Posts Tagged ‘executive order 13505’

District Court Dismisses Stem Cell Ban Suit

Thursday, July 28th, 2011

On July 27, in Sherley v. Sibelius, Judge Royce Lamberth reversed himself, and dismissed the 2010 lawsuit that initially led to a freeze on Government funding for human embryonic stem cell research, conducted under the terms of the 2009 NIH Guidelines. His decision tracks the reasoning of  an April 29th decision by the Court of Appeals that lifted the injunction that he had imposed on the implementation of the Guidelines (See, my post of May 2, 2011: “Appeals Court Overturns Stem Cell Ban”).  The Guidelines had been formulated to implement President Obama’s executive order 13505 that, in turn, lifted Bush’s 2001 Executive Order banning such funding.

The Court of Appeals had found that the preliminary injunction was improperly granted and the Guidelines were not in conflict with the 1996 Dickey-Wicker Act, banning funding for certain research involving human embryos. The plaintiffs’ counsel, Steven H Aden of the Alliance Defense Fund, a pro-life “legal alliance of Christian attorneys”,  was quoted by the WSJ as considered their options for appeal, and called embryonic stem cell research “illegal and unethical” in a story on the ADF website.

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Appeals Court Overturns Stem Cell Ban

Monday, May 2nd, 2011

On April 29th, in Sherley v. Sebelius, the U.S. Court of Appeals for the D.C. Cir., (a copy is available at the end of this post) overturned the injunction imposed by the district court, which had blocked the implementation of the 2009 NIH Guidelines on finding research using human embryonic stem cells. 74 Fed. Reg. 32170(2009). The Guidelines, in turn, had been formulated to implement President Obama’s  executive order 13505 that lifted President Bush’s executive order banning such funding. The suit, brought by two researchers working with adult stem cells, argued that the Guidelines were in conflict with the 1996 Dickey-Wicker Act, which banned funding for both research that would create human embryos for research purposes or would destroy human embryos. For more background, see my post of Sept. 1, 2010.

The Court found that preliminary injunction was improperly granted “because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although [D-W] 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.”  In other words, if some other unfunded entity disassembles an unwanted embryo obtained with informed consent of the donor from an in vitro fertilization clinic and provides the ESCs to a researcher, the researcher can obtain federal funding to study them. Since establishing the Guidelines, the NIH has approved additional ESC lines for federal funding. While this is good news for researchers working with embryonic stem cell lines approved under the NIH Guidelines, the underlying suit will continue to threaten the administration’s more liberal view of stem cell research.

Sherley – 4-29-11 Documents and Order

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Court Blocks Obama’s Stem Cell Order

Wednesday, August 25th, 2010

In December of 2009, I argued that President Obama’s Executive Order 13505, that lifted President Bush’s 2001 Order banning the use of federal funds for embryonic stem cell (ESC) research, should be a Top Biotech Story of 2009. The Bush Order had banned all federal funding for ESC research except for research on a small number of lines that existed prior to his order. Obama’s substitute order permitted agencies like NIH to fund research on cell lines produced after the Bush ban, so long as the funding was not used to produce the lines by the destruction of embryos. NIH went on to develop guidelines for approving fundable new cell lines.

In the December 2009 post, I noted that Congress had annually enacted the so-called Dickey-Wicker amendment that banned federally-funded research that harms or destroys human embryos. The Administration tried to argue that Order 13505 did not permit funding of obtention of ESCs from embryos, but the Judge found this a distinction without a difference.

Questions remain. While Judge Lamberth (D.C.D.C.) stated that the decision was intended to restore the status quo, the status quo, e.g., the Bush Order, is long gone. Research projects using newly approved lines have been started. Even if they can be continued with private funding, it is far from clear that these “illegal” cell lines can be used at all.  But what if the lines were produced abroad and sent to a U.S. lab? Would even the limited research permitted under the Bush order be fundable now? What is supposed to happen to ongoing projects that cannot find non-federal funds to keep the laboratory lights on? With patent protection for ESCs uncertain at best, the future of this research in the U.S. is cloudy at best.

Read New York Times Article on Judge Lamberth’s Decision.

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