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Obama's Order on Stem Cells Leaves Key Questions to NIH

By Rob Stein
Washington Post Staff Writer
Tuesday, March 10, 2009

President Obama's open-ended order lifting limits on federal funding for stem cell research raises the prospect that taxpayer money could be used for a much broader, much more controversial array of studies than many scientists, officials and activists anticipated.

Although the decision to allow expanded funding had been long expected, many thought Obama would limit federally funded scientists to working with cell lines derived from embryos destined to be discarded at infertility clinics. Instead, he left that key issue open.

The task of deciding what kinds of studies will be supported now falls to the National Institutes of Health, which finds itself confronting far more extensive questions than its officials were contemplating. It has 120 days to do the job.

Among other things, officials will have to decide whether to endorse studies on cells obtained from much more contentious sources, such as embryos created specifically for research or by means of cloning techniques.

"He left it wide open," said Thomas H. Murray, director of the Hastings Center, a bioethics think tank. "Now we are going to have to face a host of morally complicated, politically charged questions. There's not an easy path forward for them out of here."

Richard Doerflinger of the U.S. Conference of Catholic Bishops, a leading opponent of embryonic stem cell research, said, "If they go beyond the so-called spare embryos in fertility clinics, they are breaching an entirely new ethical line."

Obama acknowledged yesterday that the field raises many difficult questions and stressed that strong safeguards would be put in place. He made a point of condemning the most provocative concern -- that the research could somehow lead to cloning human beings.

"We will ensure that our government never opens the door to the use of cloning for human reproduction," Obama said. "It is dangerous, profoundly wrong and has no place in our society or any society."

Many scientists think that research on embryonic stem cells may lead to cures for a host of diseases because of the cells' ability to morph into any type of cell in the body. But critics oppose the research because the cells are derived by destroying embryos, which they consider to be immoral.

To prevent taxpayer money from encouraging the destruction of embryos, President George. W. Bush on Aug. 9, 2001, limited federal funding to those cell lines already in existence as of that date. That policy has long been opposed by scientists, patient advocates and others, who say the restriction stifled advances in one of the most promising medical fields in generations.

In anticipation of Obama's decision, the NIH had begun drafting guidelines assuming that funding would be limited to lines from embryos discarded after in vitro fertilization. That is what officials had proposed during President Bill Clinton's administration and what would be accomplished under legislation Congress passed twice and will consider again.

But proponents of the research had hoped that Obama's order would be free of caveats, fulfilling his promise to leave such decisions to scientists. Obama cast his decision that way, coupling it with an order aimed at removing politics from scientific decisions across the government.

"This order is an important step in advancing the cause of science in America," Obama said.

NIH officials said yesterday that they would consult guidelines produced by other groups, including the National Academy of Sciences and the International Society for Stem Cell Research, which allow for the use of cells from a wide range of sources.

"The goal is to expand the opportunities for human embryonic stem cell and human stem cell research, and the president's order offers us the opportunity to look carefully at how we might best identify responsible and scientifically worthy science that the NIH should be funding," said Story C. Landis, who heads the NIH stem cell task force.

Proponents of expansive federal funding said they were encouraged.

"I'm hopeful the NIH will look at all the different sources and make all the sources of lines available for research," said George Q. Daley, a leading stem cell researcher at Children's Hospital in Boston.

Although Congress may try to revisit this issue, federal law prohibits the direct use of taxpayer money to create or destroy embryos for research purposes. But it is legal to do so with private funding. The ethical debate centers on whether permitting federal funding on cell lines from those sources will encourage such activity.

"This is a really explosive issue," Ronald M. Green, a Dartmouth College bioethicist. "There are lot of people on the left and the right sides of our political spectrum who are opposed to that -- to create a life to destroy it," Green said. "My gut feeling is at the least that should be deferred to the future."

Likewise, critics say funding research on cells derived using cloning techniques should also be off-limits. Scientists hope such techniques will eventually enable them essentially to create replacement body parts for transplantation that would be a perfect immunological match to the patient. But the concern is that encouraging such research could yield techniques that rogue scientists could use to attempt to clone a person.

"If you fund research using stem cells from human cloning, you will be encouraging human cloning," Doerflinger said.

Aside from the source of the cell lines, NIH officials must also answer many other questions, including: What steps should be required to ensure donors of embryos are fully informed of how any resulting stem cells will used? Will donors' privacy be guaranteed?

"We're in an era of genomics where people can sometimes be identified through their genomes. What about notifying donors what is known about inadvertent findings down the line?" Green said.

Advocates on both sides said they would hope to influence the NIH's decisions.

"There are plenty of people with very powerful feelings about this and powerful interests, and they will all be doing their best to get the outcome they prefer," Murray said.

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