Federal Judge Overturns Ruling Banning NIH Funding of Human Embryonic Stem Cell Research

Today, District of Columbia District Court Judge Royce Lamberth overturned his own ruling in the case of Sherley v. Sebelius that had banned use of funds from the National Institutes of Health for human embryonic stem cell research.  The ruling is the latest, though by no means final, turn in this saga that has seen scientific arguments devolve into interpretations of dictionary definitions.

In 2009, the case against the NIH was first brought by researchers James Sherley and Theresa Deisher, who claimed that funding of human embryonic stem cell research was illegal based on the Dickey-Wicker amendment, which bans federal funding of “research in which a human embryo or embryos are destroyed.” Judge Lambert initially declared that the plaintiffs, both of whom work on adult stem cells, lacked standing to sue, being unable to demonstrate that the “injury” they would suffer due to funds being granted to projects involving human embryonic stem cells “is actual or imminent and traceable to the challenged action of the defendant, and…that a favorable decision would redress the plaintiff’s injury.”

However, this opinion was overturned on appeal, with the D.C. Circuit Court finding that “the undisputed increased competition that Plaintiffs face…is sufficient in and of itself to confer…standing.”  This ruling lead Judge Lambert to grant a preliminary injunction last August halting federal funding for all research projects involved with human embryonic stem cells, based on the merits of the case itself.

The injunction was stayed while the defendants appealed to the Circuit Court, claiming the so-called “Chevron deference,” in which the court “defer[s] to the agency’s interpretation of the statute if it is reasonable and consistent with the statute’s purpose,” applied to NIH’s interpretation of the Dickey-Wicker amendment. The Circuit Court ultimately agreed with the defendants, overturning the preliminary injunction and sending the case back to the District Court.

Forced to abide by the Circuit Court ruling, the latest ruling found that the NIH “reasonably interpreted the Dickey-Wicker Amendment to permit funding for human embryonic stem cell research because such research is not ‘research in which a human embryo or embryos are destroyed,’”  thereby dismissing the plaintiff’s argument that the Dickey-Wicker amendment unambiguously banned such work.

Judge Lambert approved the defendants’ motion for summary judgment, conversely denying the plaintiffs’ own motion, thereby removing the possibility of a jury trial.  However, the possibility of an appeal from the plaintiffs seems likely. Stay tuned to the Blotter for the latest on the case!

ASBMB Releases Position Statement on Embryonic Stem Cell Research

The American Society for Biochemistry and Molecular Biology this week called for passage of federal legislation to establish a uniform regulatory landscape for the derivation and use of human embryonic stem cells.

Calling existing legislation “ambiguous” and citing and “the constant specter of judicial challenges” that researchers face, the society representing thousands of biomedical researchers insisted that the promises of embryonic stem cell research are in peril and the development of much-needed therapies and cures is being delayed.

The statement said the lack “of a cogent, unified federal policy … has resulted in a discouraging and obstructionist research environment that has dissuaded many scientists from entering the field while driving others to work abroad.”

Benjamin Corb, Director of Public Affairs for the society, emphasized that a recent poll by the advocacy group Research!America showed that almost 70 percent of Americans approve of embryonic stem cellresearch.

Also, he said, there have been two bipartisan congressional efforts in the past decade advancing legislation to boost federal funding for embryonic stem cell research, which paved the way for the Obama administration to issue a 2009 executive order increasing the number of stem cell lines eligible for federal

ASBMB also recommended nullifying what is known as the Dickey-Wicker amendment, saying: “This onerous law, which prohibits federal funding for any research ‘in which a human embryo or embryos are destroyed,’ places ambiguous and unreasonable restrictions on human embryonic stem cell research, stifling progress and delaying the development of cures and treatments.”

To read the full statement from ASBMB, click here.

For more information about ASBMB’s advocacy efforts, contact Corb at bcorb@asbmb.org or 240-283-6625.

Stem Cell Legislation Re-Introduced in Congress

Late last week, Rep. Diana DeGette, D-Colo., and Rep. Charlie Dent, R.-Penn., introduced the Stem Cell Research Advancement Act, the latest congressional attempt to update federal policy governing human embryonic stem cell research. The bill would, according to a press release from Rep. DeGette, “codify the NIH’s guidelines for carrying out all human stem cell research, embryonic and adult,” a position repeatedly advocated for by ASBMB. A key stipulation in the current bill was that “research would have to use leftover embryos that would never be implanted in a woman and would otherwise be discarded,” which Dent praised for “establish[ing] ethical criteria for stem cell research.”

DeGette, with former Representative Michael Castle, R-Del., had previously sponsored similar bills aimed at updating existing stem cell legislation that passed Congress, but were ultimately vetoed by President Bush.  With Castle no longer in Congress, there is hope amongst members of the scientific community that Rep. Dent will now serve as a Republican champion for stem cell research.

The bill was introduced amongst the backdrop of the ever-continuing legal proceedings in the case of Sherley v. Sebelius.  In April, the U.S Appeals court overturned a district court ruling that had halted the use of federal funds for human embryonic stem cell research.  The same day that the Stem Cell Research Advancement Act was being introduced, both the plaintiffs and defendants in the court case filed briefs in the district court, responding to the appeals court ruling.  Though essentially repeating the same arguments that have been made in previous filings, the new briefs at least push the process forward.  Expectations are that the district court may make its decision within the next month.

Contact your members of Congress and urge them to support the Stem Cell Research Advancement Act!

Find your representatives: http://capwiz.com/faseb/dbq/officials/

Embryonic Stem Cell Research Legislation in the News Again

A paper released today in Cell studies the growth of the field of induced pluripotent stem (iPS) cell research and how it has been affected by both political and judicial interventions. Researchers at Stanford analyzed papers published on both human iPS and embryonic stem (hES) cells to see if the advent of iPS cells “had modified the trajectory of stem cell research.”  Their conclusion was a resounding “no”; rather, they found that the majority of studies using iPS cells were done in conjunction with corresponding experiments done using hES cells, indicating that the two cell types were being used as “complementary, interdependent research tools.” The paper also highlighted how “restrictions, regulatory uncertainty and spurious court decisions have undoubtedly retarded progress in the pluripotent stem cell field,” ultimately concluding that “a ban on funding for embryonic stem cell research could have unexpected negative ramifications on the nascent field of” human iPS cell research.

More encouraging news came earlier this week, when Sen. Mark Kirk, R-Ill., hosted a symposium on embryonic stem cell research at Northwestern University.  Praising stem cell research as “the best promise to cure juvenile diabetes and certain blood cancers,” Kirk pledged his support for legislation that would codify the National Institutes of Health Guidelines on Human Stem Cell Research into law.  “If senior Democratic Senators choose not to move this legislation in this Congress, I will,” vowed Kirk, who as a member of the House of Representatives voted in support of both the 2005 and 2007 versions of the Stem Cell Research Enhancement Act that were ultimately vetoed by President Bush.  Rep. Dianna DeGette, D-Colo., who sponsored both of the earlier bills, has not introduced a new version of the bill in the current Congress.

ASBMB has made, and will continue to make, support for legislation that promotes embryonic stem cell research a top priority during visits with congressional legislators.  We will be working with our partners at the Federation of American Societies for Experimental Biology to offer our support to Sen. Kirk in his efforts.

Stem Cell Funding Ban Lifted

In a long-awaited decision, the U.S. Court of Appeals has ruled 2-1 in favor of allowing the National Institutes of Health to continue to fund human embryonic stem cell research.  The decision invalidates the preliminary injunction, issued back in August 2010 in the case of Sherley v. Sebelius, which barred the use of federal funds for any “research in which a human embryo or embryos are destroyed.”  After the injunction was enacted, the Department of Justice appealed, and the Appeals court stayed the ruling in September, allowing the NIH to continue funding hES work while the court contemplated the case.

The majority in the case ruled that the plaintiffs were unable to demonstrate that “they are more likely than not to succeed on the merits of their case,” a key determinant for granting a preliminary injunction.  The main point of contention is the notorious “Dickey-Wicker” amendment, the source of the funding ban, and its definition of the term “research.”  The plaintiffs argued that Congress was unambiguous in deriving the language of the amendment and clearly intended to prohibit any and all research done involving material that was obtained through destruction of a human embryo.  However, the court instead deferred to the NIH’s interpretation of Dickey-Wicker, pointing out that “the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC [Embryonic Stem Cell] from an embryo, it does not prohibit funding a research project in which an ESC will be used.”  In her dissent, Judge Karen Henderson argued that the majority had performed “linguistic jujitsu” in attempting to define the context of “research.”

Unfortunately, the matter is far from settled.  The case now returns to the district court, where Judge Royce Lamberth will rule on the case itself.  Regardless of his decision, more appeals are expected.  ASBMB has previously joined with other organizations to urge Congress to explicitly codify the National Institutes of Health Guidelines on Human Stem Cell Research, in order to prevent legal challenges that would delay this critical line of work.

ASBMB Co-signs Letter Urging Passage of Stem Cell Legislation

On Friday, ASBMB joined with more than 100 other organizations in co-signing a letter sent to congressional leaders, urging them to pass pending legislation that would “authorize and continue Federal support for human embryonic stem cell research.”  The letter calls on Congress “to help ensure the potential of [stem cell] research is translated into treatments and cures” that will “alleviate human suffering and enhance the quality of human life.”

Named the “Stem Cell Research Advancement Act,” the proposed legislation would codify into law the National Institutes of Health Guidelines on Human Stem Cell Research, which were established in 2009.  The guidelines allow researchers to use federal funds, including those from the NIH, to conduct research on embryonic stem cells derived from excess embryos donated from in-vitro fertilization clinics.  Importantly, the act would not obviate the Dickey-Wicker amendment, which bars use of federal funds for destruction of human embryos.  Previous versions of this bill passed Congress in both 2005 and 2007 but ultimately were vetoed by President Bush.

The letter insists on action before the end of the 111^th Congress in December, when staunch champions of stem cell research, including Rep. Mike Castle, D-Del., Rep. David Obey, D-Wisc., and Sen. Arlen Specter, D-Pa., will step down.  Adding to the exigent circumstances is the pending decision in the case of Sherley v. Sebelius, which threatens to permanently end federal funding for human embryonic stem cell research.

Write your representatives and proclaim your support for stem cell research!

Stem Cell Rulings Continue

A series of recent court decisions have begun to clarify the legal situation surrounding the future of human embryonic stem cell (hESC) research, following the Aug. 23 ruling that barred the use of federal funds for research involving hESCs.

Newest Stem Cell Action

The past few weeks have seen a flurry of legal activity in regard to the recent ruling banning federal funding for human embryonic stem cell (hESC) research.

ASBMB Releases Statement Concerning Stem Cell Ruling

The ASBMB has released a statement decrying the recent ruling in Sherley v Sebelius that has halted federal funding for human embryonic stem cell research.  The society has also issued a press release detailing the contents of the statement.

Find the statement here and the press release here.

Update on Stem Cell Ruling

Two more developments have taken place in the past week regarding the preliminary injunction handed down by U.S. District Court for the District of Columbia judge Royce Lamberth in the case of Sherley v. Sebelius that prohibits use of federal funds for use in human embryonic stem cell research.