Gloom and Confusion in the Stem-Cell Community

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Mauricio Lima / AFP / Getty Images

Embryonic stem cells, seen through a microscope

Stem-cell scientists still reeling from a judge's ruling that their life's work violates federal law received little reassurance about their job security from the nation's largest funder of these studies, the National Institutes of Health (NIH). Describing stem-cell research as one of the more promising engines of scientific discovery, NIH director Francis Collins said the legal decision "poured sand into that engine of discovery."

Late on Tuesday, a day after U.S. District Judge Royce Lamberth filed his ruling that the NIH's use of taxpayer dollars to fund experiments on human embryonic stem cells violates a 1996 law that prohibits the government from supporting any research that harms or destroys human embryos, the Obama Administration announced that it plans to appeal the judge's preliminary injunction on all such government-funded studies currently under way in the U.S. Left unchallenged for the moment is the ban on pending studies — and there are a lot of them. According to Collins, about 50 new grant applications that were awaiting review by NIH experts were pulled from the agency's evaluation queue and put aside. A planned September meeting of an NIH advisory council to consider an additional dozen grants worth $15-$20 million that have already passed a first-level review and would undergo a second evaluation was canceled, Collins said, because "the council is not even allowed to discuss them." Another 22 grants totaling $54 million are up for an annual review and refunding in September as well, he said, but with Lamberth's decision, "those projects would basically stop in their tracks."

The only good news came for those scientists who, through serendipity, already reupped their annual grant and received their portion of the $131 million that the NIH has issued to scientists this year. Those experiments, said Collins, could continue — at least until they are due for renewal again next year. For the others in the stem-cell community, the ruling represents the worst possible scenario, with the federal government essentially walking away from an entire field of scientific study. "This is clearly sad news for all of us in the U.S. who work with embryonic stem cells," says Kevin Eggan, a principal investigator at the Harvard Stem Cell Institute.

While the appeals process unfolds, stem-cell scientists who had been receiving federal funds and were expecting more will not necessarily have to quit working, but they will have to begin a frenzied money chase, looking for private investors to pick up the bill when their current allocation runs out. That, said Collins, is not going to easy. "It's not clear that private sources would appear to meet that need," he said. "There is considerable jeopardy that a project in the middle of a multiyear effort would be prematurely stopped and the results of that research would be lost."

The success of the Obama Administration's appeal of the new ruling will depend on the higher court's interpretation of when a preliminary injunction — like the one Lamberth issued — is justified. Generally, explains Russell Korobkin, a law professor at the University of California, Los Angeles, and an expert on stem-cell law, a preliminary injunction is issued in cases in which the judge feels a plaintiff is threatened by irreparable harm if the current situation continues without any legal intervention. In this case, the plaintiffs are two scientists who work with adult stem cells, the less versatile cousins of embryonic stem cells. The scientists argued that President Obama's 2009 Executive Order expanding federal funding of studies on the embryonic cells did them harm by making it more challenging for them to compete for government grants to support their work. Korobkin is not sure that the argument will stand. "It is true that there is small reduction in the chance of getting funding if you compete in a bigger pool of applicants," he says, "but to say that the reduction in the chances of getting a grant is irreparable harm, I think, is incorrect. Also, the idea of irreparable harm means the potential harms to both sides are supposed to be compared. How much harm will the government suffer if it was prevented from carrying out its policies? What about the people who now have a reduced chance of a cure for their disease that might have come from embryonic-stem-cell research?"

Arguing that Lamberth's issuance of a preliminary injunction was not justified may convince an appeals court to prevent the temporary injunction from becoming a permanent one. But if it doesn't, says Korobkin, the government would have to take its case to the Court of Appeals, where it can argue the merits of Lamberth's interpretation of the Dickey-Wicker Amendment, the 1996 law that prohibits federal support of research that harms embryos. The Department of Justice may argue that the language of Dickey-Wicker is clear in prohibiting only research involving the act of destroying embryos and not, as Lamberth maintained, studies of the products of embryos, like embryonic stem cells. The government may rely on precedent as well: in 1999, in anticipation of just such an interpretation of Dickey-Wicker, Harriet Rabb, then counsel for the Department of Health and Human Services, declared that embryonic stem cells were not embryos as defined by Dickey-Wicker and therefore were exempt from the prohibitions of that law. Even the Bush Administration accepted Rabb's decision as a settled interpretation of the law, and in 2001, President George W. Bush allowed federal funds to be used for studying a limited number of embryonic-stem-cell lines already in existence, while preventing taxpayer dollars from generating new stem-cell lines that would require the destruction of embryos.

If this precedent isn't sufficient, says Korobkin, the government still has a backup strategy. "The way the law works in this case is that if a statute is ambiguous, the court is supposed to defer to the interpretation of the administrative agency. In this case, that's the NIH." And the NIH's interpretation of Dickey-Wicker is represented by the Rabb decision — that embryonic stem cells are not embryos and therefore the cells are eligible for federal funding.

Pursuing such a legal strategy could be notoriously frustrating and protracted. In the meantime, warned Collins, leading stem-cell scientists could decamp for more favorable political and legislative environments overseas, or turn their talents to other scientific fields. That would argue for a legislative strategy. Congress could decide to clarify the role of the federal government in embryonic-stem-cell research by passing a law that allows for government support of the field, essentially putting into law what Obama's Executive Order did in 2009. Passing such a law, says Korobkin, would "moot the whole legal case and moot the court proceedings. Congress could step in and say, Here is what we want: we want the government to be able to fund research on embryonic stem cells so long as the government is not directly funding the actual destruction of embryos themselves." In fact, over the past decade, Congress has passed such legislation twice. And twice, Bush vetoed the bill. Obama would surely sign the law if it reached his desk, but the question this time is whether a toxically partisan House and a largely dysfunctional Senate could pull themselves together to pass it. Don't expect an end to the stem-cell roller coaster anytime soon.