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 directs the National Institutes of
Health to issue guidelines to permit such funding within 120 days
(July 7, 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. The NIH Human Embryonic Stem
Cell Registry currently lists 21 human embryonic stem cell lines
that meet the eligibility criteria set by President Bush. 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 expanded 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 have 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 have 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 compelling 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. According to a fact sheet released
by the White House, federal funds could only be used for research
on existing stem cell lines that were derived:
- With the informed consent of the donors;
- From excess embryos created solely for reproductive purposes;
and
- Without any financial inducement to sponsors.
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 on August 9, 2001. Within the Bush policy limits, NIH funded
various research and training grant applications using the eligible
stem cell lines. In addition, NIH had funded an internal stem cell
characterization laboratory and various centers of excellence in
stem cell research.
On October 3, 2005, NIH announced it awarded the WiCell Research
Institute $16.1 million over four years to fund a National Stem
Cell Bank. The National Stem Cell Bank is intended to "consolidate
many of the federally funded eligible human embryonic stem (ES)
cell lines in one location, reduce the costs that researchers have
to pay for the cells, and maintain quality control over the cells."
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 directs the National Institutes of
Health to issue guidelines to permit such funding within 120 days
(July 7, 2009).
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. Federal funding for research would have been
limited to stem cells that meet the following requirements: (1)
the stem cells were derived from human embryos donated from in vitro
fertilization clinics for the purpose of fertility treatment and
were in excess of the needs of the individuals seeking such treatment;
(2) the embryos would never be implanted in a woman and would otherwise
be discarded; and (3) such individuals donate the embryos with written
informed consent and receive no financial or other inducements.
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 11th Congress, several stem cell related bills have been
introduced. Most notable are H.R.872 (DeGette) and S. 487 (Harkin)
which would 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 charter 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 considered 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."
Contacts
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Tony Mazzaschi, Interim Chief Scientific Officer, 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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