatever finally comes out of this debate in
the short-term, that a decision be made to revisit this issue periodically,
almost sunset decisions so that we have the ability to come back and review
decisions that have been made to determine whether or not, in fact, since we are
wandering and heading into unchartered areas, to put it mildly.
I hope that it will be part of the consideration that causes me to
comment and ask you to further comment yourself on Senator Kennedy's questions
regarding these mouse feeder cells. I hear you and I know that you are confident
and hopeful that the research will be there to be able to extract these mouse
feeder cells so as not to contaminate these stem cells in any way that would
jeopardize human life.
SEC. THOMPSON: That's
correct.
SEN. DODD: But there is the possibility that
won't happen. Just as you hope it will, we all understand it may not work. So my
question would be to you, to conclude this line of questioning, if in fact that
is not the case, would the administration go back and revisit the August 9
deadline and determine whether or not we can develop some new lines?
SEC. THOMPSON: It's going to take such a long period of
time to go from the laboratory to therapy to human clinical trials, Senator
Dodd, that everybody, including myself, has great anticipation and hope that we
are going to be able to move directly for a cure for Parkinson's or so on and so
forth. But it's going to take five to eight years. Yesterday the hematopoietic
blood cells were developed. It's probably going to take five years --
SEN. DODD: I understand
SEC.
THOMPSON: -- before that and during that period of time, I'm sure, what I say
today and the questions you ask will be sort of arcane and sort of -- probably
be ludicrous by the time we look at it five years from now, Senator.
SEN. DODD: It's always dangerous when Congress -- we all
get worried about mad scientists. Nobody is more frightened than when Congress
is trying to be a scientist, so I appreciate what you're saying. My point is I'm
trying to get at a sort of a mindset from the administration's standpoint as to
whether or not there is the flexibility to come back and revisit issues. I
realize we can't answer these questions and it will take time. But I'm trying to
elicit from you, as the spokesman for the administration, your policy questions.
So if, in fact, we are unable to extract the mouse feeder cells here, thereby
making these lines precarious at best, will the administration reconsider its
August 9 deadline? That's my question really. I understand all the scientific
issues can't be answered today.
SEC. THOMPSON: The
administration will not reconsider its deadline as far as the destruction of
embryos. It will reconsider all the policies and all the procedures and research
going into embryonic stem cells on an ongoing basis, as we find new things.
SEN. DODD: I understand.
SEC.
THOMPSON: But the destruction of embryos for new embryos, no, it will not.
SEN. DODD: Okay. Let me, if I can, I don't know if you
heard Senator Specter, or had a chance to read his statement. But he made some
comments in there regarding the viability of the various lines that exist and
raised questions about the Guttenberg University 19 lines, which you've
addressed to some degree in your conversations as late as yesterday with one of
the scientists there, but there is a statement I read today that says that out
of those 19 -- I'm quoting him here -- from Hamburger. I guess that's the same
fellow you talked to.
SEC. THOMPSON: Dr. Hamburger
(ph), right.
SEN. DODD: He says, and I'm quoting him:
"If we get three good lines out of them, we'll be satisfied"; out of the 19. How
many lines do we need in order to -- what's the minimum viable lines at the end
of this process that we would need in order for there to be a viable level of
research to be conducted?
SEC. THOMPSON: We believe
that the five lines that are currently existing will be able to get us a long
way down the road doing the basic research. But there are many more. We feel
right now there are roughly 25, 24, 25 fully -- cell lines established and there
are 64 in the various phases from the proliferation to the characterization to
the cell lines established and out of those remaining ones, we think there will
be a lot more that will be established, that will be able to use the vials at
the end, where the cells are frozen and be able to send out to researchers
around the world.
SEN. DODD: In fact, you may want --
at some point, I'm just trying to understand what minimums are, and I'd agree
with you, I'm hopeful that's the case as well. But I want to get some sense of
what's the bottom line we're looking at here. If in fact, we're only getting
three, four, five, would that be adequate? In your statement, as you believe it
is.
If at the end of all of this, 64 that are out
there, the potential that are out there, and you go through these steps that you
very clearly outlined here, at the end, in that last step, there are five viable
lines, your answer to my question is: "That's more than adequate".
SEC. THOMPSON: We had 25, 24, 25 adequate right now. So I
am confident that that is enough, but I am also confident there are going to be
many more of the 64 that would be available.
SEN. DODD:
Let me ask you, if I can, in the minute remaining -- I'm sort of again, like
those of us up here trying to learn, to all of us, this is pretty complicated
stuff and Bill Frist and others, that many of us here listened to very
carefully, when he speaks on these issues -- I've been fascinated, from a
personal standpoint, on cord blood research. I've been doing a lot of work in
the last few days and NIH has been very helpful, I've talked to them at length
about the subject matter and the great potential in cord blood research.
Maybe that's the subject for another discussion later
on.
But the position the administration has taken,
that, as of August 9, only those embryos that have already been moved in this
process are the ones to be considered, so that -- I think all of us would tell
you here -- that if there were any issue raised about whether or not someone was
going to create a hatchery, producing embryos specifically for developing stem
cells, I think we would vehemently oppose it, every one of us. I don't know if
anyone would take a different point of view.
The issue,
however though, of embryos being developed as a result of the wonderful advances
in sciences and of in vitro fertilization. There are those existing embryos out
there, many of which will be destroyed. Does the administration take the
position that we ought to pass legislation, or that they're going to offer
legislation that would ban the destruction of these embryos that are sitting
there today, that will be discarded?
SEC. THOMPSON: I
don't think the administration has taken a position on that, Senator Dodd. But I
would like to point out that those embryos, right now, in order to establish a
good line it takes a lot, lot of scientific ability to do that.
SEN. DODD: I understand that.
SEC. THOMPSON:
And I have discussed that with Jamie Thompson, and he says a good line takes --
he says at optimum conditions six months, but it's usually closer to eight
months, so right now we have these 64 in different stages, 24 that are almost
fully developed. It would take another eight months to be able under the best of
circumstances to establish a brand new line, and all I am saying is that we
should get the research dollars out there for these basic lines. And it's going
to take us some time, because the procedure at NIH to put out grant dollars, as
they tell me, will be eight to nine months from now.
So, during this eight to nine months, several of those remaining from
24 to 64 are going to be fully developed, so there will be many more lines
available for research and for development.
SEN. DODD:
I thank you, Mr. Chairman. My time is up. Just a brief quick comment. My concern
is, and others will express their views of your answer to the question of
whether or not you'd revisited all the August 9 deadline, if in fact it turns
out that we were not able to remove the mouse feeder cells. The rigidity of that
concerns me, and also the decision, if we're going to draw ethical lines here.
If we're going to discard cells, there will be no effort to ban the discarding
of those unused embryos. Then we're blurring the lines further it seems to me,
and creating some great conflict; potential conflict here. And so, again, I
appreciate your involvement, and your determination and your passion about the
issue I look forward to and I'm going.
SEN. KENNEDY:
Thank you, Senator Dodd.
Senator Frist.
SEN. FRIST: Thank you, Mr. Chairman. I just very briefly want to
explore, since you've had so many conversations, the relationship between public
and private funding. Right now, of the 64 cell lines, or the cell lines that are
out there, they've all been developed with private funding. Today. As of today,
the research.
SEC. THOMPSON: No, I can't answer that in
the affirmative, because some of the universities in Sweden and some of the
lines in India and Australia I'm sure could have had public --
SEN. FRIST: But in the United States --
SEC.
THOMPSON: But I'm not sure.
SEN. FRIST: In the United
States --
SEC. THOMPSON: In the United States, yes.
SEN. FRIST: We have not been funding --
SEC. THOMPSON: That is correct.
SEN. FRIST: --
the creation of these cell lines.
SEC. THOMPSON: I
don't know if they have or they haven't internationally, Senator Frist. I can't
answer that.
SEN. FRIST: As we look ahead we know that
this science is moving fast.
SEC. THOMPSON: Yes, it
is.
SEN. FRIST: It's hard even to project how long all
these lines are going to become available, what the research is going to be
like, what the breakthroughs are going to be, what the roadblocks are going to
be. There's no way to know. And we can debate it. But we're going to hear the
argument again and again. We ought to have a sort of a freestanding 'let's use
all the cells' and 'we need unlimited cell lines'. I think what we've learned a
lot recently is that you don't need unlimited cell lines. That there is a
limited number, and now, unlike four weeks ago, we're saying is it's 64, or 20.
At Senator Spector and Senator Harkin's hearing we initiated a lot of this about
four or five weeks ago, six weeks ago.
How many do you
need? It's different than transplantation where you take a heart out of one
person, you transplant it another, and it helps them. These cells are
self-perpetuating. So, we've come a long way in the debate. What is interesting,
as I listen, broadly, is that we've got federal funding which is important. It
legitimizes the field. It gives you some control in terms of ethical oversight
prioritization. But at the same time we had the private sector which, if this
promise is real, is going to be heading off full steam.
SEC. THOMPSON: Absolutely.
SEN. FRIST: And, by
having some public funding in fact we're going to accelerate that, because it
legitimizes the field. What I want to make sure, and what I've argued in the
last several months is that we have the ethical oversight. Yes, through the
hearing process here, but that we have the oversight, not just ethical, the
moral, ethical and scientific oversight of what's going on broadly. Because the
drive for science is powerful. It is to create. It is to discover. And that's
good.
On the other hand, as I said earlier in my
opening statement, the potential for unintended consequences is there, and we're
dealing with the creation of life, the manipulation of the basic building blocks
of life, and what I am concerned about, that we haven't talked about, and we
don't have time to go into much detail now, is that larger ethical oversight.
The registry is a step in the right direction because that will give you at
least a handle on state-of-the-art, private and public. The Bioethics Commission
at some point would like to hear more about that in terms of what the plans
actually are in terms of oversight, what the focus will be; composition.
You don't have to go into that right now, but again, I
would think if they're going to look at the public sector as well as the private
sector as we go forward.
And thirdly, I'm interested in
scientific oversight; how we as a nation -- should we legislate it? Do you do it
to HSS? -- provide the appropriate scientific oversight. Right now we are
arguing science. Is 64 too many? Where is it in terms of the 64? Is it 19, is it
five, is it four? It's good, because we're asking the questions, but we need the
ongoing oversight, that three months from now, when we find out that there are
200 cell lines, or there are five, that appropriate decisions can be made, or
appropriate input is received.
And I guess what I would
like to introduce as a question is: what are we doing? Not just the federal
funding for the 60 cell lines, but in terms of getting the larger, ethical,
moral and scientific construct, both to oversee; not regulate but oversee and
monitor the issues, both public as well as the private question.
SEC. THOMPSON: It's a very good question, and let me respond this way,
Senator. That that's the reason the president set up the Bioethics Commission.
To look at those questions and to be able to make the recommendations to the
administration on those particular questions that you've raised.
In regards to the Department of Health and Human Service and NIH, our
responsibilities is to implement the policy. We're doing several things to
implement that policy. We're setting up the registry. We're talking to the
scientists as to whether or not we should have a repository of these cells at
NIH.
Some scientists would like that. Other scientists
are fearful of that. We haven't been able to do that.
The third thing is to negotiate MOUs and material transfer agreements,
which we've already started. So, we are already long ways down the road, dealing
with this implementation question. The ethical questions certainly will be
considered as we go along, through the Department of Health and Human Services,
but the overall review and direction and new policies on these will come out of
this new commission set up by the president, headed by Dr. Cass.
SEN. FRIST: Thank you. Thank you, Mr. Chairman.
SEN. KENNEDY: Senator Harkin.
SEN. HARKIN:
Thank you, Mr. Chairman.
And Senator J. Thompson, I
appreciated the conversation we had on the night the president made his
decision. I have given my support to the president's decision. I think that he
has moved us ahead in this area. I, not being a scientist, but having been
involved with NIH for many, many years --
SEC.
THOMPSON: You have.
SEN. HARKIN: -- I have been
watching very carefully the development of this issue, over the last couple of
weeks. There is a lot out there that we don't know and we don't understand. A
lot of controversy about the cell lines, and how many Sweden has, or India has.
And we don't really have all the answers yet, but I think it's incumbent on us
to continue to delve into this, to see if we can shed more light on this to
expand our knowledge exactly of what we're doing and what we're talking
about.
Again, I'm not saying that I don't doubt for a
minute that the president didn't give a lot of thought and a lot of time,
consideration, because obviously he did. But, a lot of us have been giving
thought and time and consideration to this for years, and we still don't have
all the answers.
SEC. THOMPSON: Right.
SEN. HARKIN: So, I'm not going to take the position that what the
president said on August 9 is the final end-all and be-all of everything.
Because even if he did give some consideration and time and thought to it, he
couldn't have given, I mean, because of new things that are opening up and new
things that are happening we have to be able to adapt to this new science. And
so my position is going to be one of basically continuing to ask questions to
try to find out whether or not under the ethical guidelines that we have
established under the Bioethics Committee, by the way most of which the
president followed. The only difference was the timing, the 9 PM on August the
whatever the date was, August 9. But the other guidelines are all the same.
Informed consent, no monetary consideration, and only using the embryos for
--
SEC. THOMPSON: The excess.
SEN. HARKIN: And not using any therapeutic type of embryo development.
So basically that is all the same except for that time line. It is basically the
same; and we may want to think about that time line too at some other point. But
I guess what my concerns are along the lines of what you said about the
University of Sweden, and I've talked extensively with Senator Specter, my
colleague on this. Yes, there are three developed lines. I did understand that
before I came to the hearing today. But the real open question is whether or not
early on in the process those cells that were extracted will lead to viable cell
lines. We don't know that yet.
SEC. THOMPSON: We don't
know that.
SEN. HARKIN: We just don't know that. You
agree with that; we don't know that yet?
SEC. THOMPSON:
We don't know for sure.
SEN. HARKIN: So we hope they
do, obviously, but if they don't, and if we find out that in other cases in
India and some of these other places that the lines aren't fully developed, then
we might wind up with something quite less than 60 or 64. We might have
something quite a bit less than that. Is that correct?
SEC. THOMPSON: That's possible, Senator Harkin, but if I could answer
it in a little bit more detail. There are dozens that are already in existence
and the time line -- takes six to eight months to develop a good cell line, and
there's four in the characterization stage from Sweden and 12 over here that
have just been durabated (ph). And so the four look very promising, and the 12
-- there's certainly some, I'm sure, that's going to fail and some that's going
to succeed; I can't give you that number. But there are dozens right now that's
available. And even at this stage there is some great research that can be done
on those 12, and in those are questions for the scientists to do, and we haven't
seen that kind of research done yet. The president has allowed for the federal
dollars now to flow towards research in all of these areas, and hopefully, soon
to get to some therapies.
SEN. HARKIN: Well, and that's
the second thing, has to do with the therapies. And we'll be delving into this
more on our committee hearings in the future also. But as you responded to -- I
think it was either Senator Kennedy or Senator Gregg asked about the fact that
the nutrient supply used for this development of these cells were evidently
mouse cells. I did not know that before, but I guess this is true in almost --
in every case. All of them, all of them.
SEC. THOMPSON:
Yes.
SEN. HARKIN: So there is a contamination problem
that I was not aware of before. I will fully admit that I was not aware of this
contamination problem. And if we're looking at just what happened yesterday at
the University of Wisconsin with the fact that they are able to, at least
initially, take some of these embryonic stem cells and move them into
bloodlines. That's pretty astounding.
SEC. THOMPSON:
That's exciting.
SEN. HARKIN: It's astounding. In this
short a period of time we've done this. Mind you, they only derived these cells
three years ago.
SEC. THOMPSON: Three years ago.
SEN. HARKIN: So now we're making red and white and blood
platelets out of it?
SEC. THOMPSON: Platelets,
right.
SEN. HARKIN: That's pretty amazing.
SEC. THOMPSON: Yes.
SEN. HARKIN:
But if there is a contamination problem, then we could go down this line for, as
you say, the next five years or so, but be working with things that, while they
might prove out to be beneficial therapeutically, would not be able to be used
because prior on they were grown of the nutrient out of mouse cells.
It would seem then that we would have to go back and
almost start all over again, and why waste all that time? My big concern is that
I did not know and was not aware that all these cell lines were grown in mouse
cell nutrients as a basis, and that disturbs me, and we need to ask the
scientists more about what that means in terms of the therapies and how soon we
can derive those therapies if in fact they're contaminated.
SEC. THOMPSON: Can I just answer in two ways. First off, when we
started on the 64 lines nobody knew -- you didn't know, I didn't know, nobody
knew how many lines were available. I asked NIH to make a complete inventory of
the lines. Not at what place they were, but whether or not the embryos had been
derived at as of August 9. NIH did it once. They did it the second time after
the president's speech and the third time is coming in and talking to him. We
found that there are 64, but they are in different stages. But there are dozens
that have already been through the cell line established.
That's number one.
At the bottom of the petri
dish is where mouse layers are placed and the cells -- it's sort of a traumatic
experience for these cells, as I understand it. When they are taken away from
the blastocyst and removed and put in the culture, they have to have something
in order for them to grow and be able to replicate. And that's probably the most
difficult portion and according to Dr. Thompson, that was where a lot of
scientists failed. They need to do that. And then FDA has established policy.
They have looked at this procedure and Cathy Zoon is here and she has indicated,
and she is in charge of this, that right now we have 13 INDs Initiatives for New
Drugs that have already been started using xeno-transplantation (ph) and she
does not believe that this alone is going to prevent moving from here to
therapy, and neither does Dr. Jamie Thompson.
SEN.
HARKIN: I appreciate that but I -- we needn't delve into this right away.
SEC. THOMPSON: Yes. And the blood cells, hematopoietic
blood cells. I talked to Dr. Thompson yesterday and he said it's going to take,
you know, probably three, five, six, seven years.
SEN.
HARKIN: But those are still contaminated lines.
SEC.
THOMPSON: I don't classify them as contaminated.
SEN.
HARKIN: Well --
SEC. THOMPSON: They are -- they have
the cell --
SEN. HARKIN: There's a cloud over them.
There's a very dark cloud there.
(Laughter.)
SEC. THOMPSON: I don't want to argue with you because I'm
not a scientist and I can't know.
SEN. HARKIN: Well,
I'm not either. I'm not either, but --
SEC. THOMPSON:
But I don't think they are contaminated because I think that they're going to be
very and useful and useable, and I can't say for sure. All I can tell you is
what I talk to people and they tell me, Senator Harkin.
SEN. HARKIN: We've got to follow up with scientists on this.
SEC. THOMPSON: Yes.
SEN. HARKIN:
I don't know, the scientists have got to tell us that.
SEC. THOMPSON: That's why it's so important to get the scientists in
the laboratory to start answering these questions, Senator.
SEN. KENNEDY: Just as the Senator is winding up, see the -- as I
understand, mad cow resulted from a completely unanticipated transfer of
infectious agent from beef to humans. No one anticipated that, no one knew about
it. And that is why these guidelines that you have issued in the CDC are so
important to make sure that we are not going to have unanticipated and why those
guidelines are so important and those guidelines do not -- these stem cells now
that you've got outlined here in the present, I don't believe that meet those
kinds of requirements. And that I think, in looking through the letter that you
sent here, I don't think that should give us much satisfaction, but we'll have
other chance to come back to it.
SEC. THOMPSON: Can I
just respond, Senator?
SEN. KENNEDY: Yes, please.
SEC. THOMPSON: The truth of the matter is, is that the
embryonic stem cells probably would not survive from the removal from the
blastocyst into the culture dish without the layer, the mouse layers, that the
cells rest upon and get the nutrients from. In order for us to do this research,
we have to have this, and its going to take three to five years, you know, to
find out all these answers. And the truth of the matter is, we've got to get
this research, this basic research done because the questions you ask are good
ones, Senator Kennedy, and I can't answer them. But I do know that the embryonic
stem cells would not grow and replicate without the mouse layers, because they
provide the security and the proteins.
SEN. KENNEDY:
But, Mr. Secretary, they may very well have to use the mice cells, but not these
mice cells. Mice cells that meet the kind of requirement that CDC has outlined
might take six or eight months. But the ones that are now being identified in
these 64 do not meet the requirements of the protections that have been
announced by your own agency on CDC. They just do not do that. I mean, we will
have to -- you know, we'll spend more time on this.
But
the August 9 date arbitrarily says that we're only going to be able to use those
that are already out there when we -- as you have said here, we could develop
these between six and eight months and we could do it with mice that meet the
requirements of CDC. But we're not going to be able to do that because we have
the August 9 deadline. Nor will we be able to even consider research that might
be able to detect the kind of nutrition or nutrients that are so important in
the mouse cells. That what it is: it's nutrients. And many of the researchers
that are. And many of the researchers that I've talked to say we'll be able to
find out what those nutrients are, and we might not even need those mice cells
down the road, but we're going to be prohibited from using those cells in the
future because the August 9.
SEN. KENNEDY: Senator
Warner.
SEN. JOHN WARNER (R-VA): Thank you, Mr.
Chairman, I wish to commend you and our distinguished ranking member for
initiating this hearing. Those of us who have been privileged to attend this
hearing I think will remember it in the years to come because this is the
historic threshold for the Congress. This is the first full committee hearing on
a subject that will place challenges to our republic, unlike any I've seen in
the 23 years I've been privileged to serve in the Senate. We are fortunate to
have you at the helm at this particular time. You bring to your position a vast
experience and diverse subjects in most importantly as governor, caring for
people. And that's what the bottom line is in this.
And
I commend the president, even though I and others, stepped out somewhat ahead of
the president in a letter which I ask unanimous consent that letter be a part of
the record today --
SEN. KENNEDY: So included.
SEN. WARNER: -- where 11 Republican senators took a stance
on this early on. When I look upon this as sort of a not unlike our great
pastime on a football field -- one goal post on those standards of ethics and
morality, religion, which have made this strong nation in the envy of the world
that we are today. And we've got to protect those in the future. The other end
of the field of the goalpost of alleviating human suffering, of the need for
this nation to move ahead on the forefront of science.
My particular area in this Senate is national defense, and our country
is a superpower. Not because we desire to be, because the rest of the world is
ceded to us that responsibility. We're working tonight on a military budget for
the United States which is greater than cumulative adding up all the other
budgets of the world. It's astonishing. But we have taken that responsibility
on. And the question before this president and successive presidents, the
question before this Congress and successive congresses -- are we going to be a
superpower in this exciting science, or are we going to put in a lot of
arbitrary standards?
And if that's the case, what will
happen? Two things. If our federal system -- the president setting down the
leadership, the Congress enacting the laws to support our president and the
courts trying to fairly arbitrate the differences of views. All three of our
entities of government will work together on this, but if we fail to convey to
the American people and the rest of the world that we're fair, and have
objectivity, and realistic approach towards this, then the federal government
will be left in a cloud of dust as the private sector marches off on this.
We'll also no longer be a nation of importers of brain
power and scientists, our own scientists I'm fearful will go abroad to where
they can work on this. And then we lose as a nation, that degree of oversight
and control over our standards of ethics and morality if they all depart.
Then that science will come back into the United States,
either legally or illegally, because you are just not going to stop the
advancement, so this is a whale of a challenge.
Do you
basically agree with that sort of philosophical approach I have, and, if so,
what can we do, to keep the private sector in a fair set of rules to do those
things that perhaps our federal government will not do for the moment and to
keep our scientists from leaving this country and going abroad.
SEC. THOMPSON: I think your comments were very thoughtful and very
passionate and I couldn't disagree with anything you have said, Senator, and
applaud you for saying it. I would like to only clarify that, prior to August
9th, there was no federal research dollars available. As of this president's
speech, there's money available, and we made an inventory and we have found that
64 embryonic stem cell lines exist that meets the president's criteria, that
means for federal funds. There are different degrees of development, some are
the proliferation stage, some are the characterization, some are in the cell
line established, but they're all available for research. The most research on
embryonic stem cells has been going on for 20 years, and 90 percent of that work
has been done in five lines. Dr Jamie Thompson, he discovered the embryonic stem
cells. He's got five lines but he uses really for his research purposes two
lines, and he's got lines available.
And WiCell, who
has the patent, has indicated they have enough cell lines available for any
researcher in America that wants to do the research. I think in all it's a
tremendous opportunity. This whole embryonic stem cell opens up the door --
everybody that has some sort of a malady or has a loved one or dear friend that
is suffering from dementia or cancer or something, is looking for this as the
panacea. We have to be careful to not indicate that a cure is right around the
corner. It's going to take several years, and what needs to be done is we need
now to get the federal research dollars, and the basic research done, Senator,
so that private dollars can come in and develop the therapies once they are
developed.
I believe that there's more interest because
of this hearing, more interest because of the president's speech, more interest
because of all the discussions around the country about embryonic stem cells
that people know more about human biology and physiology than they ever had
before. Which is in itself a positive, and I think that scientists now are
calling NIH, are excited about the potential. And I can't answer all the
questions in none of the individuals up there can at this point in time. The
important thing is to get the research started and make the comparisons so that
we know some of the answers, so we can come back here two years, three years
from now, and talk about this issue.
SEN. WARNER: You
know, you are the president's principal adviser, as I say, we are fortunate to
have you, and I commend the president even though I personally feel somewhat we
should move a step further, but the point is let's take one adjunct question
here and that's human cloning. I'm totally opposed.
SEC. THOMPSON: So is the president and so I am.
SEN. WARNER: Should we effect here in the congress, rigid
standards of laws and indeed attach criminal penalties to that one area?
SEC. THOMPSON: I think we should prohibit human cloning, Senator.
SEN. WARNER:
And, indeed, and go so far as to attach criminal penalties.
SEC. THOMPSON: That is a decision for the senators.
SEN. WARNER: I thank the chairman; I thank the witness.
SEN. KENNEDY: Senator Mikulski?
SEN. BARBARA
MIKULSKI (D-MD): Thank you very much, Mr. Chairman. Mr. Chairman, I would like
to ask unanimous consent that my opening statement be included in the record.
SEN. KENNEDY: So included.
SEN.
MIKULSKI: Mr. Secretary, I just want to really welcome you today and want to
thank you in your six months in office, for all the courtesy and collegiality
and response you have given to many issues that I've raised with you and I want
to thank you for that. And I also want to thank you for inviting the women of
the Senate to meet with you to talk about a women's health agenda. And I must
say I'm impressed with the mastery that you have of the technical issues here.
There for a while, I thought you were defending a Ph.D. in biology.
SEC. THOMPSON: I think I could almost write one right
now
SEN. MIKULSKI: Yes, really, and you can see that
you've really put a lot of work into this personally and you are very hands-on
about it. Let me go right to my question which follows in line with Dr Frist.
First of all, in terms of President Bush's position, we
thank him for his deliberateness; I too oppose human cloning,
support the adult umbilical stem cells and glad that he took the next step in
embryonic. Let me tell me what my concern is. My concern is that the Bush
framework creates a loophole, and the loophole is that embryonic research from
discarded embryos will go on anyway but that they will go on within the private
sector environment, unscrutinized and unregulated, therefore lacking any type of
transparency.
The fears that I have about that are
twofold. Number one, that big breakthroughs could come from those who hold the
reigns of profit making, rather than being in a large public domain and
therefore could not only profit, but even profiteer by it. Number two, in an
unregulated and non-transparent atmosphere, I'm also worried about some of those
grim things that President Bush is worried about.
You
know, the biological revolution is stunning in terms of its opportunities but
it's also stunning in the way it could present to us a ghoulish, Huxley-like
environment. So I wonder what you think about this loophole and the concerns
that I have about this? And where do you see us heading that really, so much of
the research could go on in this unregulated, untransparent, very profit making
environment.
SEC. THOMPSON: Senator Mikulski, first of
all thank you for your kind words. I appreciate that very much. But the
president set up the Bioethics Commission, headed by Dr. Cass (ph), to do just
exactly what you're talking about. That is, to develop the theories, encourage
the adoption of laws, to make sure that that profiteering and problems that
you've indicated would not exist.
Saying all that,
before we get there, I don't believe that the privates are going to do the basic
research. They never really have. The basic research is not what's going to give
them the money. The basic research is what NIH does. It's what John Hopkins
does. It's what University of Massachusetts and all the other -- University of
Wisconsin. They're the ones that are going to have to do the basic research. And
once that basic research is developed, I believe then the private dollars are
going to come in and try and take that basic research, but we will have
intellectual property rights to that. Geron, WARF, NIH, the agreement we signed
yesterday, the MOU that we signed with WARF, allows us to maintain our
intellectual property rights on our discoveries at NIH, which is exciting, and
the publications that are going to be going on in this area. So it's so
important for us to get this research done.
I can't
scientifically tell you that there will not be profiteering or a problem exists,
as you point out. I can't say unequivocally, that that's possible -- that it's
not possible. I can tell you we are trying to contain any of those problems and
we're sure they're in the future and not right now. And what we need to do is
get our best scientists to get the federal dollars to do that basic research
that is just crying for discovery, I believe.
SEN.
MIKULSKI: Well, thank you very much, Mr. Secretary. As I understand it the
thrust of your presentation is that essentially this is a work-in-progress. You
want to -- the stem cell research both from an administrative perspective as
well as setting their bioethical standards. We have a benchmark, actually have
broad agreement with certain bioethical framework.
And
much is made of the prickly distinctions but, by and large --
SEC. THOMPSON: Prickly --
SEN. MIKULSKI: I
think we're all agreed, we don't want grim and ghoulish things to go on. Now,
but as I understand, while NIH begins their role, this Bioethical Commission
will also commence its role and then be looking at the issues of the greater
in-depth of a bioethical framework as well as evaluating these breakthroughs. Am
I correct in that?
SEC. THOMPSON: You're absolutely
correct.
SEN. MIKULSKI: In other words, we're going to
be continually reviewing it?
SEC. THOMPSON: Plus, you
can't forget Congress is also very much involved in holding hearings on this
subject as well, and making laws.
SEN. MIKULSKI: But my
point is that Congress would continue to hold hearings based on then what NIH is
doing --
SEC. THOMPSON: Right.
SEN. MIKULSKI: And also the work of this commission. But essentially,
this is the framework for embarking on this biological revolution?
SEC. THOMPSON: That is correct.
SEN. MIKULSKI: Now, a technical question -- and I think that's good. I
think we're going to have to periodic hearings on this. These stem lines that
we've talked about, do they have a shelf life? And if they do this could present
great dilemmas for the Bush position.
I take the
position of being allowed to do research with discarded embryos where there's
been informed consent to do so and oppose creating embryos for therapeutic
reasons. But, what do we know about the shelf life --
SEC. THOMPSON: Well, we know --
SEN. MIKULSKI:
Or should we save it for the bio-gurus here?
SEC.
THOMPSON: We know for three years, that the first embryonic stem cell line is
still replicating. And Dr. Thompson says he believes that they can continue to
replicate indefinitely, and other scientists have said the same thing. So, I'm
not a scientist, I have to take what they tell me as gospel. But I believe that
they will.
Now, can I say conclusively that there's no
shelf life? I can't say that. I can tell you that they are usable as long as
they're not differentiated. And when the cell starts differentiating into a
particular part of the body, then, like the hematopoietic blood cells -- now
what is taking place at the end, after the embryonic stem cell line has been
frozen, they've taken the cells out and they have then differentiated those cell
lines into blood cells, which is really exciting. Creating blood, white blood
corpuscles, red and platelets. And now that to me, is truly exciting, and it's a
tremendous breakthrough. But whether or not it's going to be able to be used in
therapy within three years, five years or six years, I don't think anybody can
say at this point in time, Senator Mikulski.
SEN.
MIKULSKI: Well, yes, and -- my own -- there are scientists, many of whom are
involved in cellular research at Hopkins who apprise me that they do believe
that these cells do have a shelf life. What I think -- really I think what
you're saying, the science is so new, we're going to have to see this and then
should it have shelf lives, then confront those issues because both the
commission and NIH will have had a chance to do its work. By the way, how are
they doing with getting a new head of NIH and FDA? You have great acting
directors but --
SEC. THOMPSON: I have made my views
known to Senator Kennedy and to the White House and I am hopefully going to hear
good news from both of those people.
(Laughter.)
SEN. MIKULSKI: Well --
SEN. : But
I hope to have good news too. I'm not --
SEN. MIKULSKI:
Well, like E.F. Hutton, I can't wait till I hear the news. I think both of these
flagship agencies are located in my state --
SEC.
THOMPSON: I know.
SEN. MIKULSKI: And so --
SEC. THOMPSON: I'm as anxious as you are, Senator
Mikulski.
SEN. MIKULSKI: Well, thank you. And let me
know if I can help you in the process at all, again.
SEC. THOMPSON: I appreciate that.
(Laughter.)
SEN. MIKULSKI: Heck, could we talk
later?
SEC. THOMPSON: We'll talk.
(Laughter.)
SEN. KENNEDY: Senator Murray.
SEN. PATTY MURRAY (D-WA): Thank you very much, Mr.
Chairman. And thank you for having this hearing.
Clearly this is a very complex issue and I appreciate all the knowledge
you have developed on this and the considerable amount of effort you have taken
on a very difficult subject. And certainly the public is very, very interested
in what we are doing and how we are moving forward from many different
perspectives. Obviously from moral and religious, but also from a perspective of
-- they don't want us limiting what we can do in the future in terms of life
saving processes that can be developed from what we've set out here today.
I share the concern of Senator Mikulski, in terms of
private research. And you have said very clearly that the administration has
said that there will be no further destruction of embryos after the August 9
deadline. And I'm worried about what kind of impact this will have on --
understand the commission that you've set out and sort of you see the federal
government, NIH, doing sort of basic research and then allowing private industry
to move further.
But you, yourself, know that private
industry has a different motive than the federal government, which is why we
have NIH and why we do research and why we put money in it. We can do the basic
research with the best of intentions that the development will occur for
diseases like Multiple Sclerosis or Parkinson's or other diseases. But private
companies may well see that marketing and profit comes from male baldness and
may set aside what we see as the public interest.
And
I'm very concerned that a commission set out to look at bioethical standards
isn't going to -- you know, they can't determine what profit means but that is
what private industry will do. How do you reconcile on this August 9 deadline
with what private interests are going to want to do once we've done the basic
research?
SEC. THOMPSON: I clearly can reconcile it
because the private sector would not do the basic research that I think is so
important. I don't think that the private sector would spend its time or money
making the comparison of embryonic stem cells versus adult stem cells versus
placenta versus core blood. And I think that kind of research needs to be done
for you and for me to make the proper decisions. And I don't think the private
sector will do that. And that's why prior to August 9 the public research, the
federal research, was not being done. The president has --
SEN. MURRAY: Right. But you're limiting us to that basic research
rather than to what we can develop maybe in the future, two, five, 10 years from
now on specific diseases.
SEC. THOMPSON: No, I'm not,
Senator Murray, because the MOU that we signed yesterday with WiCell allows us
to have the five cell lines available right now for research and that the
scientists at NIH will be able to keep their intellectual property rights and be
able to publish on what they discovered. And that may be a therapy on baldness,
as you've indicated. I don't think that's what we're that concerned with right
now. We're more concerned with --
SEN. MURRAY: But it
may be the best marketing and the best profit for somebody.
SEC. THOMPSON: But that's for the private sector and --
SEN. MURRAY: Right. But we have to protect the public interest and my
concern is having an August 9 deadline set, that we have no intention of ever
going back and looking at it again; may very well preclude some of the important
research we talk about at every hearing we have on this, that we tell our
constituents that may be available in the future for diseases that touch many,
many families, will never be developed because we have a hands off approach once
the basic research is complete.
SEC. THOMPSON: I can't
answer that question, except to say that we think that there is ample supply of
embryonic stem cell lines to do the basic research for the areas that you're
concerned of for your citizens; what I am concerned with for all Americans, and
what the president is concerned with. He is just as strong on moral line and
ethical line, saying that there will be no further destructions of embryo that
will get federal funding of dollars.
SEN. MURRAY: Yes,
and I guess I'm just stating a concern, yes.
SEC.
THOMPSON: And that is something that you and I will never agree.
SEN. MURRAY: Right. Well, how do you see this affecting university
research; which is often a collaboration of both private and federal dollars?
SEC. THOMPSON: I think that that will -- you know, it's
going to have to be worked on, but I am confident that --
SEN. MURRAY: How will it be worked on? Do we have a process in place to
look at that?
SEC. THOMPSON: We haven't as of yet but
we are working on it, Senator Murray, and we're -- as you know, 75 to 80 per
cent of the NIH dollars go back to universities for research dollars.
SEN. MURRAY: Right, and this often is in collaboration
with private money. If private money uses stem cell lines that were developed
after August 9, will we be precluded from doing collaborative research at
universities on that?
SEC. THOMPSON: That question has
not been raised and a decision --
SEN. MURRAY: I think
it's an important one.
SEC. THOMPSON: Has not been
made. I cannot answer that.
SEN. MURRAY: Thank you, Mr.
Secretary.
SEC. THOMPSON: Thank you.
SEN. KENNEDY: Thank you very much, Senator.
Senator Clinton?
SEN. HILLARY CLINTON (D-NY):
Thank you, Mr. Chairman.
And thank you, Mr. Secretary.
I think, as probably all of us feel after these couple of hours together,
there's a lot of unanswered questions which we will look forward to struggling
through with you and those with whom you consult, because, clearly, as Senator
Warner said, this is an issue that has such great importance and resonance, not
only throughout our country but throughout the world. I'm still at the acquiring
information, trying to get it straight level because there is just a lot of
contradictory attitudes that are being expressed about what we have and what we
don't have and I think that it is important that we have a factual base.
You were not here, Mr. Secretary, for Senator Specter's
testimony but I'm sure your staff will fill you in and give you a copy of it. He
certainly takes the position that is, I think, somewhat different from the one
that you've expressed about what the viability and accessibility of the stem
lines are. We need to come to some basic agreement about what the evidence
shows. And I hope that you will work with us on that, because certainly Senator
Specter and Senator Harkin have held a number of hearings on this issue going
back now nearly two years and Senator Specter has a different basis of
information available to him than what you've presented. So I hope that we can
work through that so that we all know what we are talking about.
Secondly, the serious question that has been raised about the potential
impact, if not contamination from the mouse cells -- and also I believe blood
serum from cattle is also used to nourish these cells and some of the settings,
is one that we have all had grave issues about. We are concerned that our
government's own standards about how to treat the introduction of animal
elements into human materials have not necessarily been followed in the various
locations where we've identified these stem cells. So clearly we have a lot more
work to do on that because, as you've pointed out, the research is going to take
a number of years and I think many of us would be very disappointed if at the
end of all those years of work, cannot be useful to the alleviation of human
suffering because of the contamination that affected these cells.
One other question that I need some guidance about is in
the president's speech. I believe he said he supported the House bill and, as I
understand the House bill, it not only bans reproductive and therapeutic cloning
in the United States, and certainly any federal involvement in such efforts, but
it goes a step further and says that if in England or Germany or Japan any
therapy or treatment is created from therapeutic cloning, that treatment could
not be imported into the United States. Am I understanding that correctly in
both the House bill and the president's position?
SEC.
THOMPSON: Senator Clinton, I have not done any research on that subject, I'm
sorry to say, so I don't particularly want to answer that question at this point
in time. I'd be more than happy to do the research and call you or write you
with an answer on that. But I would like to, hopefully, make a correction, and
not to be confrontational. The contamination -- I don't believe there's
contamination. Just because these cells rest on a mouse layer of cells doesn't
mean that they are contaminated. And I've talked to FDA, I've talked to NIH and
it's such a traumatic experience for these cells to be taken out of the embryo
that they have to have this cushion.
SEN. CLINTON: Mr.
Secretary, I understand that. But the point that was made this morning -- and
I'm just trying to get a base of information so that I can make the best
possible decision. But as I understood the chairman's point this morning, our
government had issued guidelines about how mouse nutrients are to be injected
into any kind of human material. So that clearly we know it happens. The
xeno-transplantation efforts that you referred to are ongoing. I read the letter
that was distributed. Frankly, it's still a little concerting to me because the
long list of steps to be taken to guard against any kind of untoward consequence
of xeno-transplantation are a little bit daunting to me.
But put xeno-transplantation to one side. As I understand what the
chairman said, our government has issued very strict guidelines about the
introduction of mouse nutrients into the human material and we have no guarantee
that these stem cells in India or Sweden or anywhere else have followed the
American government's guidelines, do we?
SEC. THOMPSON:
We do not.
SEN. CLINTON: We do not. So I don't think
that any of us want to be confrontational. We are trying to understand what it
is we are doing.
SEC. THOMPSON: I just don't --
SEN. CLINTON: I don't think that -- if our government has
rules about how to avoid contamination, that they have issued to researchers
about how to use mouse nutrients, I think it's a fair conclusion to draw that in
the absence of following those rules, some might conclude contamination has or
could occur. That's my only point.
So my only point is
that as we go forward to try to understand what it is we are doing here, we need
to be open. We cannot close our minds. This is not an inquisition. This is not
trying to determine who's right and who's wrong. We're trying to figure out what
we are doing. And there have been many questions raised since the president's
speech that deserve an answer. The scientific community deserves an answer, the
Congress deserves an answer, and certainly people who are out there wondering
about this deserve an answer. So on those several points, I would appreciate
additional information.
I am also hoping that as we
look at this, the question that was raised by Senator Mikulski, which I think is
a very important one, is that we have chosen to adopt a different approach than
Great Britain, for example. As I understand it, they have an embryonic research
advisory board that attempts to govern both public and private sector
investments in this research. We've adopted a different approach. We've adopted
these restrictions on federal funding and very few on private funding, and I
take seriously your point -- I happen to agree with it -- that the basic
research is likely to be done with the public sector dollars.
Now, that though raises some of the concerns that scientists have
suggested to me which is that it's very difficult to do the kind of basic
research without those public dollars. I mean, that really is the core of
whatever therapeutic use can come from this research. So that we're concerned, I
think, about the potential shelf-life of these stem cell lines, the
specialization that can occur rendering them useless for the research, the
numerous references to the mouse lines that have been developed. We don't know
how many mouse lines it took to get those that are now replicable and usable. We
are really out there in the dark trying to figure it out. If we're going to make
an analogy to mouse lines, we ought to have as much information as we can to
know -- was it a thousand mouse lines that eventually produced five viable mouse
lines or was it 64 mouse lines that produced five viable mouse lines? I don't
have any idea.
So I think that every one of us are
grateful for the hard work that you and the NIH and the professional staff have
done and we're grateful that the president had a deliberative process that led
at least to the door being opened. But as we learn more about these 64 stem
lines, as we try to figure out how we reconcile Senator Specter's very strong
statement -- it was a passionate statement this morning about what he believes
to be the facts about these stem lines -- with your very optimistic statement
about the stem lines and the fact that if we go with the optimistic view, which
is that this is all we need and this is all we're going to get, how many years
to do we lose, what do we give up; the questions that Senator Warner raised. So
I think, Secretary Thompson, that for many of us we are still in the asking
question stage.
And, if I may, just one final question.
You've said several times, you said in response to Senator Murray, that you
envisage private research as taking up where the publicly funded basic research
leaves off. What thought has been given to how these private researchers will be
able to overcome the proprietary rights issue as they engage in commercial
development? With the kind of memorandum of understanding that you've reached
between the government and the research institutions, how will the private
researchers be able to do that?
SEC. THOMPSON: Senator,
first off I didn't mean to imply anything. I just didn't want to leave this
hearing saying that all of these lines are contaminated, and I don't think they
are. Secondly, you have raised a lot of points. I don't know those answers. I
can tell you that I've been involved in this thing since a month after Jamie
Thompson discovered. First as a governor, I have been an advocate, a passionate
believe that this shows great promise, and I still believe that. We have to do
the research and we have to do the basic research, as you've indicated, to find
out what -- how can these cells be used? Maybe adult stem cells may be more
usable, more placid then embryonic stem cells. That comparison has not been
made. That has to be done.
In regards to the patent
rights, I've talked to the people at NIH and they tell me that this no
different. That the MOU and the statement of material transfer allows for this
research to continue. And the intellectual rights, the research writing of the
scientists will be able to be continued and will be saved for NIH, but once they
develop a product, like they do with any other produce that doesn't use
embryonic stem cell lines, then the private sector and the patent laws and the
commercial laws of America take over. And they will have to negotiate with
WiCell or get a license to use that. But that's no different than any other
product that has been developed by NIH or by the private sector when there's an
already existing patent out there.
SEN. KENNEDY: Thank
you very much.
Senator Edwards?
SEN. JOHN EDWARDS (D-NC): Good morning, Mr. Secretary, how are you?
SEC. THOMPSON: I'm fine.
SEN.
EDWARDS: We appreciate your passion about this issue and the work you've done in
the past on it. There were a number of us that had concerns when the president
made his speech about the rigid guidelines that he established, understanding
that there are serious scientific and ethical questions that have to be
resolved, and how those guidelines would be applied in the context of a very new
science. I think all of us would recognize this is a very new and rapidly
developing science.
SEC. THOMPSON: And very
exciting.
SEN. EDWARDS: And very exciting --
potentially very exciting. I think our concern is we want to make sure that that
potential in fact is realized. At the time the president spoke and shortly
thereafter when you talked about the subject, you talked about 60-some-odd stem
cell lines being available, the nature of the research that you thought could be
done based on those stem cell lines.
Let me ask you
first: are you aware -- have you actually been on site where these stem cell
lines are located -- and we have a list of where they are across the country and
across the world -- have you actually been on site and examined the stem cell
lines?
SEC. THOMPSON: No, I have not. I have been on
the University of Wisconsin lab many times but I haven't been any place else, if
that's your question.
SEN. EDWARDS: The American
Society for Cell Biology has established four criteria that they think should
apply in this context in order to satisfy the research that needs to be done.
The first is that cell line be available to publicly
funded scientists, both to NIH and to universities around the country.
The second is that the owners of the stem cells lines not
impose restrictions that would limit that research; third, that they have growth
and handling characteristics that are compatible with quality research; and
fourth, that they retain the capacity to generate every adult cell type.
Pretty simple actually. One is to make sure the scientists
have -- it's available to the scientists who need to do the research; second,
that there aren't legal restrictions and other restrictions that would limit the
ability to do the research; third, that the stem cell lines themselves are
usable for the research that needs to be done; and fourth, that they have the
capacity to generate the adult cell types that need to be generated. Do you
know, as you sit here today, how many of the stem cell lines that meet your test
also meet those four simple tests?
SEC. THOMPSON: I
know 64 meet the president's guidelines in regards to federal funding. There are
64 that we have inquired about and re-inquired about and have met with
personally.
SEN. EDWARDS: Can I interrupt? Do you think
those are reasonable tests, the tests that they layout, those four simple
tests?
SEC. THOMPSON: I think that those four are
adequate and I think that they will support --
SEN.
EDWARDS: You think they're reasonable?
SEC. THOMPSON:
They're reasonable.
SEN. EDWARDS: Okay. Can you tell
me, as you sit here today -- I mean, you and the president have already
established the limitations -- can you tell me, as you sit here today, how many
stem cell lines meet those four tests?
SEC. THOMPSON:
Dozens and more.
SEN. EDWARDS: What does that mean,
dozens? Twenty-five, 30 -- how many?
SEC. THOMPSON: I
would say dozens. I would say 28 or 25 at this point in time. But as -- you were
not here. There's three stages in which these embryonic stem cells go
through.
The first one is the proliferation, and
there's several of those 64 lines are in the proliferation lines; several in the
characterization lines, that's over here; and several are in the cell line
established, and it takes six to eight months to develop a good embryonic stem
cell line. And there's several months that are going to be in the process --
some of these that have not met the full cell line establishment criteria yet
will be by the time they apply for the money and the money goes out at NIH. And
that's going to take somewhere between eight and nine months to get the money
out.
To give you an example, the Sweden Goteborgenberg
University has 19 lines, Senator Edwards. Three of them are in the cell line
established, which means they're ready right now for research and that further
research could be done. There's four in the characterization and there are 12 in
the proliferation. Now, over the course of the next six to eight months, several
will move from proliferation to characterization to the cell line established,
and that's during the process that they will be applying for federal research
dollars. To tell you exactly today how many, I can't tell you. If I was pressed,
I would say there'd be 24 to 25 that would meet the cell line established
criteria, Senator Edwards.
SEN. EDWARDS: This leads me
to my next question. You said, when I originally asked you, you said dozens and
then when I asked you a follow-up question about it, you said 24 or 25. How do
you know that those 24 or 25 meet these reasonable, what you described as
reasonable, criteria that the cell biologists have established?
SEC. THOMPSON: Well, basically because the MOUs that we've discussed
with the entities, the 10 entities that have them, have indicated they want to
share with the scientists, two, that they can be used, three, that they
replicate or pluripotent, which is the scientific word for that, and -- I don't
know what the fourth one was -- I understand that they meet those four
qualifications.
SEN. EDWARDS: Let me ask you a
follow-up question to that. How many genetically diverse stem cell lines --
again, as we sit here today, not the potential, but we actually know about --
have the ability to regenerate themselves indefinitely? How many do you know
about today?
SEC. THOMPSON: We think all 64.
SEN. EDWARDS: Okay. So it's some of the other tests that
you are not certain whether or not --
SEC. THOMPSON:
The other characterization, the other things like feeder cell testing, the cell
marker assays which are SSEA (ph) 3s and 4s and PTA 61s and 80s and the
chromosome analysis when we are testing for pluripotency (ph). We are not sure
about all of those things. But we do know in order for this to be proliferating,
they're already started proliferating right after they've been removed from the
blastocysts, are in the cells and the cultural dish. They are proliferating
right then. So all 64 lines have proliferated. We do know that for a fact.
SEN. EDWARDS: But you, HHS and NIH have not physically
been to the sites to actually examine the cells yourselves?
SEC. THOMPSON: No.
SEN. EDWARDS: You plan to
do that?
SEC. THOMPSON: I probably will not, but I know
the scientists will be doing an exhaustive study, which they already are. We are
in the process of setting up the registry. We're in the process of -- we've
signed -- you were not here, but we did sign an MOU and a material transfer
agreement yesterday with Wisconsin Alumni Research Foundation, that allows for
their five embryonic stem cell lines to be made available to the NIH scientists
right now.
SEN. EDWARDS: Are those five lines available
to the non-NIH scientists around the country, publicly funded scientists?
SEC. THOMPSON: Yes, Carl Gulbrandsen (ph) is here and you
can ask him that question. But he has indicated, yes, any scientist -- they want
those lines --
SEN. EDWARDS: What do we know about the
availability of all the other stem cell lines?
SEC.
THOMPSON: All we know, all I can tell you, Senator Edwards, is that the entities
have been in to meet with Dr. Lana Skorboll (ph) and her staff. And I have
personally met with them. I have not negotiated with them, but I have met with
them, and they've all indicated to Dr. Lana Skorboll and to the staff at NIH
that they want to make their cell lines available to scientists and for NIH to
get the basic research done. They're excited --
SEN.
EDWARDS: At this point, who controls that decision? Do they control it?
SEC. THOMPSON: The entities.
SEN.
EDWARDS: We, as a nation, have left to them control over what kind of research
can be done on these cell lines?
SEC. THOMPSON: No, no.
They own it. I mean, they developed it, so they have control over them. And now
what we're doing --
SEN. EDWARDS: Yes, but we've
created -- through this decision by you and the president, we've created a
monopoly in those people who have existing cell lines. If I understand you
correctly, what you're saying is they now have control over what research, if
any, can be done by -- I mean, it's all well and good that they are well
intentioned about it; I appreciate that. But suppose they decide no, in fact,
they're not going to permit the research to take place, or they're only going to
allow the NIH to do it, they're not going to allow the other scientists to do
it?
SEC. THOMPSON: This is not what I said, Senator.
What I've said is that they all have indicated that they are in agreement and
want to cooperate not only with NIH, but with other scientists to do the basic
research on their stem cell lines.
WARF has gone a step
further. They have negotiated now with NIH in an actual agreement which was
signed yesterday with NIH to make their five cell lines, that Jamie Thompson,
the father of embryonic stem cells, has developed. He has licensed those to
WARF. WARF, in turn, has licensed them -- or has given the permission to be used
by NIH and other scientists through a MOU and a material transfer agreement for
any type of research that the scientists want to do on those.
The second thing we're doing is we're developing a registry at NIH,
making all the 64 lines hopefully available for scientists around the world to
be able to pick the line that they want to use for their research projects, when
they apply for federal research dollars.
SEN. EDWARDS:
The critical word there was "hopefully.
" And I know my
time is up, but my obvious concern is -- and I think it's a critical issue in
this ongoing process -- is by establishing the criteria that the president has
established, he limited the number of lines that even are potentially available
and left in the hands of the people, who presently have the proprietary control
of those lines, the decision-making about whether they are going to be publicly
available. We can't force them to make them available. They have a legal right
to do whatever they choose to do, and I appreciate that they are
well-intentioned, but it's certainly hasn't been an unusual thing in the past to
have people act out of their own personal financial best interest. And it
wouldn't be a shocking thing to see that happen in this case.
So the restrictions that have been imposed obviously create ongoing
problems. I am hopeful with you that we will be able to get these folks to make
these stem cell lines available. But I think that's a serious question, as we
sit here today and I thank you, Mr. Secretary, for your --
SEC. THOMPSON: Thank you. All I can tell you in answer, Senator
Edwards, is that we've got five -- the first one we've negotiated with, which is
the one that has the patent in America, is the one we've reached an agreement
with and we feel very good about that. And we think the other ones will follow
through. I can't promise you today that definitely we're going to have them all
signed up next week. But we're working on them and we're working as fast as we
possibly can to reach an agreement with them.
SEN.
EDWARDS: Thank you, Mr. Secretary.
Thank you, Mr.
Chairman.
SEN. KENNEDY: Thank you.
Mr. Secretary, I just make a very brief comment and then there's others
who want to have a final question. Obviously they're welcome.
No one could sit in through the course of this hearing now since 9.30
and not know of your own very strong commitment in terms of the research in this
area and your belief that this offers some enormous opportunities and hope for
families across this country, these dreaded diseases that afflict every family
in America and that is very commendable. The president is fortunate to have the
kind of advocate in the advocacy that you've expressed here.
There are those that view this situation somewhat differently and we
are here trying to listen, as we have, carefully to your presentation, made in a
very convincing way. Will there be the availability of stem cells for the
research and the opportunities in an area that was really unthought of, or maybe
thought of but not in reality until two and a half or three years ago. And with
all of the kinds of the best of research, research that is done at NIH, will
there be the sufficient kinds of product out there to permit the kind of
opportunities for breakthroughs?
Now, you make a very
convincing and compelling case that there is. I think that there's been some
legitimate issues and questions that have been raised that causes some concern.
I think one of those issues that I raised very briefly and others have
questioned, and that is the condition on safety and the issues of nutrients from
mice and the fact that in these various stem cell lines that you've talked about
here, you would be hard pressed to think that any of those follow the very
strict guidelines that have been issued on August 24 this year on mice from a
colony that's continually monitored for infectious diseases.
We know about mad cow disease. No one expected that that kind of
infectious disease would be able to move from animals to human beings, from a
colony that was not allowed to interbreed with animals outside the colony
routinely tested for infectious disease, quarantined for three weeks prior to
the procurement of cells. Now we're told that we have to stay with these cells;
we have to stay with the ones. Even if we are able to take mice and create new
stem cell lines further after August 9, that would meet all the requirements
that the administration's put out on CDC, we say no, no, you can't do it. August
9 is it.
And even if we are able to discover after two
and a half years that we may be able to do it without the nutrients from mice,
maybe other kinds of nutrients that would save us that kind of -- perhaps that
kind of risk, we're told we can't do it because it's after August 9. We commend
you for the arrangements that you've made enabling one of the 10 suppliers to
make a strong commitment to make available the stem cell lines and we're
impressed by your own work in the past in saying that you've been in touch with
all of the others and you believe that they will make them available.
I think that most of us would say that this is -- no one
underestimates your ability to talk to someone and get an understanding and form
an impression about whether that's for real or not, and I have a lot of respect
for that. Many would say we ought to get it in writing, because what we have
seen, as I understand it from similar situations, that there hasn't been the
kind of readily available access when similar kinds of situations have been out
there, in terms of research at the NIH.
And I think
most of us have been around here long enough to see what OPEC was able to do to
our economy and the impact it has on our society when they get together. Eleven
of them. And we're talking not 11 countries. We're talking about 10 basic --
some countries, but basically 10 entities, and that raises concerns. So, these
are all important. We had a brief comments about the patents, and you've
commented about that. I know you've worked on it. So these do raise some serious
questions. But as far as I'm concerned, I want to take what you've said here
today and hear from this next panel their reactions to some of these, and then
to sort of work with you.
I do find at the end of the
day, sort of an August 9 deadline sort of drop dateline and the unwillingness to
be able to, in spite of what follows on in terms of breakthroughs in the areas
of research, being -- serve as a barrier to important progress in terms of
cancer or Alzheimer's are very troublesome. But we have learned a good deal this
morning, and I've been enormously impressed by your presentation. We will keep
in close touch with you on this issue. We want to try -- no surprises, there
couldn't be in any event -- we want to try and work with the administration. We
again thank the president for addressing it. And it's just a desire to make sure
that we're going to be able to get done what he has said that he wanted done,
and what I think offers the greatest hope for the American people. If there
--
Senator Dodd.
SEN. DODD:
(Off mike.)
SEC. THOMPSON: Could I just say thank you,
Senator Kennedy, for your tremendous interest and passion on this subject. And
we may not totally agree on whether or not the August 9 deadline is correct or
not, but I think we both agree that we need to get the research done and the
questions answered. And I thank you for your passion, your advocacy of this
issue and I want to publicly state that I support that and want to work with you
as much --
SEN. KENNEDY: Thanks very much.
SEC. THOMPSON: -- as I possibly can to accomplish that.
SEN. DODD: Mr. Secretary, I just wish to pick up on some
of Senator Kennedy's comments. Senator Clinton used the right word; this is not
an inquisition at all. Obviously there is deep interest in the subject matter,
not only here, but obviously in the scientific community and we've heard
painfully on many cases from the people at large in the country who don't
understand all of this, and a lot of the news media may be in a sense hyping a
bit what the potential is. But, understandably, when you've got a family member,
a loved one who's suffering, and you hear about the potential to be able to deal
with Alzheimer's or diabetes or other such illnesses, it is very, very exciting,
and I for one -- I want to thank you.
You're in the box
here and we're kind of raising the questions to you. But I think you deserve a
great deal of credit for bringing this as far along as you have. I mean, some of
us here would have liked to have seen you -- the administration go a bit further
with this, in my view. Not that I wanted to see it all. I strenuously oppose the
idea of somehow creating -- someone once used the word 'hatcheries'. I would
vehemently oppose that.
But I also understand with the
ability to provide people with families through in-vitro fertilization, and that
there are excess embryos here. And I raised the issue with you earlier as to
whether or not there's going to be a position taken on banning the destruction
of those excess embryos.
And if there is, that would
sort of be consistent I suppose with the view that they can't be used. If it's
not, it raises the quandary: if you're not opposed to their destruction, how
could you be opposed to using them? If in fact these other lines that we
hopefully are going to do exactly what you've described don't pan out, we've got
another source there to deal with.
But I think you've
done a tremendous job, and you're right. We now have a position taken by this
administration to publicly finance research, having drawn lines, and I have
difficulty with the arbitrariness of an August 9 at 9 p.m. But, nonetheless,
this is breakthrough. This is good and we ought not to allow this hearing to end
on a note that somehow while there's still some disagreements over whether or
not August 9 there's some additional embryos are to be used, this is very
positive.
And so I don't want the hearing to end
without expressing my gratitude to you. I suspect you had an awful lot to do
with this; the fact that there was that speech on August 9. I suspect that you
had a lot to do with the fact that there was some breakthrough here, moving the
line a bit further than I suspect some inside the White House wanted it to be
moved. You don't have to answer that. I just have my own suspicions about it,
and I'm grateful to you -- (laughter) -- and a lot of other people are. And I
know that you've got a first-rate team. I can't tell you how excited I am about
the work that's being done in adult stem cell research.
I've had two wonderful conversations with my friend from Tennessee,
who's been enlightening me on cord blood stem cells, and the ability to -- what
that can mean. And again at NIH I've had wonderful conversations with your
acting director out there about how realistic cord blood stem cells might be.
But, nonetheless, it's very exciting, the work that's being done. And so I thank
you for being here today and thank you for the work you've done. Obviously some
of the questions that have been raised: Senator Clinton's questions, Senator
Kennedy's. We need to follow up on these pretty quickly, because if it turns out
you're wrong and we can't extract these things, then we've got to revisit this
issue.
I know you don't want to admit that this
morning. But the only thing you said that worried me is that we will never
reconsider that August 9 date. And I'm not going to ask you to repeat that,
because I like to believe you may want to rethink it. And so if we have to come
back to that, we're going to have to come back to it and we'll talk to you when
that occurs.
SEC. THOMPSON: Sir, I thank you and thank
all of the members on the panel. I tell you, this has been a great discussion,
and the beauty of it -- this holds so much promise. Everybody out there that has
a loved one that has suffered from breast cancer, or for dementia or anything,
was waiting for the possibility. We just can't get the information out there
that the cure is around the block.
SEN. DODD: I
agree.
SEC. THOMPSON: We have to get this basic
research done. The president has allowed that to continue. I'm excited about it
and I know you are, Senator Dodd, and I thank you very much for all of your
comments and all of your questions today.
SEN. FRIST:
Mr. Chairman, just two minutes. Again, I want to thank Secretary Thompson and
the president. A lot of thought, a lot of consideration, a lot of individual
meetings and this issue deserves it because it is, again, as we look at science
one of the few issues that we've had to face --- humanity has had to face that
has the opportunity both for promise, altering the basic building blocks of
life, but also could have the unintended consequences. I want to thank you for
that. I do believe that we should expeditiously implement the policy put forth
by the president. It's carefully crafted. As this moves forward it will be
important; again, because science changes so quickly, so rapidly that we
continuously reevaluate both the progress as well as the needs of this
research.
If there's one thing that's come out from
your comments and the comments of the last several weeks is that this is an
unchartered area of scientific inquiry; whether we're talking about mouse cells,
or xeno-transplantation, which we've addressed in one context of transplanting
whole organs but not quite as much in cells. It demands an ongoing public
discussion among the policy makers, like here today; the scientific community,
who we'll hear from shortly; ethicists, the religious leaders and the American
people. It's absolutely critical to have that discussion on an ongoing basis;
not just today, but an ongoing basis as science does change and progresses. We
are going to have to wait several years before we know whether or not the
embryonic stem cell research is going to yield the promise that we all hope that
it will.
In the meantime I believe we should move
forward expeditiously in implementing the president's policy, and continue to
examine the progress closely over the coming months and years.
SEC. THOMPSON: Thank you.
SEN. KENNEDY: Thank
you very much, Mr. --
SEN. : (Off mike.) -- I wouldn't
want you to leave thinking that because I and others have raised some very tough
issues, we don't totally respect what you are doing and have done. And I also
want to thank our colleague Senator Frisk, because I think he might also have
things to say and do that have led us to this point. We're very grateful for
that. But we need this kind of open, honest dialogue, where -- this is a
decision that because of living in a global media age we're bringing in millions
of people to be part of.
It's not going to be made by
scientists in a closed lab or senators behind closed doors. This is society's
decision and it has to be addressed in that way, not just -- and I know that
given your background and what you've done with this particular issue and in
general, that you understand that and will be working to lead public opinion as
well. Thank you very much.
SEN. KENNEDY: Thank you, Mr.
Secretary.
SEC. THOMPSON: Thank you.
SEN. KENNEDY: The hour is late, but I think we'll try and get started
on our panel if we could and we'll invite -- Dr. Douglas Melton is the chairman
of the department of molecular and cellular biology, Harvard University's
leading stem cell researcher. It has made numerous important discoveries in
diabetes research. Dr. Melton was honored for his outstanding accomplishments in
medical research by being named to the National Academy of Sciences in 1995.
Ms. Karen Hersey is the senior counsel for intellectual
property at the Massachusetts Institute of Technology. She can speak from
extensive professional experience from the complications that can arise in
seeking access to essential medical research materials.
Dr. James Childress is the Edwin Kyle Professor of Religious Ethics at
the University of Virginia. Dr. Childress served with distinction on the
National Bioethics Advisory Commission. There was a report on stem cells as a
thoughtful guide to the complex ethical issues raised by this research. It's a
special pleasure to welcome Dr. Childress who was formerly the Joseph P. Kennedy
senior professor of Christian ethics at Georgetown University and has been a
great, great leader in all the areas of bioethics and someone that I have
respected over a long period of time.
Dr. Kevin
FitzGerald is the Dr. Lawler professor for Catholic healthcare ethics at
Georgetown and associate professor of oncology. He has written extensively about
the moral ethical issues raised by new advances in medicine. Dr. Jon Chute
conducts research on adult stem cells Bethesda Naval Medical Center, and I
believe that research on adult stem cells should proceed in parallel with
rigorous research program on embryonic stem cells. We welcome his testimony on
this important topic. It's a pleasure to have all of you and we'll look forward
to moving ahead. I'll ask Dr. Melton if he'd be good enough to start.
MR. DOUGLAS MELTON: Good afternoon Chairman Kennedy and
Senator Frist. Thank you for inviting me to speak here today about human
embryonic stem cells. In the last three years the potential of these cells has
been widely debated in the public, and rightly so. The subject forces us all to
revisit the question of when life begins and we have to scrutinize the crossroad
between scientific inquiry, our efforts to improve the human condition, and our
moral and ethical responsibilities to preserve human dignity.
I am not here to testify on the moral religious or political aspects of
this research. I appear before you as a scientist and as the father of a young
boy with type one, or juvenile diabetes. I will, furthermore, not speak to you
about the human burden of diabetes and will simply say that I work on human
embryonic stem cells to try to treat or cure diabetes. My remarks today will
therefore be confined to the scientific potential of these cells and the
implementation of the president's plan, about which we have already heard.
In my written testimony, which I'd like submitted for the
record, I have summarized the properties of embryonic stem cells and put that
research in a larger context of recent biological activities and studies at the
NIH. Let me just say now that the ability of these cells to make any part of the
body is what holds their promise for therapies.
We've
already heard about the numerous diseases that can be potentially treated:
Parkinson's, Alzheimer's, osteoporosis and the disease that has my full
attention, juvenile diabetes. And I'd simply like to say at this point that
while adult stem cells have some similar properties, based on what we know today
adult stem cells do not have all the properties of embryonic stem cells. To give
an example: there is no credible evidence for the isolation or growth of an
adult pancreatic stem cell, and that alone justifies, in my view, the work on
embryonic stem cells.
I don't need to remind you all
that the president made an important speech on 9 August, and I'd simply like to
comment on that date as I feel it has important implications for the
implementation of his plan. That date was not chosen for scientific reasons and
its arbitrary selection will unquestionably have an effect on the progress of
research. For example, as we have already heard, it will not be possible for
federally funded researchers to explore new ways to derive human embryonic stem
cells, stem cells that have a broader genetic diversity, or perhaps were grown
in the absence of mouse tissue; for example, grown with human as opposed to
mouse tissue. Nevertheless, as Secretary Thompson has rightfully pointed out,
the door has been opened and some research can now be done. And I would like to
address two issues and make a proposal for the implementation of the president's
plan. One of the things that I feel the committee has struggled with is the lack
of information about the 60 plus cell lines, and legitimate questions were asked
about them. Let me simply say that scientists are, by their nature, inquisitive
and skeptical and we hold dear the practice of publishing results following an
independent review by qualified experts. Moreover, by publishing results,
scientists generally agree that the reagents reported therein, including cells,
are to be made available and shared with the research community. In this way the
results can be independently verified, new directions and discoveries can be
explored.
The problem with the present case is that
only a handful of these 60 plus embryonic cell lines have been published, so it
is not yet possible to give a valuation or comment on the quality of the line.
Nonetheless, legitimate questions can be asked about their growth,
differentiation potential, age and purity. These issues have already been raised
this morning.
What I can say is that decades of
experience with mouse embryonic stem cells show that they lose their
differentiation potential, become contaminated, accumulate mutations and tend
towards spontaneous differentiation or uncontrolled differentiation after a
certain period. This is related to the question that Senator Mikulski raised
about shelf life. Stated otherwise, there is incontrovertible evidence that old
mouse embryonic stem cells do not have the same potential that young ones do. If
I were to give an analogy with a human, it is true that these lines can grow
forever and are, in that sense, immortal, but they lose their potential. A
150-year-old person may still be alive but does not have the same potential as a
20 year old.
I hasten to add that I am not criticizing
the NIH nor the scientists who have reported the isolation of these 60 stem
lines. Indeed, the scientists have not published their work and they may well
wish to further characterize the cells before doing so. It is, therefore, in my
opinion too early to tell how many of the 60 lines are truly useful. Preliminary
indications, nevertheless, suggest that the final number will be significantly
less than 60. If the available lines have been extensively grown and have a high
passage number, that will further reduce their value.
Let me now turn to the question of availability. A separate issue
concerns whether these lines will be made available, and we've already heard
that the entities that have derived the lines have proprietary and commercial
interests. Experience shows that the negotiation of transfer from those who own
the reagent to federally funded scientists can be slow, expensive and sometimes
accompanied by onerous restrictions. It is obvious that the legitimate interests
of companies may not coincide with scientists' research plans and our nation's
public health policy. I was delighted to hear that Secretary Thompson has made
progress with WARF in establishing one such relationship. But it is as yet
unclear whether he will be successful in doing so with the other entities. To
get to my final point, I'd like to make a suggestion which I've made before to
Secretary Thompson and the NIH, which is a plan to move forward that I think
will be most effective given the limitations presented to the scientific
community. Specifically, I suggest that the NIH create a repository, not a
registry, for this 60 embryonic cell lines. The NIH could collect the lines,
determine their quality and certify them for distribution to qualified
researchers. Equally important, this plan would have the NIH negotiate favorable
terms with all of the suppliers that could be set out in a material transfer
agreement.
At the moment it is very difficult for
scientists to individually negotiate such arrangements and the federal
government and the NIH are in an immeasurably stronger position than are
individual investigators to obtain the human embryonic stem cell lines from
suppliers. In that way, as I have said, they could verify their quality and
arrange for their distribution. I'd like to know whether the NIH would be
willing to consider doing that, given that their resources far exceed that of
individual investigators.
In conclusion, Mr. Chairman,
I think the president and Secretary Thompson have proposed a plan that will
allow federally supported researchers to begin to explore work on human
embryonic stem cells and work towards a cure. It is an important step. If my
remarks today seem cautious, the reason is the uncertainty I have about the
quality, availability and longevity of the cell lines. Assuming that some of the
60 lines are made available, federally supported scientists can work to
understand how these cells can be directed to differentiate, and this will lead
to new insights into human biology and disease. However, it seems to me
perfectly clear that as these studies progress to the point where clinical
applications can begin, I expect the plan will have to be revisited; principally
because the viability or utility of the 60 cell lines will have been exhausted
by that point.
In closing, I thank you and the
committee once again for the privilege of speaking to you about this important
area of biology.
SEN. KENNEDY: Ms. Hersey?
MS. KAREN HERSEY: Good afternoon, Mr. Chairman and
distinguished members of the Committee. My name is Karen Hersey, I'm Senior
Counsel for Intellectual Property at the Massachusetts Institute of
Technology.
It's my understanding that I've been
invited here today for the purpose of providing you with an introduction and an
overview of the subject of material transfer agreements, known as MTAs, about
which you have already heard this morning, and the role that they traditionally
play in the exchange of materials for scientific research. As we already know,
from our colleagues at the University of Wisconsin, there is every expectation
in the academic community that access to stem cells for research will involve
the execution of a material transfer agreement between the stem cell provider
and the organization requesting them.
MIT does not have
a medical school and in terms of the numbers of materials that we request access
to, it is small compared with those institutions that have larger faculties,
larger student bodies and medical schools. However, MIT's faculty, students and
staff are engaged in a substantial volume of research in biology, biotechnology,
bioengineering and so forth, where biological materials are used every day to
investigate and teach areas of advance science. Like every research unit,
whether academic or industrial, MIT investigators depend upon the availability
of and the access to new materials developed by others to move their research
forward.
The materials are often proprietary to their
owners and not commercially available, or may be commercially available at a
very steep price that the university generally does not have to pay, only if it
accepts materials under restrictive conditions. And in some cases, the materials
will be made available to the academic and the industrial communities under a
common set of terms that we in academia find ourselves trying to work with in a
contractual framework that is not suited to our environment.
Twenty years ago, when I first joined MIT as a licensing attorney, the
term material transfer agreement was virtually unknown, or at least unknown to
those of us in the administration. We can reconstruct from the lament we often
hear, recalling the good old days, that materials were transferred from
scientist to scientist and from organization to organization through a phone
call or a verbal hand shake.
From time to time, one
page documents or releases arrive, generally containing warnings that the
materials might be toxic, that they were not to be used for human subjects
research and requiring the receiving party to release the sending party from all
responsibility for use of the materials. These one page notifications were
almost always signed by the investigator receiving the materials. A check of our
database shows that MIT institutionally signed a total of eight MTAs in 1989.
That was yesterday.
Today the story is far different.
My office at MIT has over-all responsibility for incoming material transfer
activity at MIT. We have one attorney and one paralegal negotiating more than 75
material transfer agreements a year. We have a database where all MTAs, their
status as active or inactive, the lab where the materials are placed, the
responsible investigator are logged and where the restrictions on use of the
materials are also logged. There are over 600 entries covering materials in
active use and we are a relatively small university. The larger state
universities and medical schools are looking at exponential increases in these
numbers.
So what has happened to change the simple hand
shake between scientists into a full blown negotiation between organizations
often taking months? No doubt there are any number of theories out there that
might be supported, but I consider the events over the last decade and a half
that leads me to attribute the change to three factors.
The first is the explosion of the biotechnology industry and the
recognition by both industry and the academic community during the 1980s and
1990s that certain combinations of the materials, certain methods of producing
them or methods of using them could in fact be patented. From then on, the
materials, especially those that were unique, took on an added value and the
transfer of them under terms that would protect intellectual property rights of
the owner became singularly important.
The second was
the companion recognition in the late 1980s that the sharing of materials might
just translate into an advantageous business and opportunity for the owner. If
materials could be cast among academic scientists, industry bench scientists and
government researchers, might there not be interesting know-how, improvements
and new discoveries that could be reeled back in if the materials owner
implanted hooks into its agreements.
Third, it's clear
from the negotiations that we conduct now that fear also played a roll in the
demise of the traditional transfer by hand shake. That is, a fear of deep
pockets liability if materials were misused and also a fear that a potential
business opportunity for the materials owner might be thrown away if the
materials were sent out with no hooks applied.
That
background should provide a clearer understanding of why, in today's typical
material transfer agreement received by an academic institution, it is now
common that some combination of limitations, restrictions, give-backs or
reach-throughs will be found. Before materials can be introduced into scientific
research programs the terms under which the owner is willing to make them
available will need to be reconciled with the proposed scientific research
program, the sources of funding for it and the institutional policies having to
deal with freedom to publish the importance of sharing research findings with
colleagues and with technology transfer.
If I may, I
would like to just take a very short time to take you through some of the very
common but problematic terms that we are apt to see in the agreements that must
be signed before the transfer of materials can be accomplished. I would like to
say that it's between non-profits and except for non-profits, it is totally
unusual for us to see a one page material transfer agreement unless the type
size is minute. Most often these agreements will run well beyond the two page
quick transaction limit. They will commonly define or identify the materials
they cover and routinely expand that definition of materials to subsume progeny
that might be split off or replicated.
While that's
clearly understandable, unfortunately all too often the definition of the
materials is expanded by the owner to encompass modifications and derivatives of
them. This is where the problems for the receiving scientist are likely to
begin. For if the owner owns the materials under this expanded definition, the
owner also ends up with ownership of the modifications and the derivatives made
by the receiving scientist. The ownership problem is exacerbated if the
materials provider also wants ownership rights to all improvements, inventions
or discoveries developed as a result of using the materials.
If there's not an ownership issue, there is most likely a licensing
issue. Materials owners may require an exclusive license, royalty free to all
inventions and research results made through use of the materials or they may
require open-ended options or first refusal rights to license inventions
relating to use of the materials --
SEN. KENNEDY: Let
me give you another minute or two just to wrap up.
MS.
HERSEY: Yes, sure. Thank you, senator.
At a minimum, if
the materials provider is a commercial company a university may expect to grant
that company a royalty free non- exclusive license.
I
would just like to end by giving you a couple of observations that might help as
you look at or contemplate the kinds of agreements that may come in with
materials that are going to be used by NIH research. We do have at MIT a
slightly more difficult time with material transfer agreements coming in from
foreign organizations. There is a problem with control over use of the
materials, intellectual property rights and in fact some of the materials are
not owned by the foreign institutions at all but by the faculty, the scientists
who developed them.
I would just like to end by saying,
finally, how the material transfer agreements really affect the scientific work
of the university. They tend to be comprehensive legal agreements presenting
unique and complex issues for a university. That means they're time consuming to
negotiate, as you have already heard, and hold up research efforts. They often
contain ownership licensing and reach terms and conditions that are inconsistent
with federal requirements attached to federally funded research. They may
prohibit or restrict publication of research in a way that is unacceptable to
the academic institution and they may discourage innovation because, in fact,
the materials provider will control commercialization rights.
Thank you very much.
SEN. KENNEDY: Thank
you.
Dr. Childress.
MR. JAMES
CHILDRESS: Good afternoon, Mr. Chairman, and members of the committee. I'm James
Childress and I teach religious ethics and biomedical ethics at the University
of Virginia and also serve on the National Bioethics Advisory Commission.
I've been asked to present my own views on the ethical
issues in human stem cell research. In doing so, I will sometimes draw an NBACs
report on this topic along with its recommendations, which I as a commissioner,
helped to prepare and also endorse. I will briefly summarize several points from
my longer written testimony and I would respectfully request that that testimony
be entered into the record.
SEN. KENNEDY: All of the
testimony will be included.
MR.
MR.
CHILDRESS: Thank you very much.
I appreciate the thought and consideration that went into
President Bush's policy, but other more flexible policies are also ethically
acceptable, and even preferable. President Bush's policies suggest that it is
ethically acceptable to use federal funds for research on stem cell lines that
were derived prior to his announcement August 9, if the derivation also met
certain ethical requirements. Specifically, the donors of embryos that were
created solely for reproductive purposes, must have given informed consent
without any financial inducements.
If this policy is
ethically acceptable and satisfies basic ethical standards, and I believe it
does, then it should also be ethically acceptable to do the same thing
perspectively. That is, provide federal funds for research on stem cell lines
derived in the future, after August 9 as well as before, within the same ethical
guidelines. The prospective policy would offer greater and needed flexibility,
especially in view of the scientific uncertainty about the value of the approved
cell lines. And it would be ethically preferable, because it would increase the
possibilities for important research, without violating ethical standards.
This prospective policy can be undertaken without
sanctioning or encouraging further destruction of human embryos. Those were
legitimate, major concerns in President Bush's statement. We can establish
effective, ethical safeguards to ensure that a couple's voluntary decision to
destroy their embryos is voluntary and informed. Or that their decision to
donate them for research is voluntary, informed and uncompensated. The research
then would only determine how the destruction occurs, not whether it will
occur.
In making these points I want to stress that no
consensus exists among religious and secular moral traditions in our society
about the moral status of the unimplanted human embryo. Public policy in our
pluralistic society has to respect diverse fundamental beliefs, and yet it must
not be held hostage to any single view of embryonic life.
Whichever policies are finally adopted to enable stem cell research to
go forward within ethical limits, we will need a very strong public body to
review protocols for deriving stem cells from embryos and to monitor this
research. Perhaps the Council on Bioethics which President Bush has announced,
can fulfill these functions. If not, some other public body will be needed.
For example, the U.K. has established a statute, the Human
Fertilization and Embryology Authority, which reviews all embryo research. As
well as licensing reproductive technology and fertility clinics, it reviews all
embryo research in public and private arenas, and Congress might consider that
model for our society as well.
In a recent editorial in
Science, advocist (sp) LeRoy Walters stressed that governments and their
advisors should be humble and flexible, but also decisive and courageous. We
must carefully scrutinize claims of scientific promise, but we must not unduly
constrain research that may help alleviate human suffering and reduce the number
of premature deaths.
Indeed, we have a collective moral
duty to try to alleviate human suffering and reduce premature deaths, just as we
have a collective moral duty to respect important ethical limits in dealing with
developing human life. We must also provide clear and stringent ethical
safeguards in stem cell research, along with strong review and oversight. And I
think in the final analysis we must avoid unduly rigid rules that appear to be
arbitrary and inconsistent. Thank you very much for your attention, and I'll be
glad to answer any questions.
SEN. KENNEDY: Thank
you.
Dr. Fitzgerald?
MR.
FITZGERALD: I'd like to thank the Chair, Senator Kennedy, and the members of
this distinguished committee for this opportunity to come before you today to
discuss this issue. I would like to bring to bear on this issue my background in
molecular genetics in bioethics and in religion, to present a somewhat different
perspective on this issue than I think we've heard yet today. and in doing so, I
would like to offer a caveat: there is no way that I can do justice in the brief
time allotted to me to the numerous, serious, well-informed and thoughtful
people who are deeply concerned about this research, and the ethical and moral
ramifications of pursuing it. And these people, of course, include scientists,
who have no specific religious affiliation.
Since I
have limited time, let me focus on an issue that was raised earlier by Senator
Frist and then again by Senator Dodd, and that is the issue of what do we do
when we do not know? And there is much in this area we do not know. We do not
know much of the science and we do not know much of what the ethical, moral and
social ramifications will be. How are we going to respond to that lack of
knowledge? Because in that lack of knowledge, we truly run the risk of
overselling the promise and under-emphasizing the problems associated with human
embryonic stem cell research. As Senator Clinton stated, it is extremely
important that we receive and create a factual base here on this issue, and that
factual base will of course include more than just the scientific facts.
In addressing this controversial issue, many groups and
committees, such as the National Bioethics Advisory Committee, and also the
proposed committee to be directed by Dr. Leon Cass (sp), many committees have
been gathered together bringing experts from various fields of inquiry and
interest, to propose how our pluralistic society should respond to this
controversial area of biological research, in pursuing progress while protecting
justice.
For instance, as Dr. Childress has mentioned,
in trying to balance the concerns of many people of our nation, the National
Bioethics Advisory Commission came to the understanding that human embryos are
not just tissue; they do have some moral status and value to society. In
deciding that, the National Bioethics Advisory Commission, as well as others who
have come to similar conclusions, set the bar higher for us to pursue human
embryonic stem cell research, than it might be set for other avenues of
research. So in order to clear that bar and justifiably pursue this research,
one would have to meet a higher standard.
In addressing
a comment made earlier by Senator Specter, he said it's important that science
may have the full range of opportunity. I think it's also important to recognize
and remember that we already limit what science can do, especially in terms of
human research. The two areas that are most often raised as important to address
in meeting that higher standard for human embryonic stem cell research are need,
and also the number of people who will benefit from this research.
Let me first address the issue of need. Do we need human
embryonic stem cell research? Granted, human embryonic stem cell research is
scientifically quite interesting, fascinating and of great interest to the
people who do that research to pursue. However, often times we talk about
pursuing this in connection to the number of therapies and cures that will be
discovered. In fact, I believe the phrases of "countless number of people" and,
as Senator Specter said, "it will touch virtually every family in America."
I would argue that we could make the same claims for other
avenues of research, certainly research being pursued in genetic therapies,
research in protiomics, research in drug development and of course research in
adult stem cells. All these other areas of research do not need to set the bar
as high in being pursued. Embryos, human life, is not destroyed. Yet at the same
time, scientists involved in those avenues of research could make similar claims
as to potential of their research, and the number of diseases they are
addressing.
Secondly, when we talk about the number of
people who will be treated and/or cured by any of these medical areas of
research, we must be careful again not to oversell the promise. And remember
that, in fact, there are many even in our own nation that do not have access to
these new technologies and cutting edge medical products. Actually, Senator
Murray brought up a very interesting example. She asked the question: would we
have to keep human embryonic stem cell products hostage to such things as male
baldness?
And the interesting parallel there is that in
the early '90s, a drug was developed with FDA approval to treat a disease that
afflicts hundreds of thousands of people a year. It's called sleeping sickness.
It happens in Africa. The drug was the most effective drug against that disease
known. That drug was developed because it might be a cancer research tool or a
cancer therapy.
When it proved not to be so, the
company that was producing the drug decided not to produce any more, even though
it could cure or at least treat hundreds and thousands of people. However, the
drug is back. It is back because it has a side effect, it causes hair loss. And
so they have turned it into a cream that women can use to treat excessive facial
hair.
When we said we are going to promise people these
wonderful potential therapies and cures, are we indeed giving them the accurate
assessment of how our systems work? My issue is not necessarily specifically
with the pharmaceutical industry, but in promising the people of this country,
and perhaps the world, a solution and a promise that we cannot fulfill. I very
much appreciate the work of this committee, I appreciate the reflection that has
gone into the many proposals here, the many presentations here and I certainly
hope that we continue in our reflection on this very serious issue. Thank you
very much.
SEN. KENNEDY: The drug you're talking about
is methotrexate. My son who had osteosarcoma took that. He was in an age trial
and survived. I know it's about 85-90 percent survival rate for children in that
area. So you'd have a tough time convincing me about that particular one. I just
picked that up.
MR. FITZGERALD: Well, actually the drug
is eflorazine(sp), not methotrexate.
SEN. KENNEDY:
Okay. I stand to be corrected.
Doctor Chute?
DR. JOHN P. CHUTE: First I want to thank you, Senator
Kennedy, and the committee for inviting me to appear here today.
I come to this issue as a clinician first, as a clinically trained
hematologist and oncologist. And for the past five and a-half years, I've also
been directing research in adult hematopoietic stem cell biology. I also want to
say that it's been with great interest that I follow the work of Dr. Thompson
and those who have done embryonic stem cell line research. And I've been
fascinated that they've been able to propagate these cells in vitro as long as
they have shown they can in peer review journals, and that they can get these
cells to differentiate in neuronal epithelial muscle and hematopoietic cells.
And it's very understandable that patients with very serious diseases are very
excited and hopeful that there may be cures in the future for such things as
diabetes, Parkinson's and Alzheimer's, derived from further research on these
cells.
But as the national discourse on embryonic stem
cell research has progressed, there has been, ironically, a diminishing
appreciation of the exceptional progress that has been ongoing and occurring in
adult stem cell research. And I appear today so as to highlight the critical
importance of the ongoing research in adult stem cell biology.
In the year 2000, there were 1.2 million new cases of cancer in the
United States. Cancer is the second leading cause of death in the United States,
and the incidence of cancer is increasing. Adult hematopoietic stem cells have
been, in our current use, successful in the treatment and the cure of patients
with leukemia, lymphoma and other immunological malignancies.
Also of great interest is a newly developed method of transplanting
adult hematopoietic stem cells. They have now been shown to effect major
remissions in solid tumors and there's a group in NIH led by Dr. Barrett (ph)
and Dr. Childs (ph) that have recently shown that kidney cancer can be put into
remission with the donation of donor normal peripheral blood stem cells which is
a fascinating new development in the use of these cells to treat cancer.
Therefore, as this work moves forward, an even greater
number of patients will benefit from adult stem cell transplantation. As further
evidence, I submit to you that the two most important medications that we, as
oncologists, give to patients in their cancer treatment are epogen(ph) and
neupogen(ph), which are both growth factors, both of which were developed and
isolated through federally funded adult stem cell research. These medications
promote the recovery of red and white blood cells following chemotherapy and
allow patients' quality of life to be significantly improved, while also
preventing life-threatening infections.
Adult
hematopoietic stem cells are the ideal vehicle for gene therapy to treat such
diseases as sickle cell anemia, hemophilia and immune deficiencies. One in
100,000 children in America are afflicted with these life-threatening genetic
diseases. For the first time, in the past two years, two recent publications
have shown the successful gene transfer into patients with disease. Both of
these studies used adult hematopoietic stem cells.
At
the end of the year 2000, there were 70,000 Americans awaiting organ donation
for kidney and liver, heart or lung disease. Recent animal studies indicate that
the co-administration of hematopoietic stem cells along with organ transplant
patients may dramatically lessen the need for immunosuppression. If this moves
forward, thousands more patients will be able to be successfully transplanted
with organs with much less morbidity. In addition to these current applications,
even broader clinical therapies will derive from adult stem cells in the near
future. Published reports in the last five years have shown the transplanted
bone marrow stem cells can differentiate in vivo into functional liver cells,
skeletal muscle, brain cells and even functioning cardiac myocytes. This data
indicates that a rare subset of multi-potent stem cells are in fact pluripotent
and possess at least limited plasticity.
Adult cord
blood stem cells can be maintained in culture now for up to 12 weeks. Our
laboratory has shown that bone marrow stem cells can be extended tenfold in just
a week of culture under specialized conditions. Whether adult stem cells will
match embryonic stem cells in the treatment of diseases such as Parkinson's or
Alzheimer's remains unknown, and in my opinion, is probably unlikely. But given
the dramatic progress in adult stem cell research in the last five years, I
think continued funding is merited.
To close, I'd like
to just make a few points about embryonic stem cell research that are of
scientific concern. First, immune barriers for embryonic stem cells to work in
the transplantation for treatments like Alzheimer's and Parkinson's will require
immune barriers to be crossed. Scientists who are experts in the field, and
specifically Dr. Thompson of Wisconsin, has argued that cloning is the way to
get beyond this. And in fact, the scientific community recognizes that if immune
barriers cannot be crossed with some methods such as nuclear transfer, the
translation into actual therapies for patients will be extremely difficult.
Second, animal studies indicate that the transplantation
of embryonic stem cells actually has a high incidence of teratoma or tumor
development in small animal models. In vitro differentiation and genetic
engineering of embryonic stem cells prior to transplant have been proposed to
circumvent this problem. But both of these approaches have further technical
concerns. As Dr. Thompson himself has recently cited: "The heterogeneous nature
of embryonic stem cell development in culture has hampered the use of embryonic
stem cell derivatives in transplantation."
So I close
with the very brief following statement: the limitation of embryonic stem cells
as a source of transplantable tissue should be openly and honestly presented to
the public. Since treatments and cures using these cells are certainly not
imminent, in contrast, adult hematopoietic stem cells are successfully used in
the treatment of patients with common diseases every day. Genetic engineering is
not required for these cells to be safely applied. New treatment for diseases
are imminent with adult stem cells, not hypothetical. While science continues to
explore the basic biology of embryonic stem cell lines, the needs of thousands
of patients who benefit from adult stem cell research should not be
sacrificed.
Thank you. SEN. KENNEDY: Thank you. Thank
you very much. I thank all the members of the panel.
We're going to recess. I'd like to come back for some questions at
2:15. I know this causes some concern perhaps for your schedules. But if you
can, -- if you can't, I can understand, we'll submit some written questions -- I
don't think it will take long. Hopefully we'll have you out by 3:00. But if we
could do that, we'd very much appreciate it. We've had a very full morning, and
the two parties have these caucuses that start at 12:30. I see most of our
members have gone. I think by 2:15, they'll have ended and we hopefully may have
some additional participation. I am very, very grateful to all of our
panelists.
SEN. FRIST: Mr. Chairman, let me just add
that this is fascinating, based on our discussion this morning. If some of the
panels cannot stay, if we could submit them written questions. We don't know
what their schedule is, because I do have questions and I do not want to spend a
long time this afternoon. But if we could submit written questions, if you
cannot stay.
SEN. KENNEDY: Thank you. We will meet
again at 2:15.
The committee stands for recess.
(Recess.)
SEN. KENNEDY: We'll
come back to order and I'd invite witnesses to return to the stand if they
would, please.
Thank you very much for adjusting your
schedule, and I'd like to go through some questions here, if I might. I might
start with Dr. Melton. You've expressed several concerns about the restrictions
placed on stem cell research under the president's proposal. Do you believe that
the restrictions could significantly impede the scientific progress and slow
development of new cures using these cells?
MR. MELTON:
Yes. Yes, I do. I do think they will impede progress.
SEN. KENNEDY: Do you want to elaborate on that? We talked this morning
about the issue of accessibility, reliability and the safety, the contamination.
What is your own -- as a researcher, what is your own concern about?
MR. MELTON: Well, I could give one example, which is you
could imagine that with the cells that are available, scientists discover a
means by which they can turn human embryonic stem cells into pancreatic beta
cells for the treatment of diabetes. You would then want to use human embryonic
stem cells that have been derived freshly, in the absence of these potentially
contaminating mouse feeders, and use those for therapies, because that would
eliminate concerns about known and unknown viruses. And, as I understand it, the
new cell lines which would be derived would be ineligible for federal
researchers. That's one example of possible problems that will likely arise.
SEN. KENNEDY: How concerned should we be about
contamination, do you think? I mean, have you used products from other
countries? What's your own kind of sense; what's your own knowledge? How high
would you think that the risk might be?
MR. MELTON:
Well, I'm not really qualified to comment on that. But I would say that the FDA,
as I understand it, will treat this as a xeno-transplant, which means that the
hurdles and the requirements for using it in therapy will be much more onerous.
Dr. Chute can probably comment more on the difficulties in using the animal
products for treating humans.
SEN. KENNEDY: Dr.
Chute?
DR. CHUTE: Good morning, Senator Kennedy. In our
laboratory we've worked with a feeder layer that was a porcine feeder layer, and
to grow adult hematopoietic stem cells. I have had iterations with the FDA, both
on using a porcine and a human feeder layer, and without question there is a
long series of safety tests that you have to do on the human cells that are
cultivated with xeno feeder layers, such as mouse, porcine. And even with a
human feeder layer there is still a very, very long list of safety tests that
have to be done.
But I would make a comment that I
don't think it's impossible. I don't think it's impossible that if you use a
mouse feeder layer that the human cells derived from those cultures could ever
be used in the clinic. I think it just makes it more arduous, without question.
It might add a year or two, essentially, to the time before you get to the
clinic.
SEN. KENNEDY: Well, you're certainly restricted
now under the August date, so you wouldn't probably get there. After reviewing
the agreement, Dr. Melton, signed by NIH and the University of Wisconsin, I see
that it expressly forbids use of the cells for therapeutic or diagnostic
purposes. What are the implications of restrictions of this kind for the work
you do in trying to find new treatments for juvenile diabetes?
MR. MELTON: Well, first, I'm sort of surprised by that news, because I
haven't seen the agreement. But if it is the case, as you say, that the cells
could not be used for treatment, that I would think would be a damning
condition. I mean, clearly there's no point in doing the research I'm doing if
it weren't for the possibility of treating people. So, I'd have to see the
conditions to comment further.
SEN. KENNEDY: Ms Hersey,
the present plan gives a handful of suppliers control over all the federally
approved stem cell lines, and based on your experience negotiate agreements with
private companies. Wouldn't you agree that this type of monopoly is likely to
make it difficult for NIH funded researchers to get prompt access to these
cells?
MS. HERSEY: Yes, I think it's going to make it
very difficult, Senator.
SEN. KENNEDY: Are you familiar
with other types of situations that you know from the past that are in any way
similar to this kind of monopoly as --
MS. HERSEY:
There have been several, especially where the company holds patent rights. We
have seen a number of them. In some cases the NIH has been able to step in, as
they have this time, and try to make a difference for the university
researchers. But I would say at least 20 per cent of the time we cannot get
access to the materials we want because of the encumbrances.
SEN. KENNEDY: Dr. Childress, I want to underline one point you made in
your testimony. Is it fair to say that you see no ethical differences between a
stem cell derived from a discarded embryo on August 9 and one derived at a later
date?
MR. CHILDRESS: As long as we meet the kinds of
ethical standards that President Bush laid out, and I think those are important
ones about the embryo being left over following efforts at reproduction, that
the donors give volunteering form consent, and that there is to be no financial
inducements, that if we go forward and can apply the same ethical standards to
the derivation of stem cells from embryos in the future, I can't see an ethical
difference. I can't see that what happened before August 9 and what happens
after is ethically different.
The concern that some
have expressed that this might well sanction and encourage the destruction of
embryos, I think also is problematic as a concern because, after all, even to
this point, people may well have made decisions about the destruction of embryos
and the possibility of privately funded research, since that research has been
going forward. Furthermore, we really don't have evidence from fertility clinics
that people deciding to discard embryos make this a major factor in decision
making. So I would be inclined to say that we could build ethical safeguards to
prevent the kind of scenario that has concerned many.
SEN. KENNEDY: Have you formed any -- you've followed the fetal
transplantation issue closely.
MR. CHILDRESS: Yes.
SEN. KENNEDY: Have you formed any impression or -- maybe
I'd ask others on the panel -- about whether we ought to try and -- in that
debate we had the agreement for the use of certain fetal tissue, but we also
established guidelines for utilization in the private sector. Have you thought
about that issue as well, and can you tell us what your thinking has been; what
the advantages or concerns would be or perhaps the disadvantages?
MR. CHILDRESS: First of all I think there are significant
parallels between the kinds of ethical safeguards one would try to set up, which
appear to have been effective in the area of human fetal tissue transplantation
research, and the kinds of guidelines that would be appropriate in two different
settings. One would be the use of embryos left over after in-vitro
fertilization, but also the research we've not really talked about to date: the
derivation of embryonic germ cells from aborted fetuses.
And one could draw a parallel there also, and that area of research has
been omitted from much of the recent discussion, and I'm not sure whether it
merits further attention or not. I've not followed the scientific developments
from that side but one could perhaps make a case for paying some attention to
that as well.
SEN. KENNEDY: Throughout your
distinguished career you have shown a deep reverence for life. Do you think that
allowing the federally funded doctors both to use and derive stem cells from
discarded embryos is consistent with those deep held beliefs?
MR. CHILDRESS: I believe so. First of all, if we work with the notion
which the National Bioethics Advisory Commission also tried to articulate, that
it is very important to recognize that the embryo deserves an appropriate form
of respect; appropriate to that stage of development of life. Now, there will be
widespread disagreement in society about, as I have mentioned earlier, the moral
status of the embryo, exactly what kind or respect it deserves, what kind of
protection is appropriate.
On the National Bioethics
Advisory Commission we drew several implications from a notion of respect for
the early embryo. One certainly was that in this area we should not be buying
and selling embryos. Or, if we go in the direction of fetal tissue, we should
not be buying and selling fetal tissue. And one could also argue that you should
not use leftover embryos unless they are necessary.
Now, there would be considerable debate. I happen to be on the side of
those who think that given the promise of this research for alleviating
suffering and reducing the incidence of premature death, that we ought to be
exploring all sources of stem cells at this point. I certainly agree with my
colleagues who have stressed that we should not neglect adult stem cells in this
process and just think which ones will be most important in developing the kinds
of treatments and, we hope, cures, that might be possible.
One implication that we drew of this principle of respect for the early
embryo was that at this point we should not deliberately create embryos for
purposes of use in research; whether through IVF or so- called therapeutic
cloning. Now, we emphasize, and I would agree with this emphasis, that the point
we were making was "at this time." Because it may well be necessary to revisit
this question of so-called therapeutic cloning if the basic research ends up
producing some clinically effective treatments that may well best be done, or
perhaps only be done, with matched tissue. So it may be necessary to revisit
that at some point.
But, as we've heard from many
colleagues, we still have a long way to go before that becomes a critical
question again and it might raise the issue of the necessity of going in that
direction. I would be opposed though, at this point, to a ban on therapeutic
cloning, warning that would, indeed, set an inappropriate limit for future
developments.
SEN. KENNEDY: Well, I'm going to submit
some of the questions of our colleagues and I'm grateful to our panel. I thank
all of our witnesses for the excellent testimony. It's been an extremely
informative and important hearing. It's clear that stem cell research offers a
virtually unprecedented opportunity to find cures for a host of dread
afflictions from cancer to heart disease, diabetes to spinal cord injury, to
Parkinson's disease, to Alzheimer's disease.
But it is
also clear that there is serious concern for the scientific community about
whether the restrictive rules currently imposed by the Bush administration will
allow this research to proceed speedily and effectively. These concerns range
from the number, safety and durability of the existing cell lines, to whether
they will be truly widely available to researchers.
Memoranda Of Understanding that Secretary Thompson announced this
morning specifically prohibits the use of the cell lines in clinical research,
the research that is done to actually test possible treatments for illnesses.
Millions of patients and their families expect that stem cell research will move
forward as rapidly as possible. It would be unacceptable to offer these patients
and families the promise of effective stem cell research but deny them the
reality of it. We will continue to examine the question raised at the
hearing.
I am optimistic that Congress will take
whatever steps are necessary to ensure that stem cell research proceeds
effectively and ethically.
Our committee stands in
recess. I thank our panel. Thank you very much.
Document 41 of 98. 