March 3, 2004; At least 16 of the 78 human stem cell colonies approved by President Bush for Federal research money have died or failed to reproduce in their laboratory dishes -- making them useless to scientists -- and most of the others are unlikely ever to become available for disease research, according to interviews and a new analysis by the National Institutes of Health. The unpublished NIH analysis, circulating yesterday on Capitol Hill, said only about one-quarter of the Bush-approved cell colonies are ever likely to be available, far fewer than supporters of the President's policy had predicted. Moreover, several of the Bush-approved colonies available to researchers are beginning to show genetic abnormalities, potentially undermining their medical usefulness, researchers said. Advocates of stem-cell research, who believe it offers possibilities for curing a range of diseases from diabetes to Parkinson's, said these developments confirmed fears they expressed in 2001, when Bush announced that he would allow Federal funding only for stem-cell colonies that had been extracted from human embryos as of August 9, 2001.

Two Democrats, Reps. Henry A. Waxman (CA) and Louise M. Slaughter (NY), yesterday accused the Administration of misleading the public by continuing to contend that the policy allows for robust scientific research. In a stinging letter to the White House, they declared that the new NIH analysis "casts into doubt the adequacy of your policy on stem-cell research."

A bipartisan group of House members -- including some Republicans who until now accepted the Bush policy -- are gathering signatures on a letter of their own calling for a policy change. Sensing that the tide may be shifting in their favor, scientific organizations have stepped up their campaign to ease restrictions on the controversial research, which uses embryos slated for destruction by fertility clinics. "I think the administration has been trying to implement the existing policy in good faith," said Lawrence Soler of the Juvenile Diabetes Research Foundation, which supports expanding Federally-funded research. "I think it's just come to a point now of having to face that we're not as far as we had hoped we'd be -- or even, we believe, where the Administration had hoped we'd be."

The Administration said it was planning no change of policy. "The president remains committed to exploring the promise of stem cell research but continues to firmly believe that we should not cross a fundamental moral line by funding or encouraging the destruction of human embryos," said White House spokesman Trent Duffy.

The debate centers on a policy that has been among the most contentious of Bush's tenure. Democrats have generally been united in supporting broad research on embryonic stem cells, while the Republican majority in Congress has been sharply divided.

Scientists are excited about the cells because, unlike most adult cells, they can morph into nearly any tissue in the human body. Researchers hope to grow large numbers of cells in the laboratory and then coax them into becoming brain cells that might cure Parkinson's Disease, pancreatic cells to cure diabetes, and so on. But creating a laboratory colony of stem cells requires destroying a five-day-old human embryo. Social conservatives have opposed the work, saying embryo destruction "is tantamount to murder." Torn between this group and disease-research advocates, including former first lady Nancy Reagan, Bush announced a compromise on August 9, 2001, that precluded Federally-funded research on cells from embryos destroyed after that date. That effectively froze the supply at its then-current level.

The president initially said more than 60 colonies would qualify -- a number that surprised many biologists, who had not been aware of colonies created at private companies and foreign laboratories. The large number helped to quell criticism that Bush was limiting a promising field of medicine. As others announced that they, too, had cells from before that date, the number of eligible colonies grew to 78.

But in recent weeks, the NIH has been posting information on the Internet showing that 16 of the colonies "filled to expand into undifferentiated cell cultures." That is biology-speak for saying the cells are useless for further research, though it is not clear how many colonies are dead and how many have simply stopped reproducing.

At one company, CyThera Inc. of San Diego, nine colonies have collapsed, eliminating more than ten percent of the administration's list. So have six colonies at a laboratory in Sweden and one at a company in Athens, GA. It is not unusual for cell colonies to "crash" in biology, particularly in early research, when scientists do not really know how best to grow the cells. Usually, they would simply replace a dead cell colony -- but under Bush's policy, they cannot.

Most of the remaining Bush-approved colonies are in overseas labs. The NIH acknowledged recently that most of those labs have shown no interest in supplying stem cells to U.S. researchers. Some foreign labs also face legal restrictions on exportation.

Add all the factors together and the "best-case scenario" is that only 23 cell-colonies will ever be available to U.S. researchers, an NIH administrator, James Battey, said recently in the unpublished report to Congress.

In addition, several of the 15 approved cell colonies that are being distributed to scientists have been going bad -- developing severe genetic abnormalities that could make them useless as therapies and, in some cases, impractical even for research. Experts suspect that other cells in use are also accumulating DNA glitches that will require them to be replaced at some point.

Many scientists said the Bush-approved cell colonies were sufficient to get a start on the research. But as they learn more about how to nurture stem cells and use them to create new tissues, some of them now say "the restrictions are becoming increasingly burdensome."

Some are using private money to create fresh colonies, but those funds are limited. Leading stem-cell researchers said the United States is falling behind as foreign labs, unencumbered by Bush's restrictions, grow new colonies using improved techniques. "Federally-funded scientists have to drive Model T's, while Korean scientists get to drive around in the newest Porsche," said George Daley, a stem-cell researcher at Harvard University. "It's crazy."

© 2004 The Washington Post Company.