Embryonic stem cell research in limbo after surprise injunction

Researchers say a judge's ruling jeopardizes millions of dollars in ongoing work as the argument about the merits of such study is reopened in court.

By Doug Trapp — Posted Sept. 6, 2010

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A federal judge's decision to strictly enforce a federal ban on funding research that destroys human embryos has sent a wave of confusion and uncertainty through institutions that began or expanded embryonic stem cell research after an executive order by President Obama loosened restrictions in 2009.

Researchers say they are trying to understand what they are still allowed to do with existing and future National Institutes of Health funding, some of which is used to buy equipment and pay utility bills, among other costs.

"Do I have to turn off the lights and ... not use any of the equipment to do the experiments?" asked Timothy Kamp, MD, PhD, director of the University of Wisconsin Stem Cell and Regenerative Medicine Center in Madison.

An injunction issued Aug. 23 by Chief Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia prohibits the federal government from funding research in which a human embryo is "destroyed, discarded or knowingly subjected to risk of injury or death" at a level greater than allowed for unborn fetuses.

Lamberth's ruling is based on a strict interpretation of what's known as the Dickey-Wicker amendment, which has been added to Dept. of Health and Human Services budgets annually since 1996. That amendment bars HHS from using federal funds for the creation of human embryos for research purposes, or 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."

HHS filed an appeal of the injunction on Aug. 31.

The injunction forced the National Institutes of Health to freeze funding for about 50 embryonic stem cell research proposals up for initial funding or renewal in the next few months, said NIH Director Francis Collins, MD, PhD, during an Aug. 25 conference call with reporters. These include 22 proposals in line for a total of $54 million in funding by Sept. 30, Dr. Collins said.

Researchers who have received funding can continue their work. Nearly all NIH-funded researchers receive their funding annually.

The NIH funding freeze casts doubt on the ability of dozens of embryonic stem projects to continue, especially the projects eligible for funding in coming months. There probably aren't enough private dollars to cover the projects if the injunction stands, Dr. Collins said. "They are in great jeopardy," he said.

The injunction also stops federal funding of stem cell research allowed under an August 2001 executive order by President George W. Bush, Dr. Collins said.

Dr. Collins and other researchers said the injunction is a blow to the progress toward finding cures for Alzheimer's, Parkinson's, spinal cord injuries, diabetes and other diseases and conditions.

"This decision has the potential to do serious damage to one of the most promising areas of biomedical research -- and just at the time when we were really gaining momentum," Dr. Collins said.

Interpreting the law

The suit that led to the injunction was filed by two researchers who use nonembryonic stem cells: James L. Sherley, MD, PhD, senior scientist for the Boston Biomedical Research Institute; and Theresa Deisher, PhD, managing member and research and development director at AVM Bio-technology in Seattle. They argued that using federal dollars for embryonic stem cell studies has limited their chances for federal funding.

Additional plaintiffs include the Christian Medical & Dental Assns., an adoption agency and others.

A leader of one of the plaintiff organizations said every embryo is a life and should not be sacrificed for scientific research any more than a child should. "We have crossed a line that we need to step back from," said David Stevens, MD, CEO of the Christian doctors' group. "The bottom line is the law was very clear."

HHS had interpreted the Dickey-Wicker amendment for more than a decade as allowing research that does not directly result in the destruction of an embryo. But Lamberth said the law does not draw this distinction.

"If Congress intended to limit ... Dickey-Wicker to only those discrete acts that result in the destruction of an embryo, like the derivation of [embryonic stem cells], or to research on the embryo itself, Congress could have written the statute that way," Lamberth wrote.

Dr. Stevens said embryonic stem cell research should be abandoned not only on moral grounds but also because induced pluripotent stem cells have shown more promise for curing many diseases than have embryonic stem cells.

But Larry Goldstein, PhD, director of the University of California, San Diego stem cell program, said limiting the scope of stem cell research is not a good idea, because no one knows where it will lead.

"We have to do the work," he said. "There's no substitute for that."

Since Obama's executive order, NIH has funded research on stem cell lines derived from embryos that fertility clinic patients have intentionally donated for research purposes. The number of available stem cell lines has increased to about 75, or 55 more than were available under Bush's executive order.

Nationwide impact

The NIH froze funding for 10 grant requests -- each for $250,000 -- that had been submitted by staff at the University of California, Davis Institute for Regenerative Cures, one of the largest stem cell research programs in the U.S., said Jan Nolta, PhD, its director.

Nolta said the proposals in jeopardy include studying liver regeneration and attempting to better understand the nature of tumor cells. Researchers at the institute typically use embryonic stem cells, which naturally form all cell types, as a control group against cells that have been induced to form different types of embryonic-like cells, a state known as induced pluripotency.

Nolta said the injunction would be devastating for the United States if it continues. "Meanwhile, other countries continue to race ahead in this research, and we're getting left behind."

Even researchers in California would be left behind, Nolta said. California voters authorized $3 billion for stem cell investigations in 2004, but many UC Davis stem cell teams rely on a combination of state and federal funding, or join with others around the U.S. who rely on NIH money.

Many research projects continue for years and need sustained funding, Goldstein said. Otherwise, investments of time and money will be lost. "Interruptions like this in the middle of projects ... can be enormously disruptive." Genetic material can be stored for months or years, but staff need to be paid regularly or they will find other work.

Dr. Kamp, a cardiologist, is not sure if he can find private funding to replace the $250,000 grant renewal he expected from NIH. Even if he secures other funding, the time and effort he will spend seeking it will be at the expense of his research, which in part focuses on the electrical properties of heart cells.

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Case at a glance

Can the federal government fund scientific research that causes destruction of human embryos?

A federal court said no. The Dept. of Health and Human Services is appealing.

Impact: Researchers fear that their ongoing or new embryonic stem cell research will not proceed if the injunction stands. They also are confused about the boundaries for legally using NIH funding they received. Advocates of the ban say the injunction rightly limits scientists' ability to conduct research that necessitates the destruction of embryos.

Dr. James L. Sherley, et al. v. Kathleen Sebelius, U.S. District Court for the District of Columbia

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