<DOC>
[107 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:83684.wais]
S. Hrg. 107-812
HUMAN CLONING: MUST WE SACRIFICE MEDICAL RESEARCH IN THE NAME OF A
TOTAL BAN?
=======================================================================
HEARING
before the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 5, 2002
__________
Serial No. J-107-55
__________
Printed for the use of the Committee on the Judiciary
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COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
EDWARD M. KENNEDY, Massachusetts ORRIN G. HATCH, Utah
JOSEPH R. BIDEN, Jr., Delaware STROM THURMOND, South Carolina
HERBERT KOHL, Wisconsin CHARLES E. GRASSLEY, Iowa
DIANNE FEINSTEIN, California ARLEN SPECTER, Pennsylvania
RUSSELL D. FEINGOLD, Wisconsin JON KYL, Arizona
CHARLES E. SCHUMER, New York MIKE DeWINE, Ohio
RICHARD J. DURBIN, Illinois JEFF SESSIONS, Alabama
MARIA CANTWELL, Washington SAM BROWNBACK, Kansas
JOHN EDWARDS, North Carolina MITCH McCONNELL, Kentucky
Bruce A. Cohen, Majority Chief Counsel and Staff Director
Sharon Prost, Minority Chief Counsel
Makan Delrahim, Minority Staff Director
C O N T E N T S
----------
STATEMENTS OF COMMITTEE MEMBERS
Page
Brownback, Hon. Sam, a U.S. Senator from the State of Kansas..... 76
Cantwell, Hon. Maria, a U.S. Senator from the State of Washington 77
Durbin, Hon. Richard J., a U.S. Senator from the State of
Illinois....................................................... 85
Feinstein, Hon. Dianne, a U.S. Senator from the State of
California..................................................... 1
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah...... 3
Kennedy, Hon. Edward M., a U.S. Senator from the State of
Massachusetts.................................................. 86
Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont. 86
Specter, Hon. Arlen, a U.S. Senator from the State of
Pennsylvania................................................... 15
WITNESSES
Charo, R. Alta, Professor of Law and Medical Ethics, University
of Wisconsin Law School, Madison, Wisconsin.................... 30
FitzGerald, Kevin, S.J., Georgetown University Medical Center,
Washington, D.C................................................ 44
Greely, Henry T., Professor of Law, and Director, Center for Law
and the Biosciences, Stanford University, Stanford, California. 25
Greenwood, Hon. James C., a Representative in Congress from the
State of Pennsylvania.......................................... 12
Gulden, Kris, Coalition for the Advancement of Medical Research,
Washington, D.C................................................ 34
Kimbrell, Andrew, Executive Director, International Center for
Technology Assessment, Washington, D.C......................... 38
Weissman, Irving L., M.D., Chair, National Academies Panel on
Scientific and Medical Aspects of Human Reproductive Cloning,
and Professor, Stanford University School of Medicine,
Stanford, California........................................... 20
Weldon, Hon. Dave, a Representative in Congress from the State of
Florida........................................................ 6
QUESTIONS AND ANSWERS
Questions submitted by Senator Feinstein to the witnesses........ 65
Responses of Dr. Weissman to questions submitted by Senator
Feinstein...................................................... 67
Responses of Mr. Greely to questions submitted by Senator
Feinstein...................................................... 70
Responses of Ms. Charo to questions submitted by Senator
Feinstein...................................................... 71
SUBMISSIONS FOR THE RECORD
American Society for Cell Biology, Bethesda, Maryland, statement. 75
Citizens' supporting legislation to prohibit cloning, joint
statement...................................................... 79
CNN.com, article................................................. 83
Coalition for the Advancement of Medical Research, Washington,
D.C., statement................................................ 84
NewScientist.com, article........................................ 87
New York Times:
editorial, January 19, 2002.................................. 88
Jack M. Balkin, article, January 30, 2002.................... 89
St. Louis Post-Dispatch, editorial, December 3, 2001............. 90
United Network for Organ Sharing, Richmond, Virginia, list....... 92
Verfaillie, Catherine, M.D., Professor of Medicine, and Director,
Stem Cell Institute, University of Minnesota, Minneapolis,
Minnesota...................................................... 96
Washington Post, editorial, January 22, 2002..................... 96
HUMAN CLONING: MUST WE SACRIFICE MEDICAL RESEARCH IN THE NAME OF A
TOTAL BAN?
----------
TUESDAY, FEBRUARY 5, 2002
U.S. Senate,
Committee on the Judiciary,
Washington, DC.
The committee met, pursuant to notice, at 2:10 p.m., in
room SD-226, Dirksen Senate Office Building, Hon. Dianne
Feinstein presiding.
Present: Senators Feinstein, Kennedy, Durbin, Hatch,
Specter, DeWine, and Brownback.
OPENING STATEMENT OF HON. DIANNE FEINSTEIN, A U.S. SENATOR FROM
THE STATE OF CALIFORNIA
Chairperson Feinstein. I would like to begin by calling the
hearing together and welcoming the two distinguished Members of
Congress.
I would like to begin by making a brief statement and then
the Ranking Member, who will be for this hearing Senator Hatch,
will be on his way over and he will make a brief statement.
Do you gentlemen have a time problem, because if you do, I
will accommodate you now.
Mr. Weldon. I am fine.
Mr. Greenwood. I am not leaving until he leaves.
[Laughter.]
Chairperson Feinstein. Cloning seems to be one of those
words and concepts that seems to inspire a lot of dread in
people, visions of an apocalyptic world marching lockstep.
However, as is the case with many medical technologies, it is
not cloning that is the problem, but some of its potential
applications. For example, we are all concerned about the sale
of human organs or the transplant of organs from executed
prisoners, but few people argue that the solution to these
potential problems is to ban organ transplantation.
The truth is that there is bad cloning and good cloning, I
believe. Bad cloning is human cloning, the creation of carbon
copies of whole human beings. Good cloning is nuclear
transplantation to produce stem cells.
There is broad agreement across our society, in Congress
and in the scientific, medical and religious communities, that
we should ban human cloning. Such cloning is scientifically
unsafe, morally unacceptable, and ethically flawed.
However, at least to me, it is also clear, and I think to
the overwhelming majority of the scientific and medical
community, that we should not ban nuclear transplantation to
produce stem cells. Many doctors and scientists have argued
that we must protect our ability to use cloning techniques to
try to save and improve the lives of those ravaged by disease
and other ailments.
In fact, nuclear transplantation offers enormous potential
for providing cures to diseases such as cancer, diabetes,
cystic fibrosis, and heart disease, as well as conditions such
as spinal cord injuries, liver damage, arthritis, and burns.
This technique could allow the creation of bone marrow for
transplants to leukemia victims, islet cells for the pancreas
of a diabetic, heart or liver tissue to repair the damage
caused by heart attacks or hepatitis, healthy skin for grafts
for burn victims, and many other potential cures and treatments
for a variety of diseases and ailments.
Let me make a few points. First, nuclear transplantation
could be used to create embryonic stem cells which could be
used to make tissues, and even organs, for transplant. This
would help relieve the serious shortage of tissues and organs
for transplant. Over 50,000 Americans today are waiting for
organ transplants, while hundreds of thousands more need tissue
transplants. Tragically, over 5,000 people die a year because
they can't get the organs or the tissues they need to be
donated, and many of these are very young children.
Second, the use of nuclear transplantation to produce a
tissue or organ could virtually eliminate the danger that the
patient's body would reject it. Nuclear transplantation
techniques could allow the implantation of new cells or tissues
that exactly match those of the person to whom they are
implanted, greatly reducing the likelihood that the person's
body would reject those cells or tissues. Such research has the
potential to save thousands of lives and relieve the pain and
misery of thousands more.
Third, nuclear transplantation has many other applications
as well. It could be used to produce human proteins, such as
blood-clotting factors that aid in healing wounds. It could
yield information on stem cell differentiation, providing
valuable information about the mechanism of aging and the
causes of cancer. It could even be used to find a cure for
cancer by teaching us how to reprogram cells.
Senator Brownback and I both co-chair the Senate Cancer
Coalition. I am delighted he is here today. We are also both
part of the National Cancer Dialogue.
So I believe strongly that it would be a disaster to ban
this kind of valuable research. Thus, Senator Kennedy and I
have introduced a bill, S. 1758, that takes a balanced
approach, we believe, to the cloning issue. This legislation
would make the cloning of a human being a crime, while allowing
research involving nuclear transplantation to proceed.
This is the same approach recommended by a number of blue
ribbon scientific and medical panels, including the National
Bioethics Advisory Commission, the National Academies' Panel on
Scientific and Medical Aspects of Human Cloning, and the
California Advisory Committee on Human Cloning.
All of these commissions and panels delved deeply into the
cloning issue and ended up coming to the same conclusion: ban
human cloning, but don't interfere with important areas of
scientific research using nuclear transplantation to produce
stem cells.
So I am very pleased that two of the colleagues sponsoring
this bill are on this committee, Senator Kennedy and Senator
Durbin. In addition, Senators Boxer, Miller, Corzine, Clinton,
and Mikulski are cosponsors. I am also happy that the
Federation of American Societies for Experimental Biology, as
well as 22 other scientific and medical organizations, have
endorsed the bill.
In this letter, they note that S. 1758 is a carefully
worded bill that should expedite the development of therapies
for millions of Americans. I would now like to put this letter
in the record.
I also want to acknowledge Senator Specter's leadership on
the cloning issue, as well as on stem cell research generally.
He and Senator Harkin have introduced legislation, S. 1893,
that is very similar to our bill, S. 1758, and I look forward
to working with them on this issue.
I very much look forward to hearing from the witnesses
today.
I would now like to turn to the very distinguished ranking
member of the full committee, the distinguished Senator from
the Olympic State, Senator Hatch.
STATEMENT OF HON. ORRIN G. HATCH, A U.S. SENATOR FROM THE STATE
OF UTAH
Senator Hatch. Thank you, Madam Chairman. First, I would
like to inform the Chair that Senator Kyl is managing an
important amendment on the floor and will unfortunately be
unable to attend this hearing.
Today, the committee takes up an important set of issues as
we explore how considerations of law and ethics affect, and
should affect, the science of what is commonly and perhaps
confusingly lumped together under the term ``cloning.''
In a general sense, cloning merely means making a xerox
copy, an exact duplicate. There are, in fact, many types of
entirely unobjectionable, non-controversial, common uses of
cloning in science. For example, if researchers developed a new
smallpox vaccine and needed to clone billions and billions of
copies of a snippet of genetic material as part of this new
therapy, no one would complain, or at least I believe nobody
would.
In the context of this hearing, cloning does raise
substantial questions. Today, we will examine cloning as a
technique to produce cells, or even potentially whole
individuals, with the identical genetic code of one parent
cell.
Cloning stands in sharp contrast to normal reproduction,
the proverbial birds and the bees, in which the father and the
mother each contribute one-half of the genetic makeup, the DNA,
of the offspring. While nature in some cases produces twins who
share the same two parents and virtually identical genetic
code, cloning technology could conceivably 1 day enable the
birth of literally a new type of person who springs forth from
solely the genetic contribution of a single parent.
The type of cloning we are discussing today revolves around
the technology of somatic cell nuclear transfer. This consists
of removing the nucleus of an egg and replacing it with the
full complement of 46 chromosomes from an adult body cell.
This, of course, is very different from the time-immemorial
case in which the egg and spermatozoa contribute 23 chromosomes
each to the offspring. Theoretically, an embryo produced in the
test tube through this somatic cell nuclear transfer technique
could be implanted into a womb and result in a live birth.
No doubt somewhere, some, such as the Ralians, are trying
to make a name for themselves and are busy trying to apply the
techniques that gave us Dolly the sheep to human beings.
Frankly, I am not sure that ``human being'' would even be the
correct term for such an individual heretofore unknown in
nature.
I am a conservative, and an unabashed pro-life conservative
at that, or should I say, to be more politically correct, I am
a faith-based conservative. In any event, I would be extremely
hesitant to rewrite the Book of Genesis as the story of Adam or
Eve.
We know that most everyone at this time opposes so-called
reproductive cloning, the development and birth of a completely
new type of individual through what would essentially amount to
an elaborate form of asexual reproduction.
The fact is that, today, there is not a simple,
straightforward Federal law that prohibits reproductive
cloning. I believe, and I believe that the members of this
committee and the entire Senate and House believe that it is
long past time for reproductive cloning to be prohibited by
Federal law.
Here is the rub: There is another branch of cloning, termed
by its proponents as ``therapeutic cloning,'' which I think is
a lousy name for it, whose motivation is not birth, but the
development of a broad range of new treatments and diagnostic
tests for a host of diseases. Through cloning techniques, it is
possible that the type of highly versatile pluripotent stem
cells we heard so much about last year could be produced.
As some of the testimony today reveals, many scientists and
advocates believe that this line of research is both ethically
proper and appears extremely promising. Many believe that the
problem of potential rejection of new stem cell-derived tissues
could be minimized and perhaps avoided altogether by what I
would call DNA regenerative therapy.
Other well-respected experts and groups will tell us that
not only is the science being over-hyped, but there remain
fundamental legal and ethical objections to this line of
research because the very creation and subsequent destruction
of these new types of cloned embryos is inherently immoral.
A question with which the Senate struggled in 1998 and with
which we still struggle today is to see whether we can find a
way to outlaw the offensive uses of cloning techniques but do
so in a manner that does not bar potentially life-saving and
ethically proper scientific research.
So I commend Senator Leahy and Senator Feinstein for
holding this hearing today so that we may more fully explore
these complex issues. The Senator from California, together
with our colleague Senator Kennedy, has offered legislation on
this topic. As well, Senator Specter, in partnership with
Labor-HHS Appropriations Subcommittee Chairman Tom Harkin, has
held over 12 hearings in this general area, and they have also
offered both legislation and leadership in the biomedical
research arena.
Frankly, I think we all need to take our hats off to
President Bush and congressional leaders like Arlen Specter and
Tom Harkin for the bipartisan achievement in doubling our
Nation's investment in biomedical research at NIH over the past
5 years.
My pro-life colleague and good friend, Senator Brownback,
takes a different view than Senators Feinstein, Kennedy,
Specter and Harkin on some key aspects of cloning legislation.
He, too, has offered a bill. It is similar to the measure
sponsored by one of our most influential witnesses today,
Representative Dave Weldon, that passed the House last year. We
also welcome Representative Jim Greenwood here today and
commend him for his efforts as well.
I am studying the issues and the proposed legislative
responses. I have met with experts on all sides of this issue
from all over the world, and I welcome the opportunity to learn
more today.
This debate today will inevitably and ultimately involve
questions regarding when and under what circumstances life
begins. As we saw during the debate on the Federal funding of
certain stem cell research last year, these are difficult
issues and opinion is unlikely to be monolithic.
Public education and debate are essential in our
pluralistic society if we are to reach acceptable compromises
on contentious issues. Toward this end, I would repeat a
thought I raised at a Judiciary Committee markup last August,
when I wondered aloud whether the development of an egg
incapable of implantation might alter the debate on these
issues. I intend to ask this question of the witnesses today.
I hope that today's hearing will help the members of the
committee gain a better understanding of the science, law, and
ethics of cloning. It is my hope that this committee and the
Congress will be able to arrive at a reasonable consensus on a
policy that fully respects the dignity of humanity with respect
to reproduction and research.
So I want to thank you, Madam Chairman. I appreciate being
with you.
Chairperson Feinstein. I thank you, Senator.
Now, we will turn to our two House Members, and I would
like to introduce them both at one time, beginning with
Congressman Weldon.
Congressman Dave Weldon, of Florida, was elected to
Congress in 1994. He represents Florida's 15th Congressional
District. He is a practicing physician and an Army veteran. I
am very pleased to note that he served his internship and
residency in San Francisco at the Lederman Army Medical Center,
which is unfortunately no longer there today.
Mr. Weldon serves on the House Science Committee, the House
Financial Services Committee, and the Government Oversight and
Reform Committee. He is the sponsor of H.R. 2505, the House-
passed legislation that would ban both human reproductive
cloning and therapeutic cloning.
While I am doing it, I will also introduce, if I may,
Congressman Jim Greenwood. He was elected to Congress in 1992.
He represents Pennsylvania's 8th District. He serves on the
House Commerce Committee and Education and Workforce Committee.
He served as chairman of the task force charged with reforming
the Food and Drug Administration, and he has also been active
on many health care issues, including Medicare and Medicaid.
Mr. Greenwood sponsored the House substitute to the Weldon
anti-cloning bill. That legislation would prohibit human
reproductive cloning, but permit therapeutic cloning.
So welcome, gentlemen. We are delighted to have you here.
Mr. Weldon, if we could begin with you, please.
STATEMENT OF HON. DAVE WELDON, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF FLORIDA
Representative Weldon. Thank you, Madam Chairman. I want to
thank you for the opportunity to be here to testify on this
very important issue, and I certainly want to commend you and
the ranking member for taking this issue up. I think the
American public really would like the Senate to speak on this
issue. It is very, very obvious that scientists are moving
ahead and creating cloned human embryos in the lab.
Let me just start out by saying that I practiced medicine
for 15 years. I still see patients once a month at the
veteran's clinic in my district. I have taken care of patients
with diabetes. My father had diabetes. I have taken care of
patients with Alzheimer's disease, spinal cord injuries. So I
do not approach any consideration that would preclude a
particular avenue of research lightly.
I would just like to underscore--and I believe both of you
touched on this issue in your opening statements--the belief is
that by allowing embryo cloning in the lab, you will somehow be
able to extract stem cells from this and would be able to treat
somebody with some type of condition.
Right now, today, that is purely a theoretical construct.
It does not exist, nor is there an animal model of such a
therapy. You cannot take a mouse, for example, with a disease
and extract stem cells from a cloned embryo of mouse and treat
that disease.
It certainly is well worth saying that there are hundreds
of millions of dollars being spent on all types of research
modalities to treat these conditions--surgical modalities,
pharmacologic modalities. I think the important point I would
like to underscore about this is when we use the terms
``enormous potential'' and ``tremendous breakthroughs,'' you
can lead some people who are suffering from these diseases or
their family members to develop false hopes.
I just want to underscore that the legislation that we
passed out of the House and that is very similar to the
legislation introduced by my friend, Sam Brownback, does not
preclude animal research in this arena. It would allow it to go
forward unfettered.
The real central debate here is are we now going to carry
the stem cell debate to the place where we are now creating
human embryos for this purpose. The debate 4 or 6 months ago,
or a year, 2, 3, 4, years ago was on using excess embryos from
fertility clinics, and I think many very, very thoughtful
people believed that that was morally and ethically OK.
Indeed, it was viewed that these embryos were destined for
destruction and that it would be inappropriate to just allow
them to be destroyed without having any redeeming use, and
therefore this type of embryo stem cell research should be
allowed to proceed.
I would just like to point out that many people who put
forward that argument in the past, including the Washington
Post in an editorial they did in 1994, and including some
letters to the President that actually came out of this body,
underscored the fact that creating embryos for destructive
research purposes was a direction that we did not want to go
into. But that is exactly the direction we are heading into
now.
Now, some may contend that these embryos are not human or
that they are not really embryos. I can just tell you from a
scientific basis there is absolutely no foundation to put
forward such a claim. This is a human embryo that we would be
essentially saying it is legal to create this, but only for the
purpose of exploiting it for research purposes and then it has
to be destroyed. We would be saying it is illegal to implant it
into a woman.
I just want to underscore a couple of additional points.
One important one is that some people have tried to portray
this as a pro-life/pro-choice type of debate. While there may
be some people who may view it in that context, if you actually
look at what went on in the House, it pretty much transcended
that, in that there were a lot of people who were very pro-
choice in their outlook, some of whom had a 100-percent
approval from various groups like NARAL, who voted for the ban.
Indeed, some pretty vocal feminist groups came out in
support of banning human cloning, most notably Judy Norsigian,
with the Boston women's health book group, the coauthor of Our
Bodies, Ourselves for the New Century. She and Steward Newman
of the Council for Genetic Responsibility wrote in a Boston
Globe op ed, ``Because embryo cloning will compromise women's
health, turning their eggs and wombs into commodities,
compromise their reproductive autonomy, and with virtual
certainty lead to the production of experimental human beings,
we are convinced that the line must be drawn here.''
The point they are alluding there, of course, is that if we
are going to allow research labs all over the country to start
creating these embryos in large quantities for research
purposes, they are going to have to get female eggs from
somewhere. Where are they going to get these female eggs from?
Well, the same place the group in Worcester, Massachusetts, got
them from; they paid women to do it. So you will be, in my
opinion--and they agree with me--you will be essentially
exploiting women by--it will be women who need money who will
come forward and donate their eggs.
Another very, very critical point about this relates to the
recent National Academy of Sciences report that you cited in
your opening statement, Madam Chairman, in support of embryo
cloning. They in that report interestingly opposed reproductive
cloning because they said it would involve the exploitation of
women.
But in that report, as you mentioned, they support the so-
called therapeutic cloning or research cloning that we have
had. And I would have to assert that it involves the same type
of exploitation of women and women donating their eggs in the
fashion described.
Let me just point out several other groups on the left who
have come out in opposition to this so-called therapeutic
cloning or embryonic cloning: Friends of the Earth, Council for
Responsible Genetics.
Importantly, the bill that passed the House with a strong
bipartisan majority was not only supported by the Conference of
Catholic Bishops, but it was supported by the General Board of
Church and Society of the United Methodist Church, which is, of
course, a group that has always stood in strong support of
abortion rights.
I say all this to just emphasize that this is not an
abortion debate. I think we have to ask a lot of questions as
we go through the process of moving this legislation forward in
the Senate. Do scientists have the moral authority to go
wherever they wish to go? Should the Congress pass a law that
would mandate for the first time that a certain class of human
embryo, if created, must be used for experimental research
purposes and then has to be destroyed?
Now, perhaps most importantly, if we have all of these
research labs all over the country producing hundreds or
thousands of cloned embryos, will it be possible to prevent a
physician from implanting one of those embryos in a woman? The
implantation of a cloned embryo into the womb of a woman would
occur within the confines of the doctor-patient relationship,
and it is for that reason, I think, more than any other that
many people, such as myself, believe that you really cannot
have both. You cannot have all of this research proceeding and
prevent reproductive cloning.
Because the implantation of a clone in a woman would occur
within the privacy of the doctor-patient relationship, and
because research labs throughout the world, throughout the
United States, would be producing large quantities of these
embryos, it would only be a matter of time before a rogue
physician, in defiance of the law, would implant one of these
embryos in a woman.
Indeed, in the event of that, it would put the Government
of the United States in a very, very awkward position because
though it may have been made illegal, you would be getting into
the issues of reproductive rights and autonomy of the woman, of
the doctor-patient relationship.
It is for these reasons and many others that I felt the
only way to properly prevent human reproductive cloning from
proceeding was to ban it at the very beginning, at the creation
of the embryo.
I would be very happy to field any questions. Thank you.
[The prepared statement of Mr. Weldon follows:]
Statement of Hon. Dave Weldon, a U.S. Representative in Congress from
the State of Florida
Introduction
Thank you for your invitation to appear here before you today. I
appreciate this opportunity to share with the Committee why I am
concerned about this issue and what led me to introduce in the House,
along with by good friend, Democrat Rep. Bart Stupak, a bill banning
human cloning.
I assume the debate in the Senate will, most likely, follow along
similar lines as to what occurred in The House. In that body there was
an almost universal agreement that so called reproductive cloning (an
attempt to create a live baby using cloning technology) should be
illegal, but some people would like to allow scientists to be able to
create human cloned embryos in the lab for research purposes. This
latter position is defended by its advocate because of the claim that
such research might lead to treatments for various diseases.
It also takes us beyond the position many people held by some
during the debate in support of embryo stem cell research. Destroying
human embryos was felt justified by some because these embryos in the
fertility clinics were held to be excess and destined for destruction
anyway. Now we are debating
``. . .creating human embryos specifically to be used for
research and then destroyed ``. . . creating embryos for
research purposes is entirely different from using spare
embryos leftover from infertility treatments. . . '' So wrote
13 Senators in a recent letter to the President Bush on July
20, 2001.
Also adopting this ethical principle are 59 Senators who on
July 20, 2001 wrote the following to the President regarding
embryo stem cell research: ``. . . for we must bear in mind
that the embryos used in this research are produced in vitro
fertilization clinics and if not used for humanitarian research
may otherwise be discarded.''
A 1994 Washington Post editorial labeled as ``unconscionable''
the notion of allowing embryos to be created solely for
research. These Senators, the Post and others saw clearly the
great peril of allowing the creation of human embryos, cloned
or not, specifically for research purposes. Regardless of the
issue of personhood, nascent human life has some value, it's
not bacteria, and as these statements suggest, the creation of
human embryos for the sole purpose of research is a line which
should not be crossed.
Terminology
The term ``therapeutic cloning'' has suffered an image crisis and
so there has been an effort to come up with a new label. Some call it
``nuclear transplantation'', others call it ``therapeutic cell
transplantation''. Is it an embryo. Period. The simple test is, if you
place the product of nuclear transplantation into a woman's womb could
it grow into a human baby. The answer is ``yes.'' It is an embryo
regardless of what name it is given.
complete ban has broad support/not a pro-life vs. pro-choice issue
Broad Support for Weldon/Stupak Cloning Ban
By more than a 100 vote majority (265-162) the House passed H.R.
2505, the Weldon/Stupak bill to ban human embryo cloning for both
experimental research and human reproduction.
The House considered and rejected on a 175-251 vote, a bill offered
by Rep. Greenwood. The Greenwood bill offered a simplistic solution to
a very complex issue. It allowed for the cloned human embryos to be
created for research purposes but attempted ban the use of these cloned
embryos to initiate a pregnancy. This is the very thing that the Post
called ``unconscionable.'' It is the very thing countless witnesses
before House Committees called ``unworkable.'' Unfortunately, the bill
offered by Senator Feinstein is very similar to the Greenwood bill and
it faces the same problems that the Greenwood bill faced.
Voting for the full cloning ban which passed the House were pro-
choice and pro-life Members. Some of the most liberal Members in the
House voted for the complete ban. Why did these Members vote for a
complete ban on human cloning? Why has such a large and diverse group
of Americans across political ideologies and religions affiliations
joined in support of the Weldon/Stupak/Brownback bill? I will shed some
light on that.
Exploitation of Women
Judy Norsigian noted feminist of the Boston Women's Health Book
Group and co-author of Our Bodies, Ourselves for the New Century
testified in support of the bill that passed the House. She and Stuart
Newman, Ph.D. of the Council for Genetic Responsibility wrote in a
Boston Globe Op-ed, ``Because embryo cloning will compromise women's
health, turn their eggs and wombs into commodities, compromise their
reproductive autonomy and, with virtual certainty, lead to the
production of `experimental' human beings, we are convinced that the
line must be drawn here.'' Any bill that falls short of the complete
ban enables this exploitation of women and experimentation would go
forward.
The National Academy of Sciences (NAS) cited as a reason for
opposing human reproductive cloning, the increased ``risks to women
donating eggs.'' The same principle should apply to selling eggs to
biotech companies for highly speculative human cloning research. For
every patient, at least one cloned embryo would be required, therefore
to treat millions of diseased patients, millions of women's eggs will
be required. Where will they come from?
Environmentalists
Friends of the Earth President, Dr. Brent Blackwelder, has urged
the House and Senate to enact the House-passed bill.
The Council for Responsible Genetics,<INF>t</INF>
The Nation's oldest organization scrutinizing new genetic
technologies opposes all human cloning.
Liberal and Conservative Religious Leaders
The pro-choice General Board of Church and Society of The United
Methodist Church and the pro-life United States Conference of Catholic
Bishops support the House passed bill.
HUMAN CLONING NOT THE MOST PROMISING FOR CURES
New Discovery
A significant blow was dealt to the advocates of cloning on January
23, 2002, when it was reported in the New Scientists, that `` ``A stem
cell has been found in adults that can turn into every single tissue in
the body. It might turn out to be the most important cell ever
discovered,''
Irving Weissman, who is on the next panel, stated in that article,
``It's very dramatic, the kinds of observations [Verfaillie] is
reporting. . . .The findings, if reproducible, are remarkable.''
that a new adult stem cell had been discovered that is can change
into many other types of human cells. This morning that study is
published in the peer reviewed scientific Journal of Clinical
Investigation with an accompanying commentary praising the discoveries
of Reys, Verfaillie et al.
These findings are remarkable, and I would urge that we immediately
thoroughly review these findings and see them duplicated in independent
studies.
I think everyone in this room hopes that this finding can be
independently reproduced. This finding would be one of the most
dramatic findings ever and would indeed lead us on the path seeking
cures for diseases without raising the serious moral and ethical issues
that would otherwise be raised. I would hope that this Committee would
invite these researchers to appear before your Committee as you
consider this legislation.
Autoimmune Concerns
Furthermore, while proponents of research cloning say that human
embryo cloning is necessary to develop cures and produce
``immunologically acceptable tissue'' some stem cell researchers
disagree. In the Journal Science, John Gearhart of Johns Hopkins
University states that many scientists feel ``there are ways of getting
around [the rejection problem] without the nuclear transfer [cloning]
paradigm.''
One of the most respected members of the Senate, Dr. Bill Frist,
stated in his November 27, 2001, floor statement urging the Senate to
take up and pass the House bill that, ``the idea of therapeutic
cloning, intended to combat the danger of autoimmune rejection,
something I as a transplant surgeon am very aware of, carries with it
challenges of its own and does not necessarily solve the problem of
autoimmune rejection.''
Patients Hopes Raised and Dashed
As a physician who still sees patients on a regular basis, I find
it deeply upsetting to see patients suffering from serious diseases
intentionally used by some in the debate over human cloning. These
patients' hopes were raised early in the 1 990s over the prospects of
using tissue from aborted fetuses for curing diseases. Those
experiments have been disastrous. We saw this again just a few years
ago with the promises of gene therapy. Nothing could be more cruel than
to see suffering patients used for the cause of the moment.
Even Biotech Says So. . .
Often omitted by the supporters of embryonic stem cell research and
cloning, are the serious hurdles that must be overcome. The New York
Times ran several articles on this issue, one on December 11, 2001 and
another on December 18, 2001. The December 18 article stated ``Though
not often discussed in public forums, the obstacles are so serious that
scientists say they foresee years, if not decades, of concerted work on
basic science before they can even think of trying to treat a
patient.'' The failure of researchers and biotech companies to filly
disclose and openly discuss these very serious challenges is prone to
mislead many of those who suffer from these diseases.
Most scientists, according to leading scientific journals, now
regard research cloning as impractical for treating patients. In the
December 2001 issue of Nature, Peter Aldous (chief editor of news and
features of Nature) said, ``The idea of 'therapeutic cloning' seems to
be on the wane.. . most [scientists] now believe this will be too
expensive and cumbersome for regular clinical use.''
In Stem Cells, (the first to isolate human embryo stem cells in
1998), Jamie Thomson of Johns Hopkins University writes, ``[T]he poor
availability of human oocytes, the low efficiency of the nuclear
transfer procedure, and the long population-doubling time of human ES
cells make it difficult to envision this [therapeutic cloning] becoming
a routine clinical procedure.''
And a recent New Scientist editorial states, that ``Ministers in
Britain have too easily swallowed the line that cloning human embryos
is essential to medical progress. It is not. Like stuck records,
ministers and policy makers continue to enthuse about therapeutic
cloning even though the majority of bench scientists no longer think
it's possible or practicable to treat patients with cells derived from
cloned embryos.''
Specific Objections and Concerns Raised by Researchers
University of Colorado biologist Jonathan Van Blerkom said he
supports a blanket ban on all human cloning until scientists thoroughly
understand what causes the birth defects that have plagued efforts to
clone other mammals, such as cows and sheep.
``Until you really understand the underlying biology of what you're
dealing with in a very comprehensive way, it's crazy, it doesn't make
any sense,'' said Van Blerkom, who works with human embryonic stem
cells at his Boulder lab.
The New York Times reported on December 11, 2001, reported that Dr
Tanja Dominko went to a lab in Oregon to attempt to clone monkeys.
``She left a year ago, with a cloning portfolio that she calls her
gallery of horrors.''
The National Academy of Sciences recently released a report of
scientists, no bioethicists were involved, in which they supported
research cloning while calling for a temporary ban on human
reproductive cloning. ``The greatest benefit we see as scientists is to
get [human] research models who have real diseases,'' said the panel's
chairman, Irving Weissman. He continued, ``We are stymied as scientists
in trying to study these diseases on mouse models.'' In other words,
the term ``model'' refers to living organisms used in research. It is
important to realize that regardless of potential clinical
applications, the panel's recommendation is based on the desire to do
basic research.
Conclusion
In conclusion, I suggest that there are several questions before
the Committee today. These are fundamental questions that deserve
serious consideration.
Does science have the moral authority to go wherever it wishes?
Should Congress pass a law that would mandate for the first time
ever that a certain class of human embryos if created, can only be
mined for their cells and then destroyed?
Is it realistic to think that it is possible to allow the creation
of cloned embryos and still provide 100% certainty that no rouge
scientist will take one of these embryos and implant it?
What would law enforcement do if it is found that a woman is
carrying a cloned human embryo? If nothing, then why even posit the
notion that therapeutic and reproductive cloning can be separate? If
intervention, then aren't we into a whole new realm of civil liberties
and privacy issues?
Are federal law enforcement officials going to inject themselves
into the physician-patient relationship?
Are women being exploited by biotech companies?
Are there more promising alternatives? If so, many scientists are
raising questions about the practicality of research cloning actually
being used in therapies.
Are patients' hopes being needless raised once again, only to be
dashed by scientific reality?
These just a few of the questions about the Greenwood bill that
were unresolved during the House debate. And, they remain unresolved in
the Feinstein bill.
I appreciate this opportunity to address the members of the
Committee and would invite any questions you might have either about my
bill or any of the issues I have raised.
Chairperson Feinstein. Thanks very much, Mr. Weldon.
Mr. Greenwood, welcome.
STATEMENT OF HON. JAMES C. GREENWOOD, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF PENNSYLVANIA
Representative Greenwood. Thank you, Senator Feinstein,
Senator Hatch, Senator DeWine, Senator Brownback, for the
invitation to testify today on the subject of human cloning.
I am encouraged to see the Senate take up this difficult
issue as it confronts some of our most basic questions about
science, the use of technology in improving health care, and
life itself. These are questions that, however politically
charged, we must forthrightly address.
Eighty years ago, Aldous Huxley wrote his literary
masterpiece Brave New World. In that book, he posited a future
where genetic engineering is commonplace and human beings,
aided by cloning, are mass-produced. Controllers and
predestinators have replaced mothers and fathers as the new
authors of human life.
For most of its 80 years, Brave New World was seen as a
disturbing work of science fiction, but that is no longer the
case. The cloning of human beings is no longer relegated to the
world of fiction. On March 28th of last year, I held a hearing
in the Energy and Commerce Oversight and Investigation
Subcommittee that found that the science existed and that there
were sufficiently funded fringe groups that sought to clone a
human being.
These fringe groups, combined with the recent announcement
by a Massachusetts company that it had actually succeeded in
the effort to grow stem cells for therapeutic purposes, has
forced each of us to ask what should we do with this science.
I believe that as policymakers we must not only address the
problems that come about from the use of the technology, but
the foregone opportunities, cures for diseases, ailments and
illness, that well may be lost should we entirely ban every
aspect of this technology.
Let me be clear. I oppose human cloning, both the
implantation of an embryo in a uterus and the creation of these
embryos for reproductive purposes. Cloning human beings must be
outlawed, and it must be outlawed in this Congress. But I also
reject the premise that we are unable to distinguish between
the dangers of untrammeled scientific experiments, on the one
hand, and new paradigms in biomedical research on the other.
Somatic cell nuclear transfer, the science in question,
holds the very real promise to enable a new kind of therapy,
known as regenerative medicine. This therapy is one of the
goals of stem cell research. Stem cells have the potential to
form any cell in the body, and it can replicate indefinitely.
Regenerative medicine, when perfected, will use the
knowledge we will gain in stem cell research to ultimately
replace damaged or dead cells with transplanted healthy and
vigorous new cells. These cellular therapies also hold the
potential to cause an individual's currently malfunctioning
cells to begin to function properly again.
Research with these stem cells and regenerative medicine
holds great promise in the noble struggle to cure and treat
millions of Americans who suffer from Alzheimer's and
Parkinson's disease, diabetes, stroke, and spinal cord injury.
To achieve the goals in regenerative medicine, somatic cell
nuclear transfer research is essential. This technology will
help us understand biological properties that enable a
differentiated cell nucleus to act like an undifferentiated one
in a pluripotent cell. Scientists are still not sure how this
reprogramming process works, but research to date supports the
argument that potentially we could use our own tissue to create
pluripotent stem cells, reducing the need for immunosuppressive
drugs as part of the cellular therapy.
Last year, the House faced a choice of two approaches on
how to deal with this science. The first, sponsored by
Congressman Weldon, seeks to provide a simple and
straightforward solution to this very complex matter of
science. It seeks to ban all forms of cloning, effectively
banning the related science of therapeutic cloning, thus
shutting the door to these potentially life-saving
technologies. Unfortunately, science will not yield up its
mysteries in such constricted space.
The measure that I introduced, which is similar to your
bill, Senator Feinstein, and to Senator Kennedy's, provides a
more sophisticated solution to this terribly complex issue.
Like you both, I wish to outlaw reproductive human cloning,
while permitting further and carefully circumscribed research.
Unfortunately, the House chose to yield to fear-mongering
and voted for the Weldon bill. Now, the Senate asks, what
should we do with this science? Human reproductive cloning is
not fiction and we should ban it. At the same time, I urge the
Senate to enact meaningful legislation that also recognizes and
responds to the possibilities of therapeutic cloning.
If I may, I would like to respond to a point or two that my
colleague has made.
Chairperson Feinstein. Please.
Representative Greenwood. First, he referenced or referred
to false hope, that this science is not yet proven and he
hesitates to provide false hope to the millions of our fellow
humans who suffer from these diseases.
I would hold that hope is at the core of our humanity and
we should allow our brilliant researchers to tell those who
suffer from heretofore incurable illnesses and injuries if the
hope is false or not. We should not legislatively dash their
hopes.
A second point that my colleague made was on the question
of whether this science holds out the potential to exploit
women, because somehow there has been this notion created of
embryo farms, thousands of women lining up to donate their eggs
for this science. This is an incredibly important point in this
argument.
What we want to promote is the science that would enable us
to understand how this transformation occurs between a
differentiated cell placed in a nucleus, surrounded by the
contents of the egg--how that becomes an undifferentiated cell,
and then again specializes in differentiation.
That science will enable us to identify the chemicals that
are present at that transformation. When we understand what
those chemicals are and what those processes are, we no longer
need a supply of eggs. This is not a process that has to be
replicated in order to provide the therapy.
The promise that is held out is that once we understand the
chemistry of this process at the cellular level, then in the
relatively near future when the patient comes to the hospital
with a spinal injury, with the incurable disease, the
therapist, the doctor, only needs to take that individual's
somatic cell and then, in combination with these other
chemicals, allow it to become a pluripotent cell and then a
specialized cell to repair that spinal cord damage, to repair
the damaged cells in the other organs, including the brain.
This vision of embryo farms needs to be removed from the
debate. There is no such thing. The only way you could create
this scenario is to have women line up and ask to be put
through the extraordinarily painful process of super-ovulating
so that scientists could have these eggs.
In nature, millions of fertilized eggs are flushed from the
female body daily. That is, if you will, God's process. In in
vitro fertilization, we have a surplus of fertilized eggs that,
in the name of providing couples around the world the
opportunity to have children when they couldn't otherwise do
it, are destroyed by the thousands.
The research that we are talking about, as Senator Hatch
said, is not about bringing together sperm and egg, but
allowing the division of a somatic cell, if you would, from the
inside of a cheek to study the processes that occur when that
somatic cell is in the environment of the egg, to learn from it
and then to provide therapy. We are not talking about vast
quantities of eggs necessary to do that. We are probably
talking on the order of magnitude of scores.
Thank you for the opportunity to testify, and I would also
be pleased to answer your questions.
[The prepared statement of Mr. Greenwood follows:]
Statement of Hon. James C. Greenwood, a U.S. Representative in Congress
from the State of Pennsylvania
Senator Feinstein, senator Hatch, thank you for your invitation to
testify today on the subject of human cloning. I am encouraged to see
the senate take up this difficult issue, as it confronts some of our
most basic questions about science, the use of technology in improving
heatlhcare, and life itself. These are questions that, however
politically charged, we must forthrightly address.
Eighty years ago, Aldous Huxley wrote his literary masterpiece,
brave new world. In that book, he posited a future where genetic
engineering is commonplace and human beings, aided by cloning, are
mass-produced. Controllers and predestinators have replaced mothers and
fathers as the new authors of human life.
For most of its eighty years, brave new world was seen as a
disturbing work of science fiction. That is no longer the case.
The cloning of human beings is no longer relegated to the world of
fiction. On March 28 last year, I held a hearing in the energy &
commerce oversight and investigations subcommittee that found that the
science existed and that there were sufficiently funded fringe groups
that sought to clone a human being.
These fringe groups, combined with the recent announcement by a
Massachusetts company that it had actually succeeded in the effort to
grow stem cells for therapeutic purposes has forced each of us to ask,
``what should we do with the science?''
I believe that as policymakers, we must not only address the
problems that come about from the use of the technology, but the
forgone opportunities--cures for diseases, ailments, and illness--that
may be lost should we entirely ban every aspect of this technology.
Let me be clear. I oppose human cloning both the implantation of an
embryo in a uterus and the creation of these embryos for reproductive
purposes. Cloning human beings must be outlawed. And in this congress.
But I also reject the premise that we are unable to distinguish between
the dangers of untrammeled scientific experiments on the one hand and
new paradigms in biomedical research on the other.
Somatic cell nuclear transfer, the science in question, holds the
very real promise to enable a new kind of therapy known as regenerative
medicine. This therapy is one of the goals of stem cell research.
Stem cells have the potential to form any cell in the body and can
replicate indefinitely.
Regenerative medicine, when perfected, will use the knowledge we
will gain in stem cell research to ultimately replace damaged or dead
cells with transplanted healthy and vigorous new cells. These cellular
therapies also hold the potential to cause an individual's currently
malfunctioning cells to begin to function properly again.
Research with these stem cells and regenerative medicine holds
great promise in the noble struggle to cure and treat millions of
Americans who suffer from Alzheimer's and Parkinson's diseases,
Diabetes, Stroke, and Spinal cord injury.
To achieve the goals in regenerative medicine, somatic cell nuclear
transfer research is essential. This technology will help us understand
biological properties that enable a differentiated cell nucleus to act
like an undifferentiated one in a pluripotent cell. Scientists are
still not sure how this ``reprogramming'' process works. But, research
to date supports the argument that potentially, we could use our own
tissue to create pluripotent stem cells, reducing the need for
immunosuppressive drugs as part of this cellular therapy.
Last year, the house faced a choice of two approaches on how to
deal with this science. The first, sponsored by Congressman Weldon,
seeks to provide a simple and straightforward solution to this very
complex matter of science. It seeks to ban all forms of cloning,
effectively banning the related science of therapeutic cloning, thus
shutting the door to these potentially life-saving technologies.
Unfortunately, science will not yeild up its mysteries in such
constricted space. The measure that I introduced, which is similar to
your bill, senators Feinstein and Kennedy, provides a more
sophisticated solution to this terribly complex issue. Like you both, I
wish to outlaw reproductive human cloning, while permitting further and
carefully circumscribed research.
Unfortunately, the house chose to yield to fearmongering and voted
for the Weldon bill.
Now the senate asks: what should we do with this science? Human
reproductive cloning is not fiction--and we should ban it. At the same
time, I urge the senate to enact meaningful legislation that also
recognizes and responds to possibilities of therapeutic cloning.
There is a line from John Keats' work, the fall of hyperion, which
the late Robert Kennedy once used to describe the burden of public
service that applies here, where the poet wrote of those ``who feel the
weight of the world and more like slaves to poor humanity labour for
mortal good.''
We are now called upon to labor for the needs of those millions who
suffer and whose greatest and best hope is in the benefits which can
only be derived from advances in this remarkable science.
Thank you very much.
Chairperson Feinstein. Thanks very much, Mr. Greenwood.
Do members have questions of this panel?
Senator Specter. Madam Chairman?
Chairperson Feinstein. Senator Specter, welcome.
STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR FROM THE STATE
OF PENNSYLVANIA
Senator Specter. A comment and a question of sorts. The
subject matter today is human cloning, and the frequently used
phrase has been ``therapeutic cloning.'' In hearings which we
had in the Appropriations Subcommittee for Health and Human
Services, we called it a nuclear transplant, and I see that
Senator Hatch today has called it DNA regenerative therapy.
The word ``cloning'' conjures up reproductive cloning,
which is generally objected to and has a very, very unpalatable
connotation. This, of course, is not cloning of another human
being, but is a process to enable therapy to be applied so that
the patient does not reject it.
So my question is, Congressman Greenwood, do you think it
would be a good idea not to call it therapeutic cloning, but to
call it something else?
Representative Greenwood. I do. I think ``somatic cell
nuclear transfer'' is the appropriate scientific term. And I
agree with you, Senator Specter, that everyone rejects the
notion that we should reproduce humans by cloning. I think that
every child deserves to be the unique process of reproduction
between a mother and a father, and not someone's duplicate.
That is the vision that is conjured by the word ``cloning,''
and I think it is a misnomer to refer to this somatic cell
nuclear transfer as cloning and it would be less confusing to
the public if we dropped that terminology.
Senator Specter. Well, I thank you, Congressman Greenwood,
and also Congressman Weldon, for your participation. This is a
very, very important debate. As already noted, Senator
Feinstein and Senator Kennedy have introduced legislation, as
have Senator Harkin and myself. I think Senator Brownback is
interested in this subject as well.
Chairperson Feinstein. And Senator Durbin is a cosponsor of
our bill, as well.
Senator Specter. And Senator Durbin.
It is very important to have a thorough debate and I
compliment you, Madam Chairman, for convening the hearing.
Chairperson Feinstein. Well, thank you.
Senator Durbin, any questions of these witnesses?
Senator Durbin. No.
Chairperson Feinstein. Any other questions?
Senator Brownback. I do, Madam Chairman, if I could,
briefly.
Chairperson Feinstein. Senator Brownback?
Senator Brownback. Thank you for holding the hearing. I
appreciate your doing that and I appreciate looking at the
topic carefully. I think it is an extremely important topic and
one that hopefully we are going to take action on this spring.
The Majority Leader has stated that we would have a vote on
this sometime in February or March on the floor. So I think it
is good that we lay the groundwork here.
I would ask either Congressman Weldon or Greenwood, why are
we trying to get around this notion of calling the clone an
embryo.
Congressman Greenwood, what you are describing in
therapeutic cloning is, that someone would take the egg, de-
nuclei it; then take a somatic cell from you, and then, put it
in the egg and start it growing again. Is that correct?
Representative Greenwood. That is roughly the description
of the process of somatic cell nuclear transfer, yes, sir.
Senator Brownback. So we would have a genetic copy of you,
then, if we did it the way I have just described. Is that
correct?
Representative Greenwood. Well, we would have in that cell
all 46 of my chromosomes, yes.
Senator Brownback. And they would be identical to your
genetic makeup. Is that correct?
Representative Greenwood. That is correct.
Senator Brownback. And if we are able to perfect the
system--and I think there is a way to go before we do, but if
we are able to perfect it the way Dolly the sheep was created,
at the end of that process if we nurtured that clone, if it is
able to follow on through, we would have a baby that would come
forward that would be physically identical to you. Would that
be correct?
Representative Greenwood. God forbid.
[Laughter.]
Senator Brownback. Or me or anything else like that, but
that is what would happen at the end of that process. Is that
correct?
Representative Greenwood. Yes. Theoretically, if you
planted that dividing cell into a woman's uterus and it took
and it came to term, yes, it would be a genetic reproduction of
the donor of the somatic cell. Of course, that is why we
expressly prohibit that course of action in our legislation.
Senator Brownback. You expressly prohibit the implantation,
correct?
Representative Greenwood. Correct.
Senator Brownback. It is not the creation, it is the
implantation in the Feinstein bill and in your process.
Representative Greenwood. Correct.
Senator Brownback. So you would allow the creation, but not
the implantation of it?
Representative Greenwood. That is correct.
Senator Brownback. I think here is, if I could engage
Congressman Weldon, where the rub on the bill is, that you have
then created a clone. Now, some may not deem it a clone until
it reaches a certain age, but the genetic composition in this
process doesn't change, does it, Congressman Weldon?
Representative Weldon. No, it doesn't.
Representative Greenwood. Pardon me. May I be excused? I
promised to stay longer, but I have been reminded I have a
television appearance at three.
Chairperson Feinstein. Please, and thank you very much.
Senator Brownback. Thank you for being here.
Representative Weldon. You have created a clone. It begins
the process of differentiation and it goes through various
phases. You have the blastocyst phase and then you have the
embryonic phase, and then it goes into the fetal phase after
that.
It is a genetic copy, and that is really why the
researchers want to use it. The theoretical construct is that
you develop leukemia, you go into the doctor, he creates a
clone of you and then he extracts new bone marrow cells from
the clone, or stem cells that would then become bone marrow
cells. The clone is then destroyed and the cells that were
extracted or harvested are then used to treat your condition.
That is where the term ``therapeutic cloning'' was derived.
As Senator Specter said, it has very high negative
connotations amongst the public. So an attempt is being made to
give it a different name, but it is still the same thing that
we are talking about.
Senator Brownback. Madam Chairman, I don't want to belabor
the discussion here, but I think it is a key part of what the
discussion is because we are all saying we are opposed to
cloning because of the repugnance and we don't think that seems
quite right and a number of other factors that people might
cite.
But one bill that several people have put forward bans the
implantation, not the creation. The Weldon approach and the
approach I have put forward would ban the creation of the
clone, and that is, I think, a key distinction that we need to
understand in the various approaches. Those are basically the
two approaches that are involved here with the legislation and
the legislative debate that we are involved in.
Chairperson Feinstein. Thank you, Senator Brownback.
Senator Durbin?
Senator Durbin. If I might ask Congressman Weldon for the
record, do you suggest that we should prohibit in vitro
fertilization?
Representative Weldon. Oh, no, absolutely not, absolutely
not. That is a totally different issue.
Senator Durbin. Well, help me with this because you are
trained in the science and I am not. If I understand in vitro
fertilization, at the end of the process, if you are
successful, you may have one implanted embryo that leads to a
healthy baby and many other fertilized eggs that are ultimately
discarded.
If the core of your belief here is that once you have
joined this sperm and ovum either in a Petri dish or through
another process that you have a human being, can you explain
why you would support that process?
Representative Weldon. Sure, I would be very happy to
respond to your question. Actually, the technique that is used
in in vitro fertilization is multiple eggs are usually
harvested, though in some cases they only get one or two that
are viable and then they have to do a procedure called twinning
to get more eggs.
Then they go through the fertilization phase with the sperm
and they try to get multiple embryos, and they usually implant
multiple embryos because it usually requires implanting
multiple embryos to get one to take. This is why you get the
high multi-birth incidence in women who have undergone the in
vitro fertilization.
The important distinctions in this whole process from a
moral and ethical perspective, which is I believe what you are
getting at, are really two- or three-fold. No. 1, it is sexual
fertilization, so you are not creating a clone and you don't
get into all the ethical and moral issues associated with
creating clones. We really didn't get into that, either Mr.
Greenwood nor I, in our testimony, but there are legal issues
and there are moral issues associated with that.
Typically, what happens in the in vitro clinic is after the
first attempt, there is a 25-percent success rate with the
first attempt. So 75 percent of the time you get a failure, so
then you use any of those additional embryos for the second
attempt. What is true is that 25 percent of the time you get a
success the first time around and then you will have these
extra embryos in the freezer, and that is really the issue that
you bring up.
How are they different from clones? Well, one of the things
that makes them very different is they are owned by the mother
and father, and frequently in a high percentage of cases the
reason the fertility experts like to keep these in storage is
the couples come back and they say they want a second child.
What we really didn't get into in the egg donation issue
but which is worth mentioning and why I talk about it as being
exploiting women is there are some hazards associated with the
egg-harvesting process. You have to give the women a super-
ovulatory drug. There is a certain complication rate. They can
get ovarian cysts, and it requires an anesthesia to harvest the
eggs.
Senator Durbin. I hate to interrupt you, but I am really
trying to get to the bottom-line question here, not the
process, but the result. At the end of this process, you end up
with surplus embryos.
Representative Weldon. Sometimes, sometimes.
Senator Durbin. So you are drawing a distinction of
ownership. If there is ownership of these embryos by a married
man and woman, then it is morally acceptable to store them, to
use them. But if they are created through a scientific process
through cloning, that is where you draw the line? The ownership
is different?
Representative Weldon. Well, no, it is not only the
ownership; it is the purpose and the intent. The purpose and
the intent when you go to an in vitro clinic is you want to
have a baby. You are creating these embryos because you want it
ultimately to result in a child.
During the natural process, they may insert five embryos
and only one may take and four are lost. In the other case----
Senator Durbin. Isn't that a slippery slope? If it is
intent and I know that my wife and I want one child and we are
going to end up with surplus embryos that we are never going to
use, you still think that is morally acceptable to go forward.
Yet, if there was a cloned embryo coming out of a laboratory
for whatever purpose, you would say that is morally
unacceptable?
Representative Weldon. Well, I think you are comparing
apples and oranges. What I would object to is if you and your
wife said we are going to go down to the clinic and she is
going to donate eggs, and me my sperm, and we are going to
create embryos and then we are going to give them to this
research department at the university so that they can extract
stem cells and then destroy them. I would say then you are
comparing apples to apples.
But when you say we are doing this because we want to have
a baby and, yes, during the process there may be embryos that
are lost, I think that is an ethically and morally -it is a
very, very different situation than when you are creating
embryos for the express purpose of extracting stem cells and
destroying them.
Senator Durbin. Thank you.
Chairperson Feinstein. Thanks very much, Senator.
Thank you very much, Congressmen, for taking so much time.
We appreciate it.
We will move on with the next panel, if we may, and as the
next panel comes up I am going to begin to introduce them to
save time.
The first panelist is Professor Irving Weissman. He is
Professor of Pathology and Developmental Biology at my alma
mater, Stanford, School of Medicine. He serves as a member of
numerous professional societies, institutions, and editorial
boards. He has been elected to the National Academy of Sciences
and to the American Association for the Advancement of Science.
He has also received the Kaiser Award for excellence in pre-
clinical teaching, the Passerow Award, and the Outstanding
Investigator Award from the National Institutes of Health.
Professor Weissman is also the Chair of the Panel on Scientific
and Medical Aspects of Human Cloning, of the National
Academies. That Panel just issued its long-awaited report and
recommendations about cloning.
Professor Weissman, welcome. I am going to observe the 5-
minute rule and we will go right down the line so that we have
an opportunity to ask questions. I hope that is all right.
STATEMENT OF IRVING L. WEISSMAN, M.D., CHAIR, PANEL ON
SCIENTIFIC AND MEDICAL ASPECTS OF HUMAN REPRODUCTIVE CLONING,
THE NATIONAL ACADEMIES, AND PROFESSOR, STANFORD UNIVERSITY
SCHOOL OF MEDICINE, STANFORD, CALIFORNIA
Dr. Weissman. Madam Chair and members of the committee, my
name is Irv Weissman and I am an M.D. and professor at Stanford
Medical School. My main research field for the past 20 years
has been the biology and transplantation of adult cells in mice
and in humans.
I am here as Chair of the National Academies' Panel on
Scientific and Medical Aspects of Human Reproductive Cloning,
which released its report on January 18 of this year.
The charge to the panel in June 2001 was to examine the
scientific and medical issues relevant to human reproductive
cloning, including the protection of human subjects, and to
clarify how human reproductive cloning differs from stem cell
research. Our charge did not extend to an examination of the
ethical issues related to human reproductive cloning.
We needed to determine whether current methods for
reproductive cloning are scientifically feasible and
reproducible and are medically safe. In addition, we needed to
examine whether human participants in the process could be
adequately advised and protected. Society and its leaders will
need such scientific and medical information if they are to
address the relevant ethical and public policy issues.
In reproductive cloning, the nucleus of a body cell is
transplanted into an egg whose nucleus has been removed,
stimulating it to divide to produce a blastocyst embryo. The
blastocyst is then placed into a uterus with the intent of
creating a newborn.
In a related but different procedure, cells are isolated
from a blastocyst derived by nuclear transplantation and the
cells are used to produce stem cell lines. This is shown here
in the figure where, from the inner cell mass of a blastocyst
created by nuclear transplantation, you make an embryonic stem
cell line. Such stem cells are unspecialized cells and develop
into almost all kinds of body cells. That is here, all these
different kinds of cells.
In what is sometimes called therapeutic cloning, the donor
of a nucleus for transplantation to produce stem cells can be a
person in whom the daughter cells of the stem cells are
transplanted back to regenerate damaged tissue. But there is
another medical use for nuclear transplantation equally or more
important, to produce stem cells.
Stem cells derived from a body cell or a disease cell of a
patient who has inherited the risk for that disease, and
therefore whose body cells or whose disease cells have
completed the process to make the disease and have the life
history of that process, are transplanted to make stem cell
lines, and now you can study how this goes wrong in particular
diseases.
For example, in breast cancer the body cell often has the
predilection for the disease, but numerous mutations occur,
ones that we don't understand, to take it through the rest of
the process to become a cancer cell. We need to be able to
study that in a test tube and when we transplant the cells in
mice.
We studied the scientific and medical literature and held a
workshop with world leaders in the relevant technologies. Among
the participants were persons who planned to clone human
beings. The data from animal studies of reproductive cloning
demonstrate that only a small percentage of the attempts are
successful; that many of the resulting clones die during all
stages of gestation or pregnancy, late and early; that newborn
clones often are abnormal or die; and that the procedures carry
serious risks for the mother. However, the data on nuclear
transplantation to produce stem cells shows that these cells
are functional.
Given those findings, the panel unanimously approved the
following recommendations.
Human reproductive cloning should not now be practiced. It
is dangerous and likely to fail. The panel therefore
unanimously supports the proposal that there should be a
legally enforceable ban on the practice of human reproductive
cloning.
The scientific and medical considerations that relate to
this ban should be reviewed within 5 years. The ban itself
should be reconsidered only if at least two conditions are met.
The first is that a new scientific and medical review indicates
that the procedures are likely to be safe and effective, and
that information must lead to a broad national dialog on the
societal, religious, and ethical issues to suggest whether a
reconsideration of the ban is warranted.
Finally, the scientific and medical considerations that
justify a ban on human reproductive cloning at this time are
not applicable to nuclear transplantation to produce stem
cells. Because of the considerable potential for developing new
medical therapies for life-threatening diseases and advancing
fundamental knowledge, the panel supports the conclusion of a
recent National Academies report that recommended that
biomedical research using nuclear transplantation to produce
stem cells be permitted. A broad national dialog on the
societal, religious, and ethical issues is encouraged in this
matter.
Scientists place a high value on the freedom of inquiry, a
freedom that underlies all forms of scientific and medical
research. Recommending restrictions of research is a serious
matter and the reasons for such a restriction must be
compelling. In the case of human reproductive cloning, we are
convinced that the potential dangers to the implanted fetus, to
the newborn, and to the woman carrying the fetus constitutes
just such compelling reasons. In contrast, there are no
scientific or medical reasons to ban nuclear transplantation to
produce stem cells, and such a ban would certainly close
avenues of promising scientific and medical research.
The panel stressed that all concerned segments of society
should examine and debate the broad societal and ethical issues
associated with human reproductive cloning, as well as those
associated with nuclear transplantation to produce stem cells.
We hope that our report will help this committee and President
Bush's Council on Bioethics in this regard.
Thank you for the opportunity to testify.
[The prepared statement of Dr. Weissman follows:]
Statement of Irving L. Weissman, Chair, Panel on Scientific and Medical
Aspects of Human Reproductive Cloning, National Academy of Sciences,
National Academy of Engineering, Institute of Medicine, National
Research Council and Karel and Avice Beekhuis Professor of Cancer
Biology, and Professor of Pathology and Developmental Biology, Stanford
University, Stanford, Calif.
Madam Chair and members of the Committee. My name is Irv Weissman.
I am a professor at Stanford Medical School, and my main research field
for the last 20 years has been the biology and transplantation of adult
stem cells in mice and humans. I am here as chair of the National
Academies Panel on Scientific and Medical Aspects of Human Cloning,
which released its report on January 18, 2002.
The charge to the panel in June 2001 was to examine the scientific
and medical issues relevant to human reproductive cloning, including
the protection of human subjects, and to clarify how human reproductive
cloning differs from stem cell research. Our charge did not extend to
an examination of the ethical issues related to human reproductive
cloning.
We needed to determine whether current methods for reproductive
cloning are scientifically feasible and reproducible and are medically
safe. In addition, we needed to examine whether human participants in
the process could be adequately advised and protected. Society and its
leaders will need such scientific and medical information if they are
to address the relevant ethical and public-policy issues.
In reproductive cloning, the nucleus of a body cell is transplanted
into an egg whose nucleus had been removed, stimulating it to divide to
produce a blastocyst embryo; the blastocyst is then placed into a
uterus with the intent of creating a newborn.
In a related but different procedure, cells are isolated from a
blastocyst derived by nuclear transplantation, and the cells are used
to produce stem cell lines. This is shown in the figure. Such stem
cells are unspecialized cells that can develop into almost all kinds of
body cells. In what is sometimes called therapeutic cloning, the donor
of a nucleus for transplantation to produce stem cells can be a person
in whom stem cell daughter cells will be used to regenerate damaged
tissues. There is another medical use for nuclear transplantation to
produce stem cells; stem cells derived from a body cell or a disease
cell of a patient who had inherited the risk for that disease could be
powerful tools for medical research and lead to improved therapies.
We studied the scientific and medical literature and held a
workshop with world leaders in the relevant technologies. Among the
participants were persons who planned to clone human beings. The data
from animal studies of reproductive cloning demonstrate that only a
small percentage of the attempts are successful, that many of the
resulting clones die during all stages of gestation, that newborn
clones often are abnormal or die, and that the procedures carry serious
risks for the mother. However, the data on nuclear transplantation to
produce stem cells show that these cells are functional.
Given those findings, the panel unanimously approved the following
recommendations Human reproductive cloning should not now be practiced.
It is dangerous and likely to fail. The panel therefore unanimously
supports the proposal that there should be a legally enforceable ban on
the practice of human reproductive cloning.
The scientific and medical considerations related to this ban
should be reviewed within five years. The ban itself should be
reconsidered only if at least two conditions are met: (1) a new
scientific and medical review indicates that the procedures are likely
to be safe and effective, and (2) a broad national dialogue on the
societal, religious, and ethical issues suggests that a reconsideration
of the ban is warranted.
Finally, the scientific and medical considerations that justify a
ban on human reproductive cloning at this time are not applicable to
nuclear transplantation to produce stem cells. Because of the
considerable potential for developing new medical therapies for life-
threatening diseases and advancing fundamental knowledge, the panel
supports the conclusion of a recent National Academies report that
recommended that biomedical research using nuclear transplantation to
produce stem cells be permitted. A broad national dialogue on the
societal, religious, and ethical issues is encouraged on this matter.
Scientists place high value on the freedom of inquiry--a freedom
that underlies all forms of scientific and medical research.
Recommending restriction of research is a serious matter, and the
reasons for such a restriction must be compelling. In the case of human
reproductive cloning, we are convinced that the potential dangers to
the implanted fetus, to the newborn, and to the woman carrying the
fetus constitute just such compelling reasons. In contrast, there are
no scientific or medical reasons to ban nuclear transplantation to
produce stem cells, and such a ban would certainly close avenues of
promising scientific and medical research.
The panel stressed that all concerned segments of society should
examine and debate the broad societal and ethical issues associated
with human reproductive cloning, as well as those associated with
nuclear transplantation to produce stem cells. We hope our report will
help this Committee and President Bush's Council on Bioethics in this
regard.
Thank you for the opportunity to testify. I hope that my statement
and the panel report can be put into the record. I will be happy to
answer questions.
[GRAPHIC] [TIFF OMITTED] T3684.001
Chairperson Feinstein. Thank you very much, Dr. Weissman.
We will now turn to Professor Henry Greely, who also comes
to us from Stanford University. He is the C. Wendell and Edith
M. Carlsmith Professor of Law, and Professor, by courtesy, of
Genetics. He is an expert in health law and health care policy
and has written extensively on issues concerning genetic
testing, human cloning, and the ethics of human genetics
research.
He is the Chairman of the steering committee of the
Stanford University Center for Biomedical Ethics. He co-directs
the Stanford Program on Genomics, Ethics, and Society. He is
also the Chairman of the Ethics Subcommittee of the North
American Committee of the Human Genome Diversity Project, and
serves on the California Advisory Committee on Human Cloning.
Welcome, Mr. Greely.
STATEMENT OF HENRY T. GREELY, PROFESSOR OF LAW, AND DIRECTOR,
CENTER FOR LAW AND THE BIOSCIENCES, STANFORD UNIVERSITY,
STANFORD, CALIFORNIA
Mr. Greely. Thank you. Good afternoon, Madam Chairman and
members of the committee. You have heard who I am. Let me just
add that I am deeply honored to have the opportunity to speak
to you today about this important issue.
I am here for two reasons. As a member of the California
Advisory Committee on Human Cloning, I am here to report to you
our committee's results, and then as an individual who has
studied this area to give you my own views on some of these
issues, not necessarily that committee's views.
I have submitted written testimony. I want to use my brief
time here to highlight some of its more important points. My
bottom-line conclusion is based on our report, and based on
that view, I strongly support Senate bill 1758.
The California Advisory Committee on Human Cloning grew out
of the fact that California was the first jurisdiction in the
United States to ban human cloning. California did that in
1997, shortly after Dolly was announced. It is a 5-year ban on
reproductive cloning.
The legislation also required the State to appoint an
expert committee to advise the Governor and the legislature--
before those 5 years were up--on how that bill should be
revised. The committee was appointed in early 1999 and has
spent the last 2\1/2\ years studying this issue, with public
hearings, with testimony from experts, and with an incredible
amount of argument.
We spent 8 months writing our report, debating over
sentences, words, and the placement of commas. I imagine it
would be like an 8-month conference committee, not something
that you particularly want to go through. But I am happy to say
that at the end, when we finished our negotiations 8 hours
before we turned in our report, we had five unanimous
recommendations. They are attached to the testimony as part of
the executive summary of our report.
What is important about that is that we all, the 12 of us
on the committee, came into this process with very different
views. We left with different views, but not very different
views. The more we studied it, the stronger our consensus grew.
Our most important recommendations are that reproductive
cloning should be banned and that non-reproductive cloning
should not be banned, but should be regulated. Coming from very
different positions, we ended up in that same place.
At least in California, and I think in much of the country,
there is a latent consensus on this point: ban cloning for
making babies, allow cloning but regulate it more seriously for
research purposes. In fact, Madam Chairman, I am authorized to
say that your opponent in your last election, my law school
comrade, Tom Campbell, supports your general approach to the
cloning issue.
With respect to reproductive cloning, there is not much to
say. I don't think policy issues get much easier. There are
compelling safety concerns about the health of any infants
produced. There are very serious non-safety concerns. There are
no compelling reasons to produce a baby by cloning. California
banned this 5 years ago. I agree with Senator Hatch that it is
long past time for Congress to follow that lead and to ban
human reproductive cloning.
Human non-reproductive cloning was a more difficult issue
for our committee, and clearly is a more difficult issue today.
Our position was two-fold: California shouldn't ban it, but
California should impose new regulations on it. One of the
things I particularly like about S. 1758 is that, mirroring one
of the California recommendations, it proposes that IRB review
be required for non-reproductive cloning research. We think
that is a good idea as well.
In looking at non-reproductive cloning, it is very
interesting to start with the arguments against such cloning.
There seen to be some novel coalitions against such cloning
research. I don't know whether it is ironic or appropriate that
an asexual method of reproduction is producing strange
bedfellows. But we are seeing an unusual, to say the least,
political coalition opposing non-reproductive cloning.
Two points. First, most of the arguments about non-
reproductive cloning are arguments about human embryo research
in general. Those arguments have been around for 10 years. The
related arguments about human fetal tissue research go back to
at least 1988. Arguments about the moral status of the embryo
or the fetus and the arguments about possible exploitation of
women are not new.
Our society has not come up with a happy resolution of
these, but we have come up with a compromise that everyone is
unhappy with, but everyone lives with: no Federal funding for
this kind of research, but no Federal ban on privately funded
such research. I see no reason for it to be different with non-
reproductive cloning.
The only argument about non-reproductive cloning that is
not a general argument about human embryo cloning research is
the argument that once there are cloned embryos for research,
they will be implanted. Even though the law would criminalize
such implantation--not require an abortion, but send the doctor
who implanted the cloned embryo to jail.
The research institutions that are doing this research for
developmental biology purposes aren't experts in implanting
embryos. In vitro fertilization clinics are experts in
manipulating eggs. It is very unlikely that someone who wanted
to do this 1) couldn't make the embryo itself, 2) would be able
to steal an embryo from a research institution that is not an
in vitro fertilization clinic and, then implant it
successfully.
So, in summary, the dangers of human reproductive cloning
compel responsible legislators to ban it. The promises, as well
as the dangers, of non-reproductive cloning compel that it be
permitted, but that it be more extensively regulated along the
lines of S. 1758.
Thank you, Madam Chairman.
[The prepared statement of Mr. Greely follows:]
Statement of Henry T. Greely, C. Wendell and Edith M. Carlsmith
Professor of Law, Professor, by Courtesy, of Genetics, Director, Center
for Law and the Biosciences, Stanford University
Madam Chairman and members of the Senate Judiciary Committee, my
name is Hank Greely. I am a professor of law and a professor, by
courtesy, of genetics at Stanford University.
Since early 1999, I have been a member of the California Advisory
Committee on Human Cloning, which made its statutorily-mandated report,
entitled Cloning Californians? Report of the California Advisory
Committee on Human Cloning, to the California legislature on January
11, 2002. I have made copies of that report available to the
Committee's staff; I am only attaching its Executive Summary to this
testimony.
I am here today both to report the findings of that Committee and
to provide my own insights into legislation now pending before this
body concerning human cloning. Except as specifically noted, the views
I express today are my own and not necessarily those of the California
Committee or of Stanford University. Those views lead me to support,
strongly, Senate Bill 1758.
I want to discuss four things in my testimony: The California
report, reproductive cloning, non-reproductive cloning, and the
implementation of any legislation related to human cloning.
The California Report
In 1997 California became the first U.S. jurisdiction to ban human
reproductive cloning. The ban was to last for five years, until January
1, 2003. As part of this statute, the legislature required the
executive branch to appoint a committee to make recommendations back to
the legislature about appropriate policy on human cloning by December
31, 2001. The legislature and the governor would thus have a full year
to consider the report before the existing ban on reproductive cloning
expired.
The California Advisory Committee on Human Cloning was appointed in
early 1999. Its twelve members, identified below, represented a variety
of professional backgrounds and a wide range of political viewpoints.
Francine Coeytaux, MPH.................................. Public
Prof. Theodore Friedmann, MD............................ Genetics
Dr. David Gollaher, PhD................................. Biotechnology
Prof. Henry T. Greely, JD............................... Law
Dr. Roger Hoag, MD...................................... Medicine
Prof. Bernard Lo, MD.................................... Ethics
Dr. Bert Lubin, MD...................................... Medicine
Prof. Margaret R. McLean, MDiv, PhD..................... Religion
Francis C. Pizzulli, JD................................. Law
Prof. Radhika Rao, JD................................... Law
Prof. Larry Shapiro, MD................................. Medicine
Dr. Tracy Trotter, MD................................... Medicine
Under the leadership of Dr. George Cunningham, Chief of the Genetic
Disease Branch, California Department of Health Services, the Committee
held five public meetings, beginning in May 1999, and innumerable
closed meetings. It discussed, debated, negotiated, and argued about
the subject and about its report up until the day before it delivered
that report to the State. But, remarkably, the report it delivered
contained five unanimous recommendations, as the Committee achieved a
consensus on these very difficult issues.
The exact recommendations are contained in the Executive Summary of
the Committee report, attached at the end of this statement. The most
important recommendations were the first that California should ban
human reproductive cloning and the second that California should not
ban, but should regulate, human non- reproductive cloning.
Those recommendations are not, in themselves, novel. Other groups,
and other jurisdictions, including the United Kingdom, have reached
similar conclusions. What was remarkable about the Committee's
conclusions, I believe, is not what they were but how they were
reached. The twelve members of this Committee started with very
different positions on both reproductive and non-reproductive human
cloning. As we heard more testimony and public comment, read more
deeply in the literature, and began writing (and arguing about) our
report, our views began to converge. They never converged completely.
We have some different reasons for believing human reproductive cloning
should be banned; although all of us agree more regulation of human
non-reproductive cloning is needed, we have different ideas for the
appropriate extent of such regulation. But, in 32 months of study and
effort, we came much closer together. I believe our experience is
evidence that, although the issues raised by human cloning are both
profound and complex, a latent consensus exists, in California and, I
believe, in the United States, on these issues. Government should not
allow human cloning to be used to make people; it should allow with due
care human cloning research to proceed to find ways to relieve diseases
and conditions that cause suffering to existing people. Senate Bill
1758, introduced by Senator Feinstein and others, reflects that
emerging consensus; Senate Bill 790, introduced by Senator Brownback
and others, does not.
Human Reproductive Cloning
No responsible authority has supported the current use of human
reproductive cloning. The California Committee was no exception. Every
member of our Committee concluded that the issues of the physical
health and safety of any children produced by such cloning compelled
its prohibition. Every member also had concerns about human
reproductive cloning even if it were proven safe. A large majority of
the Committee concluded that other issues would justify a ban on
reproductive cloning even if it were proven safe, although there was no
agreement on just which non-safety issues were compelling.
The safety concerns are not a smoke-screen for the other worries;
they are only too real. Many strong theoretical reasons cast doubt on
the safety of this procedure. The empirical results to date with
reproductive cloning in other mammals are a daunting record of
miscarriages, still-births, birth defects at ten times the normal rate,
and at least some possible indications of late onset illness. The
almost total failure of efforts to clone non-human primates, in spite
of substantial efforts, is yet another reason for concern. One should
not demand perfect safety the usual way of making babies has its own
serious risks for both mother and child but before we should consider
seriously allowing human reproductive cloning, the procedure should
have demonstrated, in non-human mammals (and preferably primates), that
it is as safe or nearly as safe as normal reproduction or in vitro
fertilization technologies.
Statutory prohibitions of reproductive cloning, such as exist in
California and a few other states, would be useful. It is not clear
that they are essential the unanimous condemnation of the procedure by
professional groups; the potential for civil liability; the assertion
by the Food and Drug Administration, no matter how questionable, of
jurisdiction over cloning; and their own professional duty to ``first
do no harm'' should stop all but the most reckless physicians. Adding a
statutory prohibition, with clear and serious penalties, would,
however, be another useful measure to limit such unjustified
experiments.
Human Non-reproductive Cloning
The California report's position on human non-reproductive cloning
is more complicated. We believe that its medical promise meant that it
should not be banned. At the same time, we do not believe that the
existing regulation of this research is sufficient. Both parts of that
recommendation were essential to our unanimous conclusion. Only Senate
Bill 1758 combines those two crucial points.
Consideration of human non-reproductive cloning can usefully begin
with analysis of the arguments against it. Almost every argument about
human non-reproductive cloning is, in fact, an argument against any
destructive research with the human embryos. Arguments about the moral
status of the embryo, the possible commodification of human life, the
risk of oppression to egg donors have been made for more than a decade
about human embryo research, as well as human fetal research. Our
society has not reached a consensus about any of those arguments, but
our governments have reached a compromise resolution. The federal
government does not fund research that entails the destruction of human
embryos; nor does it, under President Bush's August 9, 2001 position,
fund research on embryonic stem cell lines derived from human embryos
that were destroyed after that date. But neither the federal government
nor most states forbid such research if it is privately funded. This
resolution makes both sides unhappy, but it has proven, to date, an
acceptable compromise. There is no reason to treat human embryonic
research differently because the embryo involve was created through
cloning.
Only one argument against non-reproductive human cloning is not
just a recycled argument against human embryo research. Some have
argued that human non-reproductive cloning must be banned to forestall
human reproductive cloning. This ``slippery slope'' argument is largely
silly. One could make the same argument for banning automobiles because
they might be used for get-aways from bank robberies or banning
electricity because it might be used to commit a murder. In the case of
human cloning, the argument requires that someone who is willing to
violate the law (and incur its penalties) by performing human
reproductive cloning would not be able to make his own embryos, but
would be able to beg, borrow, or steal a most likely anonymous cloned
embryo from a research laboratory and, using an in vitro fertilization
clinic, implant the transported cloned embryo into a willing woman. If
the production of cloned human embryos proves possible, it is most
likely that, as with other cloned mammals, the creation of the cloned
embryo will be the easy part of the work bringing it successfully to
term will be the hard part.
This slippery slope argument does have one good use. It highlights
the value of increasing the regulation of human non-reproductive
cloning. The California Committee concluded that the State should
regulate non-reproductive cloning by at least a) forbidding all
research with cloned human embryos after the appearance of the so-
called ``primitive streak'' at about 14 days from its creation, b)
requiring the informed consent of all those who donated cells to the
process, and, last but most importantly, c) requiring the review and
approval of any such work by an Institutional Review Board. Such IRB
review will help ensure that the research is documented, that the
researchers are accountable, and that the means and goals of the
research are appropriate. This review is not now generally required for
research that does not involve federal funding, Food and Drug
Administration approval, or major research institutions. I am pleased
that Senate Bill 1758 includes this extension of IRB review to human
non-reproductive cloning.
Issues of Implementation
Finally, the California Committee discussed not just what policy
the State should adopt, but how that policy should be implemented. We
strongly recommended that the legislature delegate the details of
regulation, including the detailed definition of the covered procedure,
to an administrative agency. The same concerns clearly exist at the
federal level.
It is difficult for a legislature to regulate science effectively,
particularly in a fast- moving field. Drafters of the legislation, in
spite of their best efforts, may not understand scientific terms in the
same way the scientists do. Even if their understanding is correct at
the time the legislation passes, the science can and will change much
more quickly and easily than statutory language. I have studied the
definition of human cloning in the numerous bills introduced and the
few statutes passed in various jurisdictions after Dolly. See Henry T.
Greely, Banning ``Human Cloning'': A Study in the Difficulties of
Defining Science, So. Cal. Interdisc. Law Rev. 8:131-152 (1998).
Many of those bills would not have achieved their goals because
their loose use of terms like ``cloning'', ``somatic cell,'' or
``diploid'' left loopholes that could be exploited. Some used
definitions that made no sense at all. Several bills would have banned
``the replication of a human individual by cultivating a cell with
genetic material through the egg, embryo, fetal and newborn stages into
a new human individual.'' Unless the term ``replication,'' itself
undefined and ambiguous, has special meaning, this definition seems to
describe the age-old method of human reproduction. A bill introduced in
Florida would have banned human cloning, defined as ``creating a new
individual by using the complete nuclear genetic material of an
existing human being to create a second genetic duplicate of that human
being.'' Presumably the first duplicate would have been permitted. Even
the California legislation, which, in my professional view, has the
best definition of human reproductive cloning, could be read to exclude
some advanced reproductive technologies that involve transfer of a
nucleus into an egg but do not involve human cloning the resulting egg
would later be fertilized with sperm.
Although the Congress is likely to avoid making some of these
mistakes, it cannot avoid the unpredictability of the future course of
this science. Any legislation passed, therefore, should define human
reproductive cloning broadly probably as the intentional creation of a
fetus or child that is substantially genetically identical to a
previously existing human and delegate the power to define the subject
matter more precisely to an administrative agency.
Conclusion
The explosion of our knowledge about biology confronts us all as
legislators, as citizens, as moral actors with new challenges. It holds
the promise of unprecedented reductions in human suffering; it also
holds the threat of unprecedented changes. . .and dangers. . .to our
humanity. The combination of a science that is both unclear and rapidly
changing with a host of moral questions of great depth makes perfect
solutions impossible. We cannot know what is right; we can only act,
humbly, in ways that, after due consideration, seem right based on what
we now know. The various dangers of human reproductive cloning, as we
now understand them, demand that it be banned. The various promises of
human non-reproductive cloning, with the benefits they now seem likely
to offer, compel its continuation but with appropriate new regulation.
This mixed verdict is not the perfect solution to the challenge of
human cloning; it is merely the best solution we fallible humans can
come up with today. As such, Congress should enact it into federal law
through adopting Senate Bill 1758.
It has been an honor, and a pleasure, to appear before you. Thank
you for the opportunity to discuss these fascinating and compelling
issues.
Chairperson Feinstein. Thanks very much, Professor Greely.
I will now turn to R. Alta Charo. She is a professor of law
and medical ethics at the University of Wisconsin at Madison.
She is on the faculty of both the university's law and medical
schools. Since arriving at the University of Wisconsin in 1989,
Professor Charo has served on the University of Wisconsin
Hospital Clinic Ethics Committee and the university's Bioethics
Advisory Committee. From 1996 to 2001, she was a member of the
Presidential National Bioethics Advisory Commission where she
participated in drafting numerous reports, including ``Cloning
Human Beings.'' Since 2001, she has been a member of the
National Academy of Sciences Board on Life Sciences.
Welcome, Professor.
STATEMENT OF R. ALTA CHARO, PROFESSOR OF LAW AND MEDICAL
ETHICS, UNIVERSITY OF WISCONSIN LAW SCHOOL, MADISON, WISCONSIN
Ms. Charo. Thank you very much. Madam Chairman, members of
the committee, first I would like to thank you for the
opportunity to address you.
Debates over reproductive cloning, stem cell therapy, and
even genetic engineering have become hopelessly entangled in
the last 5 years. Each one is worthy of a policy debate, but I
deeply believe each one would be better debated if debated
separately.
As you have already discussed, there are bills now before
this Congress that would ban not only the irresponsible use of
cloning to make babies--a procedure we all agree is dangerous
at this time--but also the responsible use of non-reproductive
cloning for research or therapy. Some would even ban the
importation of proven medical therapies developed abroad if
their origins were entangled with cloning research.
Proponents of these bans say this is necessary in order to
be assured that reproductive cloning to make children cannot
occur. I disagree.
The proponents of the bans, for example, fear that once a
cloned embryo exists in a laboratory, either the embryo or its
so-called parent may have constitutional grounds to insist that
pregnancy be permitted. But this makes no sense. It requires
either that the embryo itself have a constitutional right to be
born--something that the U.S. Supreme Court has specifically
rejected and also has been rejected by leading State courts
hearing disputes over existing frozen IVF embryos in our
laboratory now--or this argument would require that people be
considered to have a fundamental right to use these embryos to
reproduce through cloning--in other words, to have a
fundamental right to reproduce by cloning, per se, which would
render the entire ban equally unconstitutional.
Now, others worry not about a constitutional ground for
bringing the embryo to term but simply that the cloned embryo
sitting in a lab will tempt someone to use it illegally. But I
would note that the criminal penalties in bills such as S. 1758
are equally effective whether the cloned embryo already exists
or is merely imagined. The deterrent is clear, and it is not
strengthened by criminalizing basic research.
So if criminalizing research is not needed to guard against
the unfortunate outcome of using cloning to make children, it
must have another purpose. And indeed the proponents have cited
the research ban being needed to protect embryos, women's
health, and even the future of humanity.
In my opinion, if the purpose is to protect embryos, then
criminalizing research and so-called therapeutic cloning is an
odd place to begin. As Senator Durbin has already pointed out
this afternoon, we know and, indeed, we fully expect that
embryos will unfortunately be lost by the thousands each year
at in vitro fertilization clinics, even if IVF is done
perfectly, even if every woman who wants to adopt an embryo is
successful.
Criminalizing research cannot alter the scale of this
embryo loss, and since almost no one thinks that IVF itself
could be outlawed, then banning a technique that might involve
an exceedingly small number of embryos represents, at best, a
symbolic effort at embryo protection.
Now, such symbolic efforts are important. They remind us
that life is a gift to be experienced with awe and gratitude.
But such symbols can be badly tarnished if they are adopted at
the expense of pain and suffering. And as Dr. Weissman has
noted and as the chairman noted when she first opened the
hearing, reproductive cloning at this time is a danger to
children but non-reproductive cloning might save their lives.
Whether by doing research with the cells of those who have
genetic diseases so we can study in a laboratory dish how the
defective gene operates and develop drugs to treat, or to use
it for transplantation without risk of rejection, it is
potentially life-saving. But most important--and, again, as the
chairman noted in her earlier remarks--studying research
cloning allows us to understand how cloning reprograms adult
cells, which may in the future allow us to reprogram those
cells directly without cloning and without the use of embryos
in order to generate tissue that could be used to alleviate
paralysis or save lives.
Yes, there are other promising avenues of research, and you
will hear about them this afternoon. They most certainly should
be pursued. But that is no argument for criminalizing this
research. America is not a country in which basic research or
personal choices are illegal until someone has persuaded the
government to grant permission. Quite the contrary. We
celebrate the freedom to think and to act and to inquire into
the secrets of nature until a compelling case can be made that
it must be stopped. Identifying complementary areas of research
falls far short of making that case. In my opinion, at best it
is an argument for shaping Federal funding priorities in a way
that affords these alternative avenues every chance of success.
In my last remaining seconds, I would like to note that
there are a handful of women's health and environmental
organizations long known for a particularly great skepticism
about medical science and biotechnology that have also
testified against research cloning, saying that it is the first
step on a slippery slope toward eugenics and the
commodification of life. I would say that therapeutic cloning
and research cloning is neither the beginning nor the end of
that slippery slope, nor is it even the most important
landmark.
Our power over human reproduction is as old as ancient
contraceptive potions, and it was IVF that was the true
landmark moment at which we were able to manipulate the embryo
because it now existed outside the body.
By contrast, cloning research does not engineer or design
the embryo, and, indeed, precisely because it does not involve
making babies, it does not design or engineer our children. It
is not basic research but, rather, our choices about its
applications that will shape the future.
A moratorium on attempting pregnancy with cloned embryos is
an effective and excellent speed bump on the slippery slope
toward this future so many seem to predict and fear. To ask for
more and to halt such basic research is to sacrifice the
diabetic children, paralyzed police officers, and declining
elderly of the present for a future that is neither certain nor
imminent.
Criminalizing research cloning is not the way to protect
embryos. It is not the way to guard against the future. It
merely gambles with the hope held by many people today that
they may live to see that future, whatever it may hold. Thank
you very much.
[The prepared statement of Ms. Charo follows:]
Statement of R. Alta Charo, Professor of Law and Medical Ethics,
University of Wisconsin Law School, University of Wisconsin Medical
School, Department of the History of Medicine
Madam Chairman, members of the committee, my name is Alta Charo,
and I am a professor of law and medical ethics at the University of
Wisconsin.
I was a member of the N.I.H. Human Embryo Research Panel in 1993-
94, and the National Bioethics Advisory Commission (NBAC) from 1996-
2001. I participated in drafting NBAC's 1997 report on human cloning,
but did not participate in drafting its 1999 report on human embryonic
stem cells, in order to avoid any appearance of a conflict of interest
due to my affiliation with the university where human embryonic stem
cells were first isolated and maintained. I also had the privilege of
testifying for the National Academy of Sciences (NAS) as it prepared
its recent report on cloning, and have since been appointed to the NAS
Board on Life Sciences.
I am pleased to testify in support of legislation that protects
valuable non-reproductive uses of cloning technology while also
guarding against its dangerous use to make a baby.
Such legislation is largely consistent with the recommendations of
the National Bioethics Advisory Commission (whose reports recommended a
moratorium on reproductive cloning but federal funding for research on
stem cells derived from surplus IVF embryos while monitoring on-going
private sector research on stem cells derived from cloned embryos) and
with the recommendations in the National Academy of Sciences' two
reports on stem cell research and reproductive cloning. It is also
consistent with the provisions of a bill passed last week by the
Wisconsin State Senate, a bill that is supported by the University of
Wisconsin--Madison and which is now ready for consideration by our
State Assembly.
I am here today to present my own views, however, and do not
represent NBAC, the NAS or my own university.
Debates over reproductive cloning, stem cell therapy, and even
genetic engineering have become almost hopelessly entangled in the last
five years. Each is worthy of policy debate. But each deserves a clear
and separate discussion.
Cloning, that is, somatic cell nuclear transplantation, is
currently too dangerous for making babies. Medical societies tell their
members not to try it. The Food and Drug Administration has intervened
to prevent it. It would be malpractice to attempt it, Florida has a
bill to hold professionals strictly liable should they do it, and
Senate Bill 1758 would criminalize it.
Clearly, there are many ways to stop the small number of publicity-
hungry, irresponsible people who want to risk the health of women and
children by using reproductive cloning.
But there are bills now before this Congress that would ban not
only the irresponsible use of cloning to make babies, but also the
responsible use of non-reproductive cloning for research or therapy.
Some would even ban importation of proven medical therapies developed
abroad, if their origins were entangled with cloning research.
Their proponents fear that once a cloned embryo exists in a
laboratory, either the embryo or the so-called ``parent'' may have
constitutional grounds to insist that pregnancy be permitted. But this
makes no sense. It requires either that the cloned embryo has its own
right to be born (a doctrine rejected both by the Supreme Court and by
leading state courts hearing disputes over existing, frozen IVF
embryos) or that people have a fundamental right to use these embryos
to reproduce through cloning, in which case the entire ban on
reproductive cloning is unconstitutional.
Others worry that a cloned embryo sitting in a laboratory will
tempt someone to use it illegally to make a baby. But the criminal
penalties in Senate Bill 1758 are equally effective, whether a cloned
embryo already exists or is merely imagined. The deterrent is clear,
and is not strengthened by criminalizing basic research.
But if criminalizing research is not needed to deter reproductive
cloning, then these bills must have another purpose. Indeed, their
proponents have argued that a research ban is needed to protect
embryos, women's health, and the future of humanity.
But if the purpose is to protect embryos, then criminalizing
research and therapeutic cloning is an odd place to begin.
We know indeed, we fully expect that embryos will be lost by the
thousands every year at in vitro fertilization (IVF) clinics. Even if
IVF is done perfectly, and even if everyone who wants to ``adopt'' an
embryo is successful, thousands would still be left behind.
Criminalizing research cloning cannot alter the scale of embryo loss
that occurs each year. And since almost no one thinks IVF could be
outlawed, criminalizing a technique that might involve an exceedingly
small number of embryos represents at best a symbolic effort at embryo
protection.
Such symbolic efforts are both powerful and important. They remind
us that life is a gift that should be experienced with awe and
gratitude. But a symbol can be badly tarnished if it is adopted at the
expense of pain and suffering.
While reproductive cloning at this time is a danger to children,
non-reproductive cloning could save their lives. Cloning cells from
someone with a genetic disease could produce tissue in which we study
how the defective gene malfunctions, and help us develop drug
treatments, perhaps reducing the number of human volunteers at risk in
later clinical trials. Used to generate stem cells, it might become the
fastest route to transplantation without risk of rejection. And perhaps
most importantly, studying how cloning reprograms adult cells will help
us learn how to reprogram cells directly, without cloning and without
the use of embryos, to create tissue for research, transplantation and
organ regeneration to alleviate paralysis and extend healthy life.
Yes, there are other promising avenues of research, and they most
certainly should be pursued. But that is no argument for criminalizing
this research. America is not a country in which basic research or
personal choices are illegal until someone has persuaded the government
to grant permission. Quite the contrary. We celebrate the freedom to
think and to act and to inquire into the secrets of nature, until a
compelling case can be made that it must be stopped. Identifying
complementary areas of research falls far short of making that case. At
best it is an argument for shaping federal funding priorities in a way
that affords these alternative avenues every chance of success.
A handful of women's health and environmental organizations, those
especially known for great skepticism about medical science and
biotechnology, have also testified against research cloning, claiming
it is the first step toward a world that is both unnatural and devoid
of sentiment.
These, too, are concerns worthy of independent debate. But FDA
regulation of cell-based therapies that require women's eggs will
address issues of risk to women, and markets in eggs, sperm and other
human tissue can be regulated without criminalizing basic science.
But most importantly, research and therapeutic cloning is neither
the beginning nor the end of a slippery slope toward eugenics. It is
not even the most important landmark.
Our power over human reproduction is as old as ancient
contraceptive potions. And the first announcements about IVF were
greeted with the same chorus of concerns about genetic engineering,
designer babies, and the commodification of life, because it was IVF
that first made the embryo amenable to study and manipulation outside
the body.
By contrast, therapeutic cloning does not design or engineer the
embryo, and precisely because it is not about making babies, it neither
designs nor engineers our children. It is not basic research but rather
our choices about its applications that will shape the future.
A moratorium on attempting pregnancy with cloned embryos, or
perhaps in the future with engineered embryos, is a highly effective
speed bump on the slippery slope toward the future some people predict
and fear. To ask for more, to halt basic research, is to sacrifice the
diabetic children, the paralyzed veterans, the skin-scorched
firefighters and the declining elderly of the present for a future that
is neither certain nor imminent.
In sum, we should deter those who would use cloning for
reproductive ends despite its dangers. But we shouldn't throw the bath
water out with the baby. Criminalizing research and therapeutic cloning
is not the way to protect embryos or to guard against the future. It
merely gambles with the hope held by many people today that they may
live to see that future, whatever it holds.
Thank you.
Chairperson Feinstein. Thanks very much, Dr. Charo.
And now we will proceed. I have Kris Gulden next, if I
might, and we would very much like to welcome her. She is here
on behalf of the Coalition for the Advancement of Medical
Research. It represents 60 organizations and associations
supporting therapeutic cloning. Ms. Gulden, a former veteran
police officer in Alexandria, Virginia, received several awards
for her law enforcement work. She also maintained an active
schedule outside the office, including winning the women's
triathlon gold medal in August 1996 at the Biannual
International Police Olympics in Salt Lake City. Tragically, a
car struck Ms. Gulden while she wa training for the 1998 AIDS
ride, leaving her with a severe spinal cord injury. That
accident changed her life. Nine days before the accident, she
was participating in a triathlon in Memphis. Nine days after
the accident, ``Just brushing my teeth was exhausting,'' she
said. Yet Ms. Gulden has made tremendous progress, and I am
very happy she could be here today to testify.
STATEMENT OF KRIS GULDEN, COALITION FOR THE ADVANCEMENT OF
MEDICAL RESEARCH, WASHINGTON, D.C.
Ms. Gulden. Thank you, Madam Chairperson, Senator Hatch,
and members of the committee. I would like to thank you for the
opportunity to testify today on the value of somatic cell
nuclear transfer, commonly referred to as therapeutic cloning.
As you know, the Coalition for the Advancement of Medical
Research is an organization comprised of universities,
scientific and academic societies, patients' organizations, and
other entities that are devoted to supporting stem cell
research. In addition, I realize that today I am the voice of
millions of Americans living at ALS, MS, Parkinson's disease,
spinal cord injuries, and other illnesses that may benefit from
therapeutic cloning.
Along with the Coalition for the Advancement of Medical
Research, I support efforts to prohibit human reproductive
cloning. However, it is imperative that we protect important
areas of medical research that offer hope to millions of
Americans.
As a person living with paralysis caused by a spinal cord
injury, I know how urgently a cure is needed. I do not expect a
cure tomorrow or even next year, and I do not intend to
overstate the promise of the research. But how can you
overstate hope?
On May 26th of 1998, my life was changed when I was struck
by a vehicle while riding my bike. At the time I set out for
that bike ride, I was a healthy 31-year-old triathlete, and I
was employed as a police officer in Alexandria, Virginia. I
never finished that bicycle ride because I was struck by a car.
In addition to a traumatic brain injury and a laundry list of
broken bones, I sustained a spinal cord injury at the T4 level.
The doctors told me that I had a 20 percent chance of ever
walking again. My friends and family members had to incorporate
the word ``paraplegia'' into their vocabularies. In an
instance, my future changed from adrenaline rushs and thrill-
seeking to wheelchairs and hand controls.
Six weeks after my accident, I discovered that I could move
my legs. And in that instant, I discovered hope. I knew that if
it were only a matter of strengthening the muscles in my legs,
I would, in fact, walk again. And within 3 months, I was
walking with a rolling walker.
In the summer of 1999, I went to the University of Miami to
go through EMG biofeedback training. This proved to be an
exciting therapy that gave me even more optimism that I would 1
day walk again. However, a rare complication of a spinal cord
injury--a disease called syringomyelia--has caused me to lose
considerable function. I have not, though, lost hope. I have
returned to the University of Miami for additional sessions of
biofeedback, and I remain committed to the idea of walking
again. Additionally, the potential for new therapies like
cloning gives hope to so many people.
I understand that the word ``cloning'' has caused many
individuals to imagine the worst possible abuses. But allow me
to make a critical distinction between cloning technology used
to create a human being--reproductive cloning--and the
therapeutic cloning techniques that are vital to breakthroughs
in medicine, diagnostics, and potentially vaccines used to
treat diseases like Parkinson's, Alzheimer's, cancers, heart
disease, diabetes, and even paralysis resulting from spinal
cord injuries. Therapeutic cloning cannot product a whole human
being. This work should be allowed to move forward.
Somatic cell nuclear transfer may prove to be a vital tool
in allowing scientists to fully develop the promise of stem
cell research. Somatic cell nuclear transfer involves the use
of a donor's unfertilized egg and a patient's own cells. This
research could allow a patient's own genetic material to be
used to develop stem cell therapies specifically tailored to
that individual's medical condition, thus not triggering an
immune rejection response. In other words, using somatic cell
nuclear transfer could repair patients with their own cells.
Given the scientific potential in this area, we strongly
opposed any legislative action that would ban research related
to therapeutic cloning. This would include criminalizing the
research or the researchers, and prohibiting the importation of
therapies derived from somatic cell nuclear transfer in other
countries.
Madam Chairperson, it is likely that we will continue to be
confronted with scientific advances that pose difficult social
and ethical questions. The present momentum in biomedical
research and the profound implications of what we are learning
will inevitably raise public concerns. Yet an across-the-board
ban on human cloning will dash the hopes of many Americans
living lives that, like mine, are so radically, functionally,
and emotionally different than what they once were.
In my dreams, I still walk. I run, I play basketball, and I
wear the uniform of the Alexandria Police Department. When the
sun rises each morning, it brings reality with it. I rise to
the sight of a wheelchair, yet I rise with the hope that maybe
this will be the morning that I can move my legs.
And if I could just add one more personal story, my mom
lives in Pennsylvania, and she is a constituent of Senator
Arlen Specter. Back in August, my mom attended a town hall
meeting that Senator Specter held, and she asked him about stem
cell research. Senator Specter's quote to my mom--and I have
got the newspaper article here--was, ``We're not going to let
you down.'' And I wish that Senator Specter was still in the
room. I hope that he and his colleagues will live up to that
promise.
In closing, I just want to thank the committee members for
having me here today, and on behalf of the Coalition for the
Advancement of Medical Research, the countless Americans who
stand to benefit from therapeutic cloning, and the friends and
family members who love them, I again thank you for having me
here today.
[The prepared statement of Ms. Gulden follows:]
Statement of Kris Gulden, on behalf of the Coalition for the
Advancement of Medical Research
Good morning Senator Feinstein and Members of the Committee. Thank
you for the opportunity to testify t oday on the value of somatic cell
nuclear transfer (SCNT), commonly referred to as therapeutic cloning.
My name is Kris Gulden, and I am here on behalf of the Coalition for
the Advancement of Medical Research (CAMR). The Coalition is an
organization comprised of universities, scientific and academic
societies, patient's organizations, and other entities that are devoted
to supporting stem cell research. In addition, I realize that today I
am the voice of the millions of Americans living with MS, spinal cord
injuries, ALS, Parkinson's Disease, and many other illnesses that may
benefit from therapeutic cloning.
I, along with the Coalition for the Advancement of Medical
Research, support efforts to prohibit human reproductive cloning.
However, it is imperative that we protect important areas of medical
research that offer hope to millions of Americans. As a person living
with paralysis caused by a spinal cord injury, I know how urgently a
cure is needed. I do not expect a cure tomorrow, or even next year. And
I do not intend to overstate the promise of the research. But how can
you overstate hope?
On May 26, 1998, I set out on a bicycle ride that would change my
life. When I began, I was a healthy, 31 year old-triathlete. I was
employed as a police officer in Alexandria, Virginia. I never finished
that ride; it was interrupted when I was struck from behind by a motor
vehicle. In addition to a traumatic brain injury and a laundry list of
broken bones, I sustained a spinal cord injury at the T4 level. The
doctors told me that I had about a 20% chance of ever walking again. My
friends and family had to incorporate the word ``paraplegia'' into
their vocabularies. In an instant, my future was changed from
adrenaline and thrill-seeking to wheelchairs and hand controls.
Six weeks after my accident, I discovered that I could move my
legs. And in that instant, I discovered hope. I knew that if it were
only a matter of strengthening my leg muscles, I would in fact walk
again. And within three months, I was walking with a rolling walker.
In the summer of 1999 I went to the University of Miami to go
through EMG biofeedback training. This proved to be an exciting therapy
that gave me even more optimism that I would one day walk again.
However, a rare complication of a spinal cord injury a disease called
syringomyelia - has caused me to lose considerable function.
I have not, though, lost hope. I have gone back to Miami for
additional sessions of biofeedback, and I remain committed to the idea
of walking again. Additionally, the potential for new therapies like
cloning gives hope to so many people.
I understand that the word ``cloning'' has caused many individuals
to imagine the worst possible abuses. But allow me to make a critical
distinction between the use of cloning technology to create a baby
reproductive cloning and the therapeutic cloning techniques central to
the production of breakthrough medicines, diagnostics, and potentially
vaccines to treat diseases like Parkinson's, Alzheimer's, diabetes,
heart disease, various cancers, and even paralysis resulting from
spinal cord injury. Therapeutic cloning cannot produce a whole human
being. This work should be allowed to move forward.
Somatic cell nuclear transfer may prove to be a vital tool in
allowing scientists to fully develop the promise of stem cell research.
Somatic cell nuclear transfer involves the use of a donor's
unfertilized egg and a patient's own cells. The research could allow a
patient's own genetic material to be used to develop stem cell
therapies specifically tailored to that individual's medical condition,
thus not triggering an immune rejection response. In other words, using
somatic cell nuclear transfer could repair patients with their own
cells.
Given the scientific potential in this area, we strongly oppose any
legislative action that would ban research related to therapeutic
cloning. This would include criminalizing the research or the
researchers, and prohibiting the importation of therapies derived from
somatic cell nuclear transfer in other countries.
Ms. Chairperson, it is likely that we will continue to be
confronted with scientific advances that pose difficult social and
ethical questions. The present momentum in biomedical research, and the
profound implications of what we are learning, will inevitably raise
public concerns. Yet an across-the-board ban on human cloning will dash
the hopes of many Americans living lives that, like mine, are so
radically, functionally, and emotionally different than what they once
were.
In my dreams, I still walk. I run, I play basketball, and I wear
the uniform of the Alexandria Police Department. When the sun rises
each morning, it brings reality with it. I rise to the sight of a
wheelchair, yet I rise with the hope that maybe this will be the
morning I can move my legs.
On behalf of the Coalition for the Advancement of Medical Research,
the countless Americans who stand to benefit from therapeutic cloning,
and the family members and friends who love them, I again thank the
Committee for its deliberations and for the opportunity to speak to
this issue.
Chairperson Feinstein. Thank you very much. Thank you for
that excellent testimony.
We will now go to Andrew Kimbrell. He is a public interest
attorney, activist, and author. In 1994 Mr. Kimbrell founded
the International Center for Technology Assessment, an
organization that is devoted to a holistic analysis of
technology. He continues to serve as the center's executive
director. He has authored several books and given numerous
public lectures. In 1994, the Utney Reader named Mr. Kimbrell
as one of the world's leading 100 visionaries.
Mr. Kimbrell, welcome.
STATEMENT OF ANDREW KIMBRELL, EXECUTIVE DIRECTOR, INTERNATIONAL
CENTER FOR TECHNOLOGY ASSESSMENT, WASHINGTON, D.C.
Mr. Kimbrell. Thank you, Madam Chairman. I thank the
committee for the opportunity to speak with you this afternoon.
I would add, even though I was named one of the 100 leading
visionaries, I noticed when they got us all together that we
all wore very heavy lenses. We all had glasses So maybe a
prerequisite to being a visionary is that you can't really see,
Madam Chairman, so you should probably take that caveat on my
testimony today.
I am here representing myself and also part of the
Environmental Women's Health and Consumer and Health Coalition
that Representative Weldon referred to that worked on his bill
on the House side. I have submitted written testimony. I am
going to try and summarize it here.
I am going to try and accomplish two things. One is to put
this current discussion in sort of a historical context. We all
remember George Santayana's truism that ``Those who cannot
remember the past are condemned to repeat it.'' And I think
that is an important warning that we should take into
consideration as we discuss this issue today.
Alta Charo and myself have been dealing with--and so have
many on this committee--these kinds of issues for many years.
When I heard Dr. Michael West of ACT say that he was going to
save 3,000 lives a day, and even a 6-month halt on his embryo
cloning for stem cells could cost a million and a half lives, I
realized this was unadulterated hyperbole. And subsequent to
that, we have seen numerous scientists say that Dr. West's
claims are completely false, he has completely failed in his
attempt to do that. So it is important, as Representative
Weldon has said, that this technology is not working. It is not
clear when we will be able to garner stem cells from embryos.
I remember about 12 years ago working with Senator
Kennedy's staff and then-Senator Gordon Humphrey's staff on the
gene therapy question, and we were arguing for stringent
regulations on gene therapy. There were many, many unique
ethical questions and scientific questions that we felt needed
to be resolved before we allowed human trials to take place.
Many in the research community supported us. Many did not.
Unfortunately, those who wanted a deregulated gene therapy
industry essentially won the day. Now, over a decade later,
hundreds of trials, not a single person has been cured with
gene therapy. Many patients groups call it a big
disappointment, but for many it has been more than a
disappointment. Eighteen-year-old Jesse Gelsinger volunteered
for a gene therapy trial in Philadelphia, and because of
researcher misconduct, unregulated research, he was killed.
Investigative reporting by the Washington Post showed that
perhaps a half-dozen others also have been killed by these
trials, and over a thousand, over 1,000 adverse reactions in
this unregulated research, over a thousand reactions, including
many deaths and serious injuries, were possibly linked. No
cures. If we had taken a 10-year moratorium at that time, not a
single disease, however tragic, would have been cured, but many
lives would have been saved if we had looked at the serious
questions before we allowed these technologies to be widely
disseminated.
I again worked with Senator Kennedy and with Senator
Hatch's staff and, again, Senator Humphrey's staff to try and
get adequate regulation of fetal tissue research. We were very
concerned about the sale of fetal tissue. We were concerned
that people were going to change the method and manner of
abortion in order to obtain fetal tissue. We were concerned
about informed consent in this regard, limitations on how that
tissue could be used.
We tried bravely. We got some legislation passed. But,
basically, there was inadequate regulation, inadequate
legislation, inadequate enforcement. And what have we found?
Unfortunately, right now there is a thriving fetal tissue
market, repugnant, I am sure, to all of us. There are continued
reports, verified reports of researchers changing the method
and manner of abortion to get this tissue.
In the largest trial in Parkinson's disease done up to this
point--and, by the way, there has been over 400 trials--again,
no cures. But the side effects, which certainly could have been
obtained in animal research, were devastating. Absolutely
devastating, actually. According to Dr. Paul Greene, a
neurologist at Columbia University College of Physicians and
Surgeons who oversaw that research, he said, ``It is a real
nightmare, and we can't selectively turn these fetal cells
off.'' They put them into brains, and they produce chemicals
that have his patients, 15 percent of them, twitching 24 hours
a day, unable to sleep, unable to eat, unable to talk. We
didn't regulate it adequately. We weren't precautionary. We
didn't obey the first rule of the Hippocratic oath, ``First, do
no harm.''
Now we have the next miracle cure de jour--stem cells. I
urge you this time, please, do not let this technology go out,
disseminate it, become an industry without adequately,
stringently regulating before we do that.
Now, with stem cells, we have this extraordinary
unprecedented issue of cloning that is involved. And for the
progressive community this is not a right-to-life issue. There
are six major concerns, and I will summarize them very briefly
in conclusion, and Representative Weldon did mention several of
them that I think we need to look at.
At a minimum, before we allow the cloning of human embryos
for research, we need to have regulations and legislation that
deals with this, before we allow that. There is a major problem
with allowing an unregulated market and the production of
cloned embryos and expect there to be no reproductive cloning.
Imagine, Madam Chairman and members of the committee, if we
were to have a drug war where we encourage the production of
cocaine and other drugs--encouraged it, had an open and
unregulated industry in it, but also said we were trying to
make use of drugs illegal. That is essentially what we are
doing if we encourage an unregulated industry in the production
of cloned embryos and still say we are against reproductive
cloning. It is not going to happen.
The second is that this industry in cloned embryos leads to
the commodification of life. The Patent Office as announced
that they will allow the patenting of these embryos. There is
no bar on the sale of these embryos. If you sell the
Congressional Medal of Honor, you demean and corrupt that
medal. If you sell the Nobel Prize, you corrupt and demean the
Nobel Prize. If you sell children, you corrupt and demean the
meaning of parenthood. If you sell human embryos and patent
human embryos, you demean and corrupt what it means to be a
human.
Representative Weldon also talked, and I thought rather
tellingly, about the impacts on women through this technology.
According to many researchers, there are going to need to be 5
and 8 million eggs harvested from women in order to make
therapeutic cloning possible. We all know the impacts on
women's bodies caused by the operations and drugs required to
extract eggs. Surely we are not going to let this happen
without some regulation, some legislation to make sure there is
not an open industry where poor women sell their eggs to
researchers for therapeutic cloning, with all of the impacts
that involves. Not acceptable. I don't think anybody finds that
acceptable.
Finally, it is important to view embryo cloning as the
ultimate choice question. None of us will know whether our
hair, blood cells, cheek cells are being used to produce these
research clones. There have been numerous cases, very well-
known litigation, where people's cells have been used to create
very valuable cell lines, and they didn't know it. None of us
in this room will have a choice if we allow an unregulated
industry and the cloning of human embryos for research on
whether we are being cloned thousands of times, being patented
and sold without our knowledge. I would view this as the
ultimate choice question. We cannot preserve choice unless we
at least have a moratorium or ban on embryo cloning.
Finally, I do think that it brings up the crucial issue--
and here I understand where Senator Durbin is coming from, but
I think it is important to note that for the very first time in
human history, if we do this, if we allow embryo cloning for
research, we will have produced a human life form solely for
its destruction, solely for its use as spare parts. Yes, it is
a question of intention, but as an attorney, we know that
intention is everything, the difference. Between a non-crime
and first-degree murder is intention. For the first time, we
will intentionally as a human race have done this.
I think at a minimum, at a minimum, this is an ethical
question that needs tremendous public debate, public hearings
across the country. And, again, we should have an unlimited
moratorium or ban on this form of cloning until that
unprecedented question has been resolved.
Thank you.
[The prepared statement of Mr. Kimbrell follows:]
Statement of Andrew Kimbrell, Executive Director, International Center
for Technology Assessment
At the outset I want too thank you for the opportunity of
testifying today on this crucial issue. Over the last many months I
have worked with a coalition of progressive environmental, consumer and
women's health groups to attempt to ban reproductive human cloning and
obtain at least a moratorium on human cloning for research, often
called ``therapeutic cloning.'' While there appears to be little
disagreement on the need to ban reproductive cloning, the issue of
halting research human cloning has become quite controversial. In my
testimony I would like to outline a number of reasons why many in the
progressive community support a ban or moratorium on human cloning for
research at this time. However, prior to discussing the current cloning
controversy, I would like to put our discussion today in the context of
similar issues we have faced in the last two decades. Sometimes there
is a tendency to deal with issues like cloning in an historical vacuum
a kind of technological amnesia. George Santayana's truism ``Those who
cannot remember the past are condemned to repeat it,'' applies equally
to technology issues a it does to political ones. Therefore I would
like to begin by reviewing our past mistakes in assessing and
regulating two ``miracle'' cures that preceded the current furor over
stem cell research and human cloning. I fear that if we do not remember
what happened with these prior technologies we will repeat the mistakes
that have led to grossly inadequate regulation and real tragedy for
many patients.
Hyperbole Versus Healing
Last December during a hearing before the Senate Appropriations
Subcommittee on Labor, Health and Human Services, and Education on the
controversy over stem cells and human cloning, Michael West of Advanced
Cell Technology (ACT) predicted that within six months his
biotechnology company would be ready to create ``magic'' cells that
would save no less than 3,000 lives a day. West claimed that he would
soon successfully clone human embryos, and then obtain stem cells from
those clones which would cure everything from heart disease and
Alzheimer's, to Parkinson's disease and spinal cord injuries. West
sternly warned that even a half year halt on his embryo cloning
research would cost over half a million lives. Horrified by what they
called ``these real numbers,'' some Senators pronounced themselves
against any limit on human embryo cloning, and vowed to ``push'' the
technology in any way they could.
Of course, West's promise of near term success in obtaining stem
cells from clones, and the subsequent healing of thousands a day, was
unadulterated hype. While there have been some preliminary indications
that adult, fetal and embryo stem cells may some day result in helpful
therapies, no such cells have ever been obtained from cloned human
embryos. In fact, West and his Massachusetts company, ACT, had just
published a paper that revealed that they had completely failed to
garner stem cells from cloned embryos. Dr. Donald Kennedy, editor of
the highly esteemed journal Science, summarized the ACT effort,
stating, ``Everything I have learned about the [ACT] study suggests
that it is not an advance that would interest us. This scientific
effort did not succeed by any measure.'' Even more telling was the
resignation of Dr. John Gearhart, of the Johns Hopkins Medical
Institutions, from the editorial board of the magazine that published
the ACT study. Dr. Gearhart, a pioneer in stem cell research, said that
the experiment"should be considered a failure'' and that the study
should not even have been published.
Moreover, the same day West was predicting near term cloning
success at the Senate hearing, his colleague at ACT, Tanja Dominko was
explaining the company's failures to a medical conference. She noted
that there was an unknown, unique characteristic about primates that
makes them difficult to clone. ``It might be that you just can't make
humans this way,'' Dominko told the conference.
Leading experts share this skepticism about cloning and any near
term success of stem cell technology. Dr. Gail Martin, the co-
discoverer of mouse embryonic stem cells, warns that there are still
``a gazillion issues'' to be resolved. Another stem cell expert, Dr.
David Solter who directs the Max Planck Institute of Germany said he
had ``no idea'' how someone expected injected stem cells to replace
sick and dying brain neurons in Alzheimer's victims.
Most of us have experienced the tragedy of disease or disability
either personally or through family and friends. Facing the crucible of
disease, we search for some hope when bodies and minds are cruelly
decimated by illness. Yet however much we want cures, it is essential
to get the real facts, the full story, about medical advances.
Unfortunately, in the past we have seen a continuous pattern of
researchers and companies peddling hype instead of healing. These false
promises about healing are not merely harmless self promotion by
research companies eager for venture capital, or benign wishful
thinking by naive legislators. Researchers' hype cruelly misleads those
who are suffering into thinking that cures are imminent. Perhaps even
more disturbing is that this hype is often successful in
``blackmailing'' legislators and regulators into taking a ``hands off''
approach to regulation of these new technologies, lest such regulation
delay cures. The resulting public policy toward new medical
technologies has been misguided, inadequate and even dangerous. It has
resulted in the trampling of some our most important ethical norms, and
in some cases to increased suffering and mortality among the very
people we seek to cure.
Genetic ``Wizardry''
A paradigm case of hyperbole over healing is gene therapy. In the
late 1980s ``gene therapy'' was heralded as the new ``miracle cure.''
Researchers were hailed as ``gene wizards'' and the media, policy
makers and scientist/entrepreneurs predicted cures to cancer and
virtually every other serious human ailment. Billions of public and
private research dollars poured into biotechnology companies and human
clinical trials. Despite public protest by some scientists, and law
suits by health advocacy groups, human gene therapy trials were
approved by the federal government with woefully inadequate oversight
and virtually no enforcement. Unmonitored and virtually unregulated,
the researchers themselves were relied on to report any adverse results
in their test. Over the last decade there have been more than 400 gene
therapy trials on patient groups. Despite all the hype, not a single
person in any U.S. gene therapy trial has been cured of any disease.
Abbey S. Meyers, a patients' group advocate noted, ``We haven't even
taken one baby step beyond the first clinical experiment. It's hardly
gotten anywhere . . . I have been very disappointed.''
For many, gene therapy has been far worse than a disappointment.
Jesse Gelsinger was an active and altruistic 18 year old from Tucson,
Arizona who suffered from a rare gene disorder. He volunteered to take
part in a Philadelphia based gene therapy trial study on that genetic
disorder. He hoped to participate in finding a cure. Instead, the gene
therapy killed him. The media furor over Gelsinger's death resulted in
revelations of serious misconduct by researchers in his case and in
others' trials. Subsequently a half dozen other cases were found where
patients' deaths were linked to gene therapy experiments. Eventually,
it was revealed that there were over a thousand serious adverse effects
potentially attributable to gene therapy trials, including numerous
deaths. Left on their own, researchers had only reported 37 of these
adverse events. As the hype about gene therapy held legislators and
regulators at bay, researchers violated the most basic ethical tenets
on the use of human subjects, which along with deficiencies in the
technology, resulting in significant suffering and the death. Wide
scale reporting of this scandal has led to an attempt to tighten
regulation of gene therapy trials, but most agree that the new policies
are far too little, and for the victims of the technology, far too
late.
The Fetal Revolution
There is a similar and equally disturbing history with the hype
over fetal tissue research. By the late 1980s fetal transplants were
being heralded, as the ``ultimate cure of the future.'' An editorial in
the New York Times warned that ``to interfere with these [fetal tissue]
experiments is to interfere with progress that could save countless
lives.'' Fueled by this hype, a moratorium on federally funding of
fetal tissue transplants was lifted in 1992, and the proponents
confidently predicted a cure for many of our most pernicious diseases
and disabilities. Ethical concerns which had led to the moratorium were
given only cursory attention. Now after 13 years of private and
publicly funded trials some of the ethicists' worst fears have come to
pass. There is a thriving market in the sale of various fetal parts
from clinics to hospitals and researchers. There are also reports that
clinics are changing the method and manner of abortions, potentially
creating injury in women, in order to obtain more viable and valuable
fetal tissue.
As for the hundreds of patients who have received fetal
transplants, mainly for Parkinson's disease, there have yet to be
proven benefits, but as with gene therapy we have seen very real and
shocking health impacts. As reported last year, the most comprehensive
study on the use of fetal tissue to treat Parkinson's showed no overall
benefit, but researchers described side effects of the treatment as
``absolutely devastating.'' The problem was that in a significant
percentage of fetal tissue recipients the implanted cells created too
much of the needed brain chemicals causing uncontrolled movements and
spasm in the patients. ``They chew constantly, their fingers go up and
down, their wrists flex and distend,'' reports Dr. Paul E. Greene, a
neurologist at the Columbia University College of Physicians and
Surgeons and one of the researchers involved in the federally funded
fetal tissue study. Greene also described patients as writhing and
twisting, jerking their heads and flinging their arms about. The spasms
were so severe in one patient that he could no longer eat and needed a
feeding tube. For others the spasms made their speech unintelligible.
Despite these effects, there is no way to remove the transplanted fetal
cells or stop them from creating these impacts on the patients. ``It
was tragic, catastrophic,'' Dr Greene explained. ``It's a real
nightmare, and we can't selectively turn it off.'' As for the near
future, Dr. Greene at least has seen the light: ``No more fetal
transplants. We are absolutely and adamantly convinced that there
should be research only.''
Stem Cells and Human Cloning
As the grim histories of gene therapy and fetal tissue use are left
generally unexamined, stem cell research, including the cloning of
human embryos, has succeeded them as the miracle cure du jour. As the
testimony of West and other researchers indicates, we are once again
being subjected to a full court press of hype, as companies and
researchers vie for venture capital and federal research dollars.
Unfortunately we also continue to witness a continued and
unconscionable gullibility in many of our policy makers. Once again
they appear to have become hostages to the hype about healing. This is
particularly alarming because the stakes in this debate are very high.
As noted, West and many in the research community are pushing for an
unregulated and unmonitored industry in cloned human embryos. West and
his cohorts insist that only cells from cloned human embryos will be
the panacea for all that ails us. This despite their failure to obtain
stem cells from embryos, and the current availability of adult and
placental stem cells for research.
Besides corporate profits West and some others in the research
community have another very clear aim. They want to stop the Senate
from following last year's House action in declaring a ban on human
embryo cloning, and they may well be succeeding. In the next few months
the Senate will be debating and voting on the human cloning issue.
While there is general agreement over banning human embryo cloning to
create children, there is confusion on halting the cloning of human
embryos for research. Will our policymakers finally cut through the
hype and ask the important questions about research cloning?
A number of those in the progressive community have several major
concerns about human cloning for research. Environmentalists, consumer
groups, women's and children's health advocates all want to see
unprecedented regulatory and ethical questions resolved before and
human embryo cloning for research is allowed. These issues include:
1) An unregulated industry and market in the production of cloned
human embryos will inevitably lead to reproductive cloning. Imagine
fighting the drug war by banning certain uses of drugs but allowing and
even encouraging the mass production and dessemination of such drugs
for 'legal' purposes. This is what those advocating a ban on human
reproductive cloning but encourging human embryo cloning for research
are advocating. It is irresponsible legislation. Clearly the time to
regulate reproductive cloning is at the stage of the creation of the
cloned embryo. Attempting to enforce a reproductive ban after a cloned
embryo is implanted into a surrogate mother is a regulatory nightmare.
Given the slippery slope from embryo cloning to reproductive cloning,
the only scenario in which embryo cloning for research would be
acceptable is if a strict regulatory procedure were in place which
carefully montiored the chain of custody of each and every cloned
embryo.
2) An unregulated industry in cloned human embryos will lead to
unacceptable commodification of life. The U.S. Patent and Trademark
office has already announced that cloned human embryos would be
patentable. Additionally there is no bar on the sale of embryos or
human ova necessary for this technology. Clearly if we sold the
Congressional Medals of Honor we would degrade the meaning of this
honor. If the Nobel Prize we up for sale it would cease to have
meaning. If we buy and sell children we corrupt and demean the meaning
of parenthood. Just so if we allow the patenting and sale of human
embryos and human eggs we corrupt and demean what it means to be human.
3) As currently envisioned cloning of human embryos for research
represents a serious threat to women's health. In recent testimony a
researcher stated have stated that they could do up to 1.7 million
therapies per year. this would require a minimum of 5-8 million eggs--
assuming a very high success rate of 1 out of 3-5 eggs--to accomplish
the therapeutic cloning required to support these therapies . Where
will they get theses eggs? From women in this country or abroad. Egg
donation can have significant health impacts on women including the
effects of hormone therapies and other drugs administered to facilitate
extraction and the extraction process itself. Most women who are lured
into this process are economically disenfranchised and perform this
operation for money. With research embryo cloning we could see a
massive expansion in the use of women as paid egg ``factories.'' This
presents both a real threat to women and an expansion of the repugnant
commodification of life discussed above.
4) Human embryo cloning for research could deprive us of our choice
on when, how and where our genetic heritage will be replicated.
Researchers may be able to clone ``copies'' of us by using cells from
our hair, blood, or virtually any other tissue. There have already been
several legal cases where patients have had their cells turned into
valuable cell lines without their knowledge. Unless they are carefully
monitored, how will any of us know if a researcher of company is
replicating our genetic makeup in any number of human embryos at any
time. This is a significant ``choice'' issue for all of us, especially
for those whose religious or moral beliefs find human cloning in any
form unacceptable.
5) Does the cloning of human embryos for research divert valuable
health research dollars away form proven methods into highly
speculative ones? There are only limited research and health dollars
available. Diseases such as cancer are complex in origin. Genetic
predisposition, environmental pollution, diet, stress and social habits
(such as smoking) all can contribute to this disease. While it is
tempting to believe that gene therapy, fetal tissue or stem cells form
cloned embryos will be the 'magic bullet' that will cure cancer, this
view is hopelessly naive. We have seen in the past that prevention is
the best policy when dealing with major diseases or disabilities. This
means significant contribution of resources to cleaning up the
environment and work places, educating about diet and lifestyle,
working to reduce poverty and changing some of our unhealthy compulsive
habits. While prevention may not be a good 'handle'' to raise venture
capital, it unlike speculative ``miracle'' cures has a proven record of
success.
6) Cloning human embryos for research raises the key ethical issue
of whether we should intentionally create any human life form solely
for its exploitation and destruction. As a human community we have
never done this before. Certainly there should be public hearings and
wide ranging public participation on this key ethical issue before such
cloning is allowed.
As we debate the human cloning issues, we must also demand
responsibility and caution from those making claims about stem cell
research. Many suffering from serious illnesses or disabilities have
been misled by the false promises about gene therapy, fetal tissue and
other medical ``breakthroughs.'' The continued hype about stem cells is
unconscionable. Moreover, Congress must establish stringent regulations
that assure that no human trials using stem cells technology take place
until research fully justifies such trials. Should there eventually be
human trials, they must be carefully and independently regulated and
monitored. Researchers cannot be left to regulate themselves. Our
elected representatives owe nothing less to the families of those who
have died, and the many now suffering, because of Congress' past
failures to cut through the hype and appropriately regulate medical
technology.
Thank you.
Chairperson Feinstein. Thanks very much, Mr. Kimbrell.
I will find my little biography here. Finally, but not
least, Father FitzGerald. Father Kevin FitzGerald is a research
associate professor in the Department of Oncology at Georgetown
University Medical Center. In addition, he is the Chair of
Catholic Health Care Ethics at the University's Center for
Clinical Bioethics. Father FitzGerald has received a Ph.D. in
molecular genetics and a Ph.D. in bioethics from Georgetown
University. His research has focused on ethical issues in human
genetics. For the past 10 years, he has served as an ethics
consultant to the National Society of Genetic Counselors.
Welcome, Father.
STATEMENT OF REV. KEVIN FITZGERALD, GEORGETOWN UNIVERSITY
MEDICAL CENTER, WASHINGTON, D.C.
Rev. FitzGerald. Thank you very much, Senator Feinstein,
and thank you to the committee for this marvelous opportunity
to join you today in this continuing conversation regarding
human embryo research, specifically that research which
involves transferring genetic material from a human somatic
cell into an egg that has had its nuclear genetic material
removed--in other words, cloning.
The key moral issue in research involving cloned embryos
is, as we have heard, the creation and destruction of a human
life, an embryo. Though there is no consensus in our society as
to the value of this nascent human life, there is equally no
denial that this research is highly contentious and
controversial in our society. The question before our society
and this committee is then: How do we make the decision to
proceed or not proceed with this kind of cloning research?
We Americans know from our own history with eugenics,
research on minority, the mentally disabled, and even on our
own military forces the tragedies that can occur when public
policies concerning human experimentation are shaped according
to the dictates of science. When facing the unknown or the
uncertain, the answer of science is do the research. This is
perfectly good science. This may not be good public policy nor
the ethical thing to do.
In response to the wrongs done in the name of science
mentioned previously, our society has chosen to limit what
experiments can be performed on human beings, even though these
limits may slow scientific progress. If human embryos indeed v
some significant value to our society, as the National
Bioethics Advisory Committee concluded, then considering all
the basic research that still can be done using animal models,
human tissue culture, non-cloned, non-embryonic stem cells, and
all sorts of other molecular biology, why is there still a
continuing clamor for the destruction of human embryos to fuel
cloning research?
One reason almost always put forth by proponents of human
embryo cloning research--and a reason we have heard several
times today--as justification for the creation and destruction
of cloned human embryos is the need to bring healing and cures
to the millions who suffer from illnesses and diseases that may
otherwise die without this research. Such an argument as this
is of great significance for it connects to a fundamental
principle of medicine: treat sickness and heal when you can.
Yet, as the argument is states, its significance rests in part
on two assumptions: one, that cloned embryo research will be
necessary or superior to all other options in the treatment of
certain diseases; and, two, that the thousands and millions who
need the treatments will have access to any medical advances
that might come from such research.
Addressing the first assumption, we need to recognize that
the diseases suggested as likely targets for human cloning
research are also the targets of researchers using other
approaches, such as genetic therapies, drug development, adult
stem cells, and other molecular biology approaches. It may well
be the case that for many patients the treatments for their
illnesses may come more quickly from research avenues other
than cloned human embryo research, and that these alternative
treatments may even be better than any treatment derived from
human cloning research.
Regarding the second assumption, we need to acknowledge
that even if treatments from human cloning research can prove
to be the best available or are developed first, the vast
majority of the millions of people who need these treatments
will not have access to them. For example, no one denies that
cancer research has generated many significant advances in
cancer treatment over the past 30 years. This is the war on
cancer. Yet the President's Cancer Panel in their 2001 report
conclude that ``a great many people--both the privileged and
the poor--find that at the very time they need the most
effective cancer care our research enterprise has devised, the
health care delivery system of our Nation''--our Nation--
``fails them.''
Tragically, this reality, considering it, and adding to it
the fact that millions of children die every year from diseases
preventable by vaccines, and the fact that some of the most
effective drugs we have ever developed for certain diseases are
not mass produced because no one will make a profit, one must
seriously question any assertion that our society should pursue
human cloning based on the fact that it will benefit millions.
This justification for pursuing this socially contentious and
ethically controversial research is just false. Human embryos
need not be created and destroyed in order that thousands or
millions might be saved.
Indeed, without the continual creation and destruction of
cloned human embryos, the future of medical advance will still
be one of great hope. There are many avenues of medical
research that can be pursued with broad ethical and societal
support. As a people who value progress and justice, we can
decide to pursue every avenue of medical research that is
respectful of human life in all its stages, and we can work
together to create a system that brings these advances in
medicine to all those in need.
Thank you very much for your time and attention.
[The prepared statement of Rev. FitzGerald follows:]
Statement of Kevin FitzGerald, S.J., Ph.D.
We are gathered today to continue the public dialogue regarding
human embryo research, specifically that research which involves
transferring genetic material from a human somatic cell into an egg
that has had its nuclear genetic material removed--i.e. cloning.
The key moral issue in research involving cloned embryos is the
creation and destruction of a human life--an embryo. Though there is no
consensus in our society as to the value of this nascent human life,
there is no denial that this research is highly contentious and
controversial in our society. The question before our society and this
committee is then, ``how do we make the decision to proceed or not
proceed with this kind of research?''
We Americans know from our own history with eugenics and with
research on minorities, the mentally disabled, and even our own
military forces, the tragedies that can occur when public policies
concerning human experimentation are shaped according to the dictates
of science. When facing the unknown or the uncertain, the answer of
science is always to do the research. This is good science, but it may
not be good public policy or the ethical thing to do. In response to
the wrongs done in the name of science mentioned previously, our
society has chosen to limit what experiments can be performed on human
beings, even though these limits may slow scientific progress. If human
embryos do have some significant value in our society, as the National
Bioethics Advisory Committee concluded, then considering all the basic
research that still can be done using animal models, human tissue
culture, and adult stem cells, why is there a continuing clamor for the
destruction of human embryos to fuel cloning research?
One reason almost always put forth by proponents of human embryo
cloning research as justification for the creation and destruction of
cloned human embryos is the need to bring healing and cures to the
millions who suffer from illnesses and diseases that may otherwise die
without this research. Such an argument as this is of great
significance for it connects to a fundamental principle of medicine:
treat sickness and heal when you can. Yet, as the argument is stated,
its significance rests in part on two assumptions: 1) that cloned
embryo research will be necessary, or superior to all other options, in
the treatment of certain diseases, and 2) that the thousands and
millions who need the treatments will have access to any medical
advances that might come from such research.
Addressing the first assumption, we need to recognize that the
diseases suggested as likely targets for human cloning research are
also the targets of researchers using other approaches, such as genetic
therapies, drug development, and adult stem cells. It may well be the
case that for many patients the treatments for their illnesses may come
more quickly from research avenues other than cloned human embryo
research, and that these alternative treatments may even be better than
any treatment derived from human cloning research.
Regarding the second assumption, we need to acknowledge that even
if treatments from human cloning research prove to be the best
available and are developed first, the vast majority of the millions of
people who need these treatments will not have access to them. For
example, no one denies that cancer research has generated many
significant advances in cancer treatment over the past thirty years.
Yet the President's Cancer Panel in their 2001 report conclude that ``a
great many people--both the privileged and the poor--find that at the
very time they need the most effective cancer care our research
enterprise has devised, the health care delivery system of our Nation
fails them.'' Considering this tragic reality, and adding to it the
fact that millions of children die every year from diseases preventable
by vaccines, and the fact that some of the most effective drugs
developed for certain diseases are not mass produced because no one
will make a profit, one must seriously question any assertion that our
society should pursue human cloning research because millions will
benefit. This justification for pursuing this socially contentious and
ethically controversial research is just false. Human embryos need not
be created and destroyed in order that thousands or millions might be
saved.
Indeed, without the continual creation and destruction of cloned
human embryos the future of medical advance will still be one of great
hope. There are many avenues of medical research that can be pursued
with broad ethical and societal support. As a people who value progress
and justice, we can decide to pursue every avenue of medical research
that is respectful of human life in all its stages, and we can work to
create a system that brings the advances in medicine to all those in
need.
Thank you for your time and attention.
Chairperson Feinstein. Thanks very much, Father, and thank
you, panel. It has been an excellent panel, and I think very
interesting to hear your respective arguments.
I would like to begin, if I can, with you, Dr. Weissman.
This goes to the argument made that, well, there has really
been no bona fide work in the area of somatic nuclear cell
transfer. And as I understand it, stem cells injected into mice
have partially repaired a spinal cord injury and allowed the
mouse to walk. Human embryonic stem cells have been induced to
form pancreatic tissue, providing hope that youngsters
suffering from juvenile diabetes might receive replacement
insulin-producing cells. And I think just recently scientists
have announced that they have used cells derived from cloned
cow embryos that function and are not rejected when implanted
into adult cows, marking the first time cloning technology has
been used to grow personalized genetically matched organs for
transplantation.
Could you talk a little bit about specific research in the
area of therapeutic cloning and stem cell research and explain
what is happening that can make this more real to people other
than just something very esoteric?
Dr. Weissman. Sure. Actually, I believe the first paper
that was published which showed that you could take mouse
embryonic stem cells, convert them to neural cultures, and then
use those neural cultures to treat a disease in mice, a
demyelinating disease, was done by Bressler and Makai and
published actually several years ago. I am surprised that
Congressman Weldon didn't know about this. And this led to a
reinsulating of the neural fibers of these animals that could
not walk and led to a restoration, at least a partial
restoration of the function.
The experiments you talk about with spinal cord injury are
at the beginning. They are as you reported them. What we like
to do in science--and I think it is very important for this
panel to understand--is that we need to have publications that
are peer-reviewed before we understand what the phenomenon is
and then independently replicate it. This is a very nascent
field. It is just at its beginning.
There are lots of claims that are now coming across in the
media about substitutes for stem cell research. Most of them in
the last 2 weeks have come from unpublished papers. So we don't
understand yet what might or might not be there, and, of
course, they are not yet verified. So I want to be cautious in
any claims about whether it works for spinal cord injury or
other things yet.
Certainly, you are right. Insulin-producing cells have been
produced by the same group, Makai's group, from embryonic stem
cells. There is no doubt about that, and they have also shown
that they could restore neural function, as I said, in a mutant
that lacked these insulating fibers. But the only way we are
going to go forward on this research is if we can do the
research.
Chairperson Feinstein. Thank you.
Dr. Greely, could you explain the difference between
somatic cell nuclear transfer to produce stem cells and the
parthenogenic technique used by Advanced Cell Technology?
Mr. Greely. Can I pass that one back to Dr. Weissman? My
bachelor's degree from Stanford is in science, but it was
political science.
[Laughter.]
Senator Kennedy. Then you ought to have an answer.
[Laughter.]
Mr. Greely. I can, but I am actually old and wise enough
now to know that he would have a better answer.
Chairperson Feinstein. Well, let me tell you where I am
going----
Senator Durbin. You didn't think that would be on the
final, did you?
Chairperson Feinstein. Where I am going is: Is it accurate
to say that in both somatic cell nuclear transfer and
parthenogenesis the egg cell is never fertilized by the sperm?
Dr. Weissman. That is right. And so in parthenogenesis, you
activate the cell now to start dividing with the nucleus that
it has. So it is only going to be a replica of that woman's
egg.
Chairperson Feinstein. I have one here for Dr. Charo and
then--I have so many papers here.
Doctor, in his testimony today, Father FitzGerald, if I
may, makes one moral argument and two policy statements against
therapeutic cloning. His first policy argument is that other
research avenues exist for curing diseases and treating
ailments besides therapeutic cloning. And a second policy
argument is that even if therapeutic cloning results in
promising therapies, many people may not have access to them.
How do you respond to these two policy arguments?
Ms. Charo. With regard to the first point, I don't accept
the premise. I don't believe that adult stem cell research can
replicate all the areas of research that can be done using
nuclear transplantation technology, specifically when we are
looking at the replication of cells from a person with a
particular genetic disease and we want to study how the
defective gene operates in tissue that is being studied in the
laboratory.
Further, the basic research on the reprogramming of adult
cells can only be done with embryonic stem--sorry, with nuclear
transplantation. And, again, for further details I might refer
back to Dr. Weissman.
With regard to the question of the actual range of people
who would obtain a therapy, I share his view that if we are
going to be arguing based on a balancing of the equities, and
cures are being held as one important equity, that it is
important to see how many people would actually obtain those
cures.
On the other hand, again, I find both in his testimony and,
to a large extent, in Mr. Kimbrell's testimony as well, a list
of very important issues for congressional debate: access to
health care, regulation of markets in human tissue, improved
regulation of the protection of human subjects in human
experimentation generally, FDA regulation of risks to women
associated with cell-based therapies, and so forth. But none of
these will be solved by criminalizing research that uses
nuclear transplantation.
These are a collection, a pack of very large dogs, and this
little tail simply can't wag hard enough to answer all of these
problems and solve all of these dilemmas. And so I think there
is more than enough evidence that there are enough people and
enough potential of unknown magnitude to justify the use of
this kind of research in the hope that it will achieve some
outcomes for some people and ultimately for everybody.
Chairperson Feinstein. Thanks, Doctor. My time is up.
Senator Hatch?
Senator Hatch. Let me start with the lawyers. Professor
Greely's testimony characterizes the FDA's assertion of
jurisdiction over cloning as ``questionable.''
Mr. Greely. Yes.
Senator Hatch. From the Federal perspective, what is the
legal status of cloning, both reproductive and therapeutic,
vis-a-vis the FDA and its statutes? Do you think that the FDA
view could prevail in court? Let's start with you, Dr. Greely.
Mr. Greely. I think the FDA view could prevail in court. I
think it is most likely not to. In order to be a device under
the statutory jurisdiction of the FDA, in order to be regulated
under the statutory jurisdiction of the FDA, human reproductive
cloning would have to involve a drug, a device, an article, a
product, a long list of nouns, for none of which human embryo
seems a good fit.
On the other side, it also has to be used for the treatment
of disease or the cure of a medical condition.
Now, arguably, if it is done for treatment of infertility,
it is for the treatment of a disease or condition. But if an
otherwise fertile couple chooses to have a human clone, it is
very hard to see what medical disease or medical condition is
being treated.
There are a couple of law review articles on this--I would
be happy to provide the citations to your staff--that come to a
similar conclusion.
Lurking in the background of this question there is also a
Commerce Clause issue. Although, frankly, my view is Congress
does have the power to empower the FDA to regulate this or to
ban it directly, it just hasn't done so thus far.
Senator Hatch. Would anybody else care to comment?
Mr. Kimbrell. Yes, Senator. In 1989, the FDA was asked
whether it could view fetal tissue as a device and was not
convinced they could or could not. They decided they basically
could, but Congress intervened and through the legislation made
sure that didn't happen.
I think the real problem is it is very questionable, and
the last thing we want to see is this thing resolved in court
when somebody actually litigates against the FDA for being
arbitrary and capricious and going beyond its statutory
authority in doing this when the cloning is already in process.
So I think it is a very risky business indeed to think that the
FDA could regulate this.
Ms. Charo. Senator, if I may, of course, ask three lawyers,
you will get three opinions. I disagree with both my
colleagues. I think the FDA's jurisdiction here is
unproblematic, although certainly Congress could help by making
that easier to understand.
Senator Hatch. So Congress could pass a law in this----
Ms. Charo. Congress absolutely could. But what I would like
to draw to your attention is the distinction between FDA
jurisdiction over reproductive cloning to make babies versus
non-reproductive cloning to produce embryos from which cell-
based therapies are derived.
With regard to reproductive cloning, questions have been
raised about its jurisdiction, and although Professor Greely
feels that they might lose in court, my experience looking at
this field is that courts will be extremely deferential to
agencies' own interpretations of their authorizing legislation.
But more to the point, when it comes to non-reproductive
cloning, its jurisdiction is far clearer because its entire
Division of Biologics, which regulates a range of cell-based
therapies and which has been regulating more and more
aggressively in the last 5 years a variety of therapies and
markets that involve human tissue, in this area the FDA's
jurisdiction is, as far as I can see, unproblematic and
extremely useful in guarding against exactly the kind of
concerns about retrieval of eggs being risky or markets being
unduly coercive.
Mr. Greely. I agree entirely with Professor Charo on that
second point.
Senator Hatch. Let me ask Mr. Kimbrell and Father
FitzGerald this question: Would your views on so-called
therapeutic cloning--I would call it DNA regenerative therapy.
I think ``cloning'' is a stupid title, between you and me. I
heard one of the Congressmen thought that was, you know, just a
semantic change, but I don't think it is. But would your views
on therapeutic cloning change if the cloned stem cells were
derived from an egg that was rendered incapable of implantation
in a woman's womb?
Rev. FitzGerald. How would you do this manipulation of the
egg to make it incapable of implantation?
Senator Hatch. I am asking the question.
[Laughter.]
Rev. FitzGerald. Unfortunately, I mean, I guess it would--
--
Senator Hatch. I didn't even have political science.
Rev. FitzGerald. As is the case in a lot of this area, it
is unfortunate that oftentimes the complexities of the science
do have direct impact on what particular ethical or public
policy conclusions one might come to. But I would have to say
that it might be important how one intends to render that
inability to be implanted the case. I could think of a variety
of ways one could do that without necessarily abrogating the
potential of this entity that is derived once some minor
manipulation had occurred into be reactivated and being allowed
to implant.
Senator Hatch. Let me just ask Dr. Weissman----
Mr. Kimbrell. I have a quick answer to that, if I could,
Senator, because I do think it is a very important question.
With parthenogenesis, people are asking this question more and
more, and I do think that it resolves a couple of the major
problems here. One is clearly the only regulatory scheme--and
England is trying to do this--that would work for cloning of
human embryos for research that would sort of alleviate the
problem of having this whole store for people who want to break
the law would be to have a chain of custody. You wouldn't need
a chain of custody in the scenario that you talk about, and the
fear that you would have these research clones available for
reproductive cloning wouldn't be there. So it would alleviate
that major concern.
As far as some of the other concerns, such as, you know,
commodification and choice, it would not alleviate those
concerns. But it would deal with that first concern that you
have a slippery slope and providing so many embryos out there
in an unregulated way that would lead to reproductive clones.
Senator Hatch. Dr. Weissman?
Dr. Weissman. There are two scientific ways that you could
imagine would be used to render the blastocyst or a pre-
blastocyst stage from being implantable. The first and most
direct--and it could be done today--is to remove the outer
lining of trophoblast cells. That would be entirely effective.
You cannot implant without those cells.
There is a second and theoretical way--theoretical because
nobody has done it. We now know the genes, many of the genes
that are required for making the trophoblast. So one could
employ current technologies to test whether you could introduce
into that egg those genes to be expressed during that early
stage that would prevent the development of the trophoblast.
So scientifically it could be done.
Senator Hatch. I have two more questions, if the Chair----
Rev. FitzGerald. If I could answer--do you want me to
answer that?
Senator Hatch. Sure, but I just have a little bit more
time. The chairman has agreed to give me additional time to ask
a couple more questions. But go ahead, Father.
Rev. FitzGerald. I would say, quickly, if one gets to the
point where you can remove the trophectoderm--that is the cells
outside the inner cell mass--from the perspective of many
people you would already be destroying an embryo, so that would
not necessarily solve the problem I think you are trying to
solve.
The second one is if you go in and attempt to render the
genes inactivated--and one doesn't necessarily have to do that
at the DNA level; they could do it at an epigenetic level,
which is slightly different. But then, again, I guess it goes
to that more legal and philosophical intention discussion that
we heard earlier, and that is where you would have to have that
somewhat resolved.
Senator Hatch. OK. Well, I think this is an area that is
very intriguing to me.
Rev. FitzGerald. Just one other issue. Parthenogenesis is
not therapeutic cloning.
Senator Hatch. No, no. I understand.
Rev. FitzGerald. So we wouldn't want to blend the two.
Senator Hatch. That I do understand.
Let me ask you, Ms. Gulden, you know, I hope and I will
pray that you will be able to run again and play basketball and
be a police person, as you have been in the past. And I want to
thank you for the courage that you have had in coming here
today and telling us about yourself and about your views.
Everyone wants you to get out of that wheelchair and be able to
do what you want to do. And we all want research, so long as it
is ethically appropriate.
Now, this is a tough question, but I think you can probably
handle it very well, so I feel that I am fair in asking it of
you. How do you respond to the concerns of those who believe
that therapeutic cloning entails the killing of another person,
that is, the cloned embryo? How do you respond to that
statement?
Ms. Gulden. I would defer to Dr. Weissman.
[Laughter.]
Ms. Gulden. Senator Hatch, in my opinion, another person is
not being killed. We are talking about a cluster of cells
perhaps the size of a pencil eraser. I don't think that that is
a person. I am a real person sitting here before you, and I
just don't think that the cells we are talking about constitute
a living human being.
Senator Hatch. Well, whether they do or not, you seem to be
saying that, look, they would be helping you and others
similarly situated to live and to have a better life and to be
able to do what is good in your life or good for others, that
you might be able to be even a more productive human being if
you could resolve these health problems that you have had to
suffer from.
These are tough questions for me because, you know, I am
pro-life, but I also believe we ought to help the living and we
ought to solve problems of disease and difficulties if we can.
And it is important that we help people to live. So it has been
a very, very difficult thing for me.
If I could just ask one other question, Madam Chairman, and
that is this--and I would ask it for the panel at large. Cloned
human beings do not exist in nature. I think that is a fair
statement. In reproductive cloning, as I understand it, an egg
is never fertilized with sperm. And while twins share virtually
identical DNAs, they are the product of haploid gametes, as I
understand it, of their parents and not from a single diploid
parental cell.
Now, would a diploid being created through reproductive
cloning be a person in the same scientific, legal, and moral or
religious sense, as we ordinary haploid-haploid mortals? We
will start with you, Dr. Weissman.
Dr. Weissman. Well, I think you have made the right
definition scientifically. I have nothing to add to it. The
only thing I will say is that from the animal experience, this
is very important----
Chairperson Feinstein. Perhaps you would put in lay
language what he was saying.
Dr. Weissman. What he is saying is that in nature there is
no such thing as a diploid cell that has been used to create
clones, other than twinning, which does occur when two cells
separate or four cells separate that did have the identical
nucleus.
But what I think is important is that the procedure to make
these is one in which--that is, to make clones is one in which
you have to add a nucleus in. I have nothing else scientific to
add to your judgment.
Mr. Greely. Senator Hatch, I don't have the expertise to
give a religious answer to that, but as a lawyer, I can tell
you that should reproductive cloning produce a baby that cries,
that eats, that sucks, that recycles its nutrition and needs to
be changed, I as a lawyer would feel very, very confident
arguing that that baby would be a person for purposes of the
14th Amendment, entitled to all the rights and liberties of any
other person, regardless of the way in which it came to be
born. And although one should never try to predict with
certainty how courts will react, I feel confident about this
one. Babies will be held to be people.
Mr. Kimbrell. I totally agree with Professor Greely. It
seems to me--and I don't think anybody would seriously argue
that cloned animals would not be covered under the current
Animal Welfare Act, that we would make sure that those animal
were not subject to cruelty and had the basics they needed to
live. Just because they were cloned animals, I don't think we
would suspend from them the legislative protections that we
grant animals, and I am sure the same would be true for people,
should, God forbid, they ever be cloned.
Ms. Charo. Senator Hatch, not only do I agree with
Professor Greely, but I would even take away the suggestion
that the baby needs to be able to cry and suckle. In the United
States, if you are human and you are born, you have the equal
protection of the laws and of the Government, and that is all
it takes. Nothing more.
Rev. FitzGerald. I actually very much appreciate your
question because I think it raises the much deeper issue that
we are going to wrestle with, not just here but with many of
the biological advances that are in the pipeline; and that is
that our concepts such as personhood predate the biological
information that is coming to us so rapidly, such that our
philosophical, our theological, and our legal concepts of what
it means to be human and to be a person do not necessarily
correspond with the biological data since this is something we
have only been able to uncover relatively recently in our
history.
So we are going to have to continue to struggle with making
that bridge and understanding the scientific information in
perhaps ethical and cultural frameworks which are somewhat
outmoded to integrate it.
Senator Hatch. I want to thank you all, and I certainly
want to thank you, Madam Chairman.
Chairperson Feinstein. Thank you, Senator. Appreciate it.
Senator Durbin, you are next.
Senator Durbin. Thank you, Madam Chair, and thank you to
the panel. I want to thank Kris Gulden for putting a human face
on this debate. We spend a lot of time talking about scientific
terminology and law, and you have reminded us what the bottom
line is in this debate. Thank you for being here.
And I want to thank Dr. Weissman for serving as the
lifeline for this panel. Time and again they have called you,
and your answers have worked out just fine.
I have listened to this debate and tried to reflect on a
trip I took several months ago and found to my surprise on the
South Side of Chicago at the little company of Mary Hospital
that it was the first hospital in the United States in the
1950's to have a successful kidney transplant. It was just a
fluke. It never should have happened. But it did, and they are
quite proud of that fact.
And I recall growing up Dr. Christiaan Barnard and heart
transplantation, and I tried to put myself in the place of
those who were considering organ transplantation in the 1950's
and 1960's and listen to the arguments from this panel and
wonder how that would have come out using the same standards.
Because I listened to Dr. Kimbrell, and he suggested organ
transplant--well, I think you could argue organ transplantation
created many hopes that have not been realized. You said the
same for gene therapy and other things. Many recipients of
organ transplants have died, and, of course, that has happened
with many other therapies that have been tried.
Allowing organ transplantation was an open invitation to
commercialization and even murder. It could have happened.
Maybe it has. I don't know.
In addressing Father FitzGerald's logic, even successful
organ transplantation techniques are not available to
everybody, rich and poor, in America. So using this same logic
and thinking, I am just curious as to how some of the critics
of therapeutic cloning would have come down on organ
transplantation using the same standards. But I think what it
boils down to is this: Research is research, and it doesn't
always lead to a cure. The question we have to ask is whether
we can cross that ethical threshold to justify it.
Father, I am trying to recall theology courses from a long
time ago. I think you have a morally consistent position, the
church does on this, that would even oppose in vitro
fertilization. Am I correct?
Rev. FitzGerald. The church's official position, yes.
Senator Durbin. And I listened earlier to the response from
Congressman Weldon, and I think, frankly, who owns the sperm
and the cell and what their intent is should be kind of
secondary to the moral question if you are going to take the
church's position. But he thought they made all the difference
in the world, and I think Dr. Kimbrell and others have agreed
with him.
So let me try to pursue this, Dr. Kimbrell, if I can. Do
you believe that we should prohibit in vitro fertilization as
some artificial use of science? And how would you draw a
distinction between in vitro fertilization, if you wouldn't
prohibit it, and this whole approach that uses nuclear
transplantation or therapeutic cloning?
Mr. Kimbrell. I wish Senator Wyden were with us because he
has been a real courageous leader in trying to regulate one of
the, to me, most egregious offenders of our ethics, which is
the IVF industry. It is virtually unregulated.
My plea was not to ban IVF, but to make sure before we
disseminate these technologies--and I used a couple of other
examples, but organ transplantation is as good an example as I
could ever come up with--you want to make sure that you resolve
the issues before the technology becomes disseminated,
commercialized, patented, and there is all this incentive.
For example, in 1984 and 1985, I was here on the Hill with
then-Representative Al Gore trying to pass the Organ
Transplantation Act. In this country, we allowed the sale of
organs. There were ads in USA Today, in the newspapers, for
eyes, for kidneys. The World Health Organization has just
declared this an international emergency as companies go into
the Third World and take the organs from people. These are live
donors, Senator.
You know, certainly before we get that technology out, we
need to deal with the fundamental commercialization and ethical
issues. That was the plea I was making, not to get rid of it
but to make sure for once that we act maturely and take
legislative and regulatory responsibilities to----
Senator Durbin. Isn't that what the Feinstein-Kennedy bill
is all about, to establish some standards for regulation, some
standards in research, not to ban it in its entirety, to throw
out all the possible good things that could come from it, if we
imagine all the bad things that might come from it?
Mr. Kimbrell. Let me answer that briefly, if I could, and
Senator Feinstein is a hero of mine. I have an office in San
Francisco, which is just about my favorite city in the world,
and I respect her enormously. But I don't think that her bill,
frankly, does either of these things. Unfortunately -and I
could submit this to the record; we have done a legal
analysis--there is some carelessness in the language and
definitions that would actually allow reproductive cloning, for
instance, from fetal tissue and from embryos.
So there are some problems with the bill. What the bill
does not do is in any way regulate research human cloning,
human cloning for research. There is no regulation whatsoever.
Each of the issues that I addressed is completely is
unaddressed, whether it be the commercialization, whether it be
sale, whether it be patenting, whether it be a line of custody
that we would establish through regulation. None of that is
addressed in the Senator's bill. It is, admittedly, what it is
supposed to be: a reproductive cloning ban. It is not meant to
address these other issues at all, and it does not.
Senator Durbin. Would you agree, then, that if there is
appropriate regulation, as we put in place for organ
transplantation, that therapeutic cloning and research in that
area should go forward?
Mr. Kimbrell. I believe that if we take the time--and I
believe there should be an indefinite moratorium until we do
this. We don't want to, again, provide all of the incentive,
have a whole industry in place, and then try and retroactively
-we have seen how impossible that is in the environmental
field. We know it is impossible trying to retroactively
regulate successfully. Let's, before we allow this, answer
these important regulatory and ethical questions so we know
what we are about when we begin it. We need to have a consensus
and robust national debate on this before it happens.
Senator Durbin. But you are not opposed to this research if
it is regulated?
Mr. Kimbrell. Not by definition, but by consequence.
Senator Durbin. Let me ask you, if I have a moment?
Chairperson Feinstein. Yes, please go ahead.
Senator Durbin. Dr. Weissman, if I could ask you, could you
give me an indication, what would the implications of a
complete ban on therapeutic cloning be for stem cell research
and what therapeutic interventions specifically might be halted
or slowed down?
Dr. Weissman. Sure, so long as we call it nuclear
transplantation of stem cells. Well, of course, it would end
all of the research that I described to you that used to be on
that panel. We could now directly look at how, for example, a
cancer cell--I think that Dr. FitzGerald should have sympathy
for this--how the mutations that occur after a woman has been
born with a heritable predilection for cancer, how it actually
happens that she gets it and her sister doesn't?
Senator Durbin. Breast cancer, for example.
Dr. Weissman. Breast cancer, colon cancer. You can go
through every one of the cancers. You have heritable
predilections for this disease, but we still don't understand
how the disease develops. Mutations develop, and in the unlucky
cell in the unlucky person, cancer develops. We don't
understand it yet. We are trying to go very systematically
through it, but it would be enormously helpful to have the
nucleus from that cancer cell making a cell line, which we can
then study in mice, as to what are the true important events
and which are the unimportant events. So that is just one
application.
But I do want to correct, which I have now heard several
times from other members of the panel and Congressman Weldon,
that one does not gain from some forms of research important,
large-scale therapies. So recombinant DNA research--that is,
putting together two DNAs from different life forms, bacteria
humans, bacteria mice--was fought on almost exactly the same
grounds in 1975 to 1980. I was at the first Asilomar Conference
where scientists say we need to stop for a second and talk
among ourselves what are the experiments that will allow us to
go forward or not, and then a regulatory body, the Recombinant
Advisory Committee was set up, and today it is not false to say
that hundreds of thousands of lives, people living right now
are saved or made better by the products of that research:
erythropoietin, GSCF, interferons, human insulin growth
hormones, and so on. I can't even go through the list.
So if we have the same potential, which I believe we do,
from the kind of research we are talking about, irrespective of
the therapeutic cloning, just for the research itself, I
believe it has the same enormous potential as recombinant DNA
research and, unpredictably, it will come out with the kinds of
research that leads bright scientists to develop eventually
therapies.
Senator Durbin. Thank you, Doctor.
Thank you.
Chairperson Feinstein. Thanks, Senator.
Senator DeWine?
Senator DeWine. Madam Chairman, let me thank you for
holding this hearing and thank our panel, and, Ms. Gulden,
thank you for your testimony. We appreciate it very, very much,
and I would just echo what everyone else on the panel has said.
We appreciate you coming in, your courage.
I don't know that there is much at this point that we can
add. This panel I think has illuminated very well the national
debate that we are having, and I think almost all points of
view are represented on this panel, and you have done a very
good job, each one of you, of articulating the different
arguments. In fact, you have added a great deal to those
arguments.
My understanding is, as lay person, that the cells that
develop in an embryo for purposes of therapeutic or
reproductive cloning are really indistinguishable from that of
a naturally fertilized egg. That is a basic question. That is
correct, is it not? What we end up with at this point is
indistinguishable genetically? Anybody disagree with that? OK--
--
Rev. FitzGerald. I think you might want to be a little more
careful. We don't know. I think the answer is--I think that
would be accurate to say that we could not definitively say one
way or the other.
Dr. Weissman. The important data is that with a naturally
fertilized egg, you have a high probability of going on to a
blastocyst, and when it implants, even from an IVF clinic, a
very high probability that it goes through a normal pregnancy.
All the losses occur in the first few months. But with nuclear
transfer, to clone, to do reproductive cloning, the
reprogramming doesn't work very well. You have a much lower
incidence making the blastocyst, and then you have a 100fold
loss so that only 1 percent of the implanted embryos make it
through pregnancy for a live birth, and even after that there
are many losses. So it's not exactly the same.
Rev. FitzGerald. Right. But, again, we have to be careful
because the consequences of the probabilities could be based on
very similar mechanisms, and what is going wrong
mechanistically in the cells might not be that distinguishable.
There could be cells that are the result of the fertilization
process that, once one looked at them on a molecular level,
would be difficult to distinguish between some of the cells
that were created by somatic cell nuclear transfer.
As Dr. Weissman said, we are very much at the infancy of
our understanding of all this.
Senator DeWine. All right.
[Laughter.]
Dr. Weissman. But go ahead.
Senator DeWine. I will try one more time with you, though,
Dr. Weissman, because what I hear you saying is that the
process of what will happen in the future may be different. You
are talking about different odds. It sounds like you are saying
different odds of survival, is what you sound like you are
telling me. But the snapshot of what you are looking at or what
that is at that moment, it sounds like you are saying it looks
to you, at least, as if it indistinguishable. Now, is that what
you are saying?
Dr. Weissman. No. No, I am not.
Senator DeWine. All right.
Dr. Weissman. What may look to the naked eye as a
blastocyst derived from nuclear transfer and a blastocyst
derived by sperm-and-egg fusion, if it makes it that far, to
the naked eye you can't tell the difference. But when you look
at that set of imprinted genes, that is, the gene expression
profile that normally happens, you can easily tell the
difference. It has been published before that certain genes
aren't turned off that should have been turned off. Other genes
aren't turned on that should have been turned on. And we expect
that those are the kinds of genes that are important for the
early development that leads to this high loss during fetal
life.
So a sophisticated molecular biologist today could tell the
difference.
Chairperson Feinstein. But only that person? Only a
sophisticated----
Dr. Weissman. I think that, yes--that is, not just that
person. You could, of course, develop a laboratory that would
assay the 42 or more imprintable genes and know whether they
were appropriately turned on or turned off. A common laboratory
could do that as easily as the DNA fingerprinting laboratories
establish identity.
Senator DeWine. Dr. Weissman, in your testimony before the
Appropriations Subcommittee, you stated and provided a
handout--this was your testimony on January 24th--demonstrating
that the clone used in research is no different in kind or
nature from one destined for implantation; in other words,
whether the purpose is going to be for implantation or whether
the purpose is going to be the, quote, therapeutic, as the term
is being used.
Dr. Weissman. At that stage----
Senator DeWine. At that stage.
Dr. Weissman. If you were doing an animal cloning
experiment, because that is the only experience we have, the
only experience, then that blastocyst could be implanted and
suffer, as I told you, losses or stem cells could be derived
from it, which have been done, and you give rise to stem cell
lines which, on their own, cannot make a whole organism and in
a test tube cannot make an organ directly.
Senator DeWine. Well, let me just thank all of you again. I
found Mr. Kimbrell's testimony, one particular statement, very
significant. I found a lot of his testimony, frankly, to be
chilling and give us a lot for thought. But his quote that this
is the first time that we would have produced a human life form
with specific intent to destroy it, I think that gives us all
something to think about.
Thank you.
Chairperson Feinstein. Thank you. But as I understand it,
it isn't. Am I wrong?
Ms. Charo. In fact, Senator DeWine, I would have to
disagree with Mr. Kimbrell about that because----
Senator DeWine. You certainly have the right to do that.
That is why we have a panel.
Ms. Charo. Embryos have been created specifically for
research purposes and then been destroyed for decades, and it
was exactly how in vitro fertilization was originally
developed.
Senator DeWine. So we have done this before.
Ms. Charo. Yes, for decades. And surveys of laboratories
around the United States that were done by Government agencies,
including the National Bioethics Advisory Commission, in fact,
had documented that fact to some extent.
Senator DeWine. Doctor? Mr. Kimbrell?
Mr. Kimbrell. Two issues on that. That is what you were
getting to, Senator, when you started; you know, Dolly didn't
just come from a cluster of cells. Dolly came from a sheep
embryo, so this euphemism of trying to call it a cluster of
cells, nuclear transplantations, this is just euphemism. This
is an embryo that would be appropriate for implantation. That
is what makes it so dangerous as far as being out there.
Second is that IVF is a rogue industry. There may have been
those who broke various laws, various things to try and
accomplish various aims in the IVF industry. But the IVF
industry is not an industry designed with the intention of
producing embryos solely for their destruction and the use of
spare parts. That is new. It is an ethical question. We cannot
avoid or slip through by thinking it is happening again. For or
against this technology, it is the ethical question we need to
deal with, and the public should have a voice in dealing with
it, not just here at the panel or our legislators. It should be
a robust public debate, I think.
Senator DeWine. And, Madam Chairman, I would just again
call your attention, everyone's attention to the professor's
comment wherein she said it has been done before. And I guess
my answer to that is, if it has been done before, it doesn't
mean it is necessarily right. I think the creation of human
life for its destruction is not right. And I have the right to
have that opinion, and she has the right to have a different
opinion, and that is why we have a debate.
Thank you.
Chairperson Feinstein. Senator Brownback, you have shown
great patience.
Senator Brownback. It is a great topic, and you have done a
great job putting together the panel, and I appreciate the
panel's discussion of it.
I am very pleased today to be able to announce as well that
Senator Mary Landrieu is cosponsoring the bill I put forward to
ban all human cloning. It is modeled after the House bill, and
so I am pleased that she is going to be the lead Democrat
cosponsor of the bill and is willing to take a bold, principled
position on this.
I think if we back up--this has been a very good panel--and
look at where the situation and the issue stands today, the
House has passed a broad-based ban on human cloning. This would
be both what people refer to as the reproductive and the
therapeutic cloning ban, total ban, a 100-vote margin in the
House of Representatives that passed to ban all forms of human
cloning, whether it is for research, destructive, somatic cell
nuclear transfer, whatever term you want to use, that has
passed the House.
The President has called for a ban on human cloning of all
forms. He doesn't think we should create life for the purposes
of destroying it and is now asking the Senate to pass a similar
ban as to what the House has passed by a broad bipartisan
margin. And now we need to take the issue up, and a broad-based
coalition is coming together to do that.
I would note, I would like permission to enter into the
record, Madam Chairman, a statement in support of legislation
to prohibit cloning, cloning of all types--therapeutic cloning,
and reproductive cloning. It is signed by 77 different people
of various organizations, including Norman Mailer, a writer;
Judy Norsigian, who was previously cited, executive director of
Boston's Women Health Book Collective; and a number of others.
And I would ask unanimous consent to enter this into the
record.
Chairperson Feinstein. Without objection.
Senator Brownback. I also ask unanimous consent to enter in
the record and then would like to ask Dr. Weissman about an
article that appeared about the ultimate stem cell discovery in
``New Scientist.'' This is about an adult stem cell that is in
each of our bodies presently that can turn into every single
tissue in the body, and I am quoting from it. ``It might turn
out to be the most important cell ever discovered.'' Dr.
Weissman, you are quoted in this article as well, saying it is
very dramatic kinds of observations, is reporting the findings,
if reproducible, are remarkable.
Then I would note another article that I would ask to be
put in the record, the Journal of Clinical Investigation, that
there was reproduced the findings in this study that were in
the ``New Scientist.''
The reason I put that forward is, I don't think anybody has
commented on this yet. I believe, Professor Charo, you were on
the NBAC Board under Clinton, and you noted in your report, if
there is another way of doing this without destroying an
embryo, that is a better way of doing it. And if we have this
coming about and these now are verified in the adult stem cell,
that we have adult stem cells that are pluripotent, and can go
into all forms, can be reproduced outside of the body, I think
the whole panel would agree that this is a marvelous thing and
this is the exact way that we could all agree we should pursue.
Dr. Weissman, since I first put that to you, I----
Dr. Weissman. Sure, let me respond. That is why--and I
think it is very important that we all understand. The reason
that I said what I said just a little bit ago that how
scientists operate is to publish their results in peer-reviewed
journals to demonstrate a phenomenon, and then look for
independent verification. And, Senator, although the ``New
Scientist'' has made this report, it is not a scientific or
peer-reviewed journal.
So the finding by Dr. Catherine Verfaillie at the
University of Minnesota has not yet been published, and so we
cannot examine whether her conclusions about her data would fit
with general scientific ideas. The paper has not been
published.
Now, let me just say that I, therefore, asked Dr. Catherine
Verfaillie to send to you, which you have in your office, and
to you, Senator Feinstein, and to Senator Kennedy, an exact
point of what she has and would her findings be important
enough or even relevant to the issue of nuclear transfer to
create embryonic stem cell lines. And I could read it to you,
or you could read it because you have it in your office. I will
read just a couple small parts.
She said, ``It is far too early to say whether''--the
cells--``they will stack up when compared to embryonic stem
cells in longevity and function. Further, we will not know
which stem cells, adult or embryonic, are most useful in
treating a particular disease without side-by-side comparison
of adult and embryonic cells.''
And then she went on to say, ``We support studies aimed at
developing techniques for therapeutic cloning--that is, cloning
of human embryonic stem cell lines--because they may provide
immune-compatible cells to treat a number of diseases, and
because cloning of embryonic stem cells may be critical to the
study of adult-onset diseases caused, for instance, by mutation
in the DNA of cells after birth.''
And there are a lot of qualifications, she goes on, but the
important point here is the one person who has published the
only paper where it--not published, who through the media, in a
pre-publication media blitz, has reported--she didn't do this
herself. This is the media who has pushed this very hard--that
there may be such a cell in the body, says no, it does not
substitute for embryonic stem cell research or nuclear transfer
research, particularly because she can't make those cells from
the somatically mutated cells in adults.
Senator Brownback. Could I ask you, Professor--could I have
a couple more minutes, Madam Chair?
Chairperson Feinstein. Of course. Take the time you need.
Senator Brownback. If we can do what you are desiring to do
from adult stem cells, would you agree that that is the far
more preferable way to go?
Dr. Weissman. You mean to take the nucleus from, say, a
breast cancer cell or a Lou Gehrig's disease cell and show that
you can now study for all of the cell differentiation that an
embryonic stem cell can do, both in vitro and in animal models,
the development? That is science fiction today.
Senator Brownback. If we could do with adult stem cells the
work of curing ALS, of dealing with Alzheimer's, wouldn't you
agree that that is the better way to go?
Dr. Weissman. Let me just respond for the scientific part.
I am committed, as you know, to finding adult stem cells for
the treatment of human diseases. That is my only commitment.
That is what I do. I do no research on embryonic stem cells or
nuclear transfer, have no connections. But even if we could
treat one disease, or two or five or ten, with adult stem cells
that are around, I would not block the research, the important
research that would open up whole fields, like taking disease
cells or body cells from people with heritable diseases, I
would not foreclose that because then I would be taking the
responsibility to slow down the pace of discovery and the loss
of lives that might have been saved. I could not do that.
Senator Brownback. Mr. Kimbrell, if I could ask you, what
is the worst-case scenario if we proceed, no laws in place, no
regulations, no limitation, United States doesn't act, House
has said we want a full ban, the President says we want a full
ban, Senate doesn't act on it or takes another route so no bill
gets through, so we continue on this unlimited, unregulated
market situation we are in presently? What is the worst-case
scenario that could develop in this situation?
Mr. Kimbrell. As a preface to that, and following along
with Dr. Weissman, one of the things we do need to be careful
here--and I will be careful, too--is that we shouldn't have
science by press release. I think we can all agree with that,
and we are seeing that more and more often, frankly, to try and
garner venture capital for these companies. And we can't have
policy based on that. We cannot have the media do what they do,
which is aggrandize these things. And talk about science
fiction. Right now the idea of garnering stem cells from cloned
human embryos is just that--science fiction.
Dr. John Gearhart, who is the Senate's consultant on this,
resigned from the editorship of the journal--excuse me, the
editorial board of the journal that published Dr. West's study
because he said it shouldn't have been published. Even as they
were talking about getting stem cells from cloned embryos,
numerous scientists were saying this is just not going to
happen. So it is not just one side that is science fiction,
Doctor. It is also the whole idea right now of getting stem
cells from cloned human embryos is definitely science fiction.
Should it happen, however, I don't think there is any doubt
that the time and the place to regulate this is at the creation
of the embryo. If we were to regulate this at the creation of
the embryo, which I am suggesting, that is a relatively easy
place to regulate it because you are simply banning the
creation of these embryos. If we want until implantation to
regulate, then we already have the embryo implanted; we have
got a surrogate mother who is bearing this child, and what do
we do? What is the answer to that? Certainly not abortion.
Chairperson Feinstein. Sam, would you allow me just to poke
in here for 1 second with a question?
Senator Brownback. Yes, if I can continue after you.
Chairperson Feinstein. Yes, absolutely.
Mr. Kimbrell, the rest of the world is going to move in
this direction. European countries are moving in this
direction. Embryonic stem cells, the nuclear transplantation
offers so much promise for, you know, remedial efforts with all
kinds of diseases. Let's say we ban therapeutic cloning and it
was available in Europe. Ms. Gulden, would you go to Europe? Of
course you would.
I don't know how you effectively stop people from looking
for hope when they have a condition or a disease or a problem
that might otherwise be changed.
Mr. Kimbrell. Two quick answers, if I might, Senator. One
is we want to make sure that they have hope, not hype. As I
explained in gene therapy and fetal tissues, in the hearings
very similar to the ones we are having today, it turned out to
be a lot more hype than healing. Some money was made, but
people were injured not healed. We need--again, I insist on not
being technologically amnesia when we look at this.
But the second thing is look at what England has done. Yes,
it is true that England has said let's go ahead with this,
though there has been some legal issues there that have
actually stopped that and now may continue again, but with
strict regulation that has a complete line of custody for each
and every embryo so created to avoid many of the worst-case
scenarios that I was just discussing with the Senator.
That kind of regulation, that kind of regulatory system, is
the only thing that is to prevent at least one of the worst-
case scenarios that we talk about. They realize that. I know
the German parliament is looking at this, and the United
Nations is currently looking at this. And I am convinced that
they will not allow an unregulated--just as England has not, an
unregulated industry in the creation of cloned human embryos
for research.
Chairperson Feinstein. I would very much appreciate it, if
you would care to--you said there were faults with our bill,
and I have no doubt, you know, it is an imperfect vehicle right
now. We admit that. We would like to improve it. I would be
very happy to receive any of your comments as to how to
strengthen it or any of the regulatory--we were just reviewing
them up here, and my staff feels that it is pretty good so far
that way. Now, you say it isn't.
So, you know, I for one would love to have your comments,
if you would care to submit them.
Mr. Kimbrell. Senator, I have spent hours of my life trying
to do effective legislative writing, and I realize what a
humbling process it is, and it is a lot easier to have 20-20
hindsight. As Senator Hatfield once said to me, where were you
when the paper was blank? So I realize it is a daunting task,
and I would be--thank you, I would be very, very happy to give
you some of the suggestions that we have.
Chairperson Feinstein. Thank you. I didn't mean to----
Senator Brownback. No, no, thank you, Madam Chairman.
I guess, Mr. Kimbrell, what I am asking about is, last
summer we were engaged in the discussion about embryonic stem
cell research, and everybody was pointing out, well, these are
so-called ``leftover'' embryos, which I question the
designation of ``leftover embryo,'' but they are leftover. They
are going to be destroyed, and it is just this, and no, we are
not going to clone human beings, no, we are not going to create
embryos for research purposes. It was stated by a number of
people at that time that we are not going to clone, we are not
going to do this, this is just about the embryonic stem cell,
period.
Now here we are 8 months, 9 months later from that point--
not even that far later, and people are now saying we have to
clone for therapeutic purposes if we are going to cure a number
of diseases, which I support curing these diseases. I support
doubling the NIH funding. I am a co-chairman of the Cancer
Caucus. Cancer runs in my family. I have had it. I mean, it is
not that I don't have passion for those issues as well. It is,
OK, now we are on to cloning.
Then if we don't do anything on this, which may be the
case, and so it just moves on forward, what is the next step? I
hear people talk about germ line manipulation in the egg and
sperm cells of adding outside genetic material or altering the
material already there to correct defect that may be in there.
Where are we headed to with all of this? Because it does seem
like we are on a sequential path that we have continued to
follow.
Mr. Kimbrell. There are those--and there is much published
literature which I would be happy to put into the record on
this--that are looking toward what they call a post-human
society, where they very much believe that our carbon bodies
are not adequate to deal with the slings and arrows of
outrageous fortune and that we should re-create ourselves in a
number of different ways through germ line therapy, which part
of what Dr. Weissman was talking about, the Asilomar Conference
and others, there has been an informal ban on germ line therapy
until now. People are talking about rebuilding our cells
molecule by molecule, and, by the way, we are spending about a
billion dollars of our taxpayer money on this to rebuild
ourselves through nano-technology. And MIT and others are
trying to rebuild us with silicon chip bodies. Senator, you
would be delighted to know, I know our taxpayer dollars are
going to that.
So there really is--and I am not sure how widespread it is,
to be honest, but there certainly is a rather chilling movement
called the post-human society which views us as inefficient in
our current forms, as something that is not a given good at
all, but somebody can be re-created through technology to
better deal with the future completely. That is obviously the
worst-case scenario because, clearly, when we have lost what it
means to be human, we have lost the ability that all of us have
to communicate and even discuss these issues. So it is the
wrong kind of final solution.
One quick note on that, which is that I have had to deal
with a great many instances of cancer in my own family, and one
of the things you learn when all of us who face this with a
wife and child, we know that it is a very complicated thing.
Disease is complicated. Is it genetic predisposition? Was it an
environmental poison that came in? Was it a workplace poison?
Was it diet? Was it stress? Or did all these combine?
And I sometimes think that we are a little bit too--and I
am one--I feel this myself. We are little too prone to a magic-
bullet approach, there is one easy answer, fetal tissue, gene
therapy, germ line, stem cells, cloning. And rather than say,
listen, this is a difficult job. Prevention is going to be a
difficult job. It means environmental cleanup. It means making
our cars safer. It means the difficult job that it is going to
take to get rid of all of these resources. It is much more
tempting, and I think somewhat childish, unfortunately, to say
we are going to have a magic bullet, particularly if it means
this post-human society that some would lead us toward,
Senator.
Senator Brownback. Thank you. I want to say, Madam
Chairman, too, I don't challenge anybody's motives or ethics
that participate in this panel here. I think everybody has a
wonderful notion in mind of what they want to see in the future
of there being healing in America and healing around the world
and that we have got this chance to do this and that we should
pursue it.
I don't challenge anybody's motive or ethics, and the Chair
has been absolutely phenomenal on cancer and dealing with that.
And I have been pleased to be a part of that. What I do think
we have to have, as several of you, I think Professor Greely,
you mentioned it, a robust debate about this. I have one more
point, let's pause, let's pause and have the robust debate, and
thoroughly, before we would move forward. I understand a lot of
other people would say let's move forward and debate as we go.
But I think we are at a momentous time, and we need to have
that sort of debate--let's hold up let's really debate this
before we move forward.
Madam Chairman, I appreciate your willingness and your
interest and your holding of this hearing.
Chairperson Feinstein. Thanks, Senator Brownback.
As you know, the debate is going on. I mean, we began this,
what, a year and a half ago, I think. So the debate is going
on.
I just want to extend the same offer to Dr. Charo, Dr.
Greely, anyone else that would like to submit any improvements
in our bill. We would very much appreciate them.
I must say I feel very strongly that we should move to ban
human cloning. I think our Nation should go online and say that
and be clear about it.
Now, I am one that very strongly supports the somatic
nuclear transfer for therapeutic improvements, and I think it
is going to happen if we do nothing. I think there is a point
to legislating in a proper way to see that the right protocols
are there, the right ethics, the right regulations, all of
that, and that we shouldn't delay.
You know, I am aware of people leaving universities here,
going to Europe because they feel there is more opportunity or
more this or more that. But clearly, our law doesn't relate to
what is a burgeoning new area, and it is going to burgeon
without the law, and perhaps more transgressions take place,
because I think there are people out there who are
Machiavellian and who will do the wrong thing and want to make
profit above all things, all the rest of it. And yet there are
people like Ms. Gulden who look at this as something that, you
know, really may offer them longer life, better quality of
life, all of the above. So we have got a lot of challenges on
our plate.
I want to thank this panel. It has been one of the best,
and I really appreciate the different points of view, and thank
you for coming the distances you did. We will keep the record
open.
I would like to submit a statement by the chairman of the
committee, Senator Leahy.
Chairperson Feinstein. The meeting is adjourned.
[Whereupon, at 4:50 p.m., the committee was adjourned.]
[Questions and answers and submissions for the record
follow.]
QUESTIONS AND ANSWERS
Questions submitted to Dr. Weissman by Senator Feinstein
Question 1: As I understand it, nuclear transplantation is a very
broad technique that need not involve embryos or even stem cells.
<bullet> Could you explain some applications of nuclear
transplantation that do not involve embryos or stem cells?
Question 2: I know that DNA regenerative research (also called
therapeutic cloning) offers enormous potential for providing cures for
diseases such as cancer, diabetes, cystic fibrosis, and heart disease
as well as conditions such as spinal cord injuries, liver damage,
arthritis, and burns.
<bullet> Could you explain which diseases and conditions are
most likely to be curable or treatable through DNA regenerative
research?
<bullet> Has anyone been cured or treated yet through DNA
regenerative research? If not, when do you expect this could
happen?
Question 3: It was reported recently that, in order to produce stem
cells, Advanced Cell Technology in Massachusetts has created a monkey
embryo through parthenogenesis, that is, without the use of sperm. As I
understand it, unlike embryos created from an egg (oocyte) and sperm,
parthenogenetic embryos do not go to term if placed in a womb and that
any stem cells produced could only be used in the women who produced
the eggs.
<bullet> Could you explain the difference between somatic cell
nuclear transfer to produce stem cells and the parthenogenetic
technique used by Advanced Cell Technology?
<bullet> Is it accurate to say that in both somatic cell
nuclear transfer and parthenogenesis the egg cell is never
fertilized by the sperm?
<bullet> What is your view about the medical promise of
producing stem cells through parthenogensis?
<bullet> Was parthenogenesis to produce stem cells considered
by your panel as it was preparing the National Academies
report?
Question 4: There has been much talk about whether adult stem cells
are as versatile as embryonic stem cells. Some have even said that
research with adult stem cells shows that we do not need nuclear
transplantation to produce stem cells.
<bullet> Based on your panel's analysis of the medical
literature, would you agree that adult stem cells demonstrate
sufficient potential that it would be appropriate to stop doing
nuclear transplantation?
<F-dash>
Questions submitted to Professor Greely by Senator Feinstein
Question 1: In U.S. v. Lopez, 514 U.S. 549 (1995), and U.S. v.
Morrison, 529 U.S. 598 (2000), the Supreme Court held that the Commerce
Clause gives Congress authority to pass legislation regulating
intrastate activity where it substantially affects interstate commerce.
In my view, it seems clear that a federal law banning human
reproductive cloning would pass muster under Lopez and Morrison. Much
of the equipment, materials, funding, and personnel required for
cloning, as well as the individuals seeking cloning services, would
likely have traveled in interstate commerce.
<bullet> Do you agree? Why or why not?
Question 2: In January 1998, in response to concern over a
statement by Dr. Richard Seed that he would soon clone himself, the
Food and Drug Administration (FDA) announced that it had regulatory
jurisdiction over human cloning under existing federal statutes. The
FDA also noted that anyone seeking to do human cloning would need to
get permission from the FDA for such experiments and it suggested that
it would not give such permission.
<bullet> In your view, does the FDA have jurisdiction over
human reproductive cloning?
<bullet> Does the FDA have jurisdiction over DNA regenerative
research (also called therapeutic cloning)?
<bullet> To your knowledge, has anyone sought permission from
the FDA to attempt to conduct human reproductive cloning?
Question 3: Some commentators have whipped up a frenzy about
cloning, raising the specter of a Brave New World of eugenics and
designer babies. However, others note that, as is the case with many
medical technologies, it is not cloning techniques that are the problem
but some of their potential applications. For example, few people would
argue that we should ban organ transplantation even though we are
concerned about the sales of human organs or the transplant of organs
from executed prisoners. Still, there are those who would completely
ban somatic cell nuclear transplantation. This is in spite of the fact
that the overwhelming majority of the scientific, medical, and
patients' advocacy community opposes such a complete ban.
<bullet> Is there any precedent for completely banning an area
of research against the wishes of the overwhelming majority of
the scientific, medical, and patients' advocacy community?
<bullet> Would you agree that it is generally appropriate and
desirable for the law to discriminate between proper and
improper applications of a medical or scientific technique
rather than completely ban research into the technique?
Question 4: You testified that the California Advisory Committee on
Human Cloning concluded that the state should regulate DNA regenerative
research by, among other things, ``forbidding all research with cloned
human embryos after the appearance of the so-called 'primitive streak'
at about 14 days from its creation.'' I believe that United Kingdom law
also draws the line at 14 days.
<bullet> Can you explain the basis of the committee's
recommendation?
<bullet> Do you believe that there is an ``emerging consensus''
that DNA regenerative research should be permitted before the
two week period but not after?
<F-dash>
Questions submitted to Professor Charo by Senator Feinstein
Question 1: The right to make decisions about whether to bear
children is a fundamental liberty protected by the Constitution. A
federal court has held that the right to make such decisions includes
medically assisted reproduction, such as in vitro fertilization and the
use of donated embryos [see Lifchez v. Hartigan, 735 F. Supp. 1361,
1377 (N.D. Ill. 1990)]. I believe that University of Texas Law
Professor John A. Robertson has suggested that cloning might be a
protected constitutional liberty in some instances.
<bullet> Do you believe that cloning is protected by the
Constitution? If so, under what circumstances?
Question 2: One of the major arguments put forth by those opposed
to DNA regenerative research (also called therapeutic cloning) is the
notion of a ``slippery slope.'' According to adherents of this view, if
the government banned human reproductive cloning but not DNA
regenerative research, it would be extremely difficult to prevent
cloned human embryos from ending up being implanted in women.
<bullet> How persuasive is this ``slippery slope'' argument?
<bullet> In your view, can the government effectively regulate
cloned human embryos? If so, how?
<bullet> What lessons have we learned from government's
experience with embryos derived from in vitro fertilization?
<bullet> How effective has government regulation of these
embryos been?
Question 3: One of the witnesses at the hearing, Father FitzGerald,
argued that the potential for obtaining benefits from scientific and
medical research regardless of how significant such benefits may be or
who may stand to be helped by them does not in itself translate into a
license to engage in that particular research. However, it is
undeniable that the potential benefits of DNA regenerative research
must be considered as a strong argument in favor of such research.
<bullet> In your view, how should Congress balance the
potential benefits of cures and therapies derived from clonal
research with any alleged potential harm?
<bullet> What principles should frame the debate?
<F-dash>
Questions submitted to Mr. Kimbrell by Senator Feinstein
Question 1: As I understand it, there are a number of different
methods of mammalian cloning, including (1) molecular cloning, which
involves replicating sections of DNA known as genes and has been useful
in the production of insulin for diabetes; (2) cellular cloning, which
involves duplication of somatic cells and allows scientists to test the
impact of medicines without using actual human subjects; (3) blastomere
separation, which occurs naturally in the process that results in
identical twins but can also be induced by scientists; and (4) somatic
cell nuclear transplantation, in which genetic material is removed from
a somatic cell of one organism and transferred into the enucleated egg
of another organism. And recently researchers have begun using
parthenogenesis getting unfertilized eggs to start dividing as if they
were embryos which some also consider a form of cloning.
<bullet> Do you believe that all forms of mammalian cloning and
induced parthenogenesis should be banned, including somatic
cell nuclear transfer?
<bullet> If so, do you believe that this ban should be
permanent or temporary?
<F-dash>
Responses of Irving L. Weissman, M.D. to questions submitted by Senator
Feinstein
Question 1: As I understand it, nuclear transplantation is a very
broad technique that need not involve embryos or even stem cells.
<bullet> Could you explain some applications of nuclear
transplantation that do not involve embryos or stem cells?
Answer: The term ``nuclear transplanation'' has been taken as an
abbreviation for ``nuclear transplantation for the production of stem
cells'', which itself could be qualified more precisely in the context
of the Committee's deliberations to mean ``nuclear transplantation for
the production of human pluripotent stem cells.'' In that context it is
specified to be a procedure of transplantation of the nucleus of a
normal or diseased human body cell into an enucleated human egg for the
production of pluripotent stem cell lines, these lines being cell
culture derivates from the inner cell mass of blastocysts that result
from the procedure. If one takes only the term nuclear transplantation,
it could mean any procedure involving the transplantation of the
nucleus from any donor cell into an enucleated cell of any type of host
cell. By today's technology only the nuclear transplantation of the
nucleus into an enucleated egg will allow the production of pluripotent
stem cell lines.
Question 2: I know that DNA regenerative research (also called
therapeutic cloning) offers enormous potential for providing cures for
diseases such as cancer, diabetes, cystic fibrosis, and heart disease
as well as conditions such as spinal cord injuries, liver damage,
arthritis, and burns.
<bullet> Could you explain which diseases and conditions are
most likely to be curable or treatable through DNA regenerative
research?
Answer: There are at least 4 distinct uses for nuclear
transplantation (in your terms DNA regenerative research) that could
and should lead to new medical techniques derived form new medical
knowledge.
1) To use nuclear transplantation methods to expand the genetic
base of human ES lines to be inclusive rather than exclusive.
If we assume human ES cells are today limited to the designated
approximately 64 human cell lines, and that these derive
primarily from in vitro fertilization clinic blastocysts, they
represent cell lines solely from infertile couples, and these
are a small subset of the ethnic, racial, etc. human groupings.
As such, any benefits of studying human developmental biology
from these lines will exclude most major segments of U.S.
society, and of course could be skewed to humans who are
infertile. Thus to provide full potential benefits from this
research for all subgroups of our society, nuclear
transplantation from diverse donors is the most efficient way
to address this limitation.
2) To use nuclear transplanation methods to create new human ES
lines representing humans who not only have an inherited
genetic risk for disease, but who are unlucky enough to get one
or more of these diseases. These include people with
cardiovascular diseases (stoke, aneurysm, coronary artery
disease, etc.); autoimmune diseases such as type I (juvenile)
diabetes, rheumatoid artritis, multiple sclerosis, systemic
lupus erythematosus, hemolytic anemias, ankylosing spondylitis,
etc.; neurodegenerative diseases such as Alzheimer's disease,
Lou Gehrig's disease (amyotrophic lateral sclerosis),
Huntington;s disease, probably Parkinson's disease, Batten's
disease, Tay-Sachs disease, Gaucher's disease, the mental
retardation of Down's Syndrome, perhaps schizophrenia, etc.;
blood disorders such as sickle cell anemia, thalassemia
(Mediterranean forms and Korean forms), etc.; allergic
disorders; many if not all cancers; hereditary blindness,
hereditary deafness, and many, many more.
3) To use nuclear transplantation methods to produce human
lines from the nuclei of cells that underwent somatic (not
inherited from parents) mutations as part of the disease
process. In these diseases the only body cells that have nuclei
that represent the life history of the development of those
diseases are the disease cells themselves. these include all
cancers, leukemias, and lymphomas, and huntington's disease.
The study if diseases in categories 2) and 3) involves
establishment of the cell lines, study of how they make the
cells involved in the disease in test tubes (for example, motor
nerves and the muscle cells they can innervate in ALS); and
transfer of developing cells into the corresponding tissues of
newborn or developing immunodeficient animals to understand how
disease develops in the context of the native tissues. in all
of these cases, if the disease is replicated, one can use the
model to test which genes are involved, and which treatments
are possible. These treatments could include ``therapeutic
coloning'' (see 4), with dene-corrected cells.
4) To use nuclear transplantation methods to produce human
pluripotent stem cell lines from an individual to treat that
individual when his/her own cells or organs have been
irreversibly damaged (therapeutic cloning or DNA regenerative
research, to use your term). As donor and host are closely
similar, minimal immunosuppression should be required. Damaged
tissues could include liver failure, stroke, anemia,
Parkinson's disease, blood vessel repair, etc.
<bullet> Has anyone been cured or treated yet through DNA
regenerative research? If not, when do you expect this could
happen?
Answer: Nuclear transfer to produce human pluripotent stem cell
lines is not currently practiced in the U.S. now, largely due to the
legal uncertainties and the difficulties in making this potential
therapy real. In a mouse model of severe combined immunodeficiency
(SCID), the genetic disorder that the ``bubble boy'' had in Texas,
scientists from the Whitehead Institute at the Massachusetts Institute
of Technology produced pluripotent stem cell lines with that disorder
by nuclear transplantation. They then used gene therapy techniques to
correct the genetic defect in the pluripotent cell line, and allowed
the cells to become blood-forming cells. These blood-forming cells were
modified with another gene to allow them to mature from a primitive
stage of blood formation suitable for a fetus only to more adult blood-
forming cells suitable for an adult. These adult-type blood-forming
cells were transferred to the SCID mouse strain, and low levels of
cells yielding protective immunity resulted. This is the first recorded
case of ``therapeutic cloning'' in any species. The lessons learned
look applicable to man, with considerable research required.
Question 3: It was reported recently that, in order to produce stem
cells, Advanced Cell Technology in Massachusetts has created a monkey
embryo through parthenogenesis, that is, without the use of sperm. As I
understand it, unlike embryos created from an egg (oocyte) and sperm,
parthenogenetic embryos do not go to term if placed in a womb and that
any stem cells produced could only be used in the women who produced
the eggs.
<bullet> Could you explain the difference between somatic cell
nuclear transfer to produce stem cells and the parthenogenetic
technique used by Advanced Cell Technology?
Answer: In parthenogenesis the egg chromosomes are stimulated to
duplicate, bring the DNA level in the cell from half the normal amount
to the normal amount. (Usually the sperm provides half and the egg
supplies half.) As each egg contains only half the maternal
chromosomes, when they are duplicated in parthenogenesis they now have
an unique set of genes, not the same as the mother. However, as the
mother has 1 copy of each parthenote's genes, an organ or solid tissue
(e.g., kidney, liver, skin) stem cell transplant from the parthenote
will usually not be seen as foreign by the mother. But because there
are an unusual set of immunity cells (natural killer cells) that can
reject blood-forming tissue transplants, the mother likely would reject
a blood-forming stem cell transplant from the parthenote. Therefore the
use of partenogenesis to provide transplants would only be useful for
the egg donor, and not in all cases.
<INF>F</INF> Is it accurate to say that in both somatic cell
nuclear transfer and parthenogenesis the egg cell is never fertilized
by the sperm?
Yes.
<bullet> What is your view about the medical promise of producing
stem cells through parthenogensis?
It would have the limited use for therapies described above in
Q2P1. As these cells have only half the genetic diversity of the
mother, even if the mother had a heritable disease or cancer, her
parthenogenetic pluripotent stem cells would almost certainly not
contain the full set of genes to be useful for the other 3 objectives
of nuclear transplantation research outlined in the answer to Q2.
<bullet> Was parthenogenesis to produce stem cells considered by
your panel as it was preparing the National Academies report?
Only minimally, as its potential uses were minimal, as described
above. It does require a blastocyst intermediate.
Question 4: There has been much talk about whether adult stem cells
are as versatile as embryonic stem cells. Some have even said that
research with adult stem cells shows that we do not need nuclear
transplantation to produce stem cells.
<bullet> Based on your panel's analysis of the medical literature,
would you agree that adult stem cells demonstrate sufficient potential
that it would be appropriate to stop doing nuclear transplantation?
Answer: No. There are no peer-reviewed published reports of adult
stem cells that are pluripotent. Usually public policy should only deal
with robust phenomena that are independently confirmed. We threrefore
have no way to assess the properties of such cells, if they exist.
There are many tissue-specific adult stem cells already discovered
(e.g., blood-forming, skin, muscle, brain), and pure blood-forming stem
cells as well as skin cells enriched in stem cells have been used
successfully in therapies. But we have, as yet, no stem cells for
pancreatic islets (lost in diabetes), liver, heart, blood vessels, etc.
They are the focus of promising research. Most adult stem cells have
properties that make them not useful for most of the goals of nuclear
transplanation research outlined in the answer to Q2. Specifically, no
adult stem cells exist for goals 1-3 in Q2, and it is as yet unclear
whether the full panoply of adult stem cells will be discovered for all
organs and tissues that need external cells for regeneration.
Answer: There have been several claims that stem cells are plastic
in their differentiation potential, e.g. in mouse experiments muscle,
brain, or fat to blood, blood to muscle, blood to liver, etc. No claims
for pluripotent or plastic human stem cells have been published. Recent
evidence shows most of these to be contaminating blood-forming stem
cells that circulate through all tissues. When the real stem cells from
muscle or brain were isolated, they could not make blood. And blood-
forming stem cells make little else than blood.
Given the current status of stem cell research (as of March 20,
2002), banning nuclear transplantation to produce human pluripotent
stem cells will not result in comparable research with adult stem
cells, and so for scientific and medical reasons both kinds of research
deserve focus and funding. Those responsible for banning such research
are surely responsible for the lives lost that could have benefited
from such research done in a timely fashion.
I hope this aids you in your deliberations.
<F-dash>
Responses of Hank Greely to questions submitted by Senator Feinstein
Answer 1: The Commerce Clause
Predicting the Supreme Court's position on the sweep of the
Commerce Clause seems impossible to do with any confidence. Imagine a
scenario where the patients, doctors, and most of the equipment for
human reproductive cloning all came from within one state. This is not
unlikely; human reproductive cloning, if possible at all, would seem to
require little equipment. Assume the clinic avoids, as far as possible,
any interstate advertising or even the use of instrumentalities of
interstate commerce like the mails or the telephone. Add the fact that
human reproduction hasn't usually been viewed as an item in interstate
commerce. And, just to make the scenario as extreme as possible, assume
further that the cloning is attempted without seeking a profit--perhaps
even by a non-profit organization.
Under those circumstances, I can imagine a court, struggling with
Lopez and Morrison, concluding that the Commerce Clause does not
stretch to that behavior and I could make that argument with a straight
face. On the other hand, I think it is more likely a court would hold
the opposite. Although the conventional method of reproduction has not
been commercial, in vitro fertilization and other forms of assisted
reproduction are most certainly been commercial--and a thriving
commerce at that. Both Lopez and Morrison involved activities that were
not themselves part of an ongoing business, but that were claimed to
have effects on interstate commerce. The problem there may have been as
much ``commerce'' as ``interstate.'' In the case of reproduction--seems
clear in our society. That makes me think that a court probably would
distinguish Lopez and Morrison and hold such a statute constitutional--
but I would not predict that outcome with great confidence.
(Of course, human non-reproductive cloning, aimed at medical
treatment, would seem much easier to find a part of interstate
commerce.)
Answer 2: FDA Jurisdiction
a. Over Human Reproductive Cloning
I do not think the Food and Drug Administration currently has
statutory jurisdiction over human reproductive cloning. I generally
agree with the conclusions on statutory jurisdiction of two law review
articles on this subject (although I think the Price article is
generally somewhat better).
Elizabeth C. Price, Does the FDA Have Authority to Regulate
Human Cloning, 11 Harv. J.L. & Tech. 619 (1998);
Gregory J. Rokosz, Is the Reach of FDA Authority Too Far a
Stretch? 30 Seton Hall L. Rev. 464 (2000)
The articles focus on two Points: for the FDA to have jurisdiction,
there must be a drug, device, or biological. This must be an article,
product, or similar noun, that is either a) applicable to the
prevention, treatment, or cure of a disease or condition of human
beings (to meet the definition of a biologic under the Public Health
Service Act), or b) intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in man [or] to affect
the structure or any function of the body of man (to meet the
definition of drug under the Federal Food, Drug, and Cosmetic Act).
It is quite possible that a court would find that a human embryo is
not an article or product. It seems to me even more likely that a court
would find that reproductive cloning (at least where the people
involved were otherwise fertile) would not meet the second part of the
definitions--it would neither be for the prevention, treatment, or cure
of a disease or condition, nor ``to affect the structure or any
function of the body of man.''
Of course, the courts give substantial deference to agencies in
interpreting their empowering statutes. On the other hand, the Supreme
Court has recently struck down FDA regulation of cigarettes (which
common sense would seem to group as a device for delivering nicotine,
an addictive drug). The jurisdiction of the FDA over such cloning under
existing statutory authority can only be said to be uncertain.
b. Over DNA Regenerative Research
It seems clear that cells (or other substances) produced from
human non-reproductive cloning would be biologics under the
terms of the Public Health Service Act and thus subject to FDA
jurisdiction as well as, most likely, drugs under the FFDCA.
Note, though, that this jurisdiction is only triggered by their
use in human subjects, either experimentally or in human
subjects, either experimentally or in treatment. Research short
of human trials would not, I believe, be subject to FDA
regulation.
c. Has anyone sought FDA approval for human reproductive
cloning?
Not as far as I know.
Answer 3: Banning Versus Regulating
a. Precedent for completely banning an area of research
against the wishes of the scientific, medical, and patients
advocacy communities?
No. The closest I can come at the federal level is various
restrictions on nuclear fission and fusion information after
World War II that had the effect of classifying all weapons-
related research and concentrating it in the federal
government. I suppose bans on chemical and biological weapons
also ban some research on those weapons, even under federal
government auspices. In neither of those examples was there
public support for such research. Several states have laws
banning some forms of human embryo research; again, in those
states, at the time the laws were passed (usually in the early
1980s), such research had no substantial constituency.
b. It is generally appropriate--and desirable--for the law to
discriminate between proper and improper applications of a
technique rather than completely ban research into the
technique?
Yes, when the applications can be sufficiently separated. I
believe that non-reproductive cloning, a proper application,
can be separated entirely from reproductive cloning, an
improper application.
Answer 4: The Primitive Streak
a. The basis for the California recommendation
Based on scientific evidence, the development of a ``primitive
streak'' seems to mark the first appearance of any precursor to
the nervous system. Although the primitive streak itself does
not seem to be a nervous system, it is a visible and
conservative marker that shows that before its formation, the
embryo seems incapable of experiencing any sensation.
b. Do I believe there is an emerging consensus for a two week
research period for DNA regenerative research?
Yes. The United Kingdom as well as various US advisory bodies
have recommended the two week period.
<F-dash>
Responses of R. Alta Charo to questions submitted by Senator Feinstein
Answer: Your first question concerns my opinion on whether there is
a fundamental right to use reproductive cloning. I will answer that
query in this email, and will send answers to the other questions in a
follow-up email this weekend.
Your question first asserts that Lifchez v. Hartigan (735 F. Supp.
1361, N.D. Ill. 1990) holds that the right to make decisions concerning
whether to bear children includes the right to use IVF and donated
gamete. The question then asks whether I believe that cloning is
protected by the Constitution.
First, I do not agree with your characterization of the Lifchez
case. Lifchez concerned an Illinois statute that attempted to ban fetal
experimentation. The statute specifically stated that it was not
intended to prohibit IVF, and thus the Court's review of the statute
never required it to reach the question of whether Illinois might
constitutionally prohibit IVF. Its suggestion that the reproductive
privacy cases suggest a fundamental right to use technologies that
bring about pregnancy is not a holding, merely dicta.
Further, this is no way clarified the view of this federal court,
let alone the view of other federal courts, on whether the right to
reproductive privacy also includes a right to make decisions about the
kinds of children one might have (via gamete selection, embryo
selection, or in the future, gamete or embryo genetic alteration), a
right to use donated gametes, or a right to purchase and sell gametes.
None of these medical and social developments are central to the issue
of whether or not to become a parent.
Decisions about gamete and embryo selection concern the scope of
parental entitlement to shape the parental experience, by influencing
the kinds of children who will be conceived or brought to term. And use
of donated or purchased gametes by an individual does not let him or
her reproduce genetically, thus, again, going beyond the scope of prior
decisions concerning the right to ``beget'' a child. (Arguably, the use
of donated or purchased ova does, however, allow a woman to ``bear'' a
child even though she has no usable ova of her own, and thus this may
possibly fall squarely within prior cases; those cases, however, were
written long before it was possible to separate ``bearing'' from
``begetting'' in the context of female reproduction, so the intent of
the authors of those legal opinions cannot be determined with any
precision.)
More to the point, you ask if I believe cloning is protected by the
Constitution.
Before responding, it is essential to note that whether or not
cloning is protected by the Constitution can be determined only by the
Supreme Court. Until it has ruled, the issue is unresolved. I would
predict, however, that if the Supreme Court were presented with this
question, it would rule that reproductive privacy does not extend to
cloning.
First, from a genetic point of view, the donor of a somatic cell
for cloning will not be conceiving a child but will be conceiving a
genetic twin. There are no cases that suggest a fundamental right to
have a sibling. While this may seem semantic or genetic sleight-of-
hand, I believe it is in fact a substantive point, as the earliest
cases, such as Skinner v. Oklahoma [316 U.S. 435 (1942)], were clearly
based on a model of vertical genetic transmission across genetic
generations. This, in turn, appeared to reflect a belief in the
impermissibility of government interference in an activity that is at
the center of both personal and human experience throughout human
history. As cloning represents something sui generis as a form of
family formation, it would be wrong to assume that these early cases
would necessarily be extended to apply to this new technology.
Speaking more broadly, to the spirit of the reproductive privacy
cases, I believe one finds distinctly different strands of reasoning,
only some of which would tend to support a fundamental right to use
cloning as a form of human reproduction. Further, the one strand of
reasoning that would provide such support, to wit, a liberty interest
in psychological autonomy, is the very same strand of reasoning that
the Supreme Court has declined to interpret broadly.
Various aspects of this reproductive privacy right have been
articulated in a number of landmark Supreme Court cases, including
Griswold v. Connecticut [381 U.S. 479 (1965) (striking down statute
which forbid use of contraceptives on grounds that statute invaded zone
of privacy surrounding marriage relationship)]; Eisenstadt v. Baird
[405 U.S. 438 (1972) (striking down statute forbidding distribution of
contraceptives to unmarried persons on equal protection grounds, but
observing in dicta that: ``If the right of privacy means anything, it
is the right of the individual, married or single, to be free from
unwarranted governmental intrusion into matters so fundamentally
affecting a person as the decision whether to bear or beget a
child.'')]; Roe v. Wade [410 U.S. 113 (1973) (establishing unrestricted
right to an abortion in first trimester)]; and Planned Parenthood of
Missouri v. Danforth [428 U.S. 52 (1976) (striking down provisions of
abortion statute requiring spousal consent and parental consent)]. In
Carey v. Population Services International, 431 U.S. 678 (1977), the
Court reviewed its prior privacy cases and declared that ``The decision
whether or not to beget or bear a child is at the very heart of this
cluster of constitutionally protected choices.''
What is striking about many of the early contraception cases, which
laid the ground for the subsequent abortion cases, is their emphasis on
the marital relationship. It was the intrusion of government policy
into that marital relationship, and by extension, into the marital bed
(by virtue of making sexual relations between husband and wife
difficult or unpleasant due to the need to avoid conception without the
benefit of contraceptives), that animates the visceral reaction that
these policies are an intrusion on ``privacy.''
In Eisenstadt, this concern about marital privacy is combined with
the Skinner v. Oklahoma concern about impermissible intrusion into the
realm of an individual's reproductive capacities, resulting in an
extension of the right to contraception to unmarried individuals. It is
important to note that, in Skinner, the issue concerned the bodily
integrity of felons who were faced with forcible sterilization. The
Eisenstadt case, however, necessarily goes beyond this concern with
bodily integrity when it extends the right to contraception to men as
well as women. For women, who are at risk of pregnancy, prohibitions on
contraception threaten their interest in controlling the state of their
bodies, as well as their psychological interest in freely deciding
whether to become a parent. For men, however, the interest is purely
psychological. Thus, as of 1972, it would appear that the Supreme Court
was working toward an understanding of reproductive privacy that
extended to concerns about psychological autonomy, a form of liberty
that might support a claim of constitutional protection for the use of
cloning techniques to produce a child.
But subsequent abortion and right-to-die cases have backed away
from this regard for psychological autonomy and have emphasized instead
either gender equality or the liberty interest in bodily autonomy.
While Justice O'Connor's opinion in Pennsylvania v. Casey does speak to
the notion that ``at the heart of liberty is the right to define one's
own concept of existence, of meaning, of the universe, and of the
mystery of human life, `` her subsequent statements reflect a concern
more for gender equality in society than for unfettered personal choice
in all matters touching, no matter how remotely, on human reproduction.
(``The mother who carries a child to full term is subject to anxieties,
to physical constraints, to pain that only she must bear. That these
sacrifices have from the beginning of the human race been endured by
woman with a pride that ennobles her in the eyes of others and gives to
the infant a bond of love cannot alone be grounds for the State to
insist she make the sacrifice. Her suffering is too intimate and
personal for the State to insist, without more, upon its own vision of
the woman's role, however dominant that vision has been in the course
of our history and our culture. The destiny of the woman must be shaped
to a large extent on her own conception of her spiritual imperatives
and her place in society.'' )
The dissenters in that case launched a pointed attack, too, on the
notion that fundamental rights to privacy bespeak unfettered liberty of
choice in all personal matters. In a scathing dissent, Justice Scalia
wrote: ``The best the Court can do to explain how it is that the word
``liberty'' must be thought to include the right to destroy human
fetuses is to rattle off a collection of adjectives that simply
decorate a value judgment and conceal a political choice. The right to
abort, we are told, inheres in ``liberty'' because it is among ``a
person's most basic decisions,'' it involves a ``most intimate and
personal choice,'' it is ``central to personal dignity and autonomy,''
it ``originates within the zone of conscience and belief,'' it is ``too
intimate and personal'' for state interference, it reflects ``intimate
views'' of a ``deep, personal character,'' it involves ``intimate
relationships'' and notions of ``personal autonomy and bodily
integrity,'' and it concerns a particularly ``'important decision.''
But it is obvious to anyone applying ``reasoned judgment'' that the
same adjectives can be applied to many forms of conduct that this Court
has held are not entitled to constitutional protection--because, like
abortion, they are forms of conduct that have long been criminalized in
American society. Those adjectives might be applied, for example, to
homosexual sodomy, polygamy, adult incest, and suicide, all of which
are equally ``intimate'' and ``deeply personal'' decisions involving
``personal autonomy and bodily integrity,'' and all of which can
constitutionally be proscribed because it is our unquestionable
constitutional tradition that they are proscribable.'' [citations
omitted].
Indeed, the Supreme Court has rejected the notion that a
psychological autonomy embedded in fundamental liberty interests
extends to choices about sexual practices such as consensual anal
intercourse between men [Bowers v. Hardwick, 478 U.S. 186 (1986)]. And
in Washington vs. Glucksberg, 521 U.S. 702 (1997), the Supreme Court
rejected the argument that psychological autonomy extends to a right to
commit suicide, allowing only that when bodily integrity is threatened
by unwanted medical intervention, there is a fundamental right to
refuse treatment, even at the risk of death. In these cases, which
concern sexuality and dying, the Court has declined to announce that
fundamental liberty interests extend to all aspects of defining one's
self and controlling one's future, and instead has emphasized
repeatedly that only those interests that are considered to be central
to ordered liberty and are historically grounded in common practice
will be viewed as fundamental.
Thus, cloning as an exercise of psychological autonomy is unlikely
to receive the protection of fundamental rights analysis, and as
prohibitions on cloning neither invade the body nor tread on a
historically common practice, it is unlikely to gain fundamental rights
protection on either of those grounds either. Only if it is viewed as
closely connected to the choice to bear or beget a child is there any
significant chance that it would be considered protected as a
fundamental right. And this, of course, returns the discussion full
circle to the question of whether it should be viewed as a variation on
human reproduction or as something wholly new unto itself. It is my
best guess that the Supreme Court would view cloning as something
wholly new, despite the fact that it could be used as a substitute for
sexual reproduction through intercourse or even reproduction through
the use of laboratory techniques to achieve conception by male-female
gamete combinations in a laboratory dish.
On a final note, I would like to mention that this analysis of
Supreme Court decisions does not reflect my personal preferences
concerning the relationship between liberty and personal choices. I
must confess that on matters concerning sexuality, marriage, family
formation, reproduction, dying and death, I would prefer that the
Supreme Court adopt an expansive vision, so that any state
encroachments on these choices would be impermissible absent a
compelling state purpose. I believe that this is not only politically
preferable, but also that it is a defensible interpretation of these
cases, all of which acknowledge the importance of liberty interests
that go far beyond bodily autonomy. Nonetheless, I believe that a fair
reading of the cases and the jurisprudential theories favored by the
current Supreme Court make it unlikely that a congressional ban on
reproductive cloning would be struck down as undue interference in an
individual's fundamental right to reproductive and familial privacy.
Answer: Your second question concerns slippery slope arguments and
the effectiveness of government regulation.
I do not find the slippery slope arguments persuasive, because
taken to their most logical conclusion, they would argue most
strenuously for a ban on in vitro fertilization, as it is IVF that
allows us to maintain and manipulate embryos outside the body. To the
extent that slippery slope concerns focus on genetic screening and
genetic engineering, it is IVF that is the major avenue toward such
manipulations, not cloning, but it is cloning, and not IVF, that would
be banned.
More profoundly, slippery slope arguments are by their nature
simplistic. In the late 1970s, when concerns were raised about the
power of recombinant DNA technology, many people called for an
indefinite moratorium on use of the technique. If that moratorium had
been adopted, the entire biotechnology industry would have been stopped
in its tracks.
Slippery slope arguments are for the timid. The courageous
recognize the complexity of technology, appreciate that it almost
always offers both good and bad applications, and fight through the
uncertainty, confusion and fear in order to develop nuanced policy that
salvages the good while guarding against the bad.
Fortunately, there are some governmental mechanisms already
available to do just that.
FDA has the authority to regulate medical products, including
biological products, drugs, and devices. The use of cloning technology
to clone an embryo for therapeutic purposes would be subject to both
the biologics provisions of the Public Health Service (PHS) Act and the
drug and device provisions of the Federal Food, Drug, and Cosmetic
(FD&C) Act.
In October 1993, FDA published a notice in the Federal Register, 58
FR 53248 (October 14, 1993), clarifying the application of FDA's
statutory authorities to human somatic cell therapy and gene therapy
products. The notice stated that somatic cell therapy products are
biological products under the PHS Act as well as drugs under the FD&C
Act and are subject to investigational new drug (IND) application
requirements. In the notice, FDA defined somatic cell therapy products
as ``autologous (i.e., self), allogeneic (i.e., intra-species), or
xenogeneic (i.e. inter-species) cells that have been propagated,
expanded, selected, pharmacologically treated, or otherwise altered in
biological characteristics ex vivo to be administered to humans . .
..''
Subsequently, in March 1997, the Agency proposed a more
comprehensive regulatory approach for cellular and tissue-based
products that includes somatic cell therapy products (62 FR 9721 March
4, 1997). In January 2001, after issuing and reviewing comments on a
proposed rule, FDA issued a final rule that establishes the regulatory
approach for human cells, tissue, cellular and tissue-based products
and requires establishments to register with the Agency and list their
products.
Thus, clinical research using cloning technology to clone an embryo
is subject to FDA regulation under the PHS Act and the FD&C Act. Before
such research could begin, the researcher must submit an IND request to
FDA, which FDA would review to determine if such research could
proceed.
A researcher may not conduct a clinical study unless an IND is in
effect. Sponsors are required to submit to FDA an IND describing the
proposed research plan and other pertinent scientific information, to
obtain authorization from an independent Institutional Review Board,
and to obtain the informed consent from all participating individuals.
The sponsor must wait at least 30 days after submitting its proposal to
FDA before beginning any study. During this time, FDA may take action
to prohibit a sponsor from conducting the study by placing the study on
``clinical hold'' for a variety of reasons, including but not limited
to, situations where the Agency finds that ``human subjects are or
would be exposed to unreasonable and significant risk of illness or
injury'' or that ``the IND does not contain sufficient information
required. . .to assess the risks to subjects of the proposed studies.''
(Title 21, Code of Federal Regulations 312.42.)
On the basis of these powers, FDA could withhold approval of
studies using cloned embryos if those studies did not ensure that risks
to egg donors were acceptable, that egg donation was informed and
voluntary, and that procedures were in place to track the cloned
embryos so that they could not be diverted to reproductive or other
unauthorized purposes.
Government regulation would, of course, be enhanced if federal
funding were available to a broader range of embryo research projects.
It is the absence of federal funding for embryo research throughout the
1980s that accounts for the virtually unregulated and explosive growth
of clinical applications of IVF and other reproductive technologies.
Federal funding in the 1980s would have given researchers an incentive
to proceed in a more measured fashion, and would have permitted
diffusion of the techniques to be accompanied by a set of social norms
represented in the federal funding restrictions. Instead, in the
absence of federal funding, we observed rapid expansion of medical
indications for reproductive technologies and a relative dearth of
controlled studies on the safety and efficacy of the techniques. It is
fortunate that to date there have been so few medical problems
associated with the techniques, but government funding would have
ensured that this result was due to planning rather than luck.
<F-dash>
SUBMISSIONS FOR THE RECORD
Statement of The American Society for Cell Biology
Somatic Cell Nuclear Transfer Technology is Justified and Essential for
Producing Embryonic Stem Cells For Basic Research and Therapeutic
Applications
Since 1997 The American Society for Cell Biology has stated and
stood by its strong opposition to the reproductive cloning of human
beings. Media claims notwithstanding, current scientific information
suggests that the technology now available will not be able to lead to
the creation of a cloned human being or to an embryo capable of being
born as a cloned normal human. Equally important, no responsible
scientist favors reproductive cloning.
It is unlikely that current biomedical technology can be used to
clone adult human beings. But there is substantial justification to
believe that somatic cell nuclear transfer (SCNT), or what many have
referred to as therapeutic cloning, will energize scientific progress
in the fight against the most debilitating illnesses known to man. New
embryonic stem cell lines, potentially capable of avoiding the
rejection complications of stem cell therapies for cancer, diabetes,
spinal cord injury, kidney disease, and Parkinson's disease, may be
produced by using the genetic material of the prospective transplant
recipient to generate recipient-matched stem cells. These procedures
could be vital in solving the persistent problem of a lack of
genetically matched, qualified donors of organs and tissues that we
face today. Stem cell research is an essential first step if we are
ever to be able to achieve the promise of regenerative medicine, a
wholly new approach for repairing cells and tissues in the treatment of
currently intractable human diseases. Beside the therapeutic promise,
the SCNT procedure permits entirely new approaches to the study of the
earliest phases of human development, of how a single cell is
transformed into the trillions of different cells and tissues with
myriad fates and capabilities during embryonic development. By deriving
embryonic stem cells with defined mutations scientists gain a new
approach to understanding how such inherited predispositions lead to
serious disease in adulthood.
Unfortunately, and onerous cloud has been cast on the term cloning
because it has been used in the public discourse both to refer to
attempts to create genetically identical adult humans and to describe
other procedures that are less controversial. However, cloning is a
scientific term that describes the preparation of an ``infinite''
number of copies of, for example a single molecule, cell, virus or
bacterium. For example, cloning DNA molecules was essential for solving
the human gnome sequence. Similarly, Cloning DNA is critical to fight
against bioterrorism and has already been used in the determination of
the entire gnome sequences of several organisms identified as
bioweapons. Furthermore, cloning is integral to modern forensic
procedures, medical diagnostics, vaccine development, and the discovery
and production of many of the most promising drugs. Cloning is also
used to make genetically identical plants and livestock enabling
continued agricultural breakthroughs necessary to feed a rapidly
growing and undernourished world population.
Conflating the term cloning as it is used for the creation of
genetically identical humans with the valuable and appropriate uses of
cloning embryonic stem cell lines for basic research and therapeutic
purposes is inappropriate. The two issues need to be considered
separately; otherwise we run the serious risk of sacrificing certain
great benefits to prevent a perceived undesirable practice.
<F-dash>
Statement of Hon. Sam Brownback, a U.S. Senator from the State of
Kansas
Thank you.
First, I would like to thank in particular, the Chairperson,
Senator Feinstein for calling this hearing. I have nothing but the
greatest respect for Senator Feinstein. Senator Feinstein and I have
recently had the opportunity to work very closely together to begin the
process of building a health care infrastructure that we hope will
eventually lead the way in finding a cure for cancer and also to ensure
that Congress commits the resources to finding that cure.
No matter what disagreement may exist between the members of this
committee, those who are here to testify, or the public at large on the
issue of cloning I do not believe there is any disagreement that we
must all work hard to find a cure for the diseases that plague
humanity.
I look forward to the testimony that is about to be presented.
The Chairperson and I have very different approaches to the very
important issue of human cloning.
As most of you know, I am sponsoring the Human Cloning Prohibition
Act of 2001 which differs from the Chairperson's bill in several
important ways. And I am proud to announce today, at this hearing, that
Senator Mary Landrieu has decided to join me, as the Chief Democrat
sponsor of my legislation to ban all forms of human cloning.
Senator Landrieu and I believe it is vital that the Senate fully
consider this issue. The House of Representatives has spoken, and so
has the President now the Senate must follow suit.
The issue of human cloning demands the public's attention, in part,
because it revolves around the meaning of human dignity and the
inalienable rights that belong to every person.
Some will argue that the issue simply needs to be studied before
any research begins, or that cloning be allowed to proceed in a limited
fashion such a notion clearly does not respect the new life that is
created through human cloning.
Some do not want a permanent ban, as you will hear today they want
a limited ban on ``reproductive'' cloning but not on so-called
``therapeutic,'' research or destructive cloning.
The notion that human cloning can be ``therapeutic'' is both
misleading and disingenuous.
``Therapeutic'' cloning, as some of the proponents of cloning in
the biotech industry refer to it, is really the process by which an
embryo is specially created for the directly intended purpose of
subsequently killing it for its cells. Some proponents of human cloning
claim that an embryo created in this manner will have cells that are a
genetic match to the patient being cloned, and thus the cells would not
be rejected by the patient's immune system.
But to describe the process of destructive human cloning as
``therapeutic,'' when the intent is to create a new human life that is
destined for its destruction, is deeply misleading.
The act of cloning a human being for the purposes of study, to make
``designer'' replacement cells is wrong. It makes a child into a piece
of property. The child's sole purpose in creation is to be destroyed
for someone else's benefit. This is no way to operate in a civil
society, especially the United States, which leads the world in human
rights concerns.
All human cloning is reproductive in that it creates new human
life. What is done with that life is what the Feinstein bill mandates
the Feinstein bill mandates that in most cases that life must be
destroyed for the benefit of others.
I do not believe that we should create life just to destroy it yet
that is exactly what is being proposed by those who support cloning in
limited circumstances; however they might describe those circumstances
whether it's nuclear transplantation, ``therapeutic'' cloning,
therapeutic cellular transfer or whatever the latest euphemism. Cloning
is wrong, period.
The bill being sponsored by the Chairperson calls for the creation
of human embryos for the purposes of their immediate destruction.
Among the obvious concerns that I have just mentioned, I have other
concerns, which I hope some of the witnesses today will be able to
discuss.
The first is that the Feinstein bill seems to put law enforcement
in a rather difficult position that of having to police intentions,
rather than actions in particular, in those cases where actions are
cloaked under the veil of doctor-patient confidentiality.
I also have some serious concerns regarding the excessively broad
nature of the definitions sections which would grant exclusions that I
believe would lead directly to reproductive cloning.
Finally, I would like to comments from a story that appeared in New
Scientist, ``A stem cell has been found in adults that can turn into
every single tissue in the body. It might turn out to be the most
important cell ever discovered.
``Until now, only stem cells from early embryos were thought to
have such properties. If the finding is confirmed, it will mean cells
from your own body could one day be turned into all sorts of perfectly
matched replacement tissues and even organs.
``If so, there would be no need to resort to therapeutic cloning -
cloning people to get matching stem cells from the resulting embryos.
Nor would you have to genetically engineer embryonic stem cells (ESCs)
to create a 'one cell fits all' line that does not trigger immune
rejection. The discovery of such versatile adult stem cells will also
fan the debate about whether embryonic stem cell research is
justified.''
Science continues to prove that destructive embryonic stem cell
research and so-called, ``therapeutic cloning'' is unnecessary.
As this debate continues, we need to constantly examine and re-
examine the scientific facts with a fully-informed moral conscience.
I hope that we can have a full and healthy exchange on these, and
related issues, and I welcome the panel of witnesses.
<F-dash>
Statement of Hon. Maria Cantwell, a U.S. Senator from the State of
Washington
Thank you Madam Chairwoman. I am pleased that you have convened
this hearing today to give all of us the opportunity to learn more
about the human cloning debate and its implications for medical
research.
Every day in this country we learn of exciting new scientific
discoveries that hold the promise of dramatically improving both our
daily lives and future medical treatments. There is no doubt that as
science advances, our country must continually reevaluate and reaffirm
the legal and ethical guidelines surrounding these advances. As science
on cloning and stem cell research develops, some have focused on the
possibility, however distant, that this new knowledge will lead to the
creation of human clones.
Last November's announcement of the privately funded cloning of a
human embryo for therapeutic purposes by Advanced Cell Technology of
Worcester, Massachusetts has refocused attention on the ethical
concerns of this emerging science. Researchers described their work as
an important step toward producing stem cell as treatments for
diabetes, heart disease, spinal injuries, and many other ailments. But
the value of this achievement must be balanced against the ethics of
the means to achieve it.
In fact, the scientific community has spoken clearly, and often,
that the pursuit of human clones is unwarranted and probably beyond our
current technological or biomedical capabilities. Furthermore, as some
of today's witnesses will describe, such reproductive cloning is unsafe
and ultimately likely to fail. But scientists have also made it quite
clear that there are ethical paths of research into therapeutic cloning
for legitimate biomedical reasons that we should not close with far-
reaching legislation.
While I strongly oppose cloning for reproductive purposes, I do
support therapeutic cloning and believe that imposing absolute
proscriptions on this research would unnecessarily stop valuable
biomedical research across the country. Finally, I am especially
concerned that unilateral bans could be read to prohibit DNA
replication, which is necessary for important biotechnology research.
Thank you, Madame Chairwoman for convening this hearing so that we
can learn more about this issue. I look forward to the testimony of our
distinguished panelists.
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<F-dash>
Article submitted by Jeffrey P. Kahn, Ph.D., M.P.H., Director, Center
for Bioethics, University of Minnesota
Printed by CNN--On the path to cloning?--November 26, 2001
cloning is making its way back into the news, with announcements by a
massachusetts biotechnology company, advanced cell technology.
ACT claims it has created ``normal'' cows through cloning and is
making public the results of its successful human embryo cloning
effort--and the ``recipe'' for creating cloned embryos. The company
says it created the clones for research into how it might produce stem
cells for therapeutic purposes, and has no intention of allowing any of
the embryos to be implanted into a woman's womb to create a pregnancy.
But the announcement of a successfully cloned human embryo, even
for research purposes, rekindles the fear that cloning identical copies
of humans cannot be far off. The technical reality is still a distant
prospect but the successful cloning of embryos is another step along
the path: What are the appropriate limits on stem cell research and the
application of cloning technologies?
therapeutic versus reproductive cloning
ACTs research focuses on so-called therapeutic cloning, where a
cloned embryo is made using the DNA of a patient who could benefit from
a stem cell transplant. The cloned embryo would then be allowed to
divide only a few times, after which the embryonic stem cells would be
collected and used to grow genetically- matched tissues or specific
cell type needed to treat the same patient.
Cloning embryos for their stem cells is controversial for two
reasons.
For many people the intention for which embryos are created is
critically important in thinking about the ethics of their use. For
them, using embryos that were creating in fertility clinics--originally
intended for use in reproduction--is more acceptable than creating
embryos expressly for the purpose of research. In this view, creating
embryos expressly for research purposes does not treat them with
adequate respect. But for others, the moral costs of creating early
stage embryos exclusively for research purposes are outweighed by the
promise of significant medical benefits.
While therapeutic cloning is morally very different from trying to
create an identical copy of a human through reproductive cloning, the
newly published techniques used to create the embryos would be exactly
the same. But instead of collecting stem cells, doctors would place the
cloned embryo in a woman's uterus in the hope that it would result in a
pregnancy and the birth of a cloned baby. For some, this implies that
therapeutic cloning will inevitably lead to reproductive cloning.
1stopping the slippery slope
If we believe that the benefits of therapeutic cloning outweigh its
moral costs, how can we prevent the same technology being used to clone
humans? As is the case for many medical technologies, it is not cloning
techniques that are unethical, but some of their potential
applications. For example, we reject the transplant of organs from
executed prisoners, but we don't prevent it by banning, organ
transplantation. The challenge for stem cell research policies is to
create appropriate parameters to allow its benefits while preventing
abuses or unethical applications.
The Bush administration had an important opportunity to set federal
policy when it considered whether to allow funding for stem cell
research, and if so, with what limitations.
Such decisions often have far-reaching implications--even though
they technically apply only to publicly funded research, they tend to
set the standard for practice in both publicly- and privately-funded
research. By limiting funding to only those cell lines that existed as
of August 2001, the administration was silent about what rules or
parameters ought apply to the creation of embryos--whether by in vitro
fertilization or cloning technologies--leaving a gaping policy vacuum.
We're long overdue for a reasoned public debate on how far stem
cell research ought to go, and how to limit the creation of embryos to
ways that our society deems acceptable.
If we want to realize the benefits of therapeutic cloning but
prevent reproductive clones, then we'll have to level serious penalties
against anyone who allows cloned embryos to develop past a certain
point, or to be implanted in a woman's uterus. This could include
everything from harsh fines to long prison sentences, or both.
There is every reason to think we can distinguish therapeutic from
reproductive cloning and create policies that make the distinction
stick. Clearly the science will move forward, but with no obvious
brakes or steering. A workable policy is key to determining how far we
go and how fast we get there.
<F-dash>
Statement of Coalition for the Advancement of Medical Research Position
Statement on Somatic Cell Nuclear Transfer
(``Therapeutic Cloning '')
The Coalition for the Advancement of Medical Research (CAMR)
supports efforts to prohibit human reproductive cloning while
protecting important areas of medical research, including stem cell
research.
Somatic cell nuclear transfer (SCNT), commonly referred to as
therapeutic cloning, may prove to be a vital tool in allowing
scientists to fully develop the promise of stem cell research. SCNT
involves the use of a donor's unfertilized egg and a patient's own
cells. The research could allow a patient's own genetic material to be
used to develop stem cell therapies specifically tailored to that
individual's medical condition, thus not triggering an immune rejection
response. In other words, using SCNT could repair patients with their
own cells.
Given the scientific potential in this area, CAMR strongly opposes
any legislative or regulatory action that would ban research related to
SCNT. This would include criminalizing the research or the researchers,
and prohibiting the importation of therapies derived from SCNT in other
countries.
The Coalition for the Advancement of Medical Research is comprised
of universities, scientific and academic societies, patients'
organizations, and other entities that are devoted to supporting stem
cell research.
Coalition for The Advancement of Medical Research Members
ALS Association
American Association of Neurological Surgeon/ Congress of Neurological
Surgeons
American College of Obstetricians and Gynecologists
American Diabetes Association
American Foundation for AIDS Research (AMFAR)
American Infertility Association
American Medical Association
American Pediatric Society
American Society for Cell Biology
American Society for Microbiology
American Society for Reproductive Medicine
American Society of Hematology
Association of American Medical Colleges
Association of American Universities
Association of Medical School Pediatric Department Chairs
Association for Research in Vision and Ophthalmology
Association of Reproductive Health Professionals
Biotechnology Industry Organization
Canavan Research Illinois
Cancer Research Foundation of America
Cedars-Sinai Health System
Children's Neurobiological Solutions
Christopher Reeve Paralysis Foundation
Coalition of Patient Advocates for Skin Disease Research
Columbia University
Duke University Medical Center
Genetic Alliance
Hadassah
Harvard University
International Foundation for Anticancer Drug Discovery (IFADD)
International Longevity Center--USA
Jeffrey Modell Foundation
Johns Hopkins Medicine
Juvenile Diabetes Research Foundation (JDRF)
Steven and Michele Kirsch Foundation
Lymphoma Research Foundation of America
Monash University
National Association for Biomedical Research
National Association of State Universities and Land-Grant Colleges
National Coalition for Cancer Research (NCCR)
National Coalition for Cancer Survivorship
National Council on Spinal Cord Injury
National Health Council
Parents of Infants and Children with Kernicterus (PICK)
Parkinson's Action Network
Project A.L.S.
Research ! America
Resolve: The National Infertility Association
Rett Syndrome Research Foundation
Society for Pediatric Research
Society for Women's Health Research
Stanford University
Tuberous Sclerosis Alliance
University of California System
University of Rochester Medical Center
University of Wisconsin-Madison
Washington University in St. Louis
WiCell Research Institution/ Wisconsin Alumni Research Foundation
Wisconsin Association for Biomedical Research and Education
<F-dash>
Statement of Hon. Richard Durbin, a U.S. Senator from the State of
Illinois
Madam Chairwomen, I want to thank you for holding this important
hearing. I rise today to give my support to the Human Cloning
Prohibition Act sponsored by Senators Feinstein and Kennedy.
The Feinstein-Kennedy bill specifically addresses a course of
action we all agree on, namely, prohibiting the use of cloning
technology specifically for the purpose of creating an embryo for
implantation in a women's uterus. Further, this bill takes the
important step of outlining significant civil and criminal penalties
for those who fail to respect this prohibition.
I would also however like to address a point on which there is some
disagreement: the banning of therapeutic cloning in addition to
reproductive cloning. Unlike reproductive cloning, therapeutic cloning
or somatic cell nuclear transfer aims not to create an identical and
complete human being but to create a number of genetically identical
cells which could become an organ or a tissue that one day would be
used to treat individuals suffering from disease.
These genetically identical cells can be thought of as similar in
some respects to someone donating blood for their own use later on
except with far more potential. Just as is the case with blood
transfusions, the risks of rejection or other adverse consequences in a
transplant scenario with cloned cells are greatly reduced because the
body recognizes itself.
While I support therapeutic cloning, I strongly believe that
vigilant oversight will be critical for preventing the improper use of
this technology. We have heard the argument that such oversight will be
impossible and therefore only a complete ban on any and all forms of
cloning will be able to prevent reproductive cloning.
That once we accept therapeutic cloning, we will never be able to
prevent reproductive cloning. This is the slippery slope argument and I
do not accept it. I believe that society has the ability to recognize
the differences between the harm of reproductive cloning and the
benefits of therapeutic cloning and to regulate or ban harmful
applications while still allowing beneficial applications.
The Feinstein-Kennedy bill outlines significant criminal and civil
penalties for violators who attempt to carry out reproductive cloning.
In spite of this, there may be a few bad actors in the world who will
attempt reproductive cloning out of greed, desperation, or misguided
beliefs. They will be brought to justice. However, the existence of a
total ban on cloning will not stop them anymore than a ban on
reproductive cloning will stop them. It is the researcher looking for
novel therapies, the researcher searching for cures and treatments, and
the patients who stand to benefit from this research who will be most
affected by a complete cloning ban. It is they who have the most to
lose.
As a recent article on the creation of kidney-like organs from
embryonic stem cells shows, this research holds great promise. With
continuing research, we may be able to use embryonic stem cells to
repair injured spinal cords or damaged livers or to grow new kidneys or
hearts for those desperately awaiting transplants. Not, however, if we
ban this research.
As J. Benjamin Younger, Executive Director of the American Society
for Reproductive Medicine has said: ``We must work together to ensure
that in our effort to make human cloning illegal, we do not sentence
millions of people to needless suffering because research and progress
into their illness cannot proceed.''
<F-dash>
Statement of Hon. Edward M. Kennedy, a U.S. Senator from the State of
Massachusetts
Thank you, Senator Leahy, for holding today's hearing on cloning,
and thank you, Senator Feinstein, for your important leadership on this
issue.
Today's hearing is about hope--hope for millions of Americans who
face debilitating and life threatening diseases with no known cure.
It's about our elderly facing Alzheimer's disease. It's about finding
the cure for cancer. It's about helping children battle leukemia. It's
about winning the struggle with diabetes.
I believe that we should ban human cloning. About that, there
should be no debate. It's one thing to produce Dolly the sheep. It's
quite another to produce another human life. Human cloning should be
illegal.
But the issue today whether to permit another branch of medical
science to move forward--and that's nuclear transfer. This procedure
does not produce a new human being. But it does produce new cells that
hold great promise for the miracle, life-saving cures of tomorrow.
Just as it's wrong to permit human cloning, it's also wrong to ban
nuclear transfer research to cure disease and save human life.
The National Academy of Sciences says yes to nuclear transfer
research. The National Bioethics Advisory Commission says yes. Major
medical societies and patients' groups all say yes as well.
Senator Feinstein has introduced a straightforward bill that
clearly prohibits the use of cloning to reproduce a human being, and I
strongly support her legislation. Senator Harkin and Senator Campbell
have offered similar proposals. I believe that every Member of the
Senate opposes the use of cloning to reproduce a human being, and
Congress should enact legislation to make such a practice illegal.
Yet there are some who are trying to muddy the waters by labeling
legitimate medical research as ``cloning''. Medical research involving
the transfer of DNA from one cell to an unfertilized human egg is not
cloning. It does not produce a child or a pregnancy or a living human
being.
But this essential medical research does bring the precious hope of
a cure to the millions of Americans like Kris Gulden, who are suffering
from spinal injuries, severe burns, diabetes, and countless other
illnesses. Nuclear transfer research can unlock the limitless potential
of stem cell research. With this research, doctors can make stem cells
that are a perfect genetic match for a patient's own body. Without the
research, patients may be condemned to a vicious cycle of tissue
rejection and the renewed onset of disease.
We must not allow misplaced fears to extinguish the hope that
nuclear transfer research brings to patients around the nation. We
should enact sensible legislation to ban the use of cloning to
reproduce a human being and not prevent doctors from continuing their
life-saving research.
I look forward to the testimony of our witnesses today on this
Issue.
<F-dash>
Statement of Hon. Patrick Leahy, a U.S. Senator from the State of
Vermont
Earlier generations had the luxury of speculating about human
cloning when the idea was merely science fiction. We will not have that
luxury, now that human cloning has arrived on the threshold of becoming
science fact.
This is yet another area in which our scientific knowledge and
technical prowess are outpacing our law and our social consensus. And
this is yet another instance in which decisions will be needed if we
are to keep science our servant and not our master.
This committee has a role in helping to advise the Senate so that
the Senate's actions are as informed as possible by the facts and by
the implications of what we choose to do or not to do. I greatly
appreciate the willingness of Senator Feinstein to chair this important
hearing and her leadership on this matter. She, and Senator Kennedy,
have authored a major bill on this issue which is before this
committee, along with other bills on the cloning issue such as the one
introduced by Senator Brownback.
I have been advised that the Democratic Leader has made a
commitment to take up this issue on the Senate floor to debate these
matters.
We are fortunate that our Committee includes as Members several
Senators who have devoted considerable thought to these issues--
especially Senator Hatch, Senator Kennedy, Senator Brownback, Senator
Specter, Senator Feinstein and Senator Schumer. This hearings presents
a great opportunity for all Members to ask the questions and learn more
about the complex issues raised in the various bills before the
Committee.
Last August Senator Hatch and I had a long discussion during an
executive meeting about the need for the Committee to hold a hearing on
the issue of cloning. I agreed, and we decided to schedule it, but the
events of September 11 and its aftermath have delayed this hearing
until now.
We can probably all agree on one point: The religious, medical,
ethical, privacy, Constitutional and scientif1c aspects of cloning are
controversial. This necessarily will be a debate infused with human
values and the suffering and the hopes of our fellow human beings.
One of my values involved in this debate is my strong belief that
there is constitutional right to privacy which includes reproductive
rights.
On the other hand, a guest column in The New York Times from Jan.
3?0, entitled the Cloning Conundrum, pointed out that two divided
Rehnquist Supreme Court decisions raised significant federalism issues
that could be relevant to this hearing.
The article argues that in U.S. v. Morrison, which struck down a
federal civil remedy for victims of gender-motivated violence found in
the Violence Against Women Act, and in U.S. v. Lopez, which struck down
a federal criminal law regarding gun-free school zones, Chief Justice
Rehnquist raised issues which suggests a limit on federal authority to
criminalize or regulate cloning.
In addition, as Senator Hatch pointed out in August, many are
hopeful that so-called therapeutic cloning, done in a manner which
cannot result in creating a cloned human, could produce cures that
would save lives and perhaps ameliorate life-threatening medical
disabilities. For example, many scientists hope that therapeutic
cloning could lead to cures of Parkinson's Disease, Alzheimer's
Disease, muscular dystrophy, and Lou Gehrig's Disease, as well as allow
those with spinal chord injuries to walk again.
Indeed, related assisted reproductive technologies have already
aided couples in having children which are genetically related to one,
or both, parents.
In the United States, and throughout the world, pharmaceutical
companies and scientists are attempting to develop these life-saving
cures and solutions to fertility problems and hope that central
government regulation will not prevent this medical research from being
completed. This hearing will explore the various arguments for and
against therapeutic cloning, and related technologies, and also examine
other aspects of this important issue.
We should bear in mind as we further study these issues a comment
by Albert Einstein who noted that ``the right to search for truth
implies also a duty: one must not conceal any part of what one has
recognized to be true.''
The goal of scientific research is to achieve truth, or to develop
ever more precise answers, but it has never promised mankind peace,
happiness or redemption.
<F-dash>
Article in NewScientist.com by Sylvia Pagan Westphal
A stem cell has been found in adults that can turn into every
single tissue in the body. It might turn out to be the most important
cell ever discovered.
Until now, only stem cells from early embryos were thought to have
such properties. If the finding is confirmed, it will mean cells from
your own body could one day be turned into all sorts of perfectly
matched replacement tissues and even organs.
If so, there would be no need to resort to therapeutic cloning--
cloning people to get matching stem cells from the resulting embryos.
Nor would you have to genetically engineer embryonic stem cells (ESCs)
to create a ``one cell fits all'' line that does not trigger immune
rejection. The discovery of such versatile adult stem cells will also
fan the debate about whether embryonic stem cell research is justified.
``The work is very exciting,'' says Ihor Lemischka of Princeton
University. ``They can differentiate into pretty much everything that
an embryonic stem cell can differentiate into.''
Remarkable findings
The cells were found in the bone marrow of adults by Catherine
Verfaillie at the University of Minnesota. Extraordinary claims require
extraordinary proof, and though the team has so far published little, a
patent application seen by New Scientist shows the team has carried out
extensive experiments.
These confirm that the cells--dubbed multipotent adult progenitor
cells, or MAPCs--have the same potential as ESCs. ``It's very dramatic,
the kinds of observations [Verfaillie] is reporting,'' says Irving
Weissman of Stanford University. ``The findings, if reproducible, are
remarkable.''
At least two other labs claim to have found similar cells in mice,
and one biotech company, MorphoGen Pharmaceuticals of San Diego, says
it has found them in skin and muscle as well as human bone marrow. But
Verfaillie's team appears to be the first to carry out the key
experiments needed to back up the claim that these adult stem cells are
as versatile as ESCs.
Verfaillie extracted the MAPCs from the bone marrow of mice, rats
and humans in a series of stages. Cells that do not carry certain
surface markers, or do not grow under certain conditions, are gradually
eliminated, leaving a population rich in MAPCs. Verfaillie says her lab
has reliably isolated the cells from about 70 per cent of the 100 or so
human volunteers who donated marrow samples.
Indefinite growth
The cells seem to grow indefinitely in culture, like ESCs. Some
cell lines have been growing for almost two years and have kept their
characteristics, with no signs of ageing, she says.
Given the right conditions, MAPCs can turn into a myriad of tissue
types: muscle, cartilage, bone, liver and different types of neurons
and brain cells. Crucially, using a technique called retroviral
marking, Verfaillie has shown that the descendants of a single cell can
turn into all these different cell types--a key experiment in proving
that MAPCs are truly versatile.
Also, Verfaillie's group has done the tests that are perhaps the
gold standard in assessing a cell's plasticity. She placed single MAPCs
from humans and mice into very early mouse embryos, when they are just
a ball of cells. Analyses of mice born after the experiment reveal that
a single MAPC can contribute to all the body's tissues.
MAPCs have many of the properties of ESCs, but they are not
identical. Unlike ESCs, for example, they do not seem to form cancerous
masses if you inject them into adults. This would obviously be highly
desirable if confirmed. ``The data looks very good, it's very hard to
find any flaws,'' says Lemischka. But it still has to be independently
confirmed by other groups, he adds.
Fundamental questions
Meanwhile, there are some fundamental questions that must be
answered, experts say. One is whether MAPCs really form functioning
cells.
Stem cells that differentiate may express markers characteristic of
many different cell types, says Freda Miller of McGill University. But
simply detecting markers for, say, neural tissue does not prove that a
stem cell really has become a working neuron.
Verfaillie's findings also raise questions about the nature of stem
cells. Her team thinks that MAPCs are rare cells present in the bone
marrow that can be fished out through a series of enriching steps. But
others think the selection process actually creates the MAPCs.
``I don't think there is 'a cell' that is lurking there that can do
this. I think that Catherine has found a way to produce a cell that can
behave this way,'' says Neil Theise of New York University Medical
School.
<F-dash>
Articles in the New York Times, January 19, 2002
Two Approaches to Cloning
The National Academy of Sciences called yesterday for a legally
enforceable ban on human reproductive cloning aimed at creating a
child--but strongly endorsed cloning to derive stem cells that hold
great promise for curing a wide range of human diseases. That is
precisely the distinction that should be drawn by Congress as it
wrestles with competing bills that would determine whether and how
cloning research in this country is permitted to advance.
The academy's report on human reproductive cloning, when coupled
with an earlier academy analysis that discussed stem cells derived by
cloning, offers a sound guide through these contentious issues.
Unfortunately, President Bush, pandering to religious conservatives,
opposes cloning for any purpose, whether to produce a child or to cure
disease. The House has passed a bill that would impose a total ban on
human cloning and subject any violators to criminal penalties and huge
civil judgments. The Senate will consider both a total ban and a more
discriminating bill that would allow therapeutic cloning and simply ban
reproductive cloning.
Sadly, there seems little chance that a new bio-ethics council
appointed by the president will do anything to reverse the
administration's support of a total ban. That panel held its first
meetings this week under the leadership of Leon R. Kass, an ethicist on
leave from the University of Chicago, who has publicly urged that both
therapeutic and reproductive cloning be banned. He will hardly let his
1 7-member panel do anything that could embarrass the president or
change his adamant opposition.
Indeed, Mr. Kass may have signaled his intentions by opening this
week's meeting with a discussion of a short story by Nathaniel
Hawthorne, called ``The Birthmark,'' in which a scientist who marries a
beautiful woman with a blemish on her cheek inadvertently kills her
while trying to remove it. That sounded as if Mr. Kass was more intent
on curbing any perceived excesses of science than in facilitating
medical advances.
By contrast, the academy's panel of experts reiterated the
academy's support for therapeutic cloning to produce stem cells that
are genetically equivalent to a patient's own cells. Such cloned cells
could help overcome the tendency of the body's immune system to reject
stem cell treatments it perceives as ``foreign.''
But the academy agreed with the president and the House on the need
to prevent cloning to produce a child. It argued persuasively that
human reproductive cloning would be dangerous for the woman, the fetus
and any newborn child, and would probably fail in most cases. The
academy panel took no stand on whether, if the safety problems can be
overcome, it would be acceptable to clone a child. That contentious
issue was left to another day.
<F-dash>
Article by Jack M. Balkin, the New York Times, January 30, 2002
The Cloning Conundrum
NEW HAVEN--Human cloning and hate crimes would seem to have little
in common. But in a series of shortsighted decisions on the
constitutional limits of Congressional power, the United States Supreme
Court has managed to create legal precedents that may make it difficult
for the federal government to ban cloning as well as hate crimes. This
will no doubt come as a surprise to opponents of abortion, who oppose
cloning on a moral basis and have been eager to outlaw it.
Since the New Deal, Congress has been free to regulate any activity
so long as it had substantial effects on interstate commerce. In the
last decade, however, the five-person conservative majority on the
Rehnquist court has created a set of federalism doctrines forbidding
Congress from regulating what the court calls ``noneconomic''
activities. In order to preserve the boundary between what is national
and local, the court insists, Congress must keep its hands off
``traditional'' local subjects like crime and the family.
Thus in 1995 the court said that Congress could not prohibit guns
in or near elementary and secondary schools, because this usurped local
authority to make decisions about what activity should be made
criminal. It also struck down a federal law that let women sue their
attackers in federal court. Violence against women isn't economic, the
court said; it's about crime and families. The new states' rights
doctrines would also
undermine any future Congressional effort to pass hate-crime
legislation. Although hate crimes, like domestic violence, clearly have
an economic impact, under the court's logic they are defined simply as
assaults.
In 1994, many conservatives opposed the passage of the Violence
Against Women Act because they said it infringed upon states' rights;
today many make the same argument against federal efforts to outlaw
other hate crimes or to regulate guns. They have cheered the Supreme
Court's defense of state prerogatives. Now the tables are turned.
Conservatives who decry the use of cloning to make humans want the
federal government to make the practice criminal; last year, the House
passed a ban on cloning for any reason, including for new medical
therapies.
But cloning is both an economic activity and a family-related
issue. In this case, the lines the court has drawn make no sense.
In the 2000 campaign, President Bush said he admired conservative
stalwarts like Justice Antonin Scalia and Justice Clarence Thomas, who
have championed the new restrictions on Congressional power. Now he may
understand the pitfalls of getting what you wish for.
This result is hardly surprising. Support for states' rights has
often been opportunistic, driven by substantive goals like the defense
of slavery or opposition to women's suffrage, economic regulation or
civil rights. The standard defense of federalism is that it preserves
liberty. But the real issue is what sort of liberty we are trying to
protect.
tor years liberals have pointed out that the liberty to lynch
people wasn't worth preserving. Now conservatives may conclude the same
thing about the liberty to clone. And if a single state-say Oregon-
explicitly permits cloning, they may find the old arguments for
decentralization ring hollow.
Congress can use lawyers' tricks to get around these new federalism
doctrines. It can withhold federal funds from hospitals that perform
cloning, or require proof that the doctors or the tools they use have
moved in interstate commerce. And it's entirely possible that the
Supreme Court will say that cloning is just different and uphold a
direct criminal prohibition. But if it does so, it won't be because of
a principled commitment to federalism. It will be because the justices
wanted a certain political result and stretched the law to get there,
as they did in Bush v. Gore.
But there should be no need for Congress to jump through legalistic
hoops or for the court to engage in doctrinal duplicity. Cloning is an
issue of national concern, meriting a national debate. It is irrelevant
whether it can be classified as ``economic'' or ``noneconomic.'' The
Supreme Court should scrap its ill-considered doctrines and recognize
that the national government has the power to make all laws that it
considers to be in the national interest. Then we can focus on the real
question of our moral responsibilities in a new and difficult age of
scientific achievement.
Jack A! Balkin is a professor at Yale Law School and author, most
recently, of ``What Brown v. Board of Education Should Have Said."
<F-dash>
Article by Steven L. Teitelbaum, FASEB President-Elect, St. Louis Post,
December 3, 2001
Commentary
BIOETHICS
Therapeutice coloning is designed to help people, not create new ones
Reports of ``human cloning'' experiments conducted by scientists in
Massachusetts have generated a flurry of debate and widespread concern,
but many people are still confused about what cloning is.
The term ``cloning'' describes a process where by a cell is
replicated many times producing other identical individual cells.
``Reproductive cloning'' involves the development of a full individual
from a single body cell ``Therapeutic cloning'' refers to the
replication of cells for the purpose of repairing damaged tissue or
replacing malfunctioning cells.
In reproductive cloning, the nucleus of an adult cell containing
the DNA and genetic information of an individual is used to replace the
nucleus of an egg (ovum) cell, and the product is allowed to develop to
full term. This is the process by which Ian Wilmut created the sheep
``Dolly.''
Human reproductive cloning is neither needed nor desirable. Many
animal studies have shown that cloning tends to produce less healthy
individuals. There is no medical condition that needs reproductive
cloning as its cure. Because it is potentially harmful, morally dubious
and medically unnecessary, most responsible scientific organizations
have spoken out against doing reproductive cloning. Only fringe
elements have supported its development. Reproductive cloning should be
prevented, by force of law if necessary.
Therapeutice cloning or the replication of cells for cell-based
therapies, however, has enormous potential for treating disease.
Therapeutic cloning is not a reproductive process, as no whole organism
results. Stem cells, because they can grow into a wide range of cells
and tissues, are an important result of this process. For that reason,
scientists have been very excited about new developments in this area.
One very important source of stem cells is embryos because--at the
current time--they have the most potential to become other types of
cells. For many people, the use of human embryos in research is morally
troubling. For others, it is an acceptable option in the search for
treatment of such illnesses as severe heart conditions, diabetes,
Parkinson's disease, Alzheimer's disease and spinal cord trauma.
President George W. Bush found the narrow terrain between these two
viewpoints with this compromise position on federal funding of human
embryonic stem cell research. While advocates of neither viewpoint were
entirely happy, the compromise allows embryonic stem cell research to
proceed while scientists explore potential uses of stem cells.
Before stem cells can become the basis for wide spread therapeutic
application, however, two major scientific problems must be overcome.
First, we must learn how to ``coax'' stem cells into becoming the types
of cells and tissue desired. At the same time, we must figure out ways
to ensure that a recipient's body does not reject the stem cells, if
they are transplanted into the patient. Both are significant biological
and scientific challenges.
To overcome rejection, some scientists have proposed giving the
stem cells the DNA code of the patient so the resulting cells will be
perceived as normal by the patient's immune system. One way to
accomplish this is to take the nucleus from a cell of a patient, which
contains his or her DNA, and implant it into an egg cell whose own
nucleus has been removed. This technique is called somatic cell nuclear
transfer.
The highly publicized experiments reported by Advanced Cell
Technologies Corp. in Massachusetts used SCNT to create clusters of
cells that would then be used to harvest embryonic stem cells. Reports
of the Massachusetts experiments have unleashed a torrent of criticism,
some justified and some misinformed. As we consider what was done, we
must remain cognizant of the fact that they were not cloning human
beings. Equally important is that their results were to preliminary to
be claimed as evidence of the production of embryonic stem cells, a
crucial step in developing cures for many diseases.
The nation's largest organization of medical researchers, the
Federation of American Societies for Experimental Biology, is strongly
opposed to reproductive human cloning, but supports the use of
therapeutic cloning techniques to produce molecules and cells for
research and therapeutic use. We fear that hastily crafted legislation
will prevent these important therapeutic uses of cloning technology and
block essential biomedical research.
Research on the most effective and useful ways to derive stem cells
must continue and should be given federal support so that it can be
conducted in the open at the nation's leading medical research
institutions within guidelines established by the National Institutes
of Health.
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<F-dash>
University of Minnesota
Minneapolis, MN 55455
February 4, 2002
Senator Dianne Feinstein
SH-331 Hart Senate Office Bldg.
Washington, DC 20510
Subject Stem Cell Research
Dear Senator Dianne Feinstein:
In light of recent discussions in the press on work done in the
Stem Cell Institute at the University of Minnesota, I would, as
director of like University of Minnesota's Stem Cell Institute, like to
clarifyour position on our research and its potential as we know it
today.
First, as was discussed in the press last week, it is correct that
we have found adult stem cells in bone marrow of humans as well as mice
or rats, rats, great growth potential and great versatility, much like
we've have seen in embryonic stem cells. Parts of these studies have
been published, and partsare currently being peer-reviewed. That said,
it is far too early to say whether they will stack up when compared to
embryonic stem cells in longevity and function. Further, we will not
know which stem cells, adult or embryonic, are most useful in treating
a particular disease without side by side comparison of adult and
embryonic stem cells.
Second, we support studies aimed at developing techniques for
therapeutic cloning, i.e. cloning of human embryonic stem cell lines,
because they may provide immune compatible cells to treat a number of
diseases, and because cloning of embryonic stem cell lines may be
critical to the study of adult onset diseases, caused by for instance,
mutations in the DNA of cells after birth. This does not mean that the
University of Minnesota's Stem Cell Institute supports reproductive
cloning.
Finally, I want to emphasize our belief that stem cell research
should be done in public, federally funded institutions, such as the
University of Minnesota. It is in these institutions that the public
and policymakers can be assured effective and thorough oversight of the
research and the protocols being explored. While we are excited by our
adult stem cell findings, it is not our intention to stop here. There
are still too many unknowns for researchers or policymakers to begin
closing doors to opportunities of learning.
I appreciate your attention to these issues and remain at your
disposal should you have any questions about our research.
Sincerely,
Catherine Verfaillie, M.D.
Professor of Medicine and Director, Stem Cell Institure
University of Minnesota
<F-dash>
Editorial in the Washingon Post, January 22, 2002
How to Approach Cloning
AS THE SENATE prepares to plunge anew into the human cloning
debate, the range of voices in that debate is growing broader. The
president's new council on bioethics held the first of a projected five
or six meetings last week designed to produce a report on the topic by
summer. At the same time, the National Academy of Sciences issued a
report urging that any attempt to clone an actual human baby be banned
on safety grounds, but that promising disease research involving the
cloning of human embryonic cells be allowed to go forward. Meanwhile,
state legislatures are beginning their own debates. A California panel
echoed the NAS approach, recommending that the state legislature ban
human cloning for reproduction but not research. A Florida lawmaker has
filed a bill that would allow a cloned child to sue the scientist who
cloned him for parental support and emotional damages.
The ferment of different approaches could help shed light on the
central dilemma confronting the U.S. Senate, which is whether to back
the sweeping ban on all human cloning passed by the House--one that
would levy harsh criminal penalties on any scientist who cloned a human
embryo, whatever the purpose, and stop all such research in its
tracks--or whether to craft a more limited ban that would focus on
preventing the implantation, gestation or birth of a cloned baby. We
favor the latter approach. To the prohibition of birthing human clones
there appears to be little credible opposition. As the academy report
makes clear, risks to both the cloned fetus and its mother put human
cloning outside the pale of ethical scientific experimentation barring
significant further breakthroughs.
The safety issue makes it proper to ban bringing human clones to
birth without reaching the knottier ethical questions of whether
duplicating human genomes transgresses fundamental social values.
That's more difficult with the sweeping research ban, but proponents
have likewise offered some practical arguments: Some, among them
bioethics council chair Leon Kass, have argued that banning the
creation of cloned embryos for research is the only sure way to avoid
their implantation in a human womb. Others (including Mr. Kass in other
contexts) stress the importance of respecting even several-cell forms
of human life.
In contrast to the respect-for-life question, the assertion that
adequate safeguards cannot be drawn to separate research and
implantation can be challenged and debated on practical and factual
grounds. Mr. Kass's first council meeting seemed determined to hew to a
high philosophical line of thought, weighing literature, love and
ethical boundaries--urged to it by the president, who launched them
with an exhortation to help clarify ``how to come to grips with how
medicine and science interface with. . .the notion that life is--you
know, that there is a Creator.'' But the Senate should take a less
ambitious approach. Seeking to speak for Americans from all walks of
life on such ultimately religious matters is a daunting and not
necessarily advisable task for a legislative body. The Senate debate
ought to address the pragmatic details of how best to prevent the
dangerous experimental prospect of human-clone pregnancies and births.
But it should leave scientists free to work on the experiments that
offer others great hope.