Effects of injunction against Obama administration's stem-cell policy still unclear.
US stem-cell researchers are reeling from a court order handed down yesterday that puts a temporary hold on the current policy for federal funding of human embryonic stem-cell (ESC) research. Now, many are calling for legislation that would make such research unambiguously legal once and for all.
The court order is the outcome of a lawsuit originally filed last August against the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) in Bethesda, Maryland, which contends that federal funding for research on human embryonic stem cells is illegal because it requires the destruction of embryos.
"It's the worst outcome we could imagine," says George Daley, a stem-cell researcher at the Children's Hospital Boston in Massachusetts. "It's going to be enormously disruptive to anyone holding NIH money [to conduct work on human ESCs], which has been a big deal since the Obama policy."
According to figures posted on the NIH website, the agency granted a total of US$143 million in funding for human embryonic stem-cell research in 2009, with funding estimates for 2010 and 2011 being $137 million and $126 million, respectively.
Under the previous administration of George W. Bush, scientists could not use federal funds for research on human embryonic stem-cell lines derived after 9 August 2001. In March 2009, US President Barack Obama overturned those restrictions by executive order, mandating the NIH to develop a policy for the ethical approval of newly derived lines.
Contention and appeal
The lawsuit against the HHS and NIH contends that the new policy violates the Dickey-Wicker Amendment, a law that prohibits the destruction of human embryos. The suit was dismissed last October because the original plaintiffs — listed in court documents as two Christian organizations, six individuals, and "embryos" — were deemed to have no legal standing in the case, that is, they had no tangible interest in its outcome.
However, the two scientists on the plaintiff list — James Sherley, a researcher in adult stem cells at the Boston Biomedical Research Institute, and Theresa Deisher, research and development director of the firm AVM Biotechnology in Seattle, Washington — appealed, and in June the case was granted standing on the grounds that human embryonic stem-cell research increases funding competition for scientists working on adult stem cells1.
The Dickey-Wicker Amendment had been interpreted to mean that, although researchers could not use federal funds to derive an embryonic stem-cell line (a process that involves destroying an embryo), they could study such lines derived by others, because the research itself doesn't involve destroying an embryo. The current NIH policy, established in July 2009, continues to prohibit deriving new lines with federal funds.
In a ruling filed yesterday, however, Judge Royce C. Lamberth of the US District Court for the District of Columbia argues that this distinction is spurious.
"The Dickey-Wicker Amendment unambiguously prohibits the use of federal funds for all research in which a human embryo is destroyed," he writes in the opinion. "It is not limited to prohibit federal funding of only the 'piece of research' in which an embryo is destroyed. Thus, if ESC research is research in which an embryo is destroyed, the Guidelines, by funding ESC research, violate the Dickey-Wicker Amendment."
Hank Greely, director of the Center for Law and the Biosciences at Stanford University in California, calls the decision "bizarre" from a legal standpoint. "This just looks wrong," Greely says. "This looks to me like a very surprising and questionable legal decision.
"Basically, they are saying that all ESC research is a part of a broader system of research that includes the initial destruction of embryos. Which would be kind of like saying that all research into nuclear power stems from the Manhattan Project," he says.
"It sounds like it would imply that if you're researching gravity, everything from Sir Isaac Newton forward counts as part of your research programme." This doesn't make sense, he explains, because a given NIH grant proposal requests funds for a particular research project.
The decision also goes against a long-standing interpretation of the Dickey-Wicker Amendment, Greely notes, not made only by the NIH, but also by the administrations of Bush and Bill Clinton. What's more, he says, the Dickey-Wicker Amendment is part of the annual Appropriations Act, which lays out the budget for government agencies, and thus is re-approved by Congress each year. "Every year when Congress re-passes the Appropriations Act, it could have changed the language if it thought the interpretations were wrong," he explains.
But Samuel Casey, of Advocates International of Fairfax, Virginia, one of three legal organizations representing Sherley and Deisher, says that the Bush administration was already treading on thin ice with Dickey–Wicker. "At that time, our organization had a lawsuit against the Bush administration over the same question," he says. "We were before this very same judge that just ruled."
Ultimately, the case was withdrawn. Because the Bush policy set a cut-off date for deriving new cells, Casey says, it could be argued — albeit weakly, he and his colleagues believe — that it complied with the statute, which the Obama policy does not.
Judge Lamberth's court order, also filed yesterday, prohibits the HHS and NIH from "implementing, applying, or taking any action whatsoever pursuant to the National Institutes of Health Guidelines for Human Stem Cell Research ... or otherwise funding research involving human embryonic stem cells as contemplated in the Guidelines".
So far, it's not clear what the injunction will mean for researchers. The NIH has deferred comment on the case to the Department of Justice, which says it is currently reviewing the judge's ruling. "My firm hope is that either Lamberth or the DC [court] will stay the injunction pending appeal" and that such a stay will be expedited to take effect quickly, Greely adds.
Daley says he is not waiting for clarification. When he learned of the ruling yesterday, he told members of his lab to "go back to the old ways" of making sure all human embryonic stem-cell work is done without using materials purchased with federal dollars.
Others are more circumspect. "We don't want to do anything too drastic until we understand the legal speak," says Clive Svendsen, director of the Regenerative Medicine Institute at Cedars-Sinai Medical Center in Los Angeles, California. "We're just hanging on and waiting."
Regardless of the immediate outcome, researchers say, the situation has brought home the acutely precarious nature of the legal standing of embryonic stem-cell research. "It highlights that this is a political football and that there should be some legislation that just removes this uncertainty," says Daley.
If the case mobilizes lawmakers to push for such legislation, adds Svendsen, "it could be a good thing".
"We have to solve this problem," says Daley. "It can't be that one judge can stop millions of dollars in stem-cell research."
Editorial Nature 466, 159 (2010).
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Katsnelson, A. US court suspends research on human embryonic stem cells. Nature (2010). https://doi.org/10.1038/news.2010.428