$1 Million Evaluation of Stem Cell Agency Comes Up Next Week

Directors of the California stem cell agency appear ready to commission a $1 million “gold standard” study of its operations with the hope that it will pave the way for voter approval of billions more for stem cell research, perhaps as early as November 2012.

The proposal is scheduled to be voted on at the CIRM board meeting next Wednesday and Thursday meeting at Stanford. However, few details of the latest version of the plan are currently available on the CIRM Web site.

Nonetheless, some information can be gleaned from the transcripts of the directors' Science Subcommittee meetings in May and July, when the proposed study was discussed.

Here is what we have been able to extract. The study would be performed by the prestigous Institute of Medicine(IOM). The cost would be in the $1 million range. CIRM Chairman Robert Klein is proposing that about half of the amount would come from private donors. In July, Klein referred to a 15-month timetable, which might be quite speedy for the Institute of Medicine, which moves slowly, according to the transcripts. If work begins in January, the study could be completed in time for the presidential election in the fall of 2012. Politically speaking, that is the likely to be the best time to seek approval of another multibillion dollar bond measure, given the larger voter turnout in presidential elections. Klein, however, did not mention a specific election timetable.

During the two subcommittee meetings, no CIRM director raised the possibility that the study would identify serious flaws in the agency's $3 billion operation. Klein predicted that the study “would be a solid milestone.”

Jeff Sheehy, chairman of the Science Subcommittee and a communications manager at UC San Francisco, said the IOM would provide a “gold standard objective evaluation.”

Sheehy continued,

“I certainly don't want to go off the board in two years without this report being finished. I don't think I could go to any member of the public, any editorial board, any member of the legislature, the governor, any elected official without some sort of external review of what's gone on with a billion dollars of the taxpayers money, especially in the middle of this horrible recession.”

Sheehy noted that the IOM is less than a household word. In May, he provided this description,

“The Institute of Medicine is an independent nonprofit organization that works outside government to provide unbiased and authoritative advice to decision makers and the public. established in 1870, theIOM is the health arm of the National Academy of Sciences, which was chartered under President Abraham Lincoln. The IOM asks and answers the nation's most pressing questions about health and healthcare. And the aim is to help those in government and the private sector make informed health decisions by providing evidence upon which they can rely.”

During the Science Subcommittee meetings, CIRM directors often referred to the IOM's vaunted independence, which they implicitly did not think would be affected by a $1 million contract. There also was no discussion of limitations that CIRM might impose on the scope of the study before signing a contract. In the case of a current $300,000 contract to assess the economic impact of the agency, CIRM specified that its economic consultants must “execute a vibrant and aggressive strategy” supporting CIRM, a requirement that fundamentally damages the credibility of whatever the their report says.

At subcommittee meeting in July, CIRM Director Philip Pizzo, dean of the Stanford School of Medicine and a member of the Institute of Medicine, said,

“Of any organization that I'm familiar with on a national level, there isn't any other that carries the weight of independence and critical review (of) the IOM and the National Academy of Sciences.”

Klein, who ran the 2004 Prop. 71 campaign that created the organization he now chairs, repeatedly framed the study in the context of a ballot campaign. He said he wanted it “finished in time that the public can analyze it before we go back and put forth the question about whether we're entitled to more bonds.”

Klein did not publicly identify potential donors to help pay for the study. A question could be raised about whether he or others intend to solicit funds from persons who have financial ties to enterprises that would stand to benefit from CIRM funding.

Directors acknowledged that the $1 million price tag appears steep. However, it is a tiny amount when compared to the $6 billion cost (including interest) of the stem cell research effort.

Klein's support for an IOM study seems to be in some contrast to his previous complaints about the amount of scrutiny (audits and otherwise) that CIRM has received from various sources. This spring, the agency also successfully stripped out of pending legislation a requirement that the state controller, who chairs a Prop. 71-created panel to oversee CIRM finances, commission an independent performance audit. Instead, the now CIRM-backed legislation (SB1064) places that audit squarely in the hands of the stem cell agency.

At the July meeting, Klein mentioned a proposal from the IOM. We have asked CIRM for a copy of that document.