WASHINGTON - The weakness of President Obama's March 2009 executive order expanding federal funding for human embryonic stem cell (hESC) research was evidenced Monday when a federal judge put the brakes on the policy, claiming it was illegal.
The court's ruling, said Geron Corp. CEO Thomas Okarma, whose company is the first approved in the U.S. to move forward with human testing of an hESC therapy, is the "clear impetus" for Congress to "finish what they started" and pass pending legislation to codify Obama's order.
In a surprise ruling late Monday, Judge Royce C. Lamberth, of the U.S. District Court for the District of Columbia, concluded that guidelines issued last year by the National Institutes of Health (NIH) are in violation of a 1996 provision, known as the Dickey-Wicker Amendment, which prohibits the use of federal funds for the creation of a human embryos for research purposes or research in which a human embryos are destroyed, discarded or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under applicable federal regulations. (See BioWorld Today, July 7, 2009, and Dec. 3, 2009.)
Had Congress intended to limit Dickey-Wicker to only discrete acts that result in the destruction of an embryo, like the derivation of hESCs, or to research on the embryo itself, lawmakers could have written the statute that way, but they didn't, the judge wrote in his ruling, stating that the court was "bound to apply the law as it is written."
If one step or piece of research of an hESC research project results in the destruction of an embryo, "the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment," the judge said.
Rep. Diana DeGette (D-Colo.), who has sponsored House legislation seeking to codify Obama's executive order - which revoked George W. Bush's Aug. 9, 2001, policy statement and his June 20, 2007, executive order formalizing that statement, which limited federal research funding to 21 existing hESC lines - said she "strongly" disagreed with Lamberth's ruling, arguing that "by definition, embryos and stem cells are two entirely different organisms." (See BioWorld Today, March 10, 2009, and March 11, 2009.)
DeGette accused the judge of "ignoring" the scientific facts.
Each day that waits for the judicial process to play out is "a day lost for patients and their families living with such diseases," said Jim Greenwood, CEO of the Biotechnology Industry Organization, who called the ruling a "dark cloud of uncertainty" for hESC research.
HESC research over the past decade has "consistently" demonstrated that it "holds great hope for the development of breakthrough treatments and cures for debilitating diseases, such as Alzheimer's, spinal cord injuries, diabetes and more," Greenwood said.
But David Prentice, a senior fellow for life sciences at the conservative Washington think tank Family Research Council, argued that the promise of hESC research has yet to be seen.
"This is all speculative with embryonic stem cells, whereas with adult stem cells, there are peer-reviewed published papers in terms of actual positive results for patients," said Prentice, a biochemist and cell biologist who provided advice and research background to the plaintiffs involved in Monday's ruling, known as Sherley v. Sebelius.
While "it's definitely not all cures at this point," Prentice told BioWorld Today, "patients have shown benefit, health improvement from the adult stem cell treatments, and that includes beyond the bone marrow and blood."
But Geron's Okarma disputed that claim, contending that the assertion that adult stem cells offer more promise than hECSs was "a fantasy."
Even induced pluripotent stem cells, "which we are interested in and are certainly hailed as an incredible scientific experiment, are nowhere nearly as useful as embryonic stem cells for cell therapy," Okarma said.
While Geron's research is unaffected by the ruling, its shares, nonetheless, took a 5.38 percent hit Tuesday, while shares of others in the stem cell therapy field also were bruised, including Aastrom Biosciences Inc., whose stock dropped 4.67 percent, and Cytori Therapeutics Inc., whose shares fell 6.1 percent.
But after falling earlier in the day, shares of Advanced Cell Technology Inc. gained 6.14 percent after the firm said its hESC lines produced using its single-blastomere "embryo-safe" technology, which the company insisted does not require the destruction of embryos, would not be affected by the ruling.
Those single-blastomere technology lines, however, have yet to be approved by the NIH for federal funding, ACT CEO William Caldwell acknowledged.
He noted that ACT's only approved line, MA135 hESC line, was caught in the injunction's snare.
What will be hardest hit by Monday's ruling, said Okarma, is academic research. "That kind of funding uncertainty is very difficult for an academic lab to endure," he lamented.
Indeed, NIH Director Francis Collins told reporters Tuesday that three categories of pending grants will be placed on hold, including 50 new grant applications currently in the queue for peer review. "We had to pull those out of the stack and not proceed with their review," he said.
In addition, about $20 million worth of proposals involving a dozen hESC research grants scheduled for a second-level review next month must now be set aside.
There also were 22 one-year hESC research grants totaling $54 million that were coming up for renewal next month that the court's decision stopped in their tracks, Collins said. "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," Collins said, adding that he was "stunned" by the court's injunction. "This goes beyond politics. It is about doing what we can to pursue the most effective way to overcome disease and improve human health."
Collins noted, however, that the NIH already has awarded $131 million worth of hESC research grants to about 200 grantees this year that the administration has determined are safe from the court's injunction. Nonetheless, he insisted that the decision has "poured sand" into one of the "most exciting" engines of discovery in the U.S.
Department of Justice spokeswoman Tracy Schmaler told BioWorld Today that Justice officials were reviewing the judge's ruling.
During Tuesday's daily White House media briefing, deputy press secretary Bill Burton said the administration was "exploring all possible avenues to make sure that we can continue to do this critical lifesaving research."
With federal funding currently in limbo, the California Institute for Regenerative Medicine noted that its $3 billion fund is not affected by the court's ruling and continues to be a "stable source of funding for those researchers who have committed their labs to pursuing new therapies based on work with human embryonic stem cells."
The court's ruling leaves CIRM's fund, established in 2004 under California's Prop 71 ballot measure, as the "most significant source" of dollars available for hESC research in the U.S., said the group's president, Alan Trounson, who called Lamberth's decision "a deplorable brake on all stem cell research."
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