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New Rules on Stem Cells Threaten Current Research

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.

Opponents of embryonic stem cell research criticized the proposal for allowing any expansion of federal funding for the work, arguing that adult stem cells and other types of cells offer more promising and more morally acceptable alternatives. But they were relieved that the NIH proposal did not go further by, for example, allowing the funding for stem cells obtained from embryos created specifically for research or by using cloning techniques.

Some proponents of stem cell research, meanwhile, were disappointed that the guidelines limited funding to lines created from unused embryos that otherwise would be discarded by infertility clinics. Initially, however, proponents were pleased that the proposal would allow funding of studies on the hundreds of new lines already in existence.

After studying the guidelines further, however, they concluded that, in their current form, the guidelines would severely restrict funding for the existing lines.

"They take 2009 standards and attempt to apply them retroactively, which isn't really a standard that would allow most of the preexisting lines to be acceptable for NIH funding," said George Q. Daley of the Harvard Stem Cell Institute. "This is essentially moving the goal post."

The guidelines, for example, require that the documents that couples sign when they agree to donate their embryos for research specify that they were fully informed of other options, such as donating their embryos to other couples instead. Although many clinics offered couples such options, that information was not usually laid out in detail in the written consent forms.

"That information might have been presented in another document. It might have been discussed with the couple but not written," said Sean J. Morrison, director of the University of Michigan Center for Stem Cell Biology. "But it wasn't necessarily written in the consent document itself."

No one is certain exactly how many stem cell lines exist or how many would comply with the requirements in the guidelines. But a review of the 21 lines that Bush had approved indicates that perhaps just two would be eligible, and that most of the hundreds of others created since then would fall short, Daley and others said.

"If applied retroactively, the proposed guidelines would render ineligible most stem cell lines," said Patrick L. Taylor, deputy counsel at the Boston Children's Hospital, who critiqued the proposed NIH guidelines in a paper published online May 14 in the journal Cell Stem Cell.

Proponents hope NIH will remedy the impediment in the final version of the guidelines, which are expected by July 7. The guidelines could, for example, allow funding of research on stem cell lines as long as they had been reviewed by an ethics oversight board or if they complied with guidelines produced by the National Academy of Sciences or the International Society for Stem Cell Research.

"I think NIH has been hearing from many, many people how important it is to fix this," said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin who served on Obama's transition team. "I can't say how they will do it, but I'm confident they want to."

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