The Sherley v. Sebelius lawsuitchallenging U.S. funding for human embryonic stem cell (hESC) studies wasdismissed by a federal judge after an appeals court found the government-backedresearch is probably lawful.
U.S. District Judge Royce Lamberth, chief of the federalcourt in Washington, last year said the lawsuit was likely to succeed andordered a stop to the research while the case was pending. But the injunctionwas yanked by the U.S. Circuit Court of Appeals, which thought the case waslikely to fail.
The original suit was brought by two doctors who wanted toblock the U.S. Health and Human Services Department (HHS) and the NationalInstitutes of Health (NIH) from spending federal dollars on research involvinghuman embryonic stem cells. The plaintiffs in this case, Dr. Sherley and Dr.Deisher, are scientists who conduct research using only adult stem cells. JudgeLamberth last year temporarily stopped the government from funding theresearch, finding it probably violated the so-called Dickey-Wicker Amendment byfunding hESC research projects.
The law bars government spending on research that damagesor destroys a human embryo. Now, the U.S. Court of Appeals for the District ofColumbia has overruled, in a 2-1 decision, the preliminary injunction onfederal funding of research using hESCs.
The Dickey-Wicker Amendment is an appropriations rider thatbars the NIH from funding (1) the creation of a human embryo or embryos forresearch purposes; or (2) research in which a human embryo or embryos aredestroyed, discarded or knowingly subjected to risk of injury or death greaterthan that allowed for research on fetuses inutero.
The court's analysis turned on the ambiguity of theDickey-Wicker Amendment due to a lack of definition for the word "research."The court determined that the present tense of the amendment, with no referenceto embryos that "were destroyed," implied that the amendment did not ban hESCresearch on stem cell lines in existence at the time of the amendment'senactment.
Judge Ginsburg also pointed out that Congress hascontinued to leave the Dickey-Wicker Amendment unchanged every year since 1996,even though Congress has had "full knowledge" that HHS has been funding hESCresearch since 2001.
In a related move, U.S. Rep. Diana DeGette, D-Colo., andRep. Charlie Dent, R-Pa., have reintroduced legislation to support hESCresearch. The representatives are co-sponsoring the Stem Cell ResearchAdvancement Act of 2011, H.R. 2376.
The bill would give legislative enforcement to thepresident's 2009 decree allowing federal funding for medical research performedon abandoned embryos from fertility clinics. The bill would allow supportresearch that utilizes human stem cells, including human embryonic stem cells,if:
(1) Thestem cells were derived from human embryos that have been donated from in-vitro fertilization clinics, werecreated for the purposes of reproductive treatment and were in excess of theclinical need of the individuals seeking such treatment.
(2)Embryos to be donated would never be implanted in a woman and would otherwisebe discarded.
(3) Theindividuals seeking reproductive treatment donated the embryos with writteninformed consent and without receiving any financial or other inducements tomake the donation.
Critics of the bill cite religious and moral reasons fortheir opposition, contending that the research will destroy possible embryos toharvest the stem cells. Rep. Doug Lamborn, a Colorado Springs Republican, hasbeen among those opposed to hESC on the grounds that it's unethical and immoralto use human embryos for scientific research.
Backers of the bill point out that the bill provides abasis for protecting the NIH's ability to continue to support important scientificwork that gives hope to millions of patients and their families. Currently,companies support research in Central and South America where there are fewerrestrictions on stem cell research. Stem cell cures could produce billions ofdollars of revenue for the companies that develop these cures and bring them tomarket, making federal support for stem-cell research in the United States crucialto maintaining the nation's competitive edge.
Urge your representative and senators to pass the StemCell Research Advancement Act this year. The United States needs to continue toinvest in hESC research, and a legislative solution is necessary to ensure thatfederal funding for this important research is no longer vulnerable topolitical or ideological challenge.
Stephen Jenei is apatent attorney at Frost Brown Todd LLC, serving up chat at PatentBaristas.com.Feel free to write him with comments or questions atstephen@patentbaristas.com.
