WASHINGTON, D.C.— Little more than a year after PresidentBarack Obama issued an executive order reversing former President George W.Bush's policy limiting federal funding of embryonic stem cell (eSC) research, afederal lawsuit challenging Obama's order resulted in the temporary blocking offederal funding for the controversial research method.
On Aug. 23, 2010, the U.S. District Court for the Districtof Columbia issued a preliminary injunction in the case, finding that there issufficient evidence to warrant halting funding for embryo-destructive researchwhile the case is under consideration.
But less than a month later on Sept. 28, the U.S. Court ofAppeals temporarily suspended the injunction, arguing that it would causeirreparable harm to researchers, taxpayers and scientific progress while thecase is appealed.
As the case makes its way through the courts, the scientificcommunity is dissecting the impact that these events may have on its ability toobtain funding for research using eSCs— which have greater differentiationpotential than most adult stem cells—and which many scientists argue holdgreater promise for finding ways to treat or cure devastating diseases likeParkinson's disease, spinal cord injuries or genetic conditions.
In 2001, President Bush established a policy allowingresearch on eSC lines created prior to Aug. 9, 2001. Federal funding remainedavailable, however, for research on eSCs that were created by privateresearchers prior to his policy statement.
On March 9, 2009, President Obama issued an executive orderoverturning the Bush policy and allowing taxpayer funding for research onembryonic stem cell lines created after 2001. The order, the president said,was intended to expand the National Institute of Health's (NIH) support forhuman stem cell research and "to enhance the contribution of America'sscientists to important new discoveries and new therapies for the benefit ofhumankind."
But the lawsuit, Dr. James L. Sherley, et al., v.Kathleen Sebelius, et al., alleges thatObama's order—and the ensuing new guidelines issued by the NIH—violate theDickey-Wicker Amendment, legislation signed into law by President Bill Clintonin 1995 which prohibits the Department of Health and Human Services (HHS) fromusing appropriated funds for the creation of human embryos for researchpurposes, or for research in which human embryos are destroyed.
Of chief concern to the plaintiffs was the government'sinterpretation of the word "research" as it appears in Dickey-Wicker. Thegovernment argued that it could be interpreted to mean "a piece of research,"defining the research and the derivation of eSCs from embryos as separate anddistinct "pieces of research." Using this interpretation, the governmentargued, the NIH could support research on human eSCs, as long as federalfunding did not support the initial derivation of the stem cell lines from humanembryos.
Chief Judge Royce C. Lamberth rejected that argument,finding that Dickey-Wicker "unambiguously prohibits the use of federal fundsfor all research in which a human embryo is destroyed."
"Simply because eSC research involves multiple steps doesnot mean that each step is a separate 'piece of research' that may be federallyfunded, provided the step does not result in the destruction of an embryo,"Lamberth ruled. "If one step or 'piece of research' of an eSC research projectresults in the destruction of an embryo, the entire project is precluded fromreceiving federal funding by the Dickey-Wicker Amendment."
The lead plaintiffs in the case, Dr. James L. Sherley, abiological engineer at Boston Biomedical Research Institute, and Dr. TheresaDeisher, research and development director at AVM Biotechnology LLC in Seattle,also argued that the order intensified competition for the NIH's limited grantdollars, making it more difficult for them to get government funding for theirown work.
Lamberth agreed, ruling, "The guidelines, by allowingfederal funding of eSC research, increase competition for NIH's limitedresources. This increased competition for limited funds is an actual, imminentinjury."
Deisher, who works exclusively with adult stem cells,founded AVM Biotechnology "in response to growing concerns about the need forsafe, effective, affordable and ethical medicines and therapeutic treatments,"with help from private donors. According to Deisher, the 2009 executive order"amplified Congressional obsession with funding embryonic stem cell research.
"Every adult stem cell scientist and clinician is injured bythe preferential emphasis and funding of embryonic stem cell research," shesays. "Most egregiously, U.S. citizens are being denied adult stem celltherapies that are in development in Europe and other countries for heartattack, blindness, paralysis, stroke, diabetes, multiple sclerosis, lupus andother grievous human illness."
Sherley, whose laboratory focuses on developing methods forproduction of adult stem cells, discovering biomarkers that can be used toquantify adult stem cells and elucidating cellular mechanisms that areimportant for adult stem cell function, health and longevity, says eSC research"continues to be misrepresented by many of its proponents, who misstate itspotential for providing medical advances and present it as if there were noalternatives—when if fact, both adult stem cell research and traditionaldisease research are not only effective alternatives, but better ones, in manyrespects."
"In particular, adult stem cell research addresses thedevelopment of new therapies based on repairing tissues or replacing tissueswith regenerative cells," Sherley says. "It is important that the publicunderstands that proposed treatments based on human embryonic stem cellsinvariably require that they be converted into either adult cells or adult stemcells, which are ultimately required for any therapy that will repair, replaceor treat tissues in children and adults."
Sherley and Deisher admit they have never worked together.According to The Wall Street Journal,the researchers were recruited by attorneys who wanted to challenge PresidentObama's order, and met for the first time in September, when they lobbiedagainst eSC research with members of Congress.
On Sept. 28, the appeals court permanently stayed theinjunction imposed on by Lamberth, finding that the government had "satisfiedthe standards required for a stay pending appeal." Reaction to the Lamberth'sdecision, however, was swift and strong in the weeks before the temporary banwas halted.
NIH Director Dr. Francis S. Collins issued a statementsaying in part: "The injunction threatens to stop progress in one of the mostencouraging areas of biomedical research, just as scientists are gainingmomentum—and squander the investment we have already made. We must moveforward—without delay—to sustain this field of research that provides so muchhope for thousands of patients and their families."
Academic institutions like the University of California saythey remain "optimistic that the court will recognize our significant interestsin the litigation."
"The University of California believes it is imperative thatthe scientific community be permitted to move forward with embryonic stem cellresearch that provides hope to millions of patients and their families," theuniversity said in a statement.
Actor Michael J. Fox, who advocates for advances inParkinson's disease research with the Michael J. Fox Foundation, said in acommentary, "As a person with Parkinson's, it's hugely frustrating to thinkthat one decision can actively hold back research that holds promise totransform lives. We'll … be standing with Parkinson's patients, their lovedones and the majority of Americans who want us to move beyond political agendasand advance the promise of stem cell research."
At press time, Sherley and Deisher were due to file a briefin the appeals court by Oct. 28. The government will reply by Nov. 4.
While the appeal unfolds, the main case is going forward indistrict court. Arguing that the case can be resolved based on undisputedfacts, both sides have moved for summary judgment. The government's reply tothose motions was due Oct. 28.
"President Obama made expansion of stem cell research andthe pursuit of groundbreaking treatments and cures a top priority when he tookoffice," White House Press Secretary Robert Gibbs said in a statement. "We'reheartened that the court will allow NIH and their grantees to continue movingforward while the appeal is resolved."
Meanwhile, lawmakers in the Senate and House ofRepresentatives are proposing legislation to either repeal Dickey or authorizefederal funding of eSC research. Sen. Arlen Specter, D-Pa., introduced S. 3766,to authorize federal funding of eSC research. Rep. Diane DeGette introducedH.R. 4808, a similar bill that contains language stating that the government"shall conduct and support research that utilizes human stem cells, includinghuman embryonic stem cells."
According to some political analysts, the outcomeof these proposals may depend to some degree on the outcome of Novemberelections, should a certain number of pro-life Republicans be elected.
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