Friday, April 29, 2011

U.S. Appeals Court decision--good news, but not the final word

Nine months after a U.S. district court first sent federal funding for embryonic stem cell research into a tailspin, the U.S. Court of Appeals ruled that those opposing embryonic stem cell research were unlikely to win their case. The ruling means that, for now, federal agencies such as the NIH can continue funding embryonic stem cell research.

That doesn't mean the saga is over. The story began when two scientists filed a case arguing that federal funding for embryonic stem cell research harmed the ability of adult stem cell scientists to get grant money. They also argued that embryonic stem cell research violates the Dickey-Wicker amendment, which prohibits the destruction of human embryos for the sake of research.

In response, the federal government claimed that there is no competition between adult and embryonic stem cell scientists for grants. Furthermore, the federal government does not support the creation of new stem cell lines, which is what destroys the embryo. They only fund research with selected embryonic stem cell lines, which does not violate the Dickey-Wicker amendment.

Fast forward a year. On August 23, 2010, the U.S. District Court hearing the case issued a preliminary injunction blocking the federal government from funding any embryonic stem cell research on the grounds that even though they hadn't ruled on the actual case, people were getting hurt. (We blogged about that decision here.) Those people getting hurt being the adult stem cell scientists, presumably. That ruling brought federal funding for embryonic stem cell research to a standstill, and left scientists wondering how to handle ongoing experiments.

On August 31, 2010 the federal government appealed that preliminary injunction (blogged about here).

Then, on September 9, 2010, the U.S. Court of Appeals put a hold on the preliminary injunction, temporarily allowing the federal government to resume funding embryonic stem cell research (blogged about here). Basically, since nobody was actually getting hurt, there was no reason to halt federal funding until the courts had ruled on the case.

Then we all waited. The district court heard arguments in the main case back in December, but still hasn't issued a ruling. Today's announcement is from the U.S. Court of Appeals—the one that put a hold on the district court preliminary injunction back in September. Today they ruled that, after looking at the arguments, they don't expect the adult stem cell scientists to win the case. And since they probably won't win, the judge's preliminary injunction can't stand.

In their conclusion, the U.S. District Court of Appeals wrote:
We conclude the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used. We therefore vacate the preliminary injunction.
Having heard that the appeals court doesn't think the adult stem cell scientists will win, we still have to wait for the district court to make it's final ruling. After that, it's likely that the case will make its way to the Supreme Court.

UCSF's Arnold Kriegstein had this to say about today's ruling in a UCSF press release
“This is a victory not only for the scientists, but for the patients who are waiting for treatments and cures for terrible diseases,” Kriegstein said. “This ruling allows critical research to move forward, enabling scientists to compare human embryonic stem cells to other forms of stem cells, such as the cell lines which are derived from skin cells, and to pursue potentially life-saving therapies based on that research.”
What's at stake here is more than just the fate of embryonic stem cell research. Back in August when the injunction was first announced, CIRM's Geoff Lomax sent a survey to grantees in order to learn how the injunction alters their research plans. What we learned (shown in this powerpoint) is that grantees working with adult stem cells and iPS cells all worried that that a lack of federal funding for embryonic stem cell research could slow their work as well. Halting funding for one area of stem cell research slows all areas of research toward stem cell-based therapies.

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