California agency releases 10-year plan for spending $3B on embryonic stem cell research

The California Institute for Regenerative Medicine -- which is in charge of implementing the 10-year, $2.95 billion state human embryonic stem cell research program approved under Proposition 71 -- on Wednesday released a draft spending plan that "sets a strikingly modest tone" for outcomes of the research, the San Francisco Chronicle reports (Hall, San Francisco Chronicle, 10/5).

Under the plan, about $823 million would be spent on basic stem cell research; $899 million would be allocated for preclinical or applied research; $656 million would be spent on conducting clinical trials on potential treatments; and $273 million would be given to research institutions to construct laboratories in which none of the equipment was funded by NIH (Wade, New York Times, 10/5). Federal funding for embryonic stem cell research is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by President Bush on that date (Kaiser Daily Women's Health Policy Report, 9/7). CIRM's goal in the next 10 years is to obtain "proof of principle" through a midstage clinical trial that a stem cell therapy could restore functions lost by a particular disease (San Francisco Chronicle, 10/5). It also aims to initiate earlystage trials for two to four additional treatments through its research (New York Times, 10/5). "One of the points really is to try to educate people about what a long process it is to get any 'therapeutic' approved," CIRM President Zach Hall said, adding that although the agency plans to work with private businesses on research and funding for late-stage trials, it might take 15 years for a CIRM-funded treatment to be approved (Johnson, San Jose Mercury News, 10/4). The plan -- which was developed over the last 10 months by a select committee -- will be presented next week for approval to a meeting of the Independent Citizens Oversight Committee, CIRM's governing board. According to the San Diego Union-Tribune, the committee is expected to revise the plan and adopt it at its meeting in December (Somers, San Diego Union-Tribune, 10/4).

CIRM's Finances

According to the Times, the plan also is subject to "legal problems" that have held up CIRM funding (New York Times, 10/5). Two taxpayer groups and the California Family Bioethics Council in 2005 filed a lawsuit arguing that Proposition 71, which was approved in November 2004, violated the state constitution because it created a publicly funded agency that was not "under the exclusive management and control" of the state. California Superior Court Judge Bonnie Sabraw in April ruled that the plaintiffs failed to show the proposition is "clearly, positively and unmistakably unconstitutional," adding that CIRM and the ICOC are "operating in the same fashion as other state agencies." The plaintiffs then appealed the ruling, claiming that CIRM lacks adequate state supervision. California Gov. Arnold Schwarzenegger (R) in July wrote a letter to the state director of finance that authorized a loan of up to $150 million to CIRM. In addition, the CIRM Finance Committee in April authorized up to $200 million in loans through bond anticipation notes, which would not be paid back if the state were to lose the lawsuits (Kaiser Daily Women's Health Policy Report, 7/21).