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Rabb's decision a decade earlier anticipated just such a questioning of the government's role in supporting embryonic-stem-cell studies. Her ruling was apparently sound enough for former President George W. Bush to decide that he could not justify banning all government funding of work in the field based on Dickey-Wicker. In 2001, he decided instead to restrict government support of embryonic-stem-cell studies to the two dozen or so lines already in existence, while prohibiting the NIH from issuing research grants to create new embryonic-stem-cell lines that would require the destruction of more embryos.
Lamberth's injunction, which temporarily blocks the Obama Administration's newly instituted guidelines for issuing grants to support stem-cell studies, could, if it holds, put an even tighter stranglehold on stem-cell research than Bush's restrictive policy. Under Lamberth's decision, no embryonic stem cells would be eligible for studies using federal funds, period. That includes stem-cell lines generated using private money. "There is no question this is a step backward," says Dr. Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at the University of California, San Francisco. "It turns back the clock even more than the presidential directive in 2001. At that point, at least the 20 or so lines created prior to that date were viable for study."
Even more troubling, says Kriegstein, is the possibility that more scientists like Daley will have to return to the balkanized existence they endured under the Bush policy. Because nearly every scientist and academic institution receives some form of federal research support, those studying human-embryonic-stem-cell lines were forced into a painstaking and sometimes absurd practice of keeping their federally funded research activities carefully separated from their nonfederally financed ones. That included precise segregation of all equipment, personnel and time to ensure that no government money was used to pay for so much as a lightbulb in a room where unapproved embryonic stem cells were analyzed. "In my lab now, we have activities that are both federally and nonfederally funded," says Kriegstein. "We may have to start changing the way we do research as of tomorrow if this change is to take effect immediately."
Kriegstein and Daley and the rest of the stem-cell-research community are awaiting guidance from the Department of Justice, which is reviewing the decision and will provide some interpretation of what the ruling means for ongoing experiments. Government grantees in the meantime are caught in a legal limbo that could prove scientifically devastating. "Many of us are midstream in what we consider important research, which now has an uncertain future," says Kriegstein. "What will become of those projects now? There is a lot of time, resources and effort invested in them. Should they have to stop? There is a great deal of concern about that for all of us, because it would be extremely wasteful."
Even if the government were to shut down its support of embryonic stem cells, it would likely continue to back work on both adult stem cells and the newly discovered induced pluripotent stem cells (iPSC), which resemble embryonic stem cells in their flexibility but are not generated from embryos; they can be grown from skin cells. The problem, says Daley, is that it's not entirely clear yet how useful iPSC will be for understanding or treating disease. Early work suggests that there are differences between embryonic stem cells and iPSC, and scientists need to continue to grow the embryonic version in order to compare the two groups and better understand what these differences mean.
While the research community is hopeful that the decision will be overturned, it is cautious about making any predictions. Daley sees the ruling as a reason to continue to pursue legislation supporting government involvement in embryonic-stem-cell research. Such bills passed both the House and Senate twice in the past decade but were vetoed by President Bush.
As the scientists wait and wonder, they are familiar enough with the political and ethical controversies surrounding their work to know that it's only the latest challenge in what will likely be an ongoing battle in Washington, in the courts and in the labs.