Stem cell research to temporarily resume after court ruling

A federal appeals court ordered yesterday that human embryonic stem cell research funded by the NIH can resume temporarily, while the court hears arguments in the case.

“We are pleased with the Court’s interim ruling, which will allow this important, life-saving research to continue while we present further arguments to the Court in the weeks to come,” said Francis S. Collins, director of the National Institutes of Health said yesterday.

On the other hand, “we do not expect the government to lift its current suspension of … funding,” said Samuel M. Casey, part of the legal team representing plaintiffs James L. Sherley and Theresa Deisher, who are opposing the government.

The NIH and Department of Justice requested an emergency stay before the United States Circuit Court of Appeals for the District of Columbia on Wednesday, after their request for a stay was denied by the lower court judge, Royce C. Lamberth, on Tuesday. A stay was granted yesterday:

“The purpose of this administrative stay is to give the court sufficient opportunity to consider the merits of the emergency motion for stay and should not be construed in any way as a ruling on the merits of that motion,” the appeals court said at 11:08 a.m. Thursday.

“We are not surprised the court granted the government an administrative stay,” Casey said.

Casey said they would file their opposition to the stay by the court’s deadline of Tuesday, and they expect the Court “to rule within about a week or so,” although the government has until Monday, Sept. 20, to file their reply.

MIT has not issued a formal statement, though Vice President for Research Claude R. Canizares was in Washington yesterday, “in part discussing this topic,” he said.

On Monday, Harvard President Drew Gilpin Faust said that “without the flow of essential federal funds, the promise of stem cell science is at risk of becoming a dream deferred — and for some, a dream undone.”

The case is Sherley v. Sebelius, where Sherley and Deisher have asserted that the federal funding of human embryonic stem cell research violates the Dickey-Wicker amendment, a congressional appropriations rider that prohibits federal funding of research where a human embryo is destroyed. They are suing the Department of Health and Human Services and the National Institutes of Health.

Before yesterday’s stay order, the NIH said the preliminary injunction issued Aug. 23 prohibited it from proceeding with its own human embryonic stem cell research, as well as prohibited it from funding that research externally.

Conflict over Bush lines

There has been substantial confusion about the exact meaning of the preliminary injunction. On Aug. 24, the NIH said it believed the order stopped all federally funded human embryonic stem cell research: both the cell lines approved under the Bush-era guidelines, which permitted lines where the embryos were destroyed prior to 2001, as well as lines approved under President Obama’s revised guidelines in 2009.

Last week Friday, Sherley and Deisher said they did not believe that the judge’s order restricted the stem cell lines approved under President Bush.

When he denied the first stay request on Tuesday, Judge Lamberth wrote that “plaintiffs agree that this Court’s order does not even address the Bush administration guidelines,” indicating he agreed that the NIH was not barred from doing research with the Bush-approved stem cell lines.

The NIH has not responded to questions about the interpretation of the preliminary injunction, and has referred inquiries to the Department of Justice. The DOJ declined to comment, citing their brief filed before the Appeals Court Wednesday, which did not address this issue.

Can existing money be spent?

Additionally, Sherley and Deisher believe that researchers who have already received affected grant money are prohibited from spending that money.

The NIH said “award recipients may continue to expend the funds awarded to them prior to the date of the injunction” in guidance released to researchers on Aug. 30.

“We have also asked the Court to order the government to immediately inform any NIH grant recipients … that any remaining and unspent NIH-granted funds may not be spent,” Casey said.

The judge’s Aug. 23 order is not particularly clear on the topic. Whether it prevents researchers from spending already-received grant money appears to turn on whether they qualify as “agents” of the HHS or NIH, the parties to the suit and on whom the preliminary injunction is binding.

Filing for summary judgement

As the Government’s appeal is being considered before the Circuit Court of Appeals, the case in the lower court, District Court, continues.

Yesterday evening, Sherley’s lawyers filed in the District Court for summary judgement because, they argued, the case can be resolved based on undisputed facts. Summary judgement asks a judge to decide a case when the question before it is a matter of law, rather than an issue of fact.

According to the Federal Rules of Civil Procedure, the government will have three weeks to reply to the motion for summary judgement.

Sherley’s motion for summary judgement requests the Court enter an order quite similar to the preliminary injunction, with an additional request: “that Defendants are directed to immediately inform any NIH grant recipients in possession or control of federal funds granted under the Guidelines for human embryonic stem cell research that any remaining and unspent NIH-granted funds may not be spent on human embryonic stem cell research but must be returned to NIH to fund lawful research.”

Casey said that Sherley and Deisher were not interested in “clawing back” money, or requesting that researchers return already-spent money.

About Sherley and Deisher

Sherley was an associate professor of biological engineering at MIT until he was denied tenure in spring 2007. He alleged that racism was a factor, and staged a hunger strike in protest. Sherley is now a senior scientist at the Boston Biomedical Research Institute.

Theresa Deisher is an adult stem cell researcher at Seattle-based AVM Biotechnology. Deisher’s work focuses on therapeutic applications of stem cells.