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If at first you don’t succeed …
November 2011
by Amy Swinderman  |  Email the author


WASHINGTON, D.C.—After a federal judge on July 27 dismissed their legal battle to end government funding for human embryonic stem cell research (hESC), the plaintiffs in the much-watched case of Sherley, et al., v. Sebelius, et al., are appealing the decision. On Sept. 19, attorneys for the plaintiffs in the case—adult stem cell researchers James Sherley and Theresa Deisher—filed a notice of appeal in the U.S. District Court for the District of Columbia.  
According to Samuel Casey, managing director and general counsel for the Law of Life Project—the firm representing the plaintiffs—dispositive motions are due in early November, after which a briefing schedule will be set. Arguments in the case are expected to be heard sometime around March 2012, Casey tells ddn.  
Ultimately, the controversial case and the question of whether the government should provide funding for hESC research may find its fate in the hands of the U.S. Supreme Court, according to many legal analysts.  
"This is a case where the will of Congress is clear, but ambiguity has been created by a government agency to get around Congress," alleges Casey.  
The case calls into question the language of the Dickey-Wicker Amendment, a measure signed into law in 1995 by former President Bill Clinton that prohibited the U.S. Department of Health and Human Services (HHS) and the U.S. National Institutes of Health (NIH) from using appropriated funds for the creation of human embryos for research purposes, or for research in which human embryos are destroyed. The amendment was actually a rider attached to an unrelated appropriations bill passed by the U.S. Congress. 
During his presidency, President George W. Bush issued an executive order providing for the government support of "research on the isolation, derivation, production and testing of stem cells … derived without creating a human embryo for research purposes or destroying, discarding or subjecting to harm a human embryo or fetus." As a result, faced with fewer dollars for their expensive research projects, many scientists put their research projects on the shelf.  
Shortly after taking office in 2009, President Barack Obama issued an order of his own that was intended to reverse Bush's policy. The order was quickly followed by new NIH guidelines for hESC research and a public comment period. Sherley, a biological engineer at Boston Biomedical Research Institute, and Deisher, research and development director at AVM Biotechnology LLC in Seattle, both submitted comments to the NIH—along with 40,000 others, according to Casey.
"Our comments were composed by these two people based on their scientific understanding of reality. We submitted these comments to the NIH, saying they ought to rethink it. But far from rethinking it, they said they didn't have any obligation to look at the comments—and they threw them in the trash," alleges Casey.  
That is when Casey's firm, the Law of Life Project—which says it is "dedicated to legally defending the right to life and dignity of the human being from biological conception until natural death in all matters worldwide where such a defense is required"—asked Sherley and Deisher "if they wanted to seek a court review of what the NIH had done—and they did," says Casey. Sherley and Deisher also claimed that the Obama order increased competition for funding for adult stem cell research projects.
"Since the Obama administration came on board and lifted the injunction on this research, we are now up to 136 approved hESC lines under Obama," says Casey. "What we have said all along in this case is that the government is providing an incentive for more embryo destruction—and that can't have been Congress' intention. The law is clearly being violated, and the incentives this law was designed to prevent have been abdicated completely—and U.S. taxpayers are funding research that is unlawful. That is a shame. "  
A lawsuit was filed in 2009, seeking to enjoin the NIH's new guidelines, and a long court volley ensued. In October 2009, Judge Royce C. Lamberth granted the government's motion to dismiss on the ground that the plaintiffs lacked standing.   However, in June 2010, the D.C. circuit court reversed this decision, finding that the plaintiffs had alleged sufficient competitive injury, and granted a preliminary injunction against federal hESC funding. The NIH appealed this injunction, and just a few weeks later, the Court of Appeals issued a stay while the appeal was pending.  
 As 2010 came to a close, the court heard oral arguments, and in April 2011, the court completely reversed Lamberth's ruling, saying it would impose a substantial hardship on stem cell researchers who have multi-year projects already underway. The court's 2-1 decision also found that the funding of hESC research is permissible under Dickey-Wicker, as Congress has renewed the amendment every year with the knowledge that it funds such research.  
On July 27, the court dismissed the suit altogether, finding that after applying the legal analysis of the appeals court's decision, the statutory language was ambiguous and the NIH's interpretation was reasonable.
"This court, following the D.C. Circuit's reasoning and conclusions, must find that defendants 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,'" Lamberth wrote in his ruling.   "The NIH reasonably concluded that the Dickey-Wicker Amendment prohibited federal funding for research projects 'in which' human embryos are knowingly subjected to risk, such as pre-implantation genetic diagnosis, but did not prohibit research projects, such as embryonic stem cell research, that do not involve embryos and so cannot knowingly subject them to risk 'in' the research," Lamberth wrote in his decision.    
Should the plaintiffs in this case exhaust their judicial remedies, a legislative clarification of Dickey-Wicker may be needed—and those on both sides of this issue have come out in favor of that.  
But "Congress has been asked to change Dickey-Wicker six times and hasn't," Casey notes. "No one wants to mess with Dickey-Wicker because to mess with it is to mess with an appropriations bill. We have more pro-life votes in the House right now than we have ever had, and the House would pass and amendment to Dickey-Wicker now without question. The only question would be what the Senate would do. I suspect the House–which controls appropriations—will freight it in a bill with a lot of other language in it. I don't the Senate would fall on the sword of hESC research when the fate of the country is involved."  
As for the science behind hESC research itself, although those in favor of it claim it holds the promise for potential cures or treatments for difficult-to-treat conditions and diseases, Casey argues that "America has the responsibility to chase therapies where they really are."  
"The NIH is not in the basic research game," he says. "It exists to find human therapies. There may be some important basic research breakthroughs, but those can be handled without taxpayer money. This has been the biggest, most expensive, most wasteful scientific funding football of the last decade. I am sorry that the courts and judges in this case have found that this is not clear."  

Europe's top court bans hESC technique patents  
LUXEMBOURG—On Oct. 18, the European Court of Justice—Europe's top court—ruled that any process involving the removal of a stem cell from a human embryo before the embryo is destroyed cannot be patented, a judgment expected to have far-reaching implications for the controversial field of human embryonic stem cell (hESC) research. The court ruled that the use of human embryos for therapeutic or diagnostic purposes that are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable.  
In its ruling, the court noted that it is not called upon to answer questions of a medical or ethical nature, and its opinion is restricted to a legal interpretation of Directive 98/44/EC of the European Parliament and of the Council of July 1998, which concerns the legal protection of biotechnological inventions.
The decision is the latest development in a German court case in which Greenpeace claimed a patent for the creation of nerve cells generated from hESCs violated public order on morality. Scientist Oliver Bruestle challenged this ruling, and the German court was forced to seek direction from the European Court of Justice.
In its ruling, the European court found that the context and aim of the Directive show that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could thereby be affected. It follows, in the view of the Court, that the concept of 'human embryo' must be understood in a wide sense. Accordingly, the Court considers that any human ovum must, as soon as fertilized, be regarded as a 'human embryo' if that fertilization is such as to commence the process of development of a human being."  
The court further concluded that "scientific research entailing the use of human embryos cannot access the protection of patent law. Nevertheless, the Court points out that the patentability of uses of human embryos for industrial or commercial purposes is not prohibited under the Directive where it concerns the use for therapeutic or diagnostic purposes which are applied to the human embryo and which are useful to it—for example to correct a malformation and improve the chances of life."
Following the news, Bruestle said the ruling is "an unbelievable setback for biomedical research in the area of stem cells," and he expects "huge repercussions globally," as hESC research can take place in Europe, but implementation of it will not be approved by European regulators.   Speaking to ddn about the latest court filings in the controversial U.S. stem call case Sherley v. Sebelius, Samuel Casey, an attorney for the plaintiffs, says he encouraged by the European court's ruling.
"It sounds to me like they recognize the Protection of Morals Under the European Convention for the Protection of Human Rights and Fundamental Freedoms, which is what they are supposed to enforce," says Casey, who serves as managing director and general counsel for the Law of Life Project, a public interest legal organization that envisions "a world where the innate dignity and right to life of all human beings is acknowledged in practice and protected in law."  
"They see the human embryo as a human being," Casey says. "We have always known that we can't patent human beings. But we haven't treated human embryos like human beings. Human embryos are just 'stuff.' Our law firm stands against that. They are not just 'stuff.' They are you and I when we were that age. It is a violation of civil rights and the international covenant of human rights to treat humans in this fashion, much less impose the cost of doing so on taxpayers."
Code: E111103



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