Stem Cell Researchers Seek Money, Law After Court Ruling Bans U.S. Funding

About 35 percent of the $200 million the U.S. government planned to award this year in grants for embryonic stem cell research won’t be distributed after a judge’s ruling banned the funding.

The National Institutes of Health will withhold $54 million in annual grants it expected to renew in September, plus $15 million to $20 million for new projects being considered in the next month, Francis Collins, the agency’s director, said yesterday. The ruling temporarily halted U.S. funding for the research, based on a decision that a 1996 law couldn’t be overruled by a presidential order. The Justice Department said it will appeal.

U.S. District Judge Royce Lamberth’s Aug. 23 decision in Washington has sparked researchers, biotechnology executives and lawmakers to call for permanent legislation that would allow the spending to resume. In 2009, President Barack Obama lifted restrictions on federal funding for the technology and allowed studies to be done on cells derived from embryos that would otherwise be disposed of after in-vitro fertilization.

“I thought our nation had settled this issue,” said Douglas Melton, co-director of Harvard University’s Stem Cell Institute. “The NIH had been waiting eight to 10 years to support this research, and it’s now going to have to backtrack and start all over again.”

Photographer: Sandy Huffaker/Bloomberg

Human embryos appear through a microscope at the La Jolla IVF Lab in La Jolla, California. Close

Human embryos appear through a microscope at the La Jolla IVF Lab in La Jolla, California.

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Photographer: Sandy Huffaker/Bloomberg

Human embryos appear through a microscope at the La Jolla IVF Lab in La Jolla, California.

The agency funded 977 embryonic stem cell projects at a cost of $262.3 million in fiscal years 2002 to 2009 under former President George W. Bush’s policies, NIH spokeswoman Jenny Haliski said in an e-mail. From Obama’s order in March 2009 through June of this year, the institutes provided $128.8 million for 253 projects, Haliski said.

‘Clear Mandate’

The judge’s ruling “is a clear mandate for the administration and Congress to finish what they started with the Obama executive order that extended federal funding for existing embryonic stem cell lines,” said Geron Corp. Chief Executive Officer Tom Okarma, in a telephone interview.

Okarma was joined by Advanced Cell Technology Inc. Chairman William Caldwell and researchers from the University of Pennsylvania and the American Society for Reproductive Medicine in calling for legislation that would allow U.S. funding to resume.

Embryonic stem cells can grow into any kind of tissue and are thought to have the potential to accelerate research into cures for diseases such as diabetes and Parkinson’s and into new drug treatments.

Source: U.S. District Court for the District of Columbia

U.S. District Court for the District of Columbia Chief Judge Royce C. Lamberth. Close

U.S. District Court for the District of Columbia Chief Judge Royce C. Lamberth.

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Source: U.S. District Court for the District of Columbia

U.S. District Court for the District of Columbia Chief Judge Royce C. Lamberth.

Geron is in the early stages of what it says is the first study of an embryonic stem cell-based therapy in humans, a treatment for acute spinal cord injuries.

Bush Policy

Prior to Obama’s executive order, Bush instituted rules in 2001 that allowed federal dollars to be spent on research done only on cell lines created by Aug. 9 of that year.

Lamberth ruled that a 1996 law known as the Dickey-Wicker amendment barred the funding, and couldn’t be overruled by Obama’s action. Obama was attempting to separate the derivation of embryonic stem cells from research on them and “the two cannot be separated,” he said.

The White House is reviewing Lamberth’s decision, and “exploring all possible avenues to make sure we can do this critical life-saving research,” spokesman Bill Burton told reporters yesterday. “From what we can tell, this would also stop the research that President Bush had allowed to go forward."

Jonathan Turley, a law professor at George Washington University in Washington, said the administration should have sought to pass legislation rather than use an executive order.

Appeal Planned

The Justice Department will appeal the ruling this week, spokesman Tracy Schmaler said yesterday in an e-mail. She declined to provide further details.

Photographer: Andrew Harrer/Bloomberg

Francis Collins, director of the U.S. National Institutes of Health. Close

Francis Collins, director of the U.S. National Institutes of Health.

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Photographer: Andrew Harrer/Bloomberg

Francis Collins, director of the U.S. National Institutes of Health.

Stem cell research projects up for annual review for their NIH funding ‘‘would basically stop in their tracks,’’ Collins, the agency director, said yesterday during a conference call with reporters. ‘‘This decision poured sand into that engine of discovery.’’

The agency already has awarded $131 million in grants this year for embryonic stem cell research that won’t be affected by the judge’s ruling, Collins said.

Representative Diana DeGette, a Colorado Democrat, said she had been pushing House Democratic leaders to move legislation she proposed prior to the judge’s ruling. During a conference call with House Democrats yesterday, party leaders expressed a commitment to resolving the funding issue, DeGette said in a telephone interview.

Top of Agenda

‘‘This catapults this issue to the top of the agenda,” DeGette said yesterday in a telephone interview from Lake City, Colorado. “Congress is getting right on top of this and I know we’ll be acting soon after we get back.”

Brendan Daly, a spokesman for House Speaker Nancy Pelosi, a California Democrat, said in an e-mail, “We are discussing our options.”

Senator Tom Harkin, a Democrat from Iowa and chairman of the Senate health committee and the appropriations subcommittee that funds medical research, said he will scheduled a hearing Sept. 16 on stem cell funding.

“This ruling should be appealed and I fully believe that it will be overturned,” Harkin said in an e-mail. “Embryonic stem cell research offers hope to millions of Americans who are suffering from debilitating and life-threatening diseases, and it must be allowed to proceed.”

Election-Year Politics

Supporters of federal funding for embryonic stem cell research had been divided over whether bills sponsored by DeGette and Harkin should be advanced, worrying that the election-year political climate would make lawmakers leery of passage.

“She’s turned out to be right,” Jonathan Moreno, a University of Pennsylvania professor and bioethicist, said yesterday of DeGette. Some legislative remedy is needed now, he said.

“This is a catastrophe,” he said in a telephone interview. “It’s now possible that the United States is now taken out of embryonic stem cell research.”

Caldwell of Advanced Cell Technology, which works with stem cells, said timing of the legislation may not be ideal.

“This is a very delicate period for many people in Congress right now because midterm elections are coming up,” he said. “This is probably not something they wanted to address at this time, but something has to be done.”

The Dickey-Wicker amendment has been added to the appropriations bills for the Department of Health and Human Services each year since its origin “with little substantive alteration,” Lamberth wrote in his 15-page opinion.

‘Unambiguous Intent’

The amendment’s language “reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed,” the judge wrote. “If one step or ‘piece of research’ of an embryonic stem cell research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker amendment.”

Researchers disagree, saying Obama’s policy doesn’t provide U.S. funding for the destruction of human embryos.

“What it does allow is for workers to carry out research on a broader panel of existing stem cell lines, made from different funding,” said Martin Pera, director of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at the University of Southern California in Los Angeles. “That’s important to the field.”

State, Private Funding

Sources of funding for embryonic stem cell research such as charitable foundations and state-run organizations won’t be affected by the ban. The California Institute for Regenerative Medicine, based in San Francisco, awards $200 million to $300 million a year for stem cell research, with 55 percent going to projects using embryonic cells, according to spokesman Don Gibbons.

With the federal government withdrawing as a source of funds, the state-backed institute expects an influx of grant requests.

“We’ll get more applications, and we’re already receiving three and four times as many as we can fund,” Gibbons said yesterday in a telephone interview.

To contact the reporters on this story: Meg Tirrell in New York at mtirrell@bloomberg.net; Jeffrey Young in Washington at jyoung89@bloomberg.net.

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