If at first you don’t succeed …

Plaintiffs in Sherley stem cell case appeal dismissal

Amy Swinderman
WASHINGTON, D.C.—After a federal judge on July 27 dismissedtheir legal battle to end government funding for human embryonic stem cellresearch (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—adultstem cell researchers James Sherley and Theresa Deisher—filed a notice ofappeal in the U.S. District Court for the District of Columbia.
 
 
According to Samuel Casey, managing director and generalcounsel for the Law of Life Project—the firm representing theplaintiffs—dispositive motions are due in early November, after which abriefing schedule will be set. Arguments in the case are expected to be heardsometime around March 2012, Casey tells ddn.
 
 
Ultimately, the controversial case and the question ofwhether the government should provide funding for hESC research may find itsfate 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, butambiguity has been created by a government agency to get around Congress,"alleges Casey.
 
 
The case calls into question the language of theDickey-Wicker Amendment, a measure signed into law in 1995 by former PresidentBill Clinton that prohibited the U.S. Department of Health and Human Services(HHS) and the U.S. National Institutes of Health (NIH) from using appropriatedfunds for the creation of human embryos for research purposes, or for researchin which human embryos are destroyed. The amendment was actually a riderattached to an unrelated appropriations bill passed by the U.S. Congress.  
 
During his presidency, President George W. Bush issued anexecutive order providing for the government support of "research on theisolation, derivation, production and testing of stem cells … derived withoutcreating a human embryo for research purposes or destroying, discarding orsubjecting to harm a human embryo or fetus." As a result, faced with fewerdollars for their expensive research projects, many scientists put theirresearch projects on the shelf.
 
 
Shortly after taking office in 2009, President Barack Obamaissued an order of his own that was intended to reverse Bush's policy. Theorder was quickly followed by new NIH guidelines for hESC research and a publiccomment period. Sherley, a biological engineer at Boston Biomedical ResearchInstitute, and Deisher, research and development director at AVM BiotechnologyLLC 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 ontheir scientific understanding of reality. We submitted these comments to theNIH, saying they ought to rethink it. But far from rethinking it, they saidthey didn't have any obligation to look at the comments—and they threw them inthe trash," alleges Casey.
 
 
That is when Casey's firm, the Law of Life Project—whichsays it is "dedicated to legally defending the right to life and dignity of thehuman being from biological conception until natural death in all mattersworldwide where such a defense is required"—asked Sherley and Deisher "if theywanted to seek a court review of what the NIH had done—and they did," saysCasey. Sherley and Deisher also claimed that the Obama order increasedcompetition for funding for adult stem cell research projects.
 
"Since the Obama administration came on board and lifted theinjunction on this research, we are now up to 136 approved hESC lines underObama," says Casey. "What we have said all along in this case is that thegovernment is providing an incentive for more embryo destruction—and that can'thave been Congress' intention. The law is clearly being violated, and theincentives this law was designed to prevent have been abdicated completely—andU.S. taxpayers are funding research that is unlawful. That is a shame."
 
 
A lawsuit was filed in 2009, seeking to enjoin the NIH's newguidelines, and a long court volley ensued. In October 2009, Judge Royce C.Lamberth granted the government's motion to dismiss on the ground that theplaintiffs lacked standing.
 
However, in June 2010, the D.C. circuit court reversed thisdecision, finding that the plaintiffs had alleged sufficient competitiveinjury, and granted a preliminary injunction against federal hESC funding. TheNIH appealed this injunction, and just a few weeks later, the Court of Appealsissued a stay while the appeal was pending.
 
 
 As 2010 came to a close, the court heard oral arguments, andin April 2011, the court completely reversed Lamberth's ruling, saying it wouldimpose a substantial hardship on stem cell researchers who have multi-year projectsalready underway. The court's 2-1 decision also found that the funding of hESCresearch is permissible under Dickey-Wicker, as Congress has renewed theamendment every year with the knowledge that it funds such research.
 
 
On July 27, the court dismissed the suit altogether, findingthat after applying the legal analysis of the appeals court's decision, thestatutory language was ambiguous and the NIH's interpretation was reasonable.
 
"This court, following the D.C. Circuit's reasoning andconclusions, must find that defendants reasonably interpreted the Dickey-WickerAmendment to permit funding for human embryonic stem cell research because suchresearch is not 'research in which a human embryo or embryos are destroyed,'"Lamberth wrote in his ruling.
 
"The NIH reasonably concluded that the Dickey-WickerAmendment prohibited federal funding for research projects 'in which' humanembryos are knowingly subjected to risk, such as pre-implantation geneticdiagnosis, but did not prohibit research projects, such as embryonic stem cellresearch, that do not involve embryos and so cannot knowingly subject them torisk 'in' the research," Lamberth wrote in his decision.  
 
 
Should the plaintiffs in this case exhaust their judicialremedies, a legislative clarification of Dickey-Wicker may be needed—and thoseon both sides of this issue have come out in favor of that.
 
 
But "Congress has been asked to change Dickey-Wicker sixtimes and hasn't," Casey notes. "No one wants to mess with Dickey-Wickerbecause to mess with it is to mess with an appropriations bill. We have morepro-life votes in the House right now than we have ever had, and the Housewould pass and amendment to Dickey-Wicker now without question. The onlyquestion would be what the Senate would do. I suspect the House–which controlsappropriations—will freight it in a bill with a lot of other language in it. Idon't the Senate would fall on the sword of hESC research when the fate of thecountry is involved."
 
 
As for the science behind hESC research itself, althoughthose in favor of it claim it holds the promise for potential cures ortreatments 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. "Itexists to find human therapies. There may be some important basic researchbreakthroughs, but those can be handled without taxpayer money. This has beenthe biggest, most expensive, most wasteful scientific funding football of thelast decade. I am sorry that the courts and judges in this case have found thatthis is not clear."
 
 

 
Europe's top courtbans hESC technique patents
 
 
LUXEMBOURG—On Oct. 18, the European Court of Justice—Europe'stop court—ruled that any process involving the removal of a stem cell from ahuman embryo before the embryo is destroyed cannot be patented, a judgmentexpected to have far-reaching implications for the controversial field of humanembryonic stem cell (hESC) research.
The court ruled that the use of human embryos for therapeuticor diagnostic purposes that are applied to the human embryo and are useful toit is patentable, but their use for purposes of scientific research is notpatentable.
 
 
In its ruling, the court noted that it is not called upon toanswer questions of a medical or ethical nature, and its opinion is restrictedto a legal interpretation of Directive 98/44/EC of the European Parliament andof the Council of July 1998, which concerns the legal protection ofbiotechnological inventions.
 
The decision is the latest development in a German courtcase in which Greenpeace claimed a patent for the creation of nerve cellsgenerated from hESCs violated public order on morality. Scientist Oliver Bruestlechallenged this ruling, and the German court was forced to seek direction fromthe European Court of Justice.
 
In its ruling, the European court found that the context andaim of the Directive show that the European Union legislature intended to excludeany possibility of patentability where respect for human dignity could therebybe affected. It follows, in the view of the Court, that the concept of 'humanembryo' must be understood in a wide sense. Accordingly, the Court considersthat any human ovum must, as soon as fertilized, be regarded as a 'humanembryo' if that fertilization is such as to commence the process of developmentof a human being."
 
 
The court further concluded that "scientific researchentailing the use of human embryos cannot access the protection of patent law.Nevertheless, the Court points out that the patentability of uses of humanembryos for industrial or commercial purposes is not prohibited under theDirective where it concerns the use for therapeutic or diagnostic purposes whichare applied to the human embryo and which are useful to it—for example tocorrect a malformation and improve the chances of life."
 
Following the news, Bruestle said the ruling is "anunbelievable setback for biomedical research in the area of stem cells," and heexpects "huge repercussions globally," as hESC research can take place inEurope, but implementation of it will not be approved by European regulators.
 
Speaking to ddn aboutthe latest court filings in the controversial U.S. stem call case Sherley v. Sebelius, Samuel Casey, anattorney for the plaintiffs, says he encouraged by the European court's ruling.
 
"It sounds to me like they recognize the Protection ofMorals Under the European Convention for the Protection of Human Rights andFundamental 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 innatedignity and right to life of all human beings is acknowledged in practice andprotected 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 treatedhuman embryos like human beings. Human embryos are just 'stuff.' Our law firmstands against that. They are not just 'stuff.' They are you and I when we werethat age. It is a violation of civil rights and the international covenant ofhuman rights to treat humans in this fashion, much less impose the cost ofdoing so on taxpayers."

Amy Swinderman

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