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Monitoring Stem Cell Research
The President's Council on Bioethics
Washington, D.C.
January 2004 www.bioethics.gov
Chapter Two
Current Federal Law and Policy
Any overview of the state of human stem cell research under
the current federal funding policy must begin with a thorough
understanding of that policy. This is not as simple as it
may sound. From the moment of its first announcement, on
August 9, 2001, the policy has been misunderstood (and at
times misrepresented) by some among both its detractors
and its advocates. Its moral foundation, its political context,
its practical implications, and the most basic facts regarding
the policy’s implementation have all been subjects
of heated dispute and profound confusion. Whether one agrees
with the policy or not, it is important to understand it
as it was propounded, accurately and in its own terms, in
the light also of the historical and political contexts
in which it was put forward.
This chapter attempts to place the policy in its proper
context; to articulate its moral, legal, and political underpinnings
(as put forward by its authors and advocates); to offer
an overview of its implementation thus far; and to begin
to describe its ramifications for researchers and for medicine.
By articulating the policy in its own terms, we intend neither
to endorse it nor to find fault with it.i
Indeed, in the next chapter we present an overview of arguments
on all sides of the question. Here we mean only to clarify,
as far as we are able, the original meaning and purpose
of the policy, so as to be better able to monitor its impact.
I. A brief history of the embryo
research funding debate
The federal government makes significant public resources
available to biomedical researchers each year—over
$20 billion in fiscal year 2003 alone—in the form
of research grants offered largely through the National
Institutes of Health (NIH). This level of public expenditure
reflects the great esteem in which Americans hold the biomedical
enterprise and the value we place on the development of
treatments and cures for those who are suffering. But such
support is not offered indiscriminately. Researchers who
accept federal funds must abide by ethically based rules
and regulations governing, among other things, the use of
human subjects in research. And some policymakers and citizens
have always insisted that taxpayer dollars not be put toward
specific sorts of research that violate the moral convictions
and sensibilities of some portion of the American public.
This has meant that controversies surrounding the morality
of some forms of scientific research have at times given
rise to disputes over federal funding policy. Among the
most prominent examples has been the three-decade-long public
and political debate about whether taxpayer funds should
be used to support research that involves creating or destroying
human embryos or making use of destroyed embryos and fetuses—practices
that touch directly on the much-disputed questions of the
moral status and proper treatment of nascent human life.
In the immediate aftermath of the Supreme Court’s
1973 Roe v. Wade decision legalizing abortion nationwide,
some Americans, including some Members of Congress, became
concerned about the potential use of aborted fetuses (or
embryos) in scientific research. In response to these concerns,
the Department of Health, Education and Welfare (DHEW, the
precursor to today’s Department of Health and Human
Services) initiated a moratorium on any potential DHEW sponsorship
or funding of research using human fetuses or living embryos.
In 1974, Congress codified the policy in law, initiating
what it termed a temporary moratorium on federal funding
for clinical research using “a living human fetus,
before or after the induced abortion of such fetus, unless
such research is done for the purpose of assuring the survival
of such fetus.”1
Concurrently with that moratorium (and also addressing concerns
not directly related to embryo and fetal research), Congress
established a National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research. Among
its other tasks, Congress explicitly assigned the Commission
responsibility for offering guidelines for human fetal and
embryo research, so that standards for funding might be
established and the blanket moratorium might be lifted.
The statutory moratorium was lifted once the Commission
issued its report in 1975.2
In that report, the Commission called for the establishment
of a national Ethics Advisory Board within DHEW to propose
standards and research protocols for potential federal funding
of research using human embryos and to consider particular
applications for funding. In doing so, the Commission looked
ahead to the possible uses of in vitro embryos, since the
first successful in vitro fertilization (IVF) of human egg
by human sperm had been accomplished in 1969.ii
The Department adopted the recommendation in 1975, established
an Ethics Advisory Board, and put in place regulations requiring
that the Board provide advice about the ethical acceptability
of IVF research proposals. The Board first took up the issue
of research on in vitro embryos in full in the late 1970s
and issued its report in 1979.3
By that time, human IVF techniques had been developed (first
in Britain) to the point of producing a live-born child
(born in 1978). These techniques, and their implications
for human embryo research, raised unique prospects and concerns
that were distinct from some of those involved in human
fetal research. As a consequence, starting in the late 1970s,
funding of embryo research and funding of fetal research
came to be treated as mostly distinct and separate issues.
The Ethics Advisory Board concluded that research involving
embryos and IVF techniques was “ethically defensible
but still legitimately controverted.” Provided that
research did not take place on embryos beyond fourteen days
of development and that all gamete donors were married couples,
the Board argued, such work was “acceptable from an
ethical standpoint,” but the Board decided that it
“should not advise the Department on the level of
Federal support, if any,” such work should receive.4
This left the decision in the hands of the DHEW, which decided
at that stage not to offer funding for human embryo studies.
The Ethics Advisory Board’s charter expired in 1980,
and no renewal or replacement was put forward, creating
a peculiar situation in which the regulations requiring
the Ethics Advisory Board to review proposals for funding
remained in effect, but the Board no longer existed to consider
such requests. Funding was therefore rendered impossible
in practice. Because the Ethics Advisory Board was never
replaced, a de facto ban on funding remained in place through
the 1980s.
In 1993, Congress enacted the NIH Revitalization Act, a
provision of which rescinded the requirement that research
protocols be approved by the non-existent Ethics Advisory
Board.5
This change opened the way in principle to the possibility
of NIH funding for human embryo research using IVF embryos.
The following year, the NIH convened a Human Embryo Research
Panel to consider the issues surrounding such research and
to propose guidelines for potential funding applications.
The panel recommended that some areas of human embryo research
be deemed eligible for federal funding within a framework
of recognized ethical safeguards. It further concluded that
the creation of human embryos with the explicit intention
of using them only for research purposes should be supported
under some circumstances.6
President Clinton overruled the panel on the latter point,
ordering that embryo creation for research not be funded,
but he accepted the panel’s other recommendations
and permitted the NIH to consider applications for funding
of research using embryos left over from IVF procedures.7
Congress, however, did not endorse this course of action.
In 1995, before any funding proposal had ever been approved
by the NIH, Congress attached language to the 1996 Departments
of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act (the budget bill that
funds DHHS and the NIH) prohibiting the use of any federal
funds for research that destroys or seriously endangers
human embryos, or creates them for research purposes.
This provision, known as the “Dickey Amendment”
(after its original author, former Representative Jay Dickey
of Arkansas), has been attached to the Health and Human
Services appropriations bill each year since 1996. Everything
about the subsequent debate over federal funding of embryonic
stem cell research must be understood in the context of
this legal restriction. The provision reads as follows:
None of the funds made available in this
Act may be used for—
(1) the creation of a human embryo or
embryos for research purposes; or
(2) research in which a human embryo or
embryos are destroyed, discarded, or knowingly subjected
to risk of injury or death greater than that allowed for
research on fetuses in utero under 45 CFR 46.204 and 46.207,
and subsection 498(b) of the Public Health Service Act (42
U.S.C. 289g(b)). iii
(b) For purposes of this section, the
term ‘human embryo or embryos’ includes any
organism, not protected as a human subject under 45 CFR
46 as of the date of the enactment of the governing appropriations
act, that is derived by fertilization, parthenogenesis,
cloning, or any other means from one or more human gametes
or human diploid cells. 8
This law effectively prohibits the use of federal funds
to support any research that destroys human embryos or puts
them at serious risk of destruction. It does not, however,
prohibit the conduct of such research using private funding.
Thus, it addresses itself not to what may or may not be
lawfully done, but only to what may or may not be supported
by taxpayer dollars. At the federal level, research that
involves the destruction of embryos is neither prohibited
nor supported and encouraged.
The Dickey Amendment was originally enacted before the isolation
of human embryonic stem cells, first reported in 1998 by
researchers at the University of Wisconsin, whose work was
supported only by private funds (largely from the Geron
Corporation and the University of Wisconsin Alumni Research
Foundation). The discovery of these cells and their unique
and potentially quite promising properties aroused great
excitement both within and beyond the scientific community.
It led some people to question the policy of withholding
federal funds from human embryo research. Most Members of
Congress, however, did not change their position, and the
Dickey Amendment has been reenacted every year since. For
many of its supporters, the amendment expresses their ethical
conviction that nascent human life ought to be protected
against exploitation and destruction for scientific research,
however promising that research might be, and that at the
very least such destruction should not be supported or encouraged
by taxpayer dollars.
On its face, the Dickey Amendment would seem to close the
question of federal funding of human embryonic stem cell
research, since obtaining stem cells for such research relies
upon the destruction of human embryos. But in 1999, the
General Counsel of the Department of Health and Human Services
argued that the wording of the law might permit an interpretation
under which human embryonic stem cell research could be
funded. If embryos were first destroyed by researchers supported
by private funding, then subsequent research employing the
derived embryonic stem cells, now propagated in tissue culture,
might be considered eligible for federal funding. Although
such research would presuppose and follow the prior destruction
of human embryos, it would not itself involve that destruction.
Thus, the Department’s lawyers suggested, the legal
requirement not to fund research “in which”
embryos were destroyed would still technically be obeyed.9
This has generally been taken to be a legally valid interpretation
of the specific language of the statute, and indeed the
subsequent policies of both the Clinton and Bush administrations
have relied upon it in different ways. But some critics
of the 1999 legal opinion argued that, though it might stay
within the letter of the law, the proposed approach would
contradict both the spirit of the law and the principle
that underlies it.10
It would use public funds to encourage and reward the destruction
of human embryos by promising funding for research that
immediately follows and results from that destruction—thereby
offering a financial incentive to engage in such destruction
in the future. By so doing, these critics argued, it would
at least implicitly state, in the name of the American people,
that research that destroys human embryos ought to be encouraged
in the cause of medical advance. Supporters of the Clinton
administration’s proposed approach, however, argued
that promoting such research—especially given its
therapeutic potential—was indeed an appropriate government
function, and that the policy proposed by DHHS was neither
illegal nor improper, given the text of the statute and
provided that the routine standards of research ethics (including
informed consent and a prohibition on financial inducements)
were met.11
The Clinton administration adopted this course of action
and drew up specific guidelines to enact it.iv
But the guidelines, completed just before the end of the
Clinton administration, never had a chance to be put into
practice, and no funding was ever provided. Upon entering
office in 2001, the Bush administration decided to take
another look at the options regarding human embryonic stem
cell research policy and therefore put the new regulations
on hold, pending review.
In conducting its review, the Bush administration stated
that it sought a way to allow some potentially valuable
research to proceed while upholding the spirit (and not
just the letter) of the Dickey Amendment, a spirit that
the President himself has advocated.12
The expressed hope was that the government, while continuing
to withhold taxpayer support or encouragement for the destruction
of human embryos, might find a way to draw some moral good
from stem cell lines that had already been produced through
such destruction—given that this deed, even if immoral,
could not now be undone. This is the ethical-legal logic
of the present stem cell funding policy: it seeks those
benefits of embryonic stem cell research that might be attainable
without encouraging or contributing to any future destruction
of human embryos.
II. The Present Policy
The current policy on federal government funding of human
embryonic stem cell research, then, must be understood in
terms of the constraints of the Dickey Amendment and in
terms of the logic of the moral and political aims that
underlie that amendment.
At the time of the policy’s announcement, a number
of embryonic stem cell lines had already been derived and
were in various stages of growth and characterization. The
embryos from which they were derived had therefore already
been destroyed and could no longer develop further. As President
Bush put it, “the life and death decision had already
been made.”13
The administration’s policy made it possible to use
taxpayer funding for research conducted on those preexisting
lines, but it refused in advance to support research on
any lines created after the date of the announcement. In
addition, to be eligible for funding, those preexisting
lines would have had to have been derived from excess embryos
created solely for reproductive purposes, made available
with the informed consent of the donors, and without any
financial inducements to the donors—standard research-ethics
conditions that had been attached to the previous administration’s
short-lived funding guidelines, as well as to earlier attempts
to formulate rules for federal funding of human embryo research.
The policy denies federal funding not only for research
conducted on stem cell lines derived from embryos destroyed
after August 9, 2001 (or that fail to meet the above criteria),
but also (as the proposed Clinton-era policy would have)
for the creation of any human embryos for research purposes
and for the cloning of human embryos for any purpose.v
The moral, legal, and political grounds of this policy have
been hotly contested from the moment of its announcement.
Debates have continued regarding its aims, its character,
its implementation, and its underlying principles, as well
as the significance of federal funding in this area of research.
For example, many scientists, physicians, and patient advocacy
groups contend that the policy is too restrictive and thwarts
the growth of a crucial area of research. On the other side,
some opponents of embryo research believe the policy is
too liberal and legitimates and rewards (after the fact)
the destruction of nascent human life. Some ethicists argue
that there is a moral imperative to remove all restrictions
upon potentially life-saving research; other ethicists argue
that there is a moral imperative to protect the lives of
human beings in their earliest and most vulnerable stages.
These and similar arguments are reviewed in the next chapter.
But before one can enter into these debates, it is essential
first to understand the relevant elements of the policy
itself as clearly and distinctly as possible.
III. Moral Foundation of the Policy
In articulating its proposed funding policy in 1999 and
2000, the Clinton administration expressed a firm determination
that funded research could use only those human embryos
that had been left over from IVF procedures aimed at reproduction
and that had been donated in accordance with the standards
of informed consent and in circumstances free of financial
inducements. Provided that these crucial conditions were
met, the administration argued that the potential benefits
of stem cell research were so great that publicly funded
research should go forward. In August of 2000, reflecting
on the guidelines put forward by his administration, President
Clinton remarked,
Human embryo research [as approved for funding by the NIH
guidelines] deals only with those embryos that were, in
effect, collected for in-vitro fertilization that never
will be used for that. So I think that the protections are
there; the most rigorous scientific standards have been
met. But if you just—just in the last couple of weeks
we’ve had story after story after story of the potential
of stem cell research to deal with these health challenges.
And I think we cannot walk away from the potential to save
lives and improve lives, to help people literally to get
up and walk, to do all kinds of things we could never have
imagined, as long as we meet rigorous ethical standards.14
Given the promise of embryonic stem cell research, the
existence of many embryos frozen in IVF clinics and unlikely
ever to be transferred and brought to term, and the willingness
of some IVF patients to donate such embryos for research,
the Clinton administration reasoned that research using
cell lines derived from these embryos could ethically be
supported by federal funds. That position implies, of course,
that the destruction of embryos is not inherently or necessarily
unethical, or so disconcerting as to be denied any federal
support. The Clinton-era NIH Embryo Research Panel put succinctly
one form of this view in stating that “the preimplantation
human embryo warrants serious moral consideration as a developing
form of human life, but it does not have the same moral
status as infants and children.”15
If there is sufficient promise or reason to support research,
the claim of a human embryo to “serious moral consideration”
(or, as others, including some of us, have put it, to “special
respect”16)
could be outweighed by other moral aims or principles.
This (at least implicit) understanding of the moral status
of human embryos might be seen to have put the Clinton administration
at odds with the principle animating the operative law on
this subject (the Dickey Amendment). But given its responsibility
to carry out the laws as they are enacted, the administration
sought a way to advance research within the limitations
set by the statute. Its approach to the funding of embryonic
stem cell research, therefore, seems to have sought an answer
to this question: How can embryonic stem cell research,
conducted in accordance with standards of informed consent
and free donation, be maximally aided within the limits
of the law? The NIH guidelines published in 2000 represent
the answer the Clinton administration found: funding research
on present and future embryonic stem cell lines, so long
as the embryo destruction itself is done with private funds.
The Bush administration appears to have been motivated by
a somewhat different question, arising from what seems to
be a different view of the morality of research that destroys
human embryos. President Bush put the matter this way, in
discussing his newly announced policy in August of 2001:
Stem cell research is still at an early,
uncertain stage, but the hope it offers is amazing: infinitely
adaptable human cells to replace damaged or defective tissue
and treat a wide variety of diseases. Yet the ethics of
medicine are not infinitely adaptable. There is at least
one bright line: We do not end some lives for the medical
benefit of others. For me, this is a matter of conviction:
a belief that life, including early life, is biologically
human, genetically distinct and valuable. 17
vi
While expressing a desire to advance medical research,
this argument describes a line that such research should
not cross, and therefore past which funding should not be
offered. That line, in this context, is the destruction
of a human embryo for research purposes. The Bush administration
thus appears to share the view that underlies both the word
and spirit of the Dickey Amendment. In its approach to the
stem cell issue it has sought to answer a question that
differs, subtly but significantly, from that formulated
by the previous administration: How can embryonic stem
cell research, conducted in accordance with basic research
ethics, be maximally aided within the bounds of the principle
that nascent human life should not be destroyed for research?
In seeking to answer that question, the Bush administration
(like the Clinton administration) had to take account of
the existing situation and—as always in such instances—to
mix prudential demands and opportunities with an effort
at principled judgment. Given the existence of some human
embryonic stem cell lines, derived from human embryos that
had already been destroyed, the administration determined
that it might not simply have to choose between funding
research that relies on the ongoing destruction of embryos
(and therefore tacitly supporting and encouraging such destruction
by paying for the work that immediately follows it) and
funding no human embryonic stem cell research at all. The
decision regarding the funding of research on already-derived
human embryonic stem cells came down to this question: Can
the government support some human embryonic stem cell research
without encouraging future embryo destruction?
The present funding policy is therefore not an attempt to
answer the question of how the government might best advance
embryonic stem cell research while conforming to the law
on the subject. Rather, it is an attempt to answer the question
of how the government might avoid encouraging the (presumptively)
unethical act of embryo destruction and still advance the
worthy cause of medical research. Whether or not one agrees
with the premises defining the question, and whether or
not one accepts the logic of the answer, any assessment
of the policy must recognize this starting point.
From the very beginning, the policy has been described—even
by many of its supporters and defenders—as occupying
a kind of middle-ground position in the debate over the
morality of embryo research. It has been termed a “Solomonic
compromise.” But while it may be a prudential compromise
on the question of funding, it has been argued that the
policy—as articulated by its authors—does not
seem to be intended as a compromise on the question of the
moral status of human embryos or the moral standing of the
act of embryo destruction. In this sense, it appears to
be not a political “splitting of the difference”
but an effort at a principled solution.18
To some extent, the effort reflects a traditional approach
in moral philosophy to an ancient and vexing question: Can
one benefit from the results of (what one believes to be)
a past immoral act without becoming complicit in that act?vii
The moralists’ approach suggests that one may make
use of such benefits if (and only if) three crucial conditions
are met: (1) Non-cooperation: one does not cooperate or
actively involve oneself in the commission of the act; (2)
Non-abetting: one does nothing to abet or encourage the
repetition of the act, for instance by providing incentives
or rewards to those who would perform it in the future;
and (3) Reaffirmation of the principle: in accepting the
benefit, one re-enunciates and reaffirms the principle violated
by the original deed in question.
As a plan for redeeming some good from embryo destruction
that has already taken place, while not encouraging embryo
destruction in the future, the administration’s policy
appears at least to seek to address each of these three
conditions: (1) No federal funds have been or, by this policy,
would be used in the destruction of human embryos for research.
(2) By restricting research funding exclusively to embryonic
stem cell lines derived before the policy went into effect,
the policy deliberately refuses to offer present or future
financial or other incentives to anyone who might subsequently
destroy additional embryos for research; this is the moral
logic behind a central feature of the policy, the cut-off
date for funding eligibility (though some argue that by
failing to call for an end to privately funded research
the policy does not altogether avoid complicity). And (3)
the President, in his speech of August 9, 2001, and since
(as in the passage quoted above and elsewhere), has reaffirmed
the moral principle that underlies his policy and the law
on the subject: that nascent human life should not be destroyed
for research, even if good might come of it. The policy
as a whole draws attention to that principle by drawing
a sharp line beyond which funding will not be made available.
Of course, since these terms from the parlance of moral
philosophy were not those explicitly employed by the policy’s
authors, they can go only so far in helping us to understand
the policy’s foundation. As in any public policy decision,
prudence is here mixed with principle, in the hope that
the two might reinforce (rather than undermine) each other,
and a variety of moral aims are brought together. The desire
to afford some aid to a potentially promising field of research
moderates what might otherwise have been an at least symbolically
stauncher stance against embryo destruction: no public funding
whatsoever, even for work on stem cell lines obtained from
embryos destroyed in the past. Moreover, the desire to show
regard for established principles and standards of ethical
research leads to an insistence that, to be approved, stem
cell lines must have been drawn from embryos produced for
reproduction and obtained with consent and without financial
inducements. In these ways, the policy gives some due to
competing moral and prudential demands. But the policy’s
central feature—the announcement date separating eligible
from ineligible stem cell lines—holds firm to the
principle that public funds should not be used
to encourage or support the destruction of embryos in
the future.
It is perhaps worth pointing out that one’s attitude
regarding the best federal funding policy is not simply
determined by one’s view regarding the moral standing
of human embryos, and that even persons who hold the same
view of the moral standing of human embryos may not all
agree on the best policy. For example, support for the current
policy does not necessarily require a belief that human
embryos are persons with full moral standing; and conversely,
those who believe that human embryos are persons do not
necessarily support the policy. One might believe, for instance,
that an embryo is a mystery, not clearly “one of us”
but unambiguously a life-in-process, and thus conclude that
we should err on the side of restraint (non-destruction)
when moral certainty is impossible. Or, one might believe
that embryos are not simply persons but are nonetheless
either worthy of protection from harm or at least worthy
of more respect than ordinary human tissues or animals,
and that it would be wrong to begin a massive public project
of embryo research that offends the deeply-held beliefs
of many citizens. Meanwhile, an individual who believes
that human embryos have the same moral standing as children
or adults may be deeply unsatisfied with the present policy,
since merely denying federal encouragement for future embryo
destruction while taking no action to prevent privately-funded
stem cell research that destroys embryos may be an insufficient
response to the ongoing destruction of nascent human life.
For some of its supporters, the policy goes as far as it
seems possible to go within the bounds of the spirit and
aims of the law—that the government should not encourage
or support the destruction of nascent human life for research.
Yet at the same time, it goes farther than the federal government
has gone before in the direction of actually funding research
involving human embryos, since no public funds had ever
before been spent on such research. To go further—say,
by funding research on the currently ineligible lines derived
after August 9, 2001—would not extend the logic of
the policy or of the law, but rather contradict them both:
it would be a difference not of degree but of principle.
By implying that research using embryos destroyed in the
future might one day be supported with public funding, such
a policy shift would at least implicitly encourage the very
act (embryo destruction) that the current policy aims not
to encourage. Of course, such a change might well be in
order, but the case for it must address itself to the moral
argument and its principles, and not only to the state of
research and its progress or promise.
Rather than focus on this principled aspect of the policy,
the public debate has tended to concentrate on the precise
balance of benefits and harms resulting from the combination
of the administration’s policy and the state of the
relevant science. It has focused on whether there are “enough”
cell lines or on whether the science is advancing as quickly
as it could. And it has proceeded as though the administration’s
aim was simply to maximize progress in embryonic stem cell
research without transgressing the limits of the letter
of the law.
Had the decision been based on that aim alone, then claims
or evidence of slowed progress alone might, in themselves,
constitute an effective argument against it on its own terms
(on the ground that the law technically permits federal
funding of research on cells derived from embryos whose
destruction was underwritten by private funding). But if
one accepts the premise that the decision was grounded also
in a discernible (albeit highly controversial) moral aim,
one cannot show that the policy is wrong merely by pointing
to the potential benefits of stem cell research or the potential
harm to science caused by restrictions in federal funding.
The present policy aims to support stem cell research while
insisting that federal funds not be used to support or encourage
the future destruction of human embryos. To argue with that
policy on its own terms, therefore, one would need to argue
with its view of the significance of that aim. Concretely,
this means arguing with its ethical position regarding the
destruction of nascent human life and with its ethical-political
position regarding the significance of government funding
of a contested activity.
This latter point—regarding the meaning of government
funding—is much neglected in the current debates and
deserves further clarification. That will require delving
into the important distinction between government permission
(that is, an absence of prohibitions) of an activity and
government support for an activity. This ethical-political
distinction lies at the heart of the stem cell debate.
IV. The significance of Federal Funding
The national debate over human embryonic stem cell research
often raises the most fundamental questions about the moral
status of human embryos and the legitimacy of research that
destroys such embryos. Yet, looking over this debate, it
is easy to forget that the question at issue is not whether
research using embryos should be allowed, but rather whether
it should be financed with the federal taxpayer’s
dollars.
The difference between prohibiting embryo research
and refraining from funding it has often been blurred
by both sides to the debate. Ignored in the battles over
embryo research itself, the ethical-political question regarding
funding is rarely taken up in full.
That question arises because modern governments do more
than legislate and enforce prohibitions and limits. In the
age of the welfare state, the government, besides being
an enforcer of laws and a keeper of order, is also a major
provider of resources. Political questions today, therefore,
reach beyond what ought and ought not be allowed. They include
questions of what ought and ought not be encouraged, supported,
and made possible by taxpayer funding. The decision to fund
an activity is more than an offer of resources. It is also
a declaration of official national support and endorsement,
a positive assertion that the activity in question is deemed
by the nation as a whole, through its government, to be
good and worthy. When something is done with public funding,
it is done, so to speak, in the name of the country, with
its blessing and encouragement.
To offer such encouragement and support is therefore no
small matter. The federal government is not required to
provide such material support, even for activities protected
by the Constitution, let alone for those permitted but not
guaranteed.19
The affording of most federal funding is entirely optional,
and the choice to make such an offer is therefore laden
with moral and political meaning, well beyond its material
importance. In the age of government funding, the political
system is sometimes called upon to decide not only the lowest
standards of conduct, but also the highest standards of
legitimacy and importance. When the nation decides an activity
is worth its public money, it declares that the activity
is valued, desired, and favored.
The United States has long held the scientific enterprise
in such high regard. Since the middle of the twentieth century,
the federal government, with the strong support of the American
people, has funded scientific research to the tune of many
hundreds of billions of dollars. The American taxpayer is
by far the greatest benefactor of science in the world,
and the American public greatly values the contributions
of science to human knowledge, human health, and human happiness.
And we Americans have overwhelmingly been boosters of medical
science and medical progress, deeming them worthy of support
for moral as well as material reasons.
But this enthusiasm for medical science is not without its
limits. As already noted, we attach restrictions to federally
funded research, for instance to protect human subjects.
In fact at times we even use funding to place restrictions
on research that might otherwise not be constrained. Indeed,
federal funding sometimes serves as a means by which private
research can be subjected to critical standards, since institutions
that receive federal funds are often inclined (and given
strong administrative incentives) to abide by the prescribed
ethical standards throughout all of their activities, not
only those directly receiving public dollars. Some supporters
of funding therefore argue that extending public money to
research is the most effective means of making certain that
nearly all researchers, public and private, adhere to basic
standards of ethics and safety. Public funding also requires
researchers to make their work available to the public and
for critical review by their peers, and it may encourage
some degree of responsibility not necessarily encouraged
by commercial endeavors.viii
In addition to conditions attached to government funding
of research, law sometimes erects specific limits on certain
practices that might be medically beneficial. For example,
we put limits on some practices that might offer life-saving
benefits, such as the buying and selling of organs for transplantation,
currently prohibited under the National Organ Transplant
Act. Also, as in the present case, many Americans and their
congressional representatives have moral reasons for opposing
certain lines of research or clinical practice, for example
those that involve the exploitation and destruction of human
fetuses and embryos.
The two sides of the embryo research debate tend to differ
sharply on the fundamental moral significance of the activity
in question. One side believes that what is involved is
morally abhorrent in the extreme, while the other believes
embryo research is noble or even morally obligatory and
worthy of praise and support. It would be very difficult
for the government to find a middle ground between these
two positions, since the two sides differ not only on what
should or should not be done, but also on the moral premises
from which the activity should be approached.
To this point, the federal government has pursued a policy
whereby it does not explicitly prohibit embryo research
but also does not officially condone it, encourage it, or
support it with public funds (though state governments have
often taken more active roles in both directions, as detailed
in Appendix E). This approach, again, combines prudential
demands with moral concerns. It has allowed the political
system to avoid banning embryo research against the wishes
of those who believe it serves an important purpose, while
not compelling those citizens who oppose it to fund it with
their tax money. This approach is also based, at least in
part, on the conviction that debates over the federal budget
are not the place to take up the anguished question of the
moral status of human embryos.
But the position is not only a compromise between those
who would have the government bless and those who would
have the government curse this activity. It is also a statement
of a certain principle: namely, that public sanction makes
a serious difference and ought not to be conferred lightly.
While embryo destruction may be something that some Americans
support and engage in, it is not something that America
as a nation has officially supported or engaged in.ix
Of course, if the funding issue were merely a proxy for
the larger dispute over the moral status of human embryos,
then the present arrangement might appeal only to those
who would protect human embryos, and it would succeed only
as long as they were able to enact it. The argument might
end there, with a vote-count on the question of the moral
status or standing of human embryos. But some proponents
of the present law suggest that the particulars and contours
of the embryo research debate offer an additional rationale
for that arrangement. Here again, it is important to remember
that the issue in question is public funding, not permissibility.
Opponents of embryo research have in most cases acquiesced
(likely owing to various prudential and moral factors) in
narrowing the debate at the federal level to the question
of funding. They do not argue for a wholesale prohibition
of embryo research by national legislation, even though
many of them see such work as an abomination and even a
form of homicide. In return, proponents of the Dickey Amendment
argue that it would be appropriate for supporters of research
to agree to do without federal funding in this particular
field.
On the other hand, it might reasonably be argued that part
of living under majority rule is living with the consequences
of sometimes being in the minority. Were the Congress to
overturn the current policy of withholding public funds
from the destruction of embryos, opponents of funding for
embryo research would not be alone in being compelled to
pay for activities they abhor. We all see our government
do things, in our name, with which we disagree. Some of
these might even involve life and death questions of principle,
for instance in waging wars that some citizens deeply oppose.
The existence of strong moral opposition to some policy
is not in itself a decisive argument against proceeding
with that policy.
These concerns give the question of funding its own crucial
ethical significance, even apart from the more fundamental
question of the legitimacy and propriety of the act being
funded. This matter of funding broadly understood, together
with the moral and prudential aims apparently motivating
the administration’s policy, as well as the legal
context created by the Dickey Amendment, are the essential
prerequisites for thinking about the underlying logic of
the current policy. The combination of these elements gives
form not only to the specific rules set forth in the administration’s
funding policy, but also to the implementation of that policy,
to which subject we now turn.
V. Implementation of the Present
Policy
The complex and critical task of implementing the funding
policy falls largely to the National Institutes of Health,
which administers most federal funding of biomedical research.
As noted, the administration’s policy attempts to
advance stem cell research within the bounds already laid
out regarding further destruction of human embryos. Thus,
while the funding criteria of the policy set the bounds,
the NIH, in its ongoing work, is expected to advance the
goal of maximally effective funding and support within those
bounds.
To this end, the NIH has worked to “jump-start”
this field of research through a series of coordinated activities.20
To plan and oversee these activities, the NIH has established
a Stem Cell Task Force charged with determining the best
uses for public funds in the field and with putting in place
the resources required to make effective use of those funds.
The most basic material resources in question are the human
embryonic stem cell lines themselves. In August 2001, President
Bush announced that “more than sixty genetically diverse
stem cell lines” (or stem cell preparations) already
existed, and so would be eligible for funding under his
policy.21
The NIH now believes the actual number to be somewhat higher,
so that seventy-eight lines (or preparations) are known
to be eligible for funding.x
The lines are held by universities, companies, and other
entities throughout the world. According to the National
Institutes of Health’s latest report (September 2003),
the following organizations have developed stem cell derivations
eligible for federal funding (that is, derived prior to
August 9, 2001, under the approved conditions):
Name |
Number of Derivations |
BresaGen,
Inc., Athens, Georgia |
4 |
CyThera,
Inc., San Diego, California |
9 |
ES
Cell International, Melbourne, Australia |
6 |
Geron
Corporation, Menlo Park, California |
7 |
Göteborg
University, Göteborg, Sweden |
19 |
Karolinska
Institute, Stockholm, Sweden |
6 |
Maria
Biotech Co. Ltd. - Maria Infertility Hospital
Medical Institute, Seoul, Korea |
3 |
MizMedi
Hospital - Seoul National University, Seoul,
Korea |
1 |
National
Centre for Biological Sciences/ Tata Institute of
Fundamental Research, Bangalore, India |
3 |
Pochon
CHA University, Seoul,
Korea |
2 |
Reliance
Life Sciences, Mumbai,
India |
7 |
Technion
University, Haifa,
Israel |
4 |
University
of California, San
Francisco, California |
2 |
Wisconsin
Alumni Research Foundation, Madison,
Wisconsin |
5 |
Although all of these lines (or preparations) are deemed eligible
for funding according to the criteria of the administration’s
policy, not all are presently available for use by researchers
(nor is it clear that all of them will ever be available
for widespread use). Indeed, a point critical to understanding
the current situation is that as of the autumn of 2003 only twelve
lines are available for use,22
while most of the other lines are not yet adequately characterized
or developed (some exist only as frozen stocks) and so have at
least not yet become available.xi
The process of establishing a human embryonic stem cell line,
turning the originally extracted cells into stable cultured populations
suitable for distribution to researchers, involves an often lengthy
process of growth, characterization, quality control and assurance,
development, and distribution. In addition, the process of making
lines available to federally funded researchers involves negotiating
a contractual agreement (a “materials transfer agreement”)
with the companies or institutions owning the cell lines, establishing
guidelines for payment, intellectual property rights over resulting
techniques or treatments, and other essential legal assurances
between the provider and the recipient.
The entire process—scientific and legal—has tended
to take at least a year for each cell line. Thus, determining
which of the 78 eligible lines are in sufficiently good condition,
characterizing and developing those lines, and establishing the
arrangements necessary to make them available has been a demanding
task. By September of 2003, slightly over two years after the
enactment of the funding policy, twelve of the eligible lines
had become available to federally funded researchers.xi
The NIH has made available “infrastructure award”
funds (totaling just over $6 million to date) to a number of the
institutions that possess eligible cell-lines, to enable them
to more quickly and effectively develop more lines to distribution
quality. As a result, while the number of available lines (only
one in the summer of 2002 but risen to twelve in the autumn of
2003)xi
is expected to continue to grow with time, it is unclear how many
of the 78 lines will finally prove accessible and useful. According
to the NIH, as of the autumn of 2003, the owners of the available
lines have distributed over 300 shipments of lines to researchers.
No information is presently available on the number of individual
researchers or institutions that have received lines.23
Successful implementation of the current funding policy depends
not only on the availability of eligible lines, but also on adequate
allocation of financial resources to develop and make use of those
lines and to advance the field in general. The funding policy,
though it limits the targets of funding to the eligible lines,
does not directly delimit or restrict the amount of money
and other resources that the NIH may invest in human embryonic
stem cell research. The amount invested, a decision left to NIH
and the Congressional appropriations process, is largely a function
of the number of qualified applicants for funding and of the NIH’s
own priorities and funding decisions. Of course, if more lines
were eligible for funding, it is quite possible that more funding
would be allocated, but the amount that can
be allocated to work on existing lines is not limited by the funding
criteria. In fiscal year 2002, the NIH devoted approximately $10.7
million to human embryonic stem cell research. Based upon a September
2003 estimate, it will have spent approximately $17 million in
fiscal year 2003. It is expected that further increases will follow
as the field and the number of grant applications grow.
As of November 2003, NIH funds have been allocated to support
the following new and continuing awards for human embryonic stem
cell research: nine infrastructure awards to assist stem cell
providers to expand, test, and perform quality assurance, and
improve distribution of cell lines that comply with the administration’s
funding criteria (aimed at making more of the eligible lines available);
28 investigator-initiated awards for specific projects; 88 administrative
supplements (awarded to scientists already receiving funds for
work on other sorts of stem cells, either non-embryonic or non-human,
to enable them to begin to work with eligible human embryonic
stem cell lines); two pilot and feasibility awards; three awards
to support exploratory human embryonic stem cell centers; one
institutional development award; four post-doctoral training fellowships;
one career enhancement award; and six awards to fund stem cell
training (including short-term courses) to provide hands-on training
to enable researchers to learn the skills and techniques of culturing
human embryonic stem cells.
The latter task, of training new researchers, the NIH regards
as one of its principal challenges in advancing the field, and,
along with available lines and available financial resources,
as a key measure of how the field is progressing. As NIH Director
Elias A. Zerhouni put it in his presentation before this Council,
I don’t think the limiting factor
is the cell lines. I really don’t. I really think
the limiting factor is human capital and trained human capital
that can quickly evaluate a wide range of research avenues
in stem cells. 24
The NIH has therefore devoted funding to the training of
investigators and the cultivation of career development
pathways, including short-term courses in stem cell culture
techniques and (long-term) career enhancement awards in
the field. Some critics have contended, however, that the
two issues (funding restrictions and the scarcity of personnel)
are likely connected, and that limits on the cell lines
eligible for funding and the surrounding political controversy
cause some potential researchers to stay away from the field,
contributing to a shortage of investigators.25
These federal resources, then, have been directed toward
the advancement of human embryonic stem cell research within
the bounds of the determination to refrain from supporting
or funding new destruction of human embryos. Scientists
may receive federal funding—at any level determined
appropriate by the NIH—for any sort of meritorious
research, using as many of the approved lines as they are
eventually able to use. They can, of course, also receive
federal funding for using or deriving new animal embryonic
stem cell lines, to assess the potential of these cells
for treatment of animal models of human disease (though
of course animal models provide only limited information
because they are not in many cases exactly extrapolatable
to the specific situations that hold in human disease and
development, and so cannot replace human cell sources).
Researchers can, in addition, use federal funds for work
involving human embryonic germ cells, obtained from aborted
fetuses. They can carry out research projects using embryonic
germ cell lines already derived, following review and approval
of specific institutional assurances, informed consent documents,
scientific protocol abstracts, and Institutional Review
Board approvals by the NIH’s Human Pluripotent Stem
Cell Review Group (HPSCRG). They can also receive federal
funds for the derivation and study of new embryonic
germ cell lines following the same HPSCRG review and approval
process. In addition, of course, they can develop animal
embryonic germ cell lines to assess the potential of these
cells through animal models.
Also, researchers can receive federal funds for work conducted
on human adult (non-embryonic) stem cells. There are no
restrictions regarding what American scientists can do with
regard to adult stem cells using taxpayer funds, other than
those requiring them to honor the usual human subject protections
and clinical research requirements (if they are to be transplanted
into human patients). The NIH has devoted substantial resources
to the study of human adult stem cells, allocating over
$170 million to the field in fiscal year 2002, and approximately
$181.5 million in fiscal year 2003 (approximately ten times
the amount devoted to human embryonic stem cell work).
Finally, researchers remain free to pursue work (including
the derivation of new lines of embryonic stem cells) in
the private sector, without government funding. Indeed,
as discussed above, embryonic stem cells were first isolated
and developed in the private sector, or in university laboratories
using private sector funds, and no work in the field was
publicly funded at all until 2001. Under present law, work
supported by private funds can proceed without restriction.
Under rules promulgated in the spring of 2002, such work
does not need to be conducted in a separate laboratory,
but a clear separation of the funds used to support this
work from any federally funded work of the laboratory is
required. Of course, because of the highly interlocking
and complex nature of the various aspects of operating a
laboratory, such separation can still prove extremely difficult
to manage. It is not clear precisely how much privately
funded work using human embryonic stem cells has been undertaken
in the past few years, but some general figures are available.
The most recent and thorough survey available, based on
figures from 2002,26
suggests that approximately 10 companies in the United States
were actively engaged in embryonic stem cell work, employing
several hundred researchers and, cumulatively over the past
several years, spending over $70 million in the field, which
is well over twice what the NIH has so far spent.27
Those involved in privately-funded research in the field,
however, generally do not see private funding as a substitute
for federal funds, but would much prefer that the field
had the opportunity to benefit from both. They also argue
that restrictions on federal funds, and the controversy
surrounding the subject, act to dissuade potential investors
from entering the field, and thereby have a “chilling
effect” on private as well as publicly funded research.28
Moreover, just as federal policy can affect privately conducted
research, so too a number of states have enacted policies
affecting stem cell research, ranging from all-out prohibitions
of such research to official statements of support and positive
encouragement.xii
The status of such research, and the conditions to which
it is subject, can vary dramatically from state to state,
independent of federal funding policy.
VI. Conclusion
The administration’s policy on the funding of embryonic
stem cell research rests on several moral and ethical-legal
principles, set upon the reality of existing law:
1. The law: The Dickey Amendment, which the President
is required to enforce.
2. The principle underlying the law: The conviction,
voiced by the administration, a majority of the Congress,
and some portion of the public, that federal taxpayer dollars
should not be used to encourage the exploitation or destruction
of nascent human life, even if scientific and medical benefits
might come from such acts.
3. The principle underlying the desire to offer funding:
That efforts to heal the sick and the injured are of great
national importance and should be vigorously supported,
provided that they respect important moral boundaries.
4. The significance of federal funding: That federal
funding constitutes a meaningful positive statement of national
approval and encouragement, which should be awarded only
with care, particularly in cases where the activity in question
arouses significant public moral opposition.
The significance of the policy is best understood in light
of these key elements. Its soundness is most reasonably
measured against them and against the policy’s implementation
by the National Institutes of Health.
Though the prudential and principled considerations raised
in this chapter governed the formulation of the policy,
or at least defined its articulation by its advocates and
authors, these are not the only terms by which federal funding
policy might be conceived or measured. In the next chapter
we present an overview of the ethical and policy debates
that have raged for the past two years around both the wisdom
of the present policy and the fundamental issues at stake
in human embryonic stem cell research.
_________________
Footnotes
i. Some Members of the
Council oppose the current policy, some Members support
it. Yet the descriptive account that we offer here aspires
to be seen as accurate and fair, regardless of where one
personally stands on the issue. Nearly all Members of this
Council recognize, as we said in our report Human Cloning and Human Dignity, that “all parties to this debate
have something vital to defend, something vital not only
to themselves but also to their opponents in the debate,
and indeed to all human beings. No human being and no human
society can afford to be callous to the needs of suffering
humanity, cavalier regarding the treatment of nascent human
life, or indifferent to the social effects of adopting in
these matters one course of action rather than another.”
(Human Cloning and Human Dignity, p. 121.) Thus, whatever
we think of the current funding policy, we recognize that
this is a genuine ethical dilemma and that reasonable people
of good will may come to different conclusions about where
the best ethical or policy position lies. We therefore also
believe that not only results but also reasons matter, and
that it behooves us to understand the principled or prudential
reasons for the current policy (as well as for any alternative
policy that might be offered to replace it).
ii. In its discussion
of “fetal” research, the commission defined
the fetus as the product of conception from the time of
implantation onward, which therefore included what we generally
think of (and define in this report) as embryos in utero.
Its separate consideration of embryo research was therefore
directed at in vitro embryos.
iii. These legal citations
refer to the federal regulations and federal statute relating
to research on living human fetuses.
iv. These regulations,
as published in the Federal Register, are provided in Appendix
D.
v. The official NIH
statement of this policy is provided in Appendix C.
vi. Using similar language,
but speaking even more unambiguously, President Bush reiterated
his ethical view of the destruction of human embryos for
medical research in a speech on human cloning legislation,
saying, “I believe all human cloning is wrong, and
both forms of cloning ought to be banned, for the following
reasons. First, anything other than a total ban on human
cloning would be unethical. Research cloning would contradict
the most fundamental principle of medical ethics, that no
human life should be exploited or extinguished for the benefit
of another. Yet a law permitting research cloning, while
forbidding the birth of a cloned child, would require the
destruction of nascent human life.” (“Remarks
by the President on Human Cloning Legislation,” as
made available by the White House Press Office, April 10,
2002.)
vii. Readers should
note that in reporting on this approach, as applicable to
President Bush’s stem cell decision, the Council is
not itself declaring its own views on whether the past act
of embryo destruction was “immoral.” (Some of
us think it was, some of us think it wasn’t.) We are
rather describing what we understand to be the moral logic
of the decision as put forward.
viii. Indeed, some even
argue that the terms and conditions set for federal funding
of research could be defined in such a way as not only to
subject private research to general standards but also to
help influence the eventual distribution of the products
of that research to all those in need, or to serve other
goods deemed publicly worthy.
ix. The repeated reenactment
of the Dickey Amendment by the Congress may be taken as
evidence of some support for this assertion.
x. These numbers took
almost everyone by surprise. Prior to the President’s
announcement, the best estimates of the number of human
embryonic stem cell lines then existing worldwide ranged
between 10 and 20. But eligibility is not the same thing
as availability, as we will discuss.
xi. By the time of
final publication of this document, in January 2004, the
number of available lines had risen to 15. This number is
likely to rise further, and readers are advised to keep
abreast of the current number and availability of embryonic
stem cell lines eligible for funding at the NIH Stem Cell
Registry website, stemcells.nih.gov.
xii. State policies
regarding embryo research are detailed in Appendix E.
_________________
Endnotes
1. National Research
Act, Pub. L. No. 93-348, § 213, 88 Stat. 342 (passed
by the 93rd Congress as H.R. 7724, July 12, 1974).
2. National Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research, Research on the Fetus: Report and Recommendations
(Washington, D.C.) 1975. Reprinted at 40 Fed. Reg. 33,526
(1975).
3. “HEW Support
of Human In Vitro Fertilization and Embryo Transfer: Report
of the Ethics Advisory Board,” 44 Fed. Reg. 35,033
(June 18, 1979) at 35,055-35,058.
4. Ibid.
5. National Institutes
of Health Revitalization Act of 1993, Pub. L. No. 103-43,
§ 121(c), 107 Stat. 122 (1993), repealing 45 C.F.R.
§ 46.204(d).
6. National Institutes
of Health, Report of the Human Embryo Research Panel,
Bethesda, MD: NIH (1994).
7. “Statement
by the President,” as made available by the White
House Press Office, December 2, 1994.
8. The text of the Dickey
Amendment can be found in each year’s Labor/HHS Appropriations
Bill. The original version, introduced by Representative
Jay Dickey, is in § 128 of Balanced Budget Downpayment
Act, I, Pub. L. No. 104-99, 110 Stat. 26 (1996). For subsequent
fiscal years, the rider is found in Title V, General Provisions,
of the Labor, HHS and Education Appropriations Acts in the
following public laws: FY 1997, Pub. L. No. 104-208; FY
1998, Pub. L. No. 105-78; FY 1999, Pub. L. No. 105-277;
FY 2000, Pub. L. No. 106-113; FY 2001, Pub. L. No. 106-554;
and FY 2002, Pub. L. No. 107-116. The most current version
(identical in substance to the rest) is in Consolidated
Appropriations Resolution, 2003, Pub. L. No. 108-7, 117
Stat. 11 (2003).
9. “Rendering
legal opinion regarding federal funding for research involving
human pluripotent stem cells,” Memo from Harriet S.
Rabb, General Counsel of the Department of Health and Human
Services to Harold Varmus, Director of the National Institutes
of Health, January 15, 1999. (Available through the National
Archives.)
10. This case was made,
for instance, in a letter authored by Rep. Jay Dickey and
signed by seventy other Members of Congress to DHHS Secretary
Donna Shalala, February 11, 1999.
11. DHHS Secretary
Shalala argued this point in a letter responding to the
Congressional letter of opposition (see note 10, above),
February 23, 1999.
12. President Bush
has made a number of statements articulating the position
that nascent human life (including at the early embryonic
stage) is deserving of protection and ought not be violated.
See especially: “Stem Cell Science and the Preservation
of Life,” The New York Times, August 12,
2001, p. D13; “Remarks by the President on Human Cloning
Legislation,” as made available by the White House
Press Office, April 10, 2002; “Remarks by the President
at the Dedication of the Pope John Paul II Cultural Center,”
as made available by the White House Press Office, March
22, 2001; and “President Speaks at 30th Annual March
for Life on the Mall,” as made available by the White
House Press Office, January 22, 2003.
13. “Remarks
by the President on Stem Cell Research,” as made available
by the White House Press Office, August 9, 2001.
14. “Remarks
by the President upon Departure for New Jersey,” as
made available by the White House Press Office, August 23,
2000.
15. National Institutes
of Health, Report of the Human Embryo Research Panel,
Bethesda, MD: NIH, 1994.
16. See, for instance,
the “Moral Case for Cloning-for-Biomedical-Research”
presented by some Members of the Council in the Council’s
July 2002 report Human Cloning and Human Dignity: An Ethical
Inquiry, chapter 6.
17. Bush, G.W., “Stem
Cell Science and the Preservation of Life,” The
New York Times, August 12, 2001, p. D13.
18. See, for instance,
Council discussion at its September 3, 2003, meeting. A
transcript of that session is available on the Council’s
website at www.bioethics.gov
19. This question has
been addressed by the Supreme Court on a number of occasions,
in which the Court found that even activities protected
as rights under the Constitution are not thereby inherently
worthy of financial support from the federal government.
See, for instance, Maher v. Roe 432 U.S. 464 (1977);
Harris v. McRae 448 U.S. 297 (1980); and Rust
v. Sullivan 500 U.S. 173 (1991). Also see Berkowitz,
P. “The Meaning of Federal Funding,” a paper
commissioned by the Council and included in Appendix F of
this report.
20. The information
provided in this section relies primarily on a presentation
delivered before the Council by NIH Director Elias Zerhouni
on September 4, 2003, and on data otherwise made available
by the National Institutes of Health. The full transcript
of Director Zerhouni’s presentation may be found on
the Council’s website at www.bioethics.gov.
21. “Remarks
by the President on Stem Cell Research,” as made available
by the White House Press Office, August 9, 2001.
22. As of the autumn
of 2003, the following providers have eligible lines available
for distribution: BresaGen (2 available lines), ES Cell
International, Australia (5 available lines), MizMedi Hospital,
South Korea (1 available line), Technion University, Israel
(2 available lines), University of California at San Francisco
(1 available line), Wisconsin Alumni Research Foundation
(1 available line). A complete list of available and eligible
lines, updated as more lines become available, can be found
at the NIH Stem Cell Registry website at stemcells.nih.gov.
23. This information
has been made available to the Council by the National Institutes
of Health.
24. Quoted from a presentation
before the Council by NIH Director Elias Zerhouni, September
4, 2003. The full transcript of Director Zerhouni’s
presentation may be found on the Council’s website
at www.bioethics.gov.
25. See, for instance,
the presentation of Thomas Okarma, President and CEO of
Geron Corporation, before the Council on September 4, 2003.
The full transcript of Okarma’s presentation may be
found on the Council’s website at www.bioethics.gov.
26. Lysaght, M.J.,
and Hazlehurst, A.L., “Private Sector Development
of Stem Cell Technology and Therapeutic Cloning,”
Tissue Engineering 9(3): 555-561 (2003).
27. The dollar amount
spent specifically on embryonic stem cell research in the
private sector is not apparent from Lysaght and Hazlehurst’s
survey. The $70 million figure is drawn from a presentation
before the Council by Thomas Okarma, President and CEO of
Geron Corporation, the oldest and largest of the private
companies involved in embryonic stem cell research. Okarma
told the Council, speaking only of Geron, “We have
spent over $70 million on this technology, most of it since
1999 after the cells were derived. That’s a number
against which the NIH disbursements pale by both absolute
and relative terms.” The full transcript of Okarma’s
presentation may be found on the Council’s website
at www.bioethics.gov.
28. Ibid., and see
also (for instance) Mitchell, S., “U.S. stem cell
policy deters investors,” The Washington Times,
November 2, 2002 (original source: UPI).
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