WASHINGTON, D.C.—The national debate over federal funding for embryonic stem cell (eSC) projects continues to play out in courts and research circles, with arguments in the controversial Sherley, et. al., v. Sebelius, et al. case expected to occur this month.
The case, being heard by the U.S. District Court for the District of Columbia, alleges that an order signed last year by President Barack Obama which lifted a ban on federal funding for eSC research violates the Dickey-Wicker Amendment, a law that prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes, or for research in which human embryos are destroyed. The suit's lead plaintiffs, adult stem cell researchers Dr. James L. Sherley, a biological engineer at Boston Biomedical Research Institute, and Dr. Theresa Deisher, research and development director at AVM Biotechnology LLC in Seattle, also argue that Obama's order has intensified competition for the limited government dollars, making it more difficult for them to get funding for their own work.
In August, the court, finding merits in the plaintiff's filings, issued a preliminary injunction that brought federal funding for embryo-destructive research to a halt. However, on Sept. 28, the U.S. Court of Appeals temporarily suspended the injunction while the case is still pending.
Sherley and Deisher asked the court to reinstate the ban, reasserting the basic claims in their lawsuit. On Nov. 4, attorneys for the United States government filed a brief in the appellate court, refuting the plaintiff's claims and asking the court to vacate the preliminary injunction "because it is based on legal error and an erroneous assessment of injuries." In addition, the defendants argue that the National Institute of Health's (NIH) interpretation of Dickey-Wicker "is longstanding and has been repeatedly ratified by Congress." The brief also contents that Sherley and Deisher failed to demonstrate the irreparable harm necessary to support a preliminary injunction.
"Dr. Deisher has never applied for an NIH grant, and four of Dr. Sherley's recent applications for NIH funding were not scored in the peer review process—meaning that they did not pass the first level of scientific peer review and thus were not given further consideration for funding," the brief notes. "Dr. Sherley's applications were therefore not funded because of lack of scientific merit, not because of any alleged competition from human embryonic stem cell projects."
As the research community awaits a decision on the injunction and the case itself, many advocates of eSC research are rallying to support continued government funding for their projects. The University of California, for example, filed an amicus curiae brief arguing that the plaintiffs lack legal standing because NIH awards grants to institutions, not individual scientists.
Other briefs have sided with the plaintiffs: another "friend of the court" brief, filed by Maureen Condic, an adult stem cell researcher at the University of Utah School of Medicine, affirms that destruction of human embryos for research purposes is an integral part of human embryonic stem cell research, not merely a separate preparatory step, as attorneys for the government have argued.
As the debate and court action continue, the Obama administration on Nov. 22 approved a second trial involving the use of eSCs on patients with Stargardt disease, a rare eye disease that can lead to blindness. The trial is being conducted by Advanced Cell Technology, a cloning and stem cell research firm.
The government is apparently taking advantage of the injunction suspension, as in August, the U.S. Food and Drug Administration (FDA) approved a request from Geron Corp. to test healthy scavenger cells created in a laboratory from eSC derivatives in patients with spinal cord injuries. These cells are oligodendrocyte progenitors, not made from embryonic stem cells.
The case, being heard by the U.S. District Court for the District of Columbia, alleges that an order signed last year by President Barack Obama which lifted a ban on federal funding for eSC research violates the Dickey-Wicker Amendment, a law that prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes, or for research in which human embryos are destroyed. The suit's lead plaintiffs, adult stem cell researchers Dr. James L. Sherley, a biological engineer at Boston Biomedical Research Institute, and Dr. Theresa Deisher, research and development director at AVM Biotechnology LLC in Seattle, also argue that Obama's order has intensified competition for the limited government dollars, making it more difficult for them to get funding for their own work.
In August, the court, finding merits in the plaintiff's filings, issued a preliminary injunction that brought federal funding for embryo-destructive research to a halt. However, on Sept. 28, the U.S. Court of Appeals temporarily suspended the injunction while the case is still pending.
Sherley and Deisher asked the court to reinstate the ban, reasserting the basic claims in their lawsuit. On Nov. 4, attorneys for the United States government filed a brief in the appellate court, refuting the plaintiff's claims and asking the court to vacate the preliminary injunction "because it is based on legal error and an erroneous assessment of injuries." In addition, the defendants argue that the National Institute of Health's (NIH) interpretation of Dickey-Wicker "is longstanding and has been repeatedly ratified by Congress." The brief also contents that Sherley and Deisher failed to demonstrate the irreparable harm necessary to support a preliminary injunction.
"Dr. Deisher has never applied for an NIH grant, and four of Dr. Sherley's recent applications for NIH funding were not scored in the peer review process—meaning that they did not pass the first level of scientific peer review and thus were not given further consideration for funding," the brief notes. "Dr. Sherley's applications were therefore not funded because of lack of scientific merit, not because of any alleged competition from human embryonic stem cell projects."
As the research community awaits a decision on the injunction and the case itself, many advocates of eSC research are rallying to support continued government funding for their projects. The University of California, for example, filed an amicus curiae brief arguing that the plaintiffs lack legal standing because NIH awards grants to institutions, not individual scientists.
Other briefs have sided with the plaintiffs: another "friend of the court" brief, filed by Maureen Condic, an adult stem cell researcher at the University of Utah School of Medicine, affirms that destruction of human embryos for research purposes is an integral part of human embryonic stem cell research, not merely a separate preparatory step, as attorneys for the government have argued.
As the debate and court action continue, the Obama administration on Nov. 22 approved a second trial involving the use of eSCs on patients with Stargardt disease, a rare eye disease that can lead to blindness. The trial is being conducted by Advanced Cell Technology, a cloning and stem cell research firm.
The government is apparently taking advantage of the injunction suspension, as in August, the U.S. Food and Drug Administration (FDA) approved a request from Geron Corp. to test healthy scavenger cells created in a laboratory from eSC derivatives in patients with spinal cord injuries. These cells are oligodendrocyte progenitors, not made from embryonic stem cells.
Q&A's with the stem cell plaintiffs
We have two question-and-answer interviews with Dr. James L. Sherley and Dr. Theresa Deisher on our blog, allowing you to get a better sense of why they oppose the lifting of the ban on federal funding for eSC research.
Q&A with both Sherley and Deisher (click here)
