Long court battle over stem cell research continues

Three-judge panel hears oral arguments in Sherley case

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WASHINGTON, D.C.—On April 23, attorneys for the parties inthe Sherley v. Sebelius stem cellresearch lawsuit appeared before the U.S. Court of Appeals for the District ofColumbia Circuit to offer oral arguments in the controversial ongoing legalbattle over whether the federal government should fund human embryonic stemcell (hESC) research projects.
 
 
Much of the case questions the language of the Dickey-WickerAmendment, a measure signed into law in 1995 by former President Bill Clintonthat prohibited the U.S. Department of Health and Human Services and the U.S.National Institutes of Health (NIH) from using appropriated funds for thecreation of human embryos for research purposes, or for research in which humanembryos are destroyed.
 
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." The order—and the resulting lackof funding—placed many stem cell research 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.
 
 
The plaintiffs filed a lawsuit shortly thereafter, seekingto enjoin the NIH's new guidelines, and a long court volley ensued.
 After a federal judge in July dismissed their legal battleto end government funding for hESC research, the plaintiffs in September fileda notice of appeal in the U.S. District Court for the District of Columbia. Thebroad coalition of plaintiffs includes Dr. James L. Sherley, a scientist at theBoston Biomedical Research Institute, and Dr. Theresa Deisher, the founder,managing member and research and development director of AVM Biotechnology inSeattle.
 
In the oral argument hearing, attorneys for both sidesappeared before Chief Judge David B. Sentelle and Circuit Court judges Karen L.Henderson and Janice Rogers Brown. Brian J. Watson, attorney for theplaintiffs, argued that the NIH's guidelines are invalid for three reasons:"First, by admittedly disregarding 30,000 comments addressing the scientificand ethical merits of human embryonic stem cell research, NIH blatantlyviolated the Administrative Procedure Act (APA) by ignoring important issues infailing to use an adequate notice and comment process. Second, NIH's guidelinesviolate Dickey-Wicker's prohibition on funding research in which a human embryois knowingly subjected to risk of injury or death, which is an issue that wasnot before this court in Sherley II. And finally, NIH's guidelines violateDickey-Wicker's prohibition on funding research in which a human embryo isdestroyed."
 
 
When questioned by the judges about whether the law of thecase is binding, Watson responded in part, "The case doctrine is relevant toone out of the three claims that we're making here, which is the first prong ofDickey-Wicker. But, even with respect to that claim, we believe that the law ofthe case does not bind us penal at this stage of the case."
Watson further argued, "It's arbitrary to decide which typesof scientific research to fund without considering the scientific worthiness,and the president cannot simply sign an executive order that grants the APA acoupon good for one APA violation."
 
 
Beth S. Brinkmann, attorney for the appellees, countered,"We urge the court to affirm the judgment below on both points. This court'searlier opinion provided an authoritative construction of the statutoryquestion here, a question of pure law, and plaintiffs have not presentedanything new to challenge the reasoning of that opinion." 
 
She continued, "Also, as the court has already pointed out,this has been the consistent interpretation of this statute over threepresidential administrations. It's the agency's interpretation, and it's alsosupported by the history against, the backdrop against which this provision wasenacted, the type of research on embryos that the rider was intended toprohibit funding of. And as we pointed out before, this type of research isresearch that uses cells as a research tool and differentiates them fordifferent types of 16 research projects that are looking forward. That's whatNIH is looking at when they get the application for the funding. They'relooking at that research, what they will be funding going forward."
 
 
In his rebuttal, Watson responded, "First, there's nothinginconsistent with establishing categorical eligibility criteria upfront as towhich types of research are eligible for funding and then using a case-by-caseprocess to apply those criteria and to prioritize particular research grants.Second, NIH cannot credibly dispute that here … NIH cannot now switch gears andargue that it has to resolve everything through peer review. Also … to theextent that the government tries to tie that point in with the executive order,they're citing just a boilerplate phrase in the executive order that says thatit does not affect pre-existing statutory authority. That doesn't prove theirpoint in any way."
 
 
The appeals court is not expected to rule on the case forseveral months. Attorneys for the plaintiffs have indicated they are willing totake the case all the way to the Supreme Court.
 
 
 


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