August 25, 2010

USA: All stem cell funding in jeopardy, NIH says

WASHINGTON, DC / The Washington Post / Technology / Policies / August 25, 2010

NIH cannot fund embryonic stem cell research, judge rules

By Rob Stein and Spencer S. Hsu
Washington Post Staff Writer

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."

Lamberth rejected that distinction.

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.

Earlier report
With U.S. stem cell treatments limited, patients try other countries

By Ariana Eunjung Cha
Sunday, June 6, 2010

Disillusioned by U.S. doctors who could not help their daughter with cerebral palsy, Kara Anderson's parents did something they could not have imagined a few years ago: They took her to China.

Specialists in the Chicago area, where the family lives, said that Kara's brain injury was permanent and that the 9-year-old would probably end up in a wheelchair because of severe twisting in her leg muscles. But then her parents heard stories about children who had improved after receiving injections of stem cells.

The treatment was not available in the United States. It was only commercially available abroad.

That's how the Andersons joined the desperate people who are taking leaps of faith in seeking stem cell treatments in places as far away as China, India, Russia and Brazil.

Treating Kara with stem cells:  Experimental stem cell treatments offered in China are luring American patients such as 9-year-old Kara Anderson, whose parents took her around the world to help treat her cerebral palsy.

Western scientists worry that patients are being taken in by slick marketing campaigns, wasting time, money and hope on unproven therapies, and perhaps even putting themselves in danger.

"Unregulated therapy in the absence of any evidence that these cells are going to help patients is reckless. The potential to do harm is enormous," said Arnold Kreigstein, a neurologist who is director of stem cell research at the University of California at San Francisco.

Scientists hope various kinds of stem cells can eventually be used to treat devastating and common ailments: heart attack, stroke, Parkinson's disease, diabetes, liver failure, even blindness. For now, there is scant evidence for the benefits of treatments such as the ones the Andersons sought.

Most of the stem cells used in Chinese clinics are obtained from fetuses from miscarriages. They thus fall somewhere between embryonic stem cells, which come from early-stage embryos -- raising ethical and religious questions about their use -- and adult stem cells, which are easier to obtain and are considered safer and less controversial.

They are widely considered to be less versatile than embryonic stem cells, which can develop into almost every kind of cell in the body, but more so than adult stem cells, which are useful only to treat the tissues or organs from which they came.

Fetal stem cells also have a downside: They can trigger immune-rejection responses or lead inadvertently to new or increased pain. They also have a tendency to clump together; one patient who sought treatments in Russia developed multiple brain tumors after undergoing experimental therapy with fetal stem cells, scientists reported in the journal PLoS Medicine.

Stem cell research is an area in which the United States faces new rivals -- and ones willing to move quickly from experimental research to treatment. A January report by the National Science Board warned that the U.S. position as the world's innovation leader is declining and China's influence is increasing. The report said that is the result of a surge in government investment in science and technology education, infrastructure and research.

In the United States, the use of federal funding for new lines of embryonic stem cells was banned in George W. Bush's administration. President Obama reversed that decision when he took office, but China and other countries have had a years-long head start.

Treatments using embryonic or fetal stem cells are in the experimental stage in the United States and are not approved for commercial use by the Food and Drug Administration. But they remain in a regulatory gray area in China, neither sanctioned nor banned.

The government allows 50 or so stem cell clinics to operate freely. Several Chinese health officials have expressed concern about the lack of oversight. Scholars affiliated with the government say they expect some regulations to be introduced soon.

The one trial of fetal-derived stem cells that has been started in the United States has been limited to a few patients, and none using embryonic stem cells has begun. In China, thousands have undergone treatment with embryonic, fetal, adult and cells taken from a newborn's umbilical-cord blood, Chinese scientists say. But evidence that treatment is working is merely anecdotal.

"People flock to the words 'stem cells' because they rightly feel that the potential is enormous. I'm right there with them, but there's a misalignment of progress in the scientific and medical communities with the public perception of the power of stem cells," said Hans Keirstead of the University of California at Irvine, who specializes in research on embryonic stem cells and spinal cord injury.

Variety of approaches

Stem cell treatment in China is both a government-sponsored and a commercial enterprise, with wildly varying methodologies, facilities and prices.

Chinese doctors consider the Wu Stem Cells Medical Center, where Kara was treated, among the country's premier facilities for central nervous system illnesses. Located across from an amusement park in Beijing and inside a traditional Chinese medicine hospital, it charges $30,000 for a five-week treatment.

Cheng Bo, deputy director of the center, said doctors there offer potential patients realistic assessments of the risks and benefits. "We tell them it's impossible to cure patients completely," he said. "Our goal is to improve the quality of their life or to extend their life." Many patients -- about a third are children -- come from developed countries where medical treatment is in general considered superior to China's, although they may lag behind China in stem cell research.

'It was unbelievable'

Kara managed the improbable after the first two of four stem cell shots in January. She began limping around on a crutch and walking up to 15 minutes on a treadmill with the support of a rail, according to her parents and doctors. She could lift pebbles with her left hand and raise it over her head, which she could never do before.

Her father, Brian Anderson, who learned about the treatment from a relative who suggested he do research on the Internet, said recently Kara has retained these abilities since her treatment in December. He said he is also noticing improvement in her eyesight. "We really weren't sure what to expect, but she got better and better every day. It was unbelievable," said Anderson, 41, a construction contractor, who funded the trip and treatment with money pooled from relatives, friend and their church.

Doctors said the timing of Kara's improvement may have been coincidental: Cerebral palsy symptoms periodically get better or worse for unknown reasons, but stories such as hers disseminated on the Internet are attracting thousands of patients.

In the United States, a trial involving infusions of embryonic stem cells for patients with spinal cord injury was delayed from January until August to address safety concerns raised by the FDA. Keirstead, whose work is the basis for that trial and in 2005 made headlines for getting injured rodents to walk again, said he is eager to see the trial started.

"I was jumping for joy to see those first rats walk again, thrilled when I saw the technology progress to the clinic, overjoyed to see FDA approve it," Keirstead said. "Now we are on the cusp of seeing this in humans, and I am dismayed and frustrated at how long it is taking because the need is so great."

Researchers Liu Liu and Zhang Jie contributed to this report.

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