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California stem cell research continues to stumble

Genetic Crossroads
December 15th, 2005

The California stem cell research institute has again slighted the public interest. The institute's board has adopted policies that fail to ensure that all Californians will have access to any medical treatments arising out of research it may eventually fund. In addition, members of one of the institute's advisory committees are looking for legal loopholes that may allow them to bypass legislation meant to prevent a market in eggs for research--an effort that coincided with news about the scandal over eggs for research in South Korea.

Meanwhile, the institute's shortcomings are attracting national attention. A review of the institute's progress in the New York Times stated:

[T]here is a danger of a taxpayer revolt if promises made during the campaign in 2004 and in the immediate afterglow of the ballot victory are not upheld. Leaders of the initiative said then that they hoped to begin awarding the first research grants as early as last May. The project leaders are also backpedaling somewhat on projections made during the campaign that the state would reap sizable royalties from discoveries made with taxpayer money.

"They are engaged in expectation management, both financial and scientific," said Jesse Reynolds of the nonprofit Center for Genetics and Society, which supports stem cell research but has been a frequent critic of the California institute.

Paul Berg, a Nobel laureate who holds a substitute position on the institute's governing board, is quoted as saying, "I liken it to the Iraq thinking - we won the war and didn't know what to do afterward."

In the courts. The lawsuits challenging the constitutionality of Proposition 71, which created the program, are proceeding to the trial phase. The plaintiffs, consisting of small government and religious conservatives, had requested that the judge rule in their favor without even going to trial, via a "summary judgment." But she rejected this request. The discovery phase of the trial begins February 27. Although the CIRM claimed this as a big victory, both the request for summary judgment and its rejection are routine.

The funding situation. In the meantime, the CIRM cannot issue bonds to fund its work, and has made no announcement concerning the status of its "bridge financing" proposal. Without some sort of stopgap funding, the CIRM cannot issue grants, and in fact would be forced to close its doors in June.

Intellectual property, financial returns to the state, affordable pricing. The governing board of the CIRM adopted an interim intellectual property policy. The board reluctantly conceded that the CIRM is required by law to pursue some financial returns to the state. And the policy's provision for affordable pricing, and thus accessibility of any treatments developed with CIRM funding, is weak, vague, and unenforceable. It merely calls for grantee institutions to have a preference for licensing "to companies with plans for access to resultant therapies for underserved patient populations."

Protecting women who provide eggs for research. The CIRM's working group on research standards considered guidelines for obtaining human eggs. Despite headlines about egg collection scandals in South Korea, many committee members advocated for seizing on a potential loophole in Proposition 71, which prohibits paying women to provide eggs beyond direct expenses. These members assert that compensation for egg providers would be legal as long as the funds for these payments came from a source other than the CIRM. The draft research guidelines will be discussed further by the research standards working group at the end of January, and the board is scheduled to adopt them at their next meeting on February 10.

Also, the editorial board of the San Francisco Chronicle, which endorsed Proposition 71, says, "The debate since then has, in part, focused on how much the state could reasonably expect to earn in licensing fees and royalties and how much it will cost the state to issue the bonds -- issues the voters were led to believe were established by the initiative. Not so…. [Sen. Deborah Ortiz's] legislation will return this session for another attempt at becoming law. Such a message would be in keeping with the spirit -- indeed the promises -- of Prop. 71. Decisions regarding how this unique experiment in democracy is conducted will set precedent for what follows. It is far too important to leave to the scientists only."


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