Making good on a popular campaign pledge, President Obama will sign an executive order Monday rescinding restrictions on federal funding for human embryonic stem cell research, administration officials said Friday -- instantly making hundreds of millions of new dollars available for the controversial science.
President Bush had limited the use of 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.
The signing is expected to take place during an event intended to highlight the importance of “sound science” in government policymaking, according to one official who was not authorized to discuss the matter publicly.
Details of the executive order were not available, but people who had been briefed said Obama would ask the Department of Health and Human Services, which operates the NIH, to work out the specifics.
Across the country, stem cell scientists are counting down the final hours of the Bush policy with glee. They charge that it has slowed the pace of research into cures for intractable diseases such as diabetes, Alzheimer’s and multiple sclerosis, to the detriment of millions of patients.
A policy change will give those efforts a significant boost, as well as advance scientists’ efforts to use the cells to make replacement tissues like new cardiac muscle for treating heart attack patients and nerve cells for repairing spinal cord injuries.
Reversing the policy will give scientists unfettered access to hundreds of newer stem cells that are free of the chromosomal abnormalities and animal molecules that render the so-called presidential cell lines problematic for use in potential medical therapies.
Many scientists are also eager to get their hands on the dozens of new lines that carry the genetic signatures of diseases they study. None of the presidential lines has that feature.
Stem cell scientist Julie Baker plans to celebrate by peeling dozens of color-coded stickers off of the equipment in her carefully segregated lab at the Stanford School of Medicine. Green labels are affixed to microscopes, incubators and other supplies that were permitted to be used on federally funded research. Red labels are stuck to equipment that had to be used when working with cell lines that were on the wrong side of the Bush policy.
“It was such a disaster,” Baker said.
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.
Baker said she “slogged away with the presidential lines” in her studies on the development of very early embryos, but ultimately decided she needed to make fresh stem cells. It took nearly two years to figure out how to conduct her work without running afoul of the federal government.
The air conditioning system in the building that housed her lab had been upgraded with federal dollars, prompting Stanford to declare the entire building off-limits. She wound up in a renovated lab five miles from campus, where she created four new lines of human embryonic stem cells using funds from Proposition 71, California’s $3-billion stem cell research effort.
Obama’s executive order will bring an end to such complications, and Congress will probably weigh in too. It twice passed legislation that would have expanded NIH funding for stem cell research, but Bush vetoed it both times.
Obama has said that he would sign that bill, which if it became law would prevent future presidents from unilaterally setting limits on stem cell funding, said UCLA law professor Russell Korobkin, an expert in stem cell legal issues.
Once the executive order is signed, scientists such as Dr. Andrew Feinberg, director of the Epigenetics Center at Johns Hopkins School of Medicine in Baltimore, will gain easy access to hundreds of stem cell lines created in the last 7 1/2 years that are better suited for a variety of experiments.
For a project comparing gene activity in different kinds of stem cell lines, Feinberg’s collaborator Dr. George Daley of Harvard Medical School offered to send him some human embryonic stem cells that were too new to qualify for federal funding. Feinberg demurred.
“It was so much paperwork,” he said. Instead, he and Daley studied embryonic stem cells from mice -- a decision that did yield scientific insights but not as many as if they had used human cells, he said.
Hundreds of similar decisions have hurt American efforts to stay at the vanguard of stem cell research, asserts a study published last year in the journal Cell Stem Cell. In the study, Aaron Levine, a public policy professor at the Georgia Institute of Technology, found that whereas U.S. researchers published 46% of the world’s top papers in the fields of molecular biology and genetics, they produced only 36% of the human embryonic stem cell studies.
Levine said that the Bush policy was partly to blame, and that its elimination would help reverse the trend. But other changes will have to be made as well, starting with an increase in the NIH budget, researchers said. The economic stimulus package included $10.4 billion in additional NIH funding.
The Bush rules also limit funding to cell lines made from frozen embryos left over after fertility treatments. If the NIH doesn’t amend that part of the policy, it could exclude newer cells designed to study specific diseases.
For example, stem cells have been derived from embryos destined to develop inherited disorders such as cystic fibrosis and muscular dystrophy. They were identified by genetic screens done for high-risk couples, and they were never frozen -- a technicality that might disqualify them from federal funding, even though they would otherwise have been discarded.
A wider variety of disease-specific stem cell lines that scientists are trying to create using a technique called nuclear transfer also may not qualify for federal funding, since that process has nothing to do with fertility treatment.
The practical effect 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, is already allowed, and researchers are excited about the possibility of using them to create tissues that are genetically matched 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.
To be sure, some people aren’t celebrating the imminent demise of the Bush restrictions.
“The question is whether taxpayer dollars should be used to subsidize the destruction of precious human life,” House Minority Leader John A. Boehner (R-Ohio) said in a statement Friday. “Millions of Americans strongly oppose that, and rightfully so.”
But closing the book on the Bush policy will send a welcome signal that ideology has no place in the realm of scientific inquiry, researchers said.
“It’s a really important symbolic gesture to recover from that period where policy was driven more by ideology than by facts,” said Sean Morrison, director of the University of Michigan Center for Stem Cell Biology.