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A SYSTEMIC CHANGE

The Washington Post

The Tampa Tribune

Published: March 9, 2009

WASHINGTON - President Barack Obama's decision to lift restrictions on federal funding of human embryonic stem-cell research, scheduled to be announced today, is expected to provide a major boost to one of the most promising but controversial fields of biomedical research in generations.

Obama's voiding of the restrictions will allow thousands of scientists to study hundreds of lines of cells that have been developed without government funding since the limitations were put in place eight years ago. It will also allow them to dismantle cumbersome bureaucracies constructed to work around the constraints and let them exchange scientific ideas more easily.

Across the country, stem-cell scientists are counting down the final hours of the Bush policy. They charge that it has slowed research into cures for intractable diseases such as diabetes, Alzheimer's and multiple sclerosis, to the detriment of millions of patients.

And closing the book on the Bush policy will send a signal that ideology has no place in the realm of scientific inquiry, researchers said.

MAKING THE ANNOUNCEMENT

In contrast to the low-key way Obama has reversed other Bush-era legacies related to culture war issues, the White House has invited scientists, advocates and members of Congress to a highly public ceremony for the signing.

SURROUNDED BY SUPPORTERS: Advocates of unfettered stem-cell research, as well as about 30 Democratic and Republican lawmakers who support it, have been invited to a White House ceremony scheduled for 11:45 a.m.

A BIT OF SUSPENSE: The main suspense about what Obama would do centered on whether he would seek to undo the Bush-era restrictions through legislation or by executive order. The event set for today indicates that he may have decided on the latter course, although one person expected to attend the announcement said he understood that the president might seek to involve Congress as well.

'SOUND SCIENCE': The signing is expected to take place during an event intended to highlight the importance of "sound science" in government policymaking, a fulfillment of Obama's campaign promise to draw a demarcation line between politics and science.

THE NEXT STEPS

Obama's announcement is not likely to lead to any immediate change in government policy, because it may take months for the National Institutes of Health to develop new guidelines for research.

ACCESS TO STEM CELLS: If an executive order is signed, scientists will gain easy access to hundreds of stem-cell lines created without government funding in the past 71/2 years that are better suited for a variety of experiments

NEW GUIDELINES: The NIH has started drafting guidelines that would address the many ethical issues raised by the research.

If the NIH doesn't amend the part of the policy that limits funding to cell lines made from frozen embryos left over after fertility treatments, it could exclude newer cells designed to study specific diseases.

GRANT REQUESTS: Research advocates are expected to push for the process to go as quickly as possible to ensure that universities have time to submit grant proposals that can be reviewed and accepted before September 2010, when the health institutes must commit the last of the $10.4 billion given to the NIH as part of the economic stimulus program.

WHY SCIENTISTS SAY STEM-CELL RESEARCH IS IMPORTANT

Because stem cells obtained from very early embryos are thought to be capable of morphing into any tissue in the body, scientists think they will lead to fundamental insights into the underlying causes of many diseases and repair damage caused by diabetes, Parkinson's disease, spinal cord injuries, Alzheimer's and other conditions.

Some areas in which researchers say stem cells of various types may one day prove to be of value, although all the research is in very early stages:

•California-based Geron Corp. will start the world's first study of a treatment based on human embryonic stem cells this summer, a project aimed at patients who recently suffered a spinal cord injury that left their legs paralyzed. Study participants will be given a single injection within two weeks of the injury, to see if the treatment helps repair damaged nerves.

•Scientists are working to create insulin-producing cells for diabetics, as well as cells that could produce the brain chemical needed by Parkinson's disease patients.

•Last year, researchers used human embryonic stem cells to create cells that act - in lab tests - like natural red blood cells, offering the potential to one day ramp up the blood supply.

•Embryonic stem cells aren't the only type. Studies also are under using adult stem cells, harvested from patients' own blood or bone marrow, and one using cells derived from the placenta is planned soon.

•Researchers also are learning to take ordinary cells and reprogram them to act like stem cells.

BUSH RULES

President George W. Bush had limited funding from the National Institutes of Health and other government agencies to a handful of cell lines created with private money before August 2001 so that taxpayers would not have to pay for the sacrifice of embryos, viewed by some social conservatives as tantamount to murder.

CRITICS: Critics have long complained that the cells that scientists have been permitted to study under the Bush policy have a variety of shortcomings. Many, for example, may have defects that could make them dangerous to transplant into people.

SOME PLUSES, AND MINUSES: The Bush policy wasn't always so disdained. For the first time, it allowed some of the NIH's $28 billion annual research budget to flow to human embryonic stem-cell projects, to the satisfaction of scientists and patient advocacy groups.

But discontent began to grow as scientists realized that only about 20 of the 78 lines eligible for federal funding were usable. Some were duplicates. Some weren't available to license. Some were dead, and others too difficult to work with.

RESTRICTING RESEARCH: The Bush rules forced U.S. scientists to rely on private or state funding for much of their stem-cell research. Some literally set up parallel research facilities to separate federally funded work permissible under the restrictions from studies funded in other ways. Scientists receiving federal funding also feared collaborating with those working with private money on forbidden lines.

STEM-CELL RESEARCH OPPONENTS

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.

Many of those opposed to the research say the embryos are nothing less than tiny human beings with souls, and that destroying them is akin to murder.

Critics of embryonic stem-cell research also argue that scientists can use different types of stem cells, like those found in amniotic fluid or the placenta.

STEM-CELL RESEARCH ADVOCATES

While federal law would still prohibit using federal funds to actually destroy human embryos, some scientists hope that federal funding will be allowed to support work on stem cells derived from a variety of sources, including from embryos specifically created to yield them, and not limited to those from frozen embryos destined to be discarded by infertility clinics.

Many scientists are eager to get their hands on the dozens of new lines that carry the genetic signature of diseases they study. None of the presidential lines has that feature.

Advocates of unrestricted research note that the cells are typically obtained from embryos that have been abandoned by couples seeking in-vitro fertilization, and that the embryos would be discarded anyway.

TEMPERING THE NEWS

The practical impact of changing the Bush policy will be tempered by the discovery in 2006 that adult skin cells can be reprogrammed to behave like embryonic stem cells. Funding for research on these induced pluripotent stem cells, or iPS cells, already is allowed, and researchers are excited about the possibility of using them to create tissue that is matched genetically to patients.

But the potential of iPS cells is still unclear, and researchers say it is crucial to continue studying all kinds of stem cells.