Eight years ago, President George W. Bush sharply limited federal support for stem-cell research. The move cost universities millions of dollars while slowing the hunt for life-saving medical advances. And it may now be only days before President Obama reverses course.
But for all the trouble the presidential restriction has caused, and for all the political trauma that may accompany a cancellation of Mr. Bush’s order, both the science and the economics have evolved so far since 2001 that universities may feel affected far less by Mr. Obama’s decision than they were by Mr. Bush’s. Still, an obscure piece of legislation called the Dickey-Wicker Amendment may remain an obstacle no matter what the president does.
Mr. Obama’s anticipated reversal of policy “won’t be a boon the way some people might think,” said Arnold R. Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at the University of California at San Francisco. “Time has moved on, and so has the field.”
Stem cells are capable of growing into any type of cell of the body. That ability gives them potential for curing a virtually unlimited range of ailments, including cancers, diabetes, heart disease, and various other organ failures.
Mr. Bush, however, restricted federal involvement in the use of discarded human embryos—long the most promising source of stem cells—out of a determination to protect anything that could potentially become a human life.
Several leading scientists said that ending Mr. Bush’s limits would mean a great deal to stem-cell research. His presidential order of August 2001 both took away the government money and required scientists working on any other federally supported projects to move their stem-cell research into separate facilities.
“The duplication is incredibly costly,” driving many universities and scientists out of stem-cell research altogether, said Alan O. Trounson, president of the California Institute for Regenerative Medicine. “It’s most important” for Mr. Obama to change course, Mr. Trounson said.
New Sources of Cells
And yet that importance may have grown largely symbolic. Several states are now supporting their own university research into stem cells, replacing the federal money. And scientific advances may be gradually reducing the need for human embryos as a source of stem cells.
Stem-cell research “has gone on in the United States anyway,” said Ronald G. Crystal, chairman of the department of genetic medicine at Weill Cornell Medical College. “It’s just cost more, and it’s been more cumbersome for scientists to do it.”
Key advances include the discovery in 2007 by Japanese researcher Shinya Yamanaka of a method for converting adult skin cells into near-perfect copies of stem cells.
Dr. Yamanaka’s breakthrough “is absolutely changing the field,” said David T. Scadden, co-director of the Stem Cell Institute at Harvard University.
“It may be that we’ll be able to get away from embryonic stem cells completely,” Dr. Scadden said. “That’s something we’re all hoping will happen.”
Years of stagnation in federal support have also undercut the influence of Mr. Bush’s intervention. Total federal spending on scientific research, as distributed by the National Institutes of Health, jumped 15 percent a year between 1998 and 2003. But growth in the NIH research budget hasn’t exceeded the rate of inflation since then, leaving it stuck at around $30-billion a year.
That means stem-cell researchers, even if they’re allowed greater access to federal money, will struggle to get their projects financed, Dr. Kriegstein said. If Mr. Obama promises a policy reversal without finding significantly more money, “it will tend to ring hollow,” he said.
A move by Mr. Obama might even bring scientists a counterproductive renewal of attention to the politics of stem cells. For all the attention Mr. Bush attracted with his 2001 order, stem-cell research has largely been redirected rather than blocked.
The Food and Drug Administration approved an application by Geron Corp. last month to conduct the world’s first embryonic stem-cell treatment tested in humans. Geron hopes to see if a therapy that allowed paralyzed rats to walk again, developed at the University of California at Irvine, will work in humans.
Cloudy Legislative Path
It’s not clear what action lawmakers might take if they are again pressed to take a high-stakes position on the subject. Congress has twice approved legislation in recent years that would reverse Mr. Bush’s order, with the action ending in a presidential veto. Yet Congress has, since 1995, annually approved a measure, known as the Dickey-Wicker Amendment, that prohibits either the creation or destruction of human embryos for research purposes.
The Bush order barred federally financed research from involving any stem cells that were derived from human embryos after the order’s effective date of August 9, 2001. The Dickey-Wicker Amendment’s continued ban on the use of federal funds in the creation or destruction of human embryos would mean some remaining complications for researchers. Most human embryos used in stem-cell research are discarded by couples attempting pregnancy through in vitro fertilization and are therefore not created initially for the purpose of research. And stem cells can be extracted without killing the embryo.
Richard O. Hynes, a professor of cancer research at the Massachusetts Institute of Technology, said it’s “not essential” to the cause of stem-cell research to eliminate Dickey-Wicker right away.
Dickey-Wicker nevertheless looms as an obstacle, both as a matter of principle and practice, given problems like an insufficient number of human embryos.
“The most important action the Obama administration can take is to erase ideology from the oversight and funding of all aspects of stem cell research and medicine,” Irving L. Weissman, director of Stanford University’s Stem Cell Biology and Regenerative Medicine Institute, said in a statement.
Researchers have a powerful Congressional ally in House Speaker Nancy Pelosi, Democrat of California, who says she has been assured by Obama-administration officials that the president will soon lift the Bush-administration ban. Eliminating Dickey-Wicker would be more difficult, given the level of bipartisan support it enjoys, a spokesman for Ms. Pelosi said.
And even the lifting of the Bush administration order might not be straightforward. Mr. Obama promised as a presidential candidate to lift the order, then said in an interview last month that he’d prefer that Congress enact the change though legislation, to make it more definitive.
That statement concerns some advocates, who like the idea of a more permanent revocation of the presidential order but fear that a prolonged Congressional debate could produce a less-than-complete removal of the Bush policy.
The Coalition for the Advancement of Medical Research, an association of patient and educational groups, is content for now to wait for the president to fulfill his campaign pledge. “We remain confident that it’s going to be done by executive order,” said the group’s president, Amy Comstock Rick, chief executive of the Parkinson’s Action Network.
Ethical Issues
If a political battle does resume, scientists are ready to join the argument on moral grounds. More than 400,000 embryos created for couples seeking to get pregnant lie frozen in storage tanks across the country, and if researchers don’t use them, the only other option is to destroy them, Dr. Scadden, of Harvard, said.
That’s not a “morally defensible choice,” he said. “The idea of not working to develop a therapy with something that would otherwise go in the incinerator is ethically uncomfortable.”
And American scientists over all have a record of showing good judgment about the moral implications of their work, he said, citing voluntary limits in such areas as gene-therapy experimentation.
Others aren’t so sure. William B. Hurlbut, a bioethicist and physician at the Stanford University School of Medicine, has pleaded with stem-cell researchers to find alternatives that don’t involve human embryos. Dr. Hurlbut is among the advocates of a process known as “altered nuclear transfer,” in which the genetic material of a patient is inserted into a human-donor egg, theoretically allowing the egg to function like the nucleus of an early embryo.
Stem-cell researchers discount the potential of that method. The promise of altered nuclear transfer is “absolutely bogus,” said Peter J. Donovan, co-director of the Sue and Bill Gross Stem Cell Research Center at the University of California at Irvine.
Dr. Kriegstein, of San Francisco, was also skeptical. “It’s a workaround, and not very satisfactory,” he said.
There are other problems with avoiding human embryos or relying on nonfederal funding, the researchers said. Beyond requiring logistical efforts like sticking red tags on laboratory equipment that cannot be used by stem-cell investigators because it was purchased with federal money, the government’s restriction slows human cooperation in a field so young and complex that it needs intensive collaboration, said Patrick White, vice president for federal relations at the Association of American Universities.
A “patchwork quilt of resources” has emerged in the wake of the Bush-administration restrictions, with state governments, universities, and businesses picking up the slack, Mr. White said. That has made more results proprietary, slowing down the sharing process, he said.
The federal ban did allow innovative states like California—which allocated $3-billion for stem cell research in 2004—to grab a large share of the scientific talent (The Chronicle, November 12, 2004). But with the country’s economic troubles, such commitments may wane. Harvard, which has seen a 20-percent drop in its endowment in recent months, is now reconsidering a planned new research facility for its stem-cell program.
The political uncertainty also redirected the careers of an unknown number of potential students and researchers, said Dr. Scadden, of Harvard. “It really discouraged a lot of people from being in the field,” he said.
That is a critical setback for such a complicated scientific endeavor that is probably many years from producing hard results, Dr. Crystal, of Weill Cornell, said. The challenges are immense, he said, even if researchers figure out how to grow a stem cell into a particular organ of the body. For instance, a heart built from stem cells might give a donor a new heart, but the cells could migrate, “and all of a sudden you have a beating heart in the brain,” he said.
Even if overall NIH funding remains low, stem-cell research holds so much promise that scientists—if freed from the Bush-administration constraints—will have a competitive edge that will let them rapidly gain ground against other fields, Mr. White said.
And history has shown, Dr. Crystal said, that worthwhile science will advance regardless of societal beliefs. “If there are good scientific reasons to help people, to make lives better,” he said, “then the science will go on, as it has.”
