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U.S. Asks Judge to Delay Halt to Stem-Cell Research

Aug. 31 (Bloomberg) -- The Obama administration urged a judge to allow federal funding of embryonic stem-cell research to continue while it appeals his decision banning government support for any activity using cells taken from human embryos.

The Justice Department today asked U.S. District Judge Royce Lamberth in Washington to put on hold his decision pending an appeal to the U.S. Court of Appeals in Washington. The government argued that Lamberth’s preliminary injunction changed the status quo and will itself cause irreparable harm to researchers, taxpayers and scientific progress.

Lifting the ban would allow the government to continue funneling tens of millions of dollars to scientists seeking cures for diseases such as Parkinson’s, 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 government said in court papers it will ask the appeals court for a delay unless Lamberth stays his order by Sept. 7. White House spokesman Reid Cherlin said in a statement that embryonic stem-cell research is a top priority for the administration. “We’re going to do everything possible to make sure to avoid the potentially catastrophic consequences of this injunction.”

Lamberth on Aug. 23 issued an order temporarily stopping the Health and Human Services Department and the National Institutes of Health from conducting the studies. The judge cited the still-in-force 1996 Dickey-Wicker Amendment in his ruling, saying that Congress had prohibited funding any research in which a human embryo was destroyed. By implication, that included all stem-cell research, Lamberth said.

Obama, Bush Orders

In March 2009, President Barack Obama reversed an executive order of former President George W. Bush to allow research on cells derived from embryos that would otherwise be disposed of after in vitro fertilization procedures.

Under the Bush order, Dickey-Wicker was interpreted to allow research on lines of stem cells that had already been created using human embryos. In his August 2001 executive order, Bush limited federal funding for such research to about 20 existing lines of embryonic cells and banned federal funding on lines created after that time.

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.”

In its filing today, the Justice Department said Lamberth’s interpretation of the Dickey-Wicker amendment is “difficult to square” with the fact that Congress has endorsed the amendment in the federal budget every year since 1996 and appropriated stem-cell research funds.

‘A Serious Question’

“In light of this clear history, there is, at a minimum, a serious question whether Congress could have intended the interpretation proffered by plaintiffs and adopted by this court,” Justice Department attorneys wrote.

Doctors James Sherely of Watertown, Massachusetts, and Theresa Diesher of Seattle, identified by Lamberth as adult stem-cell researchers, sued in August 2009, arguing that NIH guidelines breach the Dickey-Wicker strictures. They also argued that they were being irreparably harmed by having to compete for NIH funding with researchers using embryonic cells.

Following the ruling, Francis Collins, director of the National Institutes of Health in Bethesda, Maryland, said he would withhold annual U.S. grants of $54 million scheduled to be provided to scientists in September. In addition, he wouldn’t distribute $15 million to $20 million for new projects under consideration in the next month.

Government Researchers

Lamberth’s ruling also affected internal NIH researchers. On Aug. 27, researchers inside the NIH who work with human embryonic stem cells were instructed to “initiate procedures to terminate these projects” in a memo from Michael Gottesman, deputy director for intramural research, obtained by Bloomberg News.

Ronald McKay, a former NIH scientist who recently moved to Johns Hopkins University in Baltimore, said about eight research labs at NIH are working with human stem cells and would be affected.

“There are people at NIH who aren’t starting new experiments,” he said in a telephone interview today. “Many of them take weeks to achieve. If you’re in doubt about what’s going to happen you’re not going to start a new experiment.”

Joanna Wysocka, a stem cell researcher at Stanford University School of Medicine, recently submitted a proposal to the NIH for funding to study the early formation of the structures of the brain and face in the hope of developing better ways to diagnose and treat disorders such as cleft lip and palate. The proposal scored in the top 1 percent, was headed for funding and now will likely be shelved, she said in a telephone interview today.

While she is working with money from other sources, that money “will dry up soon unless we get a stable funding source,” she said.

The case is Sherley v. Sebelius, 09-cv-1575, U.S. District Court for the District of Columbia (Washington).

To contact the reporters on this story: William McQuillen in Washington at bmcquillen@bloomberg.net Rob Waters in San Francisco at rwaters5@bloomberg.net.

To contact the editor responsible for this story: David Rovella at drovella@bloomberg.net

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