Justice Department Urges Court to Stay|Ban on Stem Cell Research Funding

     WASHINGTON (CN) – A Justice Department lawyer told an appellate panel Monday that upholding a lower court’s decision to ban federal funding of human embryonic stem cell research would threaten tens of millions in research funds and dozens of projects that could aid in cell and tissue regeneration and could help cure disease. “It would be a setback for the field,” said Deputy Assistant Attorney General Beth Brinkmann.

     U.S. District Judge Royce Lamberth issued a preliminary injunction in August, blocking the funding after ruling that federally funded human embryonic stem cell research violated a federal law.
     The U.S. Court of Appeals for the District of Columbia allowed the funding to continue, issuing a stay of Lamberth’s ruling while it considers the government’s appeal.
     The statute, called the Dickey-Wicker amendment, bars the use of taxpayer funds for research that involves the creation or destruction of embryos.
     Brinkmann said upholding the ban will endanger $64 million in taxpayer funds that has already been invested in 24 research projects.
     As the hearing opened, Circuit Judge Thomas Griffith interrupted Brinkmann and asked if the government could show that it would suffer irreparable harm if the injunction were not lifted.
     “There’s no question that there would be harm … there’s interruption, certainly,” Griffith said, acknowledging that scientists would have to halt projects, but he asked if the harm qualified as irreparable. “If you can’t show irreparable harm, there’s nothing else,” he said.
     Brinkmann said the ban would cause irreparable harm to the government, forcing the National Institutes of Health (NIH) to shut down eight projects worth $9.5 million that involve 45 agency scientists.
     Brinkmann argued that the research should continue to receive funding under the new federal policy for stem cell research, called the Guidelines for Human Stem Cell Research, set by the NIH in July 2009 after President Obama lifted a Bush-era restriction on stem cell research that only allowed research involving existing stem cells.
     Brinkmann said the guidelines were a “longstanding and permissible interpretation” of the Dickey-Wicker statute, and argued that the court should defer to the agency’s interpretation.
     Judge Brett Kavanaugh asked if the NIH was being “internally inconsistent” in its approach to stem cell research by refusing to fund the derivation of embryonic stem cells because it involves the destruction of embryos, but then funding subsequent experiments using those stem cells.
     Brinkmann drew a line between the process of deriving stem cells and stem cell research, saying a stem cell line is often created years before a project begins, and the same line can be used for dozens of different research projects.
     “The derivation is not part of the stem cell research,” she said.
     Brinkmann said linking research using stem cells to the derivation of the stem cells is akin to tracking the origin of every tissue used as part of a research project or tracking the creator of a beaker used in an experiment.
     The judges tried to pin down when embryonic stem cell research becomes research.
     “Research can only be conducted if an embryo can be destroyed,” Griffith said. “Aren’t we getting dangerously close?”
     Griffith presented a hypothetical situation in which the same researcher who derived a line of stem cells by destroying an embryo later received federal funds to perform research with that same line of stem cells.
     Brinkmann replied that such a situation was possible under federal guidelines, but would be highly unusual. She said that under the guidelines, embryos would not be destroyed or created for the express purpose of research.
     But Griffith said his hypothetical situation showed precisely that.
     Brinkmann disagreed, insisting that the judge’s scenario was “an unusual application of these guidelines,” and that the request to permanently stay the injunction should not be struck down on that basis.
     Plaintiff lead attorney Thomas Hungar of Gibson, Dunn & Crutcher LLP, who is representing two stem cell scientists and others challenging the injunction, accused the government of “trying to create a false dichotomy between funding stem cell research and nothing.”
     He argued that the government could not establish irreparable injury or a likelihood of success on the merits in the case.
     He said the fact that some NIH projects could be shut down does not show irreparable injury, as federal funding could be redistributed to researchers doing projects involving adult stem cells, including two of the plaintiffs. He said there was “no certain showing that that harm is either imminent or actual.”
     Hungar also said the government’s guidelines violated two prongs of the Dickey-Wicker amendment: the ban on using federal funds for projects in which embryos are destroyed and a separate prohibition against using federal funds for research that subjects embryos to risk.
     Hungar said the government itself acknowledged that embryos would be destroyed as part of federally-funded human stem cell research in a section of the 2009 guidelines listing instructions on how to obtain embryos.
     “Derivation links destruction to research,” Hungar said, adding that the proposed research “necessarily falls into prohibition” on those grounds.
     Brinkmann said the court should defer to the agency’s interpretation of the Dickey-Wicker amendment and not uphold the injunction.
     “It would be a setback for the field,” she said.

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