Stem cell work in limbo awaiting court’s decision

Ruling on temporary stay may come today

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James L. Sherley, a former MIT professor, is a plaintiff in the lawsuit against the NIH to halt federal funding of human embryonic stem cell research.
Michael Mcgraw-Herdeg—2007 Tech File Photo

Many stem cell researchers have been left uncertain about their own future and the future of their field as they wait for a federal judge to decide whether to allow the NIH to fund human embryonic stem cell research, within and without of its walls.

A recent federal court injunction barred NIH labs from performing human embryonic stem cell research, and also stopped the NIH from funding grants that supported such research. The judge is currently considering an emergency stay which would temporarily allow the NIH to continue its research and to continue funding research.

The NIH has interpreted the court order to bar work with any human embryonic stem cell lines, but the plaintiffs in the case say they only meant to roll back the additional stem cell lines allowed by the Obama administration in 2009. Those plaintiffs, James L. Sherley and Theresa Deisher, said in a court filing Friday night that the Court’s ban does not apply to research approved under the Bush administration’s stem cell guidelines in 2001.

The judge, Royce C. Lamberth, is expected to rule early this week on the emergency stay, quite possibly as early as today.

The case is Sherley v. Sebelius, where plaintiffs James L. Sherley and Theresa Deisher assert 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.

The government filed its emergency motion last week Tuesday, requesting that the Court put on hold, or stay, the preliminary injunction it issued on Monday, Aug. 23. That preliminary injunction directs the NIH & HHS to stop “implementing, applying, or taking any action whatsoever pursuant to the National Institutes of Health Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009), or otherwise funding research involving human embryonic stem cells as contemplated in the Guidelines.”

Sherley’s motivation

According to an article in Thursday’s Wall Street Journal, Sherley and Deisher were “recruited separately” by lawyers looking to challenge the federal policy. They had never met until last week, the Journal said.

It’s not clear who recruited them, or how the lawsuit is being funded.

The lawsuit originally included seven additional parties on the side of Sherley and Deisher, including one called “embryos”; the Court of Appeals ruled that those parties did not have standing and they are no longer part of the lawsuit.

Lawyers from three institutions are associated with Sherley and Deisher, according to court filings: the law firm of Gibson, Dunn, & Crutcher; Alliance Defense Fund; and Human Life Advocates.

Gibson & Dunn referred inquiries to the Alliance Defense Fund. The Alliance Defense Fund and Human Life Advocates have both not returned inquiries.

Sherley and Deisher were on Capitol Hill speaking to legislative aides to make the case against a change in the law to repeal that could make human embryonic stem cell research unambiguously legal, the Journal reported.

Sherley and Deisher both claim human embryonic stem cell research is morally objectionable and unlikely to be successful, the Journal said. Both are adult stem cell researchers.

Sherley’s Friday filing

Sherley and Deisher filed their opposition to the emergency motion at 8:46 p.m. on Friday night before the long weekend. Their deadline was Friday.

The government requested the judge rule by today, otherwise they intend to ask tomorrow that the Court of Appeals for the District of Colombia intervene.

Their 23-page motion took odds with many of the government’s claims, especially comments by NIH Director Francis S. Collins.

They say “the most Dr. Collins can muster in claiming irreparable injury is that embryonic stem cell research ‘offer[s] hope’ to patients … and that beneficial treatments are ‘possible’ in the future.”

They also say that Collins “resorts to conjecture that the experiments ‘may’ take a long time to restart and that researchers ‘may’ move to other countries.” “This falls far short of the imminent and irreparable injury that law requires,” they said.

CAMR wants to file friend-of-court brief

Also on Friday, the Coalition for the Advancement of Medical Research, a stem cell advocacy group, asked the Court for permission to file a friend-of-the-court, or amicus curiae, brief.

CAMR’s brief argues that the lack of a stay on the preliminary injunction will “effectuate a dramatic change and irreparably damage one of NIH’s most important research programs.”

However, CAMR’s brief to the court relies substantially on NIH Director Collins’ declaration—many points of that declaration are challenged by Sherley’s motion.