USA : Embryonic stem cell research

Appeals court lifts ban on stem cell funding

September 9, 2010

An appeals court Thursday lifted a temporary injunction barring the federal government from funding research involving human embryonic stem cell research.
A three-judge panel of the U.S. Circuit Court of Appeals for the District of Columbia granted a request from the Justice Department to stay an injunction issued Aug. 23 blocking the funding. In a major victory for supporters of the research, the court said the Obama administration could resume funding the research pending a full appeal of the case.
U.S. District Judge Royce C. Lamberth, ruling in a lawsuit filed by two researchers working on alternatives to the cells, said the funding violated a federal rule that prohibits federal tax money from being used for research that involves the destruction of human embryos.
Here's an excerpt from Thursday's order:
O R D E R
Upon consideration of the emergency motion for stay pending appeal and for
immediate administrative stay, it is
ORDERED that the district court's August 23, 2010 order be stayed pending
further order of the court. The purpose of this administrative stay is to give the court
sufficient opportunity to consider the merits of the emergency motion for stay and
should not be construed in any way as a ruling on the merits of that motion. See D.C.
Circuit Handbook of Practice and Internal Procedures 33 (2010). It is
FURTHER ORDERED that appellees file a response to the emergency motion
by September 14, 2010, at 4:00 p.m. The appellants may file a reply by 4:00 p.m. on
September 20, 2010. The parties are directed to hand-deliver the paper copies of their
submissions to the court by the time and date due.
The original decision was hailed by opponents of the research, who argue it is immoral to destroy human embryos. But it was condemned by supporters and advocates for patients, who said it was a major setback for one of the most promising areas of biomedical research.
In response to the order, the National Institutes of Health announced it was suspending consideration of any new grants for such research. Any researchers who had already received funding could continue their work, but their grants would not be renewed when they come up for routine review, the NIH said. As a result, hundreds of scientists around the country are scrambling to try to figure out how they are going to continue their research.
The Justice Department asked that the injunction be lifted as it appeals the decision, arguing the halt to the funding was causing irreparable harm to researchers, the federal government and patients hoping for cures.
Thursday's decision was hailed by supporters of the research.
"We are very pleased that the Court of Appeals has stayed the preliminary injunction. It is crucial that federal funding for human embryonic stem cell research be restored permanently and this stay is a step in that direction," said Lisa Hughes, president of the Coalition for the Advancement of Medical Research, a coalition of patient advocacy groups, scientists and research organizations that has lobbied for the funding. "While this issue continues to be argued in the courts, we call on Congress to move swiftly to resolve this issue and secure the future of this important biomedical research."

By Rob Stein | September 9, 2010

http://voices.washingtonpost.com/checkup/2010/09/appeals_courts_lifts_ban_on_st.html?wpisrc=nl_natlalert
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Federal judge denies motion to lift stem cell funding block

September 7, 2010

http://voices.washingtonpost.com/checkup/2010/09/federal_judge_denies_motion_to.html
A federal judge Tuesday denied a motion to lift an injunction he issued two weeks ago barring the government from funding research involving human embryonic stem cells.
U.S. Chief District Judge Royce C. Lamberth of the District of Columbia rejected a request by the Obama administration to lift the temporary injunction he issued pending an appeal of the decision.
But Lamberth indicated that his injunction was less restrictive than had been originally interpreted by the Obama administration.
"Defendants are incorrect about much of their 'parade of horribles' that will supposedly result from this Court's preliminary injunction," Lamberth wrote. The ruling did not necessarily apply to research that had been funded under guidelines issued during the administration of President Bush or that had previously been "awarded and funded," Lamberth wrote. He also indicated he could make a final decision on the case soon.
Nevertheless, the decision marks a disappointment for supporters of the research, who had hoped the judge would grant the motion, allowing funding to continue under new, much less restrictive guidelines that the Obama administration had put in place until the case is finally decided.
Lamberth issued the injunction Aug. 23 in a case brought by two researchers who work on alternatives to the cells. Lamberth ruled the funding violated a federal law known as the Dickey-Wicker amendement, which bars federal tax money to be used for any research involving the destruction of human embryos.
"In this Court's view, a stay would flout the will of Congress, as this Court understands what Congress has enacted in the Dickey-Wicker Amendment," Lamberth wrote in Tuesday's ruling. "Congress has mandated that the public interest is served by preventing taxpayer funding of research that entails the destruction of human embryos."
The original decision was hailed by opponents of the research, who argue it is immoral to destroy human embryos. But it was condemned by supporters and advocates for patients, who said it was a major setback for one of the most promising areas of biomedical research.
In response to the order, the National Institutes of Health announced it was suspending consideration of any new grants for such research. Any researchers who had already received funding could continue their work, but their grants would not be renewed when they come up for routine review, the NIH said. As a result, hundreds of scientists around the country are scrambling to try to figure out how they are going to continue their research.
The Justice Department asked that the injunction be lifted as it appeals the decision, arguing the halt to the funding was causing irreparable harm to researchers, the federal government and patients hoping for cures.
Lisa Hughes, president of the Coalition for the Advancement of Medical Research, the group that has led lobbying efforts to for greater stem cell funding, issued the following statement:
"We are disappointed with today's Order to deny NIH's Emergency MotionTo Stay Preliminary Injunction Pending Appeal issued by Judge Lamberth. CAMR's primary goal is to permanently restore embryonic stem cell research freedom as it existed before August 23, 2010. We look forward to NIH's guidance on how best to interpret today's order."
The NIH referred questions to the Justice Department.The Justice Department is expected to appeal the decision, but a spokesman late Tuesday said the government was still reviewing it.

By Rob Stein |

http://voices.washingtonpost.com/checkup/2010/09/federal_judge_denies_motion_to.html

NIH cannot fund embryonic stem cell research, judge rules

By Rob Stein and Spencer S. Hsu
Washington Post Staff Writer
Tuesday, August 24, 2010
A federal judge on Monday blocked the Obama administration from funding human embryonic stem cell research, ruling that the support violates a federal law barring the use of taxpayer money for experiments that destroy human embryos
U.S. District Judge Royce C. Lamberth issued a preliminary injunction that prohibits the National Institutes of Health from funding the research under the administration's new guidelines, citing an appeals court's ruling that the researchers who had challenged the less-restrictive policy have the legal standing to pursue their lawsuit.
The decision, a setback for one of the administration's most high-profile scientific policies, was praised by opponents of the research.
"We are encouraged that the court has recognized the seriousness of the ethics and the funding of embryonic stem cell research," said David Prentice, senior fellow for life sciences at the Family Research Council.
The ruling stunned scientists and other advocates of the research, which has been hailed as one of the most important advances in medicine in decades because of its potential to cure many diseases but has been embroiled in controversy because the cells are obtained by destroying days-old embryos.
"This is devastating, absolutely devastating," said Amy Comstock Rick, immediate past president of the Coalition for the Advancement of Medical Research, a group of patient organizations that has been lobbying for more federal funding.
"We were really looking forward to research finally moving forward with the full backing of the NIH. We were really looking forward to the next chapter when human embryonic stem cells could really be explored for their full potential. This really sets us back," Rick said. "Every day we lose is another day lost for patients waiting for cures."
Tracy Schmaler, a Justice Department spokeswoman, did not discuss how the administration intends to respond to the ruling, saying only that "we're reviewing the decision." The NIH had no immediate comment.
Steven Aden, a lawyer with the Alliance Defense Fund who filed the suit, said the court will need to clarify whether the injunction affects work using money already issued to researchers under the administration's new guidelines or blocks additional funding.
In his 15-page decision, Lamberth cited "unambiguous" legislation by Congress in 1996, called the Dickey-Wicker Amendment, which prohibits federal funding for "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."
In 1999, Harriet S. Rabb, a lawyer for the Department of Health and Human Services, concluded that the NIH's support of embryonic stem cell research did not violate the amendment if the funds were used only for experiments involving the cells -- not to procure them. The cells themselves are not embryos, she said.
Said Sean Tipton of the American Society for Reproductive Medicine: "NIH carefully designed polices to allow federally funded scientists to explore the potential of human embryonic stem cell research without violating Dickey-Wicker. The NIH policies on stem cell research make it clear that federal funds can be used to investigate cells and tissues created from human embryonic stem cells, but not to create them."
"The language of the statute reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed," he wrote. "This prohibition encompasses all 'research in which' an embryo is destroyed, not just the 'piece of research' in which the embryo is destroyed," as the Justice Department argued.
On Aug. 9, 2001, President George W. Bush limited federal funding to 21 colonies of existing human embryonic stem cells to prevent taxpayer money from funding the destruction of more embryos to obtain additional cells. Critics of the research praised Bush's move, saying that destroying embryos to advance academic study is immoral and that alternative approaches, such as using stem cells derived from adults, were equally if not more promising.
But many scientists condemned the restrictions, saying they were hindering research that could lead to cures for Alzheimer's disease, diabetes, paralysis and other ailments. Embryonic stem cells, which can morph into many different types of tissue, are able to do things that other cells cannot, proponents argued. No new therapies, however, have been developed.
Soon after taking office, President Obama announced that he was lifting his predecessor's restrictions and ordered the NIH to develop new guidelines addressing the ethical issues involved. Last summer, the NIH issued detailed guidelines and began authorizing new colonies of cells eligible for funding. Seventy-five colonies have been approved so far.
Monday's ruling was in response to a lawsuit filed by James L. Sherley and Theresa Deisher, researchers who study other types of human stem cells. The pair argued that the new administration's guidelines would "result in increased competition for limited federal funding," hindering their plans to seek money for other research.
Lamberth initially threw out the case, but the U.S. Court of Appeals for the D.C. Circuit ruled June 25 that the researchers had legal standing to bring a suit. Several other plaintiffs were dropped, including the Christian Medical Association, Nightlight Christian Adoptions and two couples seeking to "adopt" unused embryos. The original suit also contended that the policy would limit the number of embryos available to people seeking them.
Lamberth's injunction does not prevent the government from taking the case to trial. However, the judge wrote that the claim was strong enough to bar federal authorities from "taking any action whatsoever" to implement funding guidelines pending trial.
"The Court finds that the likelihood of success on the merits, irreparable harm to plaintiffs, the balance of hardships, and public interest considerations each weigh in favor of a preliminary injunction," he wrote.
http://www.washingtonpost.com/wp-dyn/content/article/2010/08/23/AR2010082303448.html

Courtesy : Washington post