Stem Cell
Research
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Related ResourcesAAMC Documents
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In Brief On August 9, 2001,
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 22 human
embryonic stem cell lines that meet the eligibility criteria set by President
Bush. During the 109th Congress, legislation to allow federal funding for additional
stem cell lines passed the House on May 24, 2005 and the Senate on July 18, 2006.
The President vetoed the bill on July 19, 2006 and the House failed to override
the veto on the same day. Identical legislation (H.R.
3) was introduced in the 110th Congress. It passed the House on January 11,
2007. A slightly different bill (S.
5) passed in the Senate on April 11, 2007. The AAMC strongly supported both
bills and continues to advocate for an expanded federal stem cell policy. BackgroundStem
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 entireJuly 12, 2006 AAMC
Letter Urging Support for "Stem Cell Research Enhancement Act of 2005"
(H.R. 810) 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. Administration 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 is now 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.
As of April 15, 2007, the Registry list 22 human embryonic stem cell lines that
meet the eligibility criteria set by President Bush on August 9, 2001. Since
the President's announcement, NIH has funded various research and training grant
applications using the eligible stem cell lines. On such activities, the NIH reports
that it spent $20 million in FY 2003, $24 million in FY 2004, $40 million in FY
2005, and $38 million in FY 2006. It estimates that it will expend $37 million
in FY 2007 and $37 million in FY 2008 on human embryonic stem cell research. 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." 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 notably 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. The three Senators absent for the roll call vote have announced they
would have voted for the measure if present. The differences in the two bills
are minor and are expected to be resolved. President Bush has announced he will
veto either bill, should one be sent to him for his signature. On April
11, 2007, the Senate also passed S. 30, the so-called "Hope Offered through
Principled and Ethical Stem Cell Research Act" by a vote of 70-28. The bill
calls for research on the derivation of stem cells from what the bill calls "naturally
dead" embryos. 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. The AAMC took no position on S. 30, which passed the Senate on April 11,
2007, and seeks to promote the derivation of stem cells from what the bill calls
"naturally dead" embryos. Contacts
| Tony Mazzaschi, Senior Associate Vice President
AAMC Biomedical Health Sciences Research
tmazzaschi@aamc.org
(202) 828-0059
| Dave Moore, Senior Associate Vice President
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
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