Stem Cell Research
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Related Resources
AAMC Documents
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In Brief
On March 9, 2009, President Barack Obama issued an Executive Order
lifting restrictions on the federal funding of human embryonic stem
cell research. The Order directed the National Institutes of Health
to issue guidelines to permit such funding, which it did on July
6, 2009. President Obama's action is the first significant change
in federal stem cell policy since August 9, 2001, when President
George W. Bush announced a policy that federal funds could only
be used to support research using human embryonic stem cells lines
that were derived before that date. Between 2001 and 2009, the NIH
Human Embryonic Stem Cell Registry listed 21 human embryonic stem
cell lines that meet the eligibility criteria. Legislative efforts
to lift the policy restrictions passed Congress several times, but
were blocked by the Bush Administration. The AAMC strongly supports
the Obama Executive Order and supported earlier legislative efforts
to expand federal support for stem cell research.
Background
Stem cells are believed to have the ability to divide without
limit and to give rise to daughter cells that can form specialized
cells. These cells can be categorized as pluripotent, which are
capable of specializing into many but not necessarily all tissues
of an organism, or totipotent, which have unlimited ability to differentiate
into extraembryonic membranes, the embryo, and all postembryonic
tissues and organs. Reports published in 1998 by scientists at the
University of Wisconsin and Johns Hopkins University on the successful
isolation and culture of pluripotent human stem cells created the
prospect of developing an entire array of new cellular therapies.
Stem cell research holds the promise of helping us better understand
the most fundamental processes of cellular specialization and human
development.
However, the discoveries also raised a number of ethical and legal
issues. Under language included in the annual Labor-HHS Appropriations
bill since 1996, the federal government is prohibited from funding
research involving human embryos. In January 1999, the General Counsel
of the Department of Health and Human Services determined that the
federal government was not prohibited from funding research utilizing
human pluripotent stem cells based on the scientific determination
that stem cells are not "organisms" and therefore cannot
be considered human embryos. However, funding stem cell derivation
activities was judged to be prohibited.
To address the ethical, legal, and social issues relevant to pluripotent
stem cell research, the NIH Director commissioned a subcommittee
of the Advisory Council to the Director to develop guidelines for
the use of pluripotent stem cells in NIH-funded research. Final
guidelines were published on August 25, 2000.
Executive Branch Activity
Soon after taking office in early 2001, President George W. Bush
ordered a review of the January 1999 legal determination by HHS
that permits the use of federal funds to support research utilizing
human embryonic stem cells. Subsequently, HHS Secretary Tommy Thompson
asked NIH to provide him with a report on the scientific issues
involved in stem cell research.
On August 9, 2001, President Bush announced that federal funds could
be awarded for research using human embryonic stem cell lines that
meet certain criteria. Such research was eligible for federal funding
as long as the derivation process was initiated prior to 9:00 p.m.
EDT on August 9, 2001. This policy announcement vitiated the existing
NIH stem cell guidelines and stem cell grant applications in the
pipeline were not reviewed. The NIH on November 7, 2001 released
the Human Embryonic Stem Cell Registry. Eventually, the Registry
listed 21 human embryonic stem cell lines that met the eligibility
criteria set by President Bush. Within the Bush policy limits, NIH
funded various research and training grant applications using the
eligible stem cell lines. In addition, NIH funded an internal stem
cell characterization laboratory and various centers of excellence
in stem cell research.
On March 9, 2009, President Barack Obama issued an Executive Order
lifting many of the restrictions on the federal funding of human
embryonic stem cell research. The Order directed the National Institutes
of Health to issue guidelines to permit such funding, which it did
on July 6, 2009. Draft Guidelines were issued on April 17, 2009,
and open for public comments, of which more 49,000 were received.
The NIH Guidelines limit federal funding to lines derived from embryos
created by IVF for reproductive purposes and that are in excess
of clinical need. Stem cell lines derived from somatic cell nuclear
transfer, parthenogenesis, or via the IVF process if the embryo
was created for research purposes are not eligible for federal funding.
In addition, NIH will not fund research using otherwise eligible
stem cell lines if the cells are introduced into non-human primate
blastocysts or if the cells may have contributed to the germ line.
For stem cell lines already in existence when the Guidelines were
issued, a Working Group of the Advisory Committee to the Director,
will advise NIH on whether the "core ethical principles and
procedures used in the process for obtaining informed consent for
the donation of the embryo were such that the cell line should be
eligible for NIH funding." NIH will also use the Working Group
to assess foreign derived stem cell lines, created both before and
after the effective date of the Guidelines. Lines deemed eligible
will be listed on the NIH Registry and not need additional review.
Congressional Activity
Since President Bush's 2001 policy announcement, a number of bills
have been introduced in Congress concerning stem cell research.
In the 109th Congress (2005-2006), the most notable legislation
was H.R. 810, introduced by Representatives Mike Castle (R-Delaware)
and Diana DeGette (D-Colorado) and S. 471, introduced by Senators
Arlen Specter (R-Pennsylvania) and Tom Harkin (D-Iowa). The identical
measures would have required the Secretary of Health and Human Services
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.
H.R. 810 was considered by the full House of Representatives on
May 24, 2005, and passed by a vote of 238-194. The Senate passed
the bill on July 18, 2006 by a vote of 63-37. President Bush vetoed
the bill on July 19, 2006, and the House failed to override the
veto on the same day. The veto override attempt failed 235-193,
falling some 47 votes short of the required two-thirds necessary.
In the 110th Congress, H.R. 810 was reintroduced as H.R. 3. It passed
the House on January 11, 2007, by a vote of 253-174. On April 11,
2007, the Senate passed a similar bill, S. 5, by a vote of 63-34.
S. 5 was subsequently approved by the House on April 11, 2007, by
a vote of 247-176. The bill was vetoed by President Bush on June
20, 2007. A veto override vote was never scheduled.
In the 111th Congress, several stem cell related bills have been
introduced. Most notable are H.R.872 (DeGette) and S. 487 (Harkin),
which are identical to the legislation passed by Congress in the
110th Congress and would lift the Bush limitations.
AAMC Activity
The AAMC strongly supports the federal funding of human embryonic
stem cell research. The Association also concurs with the January
1999 legal determination of the Department of Health and Human Services
that current law permits the use of federal funds to support research
utilizing human pluripotent stem cells.
The AAMC is a founding member of the Coalition for the Advancement
of Medical Research (CAMR). The Coalition is comprised of universities,
scientific societies, patients' organizations, and other entities
that are devoted to ensuring that federal funding will be available
for stem cell research.
In a January 19, 2000, comment letter on the proposed NIH guidelines
for research utilizing human pluripotent stem cells, then-AAMC President
Jordan J. Cohen, M.D., said that federal support for such research
"should not only be viewed as permissible, but also as highly
desirable, given the beneficial oversight that accompanies government
funding, the tremendous promise of this type of research, and the
fact that the results of federally funded research will flow into
the public domain and not be sequestered in propriety databases."
On May 10, 2001, AAMC wrote President Bush calling on him to support
Federal funding for research using human pluripotent stem cells.
The letter stressed that AAMC recognizes the significant ethical
issues that are raised about embryonic stem cell research and respects
the view of those who oppose such research, including some in our
own medical school community. However, the Association is persuaded
otherwise by what we believe is an overriding consideration, namely,
that it would be tragic to waste the unique potential afforded by
embryonic stem cells, destined to be discarded in any case, to alleviate
human suffering and enhance the quality of human life.
In 2003 the AAMC urged the National Research Council and the Institute
of Medicine to develop guidelines for the responsible practice of
human embryonic stem cell research. The IOM formed a committee which
released such guidelines in April 2005. In early 2006, the NRC and
IOM announced the formation of a new panel to provide on-going review
of the guidelines. Some revisions to the Guidelines were released
in early 2007.
On April 27, 2006, the AAMC sponsored a workshop to consider institutional
compliance issues related to stem cell research. Of particular focus
were compliance issues related to laboratories that utilize stem
cell lines on the NIH Registry as well as lines not on the Registry.
A summary report on the workshop is available on-line.
The AAMC endorsed both H.R. 810 and S. 471 in the 109th Congress
and H.R. 3 and S. 5 in the 110th Congress. The Association has written
repeatedly to members of the House and Senate in support of the
legislation. In 2006, the AAMC urged President Bush to support and
sign the legislation into law. The AAMC expressed disappointment
with his veto. Similar correspondence and policy statements were
issued on the legislation introduced in the 111th Congress.
AAMC President and CEO Darrell G. Kirch, M.D., issued the following
statement on March 9, 2009, concerning the Executive Order issued
by President Obama: "The AAMC thanks President Obama for lifting
restrictions on the federal funding of human embryonic stem cell
research. This executive order recognizes the need to expand federal
support of stem cell research so that millions of patients can benefit
from the scientific and medical breakthroughs that may result from
this extremely promising research. We look forward to working with
the National Institutes of Health as it develops the strict ethical
guidelines called for by President Obama, and moves forward with
research to improve the health of the nation."
On May 22, 2009, AAMC provided NIH with comments on the draft Guidelines
implementing the Obama Executive Order. AAMC was generally supportive
but made several substantive suggestions.
Contacts
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Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059
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Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
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