Some Stem-Cell Studies Can Continue, NIH Director Says

August 24, 2010

The director of the National Institutes of Health on Tuesday gave scientists who have already received funds for studies involving human embryonic stem cells the go-ahead to continue their work, while the U.S. Department of Justice announced that it plans to quickly appeal a federal court ruling issued on Monday that temporarily halted federal support for such research.

The institutes' director, Francis S. Collins, said he was "stunned" by Monday's ruling, issued in a case that is still pending. The ruling found that President Obama's expansion of federal support for stem-cell studies violated a law that prohibits the use of federal money for the creation or destruction of human embryos for research purposes.

In a conference call with reporters on Tuesday afternoon, Dr. Collins said research projects that have already received funds from the NIH can continue. That research represents nearly 200 projects, with about $131-million in grants, he said.

But the agency has ceased its review of grants being considered for renewal and new applications for funds, the director said. It has also quit reviewing new stem-cell lines that have been submitted to be approved for use in federally supported studies.

The 22 projects due to be considered for renewal by the end of September, which represent a total of $54-million, are in "great jeopardy," Dr. Collins said.

It is unclear whether the scientists involved in those projects will be able to continue their studies if their grants are not renewed. It is unlikely that private sources, such as foundations or drug companies, will be able to step in quickly to replace NIH grants.

Monday's decision, handed down by Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia, was based on a provision of federal law known as the Dickey-Wicker Amendment. That provision, which was enacted as part of a federal spending bill for the 1996 fiscal year, forbids the use of federal funds for any research that creates, harms, or destroys human embryos.

The current NIH guidelines on embryonic-stem-cell research permit the use of federal funds for studying embryonic stem cells, but not for extracting the cells from embryos—a process that destroys the embryos.

But Judge Lamberth found that distinction meaningless. The guidelines violate the Dickey-Wicker prohibition, he reasoned, because embryonic-stem-cell research "depends upon the destruction of a human embryo."

While Judge Lamberth said his ruling would "simply preserve the status quo" for stem-cell researchers, scientists were unsure what that meant.

Dr. Collins said it could mean a return to cumbersome and expensive lab procedures that came about with the policy set by former President George W. Bush in August 2001. That policy barred the use of federal money for any projects using embryonic stem cells created after that date, but it allowed work to continue with cells derived from a limited number of stem-cell lines already existing. Under the Bush policy, scientists were unable to use equipment purchased with federal money for research with stem cells from lines that were not approved at the time.

An executive order issued by President Obama last year, however, expanded the pool of embryonic stem-cell lines eligible for federal funds. The field was just gaining momentum under the new policy, according to Dr. Collins.

In the 2009 fiscal year, the NIH awarded grants totaling $120-million for research involving human embryonic stem cells, compared with $88-million in grants the year before. Counting money from the economic-stimulus bill, the 2009 total came to $143-million. Monday's court order "poured sand into that engine of discovery," Dr. Collins said.

The Department of Justice plans to file an appeal against the court order within the week, according to Tracy Schmaler, a spokeswoman for the department.