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New Rules on Stem Cells Threaten Current Research

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By Rob Stein
Washington Post Staff Writer
Monday, May 25, 2009

When President Obama lifted restrictions on federal funding of human embryonic stem cell research in March, many scientists hailed the move as a long-awaited boost for one of the most promising fields of medical research.

Since then, however, many proponents have concluded that the plan could have the opposite effect, putting off-limits for federal support much of the research underway, including work that the Bush administration endorsed. "We're very concerned," said Amy Comstock Rick, chief executive of the Coalition for the Advancement of Medical Research, which has been leading the effort to free up more federal funding for stem cell research. "If they don't change this, very little current research would be eligible. It's a huge issue."

The concern focuses on strict new ethics criteria that the National Institutes of Health has proposed. Advocates of stem cell research say that most of the work currently underway passed close ethical scrutiny but that the procedures varied and usually did not match the details specified in the proposed new guidelines.

"It's not that past practices were shoddy," said Lawrence S. Goldstein, director of the stem cell program at the University of California at San Diego. "But they don't necessarily meet every letter of the new guidelines moving forward. We'd have to throw everything out and start all over again."

Raynard S. Kington, acting NIH director, said that the agency is aware of the concerns but that he could not comment further until officials have reviewed and considered all public comments.

"We know issues like this, among many issues, have been raised, and we will take them into consideration," Kington said in an interview Friday. The public comment period closes tomorrow, he said, adding that NIH has received more than 20,000 comments addressing almost every aspect of the proposal.

"I think it's unambiguous that the intent of the president was to expand opportunities and research in this area," Kington said, but he added that Obama had specified that federally funded research should be "scientifically worthy" and "ethically responsible."

Critics of embryonic stem cell research remain opposed to any expansion of federal funding, but they add that an attempt to relax the proposed standards would undermine the administration's assertion that it is applying tough ethical standards.

"Accepting these lines, obtained in ways that do not comply with the new guidelines, would render meaningless any claim that NIH is setting and enforcing strict 'ethical' requirements," said Richard M. Doerflinger of the U.S. Conference of Catholic Bishops.

Embryonic stem cells are capable of becoming virtually any cell in the body, and many scientists think they could lead to treatments for many major medical problems. But the research has been mired in controversy because the cells are obtained by destroying embryos.

To avoid encouraging the destruction of more embryos, President George W. Bush in 2001 restricted federal funding to what turned out to be 21 colonies, or "lines," of stem cells that were already growing in laboratories.

Critics charged that the existing lines had many limitations and that the funding restrictions severely hindered the field. So, in the ensuing eight years, scientists created hundreds of new lines using money from private sources or state governments. When Obama dropped Bush's restrictions, he asked NIH to work out the details. On April 17, NIH proposed guidelines for what research would be eligible.


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