Scientists Are Optimistic as Appeals Court Lifts Injunction Against Stem-Cell Research

Kelvin Ma for The Chronicle

Douglas Melton (left) and David Scadden, directors of the Harvard Stem Cell Institute, are among the university scientists who study the cells for cures to several devastating diseases.
September 09, 2010

The federal government can continue to finance embryonic-stem-cell research, temporarily, because a federal appeals court on Thursday lifted an injunction that had blocked such work. The move added to optimism about eventual victory for university scientists who use this research in a search for cures for a range of devastating diseases.

The original injunction was issued August 23 by Judge Royce C. Lamberth of the U.S. District Court of the District of Columbia. The appeals court lifted it after the Justice Department argued that the ban would harm both scientists and taxpayers.

But the court also ordered the two sides in the case to submit written briefs by September 20 setting out their arguments for whether the injunction should be put back into effect for an expected trial lasting several months. During that trial, Judge Lamberth will hear a full set of arguments over the legality of the Obama administration's policy of expanded federal support for embryonic-stem-cell research.

The new appeals-court action was especially welcome to stem-cell scientists because Judge Lamberth's injunction had prevented the National Institutes of Health from distributing millions of dollars in research money at a time, near the end of the federal fiscal year on September 30, when the NIH often awards many of its grants, said Anthony J. Mazzaschi, senior director for scientific affairs at the Association of American Medical Colleges.

"At least in theory by this, they can restart the grant-review process," Mr. Mazzaschi said of the NIH.

The NIH director, Francis S. Collins, issued a written statement late Thursday saying the agency was "pleased with the court's interim ruling, which will allow this important, life-saving research to continue while we present further arguments to the court in the weeks to come."  

An NIH spokeswoman, Marin P. Allen, declined to say whether the agency would restart research involving embryonic stem cells at its own laboratory facilities or resume awarding grants for such research by outside scientists. Ms. Allen, however, cited a report by the journal Nature quoting Sally J. Rockey, the NIH's deputy director for extramural research, as saying that 24 existing grants due for annual renewal this month "should be fast-tracked, as should new human-embryonic-stem-cell grants competing to get funded a first time."

And Michael M. Gottesman, the NIH's deputy director for intramural research, said researchers at the agency’s headquarters in the Washington suburb of Bethesda could resume work involving embryonic stem cells, though he suggested "prudence" in carrying out such activities given the still-tenuous legal situation, Nature reported.

A lawyer for the plaintiffs, Steven H. Aden, expressed disappointment with the latest court action. "The American people should not be forced to pay for even one more day of experiments that destroy human life, have produced no real-world treatments, and violate an existing federal law," he said in a statement.

For his injunction, Judge Lamberth found that Obama-administration policy, announced last year, appears to violate a provision of federal law that prohibits federal financial support for the creation or destruction of human embryos for research purposes. Embryos are destroyed when embryonic stem cells are taken from them.

Even before the appeals court reversed the judge's ruling, advocates of embryonic-stem-cell research said they were growing confident of victory, citing factors that include official Congressional statements during the George W. Bush and Clinton administrations that backed federally supported embryonic-stem-cell research over the legal provision cited by the judge, which is known as the Dickey-Wicker Amendment.

In particular, Congress never voiced objections to a Bush policy that allowed research on a limited number of stem-cell lines, said lawyers on both sides of the case. Mr. Aden, the plaintiffs' lawyer, acknowledged he was unclear on how the judge would rule on that argument. "That's a good question," said Mr. Aden, senior legal counsel for the Alliance Defense Fund Center for Academic Freedom.

Potential Cures

Embryonic stem cells have been touted as treatments for many diseases because they can grow to replace damaged cells of any type. At the Harvard Stem Cell Institute, for instance, scientists are exploring cells' potential use in treating diabetes. The cells are typically obtained from cell lines, a number of which were started by researchers from the excess embryos created by couples trying to start a pregnancy with the help of a doctor. Scientists have also been working with so-called adult stem cells, which are similar to the embryonic cells but are instead taken from types of body tissue, such as skin or bone.

Critics of embryonic-stem-cell research have argued that adult stem cells hold the greater scientific promise. But many stem-cell researchers disagree, saying that comparisons are unfair. Embryonic research has been limited to about 10 years of work because of the political and legal controversies, while the science of adult stem cells is 50 years old. "Yes, adult-stem-cell research is ahead—40 years ahead," said Richard O. Hynes, a professor of cancer research at the Massachusetts Institute of Technology. "That doesn't mean it has more promise."

But that promise, and whether it will be tested, now rests in the courts, not in the lab.

One key point in Justice Department appeal plans is the fact that Congressional appropriations committees, while writing the Dickey-Wicker language into each year's federal budget, began during the Bush administration to include language making clear that Dickey-Wicker didn't interfere with the Bush policy.

Judge Lamberth had also ruled that the NIH could maintain its Human Embryonic Stem Cell Registry, suggesting a potential inconsistency with his argument that any federal work with embryonic stem cells would violate the Dickey-Wicker amendment.

The two plaintiffs in the case, James L. Sherley and Theresa A. Deisher—both private researchers who study non-embryonic stem cells—are suffering no immediate harm, the department said. Dr. Sherley has received $425,500 in NIH grant money, and Ms. Deisher has never even applied, casting doubt on their claim to have suffered financial damage from the Obama policy as a result of unfair competition from researchers using embryonic stem cells.

While the court case proceeds, Congress is weighing its options. A Senate appropriations subcommittee was planning a hearing on the matter for September 16. Some on Capitol Hill have proposed enacting a bill that would codify the Obama policy as federal law, making clear its consistency with Dickey-Wicker. That effort failed to gain traction over the past year as lawmakers saw little need to take a vote that might attract the attention of anti-abortion activists, said Mr. Mazzaschi, of the medical-colleges association.

But calculations on the need for such a vote might be changing after Judge Lamberth's decision. Mr. Mazzaschi said there should be support for it because Congress twice passed bills during the Bush administration—vetoed by the president—that would have lifted Mr. Bush's restrictions on embryonic-stem-cell research. "There were strong majorities in both the House and Senate" on those bills, he said.

On the other side of the political equation, however, are the forthcoming Congressional elections, which could make elected representatives reluctant to cast controversial votes.

Politics and Research

Those uncertainties loom particularly large for young embryonic-stem-cell researchers such as Bryan T. Richardson, who earned an undergraduate degree in biology at East Carolina University in 2007 and is now pursuing a doctorate at the University of North Carolina at Chapel Hill. Mr. Richardson, 25, began work four months ago on a federally financed project aimed at seeking cures for diseases affecting blood vessels and is now contemplating a move overseas to pursue his career.

Mr. Richardson said that he agreed that policy makers should take care when setting rules for the use of embryonic stem cells and that he hoped his work would pave the way for using adult stem cells to treat vascular disease. For now, he said, embryonic stem cells are an important component of developing treatments using adult stem cells because the behavior of the embryonic cells provides a critical baseline for measuring the behavior of the undifferentiated adult cells.

"If this ruling was upheld, it certainly would cause me to consider making career changes," Mr. Richardson said. "It's not going to dissuade me from pursuing the research that I really love to do. It just may cause me to have to go overseas to do it, or do it in a different avenue than with the federal government."