Two developments in human stem cell case

DOJ files second motion to lift temporary ban, U. of California asks to join the case

Two new developments occurred yesterday in Sherley v. Sebelius, the case that has halted and restarted federally funded human embryonic stem cell research.

In one development, the Department of Justice filed its second brief in favor of lifting the temporary ban on the research. This is the last written filing expected prior to oral argument before the Circuit Court of Appeals for the District of Columbia that will be happening on Monday morning.

Also yesterday, the University of California asked the court for permission to intervene in the appeal — that is, for permission to become a party in the case and to lodge its own arguments before the court, in addition to those of the NIH and the DOJ.

Justice’s filing

The DOJ’s filing raised a few new issues, but says that several arguments raised last week by James L. Sherley and Theresa A. Deisher were invalid. Sherley and Deisher are the adult stem cell researchers suing the government. They say the government’s use of federal funds in embryonic stem cell research violates a Congressional appropriations rider that prohibits damage to human embryos.

The DOJ disputes Sherley and Deisher’s arguments about the legislative history of the rider, called the Dickey-Wicker Amendment.

They further note that the 1996 memo that Sherley and Deisher had cited as evidence of inconsistent behavior on the part of the NIH was not about stem cells at all, but instead “involved preimplantation genetic diagnosis, which is research done directly on human embryos to detect genetic abnormalities. The research discussed in the 1996 letter would thus not be eligible for funding under the 2009 NIH guidelines,” the brief said.

The DOJ also responded to the contention that the preliminary injunction barring stem cell research — which has been temporarily lifted — affected only recently derived stem cell lines and not stem cell lines that were derived prior to 2001 and approved under President Bush’s guidelines.

The DOJ maintains that the plain language of the preliminary injunction doesn’t permit distinguishing between “existing stem cell lines” and newly created ones, because the lower court “held that embryonic stem cell research is ‘research in which an embryo is destroyed.’”

California enters the case

The University of California asked for permission to join the case, saying it was “the single largest NIH grantee in the nation whose grants are directly affected by this action,” and noting a “lack of focus” on affected research external to NIH by the parties before the court.

The university said its “interest are not adequately represented” by those parties to the case.

“No grantee, however, is represented in this litigation;” it wrote. “Yet grantees are the most directly and immediately affected non-federal parties” by the ban on research.

The university said it filed because of a lack of “consideration of extramural research by the parties or the court.”

The universities’ contribution to the lawsuit does not appear to be directly related to the immediately upcoming decision before the court about whether to extend the temporary stay on the research ban; if extended, the temporary stay will last while the lower court’s ban is appealed at the appeals court. Instead, the university wishes to participate in whether the appeals court should more permanently overturn the ban. The appeals court will consider that question later on. The first filings in that portion of the case are due on September 30.

“The recent U.S. District Court preliminary injunction blocking federally funded human embryonic stem cell research threatens ongoing potential life-saving research and undermines the time-honored system of peer-reviewed science,” the university said in a statement yesterday.

The university stated that it “believes it is important that the scientific community be permitted to move forward with embryonic stem cell research that provides hope to millions of patients and their families,”

At the same time as the University of California trumpets being “the first research institution in the nation” to try to join this case, MIT has been much more cautious.

MIT continues “to be in close touch” with the American Association of Universities and the Council on Government Relations and “is helping to shape [their] collective positions,” said Claude R. Canizares, vice president for research and associate provost.

“We will take independent action only if/when we think it is both necessary and might be effective. Otherwise, we think it best to act collectively with our peers through these associations,” Canizares said in an e-mail.