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Stem Cell Funds Face Roadblock

Bill could Alter CIRM's Focus

With a $3 billion pot of stem cell research cash in the balance, California legislators want to shift money away from politically explosive human embryonic stem cells to emerging forms of stem cells.

The provision, an amendment from state Sen. George Runner that was tacked to an affordability and accessibility bill, essentially rewrites a section of the groundbreaking Proposition 71 and could open a new round of legal challenges to the state's stem cell agency, the San Francisco-based California Institute for Regenerative Medicine.

At the same time, it also could make it easier for researchers at Stanford University, the University of California, San Francisco, the J. David Gladstone Institutes and the Children's Hospital Oakland Research Institute to score money for their efforts to manipulate adult stem cells into embryonic-like stem cells or work with umbilical cord blood cells.

"We just want to make sure the best science is available," said Jana Saastad, a spokeswoman for Runner, a Republican from Antelope Valley who has been a steadfast opponent of embryonic stem cell research. "That's the people's will."

But CIRM and its supporters say Runner's amendment, which the full Assembly could take up before its Aug. 22 adjournment, sends an ill-conceived message about the future of embryonic stem cells as research and the agency itself start to generate results.

"We may be handing a political victory to people opposed to human embryonic stem cell research that hasn't been earned and that isn't supported by the science," said Jeff Sheehy, a patient advocate and member of CIRM's citizens oversight committee. "Symbolism matters."

Prop. 71, which voters approved by a nearly three-to-two margin in 2004, called on the state to sell $3 billion in bonds to fund stem cell research. That followed President Bush's August 2001 severe restrictions on federally funded embryonic stem cell studies because the process requires the destruction of human embryos.

In the meantime, Shinya Yamanaka, now a researcher at the Gladstone Institutes in San Francisco, and others have induced some adult stem cells to change into embryonic-like stem cells. That work has been hailed by embryonic stem cell opponents as a better way forward, as well as by those looking to sidestep the embryonic stem cell controversy.

Runner's amendment would allow CIRM's scientific and medical research funding working group -- which includes 15 scientists who review, score and rank grant and loan proposals -- to allow a simple majority vote to push forward non-embryonic stem cell research that already could receive federal funding.

The group currently requires a two-thirds majority to recommend such projects to CIRM's citizens oversight board.

"(The amendment) sends a false message to the rest of the world: 'See, even California doesn't put its faith in embryonic stem cell research,'" said Don Reed, a member of the Prop. 71 executive committee and co-chairman of the advocacy group Californians for Cures.

CIRM has approved funding of some adult and other non-embryonic stem cell projects, including more than $19 million for such proposals last month. Its emphasis, however, has clearly been on embryonic stem cells.

The agency, stalled for more than two years by legal challenges to Prop. 71, has approved $555 million in grants for research and facilities. Embryonic stem cell therapies may be five to 10 years off, with companies like Geron Corp. in Menlo Park moving forward with potential "cells in a bottle" therapies, said CIRM board member Sheehy, but research into manipulated adult cells is in its infancy and doesn't appear to offer broad therapies to diseases.

"The promise of (embryonic) research is so great that we shouldn't have to refight Prop. 71 all over again," Sheehy said.

Runner's amendment, however, could benefit the Gladstone Institutes and the Children's Hospital Oakland Research Institute. Gladstone last month received more than $3 million from CIRM for induced pluripotent stem cell work. Yet CHORI had a $4 million application to fund a therapy lab for children with sickle cell anemia and to isolate cord blood cells rejected late last year by the science working group.

Bert Lubin, president of CHORI, said CIRM funding should be broader, including adult stem cell research that could have an impact on minority health issues like sickle cell anemia. National Institutes of Health funding is limited, he said, plus CIRM's review process, especially in terms of conflicts of interest on the CIRM board, should be resolved.

"I trust the present CIRM administration and feel that they can do this without state/political interventions," Lubin said.

Runner amended Senate Bill 1565, which Santa Monica Democrat Sheila Kuehl cosponsored, to ensure affordable access for uninsured Californians to products and treatments that CIRM funds.

The bill also wants the bipartisan, independent state oversight agency, the Little Hoover Commission, to study perceived conflicts of interest within CIRM and suggest changes by mid-2009.

In short, Kuehl's bill takes CIRM policies regarding affordability and access and turns them into law, said John M. Simpson, stem cell project director with Consumer Watchdog, a taxpayer rights group based in Santa Monica.

"That's some sort of payback to the people who are paying for and funding this sort of stuff," Simpson said.

CIRM leaders say they have worked well with Kuehl to adjust the bill to allow flexibility for treatments that cost a lot to develop but may have a smaller patient population than diabetes and other more-common diseases.

But Runner's amendment is "the line in the sand," said Sue North, CIRM's director of government relations.

"The issue for us is, the voters believed they were giving priority to stem cell research not funded under federal policy," North said. "The Bush Administration is still the Bush Administration. The federal policy has not changed."