by E. Christian Brugger, D.Phil., Senior Fellow and Director of the Fellows Program
WASHINGTON, D.C., MAY 25, 2011 (Zenit.org).- You might recall that last summer a federal judge put a temporary hold on all government funding for human embryonic stem cell research (hESC) in the United States.
In August 2010, Judge Royce Lamberth of the U.S. District Court for the District of Columbia made headlines for halting the research on the grounds that President Barack Obama's March 2009 executive order revoking the President George Bush restrictions on hESC research was illegal. The president's order, put into policy by the NIH, freed up money for research upon stem cells derived from spare IVF embryos; but the policy required that the actual destruction of the embryos be funded privately.
The judge said the Obama policy violated the Dickey-Wicker Amendment , which prohibits federal money for research in which human embryos are created or destroyed. You see the point of the dispute? Dickey-Wicker prohibits funding for embryo destructive experimentation; the Obama policy says "no embryo destruction here, it's all been done elsewhere." The wily policy attempts to make an end run around the clear meaning of the congressional amendment. Judge Lamberth unsuccessfully went for the tackle. He issued a preliminary injunction, which dried up NIH funding for a whopping 17 days before his injunction was temporarily halted by a court of appeals on a request by the Obama Justice Department.
On April 29, 2011, Judge Lamberth's preliminary injunction was formally revoked by a 2-1 decision of the U.S. Court of Appeals for the District of Columbia Circuit. The Court ruled that the injunction if implemented would impose unreasonable burdens upon hESC researchers. Since the injunction had already been temporarily halted, the practical effect of the appeal court's decision is nill. It simply makes permanent what was only temporary.
Both Lamberth's injunction and the appeals court's ruling have occurred in the backdrop of the case, Sherley v. Sebelius, brought by two researchers, James Sherley, formerly of MIT, and Theresa Deisher, founder of AVM Biotechnology, challenging the legality of the Obama policy on the grounds that it violates Dickey-Wicker.
Sherley v. Sebelius is still pending. An unbiased court would plainly rule in favor of the plaintiffs. As Wesley Smith notes in his recent First Things blog : "The Dickey-Wicker Amendment … reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed. This prohibition encompasses all "research in which" an embryo is destroyed, not just the "piece of research" in which the embryo is destroyed."
But when it comes to issues related to human embryos unbiased courts in the U.S. are hard to find.
Whichever way the court goes, we can be sure the decision will be appealed. In the meantime, the Obama order to fund embryo-destructive research is alive and well.
Meanwhile, the California biotech company Geron Corporation announced on May 11 it had begun clinical treatments on its second spinal cord injury patient using human embryonic stem cells (hESCs). The patient, recently paralyzed from the chest down in a car accident, received an injection of stem cells at Northwestern Memorial Hospital in Chicago.
The Geron cocktail was derived from "surplus" IVFembryos donated for research by the parental donors. The cells were manipulated to produce early nerve cells (called "oligodendrocyte progenitor cells") that Geron hopes will not be subject to the same tumor-forming tendencies as undifferentiated hESCs.
The trial is not aimed at curing the patient, but rather at determining whether the stem cell treatment is safe.
The first patient treated with hESCs in the United States, 21-year-old Tim Atchison, was injected only six months ago. Doctors say it's still too early to judge the effects of the treatment. David Prentice of the Family Research Council explains that because the patient was injected within the first two weeks after his accident, as required by the Geron protocol, we may never know with certitude whether the treatment was effective, even if improvements occur: "a significant number of such patients show some spontaneous improvement within the first year after injury."
Discouraged about the old USA? Perhaps a better day is dawning for embryos in Europe. On March 10 , the European Court of Justice issued a preliminary opinion that procedures established using human embryonic stem cell lines are not patentable. The decision by Judge Yves Bot of the European Court followed upon a request for clarification by the German Supreme Court of the legal definition of human embryos in relation to patentability.
The request was precipitated by a German court case challenging the patent of a technique to generate nerve cells from established hESC lines. The case was filed by -- get ready for this -- the Amsterdam based activist organization, Greenpeace, which argued that patenting procedures derived from embryonic stem cell lines was unethical because the lines are derived from human embryos.
Judge Bot's preliminary opinion will now go before the 13 judges of the court's Grand Chamber. If the Grand Chamber agrees with the opinion, it could put a wrench in the works of European hESC research. Dare we hope?
In August 2010, Judge Royce Lamberth of the U.S. District Court for the District of Columbia made headlines for halting the research on the grounds that President Barack Obama's March 2009 executive order revoking the President George Bush restrictions on hESC research was illegal. The president's order, put into policy by the NIH, freed up money for research upon stem cells derived from spare IVF embryos; but the policy required that the actual destruction of the embryos be funded privately.
The judge said the Obama policy violated the Dickey-Wicker Amendment , which prohibits federal money for research in which human embryos are created or destroyed. You see the point of the dispute? Dickey-Wicker prohibits funding for embryo destructive experimentation; the Obama policy says "no embryo destruction here, it's all been done elsewhere." The wily policy attempts to make an end run around the clear meaning of the congressional amendment. Judge Lamberth unsuccessfully went for the tackle. He issued a preliminary injunction, which dried up NIH funding for a whopping 17 days before his injunction was temporarily halted by a court of appeals on a request by the Obama Justice Department.
On April 29, 2011, Judge Lamberth's preliminary injunction was formally revoked by a 2-1 decision of the U.S. Court of Appeals for the District of Columbia Circuit. The Court ruled that the injunction if implemented would impose unreasonable burdens upon hESC researchers. Since the injunction had already been temporarily halted, the practical effect of the appeal court's decision is nill. It simply makes permanent what was only temporary.
Both Lamberth's injunction and the appeals court's ruling have occurred in the backdrop of the case, Sherley v. Sebelius, brought by two researchers, James Sherley, formerly of MIT, and Theresa Deisher, founder of AVM Biotechnology, challenging the legality of the Obama policy on the grounds that it violates Dickey-Wicker.
Sherley v. Sebelius is still pending. An unbiased court would plainly rule in favor of the plaintiffs. As Wesley Smith notes in his recent First Things blog : "The Dickey-Wicker Amendment … reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed. This prohibition encompasses all "research in which" an embryo is destroyed, not just the "piece of research" in which the embryo is destroyed."
But when it comes to issues related to human embryos unbiased courts in the U.S. are hard to find.
Whichever way the court goes, we can be sure the decision will be appealed. In the meantime, the Obama order to fund embryo-destructive research is alive and well.
Meanwhile, the California biotech company Geron Corporation announced on May 11 it had begun clinical treatments on its second spinal cord injury patient using human embryonic stem cells (hESCs). The patient, recently paralyzed from the chest down in a car accident, received an injection of stem cells at Northwestern Memorial Hospital in Chicago.
The Geron cocktail was derived from "surplus" IVFembryos donated for research by the parental donors. The cells were manipulated to produce early nerve cells (called "oligodendrocyte progenitor cells") that Geron hopes will not be subject to the same tumor-forming tendencies as undifferentiated hESCs.
The trial is not aimed at curing the patient, but rather at determining whether the stem cell treatment is safe.
The first patient treated with hESCs in the United States, 21-year-old Tim Atchison, was injected only six months ago. Doctors say it's still too early to judge the effects of the treatment. David Prentice of the Family Research Council explains that because the patient was injected within the first two weeks after his accident, as required by the Geron protocol, we may never know with certitude whether the treatment was effective, even if improvements occur: "a significant number of such patients show some spontaneous improvement within the first year after injury."
Discouraged about the old USA? Perhaps a better day is dawning for embryos in Europe. On March 10 , the European Court of Justice issued a preliminary opinion that procedures established using human embryonic stem cell lines are not patentable. The decision by Judge Yves Bot of the European Court followed upon a request for clarification by the German Supreme Court of the legal definition of human embryos in relation to patentability.
The request was precipitated by a German court case challenging the patent of a technique to generate nerve cells from established hESC lines. The case was filed by -- get ready for this -- the Amsterdam based activist organization, Greenpeace, which argued that patenting procedures derived from embryonic stem cell lines was unethical because the lines are derived from human embryos.
Judge Bot's preliminary opinion will now go before the 13 judges of the court's Grand Chamber. If the Grand Chamber agrees with the opinion, it could put a wrench in the works of European hESC research. Dare we hope?
