Embryonic stem cell funding suit is dead
September 2011
by Stephen Jenei  |  Email the author
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The Sherley v. Sebelius lawsuit challenging U.S. funding for human embryonic stem cell (hESC) studies was dismissed by a federal judge after an appeals court found the government-backed research is probably lawful.
 
U.S. District Judge Royce Lamberth, chief of the federal court in Washington, last year said the lawsuit was likely to succeed and ordered a stop to the research while the case was pending. But the injunction was yanked by the U.S. Circuit Court of Appeals, which thought the case was likely to fail.
 
The original suit was brought by two doctors who wanted to block the U.S. Health and Human Services Department (HHS) and the National Institutes of Health (NIH) from spending federal dollars on research involving human embryonic stem cells. The plaintiffs in this case, Dr. Sherley and Dr. Deisher, are scientists who conduct research using only adult stem cells. Judge Lamberth last year temporarily stopped the government from funding the research, finding it probably violated the so-called Dickey-Wicker Amendment by funding hESC research projects.  
 
The law bars government spending on research that damages or destroys a human embryo. Now, the U.S. Court of Appeals for the District of Columbia has overruled, in a 2-1 decision, the preliminary injunction on federal funding of research using hESCs. The Dickey-Wicker Amendment is an appropriations rider that bars the NIH from funding (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.  
 
The court’s analysis turned on the ambiguity of the Dickey-Wicker Amendment due to a lack of definition for the word “research.” The court determined that the present tense of the amendment, with no reference to embryos that “were destroyed,” implied that the amendment did not ban hESC research on stem cell lines in existence at the time of the amendment’s enactment.
 
Judge Ginsburg also pointed out that Congress has continued to leave the Dickey-Wicker Amendment unchanged every year since 1996, even though Congress has had “full knowledge” that HHS has been funding hESC research since 2001.
 
In a related move, U.S. Rep. Diana DeGette, D-Colo., and Rep. Charlie Dent, R-Pa., have reintroduced legislation to support hESC research. The representatives are co-sponsoring the Stem Cell Research Advancement Act of 2011, H.R. 2376.  
 
The bill would give legislative enforcement to the president’s 2009 decree allowing federal funding for medical research performed on abandoned embryos from fertility clinics. The bill would allow support research that utilizes human stem cells, including human embryonic stem cells, if:  
 
(1)  The stem cells were derived from human embryos that have been donated from in-vitro fertilization clinics, were created for the purposes of reproductive treatment and were in excess of the clinical need of the individuals seeking such treatment.

(2) Embryos to be donated would never be implanted in a woman and would otherwise be discarded.
 
(3) The individuals seeking reproductive treatment donated the embryos with written informed consent and without receiving any financial or other inducements to make the donation.  
 
Critics of the bill cite religious and moral reasons for their opposition, contending that the research will destroy possible embryos to harvest the stem cells. Rep. Doug Lamborn, a Colorado Springs Republican, has been among those opposed to hESC on the grounds that it's unethical and immoral to use human embryos for scientific research.  
 
Backers of the bill point out that the bill provides a basis for protecting the NIH’s ability to continue to support important scientific work that gives hope to millions of patients and their families. Currently, companies support research in Central and South America where there are fewer restrictions on stem cell research. Stem cell cures could produce billions of dollars of revenue for the companies that develop these cures and bring them to market, making federal support for stem-cell research in the United States crucial to maintaining the nation's competitive edge.  
 
Urge your representative and senators to pass the Stem Cell Research Advancement Act this year. The United States needs to continue to invest in hESC research, and a legislative solution is necessary to ensure that federal funding for this important research is no longer vulnerable to political or ideological challenge.  
 
Stephen Jenei is a patent attorney at Frost Brown Todd LLC, serving up chat at PatentBaristas.com. Feel free to write him with comments or questions at stephen@patentbaristas.com.


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