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Stem cell debate plays out in court
WASHINGTON, D.C.— Little more than a year after President Barack Obama issued an executive order reversing former President George W. Bush's policy limiting federal funding of embryonic stem cell (eSC) research, a federal lawsuit challenging Obama's order resulted in the temporary blocking of federal funding for the controversial research method.
On Aug. 23, 2010, the U.S. District Court for the District of Columbia issued a preliminary injunction in the case, finding that there is sufficient evidence to warrant halting funding for embryo-destructive research while the case is under consideration.
But less than a month later on Sept. 28, the U.S. Court of Appeals temporarily suspended the injunction, arguing that it would cause irreparable harm to researchers, taxpayers and scientific progress while the case is appealed.
As the case makes its way through the courts, the scientific community is dissecting the impact that these events may have on its ability to obtain funding for research using eSCs— which have greater differentiation potential than most adult stem cells—and which many scientists argue hold greater promise for finding ways to treat or cure devastating diseases like Parkinson's disease, spinal cord injuries or genetic conditions.
In 2001, President Bush established a policy allowing research on eSC lines created prior to Aug. 9, 2001. Federal funding remained available, however, for research on eSCs that were created by private researchers prior to his policy statement.
On March 9, 2009, President Obama issued an executive order overturning the Bush policy and allowing taxpayer funding for research on embryonic stem cell lines created after 2001. The order, the president said, was intended to expand the National Institute of Health's (NIH) support for human stem cell research and "to enhance the contribution of America's scientists to important new discoveries and new therapies for the benefit of humankind."
But the lawsuit, Dr. James L. Sherley, et al., v. Kathleen Sebelius, et al., alleges that Obama's order—and the ensuing new guidelines issued by the NIH—violate the Dickey-Wicker Amendment, legislation signed into law by President Bill Clinton in 1995 which prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes, or for research in which human embryos are destroyed.
Of chief concern to the plaintiffs was the government's interpretation of the word "research" as it appears in Dickey-Wicker. The government argued that it could be interpreted to mean "a piece of research," defining the research and the derivation of eSCs from embryos as separate and distinct "pieces of research." Using this interpretation, the government argued, the NIH could support research on human eSCs, as long as federal funding did not support the initial derivation of the stem cell lines from human embryos.
Chief Judge Royce C. Lamberth rejected that argument, finding that Dickey-Wicker "unambiguously prohibits the use of federal funds for all research in which a human embryo is destroyed."
"Simply because eSC research involves multiple steps does not mean that each step is a separate 'piece of research' that may be federally funded, 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 project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment."
The lead plaintiffs in the case, Dr. James L. Sherley, a biological engineer at Boston Biomedical Research Institute, and Dr. Theresa Deisher, research and development director at AVM Biotechnology LLC in Seattle, also argued that the order intensified competition for the NIH's limited grant dollars, making it more difficult for them to get government funding for their own work.
Lamberth agreed, ruling, "The guidelines, by allowing federal funding of eSC research, increase competition for NIH's limited resources. This increased competition for limited funds is an actual, imminent injury."
Deisher, who works exclusively with adult stem cells, founded AVM Biotechnology "in response to growing concerns about the need for safe, 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 by the preferential emphasis and funding of embryonic stem cell research," she says. "Most egregiously, U.S. citizens are being denied adult stem cell therapies that are in development in Europe and other countries for heart attack, blindness, paralysis, stroke, diabetes, multiple sclerosis, lupus and other grievous human illness."
Sherley, whose laboratory focuses on developing methods for production of adult stem cells, discovering biomarkers that can be used to quantify adult stem cells and elucidating cellular mechanisms that are important for adult stem cell function, health and longevity, says eSC research "continues to be misrepresented by many of its proponents, who misstate its potential for providing medical advances and present it as if there were no alternatives—when if fact, both adult stem cell research and traditional disease research are not only effective alternatives, but better ones, in many respects."
"In particular, adult stem cell research addresses the development of new therapies based on repairing tissues or replacing tissues with regenerative cells," Sherley says. "It is important that the public understands that proposed treatments based on human embryonic stem cells invariably require that they be converted into either adult cells or adult stem cells, which are ultimately required for any therapy that will repair, replace or 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 President Obama's order, and met for the first time in September, when they lobbied against eSC research with members of Congress.
On Sept. 28, the appeals court permanently stayed the injunction imposed on by Lamberth, finding that the government had "satisfied the standards required for a stay pending appeal." Reaction to the Lamberth's decision, however, was swift and strong in the weeks before the temporary ban was halted.
NIH Director Dr. Francis S. Collins issued a statement saying in part: "The injunction threatens to stop progress in one of the most encouraging areas of biomedical research, just as scientists are gaining momentum —and squander the investment we have already made. We must move forward—without delay—to sustain this field of research that provides so much hope for thousands of patients and their families."
Academic institutions like the University of California say they remain "optimistic that the court will recognize our significant interests in the litigation."
"The University of California believes it is imperative that the scientific community be permitted to move forward with embryonic stem cell research that provides hope to millions of patients and their families," the university said in a statement.
Actor Michael J. Fox, who advocates for advances in Parkinson's disease research with the Michael J. Fox Foundation, said in a commentary, "As a person with Parkinson's, it's hugely frustrating to think that one decision can actively hold back research that holds promise to transform lives. We'll … be standing with Parkinson's patients, their loved ones and the majority of Americans who want us to move beyond political agendas and advance the promise of stem cell research."
At press time, Sherley and Deisher were due to file a brief in the appeals court by Oct. 28. The government will reply by Nov. 4.
While the appeal unfolds, the main case is going forward in district court. Arguing that the case can be resolved based on undisputed facts, both sides have moved for summary judgment. The government's reply to those motions was due Oct. 28.
"President Obama made expansion of stem cell research and the pursuit of groundbreaking treatments and cures a top priority when he took office," White House Press Secretary Robert Gibbs said in a statement. "We're heartened that the court will allow NIH and their grantees to continue moving forward while the appeal is resolved."
Meanwhile, lawmakers in the Senate and House of Representatives are proposing legislation to either repeal Dickey or authorize federal funding of eSC research. Sen. Arlen Specter, D-Pa., introduced S. 3766, to authorize federal funding of eSC research. Rep. Diane DeGette introduced H.R. 4808, a similar bill that contains language stating that the government "shall conduct and support research that utilizes human stem cells, including human embryonic stem cells."
According to some political analysts, the outcome of these proposals may depend to some degree on the outcome of November elections, should a certain number of pro-life Republicans be elected.