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[Senate Hearing 109-700]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 109-700

               RECENT CONTROVERSIES IN STEM CELL RESEARCH

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

                                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

                               __________

         Printed for the use of the Committee on Appropriations

  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html

                                 _____

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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

                              ----------                              

                      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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