Aug. 25, 2010 -- The U.S. District Court's freeze on federally funded embryonic stem cell research has sparked a firestorm of controversy as scientists in the field cope with the devastating blow this ruling deals to their work.
"If the ruling cannot be lifted soon, this will do irreparable harm to the field," says Sam Morrison, director of the Center for Stem Cell Biology at the University of Michigan.
Judge Royce Lamberth ruled this Monday in favor of a case brought by Christian medical groups and adult stem cell researchers, approving a temporary injunction of federally funded research involving embryonic stem cells on the grounds that it violates the 1995 Dickey Wicker amendment.
The amendment prohibits federal funded research in which a human embryo is "destroyed, discarded or knowingly subject of risk of injury or death."
Though the case was brought against the expanded use of embryonic stem cells sanctioned by a 2009 executive order put in place by the Obama administration, experts argue that the injunction is so broad that it could be interpreted to cover even those research projects that would have been permitted under the Bush administration.
Dr. Francis Collins, director of the National Health Institutes, told reporters Tuesday in a telephone briefing that he was "shocked" by the ruling and that "this decision has the potential to do serious damage to one of hte most promising areas of biomeidcal reserach. Iit comes just at the time when we were really gaining momentum."
Ron Stoddart, executive director of Nightlight Christian Adoptions, an agency that was one of the original plaintiffs in the lawsuit, says the suit was not intended to put a stop to all government funded embryonic stem cell studies, only to halt the federal endorsement of research that encourages future and continued destruction of human embryos for scientific purposes.
"The Obama administration tried to say that if private funding was used to create and destroy embryos, federal funding could be used for the research, but it's all part of the same process," he says.
Those in the field, however, fear that a broad interpretation of the ruling could do away with federal funding of any and all embryonic stem research and are counting on a quick appeal.
Scientists Bemoan Injunction
While awaiting the Justice Department's interpretation of the ruling, scientists and administrators nationwide are scrambling to figure out on which side of this injunction they fall.
In its broadest interpretation, this ruling could close all National Institute of Health labs dealing with embryonic stem cells. At its most limited, it could still put a halt to a significant amount of ongoing research, costing time, resources, and precious government funding.
Lamberth wrote in his ruling that his action returned federal policy to the "status quo," but stem cell experts couldn't disagree more.
"The judge made a serious error by finding that his ruling would not harm embryonic stem cell researchers. Given that this ruling would have blocked even the more restrictive Bush administration policy, it does greater harm to the human embryonic stem cell researchers than any policy ever enacted. This is the most extreme interpretation of federal law that we have seen yet," says Morrison.
Fortunately, those who have already been granted NIH money for embryonic stem cell research will not have to "step away from the petri dish" because of this ruling, Collins said. They may continue their current research, but their chances of receiving funding for advanced stages of their research is in jeopardy, he added.
Susan Solomon, CEO of New York Stem Cell Foundation, argues that this ruling has the potential to interfere with not only all federally funded research involving embryonic stem cells, but with many privately-funded labs and projects as well.
"This will stop research all over the country. Even if you have private funding, there's an impact because many of your collaborators could be federally funded and affected by this ruling," she says.
Scientists said the ruling, which came as a surprise to many in the field, highlights the danger of having medical research policy that is subject to the whims of the judicial system.
Michael West, CEO of Embryonic Sciences, Inc. and adjunct professor of bioengineering at the University of California, Berkeley likens this kind of ruling to playing "political football" with medical research and says he is "ashamed of our government."
"These roadblocks and delays could well mean the unnecessary suffering or death of a fellow human being some day in the future. We should not allow political differences to encroach on our moral duty to alleviate human suffering when it is in our power to do so," he adds.
Moving Forward Despite Injunction
Researchers say that fortunately there are some loopholes even in the event that the ruling is not overturned.
New technology allows for obtaining embryonic stem cells without destroying the fetus. There are some 3,000 children alive today that have had stem cells removed in vitro in order to test for certain genetic conditions, says CEO and Chairman of Advanced Cell Technology Bill Caldwell, and the use of these stem cells for science avoids much of the controversy.
Other technology is able to induce adult stem cells, which would not be affected by the injunction, to behave like embryonic stem cells, says Bryon Petersen, associate professor of pathology, immunology and laboratory medicine at the University of Florida.
"I don't think Obama's executive order violates the law, but I [also] don't think the injunction is as big of a deal [as some are saying]. Most of the researchers I've talked to have gone away from the embryonic side, in favor of adult stem cells" that are modified to act like embryonic cells.
Bush to Obama, What Changed?
Stoddart says that the suit was intended to overturn Obama's executive order, not the policy that was in place during the Bush administration.
While the Bush administration allowed for federally funded research involving embryonic stem cell research, Obama's predecessor sanctioned only certain, already established stem cell "lines" so as not to support the future destruction of embryos in the name of federally-endorsed science.
Once a stem cell is harvested (and the embryo discarded or destroyed), a replenishable "line" or supply of cells can be derived from the original.
In March of 2009, Soon after entering office, President Obama revoked these limitations and deferred to the National Institute of Health to decide what was a "responsible, scientifically worthy human stem cell research."
The following July, the National Institute of Health came out with its guidelines on appropriate stem cell sources. Embryos must be "derived from an embryo that was created for reproductive purposes and was no longer needed" and was donated for scientific purposes.
Because under these guidelines federally funded projects could obtain stem cells from private institutions that continue to use extra, donated embryos from in vitro fertilization to produce stem cells for research, critics of Obama's order argue that it is using federal money to support the destruction of life.
Why Challenge Dickey-Wicker Now?
Scientists argue that Obama's order is not so different than what existed before, only that instead of sanctioning those lines created as of 2001, it sanctions those lines that are already created since then.
"If having federally funded research that uses privately created stem cell lines misinterprets the Dickey-Wicker amendment, then congress had nine years during the Bush administration to say it was being misinterpreted. Obama's interpretation is the same as Bush's," says Dr. Robert Klitzman, director of the Masters of Bioethics Program at Columbia University.
MedPage Today's Emily Walker contributed on this report.