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Government Affairs Home > Research > Stem Cell Research

Stem Cell Research

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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.

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 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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