NIH cannot fund embryonic stem cell research, judge rules

By Rob Stein and Spencer S. Hsu
Washington Post Staff Writer
Tuesday, August 24, 2010; A01

A federal judge on Monday blocked the Obama administration from funding human embryonic stem cell research, ruling that the support violates a federal law barring the use of taxpayer money for experiments that destroy human embryos.

U.S. District Judge Royce C. Lamberth issued a preliminary injunction that prohibits the National Institutes of Health from funding the research under the administration's new guidelines, citing an appeals court's ruling that the researchers who had challenged the less-restrictive policy have the legal standing to pursue their lawsuit.

The decision, a setback for one of the administration's most high-profile scientific policies, was praised by opponents of the research.

"We are encouraged that the court has recognized the seriousness of the ethics and the funding of embryonic stem cell research," said David Prentice, senior fellow for life sciences at the Family Research Council.

The ruling stunned scientists and other advocates of the research, which has been hailed as one of the most important advances in medicine in decades because of its potential to cure many diseases but has been embroiled in controversy because the cells are obtained by destroying days-old embryos.

"This is devastating, absolutely devastating," said Amy Comstock Rick, immediate past president of the Coalition for the Advancement of Medical Research, a group of patient organizations that has been lobbying for more federal funding.

"We were really looking forward to research finally moving forward with the full backing of the NIH. We were really looking forward to the next chapter when human embryonic stem cells could really be explored for their full potential. This really sets us back," Rick said. "Every day we lose is another day lost for patients waiting for cures."

Tracy Schmaler, a Justice Department spokeswoman, did not discuss how the administration intends to respond to the ruling, saying only that "we're reviewing the decision." The NIH had no immediate comment.

Steven Aden, a lawyer with the Alliance Defense Fund who filed the suit, said the court will need to clarify whether the injunction affects work using money already issued to researchers under the administration's new guidelines or blocks additional funding.

In his 15-page decision, Lamberth cited "unambiguous" legislation by Congress in 1996, called the Dickey-Wicker Amendment, which prohibits federal funding for "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero."

In 1999, Harriet S. Rabb, a lawyer for the Department of Health and Human Services, concluded that the NIH's support of embryonic stem cell research did not violate the amendment if the funds were used only for experiments involving the cells -- not to procure them. The cells themselves are not embryos, she said.

Said Sean Tipton of the American Society for Reproductive Medicine: "NIH carefully designed polices to allow federally funded scientists to explore the potential of human embryonic stem cell research without violating Dickey-Wicker. The NIH policies on stem cell research make it clear that federal funds can be used to investigate cells and tissues created from human embryonic stem cells, but not to create them."

Lamberth rejected that distinction.

"The language of the statute reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed," he wrote. "This prohibition encompasses all 'research in which' an embryo is destroyed, not just the 'piece of research' in which the embryo is destroyed," as the Justice Department argued.

On Aug. 9, 2001, President George W. Bush limited federal funding to 21 colonies of existing human embryonic stem cells to prevent taxpayer money from funding the destruction of more embryos to obtain additional cells. Critics of the research praised Bush's move, saying that destroying embryos to advance academic study is immoral and that alternative approaches, such as using stem cells derived from adults, were equally if not more promising.

But many scientists condemned the restrictions, saying they were hindering research that could lead to cures for Alzheimer's disease, diabetes, paralysis and other ailments. Embryonic stem cells, which can morph into many different types of tissue, are able to do things that other cells cannot, proponents argued. No new therapies, however, have been developed.

Soon after taking office, President Obama announced that he was lifting his predecessor's restrictions and ordered the NIH to develop new guidelines addressing the ethical issues involved. Last summer, the NIH issued detailed guidelines and began authorizing new colonies of cells eligible for funding. Seventy-five colonies have been approved so far.

Monday's ruling was in response to a lawsuit filed by James L. Sherley and Theresa Deisher, researchers who study other types of human stem cells. The pair argued that the new administration's guidelines would "result in increased competition for limited federal funding," hindering their plans to seek money for other research.

Lamberth initially threw out the case, but the U.S. Court of Appeals for the D.C. Circuit ruled June 25 that the researchers had legal standing to bring a suit. Several other plaintiffs were dropped, including the Christian Medical Association, Nightlight Christian Adoptions and two couples seeking to "adopt" unused embryos. The original suit also contended that the policy would limit the number of embryos available to people seeking them.

Lamberth's injunction does not prevent the government from taking the case to trial. However, the judge wrote that the claim was strong enough to bar federal authorities from "taking any action whatsoever" to implement funding guidelines pending trial.

"The Court finds that the likelihood of success on the merits, irreparable harm to plaintiffs, the balance of hardships, and public interest considerations each weigh in favor of a preliminary injunction," he wrote.

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