The judge who halted federal funding for human embryonic stem cell research in August wasn’t budging this week. Not only did he dismiss the Justice Department’s bid to free-up the funding, but he also brushed off arguments submitted by a coalition of patient groups and research institutions, including the universities of Minnesota and Wisconsin.
Government advocates for the research, “are incorrect about much of their ‘parade of horribles’ that will supposedly result from this Court’s preliminary injunction,” U.S. District Judge Royce Lamberth said Tuesday in refusing to temporarily lift his earlier order.
The U of M is one of some 100 organizations — including patient groups, scientific institutions and foundations with investments in medical research — that collectively had filed a brief with the court last week supporting of the Justice Department’s emergency request for the funding to continue until the matter is appealed.
The umbrella group representing those organizations, the Coalition for the Advancement of Medical Research, said in its brief that holding up the funding would cause substantial and irreparable harm to scientists and to millions of patients who stand to benefit from such research.
Disruption of the funding “will halt — and in some cases, permanently impair — research projects that have been in progress for years, wasting millions of dollars invested in such research,” the coalition’s brief said.
In particular, the coalition noted that the National Institutes of Health has invested more than half a billion dollars in the research, a good share of which could be jeopardized by a funding shutoff. And it stressed that the research is on the brink of delivering life-saving treatments for debilitating disorders, beginning with therapy the Food and Drug Administration recently approved for spinal cord injuries.
Bush guidelines v. Obama guidelines
The showdown began in August when Lamberth, of the Federal District Court for the District of Columbia, issued a preliminary injunction saying federal funding for the research must stop immediately for a court-ordered review. (Minnpost’s story about the impact in Minnesota is here.)
The judge based his decision on a measure, called the Dickey-Wicker amendment, which Congress has attached to certain appropriations bills since the mid-1990s. It says, among other things, that federal funding can’t go for research in which human embryos are destroyed or discarded.
In 2001, former president George W. Bush limited federal funding for the research to some 21 lines of stem cells, but he did not shut it off entirely despite Dickey-Wicker. President Obama issued new guidelines last year expanding the funding to about 75 stem-cell lines.
Lamberth’s ruling came in connection with a legal challenge to those Obama guidelines.
This week, Lamberth cleared up some confusion over his original injunction, saying it does not address the Bush guidelines, which allowed funding for research only on stem cell lines that already had been extracted from embryos by 2001. Those guidelines foreclosed “additional destruction of embryos,” he said.
But the coalition advocating the research argued in its brief that taxpayers are not funding the destruction of embryos under the Obama guidelines either.
“This process is always funded privately,” the brief said.
Under both presidents it has been legal for privately-funded labs to extract stem cells from embryos. Once extracted, the cells reproduce almost endlessly when they are nurtured in laboratories. It is those enduring stem cell lines – not the original embryos – which are the focus of the research.
Lamberth also said that previously funded projects are not affected by the order. But most of those projects, even those funded under multi-year grants, must be submitted for annual review and renewal. The judge did not specify what should happen at those reviews.
Up to Congress
Lamberth stressed it was up to Congress to decide the future of the Dickey-Wicker amendment — and, by extension, the funding.
“Congress remains perfectly free to amend or revise the statute,” he said. “This Court is not free to do so.”
But the coalition said in its brief that Congress already has tacitly endorsed the research by approving funding for it in under the Bush and Obama administrations alike.
The next step
The original challenge to the funding was brought by two researchers who work with so-called adult stem cells. That work holds promise too.
But most scientists stress that research is needed on both types of cells and that the embryonic cells remain the gold standard by which experiments with the adult cells can be measured.
The embryonic cells, by their very nature, have the ability to generate any of some 200 different cell types in the human body. That flexibility is quickly lost in the development process whereby some cells veer off to specialize in generating, say, skin while others take on various specialties in the formation and maintenance of bones, blood, etc.
Lamberth noted that the next step in the case may come soon because the plaintiffs — researchers James Sherley and Theresa Deisher — are expected to file a motion on Sept. 10 asking that the case be decided without a trial.