A committee convened by the US Institute of Medicine (IOM) heard testimony on 10 April about shortcomings of the San Francisco-based California Institute for Regenerative Medicine (CIRM). And although members of the IOM committee asked probing questions about CIRM’s structure and performance, looming over the review is the reality that it’s difficult to make substantial revisions to some oft-criticized aspects of the agency, because the proposition that created CIRM makes it very difficult to change them.
That in itself is an important lesson, Stuart Drown of California’s Little Hoover Commission, a state oversight agency, told the IOM panel. “The most important takeaway is to really be careful what you lock yourself into in a proposition that carries the weight of constitutional law,” Drown said. He explained that in 2004, when voters approved the proposition that created CIRM, embryonic stem-cell research was under fire on the national stage, and that the proposition appeared to have been drafted to make the agency “bullet-proof” against detractors of stem-cell research.
Although it did achieve that goal, some provisions in the proposition have impeded the agency’s performance — for instance, by mandating the composition of the agency’s oversight board. The board is very large and vulnerable to charges of conflict of interest, because all of its members — from university officials to disease advocates — stand to benefit from the research that the agency is funding, the IOM panel heard.
The IOM was drafted by CIRM to complete a US$700,000-study of the agency’s “programs, operations, strategies, and performance”, and is expected to release its report this fall. The 10 April meeting in Irvine, California, differed markedly from the IOM committee’s first public meeting in San Francisco, California, at which CIRM board members, officials and grantees testified. The most recent meeting included testimony from companies, non-profit organizations and journalists who have been critical of CIRM.
At the meeting, biotechnology industry officials criticized CIRM’s lack of funding for industry, and consumer advocate John Simpson said in prepared testimony, “It is appropriate to consider seriously whether issuing all $3 billion in authorized bonds is the correct policy in light of the new environment and economic realities facing the state.” Marcy Darnovsky, executive director of the non-profit Center for Genetics and Society based in Berkeley, California, also prepared testimony saying that because it is so difficult for lawmakers to change CIRM’s structure, “there is still no meaningful oversight of CIRM by elected officials.”
Ken Taymor, a corporate-governance scholar at the School of Law at the University of California, Berkeley (UC Berkeley), said that the lack of transparency in the grant-reviewing process combined with the lack of independent board members prevents the board from rigorously reviewing grant awards: “Even to the extent that there is an opportunity for some real questioning that might occur about the validity of a grant or pursuing a certain program, that just isn’t done,” Taymor said. “There’s too much incentive to [say], ‘Well, I should support this so my disease or pet project will be supported,” he said.
And blogger and journalist David Jensen said that on a scale of 1 to 10, CIRM’s performance should be ranked a zero, because the agency has not lived up to the promises that led voters to support it.
“Voters were promised cures. Cures do not exist,” Jensen said.
Taymor, executive director of the UC Berkeley Center for Law, Business and Economy, said after the meeting that there are measures that the IOM could recommend that would not require legislative action — for instance, installing board members who have a broader range of expertise to fill the “patient-advocate” slots on the board. He also said that the IOM should make a statement about the difference in the way the agency was sold to the public and the realistic prospects for its success.
“IOM could and should speak loudly and forcefully that this was sold as Californians for cures, but don’t hold your breath,” he said.
In a blog post, Kevin McCormack, CIRM’s director of public communications and patient advocate outreach, wrote of the hearing, “[E]ven those who were most critical of CIRM admitted that things were clearly changing for the better, that over the past year the agency was working in a more open and transparent way and responding to some of the criticisms of its early years. We can all learn from our experience and do a better job as a result of them.”