<DOC>
[109 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:31011.wais]
S. Hrg. 109-700
RECENT CONTROVERSIES IN STEM CELL RESEARCH
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
SEPTEMBER 6, 2006--WASHINGTON, DC
__________
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COMMITTEE ON APPROPRIATIONS
THAD COCHRAN, Mississippi, Chairman
TED STEVENS, Alaska ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico PATRICK J. LEAHY, Vermont
CHRISTOPHER S. BOND, Missouri TOM HARKIN, Iowa
MITCH McCONNELL, Kentucky BARBARA A. MIKULSKI, Maryland
CONRAD BURNS, Montana HARRY REID, Nevada
RICHARD C. SHELBY, Alabama HERB KOHL, Wisconsin
JUDD GREGG, New Hampshire PATTY MURRAY, Washington
ROBERT F. BENNETT, Utah BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas MARY L. LANDRIEU, Louisiana
WAYNE ALLARD, Colorado
J. Bruce Evans, Staff Director
Terrence E. Sauvain, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
MIKE DeWINE, Ohio MARY L. LANDRIEU, Louisiana
RICHARD C. SHELBY, Alabama RICHARD J. DURBIN, Illinois
ROBERT C. BYRD, West Virginia (Ex
officio)
Professional Staff
Bettilou Taylor
Jim Sourwine
Mark Laisch
Sudip Shrikant Parikh
Candice Ngo
Lisa Bernhardt
Ellen Murray (Minority)
Erik Fatemi (Minority)
Adrienne Hallett (Minority)
Administrative Support
Jeff Kratz
C O N T E N T S
----------
Page
Opening statement of Senator Arlen Specter....................... 1
Statement of Senator Tom Harkin.................................. 3
Testimony of Robert Lanza, Ph.D., vice president, Advanced Cell
Technologies................................................... 4
Testimony of Hon. Ronald Green, Ph.D., professor, Dartmouth
College, and Chair, Advanced Cell Technologies Ethics Advisory
Board.......................................................... 8
Testimony of Kevin Eggan, Ph.D., assistant professor, Harvard
University..................................................... 11
Testimony of James Battey, M.D., Ph.D., Chairman, National
Institutes of Health Stem Cell Task Force...................... 13
RECENT CONTROVERSIES IN STEM CELL RESEARCH
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WEDNESDAY, SEPTEMBER 6, 2006
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:30 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter and Harkin.
opening statement of senator arlen specter
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health, Human Services,
and Education will now proceed. This morning we are going to
have a hearing on stem cell research. This is the 19th hearing
that the subcommittee will have held. In November 1998 stem
cells burst upon the scene and this subcommittee held a hearing
in early December, and we have had continuous hearings as we
have followed the development of stem cell research.
This morning's hearing is going to take a look at recent
claims that stem cells could be developed without destroying
the embryo and then a series of retractions which appear to say
that the original information was false. We want to find out
exactly what the facts are, what is the status on stem cell
research, and how there could be this kind of a serious
misrepresentation, if in fact that is what happened.
In dealing with stem cells, as we all know, we have an
extraordinary development to deal with the maladies which
confront the human race, stem cell potential, embryonic stem
cell potential, having been represented to have the potential
to cure Parkinson's, Alzheimer's, cancer, heart disease, spinal
cord, with the flexibility of these cells, virtually every
known ailment. So, a lot of people are watching stem cells. A
lot of people have hopes riding on stem cells. A lot of people
have their hopes up on stem cells if they can be developed
without killing the embryo to enable us to move Federal funding
into this important field.
So it is a matter of great concern and, candidly, some
distress to see the events of the past couple of weeks. Let me
welcome my distinguished colleague, Senator Harkin.
The Advanced Cell Technology used 16 donated human embryos,
which they took apart, therefore destroying them, as I
understand the facts, and obtained 91 individual cells, and
from these 91 cells they derived two embryonic stem cell lines.
Dr. Lanza's team showed proof of the principle that a stem cell
line can be derived from only one cell, but they did not show
that that could be done without destroying the embryo. This may
yet be possible. I hope that it is. But it has not been shown.
Several respected scientists are quoted in the September 5
Wall Street Journal saying that the conclusion drawn in the
press release requires a leap of faith, ``a little too big to
leap.''
Advanced Cell Technologies published a press release
saying, ``Company scientists have successfully generated human
embryonic cells using an approach that does not harm embryos.''
The publication Nature released a similar press release. The
research article does make it clear that the embryos were
destroyed, but neither the press release nor the Nature press
release makes that clear.
Dr. Lanza is quoted in the press release, ``We have
demonstrated for the first time that human embryonic stem cells
can be generated without interfering with embryonic potential
for life.'' That will be a key question here today, Dr. Lanza.
The chief executive officer, William Caldwell, sent a
letter to Congress stating, ``We have demonstrated for the very
first time that human embryonic stem cells can be derived from
a single cell without interfering with the embryo's potential
for full development.'' We are going to want to know what
happened on that.
Dr. Green is quoted in the Washington Post as saying, ``You
can honestly say this stem cell line is from an embryo that was
in no way harmed or destroyed.'' We are going to be asking you,
Dr. Green, how you can honestly say that or if that was an
honest statement.
Candidly, there is special concern from this subcommittee
because of the fact that this is not the first time that
Advanced Cell Technologies has overrepresented what they have
done. In November 2001 Advanced Cell Technologies made a
representation that they had achieved the first cloned embryo.
The subcommittee held a hearing on December 4 and found that
not to be the case.
The inspector general of Health and Human Services
conducted an investigation because ACT was receiving research
funds and Advanced Cell Technologies, according to the facts
presented to me, was compelled to reimburse NIH $147,000 and no
longer receives NIH funding.
Well, this is pretty serious stuff, dealing with a life and
death matter, and we have representations which create a lot of
hopes, a lot of hopes, and now they appear to be dashed. We
want to find out what the facts are, and if it is true that
these false and fraudulent representations were made, why.
Let me yield to my distinguished colleague, who has been a
partner in this. There has been no, I think, no activity in the
Congress since December 1998--we are on 8 years now and 19
hearings, a lot of energy and a lot of time and a lot of effort
and a lot of fights, a lot of fights all the way to the White
House, all the controversy and all the contentions and all the
advocacy to the President himself, the President himself,
eyeball to eyeball on this issue.
Senator Harkin and I have led the way for research funding
to go from $12 to $29 billion. It is a big black eye if
scientists are making false and fraudulent representations. We
passed the bill in the House and passed the bill in the Senate,
ready to go again to try to build up enough support to override
a veto. With 110 million people affected by maladies that could
be cured by stem cells, themselves and their families, we are
in a big, big arena.
Senator Harkin, your partnership is greatly appreciated.
Our joint accomplishments I think are very significant. Nothing
like health. Senator Harkin.
statement of senator tom harkin
Senator Harkin. Well, Mr. Chairman, thank you very much.
After that eloquent opening statement of yours and pointing out
all the facts in this, I ought to just yield back my time. But
I just want to add a couple things. First of all, I want to
thank you, Mr. Chairman. Senator Specter had the first hearing
right after the first stem cell lines were derived by Gerhart
at the University of Wisconsin--Thompson at the University of
Wisconsin, and Johns Hopkins. And he has been the leader in
this issue since December 1998.
I just echo what he said earlier about the fact that we
just cannot permit irresponsibility and irresponsible actions
to dash a lot of cold water on what is one of the most
promising lines of biomedical research in our lifetimes.
So I want to thank you again, Mr. Chairman, for your
leadership and for calling this hearing today. A lot of
confusion out there about this announcement that scientists can
derive stem cell lines from individual blastomeres. Hopefully,
this hearing will set some things straight, and I am glad to
see that the press is here to help straighten this mess out.
The confusion is regrettable and it could have been avoided if
people had acted more responsibly, responsibly.
First, I guess I could commend ACT for breaking new ground
on the derivation of stem cells. The company showed for the
first time that a stem cell line could be derived from a single
human blastomere. That is an interesting development. However,
ACT should have made it more clear from the beginning that none
of the embryos discussed in the Nature paper survived the
experiment. ACT created the impression that it had done
something that may be possible in theory, but has not actually
accomplished.
Second, the journal Nature made things worse by putting out
a press release that promoted this false impression.
Third, the media overhyped this announcement, portraying it
as a silver bullet that will solve everyone's ethical questions
about stem cell research. That is just wishful thinking.
What we need to do now is step back, examine what it was
that ACT really accomplished, and discuss what it means to the
future of stem cell research. But I think one thing is clear.
This new technique, even if it proves successful, does not in
any way diminish the need to pass H.R. 810, the Stem Cell
Research Enhancement Act, which the President vetoed in July
and about which Chairman Specter just said, just talked about,
which passed in the House, passed overwhelmingly in the Senate.
The reason it is necessary is because the NIH estimates
that there are about 400 stem cell lines worldwide. Right now,
because of the President's decision on August 9, 2001, Federal
funding can be used to study just 21 of those lines, everyone
of those being contaminated by mouse cells. So even if the
method described by ACT actually works, it will take years for
it to produce a substantial number of new lines. Those will be
years in which people continue to die of Parkinson's and ALS
and diabetes and cancers and dozens of other diseases that
could one day be treated or cured by stem cell research.
We should not make the mistake of holding out all our hope
for one new unproven method of deriving stem cells when we have
hundreds of lines that already exist. Scientists need access to
these lines now, not years from now.
Another thing. I think this incident, just like the
incident that happened in Korea earlier this year, once again,
as I said on the floor of the Senate before and I will say it
again here, proves the need to pass the Stem Cell Enhancement
Act that we worked so hard on, to open up these lines so that
NIH, with its years, with its years of ability to conduct good
peer review, to be able to oversee this, is so important.
This again points out why if we do not do this you are
going to have--I want to be careful with my words, but you will
have, I do not want to say ``rogue,'' but you will have
individual companies out there trying to hype things up. Now, I
do not know whether this company did it to enhance their stock
sales or not. That is what I read in the paper. Right after
this announcement, the stock went up. Now the stock is back
down again. Who made money during that period of time I do not
know.
But that is why it is so necessary for NIH to have
jurisdiction over this, and that is why I am glad to see Dr.
Battey here again this morning, who is the leader of the stem
cell research endeavor at NIH, and our other panelists who are
here.
But to close, Mr. Chairman, I want to thank you again for
your strong leadership on this issue from the very beginning. I
am just proud to be a partner with you and to support you in
this effort.
Senator Specter. Thank you, Senator Harkin.
Would you gentlemen stand for the administration of the
oath.
Senator Specter. Raise your right hand, Dr. Green.
Does each of you solemnly swear that the testimony you will
give before this subcommittee of the Appropriations Committee
of the U.S. Senate will be the truth, the whole truth, and
nothing but the truth, so help you God?
Dr. Battey. I do.
Dr. Lanza. I do.
Dr. Green. I do.
Dr. Eggan. I do.
Senator Specter. You may be seated.
Dr. Lanza, the floor is yours for 5 minutes.
TESTIMONY OF ROBERT LANZA, Ph.D., VICE PRESIDENT,
ADVANCED CELL TECHNOLOGIES
Dr. Lanza. Thank you. Before I even start, I want to make
it very clear: Our paper is 100 percent correct. I have always
been absolutely----
Senator Specter. How about your press release?
Dr. Lanza. The press release, okay, first of all, refers to
a procedure that has been used for over a decade and does not
appear, to the knowledge base that we have at this point, to
interfere with the development or potential of that embryo.
Senator Specter. Does your press release represent that you
can do embryo stem cell research without destroying the embryo?
Dr. Lanza. Using a technique----
Senator Specter. Are you accurately quoted as saying that?
Dr. Lanza. No. What the paper was about, the title of the
paper, the reason Nature published this paper----
Senator Specter. We're not on the title of the paper. I'm
on the statement in your press release that you can do embryo
stem cell research without destroying the embryo.
Dr. Lanza. We have developed a technique that allows us to
be able to generate embryonic stem cells without harming an
embryo, yes, that is correct, using that technique.
Senator Specter. Without destroying the embryo?
Dr. Lanza. Yes, a technique that we have shown allows us to
remove a cell, each and every cell, exactly the way it's done
in PGC, and we can use that cell that was removed in exactly
that same way to generate embryonic stem cells. Yes----
Senator Specter. You are quoted as saying, or I have your
press release, ``Until now embryonic stem cell research has
been synonymous with the destruction of human embryos,'' stated
Robert Lanza, M.D., Vice President of Research and Scientific
Development at Act and the study's senior author. ``We have
demonstrated for the first time human embryonic stem cells can
be generated without interfering with the embryo's potential
for life.''
Is that an accurate statement by you? Did you make that
statement?
Dr. Lanza. Yes.
Senator Specter. Is the statement true?
Dr. Lanza. Yes, it is.
Should I give my testimony and explain?
Senator Specter. You're under oath, Dr. Lanza. You may
proceed.
Dr. Lanza. Okay. Well, I would like to thank you for the
opportunity today to describe our technique for human embryonic
stem cells that we have isolated from single blastomeres. As
you know, stem cell lines are conventionally isolated, as you
have indicated, from left-over embryos created from couples
seeking in vitro fertilization, and I join with the sponsors of
S. 810 in my belief that scientific----
Senator Specter. The timekeeper will go back to 5 minutes
for your full 5 minutes. You may now proceed again.
Dr. Lanza. So conventionally embryos are isolated from
left-over embryos created by couples seeking in vitro
fertilization, and I commend both of you for your support of S.
810. My belief is that scientists should have continued access
to stem cells derived from the hundreds of thousands of such
surplus embryos that otherwise will be destroyed. I know you
share my frustration that this important legislation was vetoed
by the President.
Therefore, at the outset I want to make it absolutely clear
that the single-cell derivation technique that we have
developed is not a replacement for existing methods of
generating embryonic stem cell lines. In fact, our intention is
quite to the contrary. We think it would be tragic not to
pursue all the options and methods currently available to us to
get this technology to the bedside as soon as possible.
That being said, our hope is that this new method that we
described in Nature can be used to increase the number of stem
cell lines that qualify for Federal funding within the
framework of the current existing U.S. laws and regulations and
thus give this field a badly needed jump start.
Current U.S. law prohibits the use of Federal funds for
research in which human embryos are harmed or destroyed. As a
result of this policy, the field of stem cell research has been
crippled by the lack of accessible quality stem cell lines. At
present there are only, as you know, a handful of NIH-approved
lines, all of which are potentially contaminated with animal
pathogens and could lead to serious health risks, whereas
others are difficult to grow and have started to display
genetic abnormalities.
The approach we have developed does not involve the
destruction of embryos. The procedure is commonly known as PGD
and it's a well-established technique that has been used for a
decade to generate thousands of healthy babies worldwide. In
PGD, a single cell, known as a blastomere, is removed from an
eight-cell stage embryo for genetic testing. By growing this
cell overnight, the resulting cells can be used for both PGD
and generation of stem cells without affecting the clinical
outcome of the procedure or the subsequent chances of the
couple having a child.
Numerous reports show that the success rate--the survival
rate is unaffected by the biopsy procedure and that the
subsequent development and chances of implantation are the same
for both normal and biopsied embryos. In our study, multiple
individual cells were removed from the embryos in the same way
as would be employed in the clinical setting with PGD. Although
these particular embryos were not allowed to develop further,
we also carried out studies which confirmed that the biopsy
procedure we use could be used without destroying an embryo,
the embryo.
I want to be entirely, entirely clear on this point. The
embryos used to create stem cell lines in our study were
destroyed. However, in control experiments single cell biopsied
embryos were allowed to continue development and they did not--
they did indeed develop to a more advanced blastocyst stage.
They were all frozen and remain alive. In fact, they continued
developing at the same rate as non-biopsied embryos.
We also showed that individual biopsied cells have the
capacity to create stem cells. Ninteen stem cell outgrowths in
two stable embryonic stem cell lines were derived from 91
blastomeres. These stem cell lines have been growing for more
than 8 months and are genetically normal and able to create
cells from all germ layers of the body, including nerve cells,
blood cells, and even retinal cells that could be used to
prevent blindness.
Of course, embryonic stem cells derived this way could be
of great benefit, not only for the medical research community
but for the children born from transferred PGD embryos as well.
The cells would be genetically identical to the child and they
could be frozen down and used throughout the lifetime of the
person, for instance if they develop diabetes or heart disease.
First I would like to address several objections to the use
of this procedure. First is that the technique may not be
entirely without risk to the embryo, however minimal. We
totally agree and until remaining doubts are satisfied and
doubts about safety are resolved we do not recommend the
procedure be applied to healthy embryos outside the context of
PGD. However, in PGD a cell is already removed and could
therefore be used to create stem cells without any added risk
to the embryo.
Second, concerns have been raised as to whether individual
cells, such as those used in our study, are totipotent and
could themselves potentially generate a human being. It is our
opinion that this is not true. Recent reports show that the
cell fate is already being determined at the two to four-cell
stage. Importantly, individual cells from an eight-cell stage
embryo, such as those used in our study, have never been shown
to have the capacity to create a complete organism in any
mammalian species, not even a mouse or a rat.
Finally, questions have been raised as to whether the
technique is completely applicable in the clinical setting. We
believe it is and are working on procedures that could be
utilized by clinicians in the IVF clinic environment. Thus, we
believe it is now possible to create new stem cell lines
without destroying human embryos. With the support of Federal
funding, the single cell derivation technique could provide
new, robust, and animal product-free cell lines for medical
research and human clinical trials.
Since I testified here a year ago, we have managed to move
the single cell derivation technique from the mouse to the
human. But in the meantime, another million people have died of
diseases that could potentially be treated and possibly cured
using future stem cell therapies. How long are we going to
allow this intolerable situation to continue? Stem cell
scientists sorely need more lines to qualify for Federal
funding.
Make no mistake about it, there are many promising
alternatives out there, but the conventional methods and the
single cell derivation techniques are a reality. They are here
and now.
There are those who would want to set this research back,
but there is a very real human tragedy out there and it would
be a shame not to use this opportunity to try to lessen the
misery of so many Americans with disorders and disabilities.
This is my hope and it could start here with this committee.
Now is the time to move, while the United States is still in
the forefront of this research and while there is still time
enough to develop therapies that could be used to alleviate the
suffering of those we know and love.
Thank you for the opportunity to address this committee. I
hope you find these comments helpful to you in your work.
Senator Specter. Thank you, Dr. Lanza.
We're going to turn now to Dr. Ronald Green, who is
Director of Dartmouth's Institute for the Study of Applied
Professional Ethics and currently heads the Ethics Advisory
Board of Advanced Cell Technologies.
Dr. Green, the floor is yours for 5 minutes. I would like
you in your opening statement to address the quotation in the
Washington Post, ``You can honestly say this cell line is from
an embryo that was in no way harmed or destroyed''. You may
proceed.
TESTIMONY OF HON. RONALD GREEN, Ph.D., PROFESSOR,
DARTMOUTH COLLEGE, AND CHAIR, ADVANCED CELL
TECHNOLOGIES ETHICS ADVISORY BOARD
Dr. Green. Yes, thank you very much, Senator.
Let me address that initially immediately. That was an
elliptical remark taken out of context. The journalist I
believe is actually here today, and the question----
Senator Specter. What's an elliptical remark, doctor?
Dr. Green. Well, it was a part of my quotation, sir. It was
a part of my quotation. The full quotation was something to the
effect--and I don't have a recording of it--something to the
effect, if a stem cell line were produced using this method,
then you could honestly say that. That was the full quote.
Sir, I read the paper. I knew that 16 embryos were
eviscerated and that's the reality. Five or six cells were
taken from each embryo, which is incompatible with that embryo
going on to full survival. I would never personally or as an
ethicist have misrepresented that.
Senator Specter. Do you have the full quotation of which
you say this is an elliptical extract?
Dr. Green. I'm willing under oath, sir, to say that I
believe that the full quotation was something to the--was to
the effect----
Senator Specter. Answer my question. Do you have the full
quotation that you say this is an elliptical extraction?
Dr. Green. Sir, I was interviewed on the telephone. I was
speaking to a journalist. He asked me a question.
Senator Specter. Interviewed on the telephone?
Dr. Green. That's correct. It was not a written interview.
Senator Specter. Okay, reset the clock to 5 minutes for Dr.
Green.
Dr. Green. Thank you.
Good morning, Mr. Chairman and distinguished members of the
committee. My name is Ronald M. Green. I am a professor of
ethics at Dartmouth College and Director of Dartmouth's Ethics
Institute. I also serve as chairman of Advanced Cell
Technologies' Ethics Advisory Board. I would like to emphasize
that I am a university-based bioethicist and that I have no
financial interest whatsoever in ACT's technology.
I believe that the method of stem cell derivation announced
by ACT researchers in their August 23 report in the journal
Nature represents a real opportunity to move human embryonic
stem cell research forward in this country in a way that
respects the ethical sensitivities of the vast majority of our
citizens.
Dr. Lanza has already touched on some of the key ethical
issues. He has stressed how this research could be conducted in
the context of pre-implantation genetic diagnosis, PGD, without
any additional risk of harm to the embryos involved in this
procedure. That's a key phrase: without any additional risk of
harm.
Dr. Lanza has also shown that the extracted individual
cells cannot reasonably be regarded as individual or
independent human beings. No cells extracted at this stage of
development could go on to full term development.
There are two remaining ethical concerns that I would like
to address. First, there is the connection between this new
method and both in vitro fertilization, IVF, and pre-
implantation genetic diagnosis, PGD. Some people in our society
object to both of these technologies because they involve the
manipulation of embryos and because parents using these
procedures can elect not to implant some of the embryos
produced in this way.
But this objection is made by only a very small minority.
The overwhelming majority of Americans support both procedures.
IVF helps infertile couples have children and PGD allows those
who carry dread genetic diseases to have healthy children. Both
procedures help people have children that otherwise would never
have been conceived or born. In this respect, both procedures
are profoundly pro-life.
Second, there is the concern that the embryos used in this
research did not survive the experiment. Since the publication
of the Nature report some critics have emphasized the fact that
even though it remains true that the approach developed by ACT
scientists requires no further destruction of any embryos--and
that was the statement in the press report and that statement
is accurate--even though this is the case, there was an initial
destruction of embryos.
I would like to point out that because this research was
privately funded, this experiment was fully legal. It was also
approved by ACT's Ethics Advisory Board and by an additional
institutional review board that is mandated under Massachusetts
law. The embryos used were donated by people who had fully
consented to this research and understood and even required
that the embryos would not be allowed to go on to further
development.
It is not unique that the initial research needed to
develop morally acceptable methods or materials does not always
meet everyone's approval. But this does not impugn the methods
or materials produced as a result of this research. One example
is the polio vaccines we use today. Some of the initial
research back in the 1950s on these vaccines was conducted with
a technique that required the use of tissues from aborted
fetuses. Later this approach was replaced by other methods.
Almost no one today refuses to vaccinate their children on the
grounds that they object to the methods used in the initial
experiments.
I would point out that even President Bush has been willing
to use the harmless downstream results of research to which he
objects. All of the cell lines being used today in federally
funded research were produced by embryos that were destroyed
for this purpose before the President's August 9, 2001,
directive. The President could have said that none of these
lines should be used because they were created in a way that he
regarded as morally objectionable. But he did not. He concluded
that so long as no future harm is done this valuable resource
could be used.
Thanks to this surprising research breakthrough, we are in
exactly the same position today. If Congress were to approve
legislation that funded research on lines generated by this new
method and if President Bush were to permit such legislation to
pass into law, both the Members of Congress and the President
could honestly turn to the American people and say that no
human embryo ever again needs to be harmed or destroyed to
produce the stem cell lines that we need for federally funded
research.
Many scientists believe that we will need several hundred
new federally funded stem cell lines in order to have the
genetic diversity we require. Well over 2,000 pre-implantation
genetic diagnosis procedures are conducted in this country each
year. If just one out of three of the couples using this
procedure authorize the harmless derivation of a stem cell line
from the extracted cell of each of the embryos they choose to
implant, we could produce at least 50 new cell lines every year
from now on, and I believe that is a conservative estimate.
The derivation of these cell lines would cause no added
harm to any of the donor embryos, a fact of critical importance
for both the ethical and legal authorization of this research.
Let me conclude by saying that I am not a scientist.
Although I have been impressed by the quality and the integrity
of ACT scientists, their work will have to be replicated by
other researchers before we can say that it is ready for
widespread use. But if Congress begins the legislative
initiatives to test this method and fund research based on it,
we can start today to move forward to the kinds of cures and
therapies that stem cell research requires.
Thank you.
Senator Specter. Dr. Green, you talk about Congress moving
forward to fund this research. Let me tell you, our job, the
job of Senator Harkin and myself, is made a lot tougher, a lot
tougher, by these claims, these statements, one of which you
made, which have not been borne out. Talking about Congress to
do something, you have made our job a lot tougher.
Dr. Green. May I reply to that, Senator?
Senator Specter. Go ahead.
Dr. Green. I have tried to explain what I regard as a
misrepresentation of my telephone quote to a journalist. I hope
I have made that clear.
Let me say this, sir. I believe that the controversy that
we are seeing today is directly proportional to the importance
of this breakthrough. I think that a controversy, an artificial
controversy, has been generated by those who desperately do not
want to see human embryonic stem cell research go forward. I
hope that the Congress will be able to separate what I regard
as an artificial and generated controversy from the significant
scientific breakthrough that we're here talking about today.
Senator Specter. When you say you hope that Congress can
separate it, Congress is worried about Guantanamo, worried
about Iraq, worried about electronic surveillance, worried
about social security. Very hard to get Congress to focus on
stem cell research, and when you give Congress any reason not
to, and you give them a lot of good reasons not to, they brush
it off like lint off their jacket.
You're not very realistic. But then you aren't experienced
with Congress. But we are.
We now turn to Dr. Kevin Eggan, assistant professor of
Molecular and Cellular Biology at Harvard University, principal
investigator at the Harvard Stem Cell Institute and assistant
investigator at the Stowers Medical Institute. Thank you for
joining us, Dr. Eggan, and we look forward to your testimony.
TESTIMONY OF KEVIN EGGAN, Ph.D., ASSISTANT PROFESSOR,
HARVARD UNIVERSITY
Dr. Eggan. Thanks very much. Senator Specter, Senator
Harkin, members of the Appropriations Committee, colleagues and
fellow citizens: My name is Kevin Eggan and I'm an assistant
investigator at the Stowers Medical Institute, a principal
investigator of the Harvard Stem Cell Institute, and an
assistant professor of Molecular and Cellular Biology at
Harvard University.
I'm here today to provide testimony not only as a
representative of these institutions and a scientist deeply
involved in embryonic stem cell research, but also as a well-
informed American citizen. I'm a citizen who believes, like a
majority of Americans, that human embryonic stem cell research
provides hope for the development of novel therapies for
millions of people suffering from a wide variety of currently
incurable diseases like diabetes, Parkinson's disease, heart
disease, and amyotrophic lateral sclerosis.
I would in particular like to make several comments on the
noteworthy work led by my colleague Dr. Robert Lanza that was
recently published in the journal Nature. This paper describes
the derivation of new human embryonic stem cell lines from
individual cells, also called blastomeres, isolated from human
pre-implantation embryos at the eight-cell stage. In this
method the individual cells are removed from the pre-
implantation embryo and co-cultured with clumps of previously
derived stem cell lines. Under these appropriate conditions and
currently at a low frequency, this method causes the blastomere
cells to divide and eventually give rise to human embryonic
stem cells of their own.
Although it seems reasonable to extrapolate these findings
to the removal of a single blastomere from the pre-implantation
embryo, this has not yet been demonstrated. In any case, it is
my scientific opinion that these blastomere-derived embryonic
stem cell lines differ in no significant way from embryonic
stem cell lines derived by standard methods from pre-
implantation blastocyst stage embryos, such as those donated by
couples who have completed their assisted reproduction
treatment.
This new method was not more efficient than currently
published and widely used methods for deriving new embryonic
stem cell lines and it does not directly enable the derivation
of stem cell lines that carry patient genes which could be used
as sources of transplantation tissue or serve as models of
human disease. Additionally, it is unclear whether a single
blastomere itself could be considered a pre-implantation
embryo. Experiments in rabbits have shown that blastomeres
isolated at this stage have the potential to develop into an
entire animal, while experiments in mice suggest that this is
not the case.
I know of no experiment that speaks to this issue in human
pre-implantation development, although it is clear that the
human pre-embryo is morphologically more similar to the rabbit
than the mouse. As a result, professionally I can see no
scientific rationale or advantage to deriving additional human
embryonic stem cell lines by this method. Personally, I can see
no societal advantage to this approach either, as a majority of
Americans approve of methods currently used for ESL line
derivation.
I myself am not a physician involved in the treatment of
infertile patients by IVF, nor do I provide pre-implantation
genetic diagnosis with IVF for patients whose future children
are at risk for genetic disease. However, as a stem cell
scientist I have many colleagues that do practice these
important forms of medicine. From my conversations with these
individuals, I have come to understand that this proposed
method for embryonic stem cell derivation is not really
consistent with the commonly practiced standard of care that is
administered by clinicians in the United States at this time,
particularly this proposed method in which the cell is allowed
to divide overnight before it's used for derivation and PGD.
The main problem in this regard is that the proposed
approach, as has been articulated by Dr. Lanza, is that it
might require a delay in the time of IVF embryo transfer into
the woman's uterus, putting the treatment of the patient couple
at risk. As a result, I feel that few if any patients would opt
to consent to undergo this new procedure for deriving stem cell
lines or, I think it's important to point out, any procedure
which is perceived by them to possibly interfere with their
treatment. Therefore it seems unlikely from a practical point
of view that few if any embryonic stem cell lines would be
generated by this new proposed procedure.
Thus, although these experiments provide interesting
embryological findings concerning the biology of the human pre-
implantation embryo, they do not in my opinion change the
scientific landscape of human embryonic stem cell research in
the United States today. At this time there is still a profound
need for expanded Federal funding for research on new human
embryonic stem cell lines that have been and will be derived,
but that are not part of the presidential registry. This
expanding funding which would have been provided by H.R. 810
and its Senate companion bill is still sorely needed.
Finally, I would like to highlight the continued need for
experiments on a wide variety of approaches for generating stem
cell lines that carry the genes of patients and those that
cause human disease. These cell lines would not only serve as
important models for the study of disease, but could also
eventually provide a source of tissues for transplantation and
cell replacement medicine.
In closing, thank you for your--thank you for the chance to
testify today and thank you for your attention.
Senator Specter. Thank you very much, Dr. Eggan.
We now turn to the distinguished Chairman of the National
Institutes Stem Cell Task Force and Director of the NIH
Institute on Deafness and Other Communications Disorders, Dr.
James Battey, bachelor of science from California Institute of
Technology and M.D. and Ph.D. degrees from Stanford.
We thank you for your work in the field, Dr. Battey, and
the floor is yours.
TESTIMONY OF JAMES BATTEY, M.D., Ph.D., CHAIRMAN,
NATIONAL INSTITUTES OF HEALTH STEM CELL
TASK FORCE
Dr. Battey. Thank you, Senator Specter, for the opportunity
to address the subcommittee this morning, and thank you, Mr.
Harkin, and thank both of you for the wonderful work you do in
support of biomedical research.
I'm here today in my role as a scientist and Chair of the
NIH Stem Cell Task Force to discuss with you a new technique
for deriving human embryonic stem cell lines, one of several
approaches that may some day make it possible to produce
pluripotent human stem cells without the destruction of human
embryos. Scientists at ACT have modified a technique pioneered
by human fertility clinics called PGD, which we've heard
discussed in great detail, so I won't go into any additional
elaboration about PGD. The subcommittee I'm sure understands
very clearly that it involves the removal of a single cell at
the eight-cell stage.
In October 2005 Dr. Robert Lanza's research team at ACT
reported that they had removed single cells from early mouse
embryos in a process that they called single cell embryo
biopsy. Rather than testing the single cells for inherited
diseases, they used them to establish mouse embryonic stem cell
lines, and the remaining cells of the embryo were implanted in
surrogate mouse wombs and approximately half developed into
seemingly normal mouse pups. In the control group of non-
biopsied embryos, about half also developed to birth as normal
pups.
This research was the first to demonstrate that single cell
embryo biopsy can be used successfully to generate embryonic
stem cell lines in a mouse model.
In August 2006, the ACT research team reported that they
had successfully established human embryonic stem cell lines
from single cells taken from pre-implantation human embryos.
The human stem cell lines created using this technique behaved
like pluripotent stem cells, including making proteins critical
for stemness and being able to produce cells from all three
germ layers, which indicates their potential to produce most,
if not all, types of cells in a normal human being.
It's important to note that the August 2006 publication
does not describe an identical method to that demonstrated in
mice the previous October. In the human experiment published
last month, ACT researchers removed multiple cells, four to
seven per embryo, from each of the embryos used and in the
process destroyed the embryos. They also cultured multiple
cells from the same embryo together, raising questions about
whether continued cell singling in the culture medium may have
influenced their ability to produce stem cell lines and
therefore whether it can be said that they indeed produced stem
cell lines from single cells in a way that could be reproduced
without requiring the destruction of embryos in the future.
These questions would need to be resolved by additional
experiments and so, although the experiments described provide
some remarkable and interesting new insights, we are not now in
the position to say that single blastomere biopsy has been
proven as a source of human embryonic stem cell lines.
These points were not immediately obvious in the publicity
surrounding last month's publication, but have since been made
clear. Proponents of single cell embryo biopsy suggest that
since it requires only one cell from the embryo, the remaining
cells may yet implant in the womb and develop into a living
being. And although the technique proposes to avoid embryo
destruction, scientists do not yet know how much risk the
procedure might confer to an otherwise healthy embryo. PGD is a
relatively recent medical procedure and there are no systematic
studies of long-term effects on children born following PGD.
Moreover, PGD is used to avoid transferring embryos that carry
an inherited disease into the womb of the woman undergoing IVF.
The same potential benefit to the embryo does not apply in the
case of a single cell embryo biopsy performed on a presumably
healthy human embryo.
Additionally, it may be argued that the biopsied blastomere
is itself capable of developing into a living being. In sheep
and rabbits, this, for example, single cells are capable of
developing into viable animals. However, the same does not
appear to be true for mice, at least not at an efficiency that
can be reliably measured in experiments. Testing such a
prospect with a single human blastomere would raise serious
ethical questions and as a result as a scientist I cannot tell
you whether or not it is possible at some frequency for a
single human blastomere to develop into a living being.
Senator Specter. Thank you much. Thank you very much, Dr.
Battey.
The subcommittee again invited Dr. Edmund Pellegrino, Chair
of the President's Council on Bioethics, to appear before this
subcommittee and he again declined. Doctor--executive director
of the National Council of Catholic Bishops Richard Doerflinger
will be heard by the subcommittee at a later day.
Dr. Lanza, going right to the core of the press release
which quotes you, ``We have demonstrated for the first time
that human embryonic stem cells can be generated without
interfering with the embryo's potential for life.'' Is that an
accurate quotation of you?
Dr. Lanza. Yes. What the whole press release is about is
the technique. I think 100 percent we have shown that that is
correct, that we have developed a technique that we have indeed
shown does work and would be applicable in the clinical
setting.
Senator Specter. But you did not generate human embryonic
stem cells without interfering with the embryo's potential for
life.
Dr. Lanza. Can I sort of explain how this research
operates? One is----
Senator Specter. Well, you can try.
Dr. Lanza. Okay. One is is that we actually initiated our
studies first to see whether or not we could use the technique
we employed in these studies to remove a cell without harming
the embryo. We did that and we found that by removing one cell,
exactly the way we employed in this study, that we could allow
the remaining embryos to go on to become blastocyst. They are
frozen. They remain alive.
Then what our next goal was was to say, if we use that
procedure, which we confirmed works and that has been used
throughout the world literally for years and years in hundreds
of clinics, the question is if you remove each cell exactly the
same way as in that PGD procedure, can that cell, just like it
would be removed in PGD, create stem cell lines.
Senator Specter. Dr. Lanza, we understand your point. You
made it in your opening statement.
Dr. Lanza. Right.
Senator Specter. In your opening statement you say: ``The
biopsy procedure we used could be used without destroying the
embryos.'' That's enormously different from the earlier
quotation I read to you.
Is there any consideration at all on your company for the
financial benefits which will come to your company as a result
of such a dramatic, albeit false, representation?
Dr. Lanza. Let me tell you one thing, and this is honest--
I'm under oath--is I wasn't in contact with the business end--
--
Senator Specter. You're not telling us one thing that's
honest and under oath. You're telling us everything that's
honest and under oath. You're telling us everything that's
under oath.
Dr. Lanza. Right.
Senator Specter. So I hope it's all honest.
Dr. Lanza. Yes. I've been trying to be as straightforward
as I know how.
I've always focused on what the--the technique we have
developed, and this technique, everything I said is absolutely
correct and accurate.
Senator Specter. You're talking about, you're talking about
a technique which you hope, which you speculate, may lead you
to develop stem cells without destroying the human embryo, but
you haven't done it.
Dr. Lanza. We removed the cell exactly as it is done in PGD
and showed they can create stem cell. We've done that.
Senator Specter. Dr. Green, you made quite a representation
about not having any financial interest in ACT. Are you paid
for your work by ACT?
Dr. Green. Each member of the ACT Ethics Advisory Board is
paid the equivalent of the NIH per diem, the study section
payment, for any meetings, annual meetings or quarterly
meetings, depending upon the frequency.
Senator Specter. Dr. Green, is that a yes?
Dr. Green. Am I paid for? I am paid only for the meetings
that we have, which extend--we have not had a meeting for over
a year of the board, a formal meeting, sir, and as a
consequence I have received no payment whatsoever in the last
year at all.
Senator Specter. Dr. Battey, do you think that this so-
called technique has advanced the scientific research effort to
derive stem cell lines, embryonic stem cell lines, without
killing the embryo?
Dr. Battey. I think the technique is scientifically very
interesting. I think it will be very interesting to find out if
the stem cell lines derived from single blastomeres have the
same or different properties than stem cell lines derived by
removing the inner cell mass from an embryo. But at a minimum
it provides an alternative source for pluripotent cell lines.
Senator Specter. Thank you. It may have the potential to
advance that research?
Dr. Battey. Correct.
Senator Specter. Dr. Eggan, would you agree with that?
Dr. Eggan. Well, I guess I would draw into question whether
or not there's any reason to believe that these cell lines
would be different from normal embryonic stem cell lines. I
don't think we have a high confidence that that's certainly the
case. One could investigate that.
I guess I would say that it seems to me that there really
is no scientific advantage to this approach and it really in my
mind represents more of a potential patient solution, and I
would stress that it's still a potential solution, rather than
having any particular scientific benefit. I think that there
have been already many stem cell lines derived from discarded
IVF blastocysts which could be used for the research which
scientists would like to pursue, and if it could be
accomplished that a framework could be established for Federal
funding on those stem cell lines then I think this would be
very useful.
Senator Specter. The red light went on during the middle of
your answer, Dr. Eggan. So I'll yield to Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
I think one of the problems we have is that we're lay
people, we're not scientists, and we're trying to explain this
in non-scientific terms. Sometimes when you get scientific
terms and non-scientific terms meeting there is confusion. I
think this is what we're kind of caught up in right now.
I wish I had a chart Mr. Fatemi here just had drawn me
yesterday of what happened, and I think if you put it on a
chart it really makes it clear that what ACT did was rather
unique in terms of deriving a stem cell line from a blastomere,
but in fact the rest of the cells were all destroyed. Is that
correct, Dr. Lanza? The rest of the cells were all destroyed?
Dr. Lanza. We did not allow those embryos to continue, yes.
Senator Harkin. So you derived a stem cell line from that.
Now, what people thought happened was that one cell was taken
from that eight-cell mass and it was allowed to grow overnight.
Out of that, since it then divided, you took a cell for the PGD
experiment and then another for the stem line cell. That did
not happen. That's what people thought happened. That still has
never been done. That's never been done.
Dr. Lanza. We never said that or claimed that. But that's
how it would be done in the clinical setting.
Senator Harkin. We all get misquoted all the time. We are
experts in that field. I understand that. But it's all this
confusion. So there's the thought out there that you have
already done what maybe you can do in the future, maybe. We
don't know, but maybe you can do this in the future. I think
that's sort of--I hope I was interpreting Dr. Battey right on
that--that ACT did not prove--you have not yet proved what you
claimed you can do.
Dr. Lanza. You're 100 percent right. All those claims that
you're making now I never made. No one that I'm aware ever made
those claims. We were always discussing our scientific paper,
which was that we developed this technique, and then explained
to people how it would apply in the clinical setting. So we
tried to explain that.
Now, how the news reports are spinning it and how this
hearing is doing that, I can't control that. I can only tell
you the facts.
Senator Harkin. Dr. Battey, let me ask you this. The
procedure that they would like to experiment on, that is taking
a single cell from the blastomere stage, letting it grow
overnight, extracting from that a cell for experimentation on
genetic imperfections, let's say, or PGD, taking another cell,
the other part of that cell, and then growing that, attempting
to grow that into a stem cell line--am I saying it correctly
now?
Dr. Battey. Yes, you are.
Senator Specter. Would that be permissible now under
Federal guidelines?
Dr. Battey. There are two issues. There is the issue of the
Human Embryonic Research Prohibition Amendment, that is
language that is found on the Department of Health and Human
Services Appropriations Act.
Senator Harkin. The Dickey amendment.
Dr. Battey. Also known as the Dickey amendment, which says
that none of the funds made available in this act may be used
for the creation of a human embryo or embryos for research
purposes.
Senator Harkin. Well, but we're not creating an embryo. The
embryos are gotten from IVF clinics.
Dr. Battey. Then the second part--I think we should just go
through it in detail so we can be clear--the funds may also not
be used for research in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk of injury
or death greater than that allowed for research on fetuses in
utero.
Senator Harkin. Got it, got it.
Dr. Battey. So the core issue then is how sure are we that
removing a single cell doesn't in any way harm the embryo.
Senator Harkin. Well, I guess the response of the other
side would be to say that we have we don't know how many--I've
heard between 1,000 and 2,000 children have been born from IVF
clinics where this PGD experimentation has taken place.
Dr. Battey. Correct. We don't know whether it's harmful. We
don't know whether--at some level, we know that certainly
normal children can be born, so it's not always harmful, that's
for sure.
Senator Harkin. We also know that this has only been done
in the past 10 years, so none of these kids are over 10 years
of age.
Dr. Battey. That is also true.
Senator Harkin. Okay, so we don't know the long-term
effects.
Dr. Battey. So I think to answer your question with regards
to the Dickey amendment, we would probably need to get a legal
opinion----
Senator Harkin. I see.
Dr. Battey [continuing]. About whether or not indeed the
work could, Federal funds could be used for that purpose.
Senator Harkin. I think again we get back--we go around and
we come back to sort of square one again here, where Senator
Specter and I have been for a long time. I don't mean to speak
for him, but I think we both have an equal mind on this. That
is that this type of experimentation should go forward, but it
shouldn't go forward at the exclusion of--and I think, Dr.
Lanza, you said that--at the exclusion of the kind of stem cell
research that would be allowed under H.R. 810.
Dr. Lanza. Absolutely.
Senator Harkin. You agree with that?
Dr. Lanza. Absolutely.
Senator Harkin. That's because if we are looking at--you
mentioned about 2,000 a year. I think that's a little high, by
the way, for PGD, but it's somewhere between 1,000 and 2,000;
can we agree on that, somewhere in that neighborhood? These are
very expensive. I've heard the cost of this is $10,000 or
something like that, to do one of these experimentations. So
you get very few. You said maybe we get 50 a year.
Well, to get to where we are right now with the existing
stem cell lines that could be used by Federal researchers or
researchers under the Federal umbrella of NIH, 400, would take
us another 8 years, even if we could do it. We still don't even
know if you can do it or not. That may take another couple of
years, just to see whether or not we can do it.
Dr. Lanza. Let me make one point. I'm a stem cell scientist
and more so than you I want those conventional methods to
proceed. I want H.R. 810 to proceed. This is in no way supposed
to interfere with it. That is going to continue on and
hopefully that legislation will pass.
What we're trying to do now is to get some more lines
available into the hands of researchers who are very severely
limited. The field has been crippled because these people only
have a handful of these lines. Now, as we move into clinical
trials we're going to need new lines that have not been exposed
to animal pathogens. So we have an opportunity here now to
create these lines, animal-free conditions, and also with new
robust techniques. So even a few of those lines could help.
Senator Harkin. Again, fine. But see, we still don't know
if this is allowed, Federal funding would be allowed, for this
type of research. Dr. Battey said we'd have to seek some type
of legal opinion on it, I suppose. I'm not certain myself.
Dr. Lanza. That was the main reason for doing this
research, was to try to move this field forward. That was my
intent.
Senator Harkin. I understand. But, as I said in my opening
statement, fine, you derived a stem cell line from a
blastomere, that's fine. But all the rest of the cells were
destroyed, so we still haven't gotten to the point where you
can extract a single cell from a blastomere, let it grow
overnight, divide in two, take one of those for PGD, and take
the other one and develop it into a stem cell line. That has
not been done yet.
Dr. Lanza. Right, exactly. This was a scientific paper to
address the issue whether biologically, if you remove a single
cell as you do in PGD, can it create stem cells, and we didn't
know that. And this is what this paper's about. This is what
we're----
Senator Harkin. My final point on this issue is that, even
if we go down this line to the exclusion of H.R. 810, it will
take several years before we ever get there, because we don't
even know if it can be done yet. Maybe, maybe. So we've got to
prove it, proof of concept first. Second, deriving stem cell
lines from this methodology would take several years.
Then you have to worry about the diversity. I mean, let's
face it. Who gets IVF done in this country, and how many of
those have PGD done or would allow? As Dr. Eggan mentioned,
we're dealing with couples who want to have a child and you're
going to tell them, well, we're going to take this embryo and
we're going to take a cell out? I mean, they're going to say:
Hey, we just want to have a baby.
Dr. Lanza. We're exactly on the same page. This is not a
replacement for conventional methods. I 100 percent agree with
you.
Senator Harkin. That's why I think, while this is an
interesting area of experimentation and scientific research,
it's been hyped up too much, way overhyped, and we ought to
come back down to earth and say, okay, fine, we can go ahead
with this, but I think if nothing else comes out of this
hearing this morning, it does not replace in any way the
efforts that we tried to do under H.R. 810, which is to open up
hundreds of stem cell lines.
Dr. Lanza. Absolutely. It was never our intention,
absolutely.
Dr. Green. Senator.
Senator Harkin. Yes, Dr. Green.
Dr. Green. May I add a clarification----
Senator Harkin. Yes.
Dr. Green [continuing]. To Dr. Eggan's remarks as well? I
think it is a mistake to understand that this research would
proceed using IVF embryos. That is not the issue. One is not
going to infertile couples and saying to them, please let us
take a cell from one of yours. You could not do that ethically
at this time, given the harm, unknown harm.
This is directed at couples undergoing pre-implantation
genetic diagnosis. At least 2,000 such couples undergo this
procedure every year. The cell is already taken from the embryo
for the purpose of the genetic diagnosis. They have consented
to that. They have requested that. They have paid that, 2,000
people.
Now, it seems to me that many of these people would be more
than willing to see if the technique could be developed a bit
further to see those cells grown out, for two reasons. First,
those cells, if they become a stem cell line, will be
immunologically compatible to the child they bring into being.
So the child will now have in a freezer compatible stem cells
for its future health care needs. Remember, they have already
agreed to the biopsy. There's no additional risk to their
child.
Second, these are people who are suffering from dreaded
diseases, the vast majority of whom will consent to support
this research. Before coming here I spoke to one of the leading
PGD researchers in the country, who does over 700 such
procedures every year. When we discussed this matter his
initial and enthusiastic comment to me was: How can I start
doing this?
I am personally confident--I'm speaking only personally,
not as a scientist--that we will have hundreds and hundreds of
stem cell lines in the near future. As the efficiency of Dr.
Lanza's procedure is increased, we will have more than enough.
Is this a replacement for current methods? No, that's not
the issue here. It is a new method coming on line, which if you
in Congress will advance the support for its development and
perfection will alter the shape of the stem cell issue in our
country.
Furthermore, and I want to add one further thing to this.
The removal of a single cell in the context of PGD--and that is
all I am speaking about--but if this technique in fact over
time proves harmless to further research on the children
already produced by this method, the thousands, the hundreds of
children produced by this, if it proves harmless I would say
this is going to become a routine adjunct to in vitro
fertilization as couples put aside a stock of ESL lines for
their IVF child in the future.
So I am--we're speaking here of an enormous breakthrough in
American medicine, not undertaken solely for ethical reasons,
as Dr. Eggan has suggested, but for biomedical and scientific
reasons. I think the challenge before us is to separate a furor
that's been created by some opponents of this research from the
reality of the science and ethics that it involves.
Senator Harkin. Dr. Green, one correction. There has been
no big scientific breakthrough in this regard. It has never yet
been done, what you are talking about, okay?
Dr. Green. I disagree with you on that, sir.
Senator Harkin. Never been done.
Yes, Dr. Eggan.
Dr. Eggan. Thank you for the opportunity to respond, and I
apologize to Dr. Green if my testimony was not clear. But I was
referring only to these cases in which the proposed method of
obtaining blastomeres from PGD embryos was used and I was in no
way referring to use this with standard IVF procedures, because
I agree that that would be irresponsible at this time.
Again, I will not speak as a clinician who is involved in
IVF or PGD research. However, I will speak as a stem cell
scientist who is intimately involved with the process of
consenting human subjects, the patients themselves who are
involved in these IVF procedures to participate in stem cell
research. In this regard I can relate my personal experience,
and that is that couples are quite willing, it seems, to
participate in research which in no way puts their current
treatment at risk. For instance, they seem very willing to
donate discarded IVF embryos or even embryos which have been
subjected to PGD and have been determined to carry the affected
disease genes and would be discarded.
However, in my experience they tend to be quite resistant
to any sort of change in the medical procedure which would put
their current treatment at risk. Although I recognize that it
may not be always the case, my discussions with a variety of
IVF personnel lead me to believe that currently one of the
limiting factors in the PGD treatment is the time which it
takes to actually perform the pre-implantation genetic
diagnosis.
Now, in some clinics this may not be the case. But in many
clinics it is true that the blastomere is retrieved and
essentially literally sent to the genotyping company by Federal
Express to be genotyped and then the patient is often waiting
for the genotype information for the embryo transfer to be
performed. Now, again this is not always the case, but it is
often the case.
So my sense is that for many of these patients they would
be resistant to anything which would cause a delay in the time
of the embryo transfer which might be sub-optimal for their
treatment. So again, at least for some cases I think this is
reason enough for patients to not want to participate, and if
there is any perception on their part that it's going to hurt
their chances of becoming pregnant, which it may or may not,
then I think they'll be resistant to being involved in this
research.
Senator Specter. Thank you, doctor.
Dr. Lanza. Can I reply to that?
Senator Specter. Thank you, gentlemen. I think the point
has just come out, emphasized by Senator Harkin, that this in
no way affects the research which is being undertaken at the
present time. That's a very, very important point.
Dr. Green, I have to disagree with you about opponents of
this method having undercut it. It's been undercut by the
proponents of this method. I find Dr. Lanza's explanation
totally unsatisfactory, totally unsatisfactory. The only way to
read the press release and the affirmative representations made
by your company is to the effect that you can have stem cell
research without destroying the embryo.
You may have a hope and you may have a technique or you may
not, but you certainly haven't accomplished that, and that's
what you told the world.
Dr. Green, you have to--your explanation is similarly not
acceptable, although if you talked about it on the telephone
you have to be concerned with what you say on the telephone.
You're a prominent ethics expert. You're connected with ACT and
people look to you for accurate representations as to what's
going on.
It is only my hope that this doesn't set back stem cell
research generally, that the opponents of stem cell research
don't paint with a broad brush and say, you see, you haven't
done anything to prove you can deal with Parkinson's or
Alzheimer's or heart disease or cancer, and here's another big
fat representation, it's been blown to smithereens, not worth
the paper it's written on.
We had a hearing on December 4, Dr. Lanza, where we had to
call you to task for ACT's misrepresentations. I hope we don't
have it in the future, so that we can proceed, as Dr. Battey
has said, to try to develop research along stem cell lines
which will get congressional approval and ultimately lead us to
eliminate the prohibition against Federal funding.
conclusion of hearing
Thank you all very much for being here. That concludes our
hearing.
[Whereupon, at 10:10 a.m., Wednesday, September 6, the
hearing was concluded, and the subcommittee was recessed, to
reconvene subject to the call of the Chair.]
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