Stem cell freeze

New Obama administration rules make this year the first since 2001 that federal dollars have been available for newly created embryonic stem cell (ESC) lines. That means about $92 million of U.S. taxpayer dollars are budgeted for the coming year to fund scientists working with the cells of intentionally destroyed human embryos.

But one legal challenge could temporarily-or indefinitely-shut down the flow of federal cash. In the pending lawsuit, two scientists, two families, an adoption agency, and the Christian Medical Association claim that the decision of the Obama administration to expand ESC research was illegal. The case's defendants are the federal agencies responsible for handling science grants, the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH).

It isn't the first such challenge. In 2001 the Bush administration found a nearly identical lawsuit on its doorstep but it never reached a conclusion (and was withdrawn once Bush issued a new policy on stem cell research). "This case raises the central question of whether Congress does or does not want to fund the destruction of human embryos," said Samuel Casey, an attorney with Advocates International who is co-counsel for the plaintiffs. (Alliance Defense Fund and the law firm Gibson, Dunn & Crutcher are also representing the plaintiffs.) Casey, who was also co-counsel in the 2001 lawsuit, said both cases make the same legal argument: that federal grants for ESC research violate the congressional funding ban known as the Dickey-Wicker Amendment.

The Dickey-Wicker Amendment was added to a general appropriations bill in 1995 to bar tax dollars from funding "(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death."

Later, in 1998, embryonic stem cells were isolated and cultured for the first time, and some scientists became interested in working with the resulting cell lines. Harriet Rabb, who was a top lawyer for HHS at that time, interpreted the Dickey-Wicker Amendment to mean that although federal money couldn't be used to derive the stem cells (which killed the embryos), it could be used to experiment with the cells afterward. Funding was acceptable if someone else did the dirty work. Not everyone in Congress agreed with Rabb's conclusion, yet by late 2000 NIH had established grant guidelines for the research.

No money ever arrived in labs. After George W. Bush became president he called for an immediate review of the government's stem cell policy, halting grant applications. During that review in early 2001 Samuel Casey and his colleagues filed suit to stop ESC funding permanently on the grounds that it would result in the embryo destruction the Dickey-Wicker Amendment was supposed to prohibit. But when Bush announced in August that grants for ESC research would become available-but only for some 60 cell lines that were already in existence-law experts decided the Bush policy would provide "no incentives for the destruction of additional embryos," and thus did not violate the amendment. Casey and the suit's plaintiffs voluntarily dismissed their case.

But now that the Obama administration has decided to fund research on stem cells from fresh embryos-that is, from newly created cell lines-Casey believes the Dickey-Wicker problem is back on the table. "[The Obama policy] encourages you to develop an embryonic stem cell line that does not exist now," he said. "So now we're in court to find out what Dickey-Wicker means-again."

That's not the only issue. The lawsuit alleges that NIH violated administrative rules this year as it rushed to fulfill President Obama's executive order to write new guidelines for ESC funding. The agency allowed only 34 days for the public to offer input on its proposed guidelines, and it appears to have ignored comments (about 30,000 out of 49,000) that questioned the usefulness of the research on ethical or scientific grounds. "They had no interest in listening to the public," said Casey.

Federal attorneys in their initial response to the plaintiffs' claims said that NIH didn't have to follow administrative law to the letter because it was acting on orders from the president.

"That is a startling claim of executive power. Simply amazing," said Thomas Hungar, Casey's colleague at Gibson, Dunn & Crutcher. Plaintiff Nightlight Christian Adoptions, along with two families who adopted embryos through the agency, believe the Obama policy will ultimately reduce the number of embryos available for adoption. In 1997 Nightlight began to pair adopting parents with IVF (in vitro fertilization) patients who were willing to give their leftover, frozen embryos to another family. Although many embryos don't survive thawing and implantation, executive director Ronald Stoddart said 211 babies have been born through the program so far. Nightlight itself has received a federal grant to help educate the public about embryo adoption: "Most people hear about it and go, 'Wow, embryos? I didn't know you could do that!'"

Although only Georgia legally acknowledges embryo adoption (elsewhere the process relies on contracts between the two families, said Stoddart), many states protect embryos from wrongful death or hazardous experimentation. Parents who may decide to donate their embryos for research under the NIH guidelines could potentially find themselves in a tangle with state law.

Nightlight is also representing the leftover IVF embryos that expanded ESC research would affect (respectfully called "Plaintiff Embryos").

The Christian Medical Association, representing 15,000 doctors, opposes the Obama administration policy and supports non-embryonic stem cell research. Two scientists, James Sherley and Theresa Deisher, claim that the administration's inclusion of new stem cell lines in funding opportunities will increase competition for the grants needed to conduct research with adult stem cells.

In fact, it is adult and umbilical cord stem cells that have produced real breakthroughs for treatment for illnesses ranging from multiple sclerosis to lupus to stroke paralysis, said David Prentice of the Family Research Council: "Embryonic is frankly no further ahead than it's been for decades." The only existing clinical trial of ESC therapy, intended to treat spinal cord injuries, was recently halted by the FDA for safety concerns before any patients had enrolled. Embryonic cells have been problematic in part because of their propensity to grow tumors after being implanted.

Casey and his colleagues hope the judge in the case issues a preliminary injunction as early as this month, which would force HHS and NIH to freeze any grants being issued for embryonic stem cell research until the resolution of the suit. The agencies have asked the judge to deny the injunction and dismiss the case.

Children, this is a stem cell

Gov. Arnold Schwarzenegger may sign into California law legislation that is an attempt to push stem cell science on K-12 public schools. The legislation intends to "promote stronger links among [stem cell and biotechnology] industry sectors, the California Institute for Regenerative Medicine, and California public schools."

The California Institute for Regenerative Medicine (CIRM)-created through the 2004 voter approval of Proposition 71-worked directly with lawmakers on the measure. Although the final bill doesn't use the word embryonic, its inclusion can be taken for granted: CIRM itself has spent at least $120 million promoting human embryonic stem cell research.

Don Gibbons, the chief communications officer for CIRM, told a reporter the legislation would "make it more difficult for some conservative school districts to opt out of stem cell education for ethical reasons." If the measure becomes law, the state's department of education will be required to promote a "model curriculum" that CIRM is helping to write.

The bill's advocates hope to create a "stem cell culture" in California, says Dana Cody, executive director of the Life Legal Defense Foundation. "What better way to do that than getting into the minds of California public school children?"