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Tuesday, May 26, 2009


US Stem Cell Guidelines Issued

The Obama administration issued guidelines late last week limiting government funds for embryonic stem cell research only to cells from excess fertility clinic embryos. The compromise appears to have more to do with political realities than science. Still, the action will mean that tax dollars may begin flowing to such research as early as this autumn.

Related article from The Washington Post:
Compromise Rules Issued on Embryonic Stem Cells

The Obama administration issued guidelines yesterday limiting government-sponsored embryonic stem cell research to cells taken from excess fertility clinic embryos, a compromise based on its reading of public opinion about the cutting-edge science.

The decision fell short of the open-ended policy some scientists and patient advocates had hoped for, but is far less likely to spark controversy. It also will mean that tax dollars could begin flowing as early as fall to projects involving hundreds of new stem cell clusters.

Raynard S. Kington, acting director of the National Institutes of Health, said yesterday that the administration was guided by "broad public support" in establishing a policy that prohibits creation of embryos for research purposes as well as any type of therapeutic cloning.

Specifically, NIH modeled its approach after legislation that twice passed Congress, he explained. Those votes are "the strongest indication of public support," he told reporters yesterday morning. "There is not similar broad support for using stem cells from other sources."

Ironically, one of the chief architects of that legislation, Rep. Michael N. Castle (R-Del.), said yesterday that although he was pleased by the NIH action, "there is opportunity for more expansive guidelines."

Some proponents of aggressive research policies expressed disappointment in President Obama, who stressed a month ago that science ought not be hampered by political considerations.

"I am really, really startled," said Susan L. Solomon, chief executive of the private New York Stem Cell Foundation. "This seems to be a political calculus when what we want in this country is a scientific research calculus."

Researchers have long touted the potential of embryonic stem cells in treating an array of illnesses because of their unique ability to morph into any tissue in the body. Scientists say the stem cells could eventually lead to therapies for Parkinson's disease, spinal cord injuries and diabetes.

But the work has always been controversial because extracting clusters of stem cells requires destroying the embryo.

In August 2001, citing those ethical concerns, President George W. Bush announced that federally funded research would be limited to two dozen cell lines that had already been harvested.

Last month, surrounded by patient advocates and prominent scientists, Obama signed an executive order lifting the Bush restrictions.

But yesterday, one of the activists who had attended the Obama event complained bitterly that the process became "much more political than we thought it would be. This is extremely limiting," he said, asking that he not be identified criticizing the president.

Others, however, hailed the guidelines as a practical approach to complex cutting-edge science.

Calling the policy "thoughtful and balanced," Richard Laser, a spokesman for the nonpartisan think tank Third Way, said it "demonstrates President Obama's commitment to finding shared values on an issue that has long been divisive."

Scientists have long complained that the Bush-era restrictions severely slowed progress in one of the more promising areas of research today. The new policy focuses almost entirely on types of research that have been proved to be feasible, as opposed to certain types of cloning techniques that to date have not been successfully completed.

"They did not choose to write guidelines for hypothetical research," said R. Alta Charo, a bioethicist at the University of Wisconsin. "They wrote guidelines for the research that is going on and needs to go on. It's a very pragmatic solution."

Given the highly charged atmosphere of the past several years and the fact that NIH is spending taxpayer money, officials wanted "guidelines that reflect what the general public has endorsed," said James F. Battey Jr., vice chair of the NIH stem cell task force.

Pointing to the experience of harvesting viable organs from patients who are brain-dead, he stressed that both science and public sentiment can change.

"As a country, we worked our way through that," he said. Obama's executive order instructs NIH to periodically update the guidelines, Battey said, "and we have every intention of doing that."

Although there is no new money designated specifically for stem cell research, NIH received $10 billion in stimulus funds. Officials have said a portion of that money could be distributed in grants to stem cell projects.

The guidelines, which will be open for a 30-day public comment period, also spell out the written consent that scientists must secure from embryo donors. Broadly speaking, donation is permitted only if it is made voluntarily, without pressure or financial inducement. Most often, the cell lines come from couples that have completed fertility treatments and do not need their remaining embryos.

But informed consent procedures have shifted over the years and several scientists doubt the cell lines being used under the Bush policy will meet the new consent standards.

"Many laboratories spent years [studying] those existing lines. They know how to grow them and work with them," said Sean J. Morrison, director of the University of Michigan's Center for Stem Cell Biology. If those lines are no longer eligible for federal grants, "they're going to have to start from scratch."

Battey said he understands why scientists would want to continue ongoing studies, but he was equally cognizant of the "inconsistency" in having different consent standards for different clusters of cells.

"We are awaiting public comment about how to handle that tricky issue," he said in an interview. NIH is expected to issue the final regulation in early July.

By Ceci Connolly

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