TR Editors' blog

Federal Funding for Embryonic Stem Cell Research is Safe Again

A federal appeals court has overturned an August ruling barring federal money for research using embryos.

Emily Singer 04/29/2011

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In an upswing for scientists studying embryonic stem cells, a federal appeals court announced today that it would set aside a ruling from a lower court last August barring federal funds for the research. As I noted in a story last year, the surprise ruling threw the field into a state of uncertainty--few had even known about the lawsuit, brought by two scientists studying adult stem cells—and brought grant reviews at the nation's largest funding agency, the National Institutes of Health (NIH), to a halt.

According to an article from ABC news on the latest ruling,

The court found that the law--the Dickey-Wicker Amendment enacted in 1996--is "ambiguous" and that the NIH has "reasonably concluded" that while the law bans federal funding for the destructive act of deriving cells from an embryo "it does not prohibit funding a research project in which an hESC will be used."

...

"Today's ruling is a victory for our scientists and patients around the world who stand to benefit from the groundbreaking medical research they're pursuing," said Nick Papas, a spokesman for the White House.

...Sam Casey, an attorney representing Sherley and Deisher said he was "disappointed but not surprised" by the ruling. He says he is considering whether to appeal the decision to the full court.

"This is a victory not only for the scientists, but for the patients who are waiting for treatments and cures for terrible diseases," said Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF, in a statement from the university. "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." Kriegstein was one of two University of California scientists to file a Declaration in September 2010 in support of the UC Board of Regents' motion to intervene in the August lawsuit, Sherley v. Sebelius.

The ruling is a victory for the Obama Administration. Soon after becoming president, Obama had signed an executive order ending a restrictive policy enacted in 2001 by President Bush that had blocked federal funds from being used to study most human embryonic stem cells.

Ban on Federal Funding for Embryonic Stem Cell Research Temporarily Lifted

The order brings a brief reprieve for scientists and the NIH, though many uncertainties remain.

Emily Singer 09/09/2010

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A federal appeals court temporarily suspended an injunction, issued last month, that had halted federal funding for research on embryonic stem cells. The injunction had thrown the field into disarray, as the National Institutes of Health stopped all research on embryonic stem cells within the institute and suspended reviews of grants involving the cells. The Justice Department had asked that the injunction be stayed while the court considers the government's appeal of the ruling.

As I noted in my previous blog,

Researchers say the decision--even if it is later reversed--will have a damaging effect on the field, stunting promising medical research that was just building momentum. All grants under review at the nation's largest funding agency, the National Institutes of Health (NIH), that involve human embryonic stem cells have been put on hold while the NIH and other government agencies try to get the injunction reversed.

..."I've been working with embryonic stem cells for nine years and seen the waves come and go," says Sean Palecek, a stem-cell researcher at the University of Wisconsin, Madison. "Right now is the most restrictive that it's ever been." Palecek and others worry that this latest blow will discourage young scientists from entering the field. "It's really disheartening," he says. "It's hard enough to come up with cutting-edge ideas and to get funding. The possibility of having funding pulled at any time sends the wrong message."

The order states:

... the district court's August 23, 2010 order be stayed pending further order of the court. The purpose of this administrative stay is to give the court sufficient opportunity to consider the merits of the emergency motion for stay and should not be construed in any way as a ruling on the merits of that motion.


Stem Cell Funding Restricted Once Again

A federal ruling temporarily blocks expanded funding for embryonic stem cell research.

Emily Singer 08/24/2010

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Scientists studying embryonic stem cells will soon feel the funding noose tightening once again, thanks to a new ruling that temporarily blocks an executive order to expand access to federal funds. President Obama's order, made last year, reversed restrictions put in place in 2001 by President Bush, which limited federal funding of embryonic stem cell research to stem cell lines that had already been created. These restrictions were seen as a huge hindrance to the pace of research, forcing scientists who wanted to do cutting edge experiments to seek private funding. Many scientists chose to avoid the field altogether, and those who pursued it often had to create new labs that mirrored existing ones in order to carry out the privately funded research.

According to the New York Times,

The ruling came as a shock to scientists at the National Institutes of Health and at universities across the country, which had viewed the Obama administration's new policy and the grants provided under it as settled law. Scientists scrambled Monday evening to assess the ruling's immediate impact on their work.

"I have had to tell everyone in my lab that when they feed their cells tomorrow morning, they better use media that has not been funded by the federal government," said Dr. George Q. Daley, director of the stem cell transplantation program at Children's Hospital Boston, referring to food given to cells. "This ruling means an immediate disruption of dozens of labs doing this work since the Obama administration made its order."

In his ruling, Chief Judge Royce C. Lamberth of Federal District Court for the District of Columbia wrote that his temporary injunction returned federal policy to the "status quo," but few officials, scientists or lawyers in the case were sure Monday night what that meant.

According to a report in the Boston Globe,

Additionally, the judge ruled that former MIT researcher Dr. James L. Sherley and other scientists who study less controversial adult stem cells would face "actual, imminent injury'' because of the competition for federal dollars that would be stoked by expansion of research into embryonic stem cells.

The lawsuit was brought about by Sherley, now at the Boston Biomedical Research Institute, and Theresa Deisher of AVM Biotechnology, headquartered in Seattle, among others. According to the Boston Globe, the original suit included other plaintiffs, but the court had earlier found that they did not have legal standing to proceed. One of those was Nightlight Christian Adoptions, which supports the adoption of embryos for implantation. Sherley and others argue that "it is immoral for scientists to work with cells derived from embryos because they have to be destroyed to extract stem cells."

Obama's 2009 order did not lift restrictions on research that destroys a human embryo, which Congress prohibited from federal funding in a 1996 law known as the Dickey-Wicker Amendment. (Creating new stem cell lines requires the destruction of embryos.) Judge Lamberth called on this law in the ruling.

According to the Times,

The judge ruled that the Obama administration's policy was illegal because the administration's distinction between work that leads to the destruction of embryos -- which cannot be financed by the federal government under the current policy -- and the financing of work using stem cells created through embryonic destruction was meaningless. In his ruling, he referred to embryonic stem cell research as E.S.C.

"If one step or 'piece of research' of an E.S.C. research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding," wrote Judge Lamberth, who was appointed to the federal bench in 1987 by President Ronald Reagan.

In other words, the neat lines that the government had drawn between the process of embryonic destruction and the results of that destruction are not valid, the judge ruled.

For scientists, the problem with the judge's reasoning is that it may render all scientific work regarding embryonic stem cells illegal -- including work allowed under the more restrictive policy adopted by President George W. Bush in 2001.

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