Stem Cell Research in Limbo After Ruling


Some researchers studying human embryonic stem cells are surprised, disappointed, and even angry over the legal back-and-forth over the federal government policy on funding research using the cells.

On Aug. 23, a federal judge issued a ruling that barred the use of federal funds for any research involving human embryonic stem cells. As a result of the temporary injunction, the National Institutes of Health stopped accepting submissions of information on human embryonic stem cell lines for NIH review and suspended all review of embryonic stem cell lines. On Aug. 31, the Justice Department asked for a stay of the lower court's injunction, which was granted on a very short basis on Sept. 9. The Sept. 9 temporary administrative stay granted by the U.S. Court of Appeals for the District of Columbia Circuit called on both parties to the suit to present information to the court by Sept. 20.

Last year, President Obama greatly expanded opportunities for embryonic stem cell research when he issued an executive order that eliminated many of the restrictions placed on funding during the George W. Bush administration. The NIH followed with guidelines that allowed research to be conducted on embryonic stem cells derived from embryos created through in vitro fertilization and donated for research.

With the judicial ping-ponging, some researchers worry that the development of therapies that use embryonic stem cells will be set back and that the loss of federal funding will have a chilling effect on newly minted researchers who are considering whether to enter the field.

The Coalition for the Advancement of Medical Research, which advocates for stem cell funding, called the original injunction a “blow to the hopes of millions of patients and their families suffering from fatal and chronic diseases and disorders.”

The halt on funding for embryonic stem cell research has implications for all types of stem cell research, said Alan Trounson, Ph.D., president of the California Institute for Regenerative Medicine, which issues grants to researchers in California who use state funds.

“The decision is a deplorable brake on all stem cell research,” he said in a statement. “Many discoveries with other cell types, notably the so-called reprogrammed [induced pluripotent stem] cells, would not happen without ongoing research in human embryonic stem cells.”

Dr. Trounson said the California institute's funding plans would not be affected by the federal court decision. Institutions that have obtained private funding for their stem cell work will also be able to continue their work. However, even those with deep pockets are concerned that private funding alone is not enough.

“It's a blow to us,” said B.D. Colen, a spokesman for the Harvard Stem Cell Institute. “It's a blow to the field.” The institute, a collaborative of stem cell researchers from around Massachusetts, has raised $120 million in private funds since its founding 2004, but those sources are not unlimited, Mr. Colen said. The loss of federal funding that was expected to go to the institute's researchers will be disruptive, he said, and the impact will be worse for those researchers who do not have private funding sources to fall back on.

Another concern involves legal issues. An earlier lawsuit challenging the Obama stem cell guidelines had been dismissed after the court ruled that the plaintiffs had no standing to challenge it. However, the recent injunction came about after the court decided that two researchers who work with adult stem cells could challenge the guidelines because funding of embryonic stem cell research was harming their chances for receiving federal funds for adult stem cells.

“This judge opens the door for every scientist who ever has a grant request rejected on the merits to sue the federal government,” the American Society for Reproductive Medicine said in a statement condemning the court decision.

In granting the temporary injunction, Judge Royce C. Lamberth, chief judge in the U.S. District Court for the District of Columbia, said the NIH guidelines violated the intent of Congress to bar the use of federal funds for research in which human embryos are destroyed. He said the rules violated the Dickey-Wicker amendment, a rider generally attached to health spending bills each year. It prohibits the use of federal funds for the creation of a human embryo or embryos for research purposes or research in which a human embryo or embryos are destroyed or discarded. The Obama administration has argued that the amendment doesn't apply because federal funds are used for research on the embryonic stem cell lines, not in the destruction of the embryos.


Recommended Reading