In keeping with
the President's
intention, the Council
has been monitoring
developments in
stem cell research,
as it proceeds under
the implementation
of the administration's
policy. Our desire
has been both to
understand what
is going on in the
laboratory and to
consider for ourselves
the various arguments
made in the ongoing
debates about the
ethics of stem cell
research and the
wisdom of the current
policy. Although
both the policy
and the research
are still in their
infancy, the Council
is now ready to
give the President
and the public an
update on this important
and dynamic area
of research.
This report is
very much an "update."
It summarizes some
of the more interesting
and significant
recent developments,
both in the basic
science and medical
applications of
stem cell research
and in the related
ethical, legal,
and policy discussions.
It does not attempt
to be a definitive
or comprehensive
study of the whole
topic. It contains
no proposed guidelines
and regulations,
nor indeed any specific
recommendations
for policy change.
Rather, it seeks
to shed light on
where we are now-ethically,
legally, scientifically,
and medically-in
order that the President,
the Congress, and
the nation may be
better informed
as they consider
where we should
go in the future.
I. What Are
Stem Cells, and Why Is There Contention about Them?
The term "stem
cells" refers to
a diverse group
of remarkable multipotent
cells. Themselves
relatively undifferentiated
and unspecialized,
they can and do
give rise to the
differentiated and
specialized cells
of the body (for
example, liver cells,
kidney cells, brain
cells). All specialized
cells arise originally
from stem cells,
and ultimately from
a small number of
embryonic cells
that appear during
the first few days
of development.ii
As befits their
being and functioning
as progenitor cells,
all stem cells share
two characteristic
properties: (1)
the capacity for
unlimited or prolonged
self-renewal
(that is, the capability
to maintain a pool
of similarly undifferentiated
stem cells), and
(2) the potential
to produce differentiated
descendant cell
types. As stem cells
within a developing
human embryo differentiate
in vivo, their capacity
to diversify generally
becomes more limited
and their ability
to generate many
differentiated cell
types generally
becomes more restricted.
Stem cells first
arise during embryonic
development and
exist at all developmental
stages and in many
systems of the body
throughout life.
The best described
to date are the
blood-forming (hematopoietic)
stem cells of the
bone marrow, the
progeny of which
differentiate (throughout
life) into the various
types of red, white,
and other cells
of the blood. It
appears that some
stem cells travel
through the circulatory
system, from their
tissue of origin,
to take up residence
in other locations
within the body,
from which they
may be isolated.
Other stem cells
may be obtained
at birth, from blood
contained in the
newborn's umbilical
cord. Once isolated
and cultured outside
the body, stem cells
are available for
scientific investigation.
Unlike more differentiated
cells, stem cells
can be propagated
in vitro for many
generations-perhaps
an unlimited number-of
cell-doublings.
Stem cells are
of interest for
two major reasons,
the one scientific,
the other medical.
First, stem cells
provide a wonderful
tool for the study
of cellular and
developmental processes,
both normal and
abnormal. With them,
scientists hope
to be able to figure
out the molecular
mechanisms of differentiation
through which cells
become specialized
and organized into
tissues and organs.
They hope to understand
how these mechanisms
work when they work
well, and what goes
wrong when they
work badly. Second,
stem cells and their
derivatives may
prove a valuable
source of transplantable
cells and tissues
for repair and regeneration.
If these healing
powers could be
harnessed, the medical
benefits for humankind
would be immense,
perhaps ushering
in an era of truly
regenerative medicine.
No wonder that scientists
around the world
are actively pursuing
research with stem
cells.
Why, then, is there
public contention
about stem cell
research? Not because
anyone questions
the goals of such
research, but primarily
because there are,
for many people,
ethical issues connected
to the means of
obtaining some
of the cells. The
main source of contention
arises because some
especially useful
stem cells can be
derived from early-stage
human embryos, which
must be destroyed
in the process of
obtaining the cells.
Arguments about
the ethics of using
human embryos in
research are not
new. They date back
to the mid-1970s,
beginning not long
after in vitro fertilization
(IVF) was first
successfully accomplished
with human egg and
sperm in 1969. A
decade later, after
IVF had entered
clinical practice
for the treatment
of infertility,
arguments continued
regarding the fate
and possible uses
of the so-called
"spare embryos,"
embryos produced
in excess of reproductive
needs and subsequently
frozen and stored
in the assisted-reproduction
clinics. Although
research using these
embryos has never
been illegal in
the United States
(except in a few
states), the federal
government has never
funded it, and since
1995 Congress has
enacted annual legislation
prohibiting the
federal government
from using taxpayer
dollars to support
any research in
which human embryos
are harmed or destroyed.
Although the arguments
about embryo research
had been going on
for twenty-five
years, they took
on new urgency in
1998, when the current
stem cell controversy
began. It was precipitated
by the separate
publication, by
two teams of American
researchers, of
methods for culturing
cell lines derived,
respectively, from:
(1) cells taken
from the inner cell
mass of very early
embryos, and (2)
the gonadal ridges
of aborted fetuses.2,3
(In this report,
we shall generally
refer to the cell
lines derived from
these sources as,
respectively, embryonic
stem cells [or
"ES cells"] and
embryonic germ
cells [or "EG
cells"]). This work,
conducted in university
laboratories in
collaboration with
and with financial
support from Geron
Corporation, prompted
great excitement
and has already
led to much interesting
research, here and
abroad. It has also
sparked a moral
and political debate
about federal support
for such research:
Is it morally permissible
to withhold support
from research that
holds such human
promise? Is it morally
permissible to pursue
or publicly support
(even beneficial)
research that depends
on the exploitation
and destruction
of nascent human
life?
Persons interested
in the debate should
note at the outset
that ES and EG cells
are not themselves
embryos; they are
not whole organisms,
nor can they be
made (directly)
to become whole
organisms. Moreover,
once a given line
of ES or EG cells
has been derived
and grown in laboratory
culture, no further
embryos (or fetuses)
need be used or
destroyed in order
to work with cells
from that line.
But it is not clear
whether these lines
can persist indefinitely,
and only very few
lines, representing
only a few genetic
backgrounds, have
been made. Thus
there is continuing
scientific interest
in developing new
embryonic stem cell
lines, and the existence
of large numbers
of stored cryopreserved
embryos in assisted-reproduction
clinics provides
a potential source
for such additional
derivations. Complicating
the debate has been
the study of another
group of stem cells,
commonly called
"adult stem cells,"
derived not from
embryos but from
the many different
tissues in the bodies
of adults or children-sources
exempt from the
moral debate about
obtaining ES and
EG cells. For this
reason, we often
hear arguments about
the relative scientific
merits and therapeutic
potential of embryonic
and adult stem cells,
arguments in which
the moral positions
of the competing
advocates might
sometimes influence
their assessments
of the scientific
facts. Further complicating
the situation are
the large commercial
interests already
invested in stem
cell research and
the competition
this creates in
research and development
not only in the
United States but
throughout the world.
The seemingly small
decision about the
funding of stem
cell research may
have very large
implications.
II. Broader Ethical
Issues
While most of the
public controversy
has focused on the
issue of embryo
use and destruction,
other ethical and
policy issues have
also attracted attention.iii
Although entangled
with the issue of
embryos, the question
of the significance
and use of federal
funds is itself
a contested issue:
Should moral considerations
be used to decide
what sort of research
may or may not be
funded? What is
the symbolic and
moral-political
significance of
providing national
approval, in the
form of active support,
for practices that
many Americans regard
as abhorrent or
objectionable? Conversely,
what is the symbolic
and moral-political
significance of
refusing to support
potentially life-saving
scientific investigations
that many Americans
regard as morally
obligatory?
Even for those
who favor embryo
research, there
are questions about
its proper limits
and the means of
establishing and
enforcing those
limits through meaningful
regulation. Under
the present arrangement,
with the federal
government only
recently in the
picture, what is
done with human
embryos, especially
in the private sector,
is entirely unregulated
(save in those states
that have enacted
special statutes
dealing with embryo
or stem cell research).
Is this a desirable
arrangement? Can
some other system
be devised, one
that protects the
human goods we care
about but that does
not do more harm
than good? What
are those human
goods? What boundaries
can and should we
try to establish,
and how?
Although well-established
therapies based
on transplantation
of stem cell-derived
tissues are still
largely in the future,
concern has already
been expressed (as
it has been about
other aspects of
health care in the
United States) about
access to any realized
benefits and about
research priorities:
Will these benefits
be equitably available,
regardless of ability
to pay? How should
the emergence of
the new field of
stem cell research
alter the allocation
of our limited resources
for biomedical research?
How, in a morally
and politically
controverted area
of research, should
the balance be struck
between public and
private sources
of support? As with
any emerging discovery,
how can we distinguish
between genuine
promise and "hype,"
and between the
more urgent and
the less urgent
medical needs calling
out for assistance?4
There are also
sensitive issues
regarding premature
claims of cures
for diseases that
are not scientifically
substantiated and
the potential exploitation
of sick people and
their families.
Some advocates of
stem cell research
have made bold claims
about the number
of people who will
be helped should
the research go
forward, hoping
to generate sympathy
for increased research
funding among legislators
and the public.
A few advocates
have gone so far
as to blame (in
advance) opponents
of embryonic stem
cell research for
those who will die
unless the research
goes forward today.
At the same time,
other scientists
have cautioned that
the pace of progress
will be very slow,
and that no cures
can be guaranteed
in advance. Which
of these claims
and counterclaims
is closer to the
truth cannot be
known ahead of time.
Only once the proper
scientific studies
are conducted will
we discover the
potential therapeutic
value of stem cells
from any source.
How, then, in the
meantime should
we discuss these
matters, offering
encouragement but
without misleading
or exploiting the
fears and hopes
of the desperately
ill?
Finally, questions
are raised by some
about the social
significance of
accepting the use
of nascent human
life as a resource
for scientific investigation
and the search for
cures. Such questions
have been raised
even by people who
do not regard an
early human embryo
as fully "one of
us," and who are
concerned not so
much about the fate
of individual embryos
as they are about
the character and
sensibilities of
a society that comes
to normalize such
practices.5
What would our society
be like if it comes
to treat as acceptable
or normal the exploitation
of what hitherto
were regarded as
the seeds of the
next generation?
Conversely, exactly
analogous questions
are raised by some
about the social
significance of
refusing
to use these 150-to-200-cell
early human embryos
as a resource for
responsible scientific
investigation and
the search for cures.
What would a society
be like if it refused,
for moral scruples
about (merely) nascent
life, to encourage
every thoughtful
and scientifically
sound effort to
heal disease and
relieve the suffering
of fully developed
human beings among
us?6
It is against the
background of such
moral-political
discussion and argument
that the Council
has taken up its
work of monitoring
recent developments
in stem cell research.
We are duly impressed
with the difficulty
of the subject and
the high stakes
involved. All the
more reason to enable
the debate to proceed
on the basis of
the best knowledge
available, both
about science and
medicine and about
ethics, law, and
policy. Before proceeding
to the results of
our monitoring,
we complete this
introduction with
some additional
comments on the
different types
of stem cells, a
few terminological
observations and
clarifications,
and an overview
of the report as
a whole.
III. Types of
Stem Cells: An Introduction
Although we shall
report later (in
Chapter 4) on recent
developments in
basic and clinical
research using various
types of stem cells,
we think the following
introduction to
the "cast of characters"
would be useful
at the start.iv
A.
Embryonic Stem (ES)
Cells
As noted above,
ES cells are derived
from the inner cell
mass of embryos
at the blastocyst
stage, roughly five
to nine days after
fertilization-after
the zygote has divided
enough times to
result in about
200 cells, but before
it has undergone
gastrulation and
differentiation
into the three primary
germ layers (see
Appendix A).v
The inner cell mass
is the part of the
blastocyst-stage
embryo whose cells
normally go on to
become the body
of the new individual.
The outer cells
of the blastocyst-stage
embryo (the trophoblast
cells) normally
(that is, in vivo)
go on to become
the fetal contribution
to the placenta
and other structures
that connect the
developing individual
to the mother's
bloodstream and
that otherwise support
the embryo's further
development. Collecting
the cells of the
inner cell mass
results in the destruction
of the developing
organism. The embryos
from which human
stem cells can be
derived are available
(so far) only from
in vitro fertilization
(IVF): they have
been conceived by
a combination of
egg and sperm, occurring
outside the body.vi
B.
Embryonic Germ (EG)
Cells
EG cells are stem
cells that are isolated
from the gonadal
ridge of a developing
fetus. These are
the cells that ultimately
give rise to sperm
cells or egg cells,
depending on the
sex of the fetus.
The EG cells are
collected from the
bodies of five-to-nine-week-old
fetuses that have
been donated after
induced abortions.vii
In federally funded
research, collection
of the EG cells
is governed by existing
federal regulations
for fetal-tissue
donation, designed
(among other things)
to ensure the separation
of the decision
to terminate pregnancy
from the decision
to donate the fetal
tissue for research.7
Cell lines established
from either of these
two sources (ES
and EG cells, from
embryos and fetal
gonads, respectively)
have demonstrated
two important properties:
great ability to
multiply and form
stable lines that
can be characterized,
and great flexibility
and plasticity.
Their progeny can
differentiate in
vitro into cells
with characteristics
of those normally
derived from all
three embryonic
germ layers (ectoderm,
endoderm, and mesoderm),
which layers (in
vivo) give rise
in turn to all the
different types
of cells in the
body. Because they
are so flexible,
it also seems likely
that they could
be used to produce
cell preparations
that could then
be transplanted
(assuming that the
recipient's immune
response could be
managed) to repopulate
a part of the body
such as the pancreas
or spinal cord that
has lost function
due to disease or
injury. As with
stem cells derived
from the various
tissues of the adult
body, ES cells and
EG cells seem to
hold out hope for
an era of regenerative
medicine.
C.
Adult (or Non-embryonic)
Stem Cells
Adult stem cells
are more differentiated
than ES or EG cells,
but not yet fully
differentiated.
Like stem cells
of embryonic origin,
they can give rise
to lineages of cells
that are more specialized
than themselves.
The term "adult"
is a bit of a misnomer
("non-embryonic"
would be more accurate):
these cells are
found in various
tissues in children
as well as adults
(and in fetuses
as well), and they
have been isolated
from umbilical cord
blood at the time
of delivery. Despite
its inaccuracy regarding
the origin
of the cells, the
term "adult" helpfully
emphasizes that
the cells have been
partially differentiated.
Although they can
give rise to various
cell types, these
non-embryonic stem
cells are generally
all within the same
broad type of tissue
(for example, muscle
stem cells, adipose
stem cells, neural
stem cells). For
this reason, it
had long been thought
that they are less
flexible than those
derived from embryos
or fetal gonads.
Yet this presumption
has been disputed
in recent years
by those who think
that certain forms
of adult stem cells
may be equally or
nearly as plastic
as non-adult stem
cells. Indeed, possible
exceptions to the
generalization that
adult stem cells
give rise only to
cell types found
within their own
broad type of tissue
have recently been
reported (though
most of these cells
may well be shorter-lived
than ES cells, and,
if so, potentially
less useful in therapy).
This finding has
ignited a debate
about the relative
merits of embryonic
stem cells and adult
stem cells: which
is more valuable,
both for research
and (especially)
for clinical treatment?viii
Research involving
adult stem cells
raises few difficult
ethical concerns,
beyond the usual
need to secure free
and fully informed
consent from donors
and recipients,
a favorable benefit-to-risk
ratio for all participants
in attempts at therapy,
and protection of
privacy. Adult stem
cells are less controversial
than embryonic ones,
as we have noted,
because the former
can be collected
without lasting
harm to the donor.
D.
Cord Blood Stem
Cells
Though clearly
a type of non-embryonic
stem cell, cord
blood stem cells
deserve some special
mention. Blood found
in the umbilical
cord can be collected
at birth and hematopoietic
stem cells (and
other progenitor
cells) isolated
from it. It has
been proposed that
individually banked
cord blood cells
may, at some later
time, offer a good
match for a patient
needing stem cell-based
treatments, whether
the individual cord-blood-donor
himself or a close
relative, and in
unrelated recipients
may require a less
exact genetic match
than adult bone
marrow.ix
, x
IV. Terminology
In considering
complicated or contested
public questions,
language matters-even
more than it ordinarily
does. Clear thinking
depends on clear
ideas, and clear
ideas can be conveyed
only through clear
and precise speech.
And fairness in
ethical evaluation
and judgment depends
on fair framing
of the ethical questions,
which in turn requires
fair and accurate
description of the
relevant facts of
the case at hand.
Such considerations
are highly pertinent
to our topic and
to the arguments
it generates.
Confounding the
discussions of stem
cell research, there
are, to begin with,
difficult technical
concepts, referring
to complicated biological
entities and phenomena,
that can cause confusion
among all but the
experts. Some of
these concepts we
will clarify in
Chapter 4 and others
are defined in the
Glossary and, in
some cases, illustrated
in Appendix A on
early embryonic
development. But
the more important
terminological issues
are those used to
formulate the ethical
and policy issues
about which people
so vigorously disagree.
We pause to comment
on three of them:
"the embryo" (or
"the human embryo"),
"spare embryos,"
and "the moral status
of the embryo."
Strictly speaking,
there is no such
thing as
"the embryo,"
if by this is meant
a distinctive being
(or kind
of being) that deserves
a common, reified
name-like "dog"
or "elephant." Rather,
the term properly
intends a certain
stage of development
of an organism of
a distinctive kind.
Indeed, the very
term comes from
a Greek root meaning
"to grow": an embryo
is, by its name
and mode of being,
an immature and
growing organism
in an early phase
of its development.xi
The advent of in
vitro fertilization,
in which living
human embryos from
their first moments
are encountered
as independent entities
outside the body
of a mother, before
human eyes and in
human hands, may
also have contributed
to this tendency
to reify "the
embryo" in its early
stages (though such
reification has
likely always played
a role in embryology.)
The ex vivo existence
of nascent human
life is genuinely
puzzling and may
invite terminology
that can be distorting.xii
If the term "the
embryo" risks
conveying the false
notion that embryos
are distinct kinds
of beings or things,
the term "spare
embryo" risks making
a difficult moral
question seem easier
than it is. The
term is frequently
used to describe
those embryos, produced
(each with reproductive
intent, but in excess
of what is needed)
in assisted-reproduction
clinics, that are
not transferred
to a woman in attempts
to initiate a pregnancy.
No longer needed
to produce a child,
they are usually
frozen and stored
for possible later
use, should the
first efforts fail.
But the "spareness"
of a "spare embryo"
is not a property
of a particular
embryo itself; it
bespeaks rather
our attitude toward
it, now that it
may no longer be
needed to serve
the purpose for
which it was initially
brought into being.
Calling something
"spare," or only
"extra," invites
the thought that
nothing much is
lost should it disappear,
because one already
has more than enough:
one has "embryos
to spare." It also
abstracts from the
distinct genetic
individuality of
each embryo and
invites the view
that embryos are,
like commercial
products, simply
interchangeable-an
outlook that may
affect the further
judgment of any
embryo's moral standing.
To be sure, most
of these unused
embryos will die
or be destroyed.
To be sure, if these
unused embryos are
otherwise destined
for destruction,
a case can be made-and
debated-that their
unavoidable loss
should be redeemed
by putting them
to use beforehand.
But the moral question
regarding their
possible use and
destruction should
not be decided-here,
as elsewhere-on
terminological grounds,
in this case, by
the naming of the
embryo "spare."
Rather it should
be decided on the
basis of a direct
moral appraisal
of the rights and
goods involved:
on the basis of
what we owe to suffering
humanity and the
obligations we have
to seek the means
of its relief; and
on the basis of
the nature of human
embryos, what we
owe them as proper
respect and regard,
and whether and
why such respect
or regard may be
overridden.xiii
For many people,
the moral question
depends, in other
words, on what some
bioethicists call-and
we ourselves will
sometimes call-"the
moral status
of the embryo."
If embryos lacked
all "moral status,"
there would be little
moral argument about
their use and destruction.
Yet the notion
"moral status" is
problematic, even
though it is easy
to understand why
it has come into
fashion. For many
people, the central
ethical question
regarding embryonic
stem cell research
is whether an embryonic
organism from which
cells may be removed
to develop ES cells
is fully "one of
us," deserving the
same kind of respect
and protection as
a newborn baby,
child, or adult.
What they want to
know is the moral
standing of these
organisms-entities
that owe their existence,
their extra-uterine
situation, and their
"spare-ness" to
deliberate human
agency-at such early
stages of development.
As we shall see,
some people try
to find structural
or functional markers-for
example, the familiar
human form or the
presence or absence
of sensation-to
decide the moral
worth of a human
embryo. Others use
an argument from
continuity of development
to rebut any attempt
to find a morally
significant boundary
anywhere along the
continuum of growth
and change. But,
to judge from countless
efforts to provide
a biologically based
criterion for ascribing
full human worth,
it seems certain
that we shall never
find an answer to
our moral question
in biology alone,
even as the answers
we give must take
into account the
truths of embryology.
At least until now,
philosophical attempts
to draw moral inferences
from the biological
facts have not yielded
conclusions that
all find necessary
or sound.
Under these circumstances,
some people believe
that we have no
choice but to stipulate
or ascribe some
degree of moral
"status" to the
entity, based either
on how it strikes
us and the limited
range of what we
are able to know
about it, or on
what we wish to
do with it: we confer
upon it some moral
status in regard
to us, much
as we confer one
or another class
of immigration status
upon people.8
For this very reason,
others object to
the term, fearing
that it enables
us to beg the question
of the intrinsic
moral worth or dignity
of the entity itself,
seen in its own
terms and without
regard to us. Different
Members of this
Council hold different
views of this terminological
and ontological
matter, but we all
recognize the moral
freight carried
by attempts to speak
about and ascribe
"moral status"
to human embryos
in their earliest
stage of development.xiv
We encourage readers
to be self-conscious
about this and similar
terms, even as we
proceed ourselves
to make use of them.
V. About the
Report
Monitoring stem
cell research can
be a bit like watching
Niagara Falls. Not
only do scientific
reports pour forth
daily, as they do
in many other areas
of research, but
a kind of mist rises
up for the torrent
of news flashes
and editorials,
making it difficult
to separate knowledge
from opinion and
hope from hype.
The underlying biology-whether
viewed at the level
of the gene, cell,
tissue, organ, or
organism-is dauntingly
complex, as is all
cell biology. At
any of these levels,
in this new and
dynamic field it
is frequently difficult
for even the most
knowledgeable scientist
to be truly certain
of "what really
causes what." For
example, how exactly
do certain kinds
of stem cells have
their apparently
beneficial effects
on heart disease
when the cells are
extracted from a
cardiac patient's
bone marrow or muscle,
expanded in culture,
and injected into
the patient's heart?
Or what is responsible
for the positive
effects on a Parkinson
Disease patient
when cells from
his own brain are
similarly extracted,
treated, and re-injected?
We do not yet really
know precisely what
stem cell-based
preparations do
when put into the
body.
At the same time,
all discussion in
this area suffers
from a persistent
background tension.
The stakes are high,
or seem so, to many
of the discussants,
and there is much
politicking involved.
As noted earlier,
opponents of embryo
research try to
tout the virtues
of adult stem cells,
because they regard
their use as a morally
permissible alternative.
Proponents, for
their part, often
find it tempting
to disparage or
downplay all adult
stem cell studies
and to emphasize
instead what they
believe to be the
superior potential
of embryonic stem
cells for successful
future therapeutic
use. Navigating
between these tendencies
in search of the
full truth can be
daunting, and few
people are altogether
immune to the partial
but seductive calls
from the scientific
or moral side they
prefer.
Yet without denying
our individual differences
on the ethical and
policy questions
at issue, the Council
has sought in this
monitoring report
to present a fair-minded
and thorough overview,
both of the ethical
and policy debates
and of the scientific
and medical results
to date. To aid
us in our task of
monitoring, we have
commissioned six
review articles
and heard several
oral presentations
on the state of
research, covering
studies using embryonic
and studies using
adult stem cells.
We have commissioned
a review article
and heard a presentation
on the problem of
immune rejection,
a potential major
stumbling block
to effective cell
transplantation
therapies.
We have read papers,
commissioned writings,
heard presentations,
and debated among
ourselves about
the various ethical
and philosophical
issues involved,
from "the moral
status of the embryo,"
to the existence
of a moral imperative
to do research,
to the meaning of
federal funding
of morally controversial
activities. We have
read and heard public
testimony from both
supporters and opponents
of the current policy
on federal funding
of ES cell research.
We have considered
arguments-presented
by scientists and
patient-advocacy
groups, and shared
by some Members
of the Council-that
the current policy
is impeding potentially
life-saving research,
for example, by
offering researchers
too few useful ES
cell lines to work
with, by causing
a chilling effect
on the whole field,
or by allowing the
field to be dominated
by private companies,
less given (than
are publicly-funded
academic scientists)
to publishing and
sharing the results
of their research.
We have considered
arguments-presented
by various critics
and opponents of
embryonic stem cell
research, and shared
by some Members
of the Council-that
the current policy
has opened the path
toward the possibility
of "embryo farming"
or that it risks
weakening our respect
for nascent life
and our willingness
to protect the weakest
lives among us.
We have heard from
ethicists and scientific
researchers, representatives
of biopharmaceutical
companies and disease
research foundations,
and senior government
officials from such
agencies as the
National Institutes
of Health and the
Food and Drug Administration.
We benefited from
working papers prepared
by the Council's
staff and from existing
reports on stem
cell research, and
in particular reports
by the National
Bioethics Advisory
Commission (1999)
and the National
Academies (2001).9
Holding our own
personal views in
abeyance, we have
tried in the three
chapters that follow
to synthesize accurately
and fairly what
we have heard and
learned: about current
law and policy,
about the state
of the ethical debate,
and about the current
state of scientific
research.
Chapter
2, "Current
Federal Law and
Policy," describes
and explains the
current federal
policy regarding
stem cell research.
It locates that
policy in relation
to previous law
and policy touching
this area of research
and tries to make
clear the ethical,
legal, and prudential
foundations on which
the policy rests.
It then describes
the implementation
of the policy and
other relevant considerations.
Our goal in that
chapter is to describe
and understand the
present policy situation,
in its legal, political,
scientific, and
ethical colorations,
and to present accurately
the various features
of the current federal
policy, many of
which are not generally
well understood.
Chapter
3, "Recent Developments
in the Ethical and
Policy Debates,"
provides an overview
of the ethical and
policy debates surrounding
stem cell research
in the past two
years. Special attention
is, of course, given
to arguments about
what may (or may
not) be done with
human embryos, and
why. But those arguments
are also reviewed
in relation to larger
debates about the
other ethical and
policy issues mentioned
earlier. Our goal
in that chapter
is to present the
arguments and counter-arguments,
faithfully and accurately,
rather than finally
to assess their
validity.
Finally, in Chapter
4, "Recent Developments
in Stem Cell Research
and Therapy," we
offer an overview
of some recent developments
in the isolation
and characterization
of various kinds
of stem cell preparations
and a partial account
of some significant
research and clinical
initiatives. In
addition, by means
of a selected case
study, we consider
how stem cell-based
therapies might
some day work to
cure devastating
human diseases,
as well as the obstacles
that need to be
overcome before
that dream can become
a reality. Our goal
in that chapter,
as supplemented
by several detailed
commissioned review
articles contained
in the appendices,
is to enable (especially
non-scientific)
readers to appreciate
the reasons for
the excitement over
stem cell research,
the complexities
of working with
these materials,
some early intriguing
research and therapeutic
findings, and the
difficult road that
must be traveled
before we can reap
therapeutic and
other benefits from
this potentially
highly fertile field
of research.
After these three
substantive chapters-on
policy, ethics,
and science-we offer
a Glossary and a
series of appendices,
beginning (in Appendix
A) with a brief
primer on early
human embryonic
development. That
primer aspires to
provide the basic
facts and concepts
that any thoughtful
and public-spirited
person needs to
know about human
development and
especially about
(early) human embryos
if he or she is
to participate intelligently
in the ethical and
political deliberations
that are certain
to continue in our
society for some
time. There follow
the texts of President
Bush's August 9,
2001, stem cell
speech and the NIH
guidelines (for
both the Clinton
and Bush administrations)
regarding the funding
of embryonic stem
cell research. Completing
the appendices are
the texts of all
the papers that
the Council commissioned,
as revised by their
authors in the light
of subsequent developments
or comments received.
These papers appear
in the authors'
own words, unedited
by the Council.
In all that we
offer in this monitoring
report, we have
aspired to be careful
and fair in our
approach, precise
in our use of language,
accurate in presenting
data and arguments,
and thoughtful in
our laying out of
the various issues
that remain before
us. It is up to
our readers to judge
whether or not we
have succeeded.
The policy debates
over stem cell research
that led to the
creation of this
Council continue;
they, and other
debates on related
topics, are unlikely
to go away any time
soon. Our hope is
that our work will
help to make those
debates richer,
fairer, and better
informed.
_________________
Footnotes