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Embryonic Stem Cell Research

Stem cells are believed to have the ability to divide without limit and to give rise to specialized cells. Reports published in 1998 by scientists at the University of Wisconsin External Link and Johns Hopkins University on the successful isolation and culture of pluripotent stem cells (capable of specializing into many but not necessarily all tissues of an organism human) 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.

On March 9, 2009, President Barack Obama issued an Executive Order lifting restrictions on the federal funding of human embryonic stem cell research that had been in place 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 Obama Executive Order directed the National Institutes of Health to issue Guidelines to permit such funding. The NIH finalized its stem cell Guidelines on July 7, 2009. The NIH Human Embryonic Stem Cell Registry currently lists more than 100 human embryonic stem cell lines that meet the eligibility criteria set by NIH under the Obama policy. The criteria require that the hESC line:

• Was created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose; and
• Was donated by individuals who sought reproductive treatment and who gave voluntary written consent for the human embryos to be used for research purposes.

The NIH also set stringent documentation and review requirements.

Shortly after the NIH Guidelines were in place, James L. Sherley, M.D., Ph.D., (Boston Biomedical Research Institute) and Theresa Deisher, Ph.D., (Ave Maria Biotechnology Company) filed suit (Sherley v. Sebelius) in federal court challenging the Guidelines and the federal funding of hESC research. The plaintiffs alleged that the Guidelines violate the so-called Dickey-Wicker provision that has appeared in every Labor-HHS appropriations bill since 1996. That provision prohibits federal funding for research in which embryos are created for research purposes, or in which human embryos are destroyed, discarded or subject to risk.

On August 23, 2010, U.S. Federal District Court Judge Royce C. Lamberth issued a temporary restraining order immediately prohibiting the NIH from further funding human embryonic stem cell (hESC) research. Judge Lamberth’s order came following a Federal Appeals Court decision giving Sherley and Deisher standing to bring their suit. Judge Lamberth ruled that the plaintiffs were likely to win their case when it came to trial.

The U.S. Court of Appeals for the D.C. Circuit stayed the preliminary injunction pending appeal and on April 29, 2011, a split three-judge panel lifted the preliminary injunction. The majority opinion concluded that the opponents of hESC “are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.” Federal District Court Judge Royce Lamberth on July 27, 2011, rejected the claims of the plaintiffs and dismissed their suit. Judge Lamberth’s decision closely tracked the decision of the U.S. Court of Appeals panel that ruled on the appeal of his preliminary injunction.

Attorneys for Drs. Sherley and Deisher, Ph.D., on September 19, 2011, filed a notice of appeal seeking to overturn the decision. A briefing schedule has been posted by the U.S. Court of Appeals for the D.C. Circuit and a decision is expected by late 2012. Meanwhile, NIH funding of hESC research continues.

AAMC is a co-founder and a member of the board of the Coalition for the Advancement of Medical Research (CAMR). The Coalition has submitted various amicus curiae briefs in the case in support of continued federal funding of hESC research.

Congressional Reaction: Many members of the House and the Senate have called for Congressional action to authorize explicitly human embryonic stem cell research and make the legal case moot. Legislation was introduced in both the House and the Senate during the First Session of the 112th Congress (2011) in support of stem cell research (for example, The Stem Cell Research Advancement Act of 2010 (S. 3766) and the “Stem Cell Research Advancement Act” (H.R. 4808)); however, no legislation was advanced during the session.