Injunction Leaves Stem Cell Researchers in Legal Limbo

Yesterday's court decision temporarily blocking federal funding for work with human embryonic stem cells (hESCs) has left researchers working with the cells in a legal limbo as government lawyers decide how to respond.

Judge Royce Lamberth of the U.S. District Court for the District of Columbia issued a temporary injunction blocking the federal government from implementing the current National Institutes of Health (NIH) guidelines governing research with hESCs. In his 15-page ruling, Lamberth said that "ESC research necessarily depends upon the destruction of a human embryo." And because Congress for every year since 1996 has enacted the so-called Dickey-Wicker Amendment, which prevents the government from funding "research in which a human embryo or embryos are destroyed," the government cannot fund work with the cells.

The ruling came as part of a lawsuit filed a year ago by Christian groups opposed to embryo research. The U.S. District Court rejected the suit because it found the plaintiffs, including certain embryos listed with names, had no legal standing. But in June, the U.S. Court of Appeals in Washington, D.C. reinstated the suit. The court found that two doctors on the suit, stem cell scientists James Sherley and Theresa Deisher, do have standing because NIH's stem cell guidelines harmed them by lessening their chance of receiving funding for work on adult stem cells.

Although the lawsuit was directed at the Obama Administration's rules for expanding funding for hESC research, Lamberth's opinion strongly suggests that funding under the Bush Administration was also illegal under the Dickey-Wicker Amendment.

It was unclear this morning whether researchers who had already received grant money to study hESCs—a total of $137 million in 2010—could continue their projects. NIH referred reporters to the Department of Justice; a Justice Department spokesperson said the department is reviewing the ruling and has no further comment.

Anthony Mazzaschi, senior director for scientific affairs for the Association of American Medical Colleges in Washington, D.C., sees two options for the Obama Administration to avoid a halt to current research. Federal lawyers could ask the appeals court to stay the injunction until after a trial takes place. Or they could issue a narrow interpretation of the ruling that allows ongoing research to proceed and see if it stands. "We need to take a deep breath and see what Justice's plans are," Mazzaschi says.

Harvard University told its researchers that until NIH informed them otherwise, they could continue to work on grants already awarded. But some scientists were not taking any chances. George Daley, a stem cell researcher at the Harvard Stem Cell Institute, said he had asked his lab members to keep any work with hESCs separate from materials bought with NIH money. "I read the ruling, and I would be surprised if someone else can figure out a way to interpret this as anything less than a blanket prohibition against using any federal dollars for human ES cell research," he said.

If the injunction holds, the only way federal funding of hESC research could continue is if Congress passes legislation overriding the Dickey-Wicker Amendment. Representative Diana DeGette (D–CO), cosponsor of a bill to codify the Obama stem cell policy, issued a statement calling the ruling "deeply disappointing" and saying that "we must pass common-sense embryonic stem cell research legislation." As an alternative to a standalone bill, Congress could add a rider to an existing bill ending the Dickey-Wicker rule.

But Mazzaschi says it's uncertain whether lawmakers will want to take up stem cell legislation during the "craziness" of a midterm election year when many Democrats and moderate Republicans are vulnerable.

ScienceInsider will relay updates on the implications of the injunction.

For more on the stem cell ban, see our full coverage.