Court Vacates Stem Cell Research Funding Ban

(CN) - The D.C. Circuit on Friday vacated an injunction that would have barred the government from funding human embryonic stem cell research. Previously the court has let funding continue pending the outcome of this appeal.

In March 2009, President Barack Obama signed an executive order that allowed the use of federal dollars for stem cell research, removing a restriction that President George W. Bush had enacted that limited funding to research on existing stem cells in storage.

Obama ordered all departments and agencies of the federal government that support or conduct stem cell research to adopt new National Institutes of Health guidelines that apply to spending NIH funds for research using human embryonic stem cells that were created by in vitro fertilization for reproductive purposes and were no longer needed for that purpose. It also opened funding for research on certain uses of human-induced pluripotent stem cells.

Two doctors who use only adult stem cells in their research, James Sherley and Theresa Deisher, challenged the institute's relaxed guidelines in a lawsuit last year.

After Chief U.S. District Judge Royce Lamberth dismissed their challenge for lack of standing, the D.C. Circuit revived the doctors' claims because the doctors compete for funding with scientists that can now use embryonic stem cells.

By August, Lamberth had enjoined Obama's order, finding it violated Congress' Dickey-Wicker Amendment of 1996, which prohibits federal funding of research in which human embryos are destroyed.

Because embryonic stem cells are pluripotent, and can develop into a variety of human cells, stem cell research offers promising treatments and cures for a panoply of diseases and injuries. The research has been made controversial because some groups claim that it destroys a potential human life, even if the stem cells were going to be thrown away anyway.

After Lamberth refused to lift the ban, the D.C. Circuit intervened and granted a stay in September. A subsequent ruling let funding continue.

In oral arguments later that month, Deputy Assistant Attorney General Beth Brinkmann.

said upholding Lamberth's decision "would be a setback for the field."

Affirming Lamberth's ban on federal funding would threaten $64 million in taxpayer funds that had already been invested in 24 research projects that could aid in cell and tissue regeneration and could help cure disease, the Justice Department had claimed.

Brinkmann said the ban would cause irreparable harm to the government, forcing the NIH to shut down eight projects worth $9.5 million that involve 45 agency scientists.

He also said the derivation of a stem cell line, which involved the destruction of an embryo, was not part of later stem cell research.

Ultimately, a majority of the circuit's three-judge panel agreed.

"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 [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an ESC will be used," Judge Douglas Ginsburg wrote for the court. "We therefore vacate the preliminary injunction."

Ginsburg found that the injunction unfairly hurts the government more than it protects the plaintiffs in their quest for funding. "As we see it, however, a preliminary injunction would in fact upend the status quo," the decision states.

"We cannot say that, if the plaintiffs are to litigate this case without the benefit of interim relief, then the 2009 Guidelines will place a significant additional burden upon their ability to secure funding for their research," Ginsburg added.

"The hardship a preliminary injunction would impose upon ESC researchers, by contrast, would be certain and substantial," the ruling continues. "The injunction entered by the district court would preclude the NIH from funding new ESC projects it has or would have deemed meritorious, thereby inevitably denying other scientists funds they would have received. Even more problematic, the injunction would bar further disbursements to ESC researchers who have already begun multi-year projects in reliance upon a grant from the NIH; their investments in project planning would be a loss, their expenditures for equipment a waste, and their staffs out of a job."

In a dissent authored by Judge Karen LeCraft Henderson, she accuses her colleagues of performing "linguistic jujitsu."

"The majority opinion has taken a straightforward case of statutory construction and produced a result that would make Rube Goldberg tip his hat," Henderson wrote. "Breaking the simple noun 'research' into 'temporal' bits, narrowing the verb phrase 'are destroyed' to an unintended scope, dismissing the definition section of implementing regulations promulgated by the Department of Health and Human Services (in case the plain meaning of 'research' were not plain enough), my colleagues perform linguistic jujitsu." (Parentheses in original.)

Proceedings in the District Court are ongoing with each party having requested summary judgment."

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