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Federal suit challenges stem cell funding guidelines

WASHINGTON (BP)–The Obama administration’s guidelines for federal funding of stem cell research that results in the destruction of human embryos have been challenged in court, and a lawyer behind the suit says he thinks its “chances are very good.”

The National Institutes of Health’s decision to fund embryonic stem cell research is “unethical, scientifically unnecessary, fiscally irresponsible and counterproductive,” opponents said in their complaint filed Aug. 19 in District of Columbia federal court.

Their suit contends the guidelines violate a 13-year-old congressional ban on funds for research that destroys embryos. It also says the National Institutes of Health (NIH) failed to follow procedures required by law before issuing the guidelines, including in its dismissal of substantial studies that show other stem cells are “ethically and medically superior alternatives.”

According to NIH’s interpretation of the congressional ban, federal funds can be used for embryonic stem cell research as long as the embryos themselves are destroyed using private sector money.

Federal judge Royce Lamberth, who was nominated by President Reagan, has been assigned to the case. The parties filing the lawsuit are hopeful a hearing will be conducted in mid-October to consider their request for a preliminary injunction that would block embryonic stem cell research funding.

The Obama administration has not requested a dismissal of the case, but it “is going to fight us tooth and nail,” said Samuel Casey, a lawyer for the plaintiffs and general counsel of Advocates International’s Law of Life Task Force who expressed optimism about the suit’s chances.

“The humanity of the human embryo is the civil rights movement of the 21st century,” Casey told Baptist Press Aug. 28.

“If we tell the world that the human embryo is not a member of our species, you cannot overestimate the hurt that is going to put on humanity…. If we let the wall down here, we’ll never be able to erect it again,” he said.

Among the plaintiffs in the case are the Christian Medical Association; Nightlight Christian Adoptions (the California-based agency that is known for its “snowflakes” embryo adoption program); two researchers who work with adult stem cells and not embryonic ones; and two sets of parents who have adopted and seek to adopt more embryos.

NIH issued guidelines July 7 in response to President Obama’s March executive order overturning a ban on grants for embryonic stem cell research and his directive for the agency to provide rules for embryonic stem cell research funding within 120 days.

Obama’s order rescinded a policy instituted by President Bush in August 2001. Bush’s rule barred the use of federal funds for stem cell research that results in the destruction of human embryos. Bush permitted, however, grants for experiments on stem cell lines, or colonies, already in existence.

Because of their ability to develop into other cells and tissues, stem cells provide hope for producing cures for a variety of diseases. Though embryonic stem cells have been promoted for their pluripotency, meaning they theoretically can transform into any cell or tissue, extracting them destroys the embryo.

NIH’s new guidelines limit federal funds to research involving embryos produced by in vitro fertilization for reproductive purposes and donated by couples who no longer want them. The couples must provide voluntary, written permission.

The plaintiffs in the suit contend the guidelines violate the 1996 Dickey-Wicker Amendment, a rider to the spending bill for the Department of Health and Human Services. The amendment prohibits federal funds for “(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 amendment, the suit argues, “evinces a clear congressional intent to prohibit federal funding for research that is dependent on harming or destroying human embryos. Because the process by which human embryonic stem cells are extracted from human embryos necessarily destroys the embryos, the Federal Funding Ban expressly prohibits federal funding of human embryonic stem cell research.”

In a written statement when the suit was filed, Thomas Hunger, another lawyer for the plaintiffs, said the “language of the statue is clear. It bans public funding for any research that leads to the destruction of human embryos. NIH’s attempt to avoid Congress’ command by funding everything but the act of ‘harvesting’ is pure sophistry.”

Congress has approved Dickey-Wicker — named after its sponsors, former Republican Reps. Jay Dickey of Arkansas and Roger Wicker of Mississippi — every year since 1996. Most recently, Obama in March signed legislation that includes the amendment into law.

The suit also says NIH failed to take into account the scientific and ethical superiority of research using adult stem cells and induced pluripotent stem (iPS) cells. The success of experimentation with such cells, as well as their harmlessness to donors, makes the funding of destructive embryonic research unnecessary, they contend.

Trials using adult stem cells have produced therapies for at least 73 ailments in human beings, despite the fact such cells are not considered pluripotent, according to Do No Harm, a coalition promoting ethics in research. Among the afflictions treated by adult stem cells are cancer, juvenile diabetes, multiple sclerosis, heart damage, Parkinson’s, sickle cell anemia and spinal cord injuries, according to Do No Harm.

Scientists have discovered iPS cells in the last two years, producing great promise for cures without the ethical problems of embryonic stem cell research. In iPS research, scientists convert adult cells into cells that have nearly the identical properties of embryonic ones.

Embryonic stem cell research has yet to produce therapies in human beings and has been plagued by the development of tumors in lab animals.

The suit also contends NIH transgressed the Administrative Procedure Act by failing “to respond to or even consider comments asking NIH to reconsider its decision to fund” embryonic stem cell research.

NIH received about 49,000 public comments before issuing the guidelines, and about 30,000 opposed federal money for embryonic stem cell research. NIH disregarded comments calling for no ESCR funding, considering them “unresponsive,” according to The Hill newspaper.

“We actually did not ask the public whether we should fund research on human embryonic stem cells. We asked the public how we should fund human embryonic stem cell research,” said Raynard Kington, NIH’s acting director at the time, The Hill reported.

Casey and others filed a similar suit in 2000, when NIH under President Clinton drew up guidelines that would have permitted embryonic stem cell research funding as long as the stem cells were derived — and the embryo destroyed — using private money. The Bush administration blocked the Clinton guidelines the next year, however, leading to Bush’s new policy.

The discovery of iPS cells and the effectiveness demonstrated by adult stem cells has been helpful to the plaintiffs in the new suit.

“The passage of time has made our case better,” Casey said.

If they win in court, the legislative overthrow of Dickey-Wicker will be the “fallback position” of the proponents of embryonic stem cell research funding, Casey told BP.

“And they don’t have the votes to overturn Dickey-Wicker, I don’t think,” Casey said. “If [Speaker of the House Nancy] Pelosi could have done it,” she would have done so, he said.

In addition to being a plaintiff in the case, Nightlight Christian Adoptions also is seeking to be considered in court as guardian ad litem for the embryos who have been created or will be created using IVF but will not be implanted in their mothers’ wombs.
Tom Strode is Washington bureau chief for Baptist Press. For a Q&A about stem cell research, visit www.bpnews.net/bpnews.asp?id=30032.