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Ruling a blow to stem cell research

A federal judge blocks U.S. funding for all projects involving the use of material from human embryos.

August 24, 2010|By Karen Kaplan and Noam N. Levey,

Reporting from Los Angeles and Washington — A U.S. district judge on Monday blocked the federal government from funding all research involving human embryonic stem cells on the grounds that it violates a 1996 law intended to prevent the destruction of of human embryos.

The ruling came in the form of a preliminary injunction in a case involving two scientists who challenged the Obama administration's stem cell funding policy, which was designed to expand federal support for the controversial research.

Embryonic stem cell researchers said the decision would throw the field into turmoil.

"The long-term practical impact is a massive halt to most embryonic stem cell research in the U.S." said Dr. Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine.

The Obama rules allowed the use of stem cell lines derived from frozen embryos no longer needed for fertility treatments that were donated according to strict ethical guidelines. The rules did not allow the National Institutes of Health to pay for the creation of the stem cells themselves — a process involving the dismantling of days-old human embryos that is clearly forbidden by a federal law known as the Dickey-Wicker Amendment.

The scientists who challenged the guidelines argued that Dickey-Wicker also forbids the use of federal funds for any subsequent research on those stem cells, even if the embryos they came from had been destroyed years before.

U.S. District Judge Royce C. Lamberth agreed in a 15-page ruling.

It was "the unambiguous intent of Congress to prohibit the expenditure of federal funds on 'research in which a human embryo or embryos are destroyed,' " Lamberth wrote, citing language from Dickey-Wicker.

The Department of Health and Human Services, which operates the NIH, had argued that the act of creating embryonic stem cells was distinct from research that used the cells to study the development of genetic diseases or to create replacement cells that might treat conditions like diabetes, Alzheimer's and the paralysis that results from spinal cord injuries.

But research is a long, continuous process that can't be partitioned into discrete pieces, Lamberth wrote. If Congress meant to prohibit funding only for specific scientific acts, it could have said so. "Congress, however, has not written the statute that way, and this Court is bound to apply the law as it is written," the ruling said.

The NIH and the White House declined to comment on the ruling Monday and referred calls to the Department of Justice.

"We're reviewing the judge's ruling," department spokeswoman Tracy Schmaler said Monday evening.

Lamberth issued the injunction because the plaintiffs — James L. Sherley of the Boston Biomedical Research Institute and Theresa Deisher of AVM Biotechnology in Seattle — have "a strong likelihood" of winning their case at trial. In the meantime, he said, the researchers and "the public interest" would suffer irreparable harm if federal tax dollars were used to study human embryonic stem cells.

"The Obama administration has attempted to skirt the law by arguing that they are only funding research after the embryos are destroyed," said Charmaine Yoest, chief executive of Americans United for Life. "That Administration policy is in violation of the law."

Scientists working with embryonic stem cells said patients will suffer by having to wait longer for science to develop new treatments and cures.

Advanced Cell Technology Inc. is using the cells to grow retinal pigment epithelium cells that restored vision in rats and mice with a rare childhood disease called Stargardt's macular dystrophy. The Santa Monica-based company has asked the Food and Drug Administration for permission to use the cells in a clinical trial. But without any prospect of federal funding, the research would be in doubt, said Dr. Robert Lanza, the company's chief scientific officer.

"This is criminal," Lanza said. "We are talking about people going blind, people who are dying from a terrifying array of diseases."

Even in California, where Proposition 71 made billions of dollars available for research involving human embryonic stem cells, scientists face a chaotic future because so many rely on NIH grants, said Alan Trounson, president of the California Institute of Regenerative Medicine.

During the George W. Bush administration, when federal research funds could be used on only a few human embryonic stem cell lines, many scientists operated parallel labs supported entirely with state and private funds. It was an inefficient and expensive work-around that scientists were eager to abandon after President Obama's election. But Monday's ruling would force them to return to that practice.

"It's going to be chaos," Trounson said. Researchers will have to furlough some of their staff in order to keep their labs open, he predicted.

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