By Rob Stein
Washington Post Staff Writer
Thursday, February 19, 2009
At the National Institutes of Health, officials have started drafting guidelines they will need to start funding human embryonic stem cell research that has been off-limits for nearly eight years.
At the University of California at San Francisco, scientists are poised to dismantle the cumbersome bureaucracy they created to segregate experiments that were acceptable under the federal restrictions from studies that were not.
At the Harvard Stem Cell Institute in Cambridge, Mass., graduate students and other scientists paid with federal grants are eagerly awaiting the day when they can contribute their eureka moments to projects that are forbidden under the current policy.
But in the month since Inauguration Day, the moment they have been awaiting has not come, prompting some to ask: When will President Obama deliver on his campaign promise to lift one of the most contentious policies imposed by his predecessor?
"Everyone is waiting with bated breath," said George Daley, a leading stem cell scientist at Children's Hospital in Boston. "We're all waiting to breathe a huge sigh of relief."
President George W. Bush imposed the restriction in 2001, limiting federal funding to studies of cell lines that were already in existence on that date to prevent tax dollars from encouraging the destruction of more embryos.
The limitation, welcomed by those who believe that destroying human embryos is immoral, has been denounced by many scientists for severely hindering research on hundreds of new cell lines developed since then. Such cells could lead to cures for a host of ailments because they can become any type of tissue in the body, they say.
Proponents expected Obama to lift the restriction in his first week in office, when he issued a flurry of executive orders to close the prison at Guantanamo Bay, Cuba, make government less secretive and lift a ban on funding international family planning groups that support abortion, among other things.
"We were surprised and disappointed it wasn't in there," said Amy Comstock Rick of the Coalition for the Advancement of Medical Research, which has been leading the lobbying effort to lift the restriction. "We're wondering why it's taking so long."
Advocates on both sides still expect Obama to act. Obama repeated his promise in a private meeting with House Democrats last week, and top adviser David Axelrod said on "Fox News Sunday" that the president is "considering" an executive order and will act soon.
But the delay and the vague language are making proponents nervous. Has Obama simply been too preoccupied with the economic crisis to focus on the issue? Is he hesitant to wade into one of the flashpoints of the culture wars? Could he even be considering a moderate move as part of his broad strategy of seeking the middle ground on even the most contentious issues?
"The word the president is 'considering' it is too vague a word for me," Rick said. "I don't know entirely what that means. If it means he's just working out the details, that's great. But if 'considering' means 'reconsidering' we would be very upset."
In response to a query, White House spokesman Reid H. Cherlin wrote in an e-mail: "The president has made it clear that increasing stem cell research is a priority for his administration, and he'll be acting soon to reverse restrictions on this critical science."
Not everyone, of course, is disappointed by the delay.
"We continue to oppose federal funding of research that destroys human embryos," said David Christensen of the Family Research Council. "We don't think the federal government should fund or create an incentive to destroy human life."
Some opponents have suggested that Obama might qualify his executive order to try to take the sting out of the move. Proponents, however, hope Obama will simply lift the restriction without caveats and let the NIH work out the details. In anticipation, the NIH has started drafting guidelines that would address the many ethical issues raised by the research, using as models templates compiled by the National Academy of Sciences and the International Society for Stem Cell Research.
"We want to be able to move as quickly as possible," said Story Landis, who heads NIH's stem cell task force. "The science is waiting."
Among the issues the guidelines will address is whether funding should be limited to cells from leftover embryos that are destined for destruction at infertility clinics.
"We are assuming that what we will be asked to do is develop guidelines for stem cell lines derived from embryos produced for reproductive purposes in excess of need," Landis said.
Proponents of the research hope the executive order and resulting NIH guidelines would be more open-ended than that, allowing research on stem cells derived in other ways. But that would make the move even more controversial.
Although the guidelines will need to be approved by the Health and Human Services Department and undergo 30 days of public comment before becoming final, Landis said she expects that the NIH could approve the first supplemental grants to current grantees to study new cell lines within four months and the first new grants within six to nine months.
"If I were a smart scientist, I would be writing a grant right now," said Landis, noting that some of the $10 billion the NIH will receive as part of the stimulus package could be used to expand stem cell research.
The 21 cell lines that scientists are permitted to study under the Bush policy have a variety of shortcomings, critics say. Many, for example, may have defects that could make them dangerous to transplant into people. But perhaps more important, hundreds of newer lines have been developed that offer a host of opportunities. Many lines, for example, carry defects for specific diseases, which could provide crucial insights into Parkinson's disease, Lou Gehrig's disease, diabetes and other devastating ailments.
"People with these diseases are running out of time every day," said Lawrence A. Soler of the Juvenile Diabetes Research Foundation. "That's why we need this to move forward as soon as possible."
Opponents have argued that research on human embryonic stem cells has become unnecessary because of scientific advances in the interim, including promising studies involving adult stem cells and the ability to turn adult cells into cells that appear to have many of the properties of embryonic cells.
"We think the science has bypassed the debate," Christensen said. "We think the administration would be better served to advance that kind of stem cell research."
But many scientists say it remains far from clear which cells will ultimately lead to the most important advances, making it crucial to continue to study those cells along with embryonic cells.
Whatever Obama does, Congress is also likely to get involved by considering legislation designed to prevent any future presidents from reinstating restrictions.
"We need to codify the opening up of the research so it doesn't turn into a Ping-Pong ball of administrations," said Rep. Diana DeGette (D-Colo.), who noted that the legislation could address another potential roadblock: the perennial Dickey-Wicker amendment that prohibits federal funding of research involving human embryos. She has been consulting with the White House on both issues.