Stem Cell Research

Stem Cell Research
Order Code RL31015
CRS Report for Congress
Received through the CRS Web
Stem Cell Research
Updated January 11, 2006
Judith A. Johnson
Specialist in Life Sciences
Domestic Social Policy Division
Erin D. Williams
Specialist in Bioethical Policy
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
Stem Cell Research
Summary
Embryonic stem cells have the ability to develop into virtually any cell in the
body, and they may have the potential to treat medical conditions such as diabetes
and Parkinson’s disease. In August 2001, President Bush announced that for the first
time federal funds would be used to support research on human embryonic stem
cells, but funding would be limited to “existing stem cell lines.” NIH has established
a registry listing the 78 human embryonic stem cell lines that are eligible for use in
federally funded research, but only 22 cell lines are currently available. Scientists are
concerned about the quality and longevity of these 22 stem cell lines. For a variety
of reasons, many believe research advancement requires new embryonic stem cell
lines, and for certain applications, stem cells derived from cloned embryos may offer
the best hope for understanding and treating disease. However, an investigation by
Seoul National University found that scientist Hwang Woo Suk had fabricated results
on deriving patient-matched stem cells from cloned embryos — a major setback for
the field. A significant cohort of pro-life advocates supports stem cell research; those
opposed are concerned that stem cell isolation requires embryo destruction.
Some have argued that stem cell research be limited to adult stem cells obtained
from tissues such as bone marrow or umbilical cord blood. They argue that adult
stem cells should be pursued instead of embryonic stem cells because they believe
the derivation of stem cells from embryos is ethically unacceptable. Other scientists
believe adult stem cells should not be the sole target of research because of important
scientific and technical limitations. Some scientists are exploring the possibility of
obtaining human embryonic stem cells that bypass the destruction of living human
embryos. The President’s Council on Bioethics cite four potential alternative sources
of human embryonic stem cells in a May 2005 paper.
On May 24, 2005, the House passed H.R. 810 (Castle) which would allow
federal support of research that utilizes human embryonic stem cells regardless of the
date on which the stem cells were derived from a human embryo, thus negating the
August 2001 Bush stem cell policy limitation on “existing stem cell lines.” On July
29, 2005, Senate Majority Leader Bill Frist announced his support for H.R. 810/S.
471 (Specter); President Bush has threatened a veto. Action on the Weldon bill
(passed the House in the 107th and 108th and stalled in the Senate) is likely; it was
reintroduced in the 109th Congress as H.R. 1357 and S. 658 (Brownback). The bill
bans the process of cloning as well as the importation of any product derived from
an embryo created via cloning. It bans not only reproductive applications, but also
research on therapeutic uses, which has implications for stem cell research.
Advocates of the legislative ban say that allowing any form of human cloning
research to proceed raises serious ethical issues and will inevitably lead to the birth
of a baby that is a human clone. Critics argue that the measure would curtail medical
research and prevent Americans from receiving life-saving treatments created
overseas. S. 876, H.R. 1822 and S. 1520 ban only human reproductive cloning. Bills
focused on alternative sources of stem cells (H.R. 3144/S. 1557) have also been
introduced. On December 20, 2005, the President signed H.R. 2520 (P.L. 109-129),
which provides for the collection and maintenance of human cord blood stem cells
for the treatment of patients and for research. This report will be updated as needed.
Contents
Basic Research and Potential Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Embryonic Stem Cells from IVF Embryos or Fetal Tissue . . . . . . . . . . . . . . 1
Embryonic Stem Cells Obtained via SCNT (Cloning) . . . . . . . . . . . . . . . . . 2
Alternative Sources of Human Embryonic Stem Cells . . . . . . . . . . . . . . . . . 3
Dead Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Embryo Biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Biological Artifacts — Altered Nuclear Transfer . . . . . . . . . . . . . . . . . 5
Dedifferentation of Somatic Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Stem Cells from Adult Tissue or Umbilical Cord Blood . . . . . . . . . . . . . . . . 7
Potential Applications of Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . 8
Current Federal Regulatory Landscape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
The Dickey Amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Clinton Administration Stem Cell Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Bush Administration Stem Cell Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Agency Regulation: FDA and NIH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
FDA Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
NIH Research Funding and Stem Cell Registry . . . . . . . . . . . . . . . . . . 13
Concerns Over Access to Stem Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Reproductive Genetics Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Harvard Stem Cell Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Stanford Institute for Cancer/Stem Cell Biology . . . . . . . . . . . . . . . . . . . . . 16
UCSF Developmental and Stem Cell Biology Program . . . . . . . . . . . . . . . 16
Worldwide Survey of Stem Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Congressional Letters on Bush Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
National Academies Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
State Actions on Embryonic Stem Cell Research . . . . . . . . . . . . . . . . . . . . . . . . 19
State Embryonic and Fetal Research Laws . . . . . . . . . . . . . . . . . . . . . . . . . 19
State Initiatives to Encourage Stem Cell Research . . . . . . . . . . . . . . . . . . . 20
California . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Connecticut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Florida . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Illinois . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Indiana . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Maryland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Massachusetts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Missouri . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
New Jersey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Ohio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Virginia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Wisconsin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Congressional Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
International Actions on Embryonic Stem Cell Research . . . . . . . . . . . . . . . . . . 30
Australia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
China . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Israel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Singapore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
South Korea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Sweden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
United Kingdom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Ethical Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Embryo Destruction and Relief of Human Suffering . . . . . . . . . . . . . . . . . 39
Viability of Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Purpose of Embryo Creation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
New and Existing Cell Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Consent of Donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Egg Procurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Effectiveness of Alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Generating Embryonic Stem Cells Without Destroying Human
Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Use of Federal Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
List of Tables
Table 1. National Institutes of Health Funding . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Table 2. NIH List of Human Embryonic Stem Cell Lines Eligible for Use in
Federal Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Stem Cell Research
Basic Research and Potential Applications
Most cells within an animal or human being are committed to fulfilling a single
function within the body. In contrast, stem cells are a unique and important set of
cells that are not specialized. Stem cells retain the ability to become some or all of
the more than 200 different cell types in the body and thereby play a critical role in
repairing organs and body tissues throughout life. Although the term stem cells is
often used in reference to these repair cells within an adult organism, a more
fundamental variety of stem cells is found in the early stage embryo. Embryonic
stem cells may have a greater ability to become different types of body cells than
adult stem cells.
Embryonic Stem Cells from IVF Embryos or Fetal Tissue
Embryonic stem cells were first isolated from mouse embryos in 1981 and from
primate embryos in 1995. Animal embryos were the only source for research on
embryonic stem cells until November 1998, when two groups of U.S. scientists
announced the successful isolation of human embryonic stem cells. One group, at
the University of Wisconsin, derived stem cells from five-day-old embryos produced
via in vitro fertilization (IVF).1 The work is controversial, in the opinion of some,
because the stem cells are located within the embryo and the process of removing
them destroys the embryo. The second group, at Johns Hopkins University, derived
stem cells with very similar properties from five- to nine-week-old embryos or
fetuses obtained through elective abortion.2 Both groups reported the human
embryos or fetuses were donated for research following a process of informed
consent. The cells removed from embryos or fetuses were manipulated in the
laboratory to create embryonic stem cell lines that may continue to divide for many
months to years. The vast majority of research on human embryonic stem cells
utilizes cell lines derived via the University of Wisconsin method.
1
The IVF embryos were originally created for the treatment of infertility. Excess embryos
are often frozen for future use. A couple may elect to discard their excess embryos, donate
the embryos for research, or allow another couple to adopt an embryo. According to a survey
of over 430 infertility clinics performed by the Society for Assisted Reproductive
Technology and RAND, nearly 400,000 embryos are being stored in the United States; 88%
of the embryos are being held to help the couples have children at a later date.
2
Scientists and physicians use the term “embryo” for the first eight weeks after fertilization,
and “fetus” for the ninth week through birth. In contrast, the Department of Health and
Human Services (HHS) regulations define “fetus” as “the product of conception from the
time of implantation” (45 C.F.R. § 46.203).
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Embryonic Stem Cells Obtained via SCNT (Cloning)
Another potential source of embryonic stem cells is somatic cell nuclear transfer
(SCNT), also referred to as cloning.3 In SCNT the nucleus of an egg is removed and
replaced by the nucleus from a mature body cell, such as a skin cell. The cell created
via SCNT is allowed to develop for several days and then the stem cells are removed.
In 1996, scientists in Scotland used the SCNT procedure to produce Dolly the sheep,
the first mammalian clone.4
Charges of ethical and scientific misconduct have clouded the reputation of
scientists involved in deriving stem cells from cloned human embryos. In February
2004, scientists at the Seoul National University (SNU) in South Korea announced
the first isolation of stem cells from a cloned human embryo. In May 2005, this
same group announced they had achieved major advances in the efficiency of
creating human cloned embryos using SCNT and in isolating human stem cells from
the cloned embryos. Serious concerns about the achievements of the SNU group
arose in November 2005 when a co-author of the 2005 paper, Gerald Schatten of the
University of Pittsburgh, accused Hwang Woo Suk, the lead researcher of the SNU
group, of ethical misconduct.5 The accusation halted plans for a collaboration
between the SNU scientists and U.S. and UK labs that had been announced only one
month earlier.
In early December, scientists in South Korea began questioning the validity of
photographs and other scientific evidence presented in the 2005 paper and called for
an independent analysis of the data. On December 12, 2005, Schatten asked that his
name be removed from the 2005 paper.6 The University of Pittsburgh and SNU
began separate investigations into the charges. On December 15, 2005, another coauthor of the 2005 paper, Sung Il Roh, stated to the Korean media that the research
was fabricated and the 2005 paper should be retracted. Hwang agreed to the
retraction on December 16, but continued to defend the scientific results.7 In reports
released on December 23 and 29, 2005, SNU stated that the stem cell lines described
in the 2005 paper were neither patient-matched nor derived through cloning, and
3
A somatic cell is a body cell. In contrast, a germ cell is an egg or sperm cell.
4
Dolly was euthanized in Feb. 2003 after developing a lung infection. Some claim her
death at six years was related to being a clone, but her ailment may also have occurred
because she was raised indoors (for security reasons) rather than as a pastured sheep, which
often live to 12 years of age. G. Kolata, “First Mammal Clone Dies,” New York Times, Feb.
15, 2003, p. A4.
5
Gretchen Vogel, “Collaborators Split over Ethics Allegations” Science, Nov. 18, 2005, p.
1100.
6
The Associated Press, “South Korean’s Cloning Research Challenged,” The New York
Times, Dec. 13, 2005.
7
Gordan Fairclough, “South Korean Scientist Denies Falsifying Stem-Cell Research,” The
Wall Street Journal, Dec. 17, 2005, p. A4.
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were deliberately fabricated.8 9 On January 10, 2006, SNU stated that results of the
2004 paper, which reported the first derivation of stem cells from a cloned human
embryo, were also a deliberate fabrication.10
Scientists at the University of Newcastle, the University of Edinburgh and
Harvard University are working on deriving patient-matched stem cells from cloned
human embryos.11
The ethical and scientific misconduct developments in South Korea as well as
the unsubstantiated announcement by Clonaid in December 2002 of the birth of a
cloned child have contributed to the controversy over research on human embryos.12
Alternative Sources of Human Embryonic Stem Cells
Most scientists involved in human embryonic stem cell research are focused on
using stem cells derived from human embryos via the methods developed by
scientists at the University of Wisconsin. However, a small number of scientists
have begun to explore ways of obtaining human embryonic stem cells that bypass the
destruction of living human embryos and, therefore, may be less troubling to certain
individuals, including some Members of Congress. The President’s Council on
Bioethics identified four potential methods in a paper released in May 2005.13 The
four alternative methods would require additional research to determine whether
human embryonic stem cells could be generated.
Some council members, however, expressed concern that work on alternative
sources is a “diversion from the simple task at hand which is to move forward with
the established laboratory techniques ... for studying embryonic stem cell research
and biomedical cloning” and that the four proposals would “use financial resources
that would be better devoted to proposals that are likely to be more productive.”14
Laurie Zoloth, professor of Medical Humanities and Bioethics, and of Religion at
Northwestern University’s Feinberg School of Medicine, maintains that public
funding should not be used to satisfy the moral qualms of a minority and proposes
8
Rick Weiss, “Korean Stem Cell Lines Faked,” The Washington Post, Dec. 23, 2005, p. A1.
9
Choe San-Hun, “Panel further discredits Stem Cell Work of South Korean Scientist,” The
New York Times, Dec. 29, 2005, p. 9.
10
Nicholas Wade and Choe Sang-Hun, “Researcher Faked Evidence of Human Cloning,
Koreans Report,” The New York Times, Jan. 10, 2006, p. A1.
11
Dennis Normile, Gretchen Vogel, and Constance Holden, “Cloning Researcher Says Work
is Flawed but Claims Results Stand,” Science, Dec. 23, 2005, p. 1886-1887.
12
For further information, see CRS Report RL31358, Human Cloning, by Judith A. Johnson
and Erin Williams.
13
The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, at [http://www.bioethics.gov/reports/white_paper/
index.html].
14
Ibid., Personal Statement of Michael S. Gazzaniga, p. 76 and Personal Statement of Dr.
Janet D. Rowley, p. 90.
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that private religious groups should consider funding research on alternative sources
of human embryonic stem cells just as Jehovah’s Witnesses supported efforts to
develop blood-saving surgical techniques to avoid transfusions.15
Dead Embryos. One possible method under discussion is deriving human
embryonic stem cells from dead embryos. Early embryos frequently fail to develop
in naturally occurring conceptions.
Slightly fewer than a third of all conceptions lead to a fetus that has a chance of
developing. In other words, if you were to choose [an embryo] at random and
follow it through the first week of development, the chances are less than one in
three that it would still be there at full term, even though there has been no
human intervention. Nature, it seems, performs abortions at a much higher rate
than human society. It is simply not true that most [embryos], if undisturbed,
will produce a human being. The probability that a conception will result in a
live birth is actually quite low. Note that since we have assumed that all
conceptions lead to cell division, we have almost surely overestimated the true
success rate.16
As many as 60% of IVF embryos produced by infertility clinics are judged to
be incapable of developing to live birth, due to abnormal appearance or failure to
divide appropriately, and are not used by the infertile couple. Although failure to
divide is often caused by genetic abnormalities and might seem to eliminate any
prospect of using these embryos even for research, several studies suggest that some
normal cells may be obtained from such organismically dead embryos and may be
useful in creating stem cell lines.
The possibility that normal cells removed from dead embryos could potentially
develop into an embryo (and if transferred into a uterus — a child) would be
disturbing to some individuals. In addition, such a possibility would likely preclude
federal funding for producing stem cell lines from such cells because of restrictions
contained in the Dickey Amendment (see subsection, below, Embryo Biopsy).
Research studies to determine the precise criteria for embryonic organismic death
would be needed; however, such “natural history” studies could not be conducted
with federal dollars. Federal funding of any type of research involving human
embryos, starting with IVF then later cloning and the creation of stem cell lines from
embryos, has been blocked by various policy decisions dating back more than 25
years and is currently controlled by the Dickey Amendment (see section, below, The
Dickey Amendment and Clinton Administration Stem Cell Policy).
The President’s Council points out that this method of obtaining stem cells from
dead embryos may not be acceptable to scientists because they understandably want
to work only with the best materials. Why would scientists want to use cells derived
from dead embryos, which may be abnormal, or even bother trying to create these
cell lines when they can use existing cell lines or derive new ones from IVF
15
Molly Laas, “Alternative Stem Cell Derivation Methods Should Be Funded By Private
Religious Groups,” Research Policy Alert, Nov. 10, 2005.
16
Harold J. Morowitz and James S. Trefil, The Facts of Life: Science and the Abortion
Controversy (Oxford University Press, 1992), p. 51.
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embryos? The only advantage may be eligibility for federal funding. One Council
member points out that the proposal entails thawing out embryos to follow the
natural history of dead embryos, and because it is unknown “which embryos will not
divide and which will, some portion (about half) will continue to divide and will be
healthy embryos. What happens to these healthy embryos? ... [I]t would be strange,
while allowing large numbers of unwanted but otherwise normal and viable IVF
embryos to die, to ask scientists to make strenuous efforts to rescue cells, potentially
abnormal, only from those thawed embryos that have spontaneously stopped
dividing. ... This seems to me to be the height of folly.”17
Embryo Biopsy. A second method of obtaining embryonic stem cells without
destroying the embryo employs a technique used by IVF clinics that offer preimplantation genetic diagnosis (PGD). At the 6-8 cell stage, one or two cells are
removed from the embryo created via IVF; these cells are then screened for genetic
or chromosomal abnormalities before the embryo is transferred to a woman’s uterus.
More than 1,000 children have been born following PGD, though it is still unclear
whether subtle or late onset injuries may occur in children born following PGD.18
In October 2005, scientists at Advanced Cell Technology of Massachusetts
announced success in deriving mouse embryonic stem cells by removing one cell
from an eight-cell mouse embryo. Following implantation into a surrogate mother,
the seven-cell embryos developed into healthy mice at the same rate as embryos that
had not been biopsied. However, creation of the stem cell lines was much less
efficient than when a later-stage embryo was used.
It may be possible to create human stem cell lines using cells obtained in this
manner; after cell removal, the seven-cell embryo could presumably be used to
initiate a pregnancy. Although it is understandable that couples who are at risk of
having a child with a genetic disease may willingly agree to the potential added risk
of PGD, it is difficult to understand what circumstances might motivate any couple
to agree to such a procedure for the sole purpose of creating stem cell lines for
research. Research studies to determine if there is a risk of harm to a human embryo
by the cell biopsy procedure could not be funded with federal dollars due to, as
mentioned above, longstanding opposition to federal support for any type of research
involving human embryos. Furthermore, a single cell from a sheep or rabbit 4- or 8cell embryo is capable of developing into a normal sheep or rabbit. The possibility
that a biopsied human cell may have “the potential to develop into an embryo and a
child on its own” could preclude federal funding for producing stem cell lines from
such cells because of restrictions contained in the Dickey Amendment (see section,
below, The Dickey Amendment and Clinton Administration Stem Cell Policy).19
Biological Artifacts — Altered Nuclear Transfer. A third possible
method involves using the techniques of genetic engineering and SCNT (cloning) to
17
The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, p. 21 and p. 89.
18
19
Ibid., pp. 24-25.
Ibid., p. 29.
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obtain embryonic stem cells from embryo-like groups of cells which are not, in the
strict sense, human embryos. In this approach, called altered nuclear transfer (ANT),
a gene in the nucleus of the somatic cell is altered, so that normal embryo
development is not possible, before the nucleus is placed within an enucleated egg.
In October 2005, scientists at the Massachusetts Institute of Technology reported
success in generating mouse embryonic stem cells utilizing the ANT approach. A
gene was disabled that allows for embryo implantation; gene function can be restored
later so the stem cell line is unaffected. As is the case with SCNT, if the ANT
approach is ever used to generate human embryonic stem cells a major obstacle
would be obtaining an adequate supply of human eggs. This is the subject of intense
scientific research. Researchers are trying to develop methods of obtaining human
eggs without resorting to superovulation of female patients, an expensive procedure
that some find morally questionable.
Some researchers believe ANT might serve as a temporary bridge until other
technologies are developed, such as dedifferentiation of somatic cells. Until then, if
federal support is provided, its proponents believe ANT would allow embryonic stem
cell research collaboration on a national level without the ethical concerns involved
in using leftover IVF embryos. Others believe that the procedures involved in ANT
are more complex than deriving human embryonic stem cells from normal embryos,
and many scientists “would be reluctant to attempt such challenging feats with no
rational purpose other than to satisfy the ethical objections of others.”20
Critics are concerned over the questionable morality of creating a biological
artifact with a built in genetic defect, or what might be considered as the deliberate
creation of a doomed or disabled human embryo. “Some find it aesthetically
repulsive and ethically suspect to be creating such neither-living-nor-nonliving, nearhuman artifacts, a practice they regard as ethically no improvement over destroying
early embryos.”21 Proponents of the ANT approach argue that “such an entity would
be a ‘biological artifact,’ not an organism. Removal of cells from, or even
disaggregation of, this artifact would not be killing or harming, for there is no living
being here to be killed or harmed.”22 Given the ethical uncertainties, it is unclear
whether or not research involving ANT to generate human embryonic stem cells
could be supported with federal funds.
Dedifferentation of Somatic Cells. The fourth method identified by the
President’s Council on Bioethics involves the dedifferentiation of somatic cells,
literally reprogramming or winding back the clock on cell development to produce
cells with the capabilities of embryonic stem cells. In August 2005, researchers at
Harvard announced qualified success at producing a hybrid cell that has some of the
characteristics of an embryonic stem cell.23 The Harvard group fused human skin
cells with human embryonic stem cells, but the process is very inefficient — 50
20
Ibid., p. 47.
21
The President’s Council on Bioethics, White Paper, p. 41.
22
Ibid., p. 37.
23
Rick Weiss, “Skin Cells Converted to Stem Cells,” The Washington Post, Aug. 22, 2005,
p. A1.
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million skin cells and 50 million embryonic stem cells yielded only 10 to 20 fused
cells — and unfortunately all the hybrid cells have twice the normal amount of
DNA. However, Yuri Verlinski and his team at the Reproductive Genetics Institute
in Chicago claim to have created 10 patient-matched embryonic stem cell lines,
called stembrids, with the normal amount of DNA. First the nucleus, which contains
the DNA, is removed from the human embryonic stem cells and then these
enucleated cells are fused with cells from a patient.24 Alan Trounson at Monash
University in Melbourne, Australia, is working on a similar method involving cell
fusion.25
Because embryos are not involved, federal funding for research on this method
would presumably not be blocked by the Dickey Amendment. However, the
President’s Council on Bioethics expresses some concern that dedifferentiation might
proceed too far, resulting in the functional equivalent of an embryo. This possibility
would raise serious ethical issues for some, and presumably the Dickey Amendment
may again preclude the use of this method in the production of human embryonic
stem cells for research. Moreover, such an embryo would be a clone of the
individual who donated the somatic cell and any attempt to “save” such an embryo
through the implantation in a woman’s uterus would raise additional moral and
ethical questions.
Stem Cells from Adult Tissue or Umbilical Cord Blood
Stem cells obtained from adult organisms are also the focus of research. There
have been a number of recent publications on the abilities and characteristics of adult
stem cells from a variety of different sources, such as bone marrow and the umbilical
cord following birth. In fact, bone marrow transplantation, a type of adult stem cell
therapy, has been used for 30 years to successfully treat patients for a variety of
blood-related conditions. Several private companies (such as MorphoGen,
NeuralStem, Osiris Therapeutics, StemSource, ViaCell) are working on additional
therapeutic uses of adult stem cells.
Some advocate that adult instead of embryonic stem cell research should be
pursued because they believe the derivation of stem cells from either IVF embryos
or aborted fetuses is ethically unacceptable. Others believe that adult stem cells
should not be the sole target of research because of important scientific and technical
limitations. Adult stem cells may not be as long lived or capable of as many cell
divisions as embryonic stem cells. Also, adult stem cells may not be as versatile in
developing into various types of tissue as embryonic stem cells, and the location and
rarity of the cells in the body might rule out safe and easy access. For these reasons,
many scientists argue that both adult and embryonic stem cells should be the subject
of research, allowing for a comparison of their various capabilities.
24
Michael LePage and Rowan Hooper, “Double Triumph in Stem Cell Quest,” New
Scientist, May 28, 2005, p. 8.
25
Rick Weiss, “Stem Cell Advances May Make Moral Issue Moot,” The Washington Post,
June 6, 2005, p. A7.
CRS-8
Potential Applications of Stem Cell Research
Stem cells provide the opportunity to study the growth and differentiation of
individual cells into tissues. Understanding these processes could provide insights
into the causes of birth defects, genetic abnormalities, and other disease states. If
normal development were better understood, it might be possible to prevent or
correct some of these conditions. Stem cells could be used to produce large amounts
of one cell type to test new drugs for effectiveness and chemicals for toxicity. Stem
cells might be transplanted into the body to treat disease (diabetes, Parkinson’s
disease) or injury (e.g., spinal cord). The damaging side effects of medical treatments
might be repaired with stem cell treatment. For example, cancer chemotherapy
destroys immune cells in patients, decreasing their ability to fight off a broad range
of diseases; correcting this adverse effect would be a major advance.
Before stem cells can be applied to human medical problems, substantial
advances in basic cell biology and clinical technique are required. In addition, very
challenging regulatory decisions will be required on the individually created tissuebased therapies resulting from stem cell research. Such decisions would likely be
made by the Center for Biologics Evaluation and Research (CBER) of the Food and
Drug Administration (FDA). The potential benefits mentioned above would be likely
only after many more years of research. Technical hurdles include developing the
ability to control the differentiation of stem cells into a desired cell type (like a heart
or nerve cell) and to ensure that uncontrolled development, such as a cancerous
tumor, does not occur. Some experiments may involve the creation of a chimera, an
organism that contains two or more genetically distinct cell types, from the same
species or different species.26 If stem cells are to be used for transplantation, the
problem of immune rejection must also be overcome. Some scientists think that the
creation of many more embryonic stem cell lines will eventually account for all the
various immunological types needed for use in tissue transplantation therapy. Others
envision the eventual development of a “universal donor” type of stem cell tissue,
analogous to a universal blood donor.
However, if the SCNT technique (cloning) was employed using a cell nucleus
from the patient, stem cells created via this method would be genetically identical to
the patient, would presumably be recognized by the patient’s immune system, and
thus would avoid any tissue rejection problems that could occur in other stem cell
therapeutic approaches. Because of this, many scientists believe that the SCNT
technique may provide the best hope of eventually treating patients using stem cells
for tissue transplantation.
26
Chimeras have been created by scientists in a variety of different ways and have been the
subject of research studies for many years. Human chimeras occur naturally when two eggs
become fertilized and, instead of developing into twins, they fuse in the uterus creating a
single embryo with two distinct sets of genes. For one example, see Constance Holden,
“Chimera on a Bike?” Science, June 24, 2005, p. 1864.
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Current Federal Regulatory Landscape
The Dickey Amendment
Prior to an August 2001 Bush Administration decision (see below), no federal
funds had been used to support research on stem cells derived from either human
embryos or fetal tissue.27 The work at the University of Wisconsin and Johns
Hopkins University was supported by private funding from the Geron Corporation.
Private funding for experiments involving embryos was required because Congress
attached a rider to legislation that affected FY1996 National Institutes of Health
(NIH) funding. The rider, an amendment originally introduced by Representative Jay
Dickey, prohibited HHS from using appropriated funds for the creation of human
embryos for research purposes or for research in which human embryos are
destroyed. The Dickey Amendment language has been added to each of the Labor,
HHS, and Education appropriations acts for FY1997 through FY2006.28 For
FY2006, the provision is found in Section 509 of the Labor, HHS and Education, and
Related Agencies Appropriations Act, 2006 (P.L.109-149). It states that:
(a) 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(b) and Section 498(b) of the
Public Health Service Act (42 U.S.C. 289g(b)).
(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 [the Human
Subject Protection regulations] as of the date of enactment of this Act, that is
derived by fertilization, parthenogenesis, cloning, or any other means from one
or more human gametes [sperm or egg] or human diploid cells [cells that have
two sets of chromosomes, such as somatic cells].
There is no similar federal prohibition on fetal tissue research; however, other
restrictions do apply.
Clinton Administration Stem Cell Policy
Following the November 1998 announcement on the derivation of human
embryonic stem cells, NIH requested a legal opinion from HHS on whether federal
27
However, federal funds have been provided for research on both human and animal adult
stem cells and animal embryonic stem cells.
28
The rider language has not changed significantly from year to year (however there was a
technical correction in P.L. 109-149). The original rider can be found in Section 128 of P.L.
104-99; it affected NIH funding for FY1996 contained in P.L. 104-91. 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: FY1997, P.L. 104-208; FY1998, P.L. 10578; FY1999, P.L. 105-277; FY2000, P.L. 106-113; FY2001, P.L. 106-554; FY2002, P.L.
107-116; FY2003, P.L. 108-7; FY2004, P.L. 108-199; and, FY2005, P.L. 108-447.
CRS-10
funds could be used to support research on human stem cells derived from embryos.
The January 15, 1999, response from HHS General Counsel Harriet Rabb found that
the Dickey Amendment would not apply to research using human stem cells “because
such cells are not a human embryo within the statutory definition.” The finding was
based, in part, on the determination by HHS that the statutory ban on human embryo
research defines an embryo as an organism that when implanted in the uterus is
capable of becoming a human being. Human stem cells are not and cannot develop
into an organism; they lack the capacity to become organisms even if they are
transferred to a uterus. As a result, HHS maintained that NIH could support research
that uses stem cells derived through private funds, but could not support research that
itself, with federal funds, derives stem cells from embryos because of the federal ban
in the Dickey Amendment.
Shortly after the opinion by the HHS General Counsel was released, NIH
disclosed that the agency planned to fund research on stem cells derived from human
embryos once appropriate guidelines were developed and an oversight committee
established. NIH Director Harold Varmus appointed a working group that began
drafting guidelines in April 1999. Draft guidelines were published in the Federal
Register on December 2, 1999. About 50,000 comments were received during the
public comment period, which ended February 22, 2000. On August 25, 2000, NIH
published in the Federal Register final guidelines on the support of human
embryonic stem cell research. The guidelines stated that studies utilizing “stem cells
derived from human embryos may be conducted using NIH funds only if the cells
were derived (without federal funds) from human embryos that were created for the
purposes of fertility treatment and were in excess of the clinical need of the
individuals seeking such treatment.” Under the guidelines, NIH would not fund
research directly involving the derivation of human stem cells from embryos; this
was prohibited by the Dickey Amendment.
Other areas of research ineligible for NIH funding under the guidelines include
(1) research in which human stem cells are utilized to create or contribute to a human
embryo; (2) research in which human stem cells are combined with an animal
embryo; (3) research in which human stem cells are used for reproductive cloning of
a human; (4) research in which human stem cells are derived using somatic cell
nuclear transfer, i.e., the transfer of a human somatic cell nucleus into a human or
animal egg; (5) research utilizing human stem cells that were derived using somatic
cell nuclear transfer; and (6) research utilizing stem cells that were derived from
human embryos created for research purposes, rather than for infertility treatment.
NIH began accepting grant applications for research projects utilizing human
stem cells immediately following publication of the guidelines; the deadline for
submitting a grant application was March 15, 2001. All such applications were to be
reviewed by the NIH Human Pluripotent Stem Cell Review Group (HPSCRG),
which was established to ensure compliance with the guidelines. James Kushner,
director of the University of Utah General Clinical Research Center, served briefly
as chair of the HPSCRG. Applications would also have undergone the normal NIH
CRS-11
peer-review process.29 The first meeting of the HPSCRG was scheduled for April 25,
2001. The HPSCRG was to conduct an ethical review of human pluripotent stem
cell lines to determine whether the research groups involved had followed the NIH
guidelines in deriving the cell lines. However, in mid April 2001, HHS postponed
the meeting until a review of the Clinton Administration’s policy decisions on stem
cell research was completed by the new Bush Administration.30 According to media
sources, the 12 HPSCRG members, whose names were not made public, represented
a wide range of scientific, ethical and theological expertise and opinion, as well as
at least one “mainstream Catholic.”31
The Bush Administration conducted a legal review of the policy decisions made
during the Clinton Administration regarding federal support of stem cell research, as
well as a scientific review, prepared by NIH, of the status of the research and its
applications. The scientific review was released on July 18, 2001, at a hearing on
stem cell research held by the Senate Appropriations Subcommittee on Labor, Health
and Human Services and Education.32 The NIH report did not make any
recommendations, but argued that both embryonic and adult stem cell research
should be pursued.
Bush Administration Stem Cell Policy
On August 9, 2001, President Bush announced that for the first time federal
funds would be used to support research on human embryonic stem cells, but funding
would be limited to “existing stem cell lines where the life and death decision has
already been made.”33 President Bush stated that the decision “allows us to explore
the promise and potential of stem cell research without crossing a fundamental moral
line, by providing taxpayer funding that would sanction or encourage further
destruction of human embryos that have at least the potential for life.” The President
29
According to media sources, as of Apr. 2001 only three grant applications had been
submitted to NIH, and one was subsequently withdrawn. (Washington FAX, Apr. 19, 2001.)
Presumably, scientists were reluctant to invest the time and effort into preparing the
necessary paperwork for the NIH grant application process when the prospects of receiving
federal funding were uncertain under the new Bush Administration. (P. Recer, “Stem Cell
Studies Said Hurt by Doubt,” AP Online, May 2, 2001.) In a related development, one of
the leading U.S. researchers on stem cells, Roger Pederson of the University of California,
San Francisco, decided to move his laboratory to the United Kingdom for “the possibility
of carrying out my research with human embryonic stem cells with public support.” (Aaron
Zitner, “Uncertainty Is Thwarting Stem Cell Researchers,” Los Angeles Times, July 16,
2001, pp. A1, A8.) Human embryonic stem cell research was approved overwhelmingly by
the House of Commons in Dec. 2000 and the House of Lords in Jan. 2001.
30
Rick Weiss, “Bush Administration Order Halts Stem Cell Meeting; NIH Planned Session
to Review Fund Requests,” Washington Post, Apr. 21, 2001, p. A2.
31
Ibid.
32
National Institutes of Health, Department of Health and Human Services. Stem Cells:
Scientific Progress and Future Research Directions, June 2001. The NIH scientific report
can be found at [http://stemcells.nih.gov/info/scireport/].
33
The Aug. 9, 2001, Remarks by the President on Stem Cell Research can be found at
[http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html].
CRS-12
also stated that the federal government would continue to support research involving
stem cells from other sources, such as umbilical cord blood, placentas, and adult and
animal tissues, “which do not involve the same moral dilemma.”
Under the Bush policy, federal funds may only be used for research on existing
stem cell lines that were derived (1) with the informed consent of the donors; (2)
from excess embryos created solely for reproductive purposes; and (3) without any
financial inducements to the donors.34 NIH was tasked with examining the derivation
of all existing stem cell lines and creating a registry of those lines that satisfy the
Bush Administration criteria. According to the White House, this will ensure that
federal funds are used to support only stem cell research that is scientifically sound,
legal, and ethical. Federal funds will not be used for (1) the derivation or use of stem
cell lines derived from newly destroyed embryos; (2) the creation of any human
embryos for research purposes; or (3) the cloning of human embryos for any purpose.
Agency Regulation: FDA and NIH
Many entities and individuals that conduct research on humans (“human
subjects” research) are both federally and institutionally regulated. Ex vivo embryos
(those not in a uterus) are not considered “human subjects” for these purposes,
though federally funded research on them is regulated by the Dickey Amendment as
described above. Stem cells and stem cell lines are not considered “human subjects,”
nor are they governed by the Dickey Amendment.
Two HHS agencies, FDA and NIH, regulate some aspects of stem cell research,
even if research on stem cell lines is not classified as “human subjects” research.
FDA, the agency that ensures the safety and efficacy of food, drugs, medical devices
and cosmetics, regulates stem cell research aimed at the development of any
“product” subject to its approval. NIH, the medical and behavioral research agency
within HHS, regulates stem cell research that it funds in compliance with President
Bush’s 2001 policy. In accordance, NIH has created a Human Embryonic Stem Cell
Registry that lists the human embryonic stem cell lines that meet the eligibility
criteria as outlined in the Bush Administration stem cell policy.
FDA Regulation. All of the human embryonic stem cell lines listed on the
NIH Human Embryonic Stem Cell Registry (see Table 2) have been grown on beds
of mouse “feeder” cells. The mouse cells secrete a substance that prevents the human
embryonic stem cells from differentiating into more mature cell types (nerve or
muscle cells). Infectious agents, such as viruses, within the mouse feeder cells could
transfer into the human cells. If the human cells were transplanted into a patient,
these infected human cells may cause disease in the patient which could be
transmitted to close contacts of the patient and eventually to the general population.
Public health officials and regulatory agencies such as the FDA are specifically
concerned about retroviruses, which may remain hidden in the DNA only to cause
disease many years later, as well as any unrecognized agents which may be present
in the mouse cells.
34
The White House, Fact Sheet on Embryonic Stem Cell Research, Aug. 9, 2001, found at
[http://www.whitehouse.gov/news/releases/2001/08/20010809-1.html].
CRS-13
The FDA defines “xenotransplantation” as “any procedure that involves the
transplantation, implantation, or infusion into a human recipient of either (a) live
cells, tissues, or organs from a nonhuman source, or (b) human body fluids, cells,
tissues or organs that have had ex vivo contact with live nonhuman animal cells,
tissues or organs.”35 So transplantation therapy involving Bush approved stem cell
lines, which all have been exposed to mouse feeder cells, would constitute
xenotransplantation. Xenotransplantation products are subject to regulation by the
FDA under Section 351 of the Public Health Service Act (42 USC 262) and the
Federal Food, Drug and Cosmetic Act (21 USC 321 et seq.). FDA has developed
guidance documents and the U.S. Public Health Service has developed guidelines on
infectious disease issues associated with xenotransplantation.36
During a Senate hearing on stem cell research held by the Health, Education,
Labor and Pensions Committee on September 5, 2001, HHS Secretary Thompson
stated that the FDA is overseeing 17 investigational protocols involving
xenotransplantation in other areas of clinical research that involve patients.
Therefore, the xenotransplantation-related public health concerns over the human
embryonic stem cell lines may not necessarily preclude the development of
treatments for patients. While the problems presented by xenotransplantation for
clinical research are neither unique to stem cell research nor insurmountable, many
scientists believe it will be preferable to use sterile cell lines when attempting to treat
patients via stem cell transplantation, and scientists have been successful in
developing human embryonic stem cells that can be maintained without the use of
mouse feeder cells.37
NIH Research Funding and Stem Cell Registry. The August 9, 2001,
Bush Administration policy statement on stem cell research and the NIH Stem Cell
Registry effectively replaced the NIH stem cell guidelines that were developed under
the Clinton Administration and never fully implemented. Grant proposals for
embryonic stem cell research undergo only the normal peer-review process without
the added review of the HPSCRG as had been specified under the Clinton NIH stem
cell guidelines. In February 2002, NIH announced the approval of the first
expenditures for research on human embryonic stem cells. Funding for stem cell
research by NIH is shown in Table 1. The NIH website provides additional
information about current stem cell activities and funding opportunities.38
The NIH Human Embryonic Stem Cell Registry lists stem cell lines that are
eligible for use in federally funded research and currently available to be shipped to
35
Xenotransplantation Action Plan: FDA approach to the regulation of xenotransplantation.
Available at [http://www.fda.gov/cber/xap/xap.htm].
36
These documents are available at [http://www.fda.gov/cber/xap/xap.htm].
37
National Institutes of Health, Department of Health and Human Services, Stem Cells:
Scientific Progress and Future Research Directions, June 2001, pp. 95-96; Susanne Rust,
“UW Grows Animal-Free Stem Cell Lines,” The Milwaukee Journal Sentinel, Jan. 2, 2006,
p. A1.
38
See [http://stemcells.nih.gov/research/funding/].
CRS-14
scientists.39 As shown in Table 2, the NIH registry originally listed universities and
companies that had derived a total of 78 human embryonic stem cell lines which
were eligible for use in federally funded research under the August 2001 Bush
Administration policy. However, many of these stem cell lines were found to be
either unavailable or unsuitable for research. As of August 11, 2004, the NIH
registry listed a total of 22 stem cell lines available from seven sources.
Table 1. National Institutes of Health Funding
($ in millions)
FY99
FY00
FY01 FY02
FY03
FY04 FY05
FY06
Stem cell research
$226
$256
$306
$387
$517
$553
$566
$568
Human embryonic
stem cell research
(0)
(0)
(0)
(10.7)
(20)
(24)
(24.3)
N/A
Source: NIH Budget Office, May 3, 2005.
Table 2. NIH List of Human Embryonic Stem Cell Lines
Eligible for Use in Federal Research
Number of stem cell
lines
Namea
Eligible
Available
BresaGen, Inc., Athens, GA
4
3
Cell & Gene Therapy Institute (Pochon CHA University), Seoul,
Korea
2
Cellaritis AB, Goteborg, Sweden
3
2
CyThera, Inc., San Diego, CA
9
0
ES Cell International, Melbourne, Australia
6
6
Geron Corporation, Menlo Park, CA
7
Goteborg University, Goteborg, Sweden
16
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 Center for Biological Sciences/Tata Institute of
Fundamental Research, Bangalore, India
3
Reliance Life Sciences, Mumbai, India
7
Technion University, Haifa, Israel
4
3
University of California, San Francisco, CA
2
2
Wisconsin Alumni Research Foundation, Madison, WI
5
5
78
22
Total
39
0
1
Information about the NIH Human Embryonic Stem Cell Registry is available at
[http://stemcells.nih.gov/research/registry/index.asp].
CRS-15
a. Entities in italics do not have stem cell lines available for shipment to U.S. researchers because of
a variety of scientific, regulatory and legal reasons. The zeros entered in the “Available”
column indicate that “the cells failed to expand into undifferentiated cell cultures.”
Concerns Over Access to Stem Cell Lines
Many scientists, disease advocates and others remain concerned that federally
supported research on human embryonic stem cells is limited to the number of cell
lines that meet the criteria of the August 9, 2001 Bush policy. As stated above,
currently 22 cell lines are available for research with federal dollars, and an
unpublished NIH report indicates that under a best case scenario, a total of 23 human
embryonic stem cell lines will ever be ready for use in research.40 Because the preAugust 9 cell lines were developed in the early days of human stem cell research
using older 1990s techniques, the cell lines not only have the problems of
xenotransplantion (described in the previous section on FDA regulation), but they are
harder to work with, not well characterized, and genetically unstable.
In reaction to the limitations imposed by the Bush policy, some U.S. research
groups have decided to develop additional human embryonic stem cell lines using
private funding.
Reproductive Genetics Institute
In June 2004, a team of scientists at the Reproductive Genetics Institute, a
private fertility clinic in Chicago, announced that they had isolated 50 new human
embryonic stem cell lines from frozen embryos that were donated by patients
following fertility treatment.41 By using genetic diagnosis techniques, the Chicago
team was able to create stem cell lines that carry the gene for muscular dystrophy as
well as stem cell lines with the gene for six other diseases.42 The new stem cell lines
are to be used to understand the origins of disease-related symptoms and to develop
and test new treatments.
Harvard Stem Cell Institute
In March 2004, a Harvard University laboratory headed by Douglas Melton
announced that using private research dollars they had isolated 17 new human
embryonic stem cell lines.43 One year later the Harvard team has increased that
40
Farhad Manjoo, “Thou Shalt Not Make Scientific Progress,” Salon.com, Mar. 25, 2004,
[http://www.salon.com/tech/feature/2004/03/25/stem_cells/index_np.html].
41
Gareth Cook, “Clinic in U.S. Isolates 50 Lines of Stem Cells,” Boston Globe, June 9,
2004, p. A1.
42
The six diseases are beta thalassemia, neurofibromatosis type 1, Marfan’s syndrome,
myotonic dystrophy, fragile X syndrome, and Fanconi’s anemia.
43
Rick Weiss and Justin Gillis, “New Embryonic Stem Cells Made Available,” Washington
Post, Mar. 4, 2004, p. A2.
CRS-16
number to 28 new human embryonic stem cell lines.44 In order to perform this work
it was necessary to build a new laboratory so that the group’s federally funded
research would be conducted separately from research on the new stem cell lines.
Likewise, although the Harvard stem cell lines are available for use by other
laboratories, any research using the new stem cell lines must be performed at a
facility that does not receive federal support. The Harvard group intends to raise
$100 million in private funding to establish a stem cell research institute in order to
continue the work begun by Melton and his group of scientists; as of March 2005 $26
million had been raised. In October 2004 media reports stated that researchers at the
newly formed Harvard Stem Cell Institute intend to produce cloned human embryos
for research studies on juvenile diabetes, Parkinson’s disease, and several other
diseases.45 In November 2003 Melton and collaborators submitted their proposal to
a Harvard committee composed of ethicists, scientists and public policy experts.
Permission to proceed with the research was granted in January 2005 provided that
approval was received from the Standing Committee on the Use of Human Subjects
in Research.46
Stanford Institute for Cancer/Stem Cell Biology
In December 2002, Stanford University announced that a gift of $12 million
from an anonymous donor would be used to establish an institute that will use
expertise in stem cell biology and cancer biology to develop novel treatments for
cancer and other diseases.47 The new institute is headed by Dr. Irving Weissman, a
Professor in Cancer Biology at Stanford. Scientists at the Institute for Cancer/Stem
Cell Biology and Medicine are developing new stem cell lines, some through the
process of SCNT, to study the disease process of a wide range of disorders including
cancer, diabetes, cardiovascular disease, autoimmune disease, allergies, and
neurological disorders such as Parkinson’s and Lou Gehrig’s disease. Initial studies
are performed in mice; however, the work may be extended to human cells and eggs.
The new stem cell lines may allow investigators to better understand the biological
and genetic basis of a disorder and thereby develop new treatments.
UCSF Developmental and Stem Cell Biology Program
In August 2002, the University of California at San Francisco established the
UCSF Developmental and Stem Cell Biology Program with a $5 million matching
grant from Andy Grove, the chairman of Intel Corporation. The program funds basic
studies (using both animal and human cells) in stem cell biology and their translation
into clinical practice with a goal of developing treatments for such diseases as
diabetes, cardiovascular disease, Parkinson’s disease, Alzheimer’s disease and spinal
44
Gareth Cook, “Harvard Provost OKs Procedure,” Boston Globe, Mar. 20, 2005, p. A29.
(Hereafter cited as Cook, “Harvard Provost OKs Procedure.”)
45
Gareth Cook, “Harvard Team Wants OK to Clone; Human-Cell Work Would Be First in
Nation,” Boston Globe, Oct. 13, 2004, p. A1.
46
47
Cook, “Harvard Provost OKs Procedure.”
For further information, see the Stanford University Medical Center website at
[http://mednews.stanford.edu/stemcellQA.html].
CRS-17
cord injury. UCSF and the University of Wisconsin are the only two universities in
the United States that have derived human embryonic stem cell lines that qualified
for inclusion on the NIH Stem Cell Registry. This past winter, the new UCSF stem
cell program announced it had met the Grove “Stem Cell Challenge” and had raised
the total funding for the program to more than $11 million in gifts and matching
funds. The program recently awarded $50,000 grants to four scientists who are
studying various aspects of stem cell biology.48
Worldwide Survey of Stem Cell Lines
A worldwide survey of laboratories conducted by the Boston Globe found that
as of May 23, 2004, 128 human embryonic stem cell lines had been created since
August 9, 2001; all would be ineligible for use in federally funded research under the
Bush policy on stem cell research.49 More lines are being created in laboratories
overseas than in the United States, according to the survey. The survey found that
94 were created in labs outside the United States and 34 were created in this country.
Of the 128 lines, 51 of the new stem cell lines are currently available for use, the
remaining cell lines are not available for a variety of technical or legal reasons. For
example, some cell lines have not yet been fully characterized to determine their
stability or suitability for research. However, eventually their status is to be
determined by using laboratory techniques. In Japan, stem cell lines are not allowed
to be shipped to laboratories in other countries. In the United Kingdom, stem cell
lines cannot be shipped abroad until they have been processed by the new UK Stem
Cell Bank.50
Congressional Letters on Bush Policy
In response to concerns over access to human embryonic stem cell lines, in April
2004, a group of over 200 Members of the House of Representatives sent a letter to
President Bush requesting that the Administration revise the current stem cell policy
and utilize the embryos that are created in excess of need during the treatment of
infertile couples.51 The letter points out that an estimated 400,000 frozen IVF
embryos52 “will likely be destroyed if not donated, with informed consent of the
couple, for research.” According to the letter,
48
UCSF News Office, UCSF Names First Director of its Stem Cell Biology Program, Apr.
26, 2004. See [http://pub.ucsf.edu/newsservices/releases/200404261/].
49
Gareth Cook, “94 New Cell Lines Created Abroad since Bush Decision,” Boston Globe,
May 23, 2004, p. A14.
50
For further information on the UK Stem Cell Bank, see [http://www.nibsc.ac.uk/divisions/
cbi/stemcell.html].
51
52
See [http://www.house.gov/degette/news/releases/040428.pdf].
A survey conducted in 2002 and published in 2003 by the Society for Assisted
Reproductive Technology and RAND determined that nearly 400,000 frozen embryos are
stored in the United States, but most are currently targeted for patient use. See David I.
Hoffman et al., “Cryopreserved Embryos in the United States and Their Availability for
Research,” Fertility and Sterility, vol. 79, May 2003, pp. 1063-1069.
CRS-18
scientists are reporting that it is increasingly difficult to attract new scientists to
this area of research because of concerns that funding restrictions will keep this
research from being successful. ... We have already seen researchers move to
countries like the United Kingdom, which have more supportive policies. In
addition, leadership in this area of research has shifted to the United Kingdom,
which sees this scientific area as the cornerstone of its biotech industry.
Under the direction of the White House, NIH Director Elias A. Zerhouni sent
a letter in response to the House Members which restates the Bush Administration
position against using federal funds for research involving the destruction of human
embryos.53 The letter from NIH Director Zerhouni did contain the following sentence
which some observers believe indicates a potential future policy shift: “And
although it is fair to say that from a purely scientific perspective more cell lines may
well speed some areas of human embryonic stem cell research, the president’s
position is still predicated on his belief that taxpayer funds should not ‘sanction or
encourage further destruction of human embryos that have at least the potential for
life.”54 Although White House spokesperson Claire Buchan stated that the sentence
does not indicate the president’s position has changed, supporters of stem cell
research point out that it concedes that science could benefit from additional stem
cell lines and that the president’s position now rests solely on ethical arguments.
A letter signed by 58 Senators urging President Bush to expand the current
federal policy concerning embryonic stem cell research was sent on June 4, 2004.55
The letter states that “despite the fact that U.S. scientists were the first to derive
human embryonic stem cells, leadership in this area of research is shifting to other
countries such as the United Kingdom, Singapore, South Korea and Australia.”
On July 14, 2004, HHS Secretary Thompson announced in a letter to Speaker
of the House Dennis Hastert that NIH would establish Centers of Excellence in
Translational Stem Cell Research.56 The new centers will be funded by $18 million
in grants over a four year period and will investigate how stem cells can be used to
treat a variety of diseases. NIH will also create a National Embryonic Stem Cell
Bank that will collect in one location many of the stem cell lines that are eligible for
federal research funding. In the letter to Speaker Hastert, Secretary Thompson stated
that “before anyone can successfully argue the stem cell policy should be broadened,
we must first exhaust the potential of the stem cell lines made available with the
policy.”57 In reaction to the announcement, the President of the Coalition for the
Advancement of Medical Research stated that “creating a bank to house stem cell
53
Rick Weiss, “Bush’s Stem Cell Policy Reiterated, but Some See Shift,” The Washington
Post, May 16, 2004, p. A18.
54
Letter from Elias A. Zerhouni, Director, National Institutes of Health, to The Honorable
Diana DeGette and The Honorable Michael Castle, May 14, 2004.
55
See [http://feinstein.senate.gov/04Releases/r-stemcell-ltr.pdf].
56
Andrew J. Hawkins, “NIH Stem Cell Bank, Centers of Excellence Will Fast-Track
Translational Research, Says Thompson,” Washington FAX, July 15, 2004.
57
Ibid.
CRS-19
lines created before August 2001 does nothing to increase the wholly inadequate
supply of stem cell lines for research.”58
National Academies Guidelines
Because of the current lack of federal regulation, the National Academies
established in July 2004 the Committee on Guidelines for Human Embryonic Stem
Cell Research to develop voluntary guidelines for deriving, handling and using
human embryonic stem cells. The stated position of the National Academies is that
there should be a global ban on human reproductive cloning and therefore the
guidelines will focus only on therapeutic and research uses of human embryonic stem
cells and somatic cell nuclear transfer.
The Committee released its “Guidelines for Human Embryonic Stem Cell
Research” on April 26, 2005. The guidelines recommend that each institution
conducting human embryonic stem cell research establish an oversight committee,
including experts in the relevant areas of science, ethics and law, as well as members
of the public, to review all proposed experiments. The guidelines recommend that
a national panel also be established to oversee the issue in general on a continuing
basis. The guidelines state that culture of any intact embryo, regardless of derivation
method, for more than 14 days should not be permitted at the present time. The
insertion of any embryonic stem cells into a human embryo or the insertion of human
embryonic stem cells into a nonhuman primate embryo should also not be permitted.
Such an organism containing two or more genetically distinct cell types, from the
same species or different species, is often called a chimera. The guidelines state that
chimeric animals in which human embryonic stem cells have been introduced, at any
stage of development, should not be allowed to breed. The document also provides
guidance on informed consent of donors and states that there should be no financial
incentives in the solicitation or donation of embryos, sperm, eggs, or somatic cells
for research purposes.
State Actions on Embryonic Stem Cell Research
The Dickey Amendment restricts federal funding for embryo research; however,
states are the principal sources of direct regulation of non-federally funded embryo
research. State laws vary widely in their application and content.
State Embryonic and Fetal Research Laws59
Approaches to stem cell research policy range from laws in California,
Connecticut, Massachusetts and New Jersey, which encourage embryonic stem cell
research, including on cloned embryos, to South Dakota’s law, which strictly forbids
58
59
Ibid.
The information in this subsection was quoted from “State Embryonic and Fetal Research
Laws,” National Council of State Legislatures website, at [http://www.ncsl.org/programs/
health/genetics/embfet.htm#b], visited Dec. 22, 2005.
CRS-20
research on embryos regardless of the source. States that specifically permit
embryonic stem cell research have established guidelines for scientists, including
consent requirements and approval and review processes for projects.
Many states restrict research on aborted fetuses or embryos, but research is often
permitted with consent of the patient. Almost half of the states also restrict the sale
of fetuses or embryos. Louisiana is the only state that specifically prohibits research
on in vitro fertilized (IVF) embryos. Illinois and Michigan also prohibit research on
live embryos. Finally, Arkansas, Indiana, Iowa, Michigan, North Dakota and South
Dakota prohibit research on cloned embryos. Virginia’s law also may ban research
on cloned embryos, but the statute may leave room for interpretation because human
being is not defined. Therefore, there may be disagreement about whether human
being includes blastocysts, embryos or fetuses. California, Connecticut,
Massachusetts, New Jersey and Rhode Island also have human cloning laws. These
laws prohibit cloning only for the purpose of initiating a pregnancy, or reproductive
cloning, but allow cloning for research.
Several states limit the use of state funds for cloning or stem cell research.
Missouri forbids the use of state funds for reproductive cloning but not for cloning
for the purpose of stem cell research, and Arizona prohibits the use of public monies
for reproductive or therapeutic cloning. Nebraska limits the use of state funds for
embryonic stem cell research. Restrictions only apply to state healthcare cash funds
provided by tobacco settlement dollars. State funding available under Illinois
Executive Order 6 (2005) may not be used for reproductive cloning or for research
on fetuses from induced abortions. Other states have taken steps to fund embryonic
and adult stem cell research.
State Initiatives to Encourage Stem Cell Research
Despite federal policy, many states are moving forward with their own
initiatives to encourage or provide funding for stem cell research (in some cases
therapeutic cloning as well) in order to remain competitive and prevent the relocation
of scientists and biotechnology firms to other states or overseas. However, without
the central direction and coordinated research approach that the federal government
can provide, many are concerned that the states’ actions will result in duplication of
research effort among the states, a possible lack of oversight for ethical concerns and
ultimately a loss of U.S. preeminence in this important area of basic research.
California. In September 2002 California enacted the nation’s first law that
expressly permits and encourages research involving the derivation of human
embryonic stem cells and cloned embryos (California Health and Safety Code §
123440, 24185, 12115-7, 125300-320). The law does not authorize practices that
were previously proscribed, but instead provides assurances to researchers and
sponsors hesitant to invest in embryonic stem cell research since the 2001 Bush
policy took effect. The law has reportedly enticed several prominent researchers to
move to California from other states.
In November 2004, with the endorsement of Governor Arnold Schwarzenegger,
Californians passed Proposition 71 with 59% of the vote, amending the state
Constitution to facilitate embryonic stem cell research. Proposition 71 establishes
CRS-21
a California Institute for Regenerative Medicine (CIRM), and generates $3 billion in
state-bond funding for embryonic stem cell research over the next 10 years. Ninety
percent of the funds will be spent on research, 10% will go toward facilities. All
grants will be limited to scientists and facilities in California. Funds may not be used
for reproductive cloning but may be used for therapeutic cloning.60 In early May
2005 the 29 member governing board of CIRM, the Independent Citizens Oversight
Committee (ICOC), announced that CIRM would be located in San Francisco.
However, CIRM has had a few legislative and legal challenges that are holding
up the bond sale. CIRM officials reached a tentative agreement with state legislators
regarding concerns over conflicts of interest and the need for open meetings: Other
concerns involving intellectual property and patent rights are yet to be resolved.61
Lawsuits have been filed by various groups: one claims that individuals on the ICOC
have conflicts of interest that impede the ICOC’s ability to fairly allocate money; a
second charges that CIRM violates the state constitution because it lacks proper state
oversight; and the third claims that the CIRM program violates the rights of human
embryos.62 The first two lawsuits have been consolidated and the trial is scheduled
to begin in state court on February 27, 2006. Resolution of the lawsuits could take
many months.63 CIRM is currently funded by a $3 million state loan and a $5 million
grant from the Dolby Foundation; funding will run out in May 2006.64 CIRM hopes
to raise $50 million in bridge financing early in 2006 from philanthropic groups and
wealthy individuals.
Connecticut. In January 2005, Connecticut Governor M. Jodi Rell proposed
$20 million of the $315 million state budget surplus for human embryonic stem cell
research.65 Both Yale University and the University of Connecticut at Storrs have
labs engaged in stem cell research. In March 2005 the Storrs lab announced that, in
collaboration with Chinese scientists, it has become the first to create embryonic
stem cells from cloned cattle embryos.66 The Storrs lab wants to begin a human
therapeutic cloning program. Lab chief Xiangzhong “Jerry” Yang, threatened to
leave for China if state funding was not provided. On June 15, 2005, Governor Rell
signed legislation providing $100 million over 10 years for human embryonic stem
60
Proposition 71, at [http://www.voterguide.ss.ca.gov/propositions/prop71text.pdf].
61
Carl T. Hall, “Stem Cell Group Ready to Disburse Funds; Institute, Critics Near
Agreement on Conflicts, Meetings,” San Francisco Chronicle, July 2, 2005, p. B1.
62
Steve Johnson, “Lawsuits Will Delay Stem-Cell Research,” The Mercury News, Aug. 2,
2005, p. 1.
63
Andrew Pollack, “California’s Stem Cell Program is Hobbled but Staying the Course,”
The New York Times, Dec. 10, 2005, p. B1.
64
Ibid.
65
Marcel Przymusinski and Susie Poppick, “Locals Seek More Stem Cell Funds,” Yale
Daily News, Jan. 26, 2005.
66
William Hathaway, “State Lab Nears Cloning Goal, UConn Scientist: Creating Human
Embryonic Cells is Within Sight,” The Hartford Courant, Mar. 25, 2005, p. A1.
CRS-22
cell research.67 The state stem cell advisory committee is scheduled to approve
research grants by the spring of 2006.68
Florida. An amendment to the Florida constitution that would provide $20
million per year for ten years for embryonic stem cell research has been submitted to
the state Division of Elections for approval as a ballot initiative. The initiative —
sponsored by a Palm Beach County group Floridians for Stem Cell Research and
Cures — also needs the approval of the Florida Supreme Court. If the initiative is
to appear on the 2006 ballot, supporters must collect 611,000 signatures by
December 31, 2005. Because this proved unrealistic, they are now trying for the
2008 ballot.69
Illinois. Following the defeat of several stem cell research measures during the
spring session of the Illinois legislature, on July 12, 2005, Governor Rod Blagojevich
signed an executive order authorizing $10 million in funding for adult, cord blood,
and embryonic stem cell research. The money was added to the budget of the Illinois
Department of Public Health.70 In August 2005, as Missouri legislators were
debating whether to ban such research, Governor Blagojevich sent a letter to
Missouri scientists and researchers inviting them to move to Illinois and find the
“freedom to explore the promise of stem cell research.”71
Indiana. In May 2005 Indiana enacted legislation that prohibits reproductive
and therapeutic cloning and creates an adult stem cell research center at Indiana
University but did not provide any state funding for the center.
Maryland. On March 28, 2005, in an 81-53 vote the Maryland House
approved a bill that would provide $23 million each year for human embryonic stem
cell research, including therapeutic cloning, beginning in FY2007. However, the bill
died in the Senate in April 2005 on the last day of the legislative session due to a
threatened filibuster.72 On January 10, 2006, Governor Robert L. Ehrlich announced
that he will propose spending $20 million in state funding on stem cell research.
Decisions on whether the money will be spent on human embryonic stem cells or less
67
Fran Silverman, “$100 million Commitment for Stem Cell Research,” The New York
Times, June 19, 2005, p. 2.
68
William Hathaway, “Stem Cell Funding may Thwart Expert as UConn Splits Up Research
Money to Open Up the Process,” The Hartford Courant, Dec. 23, 2005, p. A1.
69
Josh Hafenbrack, “Stem Cell Showdown Heats Up,” South Florida Sun-Sentinel, Dec. 6,
2005, p. 1A.
70
John Chase, “Governor Slips Stem-Cell Grant by Lawmakers,” Chicago Tribune, July 13,
2005, p. 1.
71
Paul Hampel, “Illinois Governor Invites Stem Cell Research,” St. Louis Post Dispatch,
Aug. 29, 2005, p. B1.
72
David Nitkin, Sumathi Reddy, and Ivan Penn, “Stem-Cell Bill Dies in Senate Threatened
Filibuster on Research Funding Spelled End For Legislation,” Baltimore Sun, Apr. 12, 2005,
p. A1.
CRS-23
controversial forms of stem cell research will be made by a state-created technology
development corporation.73
Massachusetts. In March 2005, the Massachusetts legislature overwhelming
approved a bill (Senate 35-2, House 117-37) that clarifies state law on research
involving human embryonic stem cells and therapeutic cloning and ensures that such
research is permitted within a regulatory framework. On May 27, 2005, Governor
Mitt Romney vetoed the stem cell bill; he is opposed to the therapeutic cloning
portion of the bill. On May 31, 2005, the House overrode the Governor’s veto on a
vote of 112 to 42, the Senate did the same later that day on a vote of 35-2.74
Mechanisms for state funding of research are under consideration.
Missouri. A petition drive is underway to place an initiative on the November
2006 state wide ballot that would support stem cell research. The amendment to the
state constitution was proposed by the Missouri Coalition for Lifesaving Cures;
former U.S. Senators Thomas Eagleton and John Danforth are members of the
coalition.75 Supporters of the initiative include Governor Matt Blunt, the Lance
Armstrong Foundation, the Christopher Reeve Foundation, the Parkinson’s Action
Network and the American Diabetes Foundation. The amendment would ban human
reproductive cloning but protect all stem cell research permitted by federal law,
including SCNT or therapeutic cloning. The petition is in response to efforts in the
state legislature that would criminalize such research in the state. The Stowers
Institute for Medical Research, a private institution in Kansas City with a $2 billion
endowment, has stopped hiring and delayed a $300 million expansion until the status
of research is resolved either by the legislature or by the public via the petition.
Instead, Stowers made a $6 million donation to Harvard Stem Cell Institute in 2005.76
A lawsuit filed in November 2005 asks the court to block the petition signing
because it claims that the ballot language, which states the amendment would “ban
human cloning or attempted human cloning,” is deceptive.77 Many abortion
opponents and others opposed to embryonic stem cell research believe that
therapeutic cloning creates a human life, even though it may consist of only one or
a few hundred cells, and therefore the amendment is sanctioning a type of human
cloning. A hearing is set for January 19, 2006. The suit was filed by the Arizonabased Alliance Defense Fund on behalf of Missourians Against Human Cloning. The
Missouri Catholic Conference and the Missouri Baptist Convention joined the case
in December 2005.
73
John Wagner, “Ehrlich Hopes to Spend $20 Million on Stem Cell Research,” The
Washington Post, Jan. 11, 2006, p. B2.
74
Raphael Lewis, “Stem Cell Bill Override Turns to Talk of Research Support,” The Boston
Globe, June 1, 2005, p. A1.
75
Matthew Franck, “Court Allows Two Church Groups to Join Stem Cell Research
Lawsuit,” St. Louis Post Disatch, Dec. 16, 2006, p. C7.
76
Peter Slevin, “Mo. May Vote on Stem Cell Research,” The Washington Post, Dec. 25,
2005, p. A4.
77
“Judge to Allow Stem Cell Debate,” The Kansas City Star, Dec. 26, 2005, p. 3.
CRS-24
New Jersey. In January 2004 New Jersey became the second state in the
nation to enact a law that specifically permits embryonic stem cell research. The
state law bans human reproductive cloning but permits the use of cloned embryos for
stem cell research (NJ Permanent Statutes, Title 26:2Z-2). Like the 2002 California
law, New Jersey’s stem cell statute provides assurances to researchers and does not
contradict the 2001 Bush policy which only limits federal funding.
In May 2004, Governor James McGreevey signed a bill to create the first
state-funded embryonic stem cell research center, a $25 million endeavor.78 The
legislature funded the measure on June 25, 2004, passing a state budget that allocates
$11.5 million to the newly chartered Stem Cell Institute of New Jersey.79
In a January 11, 2005, State of the State speech, Acting Governor Richard
Codey called for $380 million for stem cell research.80 The plan entails using $150
million to construct a facility for the Stem Cell Institute of New Jersey using money
from the state’s share of the national tobacco settlement. The remaining $230 million
for research grants would be raised via a bond initiative on the November 2005 ballot
which would require legislative approval. In June 2005 the state Senate passed a bill
which would authorize $150 million for the construction of a state stem cell institute
with the proceeds of cigarette tax securitization bonds.81 In December 2005 the state
Senate passed a bill that would place a $350 million bond initiative on the November
2006 ballot. The measure would provide funds for stem cell research in New Jersey
over a seven year period at $50 million per year.82 Both bills expired at the end of
the legislative session.
In December 2005 the New Jersey Commission on Science and Technology
announced that it would be awarding 17 grants on stem cell research totaling $5
million; three of the grants focus on human embryonic stem cell research.83
Ohio. The Center for Stem Cell and Regenerative Medicine was started in
2003 with a $19.5 million in funding from the state of Ohio.84 The Center is
composed of researchers from Case Western Reserve University, University
Hospitals of Cleveland, The Cleveland Clinic Foundation, Athersys, Inc., and Ohio
State University. The Center uses adult human stem cells and tissue engineering
technology to develop treatments for human disease. On June 30, 2005, Governor
Bob Taft vetoed language in the state budget that would have prevented state
78
“U.S. States Making Stem Cell Policies,” Bionews, no. 258, May 5, 2004.
79
Barbara Mantel, “Analysis: New Jersey Is First State to Fund Research on Stem Cell,”
NPR: All Things Considered, June 25, 2004.
80
Andrew J. Hawkins, “NJ Stem Cell Initiative Supports Research Institute, Grant Making,
Governor Codey Says,” Washington Fax, Jan. 12, 2005.
81
[http://www.njleg.state.nj.us/2004/Bills/S3000/2649_S1.PDF]
82
[http://www.njleg.state.nj.us/2004/Bills/S3000/2913_S1.PDF]
83
Kitta MacPherson, “NJ Stem Cell Research Takes a First Step as State Awards $5M,” The
Star-Ledger, Dec. 17, 2005, p. 1.
84
[http://ora.ra.cwru.edu/stemcellcenter/].
CRS-25
research funds from being used for human embryonic stem cell research. The veto
allows state funds to be used for research on human embryonic stem cell lines that
existed before August 2001 in accordance with Bush Administration policy.85
Virginia. In March 2005 Virginia enacted legislation that would fund research
on adult stem cells via state appropriations to the Christopher Reeve Stem Cell
Research Fund. A joint subcommittee was also established to examine the medical,
ethical, and scientific policy implications of stem cell research.
Wisconsin. In response to the California initiative, Wisconsin Governor Jim
Doyle announced on November 17, 2004, that the state was providing nearly $750
million in public-private investment for biotechnology, health sciences and stem cell
research over the next several years.86 The Wisconsin investment strategy includes
$375 million for a new research institute, the Wisconsin Institute for Discovery, on
the University of Wisconsin, Madison campus. WiCell, a foundation that is using
private and federal funds to support stem cell research, will be a part of the Institute.
The state also plans to invest $105 million over the next five years in research,
education, and public health efforts at the University of Wisconsin Medical School
and the Medical College of Wisconsin for stem cell research as well as regenerative
medicine, molecular medicine, neuroscience, and cancer research.
In June 2005 the Wisconsin State Assembly passed a bill (59 to 38) prohibiting
both reproductive and therapeutic cloning; the Senate passed the bill (21 to 12) in
September 2005. Governor Doyle vetoed the bill on November 3, 2005, stating that
the “bill would criminalize some of the most promising scientific techniques used by
stem cell researchers, not only potentially delaying cures to some of humanity’s
oldest and deadliest diseases but also costing Wisconsin jobs in the future.”87
Other states, including Delaware, Pennsylvania, Texas, New York, and Florida,
are considering available options to remain competitive and prevent the relocation
of their scientists and biotechnology firms.88 States such as Louisiana considered
competing bills, one of which would support ES research and one of which would
undermine it.89
85
“Ohio Governor Vetoes Stem Cell Budget Limitations,” Research Policy Alert, July 6,
2005.
86
[http://www.wisgov.state.wi.us/journal_media_detail_print.asp?prid=832].
87
[http://www.wisgov.state.wi.us/docview.asp?docid=5302].
88
Kelly Rayburn, “States Grapple with Stem Cell Research,” The Wall Street Journal, Dec.
24, 2004, p. A4; Martin Kasindorf, “Calif. Moves Fast on Stem Cell Grants,” USA Today,
Dec. 17, 2004, p. A3; Andrew J. Hawkins, “State Stem Cell Efforts Gain Momentum in
Wake of California’s Prop 71,” Washington Fax, Jan. 18, 2005.
89
“US Stem Cell News,” BioNews, June 20, 2005, at [http://www.bionews.org.uk/
new.lasso?storyid=2622], visited Sept. 1, 2005.
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Congressional Actions
Legislative action during the 109th Congress may include efforts to alter or
abolish the Dickey Amendment, during consideration of Labor, HHS, and Education
appropriations, in order to permit embryo research and the development of stem cell
lines with federal support. Also likely is passage of the Weldon bill, which passed
the House in the 107th and the 108th and stalled in the Senate. Given the changed
composition of the Senate, it is more likely that this legislation would move forward
for a vote in that body during the 109th Congress.
The 109th Congress addressed the issue of stem cell research in the Labor, HHS
and Education Appropriations Act, 2006 (P.L. 109-149) by again including the
Dickey Amendment, which has banned, since FY1996, almost all publically funded
human embryo research. In addition, the Science, Justice and Commerce
Appropriation Act, 2006 (P.L. 109-108) bars the Patent and Trademark Office from
spending money “to issue patents on claims directed to or encompassing a human
organism.” This restriction, which was first included in the Consolidated
Appropriations Act, 2004 (P.L. 108-199) and in the Consolidated Appropriations
Act, 2005 (P.L. 108-447), could potentially deter human stem cell research because
researchers might not be able to claim ownership of their work.
In FY2004, the Consolidated Appropriations Act, 2004 (P.L. 108-199) provided
$10,000,000 to establish a National Cord Blood Stem Cell Bank within the Health
Resources and Services Administration (HRSA). HRSA was directed to use
$1,000,000 to contract with the Institute of Medicine (IoM) to conduct a study that
would recommend the optimal structure for the cord blood program. The IoM study,
Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program, was
released on April 14, 2005. The blood cell forming stem cells found in cord blood
can be used as an alternative to bone marrow transplantation in the treatment of
leukemia, lymphoma, certain types of anemia, and inherited disorders of immunity
and metabolism. The report provides the logistical process for establishing a national
cord blood banking system, establishes uniform standards for cord blood collection
and storage, and provides recommendations on ethical and legal issues associated
with cord blood collection, storage and use. For FY2005, the Consolidated
Appropriations Act, 2005 (P.L. 108-447) provides $9,941,000 for the National Cord
Blood Stem Cell Bank Program in HRSA. For FY2006, the House did not provide
funding for this program, the Senate provided $9,859,000, and the final conference
report on the Labor-HHS-Education Appropriation Act, 2006 (H.R. 3010, H.Rept.
109-337) provided $4 million.
On May 24, 2005, the House passed H.R. 2520 (Christopher Smith), the Stem
Cell Therapeutic and Research Act of 2005, on a vote of 431-1. The Senate passed
the bill by voice vote, with an amendment in the nature of a substitute, on December
16, 2005, the House agreed to the Senate amendment on December 17 and the
President signed the measure on December 20 (P.L. 109-129). H.R. 2520 provides
for the collection and maintenance of human cord blood stem cells for the treatment
of patients and for research. It stipulates that amounts appropriated in FY2004 or
FY2005 for this purpose shall remain available until the end of FY2007 (about $18.9
million, see paragraph above), and authorizes $60 million over FY2007-FY2010.
The act also reauthorizes the national bone marrow registry with $186 million over
CRS-27
FY2006-FY2010. In addition, it creates a database to enable health care workers to
search for cord blood and bone marrow matches and links all these functions under
a new name, the C.W. Bill Young Cell Transplantation program. H.R. 596
(Christopher Smith) is an earlier version of this legislation.
On May 24, 2005, the House passed H.R. 810 (Castle), the Stem Cell Research
Enhancement Act of 2005, on a vote of 238-194. H.R. 810 would amend the Public
Health Service Act and direct the Secretary of HHS to conduct and support research
that utilizes human embryonic stem cells regardless of the date on which the stem
cells were derived from a human embryo. Stem cell lines derived after enactment
must meet ethical guidelines established by the NIH. Only embryos that were
originally created for fertility treatment purposes and in excess of clinical need are
eligible for stem cell derivation. Only embryos that the individuals seeking fertility
treatments have determined will not be implanted in a woman and will be discarded
are eligible for stem cell derivation. Written consent is required for embryo donation.
The Secretary in consultation with the Director of NIH shall promulgate guidelines
60 days after enactment. No federal funds shall be used to conduct research on
unapproved stem cell lines. The Secretary shall annually report to Congress about
stem cell research. A companion bill, S. 471 (Specter) was introduced on February
28, 2005.
H.R. 3144 (Bartlett), the Respect for Life Pluripotent Stem Cell Act of 2005,
was introduced on June 30, 2005. H.R. 3144 would amend the Public Health Service
Act to provide for a program at NIH to conduct and support stem cell research that
does not harm human embryos. Such research may include research on animal
embryos or human postnatal tissues or umbilical cord blood. The bill specifically
prohibits research that (1) involves the use of human embryos; (2) involves the use
of stem cells not otherwise eligible for funding by NIH; (3) involves the use of any
stem cell to create or to attempt to create a human embryo; or (4) poses a significant
risk of creating a human embryo by any means. H.R. 3144 authorizes $15 million
for research in FY2006 and such sums as may be necessary for FY2007 through
FY2010. H.R. 3144 was referred to the House Committee on Energy and Commerce.
H.R. 2574 (Bartlett), the Respect for Life Embryonic Stem Cell Act of 2005,
introduced on May 24, 2005, appears to be an earlier version of this legislation. A
companion bill, S. 1557 (Coburn), was introduced on July 29, 2005.
S. 1373 (Brownback), the Human Chimera Prohibition Act of 2005, was
introduced on July 11, 2005. S. 1373 amends the federal criminal code to prohibit
and to set penalties for (1) creating or attempting to create a human chimera (a being
with human and non-human tissue as specified in this act); (2) transferring or
attempting to transfer a human embryo into a non-human womb, or a non-human
embryo into a human womb; or (3) transporting or receiving a human chimera. S.
1373 defines a human chimera as (A) a human embryo into which a non-human cell
or cells (or the component parts thereof) have been introduced to render its
membership in the species Homo sapiens uncertain through germline or other
changes; (B) a hybrid human/animal embryo produced by fertilizing a human egg
with non-human sperm; (C) a hybrid human/animal embryo produced by fertilizing
a non-human egg with human sperm; (D) an embryo produced by introducing a
non-human nucleus into a human egg; (E) an embryo produced by introducing a
human nucleus into a non-human egg; (F) an embryo containing haploid sets of
CRS-28
chromosomes from both a human and a non-human life form; (G) a non-human life
form engineered such that human gametes develop within the body of a non-human
life form; or (H) a non-human life form engineered such that it contains a human
brain or a brain derived wholly or predominantly from human neural tissues. S. 1373
was referred to the Senate Committee on the Judiciary. S. 659, introduced on March
17, 2005, was an earlier version of this legislation.
H.R. 1357 (Dave Weldon), the Human Cloning Prohibition Act of 2005, was
introduced on March 17, 2005. H.R. 1357 amends Title 18 of the United States Code
and would ban the process of human cloning as well as the importation of any
product derived from an embryo created via cloning. Under this measure, cloning
could not be used for reproductive purposes or for research on therapeutic purposes,
which would have implications for stem cell research. H.R. 1357 includes a criminal
penalty of imprisonment of not more than 10 years and a civil penalty of not less than
$1 million. H.R. 1357 is essentially identical to the measure that passed the House
in the 107th Congress (H.R. 2505) and the 108th Congress (H.R. 534). H.R. 1357 was
referred to the House Committee on the Judiciary.
A companion bill, S. 658 (Brownback), was introduced on March 17, 2005. It
is similar to H.R. 1357, except that (1) it does not contain the ban on importation of
products derived from therapeutic cloning; and (2) it amends Title 4 of the Public
Health Service Act (42 U.S.C. §§ 289 et seq.) instead of Title 18 of the United States
Code.90 S. 658 includes a criminal penalty of imprisonment of not more than 10
years and a civil penalty of not less than $1 million. It requires GAO to conduct a
study to assess the need (if any) for any changes of the prohibition on cloning in light
of new developments in medical technology, the need for SCNT to produce medical
advances, current public attitudes and prevailing ethical views on the use of SCNT
and potential legal implications of research in SCNT. The study is to be completed
within four years of enactment. S. 658 has been referred to the Senate Health,
Education, Labor, and Pensions Committee.
S. 876 (Hatch), the Human Cloning Ban and Stem Cell Research Protection Act
of 2005, was introduced on April 21, 2005. A similar bill, H.R. 1822 (Bono), the
Human Cloning Ban and Stem Cell Research Protection Act of 2005, was introduced
on April 26, 2005. S. 876 amends Title 18 of the United States Code and H.R. 1822
amends the Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.).91 Both bills
would ban human reproductive cloning but allow cloning for medical research
purposes, including stem cell research. S. 876 and H.R. 1822 include a criminal
penalty of imprisonment of not more than 10 years; S. 876 has a civil penalty of not
less than $1 million, H.R. 1822 has a civil penalty not to exceed $10 million.
S. 876 requires the Comptroller General to prepare a series of four reports
within one year of enactment. The first report describes the actions taken by the
Attorney General to enforce the prohibition on human reproductive cloning, the
90
By seeking to amend Title 18 of the U.S. Code rather than the Public Health Service Act,
S. 658 would likely be subject to different committee jurisdiction.
91
Because they amend different titles of the U.S. Code, the bills would likely be subject to
different committee jurisdiction.
CRS-29
personnel and resources used to enforce the prohibition, and a list of any violations
of the prohibition. A second report describes similar state laws that prohibit human
cloning and actions taken by the states’ attorney general to enforce the provisions of
any similar state law along with a list of violations. A third report describes the
coordination of enforcement actions among the federal, state and local governments.
A fourth report describes laws adopted by foreign countries related to human cloning.
H.R. 1822 requires a similar set of three reports to be prepared by the Secretary of
Health and Human Services.
S. 876 and H.R. 1822 would amend the Public Health Service Act by requiring
that human SCNT be conducted in accordance with the ethical requirements (such
as informed consent, examination by an Institutional Review Board, and protections
for safety and privacy) contained in subpart A of 45 C.F.R. Part 46,92 or Parts 50 and
56 of 21 C.F.R.93 S. 876 and H.R. 1822 have a prohibition on conducting SCNT on
fertilized human eggs (oocytes), and both state that “unfertilized blastocysts” shall
not be maintained after more than 14 days from its first cell division, aside from
storage at temperatures less that zero degrees centigrade. S. 876 and H.R. 1822
stipulate that a human egg may not be used in SCNT research unless the egg is
donated voluntarily with the informed consent of the woman donating the egg. Both
bills also specify that human eggs or unfertilized blastocysts may not be acquired,
received or otherwise transferred for valuable consideration if the transfer affects
interstate commerce. In addition, SCNT may not be conducted in a laboratory in
which human eggs are subject to assisted reproductive technology treatments or
procedures, such as in vitro fertilization for the treatment of infertility. Violation of
these provisions in S. 876 and H.R. 1822 regarding ethical requirements would result
in a civil penalty of not more than $250,000. S. 876 has been referred to the Senate
Judiciary Committee. H.R. 1822 has been referred to the House Energy and
Commerce Committee.
S. 1520 (Feinstein), the Human Cloning Ban Act of 2005, was introduced on
July 27, 2005. S. 1520 is the same as S. 876 except that it does not require oversight
reports prepared by the Comptroller General and does not delineate specific ethical
requirements on the separate topic of SCNT research.
Supporters of a total ban on human cloning, such as that contained in H.R. 1357,
argue that a partial ban on human cloning, like the one in S. 876, would be
impossible to enforce. Critics of the total ban on human cloning argue that SCNT
creates a “clump of cells” rather than an embryo, and that the ban would curtail
medical research and prevent Americans from receiving life-saving treatments
created overseas.
92
This provision specifies protections due to human beings who participate in research
conducted or supported by HHS and many other departments.
93
This provision specifies protections due to human beings who participate in research
involved in testing a drug or medical device for FDA approval.
CRS-30
The U.S. Supreme Court has recognized in past cases certain personal rights as
being fundamental and protected from government interference.94 Some legal
scholars believe a ban on human cloning may be struck down by the Supreme Court
because it would infringe upon the right to make reproductive decisions which is
“protected under the constitutional right to privacy and the constitutional right to
liberty.”95 Other scholars do not believe that noncoital, asexual reproduction, such
as cloning, would be considered a fundamental right by the Supreme Court. A ban
on human cloning research may raise other constitutional issues: scientists’ right to
personal liberty and free speech. In the opinion of some legal scholars, any
government limits on the use of cloning in scientific inquiry or human reproduction
would have to be “narrowly tailored to further a compelling state interest.”96
However, no case involving these issues is scheduled to come before the Supreme
Court this term.
International Actions
on Embryonic Stem Cell Research
The international community has taken a variety of action regarding stem cell
research. In November 2004, the UNGA “averted a divisive vote” on two
international conventions against human cloning by adopting Italy’s proposal “to take
up the issue again as a declaration at a resumed February session.”97 “A convention
is a legally binding treaty, coming into force upon ratification by a certain number of
States. A declaration is not legally binding but carries moral weight because it is
adopted by the international community.”98 Two convention proposals had been
under consideration. One, introduced by Costa Rica and backed by the United States,
aimed to proscribe all human embryonic cloning. A second proposal, introduced by
Belgium, sought to proscribe only reproductive cloning. Both convention proposals
were supplanted by the adoption of the Italy’s proposal for a declaration. On March
8, 2005, the United Nations General Assembly (UNGA)99 approved a nonbinding
resolution urging member states to adopt legislation “to prohibit all forms of human
94
For further discussion of these issues and their relationship to human cloning, see CRS
Report RL31422, Substantive Due Process and a Right to Clone, by Jon O. Shimabukuro.
95
L.B. Andrews, “Is There a Right to Clone? Constitutional Challenges to Bans on Human
Cloning,” Harvard Journal of Law and Technology, summer 1998, pp. 643-680.
96
Ibid., p. 667.
97
Press Release GA/L/3270 “Legal Committee Text Calls for Further Discussions on
Human Cloning aimed at ‘Declaration’,” United Nations, November 19, 2004, at
[http://www.un.org/News/Press/docs/2004/gal3270.doc.htm].
98
United Nations, “Human Rights at Your Fingertips,” 1997 at [http://www.un.org/
rights/50/game.htm#28].
99
The General Assembly is the main deliberative organ of the United Nations. It is
composed of representatives of all 191 member states, each of which has one vote.
Decisions on important questions, such as those on peace and security, admission of new
Members and budgetary matters, require a two-thirds majority. Decisions on other questions
are reached by a simple majority, at [http://www.un.org/ga/58/ga_background.html].
CRS-31
cloning in as much as they are incompatible with human dignity and the protection
of human life.” The resolution passed with a vote of 84 to 34 and 37 abstentions; the
United States voted for the measure.
In April 2005, the European Commissioner for Science and Research announced
that the European Union (EU) would continue to fund ES research from 2007 - 2013,
via its Seventh Research Framework Programme (FP7).100 Funding levels for stem
cell research are expected to remain the same as they were under the last Research
Framework Programme (FP6), although the money allocated for scientific research
in FP7 (67.8 billion euros) is approximately double that allocated in FP6. FP6
funded 25 stem cell related programs, two of which used ES cells. The funding for
the stem cell programs totaled approximately 500,000 euros — less than 0.1% of the
total EU health research funds, and less than 0.002% of the FP6 budget.
To allow initial EU funding for stem cell research (under FP6), the EU clarified
its stem cell rules in November 2003.101 Under the terms of its FP6, the EU was able
to fund embryonic stem cell research regardless of the date that the stem cells were
procured from embryos. A cut-off date, which would have created a restriction
similar to the one in the 2001 Bush policy, was under consideration, but was
dropped.102 FP6 allowed funding for research on tissue derived from “spontaneous
or therapeutic abortion,” but not for the creation of human embryos for the purpose
of stem cell procurement.103 FP6 implied but did not state that it would allow
funding for research on embryos that remain after IVF, in that it “no longer requir[ed]
parental consent where embryos [had] to be destroyed in order to produce embryonic
stem cell lines.”104 According to Members of the European Parliament, FP6 funding
decisions depended “both upon the contents of the scientific proposal and the legal
framework of the Member States involved.”105
EU member states have a range of legislation on the subject. According to the
European Commission, the following distinctions could be made as of July 2004
(unless another date is noted):106
100
Unless otherwise noted, information in this paragraph is cited from “No Increase in EU
Stem Cell Funding,” BioNews website (Apr. 25, 2005), at [http://www.bionews.org.uk/
new.lasso?storyid=2538], visited Sept. 2, 2005.
101
Committee on Industry, External Trade, Research and Energy, “Integrating and
Strengthening the European Research Area” (2002-2006) (COM(2003) 390 —
C5-0349/2003 — 2003/0151(CNS)) European Parliament (A5-0369/2003), Nov. 4, 2003.
102
John T. Softcheck, “European Union Moves Close to Funding Stem Cell Research with
Two Parliament Votes,” Washington Fax, Nov. 10, 2003.
103
Ibid.
104
“Sixth Framework Programme,” Bulletin EU 11-2003, Research and technology (8/10),
Nov. 26, 2003, at [http://europa.eu.int/abc/doc/off/bull/en/200311/p103069.htm].
105
John T. Softcheck, “European Union Moves Close to Funding Stem Cell Research with
Two Parliament Votes,” Washington Fax, Nov. 10, 2003.
106
Matthiessen-Guyader, ed., “Survey on Opinions from National Ethics Committees or
Similar Bodies, Public Debate and National Legislation in Relation to Human Embryonic
(continued...)
CRS-32
!
!
!
!
!
Allowing for the procurement of human embryonic stem cells
from excess IVF embryos107 by law under certain conditions:
Belgium, Denmark, Finland, France, Greece, the Netherlands,
Spain,108 Sweden, Switzerland,109 and the United Kingdom (UK).110
Allowing some research activities on excess IVF embryos, but
having no specific reference to human embryonic stem cell
research: Estonia, Hungary, Latvia and Slovenia.
Prohibiting the procurement of human ES cells from excess IVF
embryos but allowing by law for the import and use of human
embryonic stem cell lines under certain conditions: Germany,
although Chancellor Gerhard Schroeder recently said the country’s
laws restricting ES research should be loosened.111 The import and
use of human ES cell lines is not explicitly prohibited in, e.g.,
Austria and Italy.
Prohibiting the procurement of human ES cells from excess IVF
embryos: Austria, Ireland Lithuania, Poland and Slovak Republic.
No specific legislation regarding human embryo research or
human ES cell research: Czech Republic, Luxembourg, Malta,
Portugal and the republic of Cyprus.
106
(...continued)
Stem Cell Research and Use,” European Commission, Directorate General: Research, July
2004, at [http://www.europa.eu.int/comm/research/biosociety/pdf/mb_states_230804.pdf].
107
The European Commission used the term “supernumerary” rather than “excess IVF”
throughout their description.
108
Spain “will initially have two ES cell research centers.” “Spain to Begin ES Cell
Research,” Bionews, no. 278, Sept. 27-Oct. 3, 2004, at [http://www.bionews.org.uk/
new.lasso?storyid=2292]. In Oct. 2004, Spain’s new Socialist government “made it easier
for stem cell research to be undertaken” by providing a “framework for granting
authorization for embryo use as well as setting out requirements for corresponding embryo
studies.” Xavier Bosch, “Spain Eases Embryo Research,” The Scientist, Nov. 1, 2004, at
[http://www.the-scientist.com/news/20041101/01].
109
In November 2004, Swiss voters “endorsed legislation on stem cell research that forbids
the cloning of human embryos but allows scientists to extract the cells from unwanted
embryos to use in research.” “Swiss Voters Back Stem Cell Research,” Los Angeles Times,
Nov. 29, 2004, A4.
110
The UK opened “the world’s first embryonic stem cell bank,” in May 2004, and two
months later “founded a new £16.5 million (USD $30 million) stem cell center in Cambridge
... with a commitment to fundamental research on both human embryonic and adult stem
cells as a precursor to studying therapeutic applications.” Philip Hunter, “UK to Open Stem
Cell Center,” The Scientist, June 22, 2004, at [http://www.the-scientist.com/news/
20040622/04]. In Aug. 2004, the UK’s Human Fertilisation and Embryology Authority
granted the first license to create embryonic stem cells using SCNT. “HFEA Grants the
First Therapeutic Cloning License for Research” HFEA, Aug. 11, 2004, at
[http://www.hfea.gov.uk/PressOffice/Archive/1092233888].
111
“Schroeder Says Stem Cell Laws Should Be Eased,” BioNews, June 20, 2004, at
[http://www.bionews.org.uk/new.lasso?storyid=2615], visited Sept. 1, 2005.
CRS-33
!
!
Allowing by law for the creation of human embryos for research
purposes: UK, Belgium, and Sweden112 allow by law for the
creation of human embryos either by fertilization of an egg by a
sperm, or by somatic cell nuclear transfer (SCNT, also called
therapeutic cloning) for stem cell procurement. The Dutch Embryo
Act of 2002 includes a five-year moratorium for the creation of
embryos for research purposes including by SCNT.
Prohibiting the creation of human embryos for research
purposes and for the procurement of stem cells by law or by
ratification of the Convention of the Council of Europe on
Human rights and Biomedicine signed in Oviedo on April 4,
1997: Austria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Italy,113 Ireland, Netherlands,
Lithuania, Portugal, Slovak Republic, Slovenia and Spain.
Non-EU countries have enacted measures that promote or prohibit ES research
as well.114 For example, Japan, Columbia and China permit therapeutic cloning as
well as ES research. Canada allows stem cell and other research to be conducted on
donated embryos created but no longer needed for reproductive purposes, and
prohibits all forms of human cloning.115 Israel permits and Turkey does not prohibit
ES research, and both permit therapeutic cloning and prohibit reproductive cloning.
Likewise, India, Brazil, Argentina, Chile, Peru, South Africa, Tunisia, and Uruguay
either allow or do not prohibit ES research, however they also ban both therapeutic
and reproductive cloning. Ecuador bans ES research as well as reproductive and
therapeutic cloning.
112
Richard Gardner and Tim Watson, “A Patchwork of Laws,” Scientific American (July
2005), p. A19.
113
A 2003 Italian law prohibits experiments on human embryos, the production of embryos
for research purposes, and any destruction of human embryos. Guidelines for the Italian
law’s implementation, revealed in July 2004, have been criticized by some, and have
buttressed calls “for the resignation of Health Minister, Girolamo Sirchia,” a supporter of
the law. The new law compels couples using IVF to transfer all fertilized embryos to the
uterus (including those with genetic disorders), despite the fact that, once implanted, they
could legally aborted. Criticism has also arisen due to the law’s chilling effect on stem cell
research. Rosella Lorsnzi, “Italian Minister in Trouble,” The Scientist, Sept. 9, 2004, at
[http://www.the-scientist.com/news/20040909/04]; Rosella Lorsnzi, “Outrage Over Italian
Law,” The Scientist, Aug. 2, 2004, at [http://www.the-scientist.com/news/20040802/03].
A referendum, held in June 2005, enabled citizens to vote on the law. The referendum failed
because a 50% turnout was required, and only 29.5% of Italians voted. Eighty percent of
those who voted favored overturing the law. “The fate of frozen embryos under the Italian
fertility law,” BioNews, June 21, 2005, at [http://www.bionews.org.uk/new.lasso?
storyid=2626], visited Sept. 1, 2005.
114
Unless otherwise noted, information in this paragraph derives from Richard Gardner and
Tim Watson, “A Patchwork of Laws,” Scientific American (July 2005), p. A19.
115
Assisted Human Reproduction Act (Canadian Bill No. C-6, 2004), LS-466E.
CRS-34
Certain countries’ activities designed to regulate and promote stem cell research
have come to the attention of Congress.116 Several governments, including those of
France, Germany, Finland, Italy, and Brazil reportedly provide $4-10 million of
public funding for the research.117 Others have invested more:
Australia. In 2002, the Australian government awarded a grant of $43.55
million, which was complemented by a $10 million award from the State
Government of Victoria, to establish and maintain the Australian Stem Cell Centre.
In May 2004, the Prime Minister announced a further $55 million grant to support
the Centre’s activities from 2006 to 2011.118 Australia permits the use of spare IVF
embryos for stem cell research,119 and in July 2005, the government set up an
independent committee to review the controlling laws and consider whether they
should be relaxed to permit more types of ES research.120
China. The Chinese government has reportedly spent approximately $40
million on ES research, where the climate is described as “probably the most liberal
environment for embryo research in the world.” China has no laws governing ES
research, although an endorsement from the Ministry of Health is required.121
Israel. While the Israeli government has reportedly spent only $5 million on
ES research, private funding is estimated to be $15-30 million. As noted above, both
therapeutic cloning and the production of new ES lines are permitted.122
Singapore. Singapore, which allows scientists to clone human embryos and
keep them alive for up to 14 days to extract the stem cells, is reported to have
“research-friendly policies and generous government funding have already helped
jump-start the tiny city-state’s nascent stem cell sector. ... Singapore and the New
York-based Juvenile Diabetes Research Foundation International launched a $3
million funding program to support stem cell research [in Singapore], ... [and in May
2004, Singapore unveiled] its resort-like Biopolis, created to give biotech researchers
116
See, e.g., Letter from 58 Senators to President George W. Bush, June 4, 2004; Letter from
206 Members of the House of Representatives to President George W. Bush, Apr. 28, 2004.
117
Richard Gardner and Tim Watson, “A Patchwork of Laws,” Scientific American (July
2005), p. A20-21.
118
“Funding,” at [http://www.nscc.edu.au/cen_funding.html], visited Sept. 1, 2005. Note:
until Aug. 17, 2004 the Australian Stem Cell Centre was known as the National Stem Cell
Centre. “Home”, Australian Stem Cell Centre website, at [http://www.nscc.edu.au/
ascc_home.html], visited Sept. 1, 2005.
119
Research Involving Human Embryos Act, no. 145, 2002.
120
“Australian Cloning Laws Under Review,” BioNews, July 8, 2005, at [http://www.bionews.org.uk/new.lasso?storyid=2647].
121
Richard Gardner and Tim Watson, “A Patchwork of Laws,” Scientific American (July
2005), p. A21.
122
Ibid.
CRS-35
and their families a place to live and work.”123 Academic and industrial spending on
ES research in the country reportedly total $20 million.124
South Korea. The South Korean government has reportedly spent
approximately $10 million on ES research, and the private sector $50 million.125
South Korea, the home of the doctor who announced in February 2004 that he had
cloned human embryos and extracted stem cells from them, subsequently enacted
legislation to regulate and license reproductive cloning: the Bioethics and Biosafety
Act.126 The act allows the continuation of some existing ES and embryo research,
specifically permits governmental support for adult stem cell research, and prohibits
reproductive human cloning and the transfer of embryos between different species.
It allows, with a government-issued permit, the creation human embryos via IVF for
reproductive purposes, and the use of some remaining embryos for research related
to incurable diseases specified by presidential decree. By the same regulatory
process, the act also allows the cloning and the creation of embryo clones for
research purposes.
The act establishes a National Bioethics Committee to review certain items
concerning bioethics and biosafety in the life sciences and biotechnologies, and
requires certain institutions to set up Institutional Review Boards in order to ensure
bioethics and bioethical safety in the life sciences and biotechnologies. In addition,
the act regulates DNA testing and baking, and prohibits genetic discrimination in
educational opportunities, employment or promotion, and insurance eligibility.
Sweden. The Swedish government has reportedly spent $10-$15 million on
ES research, which is complimented by private funding of $35 million per year. As
noted above, both the production of new ES lines, and therapeutic cloning are legal
in the country.127
United Kingdom. The government of the UK has reportedly provided $80
million for ongoing research which has been complimented by $15-$20 million of
private funds.128 In February 2005, leading names from science, industry and
government in the UK formed the Stem Cell Foundation, calling for £100 million to
fund the center and maintain the UK as one of the world leaders in stem cell
123
“Singapore Hosts Stem Cell Meeting” MSNBC, May 19, 2004, at the MSNBC website
[http://msnbc.msn.com/id/3341644/].
124
Richard Gardner and Tim Watson, “A Patchwork of Laws,” Scientific American (July
2005), p. A21.
125
Ibid.
126
South Korea’s Bioethics and Biosafety Act, no, 7150, enacted Jan. 1, 2004, effective Jan.
1, 2005. An unofficial translation is available at [http://www.koreabioethics.net/5-2/7.doc],
visited Sept. 1, 2005; see also Jung Hwa Lee, Contract Foreign Law Specialist, “South
Korea Act On Bioethics,” Law Library of Congress (2005-017770), June 2005.
127
Richard Gardner and Tim Watson, “A Patchwork of Laws,” Scientific American (July
2005), p. A20.
128
Ibid.
CRS-36
research.129 As noted above, the UK allows and regulates the production of new ES
lines and therapeutic cloning, which may be funded by the federal government under
the terms of the Human Fertilisation and Embryology Act of 1990 (HFEA).130 In
2004, the government announced that it would review the HFEA to ensure that the
law remains effective, broadly acceptable to society, and fit for purpose in the early
21st century.131 One component of the review, a public consultation, is ongoing
through November 2005.
Ethical Issues
Stem cell research is controversial not because of its goals, but rather because
of the means of obtaining some of the cells. Research involving most types of stem
cells, such as those derived from adult tissues and umbilical cord blood, is
uncontroversial, except when its effectiveness as an alternative to embryonic stem
cells is debated. The crux of the debate centers around embryonic stem cells, which
enable research that may facilitate the development of medical treatments and cures,
but which require the destruction of an embryo to derive.132 In addition, because
cloning is one method of producing embryos for research, the ethical issues
surrounding cloning are also relevant.
As previously mentioned, the Bush Administration, a group of Representatives,
a group of Senators, and a group of Nobel Laureates have each presented their
respective positions on embryonic stem cell research. In addition, various other
organizations, individuals, and councils have issued opinions and reports on the
topic. Some groups, such as the Christian Legal Society,133 Focus on the Family,134
and the Christian Coalition,135 support the 2001 Bush policy. Others, such as the
129
“UK Group wants £100 Million for Stem Cell Research,” BioNews website (Feb. 9,
2005), at [http://www.bionews.org.uk/new.lasso?storyid=2443], visited Sept. 2, 2005.
130
Human Fertilisation and Embryology Act 1990 (c. 37), at
[http://www.opsi.gov.uk/acts/acts1990/Ukpga_19900037_en_1.htm], visited Sept. 1, 2005.
131
“Review of the Human Fertilisation and Embryology Act: A public consultation,” UK
Department of Health website (Aug. 16, 2005), at [http://www.dh.gov.uk/Consultations/
LiveConsultations/LiveConsultationsArticle/fs/en?CONTENT_ID=4117820&chk=vchu
%2B9], visited Sept. 1, 2005.
132
For an overview of various religious perspectives on embryonic stem cell research, see
LeRoy Walters, “Human Embryonic Stem Cell Research: An Intercultural Perspective,”
Kennedy Institute of Ethics Journal, vol. 14, no. 1 (Mar. 2004), p. 3.
133
The Christian Legal Society is a “national grassroots network of lawyers and law
students, committed to ... advocating biblical conflict reconciliation, public justice, religious
freedom and the sanctity of human life.” At [http://www.clsnet.org/clsPages/vision.php],
visited July 15, 2005.
134
Focus on the Family was founded in 1977 by Dr. James Dobson to promote teachings of
Jesus Christ. See [http://www.family.org].
135
The Christian Coalition is “the largest and most active conservative grassroots political
organization in America,” at [http://www.cc.org].
CRS-37
National Academies,136 the Coalition for the Advancement of Medical Research
(CAMR),137 former First Lady Nancy Reagan,138 former Presidents Gerald Ford,
Jimmy Carter, Bill Clinton,139 and the Union of Orthodox Jewish Congregations of
America (UOJCA),140 favor more embryonic stem cell research than the Bush policy
allows. Still others, such as the National Right to Life Committee141 and the United
States Conference of Catholic Bishops,142 oppose all embryonic stem cell research.
Two presidential bioethics advisory panels have considered the issues involved
in embryonic stem cell research. The President’s Council on Bioethics (President’s
Council)143 published one report directly on the topic, Monitoring Stem Cell
Research,144 in which it sought to characterize the issues. While the Council made
no recommendations there, in two other reports it has recommended that “Congress
should ... [p]rohibit the use of human embryos in research beyond a designated stage
in their development (between 10 and 14 days after fertilization),”145 and
136
The National Academies brings together “committees of experts in all areas of scientific
and technological endeavor” as “advisors to the Nation.” For statements on embryonic stem
cell research and cloning, see National Research Council, Institute of Medicine, National
Academies, Stem Cells and the Future of Regenerative Medicine (Washington: National
Academies, 2001); Committee on Science, Engineering and Public Policy and Global
Affairs Division et al., Scientific and Medical Aspects of Human Reproductive Cloning
(Washington National Academy Press, 2002) at [http://www.nationalacademies.org/
about/#org].
137
CAMR is a nonprofit organization comprised of patient organizations, universities,
scientific societies, foundations, and individuals with life-threatening illnesses and disorders
[http://www.camradvocacy.org/fastaction/]. For a statement on embryonic stem cell
research, see Coalition for the Advancement of Medical Research, “Embryonic Stem Cell
Research,” talking points [http://www.camradvocacy.org/fastaction/news.asp?id=167],
visited May 14, 2004.
138
“Nancy Reagan Urges Stem Cell Research,” MSNBC, May 9, 2004, at
[http://www.msnbc.msn.com/id/4937850/], visited May 14, 2004.
139
Ibid.
140
Letter from Harvey Blitz, President, UOJCA, et al., to President George W. Bush, July
26, 2001, at [http://www.ou.org/public/statements/2001/nate34.htm], visited July 14, 2005.
(Hereafter cited as UOJCA letter.)
141
The National Right to Life Committee was founded in 1973 to “restore legal protection
to innocent human life,” at [http://www.nrlc.org/Missionstatement.htm].
142
The United States Conference of Catholic Bishops is “is an assembly of the hierarchy of
the United States and the U.S. Virgin Islands who jointly exercise certain pastoral functions
on behalf of the Christian faithful of the United States,” at [http://www.nccbuscc.org/
whoweare.htm].
143
The President’s Council was created by President Bush in Nov. 2001 to “advise the
President on bioethical issues that may emerge as a consequence of advances in biomedical
science and technology.” George W. Bush, “Creation of The President’s Council on
Bioethics,” Executive Order 13237, Nov. 28, 2001.
144
The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004.
145
The President’s Council on Bioethics, Reproduction and Responsibility, Mar. 2004,
CRS-38
unanimously recommended “a ban on cloning-to-produce-children,” with a 10member majority also favoring “a four-year moratorium on
cloning-for-biomedical-research,” and a seven-member minority favoring “regulation
of the use of cloned embryos for biomedical research.”146 More recently, the
President’s Council published Alternative Sources of Human Pluripotent Stem Cells,
a white paper exploring the ethics of four proposals to attempt to generate human
embryonic stem cells “without creating, destroying, or harming human embryos.”147
A predecessor to the President’s Council, the National Bioethics Advisory
Committee (NBAC),148 recommended federal funding for stem cell research using
“embryos remaining after infertility treatments,” but not for the “derivation or use of
embryos ... made for research purposes.”149
Detailed review of the assorted reports and statements reveals that, while
positions on embryonic stem cell research may be broadly categorized as for or
against, there is an array of finer distinctions present. These finer distinctions in turn
reveal the variation in ethical and moral as well as factual beliefs. The following
discussion breaks down the arguments about embryonic stem cell research according
to these finer distinctions, demonstrating both the complexity of the issues and the
points of resonance among the groups.
145
(...continued)
p. xlviii.
146
The President’s Council on Bioethics, Human Cloning and Human Dignity, July 2002,
pp. xxxv-xxxviii). Note: At the June 20, 2002, meeting, nine of 17 Council members voted
to support cloning for medical research purposes, without a moratorium, provided a
regulatory mechanism was established. Because one member of the Council had not
attended the meetings and was not voting, the vote seemed to be nine to eight in favor of
research cloning. However, draft versions of the Council report sent to Council members
on June 28, 2002, indicated that two of the group of nine members had changed their votes
in favor of a moratorium. Both made it clear that they have no ethical problem with cloning
for biomedical research, but felt that a moratorium would provide time for additional
discussion. The changed vote took many Council members by surprise, and some on the
Council believe that the moratorium option, as opposed to a ban, was thrown in at the last
minute and did not receive adequate discussion. In addition, some on the Council believe
that the widely reported final vote of 10 to 7 in favor of a moratorium does not accurately
reflect the fact “that the majority of the council has no problem with the ethics of biomedical
cloning.” (Transcripts of the Council meetings and papers developed by staff for discussion
during Council meetings can be found at [http://www.bioethics.gov]; S. S. Hall, “President’s
Bioethics Council Delivers,” Science, vol. 297, July 19, 2002, pp. 322-324.) “Wise Words
from Across the Pond?,” BioNews, no. 252, Mar. 29, 2004.
147
The President’s Council on Bioethics, Alternative Sources of Human Pluripotent Stem
Cells (May 2005), at [http://www.bioethics.gov/reports/white_paper/index.html], visited
July 14, 2005.
148
In 1995, President Clinton created the National Bioethics Advisory Commission by
Executive Order, to advise him on bioethical issues. The Order expired in 2001. “Former
Bioethics Commissions,” President’s Commission on Bioethics website, at [http://www.
bioethics.gov/reports/past_commissions/index.html], visited Jun. 30, 2004.
149
National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, pp. 70-71.
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Embryo Destruction and Relief of Human Suffering
Most positions on embryonic stem cell research rest at least in part on the
relative moral weight accorded to embryos and that accorded to the prospect of
saving, prolonging, or improving others’ lives. For some, the inquiry begins and
ends with this question. For instance, one opponent of the research, the American
Life League, posits that “human life begins at conception / fertilization and that there
is never an acceptable reason for intentionally taking an innocent human life.”150
Similarly, the United States Conference of Catholic Bishops states that the research
is immoral because it “relies on the destruction of some defenseless human beings
for the possible benefit to others.”151
Some groups explore the moral standing of human embryos, and also consider
the “duty to relieve the pain and suffering of others.”152 Others take the position that
embryos do not have the same moral status as persons. They acknowledge that
embryos are genetically human, but hold that they do not have the same moral
relevance because they lack specific capacities, including consciousness, reasoning
and sentience.153 They also argue that viewing embryos as persons would “rule out
all fertility treatments that involve the creation and discarding of excess embryos,”
and further assert that we do not have the same “moral or religious” response to the
natural loss of embryos (through miscarriage) that we do to the death of infants.154
Some have also rooted their arguments in religious texts, which inform them that an
“isolated fertilized egg does not enjoy the full status of person-hood and its attendant
protections.”155 They conclude that performing research to benefit persons justifies
the destruction of embryos. Acceptance of the notion that the destruction of embryos
can be justified in some circumstances forms the basis of pro-stem cell research
opinions, and is usually modified with some combination of the distinctions and
limitations that follow.
Viability of Embryos
Some proponents of embryonic stem cell research base their support on the
question of whether an embryo is viable. The relevance of the viability distinction
rests on the premise that it is morally preferable for embryos that will not grow or
150
American Life League, Analysis of George W. Bush’s Stem Cell Decision, 2001, at
[http://www.all.org/issues/scanalyz.htm] visited May 11, 2004.
151
Office of Communications, United States Conference of Catholic Bishops, Catholic
Bishops Criticize Bush Policy on Embryo Research (Aug. 9, 2001), at [http://www.usccb.
org/comm/archives/2001/01-142.shtml].
152
The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, pp. 58, 62.
153
Presentation by B. Steinbock, Department of Philosophy, SUNY, Albany, NY, NIH
Human Embryo Research Panel Meeting, Feb. 3, 1994.
154
Michael Sandel, “Embryo Ethics — The Moral Logic of Stem-Cell Research,” New
England Journal of Medicine, vol. 351, no. 3, July 15, 2004, p. 208.
155
UOJCA letter.
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develop beyond a certain stage and/or those that would otherwise be discarded to be
used for the purpose of alleviating human suffering.
The 2001 Bush policy requires, among other things, use of only excess (nonviable) embryos for federally funded research. One report of the President’s Council
explores the moral significance of viability that is based upon “human choices” rather
than an embryo’s “own intrinsic nature,” but draws no conclusions.156 A second
report broaches the subject of viability, recommending that Congress ban both the
transfer of a human embryo to a woman’s uterus for any purpose other than to
produce a live-born child, and also research conducted on embryos more than 10 to
14 days after fertilization.157 The NBAC report touches on the moral status of
embryos in utero and those in vitro,158 though NBAC does not specify whether
viability was a key rationale for its recommendations. A group of Representatives,
a group of Senators,159 and CAMR imply but do not state a distinction based on
viability by expressly calling for the use of “excess” embryos developed for IVF, and
making no mention of those in utero.160 UOJCA makes a similar argument in its
letter. By contrast, the National Academies and the group of Nobel Laureates more
broadly support research on embryos, making no mention of viability.
Purpose of Embryo Creation
A separate distinction that often leads to the same conclusions as viability is the
purpose for which embryos are created. This distinction draws an ethical line based
upon the intent of the people creating embryos. In the view of some, it is permissible
to create an embryo for reproductive purposes (such as IVF), but impermissible to
create one with the intention of destroying it for research.
Most groups at least note the potential ethical significance of reproductive
versus research motives for creating embryos. The 2001 Bush policy draws a motive
distinction by including a requirement that federally funded research be conducted
only on embryonic stem cell lines derived from embryos created solely for
reproductive purposes. NBAC draws the same distinction by recommending that
federal funding be used for embryos remaining after infertility treatment but not for
research involving the derivation or use of stem cells from embryos made for
research purposes or from embryos made using cloning (SCNT).161 UOJCA argue
similarly that they “believe it is entirely appropriate to utilize for this research
156
The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, p. 87.
157
The President’s Council on Bioethics, Reproduction and Responsibility, Mar. 2004.
158
National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 50.
159
Letter from 58 Senators to President George W. Bush, June 4, 2004. (Hereafter cited as
Letter from 58 Senators.)
160
Letter from 206 Members of the House of Representatives to President George W. Bush,
Apr. 28, 2004. (Hereafter cited as Letter from 206 Members of the House of Representatives.)
161
National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, pp. 70-72.
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existing embryos, such as those created for IVF purposes that would otherwise be
discarded but for this research. We think it another matter to create embryos ab initio
for the sole purpose of conducting this form of research.”162
The President’s Council recommends that Congress ban attempts at conception
by any means other than the union of egg and sperm (essentially banning cloning via
SCNT) but does not specify whether embryos might be created in vitro specifically
for research purposes.163 Two Council members expressed a dissenting opinion in
a medical journal article, arguing that SCNT “resembles a tissue culture” and that the
products of SCNT should be available for research.164 A group of Representatives,
a group of Senators, and CAMR imply but do not state that embryos should not be
created for research purposes. They overtly call for the use of “excess” embryos
developed for IVF and make no mention of embryos created expressly for research.165
By contrast, the National Academies supports the creation of embryos for research
purposes, including via cloning (SCNT), to “ensure that stem cell-based therapies can
be broadly applied for many conditions and people [by] overcoming the problem of
tissue rejection.”166 Mrs. Nancy Reagan, her supporters, and the group of Nobel
Laureates also take this position.
New and Existing Cell Lines
A further distinction has been drawn based upon the timing of the creation of
embryonic stem cell lines. Here, the premise is that it is unacceptable to induce the
destruction of embryos for the creation of new lines. However, in cases in which
embryos have already been destroyed and the lines already exist, it is morally
preferable to use those lines for research to improve the human condition.
This was one central distinction drawn in the 2001 Bush policy, which limited
the use of federal funding to research on lines derived on or before the date of the
policy. Supporters of the Bush policy on both sides of the issue favor this distinction
as a compromise. It allows research on some embryonic stem cell lines. It deters the
future destruction of embryos for research. The President’s Council writes that the
Bush policy mixes “prudence” with “principle, in the hope that the two might
reinforce (rather than undermine) each other.”167 The Council notes that the policy
is supported by what it titles a moralist’s notion of when one may benefit from prior
bad acts (referring to embryo destruction): it prevents the government from
162
UOJCA letter.
163
The President’s Council on Bioethics, Reproduction and Responsibility, Mar. 2004,
p. xlviii.
164
Paul McHugh, “Zygote and “Clonote” — The Ethical Use of Embryonic Stem Cells,”
New England Journal of Medicine, vol. 351, no. 3, July 15, 2004, p. 210.
165
Letter from 206 Members of the House of Representatives; Letter from 58 Senators.
166
National Research Council, Institute of Medicine, National Academies, Stem Cells and
the Future of Regenerative Medicine (Washington: National Academies, 2001), p. 58.
167
The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, pp. 3334.
CRS-42
complying in the commission of or encouraging the act in the future, and it reaffirms
the principle that the act was wrong.168 The same report also contains analyses of the
Bush policy that characterize distinction between new and existing cell lines as
“arbitrary,” “unsustainable,” and “inconsistent.”169 The Council itself takes no
position in the report on this or any other issue.
Opponents of the Bush policy on both sides of the issue view the distinction
between new and existing stem cell lines with reproach. One side, which includes
The National Right to Life Committee and the United States Conference of Catholic
Bishops, objects because the distinction validates destruction of embryos, and in fact
rewards those who did so first with a monopoly. The other side, which includes the
National Academies, a group of Representatives, a group of Senators, Nancy Reagan
and her supporters, Gerald Ford, CAMR, and the group of Nobel Laureates, objects
because the distinction limits the number of embryonic stem cell lines available for
research, particularly since the number of authorized lines are dwindling and are
“contaminated with mouse feeder cells.”170 Likewise, though NBAC recognized the
distinction between destroying embryos and using ones previously destroyed (e.g.,
“derivation of [embryonic stem] cells involves destroying the embryos, whereas
abortion precedes the donation of fetal tissue and death precedes the donation of
whole organs for transplantation”),171 it still recommended future development of
embryonic stem cell lines. UOJCA also recognizes a distinction between new and
existing lines: “research on embryonic stem cells must be conducted under careful
guidelines [that] ... relate to where the embryonic stem cells to be researched upon
are taken from.”172
Consent of Donors
There is consensus throughout a wide array of viewpoints about embryonic stem
cell research that embryos should only be obtained for research with the consent of
their biological donors. This consent requirement necessitates that embryos be taken
only with donors’ knowledge, understanding, and uncoerced agreement. The donor
consent requirement is consistent with the rules governing human beings’
participation in research, and with individuals’ general legal authority to make
decisions regarding embryos they procreate. A drawback of the requirement is that
it may restrict the number of embryos available for research purposes.
The 2001 Bush policy contains a donor consent requirement. It limits approved
stem cell lines to those derived with the informed consent of the donors, and obtained
without any financial inducements to the donors. The NBAC, the President’s
Council, and the UOJCA also favor donor consent requirements. The National
168
Ibid.
169
The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, pp. 6367.
170
Letter from 206 Members of the House of Representatives; Letter from 58 Senators.
171
National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 49.
172
UOJCA letter.
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Academies notes the importance of informed consent in its discussion of stem cell
research oversight requirements.173 A group of Representatives and a group of
Senators mention and imply their support for donor consent requirements.174
Egg Procurement. The topic of informed consent in egg procurement came
to the public’s attention in November 2005 with allegations that some human eggs
used in South Korean scientist Dr. Hwang’s laboratory had been obtained under
coercive conditions (see p. 2). Informed consent can be undermined when a coercive
situation prevents a free choice from being made, or when insufficient information
is provided to the person making a decision. The situation alleged in Dr. Hwang’s
laboratory raises the issue of coercion both because subordinate women in the
laboratory allegedly donated eggs, and because some women were allegedly paid for
their eggs. A 2002 study conducted by a University of Pennsylvania student raised
the issue of insufficient information, finding that a number programs seeking donor
eggs for reproductive purposes were not up front about the risks involved in egg
retrieval.175 The wide consensus regarding the need for informed consent necessarily
implies similar consensus on the need for an information-rich, coercion-free method
of obtaining eggs, however there is some disagreement on the specifics of whether
payment for eggs necessarily constitutes coercion.
The prospect of paying women for their eggs, which has been debated in the
context of seeking donor eggs both for reproductive purposes (for example, to enable
women who do not produce their own eggs to become pregnant), and for research
purposes, is not unheard of in the United States. According to a 2000 study by the
American Society of Reproductive Medicine (ASRM), some IVF programs
reportedly offered as much as $5,000 for one egg retrieval cycle, though $2,500
appeared to be a more common amount.176 Offers of much higher amounts ($50,000
- $100,000) have been reported elsewhere.177 Dr. Huang’s laboratory reportedly
made payments of $1,400 to each woman who donated eggs.178 Payments are not
illegal in the Unites States, nor were they illegal in South Korea at the time Dr.
Huang’s laboratory allegedly made them. The questions are, is payment for egg
donation ever acceptable, and if so, what amount is appropriate?
173
National Research Council, Institute of Medicine, National Academies, Stem Cells and
the Future of Regenerative Medicine (Washington: National Academies, 2001), p. 53.
174
Letter from 206 Members of the House of Representatives; Letter from 58 Senators.
175
“Egg Donation Ethics Study Wins Award,” Research at Penn, (Mar. 7, 2005), at
[http://www.upenn.edu/researchatpenn/article.php?113&soc], visited Dec. 5, 2005.
176
American Society of Reproductive Medicine, “Financial incentives in recruitment of
oocyte donors,” Fertility and Sterility, vol. 74, no. 2 (Aug. 2000), p. 216.
177
See e.g., “Egg Donation Ethics Study Wins Award,” Research at Penn, (Mar. 7, 2005),
at [http://www.upenn.edu/researchatpenn/article.php?113&soc], visited Dec. 5, 2005.
178
James Brooke, “Korean Leaves Cloning Center in Ethics Furor,” Professional Ethics
website (Nov. 25, 2005), at
[http://ethics.tamucc.edu/article.pl?sid=05/11/26/1524206&mode=thread] visited Dec. 12,
2005.
CRS-44
Several arguments have been put forth in favor of payment for egg donation,
many focused on donation for reproductive purposes.179 First, some have argued that
payment creates incentives to increase the number of egg donors, thus facilitating
research and benefitting infertile couples. Second, some reason that payment for
eggs gives women parity with sperm donors, who may be compensated for donating
gametes at a lower rate given that they require a much less involved procedure.
Third, some allege that fairness dictates that women who donate eggs ought to be
able to benefit from their action. Fourth, some claim that pressures created by
financial incentives may be no greater than those experienced by women asked to
make altruistic egg donations for relatives or friends, and may thus not rise to the
level of coercion. These are the types of arguments that led ASRM to recommend
in 2000 that sums of up to $5000 may be appropriate for typical egg donation, while
sums of up to $10,000 may possibly be justified if there are particular difficulties a
woman must endure to make her donation.
Several arguments have also been put forth against payment for egg donation.
First, some voiced fears that payment might lead to the exploitation of women,
particularly poor women, and the commodification of reproductive tissues.180
Second, some have argued that payment for eggs for research purposes might
undermine public confidence in endeavors such as human embryonic stem cell
research.181 Arguments such as these have prompted both the NAS and the PCBE to
recommend that women not be paid for donating their eggs for research purposes.
It also led the PCBE to note that in theory, there is the possibility that eggs could be
procured from ovaries harvested from cadavers, which might at least alleviate
concerns related to coercion.
It is worth noting a woman may choose to undergo egg retrieval for her own
reproductive purposes, which would effectively take the process of egg procurement
out of the research arena and avoids the question of payment entirely. (For example,
this could be an option for a woman seeking IVF because her fallopian tubes are
blocked). While not making specific recommendations about payment for researchrelated egg donation, several groups’ recommendations that only embryos left over
from IVF procedures be used for stem cell research (noted above in the Purpose of
Embryo Creation section) effectively takes the process of egg procurement from
women out of the research arena.
179
Unless otherwise noted, these arguments can be found, among other places, at American
Society of Reproductive Medicine, “Financial incentives in recruitment of oocyte donors,”
Fertility and Sterility, vol. 74, no. 2 (Aug. 2000), p. 218; and Claudia Kalb, “Ethics, Eggs
and Embryos,” MSNBC.com, Newsweek website, at [http://www.msnbc.msn.com/
id/8185339/site/newsweek/], visited Dec. 12, 2005.
180
See e.g., PCBE, White Paper: Alternative Sources of Pluripotent Stem Cells (May 2005),
pp. 40-41 at [http://www.bioethics.gov/reports/white_paper/index.html], visited Dec. 12,
2005.
181
National Academies, Guidelines for Human Embryonic Stem Cell Research,
(Washington, DC: National Academies Press, p. 87, at [http://books.nap.edu/books/
0309096537/html/87.html], visited, Dec. 12, 2005.
CRS-45
Effectiveness of Alternatives
One factual distinction that has been used to support competing ethical
viewpoints is the efficacy of alternatives to embryonic stem cell research. The
promise of stem cell therapies derived from adult tissue and umbilical cord blood
have buttressed opposition to embryonic stem cell research. Alternatives such as
those proposed for consideration by the PCBE are discussed in the next section.
These opponents argue that therapies and cures can be developed without the morally
undesirable destruction of embryos. However, not all scientists agree that adult stem
cells hold as much potential as embryonic stem cells. Most supporters of embryonic
stem cell research believe that it is the quickest and, perhaps in some cases, the only
path that will yield results. Supporters also stress that embryonic and other stem cell
research should be conducted collaboratively, so that they can inform one another.
On a related note, some have pointed out that benefits from one alternative to
embryonic stem cell research, umbilical cord blood banking, may only be available
to families who can afford to pay private companies’ storage fees.
Findings regarding the effectiveness of alternatives to embryonic stem cell
research are mixed. The President’s Council notes that there is a “debate about the
relative merits of embryonic stem cells and adult stem cells.”182 Focus on the Family
cites promising non-embryonic stem cell research: “adult stem cells may be as
“flexible” as embryonic ones and equally capable of converting into various cell
types for healing the body.”183 By contrast, the National Academies finds that the
“best available scientific and medical evidence indicates that research on both
embryonic and adult human stem cells will be needed.”184 NBAC finds in its
deliberations that “the claim that there are alternatives to using stem cells derived
from embryos is not, at the present time, supported scientifically.”185 CAMR
supports both embryonic and adult stem cell research, and adds that “many scientists
believe and studies show that embryonic stem cells will likely be more effective in
curing diseases because they can grow and differentiate into any of the body’s cells
and tissues and thus into different organs.”186 Mrs. Nancy Reagan and her supporters
favor expedient approaches including embryonic stem cell research.187
Generating Embryonic Stem Cells Without Destroying Human
Embryos. One possible alternative to embryonic stem cell research as it has
182
The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, p. 10.
183
Carrie Gordon Earll, “Talking Points on Stem Cell Research,” Focus on the Family,
Sept. 17, 2003 at [http://www.family.org/cforum/fosi/bioethics/faqs/a0027980.cfm].
184
National Research Council, Institute of Medicine, National Academies, Stem Cells and
the Future of Regenerative Medicine (Washington: National Academies, 2001), p. 56.
185
National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 53.
186
Coalition for the Advancement of Medical Research, “Embryonic Stem Cell Research,”
talking points [http://www.camradvocacy.org/fastaction/news.asp?id=167].
187
“Nancy Reagan Urges Stem Cell Research,” MSNBC, May 9, 2004, available online at
[http://www.msnbc.msn.com/id/4937850/].
CRS-46
typically been conducted, the ability to generate embryonic stem cells without
destroying human embryos, was explored by the President’s Council in their 2005
white paper,188 described in the introductory section of the report. The white paper
discusses four potential methods of obtaining embryonic stem cells without having
to destroy embryos. Those methods, the scientific and practical merits of which
remain far from settled, are (1) extracting cells from organismically dead embryos;
(2) non-harmful biopsy of living embryos; (3) bioengineering embryo-like artifacts;
and (4) dedifferentiating somatic cells.
In the white paper, the President’ Council examined the ethical acceptability of
each method. The first two seek to avoid the destruction of embryos either by
developing standards for declaring an embryo “dead” when its cells have stopped
dividing or by removing a cell from an embryo without destroying the embryo itself.
The other two methods would avoid having to use an embryo altogether, by
attempting to obtain embryonic stem cells through the destruction of something that
is not an embryo.
The Council concluded that the use of organismically dead embryos raises a
number of ethical questions that have yet to be answered. They include whether it
is possible to be certain that an embryo is really dead, whether the proposal would put
embryos at additional risk, and whether IVF practitioners would be encouraged to
create extra embryos. Regarding the use of non-harmful biopsy, the Council found
that it would be ethically unacceptable to test in humans because risks should not be
imposed on living embryos destined to become children for the sake of getting stem
cells for research.
The Council also concluded that bioengineering embryo-like artifacts raises
many serious ethical concerns, including whether the artifact would really be a very
defective embryo, the ethics of egg procurement, concerns about ANT (the use of
genetic engineering) itself, and the possibility if its use creating a “slippery slope.”
Finally, the Council found the proposal to dedifferentiate somatic cells to be ethically
acceptable if and when it became scientifically practical, provided that de facto
embryos were not created.
Although some Council members expressed their support for efforts to identify
means of obtaining human embryonic stem cells for biomedical research that do not
involve killing or harming human embryos, not all of the members agreed. Some
expressed concern that all four methods would “use financial resources that would
be better devoted to proposals that are likely to be more productive.” One member
wrote that he did not support publishing the white paper “with the implied
endorsement that special efforts be made in the scientific areas described. While
some of the suggestions could be explored in a scientific setting, most are high-risk
options that only have an outside chance of success and raise their own complex set
of ethical questions.”
188
The President’s Council on Bioethics, White Paper: Alternative Sources of Human
Pluripotent Stem Cells, May 2005, online at [http://www.bioethics.gov/reports/white_paper/
index.html].
CRS-47
Use of Federal Funding
Some division over the support for and opposition to embryonic stem cell
research focuses on the question of whether the use of federal funding is appropriate.
Those who oppose federal funding argue that the government should not be
associated with embryo destruction.189 They point out that embryo destruction
violates the “deeply held moral beliefs of some citizens,” and suggest that “funding
alternative research is morally preferable.”190 Proponents of federal funding argue
that it is immoral to discourage life-saving research by withholding federal funding.
They point out that consensus support is not required for many federal spending
policies, as it “does not violate democratic principles or infringe on the rights of
dissent of those in the minority.”191 They argue that the efforts of both federally
supported and privately supported researchers are necessary to keep the United States
at the forefront of what they believe is a very important, cutting edge area of science.
Furthermore, supporters believe that the oversight that comes with federal dollars
will result in better and more ethically controlled research in the field.
Groups’ positions on federal funding tend to mirror their positions on stem cell
research generally. The Bush policy authorizes federal funding for some embryonic
stem cell research. The President’s Council does not take a position on the issue, but
notes the pros and cons and stresses that there is a “difference between prohibiting
embryo research and refraining from funding it.”192 Focus on the Family generally
supports the President Bush and his policy, but is “disappointed by his decision to
allow federal funding of research on the existing stem cell lines.”193 NBAC finds the
arguments in favor of federal funding more persuasive than those against it.194 The
National Academies, a group of Representatives, a group of Senators, Mrs. Nancy
Reagan and her supporters, CAMR, the Nobel Laureates, and the UOJCA favor
federal funding for embryonic stem cell research.
189
National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 57.
190
Ibid.
191
Ibid.
192
The President’s Council on Bioethics, Monitoring Stem Cell Research, Jan. 2004, p. 37.
193
Carrie Gordon Earll, “Talking Points on Stem Cell Research,” Focus on the Family,
Sept. 17, 2003 at [http://www.family.org/cforum/fosi/bioethics/faqs/a0027980.cfm].
194
National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research,
vol. 1, Sept. 1999, p. 70.
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