U.S. Stem-Cell Research Can Continue, Appeals Court Says

U.S. funding of human embryonic stem-cell studies can continue while a lower court decides whether the government-backed research violates the law, a federal appeals court said.

The U.S. Court of Appeals in Washington today reversed a preliminary order that would have blocked the U.S. Health and Human Services Department and the National Institutes of Health from spending government money on researching embryonic stem- cells, known as ESC, until the district court judge rules. The court had put a hold on the order in September.

“The hardship a preliminary injunction would impose on ESC researchers” would be “certain and substantial,” the court said. “Their investment in project planning would be a loss, their expenditures for equipment a waste, and their staffs out of a job.”

The government argued that without the ability to support research on embryonic stem-cell lines, years of progress toward finding cures for diseases and disorders will be lost and scientists will look to other countries such as China to continue their work.

The appeals court found that the plaintiffs were unlikely to succeed on the merits of their case so the “extraordinary remedy” of a preliminary injunction could not be justified.

In fiscal 2010, NIH spent about $200 million to fund more than 200 human embryo research grants, the Justice Department and the institutes’ director, Francis Collins, said in court papers.

“This is a victory for the patients around the world suffering from incurable diseases,” Susan L. Solomon, the chief executive officer of the New York Stem Cell Foundation, a research and policy group, said in a statement.

Embryonic stem cells can grow into any of the 200 types of cells in the human body. Scientists say these cells have the potential to be used for repairing cells damaged by injury or disease.

President Barack Obama in March 2009 opened up government funding for the study of embryonic stem cells when he reversed an executive order of his predecessor, George W. Bush, limiting research to about 20 existing lines of the cells.

In response to Obama’s order, the NIH wrote guidelines allowing research on cells derived from embryos that would otherwise be disposed of following in vitro fertilization procedures.

Two doctors, identified in court papers as adult stem cell researchers, sued in August 2009, arguing that the guidelines breach a 1996 law called the Dickey-Wicker Amendment. The law prevents expenditure of government money on research where a human embryo is damaged or destroyed.

James Sherley, a researcher at Boston Biomedical Research Institute, and Theresa Deisher of Seattle won the right to sue by claiming they were unfairly disadvantaged in competing for NIH funding with researchers who used embryonic cells.

The government said the stem-cell research is separate from any that destroys the embryo because the cells must be grown in a medium and are then “differentiated” into other cells, such as nerve cells.

The appeals court agreed with the government’s contention that because the Dickey-Wicker Amendment is written in the present tense the “statute strongly suggests it does not extend to past actions.”

“It is entirely reasonable for the NIH to understand Dickey-Wicker as permitting funding for research using cell lines derived without federal funding, even as it bars funding for the derivation of additional lines,” according to the court’s opinion.

In a dissenting opinion, Judge Karen LeCraft Henderson accused her colleagues on the three judge panel of “linguistic jujitsu” in parsing verb tenses in order to narrow the amendment’s meaning from what Congress intended.

The plaintiffs’ challenge is likely to succeed because the amendment prohibits federal funding of embryonic stem cell research “in all of its sequences,” LeCraft Henderson wrote.

Today’s decision reverses an Aug. 23 order by U.S. District Judge Royce Lamberth in Washington requiring the U.S. Health and Human Services Department and the NIH to stop funding embryonic stem-cell research.

Stem Cells’ Derivations

Lamberth said the administration was attempting to separate the derivation of the embryonic stem cells from research on them, and “the two cannot be separated.”

The appeals court in September put Lamberth’s injunction against funding on hold until it reviewed his decision. The case remains with Lamberth, who is considering motions from both sides to end the matter in their favor.

Since 2002, the government has spent $546 million on human embryo research, Collins wrote in an Aug. 31 court filing. If the ban were upheld, Collins said, it would result in the loss of more than 1,300 full-time or part-time jobs, as well as “the potential loss of top U.S. scientific talent as lead scientists may be forced to move to other countries to pursue their cutting-edge research.”

Stem-cell researchers are seeking cures for illnesses such as Parkinson’s disease, spinal cord injuries, and genetic conditions. Embryonic stem cells can grow into any kind of tissue and may have the potential to accelerate a range of research.

The appeal case is Sherley v. Sebelius, 10-5287, U.S. Court of Appeals for the District of Columbia Circuit (Washington). The original case is Sherley v. Sebelius, 1:09-cv-01575, U.S. District Court, District of Columbia (Washington).

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