Judge Leaves Stem Cell Ban in Place

Sept. 8, 2010— -- New federally funded research on human embryonic stem cells remains blocked after a federal judge left in place a temporary injunction he issued on Aug. 23. The ruling puts research projects from coast to coast in limbo.

In a three-page order issued Tuesday, Judge Royce C. Lamberth, chief U.S. District judge for the District of Columbia, rejected the Obama administration's Sept. 1 emergency request that he lift the order while the issue gets settled in court. The administration had warned that Lamberth's injunction could halt research projects and reverse advances in finding new treatments for many illnesses.

"Because federal funding of biomedical research is a major driver of progress in this country, the loss of this funding undeniably will slow progress," said Timothy Kamp, a University of Wisconsin researcher who has been focusing on embryonic stem cells in heart disease. "Patients suffering a broad spectrum of diseases from Parkinson's disease to forms of blindness, to spinal injury to diabetes will simply have to wait longer for potentially revolutionary new treatments fostered by human embryonic stem cell research."

Lamberth wrote that the administration was "incorrect about much of their 'parade of horribles' that will supposedly result" from his Aug. 23 ruling. Lifting it would "flout the will of Congress," as the Court understands what Congress has enacted in the Dickey-Wicker Amendment," a 1996 law prohibiting the use of taxpayer funds for research in which embryos are destroyed. Lamberth added that Congress "remains perfectly free to amend or revise the statute," but the Court isn't free to do so.

But researchers who depend upon federal grants expressed frustration at the latest development.

Eric Bouhassira, principal investigator of the National Institutes of Health-funded Center for Embryonic Stem Cell Research at Albert Einstein College of Medicine in New York, said Wednesday that Lamberth had issued "a very negative ruling" that will stop "exciting, important research projects, if it is not reversed rapidly." Bouihassira said two of his NIH grants were affected, and added: "I do not know what will happen to the projects yet."

Ruling Will Impact Stem Cell Research, Experts Warn

Bouhassira predicted that the ruling could have a long-term effect upon progress in curing diseases, noting that "it takes a lot of time to train students and post-docs and get projects going."

He said that even if funding were stopped "for a relatively short amount of time, the consequences will be considerable and very hard to reverse if post-docs, students and investigators have to start other projects or are dismissed because of lack of funds. " He also said that blocking human embryonic stem cell research was "likely to discourage young people to enter the field because they might justifiably become concerned that politicians and judges will continue to interfere with their studies in the future."

At the University of Wisconsin-Madison, which isolated the world's first human embryonic stem cells, "there are approximately 18 investigators directing federally funded grants that use human embryonic stem cells ... including myself," said Kamp, an associate professor of medicine and physiology. "All of these grants are in jeopardy over the coming year. In addition, grants in review have been put on hold. Researchers will look for alternative scientific approaches and sources of funding, but all of this will take precious time and effort."

Among those grants is one for using stem cells to treat retinal disorders and another for using them to investigate Down Syndrome, said UW-Madison spokeswoman Susan L. Smith.

Jonathan Moreno, a professor of medical ethics at the University of Pennsylvania, and an advisor to the Gates Foundation on embryonic stem cell regulation, has warned repeatedly that such limitations will send stem cell research overseas, especially to Asian countries that are happy to roll out the welcome mat to U.S. researchers whose work has been thwarted at home.

Kamp agreed that the ruling could leave U.S. researchers at a competitive disadvantage. "Human embryonic stem cells have stood the test of time and are the current gold standard for human master stem cells. Losing the ability to compare other stem cells to this gold standard puts federally funded investigators at a scientific disadvantage," Kamp said. "Overall, U.S. researchers will be at a competitive disadvantage compared to others in many parts of the world."

Injunction Halts Stem Cells Research, For Now

In March 2009, President Obama honored a campaign promise by revoking limitations on the use of human embryonic stem cells imposed by his predecessor, which only allowed experiments involving embryonic stem cells lines approved by President George W. Bush. In July of last year, the NIH followed up, saying researchers could use embryos created for reproductive purposes that were no longer needed.

Lamberth's Aug. 23 injunction was part of a case brought by some Christian organizations and two researchers, James L. Sherley of the Boston Biomedical Research Institute in Watertown, Mass., and Theresa Deisher of AVM Biotechnology in Seattle, who last Friday said they planned to file on Sept. 10 a motion for a judge's summary judgement, which they hoped would bring a quick decision and keep the case from going to trial.