Federal Judge Overturns Obama Policy on Stem Cells

August 24, 2010

Seventeen months after President Obama bolstered stem-cell research on university campuses by allowing federal support for studies involving a broad range of cells derived from human embryos, a federal judge has ordered the policy suspended, alarming academic scientists who warn of slower progress in studies seeking treatments for a variety of devastating diseases.

The judge, Royce C. Lamberth of the U.S. District Court for the District of Columbia, said Mr. Obama's executive order of March 2009 violated a provision that has existed in federal law since 1996, known as the Dickey-Wicker Amendment, that prohibits the use of federal money for the creation or destruction of human embryos for research purposes. Embryos are destroyed when embryonic stem cells are obtained from them.

Mr. Obama's action largely overturned the policy announced in August 2001 by then-President George W. Bush that barred the use of federal money for any projects using embryonic stem cells created after that date, but allowed work to continue with cells derived from a limited number of stem-cell lines already existing. The idea, Mr. Bush said, was that the life-or-death decision had already been made for those embryos.

The Obama policy, by contrast, would allow federal support for studies involving new lines of cells derived from embryos created by in vitro fertilization and donated by couples who no longer wanted them for the purposes of creating a child. The policy, as set forth in guidelines issued by the National Institutes of Health last year, was intended to avoid any conflict with the Dickey-Wicker restrictions by stipulating that the actual extraction of stem cells from embryos would occur without federal money.

The guidelines' distinction between deriving stem cells and studying them, however, wasn't sufficient for Judge Lamberth. In a 15-page ruling, he declared that any embryonic-stem-cell research "is clearly research in which an embryo is destroyed."

Question of Harm

Judge Lamberth issued his decision in a case whose plaintiffs include two private researchers who study stem cells obtained from adults. They argued that Mr. Obama's policy unfairly deprived them of federal money for their own studies by increasing the competition for NIH funds. The judge agreed that the increased competition they faced was "an actual, imminent injury."

Although the plaintiffs needed to show a financial harm in order to bring their case, Judge Lamberth's ruling deals with issues far more important than money, said William B. Hurlbut, a bioethicist and physician at the Stanford University Medical Center.

Mr. Obama's policy shift raised many questions at the intersection of ethics and medical research, said Dr. Hurlbut, a consulting professor in neurology and neurological sciences who served on President Bush's Council on Bioethics. "We've barely given them any thoughtful reflection," he said.

Many other medical experts, however, were mourning Judge Lamberth's decision, saying it once again squelches the hopes of millions of people suffering from a range of ailments that include cancers, diabetes, and heart disease.

Because Mr. Bush's restrictions made so few stem-cell lines eligible for federal research support, universities either avoided the field or engaged in elaborate and costly procedures to establish privately financed laboratories and keep that work strictly quarantined from their larger government-financed activities.

"It's a shame," said George Q. Daley, an associate professor of biological chemistry and molecular pharmacology at Harvard Medical School and a pediatric clinician who treats children with blood disorders.

"Our lab will have to return to the old mode of keeping human-embryonic-stem-cell research separate from everything else, which means slower progress," Dr. Daley said. The problem is made even worse by the continuing financial crisis, which is making private research money harder to find, he said.

"Just when the dark shadow of political ideology seemed to be lifting from stem-cell research, this news puts us back under the pall," said David T. Scadden, co-director of the Harvard Stem Cell Institute.

It wasn't immediately clear what the Obama administration would do in response. Spokesmen for the White House and the National Institutes of Health referred questions to the Justice Department, where a spokesman, Charles S. Miller, said lawyers were reviewing the case.

At an earlier stage of the case, Judge Lamberth refused to hear the matter, saying an original plaintiff, an adoption agency that argued that Mr. Obama's new policy reduced the availability of fertilized human eggs for adoption, didn't have sufficient legal standing to challenge the president's executive order. On appeal, however, the U.S. Court of Appeals in Washington ordered the judge to consider the financial-loss argument raised by the researchers.

Hopes for a Reversal

The case could yet be overturned on the grounds that those researchers don't have a credible claim to have lost any federal money, said Richard O. Hynes, a professor of biology at the Massachusetts Institute of Technology.

"If the plaintiffs' research applications have merit," Mr. Hynes said, "they will be able to apply for funding and to reapply even if their first application is not funded." One of the plaintiffs, James L. Sherley of the Boston Biomedical Research Institute, served from 1998 to 2007 as a professor of biological engineering at MIT.

Mr. Sherley, who attracted national attention in 2007 by going on a hunger strike after MIT denied him tenure, has championed adult-stem-cell research not only on scientific but on moral grounds, contending, as did the judge, that research involving embryonic stem cells is unavoidably linked with the destruction of embryos.

Even if Judge Lamberth's ruling is ultimately overturned, just a brief halt in embryonic-stem-cell research could mean prolonged sickness or death for many patients awaiting cures, said Amy Comstock Rick, past president of the Coalition for the Advancement of Medical Research. "We're pretty devastated by the ruling," she said.

The California Institute of Regenerative Medicine, the state stem-cell agency, has already stated that it will use its own money to support research using embryonic-stem-cell lines approved by the NIH in the past year, as well as the lines previously approved by the Bush administration.

Ironies of the case include the fact that the same essential claim of a violation of the Dickey-Wicker Amendment could have been lodged against the earlier Bush administration policy, Ms. Rick said.

Dr. Hurlbut said that argument might have been technically possible under the previous guidelines, although the Obama policy appears to have allowed clearer and more-widespread violations.

Rather than lament the loss of research involving human embryos, ethicists should consider the ruling's implications more thoroughly, he said, and researchers should take more seriously alternative methods of producing stem cells.

"The living human embryo is a human being in process," Dr. Hurlbut said, "and I think that's the correct scientific interpretation of it—the earliest stages of human life."