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A day after a U.S. district judge halted federal funding of all research involving embryonic stem cells, the government froze about $70 million for projects that were either up for renewal or well along in the approval process, effectively shutting down one of President Barack Obama's top scientific priorities.
In Wisconsin, the temporary injunction triggered praise from opponents of the research and anxiety from scientists who have dozens of projects and millions in federal money at stake. The ruling put at risk hundreds of millions of dollars in royalties the Wisconsin Alumni Research Foundation could potentially reap from its three key embryonic stem cell patents. And in the space of 24 hours, the court action thrust the issue of embryonic stem cell research into an already heated campaign for governor.
The University of Wisconsin-Madison, known around the world as the place where James Thomson isolated and grew human embryonic stem cells for the first time, now has 21 projects and about $5 million a year in federal money that depend on the use of the controversial cells. At the Medical College of Wisconsin, embryonic stem cell research accounts for federal grants of $2 million to $3 million a year.
"There's huge uncertainty," said Stephen A. Duncan, director of the Medical College's Program in Regenerative Medicine and Stem Cell Biology. "I've got Ph.D. candidates who are working with embryonic stem cells who will have to stop working with them. Everything will die."
Duncan added that the loss of federal funding could also lead to the poaching of some of Wisconsin's leading researchers by states such as California that fund large stem cell programs independently.
At Wisconsin Right to Life, Legislative Director Susan Armacost celebrated Monday's decision by Judge Royce Lamberth of the District of Columbia: "We are very pleased that the court recognized that extracting embryos for research amounts to the destruction of human life . . . It really confirmed what we already knew - that the Obama policy was in violation of the Dickey-Wicker Amendment and the law."
The amendment, passed by Congress in 1995, banned federal funding of research that involves the destruction of human embryos. However, Thomson and other scientists used private funding to isolate embryonic stem cells, and former President George W. Bush allowed federal funding of research involving a limited number of embryonic stem cell lines. The Bush policy appeared to avoid a conflict with the congressional ban by not actually funding the destruction of embryos, just work that used the cells derived from them.
But Lamberth rejected this distinction, stating that because the cells for research can be obtained only by destroying embryos, all embryonic stem cell research "necessarily depends upon the destruction of a human embryo."
His ruling put the brakes on more than a year of work by the Obama administration and NIH aimed at lifting the Bush restrictions and expanding embryonic stem cell research. To do that, NIH essentially wrote new guidelines for research and even put the Bush lines through a fresh evaluation.
As of Tuesday, NIH had approved 75 lines of embryonic stem cells for use in federally funded research. Twenty-one cell lines were approved for funding under the Bush policy.
"This decision has poured sand into the engine of discovery," declared NIH Director Francis S. Collins in a telephone conference with reporters.
As a result of the temporary injunction, Collins said, $54 million in previously approved research had "stopped in its tracks." Those projects were all facing an annual funding review. Another $15 million to $20 million in research that had already passed the first peer review was also removed from consideration, as were 50 other grant applications awaiting review.
Although stem cell researchers have been developing techniques to reprogram adult cells back to the embryonic state as an alternative to embryonic stem cell research, recent studies have revealed problems. The reprogrammed cells appear to retain a memory of their previous role - as skin, for example - and differ in subtle ways from embryonic stem cells.
The Justice Department said Tuesday it expects to appeal Lamberth's ruling this week.
The lawsuit was initially thrown out because the federal district court decided the people who brought the lawsuit didn't have standing to sue. An appeals court returned it to the federal court.
"Now we're back, and boy we're back with a really surprising result," said Grady Frenchick, a Madison patent lawyer.
Wisconsin's influence
Because of Thomson's pioneering role with embryonic stem cells, companies aiming to commercialize products based on the cells must go through the Wisconsin Alumni Research Foundation, or WARF. Consultants have estimated WARF could bring in as much as $200 million in royalties from its three basic patents and others it has since filed.
About 39 companies, including Pfizer Inc. and other large pharmaceutical companies, and well over 100 researchers license the technology from WARF, said Carl Gulbrandsen, WARF's managing director.
WARF's WiCell Research Institute affiliate operates the Wisconsin International Stem Cell Bank, which distributes to scientists and companies around the world the five human embryonic stem cell lines developed at UW-Madison as well as other lines. The Wisconsin lines are the most widely used. Three of them account for 90% of the studies on the subject cited in scientific journals, Gulbrandsen said.
Menlo Park-based Geron Corp. got approval in late July from the U.S. Food and Drug Administration to hold the first-ever human clinical trial for a therapy based on them. Geron's proposed therapy would be used to treat certain spinal cord injuries.
Geron used a Wisconsin stem cell line to develop the therapy, Gulbrandsen said.
The injunction won't affect WiCell's customers outside the U.S., and it won't affect companies seeking to commercialize embryonic stem cell products if they're funding the work themselves, said Erik Forsberg, WiCell's executive director.
Playing politics
Candidates for governor seized on the ruling's implications for Wisconsin.
The state is a global leader in stem cell research, said Milwaukee Mayor Tom Barrett, a Democrat, pledging, if elected, "I will make sure scientists and researchers - not politicians - drive our research and technology agenda." Milwaukee County Executive Scott Walker, Barrett said, would snuff out such research "for purely ideological reasons."
Walker and Mark Neumann, the other Republican in the race, have both said previously they support research with adult stem cells, but not human embryonic stem cells.
"We can realize the potential of stem cell research without destroying human embryos or resorting to human cloning," said Jill Bader, Walker's campaign spokeswoman. "We can both protect the earliest stages of life and find cures."
At the Medical College, Duncan said it takes two to four months to take embryonic stem cells from the freezer and prepare them for research. Legal or political reversals can set work back months.
"I'm at the point where I'm ready to give up (embryonic stem cell) work to focus on (reprogrammed cells)," he said. "I've got a lab to run. I can't keep doing this stop-start, stop-start.
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